RESPONSE TO COMMENTS DOCUMENT

STANDARDS APPLICABLE TO GENERATORS OF HAZARDOUS WASTE; SUBPART K –
STANDARDS APPLICABLE TO ACADEMIC LABORATORIES; PROPOSED RULE

PUBLISHED ON MAY 23, 2006

November 12, 2008

TABLE OF CONTENTS

  TOC \o "1-3" \h \z    HYPERLINK \l "_Toc214262106"  BACKGROUND AND
PURPOSE OF DOCUMENT	  PAGEREF _Toc214262106 \h  1  

  HYPERLINK \l "_Toc214262107"  Background	  PAGEREF _Toc214262107 \h  1
 

  HYPERLINK \l "_Toc214262108"  Purpose of Document	  PAGEREF
_Toc214262108 \h  1  

  HYPERLINK \l "_Toc214262109"  SUMMARY OF PUBLIC COMMENTS AND AGENCY
RESPONSE:S ON PROPOSED STANDARDS APPLICABLE TO ACADEMIC LABORATORIES	 
PAGEREF _Toc214262109 \h  3  

  HYPERLINK \l "_Toc214262110"  1.0	General	  PAGEREF _Toc214262110 \h 
3  

  HYPERLINK \l "_Toc214262111"  1.1	Overarching Support for Proposed
Rule	  PAGEREF _Toc214262111 \h  3  

  HYPERLINK \l "_Toc214262112"  1.2	Overarching Opposition to Proposed
Rule	  PAGEREF _Toc214262112 \h  3  

  HYPERLINK \l "_Toc214262113"  1.3	Performance-Based Versus
Prescriptive Requirements	  PAGEREF _Toc214262113 \h  5  

  HYPERLINK \l "_Toc214262114"  1.4	Other	  PAGEREF _Toc214262114 \h  7 


  HYPERLINK \l "_Toc214262115"  2.0 	Applicability of Subpart K	 
PAGEREF _Toc214262115 \h  8  

  HYPERLINK \l "_Toc214262116"  2.1	General	  PAGEREF _Toc214262116 \h 
8  

  HYPERLINK \l "_Toc214262117"  2.2	Laboratories in Teaching Hospitals	 
PAGEREF _Toc214262117 \h  10  

  HYPERLINK \l "_Toc214262118"  2.3	Laboratories in Non-profit Research
Institutes	  PAGEREF _Toc214262118 \h  12  

  HYPERLINK \l "_Toc214262119"  2.4	Conditionally Exempt Small Quantity
Generators	  PAGEREF _Toc214262119 \h  14  

  HYPERLINK \l "_Toc214262120"  2.5	Facilities with Laboratories not
Eligible to Participate in Subpart K	  PAGEREF _Toc214262120 \h  15  

  HYPERLINK \l "_Toc214262121"  2.5.1	Government Research Laboratories	 
PAGEREF _Toc214262121 \h  17  

  HYPERLINK \l "_Toc214262122"  2.5.2	Commercial R&D Laboratories and
Others	  PAGEREF _Toc214262122 \h  18  

  HYPERLINK \l "_Toc214262123"  2.6	Broadening Subpart K to
Non-Laboratory Facilities	  PAGEREF _Toc214262123 \h  19  

  HYPERLINK \l "_Toc214262124"  3.0	Definitions	  PAGEREF _Toc214262124
\h  20  

  HYPERLINK \l "_Toc214262125"  3.1	Definition of Central Accumulation
Area	  PAGEREF _Toc214262125 \h  20  

  HYPERLINK \l "_Toc214262126"  3.1	Definition of Central Accumulation
Area	  PAGEREF _Toc214262126 \h  20  

  HYPERLINK \l "_Toc214262127"  3.2	Definition of College or University	
 PAGEREF _Toc214262127 \h  21  

  HYPERLINK \l "_Toc214262128"  3.2.1	General Support	  PAGEREF
_Toc214262128 \h  21  

  HYPERLINK \l "_Toc214262129"  3.2.2	Concerns and Questions	  PAGEREF
_Toc214262129 \h  22  

  HYPERLINK \l "_Toc214262130"  3.3	Definition of Laboratory	  PAGEREF
_Toc214262130 \h  23  

  HYPERLINK \l "_Toc214262131"  3.3.1	General	  PAGEREF _Toc214262131 \h
 23  

  HYPERLINK \l "_Toc214262132"  3.3.2	Expanding the Definition of
Laboratory	  PAGEREF _Toc214262132 \h  28  

  HYPERLINK \l "_Toc214262133"  3.4	Definition of Laboratory Clean-out	 
PAGEREF _Toc214262133 \h  33  

  HYPERLINK \l "_Toc214262134"  3.5	Definition of Laboratory Worker	 
PAGEREF _Toc214262134 \h  36  

  HYPERLINK \l "_Toc214262135"  3.6	Definition of RCRA-Trained
Individual	  PAGEREF _Toc214262135 \h  39  

  HYPERLINK \l "_Toc214262136"  3.7	Definition of Reactive Acutely
Hazardous Unwanted Material	  PAGEREF _Toc214262136 \h  42  

  HYPERLINK \l "_Toc214262137"  3.8	Definition of Unwanted Material	 
PAGEREF _Toc214262137 \h  46  

  HYPERLINK \l "_Toc214262138"  4.0 	Notification	  PAGEREF
_Toc214262138 \h  49  

  HYPERLINK \l "_Toc214262139"  5.0 	Labeling Containers of Unwanted
Material	  PAGEREF _Toc214262139 \h  53  

  HYPERLINK \l "_Toc214262140"  5.1	General	  PAGEREF _Toc214262140 \h 
53  

  HYPERLINK \l "_Toc214262141"  5.2	The Term “Unwanted Material”	 
PAGEREF _Toc214262141 \h  57  

  HYPERLINK \l "_Toc214262142"  5.3	Emergency Response Information	 
PAGEREF _Toc214262142 \h  58  

  HYPERLINK \l "_Toc214262143"  5.4	Accumulation Start Date	  PAGEREF
_Toc214262143 \h  61  

  HYPERLINK \l "_Toc214262144"  5.5	Information for Hazardous Waste
Determination	  PAGEREF _Toc214262144 \h  64  

  HYPERLINK \l "_Toc214262145"  6.0 	Managing Containers of Unwanted
Material	  PAGEREF _Toc214262145 \h  65  

  HYPERLINK \l "_Toc214262146"  6.1	General	  PAGEREF _Toc214262146 \h 
65  

  HYPERLINK \l "_Toc214262147"  6.2	Working Containers	  PAGEREF
_Toc214262147 \h  68  

  HYPERLINK \l "_Toc214262148"  7.0 	Training	  PAGEREF _Toc214262148 \h
 75  

  HYPERLINK \l "_Toc214262149"  7.1	General	  PAGEREF _Toc214262149 \h 
75  

  HYPERLINK \l "_Toc214262150"  7.2	Commensurate with Duties	  PAGEREF
_Toc214262150 \h  80  

  HYPERLINK \l "_Toc214262151"  7.3	Training of Personnel Conducting
On-site Transfers	  PAGEREF _Toc214262151 \h  81  

  HYPERLINK \l "_Toc214262152"  7.4	Other Trainings Provided to
Laboratory Personnel	  PAGEREF _Toc214262152 \h  82  

  HYPERLINK \l "_Toc214262153"  8.0 	Removal Frequency for Unwanted
Materials	  PAGEREF _Toc214262153 \h  84  

  HYPERLINK \l "_Toc214262154"  8.1	General	  PAGEREF _Toc214262154 \h 
84  

  HYPERLINK \l "_Toc214262155"  8.2	Regularly Scheduled Removals of
Unwanted Material	  PAGEREF _Toc214262155 \h  86  

  HYPERLINK \l "_Toc214262156"  8.3	Removal of Unwanted Material when
Volumes are Exceeded	  PAGEREF _Toc214262156 \h  89  

  HYPERLINK \l "_Toc214262157"  9.0	On-site Transfers of Unwanted
Material Outside the Laboratory	  PAGEREF _Toc214262157 \h  94  

  HYPERLINK \l "_Toc214262158"  9.1	General	  PAGEREF _Toc214262158 \h 
94  

  HYPERLINK \l "_Toc214262159"  9.2	Comments on “Directly”	  PAGEREF
_Toc214262159 \h  94  

  HYPERLINK \l "_Toc214262160"  10. 0	On-site Consolidation Areas	 
PAGEREF _Toc214262160 \h  97  

  HYPERLINK \l "_Toc214262161"  11.0 	Hazardous Waste Determinations	 
PAGEREF _Toc214262161 \h  104  

  HYPERLINK \l "_Toc214262162"  11.1	General	  PAGEREF _Toc214262162 \h 
104  

  HYPERLINK \l "_Toc214262163"  11.2	Assignment of Hazardous Waste Codes
  PAGEREF _Toc214262163 \h  109  

  HYPERLINK \l "_Toc214262164"  11.3	Four-Day Limit for Hazardous Waste
Determination	  PAGEREF _Toc214262164 \h  112  

  HYPERLINK \l "_Toc214262165"  12.0 	Laboratory Clean-outs	  PAGEREF
_Toc214262165 \h  116  

  HYPERLINK \l "_Toc214262166"  12.1	General	  PAGEREF _Toc214262166 \h 
116  

  HYPERLINK \l "_Toc214262167"  12.2	Incentives to Conduct Clean-outs	 
PAGEREF _Toc214262167 \h  121  

  HYPERLINK \l "_Toc214262168"  12.2.1	 30-Day Limit for Laboratory
Clean-outs	  PAGEREF _Toc214262168 \h  123  

  HYPERLINK \l "_Toc214262169"  12.2.2	 Not Counting Hazardous Wastes
from Laboratory Clean-outs	  PAGEREF _Toc214262169 \h  125  

  HYPERLINK \l "_Toc214262170"  12.2.3	 Expanding Laboratory Clean-out
Incentives	  PAGEREF _Toc214262170 \h  130  

  HYPERLINK \l "_Toc214262171"  12.3	12-Month Interval Between
Laboratory Clean-outs	  PAGEREF _Toc214262171 \h  132  

  HYPERLINK \l "_Toc214262172"  12.4	Compulsory Laboratory Clean-outs	 
PAGEREF _Toc214262172 \h  134  

  HYPERLINK \l "_Toc214262173"  13.0	Laboratory Management Plan	 
PAGEREF _Toc214262173 \h  136  

  HYPERLINK \l "_Toc214262174"  13.1	General	  PAGEREF _Toc214262174 \h 
136  

  HYPERLINK \l "_Toc214262175"  13.2	Enforceability of LMP	  PAGEREF
_Toc214262175 \h  143  

  HYPERLINK \l "_Toc214262176"  13.3	Adding an Element to the LMP about
Procedures for Unknowns	  PAGEREF _Toc214262176 \h  145  

  HYPERLINK \l "_Toc214262177"  14.0	Recordkeeping Requirements	 
PAGEREF _Toc214262177 \h  147  

  HYPERLINK \l "_Toc214262178"  14.1	Retention of Label Information	 
PAGEREF _Toc214262178 \h  148  

  HYPERLINK \l "_Toc214262179"  14.2	Training Records	  PAGEREF
_Toc214262179 \h  148  

  HYPERLINK \l "_Toc214262180"  15.0	Enforcement and Compliance under
Proposed Rule	  PAGEREF _Toc214262180 \h  151  

  HYPERLINK \l "_Toc214262181"  16.0	Issues that are Outside the Purview
of this Rulemaking	  PAGEREF _Toc214262181 \h  153  

  HYPERLINK \l "_Toc214262182"  16.1	Treatment in Labs	  PAGEREF
_Toc214262182 \h  153  

  HYPERLINK \l "_Toc214262183"  16.2	One EPA ID Number per Campus	 
PAGEREF _Toc214262183 \h  155  

  HYPERLINK \l "_Toc214262184"  16.3	Eliminate Acutely Hazardous Waste	 
PAGEREF _Toc214262184 \h  155  

  HYPERLINK \l "_Toc214262185"  16.4	Other Issues that are Outside the
Purview of this Rulemaking	  PAGEREF _Toc214262185 \h  156  

  HYPERLINK \l "_Toc214262186"  17.0	Miscellaneous Comments	  PAGEREF
_Toc214262186 \h  159  

  HYPERLINK \l "_Toc214262187"  Appendix I: Organizations Commenting on
Proposed Rule	  PAGEREF _Toc214262187 \h  165  

  HYPERLINK \l "_Toc214262188"  Appendix II:  Organizations Whose
Comments Received Support from Other Organizations	  PAGEREF
_Toc214262188 \h  170  

 BACKGROUND AND PURPOSE OF DOCUMENT

Background

On May 23, 2006, the U.S. Environmental Protection Agency (EPA) proposed
alternative generator requirements applicable to college and university
laboratories as defined in the proposed rule (71 FR 29712).  The
proposed rule provided a flexible and protective set of regulations that
address the specific nature of hazardous waste generation and
accumulation in laboratories at colleges and universities.  The
flexibility in the proposed rule would allow colleges and universities
the discretion to determine the most appropriate and effective method f
compliance with the proposed requirements.  Additionally, the proposed
rule is optional and colleges and universities have the choice of
managing their hazardous wastes in accordance with the new alternative
regulations or remaining subject to the existing generator regulations.

	The comment period for the proposed rule was originally due to close on
August 21, 2006.  However, EPA received a request from the National
Association of College and University Business Officers (NACUBO), on
behalf of the American Council on Education (ACE), the Campus Safety
Health and Environmental Management Association (CSHEMA), and the Campus
Consortium for Environmental Excellence (C2E2) to extend the comment
period for 45 days.  On August 21, 2006, EPA extended the public comment
period by 30 days (see 71 FR 48500).  The comment period for the
proposed rule closed on September 20, 2006.

EPA received 111 sets of comments in response to the proposal.

Purpose of Document

This document presents a summary of the public comments received in
response to the proposed rule.  The public comments (e.g., suggestions,
concerns, questions) are summarized according to specific issues related
to the proposed rule and preamble.  

In each summary, we indicate the number of organizations whose comments
are reflected in it.  We also identify the organizations.  To do so, we
assigned each organization a unique commenter number.  We then prepared
the summaries and inserted commenter numbers into each summary to
identify the organizations whose comments are reflected in it.  Appendix
I of this document includes a table identifying each organization that
commented on the proposed rule and its commenter and document ID
numbers.  

In addition, a number of commenters expressed general support for the
comments submitted by another organization.  Appendix II identifies
these commenters and the organizations whose comments they
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The public can view the comment letters in their entirety at the EPA
Docket Center.  It is located at the EPA Headquarters West Building,
Room 3334, 1301 Constitution Avenue, NW, Washington D.C.  Comment
letters are also available electronically at the following website:
www.regulations.gov.  The docket identification number for the proposed
rule is EPA-HQ-RCRA-2003-0012.

SUMMARY OF PUBLIC COMMENTS AND AGENCY RESPONSES ON PROPOSED STANDARDS
APPLICABLE TO ACADEMIC LABORATORIES

1.0	General 

	1.1	Overarching Support for Proposed Rule 

Comment:  We heard from 90 commenters that indicated general support for
EPA’s efforts to modify the hazardous waste regulations for
laboratories (Commenter Nos. 2, 3, 4, 5, 7, 8, 9, 10, 11, 13, 14, 15,
16, 17, 18, 19, 20, 21, 22, 23, 25, 29, 30, 31, 32, 33, 34, 35, 36, 37,
39, 42, 44, 45, 46, 48, 49, 51, 52, 53, 54, 57, 59, 60, 61, 62, 64, 65,
67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 83, 84, 85,
86, 87, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 104,
106, 107, 108, 109, 110, 111, and 112).  Note that many of these
commenters expressed concerns about the rule and suggested further
modifications.  Please refer to other sections of this document for
these comments and the Agency’s responses.

Response:  EPA thanks the commenters for their support and took into
account their specific comments in finalizing Subpart K.

1.2	Overarching Opposition to Proposed Rule

Comment:  We heard from three commenters expressing concern about
extending regulatory relief to a specific segment of the regulated
community, as this could be problematic (e.g., it would place increased
demands on regulators in compliance/enforcement, and create a
“slippery slope” for other regulated entities seeking relief)
(Commenter Nos. 40, 41, 56).  And, we heard from one commenter stating
that it views the proposed rule as generally unnecessary (Commenter No.
58).  The commenter views the addition of regulations specifically for
college or university labs as unsupported by the rationale provided in
the proposed rule.  The commenter disagrees with the Agency’s
arguments that colleges and universities face unique and overly
challenging compliance problems under RCRA.  

Response:  EPA disagrees with the commenters’ assessment of Subpart K.
 We have a long history of working with the academic sector.  This
rulemaking is a culmination of many years of investigation and
participation by EPA in efforts designed to better understand the
challenges that the academic community faces when managing hazardous
wastes generated in laboratories under the hazardous waste regulations. 
As discussed at length in the preamble to the proposed rule (see 71 FR
29715), these efforts include two Reports to Congress; a project under
EPA’s eXcellence and Leadership program (Project XL) with three
colleges and universities in New England; a pilot project led by the
Howard Hughes Medical Institute (HHMI) to develop and implement a
performance-based approach to the management of laboratory waste at ten
colleges and universities; and a public meeting on June 18, 2003,
sponsored by EPA to discuss the management of hazardous waste in
research and/or academic laboratories. (See the announcement of the
public meeting at 68 FR 33121, June 3, 2003.  The comments submitted to
EPA in response to the public meeting are included in the docket for
today’s rulemaking.)  All of these efforts and comments from colleges
and universities and their trade associations on the proposed rule
confirm EPA’s conclusion that differences in hazardous waste
generation and management activities at laboratories at academic
institutions warrant this alternative set of requirements.

Comment:  We heard from one commenter that the proposed rule provides
remedies to specific problems encountered by college or university
laboratories, but it does not recognize the basic differences between
college or university laboratory operation and the paradigm that
underlies the current regulations (Commenter No. 43).  The commenter
stated that the proposed rule offers "work-a-rounds" for some selected
items but leaves a large number of unresolved issues.  The commenter
suggested that the proposed provisions could make an excellent outline
for a “best practices” document.  

Response:   EPA disagrees with the commenter.  Specifically in the
development of Subpart K, the Agency identified how the hazardous waste
generation and management practices at college and university
laboratories differ from both industrial production and industrial
laboratory operations in four meaningful ways.  These differences, which
were confirmed by many of the commenters, provide the rationale for
today’s final rule.  Further, throughout the years of working with
academic institutions, EPA has heard consistently that the greatest
challenge that academic institutions face in managing their laboratory
hazardous wastes under the existing generator regulations is making the
RCRA hazardous waste determination at the point of generation pursuant
to 40 CFR 262.11 (i.e., determining whether their solid waste is
hazardous waste and assigning the proper hazardous waste code(s) in the
laboratory at the time the hazardous waste is generated).  This is
largely because the individuals in the laboratory generating the
hazardous waste and other materials are students, who are often not
trained to make a hazardous waste determination.  We, therefore,
proposed and finalized removing the responsibility for the hazardous
waste determination from the students in the laboratory and place it in
the hands of trained environmental health and safety (EH&S)
professionals.  While this rulemaking could not address every issue the
academic sector has with the SAA regulations, due to our history of
working with the academic sector and taking their many comments on the
rule into account, we believe that the final rule creates a laboratory
hazardous waste management system that better fits the hazardous waste
generation pattern in academic laboratories.  

Comment:  We heard from two commenters stating that EPA consider
revising and clarifying the satellite accumulation provision for all
generators, instead of creating a unique rule for just university and
college laboratories (Commenter Nos. 56 and 88).  One of the commenters
stated that this suggestion would address the problems cited by EPA more
broadly, as it appears that the proposed rule is the result of
unsupported interpretations of the SAA provisions (Commenter No. 88). 

Response:  EPA intended to promulgate a rule to address specific
hazardous waste determination issues for laboratories at eligible
academic entities and in doing so, addressed various SAA issues related
to these types of laboratories.  It did not intend to promulgate a rule
on SAA issues in general and thus did not propose revising the SAA
regulations for all generators.  Thus, this comment is out of the scope
of this rulemaking.

Comment:  We heard from one commenter stating that, in the long run, it
is more advantageous to human health and safety and the environment to
leave academic laboratories subject to the present RCRA generator
requirements (Commenter No. 115).  The commenter does not agree that it
is onerous to educate students, researchers and others generating
hazardous waste in academic laboratories about proper hazardous waste
management.  

Response:  The Agency disagrees with the commenter.  EPA believes that
today's rule will lead to the safe management of unwanted materials and
greater environmental protection by requiring that RCRA hazardous waste
determinations be performed by trained personnel, rather than by
untrained students.  We also believe that today's final rule will
promote the protection of human health and the environment by ensuring
that all unwanted materials which may, in whole or in part, be RCRA
hazardous wastes, are safely managed while in the laboratory prior to
the time that the hazardous waste determination is made.  In addition,
EPA believes that the requirement to develop and implement an LMP will
improve the coordination and integration of hazardous waste management
procedures and enhance environmental awareness among researchers and
students at eligible academic entities, leading to a transfer of good
environmental management practices to the larger community.  

Comment:  Three commenters stated that it is advantageous to teach
students environmental protection and hazardous waste regulation before
they enter the workforce and that the proposed rule may not achieve this
effectively (Commenter Nos. 40, 41, 115).  One of the commenters stated
that many of the students and staff are likely to continue to work in
various laboratory settings throughout their careers and that exposing
them to the hazardous waste management standards will improve compliance
and provide greater protection of the public health and the environment
(Commenter 115).  

Response:  EPA agrees that it is important to teach students and staff
how to manage hazardous waste in the laboratory to the level needed to
perform their duties in the laboratory.  There are many students at a
college or university taking science classes who will not go on to work
in a laboratory in the future, however.  Thus, Subpart K requires that
eligible academic entities train their laboratory workers and students. 
And, the training must provide sufficient information so that laboratory
workers and students can understand and implement the requirements of
Subpart K, commensurate with their duties.

1.3	Performance-Based Versus Prescriptive Requirements

Comment: We heard from 28 commenters that Subpart K should be a
performance-based regulation (Commenter Nos. 7, 8, 10, 11, 14, 20, 25,
30, 53, 54, 60, 61, 62, 68, 75, 77, 80, 87, 89, 93, 95, 96, 97, 98, 99,
107, 108, 110).  These commenters stated that performance-based
regulations encourage colleges and universities to achieve better
performance because they allow for tailored approaches to specific needs
and encourage college or university participation under Subpart K.  

Response:  EPA thanks the commenters for their support.  We reiterate 
the statements we made in the preamble to the proposed rule that Subpart
K pairs a performance-based approach for management of unwanted
materials in the laboratory with a requirement for the eligible academic
entity to develop and implement an LMP.  We agree with the commenters
that a performance-based approach will allow eligible academic entities
greater flexibility by allowing them to tailor their laboratory waste
management program with respect to container labeling, container
management, and training, while ensuring better environmental results.  

Comment:  We heard from four commenters that the proposed
performance-based regulations would place an increased burden on states
in compliance monitoring and enforcement (Commenter Nos. 41, 56, 58,
66).  The commenters stated that the proposed rule would require
additional resources by state compliance and enforcement personnel to
review college or university-specific practices (e.g., because the rule
is not prescriptive and focuses on a subset of the regulatory
community).  One commenter expressed concern about the proposed rule’s
apparent lack of balance between flexibility for the regulated community
and practical ability of the regulatory agencies to ensure protection
for human health and the environment through inspections (Commenter No.
41).  The commenter stated that regulating agencies must simultaneously
determine whether the laboratory is maintaining compliance with its own
specified methods and whether those methods would even meet the
performance-based standards if fully complied with.  Another commenter
stated that flexible regulations are unenforceable in the “real
world,” and that the rule would place an “unfunded mandate” on
regulators who would need to review individual elements of a LMP
(Commenter No. 58).  One commenter expressed its strong preference for
straightforward, specific requirements and stated its belief that the
proposed regulation may not be protective of human health and the
environment (Commenter No. 66).

Response:  Subpart K is an optional rule meaning that states have the
option  to adopt the rule or not.  Like any new regulation, it takes
time for state inspectors to learn the new rules and provisions.  In the
Economic Analysis for the final Subpart K regulation, the main areas
analyzed for impacts on state governments are reviewing notifications,
inspector training, and increased duration of inspections.  The
commenters are correct in that it will take some extra time for
inspectors; however the aggregate costs of this burden assuming 100%
adoption is not considered an unfunded mandate under the Unfunded
Mandates Reform Act of 1995 because Subpart K does not contain a federal
mandate that would result in expenditures of $100 million or more for
State, local, and tribal governments, in the aggregate, or the private
sector in any one year.  Further, EPA believes that the flexibility in
Subpart K is balanced with the required planning document, the LMP, and
we anticipate that participation in Subpart K will increase compliance
and management of hazardous laboratory waste because of this balance. 
As we stated in the preamble of the proposed rule, we recognize that
performance-based standards inherently lack specificity.  However, this
is the reason we added a requirement to develop an LMP, a planning
component to ensure that an eligible academic entity thoroughly
considers its specific circumstances, and provides the detail needed to
ensure safe management of its unwanted materials.

Comment:  One commenter stated that EPA should make every effort to use
clear terminology in the preamble and regulatory text (Commenter No.
55).  The commenter stated that the wording "standard" or "standards'
should be avoided.  The commenter stated that the term can be
misinterpreted and encouraged EPA to use alternative words (e.g.,
“requirement”).

Response:  EPA believes that we used clear and concise terminology in
the preamble and regulatory text.  In fact, we did not use the word
standard or standards in the regulatory text of the final rule
addressing the commenters concern.  However in the preamble, there are
certain phrases used such as performance-based standard that continues
to the use the word standard.  We believe that this terminology in the
preamble is clearly a synonym for requirements or provisions and would
not likely be misinterpreted.  

1.4	Other

Comment:  We heard from eight commenters expressing concern about
EPA’s estimate that approximately nine percent of college or
university hazardous waste is from their laboratories (Commenter Nos. 7,
11, 25, 29, 76, 86, 91, 101).  These commenters stated that, in their
experience, laboratory waste represents significantly more of a college
or university’s total waste stream and provided estimates ranging from
60 percent to 95 percent.  

Response:  Based on these comments, the Agency sent follow-up letters to
several commenters requesting additional information in support of their
comments.  In response to our inquiries, many of the commenters supplied
detailed information about their hazardous waste generation and one
commenter provided a detailed analysis of our methodology for
determining the percentage of laboratory hazardous waste, including
specific suggestions on how to improve the methodology for the final
rule.  As a result of these comments, EPA has significantly revised the
methodology used in the proposal to determine the total quantity of
hazardous waste and laboratory hazardous waste.  Specifically, in the
proposal, we used key-word searches of the description field on Biennial
Report (BR) forms to identify laboratory hazardous waste as a percent of
the total hazardous waste generated.  Our revised methodology uses three
source codes from the BR to identify which hazardous wastes are from
laboratories:

G11 - Discarding off-specification or out-of-date chemicals or products
(unused chemicals or products – corresponds to P and U hazardous waste
codes);

G22 – Laboratory analytical wastes (used chemicals from laboratory
operations), and

G09 - Other production or service-related processes from which the waste
is a direct outflow or result.

Because hazardous waste from the source code G09 could also be generated
in non-laboratory operations, these wastes were only considered
laboratory wastes if the waste form codes indicated it was shipped in a
lab pack (i.e., waste form codes W001 or W004).  

Additional laboratory wastes were identified using key-word searches of
the description field.  This revised method resulted in a much higher
estimate for laboratory hazardous waste as a percent of total hazardous
waste at colleges and universities – 73% under the revised
methodology, compared to 9% under the original methodology used in the
proposed rule.  This revised methodology was used to calculate the
amount of laboratory hazardous waste generated as a percent of the total
hazardous waste generated for colleges and universities, as well as for
other types of facilities with laboratories that we considered including
in today’s final rule:  teaching hospitals, non-profit research
institutes, governmental research laboratories, and commercial R&D
laboratories.  For a full explanation of the methodology used to
determine the amounts of total hazardous waste and laboratory hazardous
waste generated at colleges and universities, teaching hospitals, and
non-profit research institutes, see the memo entitled, Lab Rule Data
Analyses, from ICF International to Patricia Mercer, May 1, 2008; and
for hazardous waste information for LQG government research laboratories
and LQG commercial R&D laboratories see the memo entitled, Final
Analyses of College and University Laboratory Hazardous Waste, from ICF
International to Patricia Mercer, August 17, 2007.  Copies of both memos
are in today’s docket.  Using the revised methodology, we now estimate
that for college and university LQGs, 73% of their total hazardous waste
is from laboratories.  The percent of hazardous waste coming from
laboratories at teaching hospitals and non-profit research institutes is
even higher – 81% and 92%, respectively.  Further, with all three
types of eligible academic entities, nearly all LQGs generate laboratory
hazardous waste.

Comment: We heard from eight commenters asking EPA to work with the
states to encourage them to adopt the final rule so that colleges and
universities can participate under the proposed provisions at the
earliest practicable time (Commenter Nos. 10, 23, 31, 62, 64, 78, 95,
112).  One commenter stated that EPA should allow individual states to
adopt the rule in a manner that is consistent across borders and is
consistent with EPA’s intent of the rule (Commenter No. 10).

Response:  EPA plans to work with the states to encourage them to adopt
the rule quickly.  We’re hoping to provide training sessions on the
final rule in the regions and will encourage states to attend.

2.0 	Applicability of Subpart K

2.1	General

Comment:  We heard from 26 commenters suggesting that the scope of the
rule be broadened to include laboratories in the non-academic sector
(Commenter Nos.  3, 4, 5, 7, 13, 14, 24, 33, 38, 39, 44, 47, 51, 57, 60,
62, 67, 82, 86, 87, 89, 94, 95, 99, 107, 112).  These commenters stated
that many non-academic laboratories are comparable to labs eligible for
the rule (e.g., in regard to waste generation, operations) and would
benefit from the rule’s performance-based approach.  Refer to the
comments below for additional information on their suggestions.  

Response:  EPA thanks the commenters for their suggestion of broadening
the scope of the rule.  Based on the comments above and below and
additional research by EPA regarding the presence of students in
laboratories at institutions other than colleges and universities, we
have expanded the scope of the final rule to include specific additional
entities that fit all aspects of the rationale for this rule such as a
hazardous waste generation pattern that is similar to that found at
college and university laboratories and a significant student
population.  EPA did not expand the scope of the final rule to include
certain entities because they did not fit all aspects of the rationale
for this rule such as government research laboratories and commercial
R&D laboratories (for more on these two types of facilities see below). 
Therefore, today’s final rule allows colleges and universities,
teaching hospitals that are owned by or have a formal written
affiliation agreement with a college or university, and non-profit
research institutes that are owned by or have a formal written
affiliation agreement with a college or university, to opt into Subpart
K.  This expansion includes laboratories at facilities that we and many
commenters believe are closely integrated with laboratories at colleges
and universities.  Collectively, we are calling the entities that are
eligible to opt into today’s final rule, “eligible academic
entities.”  

Comment:  We heard from twelve commenters to extend the rule to labs in
all sectors (Commenter Nos. 4, 7, 13, 24, 38, 39, 51, 67, 86, 89, 99,
107).  Five commenters indicated that any workplace (e.g., academic,
government, industry) potentially covered under the OSHA Lab Standard
should be covered under the rule (Commenter No. 4, 7, 39, 67, 86).   Two
commenters stated that the rule should be extended to all institutional
research organizations (Commenter Nos. 51, 99).

Response:  EPA thanks the commenters for their suggestion of broadening
the scope of the rule to labs in all sectors/workplace or to all
institutional research organizations.  Based on the comments above and
below and additional research by EPA regarding the presence of students
in laboratories at institutions other than colleges and universities, we
have expanded the scope of the final rule to include specific additional
entities that fit all aspects of the rationale for this rule such as a
hazardous waste generation pattern that is similar to that found at
college and university laboratories and a significant student
population.  EPA researched the sectors suggested above: academic,
government, and industry to determine if their research laboratories fit
the rationale of having a significant student presence.  Based on our
findings, EPA did not expand the scope of the final rule to include
government research laboratories (at this time) and commercial R&D
laboratories because they did not seem to have a significant student
presence (for more on these two types of facilities see below).  Through
our research, we concluded that laboratories at teaching hospitals that
are owned by or have a formal written affiliation agreement with a
college or university and non-profit research institutes that are owned
by or have a formal written affiliation agreement with a college or
university have a significant student presence and thus fit all aspects
of the rationale of Subpart K.  Therefore, today’s final rule allows
colleges and universities, teaching hospitals that are owned by or have
a formal written affiliation agreement with a college or university, and
non-profit research institutes that are owned by or have a formal
written affiliation agreement with a college or university, to opt into
Subpart K.  This expansion includes laboratories at facilities that we
and many commenters believe are closely integrated with laboratories at
colleges and universities.  Collectively, we are calling the entities
that are eligible to opt into today’s final rule, “eligible academic
entities.”  

Comment:  We heard from three commenters that stated that the proposed
rule should not be extended to non-college or university laboratories
(Commenter Nos. 74, 84, 102).  The commenters stated that college or
university labs face unique challenges (e.g., transient student
populations), which need to be addressed. 

Response:  EPA agrees that challenges with transient students in terms
of training them and having them make hazardous waste determinations are
unique to academic laboratories and this factor sets them apart from
industrial research laboratories.  However, based on the comments above
and below and additional research by EPA regarding the presence of
students in laboratories at institutions other than colleges and
universities, we have expanded the scope of the final rule to include
specific additional entities that fit all aspects of the rationale for
this rule, including having transient students.  EPA agrees that the
rule should not be extended to those types of facilities for which EPA
did not find a significant student presence in their laboratories. 
Therefore, Subpart K allows colleges and universities, teaching
hospitals that are owned by or have a formal written affiliation
agreement with a college or university, and non-profit research
institutes that are owned by or have a formal written affiliation
agreement with a college or university, to opt into Subpart K.

2.2	Laboratories in Teaching Hospitals

Comment:  We heard from 37 commenters stating that the definition of lab
should include laboratories in hospitals (e.g., clinical and/or research
labs) and related medical units (e.g., dental offices) that are
affiliated with colleges and universities or that the scope should be
expanded to include teaching hospitals, and affiliated hospitals
(Commenter Nos. 2, 3, 7, 8, 11, 13, 14, 22, 25, 28, 30, 32, 34, 38, 47,
54, 57, 60, 61, 62, 65, 68, 74, 76, 77, 78, 79, 81, 83, 86, 88, 90, 93,
100, 108, 110, 112).  The commenters stated these labs are comparable to
college or university laboratories eligible for the rule (e.g., they
have comparable waste generation patterns), and the labs share faculty
and equipment with eligible labs, creating a possibly difficult
compliance situation under dual regulation. The commenter stated that
there is not information about turnover rates of staff in research
enterprises at hospitals.  The commenter stated that EPA’s working
groups used to frame the discussion and proposed rule did not include
any experts from hospital research enterprises. One commenter stated
that teaching hospitals contain many laboratories that act as chemistry
laboratories and the amount of time a student spends at a teaching
hospital is comparable to that of a graduate student in another
laboratory discipline (Commenter No. 7).  Another commenter asked the
Agency to include laboratories at college and university affiliated
hospitals and other similar locations (i.e., dental colleges or clinics
and associated laboratories).  This commenter asserted that these
laboratories are used by a large number of students; they are used for
instructional and research purposes; while some processes are status and
predictable, others are not; large numbers of different waste streams
are produced, but in relatively small quantities (Commenter No. 8).  One
commenter states that personnel, including students, faculty, and
researchers routinely move between the teaching hospital and other
academic facilities in the course of their work, and the waste streams
are often quite diverse at teaching hospitals not unlike those from
other research endeavors (Commenter No. 30).  Two commenters suggested
that the rule be extended to affiliated hospitals (Commenter Nos. 3 and
57).

Response:  EPA agrees with the commenters based on our additional
research into the hazardous waste generation pattern and the presence of
students in teaching hospitals.  

Based on EPA’s observations, as well as comments that we have received
and given the nature of teaching and research, activities conducted at
teaching and research laboratories in colleges, universities, teaching
hospitals, and non-profit research institutes are comparable and
therefore share similar hazardous waste generation patterns.  Given that
these types of organizations with research and teaching laboratories
share similar hazardous waste generation patterns, we focused on the
extent to which these entities had a significant student presence, which
is a very important basis of today’s rule.  Because students are
inherently transient, and generally have less accountability than
professionals employed in laboratories, it is unlikely that they will
make a proper hazardous waste determination which requires detailed
knowledge of RCRA.

In terms of the transient students, EPA has learned from its research
that teaching hospitals instruct a variety of students -- interns,
residents, nursing students, laboratory technicians, and more, in the
hospital.  Instruction of these students includes work in the
laboratories to learn about the processes and tests conducted there,
introducing similar difficulties as those encountered at colleges and
universities in teaching and training transient students and making the
hazardous waste determination.  Also, medical research at a college and
university oftentimes is shared between the college and university
laboratories and teaching hospital laboratories.  

EPA recognizes that a teaching hospital that is owned by a college or
university will instruct students from its medical school.  However, due
to the complex healthcare system, many times medical students or
residents from a medical school will train in a teaching hospital that
is affiliated with a college or university, but not owned by the college
or university.  We do not want to preclude these teaching hospitals that
are training students and have a significant transient student
population from participating in Subpart K.  Therefore, EPA looked for a
way to define the concept of “affiliated teaching hospital.”  We
discovered that the Accreditation Council for Graduate Medical Education
(ACGME) defines two types of agreements between a medical school and a
teaching hospital:  a master affiliation agreement and a program letter
of agreement.  EPA has determined that the presence of these agreements
indicates that a teaching hospital is formally affiliated with a college
or university.

Based on the evidence provided by commenters and additional EPA
research, we have concluded that teaching hospitals owned by or formally
affiliated with a college or university fit within all aspects of the
rationale of today’s final rule:  many hazardous wastes that vary over
time are generated in small quantities at many points of generation, and
there is a significant and transient student population that is not
familiar with the RCRA hazardous waste requirements.  Therefore, EPA is
allowing teaching hospitals, as defined in this final rule that are
either owned by or have a formal written affiliation agreement with a
college or university, to opt into Subpart K for their laboratories

2.3	Laboratories in Non-profit Research Institutes

Comment:  We heard from 11 commenters to extend the rule to labs in the
non-profit sector (Commenter Nos. 4, 13, 57, 60, 62, 67, 81, 82, 94, 95,
112).  Two of the commenters stated that the rule should be extended to
non-production, non-diagnostic labs with similar waste generation
patterns at non-commercial, non-profit research organizations (Commenter
No. 62, 112).  One commenter stated that they collaborate with the local
university on projects and many of its investigators hold positions at
the university, and because of this collaborative relationship, their
hazardous waste practices are similar (Commenter No. 67).  One of the
commenters stated that it is not uncommon for individuals who are
faculty members at a college or university to be assigned space to
perform their research at an affiliated hospital or research foundation
(Commenter No. 57). One commenter stated that their university is
affiliated with laboratories which currently would not be covered under
the scope of the rule and that this would make it difficult to train
laboratory personnel and faculty in two different laboratory
requirements (Commenter No. 81).  The commenter stated that this would
affect situations involving a privately funded research laboratory on
the university’s property.

Response:  In response to these comments, EPA conducted additional
research and identified from the BR information housed in the RCRAInfo
database, nine non-profit research institutes that are LQGs (see Section
III.A.1 for information on their hazardous waste generation).  For all
nine LGG non-profit research institutes, we were able to obtain readily
available information on student populations and programs, as well as
substantial evidence that non-profit research institutes are similar to
colleges and universities in that they sometimes grant degrees of their
own, co-sponsor degrees with colleges and universities, teach classes,
and share faculty, funding sources, and laboratory space with colleges
and universities.  We determined that the information obtained is
generally representative of the universe of laboratories at non-profit
research institutes, because among the non-profits we researched, we
found that their hazardous waste generation patterns and student
programs were remarkably homogenous. We also determined that a research
laboratory at a non-profit research institute that is owned by or has a
formal written affiliation agreement with a college or university shares
the same hazardous waste generation pattern rationale identified in the
rule

As EPA conducted additional study into non-profit research institutes,
it was difficult for the Agency to draw a hard line between college and
universities and non-profit research institutes.  For example, Memorial
Sloan-Kettering Cancer Center (MSKCC) is a non-profit cancer research
institute, a teaching hospital, a graduate school in biomedical
sciences, and is in partnership with the Weill Cornell Graduate School
of Medical Sciences and Cornell University to train students in research
and patient care.  MSKCC also partners with New York-Presbyterian
Hospital, the Hospital for Special Surgery, and the Rockefeller
University.  Via these partnerships, the majority of the faculty of the
Weill Cornell Medical Graduate School of Medical Sciences has their
research laboratories and other facilities located within the Weill
Cornell Medical College-New York-Presbyterian Hospital Complex and the
MSKCC’s research laboratory buildings.  Another outgrowth of this
partnership is that MSKCC jointly administers a Ph.D. program with
Cornell and Weill Medical College in computational biology and medicine.
 Finally, besides its own graduate school of biomedical sciences, MSKCC
offers two certificate programs for students to learn cytotechnology and
radiation therapy.  

As shown in the example above, a non-profit research institute owned or
formally affiliated with a college or university may be so closely
associated with the college and university that excluding them will
prevent colleges and universities from establishing one laboratory waste
management system, introducing confusion among researchers working in
laboratories at both institutions.  In this situation, such non-profit
research institutes are virtually identical to a college and university
and their hazardous waste generation patterns and student presence fit
within the rationale of this rule.  This information made it clear to us
that non-profit research institutes often are “academic” and should
be eligible to opt into today’s final rule, when they are owned by or
formally affiliated with a college or university. 

One of the commenters above recommended that EPA expand the scope of the
rule to any institution that has a formal affiliation with a college or
university.  While the Agency does not believe it should expand the
scope of the rule to all institutions that have any kind of an
affiliation with a college or university, we do believe it is
appropriate to allow those non-profit research institutes that have a
formal written affiliation agreement with a college or university to opt
into Subpart K.  And, in order to ensure that the formal written
affiliation agreement between the two entities represents an affiliation
that is longstanding, we believe that the affiliation must be at the
institutional level, as opposed to an agreement between staff or
professors at the two eligible academic entities.  Of the nine
non-profit research institutes that are identified as LQGs in the BR, we
determined that eight had formal affiliations with colleges and
universities on an institutional level.  For example, the Burnham
Institute not only administers its own graduate program, it also has an
institutional affiliation with the University of California at San Diego
by participating in a joint graduate training program in molecular
pathology (where approximately 30 graduate students a year obtain their
primary scientific training at the Institute).  

The reason we are requiring a formal written affiliation agreement at
the institutional level is because having a formal affiliation at the
institutional level with a college or university seemed to increase the
likelihood that the non-profit research institutes would have students
in their laboratories.  And, the presence of a significant transient
student presence is an important part of the rationale for today’s
rule.  Typically, a formal affiliation at the institutional level allows
students at a college or university to conduct thesis research at the
non-profit research institute, use non-profit researchers as mentors,
and at times take some of their degree classes at the non-profit
research institute.  Further, requiring a formal written affiliation
agreement between the non-profit research institute and a college or
university will assist the implementing agency verify that an
affiliation at the institutional level exists.  Thus, for these reasons,
we decided to limit today’s rule to those non-profit research
institutes that have a formal written affiliation at the institutional
level with a college or university.

2.4	Conditionally Exempt Small Quantity Generators

Comment:  We heard from 27 commenters that conditionally exempt small
quantity generators (CESQGs) should be allowed to opt into the Subpart K
regulations (Commenter Nos. 7, 8, 10, 11, 25, 29, 30, 37, 49, 53, 54,
60, 61, 64, 65 71, 73, 74, 76, 81, 85, 89, 91, 96, 100, 101, 109).  The
commenters generally noted that many colleges and universities have
large quantity generator (LQG) and/or small quantity generator (SQG)
sites and that extending the rule to CESQGs will assist these colleges
and universities in managing all of their college or university lab
waste in a uniform manner.

Response:  In light of the comments received, EPA agrees that it makes
sense that at least some CESQGs would want to opt into Subpart K.  EPA
recognizes that laboratories at eligible academic entities that are
CESQGs share the same hazardous waste generation patterns as
laboratories at larger generators, except the eligible academic entities
that are CESQGs generate smaller quantities of hazardous waste. 
However, while laboratories at CESQGs fit within the rationale used to
define the scope of this rule, the proposal did not allow them to opt
in.  At the time of the proposal, we had thought CESQGs would not want
to opt into Subpart K since they currently are not subject to the
controls that apply to satellite accumulation areas (SAAs) and do not
have to comply with most of the other requirements that apply to LQGs
and SQGs.  In fact, many of the provisions in today’s final rule would
be more stringent than those to which they are currently subject under
§ 261.5.  However, as illustrated above, numerous commenters indicated
that we should provide CESQGs with the same opportunity as SQGs and LQGs
to assess which set of generator regulations is most appropriate for
their laboratories and that we should not prohibit them from opting into
Subpart K.  EPA also agrees with the commenters who noted that one
campus can potentially include many separate generator sites, some LQGs,
some SQGs, and some CESQGs.  And this issue is particularly pertinent
for urban college and university campuses that are divided by public
roads.  Thus, EPA is allowing eligible academic entities to opt into
Subpart K for their CESQG sites and is allowing stand-alone CESQGs to
opt into Subpart K, as well.  CESQG sites at an eligible academic entity
may include field laboratories and small laboratories separated from the
main campus by public roadways.  In addition, we expect that some
eligible academic entities that are themselves CESQGs (i.e., stand-alone
CESQGs), such as small non-profit research institutes, may choose to opt
into the rule to take advantage of the clean-out provisions.

Comment:  We heard from 24 commenters stating that the rule’s
clean-out incentives should be extended to CESQGs (Commenter Nos. 6, 7,
8, 10, 11, 25, 30, 37, 53, 54, 61, 64, 70, 73, 74, 76, 78, 81, 85, 97,
100, 101, 108, and 109).  These commenters generally stated that the
proposed incentives would relieve CESQGs from a change in generator
status due to a clean-out and encourage them to clean out their labs. 
Fifteen commenters stated that CESQGs should be allowed to adopt the
clean-out provisions without adopting the entire Subpart K regulation 
(Commenter Nos. 11, 25, 30, 54, 61, 64, 70, 73, 74, 76, 78, 85, 100,
108, and 109).  

Response:  EPA agrees that stand-alone CESQGs and CESQG sites that are
part of a larger eligible academic entity will benefit by removing
legacy chemicals from the laboratory by taking advantage of the
clean-out incentives of today’s rule.  However, EPA is not allowing a
stand-alone eligible academic entity or a CESQG site that is part of a
larger eligible academic entity to partake only in the laboratory
clean-out provisions and not the other Subpart K requirements because
this would prevent CESQGs from taking advantage of the two main benefits
of today’s final rule.  That is, if a CESQG site only participated in
the laboratory clean-out provisions, it would not be able to take
advantage of the flexibility in where and when to make the hazardous
waste determination.  Second, if a CESQG site that is part of a larger
eligible academic entity only participated in the laboratory clean-out
provisions, it would be unable to establish one hazardous waste
management system in all the laboratories at the eligible academic
entity.  The ability to establish a unified hazardous waste management
system for all laboratories is one of the priorities cited by academic
commenters.  Therefore, in order for a CESQG site at an eligible
academic entity or an eligible academic entity that is itself a CESQG,
to take part in the laboratory clean-out incentives, the eligible
academic entity must opt into Subpart K in its entirety and follow the
management standards for unwanted materials in the laboratories.  

2.5	Facilities with Laboratories not Eligible to Participate in Subpart
K

Comment:  We heard from two commenters stating that government and
private labs are often located and/or operated in conjunction with
college or university labs (Commenter Nos. 81, 83).  One commenter
stated that EPA should allow these labs to use Subpart K when working at
a college or university lab, to prevent dual regulation.  The other
commenter stated that these laboratories are essentially
indistinguishable from the University’s labs and the federal
researchers are courtesy, associate, or adjunct faculty of the
University.

Response:  While the instance where a government research laboratory or
a commercial private laboratory are located on a college or university
campus can create a complicated situation, EPA has never proposed basing
the applicability of  Subpart K on location.  Rather, the applicability
of Subpart K is based on how entities fit the rationale of the rule. EPA
has determined that, at this time, laboratories at government research
and commercial R&D facilities are not eligible to participate in Subpart
K.  Thus, regardless of where government research and commercial R&D
facilities are located, they are not eligible to participate in Subpart
K.   Finally, only eligible academic entities can participate under
Subpart K for the laboratories they own.  See below for more information
about government research and commercial R&D laboratories.

Comment:  Two commenters suggested that the Agency expand the scope to
institutions affiliated with colleges and universities (Commenter Nos.
60, 90).  One commenter recommended that EPA expand the scope of Subpart
K to include those institutions that have a formal affiliation with a
college or university but are not themselves a college or university
(Commenter No. 60).  The commenter also recommended that EPA establish a
mechanism whereby non-college or university institutions with no
affiliations with a college or university but with research laboratories
with characteristics and hazardous waste generation patterns similar to
a college or university, can petition to be regulated under Subpart K. 
Another commenter suggested that the definition of laboratory should
include other teaching and research “laboratories” affiliated with
the college or university (Commenter No. 90).

Response:  The Agency does not believe it should expand the scope of the
rule to all institutions that have any kind of an affiliation with a
college or university.  We did expand the scope of the rule to include
institutions that fully fit the rationale of the rule.  Therefore,
today’s final rule allows colleges and universities, teaching
hospitals that are owned by or have a formal written affiliation
agreement with a college or university, and non-profit research
institutes that are owned by or have a formal written affiliation
agreement with a college or university, to opt into Subpart K.  We do
believe it is appropriate to allow those non-profit research institutes
that have a formal written affiliation agreement with a college or
university and those teaching hospitals that have a formal written
affiliation agreement with a college or university to opt into Subpart
K.

Comment:  We heard from three commenters that stated that the definition
should be broadened to include academic laboratories at secondary
educational institutions (Commenter Nos. 40, 41, 45).  The commenters
stated that one of the primary purposes of the rule is to address the
difficulty of colleges and universities in training its students on RCRA
compliance.  These commenters stated that this same concern is present
at secondary institutions.  Two of the commenters stated that the rule
should not be expanded to include other types of organizations than
secondary and post-secondary institutions (Commenter Nos. 40, 41).  The
commenters do not believe that other organizations face the same level
of difficulties in regard to training of students.

Response:  While these commenters are asking for secondary educational
institutions to be included, none of the commenters are secondary
educational institutions nor do they represent secondary educational
institutions.  EPA believes that is may be inappropriate to allow
secondary educational institutions to opt into Subpart K because they do
not operate with a centralized Environmental Health and Safety
department similar to eligible academic entities.  Subpart K is designed
so that trained professions, aka EH&S staff, make the hazardous waste
determination or transport laboratory hazardous waste to central
accumulation areas.  This type of management scheme does not exist at
secondary educational institutions rendering Subpart K inappropriate for
these types of facilities.   Further, EPA already has a program called
the Schools Chemical Clean-out Campaign (SC3) whose mission “aims to
ensure that all schools are free from hazards associated with mismanaged
chemicals. SC3 gives K-12 schools information and tools to responsibly
manage chemicals.”  

2.5.1	Government Research Laboratories

Comment:  We heard from 12 commenters to extend the rule to labs in the
public sector (Commenter No. 4, 5, 13, 14, 33, 44, 62, 67, 82, 107, 112,
116).  One commenter stated that its government research laboratories
meet the essential criteria for eligibility under the rule, such as
similar waste accumulation practices, multiple points of waste
generation, student populations, and highly variable waste streams
(Commenter No. 33).  The commenter pointed out areas of the proposed
regulatory text that could be modified to accommodate this suggestion. 
One commenter stated that Federal government biomedical research
laboratories meet all aspects of the proposed definition of lab, except
for accreditation (Commenter No. 14).  Another commenter stated that
government labs could benefit particularly from the clean-out provisions
(Commenter No. 44). Finally one commenter asked EPA to include
flexibility in the hazardous waste management at government research
facilities (Commenter No. 116).

Response:  In addition to the public comments above, EPA collected
readily available information on hazardous waste generation patterns and
student presence in government research laboratories.  From EPA’s BR
on hazardous waste generated by LQGs, we identified 39 LQG government
research laboratories.  Overall, from the information available at this
time, it appears that laboratories at government research laboratories
have hazardous waste generation patterns similar to laboratories at
colleges and universities—i.e., generating small quantities of many
types of waste that vary over time at many points of generation—since
they are research laboratories. In addition, one commenter above, a
Federal agency, provided student numbers for ten of its laboratories,
three of which we have identified as LQGs.  We also acquired aggregated
student numbers or estimates for three other Federal agencies.  We were
unable to obtain student population data at laboratories at the
remaining government research laboratories, including State and Local
governmental laboratories.  Based on this lack of available information
about the other key aspect of the rationale for today’s rule, that is,
significant student presence, EPA has decided to defer our decision on
government research laboratories.  Therefore, government research
laboratories are not included in this final rulemaking.  Rather, in
2009, EPA expects to prepare a Federal Register Notice soliciting
additional information about government research laboratories,
particularly the presence of students at such research laboratories in
order to make a more informed decision regarding whether or not to allow
them to opt into Subpart K in the future.

2.5.2	Commercial R&D Laboratories and Others

Comment:  We heard from 13 commenters to extend the rule to commercial
or for-profit laboratories (Commenter Nos. 4, 13, 33, 38, 39, 47, 51,
62, 67, 82, 87, 99, 111).  One commenter expressed support for
sector-based strategies and urged EPA to expand the rule to research and
development laboratories in the specialty batch chemical manufacturing
sector (Commenter No. 87).  One commenter stated that the problems
confronted by academic laboratories as cited in the rule are symptomatic
of most if not all laboratories, including low-level production
laboratories such as a clinical laboratory or an environmental chemistry
laboratory (Commenter No. 38).  The commenter goes on to say that
non-academic laboratories should be covered under Subpart K because they
are indistinguishable from research labs at academic institutions, not
withstanding the student factor.  Another commenter stated that the
definition of laboratory should be changed to include research
laboratories in the private sector that engage in essentially the same
type of work; i.e., use of relatively small quantities of a wide variety
of materials for research purposes (not production or pilot scale)
(Commenter No. 47).  

Response:  Based on these comments and responses to follow-up letters to
commercial research and development laboratories (copies of which are in
today’s docket), it appears that there is a similar hazardous waste
generation pattern (i.e., small amounts of many different types of waste
generated at multiple points of generation) as at laboratories at
colleges and universities.  However, there is little evidence of student
presence in these laboratories as indicated in the comments above and in
follow-up responses from commenters and EPA’s own research.  Without
the presence of students, commercial R&D laboratories do not have the
same challenges in making hazardous waste determinations for their
laboratory hazardous wastes and in training their laboratory personnel. 
Having similar hazardous waste generation patterns is only one element
in determining which entities should be eligible to opt into Subpart K. 
EPA believes that having a significant student presence in the
laboratories (which increases the difficulty in training and in making
hazardous waste determinations) is extremely important.  Therefore,
without meeting the rationale that a significant number of students must
be present, EPA has decided not to allow commercial R&D laboratories to
opt into Subpart K.

Comment:  One commenter recommended that the Agency extend portions of
the rule to commercial industrial labs (Commenter No. 84). The commenter
stated that commercial and industrial labs have personnel to make the
RCRA characterization whereas colleges and universities do not. 
However, the commenter recommended that the performance standards of the
working container, Laboratory Management Plan, clean-out proposals add
to environmental protection if applied to commercial and industrial
laboratories.

Response:  EPA did not take comment on whether to apply only certain
provisions of Subpart K to the commercial research and development
laboratories.  Therefore the commenter’s request is out the scope of
this rulemaking.

2.6	Broadening Subpart K to Non-Laboratory Facilities

Comment:  We heard from 13 commenters stating that the definition of lab
should include machine shops, maintenance shops, motor vehicle stations,
and/or fabrication units, mechanic units (Commenter Nos. 10, 11, 13, 25,
29, 31, 37, 54, 70, 79, 80, 91, 104). We also heard from 18 commenters
that expressed concern about dual regulation at colleges and
universities as a result of Subpart K, i.e., for college or university
lab unwanted material and all other RCRA hazardous waste at the college
or university campus and indicated that EPA should extend Subpart K to
the entire campus (Commenter Nos. 13, 19, 29, 31, 43, 48, 54, 70, 76,
77, 81, 83, 90, 91, 92, 104, 107, 108).  These commenters stated that a
dual system is burdensome and inefficient, would create compliance
problems, and would discourage participation under Subpart K

Response:  While the Agency understands the concerns raised by the
commenters, we also believe that the Subpart K requirements were
developed to address specific concerns raised by the academic community
as they related to hazardous wastes generated in their
laboratories—that is, the situations and challenges that exist in
teaching and research laboratories are unique (e.g., having to identify
which of the potentially hundreds of different wastestreams meet the
definition of hazardous waste).  The academic community has not raised
such concerns about the hazardous wastes generated outside of the
laboratories.  For this reason, we believe it is inappropriate to expand
the scope of the rule beyond laboratories at eligible academic entities.

Comment:  We heard from one commenter stating that, if EPA does not
broaden Subpart K to the entire college or university campus, it should
allow colleges and universities to select specific labs on a campus to
participate in Subpart K (i.e., labs large enough to benefit from the
rule) while the others do not (Commenter No. 48).

Response:  EPA understands the commenter’s suggestion but disagrees
with the concept and did not change Subpart K to allow this practice. 
Under Subpart K, all laboratories owned by the eligible academic entity
within one EPA Identification Number must comply with the same set of
regulations.  In other words, the alternative approach can not be
applied to only one or a few laboratories within that EPA Identification
Number, but rather must apply to all laboratories or no laboratories. 
The reason for this is that EPA believes it would be difficult for an
eligible academic entity to keep track of which set of generator
regulations apply to which laboratory or group of laboratories. 
Moreover, it would be extremely difficult, if not impossible, for the
States or Regions to keep track of the applicable set of regulations if,
within a single EPA Identification Number, different laboratories were
choosing to be regulated under different requirements.  No mechanism
currently exists at EPA or the States to track such distinctions.

Comment:  We heard from one commenter that stated that EPA should not
expand Subpart K to non-labs at colleges and universities (Commenter No.
74).  The commenter supports EPA's efforts in providing specialized
regulations to laboratories based upon the unique challenges involved. 
The commenter noted that colleges and universities have the option of
remaining under existing RCRA regulations if Subpart K is not desired.

Response:  EPA thanks the commenter for its support and we maintain that
Subpart K only applies to laboratories that fit the definition of
laboratory at eligible academic entities.  

3.0	Definitions

	3.1	Definition of Central Accumulation Area

Comment:  We heard from one commenter that suggested that the definition
of “Central Accumulation Area” should not require compliance with
section 262.211 for “unwanted material” for which a hazardous waste
determination has not been made and which may not even be a solid waste
(Commenter No. 79).  This commenter stated that the provision requires
personnel to unnecessarily add additional labeling to and manage
materials that may not be waste.

Response:  We disagree with the commenter.  The rule provides
flexibility with regard to where and when the hazardous waste
determination is made for unwanted materials generated in the laboratory
– in the laboratory, before the unwanted materials are removed from
the laboratory; or within four days of arriving at an on-site central
accumulation area or on-site treatment, storage or disposal facility. 
Section 262.211 contains the requirements for making the hazardous waste
determination in an on-site central accumulation area.  If the eligible
academic entity chooses to make the hazardous waste determination in its
on-site central accumulation area, then it will be subjecting those
unwanted materials to regulation under § 262.211, even though some of
those unwanted materials may turn out not to be solid or hazardous
waste.  The extra labeling would be limited to dating the container upon
arrival.  The date on the container is for  calculating whether the
hazardous waste determination is made within four calendar days and for
calculating the maximum accumulation time (i.e., 90, 180 or 270 days). 
If, when the hazardous determination is made, it turns out that an
unwanted material is not a solid waste, then it is not subject to Part
262 Subpart K, or to the RCRA hazardous waste regulations.  If it turns
out to be a solid waste, but not a hazardous waste, then it is not
subject to Part 262 Subpart K, but must be managed in compliance with
any other applicable regulations and/or conditions.

Comment:  We heard from one commenter asking that college and university
central accumulation areas be exempt from the special requirements for
ignitable or reactive waste at 40 CFR 264.176 (Commenter No. 81).  The
commenter stated that college and university waste streams are typically
small in quantity and the total volumes of flammable and reactive
chemical wastes present in its central accumulation areas present a
lower risk than volumes of like hazardous wastes produced in industry
and production facilities.  The commenter stated that, if proper
pollution prevention and preparedness measures are established to
minimize releases to the environment, the 50-foot property line safe
distance requirements for flammable and reactive wastes can be overly
restrictive.

Response:  Under existing generator regulations small quantity
generators that store containers of hazardous waste in what is commonly
referred to as a <180-day area in compliance with 262.34(d) are not
subject to 40 CFR 265.176 (see 40 CFR 262.34(d)(2)).  However, large
quantity generators that store containers of hazardous waste in what is
commonly referred to as a <90-day area in compliance with 262.34(a) are
subject to 40 CFR 265.176 for the storage of ignitable or reactive
hazardous wastes.  When codifying the term “central accumulation
area,” the Agency did not propose to change the regulations for the
management of hazardous waste at such areas.  The intent was merely to
develop a term to refer easily to these types of areas collectively.

3.2	Definition of College or University

3.2.1	General Support

Comment:  We heard from ten commenters expressing general support for
EPA’s definition of “College/University” (Commenter Nos. 7, 8, 11,
30, 47, 59, 66, 74, 90, and 98).  Two of the commenters stated that
broadening the definition to include institutions that offer
certificates but not degrees probably would not have an appreciable
impact because such institutions do not typically engage in research or
have a significant number of teaching laboratories (Commenter Nos. 11
and 30).

Response:  We agree with the commenter.  Broadening the definition of
college or university to include institutions that offer certificates is
not necessary.  These institutions are unlikely to engage in research of
have a significant number of teaching laboratories, and therefore have
no need to be eligible to opt into today’s rule. 

Comment:  We heard from one commenter expressing support for the
rule’s definition, except that it does not support the exception of
the limiting language of “accredited by an accrediting agency listed
annually by the U.S. Department of Education (Commenter No. 8).

Response:  We disagree with the commenter.  The Agency is requiring that
a college or university must be accredited in order to provide some
assurance that an institution of higher education that is opting into
Subpart K is a legitimate college or university, as determined by a
recognized organization.

Comment:  We heard from five commenters expressing general support to
limit the definition to accredited colleges and universities (Commenter
Nos. 11, 25, 30, 59, 74).  Four of these commenters expressed their
belief that accreditation is a sound quality control measure (Commenter
Nos. 11, 25, 30, 59).  One of the commenters recommended that criteria
for the definition include either accreditation by one of the eight U.S.
regional higher education accrediting organizations, or listing in the
Carnegie Foundation for the Advancement of Teaching higher education
database (Commenter No. 25).  The commenter stated that inclusion in the
Carnegie Foundation database as an alternative to accreditation assures
inclusion of institutions such as some faith-based institutions (e.g.,
Bob Jones University) that decline accreditation on principle. 

Response:   The Agency proposed to limit Subpart K to those colleges and
universities that are accredited by an accrediting agency listed
annually by the U.S. Department of Education.  The Agency has decided
against changing the definition of college or university to include
colleges and universities accredited by other accrediting agencies.  The
U.S. Department of Education must publish its list of accrediting
agencies annually in the Federal Register.  This process provides an
opportunity for regular revisions and public input, while ensuring
accountability for the list of accrediting agencies.

	3.2.2	Concerns and Questions

Comment:  We heard from one commenter that stated its belief that EPA
should reconsider the college or university definition because it may be
too broad (Commenter No. 25).  The commenter stated that the proposed
rule’s definition would result in approximately 6,900 institutions
being eligible for Subpart K.  This would include some institutions that
should be excluded from Subpart K participation (e.g., institutions that
do not, as a minimum, grant degrees at the Associate level).

Response:  The Agency disagrees with the commenter.  We proposed that a
college or university must be a private or public, post-secondary
academic institution that grants degrees.  The final rule retains the
requirement that a college or university must grant degrees to be
eligible to opt into Subpart K.  Therefore, we estimate that the number
of colleges and universities that generate laboratory hazardous waste
that would be eligible to opt into Subpart K would be 1,256.

Comment:  We heard from one commenter asking for clarification of the
college or university definition (Commenter No. 20).  The commenter
stated that its college or university has several outreach programs that
are associated with two-year technical schools; in some cases, these
institutions grant certificates of completion, rather than degrees. The
commenter believes it would be appropriate for these institutions’
unwanted materials to be included in the rule.

Response:  The Agency has retained the requirement for a college or
university to grant degrees in order to be eligible to opt into Subpart
K.  Although it is difficult to obtain hazardous waste data that
distinguish between institutions of higher education based on whether
the institution grants degrees or certificates, the Agency has assumed,
and commenters have confirmed that institutions that grant certificates
are unlikely to generate much laboratory hazardous waste and therefore,
it is not necessary to revise the definition of college or university to
include them.

Comment:  We heard from one commenter asking EPA to broaden the
definition of college or university to include more post-secondary
educational institutions (Commenter No. 83).  The commenter is
particularly interested in extending the rule to facilities that may not
be associated with a post-secondary institution, such as art studios. In
addition, the commenter believes additional outreach to art studios that
may be SQGs is needed because they may not be aware of the applicable
requirements.

Response:  As we discussed in the preamble to the proposed rule, art
studios are considered laboratories (we have included this concept in
the definition of laboratory in the final rule).  Therefore, art studios
that are at an eligible academic entity, such as a college or
university, would be eligible to participate in Subpart K, if the
college or university that owns the art studios opts into Subpart K. 
However, art studios that are not part of an eligible academic entity
would not be eligible to participate in Subpart K.  One main goal of the
rule is to remove the responsibility for the hazardous waste
determination from untrained students and place it in the hands of
professional EH&S staff.  The Agency doubts that the type of art studio
to which the commenter refers would have professional EH&S staff.

3.3	Definition of Laboratory

	3.3.1	General

Comment:  We heard from 17 commenters expressing concern with the
definition's last sentence: "An area where the same hazardous wastes are
routinely generated…is not a laboratory" (Commenter Nos. 7, 11, 25,
29, 49, 53, 54, 60, 61, 68, 73, 76, 77, 79, 81, 96, 114).  These
commenters stated that many laboratory areas covered under the rule
repeat the same analytical processes during a span of time (e.g., a
month, semester, or years) and routinely generate the same waste types. 
Refer to Section 3.3.2 of this document for additional comments asking
for inclusion of photo labs in the definition.

Response:  We agree with the commenters.  We have deleted the last
sentence from the proposed definition of laboratory:  “An area where
the same hazardous wastes are routinely generated, such as photo
processing, is not a laboratory.”  The reason the Agency originally
included this statement in the proposed definition is that part of our
basis for proposing this rule is that laboratories at colleges and
universities, unlike other types of hazardous waste generators, generate
many different types of wastes that vary over time.  However, based on
comments received, we believe it is no longer appropriate to include
this sentence for the following reasons.  First, comments indicated that
some photo laboratories do, in fact, generate many wastestreams that
vary over time – this is especially true when the photo laboratories
are art studios where students may be experimenting with different
photographic techniques, such as daguerreotype and calotype finishing.

Second, commenters pointed out that is it not unusual for an individual
research laboratory to generate the same hazardous waste routinely for
lengthy periods of time, as it focuses on a single area of research. 
Additionally, commenters pointed out that teaching laboratories can have
an experiment that is part of the ongoing curriculum and that generates
the same hazardous wastes each semester.  We did not intend to create a
system whereby some laboratories at the eligible academic entity would
be eligible and some would not, based on the hazardous waste generation
pattern of each individual laboratory.  To the contrary, for ease of
implementation and enforcement, if the eligible academic entity chooses
to be subject to Subpart K, the Agency is requiring that all
laboratories covered under an individual EPA Identification Number must
operate under those provisions.  Therefore, we believe that it is
sufficient that an eligible academic entity’s laboratories, as a
category, rather than each laboratory, generate many different wastes
every day.

Third, based on comments and follow-up discussion, we now understand
that in many cased photo processing takes place alongside teaching and
research and that it would be difficult to regulate differently the
various laboratory operations, as the same students and laboratory
workers operate in both areas.  Therefore, we have not only removed the
last sentence of the proposed definition of laboratory, we have revised
the definition of laboratory to include photo laboratories.

Comment:  We heard from two commenters asking EPA to clarify that
several "laboratories" may be present in the same physical space
(Commenter Nos. 11, 25).  

Response:  The definition of laboratory does not include a description
of the size of area that would be considered one laboratory versus more
than one laboratory.  We realize that some laboratories are very large
rooms, with multiple work stations.  Under Subpart K, there is a shift
toward regularly scheduled pick-ups of unwanted materials, with volume
limits per laboratory kept as a back-up.  We anticipate that this will
reduce the need to distinguish what is one laboratory versus multiple
laboratories.  In cases where it is necessary to distinguish between
what is one laboratory versus multiple laboratories, we will defer to
the State or Region to make such decisions.  It is not possible for EPA
to anticipate all site-specific situations and include them in a
definition.

Comment:  We heard from one commenter suggesting that EPA revise the
“Applicability” section of the rule (262.201) to provide a
comprehensive list of all types of areas/locations that fall under the
rule (e.g., college or university labs, stockrooms, photo labs, etc.
(Commenter No. 100).

Response:  We agree with the commenter.  However, the applicability
section of the rule is intended to identify the types of institutions
that may opt into Subpart K for their laboratories.  It is not intended
to exhaustively and inclusively enumerate all areas or locations that
fall under the rule.  Therefore, instead we have revised the definition
of laboratory in the final rule to make our intent clearer, and we
provide examples of certain areas that would be considered laboratories.
 It now reads:

an area owned by an eligible academic entity where relatively small
quantities of chemicals and other substances are used on a
non-production basis for teaching or research (or diagnostic purposes at
a teaching hospital) and are stored in containers that are easily
manipulated by one person.  Photo laboratories, art studios, and field
laboratories are considered laboratories.  Areas such as chemical
stockrooms and preparatory laboratories that provide a support function
to teaching and research laboratories (or diagnostic laboratories at
teaching hospitals) are also considered laboratories.

Comment:  We heard from one commenter that EPA should address the
dilemma of a single area that both meets and fails the laboratory
definition (Commenter No. 54).  The commenter provided an example of
college and university laboratory workers that work side-by-side with
workers employed by the state or Federal government, private research
institutions and medical centers.  The laboratory will typically have
students and varied waste streams, and be serviced by the college or
university's hazardous waste program.  The commenter believes such
scenarios need to be clarified.  

Response:  The Agency agrees with the commenter.  The definition of
laboratory has been revised to clarify that a laboratory must be owned
by an eligible academic entity to participate under Subpart K.  

To be eligible to opt into Subpart K, an institution first must meet the
definition of “eligible academic entity.”  That is it must be a
college or university, or a non-profit research institute or teaching
hospital that is owned by or has a formal written affiliation agreement
with a college or university, as these terms are defined in the final
rule.  Second, an eligible academic entity may opt into Subpart K for
the laboratories that it owns.  Therefore, government facilities with
laboratories that are operated by colleges and universities (such as
many of the Department of Energy’s laboratories) would not be eligible
to opt into Subpart K, because the government facility is not an
eligible academic entity and the laboratories are not owned by an
eligible academic entity.

Any laboratory workers, students, guest researchers, interns, etc., that
work in a laboratory at an eligible academic entity that opts into
Subpart K must comply with Subpart K while teaching or conducting
research in the laboratories at the eligible academic entity, regardless
of whether the researcher is an employee of the eligible academic
entity.

Comment:  We heard from one commenter that took issue with descriptions
used in the definition to define a college or university laboratory
(e.g., “high turnover rate,” “non-production basis) (Commenter No.
76).  The commenter expressed concern that these terms are not clearly
defined and are open to different interpretations.  The commenter
suggested that, if EPA is using these words to restrict the definition
from non-academic, commercial laboratories, the Agency should use these
words specifically.  

Response:  EPA elected to use the term “non-production basis” within
the definition of laboratory, because it was used by OSHA in its
Laboratory Standard (see 29 CFR 1920.1450) and we had been told by
stakeholders that they would prefer us to use existing terminology when
possible.  It is intended to distinguish research and teaching
laboratories from pilot and production laboratories.

The term “high turnover rate” is not used in the definition of
laboratory, although it is used in the preamble when discussing the part
of the rationale for the rule that concerns students.

Comment:  We heard from one commenter that noted that EPA states that
“laboratories not located at colleges or universities would not be
covered” (Commenter No. 83).  The commenter asked for clarification
whether the definition includes such facilities such as remote
university research stations, farms or other university leased, owned or
operated facilities.  

Response:  The applicability of the final rule has been expanded to
include colleges and universities, as well as teaching hospitals and
non-profit research institutes that are owned by or have a written
affiliation agreement with a college or university.  A laboratory must
be owned by an eligible academic entity in order to operate under
Subpart K.  If a remote research station or farm is owned by an eligible
academic entity, and otherwise meets the definition of a laboratory,
then it would be able to operate under Subpart K.  

Comment:  We heard from one commenter that the definition of a
laboratory, as written in the proposed rule, does not take into
consideration the diverse nature of research (Commenter No. 29).  The
commenter stated that labs may be located on or off campus on property
that is owned, leased or even borrowed.  

Response:  The applicability of the final rule has been expanded to
include colleges and universities, as well as teaching hospitals and
non-profit research institutes that are owned by or have a written
affiliation agreement with a college or university.  A laboratory must
be owned by an eligible academic entity in order to operate under
Subpart K.  If a laboratory is off campus, is owned by an eligible
academic entity, and otherwise meets the definition of a laboratory,
then it would be able to operate under Subpart K.  

Comment:  We heard from one commenter that the definition could be read
to infer a laboratory with more than one person is not a laboratory
(Commenter No. 52).  The commenter stated that there is normally more
than one person in most laboratories and the chemicals handled in these
laboratories are of such size that one person can easily handle them. 
The commenter asked EPA to consider rewording the definition.

Response:  The Agency did not intend to infer that a laboratory with
more than one person could not operate under Subpart K.  To the
contrary, EPA intends for a laboratory with more than one person to be
able to operate under Subpart K if it otherwise meets the definition of
“laboratory.” In the definition of laboratory, we elected to use the
phrase “stored and used in containers that are easily manipulated by
one person,” because it was used by OSHA in its Laboratory Standard
(see 29 CFR 1920.XXX) and we had been told by stakeholders that they
would prefer us to use existing terminology when possible.  The phrase
is intended to describe the types of containers that are typically used
in teaching and research laboratories on a non-production basis.  This
is to distinguish teaching and research laboratories from pilot and
production laboratories where larger containers, such as vats, or tanks
are used which can not be manipulated by one person without the aid of
equipment or machinery. 

Comment:  We heard from one commenter that that some college or
university laboratories have dual roles (e.g., academic and commercial
components); this could create confusion under the current definition
(Commenter No. 8).  

Response:  We realize that some laboratories owned by eligible academic
entities may have contracts to perform research or analyses for
non-eligible academic entities.  If the laboratory is owned by an
eligible academic entity, it may operate under Subpart K, provided the
laboratory otherwise meets the definition of laboratory.  That is, as
long as such a laboratory is used for teaching or research on a
non-production basis, it would be allowed to operate under Subpart K. 
If the laboratory were manufacturing products for commercial use,
however, it would not be considered a laboratory.

Comment:  We heard from one commenter that the definition and
applicability criteria may be better served if the requirements were
based on laboratory workers and their waste operations/management and
training requirements, rather than on specific operations (Commenter No.
81).  The commenter stated that this would relieve colleges and
universities from having to train the same lab workers on two different
waste management procedures and requirements for lab and non-lab
settings.

Response:  We recognize that there will be some personnel at an eligible
academic entity that will have to be familiar with two sets of hazardous
waste regulations – those for laboratories and those for
non-laboratories.  We anticipate that those personnel will be limited to
EH&S professionals or others fulfilling that role, because they
typically provide services to the entire eligible academic entity’s
campus.  We have not been told of situations in which personnel, such as
students, researchers, or other laboratory workers, perform additional
duties that would require them to learn hazardous waste regulations
other than those for the laboratory.

Comment:  We heard from one commenter stating that an art studio should
not be included in the definition of laboratory (Commenter No. 24).  The
commenter stated that, since the proposed rule is mainly geared to those
locations familiarly known as "laboratories," it believes the definition
of "laboratory" should ensure there is a relatively bright line to
describe whether a location is or is not included.  It believes this
will greatly assist the regulated community in determining whether a
particular location is a "laboratory" and will ensure greater
consistency when applying the rule nationwide.

Response:  We disagree with the commenter.  We have heard from many
stakeholders and commenters that art studios share the same hazardous
waste generation patterns as areas that are typically referred to as
laboratories.  That is, they generate many wastestreams in small
quantities that vary over time.  Art students are taught and experiment
in art studios much the same way that chemistry and biology students use
their laboratories.  Therefore, as we discussed in the preamble to the
proposed rule, although art studios are rarely referred to as
laboratories, we will continue to consider them laboratories, provided
they are owned by an eligible academic entity and they otherwise meet
the definition of laboratory.  We have revised the definition of
laboratory in the final rule to state that art studios are considered
laboratories.  

Comment:  We heard from one commenter stating that its university hosts
Federal laboratory research and Federally funded labs; as the rule is
currently written, these laboratories would not be eligible for the rule
even though they essentially are indistinguishable from the university
labs (Commenter No. 81).  

Response:  Under the final rule, if the laboratories that host the
federally funded research are owned by an eligible academic entity, the
laboratories would be allowed to operate under Subpart K.  If, however,
the laboratories that host the federally funded research are owned by an
institution that does not meet the definition of “eligible academic
entity,” they would not be allowed to operate under Subpart K.

Comment:  We heard from one commenter stating that government and
private labs are often located and/or operated in conjunction with
college or university labs (Commenter No. 83).  The commenter stated
that EPA should allow these labs to use Subpart K when working at a
college or university lab, to prevent dual regulation.

Response:  Under the final rule, if the laboratories are owned by an
eligible academic entity, the laboratories would be allowed to operate
under Subpart K.  If, however, the laboratories are owned by a
governmental or private entity that does not meet the definition of
“eligible academic entity,” they would not be allowed to operate
under Subpart K.  

	3.3.2	Expanding the Definition of Laboratory

Comment:  We heard from 66 commenters expressing a general and/or
specific desire that EPA broaden the scope of the lab definition to
include additional types of labs at colleges and universities (Commenter
Nos. 2, 3, 4, 7, 8, 10, 11, 13, 14, 19, 20, 22, 24, 25, 29, 30, 31, 32,
36, 34, 37, 39, 43, 47, 48, 49, 53, 54, 57, 60, 61, 62, 64, 65, 66, 67,
68, 69, 70, 72, 73, 74, 76, 77, 78, 79, 80, 81, 83, 84, 86, 88, 90, 91,
92, 93, 96, 98, 100, 102, 104, 107, 108, 110, 111, 112).  The commenters
generally believe that other types of labs qualify for the proposed rule
(e.g., based on their staffing/waste operations), and that a broader
definition would encourage more protective waste management (e.g., by
obviating the need for dual regulations, simplifying compliance) and
encourage greater participation in Subpart K.  Refer to the comments
below for additional information on their suggestions.  

Response:  In the final rule, we have revised the definition of
laboratory to include additional types of areas.  Specifically, the
definition of laboratory now includes photo laboratories, art studios,
and field laboratories.  Additionally, areas such as chemical stockrooms
and preparatory laboratories that provide a support function to teaching
and research laboratories (or diagnostic laboratories at teaching
hospitals) are also considered laboratories.

Comment:  We heard from five commenters suggesting that the proposed
rule defer to the OSHA definition of "laboratories" promulgated in 29
CFR 1910.1450 (Commenter Nos. 4, 7, 39, 67, 86).  One of the commenters
stated that this change would target equivalent risk groups, while
promoting a level of regulatory harmony between OSHA and EPA regulations
which impact the same user community (Commenter No. 4).

Response:  Under 29 CFR 1910.1450, OSHA defines “laboratory” as,
“a facility where the “laboratory use of hazardous chemicals”
occurs.  It is a workplace where relatively small quantities of
chemicals are used on a non-production basis.”  In addition, OSHA
defines “laboratory scale” as, “work with substances in which the
containers used for reactions, transfers, and other handling of
substances are designed to be easily and safely manipulated by one
person.  “Laboratory scale” excludes those workplaces whose function
is to produce commercial quantities of materials.”  

Under 40 CFR 262.200, “laboratory” is defined as, “an area owned
by an eligible academic entity where relatively small quantities of
chemicals and other substances are used on a non-production basis for
teaching or research (or diagnostic purposes at a teaching hospital) and
are stored and used in containers that are easily manipulated by one
person.  Photo laboratories, art studios, and field laboratories are
considered laboratories.  Areas such as chemical stockrooms and
preparatory laboratories that provide a support function to teaching or
research laboratories (or diagnostic laboratories at teaching hospitals)
are also considered laboratories.”

At the suggestion of many stakeholders, the Agency used several phrases
from OSHA’s definitions that were useful and relevant, such as
“relatively small quantities of chemicals,” “used on a
non-production basis,” and “containers that are easily manipulated
by one person,” and combined them into a single definition.  However,
it is important to point out that although the definitions share many
similarities, EPA chose not to defer completely to the OSHA definition
and that the applicability of EPA’s and OSHA’s laboratory rules are
different.  Under EPA’s rule, only laboratories that are owned by an
eligible academic entity may choose to operate its laboratories under
Subpart K. 

Comment:  We heard from 21 commenters that the definition of a
laboratory be revised to read, "Laboratory means an area under the
administrative or managerial control of a college or university where
relatively small quantities of chemicals and other substances are used
on a non-production basis for teaching or research purposes and are
stored and used in containers that are easily manipulated by one
person”  (Commenter Nos. 11, 25, 34, 37, 49, 54, 60, 61, 64, 69, 70,
73, 77, 78, 79, 91, 96, 98, 100, 108, 110).  These commenters generally
stated their belief that the administrative or managerial control of a
college or university laboratory is more appropriate than its location
(e.g., a college or university's research and teaching laboratories may
be in various locations).

Response:  We agree with the commenters, in principle.  However, the
terminology, “under the administrative or managerial control” is not
currently used or defined under RCRA.  The Agency agrees that the
definition of laboratory should be revised so that the location of the
laboratory is not pertinent and we have incorporated into the final
definition of laboratory a similar concept as suggested by the
commenters.  However, we have relied on terminology that is already used
and defined n RCRA.  Specifically, under the final rule, a laboratory is
“an area that is owned by and eligible academic entity…”  

Comment:  We heard from one commenter suggesting that the definition of
laboratory should be:  “An area where small quantities of chemicals
and other substances are used on a non-production basis for teaching
and/or research purposes and are stored and used in containers that are
easily manipulated by one person.  Laboratory associated wastes include
areas generating unwanted materials or wastes in small quantities in
support of laboratory operations, including
maintenance/heating/wastewater facilities, photographic laboratories,
and computer laboratories” (Commenter No. 107).

Response:  We have revised the definition of laboratory to include some
areas that provide a support function to laboratories.  This includes
chemical stockrooms and preparatory laboratories, because these areas
are well integrated with the operation of the laboratories.  That is
they are often in close proximity to laboratories, and share laboratory
personnel, and thus should properly be viewed as part of the laboratory.
 However, this revision would not include maintenance, heating and
wastewater facilities because they typically provide support functions
for an entire campus and not just the laboratories.

Comment:  We heard from one commenter that items such as exclusion of
photographic operations, "easily manipulated by one person", and
restrictions on anything even resembling a commercial operation do not
lend themselves to a clear delineation of who's in and who's out of the
rule (Commenter No. 43).  The commenter suggested that the proposal be
made applicable to "administrative sub units (colleges, schools,
departments, etc. whose primary function is instruction and/or
research."

Response:   EPA has revised the applicability of the rule from what was
proposed.  We believe that the final rule is clear as to who is eligible
to participate under this rule.  To be eligible to opt into Subpart K,
an institution first must meet the definition of “eligible academic
entity.”  That is, it must be a college or university, or a non-profit
research institute or teaching hospital that is owned by or has a formal
written affiliation agreement with a college or university, as these
terms are defined in today’s rule.  Second, an eligible academic
entity may opt into Subpart K for the laboratories that it owns.  We
have revised the definition of laboratory to include photographic
laboratories (as discussed below in detail).  However, in response to
other commenters, we have retained several phrases from OSHA’s
definitions, such as “relatively small quantities of chemicals,”
“used on a non-production basis,” and “containers that are easily
manipulated by one person.”  These phrases have been in use by OSHA
for nearly 20 years and therefore the regulated community is already
familiar with them.

Comment:  We heard from one commenter suggesting that the definition is
too restrictive and recommending that EPA base the definition on the
laboratory type operations conducted as opposed to the wastes generated
(Commenter No. 68).  The commenter stated that providing a list of
examples tends to add confusion when contained in a regulatory
definition. The commenter stated that, by necessity, no list of examples
can be complete.  Instead, the preamble should discuss the intent of the
definition as written, and include some examples of covered operations
for illustrative purposes, but the examples should be annotated by
“such as, but not limited to” to avoid later confusion. The
commenter asked EPA to revise the definition of lab to read: 
“Laboratory means an area owned/operated by or affiliated with a
college or university where relatively small quantities of chemicals and
other substances are used on a non-production basis for teaching or
research purposes and are stored and used in containers that are easily
manipulated by one person.”

Response:  We disagree with the commenter.  Many other commenters
requested that we explicitly include types of laboratories that we
intend to be included in the definition of laboratory.  We included many
of the types of laboratories that commenters suggested because we
believe that including these examples in the definition of laboratory
provides clarity for both implementers and enforcers. We do not intend
to suggest, and believe that the language in the definition does not
suggest, that the list of examples is exhaustive or all-inclusive.

Comment:  We heard from one commenter stating that the definition of lab
should include recreation department studios (Commenter No. 102).  The
commenter stated its support for the inclusion of art studios in the
definition of laboratory and recommended adding the non-instructional
art studios commonly operated by the recreation departments of many
schools.  The commenter stated that these student workshops generate
much the same waste as instructional studios, and in much the same
quantities. The commenter also stated that frequently, institutions with
small or nonexistent art departments, such as engineering schools, will
have substantial generation of paint, solvent, and ceramics waste from
these recreational studios.  The commenter suggested an addition
specifically including recreation department studios.

Response:  Based on this one comment, we do not believe that we have
enough information to make a determination about whether it is
appropriate to include recreation department studios in the definition
of laboratory and therefore we have not made the suggested addition.

Comment:  We heard from 13 commenters stating that the definition of lab
should include machine shops, maintenance shops, motor vehicle stations,
and/or fabrication units, mechanic units (Commenter Nos. 10, 11, 13, 25,
29, 31, 37, 54, 70, 79, 80, 91, 104).

Response:  We disagree with the commenters.  The hazardous waste
generation pattern in laboratories is different than in other parts of
an eligible academic entity.  Laboratories tend to generate relatively
small volumes of many different hazardous wastes that vary over time. 
In addition, the personnel that generate hazardous waste in laboratories
are often students who lack accountability and are inherently transient,
and therefore are difficult to train.  This combination of the hazardous
waste generation pattern and students in laboratories makes accurate
hazardous waste determinations particularly difficult.  In contract,
machine shops, maintenance shops, motor vehicle stations, etc., tend to
generate relatively large volumes of a few, predictable hazardous
wastes.  The personnel that generate hazardous waste in these
non-laboratory areas tend to be employees and therefore are expected to
have lower turnover and more accountability than students.  Since these
non-laboratory areas do not share the hazardous waste generation pattern
or have students generating hazardous waste, we do not believe it is
appropriate for the definition of laboratory to include these areas.

Comment:  We heard from 22 commenters stating that the definition of lab
should include chemical stockrooms and other areas ancillary to the
laboratory (Commenter Nos. 2, 8, 11, 25, 30, 31, 37, 54, 61, 62, 68, 69,
70, 72, 76, 77, 78, 79, 91, 100, 111, 112).  The commenters stated that
these areas are comparable to college or university labs eligible for
the rule and often share a physical proximity. 

Response:  We agree with the commenters and have revised the definition
of laboratory to include chemical stockrooms, preparatory laboratories
and other areas that perform a support function to teaching or research
laboratories (or diagnostic laboratories at teaching hospitals).  The
reason for this change is that the operation of these areas is well
integrated with the operation of the laboratories; that is, they are
often in close proximity to laboratories, and share laboratory
personnel, and thus should properly be viewed as part of the laboratory.
 Chemical stockrooms that are not associated with laboratory operations
would not however, be eligible to operate under Subpart K.  For example,
a chemical stockroom that stores cleaning chemicals or pesticides for
maintenance at the facility would not be providing a support function to
a laboratory and would not be considered a laboratory that is allowed to
operate under Subpart K.     

Comment:  We heard from 19 commenters stating that the definition of lab
should include field laboratories (Commenter Nos. 8, 11, 20, 25, 31, 37,
47, 54, 61, 66, 68, 77, 79, 90, 91, 96, 100, 102, 110).  The commenters
stated that many colleges and universities operate field laboratories
that entail similar operations as college or university labs eligible
for the rule and involve faculty and students working in both settings
that should not be subject to dual regulation.

Response:  We agree with the commenters that field laboratories should
be considered laboratories because we agree that field laboratories,
like other laboratories under this rule, exhibit similar hazardous waste
generation patterns.  By considering field laboratories as laboratories,
laboratory personnel would thus only need to operate under one set of
hazardous waste regulations.  

Comment:  We heard from 40 commenters stating that the definition of lab
should include photo labs/dark rooms (Commenter Nos. 2, 7, 8, 10, 11,
13, 14, 20, 25, 29, 30, 31, 32, 36, 37, 43, 47, 48, 53, 54, 61, 68, 69,
70, 72, 73, 76, 77, 79, 80, 81, 83, 86, 90, 91, 96, 100, 108, 110, 112).
 The commenters stated that many of their laboratories or lab buildings
include photo processing areas that should be eligible for the rule to
avoid dual regulation.  

Response:  We agree with the commenters and in response we have deleted
the last sentence from the proposed definition of laboratory:  “An
area where the same hazardous wastes are routinely generated, such as
photo processing, is not a laboratory.”   The reason the Agency
originally included this statement in the proposed definition is that
part of our basis for proposing this rule is that laboratories at
colleges and universities, unlike other types of hazardous waste
generators, generate many different types of wastes that vary over time.
 However, based on the comments received, we believe it is no longer
appropriate to include this sentence for the following reasons.  First,
comments indicated that some photo laboratories do, in fact, generate
many wastestreams that vary over time - this is especially true when the
photo laboratories are art studios where students may be experimenting
with different photographic techniques, such as daguerreotype and
calotype finishing.  

Second, commenters pointed out that it is not unusual for an individual
research laboratory to generate the same hazardous waste routinely for
lengthy periods of time, as it focuses on a single area of research. 
Additionally, commenters pointed out that teaching laboratories can have
an experiment that is part of the ongoing curriculum and that generates
the same hazardous wastes each semester.  We did not intend to create a
system whereby some laboratories at the eligible academic entity would
be eligible and some would not, based on the hazardous waste generation
pattern of each individual laboratory.  To the contrary, for ease of
implementation and enforcement, if the eligible academic entity chooses
to be subject to Subpart K, the Agency is requiring that all
laboratories covered under an individual EPA Identification Number must
operate under those provisions.  Therefore, we believe that it is
sufficient that an eligible academic entity’s laboratories, as a
category, rather than each individual laboratory, generate many
different wastes every day.

Third, based on comments and follow-up discussion, we now understand
that in many cases photo processing takes place alongside teaching and
research and that it would be difficult to regulate differently the
various laboratory operations, as the same students and laboratory
workers operate in both areas.  Therefore, we have revised the
definition of laboratory to include photo laboratories.

	3.4	Definition of Laboratory Clean-out

Comment:  We heard from three commenters for EPA to delete reference to
“or that have expired” (Commenter Nos. 11, 60, and 91).  One
commenter stated that expired material is not necessarily unwanted and
that, in most laboratories, only the laboratory worker is capable of
deciding that an expired material is unwanted (Commenter No. 11).
Because this has caused misunderstandings in the past, the commenter
requests deletion of "or that have expired."  Another commenter stated
that “expired materials” is a subjective concept (Commenter No. 60).
 Two commenters offered an alternative definition and suggested that the
colleges and universities describe in the Laboratory Management Plan the
procedure used by the college or university to address expired materials
(Commenter Nos. 11 and 60). 

Response:  We disagree with the commenters and have left the phrase
“or that have expired” in the definition of laboratory clean-out to
describe one situation in which is might be appropriate for a chemical
to be removed from a laboratory during a laboratory clean-out.  We are
not suggesting that every chemical that has expired is an unwanted
material and should be removed during a laboratory clean-out.  But the
expiration date of a chemical should certainly be one factor in deciding
whether or not a chemical should be removed during a laboratory
clean-out.  We agree with the commenter that the LMP should include
procedures for identifying and disposing of chemicals that can become
more dangerous when they exceed their expiration date.  Therefore, in
Part II of the LMP, we have added such a requirement. [See Section 13.0
of this document for more detail on the requirements of the LMP].

Comment:  We heard from three commenters suggesting alternate
definitions of laboratory clean-out (Commenter Nos. 60, 76, 107):

One commenter suggested revising the definition of Laboratory Clean-out
to read: “Laboratory Clean-out means an evaluation of the inventory of
chemicals and other materials in a laboratory that are no longer needed
and the subsequent removal of those chemicals or other unwanted
chemicals from the laboratory.  A clean-out may occur for several
reasons.  It may be on a routine basis (e.g., at the end of a semester
or academic year) or as a result of a renovation, relocation, or change
in laboratory supervisor/occupant.  A regular removal of unwanted
chemicals as required by section 262.208 does not qualify as a
laboratory clean-out” (Commenter No. 60).  

One commenter stated that it would be more useful for the definition to
read:  “Laboratory clean-out means an evaluation of an inventory of
chemicals in a work area that is no longer used or needed by the space
occupant and ….” (Commenter No. 76).  The commenter stated that each
college or university should define the procedure for that determination
in its performance-based Laboratory Management Plan.  

One commenter suggested that the definition be revised to say that a
clean out  “means an evaluation of the inventory of chemicals and
other materials in a laboratory, stock room, product storage area….”
(Commenter No. 107).  

Response:  We disagree with commenters because we believe our definition
best captures EPA’s intent, and, therefore, the definition of
laboratory clean-out remains unchanged from the proposal.  However, we
agree that an eligible academic entity should include in Part II of its
LMP, procedures for conducting and documenting laboratory clean-outs. 
In addition, the definition of laboratory has been revised to include
additional areas, such as chemical stockrooms, and therefore, such
ancillary support areas are also able to conduct laboratory clean-outs
under 40 CFR 262.213

Comment:  We heard from one commenter that the definition should be
clarified to allow the removal of unwanted material associated with a
laboratory clean out to qualify as a regularly scheduled removal to
allow smaller facilities to coordinate their waste management activities
(Commenter No. 77).  

Response:  We view laboratory clean-outs to be distinct from routine,
regularly scheduled removals of unwanted materials.  In the course of
normal laboratory operations, many chemicals are used and will become
unwanted materials and ultimately may be determined to be hazardous
wastes.  This can occur as a result of teaching or research activities
or, in the case of teaching hospitals, as a result of clinical or
diagnostic activities.  We expect that these routinely generated
wastestreams will comprise the bulk of the unwanted materials that are
removed from the laboratory during regularly scheduled removals.  On the
other hand, a laboratory often can accrue a large number of unused
chemicals in its inventory, some of which can become dangerous over
time, developing the potential to cause significant harm.  It has been
our observation that it is unusual for laboratories to remove unused
chemicals from their inventories on any regular basis.   Therefore, a
regularly scheduled removal of unwanted material does not qualify as a
laboratory clean-out.  Nor does a laboratory clean-out qualify as a
regularly scheduled removal.  However, nothing prohibits these two
events from happening concurrently in order to coordinate waste
management activities.

Comment:  We heard from one commenter that there are inconsistencies in
the definition of laboratory clean-out as it relates to discussions in
the preamble and rule (Commenter No. 114).  The commenter noted that EPA
says that it envisions laboratory clean-outs as more comprehensive than
the regularly scheduled removals of unwanted material.  It also notes
that the Agency discusses past inspections and enforcement cases that
have revealed used and unused chemicals at college or university labs
that have remained for long periods of time, and it discusses the
hazards of these chemicals but it does not equate the hazards with
quantity of the chemicals found.  The commenter also pointed out that
the definition of a laboratory clean-out includes language referring to
the “subsequent removal of those chemicals or other unwanted materials
from the laboratory.”  The commenter pointed out, however, that, under
the current proposal, if at the conclusion of a laboratory clean-out the
total volume of unwanted materials in the laboratory does not exceed 55
gallons (or 1 quart of reactive acutely hazardous waste), the materials
may remain in the laboratory until the next regularly scheduled removal
of the unwanted material.  The commenter stated its belief that, if the
used and unused chemicals (along with other unwanted materials) are not
removed after a clean-out, then there would appear to be no immediate
benefit or incentive for a safer laboratory environment and better waste
management and timely removal and disposal of these materials.  The
commenter expressed concern that a clean-out could conclude without the
unwanted materials being removed promptly from the laboratory.  The
commenter stated that, if the definition does not mean that materials
must be removed at the conclusion, regardless of quantity, then the name
and definition should more appropriately reflect this. 

Response:  We agree with the commenter that the preamble and the
regulatory text of the proposed rule are somewhat inconsistent, as
described.  In the final rule, we have retained the proposed regulatory
text.  Therefore, 40 CFR 262.213(a)(1) requires that an “eligible
academic entity must remove all unwanted materials from the laboratory
within 30 calendar days from the start of the laboratory clean-out.” 
The discussion in the preamble to the proposed rule to which the
commenter refers should no longer be considered relevant.  We agree with
the commenter that the timely removal and disposal of the laboratory
clean-out chemicals is the main goal of conducting laboratory clean-outs
and to let the chemicals remain in the laboratory at the conclusion of
the laboratory clean-out is counter-intuitive.  Therefore, regardless of
the quantity of unwanted materials generated during a laboratory
clean-out, all unwanted materials must be removed at the conclusion of
the laboratory clean-out.  

	3.5	Definition of Laboratory Worker

Comment:  We heard from nine commenters that expressed general support
for the proposed definition of laboratory worker (Commenter No. 7, 8,
11, 25, 54, 71, 73, 79, 86).  One of the commenters stated that, if a
more detailed description is necessary, it will vary from campus to
campus and it is most appropriately written into the LMP (Commenter No.
7).  

Response:  We don’t expect that eligible academic entities will have a
need to provide a more detailed description of laboratory worker, beyond
what is provided.  But, if the need arises, the eligible academic entity
could write it into Part II of its LMP, such as under the element
describing intended best practices for training.

Comment:  We heard from one commenter stating that, if EPA broadens the
rule to include non-college or university labs, EPA should broaden the
definition of “lab worker” to address workers in non-college or
university lab settings (Commenter No. 14).   It suggested that, at
non-academic institutions, the transient workforce that would be allowed
to receive instruction, in lieu of training, be limited to individuals
who do not perform independent research tasks (i.e., are under direct
supervision of a trained laboratory worker) and are serving in
appointments of one year or less.  

Response:  Under the final rule, the distinction between training for
laboratory workers and instruction for students has been eliminated.  
Now both students and laboratory workers must be trained commensurate
with duties.  Therefore, the comment is now moot.

Comment:  We heard from one commenter that many students will be present
in a laboratory, but may not fulfill the true definition of a laboratory
worker; therefore, they may not need to meet the training requirements
specified in the rule (Commenter No. 80).  The commenter suggested the
differentiation of a laboratory worker and student worker, or use of
discretion of lab supervisors when the determination of training needs
is made.  

Response:  Under the final rule, the distinction between training for
laboratory workers and instruction for students has been eliminated.  
Now both students and laboratory workers must be trained commensurate
with duties.  Therefore, the comment is now moot.

Comment:  We heard from one commenter that the definition should be
revised to include the phrase “contractors or vendors” after the
word “technician” (Commenter No. 84).  The commenter stated that
contractors and vendors are commonly used by colleges and universities. 


Response:  We realize that contractors and vendors are commonly used by
eligible academic entities to make or verify hazardous waste
determinations.  Contractors and vendors used in this capacity should
have the appropriate RCRA training.  However, while it is the
responsibility of the eligible academic entity to provide training to
laboratory workers, it is not the responsibility of the eligible
academic entity to provide the required training to a contractor or
vendor.  Therefore, we have not included contractors or vendors in the
definition of laboratory worker.

Comment:  We heard from one commenter that suggested adding a definition
for “student” that allows undergraduate students, including paid
temporary students that conduct research or teach, not to be considered
laboratory workers (Commenter No. 107).  The commenter also suggested
revising the definition of laboratory worker to include: “…but is
not limited to faculty, staff, post-doctoral fellows, visiting
scientists/researchers, interns, researchers….” 

Response:  The definition of “laboratory worker” in the preamble to
the proposed rule differed slightly from the definition in the proposed
regulatory text.  In the definition included the regulatory text, the
last sentence of the definition included the words “Undergraduate and
graduate” when referring to students.  However, the definition
included in the preamble discussion omitted the words “Undergraduate
and graduate.”  Today, we are finalizing the definition in the
regulatory text, as it was proposed, so that the final sentence reads,
“Undergraduate and graduate students in a supervised classroom setting
are not laboratory workers.”

However, contrary to the commenter’s suggestion EPA would consider
undergraduate or graduate students in an unsupervised research setting
or in a supervisory role, such as teaching, to be laboratory workers. 
Additionally, any student performing duties of a trained professional,
such as transferring unwanted materials and hazardous wastes outside of
a laboratory, would be considered a trained professional, rather than a
student.

Our list of examples of types of laboratory personnel that could be
considered laboratory workers is not exhaustive.  And, as the commenter
suggests, visiting scientists or researchers could also be considered
laboratory workers. 

Comment:  We heard from one commenter that offered the following revised
definition: “Laboratory Worker means a person who handles chemicals or
unwanted chemicals in a laboratory and may include, but is not limited
to faculty, staff, post-doctoral fellows, interns, researchers,
technicians, supervisors, managers, and principal investigators.  A
person does not need to be paid or otherwise compensated for his/her
work in the laboratory to be considered a laboratory worker. 
Undergraduate and graduate students in an instructional or teaching
setting are not laboratory workers” (Commenter No. 60).  Specifically,
the commenter suggested replacing the current language “in a
supervised classroom setting” with “in an instructional or teaching
setting.” 

Response:  We believe that the phrase “in a supervised classroom
setting” more accurately conveys our meaning and is therefore less
confusing than the phrase “in an instructional or teaching setting.”
 EPA expects that students in a classroom setting will be under the
direct supervision of an instructor or professor who would be considered
a laboratory worker.   If we were to use the commenter’s suggested
phrase we would be concerned that students in an unsupervised research
setting could be interpreted as being in an instructional or teaching
setting.

Comment:  We heard from one commenter that the definition’s last
sentence, beginning "(u)ndergraduate and graduate students in a
supervised classroom . . ." seems to leave a loophole, in that those
students in an unsupervised classroom setting would be classified as
laboratory workers (Commenter No. 102).  The commenter suggested that,
if this person is an unsupervised student, he or she should be subject
to the same requirements as any faculty, staff, or other person handling
chemicals.  The commenter asked EPA to clarify that undergraduate and
graduate students in a supervised classroom are included as laboratory
workers.

Response:  Undergraduate and graduate students in a supervised classroom
setting are not laboratory workers.  EPA expects that students in a
classroom setting will be under the direct supervision of an instructor
or professor who would be considered a laboratory worker.  If however,
an undergraduate or graduate student were working in a laboratory that
is not a supervised classroom setting, as with many research projects,
the students could be considered laboratory workers.  Under the final
rule, both laboratory workers and students must be trained commensurate
with their duties; therefore, the distinction between student and
laboratory worker is less important than under the proposed rule.

Comment:  We heard from one commenter suggesting that the Agency remedy
a discrepancy between the definition stated in the preamble and that
stated in the text of the proposed rule (Commenter No. 88).  The
commenter pointed out that the preamble refers to students in a
supervised classroom while the proposed rule refers to undergraduate and
graduate students in a supervised classroom.  The commenter stated that
graduate students are normally, but not always, employed by the
institution and while they are in fact students, they are more
appropriately treated as employees (workers) regardless of the setting
or whether supervision is present.  The commenter believes that
undergraduates should normally be excluded from the definition of
laboratory workers.  The commenter suggested that the criteria of
employment is more important than graduate or undergraduate status, and
that relating worker to criteria such as used under the Hazard
Communication Act requirements would reduce the regulatory burden and
add clarity.  The commenter suggested replacing:  “Undergraduate and
graduate students in a supervised classroom setting are not laboratory
workers.” with “Undergraduate and graduate students employed by the
institution for work in areas or with job duties that include working
with hazardous materials are considered laboratory workers.  Students
not so employed are not laboratory workers.”

Response:   The definition of “laboratory worker” in the preamble to
the proposed rule differed slightly from the definition in the proposed
regulatory text.  In the definition included the regulatory text, the
last sentence of the definition included the words “Undergraduate and
graduate” when referring to students.  However, the definition
included in the preamble discussion omitted the words “Undergraduate
and graduate.”  Today, we are finalizing the definition in the
regulatory text, as it was proposed, so that the final sentence reads,
“Undergraduate and graduate students in a supervised classroom setting
are not laboratory workers.”

We disagree with the commenter that the employment status of a student
should determine whether the student should be considered a laboratory
worker.  Many individuals in a laboratory that may not be employed by
the institution could be considered laboratory workers.  For example,
some students may be working in a laboratory for credit rather than pay.
 Similarly, interns or guest researchers would be unlikely to be paid
employees.  We believe if a student in a laboratory is not under direct
supervision by a laboratory worker in a classroom setting, that student
should be considered a laboratory worker.

	3.6	Definition of RCRA-Trained Individual

Comment:  We heard from eight commenters that expressed general support
for the proposed definition of RCRA trained person (Commenter No. 11,
25, 46, 53, 54, 71, 73, 102). 

Response:  We thank the commenters for their support.

Comment:  We heard from one commenter stating its agreement that all
hazardous waste determinations must be made by a RCRA trained person
(Commenter Nos. 5).  

Response:  We strongly agree with the commenter that it is important for
all hazardous waste determinations to be made by an individual with the
standard RCRA generator training.  In the final rule we have changed the
name of this type of individual from “RCRA-trained individual” to
“trained professional.”  This does not affect the substance of the
definition, but is merely a change in terminology since Subpart K is
part of the RCRA hazardous waste regulations and including “RCRA” as
part of the term is unnecessary and may, in fact, imply that anyone who
is trained under Subpart K is not “RCRA” trained.

Comment:  We heard from 12 commenters on the extent to which colleges
and universities rely on non-employees to make hazardous waste
determinations (Commenter Nos. 7, 8, 11, 14, 25, 47, 54, 70, 79, 81, 84,
86).  One commenter stated that there are campuses which have the
expertise required to make RCRA hazardous waste determinations and
campuses that do not have such expertise (Commenter No. 7).  At those
facilities with larger EHS staffing, the level of expertise and training
is generally sufficient to allow the proper determination of such
classifications; however, many colleges and universities, particularly
smaller institutions with fewer resources and little or no EHS staff,
depend almost exclusively on outside contractors to manage their
chemical wastes. The commenter believes that such colleges and
universities should be encouraged to have their own personnel trained in
making waste determinations, both for economic and legal reasons.  Three
commenters indicated that many colleges and universities hire
environmental services contractors or hazardous waste contractors to
perform a variety of functions, including at least a portion of the
waste determination, and stated that EPA should allow this to continue
(Commenter No. 11, 25, and 54).  Seven commenters described the extent
to which non-employees and site employees make hazardous waste
determinations at their sites (Commenter Nos. 8, 14, 47, 70, 79, 81,
86).  Another commenter stated that vendors or contractors make RCRA
determinations at many facilities including colleges and universities
(Commenter No. 84).   The commenter noted that the RCRA requirements are
complicated and often inconsistent because of state variations and that
waste generating facilities look to experts, who spend all their time
dealing with the various RCRA and State hazardous waste requirements. 
The commenter pointed out that companies that offer waste services are
expert on RCRA and are highly trained, and using such services enhances
compliance and should be encouraged.  

Response:  We agree with commenters and have retained the flexibility in
the definition of “trained professional” to allow eligible academic
entities to use contractors to make and or confirm hazardous waste
determinations and to transfer unwanted materials outside of the
laboratories.  

Comment:  We heard from one commenter recommending that EPA develop a
more complete set of criteria, or specific minimum standards, for an
individual to be considered "RCRA trained" (Commenter No. 7).  The
commenter stated this is important because it has found that some
vendors do not have the expertise to properly make such classifications,
and there are currently no standards or controls on the level of RCRA
training vendors must receive.  The commenter stated that the proposed
definition of a RCRA-trained individual does not adequately describe the
depth and nature of training vendors should receive. 

Response:   We believe it is appropriate to rely on existing training
requirements for generators of hazardous waste for trained professionals
that must make hazardous waste determinations under Subpart K.  First,
the existing training requirements for generators are more specific than
the performance-based training requirements under Subpart K and are what
EH&S professionals or others that are making the hazardous waste
determination should already have received under existing training
requirements.  Second, if we created new Subpart K training requirements
for trained professionals, an eligible academic entity that currently
relies on a vendor or contractor to make or confirm its hazardous waste
determinations would not be able to continue its contract unless the
contractor received the new Subpart K training.

Comment:  We heard from 11 commenters that expressed support for
allowing non-employees to make the determinations (Commenter Nos.  8,
11, 25, 31, 52, 53, 54, 58, 70, 79, and 88).  Three of these commenters
indicated that many colleges and universities hire environmental
services contractors or hazardous waste contractors to perform a variety
of functions (Commenter No. 11, 25, and 54).  These commenters indicated
their belief that all of these practices are prudent and should remain
acceptable under Subpart K.  Another commenter stated that the
university or college that hires contractors to manage their hazardous
waste needs to review the training and audit the training and training
records annually; the purpose of the audit is to ensure the proper level
of training is conducted and that each current employee is up-to-date
with their training (Commenter No. 52).

Response:  We have retained the flexibility in the definition of
“trained professional” to allow contractors to make hazardous waste
determinations and transfer unwanted materials outside of the
laboratories.  Although we are not requiring an eligible academic entity
that hires contractors in this capacity to review the training and
training records of the contractor it hires, as the commenter suggests,
we agree with the commenter that this would be a good business practice.


Comment:  We heard from one commenter that stated that
contractors/vendors should only be making the waste determination on
behalf of the generator if they have true knowledge of the waste
generation at a particular site (Commenter No. 14).  The commenter
stated that contractors/vendors who are on-site on a regular basis (such
as contracted to provide on-site technical assistance and hazardous
waste management support) would generally have the knowledge to make the
waste determination on behalf of the generator. These types of
arrangements usually have the same employee(s) of the contractor/vendor
on site full-time, or on a recurring and on-going basis.  The commenter
expressed some uncertainty in contractor/vendors who have limited
on-site involvement.

Response:  We agree with the commenter that under Subpart K, it is
critical that anyone making the hazardous waste determination (whether
it is an employee of the eligible academic entity or a
contractor/vendor) must be provided sufficient information by the
laboratory personnel that are generating the unwanted material in order
to make accurate hazardous waste determinations.  The container labeling
requirements for unwanted material in the laboratory are designed to
convey that information.

Comment:  We heard from two commenters on the liability of each party in
a vendor/university relationship when a contractor makes the hazardous
waste determination on behalf of the university customer (Commenter Nos.
74 and 84).  One of the commenters noted that, in the preamble, EPA
makes the following statement: “...a college or university that allows
a non-employee to make the hazardous waste determination on its behalf
and could be held liable…” (71 FR 29735) (Commenter No. 74).  The
commenter expressed concern that such wording could be used to
contradict current RCRA requirements that a generator is always
responsible for proper waste designation regardless of who does the
actual designation. The commenter strongly supports the continued
requirement for generators to be held responsible for proper designation
of their waste.  The commenter asked EPA to correct its wording
accordingly.  Another commenter stated that, as with all agent-principal
relationships, the liabilities of each party are spelled out in contract
documents in the normal course of business (Commenter No.  84).  While
the customer may be liable under the RCRA statute for the waste
determination, the vendor and customer provide appropriate
cross-indemnifications for liability in the event that a mistaken
determination leads to mismanagement of hazardous waste.  The commenter
stated that EPA should be careful not to interfere with these contract
arrangements.

Response:  We did not intend this preamble language to suggest the
potential interpretation for which the commenter expressed concern. 
Indeed, we agree with the commenter that making the proper hazardous
waste determination is, and always has been, the responsibility of the
generator (as described in 40 CFR 262.11), which in this case, would be
the eligible academic entity, and did not intend to suggest otherwise. 
Similarly, we did not intend this preamble language to have any effect
on existing agent-principal relationships or liabilities that may result
in the event that a mistaken determination leads to mismanagement of
hazardous waste.

	3.7	Definition of Reactive Acutely Hazardous Unwanted Material

Comment:  We heard from one commenter expressing support for the
definition of reactive acutely hazardous unwanted material (Commenter
No. 108).

Response:  We thank the commenter for his support.

Comment:  We heard from one commenter asking for clarification
concerning whether a used container that once held a P-listed chemical
and does not meet the criteria in 40 CFR 261.7(b)(3) for being
“empty” would be a “reactive acutely hazardous unwanted
material” under the proposed Subpart K regulations (Commenter No. 33).
If so, the commenter asked how such a used container would be counted
for the purpose of evaluating compliance with the 1-quart limit on
accumulation of reactive acutely hazardous unwanted material.

Response:  A container that once held a P-listed chemical and does not
meet the criteria in 40 CFR 261.7(b)(3) for being “empty” would not
be a reactive acutely hazardous unwanted material and the container
would not have to be counted toward the 1-quart limit on accumulation in
the laboratory.  The contents of the container; however, would be
reactive acutely hazardous unwanted material if the contents were any of
the P-listed chemicals listed for reactivity and the contents must be
counted toward the 1-quart limit on accumulation in the laboratory. 
This is because 261.33(c) regulates as hazardous waste “any residue
remaining in a container,” it does not regulate the container itself
as hazardous waste.  In addition, when the container is discarded, if it
still does not meet the criteria for being “empty,” the contents
would be considered acute hazardous waste and must be counted in
determining whether 1 kg/month of acute hazardous wastes has been
generated.  The weight of the container, however, would not be counted
toward determining generator status (see 45 FR 78527).

Comment:  We heard from nine commenters on discrepancies in the
definition (Commenter Nos. 8, 11, 24, 25, 47, 71, 76, 81, 101).   They
pointed out that the proposed definition states that a "reactive acutely
hazardous unwanted material" is a material listed in section 261.33(e)
for both reactivity and toxicity; however, EPA’s list includes waste
codes P009, P081, and P112 that are listed only for reactivity.  The
commenters also pointed out that the (R)- at the end of
(R)-4-[1-hydroxy-2-(methylamino)ethyl]-1,2-Benzenediol (P042) in section
261.33(e) is a reference to the R enantiomer and is not an indication of
the reactivity characteristic.  These commenters asked EPA to resolve
these discrepancies.  In addition, two comments asked EPA to drop the
P042 waste code from the list (Commenter Nos. 81 and 101).

Response:  At proposal, the Agency intended to maintain more stringent
regulations in the laboratory for the “P-listed” commercial chemical
products that are listed for reactivity because of their high potential
for causing immediate harm.  In the preamble to the proposed rule, we
provided a list of seven commercial chemical products that we believed
met this definition:

P006 (CAS Number: 20859-73-8) Aluminum phosphide;

P009 (CAS Number: 131-74-8) Ammonium picrate; Pheno, 2,4,6-trinitro-,
ammonium salt;

P042 (CAS Number: 51-43-4) 1,2-Benzenediol,
4-[1-hydroxy-2-(methylamino)ethyl];

P065 (CAS Number: 628-86-4) Fulminic Acid, mercury(2+) salt; Mercury
fulminate;

P081 (CAS Number: 55-63-0) Nitroglycerine; 1,2,3-Propanetriol,
trinitrate;

P112 (CAS Number: 509-14-8) Methane, tetranitro-; Tetranitromethane; and

P122 (CAS Number:  1314-84-7) Zinc phosphide Zn3P2 when present at
concentrations greater than 10%.

Commenters are correct that P042 (CAS Number 51-43-4) 1,2-Benzenediol,
4-[1-hydroxy-2-(methylamino)ethyl]-, which is actually Benzenediol,
4-[1-hydroxy-2-(methylamino)ethyl]-, (R)-, (and is also known as
epinephrine) is not listed on the “P-list” because of reactivity. 
Commenters are also correct that the (R)- following the listing for P042
refers to the R enantiomer of the chemical and does not refer to the
reactivity characteristic.  We thank the commenters for these
clarifications, and acknowledge that if epinephrine were an unwanted
material in a laboratory, it would not meet the definition of reactive
acutely hazardous unwanted material.  EPA’s acknowledgment is simply a
matter of clarification and does not affect the definition as proposed.

Commenters also are correct that three of the chemicals on the list
above are listed only for reactivity (P009, P081, P112), and not for
toxicity and, therefore, do not meet the definition of reactive acutely
hazardous unwanted material, as proposed.  While the commenters are
correct that P009, P081, and P112 are listed only for reactivity, we
believe that the proposal was clear as to the Agency’s intent – that
a “reactive acutely hazardous unwanted material” includes those
chemicals included on the P-list for reactivity, and that some of those
chemicals were listed for toxicity, as well.  The wording of the
proposed definition, however, did not convey that clearly.  Therefore,
we are revising the definition of “reactive acutely hazardous unwanted
material” to be consistent with the intent discussed in the preamble,
by omitting the reference to toxicity.

Comment:  We heard from one commenter that reactive acutely hazardous
unwanted material, by definition, must be unused commercial chemical
products that are both reactive and acutely toxic, not just acutely
toxic (Commenter No. 12).  Given this, the commenter does not see
sufficient justification from a risk or hazard perspective to make
lesser regulation of acutely toxic (but not reactive) hazardous waste. 
The commenter wondered why EPA would not regulate large quantities of
acutely hazardous P-listed materials similarly.

Response:  As the term implies, we intended to include in the definition
of reactive acutely hazardous unwanted materials those chemicals
included on the P-list for reactivity, and that some of those chemicals
were listed for toxicity, as well.  The wording of the proposed
definition, however, did not convey that clearly.  Therefore, we are
revising the definition of “reactive acutely hazardous unwanted
material” to be consistent with the intent discussed in the preamble,
by omitting the reference to toxicity.  We intended to maintain more
stringent regulations in the laboratory for the “P-listed”
commercial chemical products that are listed for reactivity because of
their high potential for causing immediate harm.  

Comment:  We heard from three commenters offering alternative
definitions (Commenter Nos. 24, 52, 71):  

One commenter offered the following definition: “Reactive Acutely
Hazardous Unwanted Material means an unwanted material that is one of
the acutely hazardous commercial chemical products for which reactivity
is identified as a basis for listing in section 261.33(e)” (Commenter
No. 24).  

One commenter stated that, in a research laboratory, there can be many
reactive chemicals that are not on EPA’s proposed list (Commenter No.
52).  The commenter stated that providing such a list may give the
laboratory worker a false sense of security.  The commenter suggested
that the National Fire Protection Association (NFPA) Diamond hazard
rating of 4 could be used to identify reactive and acutely hazardous
unwanted material.  

One commenter urged EPA to consider adding a new defined term such as
“highly reactive chemicals” rather than using the acutely hazardous
commercial chemical products list (P List) (Commenter No. 71).  The
commenter stated that “Highly reactive chemicals” could be defined
as chemicals with the potential for explosion (or an extremely rapid
release of gas and heat) or that have a self-accelerated decomposition
temperature (SADT) of less than 50 degrees Celsius.  The commenter
stated that this would coincide with the Department of Transportation
definition of explosive material and materials requiring temperature
controls.  The commenter believes this is a preferable definition
because 1) there are many highly reactive chemicals that are not on
EPA’s list and 2) some chemicals on the EPA list may be relatively
no-reactive depending on the state of the material (e.g., a dilute
chemical).

Response:  We agree with Commenter No. 24 and have omitted the reference
to toxicity, as suggested.

We agree with Commenters No. 52 and No. 71 that there may be additional
reactive chemicals in a laboratory that are not on the P-list.  Nothing
precludes an eligible academic entity from broadening its list of
reactive chemicals that would be subject to the 1-quart limit for
accumulation in the laboratory.  Eligible academic entities are
encouraged to add such additional best practices to their LMPs.

Comment: We heard from one commenter requesting clarification regarding
the statement: “Only unused chemicals are considered commercial
chemical products that could carry a “P-listed” waste code. Once a
reactive chemical that is on the P-list has been used, it is not
considered a commercial chemical product.  Therefore, it cannot be a
reactive acutely hazardous unwanted material….” (Commenter No. 107).
 The commenter stated that the P-list also includes containers that have
once held a P-listed waste until it has been emptied per 40 CFR
261.7(b)(3).  

Response:  We disagree with the commenter.  A container that once held a
P-listed chemical and has not been emptied per 40 CFR 261.7(b)(3) is not
a P-listed acutely hazardous wastes when discarded.  The contents of the
container; however, would be reactive acutely hazardous unwanted
material if the contents were any of the P-listed chemicals listed for
reactivity.  This is because 261.33(c) regulates as hazardous waste
“any residue remaining in a container,” it does not regulate the
container itself as hazardous waste.  In addition, when the container is
discarded, if it still does not meet the criteria for being “empty,”
the contents would be considered acute hazardous waste.

We agree with the commenter on the point that it is not only the
residues in a non-empty container that can be a P-listed hazardous
waste.  When we stated that “Only unused chemicals are considered
commercial chemical products that could carry a “P-listed” waste
code,” we were trying to draw a distinction between unused chemicals
and used chemicals.  Our statement focused on chemicals, because
chemicals are the most common type of unwanted material from a
laboratory.  However, chemicals are not the only type of unwanted
material from a laboratory and we did not mean to imply that
contaminated media or other materials could not be P-listed hazardous
waste when discarded.

3.8	Definition of Unwanted Material

Comment:  We heard from eight commenters expressing general support for
the proposed definition (Commenter Nos. 5, 53, 54, 58, 73, 84, 86, and
87).  Another commenter agreed with the definition, endorsed its
specificity, and indicated its desire to see it added to 40 CFR 260.10
so it applies solely to laboratory clean-out commercial chemical
products, in the event that the rest of the proposed rule is not
finalized (Commenter No. 58).

Response:  We thank the commenters for their support of the definition
of “unwanted material” and we have finalized the definition with
only minor changes.  The first change is to reflect the flexibility
allowed in using an “equally effective term” in lieu of the term
“unwanted material,” provided that the term is identified in Part I
of the LMP and is used consistently. The second change is to reflect the
change in terminology from “RCRA-trained individual” to “trained
professional.”  All the definitions for this Subpart remain in 262.200
and apply only to Part 262 Subpart K.

Comment: We heard from six commenters that the definition of “unwanted
materials” is overly broad (Commenter Nos. 5, 8, 11, 25, 79, 107).  
Three commenters stated, as an example, that packing peanuts, packing
boxes, lab coats, and clean broken glass could be subject to removal and
transport by a RCRA-trained individual, which would be completely
infeasible and an insurmountable barrier to participation in the Subpart
K rules (Commenter Nos. 8, 11, and 25).  The commenters suggested
wording changes to address this issue.  Two of these commenters stated
their belief that materials that should be included in this definition
include surplus chemicals for redistribution, process waste, and unused
off-specification material; however, the phrase, "other material from a
laboratory" is overly broad (Commenter Nos. 11 and 25).  Another
commenter expressed its concern about the breadth of the definition and
offered an alternative: “any chemical, mixtures of chemicals, products
of experiments, or other materials from a laboratory or a
laboratory-support operation (such as maintenance shops, wastewater
laboratories, steam plant laboratories, photographic laboratories,
computer laboratories, etc.)….” (Commenter No. 107).  The commenter
also provided a second revised definition that could be suitable in the
event that EPA broadens the rule to cover non-laboratory accumulation
areas.  Another commenter stated that, under the existing RCRA
regulations, the only material that should be classified as “hazardous
waste” at a satellite accumulation area is spent material from a
process (Commenter No. 5).  The commenter does not believe that unused
product left over from an experiment should be considered a hazardous
waste if it can be used.  Another commenter stated that unwanted
materials that do not meet the definition of a solid or hazardous waste
should be excluded from the definition (Commenter No. 79).  The
commenter stated that, as it currently stands, the definition places
unnecessary container management restrictions on non-hazardous unused
chemical reagents that are still in their original containers and may
have a great potential for redistribution.

Response:  We agree with the commenter that not all wastes coming from a
laboratory would be considered unwanted materials.  For example, packing
peanuts, packing boxes, lab coats, and clean broken glass would not be
considered unwanted material.  However, we believe that incorporating a
list of examples into the definition of unwanted material would be
impractical because of the myriad of wastestreams that are generated in
a laboratory.

In light of the fact that the hazardous waste determination is no longer
being made at the point of generation of the waste, it is necessary to
be overly broad in the definition of unwanted material, so that any
chemical or other material from the laboratory that has the potential
for being a hazardous waste is retained and labeled appropriately for a
trained professional to make the determination at a later time.  

Under Subpart K, we realize that some chemicals that are initially
identified as unwanted materials will turn out not to be solid or
hazardous wastes.  If, for example, an unwanted material is brought to
an on-site CAA or TSDF for a hazardous waste determination, and it is
determined that such unwanted material can be reused, then it is not a
solid or hazardous waste and is not subject to Subpart K or the Subtitle
C hazardous waste regulations, once the determination is made.  That is,
if a chemical is initially labeled as an unwanted material and then it
is subsequently discovered that it can continue to be used, the chemical
can be returned to a laboratory or chemical stockroom for
redistribution.  EPA selected the term “unwanted material” over
“laboratory waste,” in part to indicate that the material may still
be useable.  On the other hand, if it is determined that an unused
chemical can no longer be used, then it is a solid waste and potentially
a hazardous waste, as well.

Comment: We heard from one commenter that suggested wording changes to
the definition to clarify that “unwanted material includes any other
material from a laboratory that is no longer needed, wanted or useable,
and has the potential for being a RCRA hazardous waste” (Commenter No.
91).

Response:  We agree with the commenter’s general point , although we
have not made the specific change suggested.  We believe that our use of
the phrase, “…and that is destined for hazardous waste determination
by a trained professional” conveys the same meaning.  

Comment: We heard from five commenters suggesting to change the term
“unwanted material” to another term (Commenter Nos. 46, 60, 76, 88,
102).  Two commenters stated that EPA should change “unwanted
material” to “unwanted chemical” throughout the regulation and
revise the definition to clarify that Subpart K is concerned with
chemicals, specifically those that are determined to be RCRA-hazardous
waste (Commenter No. 60, 88).  Another commenter stated that it would be
very difficult to rename hazardous waste to “unwanted material” for
several reasons (Commenter No. 76). It stated that “unwanted
material” is a vague term that a researcher might conclude includes
“trash”, broken glass, biohazardous waste, and more.  The commenter
believes this could cause confusion, as it would take a long time to
retrain all laboratory workers to accept a new definition.  The
commenter suggested that there should be flexibility under Subpart K to
continue using the words “hazardous waste,” “laboratory waste,” 
“unwanted chemicals,” or other reasonable terms instead of
“unwanted materials.”  The commenter also suggested that the term
“unwanted material” be changed to “hazardous waste” or some
other term throughout the proposed rule, to reflect any flexibility that
EPA decides to offer for what to call hazardous waste generated by
laboratories.  One commenter stated that the term “unwanted
material” is a step in the right direction; however, “Recyclable
Chemical Reagent” may be a better designation (Commenter No. 46).  The
commenter stated that this term connotes that the material has
reclaimable value. The commenter stated, for example, that a bottle of
potassium hydroxide used to calibrate pH meters has an expiration date
for quality assurance in analysis, not because the compound has
degraded.  It can still be used for other purposes.  Another commenter
stated that the term "unwanted material" should not apply to wastes
which are generated in the laboratory through research and experiments,
as most wastes generated during research and experiments are no longer
useable, and are thus deemed waste (Commenter No. 102).  The commenter
believes the term "unwanted material" should apply to unused materials
that the laboratory may have needed for previous experiments, but does
not currently need, and may be able to find another laboratory at the
institution that can use the unwanted material.  The commenter
recommends that EPA revise the definition of "unwanted material" to
reflect this and provide a definition for "laboratory waste" in the
proposed rule for the waste generated during research and experiments in
the laboratory. [Note:  A number of commenters suggested that EPA allow
colleges and universities greater flexibility to use terms other than
“unwanted materials” to label their containers.  Refer to Section
6.2 of this document for these comments.]

Response:  We continue to use the term “unwanted material” in the
final rule.  The Agency prefers this terms over the term “laboratory
waste” which was used in the University Laboratories XL rule (see 64
FR 52380; September 28, 1999), or any other term that includes the word
“waste” because some fraction of the unwanted materials may turn out
not to be solid or hazardous waste.  Stakeholders have frequently told
EPA that putting a “waste” label on a container stigmatizes the
material so that it is difficult to redistribute.  Further, we believe
it would be too confusing to create a system whereby the used chemicals
from a laboratory are called one thing (such as laboratory waste) while
the unused, discarded chemicals are called another (such as unwanted
material).  Therefore, we continue to refer to any chemical that is no
longer wanted, needed, or useable in the laboratory an “unwanted
material” for purposes of drafting this rulemaking.

Nevertheless, we recognize that many commenters object to this term and
we have added flexibility to the final rule to allow eligible academic
entities to use an “equally effective term” in lieu of the term
“unwanted material.  This “equally effective term” must be
identified in Part I of the eligible academic entity’s LMP and must be
used consistently throughout all its laboratories.  It would not be
acceptable for one laboratory at an eligible academic entity to use the
term “laboratory waste” and another laboratory to use the term
“unwanted material.”  In addition, the “equally effective term”
will have the same 

meaning and is subject to all the same requirements as “unwanted
material.”  

4.0 	Notification

Comment: We heard from 15 commenters that expressed general support for
the proposed notification (Commenter Nos. 7, 8, 11, 14, 25, 54, 56, 58,
62, 79, 81, 86, 87, 88, 112).  

Response:  EPA appreciates the support of the commenters.  

Comment: We heard from 12 commenters that expressed support for the use
of EPA Form 8700-12 in notifying EPA or State (Commenter Nos. 8, 11, 25,
53, 54, 56, 66, 71, 79, 81, 88, 113).  The commenters stated that the
form is already familiar to users, compatible with existing tracking
systems, and can be modified easily for this purpose.

Response:  EPA appreciates the support and due to rationale expressed by
the commenters, we have finalized use of EPA Site Identification Form
8700-12 for the notification requirement of Subpart K.  We also believe
by requiring the use of the Site Identification Form for notifying,
there would be increased consistency in reporting.

Comment: We heard from four commenters that expressed opposition to the
use of EPA Form 8700-12 in notifying EPA or State because (Commenter
Nos. 14, 58, 73, 87).  The commenters stated that there is no need to
create or revise a form for this purpose.  Two commenters stated that
the form would limit users’ ability to submit one notice for multiple
sites, since the existing regulations require each site to submit a
separate form (Commenter Nos. 14, 87).

Response:  While commenters are correct that using the EPA Site
Identification Form 8700-12 to notify limits user’s ability to submit
one notice for multiple sites, more commenters supported the use of the
form.  The form is familiar to users and EPA anticipates increased
consistency in reporting by requiring the use of the Site Identification
Form.  EPA finalized the notification requirement with the use of the
EPA Form 8700-12.

Comment: We heard from three commenters that expressed support for EPA
or the State to provide a written receipt of the one-time notice
(Commenter Nos. 14, 79, 81).  One of the commenters clarified that the
notice should be not be required to begin participation under Subpart K
(Commenter No. 14).  Another commenter stated that the Agency should be
required to respond within a specific timeframe (e.g., 2 months)
(Commenter No. 81). 

Response:  EPA and other commenters disagree.  We are not requiring that
the Regional Administrator (or State Director in authorized States)
provide a written receipt of the one-time notice before the eligible
academic entity can manage its unwanted materials under the Subpart K
requirements.  EPA believes waiting for a receipt of notification could
cause delay and confusion for the eligible academic entities.  In
addition, as a commenter below points out, many States already respond
in writing when the Site Identification Form is received.

Comment: We heard from nine commenters that expressed opposition for EPA
or the State to provide a written receipt of the one-time notice
(Commenter Nos. 7, 8, 11, 25, 54, 73, 81, 86, 87).  The commenters do
not see a reason to wait for the notice before participating under
Subpart K, and believe that delays in receiving the notice could cause
confusion.  One commenter stated that the regulatory agency should keep
a copy of the notice in lieu of the college or university (Commenter No.
81).

Response:  EPA agrees with the commenters and is not requiring that the
Regional Administrator (or State Director in authorized States) provide
a written receipt of the one-time notice before the eligible academic
entity can manage its unwanted materials under the Subpart K
requirements for the reasons they submitted.

Comment: We heard from one commenter that stated that many of the states
already respond in writing when a Form 8700-12 is received; therefore,
if the form is used under Subpart K, there is no reason to require a
response from regulators (Commenter No. 113).

Response:  EPA appreciates this comment and is not requiring that the
Regional Administrator (or State Director in authorized States) provide
a written receipt of the one-time notice before the eligible academic
entity can manage its unwanted materials under the Subpart K
requirements for the reasons they submitted.

Comment: We heard from one commenter that asked for clarification on who
at the college or university should issue the notification (Commenter
No. 81).  The commenter’s preference is for the authorized
representative (e.g., EH&S staff) to file the notice.

Response:  The commenter’s preference for the authorized
representative to file the notification is what is required by the Site
ID form instructions.  EPA is requiring the use of the Site
Identification Form for notification of opting into, as well as
withdrawing from Subpart K.  We are not changing the requirements of the
Site Identification Form which must be signed by an operator, an owner
or an authorized representative. 

Comment: We heard from four commenters that expressed concern about the
record retention period for the notification (Commenter Nos. 11, 25, 54,
and 73).  These commenters asked for the period to be reduced to three
years, so that it is consistent with the record retention period for the
withdrawal notice.

Response:  EPA believes that retaining the notification of opting into
Subpart K for the duration that an eligible academic entity is operating
under Subpart K is an essential requirement in this rule.  By retaining
this record, inspectors and implementers will be able to verify that an
eligible academic entity satisfied the notification requirement of
Subpart K and that they are operating under today’s final rule. 

Comment: We heard from one commenter suggesting that notifiers that have
both clinical and academic research laboratories should be required to
note when they operate both types of labs under the same EPA ID number,
along with an indication whether the labs are being operated under the
proposed or existing regulations  (Commenter No. 79).

Response:  EPA includes clinical research laboratories at teaching
hospitals that are either owned by or formally affiliated with a college
or university under the revised definition of laboratory in today’s
final rule.  Therefore, EPA does not include a way to notify which types
of laboratories are operating under Subpart K.  Furthermore, EPA is
requiring that all laboratories owned by the eligible academic entity
within one EPA Identification Number must comply with the same set of
regulations whether that is Subpart K or the existing regulations.

Comment: We heard from one commenter stating that EPA’s estimated
burden for the college to notify EPA appears to be accurate and would be
the same regardless of whether a letter or Site ID Form is used
(Commenter No. 113). However, the commenter stated that the burden for
the implementer for clerical time should be cut in half, from 0.5 hours
to 0.25 hours.

Response:  EPA appreciates the comment on the estimated burden of using
a letter or Site ID Form to notify.  The Notification of Regulated Waste
Activity Information Collection Request (ICR) (#261.15), dated January
2006, includes a different mix of Agency labor hours for initial
notifications versus revised notifications.  For initial notifications,
the ICR assumes 0.55 hr technical/0.20 hrs clerical.  For revised
notifications, it assumes 0.25 hr technical/0.50 hr clerical.  EPA’s
burden estimate of 0.5 hours of clerical time for the implementer is
used in order to be consistent with the estimate used in other
Information Collection Requests.  Therefore, EPA did not reduce the
clerical time from 0.5 hours to 0.25 hours.

Comment: We heard from one commenter expressing its concern that the
regulations require all college or university labs at a site to comply
with the same set of requirements (i.e., either Subpart K or existing
RCRA requirements) (Commenter No. 99).  The commenter believes this is
too burdensome for colleges and universities with multiple organizations
and departments.

Response:  EPA disagrees with the commenter in that requiring all the
laboratories at one site must either operate under Subpart K or the
existing generator regulations is burdensome.  EPA believes it would be
more difficult for an eligible academic entity to keep track of which
set of generator regulations apply to which laboratory or group of
laboratories.  Moreover, it would be extremely difficult, if not
impossible, for the States or Regions to keep track of the applicable
set of regulations if, within a single EPA Identification Number,
different laboratories were choosing to be regulated under different
requirements.  No mechanism currently exists at EPA or the States to
track such distinctions.  Thus, EPA continues to require that all
laboratories owned by the eligible academic entity within one EPA
Identification Number must comply with the same set of regulations.

Comment:  We heard from five commenters suggesting that EPA allow for a
period of time for notifiers under section 262.203 to transition to the
new Subpart K provisions (i.e., a “transition period”) (Commenter
Nos. 11, 25, 62, 102, 112).  One of the commenters suggested a
“waiting period” of 90 days between changes in status (Commenter No.
102).

Response:  While EPA understands that time will be needed to prepare to
switch into a new set of hazardous waste management requirements, at all
times, an eligible academic entity’s laboratories must comply with
either the existing hazardous waste generator regulations or the Subpart
K regulations.  Thus, once an eligible academic entity notifies by Site
Identification Form that it is opting into Subpart K, EPA expects that
the site will be in compliance with the Subpart K requirements. 
Therefore, we strongly suggest that an eligible academic entity prepare
its LMP and ready its facilities for the Subpart K laboratory hazardous
waste management system before it submits a Site Identification Form to
the EPA Regional Authority (or State Director in authorized States). 
Further, an eligible academic entity may, for example, want to train its
employees in the Subpart K labeling requirements and container
management standards before notifying.  In addition, an eligible
academic entity may want to contact its hazardous waste vendors to
prepare the vendor for the eligible academic entity’s switch to
Subpart K.

Comment:  The following are suggested specific edits to the regulatory
text. One commenter stated that sections 262.203(a) and 262.204(a) of
the proposed rule begin with the phrase: “A college or university must
notify the appropriate EPA Regional Administrator in writing that it is
electing …” (Commenter No. 33).  The commenter suggested that the
phrase be modified in the text of the final rule to read as follows:
“A college or university must notify the Director (as defined in 40
CFR 270.2) in writing that it is electing to …”. The commenter
stated that this change would make the language of sections 262.203 and
262.204 in the final rule consistent with the language in other RCRA
hazardous waste regulations that may be implemented by authorized
States. The commenter stated that, if the term “EPA Regional
Administrator” is used in the final rule, it will suggest that
colleges and universities must notify the EPA Regional Administrator,
whether or not the State in which they are located has been authorized
to implement Subpart K. 

Response:  EPA agrees that the wording, “must notify the appropriate
EPA Regional Administrator in writing,” could be confusing to eligible
academic entities.  In addition, EPA intends for eligible academic
entities to notify their States that they are electing to participate in
Subpart K if they are located in states authorized to run their own RCRA
hazardous waste program.  However, we did not change this phrase in the
final rule.  First, the term EPA Regional Administrator is appropriate
for those entities in states that are not authorized to implement their
own hazardous waste program.  And second, it is a typical practice for
the States to alter this language when they adopt rules.  We anticipate
that when states adopt the rule, they will change the above language to
indicate that eligible academic entities must notify their state in
writing.

5.0 	Labeling Containers of Unwanted Material

	5.1	General

Comment: We heard from 19 commenters expressing general or partial
support for the proposed performance-based labeling standards instead of
the prescriptive alternative standards (Commenter Nos. 1, 5, 7, 11, 14,
25, 30, 47, 51, 54, 68, 70, 73, 79, 81, 88, 97, 99, 100).  

Response: EPA thanks the commenters for their support of the proposal
and is finalizing the performance-based labeling standards with a few
changes from the proposal.  EPA believes that the changes add more
flexibility and clarity to the labeling provisions.  See below for more
specifics.

Comment: We heard from 14 commenters that asked for EPA to make the
proposed labeling requirements even more flexible and performance-based
(Commenter Nos. 11, 19, 25, 48, 51, 60, 61, 79, 85, 96, 104, 107, 109,
110).  We heard from two commenters stating that, in lieu of the
requirement to label containers, EPA should consider other labeling
options, such as labeling a given shelf or collection of shelves, with
appropriate information (e.g., accumulation start date or “unwanted
material”) (Commenter Nos. 104, 107).  One of the commenters stated
that its college or university uses between 12,000 and 17,000 containers
annually (Commenter No. 104).  The commenter stated that it would be too
burdensome to implement the proposed labeling procedures.

Response:  EPA did add more flexibility to the labeling requirements by
allowing eligible academic entities to choose another equally effective
term in the place of unwanted material.  However, we disagree that the
suggested method of labeling a shelf with the accumulation start date
and other information would not provide the information necessary to
verify that a particular container had not been accumulating unwanted
material for more than six months in the laboratory and, therefore,
would not allow EPA or an authorized State to determine whether the
laboratory was in compliance with Subpart K.  Some commenters believe
that the labeling procedures are too burdensome because laboratories
typically have a large number of small containers.  EPA believes that
the labeling provisions are flexible yet protective of human health and
the environment.  Because today’s rule provides laboratories owned by
eligible academic entities with flexibility in where and when to make
the hazardous waste determination, labeling requirements for unwanted
materials in the laboratory are needed.  For example, labeling is
critical to ensure that non-laboratory personnel, such as firefighters
can quickly ascertain the hazardous materials that are in the laboratory
in case of an emergency.  The labeling provisions are intended to convey
the most essential information that one needs to know about the contents
of the containers.

Comment: We heard from two commenters expressing support for
prescriptive labeling requirements (Commenter Nos. 53 and 66).  One of
the commenters stated that an enforceable container-labeling regulation
would help inspectors determine where unwanted materials went and how
they were characterized.  Such container labels should include a
chemical description of the unwanted material, whether the material is
used or unused, the manner in which the chemicals were used, and a
description of the possible hazardous properties of the material
(Commenter No. 53).

Response:  EPA appreciates the comments however we believe that the
performance-based container provisions are protective while providing
flexibility to individual eligible academic entities.  Thus, in keeping
with the original intent of the rulemaking, the final rule maintains the
performance-based two-tiered labeling structure.  EPA would like to
point out that the container labeling provisions as proposed and
finalized are enforceable and an eligible academic entity must be in
compliance with them.  The suggested information for container labels in
the comment is similar to the type of information that EPA includes as
examples of information sufficient to make a hazardous waste
determination.  Section 262.206(a)(2)(ii) of Subpart K includes but is
not limited to the following examples of information sufficient to make
a hazardous waste determination:  the name and/or description of the
chemical contents or composition of the unwanted material, or, if known,
the product of the chemical reaction, whether the unwanted material has
been used or is unused, and a description of the manner in which the
chemical was processed, if applicable.  

Comment: We heard from one commenter that all identifying information
regarding the contents of a hazardous waste container should accompany
the container in human readable form (Commenter No. 82).  The commenter
stated that, unlike the use of machine readable price and inventory
codes in the retail environment, a single mismatch in hazardous
materials management can have catastrophic results. Without human
readable checks and balances, accidents and waste mismanagement are
inevitable.

Response:   EPA understands the concerns expressed by the commenter. 
While we did not use the words human readable form in Subpart K, we have
essentially achieved the same standard with the two tiered labeling
requirements.  The label that is “affixed or attached to” the
container must include information to alert emergency responders to the
contents of the containers.  Examples of this information include but
are not limited to the names of the chemicals and the type or class of
chemical such as organic solvents or halogenated organic solvents.  This
type of information needs to be printed or written on the label
“affixed or attached to” each container which means it will be in
human readable form.  We are not allowing the information on the
“affixed or attached to” label to be in bar code form.  We would
also like to stress that we do not believe that chemical formulas on the
“affixed or attached to” labels would supply information for
emergency responders to be able easily discern the contents of the
containers and would not consider this to meet the requirement.

Comment: We heard from one commenter describing its organization’s
requirement that all containers of material that have been used be
labeled with the words “waste” and a listing of each constituent and
a percentage range of each constituent (Commenter No. 5).  The commenter
stated that, if it adds a date that the waste collection containers are
first used, it would assume that this will meet the labeling requirement
of the waste containers covered under the proposed rule.

Response:  EPA agrees with the commenter that they will have the almost
all the necessary information on the container labels by adding the
accumulation start date to the container however the commenter would
have to do other actions to be in compliance.  In summary of Subpart
K’s labeling provision, the first part of the final labeling
requirement consists of information that must be “affixed or attached
to” the container.  The information must consist of the words
“unwanted material” or another equally effective term that is used
consistently by the eligible academic entity and is identified in Part I
of the entity’s LMP.  Since the commenter uses the words “waste”,
the commenter must list this in Part I of its LMP.  Additionally, the
label must contain sufficient information to alert emergency responders
to the contents of the container which would most likely be accomplished
by list of constituents the commenter requires on the container.  The
second part of the final labeling requirement consists of information
that must be “associated with” the container in some manner, which
could include affixing or attaching it to the container.  The
information required includes the date that unwanted material first
begins accumulating in the container, and information sufficient to
allow trained professionals to determine whether the unwanted material
is a solid and hazardous waste, as well as assign the proper hazardous
waste code(s), pursuant to § 262.11.  The list of constituents the
commenter requires on the container may allow a trained professional to
make the hazardous waste determination.  However, whether this list of
constituents is enough information to make a hazardous waste
determination would be chemical specific.  For example, in order to
label some discarded solvents with the correct hazardous waste code, the
label would need to specify what solvent is in the container and how it
was used.  So, while the commenter is right in that he needs to add the
accumulation start date to the container to be in compliance with
Subpart K’s labeling provisions, he may or may not have to do
additional labeling depending on the site specific situations.  

Comment: We heard from one commenter that there should be an allowance
for materials labeled as “RCRA hazardous waste” to also be handled
with unwanted materials that are not yet classified as hazardous waste
(Commenter No. 99).

Response:  Subpart K allows an eligible academic entity to transport
unwanted materials from laboratories and hazardous waste generated in
non-laboratory areas together to the 90 or 180-day area for LQGs and
SQGs respectively.  Under Subpart K, eligible academic entities have the
ability to make the hazardous waste determination to be in the
laboratory before the unwanted materials are removed from the
laboratory, or within four calendar days of arriving at an on-site
central accumulation area (CAA) or interim status or permitted TSDF.  
For eligible academic entities with on-site CAAs or TSDFs, it is not
necessary for the eligible academic entity to limit itself to making the
hazardous waste determination in the same place all the time.  We
realize that this could change depending upon circumstances.  Therefore,
it is possible that containers labeled unwanted materials and containers
for which the hazardous waste has been made will be removed from the
laboratory together for transport to an on-site CAA or TSDF.

Comment:  The following are suggested specific edits to the regulatory
text. One commenter stated that use of the words “physically
accompany” in section 262.206(a) could give rise to multiple
interpretations and recommended that the Agency adopt language such as
“affixed to or within reach of” (Commenter No. 88).

Response:  EPA agrees with the commenter that the words “physically
accompany” in section 262.206(a) could give rise to multiple
interpretations.  In response, we have revised the proposed labeling
requirements in the finalized Subpart K to clarify that the first part
of the labeling requirement requires the label to be “affixed or
attached to” the container of unwanted material rather than be
“affixed to or physically accompany” the container.  We believe this
modified language provides clarity and ensures that, during the
accumulation period in the laboratory or during on-site transfer, the
identifying information will not be inadvertently separated from a
container of unwanted material and thus the contents of any container
can be quickly identified in an emergency situation.  Examples of labels
that are “affixed or attached to” containers of unwanted materials
are stickers that have been affixed on the container by adhesive, or
labels that are attached to a small container of unwanted material
(i.e., too small for an adhesive label) by wire or a piece of tape.

Comment:  One commenter suggested that EPA eliminate the word
“container” from several areas of the rule in order to allow for
more flexible material storage and labeling configurations (Commenter
No. 33).  The commenter provided revised regulatory text, which
incorporated this suggestion as well as other wordsmithing edits.

Response:  EPA disagrees with the commenter.  Subpart K was written as
an alternative set of generator regulations for teaching and research
laboratories owned by eligible academic entities and operating under the
satellite accumulation area regulations.  SAA regulations discuss
containers only as well.  In addition, the definition of container is
fairly broad.  According to 260.10 the definition of container is “any
portable device in which a material is stored, transported, treated,
disposed of, or otherwise handled.”  Further from our site visits to
academic laboratories, we have never a container that would not meet the
definition of container in 260.10.  EPA believes that the use of the
word container is broad, flexible, and appropriate and continues to use
the word container in Subpart K.

	5.2	The Term “Unwanted Material”

Comment: We heard from 19 commenters expressing concern about the
proposed requirement to label unwanted material with the words
“unwanted material” because it does not allow individual colleges
and universities to label their containers as they deem appropriate
based on their specific needs (Commenter Nos. 8, 11, 15, 25, 31, 54, 56,
60, 61, 65, 68, 70, 72, 73, 76, 86, 88, 101, 107).  They asked EPA to
give colleges and universities the flexibility to use different words
and methods (e.g., signage) to identify the contents if they are more
appropriate, as this will help with compliance and suit site-specific
needs. 

Response:  EPA agrees with the commenters and has changed the final rule
to reflect this added flexibility to the labeling requirement.  EPA has
changed the requirement to put the words, “unwanted material” on the
label that must be affixed or attached to the container.  In the final
rule, we are requiring that containers be labeled with the words
“unwanted material” or another “equally effective term” that is
used consistently by the eligible academic entity and is identified in
Part I of the eligible academic entity’s LMP.  Examples of an
“equally effective term” include, but are not limited to,
“laboratory waste” or “chemical lab waste.”  We believe this
approach provides each eligible academic entity with flexibility, yet
conveys the basic information that the material is no longer needed or
wanted in the laboratory.  To this end, if an eligible academic entity
elects to use another equally effective term in lieu of “unwanted
materials,” that term must address and have the same meaning as
“unwanted material,” and is subject to the same requirements in
Subpart K for “unwanted material.”  Additionally, if an eligible
academic entity chooses to use an equally effective term instead of
“unwanted materials,” the eligible academic entity must use the term
consistently in all its laboratories that are covered by its LMP.  It
would not be acceptable for each laboratory at an eligible academic
entity to be free to use its own term of choice because the use of
different terms at the same eligible academic entity would cause
confusion for implementers and enforcers. 

Comment: We heard from one commenter stating that it would support a
proposal that would, at the time of removal from the laboratory for
transport to the central accumulation facility, require labeling with
the words “unwanted material” if a waste determination is not made
at the laboratory and the required hazardous waste labeling is added at
that time (Commenter No. 8).  

Response:  EPA appreciates the commenter’s support of this requirement
of Subpart K.  While the commenter almost exactly paraphrases the
labeling requirements to place the words unwanted material on the
containers, the timing is incorrect.  Eligible academic entities must
label the container with the words “unwanted material” or another
equally effective term that must be identified in Part I of the LMP when
the container first starts accumulating unwanted materials not at the
time of the container’s removal from the laboratory.

Comment: We heard from one commenter suggesting that EPA should allow
the college or university to define its desired terminology in the LMP
(Commenter No. 60).

Response:  EPA agrees with the commenter and has changed the labeling
requirement to allow just this.  Again in the final rule, we are
requiring that containers be labeled with the words “unwanted
material” or another “equally effective term” that is used
consistently by the eligible academic entity and is identified in Part I
of the eligible academic entity’s LMP.  Examples of an “equally
effective term” include, but are not limited to, “laboratory
waste” or “chemical lab waste.”  If an eligible academic entity
decides to use another term instead of “unwanted materials,” then it
must describe it in Part I of its LMP.  To this end, if an eligible
academic entity elects to use another equally effective term in lieu of
“unwanted materials,” that term must address and have the same
meaning as “unwanted material,” and is subject to the same
requirements in Subpart K for “unwanted material.”  

Comment: We heard from one commenter that believes “unwanted
material” could be confusing to the general college or university
campus population and recommended the term “material that requires a
hazardous waste determination” (Commenter No. 65).

Response:  EPA thanks the commenter for its terminology suggestion.  For
the final rule, we are requiring that containers be labeled with the
words “unwanted material” or another “equally effective term”
that is used consistently by the eligible academic entity and is
identified in Part I of the eligible academic entity’s LMP.  Thus,
with this added flexibility, the commenter could use the term,
“material that requires a hazardous waste determination” for its
containers should it wish as long as it records this term in Part I of
its LMP and uses the term consistently.

	5.3	Emergency Response Information

Comment: We heard from 14 commenters objecting to the proposed
requirement to label containers with emergency response information
because the requirement is unnecessary and burdensome (Commenter Nos. 8,
11, 15, 25, 54, 70, 73, 79, 81, 85, 86, 91, 101, 109).  

Response:  EPA disagrees with these comments and believes that
maintaining the emergency response provision is necessary to protect the
safety of workers, students, emergency responders, and others that may
come into contact with containers of unwanted materials.  For safety
purposes, emergency responders need to have a quick way to assess the
contents of a container.  However, we understand that at least part of
the concern was the use of the term “hazards,” in that it caused
some confusion among commenters, many of whom thought that the Agency
was proposing to require Department of Transportation (DOT) hazard
classes or National Fire Protection Agency (NFPA) chemical hazard labels
to be on the label that must be “affixed to or attached to” the
container.  This was not the Agency’s intent.  To address this
misunderstanding, in today’s final rule we have clarified the
requirement that the label contain sufficient information to alert
emergency responders to the contents of the container.  This
performance-based standard could be met by including information such as
the name of the chemical(s) in the container or, alternatively, a
descriptive phrase, such as “inorganic solvents,” “halogenated
organic solvents,” or “water reactive chemicals.”  This
requirement is flexible, yet provides sufficient information to
emergency responders in an easily understandable manner that would allow
them to ascertain the potential dangers associated with the contents of
containers in the laboratory, while being protective of health and
safety.

Comment: We heard from one commenter that believes the information in
section 262.206(a)(2)(ii)(A), the requirement to put sufficient
information about the contents of the container on the label so that a
RCRA trained professional can make a hazardous waste determination
should replace the requirement in section 262.206 (a)(1)(ii) since it
would be more efficient and provides sufficient emergency response
information (Commenter No. 8).

Response:  EPA understands that the commenter is looking to streamline
the container standards but recognizes that information sufficient to
alert emergency responders to the contents of the container
(262.206(a)(1)(ii)) is necessary.  This requirement for the “affixed
or attached to” label was intended to convey the most essential
information that one needs to know about the contents of the container
in an emergency situation.  The types of information an eligible
academic entity may use for this requirement can differ from the
information required by section 262.206(a)(2)(ii) which states that the
label associated with the container (may be on the label that is
“affixed or attached to” the container) must contain information
sufficient to make a hazardous waste determination.  Examples of
information for emergency responders include but are not limited to the
name of the chemical(s) in the container or, alternatively, a
descriptive phrase, such as “inorganic solvents,” “halogenated
organic solvents,” or “water reactive chemicals.”  If an eligible
academic entity chooses to label the container with the words
“inorganic solvents” to meet the emergency responder labeling
standard, this information is not sufficient to make a hazardous waste
determination and this would not meet both requirements.  In addition,
to meet the standard required by section 262.206(a)(2)(ii) to include
enough information to make a hazardous waste determination, an eligible
academic entity may include chemical formulas which would not meet the
emergency responder labeling standard as emergency responders are not
expected to know chemical formulas.  However, EPA made the associated
label flexible in that it is acceptable to have the information
sufficient to make a hazardous waste determination “associated with”
the container or on the label that is “affixed or attached to” the
container.  Thus, an eligible academic entity could potentially place
the information sufficient to make a hazardous waste determination on
the affixed or attached to label and meet the requirements in both
sections 262.206(a)(1)(ii) and 262.206(a)(2)(ii).  For example, an
eligible academic entity could list the names of the solvent in the
container and if it had been used for its intended purpose.  The
chemical name on the label “affixed or attached to” would provide
the necessary information for emergency responders and in combination of
whether the solvent had been used for its intended purpose this
information would provide the necessary information sufficient to make
the hazardous waste determination.  In essence, the commenter could
achieve its suggested change by utilizing the flexibility in the
container labeling requirements.

Comment: We heard from one commenter stating the rule should be revised
to require a hazard label (such as Flammable, Corrosive, Explosive,
etc.) or a National Fire Protection Association (NFPA) "Health,
Flammability, Reactivity" label be affixed to each container of unwanted
material (Commenter No. 24).  

Response:  EPA agrees that for safety purposes, emergency responders
need to have a quick way to assess the contents of a container.  This
labeling requirement is necessary to protect the safety of workers,
students, emergency responders, and others that may come into contact
with containers of unwanted materials.  In the proposal, EPA proposed
that container labels need to alert emergency responders to either the
contents or the hazards of the container.  Under the proposal, putting a
hazard class on the container such at NFPA or DOT placards would fit the
requirement.  However, the requirement was flexible and did not require
these hazard codes.  Due to overwhelming comments to the contrary saying
that it would be difficult to put the hazard codes on the containers,
EPA finalized the labeling requirement to state that the “affixed or
attached to” label must contain sufficient information to alert
emergency responders to the contents of the container.  This
performance-based standard could be met by including information such as
the name of the chemical(s) in the container or, alternatively, a
descriptive phrase of the type or class of chemicals, such as
“inorganic solvents,” “halogenated organic solvents,” or
“water reactive chemicals.”  This requirement is flexible, yet
provides sufficient information to emergency responders in an easily
understandable manner that would allow them to ascertain the potential
dangers associated with the contents of containers in the laboratory,
while being protective of health and safety

Comment: We heard from one commenter stating that the generator should
be asked to put more information other than unwanted materials on the
label of the container (Commenter No. 1).  The commenter states that it
would be extremely shortsighted to simply require waste to be labeled as
"unwanted materials" because even though in small quantities some waste
is extremely hazardous, i.e. mercury, thallium and some organic sulfates
and phosphates. The generator should still be asked/required to make
reasonable efforts to identify materials according to acute hazard, but
not require extensible segregation of waste classes. Failure to do this
would result, after an incident, of requiring all waste generated by
academic institutions handled as though it were a high hazard class. 

Response:  EPA agrees with the commenter and proposed and finalized
requirements to label containers of unwanted materials with the words
unwanted materials or an equally effective term identified in Part I of
the LMP, enough information to alert emergency responders to the
contents of the container, an accumulation start date, and sufficient
information to make a hazardous waste determination.  Thus, eligible
academic entities do need to identify the materials in the container on
the label attached to the container for emergency responders.  The
information required on the container is expected to assist in the
reduction of emergencies as well as the increase in response to an
emergency since emergency responders should be able to determine quickly
what the containers of unwanted materials hold.  Further, the
flexibility of Subpart K’s requirements combined with the structured
nature of the LMP is expected to result in safer laboratory practices
and increased awareness of hazardous waste management.  This will
minimize exposure of humans and the environment to hazardous wastes.  

	5.4	Accumulation Start Date

Comment: We heard from 23 commenters that objected to the proposed
requirement to associate the accumulation start date with containers of
unwanted material because it is unnecessary and more burdensome than the
existing labeling requirements for SAAs (Commenter Nos. 8, 11, 15, 25,
31, 51, 53, 54, 60, 65, 70, 73, 76, 77, 79, 81, 85, 99, 100, 101, 105,
108, 109).  

Response:  EPA understands the commenters’ concerns; however we
maintain that this requirement is necessary to ensure that accumulation
time limits in the laboratory are complied with for containers of
unwanted material.  Without the accumulation start date on the
container, there would be no way for either the implementer or the
inspector to determine how long the container had been in the laboratory
and whether it has exceeded the 6 month time limit.  In addition,
maintaining the requirement to have an accumulation start date on the
label that at a minimum must be associated with the container, allowed
EPA to build in more flexibility in to Subpart K.  First, by having the
accumulation start date on the containers of unwanted materials, EPA
could add another method of removing the containers from the lab: (1)
all containers of unwanted material must be removed from the laboratory
on a regular basis, not to exceed six months or (2) rolling 6 months
where no individual container of unwanted material could remain in the
laboratory for more than six months from its accumulation start date. 
Second, with the accumulation start dates on the container, EPA can now
allow on-site consolidation between laboratories.  Therefore, the dating
requirement for each container of unwanted material has been retained in
Subpart K.

Comment: We heard from eight commenters suggesting that language be
added to the standards to enable recordkeeping of regular removals and
removal offer dates for labs without unwanted materials, in lieu of the
container dating requirement (Commenter No. 11, 15, 25, 31, 54, 73, 77,
85).  

Response:  EPA disagrees with this comment because we believe that the
suggested method would not provide the information necessary to verify
that a particular container had not been accumulating unwanted material
for more than six months in the laboratory and, therefore, would not
allow EPA or an authorized State to determine whether the laboratory was
in compliance with Subpart K.  

Comment: We heard from one commenter that EPA should revise section
262.206(a)(2)(i) to require the date the container of unwanted material
first exceeded the 55-gallon accumulation limit (or one quart of acutely
reactive unwanted material); the commenter believes the proposed
requirement to provide the date that unwanted material first began
accumulating in the container would be less useful for inspectors
(Commenter No. 53). 

Response:  EPA thanks you for your comment but disagrees that the
accumulation start date is less useful for inspectors.  In Subpart K, we
require the removal of unwanted materials from laboratories based
primarily on time, and secondarily by the volume of unwanted materials
in large part because colleges and universities explained to us that
they rarely accumulate 55 gallons of hazardous waste in a laboratory,
except during a laboratory clean-out.  Given that removal of unwanted
materials from the laboratory is time driven, the date that the unwanted
material first started accumulating in a container is the only way that
inspectors and implementers can know that unwanted materials are being
regularly removed from the lab and that an eligible academic entity is
compliance with this provision of Subpart K.  In addition, sections
262.208(d)(1)(i) and 262.208(d)(2)(i) require that when 55 gallons of
unwanted material (or 1 quart of reactive acutely hazardous unwanted
material) is exceeded in a laboratory, the date that the maximum volume
is exceeded must be added to either type of label.  That is, the date
may be added to the label that is “affixed or attached to” the
container, but at a minimum it must be added to the label that is
“associated with” the container.  Thus, eligible academic entities
are required to mark the container with an accumulation start date and
the date that the maximum volumes are exceeded.

Comment: We heard from two commenters about how to label and date unused
materials in their original containers (Commenter No. 5 and 79).  One
commenter stated that since the proposed definition of unwanted material
includes containers of unused material that still have the label from
the manufacturer attached, the commenter assumes that this label on a
container of unused material will meet the labeling requirement for
unwanted material (Commenter No. 5).  The commenter pointed out that
such labeling meets the OSHA requirements for chemical container
labeling.  We heard from the other commenter stating that clarification
is needed with respect to the method for determination of the start date
for an unused material in its original container (Commenter No. 79). 

Response:  It has always been the case under existing RCRA regulations,
and continues to be the case under Subpart K, that chemicals that are
fit for continued use are not solid or hazardous wastes (see §
261.2(e)(1)) until there is a decision to discard the unused material. 
Thus, until the commenter makes the decision to discard the unused
chemical, it would be regarded as product and not waste.  However, once
the decision is made to discard, the unused chemical would be regarded
as unwanted material and the container must then be labeled according to
the provisions in section 262.206.   The commenter would need to add the
words “unwanted material” or another equally effective term that is
used consistently by the eligible academic entity and is identified in
Part I of the entity’s LMP to the “affixed or attached to” label
on the container and mark the date the decision is made to dispose of
the unused material i.e., the accumulation start date for the unused
unwanted material.  EPA agrees with the commenter’s assessment that
the manufacturer label on a container of unused unwanted material could
meet parts of the labeling requirements for unwanted materials under
Subpart K.  The eligible academic entity must ensure that the labels for
the container of unused unwanted material contain enough information to
alert emergency responders to the contents of the containers and to
supply information sufficient to make a hazardous waste determination. 
If the manufacturer label on an original container of unused unwanted
material meets these requirements, then containers only need the
addition of an accumulation start date and the words “unwanted
material” or another equally effective term that is used consistently
by the eligible academic entity and is identified in Part I of the
entity’s LMP to meet the labeling requirements.  

Comment: We heard from one commenter stating that it is not clear
whether EPA intends that the generator maintain a log of each addition
to the container, or to mark an accumulation start date in the sense
afforded by 40 CFR 262.34(a)(2) (Commenter No. 102).

Response:  EPA intends for the generator to mark an accumulation start
date either on the label affixed or attached to the container or at a
minimum on the label associated with the container.  The accumulation
start date must be added to a container’s label when it first starts
to accumulate unwanted materials.  The flexibility in where to mark the
accumulation date as well as the flexibility of the associated label
allows eligible academic entities to mark the accumulation start date in
various ways to best meet their needs.  Some examples of how to mark the
accumulation start date on container labels include but are not limited
to laboratory personnel could number containers of unwanted material and
create an accompanying spreadsheet, laboratories could affix a bar code
to each container of unwanted material that when scanned would provide
the necessary information, and laboratory personnel might choose to
include a printed inventory of the unwanted materials and the associated
information for each container.  Each of these methods of adding an
accumulation start date is acceptable.  An eligible academic entity may
also choose to simply write the accumulation start date on the
“affixed or attached to” container label which also meets the
standard.  EPA would like to clarify that Subpart K does not require a
log of each addition of unwanted materials to the container.

	5.5	Information for Hazardous Waste Determination

Comment: We heard from one commenter who stated its belief that the
hazardous waste determination should be made as soon as possible to the
time that the waste has been generated so the process knowledge of
chemicals used will not be lost (Commenter No. 66).  If that is not
possible, the commenter stated that the waste should be labeled with the
laboratory chemical mixture process knowledge information before being
transported to a central accumulation area. The commenter believes this
is particularly important (e.g., because student populations that use
these chemicals are very transient). 

Response:  EPA appreciates the commenter’s concerns.  However, Subpart
K was written in order to provides laboratories owned by eligible
academic entities with flexibility in where and when to make the
hazardous waste determination.  Along with the flexibility EPA developed
labeling requirements for unwanted materials in the laboratory to ensure
that the commenters concern that the process knowledge of the chemicals
will not be lost is not the case.  Subpart K requires that the label
associated with the container must contain information sufficient to
make a hazardous waste determination.  This requirement provides
flexibility to eligible academic entities in that this information can
be on the label that is “affixed or attached to” the container, but
it must at least be on the label that is “associated with” the
container.  However, we stress that “information sufficient” to make
a hazardous waste determination, whether that information is
“associated with” or “affixed or attached to” containers of
unwanted materials, must ensure that a hazardous waste determination of
the contents can be made.  Examples of information sufficient to make a
hazardous waste determination include, but are not limited to:  the name
and/or description of the chemical contents or composition of the
unwanted material, or, if known, the product of the chemical reaction,
whether the unwanted material has been used or is unused, and a
description of the manner in which the chemical was processed, if
applicable. 

Comment: We heard from four commenters stating that the requirement at
section 262.206(a)(2)(ii) should be revised for the sake of unknown
materials, because information may not be available (e.g., revise it to
say that the label must provide “available” information) (Commenter
Nos. 11, 15, 25, 54).  We heard from one commenter encouraging EPA to
add language to the proposed rule to account for unwanted material that
requires analysis to complete a waste determination (Commenter No. 88). 
The commenter suggested adding a requirement for colleges and
universities to label such unwanted material in such a manner to
indicate that analysis is pending.

Response:  EPA understands that unknown materials can make it difficult
to meet the labeling requirement under 262.206(a)(2)(ii) to provide
information either affixed to, or associated with, a container that is
sufficient to allow a trained professional to properly make the
hazardous waste determination.  Sometimes laboratories end up discarding
chemicals for which little or no identifying information is available. 
We recognize that, in some cases, chemicals will be managed in the
laboratory and that when those chemicals are eventually disposed, it may
not be possible to identify the chemicals.  This sometimes happens when
a researcher retires and leaves unlabeled chemicals behind.  In
addition, some laboratories synthesize new compounds as part of their
research.  In these situations, EPA believes that an eligible academic
entity should put as much information on the label of the container of
unknown unwanted material as possible.  For example, if new compounds
have been synthesized, the researcher can label the container with the
reagents used for the experiment.  Or lab managers can relatively easily
determine the pH of a container of unknown unwanted material to provide
some information on the label.  

While EPA recommends that eligible academic entities put as much
information on the label as possible in the case of unknown materials,
we have also included a requirement that an eligible academic entity
must develop, in Part II of its LMP, procedures for the timely and
reliable characterization of unknown chemicals to help address this
issue in laboratories.  In this element of the LMP, an eligible academic
entity may develop a procedure where the laboratories put words such as
“analysis pending” on the labels of the containers of unknown
unwanted materials.  Finally, when these “unknowns” are disposed of,
it may not be possible to make a hazardous waste determination without
analysis.  Once the containers of unwanted material are brought to the
central accumulation area, an eligible academic entity has 4 calendar
days to make an initial hazardous waste determination and mark the
containers with the words “hazardous waste.”  Because Subpart K
provides the flexibility to associate the hazardous waste codes with the
container before the hazardous waste is shipped off-site, the eligible
academic entity can send the material out for analysis or can have a
vendor come in to determine the hazardous waste codes.

6.0 	Managing Containers of Unwanted Material

	6.1	General

Comment: We heard from 24 commenters expressing general support for the
proposed performance-based container management standards in lieu of
prescriptive standards (Commenter Nos. 5, 8, 11, 14, 17, 20, 25, 29, 30,
47, 51, 54, 58, 60, 68, 73, 76, 79, 81, 82, 86, 87, 97, 99).  Six of
these commenters stated their support of EPA’s approach for container
management standards that require minimizing loss of unwanted materials
via emissions to the air without prescribing closed containers
(Commenter No. 11, 29, 25, 54, 68, 82).  One of these commenters
recommended the use of capping systems which preclude excessive
evaporation while providing for displacement of air while filling from
in-line systems such as High Performance Liquid Chromatography (HPLC) or
allow pressure relief from wastes which have not fully reacted
(Commenter No. 82)

Response:  EPA appreciates the commenters’ support and finalized
Subpart K’s proposed performance-based container management standards
with one minor change and a new requirement.  The requirement that
eligible academic entities must properly manage containers of unwanted
material to assure safe storage of the unwanted materials, to prevent
leaks, spills, emissions to the air, adverse chemical reactions, and
dangerous situations that may result in harm to human health or the
environment has remained the same from proposal.  Similarly, containers
must be compatible with their contents.  A minor clarification was added
to the requirement that damaged containers be replaced because several
other commenters requested that the Agency add language clarifying that
replacing damaged or degraded containers is not the only method of
reducing their threat.  We agree and have added the requirement in the
final rule that damaged or degraded containers be replaced, overpacked,
or repaired, in order to prevent releases of the container’s contents
into the environment.  An example of overpacking a container is taking a
damaged container of unwanted materials and placing it into a second
container in good condition and then packing the second container with
absorbent filler similar to the practice of lab-packing.  An example of
repairing a damaged container would be if a small leak appears in the
cap of a container of unwanted material, and a laboratory worker covered
the broken cap with a polymer film.  

In addition, EPA has added a new requirement for container management.
As EPA explained in the proposal, if we added a working container
provision, we would also add a more specific container management
provision, requiring that any container of unwanted materials that does
not fit the definition of a working container be closed at all times
except when adding or removing unwanted materials.  Because many of the
commenters above also wrote in favor of a working container provision,
we have decided to include a provision in Subpart K allowing
laboratories to use “working containers” along with the requirement
that these non-working containers remain closed, except to add or remove
unwanted material.

The comment about “in-line” collection of unwanted materials is
consistent with what the Agency has heard over the years through our
Project XL with the three New England colleges and universities, as well
as through public meetings.  In many cases, automated laboratory
equipment will shut down if air is not able to escape from an in-line
collection system because of a build-up of pressure.  Thus in response,
we have modified the container management regulations to add two
additional situations (besides working containers) in which containers
are not required to be completely closed, because in these two
situations keeping a container of unwanted materials closed may be
problematic.  Specifically, the final rule allows containers to be
vented when it is necessary (1) for the operation of laboratory
equipment, such as in-line collection, and (2) to avoid dangerous
situations, such as the build-up of extreme pressure.

Comment: We heard from five commenters indicating a preference for the
alternative, prescriptive container management standards (Commenter Nos.
40, 41, 66, 102 and 105).  Two of the commenters stated that containers
should remain closed, except when adding or removing waste (Commenter
Nos. 102 and 105).

Response:  EPA appreciates the commenters’ preference.  However, we
decided to maintain the performance-based container standards because we
believe they are protective of human health and the environment, while
providing flexibility to eligible academic entities.  Further, with the
inclusion of a working container provision, we allow containers that are
in use for collecting unwanted materials to be open while the experiment
is running, while at the same time we provide protection by requiring
that non-working containers be closed at all times, except when adding,
removing, or consolidating unwanted materials.  We believe that the
requirement that containers remain closed, except when adding, removing,
or consolidating unwanted material is straightforward and is protective
of human health and the environment.  Requiring that containers remain
closed, except in certain instances, will prevent or mitigate accidents
in the laboratory that could otherwise lead to spills or releases.

Comment: We heard from seven commenters that recommended language for
EPA to insert into section 262.206(b) to integrate “hazardous
emissions” into the performance-based standards for management of
containers (Commenter Nos. 11, 20, 25, 54, 68, 82, 86).  The commenters
also suggested that there are variety of ways to properly manage damaged
containers to prevent releases other than replacing damaged or degraded
containers such as overpacking or repairing.  The commenters suggested
language to clarify that “degraded containers” must be managed to
mitigate hazards.  One of these commenters recommended that such hazards
be addressed in the LMP (Commenter No. 68).

Response:  EPA has decided against incorporating language into Subpart K
that specifies that containers must be managed to prevent
“hazardous” air emissions from containers because the term is not
defined in the Resource Conservation and Recovery Act and could lead to
inconsistent interpretations.  In terms of the second part of the
commenters concerns about replacing damaged or degraded containers to
prevent releases, we agree that there are other ways to mitigate the
hazards.  However, instead of the using the language suggested by one
commenter, we have added the requirement in the final rule that damaged
or degraded containers be replaced, overpacked, or repaired, in order to
prevent releases of the container’s contents into the environment.  We
believe by providing proven options on how to manage damaged containers
we are providing flexibility to laboratories while continuing to be
protective of human health and the environment.  An example of
overpacking a container is taking a damaged container of unwanted
materials and placing it into a second container in good condition and
then packing the second container with absorbent filler similar to the
practice of lab-packing.  An example of repairing a damaged container
would be if a small leak appears in the cap of a container of unwanted
material, and a laboratory worker covered the broken cap with a polymer
film.

Comment: We heard from one commenter that encouraged the Agency to
modify the container management standards to reflect the language used
in the preamble: “management to prevent spills, leaks, or adverse
environmental releases, including minimizing loss of unwanted materials
via emissions into the air; practices to ensure containers are kept in
good condition and damaged containers are replaced; and management to
ensure that unwanted materials are compatible with their containers to
avoid reactions between the contents and its container” (Commenter No.
8).  

Response:  While EPA appreciates the comment, the language used for the
container management standards remains the same except in certain
instances.  EPA believes the language is straightforward and
understandable.  The preamble language was more descriptive because it
is where EPA can explain the regulatory requirements in depth.   

Comment: We heard from one commenter that suggested replacing the
proposed container standards with alternative standards that are more
performance-based as follows: “(b) Management of Containers in the
Laboratory:  A college and university must properly manage containers of
unwanted chemicals as described in a Laboratory Management Plan, to
assure safe storage, to prevent spills, and to avoid dangerous situation
in which adverse chemical reactions may occur” (Commenter No. 60). 

Response:  EPA disagrees with the commenter.  We have determined that a
combination of both performance-based and prescriptive approaches (as it
relates to whether containers must be kept closed) is more protective of
human health and the environment than performance-based requirements
alone for container management standards.  Today’s final rule contains
container management standards that require that containers be managed
to assure the safe storage of the unwanted material, to prevent leaks,
spills, emissions to the air, adverse chemical reactions, and dangerous
situations that may result in harm to human health or the environment. 
Specifically, Subpart K continues to require that containers be
maintained and kept in good condition and that damaged containers be
replaced, overpacked, or repaired.  Additionally, containers must be
compatible with their contents to avoid reactions between the contents
and the container and must be made of, or lined with, material that is
compatible with the unwanted material so that the container's integrity
is not impaired.  Finally, containers of unwanted material must be kept
closed at all times, with three exceptions:  (1) when adding, removing
or consolidating unwanted material, (2) when using working containers,
which may be open until the end of the procedure or work shift, or until
they are full, whichever comes first, and (3) allowing containers to be
vented if necessary for the proper operation of laboratory equipment,
such as with in-line collection, or to prevent dangerous situations,
such as build-up of extreme pressure.  The Agency believes it is
preferable to maintain the requirement that containers remain closed,
except when adding, removing or consolidating unwanted material in most
instances, while allowing for a few specific instances in which it is
not appropriate, rather than to eliminate the requirement for closed
containers altogether.  This is because such an approach provides the
flexibility in specific situations where commenters have shown that
requiring closed containers is inappropriate and does not compromise
protection for all the other containers of unwanted materials that have
no cause to be open.

Comment: We heard from one commenter that pointed out that the standards
provide that “unwanted materials would have to be properly controlled
within the container” (Commenter No. 107).  The commenter noted that
unwanted materials in laboratories may include manufactured items such
as thermometers, circuit boards, lead shielding or other articles, which
are reasonably self-contained.  

Response:  EPA thanks you for your comment and agrees that unwanted
materials must be properly managed within their containers and that
certain unwanted materials in the laboratory are already reasonably
self-contained.  

	6.2	Working Containers

Comment: We heard from 21 commenters expressing general or partial
support for the proposed working container approach (Commenter Nos.  8,
11, 14, 20, 25, 37, 47, 51, 53, 54, 68, 70, 73, 77, 79, 81, 84, 86, 91,
99, 108).  One of these commenters stated that EPA should make the
working container approach more widely available to generators by
codifying it at section 262.34(c) (Commenter No. 84).

Response:  EPA thanks the commenters for their support and
consequentially we included a provision in Subpart K allowing
laboratories to use “working containers.”  EPA cannot codify a
working container approach in section 262.34(c) because that is beyond
the scope of this particular rulemaking.  

Comment: We heard from three commenters expressing general opposition to
the proposed working container approach (Commenter Nos. 40, 41, 102). 
One of the commenters stated that the presence of working containers in
a lab makes it difficult for inspectors to discern between working
containers and other containers, complicating compliance inspections
(Commenter No. 102).  Two of the commenter stated that the working
container approach is not protective of human health and the environment
because it would essentially be comparable to allowing open containers
at satellite accumulation areas (SAAs) and enabling the inadvertent
release of the contents (Commenter Nos. 40, 41).  They stated that the
proposed container management standards are sufficiently flexible in
container and material management.  

Response:  EPA understands the concerns of the commenters but disagrees.
 We believe that we’ve developed definitions and container management
standards that are specific enough to easily allow inspectors to discern
between working containers and other containers.  In addition, the
inclusion of a working container provision in Subpart K is not
comparable to allowing open containers at SAA regulations because we
have also added specific closed container requirements to accompany the
working container.  We have finalized Subpart K with the requirement
that containers of unwanted material must be kept closed at all times,
with three exceptions:  (1) when adding, removing or consolidating
unwanted material, (2) when using working containers, which may be open
until the end of the procedure or work shift, or until they are full,
whichever comes first, and (3) when containers need to be vented for the
proper operation of laboratory equipment, such as with in-line
collection, or to prevent dangerous situations, such as build-up of
extreme pressure.  The Agency believes it is preferable to maintain the
requirement that containers remain closed, except when adding, removing
or consolidating unwanted material in most instances, while allowing for
a few specific instances in which it is not appropriate, rather than to
eliminate the requirement for closed containers altogether.  This is
because such an approach provides the flexibility in specific situations
where commenters have shown that requiring closed containers is
inappropriate and does not compromise protection for all the other
containers of unwanted materials that have no cause to be open.  

Comment: We heard from nine commenters that were opposed to the
requirement that containers that are not working containers must remain
closed (Commenter Nos. 5, 11, 17, 25, 31, 51, 68, 77, 79).  These
commenters assert that this requirement is not performance-based and
could increase hazards in the laboratory.  

Response:  EPA disagrees with the commenters.  We believe that the
requirement that containers remain closed, except when adding, removing,
or consolidating unwanted material is straightforward and is protective
of human health and the environment.  The Agency believes it is
preferable to maintain the requirement that containers remain closed,
except when adding, removing or consolidating unwanted material in most
instances, while allowing for a few specific instances in which it is
not appropriate, rather than to eliminate the requirement for closed
containers altogether because it will prevent or mitigate accidents in
the laboratory that could otherwise lead to spills or releases.  We have
finalized Subpart K with the requirement that containers of unwanted
material must be kept closed at all times, with three exceptions:  (1)
when adding, removing or consolidating unwanted material, (2) when using
working containers, which may be open until the end of the procedure or
work shift, or until they are full, whichever comes first, and (3)
allowing containers to be vented if necessary for the proper operation
of laboratory equipment, such as with in-line collection, or to prevent
dangerous situations, such as build-up of extreme pressure.  his is
because such an approach provides the flexibility in specific situations
where commenters have shown that requiring closed containers is
inappropriate (for example where venting is necessary) and does not
compromise protection for all the other containers of unwanted materials
that have no cause to be open.  Furthermore, this approach is simpler
for an eligible academic entity to implement and is more easily
enforceable.

Comment: We heard from one commenter stating that whether or not a
container can be left open for a period of time should be based on the
hazards of the waste being placed into the container (Commenter No. 5). 
The commenter stated that, if the chemicals used have hazards associated
with them that require the work be performed inside a chemical fume
hood, then the waste container should probably only be opened inside a
chemical fume hood and only for the period of time that waste is being
transferred into it.  For work that can be safely performed on the bench
top, the waste container could remain open for the duration of time the
procedure is being performed.  The commenter stated that container
condition and compatibility with the contents is always an important
container management concern.

Response: EPA agrees with the commenter that container condition and
compatibility with the contents is always an important container
management concern and it is why Subpart K requires that containers must
be compatible with their contents and that damaged or degraded
containers be replaced, overpacked, or repaired, in order to prevent
releases of the container’s contents into the environment.  In
addition, we added a working container provision to the container
management standards to allow containers that fit the definition of a
working container to be open until the end of the procedure or work
shift, or until they are full, whichever comes first.  Non-working
containers must remain closed with 2 exceptions:  (1) when adding,
removing or consolidating unwanted material and (2) when containers need
to be vented for the proper operation of laboratory equipment, such as
with in-line collection, or to prevent dangerous situations, such as
build-up of extreme pressure.  The performance-based container
management provisions require that eligible academic entities properly
manage containers of unwanted material to assure safe storage of the
unwanted materials, to prevent leaks, spills, emissions to the air,
adverse chemical reactions, and dangerous situations that may result in
harm to human health or the environment.  This container management
provision extends to working containers.  If a container of unwanted
material should only be opened under a chemical fume hood to prevent
emissions to the air, then the eligible academic entity should ensure
that this is the practice in its laboratories.  Furthermore, the
commenter’s suggestion that the period of time a working container can
be left open should be based on the hazards of the contents of the
container of unwanted materials, assumes a high level of knowledge of
the contents of the container.  One of the reasons EPA developed Subpart
K is that most individuals involved in hazardous waste generation
activities at eligible academic entities’ laboratories are students. 
Students are inherently transient, which makes it more difficult to
train them.  Therefore in Subpart K, we removed the responsibility for
the hazardous waste determination from the students in the laboratory
and placed it in the hands of trained environmental health and safety
(EH&S) professionals.  Thus, it is unlikely that students would have the
required knowledge of the hazards of the contents of a working container
and how long it is safe to remain open since this information is very
similar to the specialized knowledge needed to make a hazardous waste
determination.

Comment: We heard from 11 commenters that expressed a desire for EPA to
increase the maximum size limit of a working container (e.g., to five
gallons) (Commenter Nos. 8, 11, 13, 20, 25, 37, 54, 70, 76, 81, 91) or
to not define the size of a working container but allow colleges and
universities to link the volume of a container to the hazardous
properties of the material in it (Commenter No. 108).  These commenters
believe a higher maximum size is safe and appropriate.  One of the
commenters asked that, if EPA decides on one gallon or less, it should
change the specification to four liters or less because most solvent
bottles are four liters in size (Commenter No. 81).

Response:  Commenter 81 is correct.  Since one gallon is equal to 3.78
liters, the one-gallon limit discussed in the preamble to the proposed
rule would have precluded the use of four-liter solvent bottles as
working containers.  The Agency believes that a 5-gallon limit for
working container is too large to be appropriate despite suggestions
from commenters.  Given that water weighs 8.34 pounds per gallon, a full
5-gallon container would weigh in excess of 40 pounds, which may be
pushing the limits of what can be easily manipulated by one person
(without the aid of equipment or other devices).  This is especially
true considering that the contents of many working containers will be
transferred to other containers for disposal.  In fact, this example
with the weight of water also demonstrates why a limit on the size of
the working container is needed.  Nevertheless, we do agree that since
4-liter solvent bottles are commonly used as collection containers in
laboratories and are easily manipulated by one person, even if full, the
Agency believes a two-gallon limit for working containers is more
appropriate.  Furthermore, two gallons is consistent with an
interpretive letter signed by both Region I and the State of
Massachusetts (September 2004; a copy of which is in today’s docket),
that originally introduced the concept of a working container under
RCRA.  Therefore, in response to these comments, the Agency has
increased the maximum size of a working container to two gallons but not
five.  

Comment: We heard from five commenters stating that working containers
may be associated with/attached to analytical equipment and may require
a period of time (e.g., months) to fill up and that this should be
addressed in the rule (Commenter Nos. 8, 11, 25, 61, 81).  The
commenters expressed concern about the requirement to empty such
containers “at the end of the procedure,” in cases when the
container is not filled up.

Response:  Under Subpart K, we have made a distinction between working
containers and in-line containers.  We believe that the commenters'
concern actually relates to in-line containers and not working
containers as defined in Subpart K.  EPA added a working container
provision to Subpart K and defined working containers as, “a small
container (i.e., two gallons or less) that is used at a laboratory
bench, hood, or other work station in order to collect unwanted material
from a laboratory experiment or procedure.”  An in-line collection
system is a piece of laboratory equipment, such as a high performance
liquid chromatograph (HPLC) that is directly connected to a container
that collects unwanted material, including hazardous waste, typically by
tubing.  The tube carries the unwanted material from the equipment
directly into the container.  

In previous guidance relating to the SAA regulations, we stated that
when a facility has equipment that discharges hazardous wastes to
attached containers (i.e. in-line containers), the attached containers
must be in compliance with the SAA regulations (see memo from Springer
to the Regions, dated March 17, 2004.  Likewise, under Subpart K,
in-line containers must be in compliance with the container labeling and
container management standards applicable to containers of unwanted
material.  Specifically, an in-line container of unwanted material can
accumulate for a maximum of six months in the laboratory and must be
labeled according to section 262.206(a).  In-line containers of unwanted
materials must be closed at all times except when adding, removing, or
consolidating unwanted material, or when venting of the container is
necessary for the operation of the equipment.  Therefore, the
commenters' concern about a requirement to empty an in-line container
before it is full is less of a concern, as in-line containers can
accumulate unwanted materials for up to six months before the unwanted
material must be removed from the laboratory.  

On the other hand, we have included a working container provision to
provide flexibility for temporary container such as beakers used at
benchtops to collect unwanted materials.  Unlike in-line containers,
working containers "may be open until the end of the procedure or work
shift, or until it is full, whichever comes first, at which time it must
either be closed or the contents must be emptied into a container that
is closed after the contents of the working container are added.” 

Comment: We heard from seven commenters that encouraged EPA to add a
definition of working container to the regulations (Commenter Nos. 11,
13, 25, 54, 73, 81, 91).  These commenters believe a definition would
resolve potential container management difficulties.  Five of these
commenters recommended the following definition: “A working container
is a container of five gallons or less used at the bench or work station
to actively accumulate unwanted material prior to the end of the
procedure, and managed accordance with section 262.206(b)” (Commenter
Nos. 11, 25, 54, 73, 91).  Another commenter offer the definition: “A
container of less than five gallons in volume used at the bench or work
station that is receiving, or could reasonably be assumed to receive,
additional waste” (Commenter No. 13).

Response:  EPA agrees with the commenters that a working container
provision resolves certain container management difficulties in that it
allows containers that are in use for collecting unwanted materials to
be open while the experiment is running, while at the same time it
provides protection by requiring that non-working containers be closed
at all times, except when adding, removing, or consolidating unwanted
materials.  Thus we included a provision in Subpart K to allow
laboratories to use “working containers.  A working container is
defined in Subpart K as a “small container (i.e., two gallons or less)
that is used at a laboratory bench, hood, or other work station in order
to collect unwanted material from a laboratory experiment or
procedure”.  In addition, we have added to the container management
standards under 262.206(b) a requirement that a working container may be
open until the end of the procedure or work shift, or until it is full,
whichever comes first, at which time it must either be closed or the
contents must be emptied into a container that is closed after the
contents of the working container are added.  We feel that these
additions are responsive to the comments above.  In regards to the
2-gallon limit placed on working containers, see the comment above for
an explanation.

Comment: We heard from two commenters that expressed concern that the
working container alternative would require the container to be under
the control of a laboratory worker (Commenter Nos. 11, 25).  The
commenters offered alternative performance-based standards for
containers that they believe would obviate the need for this provision.

Response:  EPA understands the commenters’ concerns and changed the
definition of working container to: “a small container (i.e., two
gallons or less) that is used at a laboratory bench, hood, or other work
station in order to collect unwanted material from a laboratory
experiment or procedure”.  Any laboratory personnel, including
students and laboratory workers are allowed to use working containers in
the laboratory and we did not intend to inadvertently limit the use of a
working container.

Comment: We heard from ten commenters that expressed concern about a
requirement to label working containers with the date that accumulation
began and/or to remove working containers regularly from the lab
(Commenter Nos. 11, 13, 25, 31, 54, 61, 76, 77, 81, 91).  Two commenters
suggested that EPA require labeling and removal when the working
container is filled or can no longer receive waste from active research
(Commenter Nos. 11, 13).  

Response:  EPA has added to the container management standards a
requirement that a working container may be open until the end of the
procedure or work shift, or until it is full, whichever comes first, at
which time it must either be closed or the contents must be emptied into
a container that is closed after the contents of the working container
are added.  EPA understands the concerns of the commenters about
labeling working containers with an accumulation start date and other
labeling requirements.  Under Subpart K, working containers do not have
to be labeled like other containers of unwanted material until the end
of the procedure or work shift, or until it is full, whichever comes
first, at which time they not only have to be closed, but labeled
according to section 262.207 or put into another container that is
closed and labeled according to section 262.207.  In terms of removing
containers of unwanted material from the laboratory, an eligible
academic entity must either (1) remove all containers of unwanted
material from each laboratory on a regular interval, not to exceed 6
months or (2) remove containers of unwanted material from each
laboratory within 6 months of each container’s accumulation start
date.

Comment: We heard from one commenter stating that its organization’s
current requirement is that all working solutions in the lab be labeled
with the individual constituents and percent of each constituent and
either the date the solution was made or an expiration date that is two
years from the date the working solution was made (Commenter No. 5). 
The commenter assumes that such a label will meet the requirement for
labeling for working solutions that are covered in the rule.

Response:  It appears that the commenter is asking about working
solutions and not working containers.  Working solutions that are being
used are neither waste nor unwanted materials.  It has always been the
case under existing RCRA regulations, and continues to be the case under
Subpart K, that chemicals that are fit for continued use are not solid
or hazardous wastes (see § 261.2(e)(1)) until the decision to discard
the unused material.  As long as working solutions are being used, then
they are not regulated as a solid or hazardous waste and would not be
regulated under Subpart K.  Until the commenter makes the decision to
discard the working solution, it is a product and not a waste.  Thus,
the labeling the commenter chooses to use for its products or working
solutions is at their discretion.  

Comment: We heard from one commenter expressing its support for
management procedures for working containers that are distinguished from
the management procedures for full “unwanted material” containers
(Commenter No. 81).  The commenter also expressed its preference for EPA
to state “safe distance from” in qualitative terms instead of
including actual distances, to enable colleges and universities greater
flexibility in the lab.

Response:   EPA thanks the commenter for its support of a working
container provision as we did include this provision in the final
Subpart K requirements.  The second part of the commenters concern for
container management deals with storing containers a safe distance from
each other.  In the preamble to the proposed rule, we included some
examples of specific requirements we were considering in lieu of the
proposed performance-based container management requirements, such as
secondary containment and imposing a minimum safe distance for the
storage of incompatibles.  In the final rule, we did not include
specific requirements for a minimum safe distance to store incompatibles
in the laboratory because we wanted to still allow eligible academic
entities some appropriate level of flexibility.  Subpart K is finalized
with most of the performance-based container management standards we
proposed due to a significant number of comments supporting this option.

7.0 	Training

	7.1	General

Comment: We heard from 17 commenters expressing general or partial
support for the proposed performance-based training and instruction
requirements, in lieu of the prescriptive training requirements
(Commenter Nos. 7, 8, 11, 14, 17, 25, 30, 37, 54, 60, 68, 73, 79, 81,
86, 88, 97). 

Response:  After careful analysis of the comments concerning the
performance-based nature of the training requirements under Subpart K,
EPA agrees with commenters supporting the performance-based approach.   

Comment: We heard from 13 commenters asking for the proposed training
requirements to be made more performance-based and include greater
flexibility in training approaches (e.g., use of postings and signage)
(Commenter Nos. 8, 11, 19, 25, 36, 37, 48, 54, 60, 71, 73, 96, 110). 

Response:  We maintain the level of flexibility provided in the proposal
is appropriate and gives eligible academic entities the flexibility to
offer training to laboratory workers and students through their choice
of an effective method, provided the information is sufficient and
thorough enough to ensure proper management of the unwanted materials by
laboratory personnel in order to avoid dangerous situations.  The
flexibility provided gives participating eligible academic entities a
wide variety of choices in approaches for training that may be
customized to each individual entity’s operations.   However, EPA
disagrees that merely posting a sign would adequately instruct
laboratory workers and students on the proper and safe management of
unwanted materials.  Rather, use of postings or signs may supplement and
serve as a reminder of the more formal training, but does not itself
constitute “training” for the purposes of today’s final rule.

Comment: We heard from two commenters expressing support for a more
prescriptive approach to training and instruction (Commenter Nos. 7,
66).  One commenter stated that, although the proposed training
requirements for students seems to be appropriate, the proposed
alternative approach of a job-specific level of training makes sense, as
long as the job descriptions of employees match their actual level of
expected responsibility within the Laboratory Management Plan (Commenter
No. 7).  The commenter believes that EPA needs to establish a clear and
concise required curriculum for RCRA training in order to make the
Subpart K requirement meaningful. The commenter believes such training
should cover all aspects of hazardous waste identification, generator
requirements, and container management.  The commenter stated that
training requirements should apply to both generators and vendors who
may make regulatory decisions.  

Response:  EPA agrees with the commenter’s general statement with
respect to the degree of training necessary for students, laboratory
workers and personnel involved with hazardous waste determinations and
on-site transfers of unwanted materials.  The training provisions in the
final rule requires that students, laboratory workers and individuals
involved in the waste management activities must  be trained
commensurate with their individuals duties.  Commensurate training
constitutes training aligned with an individual’s assigned duties and
job or enrollment classifications and the degree of involvement with the
management of unwanted materials.  In addition, vendors must also be
adequately trained commensurate with the duties they perform.  However,
EPA disagrees with the need for a regulatory requirement establishing a
prescribed training curriculum under Subpart K and maintains
performance-based training requirements setting training standards
provides adequate training requirements that will lead to safer unwanted
materials management that is protective of human health and the
environment.

Comment: We heard from one commenter stating that the proposed training
requirements are overdone and would place undue burden on CUs and
regulatory inspectors (Commenter No. 58).  The commenter stated its
preference for EPA to retain the existing training requirements.

Response:  After careful consideration of comments on the proposed
training requirements, we agree that the proposed requirements added a
layer of complexity in relation to the distinction made between
“instruction” for students and “training” for laboratory
workers.  The final training requirements removed this complexity by
eliminating this distinction and making training requirements the same
for students and laboratory workers.  Under Subpart K both students and
laboratory workers must be trained commensurate with their assigned
duties or job/enrollment classifications.  However, we maintain that
performance-based provisions for training students and laboratory
workers in the laboratory are appropriate under Subpart K and do not
place undue burden on eligible academic entities or regulatory
inspectors.  EPA further maintains that individuals involved in
hazardous waste determination or on-site transfers of unwanted materials
are “trained professionals”  which requires that the individual
complete the applicable RCRA training requirements of § 265.16 for
LQGs, or § 262.34(d)(5)(iii) for SQGs and CESQGs.  Although current
satellite regulations do not require training in the laboratory, EPA
believes training students and laboratory workers in proper unwanted
materials management in the laboratory commensurate with their duties is
an essential ingredient under Subpart K. 

EPA has sought to minimize burden wherever possible for training
requirements or considered minimization of burden in the following ways:
 (1)  the training provision for “trained professionals” utilizes
current RCRA training requirements which requires that the individual
complete the applicable RCRA training requirements of § 265.16 for
LQGs, or § 262.34(d)(5)(iii) for SQGs and CESQGs, (2) Subpart K is an
optional regulation whereby individual eligible academic entities may
choose to continue to operate under current regulations, (3) training is
commensurate with duties and does not require that all individuals in
the classroom setting or individuals not involved in making the
hazardous waste determination or transfers of unwanted materials on-site
receive the full complement of RCRA training, and (4) under the
laboratory clean-out provision some eligible academic entities may be
able to maintain a lower RCRA generator status which would enable them
to benefit from reduced training requirements.

Comment: We heard from one commenter suggesting that the effectiveness
of a college or university’s performance-based communication of
information can be periodically reviewed for adequacy (e.g., through
measurement of results, knowledge of personnel) (Commenter No. 60).  

Response:  The Agency thanks the commenter for his suggestion.  In
general, we believe periodic review of the effectiveness of an
entity’s developed practices (including performance-based
communication of information) may provide valuable and insightful
information.  We believe the development of a planning document that is
reviewed as needed will provide a useful tool that will lead to
continued development of best practices that keeps pace with changes at
the institution.  Therefore, Subpart K retains the requirement to
develop a Laboratory Management Plan and to review the document as
needed.   The Agency does not believe this requirement would preclude
participating eligible academic entities from utilizing additional
methods to monitor the adequacy of their practices and believe other
means of review in conjunction with the LMP provisions of Subpart K
would enhance planning and improvements at a participating institution. 

Comment: We heard from two commenters suggesting that the training and
instruction requirements might better be placed in the chemical hygiene
plan for the site (Commenter Nos. 51 and 99). 

Response:  Subpart K has two training components that take a
performance-based approach.  First, participating eligible academic
entities must comply with the training requirements set forth in §
262.207.  These requirements are performance-based in nature and provide
flexibility for institutions to provide an effective method of training
to students and laboratory workers provided the training meets the
specific requirements for training relevant individuals.  The second
training component, also performance-based in nature, is a requirement
under § 262.214 to describe in Part II of a participating entity’s
Laboratory Management Plan (LMP) their intended best practices for
providing training to students and laboratory workers commensurate with
their duties, and for ensuring safe transfers of unwanted materials and
hazardous wastes on-site by trained professionals.  In addition, the
final rule stipulates that participating eligible academic entities may
revise an existing plan such as a Chemical Hygiene Plan or other
existing plan to fulfill the LMP requirements of Subpart K.  However, we
disagree that the training requirements should solely be placed in a
planning document.  Instead, EPA believes a more traditional approach
with specific performance-based requirements in the regulations
accompanied by an eligible academic entity’s planning document
describing its intended best practices for training will result in
overall better environmental management, safer unwanted materials
handling and protection of human health in the environment. 

Comment: We heard from one commenter suggesting that if EPA adds
non-academic institutions to the rule, EPA should allow the transient
workforce to receive waste management instruction, in lieu of training,
including individuals who do not perform independent research tasks
(Commenter No. 14).  The commenter stated that, under these criteria,
undergraduate summer hires and student interns would be equivalent to
the university student for purposes of receiving instructions.

Response:  We thank the commenter for this suggestion; however, Subpart
K, as finalized, does not include non-academic entities in the scope of
the rule.  In addition, the distinction between instruction and training
has been removed from the final rule.

Comment: We heard from one commenter expressing concern that there are
no specified time frames for the initial training for lab workers or
students such as requiring training within a specified time from first
conducting laboratory duties, and there are also no time requirements
specified for recurring training (Commenter No. 105).  The commenter
also stated that the type and amount of training that will be given by
the university or laboratory should be a required part of the Laboratory
Management Plan.  

Response:  We agree with the commenter that the participating entity’s
LMP should include a required training component.  Therefore, as was
proposed, the final rule requires that all participating eligible
academic entities develop an LMP and review the LMP as needed.  The
training requirements are performance-based in nature and provide
flexibility for institutions to provide an effective method of training
to students and laboratory workers provided the training meets the
specific requirements for training relevant individuals.  § 262.214
requires participating eligible academic entities to describe in Part II
of its Laboratory Management Plan (LMP) their intended best practices
for providing training to students and laboratory workers commensurate
with their duties, and for ensuring safe transfers of unwanted materials
and hazardous wastes on-site by trained professionals.  The Agency
believes the performance-based training requirements under this rule are
sufficient to ensure that students, laboratory workers and those
conducting the hazardous waste determination and transferring unwanted
materials on-site are adequately trained commensurate with their duties.
 In keeping with the nature of performance-based requirements the final
rule does not set time-based requirements for initial training or
recurring training.  However, individuals must be trained commensurate
with their duties and, thus, it follows that individuals must first
possess the training or knowledge to adequately perform their duties. 
Additionally, trained professionals must receive the full compliment of
RCRA training in accordance with the generator status (SQG status for
CESQGs).  Current LQG training requirements do contain time-based
provisions for initial training and provides for an annual review.  

Comment: We heard from one commenter noting that, on page 29731 of the
preamble, the Agency implies that laboratory workers must be
RCRA-trained (Commenter No. 88).  The commenter recommended deleting the
sentence in column 1 of page 29731, which states “Therefore, for the
purpose of Subpart K, laboratory workers must…emergency response
duties or other duties, as appropriate.”  

Response:  The Agency is replacing the term “RCRA-trained
individual” with “trained professional.”  This does not affect the
substance of the definition from the proposal, but is merely a change in
terminology since Subpart K is part of the RCRA hazardous waste
regulations and including “RCRA” as part of the term is unnecessary
and may, in fact, imply that anyone who is trained under Subpart K is
not “RCRA” trained.  The final preamble explains more clearly that
students and laboratory workers must be trained commensurate with their
duties.  Training commensurate with ones duties should correspond with
the level of knowledge or practical application needed by individuals to
perform their assigned functions or fulfill their job or enrollment
classification including emergency response duties performed by the
laboratory worker.  The preamble further clarifies that the hazardous
waste determinations and on-site transfers of unwanted materials outside
the laboratory must be performed by trained professionals (also see §
262.207).  

Comment: We heard from one commenter stating that the proposal appears
to be silent in the matter of personal protection and safety for the
laboratory workers.  The commenter suggested minimum standards for
training content, and particularly regarding personal protection and
safety (Commenter No. 102).  

Response:  We believe the requirements under Subpart K provide a
protective set of regulations for human health and the environment. 
Subpart K contains provisions focused on safe management of unwanted
materials and specifically requires training in the laboratory for
students and laboratory workers which current satellite area regulations
do not.  Additionally, individuals performing the hazardous waste
determination and transferring unwanted materials on-site must also be
“trained professionals”.   We believe the requirement for
participating eligible academic entities to develop and maintain a
Laboratory Management Plan as contained in this final rule will lead to
better planning and continued improvements to standard practices.  We
believe compliance with the provisions in this final rule ultimately
translates into better personal safety for those involved in unwanted
materials management in the laboratory.  Additionally, EPA realizes that
other regulatory bodies such as the US Occupational Safety and Health
Administration and the US Department of Transportation require
laboratory safety training and it is not EPA’s intention to duplicate
training but rather to ensure proper handling and management of unwanted
materials that will enhance safety in the laboratory setting.

Comment:  We heard from one commenter stating that it is not clear in
the regulation how the regulator will determine whether the contractor
or vendor has the requisite training to conduct the waste determination
correctly, since the training records of a contractor or vendor are not
required to be kept on-site by the college or university (Commenter No.
102).  The commenter recommended that either the training records of the
contractor or vendor be kept on-site at the college or university where
that contractor or vendor makes a waste determination, or that
"contractors or vendors" be removed from the definition of "RCRA-trained
individual."  

Response:  We have retained the flexibility in the definition of
“trained professional” to include contractor/vendors.  We realize
that contractors and vendors are commonly used by eligible academic
entities to make or verify hazardous waste determinations.   Contractors
and vendors used in this capacity should have the appropriate RCRA
training.  However, while it is the responsibility of the eligible
academic entity to provide training to its employees or laboratory
workers, it is not the responsibility of the eligible academic entity to
provide the required training to a contractor or vendor.  Although we
are not requiring an eligible academic entity that hires contractors to
review the training and training records or to keep training records of
the contractor it hires on-site we strongly believe that this would be a
good business practice.

Comment: We heard from one commenter suggesting that additional details
need to be provided for the training requirements for the RCRA-trained
individual (Commenter No. 44).  

Response:  We received a host of comments pertaining to the level of
detail for training requirements under Subpart K, not all of which were
consistent with each other.  Some commenters stated the proposed
performance-based training requirements were not flexible enough, others
agreed with the requirements as proposed while some said the
requirements should be more prescriptive.  After careful review of the
comments, we maintain a performance-based set of training requirements
coupled with a more traditional regulatory approach is most appropriate
under this final rule.   Therefore, § 262.207 provides the base set of
training requirements a participating eligible academic entity must
adhere to and § 262.214 requires each eligible academic entity to
describe its intended best practices for meeting these requirements. 
EPA believes this approach will foster better planning, and
identification and implementation of improvements as needed

7.2	Commensurate with Duties

Comment: We heard from 11 commenters stating that all training and
instruction be commensurate with the duties and activities of the
personnel (Commenter Nos. 11, 16, 17, 25, 54, 60, 61, 76, 78, 100, 108).
 One of these commenters clarified that colleges and universities should
provide a training and instruction program offering information to
laboratory personnel commensurate with their duties, irrespective of
their status as students or laboratory workers (Commenter No. 60). 
Under a performance-based approach, the commenter believes this
distinction is not necessary provided proper waste management duties are
carried out.  The commenter stated that that the laboratory waste
management activities should be risk-informed, and workers need to
understand the risk associated with the material and/or activity and
take commensurate precautions.  Another commenter stated that there
should be only two categories of training requirements: (1) a
comprehensive program for those responsible for the collection, transit
and management of central accumulation areas (“fully RCRA trained
employees”); and (2) a more tailored training program for others
working with or generating unwanted materials (Commenter No. 108).  The
commenter stated that training for both groups should be commensurate
with responsibilities, and believes this two-tiered system will be much
simpler to administer while adequately ensuring the safe and appropriate
management of all unwanted materials.  

Response:  We agree with the commenters stating that all training and
instruction be commensurate with the duties and activities of the
personnel and that the distinction between instruction for students and
training for laboratory workers is unnecessary provided proper waste
management duties are carried out.  Therefore, EPA has eliminated the
distinction between students and laboratory workers thereby removing an
unneeded layer of complexity.  The final training requirements removed
this complexity by collapsing training requirements for students and
laboratory workers.  Under Subpart K, both students and laboratory
workers must be trained commensurate with their assigned duties or
job/enrollment classifications.  The final training requirements closely
resemble the suggestion offered by commenter No. 108 in that students
and laboratory workers receive training commensurate with their
individualized assigned duties while individuals performing hazardous
waste determinations and on-site transfers of unwanted materials must be
trained professionals which have received the full complement of RCRA
training in accordance with the eligible academic entity’s generator
status (CESQGs must receive SQG training).  We also believe this
approach will be simpler to administer while ensuring proper training to
adequately protection human health and the environment.

7.3	Training of Personnel Conducting On-site Transfers

Comment: We heard from 15 commenters expressing concern about the
requirement for college or university on-site transportation personnel
to be RCRA trained (Commenter Nos. 11, 16, 25, 43, 48, 52, 54, 60, 68,
76, 77, 79, 92, 100, 110).   The commenters stated that this requirement
is unnecessary and does not recognize that colleges and universities
have been safely transporting hazardous waste on site for years and that
a person can safely transport unwanted material with appropriate safety
training.  In addition, one commenter pointed out that RCRA-trained
personnel are not required to take virgin material into a laboratory;
virgin material often presents a greater hazard to personnel and the
environment (Commenter No. 43).  Another commenter stated that
individuals involved in transporting materials must most importantly
have good driving skills and additionally they must have knowledge of
proper packing techniques, vehicle bracing, security, and emergency
response; none of these skills or knowledge is related to RCRA training
(Commenter No. 68).  The commenter stated that a better approach would
be to include in the LMP a list of appropriate skills and knowledge, and
let an institution develop applicable training.

Response:  We believe that the person transferring unwanted materials
on-site must be a “trained professional” according to the definition
in § 262.200, which requires that the individual complete the
applicable RCRA training requirements of § 265.16 for LQGs, or §
262.34(d)(5)(iii) for SQGs and CESQGs.  Despite the fact that commenters
stated otherwise, this requirement is consistent with the Agency’s
existing interpretation for on-site transfers of hazardous waste (see
memo March 17, 2004, Springer to Regions, RCRA Online #14703).  
Furthermore, we believe that this level of training is
“commensurate” with the duties of the individual transferring the
unwanted materials on-site, which are to transfer the materials safely,
to avoid spills or releases, and to respond properly to any releases,
among other things.  Specifically, we believe that the on-site transfer
of unwanted materials outside of the laboratory should be conducted by
an individual who has received the full complement of RCRA training in
accordance with the eligible academic entity’s generator status, to
ensure that that individual is knowledgeable about the RCRA
requirements, especially with regard to compatibility of chemicals,
spill prevention, and emergency response.  This is especially important
considering that the unwanted materials from many individual
laboratories will often be collected together during the on-site
collection and transfer of those materials.  

Comment: We heard from one commenter stating that students and non-RCRA
trained staff should not transport wastes to a CAA (Commenter No. 84). 
The commenter stated that the rule should address this more directly, or
EPA should revise the definition of “transportation” to include
“removal from a lab.”

Response:  We agree with this commenter and have specifically stated in
the preamble to final rule that the person transferring unwanted
materials on-site must be a “trained professional” according to the
definition in § 262.200, which requires that the individual complete
the applicable RCRA training requirements of § 265.16 for LQGs, or §
262.34(d)(5)(iii) for SQGs and CESQGs.  Despite the fact that certain
commenters stated otherwise, this requirement is consistent with the
Agency’s existing interpretation for on-site transfers of hazardous
waste (see memo March 17, 2004, Springer to Regions, RCRA Online
#14703).   Furthermore, we believe that this level of training is
“commensurate” with the duties of the individual transferring the
unwanted materials on-site, which are to transfer the materials safely,
to avoid spills or releases, and to respond properly to any releases,
among other things.  Specifically, we believe that the on-site transfer
of unwanted materials outside of the laboratory should be conducted by
an individual who has received the full complement of RCRA training in
accordance with the eligible academic entity’s generator status, to
ensure that that individual is knowledgeable about the RCRA
requirements, especially with regard to compatibility of chemicals,
spill prevention, and emergency response.  This is especially important
considering that the unwanted materials from many individual
laboratories will often be collected together during the on-site
collection and transfer of those materials.

7.4	Other Trainings Provided to Laboratory Personnel

Comment: We heard from seven commenters describing other regulatory
bodies (e.g., U.S. Department of Transportation, U.S. Nuclear Regulatory
Commission, OSHA, Hazard Communication Act (HazCom)) that require
trainings on hazardous chemicals (Commenter Nos. 5, 8, 11, 25, 54, 79,
88).  These commenters emphasized the importance of being allowed to
coordinate with Subpart K’s training requirements, to avoid redundant
trainings.  Three of the commenters stated that they would intend to
satisfy the proposed training requirements through the OSHA training
(Commenter Nos. 5, 8 and 79).  

Response:  The Agency believes that neither the “traditional” RCRA
generator regulations nor Subpart K prohibits the use of other training
programs to satisfy the training requirements of Subpart K, provided the
other training program(s) address the relevant RCRA requirements for
trained professionals, and the relevant Subpart K requirements to train
laboratory workers and students commensurate with their duties.  

Comment: We heard from one commenter expressing concern that there are
no other appropriate regulatory requirements for training specific
enough to be appropriate for RCRA compliance (Commenter No. 7).  The
commenter stated that 24 or 48 hour OSHA “HAZWOPER” training (29CFR
1910.120) is the only regulatory compliance training routinely required
by many lab-pack vendors as well as waste generators.  The commenter
stated that this usually does not effectively cover the making of waste
determinations.

Response:  EPA shared this commenter’s concern and, after careful
review of existing training requirements, finalized Subpart K to include
performance-based training requirements in order to provide flexibility
to participating eligible academic entities.  Therefore, the final rule
requires participating eligible academic entities to train their
students and laboratory workers in Subpart K requirements commensurate
with their assigned duties and degree of involvement in handling
unwanted materials.  Participating eligible academic entities have
flexibility in choosing how they go about meeting these requirements,
and can meet these training requirements in a variety of ways.  For
instance, students in a supervised classroom setting should be trained
to place the products of experiments in the appropriate containers of
unwanted materials.  On the other hand, students conducting research
where such containers are not provided should be trained to store
unwanted materials in containers to minimize risk and label containers
with the words “unwanted materials,” or another equally effective
term, so that EH&S staff know that the containers are not longer wanted,
as well as the contents of the container and the accumulation start
date.  Additionally, training for laboratory workers commensurate with
one’s duties include, but are not limited to, training to perform
their duties to comply with the Subpart K labeling and container
management standards, supervising students in the laboratory, preparing
containers for transport, emergency response duties, and/or other
duties, as appropriate.  Finally, individuals entrusted to make the
hazardous waste determination or transfer unwanted materials on-site
must receive the full complement of RCRA training in accordance with
their particular generator status (i.e.,  § 265.16 for LQGs, or §
262.34(d)(5)(iii) for SQGs and CESQGs). 

Comment: We heard from two commenters on the importance of RCRA training
for personnel who make hazardous waste determinations (Commenter Nos. 5
and 44).  These commenters agreed that hazardous waste determinations be
performed only by personnel that have received proper training.  

Response:  We agree with commenters on the importance of RCRA training
for individuals making the hazardous waste determination and support a
requirement that only RCRA trained individuals may perform the hazardous
waste determination.  Further, the Agency maintains that only
individuals properly trained in RCRA may transfer unwanted materials
on-site.  The final rule requires that these functions are only
performed by RCRA trained individuals to assure safe and proper unwanted
materials management that will adequately protect human health and the
environment.

8.0 	Removal Frequency for Unwanted Materials

	8.1	General

Comment: We heard from 17 commenters expressing general or partial
support for the removal frequency requirements (Commenter Nos. 7, 11,
15, 25, 39, 51, 53, 54, 71, 73, 77, 79, 86, 87, 88, 99, 102). One of the
commenters stated that it is in favor of the proposal to regulate the
removal of unwanted material primarily by time and secondarily by
volume; it agrees with the EPA that this proposed rule will result in
much safer and environmentally sound waste management (Commenter No.
71).  One of the commenters stated that it generally supports the
extended timeframes for waste collection and characterization contained
in the proposed rule, but encouraged EPA to consider revising certain of
the timeframes to correspond to the lab practices currently in place in
most teaching and research facilities (Commenter No. 77).

Response:  We thank the commenters for their support and we have
maintained the time-driven approach as the primary approach for removing
unwanted materials from the laboratory, with a volume-driven approach as
the secondary approach.  We prefer time as the primary approach, with
volume as a secondary approach because, for most laboratories, it is
rare to accumulate 55 gallons of unwanted material.  Without a time
limit, unwanted materials could remain in the laboratory for extended
periods of time.  

Comment: We heard from ten commenters stating that EPA should modify the
requirement to remove all unwanted material from a laboratory during
either the regularly scheduled removal or when greater than 55 gallons
of material is accumulated (Commenter Nos. 8, 33, 39, 51, 61, 72, 81,
99, 107, 110).  The commenters expressed concern that the requirement
would require partially filled containers and/or containers still in
active use to be removed, creating unnecessary burden and wasted
containers.  Three commenters (Commenter No. 8, 72, 81) specifically
suggested that we should require only full containers of unwanted
material to be removed at regularly scheduled removals. 

Response:  	We recognize the commenters’ concerns regarding the
requirement to remove “all” unwanted materials from the laboratory
during regularly scheduled removals or when volumes have been exceeded. 
However, we do not consider the alternative suggested by commenters - to
require that only full containers of unwanted material have to be
removed from the laboratory - to be practical.  It would be easy to
circumvent the intent of the regulations for regular systematic removals
of unwanted materials from the laboratory by simply not completely
filling containers of unwanted materials.  In this scenario, the removal
of unwanted materials from the laboratory would be based primarily on
volume, rather than based on EPA’s preferred approach of time.  As for
the concern about using too many containers, consolidation of compatible
materials is allowed within in a laboratory as well as at an on-site CAA
or on-site TSDF, which could then return some or most of the reuseable
containers for use in collecting unwanted material.

Comment:   We heard from 11 commenters stating that EPA should increase
the removal intervals and/or make the removal provisions more flexible
and performance-based so that colleges and universities can tailor their
operations accordingly (Commenter Nos. 11, 19, 25, 48, 52, 60, 68, 77,
107, 108, 110).  We heard from one commenter suggesting that EPA
consider adopting a system that mirrors the Universal Waste system at 40
CFR 273.15 for tracking the amount of time that unwanted materials are
stored (Commenter No. 33).  Under such a system, a lab would be allowed
to demonstrate the length of time that each container stores unwanted
material from the date the container first receives the material.  

Response:  We agree with the commenters and under the final rule there
are now two alternative time-driven approaches allowed for regular
removals of unwanted materials.  The first approach is the one that was
proposed.  That is, all containers of unwanted material must be removed
from the laboratory on a regular basis, not to exceed six months.  Under
this approach, however, it is possible that a container that began
accumulating unwanted materials the day before the regularly scheduled
removal would be required to be removed.  This approach is easy to
implement, as all containers of unwanted material would be removed from
the laboratory, regardless of when they began accumulating unwanted
materials. 

The second alternative being added today allows the removal of
containers of unwanted material using a “rolling” six months
approach.  That is, no individual container of unwanted material could
remain in the laboratory for more than six months.  We believe this
alternative approach provides additional flexibility that many
commenters sought by adding a choice of implementation methods for the
removal of unwanted materials, while maintaining the intent of the
regulations by requiring regular, systematic, time-driven removals of
unwanted materials.  Since there is already a requirement that all
containers have an accumulation start date associated with them, this
approach would rely on checking the dates associated with each container
in order to determine which containers would have to be removed from the
laboratory.  Individual containers could potentially remain in the
laboratory longer than under the other alternative approach and
therefore, would be more likely to be full or nearly full.  On the other
hand, this approach would likely require more frequent removals from the
laboratory to ensure that no container accumulating unwanted materials
remains in the laboratory longer than six months.

	

Each eligible academic entity choosing to be subject to Subpart K must
select and identify in Part I of its LMP, the approach it chooses for
complying with regular removals of unwanted materials from the
laboratory.  In Part II of its LMP, the eligible academic entity must
describe how it plans to comply with the approach it has chosen for
regular removal of unwanted materials from the laboratory.  

Comment: We heard from one commenter asking for further explanation on
what supporting information may be required to show that a removal was
offered but was determined not to be necessary because no material was
unwanted (Commenter No. 79).

Response:  	We realize that some laboratories will not generate any
unwanted materials during a six month period and we do not intend for
EH&S personnel or other staff or contractors to make a trip to the
laboratory if they know that the laboratory does not have any unwanted
materials.  The eligible academic entity must describe in Part II of its
LMP how it will determine whether a removal of unwanted material is
necessary at each individual laboratory.  For example, a form or an
e-mail could be sent to each laboratory asking whether the laboratory
has any accumulated unwanted material and the EH&S could respond
accordingly.

	8.2	Regularly Scheduled Removals of Unwanted Material

Comment: We heard from one commenter stating that, in its experience,
regularly scheduled pickups are not efficient because of the varying
nature of research; rather, waste is picked up when a request is made
(Commenter No. 5).  The commenter described its procedures for picking
up unwanted material, including excerpts from its Chemical Hygiene Plan.
 The commenter noted that, even though it does not conduct regular
removals, it has established maximum shelf lives for all chemicals.  The
commenter stated that, if Subpart K is extended to its government lab,
its policy would be that unwanted material may be accumulated for
whichever comes first, six months or the individual collecting container
is full.   

Response:  We disagree with the commenter that regularly scheduled
pickups are inefficient.  On the contrary, we have often heard from
stakeholders that the current satellite accumulation area regulations
are inefficient because their requirement to remove an excess of 1 qt of
acute hazardous waste or 55 gallons of hazardous waste within 3 days
creates a barrier to establishing regularly schedule pickups.  These
commenters have indicated that a regulatory approach that allows
regularly scheduled pickups is preferable because it allows for better
planning and use of limited EH&S personnel.

Comment: We heard from 23 commenters asking for a longer or more
flexible timeframe (e.g., an academic year) for regular removals of
unwanted material from labs (Commenter Nos. 8, 11, 15, 16, 19, 20, 25,
31, 47, 48, 54, 58, 61, 70, 72, 76, 77, 79, 81, 86, 88, 108, 110). 
These commenters believe that six months is too frequent for some
laboratories (e.g., laboratories that have episodic generation,
containers that have not filled up yet), would be burdensome, and is
unnecessary.  They provided the following alternative
approaches/timeframes:

One commenter expressed concern about a time-based system for removals
because it is too restrictive (Commenter No. 76).  The commenter
suggested that lab containers should continue to be subject to the
existing SAA time requirements and/or be subject to performance-based
provisions to be addressed in the LMP.

Ten commenters suggested the interval be an “academic year” (i.e.,
11 to 13 months) (Commenter Nos. 11, 15, 16, 20, 25, 54, 61, 72, 77,
86).  These commenters believe this removal frequency would coincide
better with colleges and universities’ academic timeframes.  We heard
from five commenters suggesting that EPA create a definition for
“academic year,” to better align with college or university research
and academic schedules (Commenter Nos. 11, 25, 76, 85, and 109). 
Commenters suggested the following: "An academic year means the 11-13
month period that corresponds to a college or university's annual
teaching and research activities.”  The commenters noted that each
college or university has appropriate landmark dates on its calendar
(e.g., spring commencement or the end of summer session) that signal the
date of transition from one academic year to the next.  The commenters
believe the 11-13 month interval is necessary because the academic year
typically varies by a week or two due to placement of holidays and class
schedules.  

Two commenters suggested a removal frequency of 12 months (Commenter
Nos. 47, 70).  One of the commenters noted that the American Chemical
Society recommends an annual integrity check of chemicals (Commenter No.
70).  The commenter stated that its university conducts routine
laboratory inspections annually. The commenter believes this annual
inspection would provide an opportunity to ensure that small generators
are removing their wastes on an annual basis (at a minimum), while
larger generators could continue to remove waste materials on the
routine schedule, which would be provided in the LMP.

Four commenters stated that EPA should establish a performance-based
requirement rather than setting specific timeframes for regular removals
(Commenter Nos. 60, 88, 108, 110).  The commenters suggested that
colleges and universities should address the safe and timely removal of
unwanted material in their LMPs.  One commenter believes the intent of
the removal frequency can be accomplished though approaches described in
the Laboratory Management Plan; these approaches may include a routine
review of laboratory waste generation, scheduled waste pickups, on-call
and on-line pickup request systems, clean-outs and similar
administrative or management systems (Commenter No. 110).  Another
commenter stated that, consistent with the performance-based approach of
Subpart K, the commenter believes that rather than a fixed time
limitation, institutions should be able to assess their own removal
needs (Commenter No. 108). For laboratories that typically generate
greater volumes of hazardous waste, the commenter believes an
institution can schedule more frequent pickups than it would for those
that generate small volumes or only generate hazardous waste on a
sporadic basis.  If EPA feels that a removal time limit is necessary,
the commenter believes it should be risk-based, defined by the
institution’s LMP and should be no less than a full academic year.  

Response:  We disagree with the commenters and we have determined, based
on all the available information, to keep six months as the maximum time
between regularly scheduled removals.  We have retained six months as
the maximum time between regularly scheduled removals of unwanted
materials from the laboratory for several reasons.  First, we believe
that implementing regular removals on the basis of an “academic
year” could be confusing because not all eligible academic entities
operate according to an “academic year” and even within an
institution, the length of an “academic year” varies from year to
year.  Second, as we indicated in the preamble to the proposed rule, our
goal is to have unwanted materials removed from laboratories at least
once each semester because we agree with one commenter that explained
its preference for a schedule that allows removals on a semester basis
as follows: “colleges and universities generally use the semester’s
end to encourage laboratory workers and students to have unwanted
materials removed from their laboratories before leaving campus.  This
practice reduces the risk that unknown materials will be left behind by
a student or laboratory worker who does not return the following
semester.  Also it limits the amount of waste material stored in
laboratories during the break, when fewer people are around to monitor
or be aware of the conditions in the laboratory.”  Finally, as
discussed in the proposal, we believe that allowing unwanted materials
to accumulate for longer than six months would not serve to reduce risk
to laboratory personnel and provide the benefits to human health and the
environment to the same extent as allowing unwanted materials to
accumulate for a six month period.

Finally, we believe that allowing each eligible academic entity to
decide for itself an appropriate time interval for the removal of
unwanted material, without providing a maximum interval, would not
provide adequate protection to human health and the environment.

Comment: We heard from one commenter stating that a timeframe is not
needed, because it is too restrictive for the level of protection
provided (Commenter No. 58). 

Response:  We disagree with the commenter.  We prefer the time-driven
approach, with the maximum volumes as a backup because, for most
laboratories, it is rare to accumulate 55 gallons of unwanted material. 
Without a time limit, unwanted materials could remain in the laboratory
for extended periods of time and be more likely to result in dangerous
situations.

Comment: We heard from three commenters asking EPA to clarify that
unwanted materials can be picked up within the regularly scheduled
intervals (Commenter Nos. 11, 25, 54).

Response:  Six months is the maximum interval allowed between regularly
scheduled removals of unwanted materials.  Of course, unwanted materials
may always be picked up with greater frequency than specified in either
the regulations or the eligible academic entity’s LMP.  

Comment: We heard from three commenters asking EPA to clarify that a lab
clean-out qualifies as a regular removal (Commenter Nos. 11, 25, 77).

Response:  We view laboratory clean-outs to be distinct from routine,
regularly scheduled removals of unwanted materials.  In the course of
normal laboratory operations, many chemicals are used and will become
unwanted materials and ultimately may be determined to be hazardous
wastes.  This can occur as a result of teaching or research activities
or, in the case of teaching hospitals, as a result of clinical or
diagnostic activities.  We expect that these routinely generated
wastestreams will comprise the bulk of the unwanted materials that are
removed from the laboratory during regularly scheduled removals.  On the
other hand, a laboratory often can accrue a large number of unused
chemicals in its inventory, some of which can become dangerous over
time, developing the potential to cause significant harm.  It has been
our observation that it is unusual for laboratories to remove unused
chemicals from their inventories on any regular basis.   Therefore, a
regularly scheduled removal of unwanted material does not qualify as a
laboratory clean-out.  Nor does a laboratory clean-out qualify as a
regularly scheduled removal.  However, nothing prohibits these two
events from happening concurrently in order to coordinate waste
management activities.

Removal of Unwanted Material when Volumes are Exceeded 

Comment: We heard from fourteen commenters that indicated support for
the 10-day removal frequency for unwanted materials that exceed
specified volume limits in the laboratory (Commenter Nos. 11, 15, 25,
51, 53, 54, 71, 73, 77, 79, 86, 87, 88, 99).

Response:  We thank the commenters for their support.  We have retained
the requirement that if a laboratory accumulates more than 55 gallons of
unwanted material, all unwanted materials (including reactive acutely
hazardous unwanted material) must be removed within 10 calendar days, or
at the next regularly schedule removal, whichever comes first. 
Likewise, we have retained the requirement that if a laboratory
accumulates more than 1 quart of reactive acutely hazardous unwanted
material, all reactive acutely hazardous unwanted materials must be
removed within 10 calendar days, or at the next regularly schedule
removal, whichever comes first.  

Comment: We heard from one commenter suggesting an increased volume
limit for unwanted material in a lab (Commenter Nos. 107).  The
commenter stated its belief that the proposed rule would result in the
accumulation of greater quantities of unwanted materials in college or
university labs.  The commenter noted that the proposed revisions would
apply to all unwanted materials in the laboratory that have the
potential for being RCRA hazardous wastes.  The commenter was uncertain
that EPA had considered the quantity of unwanted materials that would
result from such provisions.  The commenter encouraged EPA to increase
the volume limit for accumulation of unwanted materials in a lab to 110
gallons.

Response:  We agree with the commenter that there may be greater
quantities of unwanted materials in the laboratories, because the
definition of unwanted material may capture materials that eventually
turn out not to be solid or hazardous waste.  However, we do not believe
it is necessary to increase the volume limit for accumulation of
unwanted materials to 110 gallons because most commenters have told us
that their laboratories rarely accumulate 55 gallons of hazardous waste.
  We also do not believe that increasing the volume limit for
accumulation of unwanted materials would provide the protection that we
are seeking in promulgating these alternative regulations for
laboratories.

Comment: We heard from one commenter stating its preference for either
10 working days or 14 calendar days (Commenter No. 107).  The commenter
also stated that, under the rule, if the volume limits for accumulation
of unwanted materials and acutely reactive unwanted materials are
reached in a laboratory, the materials must be picked up within 10
calendar days or at the next regularly scheduled removal, whichever
occurs first.  The commenter expressed concern that the next scheduled
removal may be the next day and this would put a strain on a site’s
limited waste management resources.  The commenter suggested rewording
the provision to address this.

Response:  We have decided to retain ten calendar days for removing
unwanted materials from the laboratory when maximum volumes are
exceeded.  We believe that ten calendar days will provide sufficient
flexibility to respond to the occasions when 55 gallons of unwanted
material (or 1 quart of reactive acutely hazardous unwanted material) is
exceeded, while maintaining protection to human health and the
environment.  We prefer to rely on “calendar days” rather than
“working days,” because there is no ambiguity over what a
“calendar day,” is and therefore the term provides more consistency
and is easier to implement.

The final rule retains the requirement that if the volume limits for
accumulation of unwanted materials and acutely reactive unwanted
materials are reached in a laboratory, the materials must be picked up
within 10 calendar days or at the next regularly scheduled removal -
whichever occurs first.  With the requirement to pick up the unwanted
materials at whichever date occurs first, we intended to ease the strain
on a site’s limited waste management resources.  We do not agree with
the commenter that this would be a burden.

Comment: We heard from one commenter stating that a problem with the
section 262.208 provisions is that the physical dimensions of
“laboratory” are not clear as it relates to the 55 gallon limit
(Commenter No. 39).  The commenter stated that, with open laboratory
configurations, which allow for more collaboration, a “laboratory”
appears to include a large number of laboratory hoods or bays and
encompass the work of many researchers.  Since some streams can be
generated in larger volumes on occasion, like hazardous wastewater and
spent solvents, the commenter believes the rule could require that all
the researchers would have to label all their different waste stream
containers with the date that 55 gallons was exceeded and move all of
their partially full containers of accumulating material to the
centralized collection area in an abrupt manner.

Response:  We agree with the commenter that the physical dimensions of
“laboratory” are not clear as it relates to the 55 gallon limits. 
This has also been true of the existing satellite accumulation area
(SAA) regulations.  With all the possible permutations for laboratory
arrangements and configurations, we believe that it is not possible, in
a regulation or in guidance, to delineate for all situations what
constitutes a single laboratory (or SAA) or multiple laboratories (or
SAA).  Therefore, what constitutes one laboratory (or SAA) versus
multiple laboratories (or SAAs) has and will continue to    depend on
the facts. 

Comment: We heard from three commenters that objected to the extended
time for removals (Commenter Nos. 40, 41, 58).  Two commenters stated
that it would not be protective of human health or the environment, as
it would allow and even reward generators for failing to maintain some
awareness of the amount of unwanted materials accumulating at various
laboratories on a campus (Commenter Nos. 40, 41).  These commenters
recommended retention of the three-day period.  Another commenter stated
that the extended timeframe is not needed (Commenter No. 58).  The
commenter stated that colleges and universities could remove an unwanted
material to the CAA before it reaches the volume limit, thereby avoiding
the need for an extended removal timeframe.

Response:  Under the SAA regulations of § 262.34(c), if the maximum
volumes are exceeded, the excess of 55 gallons of hazardous waste (or 1
quart of acutely hazardous waste) must be removed from the area within
three days.  We have frequently heard that the three-day time limit was
problematic, especially during long weekends and holidays.  This has
been particularly problematic at large institutions that can have
hundreds of individual laboratories.  Many commenters were supportive of
the extension from three days to ten calendar days the removal of
unwanted materials from the laboratory when the maximum volumes are
exceeded and therefore we have retained the ten calendar days.  We
should note, however, that we view this volume limit as a secondary
approach to the primary approach of time-driven removals required by
Subpart K.  As such, we agree with the commenter, and believe that most
removals of unwanted materials will occur during regularly scheduled
removals, before maximum volumes are exceeded.

Comment: We heard from one commenter expressing puzzlement with the
notion that a regulatory change is needed to allow additional time for a
college or university to remove unwanted material that has exceeded
specified limits (Commenter No. 43).  The commenter believes regulators
should already recognize that colleges and universities may need
additional time to remove their wastes (e.g., because of holidays and
weekends).

Response:  Although we have long recognized that colleges and
universities may need additional time to remove from the laboratory
their hazardous wastes in excess of 55 gallons (e.g., because of
holidays and weekends), until now, the generator regulations have,
nonetheless, required the excess of 55 gallons of hazardous waste (or 1
quart of acutely hazardous waste) to be removed within 3 days.

Comment: We heard from one commenter that stated that the proposed
requirement to move the unwanted material when 55 gallons have been
accumulated would be better crafted to mean "in any one container "
(Commenter No. 51).  

Response:  We disagree with the commenter.  First, it is rare for a
teaching or research laboratory to accumulate unwanted materials or
hazardous waste in 55 gallon containers.  The containers used for
accumulating unwanted materials in such laboratories tend to be liter,
4-liter, and sometimes 5-gallon containers.  Second, under the existing
SAA regulations it has always been our interpretation, and it continues
to be under Subpart K, that the 55 gallon accumulation limit applies to
all hazardous wastes or unwanted materials combined.  That is, all
unwanted materials (or hazardous wastes) in the laboratory (or SAA) must
be counted toward the 55 gallon limit.

Comment: We heard from one commenter requesting that Subpart K be
consistent with current satellite regulations regarding the volume limit
“per waste stream”, rather than total volume (Commenter No. 76). The
commenter stated that, in lieu of the time limit, EPA should use current
satellite accumulation area limits per waste stream and/or establish a
performance-based requirement to be included in the Laboratory
Management Plan.

Response:  We disagree with the commenter on his/her interpretation of
the satellite accumulation area regulations.  Under the existing SAA
regulations it has always been our interpretation, and it continues to
be under Subpart K, that the 55 gallon accumulation limit applies to all
hazardous wastes or unwanted materials combined.  That is, all unwanted
materials (or hazardous wastes) in the laboratory (or SAA) must be
counted toward the 55 gallon limit.

Comment: We heard from one commenter that stated that, because the
individual containers of unwanted materials will be of varying size
(original bottles, beakers, other laboratory containers), it will be
very difficult to determine if 55-gallons has been accumulated at any
one time (Commenter No. 105).  The commenter also stated that it will be
difficult to determine the quantity accumulated for reactive acutely
hazardous unwanted materials.

Response:  We appreciate the commenter’s concern that because the
individual containers of unwanted materials will be of varying size
(original bottles, beakers, other laboratory containers), it may be
somewhat difficult to determine if 55-gallons has been accumulated at
any one time.  We view this volume limit as a secondary approach to the
primary approach of time-driven removals required by Subpart K.  As
such, we believe that most removals of unwanted materials will occur
during regularly scheduled removals, before maximum volumes are
exceeded, and therefore any such difficulty will occur in only a few
laboratories.

Comment: We heard from one commenter that the proposed rule would
require unwanted material to be removed from the lab when specified
volume limits are met (Commenter No. 7).  The commenter stated, however,
that EPA does not state how this removal will occur at colleges and
universities that choose to make hazardous waste determination in the
laboratory and do not have a central accumulation area. The commenter
states that, if waste is eventually shipped directly from the
laboratory, then this requirement would require having a hazardous waste
vendor on site to dispose of the materials within 10 calendar days.

Response:  We agree with the commenter’s assessment and point out that
this is an increase in the time allowed under the current SAA
regulations, under which the same generator would have only three days
in which to ship the hazardous waste off-site (or come into compliance
with the requirements for 90/180/270-day generator accumulation areas).

Comment:  We heard from five commenters suggesting that EPA drop the
requirement for designation of reactive acutely hazardous unwanted
materials in the proposed rule (Commenter Nos.  61, 70, 72, 86, 101). 
Two commenters stated that this requirement means that laboratory
workers must make a similar type of hazardous waste determination to
those that have been problematic to colleges and universities previously
(Commenter Nos. 61 and 72).  They encouraged EPA to keep the
requirements for hazardous waste determinations and labeling simple to
implement.  Another commenter stated that, given that all but seven
P-listed materials are exempted from the one-quart limit, it is
appropriate to exempt all P-listed wastes from the one-quart limit
(Commenter No. 70). The commenter believes that the safe handling and
disposal of the seven P-listed materials can be facilitated through
education and proper guidance without the need for the one-quart storage
limit requirement.  Another commenter noted that its college program has
not generated the EPA listed materials in the past five years and
believes it is very unlikely it would generate more than a quart of them
at a given location (Commenter No. 86).  In addition, the commenter
believes the list could be confusing and divert attention away from
other waste handling issues.  Another commenter noted that EPA’s list
is relatively short and should be dropped (Commenter No. 101).

Response:  Under the SAA regulations of § 262.34(c), if more than 1
quart of an acutely hazardous waste listed in § 261.33(e) is
accumulated, the excess of 1 quart must be removed from the SAA within
three days and taken either to an on-site CAA or TSDF, or transported
off-site.  Section 261.33(e), which is commonly referred to as the “P
list” of hazardous wastes, currently comprises 124 chemicals.  The
P-list is a list of commercial chemical products that are considered
acutely hazardous waste when discarded because they are considered
hazardous even when managed in small quantities.  Under Subpart K, the
Agency is reducing the number of chemicals that are subject to removal
from the laboratory at the 1-quart threshold from all 124 chemicals on
the P-list to the six chemicals that are on the P-list because they are
reactive.  We focused on the reactive chemicals on the P-list because,
as reactive chemicals, they have the potential to cause significant and
immediate harm to individuals and property.  Given that commenters have
not disagreed with our assessment of the danger of these reactive
chemicals and that a list of six chemicals is far easier to implement
than the current 124, we are finalizing this provision as proposed,
along with the change to the definition of reactive acutely hazardous
unwanted material that was previously discussed under Section 3.7 of
this document.

9.0	On-site Transfers of Unwanted Material Outside the Laboratory

	9.1	General

Comment: We heard from two commenters asking EPA to clarify the meaning
of “transportation” in the preamble to the final rule, or in the
language of the regulatory text (Commenter Nos. 8, 84).  One of the
commenters stated that the term “transport” does not mean movement
within the same building or laboratory; this will be particularly
important if the concept of a “super satellite area” is adopted by
the Agency (Commenter No. 8).  The other commenter stated that students
and non-RCRA trained staff should not transport wastes to a CAA
(Commenter No. 84).  The commenter stated that the rule should address
this more directly, or EPA should revise the definition of
“transportation” to include “removal from a lab.”

Response:  We agree with the commenter that the use of the term
“transport” in Subpart K is confusing.  The term “transport” is
not defined, but the term “transportation” is defined in 40 CFR
260.10 as the movement of hazardous waste by air, rail, highway or
water.”  And the term “transporter” is defined in 40 CFR 260.10,
as “a person engaged in the off-site (emphasis added) transportation
of hazardous waste by air, rail, highway or water.”  Therefore, we
have revised the regulatory language to replace the term “transport”
with the term “transfer” when we are referring to on-site movement
of unwanted materials and hazardous wastes outside the laboratory. 
Thus, trained professionals must accompany all transfers of unwanted
materials and hazardous wastes when they are removed from the laboratory
and brought to other on-site areas, such as other laboratories, central
accumulation areas, and TSDFs.  The term “transport” is now used
only in reference to off-site movements or shipments of hazardous waste.
 

	9.2	Comments on “Directly”

Comment:  We heard from one commenter that “directly” needs to be
defined as a specific timeframe (e.g., one day) (Commenter No. 66).  We
heard from one commenter stating that “directly” should be defined
as one working day (Commenter No. 53).  One commenter stated that EPA
should clarify the term “directly” even if it does not finalize the
rule (Commenter No. 58).  Two other commenters stated that
“directly” should be defined as “same day” (Commenter Nos. 14,
79).  One of these commenters stated that the definition of
“directly” should take into account that many institutions may have
several “on-campus” buildings (Commenter No. 14).  The commenter
stated that the definition should allow wastes to be picked up from
multiple locations on campus before being delivered to the central
accumulation area or treatment, storage, and disposal facility (TSDF) as
long as the wastes are transported in secondary containment, and the
transport vehicle is kept locked when not attended. The commenter stated
that the definition of “directly” should also state that wastes that
are picked up from laboratories must be delivered to the central
accumulation area or TSDF the same day that they are picked up. 

Response:  In reviewing the comments, we have decided it is not
necessary to add a regulatory definition of “directly” because it
could eliminate necessary flexibility.  Rather we will simply reiterate
and expand upon the preamble discussion from the proposed rule.  

In general, if the unwanted material is sent from the laboratory or
laboratories to the on-site CAA or TSDF within the same work day, this
would meet the intent of the regulation.  We realize that many eligible
academic entities will collect unwanted materials from many laboratories
at a time, in series, and will deliver all the unwanted materials to an
on-site CAA or TSDF at the end of the collection process.  This would be
an acceptable practice under today’s regulations, provided the
unwanted materials are in continuous custody of the trained professional
that is collecting and transferring the unwanted materials and they are
delivered to the on-site CAA or TSDF at the end of the work shift.  It
is not necessary to bring the unwanted material from each individual
laboratory directly to the on-site CAA or TSDF and then in a separate
trip bring the unwanted materials from the next laboratory.  Such an
arrangement would only increase the amount of time that trained
professionals would spend in removing unwanted materials from
laboratories and that unwanted materials would spend in transport, with
no benefit.  On the other hand, if unwanted materials were left on a
cart in the hallway overnight, this would not be an acceptable practice
and would not meet the intent of the regulation.

Comment: We heard from one commenter that as long as the term
“directly” negates any interim unloading/storage but does not
interfere with the transportation phase, it is appropriate (Commenter
No. 7). 

Response:  We agree with the commenter that our use of the term
“directly” is intended to prevent interim storage of unwanted
materials during the course of collecting them from the laboratories. 
We also agree that we do not intend to interfere with the routine
practices currently in use for the on-site collection and transfer of
unwanted materials outside the laboratory, provided those transfers are
carried out by a trained professional.

Comment: We heard from one commenter that “directly” need not be
defined (Commenter Nos. 8).  The commenter believes the term is
sufficiently clear given the preamble discussion.  We also heard from
four commenters stating that the term “directly” should not be
replaced with a more specific time-frame or same-day requirement
(Commenter Nos. 11, 25, 54, 73).  Four commenters stated that
flexibility is important because colleges and universities transport
material on campus in many different ways; as such, they recommended
that “without unnecessary delay” replace “directly” in the
regulations (Commenter Nos. 11, 25, 54, 77).  Two of these commenters
stated that it is reasonable to require that an appropriately trained
person supervise the unwanted material or that it be in a secure
location (e.g., locked in a vehicle) during the time between collection
from the laboratory and delivery to the central accumulation area
(Commenter Nos. 11 and 25). The commenters stated that, if a specific
timeframe, security precaution, or safety procedure is appropriate for a
college or university, it should be described in section 262.214(a)(5)
of the Laboratory Management Plan.  

Response:  We agree with the commenters and we have decided it is not
necessary to add a regulatory definition of “directly” because it
could eliminate necessary flexibility.  Rather we will simply reiterate
and expand upon the preamble discussion from the proposed rule.  

In general, if the unwanted material is sent from the laboratory or
laboratories to the on-site CAA or TSDF within the same work day, this
would meet the intent of the regulation.  We realize that many eligible
academic entities will collect unwanted materials from many laboratories
at a time, in series, and will deliver all the unwanted materials to an
on-site CAA or TSDF at the end of the collection process.  This would be
an acceptable practice under today’s regulations, provided the
unwanted materials are in continuous custody of the trained professional
that is collecting and transferring the unwanted materials and they are
delivered to the on-site CAA or TSDF at the end of the work shift.  It
is not necessary to bring the unwanted material from each individual
laboratory directly to the on-site CAA or TSDF and then in a separate
trip bring the unwanted materials from the next laboratory.  Such an
arrangement would only increase the amount of time that trained
professionals would spend in removing unwanted materials from
laboratories and that unwanted materials would spend in transport, with
no benefit.  On the other hand, if unwanted materials were left on a
cart in the hallway overnight, this would not be an acceptable practice
and would not meet the intent of the regulation.

We also agree with the commenter that the LMP is the appropriate place
to outline the procedures the eligible academic entity will use for
ensuring safe on-site transfers of unwanted materials and hazardous
wastes by trained professionals.  Due to the splitting of the LMP into
two sections, however, this section of the LMP has been renumbered and
is now found in 40 CFR 262.214(b)(3).

Comment: We heard from one commenter that suggested that exceptions to
the “directly” requirement be specified to allow for daily
collections at multiple sites within the college or university’s
contiguous campus (e.g., storage in transport vehicle while collecting
materials at multiple sites) Commenter No. 90).

Response:  We do not view the commenter’s example as an exception to
the requirement for unwanted materials to be brought “directly” from
the laboratory to an on-site CAA or TSDF.  Rather, we view collections
at multiple laboratories within a contiguous campus to be within our
meaning of the term, provided the unwanted materials are in continuous
custody of the trained professional that is collecting and transferring
the unwanted materials and they are delivered to the on-site CAA or TSDF
at the end of the work shift.

10. 0	On-site Consolidation Areas

Comment: We heard from three commenters that expressed opposition to the
creation of a consolidation area (Commenter No. 53, 58, 66).  One
commenter stated that a consolidation area would complicate inspections
since there would be too many different types of accumulation areas for
inspectors to keep track of, each with different regulatory requirements
(Commenter No. 53). The commenter also stated that a consolidation area
as proposed would lack the appropriate level of oversight, such as what
is required under the satellite accumulation rule (e.g. “under the
control of the key staff individual”). The commenter is concerned that
a consolidation area would not be adequately monitored for releases and
could easily become the repository for significant quantities of
unwanted materials from different teaching laboratories.  Another
commenter stated that it opposes a “super satellite collection area”
because safe chemical management controls may not be in place (Commenter
No. 66).  The commenter stated that, if a university or college desires
to take advantage of the rule, it should designate a central
accumulation area that is defined and regulated by the rule.

Response:  After analyzing the comments and considering the flexibility
that is already provided in the regulations, we have decided not to
establish a “consolidation area” as another type of accumulation
area for unwanted materials.  We agree with the commenters that argued
that adding another type of accumulation area with another set of
standards would be confusing for implementers and enforcers with little,
if any, benefit.  Therefore, the final rule does not include a new type
of accumulation area such as a “consolidation area” or “super
satellite area.”

Comment:  We heard from 26 commenters that expressed general or partial
support for the creation of a consolidation (i.e., super-satellite) area
(Commenter No. 5, 7, 8, 11, 15, 16, 24, 25, 43, 51, 54, 61, 69, 70, 73,
76, 77, 79, 81, 83, 85, 86, 87, 97, 99, 109).  The commenters stated
that a consolidation area could be beneficial to colleges and
universities (e.g., as staging area prior to transfer to the CAA or
onsite TSDF, enable for the safe and efficient management of unwanted
materials until the pickup is made, and encourage greater college or
university participation in the rule.  One of the commenters stated that
EPA should extend the consolidation area approach to non-academic labs
(Commenter No. 87).  One commenter stated that the concept of a central
accumulation area should be a benefit to the university settings, but
could also be expanded to all RCRA generators (Commenter No. 24).  

Response:  Although we have not added to the final rule a new type of
accumulation area such as a “consolidation area” or “super
satellite area,” we believe that the flexibility that is already in
Subpart K can provide the benefits of a consolidation area, without
establishing a new regulatory category for them.  

	

It has been EPA’s regulatory interpretation that hazardous wastes can
not be moved from one SAA to another (see memo from Robert Springer,
Director, OSW, to EPA Regional Directors; March 17, 2004, RCRA Online
#14703).  One reason for this prohibition is that it would be easy to
circumvent the 55-gallon limit in an SAA by moving hazardous wastes from
one SAA to another SAA and thus remain below the volume limits, allowing
hazardous wastes to remain in the SAA indefinitely.

Under Subpart K, however, the removal of unwanted materials is based on
time primarily, and volume secondarily.  Containers must be marked with
the date that unwanted materials first begin to accumulate.  This
requirement is necessary in order to verify that unwanted materials are
being removed from the laboratory on a regular basis.  The requirement
for a date to be associated with each container provides laboratories
with additional flexibility that does not exist in SAAs.  That is, under
Subpart K, unwanted materials can be safely consolidated within an
on-site laboratory, such as in a chemical stockroom.

As with all on-site transfers of unwanted material outside of a
laboratory, the transfer of unwanted materials between laboratories must
be accompanied by a trained professional.  Further, any laboratory in
which unwanted materials are consolidated from other laboratories is
subject to the time and volume limits for all laboratories that are
subject to Subpart K (i.e., if the laboratory accumulates more than 55
gallons of unwanted material (or 1 quart of reactive acutely hazardous
unwanted material), the unwanted material must be removed from the
laboratory within 10 calendar days).   In addition, the date that an
unwanted material first begins to accumulate in a container would remain
the same, regardless of where the container is moved.  In other words,
no re-dating of a container would be permitted if it were moved to
another laboratory or chemical stockroom.  If the contents of two or
more containers with compatible materials are combined into one
container; however, the earliest date associated with the original
containers must be used.  The date that is associated with each
container will allow inspectors to verify that containers are being
removed from the laboratory on a routine basis not to exceed six months,
as required.  And the 55-gallon volume limit will ensure that large
quantities of unwanted materials are not consolidated without the
additional protections required at CAAs.

Comment: We heard from eight commenters that provided input on the
definition for a consolidation area (Commenter Nos. 11, 25, 54, 61, 64,
68, 80, 97):  

Four commenters suggested the definition:  “A consolidation area means
an accumulation area for unwanted materials, within the same building as
the laboratory generating the unwanted materials, managed in accordance
with section 262.206(c) of this Part” (Commenter Nos. 11, 25, 61, 97).
 Two of these commenters also included suggested regulatory language for
a new section 262.206(c), entitled Management of Containers in a
Consolidation Area.

Another commenter recommended a modified version of the definition
offered above: “A consolidation area means an accumulation area for
unwanted materials, within the same building as the laboratory
generating the unwanted materials, managed in accordance with section
262.206(c) of this Part. A college or university may accumulate as much
as 55 gallons of unwanted material or 1 quart of reactive acutely
hazardous unwanted material in containers in a consolidation area
without a permit and without complying with either section 262.34(a) of
this Part (large quantity generators), section 262 .34(c) of this Part
(satellite accumulation), or section 262.34(d) of this Part (small
quantity generators)" (Commenter No. 54).  

Another commenter suggested the definition: “A consolidation area”
means an accumulation area for unwanted materials, within the same
building or located within 50 feet of the same building which is under
the administrative control of the university or college, managed in
accordance with section 262.206(c) of this Part” (Commenter No. 64). 
The commenter believes this definition will give colleges and
universities greater flexibility than requiring the consolidation area
to be within the laboratory building.

Another commenter suggested the definition: “A consolidation area
means an accumulation area for unwanted materials, located as close as
is practical to the laboratory generating the unwanted materials,
managed in accordance with §262.206(b) of this Part. A college or
university may accumulate as much as 55 gallons of unwanted material or
1 quart of reactive acutely hazardous unwanted material in containers in
a consolidation area without a permit and without complying with either
§262.34(a) of this Part (large quantity generators), section 262.34(c)
of this Part (satellite accumulation), or §262.34(d) of this Part
(small quantity generators)” (Commenter No. 68).  The commenter
believes the standards applicable to labs should apply to consolidation
areas because the risks are comparable.

Another commenter stated that the definition should denote the area as a
non-permitted area outside of the laboratory, utilized for storage of
unwanted materials prior to removal for disposal.  This area would be in
the same building as the laboratory, and would provide a safe
alternative for laboratory space constraints, without the need to meet
all current “satellite accumulation area” restrictions (Commenter
No. 80).

Response:  Because we are not to adding to the final rule a new type of
accumulation area such as a “consolidation area” or “super
satellite area,” the suggested definitions are moot.

Comment: We heard from one commenter stating that the consolidation area
should be subject to quantity limits and time-based removal requirements
(Commenter No. 73).

Response:  We agree with the commenter and although we have not added a
new type of accumulation area called a “consolidation area,” or
“super satellite area,” as discussed above, we believe that Subpart
K provides the flexibility to consolidate unwanted materials within
another laboratory.  Any laboratory in which unwanted materials are
consolidated from other laboratories is subject to the time and volume
limits for all laboratories that are subject to Subpart K (i.e., if the
laboratory accumulates more than 55 gallons of unwanted material (or 1
quart of reactive acutely hazardous unwanted material), the unwanted
material must be removed from the laboratory within 10 calendar days).  


Comment: We heard from three commenters that an unwanted material should
not be considered a hazardous waste before it arrives at the
consolidation area (Commenter Nos. 5, 51, 99).  These commenters do not
believe hazardous waste determinations should necessarily be made before
the unwanted material arrives at the consolidation area, and believe a
hazardous waste designation would unfairly penalize such wastes, which
could have the potential for beneficial reuse elsewhere at the college
or university.  

Response:  It has always been the case under existing RCRA regulations,
and continues to be the case under Subpart K, that chemicals that are
fit for continued use are not solid or hazardous wastes (see §
261.2(e)(1)) and can be transferred between SAAs, laboratories, and
chemical stockrooms.  Under Subpart K, we realize that some chemicals
that are initially identified as unwanted materials will turn out not to
be solid or hazardous wastes.  If, for example, an unwanted material is
brought to an on-site CAA or TSDF for a hazardous waste determination,
and it is determined that such unwanted material can be reused, then it
is not a solid or hazardous waste and is not subject to Subpart K or the
Subtitle C hazardous waste regulations, once the determination is made. 
That is, if a chemical is initially labeled as an unwanted material and
then it is subsequently discovered that it can continue to be used, the
chemical can be returned to a laboratory or chemical stockroom for
redistribution.  EPA selected the term “unwanted material” over
“laboratory waste,” in part to indicate that the material may
potentially still be useable.

Nevertheless, EPA continues to stress that today's final rule does not
alter or move the point of generation of any hazardous waste, but merely
allows the hazardous waste determination to be made at an on-site CAA or
on-site TSDF; or in the laboratory, but at a point in time after the
initial generation of the waste.  The point of generation of the
hazardous waste continues to be the location and time at which the
hazardous waste is first generated.  Therefore, the applicability of the
land disposal restrictions (LDRs) to hazardous wastes generated in the
laboratory are not affected by today’s rule and continue to
“attach” at the point of generation of the hazardous waste.  In
addition, RCRA’s statutory inspection and enforcement authorities
continue to apply in the laboratory, even though under Subpart K the
hazardous wastes are referred to as “unwanted materials,” while they
remain in the laboratory.

Comment: We heard from six commenters stating that hazardous waste
determinations should be allowed at the consolidation area (Commenter
Nos. 11, 25, 51, 54, 76, 79).

Response:  Because we are not to adding to the final rule a new type of
accumulation area such as a “consolidation area” or “super
satellite area,” the suggestion is moot.  However, since Subpart K
provides the flexibility to allow the consolidation of unwanted
materials within a laboratory and the hazardous waste determination may
be made in the laboratory before the unwanted materials are removed, the
hazardous waste determination may be made in a laboratory where unwanted
materials are consolidated.  In such a situation, the eligible academic
entity does not have to make the hazardous waste determination when the
unwanted material is removed from the first laboratory.  Rather, the
hazardous waste determination may be made when the unwanted material is
removed from the final laboratory where the unwanted materials are
consolidated.  

Comment: We heard from one commenter that the LMP could describe how the
consolidation area is being used (Commenter No. 76).

Response:  Because we are not to adding to the final rule a new type of
accumulation area such as a “consolidation area” or “super
satellite area,” the suggestion is moot.  However, an eligible
academic entity could choose to include in Part II of its LMP procedures
for consolidating unwanted materials into a laboratory.

Comment: We heard from three commenters that EPA should clarify that one
cannot transport unmanifested hazardous wastes to offsite locations
(e.g., CAA) that are not subject to a permit (Commenter No. 24, 56, 88).
 The commenters were concerned that some colleges and universities may
misinterpret the consolidation provisions.  One of the commenters
suggested that, as an alternative, EPA could provide a new definition of
“onsite generator” that allows colleges and universities to
establish offsite accumulation areas (Commenter No. 56).

Response:  We agree with the commenters.  Consolidation of unwanted
materials is limited to on-site laboratories at the eligible academic
entity.  This is because, in all cases, regardless of where the eligible
academic entity chooses to make the hazardous waste determination, the
hazardous waste determination must be made on-site before the unwanted
material can be sent off-site.

Off-site consolidation of hazardous wastes is another matter, and in
most cases, a permit or interim status is required in order for a
facility to receive hazardous waste from off-site locations.  

Comment: We heard from one commenter recommending that EPA clarify in
the preamble that all transfers that would occur under Subpart K could
be conducted without requiring that the waste be sent to a treatment,
storage, or disposal facility (TSDF) that is under a permit and without
use of a manifest (Commenter No. 64).  The commenter believes this would
result in benefits such as the beneficial reuse of unwanted materials.

Response:  We disagree with the commenter.  In all cases, regardless of
where the eligible academic entity chooses to make the hazardous waste
determination, the hazardous waste determination must be made on-site
before the unwanted material can be sent off-site.  Further, those
unwanted materials that are hazardous wastes must be manifested when
sent off-site and must be sent to a designated facility such as a
permitted or interim status TSDF.

Comment: We heard from one commenter expressing a desire for EPA to
allow colleges and universities to redistribute unwanted materials that
have arrived at the consolidation area, if it determines such material
is recyclable (Commenter No. 16).

Response:  It has always been the case under existing RCRA regulations,
and continues to be the case under Subpart K, that chemicals that are
fit for continued use are not solid or hazardous wastes (see §
261.2(e)(1)) and can be transferred between SAAs, laboratories, and
chemical stockrooms.  Under Subpart K, we realize that some chemicals
that are initially identified as unwanted materials will turn out not to
be solid or hazardous wastes.  If, for example, an unwanted material is
brought to an on-site laboratory for consolidation or an on-site CAA or
TSDF for a hazardous waste determination, and it is determined that such
unwanted material can be reused, then it is not a solid or hazardous
waste and is not subject to Subpart K or the Subtitle C hazardous waste
regulations, once the determination is made.  That is, if a chemical is
initially labeled as an unwanted material and then it is subsequently
discovered that it can continue to be used, the chemical can be returned
to a laboratory or chemical stockroom for redistribution.  EPA selected
the term “unwanted material” over “laboratory waste,” in part to
indicate that the material may still be useable.

Comment: We heard from one commenter stating that the concept of a
consolidation area should be extended to other RCRA generators
(Commenter No. 24).

Response:  Because we are not to adding to the final rule a new type of
accumulation area such as a “consolidation area” or “super
satellite area,” the suggestion to extend them to other RCRA
generators is moot.  

Comment: We heard from five commenters suggesting new and revised
language applicable to the use of consolidation area, including
requirements such as labeling/dating, container management, training,
removal frequency, hazardous waste determinations, inspection, spill
response, signage, and documentation in the LMP  (Commenter Nos. 11, 25,
54, 70, 76).  

Response:  Because we are not to adding to the final rule a new type of
accumulation area such as a “consolidation area” or “super
satellite area,” the suggestions for how to regulate them are moot.  

Comment: We heard from two commenters stating that consolidation areas
should not be subject to the existing requirements for SAAs, 90/180-day
accumulation areas, or permitted units (Commenter Nos. 11, 25).  

Response:  We agree with the commenter and although we have not added a
new type of accumulation area called a “consolidation area,” or
“super satellite area,” as discussed above, we believe that Subpart
K provides the flexibility to consolidate unwanted materials within
another laboratory while the SAA regulations do not.  Therefore, any
laboratory in which unwanted materials are consolidated from other
laboratories is subject to the time and volume limits for all
laboratories that are subject to Subpart K (i.e., if the laboratory
accumulates more than 55 gallons of unwanted material (or 1 quart of
reactive acutely hazardous unwanted material), the unwanted material
must be removed from the laboratory within 10 calendar days).  Under
Subpart K laboratories are not subject to the requirements for
90/180-day accumulation areas or permitted units.

Comment: We heard from one commenter stating that the provisions
applicable to a consolidation area should be comparable to those for a
laboratory (Commenter No. 68).  

Response:  We agree with the commenter and although we have not added a
new type of accumulation area called a “consolidation area,” or
“super satellite area,” as discussed above, we believe that Subpart
K provides the flexibility to consolidate unwanted materials within
another laboratory.  Any laboratory in which unwanted materials are
consolidated from other laboratories is subject to the time and volume
limits for all laboratories that are subject to Subpart K (i.e., if the
laboratory accumulates more than 55 gallons of unwanted material (or 1
quart of reactive acutely hazardous unwanted material), the unwanted
material must be removed from the laboratory within 10 calendar days).  


Comment: We heard from one commenter recommending that the management
standards for “super satellite areas” be qualitative measures
designed to protect human health and the environment and allow the
facilities to best develop the requirements for their specific “super
satellite areas” (Commenter No. 81).  The commenter also suggested EPA
select a name for consolidation area that clearly distinguishes it from
existing accumulation areas under RCRA (e.g. “10-day accumulation
area).

Response:  Because we are not to adding to the final rule a new type of
accumulation area such as a “consolidation area” or “super
satellite area,” the suggestions for how to regulate and name them are
moot.  

Comment: We heard one commenter stating that unwanted material arriving
at the consolidation area should not be subject to RCRA requirements
because it has not been determined to be hazardous waste and OSHA
regulations apply in any case (Commenter No. 79).

Response:  Because we are not to adding to the final rule a new type of
accumulation area such as a “consolidation area” or “super
satellite area,” the suggestions for how to regulate them are moot.  

Nevertheless, EPA continues to stress that today's final rule does not
alter or move the point of generation of any hazardous waste, but merely
allows the hazardous waste determination to be made at an on-site CAA or
on-site TSDF; or in the laboratory, but at a point in time after the
initial generation of the waste.  The point of generation of the
hazardous waste continues to be the location and time at which the
hazardous waste is first generated.  Therefore, the applicability of the
land disposal restrictions (LDRs) to hazardous wastes generated in the
laboratory are not affected by today’s rule and continue to
“attach” at the point of generation of the hazardous waste.  In
addition, RCRA’s statutory inspection and enforcement authorities
continue to apply in the laboratory, even though under Subpart K the
hazardous wastes are referred to as “unwanted materials,” while they
remain in the laboratory.

Comment: We heard from one commenter that described its own process for
transferring chemicals from individual labs to a central workroom and
accumulating the chemicals in the workroom while determining if the
chemical qualified as a solid and hazardous waste (Commenter No. 5).  If
the material had a further use, it would be redistributed to another
user, but if it qualified as hazardous waste, it is sent to the 90-day
accumulation area.  The commenter stated that it is unclear whether or
not an accumulation start date needs to be placed on a container if the
determination happens to be made on the day that the material arrives at
its workroom.  

Response:  The accumulation start date must be added to the container
label when the container first begins accumulating unwanted material in
the laboratory.  In addition, the date that an unwanted material first
begins to accumulate in a container would remain the same, regardless of
where the container is moved.  In other words, no re-dating of a
container would be permitted if it were moved to another laboratory or
chemical stockroom.  If the contents of two or more containers with
compatible materials are combined into one container; however, the
earliest date associated with the original containers must be used.  

11.0 	Hazardous Waste Determinations

	11.1	General

Comment: We heard from seven commenters expressing general support for
providing flexibility to colleges and universities in making a hazardous
waste determination for their lab waste (Commenter Nos. 11, 15, 25, 54,
87, 92, 99). 

Response:  We thank the commenters for their support and today we are
finalizing the regulations pertaining to where and when the hazardous
waste determination must be made with some minor changes to address the
expansion of the applicability of the final rule to include eligible
academic entities that are CESQGs.  Eligible academic entities that are
LQGs or SQGs will continue to have the choice of making the hazardous
waste determination in the laboratory before the unwanted material is
removed from the laboratory, or within four calendar days of arriving at
an on-site CAA or interim status or permitted TSDF.  Because CESQGs
would not have an on-site CAA or TSDF, CESQGs are required to make the
hazardous waste determination in the laboratory before the unwanted
material is removed from the laboratory.  

Comment: We heard from two commenters asking EPA to clarify that the
hazardous waste determination can be made in any of the three areas
identified in the rule, rather than in one of the three areas identified
in §262.209 (i.e., CAA, lab, on-site TSDF) (Commenter Nos. 11, 25).  

Response:  We agree with the commenter and have changed the regulatory
language to reflect the comment.  For LQGs and SQGs, it is not necessary
for the eligible academic entity to limit itself to making the hazardous
waste determination in the same place all the time.  We realize that
this could change depending upon circumstances.  For instance, during
typical operations, an eligible academic entity may choose to make the
hazardous waste determination in its on-site CAA.  However, during a
laboratory clean-out, the hazardous waste determination might be made in
the laboratory.  Eligible academic entities that are CESQGs; however,
are limited by regulation to making the hazardous waste determination in
the laboratory before the unwanted materials are removed from the
laboratory and sent off-site.

Comment: We heard from one commenter noting that the preamble states
that once the hazardous waste determination is made in the central
accumulation area, the discarded chemical is a RCRA hazardous waste
retroactive to its generation back in the lab (Commenter No. 84).  The
commenter asked EPA to clarify the compliance and enforcement
implications under this scheme (e.g., If there is a fire in the central
accumulation area due to the mixing of incompatible wastes which
arguably were misidentified based on information from the laboratory, is
the lab worker then potentially liable under RCRA for a hazardous waste
violation?). 

Response:  EPA continues to stress that the final rule does not alter or
move the point of generation of any hazardous waste, but merely allows
the hazardous waste determination to be made at an on-site CAA or
on-site TSDF; or in the laboratory, but at a point in time after the
initial generation of the waste.  The point of generation of the
hazardous waste continues to be the location and time at which the
hazardous waste is first generated.  Therefore, the applicability of the
land disposal restrictions (LDRs) to hazardous wastes generated in the
laboratory are not affected by today’s rule and continue to
“attach” at the point of generation of the hazardous waste.  In
addition, RCRA’s statutory inspection and enforcement authorities
continue to apply in the laboratory, even though under Subpart K the
hazardous wastes are referred to as “unwanted materials,” while they
remain in the laboratory.  

Comment: We heard from one commenter that asked for clarification on the
timing of the hazardous waste determination in regard to unwanted
materials destined for redistribution (Commenter No. 81).  The commenter
believes, for example, that clarification is needed on whether such
unwanted materials can be legally transferred from one site’s
stockroom to another before the RCRA hazardous waste determination is
made.

Response:   It has always been the case under existing RCRA regulations,
and continues to be the case under Subpart K, that chemicals that are
fit for continued use are not solid or hazardous wastes (see §
261.2(e)(1)) and can be transferred between SAAs, laboratories, and
chemical stockrooms.  Under Subpart K, we realize that some chemicals
that are initially identified as unwanted materials will turn out not to
be solid or hazardous wastes.  If, for example, an unwanted material is
brought to an on-site CAA or TSDF for a hazardous waste determination,
and it is determined that such unwanted material can be reused, then it
is not a solid or hazardous waste and is not subject to Subpart K or the
Subtitle C hazardous waste regulations, once the determination is made. 
That is, if a chemical is initially labeled as an unwanted material and
then it is subsequently discovered that it can continue to be used, the
chemical can be returned to a laboratory or chemical stockroom for
redistribution.  EPA selected the term “unwanted material” over
“laboratory waste,” in part to indicate that the material may still
be useable.

Comment: We heard from one commenter noting that EPA has not discussed
how it will be determined when and where the hazardous waste
determination is made (Commenter No. 102). The commenter stated that
this information is necessary in order to determine if the college and
university complied with §262.209(b) and (c), which requires a
hazardous waste determination to be made within four days of arriving at
the on-site central accumulation area or TSDF.

Response:  In Part II of its LMP, an eligible academic entity is
required to describe its intended best practices for making hazardous
waste determination, including specifying the duties of the individuals
involved in the process.  While the contents of Part II of the LMP are
not enforceable, the regulations pertaining to making the hazardous
waste determination (i.e., 40 CFR 262.11, 262.209-262.212), are
enforceable.  These regulations require that the hazardous waste
determination must be made within four calendar days of arriving at an
on-site central accumulation area or TSDF.  If the unwanted material is
a hazardous waste, the words “hazardous waste” must be written on
the container label that is affixed or attached to the container.  If
the unwanted material is not a hazardous waste, it is not regulated
under the RCRA Subtitle C regulations.  In its LMP, however, an eligible
academic entity may choose to indicate on the container label that the
container’s contents have been examined and determined not to be a
hazardous waste (e.g., non-hazardous).

Comment: We heard from one commenter suggesting two modifications to the
rule’s provisions on hazardous waste determinations: 1) that no mixing
or blending of the waste with other wastes or materials can occur until
the waste determination is made (e.g., no dilution to mask
characteristics or blur listing criteria), and 2) the determination must
be made before the waste is offered for transportation off of the
generator’s site. It cannot be made at an off-site TSDF (Commenter No.
24).  

Response:  With regard to the commenter’s first point, EPA interprets
Subpart K to mean that in order to ensure accurate hazardous waste
determinations, only containers of the same unwanted material may be
consolidated in the laboratory, before the hazardous waste determination
is made.  Furthermore, because the land disposal restrictions apply from
the point of generation to those unwanted materials that are hazardous
wastes, the dilution prohibition of 40 CFR 268.3 applies, as well. 
Therefore, unwanted materials may not be diluted prior to making the
hazardous waste determination.  Additionally, unwanted materials may not
be diluted after making the hazardous waste determination, except as
allowed by 40 CFR 268.3.  Because EPA's interpretation under Subpart K
is consistent with the commenter's suggested modification, EPA does not
believe that any modification is necessary.

With regard to the commenter’s second point, we agree with the
commenter that the hazardous waste determination must be made, in all
cases, before the hazardous wastes may be transported off-site.  This is
true regardless of whether the hazardous waste determination is made in
the laboratory, or at an on-site central accumulation area or on-site
TSDF.  We have modified the final regulatory language to make this
clearer and addressed this in the preamble to the final rule.  

Comment: We heard from one commenter suggesting that the LMP be allowed
to include procedures whereby a RCRA-trained person can create a
one-time written documentation that specific streams are not considered
hazardous waste (Commenter No. 61).  The commenter believes this will
allow important efficiencies by avoiding unnecessary paperwork and
evaluations of materials determined to be non-hazardous.

Response:  In Part II of its LMP, an eligible academic entity is
required to describe its intended best practices for making hazardous
waste determination, including specifying the duties of the individuals
involved in the process.  Part II of the LMP is intended to include the
eligible academic entity’s best management practices and may include
the types of procedures that the commenter suggests.  It is important to
note that the eligible academic entity is responsible for making
accurate hazardous waste determinations, regardless of the procedures
used to make the hazardous waste determination.

Comment: We heard from one commenter stating section 262.215 should be
revised as follows, so as not to add additional requirements with
respect to material that is not solid or hazardous waste: “Unwanted
materials are not subject to this subpart until they are determined to
meet the definition of solid waste or hazardous waste by a RCRA trained
individual” (Commenter No. 79).

Response:  We disagree with the commenter.  On the contrary, all
unwanted materials are subject to Subpart K even if it is later
determined that they are not solid waste or hazardous waste.  Once the
hazardous waste determination is made, those unwanted materials that are
not solid wastes or hazardous wastes are no longer subject to Subpart K.
 

Comment: We heard from one commenter requesting clarification on the
requirements for making the various determinations for unwanted
materials at the central accumulation area or the on-site TSDF
(Commenter No. 107).  The commenter stated that, as provided in the
rule, the RCRA trained staff is required to determine if the unwanted
material is useable, is not solid waste, or is a hazardous waste.  The
commenter stated that, if the unwanted material is useable or is only
solid waste, no documentation or record of those determinations is
required.  If the unwanted material is hazardous waste, then additional
labeling is required.   The commenter asked if there should be a
requirement for the RCRA trained staff to document the useable and solid
waste. 

Response:  In Part II of its LMP, an eligible academic entity is
required to describe its intended best practices for making hazardous
waste determination, including specifying the duties of the individuals
involved in the process.  While the contents of Part II of the LMP are
not enforceable, the regulations pertaining to making the hazardous
waste determination (i.e., 40 CFR 262.11, 262.209-262.212), are
enforceable.   These regulations require that the hazardous waste
determination must be made within four calendar days of arriving at an
on-site central accumulation area or TSDF.  If the unwanted material is
a hazardous waste, the words “hazardous waste” must be written on
the container label that is affixed or attached to the container.  If
the unwanted material is not a hazardous waste, it is not regulated
under the RCRA Subtitle C regulations.  In its LMP, however, an eligible
academic entity may choose to indicate on the container label that the
container’s contents have been examined and determined not to be a
hazardous waste (e.g., non-hazardous).

Comment: We heard from three commenters stating that material that may
otherwise be hazardous, but can be reused, is not considered a
“waste” and may be returned to a chemical stockroom or to another
user (Commenter Nos. 5, 77, 81).  The commenters asked EPA to clarify
this point. 

Response:  It has always been the case under existing RCRA regulations,
and continues to be the case under Subpart K, that chemicals that are
fit for continued use are not solid or hazardous wastes (see §
261.2(e)(1)) and can be transferred between SAAs, laboratories, and
chemical stockrooms.  Under Subpart K, we realize that some chemicals
that are initially identified as unwanted materials will turn out not to
be solid or hazardous wastes.  If, for example, an unwanted material is
brought to an on-site CAA or TSDF for a hazardous waste determination,
and it is determined that such unwanted material can be reused, then it
is not a solid or hazardous waste and is not subject to Subpart K or the
Subtitle C hazardous waste regulations, once the determination is made. 
That is, if a chemical is initially labeled as an unwanted material and
then it is subsequently discovered that it can continue to be used, the
chemical can be returned to a laboratory or chemical stockroom for
redistribution.  EPA selected the term “unwanted material” over
“laboratory waste,” in part to indicate that the material may still
be useable.

Comment: We heard from four commenters that disagreed with EPA’s
statement that under existing RCRA regulations the "hazardous waste
determination" must be made in the laboratory, at the point of
generation (Commenter Nos. 5, 43, 56, 58).  One commenter stated that it
is not aware of any language in the regulation that requires spent
material that is accumulated at the point of generation to be classified
in the satellite accumulation area and then be taken directly to a 90 or
180 day storage area (Commenter No. 5).  The commenter stated that the
only guidance in the RCRA regulation is for the quantity exceeding 55
gallons in a satellite accumulation area.  Another commenter stated that
the only determination required of the laboratory worker is whether or
not the material can be discarded as normal trash (Commenter No. 43). 
The commenter referenced an Aug 16, 2002 memo from Ms. Cotsworth, cited
in the preamble, wherein: "The issue is whether a hazardous waste
determination must be made in the laboratory...EPA is not addressing
that question in this memo, but intends to address this question in a
future guidance or rulemaking." 

Response:  We disagree with the commenters.  40 CFR 262.11 contains the
regulations for making the hazardous waste determination.  In addition
to the regulations, EPA has had a long-standing policy that the
hazardous waste determination must be made at the point of generation. 
In fact, over the years colleges and universities have had enforcement
actions taken against them for neglecting to make the hazardous waste
determination at the point of generation.  We recognize that making the
hazardous waste determination at the point of generation has been
difficult due to the variable nature of wastes from laboratories, and
the fact that students are involved in generating many of the hazardous
wastes.  The recognition of this difficulty forms the basis for
undertaking this rulemaking.  The fact that EPA did not address this
question in the memo cited by the commenter is not an indication EPA had
not previously addressed the question of when and where to make a
hazardous waste determination.  It was merely an indication that it was
not included in that particular memo.

Comment: We heard from one commenter disagreeing with EPA’s discussion
that a hazardous waste determination can be simplified into several
basic steps (Commenter No. 5).  The commenter stated that the first step
(i.e., determining if the material is a solid waste) is not simple and
is open to many interpretations.  

Response:  We were summarizing the regulations found in 40 CFR 262.11
for making the hazardous waste determination.  These regulations are
broken into four paragraphs, or “steps,” in the process.  We agree
with the commenter, that each of these steps can be complicated and did
not intent to suggest otherwise.

Comment: We heard from one commenter noting that section 262.215
provides that it is the determination of the RCRA trained individual
that removes a material from the definition of solid or hazardous waste
(Commenter No. 12).  The commenter expressed concern that this language
implies that a material is a solid or hazardous waste based on the
accuracy of the RCRA trained individual’s determination, not on
whether the material is in fact a solid or hazardous waste.  The
commenter asked EPA to revise this language by referring to the existing
hazardous waste determination provisions at 40 CFR 262.11

Response:  We agree with the commenter that the wording of the proposed
regulatory text implied that whether an unwanted material was a solid or
hazardous waste was up to the discretion of the RCRA-trained
professional, and did not depend on whether the unwanted material is, in
fact, a solid or hazardous waste.   This, of course, was not the intent
of the regulation, and we have revised the final regulatory text to make
our intent clearer.  The definitions of 40 CFR 261.2 and 261.3 determine
whether an unwanted material is a solid and hazardous waste,
respectively.  40 CFR 262.11, contains the process for making the
hazardous waste determination.

	11.2	Assignment of Hazardous Waste Codes

Comment: We heard from 26 commenters objecting to the requirement to
label hazardous waste containers with waste codes (Commenter Nos. 7, 8,
11, 16, 25, 31, 54, 58, 61, 69, 70, 71, 72, 73, 76, 79, 80, 81, 82, 85,
86, 91, 96, 101, 109, and 110).  These commenters stated that the
requirement is burdensome, unnecessary (e.g., it is of no value to
on-site personnel) and more stringent than existing RCRA regulations. 
We heard from 15 commenters stating that the requirement should be
changed to require only that appropriate waste codes be associated with
the container before the hazardous waste may be transported off-site
(Commenter Nos. 11, 25, 54, 61, 69, 70, 72, 73, 80, 85, 86, 91, 96, 101,
109).  Commenters argued against the requirement that the hazardous
waste code(s) be placed on the container within four days of arriving at
the on-site CAA because this essentially would preclude these entities
from using vendors to make the hazardous waste determinations for them. 
These commenters believe that placing the words “hazardous waste” on
the container is sufficient to indicate that a hazardous waste
determination has been made and that they should be allowed to delay
putting the hazardous waste code(s) on the container until the vendor
comes to ship the hazardous wastes off-site.  Additionally these
commenters pointed out that the majority of hazardous wastes generated
in a laboratory are lab-packed when they are transported off-site and
that putting the hazardous waste code(s) on the label that is affixed to
the container, then placing the container inside of a lab pack is of no
value because the hazardous waste code(s) would not be able to seen. 
The commenters suggested allowing the hazardous waste code(s) to be
placed on the label that is “associated with the container” rather
than the label that is “affixed or physically accompanies the
container.”  

Response:  We agree with these commenters that the practice of using
vendors to make the hazardous waste determination should not be limited
to those eligible academic entities that make the hazardous waste
determination in the laboratory.  Eligible academic entities that make
the hazardous waste determination in an on-site CAA or interim status or
permitted TSDF also should be able to use vendors to assist them with
their hazardous waste determination.  In today’s final rule;
therefore, the hazardous waste determination must still be made within
four calendar days of arriving at an on-site CAA or TSDF, and for those
unwanted materials that are hazardous waste, the words “hazardous
waste” still must be added to the label that is affixed or attached to
the container within those four calendar days.  We also continue to
require that hazardous waste code(s) must be added to the label that is
affixed or attached to the container.  However, in response to comments,
the Agency is amending the final rule so that eligible academic entities
may delay assigning the hazardous waste code(s) until immediately prior
to shipping the hazardous waste(s) off-site.  When containers of
unwanted materials arrive at an on-site CAA, they are subject to the CAA
regulations appropriate to the site’s generator status, including
dating of the containers to calculate the 90/180/270 days that the
containers may be accumulated on-site, and the container management
standards.  Likewise, when containers of unwanted materials arrive at an
on-site TSDF, the unwanted material becomes subject to the terms of the
facility’s hazardous waste permit or interim status, as soon as it
arrives.  Therefore, since the containers must be managed as hazardous
waste upon arriving at an on-site CAA or TSDF, we believe there is no
decrease in protection of human health and the environment by delaying
the addition of the hazardous waste code(s).  

Since the final regulations have been revised so that the hazardous
waste code(s) do not need to be added until just before the hazardous
waste is transported off-site and since most containers will be
lab-packed, we agree that placing the hazardous waste code(s) on the
container label that is affixed or attached to the container provides no
value.  Therefore, we have revised the regulatory language in §§
262.210(b)(2), 262.211(e)(2), and 262.212(e)(2) to allow the appropriate
hazardous waste code(s) to be placed on the container label that is
associated with the container.  This will allow the practice of putting
hazardous waste code(s) on a packing slip or inventory list for a lab
pack to continue.  

Comment: We heard from one commenter requesting that the post-hazardous
waste determination labeling and waste management requirements be
flexible to allow facilities to choose to use the same labeling
requirements for all hazardous wastes generated on their campus (i.e.,
laboratory and non-laboratory wastes) (Commenter No. 81).  

Response:  Subpart K applies only to unwanted materials generated in the
laboratory.  Therefore, the hazardous waste determination for
non-laboratory hazardous wastes must continue to be made at the point of
generation.  Non-laboratory hazardous wastes that accumulate on-site
continue to be subject to the labeling requirements in 40 CFR 262.34(a)
for LQGs, 262.34(d) for SQGs, or 262.34(c) for hazardous wastes at SQGs
or LQGs in satellite accumulation areas.  

Comment: We heard from one commenter expressing concern about the
wording of when the label with the hazardous waste codes must be applied
(Commenter No. 5).  The commenter notes that the proposal states,
“Once the RCRA-trained individual makes the determination, whether it
is in the laboratory or an on-site CAA or TSDF…”.  The commenter
stated that, under its governmental procedures, its determinations are
made in an office where information is available to assist in making the
determination, and the process may involve several days before the
information is taken back to the area where the chemicals are located. 
The commenter stated that, depending on the definition of the term
“once,” its labs could be cited for not labeling in a timely manner
if there is a day or two between the knowledge of the classification of
a given container and the application of the label even though the time
interval was spent in the office classifying other material located in
the same workroom.

Response:  We are amending the final rule so that eligible academic
entities may delay assigning the hazardous waste code(s) until
immediately prior to shipping the hazardous waste(s) off-site. 
Therefore, we believe the comment is now moot.

Comment: We heard from one commenter that described its process for
placing small containers into a larger secondary container, and asked
EPA to allow labs to place the label (e.g., waste codes, accumulation
start date) on the secondary containers instead of the smaller ones that
are inside (Commenter No. 5).  The commenter stated that a lab pack may
contain numerous, small containers.  Its practice is to label the
secondary container, accompanied by other descriptive paperwork.

Response:  Under the existing satellite accumulation area regulations,
we have interpreted the regulations to allow generators to place small
containers that are too small to label inside larger, secondary
containers and to label the secondary container instead of each
individual small container.  This has the added benefit of secondary
containment, should the small containers break.  Under Subpart K, this
also would be an acceptable practice.

	11.3	Four-Day Limit for Hazardous Waste Determination

Comment: We heard from 20 commenters expressing concern about the
four-day limit for making a hazardous waste determination at the CAA or
on-site TSDF and asking that it be extended (Commenter Nos. 5, 7, 8, 11,
25, 31, 43, 52, 60, 68, 69, 70, 73, 76, 77, 79, 86, 99, 107, 108).  The
commenters stated that four days is not a sufficient time for colleges
and universities to make hazardous waste determinations for their lab
waste, particularly for unknown materials, and the requirement is more
stringent than the existing regulations. 

Response:  Given that (1) under existing regulations the hazardous waste
determination is required to be made at the point of generation and that
the Agency is providing considerable flexibility in Subpart K for where
and when to make the hazardous waste determination and (2) the initial
hazardous waste determination should be more straight forward without
the addition of the hazardous waste code(s), we are not providing
additional time.  Thus, under today’s final rule, the hazardous waste
determination must be made within four calendar days of arriving at an
on-site CAA or TSDF.

We recognize that, in some cases, chemicals will be managed in the
laboratory and that when those chemicals are eventually disposed, it may
not be possible to identify the chemicals.  This sometimes happens when
a researcher retires and leaves unlabeled chemicals behind.  In
addition, some laboratories synthesize new compounds as part of their
research.  When these “unknowns” are disposed of, it may not be
possible to make a hazardous waste determination without analysis.  As a
result, we have added a requirement that an eligible academic entity
must develop, in Part II of its LMP, procedures for the timely and
reliable characterization of unknown chemicals.  We did not believe it
was appropriate to extend the four day time limit for all instances, in
order to accommodate the more atypical instances of unknowns.

Comment:  We heard from one commenter suggesting a seven calendar day
time limit (Commenter No. 8).  We heard from one commenter suggesting a
two-week maximum time limit and the LMP should set the practical time
limit based on college or university-specific conditions (Commenter No.
7).  We heard from one commenter suggesting that the timeframe be
increased to 30 days (Commenter No. 79).  We heard from two commenters
asking for the timeframe to be left to the college or university
discretion (Commenter Nos. 68 and 108).  The commenters stated that a
college or university could document in its LMP the appropriate
timeframe for its hazardous waste determinations, taking relevant
considerations (e.g., relevant risks) into account.

Response:  Given that (1) under existing regulations the hazardous waste
determination is required to be made at the point of generation and that
the Agency is providing considerable flexibility in Subpart K for where
and when to make the hazardous waste determination and (2) the initial
hazardous waste determination should be more straight forward without
the addition of the hazardous waste code(s), we are not providing
additional time.  Thus, under today’s final rule, the hazardous waste
determination must be made within four calendar days of arriving at an
on-site CAA or TSDF.

Comment:  We heard from 11 commenters that the appropriate timeframe
should be anytime before the material is transferred off-site under the
90/180/270-day accumulation requirements (Commenter Nos. 11, 25, 31, 43,
60, 69, 70, 73, 77, 86, 99). 

Response:  Although we are allowing eligible academic entities to delay
assigning the hazardous waste code(s) until immediately prior to
shipping the hazardous waste(s) off-site, we have retained the
requirement to make the hazardous waste determination within four
calendar days of arriving at an on-site central accumulation area or
TSDF.  Therefore, for those unwanted materials that are hazardous
wastes, the words “hazardous waste” still must be added to the label
that is affixed or attached to the container within those four calendar
days.  This is necessary to distinguish hazardous waste from
non-hazardous waste that may also be accumulating in the 90/180/270-day
area.

Comment: We heard from one commenter suggesting a four “working day”
limit (Commenter No. 76).  We heard from another commenter that it
should be spelled out in “business days,” not “calendar days”
(Commenter No. 79).  

Response:  We believe that relying on “working days” or “business
days” would be confusing because not everyone shares the same
“working” or “business” days.  By relying on “calendar”
days, we are providing consistency and clarity in calculating the
timeframes within the rule.

Comment: We heard from one commenter suggesting 45 days is needed for it
to accommodate materials that require characterization (Commenter No.
107).  

Response:  We recognize that, in some cases, chemicals will be managed
in the laboratory and that when those chemicals are eventually disposed,
it may not be possible to identify the chemicals.  This sometimes
happens when a researcher retires and leaves unlabeled chemicals behind.
 In addition, some laboratories synthesize new compounds as part of
their research.  When these “unknowns” are disposed of, it may not
be possible to make a hazardous waste determination without analysis. 
As a result, we have added a requirement that an eligible academic
entity must develop, in Part II of its LMP, procedures for the timely
and reliable characterization of unknown chemicals.  We did not believe
it was appropriate to extend the four day time limit for all instances,
in order to accommodate the more atypical instances of unknowns.

Comment: We heard from one commenter stating that it needs 30 to 40 days
to classify its incoming materials collected from its government labs
(Commenter No. 5).  The commenter stated that this timeframe is in
addition to the 90-day accumulation clock.  The commenter stated that
the proposed rule would not provide it any relief because it only
provides four days from the time the material is removed from a lab.

Response:  This rule was never intended to extend on-site accumulation
times for generators in the manner suggested by the commenter.  

Nevertheless, we understand the commenter’s concern and under the
final rule the initial hazardous waste determination should be more
straightforward without the addition of the hazardous waste code(s). 
Thus, under the final rule, although the hazardous waste determination
must be made within four calendar days of arriving at an on-site CAA or
TSDF, eligible academic entities may delay assigning the hazardous waste
code(s) until immediately prior to shipping the hazardous waste(s)
off-site.  

Comment: We heard from two commenters stating that it deems moot the
question of allowing four calendar days to do a hazardous waste
determination in the central accumulation area (Commenter No. 56, 58).
The commenter stated that the current regulations have already been
clearly interpreted to allow whatever time is needed so long as the
waste has been properly managed from the point of generation .

Response:  We disagree with the commenter and find the commenter’s
interpretation of the existing regulations regarding making the
hazardous waste determinations to be erroneous.  On the contrary, the
existing hazardous waste generator regulations have consistently been
interpreted to require that the hazardous waste determination be made at
the point of generation.

Comment: We heard from one commenter expressing support for the four-day
limit for making a hazardous waste determination at the CAA or on-site
TSDF (Commenter No. 71).  

Response:  We thank the commenter for his/her support and have retained
requirement that the hazardous waste determination must be made for
unwanted materials within four calendar days of arriving at the on-site
central accumulation area or on-site TSDF.

Comment: We heard from six commenters stating that the four day
timeframe should be included in the 90/180-day accumulation time limit
(Commenter Nos. 8, 11, 58, 71, 79, 81).  One of the commenters expressed
concern that adding the four days to the 90/180-day timeframe would
prolong the process (Commenter No. 79).   Two commenters expressed
concern about the added administrative burden of a new dating
requirement (Commenter No. 8 and 71).  Another commenter stated that
inclusion of the four days within the 90/180 day timeframe would ensure
alignment with other hazardous wastes being accumulated (Commenter No.
81).

Response:  We agree with the commenters and under the final rule, the
four calendar days for making the hazardous waste determination is
included as part of the 90/180/270 days allowed for on-site accumulation
of hazardous wastes.  Therefore, under the final rule, a container’s
date of arrival at an on-site CAA will be used for two purposes:  (1)
calculating the four calendar days allotted for making the hazardous
waste determination and (2) calculating the maximum accumulation time in
the CAA.

Comment: We heard from two commenters stating that, if EPA agrees that
the determination can be made anytime before the waste is shipped
off-site, then it is moot whether the four day timeframe should be
included in the 90/180-day accumulation time limit (Commenter Nos. 11,
25).  They stated that the containers should be dated when they arrive
at the CAA or on-site TSDF and the 90/180-day clock should begin.

Response:  Although we have changed the final rule to allow eligible
academic entities to delay assigning the hazardous waste codes until
just prior to shipment off-site, the hazardous waste determination must
still be made within four calendar days of arriving at the on-site CAA
or on-site TSDF.  Therefore, under the final rule, a container’s date
of arrival at an on-site CAA will be used for two purposes:  (1)
calculating the four calendar days allotted for making the hazardous
waste determination and (2) calculating the maximum accumulation time in
the CAA.

Comment: We heard from two commenters stating that the four day
timeframe should not be included in the 90/180-day accumulation time
limit (Commenter Nos. 7 and 107).  One commenter stated that it would be
burdensome to “back-date” material accumulation dates and such dates
would be largely unenforceable (Commenter No. 7).  The other commenter
stated that the clock should not begin until the material is determined
to be hazardous waste (Commenter No. 107).  The commenter stated that a
second dating provision would be needed.

Response:  We disagree with the commenters and under the final rule, the
four calendar days allowed for making the hazardous waste determination
at an on-site accumulation area are included in the 90/180/270 days
allowed for accumulation.  This method requires only a single dating of
containers when they arrive in the on-site central accumulation area. 
Under the commenters’ suggestion, it would be necessary to have a two
dating requirements:  one for calculating the four calendar days
allotted for making the hazardous waste determination and a second date
for calculating the maximum accumulation time in the CAA.  Having two
dates on a container would not only add burden but could be confusing to
both implementers and enforcers.  Therefore, under the final rule, a
single date is required upon arrival at an on-site CAA that will be used
for two purposes:  (1) calculating the four calendar days allotted for
making the hazardous waste determination and (2) calculating the maximum
accumulation time in the CAA.

Comment: We heard from two commenters expressing opposition to the
requirement to add an additional dating requirement for the four day
time limit (Commenter Nos. 11, 25).  The commenters believe the proposed
recordkeeping requirements are sufficient, and any additional
requirements will limit college or university participation.  

Response:  We agree with the commenters and have not added an additional
dating requirement for determining the four day time limit for making
the hazardous waste determination.  Therefore, under the final rule,
there is a single dating requirement for containers arriving at an
on-site CAA.  A container’s date of arrival at an on-site CAA will be
used for two purposes:  (1) calculating the four calendar days allotted
for making the hazardous waste determination and (2) calculating the
maximum accumulation time in the CAA.

Comment: We heard from one commenter stating that the hazardous waste
determination should be made as soon as possible so the process
knowledge will not be lost (Commenter No. 66).  The commenter believes
that, if this is not possible, the waste should be labeled with chemical
mixture process knowledge before transfer to the CAA.

Response:  We agree with the commenter that the hazardous waste
determination should be made as soon as possible to avoid the loss of
process knowledge.  Therefore, we have maintained the requirement that
the hazardous waste determination be made within four days of arriving
at an on-site central accumulation area or on-site TSDF (or in the
laboratory before the unwanted materials are removed from the
laboratory).  We believe that the container labeling requirements are
sufficient to convey the necessary information to make proper hazardous
waste determinations.

12.0 	Laboratory Clean-outs

	12.1	General

Comment: We heard from 31 commenters expressing general or partial
support for the proposed clean-out provisions (Commenter Nos. 8, 11, 14,
17, 25, 37, 44, 51, 52, 56, 70, 71, 73, 74, 78, 84, 85, 99, 107, 108,
109, 111).  

Response:  We thank the commenters for their support.  We continue to
believe that providing incentives for eligible academic entities to
remove “legacy chemicals” from laboratories is important for
improving the safety of laboratories and thereby protecting human health
and the environment.  We have maintained the laboratory clean-out
provisions in the final rule, although we have made some revisions from
the proposed laboratory clean-out provisions.

Comment: We heard from one commenter expressing general opposition to
the proposed clean-out provisions (Commenter No. 58).  The commenter
stated that it does not agree that colleges doing lab clean-outs should
be provided added additional time to get it done. The commenter does not
believe there is evidence that EPA’s intended encouragement of lab
clean-outs would actually be effective in its purported aim. The
commenter also believes the proposed counting exemption would become an
enforcement nightmare for inspectors attempting to determine dates of
waste generation to determine what wastes and quantities of wastes are
eligible for the exemption. The commenter stated that there is the
probability of colleges being a CESQG as a result of the clean-out
exemption and then being allowed to dispose the now CESQG wastes to
municipal solid waste landfills.  The commenter does not believe this is
in the best interests of the public or the environment and cannot be
characterized as promoting "safer management of laboratory hazardous
wastes."

Response:  We disagree with the commenter and believe that the
laboratory clean-out provisions are necessary to remove the regulatory
barriers that act as disincentives for conducting laboratory clean-outs.
 EPA has often been told that the current satellite accumulation area
regulations are a barrier to conducting clean-outs of laboratories. 
Specifically, when laboratory clean-outs are conducted, it is likely
that more than 55 gallons of chemicals will be generated.  The existing
satellite accumulation area rules require that once 55 gallons of
hazardous waste (or 1 quart of acutely hazardous waste) is exceeded, the
excess of 55 gallons must be removed within three days.  Stakeholders
have told EPA that the current requirement to remove the excess of 55
gallons (or 1 quart of acutely hazardous waste) within three days is an
impediment to comprehensive laboratory clean-outs, because it does not
provide enough time to sort through and evaluate the many chemicals that
can be part of a laboratory clean-out.  EPA has been told that another
barrier to conducting laboratory clean-outs is the possibility that the
volume of hazardous waste generated during a laboratory clean-out would
be sufficient to change the entity’s generator status.  This change in
generator status would add additional regulatory burden, such as fewer
days for on-site accumulation in a central accumulation area, or a
requirement to have a contingency plan.  The result of these
disincentives, as EPA inspections and enforcement cases have revealed,
is that used and unused chemicals that are clearly no longer useable,
have in some cases remained in laboratories at academic institutions for
years and even decades. 

We share the commenter’s concern that as a result of the laboratory
clean-out provision that allows some hazardous waste not to count toward
the eligible academic entity’s generator status, some eligible
academic entities that are typically CESQGs but would become either SQGs
or LQGs as a result of a laboratory clean-out (absent Subpart K), would
be able to maintain their CESQG status.  If this were the case,
hazardous wastes that should normally be managed as hazardous waste
would be eligible to be disposed of in a municipal solid waste landfill,
which is allowed under the CESQG regulations of 40 CFR 261.5.  In fact,
in the preamble to the proposed rule we stated, “any hazardous waste
that is not counted toward generator status during a laboratory
clean-out is still a hazardous waste and is subject to all applicable
regulations, including the land disposal regulations, and the
regulations for on-site and off-site management, transportation, and
treatment and disposal of hazardous waste.  The incentive that the
Agency is proposing to provide for hazardous wastes generated during a
laboratory clean-out affects only the length of time that hazardous
wastes are stored on-site and other associated regulations of 40 CFR
262.34 pertaining to generator status, such as biennial reporting and
contingency plans” (see 71 FR 29739).

Nevertheless, we believe that for clarity it is appropriate to revise
the regulatory language of § 262.213 to reflect the intent of the rule
as stated in the preamble to the proposed rule.  This is made all the
more necessary by the expansion of scope of the final rule to include
eligible academic entities that are CESQGs.  If an SQG avoided LQG
status as the result of a laboratory clean-out incentive, the hazardous
waste would still be regulated as hazardous waste once it is taken
off-site, since both SQGs and LQGs must comply with the same
transportation and disposal regulations.  With the inclusion of CESQGs
into the final rule, however, if a CESQG avoided becoming an SQG or LQG
as the result of a laboratory clean-out incentive, then potentially
regulated hazardous waste would be allowed to be disposed of at a
municipal solid waste landfill.  Therefore, we are modifying the
language of § 262.213(a)(2) to indicate that the effect of not counting
hazardous wastes that are unused commercial chemical products toward the
eligible academic entity’s generator status is limited to the on-site
accumulation of the hazardous waste.  In tandem, we also are including a
new paragraph, § 262.213(a)(3), to indicate that for the purposes of
off-site management, if an eligible academic entity generates more than
the monthly CESQG limits (i.e., >1 kg of acutely hazardous waste, or
>100 kg of hazardous waste), then the eligible academic entity must
manage its hazardous waste according to all applicable hazardous waste
regulations for SQGs and LQGs.  When determining whether these monthly
limits have been exceeded, the eligible academic entity must count all
of its hazardous wastes, including those generated during laboratory
clean-outs.  In other words, even when hazardous wastes are not counted
toward the site’s generator status on-site, if they are generated in
excess of the CESQG monthly limits, they are regulated as hazardous
waste when they are transported, treated, stored or disposed of
off-site.  EPA intended to create an incentive to conduct laboratory
clean-outs by relieving the generator of some of the additional burden
that would be incurred by changing generator status.  However, we did
not intend to allow regulated hazardous waste in excess of the CESQG
monthly limits to be disposed of in municipal solid waste landfills.

Comment: We heard from two commenters noting that the proposed
regulatory text at 40 CFR 262.213(a)(3) indicates that colleges and
universities must maintain records related to a laboratory clean-out
“for a period of three years from the date the clean-out ends,”
rather than “for as long as the college or university operates
under” the new Subpart K, as stated in the preamble (71 FR 29739)
(Commenter Nos. 33 and 107).  The commenters suggested that the final
rule clarify that the retention period for laboratory clean-out records
is three years, as stated in the proposed regulatory text.

Response:  We thank the commenters for pointing out the discrepancy
between the preamble and the proposed regulatory text.  We agree with
the commenter that the proposed regulatory text reflects what we
intended for record retention pertaining to laboratory clean-outs. 
Thus, the final rule makes clear that records for laboratory clean-outs
must be kept for three years from the date the clean-out ends and we
have revised the preamble to the final rule to also reflect this
three-year period.

Comment: We heard from one commenter stating that the Agency should
consider not requiring colleges and universities to document the waste
taken from the laboratory during the clean-out (Commenter No. 52). The
commenter believes this raises questions of self-reporting if the amount
collected is over the accumulation limit or at least a potential
violation for not identifying unwanted material.

Response:  We did not propose, nor are we finalizing, a requirement to
report the results of a laboratory clean-out.  However, we did propose
and are finalizing unchanged the recordkeeping requirements for
laboratory clean-outs.  There is no requirement to submit these records.

Comment: We heard from two commenters stating that the procedures for
clean-outs are too prescriptive (Commenter Nos. 68 and 74).  The
commenter suggested that the college or university develop written
procedures and timeframes in the LMP regarding lab clean-out process
including, if applicable: requests for clean-out, initial review,
management of unknowns, start date, and completion date; include
provisions for extending timeframes in case of extenuating
circumstances; describe documentation procedures (Commenter No. 68). 
Another commenter encouraged EPA to provide more discretion to colleges
and universities in how they conduct clean-outs (Commenter No. 74).  The
commenter stated that EPA should require that clean-outs or some other
chemical management process be included in the LMP. The commenter
suggested that Subpart K should include information on what criteria
must be met for a clean-out including any restrictions (such as only
conducted once every twelve months). .

Response:  We disagree with the commenter that the procedures for
clean-outs are too prescriptive.  In fact, we did not propose, nor are
we finalizing, procedures for conducting laboratory clean-outs.  We
proposed and finalized a requirement that the LMP describe procedures
for conducting laboratory clean-outs, as the commenter suggests.  The
final rule also includes a requirement that the LMP describe the
procedures for documenting laboratory clean-outs.  The recordkeeping
requirements for laboratory clean-outs and the restriction that a
laboratory can only take advantage of the laboratory clean-out
incentives once per 12 month period are both intended to reduce the
potential for abusing the laboratory clean-out incentives.

We agree with the commenter that eligible academic entities would
benefit from a chemical management process.  We believe that conducting
laboratory clean-outs is only one part of that process.  Although we are
not requiring a comprehensive chemical management process, we have added
a requirement that Part II of the LMP must include a list of chemicals
that the eligible academic entity has, or is likely to have, that become
more dangerous when they exceed their expiration date and/or as they
degrade, and it must describe procedures to safely dispose of chemicals
that become more dangerous when they exceed their expiration date and/or
as they degrade.  This requirement allows eligible academic entities to
focus on the more dangerous chemicals in the laboratory.  However, an
eligible academic entity is encouraged to go beyond the basic
requirements of the LMP, and may include additional best practices in
Part II of its LMP.

 

Comment: We heard from one commenter asking for clarification as to
whether the unwanted materials generated in clean-outs are to be sent to
the on-site central accumulation area or an on-site TSDF at the
conclusion of the clean-out (Commenter No. 107).

Response:  It is up to the eligible academic entity to decide whether to
bring the unwanted materials that it generates during a laboratory
clean-out to its on-site central accumulation area or on-site TSDF. 
There is no requirement in Subpart K to send unwanted materials
generated during laboratory clean-outs to an on-site central
accumulation area or on-site TSDF.  Nor is there anything in Subpart K
prohibiting eligible academic entities from sending unwanted materials
generated during laboratory clean-outs to an on-site central
accumulation area or on-site TSDF.

Comment: We heard from two commenters suggesting that EPA extend the
labeling and container management standards to clean-out wastes
(Commenter Nos. 102 and 105).  They stated that such requirements are
not clearly spelled out in the proposed regulations.

Response:  We agree with the commenter.  In fact, the proposed
regulations, and now the final regulations, require that the labeling
and container management standards apply to unwanted materials generated
during a laboratory clean-out.  This intent is captured in the first
paragraph of the regulatory text for laboratory clean-outs in 262.213,
which reads:

One time per 12 month period for each laboratory, a eligible academic
entity may opt to conduct a laboratory clean-out that is subject to all
the applicable requirements of this subpart, except that: [emphasis
added]

During the course of a laboratory clean-out, some chemicals will be
considered unwanted materials and ultimately hazardous wastes, while
others will not.  Those laboratory clean-out chemicals that become
unwanted materials are subject to all the same labeling and container
management standards - as well as all other applicable requirements of
Subpart K - as any other unwanted material in the laboratory, with the
exceptions noted in                      § 262.213(a)(1)-(4).  On the
other hand, those chemicals that can continue to be used in the same
laboratory would be considered products, not unwanted materials, and
would not be subject to the labeling and container management standards
of Subpart K.  If a clean-out chemical from one laboratory can be used
in a different laboratory, we can envision two probable scenarios.  If
the determination is made in the laboratory that a chemical can be used
in another laboratory, it would not be considered an unwanted material;
rather, it would be considered a product and thus not regulated under
RCRA.  If, on the other hand, the determination that the chemical can be
used in another laboratory is made after it is removed from the
laboratory, in an on-site CAA or TSDF, the clean-out chemical would be
regulated as an unwanted material until it is redistributed from the CAA
to another laboratory for further use.  

Comment: We heard from one commenter asking for clarification on whether
laboratory clean-outs would be subject to the size restriction imposed
under the definition of “unwanted material” (Commenter No. 107). 
The commenter indicated that it generates large items (e.g., High
Efficiency Particulate Air (HEPA) filters) that could not be easily
picked up under the 10-day removal frequency specified in the proposed
rule for unwanted material that exceeds specified volume limits.  The
commenter believes such large items could be better addressed under the
clean-out provisions.

Response:  Neither the proposed or final definition of unwanted material
includes any size restriction.  We believe the commenter meant to refer
to the definition of laboratory, which includes the requirement that
containers must be easily manipulated by one person.  Based on the
information provided by the commenter, we believe that the large items
to which the commenter refers, would not be considered unwanted
materials generated in a laboratory and therefore would not be subject
to Subpart K or the Subpart K clean-out provisions.  Subpart K is
intended to regulate the management and disposal of laboratory chemicals
and other materials that are routinely generated in laboratories.  We
would not consider large equipment, such as HEPA filters (which can not
be easily manipulated by one person) to be unwanted materials.  As the
commenter points out, the Subpart K requirements, such as the volume and
time limits, do not appropriately address large equipment.  If such
large equipment were hazardous waste, it would be regulated under the
existing RCRA generator regulations.

	12.2	Incentives to Conduct Clean-outs

Comment: We heard from two commenters stating that EPA can encourage the
best practice of laboratory clean-outs by adopting their suggestions to
make Subpart K more attractive to colleges and universities (Commenter
Nos. 11 and 25): allowing CESQGs to use the clean-out provisions without
adopting all of Subpart K; lengthening the time for a laboratory
clean-out from 30 to 60 days; and allowing a laboratory clean-out to
count as a regular removal.  

Response:  We disagree with the commenters three suggestions for making
the laboratory clean-out incentives more attractive.  First, EPA agrees
that stand-alone CESQGs and CESQG sites that are part of a larger
eligible academic entity will benefit by removing legacy chemicals from
the laboratory by taking advantage of the clean-out incentives of
today’s rule.  However, EPA is not allowing a stand-alone eligible
academic entity or a CESQG site that is part of a larger eligible
academic entity to partake only in the laboratory clean-out provisions
and not the other Subpart K requirements because this would prevent
CESQGs from taking advantage of the two main benefits of today’s final
rule.  That is, if a CESQG site only participated in the laboratory
clean-out provisions, it would not be able to take advantage of the
flexibility in where and when to make the hazardous waste determination.
 Second, if a CESQG site that is part of a larger eligible academic
entity only participated in the laboratory clean-out provisions, it
would be unable to establish one hazardous waste management system in
all the laboratories at the eligible academic entity.  The ability to
establish a unified hazardous waste management system for all
laboratories is one of the priorities cited by academic commenters. 
Therefore, in order for a CESQG site at an eligible academic entity or
an eligible academic entity that is itself a CESQG, to take part in the
laboratory clean-out incentives, the eligible academic entity must opt
into Subpart K in its entirety and follow the management standards for
unwanted materials in the laboratories.  

Second, we anticipate that in most instances, laboratory clean-outs will
be planned events.  Therefore, we continue to believe that 30 days is
sufficient time to conduct a thorough laboratory clean-out and we are
finalizing the time limit for laboratory clean-outs, as proposed.  

Third, we view laboratory clean-outs to be distinct from routine,
regularly scheduled removals of unwanted materials.  In the course of
normal laboratory operations, many chemicals are used and will become
unwanted materials and ultimately may be determined to be hazardous
wastes.  This can occur as a result of teaching or research activities
or, in the case of teaching hospitals, as a result of clinical or
diagnostic activities.  We expect that these routinely generated
wastestreams will comprise the bulk of the unwanted materials that are
removed from the laboratory during regularly scheduled removals.  On the
other hand, a laboratory often can accrue a large number of unused
chemicals in its inventory, some of which can become dangerous over
time, developing the potential to cause significant harm.  It has been
our observation that it is unusual for laboratories to remove unused
chemicals from their inventories on any regular basis.   Therefore, a
regularly scheduled removal of unwanted material does not qualify as a
laboratory clean-out.  Nor does a laboratory clean-out qualify as a
regularly scheduled removal.  However, nothing prohibits these two
events from happening concurrently in order to coordinate waste
management activities.

Comment: We heard from one commenter that SQGs are likely to benefit
from the laboratory clean-out allowance (Commenter No. 60).  The
commenter suggested that  EPA could increase the incentive by: (1)
extending the length of time to conduct the clean-out to at least 60
days; (2) allowing an extension beyond 60 days, if required; and (3)
allowing the institution to determine the clean-out start date.  The
commenter stated that, although some large quantity generators (LQGs)
may benefit from the laboratory clean-out allowance, most will find
EPA’s encouragement for both conducting laboratory clean-outs and
including laboratory clean-out procedures in the Laboratory Management
Plan as sufficient incentives.  

Response:  We anticipate that in most instances, laboratory clean-outs
will be planned events.  Therefore, we continue to believe that 30 days
is sufficient time to conduct a thorough laboratory clean-out and we are
finalizing the time limit for laboratory clean-outs, as proposed.  We
believe that providing a mechanism for extensions beyond the maximum
time limit allowed for clean-outs would be burdensome for eligible
academic entities and States.  Therefore, we are not allowing extensions
beyond the 30 days.  We proposed and are finalizing recordkeeping
provisions for laboratory clean-outs that require that an eligible
academic entity that conducts a laboratory clean-out identify the start
date of the laboratory clean-out.  

Comment: We heard from one commenter stating that, for a very large LQG,
not counting the hazardous waste toward RCRA generation limits is not an
incentive (Commenter No. 81).  The commenter stated, however, that
having a formal regulatory recognition of laboratory clean-outs with a
time limit will force colleges and universities to formally address
clean-outs in their hazardous waste management systems.  For CESQGs and
SQGs, the commenter believes the lab clean-out provisions would be very
advantageous because the amount of acutely hazardous waste generated
from laboratory clean-outs is a primary concern because of the
implications of exceeding LQG status.  

Response:  We agree with the commenter that for a very large LQG, not
counting the unused hazardous waste toward RCRA generation limits is
unlikely to change its generator status and may not provide as much of
an incentive as for other generators.  That is because even after
subtracting laboratory clean-out wastes when calculating their generator
status, many eligible academic entities will still generate enough
hazardous waste to be LQGs, based on their routinely generated
laboratory waste, as well as their non-laboratory hazardous wastes.  For
these very large LQGs, we believe that allowing 30 days to conduct a
laboratory clean-out establishes a mechanism to conduct laboratory
clean-outs that currently does not exist, and therefore will encourage
laboratory clean-outs.  

	12.2.1		30-Day Limit for Laboratory Clean-outs

Comment: We heard from ten commenters expressing support for the
proposed 30-day limit for conducting a lab clean-out (Commenter Nos. 14,
17, 47, 51, 56, 71, 74, 81, 84, 99).  These commenters believe that 30
days is sufficient time to conduct clean-outs.

Response:  We thank the commenters for their support and we are
finalizing the provision as proposed.  Therefore, eligible academic
entities conducting laboratory clean-outs under Section 262.213 must
remove all unwanted materials from the laboratory within 30 days from
the start of the laboratory clean-out. 

Comment: We heard from 12 commenters asking for a longer timeframe for
conducting a lab clean-out (Commenter Nos. 5, 8, 11, 15, 25, 60, 76, 77,
78, 86, 88, 107).  The commenters stated that additional time is needed
for such activities as arranging for and mobilizing a contractor,
characterizing unknown materials, and finalizing distribution of
unwanted materials. 

One commenter stated the timeframe should coincide with the 90/180-day
accumulation limit (Commenter No. 8).  

Eight commenters stated that 60 days is a more appropriate timeframe
(Commenter Nos. 11, 15, 25, 60, 77, 78, 86, 88).  Two of these
commenters also asked EPA to require colleges and universities to define
the start of the lab clean-out in the LMP and to clarify that the
inventory evaluation is not included in the clean-out period (Commenter
No. 11, 25).  

One commenter stated that a 90 calendar day timeframe is more
appropriate (Commenter No. 76).  The commenter clarified that 90 days
should include the entire timeframe from designation of unwanted
material to shipment off-site.

One commenter recommended a minimum of 75 days for the clean-out
(Commenter No. 107).  

One commenter stated that it needs 30 to 40 days to classify waste from
its clean-outs (Commenter No. 5); if it must put an accumulation start
date on the container the day it is removed from a lab, this can result
in 45 to 50 days before the container is received at its 90-day
accumulation area.  The commenter described the paperwork requirements
and timeframes associated with its governmental organization to support
this estimated duration.

Response:  We anticipate that in most instances, laboratory clean-outs
will be planned events.  Therefore, we continue to believe that 30 days
is sufficient time to conduct a thorough laboratory clean-out and we are
finalizing the time limit for laboratory clean-outs, as proposed.  

The definition of “laboratory clean-out” in today’s final rule is:

an evaluation of the inventory of chemicals and other materials in a
laboratory that are no longer needed or that have expired and the
subsequent removal of those chemicals or other unwanted materials from
the laboratory. A clean-out may occur for several reasons. It may be on
a routine basis (e.g., at the end of a semester or academic year) or as
a result of a renovation, relocation, or change in laboratory
supervisor/occupant. A regularly scheduled removal of unwanted material
as required by § 262.208 does not qualify as a laboratory clean-out.

Therefore, the 30 days of a laboratory clean-out starts when a trained
professional or laboratory personnel begins sorting through and
evaluating the inventory of laboratory chemicals and making decisions
about whether they are unwanted materials or not.  Once it has been
determined that a chemical, is indeed, an unwanted material, as opposed
to a chemical or other material that can be kept in the laboratory for
further use, then the unwanted material becomes subject to the
requirements of Subpart K.  We realize that a laboratory clean-out can
involve considerable planning before the laboratory clean-out begins. 
Advanced planning for a laboratory clean-out prior to sorting and
evaluating a laboratory’s chemical inventory is not considered the
start of the 30 days allowed for a laboratory clean-out.

Comment: We heard from one commenter stating that EPA should not provide
30 days, or any additional time beyond the three days under current
regulations for current satellite accumulation areas, to complete a
clean-out (Commenter No. 58).  The commenter does not believe the
extended timeframe would be effective in encouraging clean-outs.

Response:   We disagree with the commenter and believe that the extended
time allowed for laboratory clean-out is necessary to remove one of the
regulatory barriers that act as a disincentive for conducting laboratory
clean-outs.  EPA has often been told that the current satellite
accumulation area regulations are a barrier to conducting clean-outs of
laboratories.  Specifically, when laboratory clean-outs are conducted,
it is likely that more than 55 gallons of chemicals will be generated. 
The existing satellite accumulation area rules require that once 55
gallons of hazardous waste (or 1 quart of acutely hazardous waste) is
exceeded, the excess of 55 gallons must be removed within three days. 
Stakeholders have told EPA that the current requirement to remove the
excess of 55 gallons (or 1 quart of acutely hazardous waste) within
three days is an impediment to comprehensive laboratory clean-outs,
because it does not provide enough time to sort through and evaluate the
many chemicals that can be part of a laboratory clean-out.  The result
of this disincentive, as EPA inspections and enforcement cases have
revealed, is that used and unused chemicals that are clearly no longer
useable, have in some cases remained in laboratories at academic
institutions for years and even decades. 

Comment: We heard from one commenter expressing its preference that all
unwanted material be removed from the lab at the end of the 30-day
period, regardless of quantity (Commenter No. 47).

Response:  We agree with the commenter.  In the final rule, we have
retained the proposed regulatory text.  Therefore, 40 CFR 262.213(a)(1)
requires that an “eligible academic entity must remove all unwanted
materials from the laboratory within 30 calendar days from the start of
the laboratory clean-out.”  The discussion in the preamble to the
proposed rule which was somewhat inconsistent with the text of the
proposed rule should no longer be considered relevant.  We agree with
the commenter that the timely removal and disposal of the laboratory
clean-out chemicals is the main goal of conducting laboratory clean-outs
and to let the chemicals remain in the laboratory at the conclusion of
the laboratory clean-out is counter-intuitive.  Therefore, regardless of
the quantity of unwanted materials generated during a laboratory
clean-out, all unwanted materials must be removed at the conclusion of
the laboratory clean-out.  

	12.2.2		Not Counting Hazardous Wastes from Laboratory Clean-outs

Comment: We heard from 13 commenters expressing support for the proposed
provisions for exempting clean-out wastes from generator counting
requirements (Commenter Nos. 8, 10, 11, 17, 19, 25, 60, 74, 84, 85, 88,
108, 109).  These commenters stated their belief that the exemption
would reduce the risk of episodic generation and a potential change in
generator status, and would encourage more colleges and universities to
conduct clean-outs, leading to more protective waste management.

Response:  We thank the commenters for their support.  We agree that the
laboratory clean-out incentives will encourage eligible academic
entities to conduct clean-outs and therefore lead to safer laboratory
conditions and more protective waste management, although based on
comments we received on the proposal, we are finalizing the laboratory
clean-out incentives with some modifications.

Comment: We heard from one commenter objecting to the clean-out
exemption because college or university labs are overseen by trained
instructors who are experienced in proper lab procedures; a goal of RCRA
is to improve waste management by raising awareness among the U.S.
public and the clean-out exemption would not train students on effective
waste management decision-making; non-academic sites are able to count
their clean-out wastes; and the proposed provisions could create a
disincentive for colleges and universities to conduct clean-outs more
frequently than annually (Commenter No. 24).  The commenter also
expressed concern that the exemption would require the lab to handle
clean-out unwanted materials differently than unwanted materials
accumulating before the clean-out began, and this would entail burden
(e.g., recordkeeping burdens).  

Response:  We disagree with the commenter.  We anticipate that regular,
time-driven removals of unwanted materials will help remove mostly used
materials from the laboratory, but may not address the problem of
unused, “legacy” chemicals that often accumulate over many years in
a laboratory.  We believe the incentives that Subpart K provides to
conduct laboratory clean-outs of unused chemicals will increase the
number of laboratory clean-outs, even if eligible academic entities are
limited to using the incentives once per 12-month period.  Eligible
academic entities that conduct laboratory clean-outs under 262.213 are
not required to count their hazardous waste that is unused commercial
chemical products toward their generator status.  This may cause them to
segregate their laboratory clean-out wastes from their non-clean-out
wastes to ensure proper counting.  We believe the benefit of the
clean-outs will outweigh any burden associated with the recordkeeping
for laboratory clean-outs.

Comment: We heard from four commenters expressing concern that the
clean-out exemption would result in the underreporting of college or
university waste (Commenter Nos. 24, 41, 56, and 113).  One commenter
suggested that colleges and universities that become large quantity
generators due solely to clean-out wastes be exempt from the large
quantity generator rules except biennial reporting and be subject to the
small quantity generator rules (Commenter No. 56).  Another commenter
stated that the lack of Biennial Report data could hinder regulators’
ability to monitor them; not counting toward generator status hazardous
waste that has been shipped is unprecedented; the largest colleges and
universities already file Biennial Reports so there is no added burden
for them to continue to do so (Commenter No. 113).

Response:  We acknowledge that there may be fewer generators reporting
hazardous waste generation as a result of the laboratory clean-out
provisions that allow not counting toward the eligible academic
entity’s generator status hazardous waste that consists of unused
commercial chemical products.  Under the Federal regulations, only LQGs
have to submit the BR.  Nevertheless, we anticipate that even after not
counting laboratory clean-out wastes when calculating their generator
status, many eligible academic entities will still generate enough
hazardous waste to be LQGs, based on their routinely generated
laboratory waste, as well as their non-laboratory hazardous wastes, in
which case they will still be required to submit the BR.  Moreover, some
States require SQGs to submit a BR.

Comment:  We heard from one commenter that the proposed clean-out
incentives could encourage colleges and universities to hold onto their
unwanted materials longer (Commenter No. 113). We heard from another
commenter that objected to the exemption because the clean-out
provisions are not protective of human health and the environment could
create an incentive for colleges and universities to hoard their
unwanted materials until the annual clean-out (e.g., to avoid payment of
state fees associated with waste quantity) (Commenter No. 41).  The
commenter stated that the clean-out exemption is inconsistent with RCRA,
in which generator status is a measure of risk based on waste quantity. 
Because the commenter believes some clean-outs are better than none, it
stated that the clean-out incentives should be applied on a state-level
under EPA approval and be available to all industries.

Response:  We share the commenters’ concerns and have changed the
laboratory clean-out incentive provision so that only laboratory
clean-out hazardous wastes that are unused commercial chemical products
are not counted toward the eligible academic entity’s generator
status.  Unused commercial chemical products include chemicals that are
discarded P- or U-listed commercial chemical products, and unused
discarded chemicals that are hazardous waste because they exhibit one or
more characteristics.  Any unwanted material that has been used and is a
hazardous waste must be counted toward the eligible academic entity’s
generator status, even if it is removed during the 30-day period of a
laboratory clean-out.  We intend for routinely generated unwanted
materials to be removed from the laboratory during regularly scheduled
removals, and we expect that the bulk of these routinely generated
unwanted materials will be used chemicals.  We do not consider these
used, routinely generated unwanted materials to be laboratory clean-out
wastes and thus they must be counted toward the eligible academic
entity’s generator status.  Therefore, we have revised the regulatory
language to be consistent with our intent and to safeguard against the
potential for abuse of the laboratory clean-out incentive.  This change
will also emphasize that the purpose of the laboratory clean-outs is to
remove unneeded or unuseable chemicals from the laboratory’s inventory
in order to increase safety within the laboratory.

Comment: We heard from two commenters expressing concern that the
exemption would create difficulties for compliance personnel attempting
to determine the circumstances of waste generation (e.g., because the
labeling requirements do not require differentiation of clean-out
materials versus non-clean-out materials) (Commenter No. 58 and 105). 
One of the commenters stated that the tracking requirements for
documenting which lab has had a clean out in the past 12 months adds
more complexity and opportunities for non-compliance (Commenter No.
105).  

Response:  With this “no counting” incentive, we were and remain
concerned about inadvertently encouraging eligible academic entities to
retain unwanted materials that are generated in the laboratory on a
routine basis and to remove them only during a laboratory clean-out,
thereby improperly manipulating their generator status.  Two provisions
are intended to safeguard against this.  First is the requirement for
the eligible academic entity to identify the start date of the
laboratory clean-out in its records.  This, in combination with the
labeling requirement for each container to have an accumulation start
date associated with it, provides a method of verification to ensure
that any container of unwanted material that has a date that pre-dates
the onset of the laboratory clean-out would not be considered to be from
the laboratory clean-out and the unwanted material would have to be
counted toward calculating the facility’s generator status, assuming
it is determined to be hazardous waste.  The second safeguard is that
each laboratory at an eligible academic entity could take advantage of
the laboratory clean-out incentives only once per 12 month period. 
Given that each laboratory is required to have a regularly scheduled
removal of unwanted material at least every six months, this is intended
to ensure that each laboratory would have at least one regularly
scheduled removal during a calendar year between laboratory clean-outs.

Comment: We heard from one commenter that stated that a provision to
count clean-out waste would make the academic laboratories more
accountable to buy only the chemicals needed and encourage waste
minimization, and it would result in better overall inventory management
(Commenter No. 66).  The commenter suggested that lab chemical reviews
be conducted in labs and ancillary areas and recorded once per year. 
The commenter believes this will encourage good inventory management and
waste minimization.  In addition, the commenter stated that, if acutely
hazardous chemicals are handled, then they should be fully regulated due
to risk.

Response:  We disagree with the commenter.  The existing generator
regulations require clean-out chemicals to be counted toward determining
generator status, yet they have not always resulted in encouraging waste
minimization or better overall inventory management.  On the contrary,
EPA inspections and enforcement cases have revealed that used and unused
chemicals that are clearly no longer useable, have in some cases
remained in laboratories at academic institutions for years and even
decades.  Therefore, we believe it is necessary to provide the
laboratory clean-out incentives to encourage eligible academic entities
to remove their legacy chemicals.

Comment: We heard from two commenters expressing concerns that the
proposed clean-out exemption could interfere with the existing
requirements for college or university emergency planning and
preparedness (Commenter Nos. 82 and 87).  These commenters noted that,
under the existing regulations, hazardous waste generators are required
to plan and prepare for emergencies.  By exempting clean-out wastes from
generator counting, EPA would relieve some CESQGs and SQGs from the more
rigorous emergency planning and preparedness requirements applicable to
LQGs.  The commenters stated that emergency planning and preparedness
requirements should apply to colleges and universities, regardless of
the counting exemption.

Response:  We agree with the commenters assessment that as a result of
the laboratory clean-out provisions that allow not counting hazardous
waste that consists of unused commercial chemical products toward the
eligible academic entity’s generator status, some generators will no
longer be required to prepare contingency plans.  In fact in the
preamble to the proposed rule, we stated, “as a result of the any
hazardous waste that is not counted toward generator status during a
laboratory clean-out is still a hazardous waste and is subject to all
applicable regulations, including the land disposal regulations, and the
regulations for on-site and off-site management, transportation, and
treatment and disposal of hazardous waste.  The incentive that the
Agency is proposing to provide for hazardous wastes generated during a
laboratory clean-out affects only the length of time that hazardous
wastes are stored on-site and other associated regulations of 40 CFR
262.34 pertaining to generator status, such as biennial reporting and
contingency plans”.

We believe that providing incentives to remove the legacy chemicals from
laboratories will reduce these legacy chemicals from laboratories and
thus reduce the significance of such contingency plans

Comment:  The following are suggested specific edits to the regulatory
text. Four commenters recommended that EPA clarify section 262.210(c) to
read:  “If an unwanted material is a hazardous waste, the college or
university must count the hazardous waste toward the college or
university’s generator status, pursuant to §261.5, unless the
generation of the waste was part of a laboratory clean-out, subject to
§262.213” (Commenter Nos. 11, 25, 54, 76).

Response:  An unwanted material that is a hazardous waste must be
counted toward  generator status, unless it is an unused commercial
chemical product that was generated during a laboratory clean-out under
262.213.  Therefore, we believe it is sufficiently clear to refer to the
“no counting” incentive in the laboratory clean-out section of the
regulations only.  Referring to the “no counting” incentive under
other sections of the regulatory text, could add confusion and mislead
eligible academic entities about their responsibility to count all other
hazardous wastes.  

Comment:  We heard from two commenters expressing opposition to allowing
SQGs and CESQG generators to adopt the clean-out provisions (Commenter
Nos. 58, 82).  One of the commenters stated that EPA should not waive
the acute hazardous waste threshold in any case (Commenter No. 82).  One
of the commenters noted the probability of colleges being a CESQG as a
result of the clean-out exemption and then being allowed to dispose the
now CESQG wastes to municipal solid waste landfills (Commenter No. 58).
The commenter does not believe this is in the best interests of the
public or the environment and cannot be characterized as promoting
"safer management of laboratory hazardous wastes."  The commenter also
indicated its belief that some of the rule’s requirements (e.g., for
container management, training, and lab management plan) are overly
restrictive or burdensome for CESQGs.  Another commenter stated that
CESQGs who do not adopt the rule should not be allowed to selectively
use the laboratory clean-out provision (Commenter No. 82).  

Response:  EPA agrees that it is not in the best interest of the public
or the environment to allow quantities larger than the CESQG limits of
100 kg of hazardous waste or 1 kg of acute hazardous waste to be
disposed of in municipal solid waste landfills.  Therefore, EPA is not
allowing a stand-alone eligible academic entity or a CESQG site that is
part of a larger eligible academic entity to partake only in the
laboratory clean-out provisions and not the other requirements of
Subpart K.  A CESQG site at an eligible academic entity or an eligible
academic entity that is itself a CESQG must opt into Subpart K in its
entirety and follow the management standards for unwanted materials in
the laboratories.  

EPA intends for hazardous waste generated from laboratory clean-outs to
be properly managed no matter which type of generator generates the
waste.  In the preamble to the proposed rule we stated, “any hazardous
waste that is not counted toward generator status during a laboratory
clean-out is still a hazardous waste and is subject to all applicable
regulations, including the land disposal regulations, and the
regulations for on-site and off-site management, transportation, and
treatment and disposal of hazardous waste.

We revised the regulatory language of § 262.213 to reflect the intent
of the rule as stated in the preamble to the proposed rule.  This is
made all the more necessary by the expansion of scope of the final rule
to include eligible academic entities that are CESQGs.  If an SQG
avoided LQG status as the result of a laboratory clean-out incentive,
the hazardous waste would still be regulated as hazardous waste once it
is taken off-site, since both SQGs and LQGs must comply with the same
transportation and disposal regulations.  With the inclusion of CESQGs
into the final rule, however, if a CESQG avoided becoming an SQG or LQG
as the result of a laboratory clean-out incentive, then potentially
regulated hazardous waste would be allowed to be disposed of at a
municipal solid waste landfill.

Therefore, we are modifying the language of § 262.213(a)(2) to indicate
that the effect of not counting hazardous wastes that are unused
commercial chemical products toward the eligible academic entity’s
generator status is limited to the on-site accumulation of the hazardous
waste.  In tandem, we also are including a new paragraph, §
262.213(a)(3), to indicate that for the purposes of off-site management,
if an eligible academic entity generates more than the monthly CESQG
limits (i.e., >1 kg of acutely hazardous waste, or >100 kg of hazardous
waste), then the eligible academic entity must manage its hazardous
waste according to all applicable hazardous waste regulations for SQGs
and LQGs.  When determining whether these monthly limits have been
exceeded, the eligible academic entity must count all of its hazardous
wastes, including those generated during laboratory clean-outs.  In
other words, even when hazardous wastes are not counted toward the
site’s generator status, if they are generated in excess of the CESQG
monthly limits, they are regulated as hazardous waste when they are
transported, treated, stored or disposed of off-site.  EPA intended to
create an incentive to conduct laboratory clean-outs by relieving the
generator of some of the additional burden that would be incurred by
changing generator status.  However, we did not intend to allow
regulated hazardous waste in excess of the CESQG monthly limits to be
disposed of in municipal solid waste landfills.

	12.2.3		Expanding Laboratory Clean-out Incentives

	

Comment: We heard from one commenter stating that the definition of a
stockroom needs to be clarified (Commenter No. 81).  The commenter
stated that, across its university campus, stockrooms exist in multiple
formats ranging from a common storage room for chemicals that are
individually owned by different researchers to the more traditional
formal Chemistry Department stockroom that operates as a business
selling users individual chemical bottles from the stock.  

Response:  EPA agrees with these commenters and we have revised the
definition of laboratory to include chemical stockrooms and preparatory
laboratories and other areas that provide a support function to teaching
or research laboratories (or diagnostic laboratories at teaching
hospitals).  The reason for this change is that the operation of these
areas is well integrated with the operation of the laboratories; that
is, they are often in close proximity to laboratories, and share
laboratory personnel, and thus should properly be viewed as part of the
laboratory.  Chemical stockrooms that are not associated with laboratory
operations would not; however, be eligible to operate under Subpart K. 
For example, a chemical stockroom that stores cleaning chemicals or
pesticides for maintenance at the facility would not be providing a
support function to a laboratory and would not be considered a
laboratory that is allowed to operate under Subpart K.

	

Comment: We heard from 12 commenters expressing support for extending
the proposed lab clean-out provisions to non lab areas (Commenter Nos.
8, 11, 14, 16, 25, 54, 60, 71, 76, 79, 81, 111).  These commenters
agreed that ancillary spaces (e.g., stockrooms, preparatory rooms)
should be able to participate in the proposed clean-out provisions.  One
commenter believes that inclusion of chemical stock rooms in laboratory
clean-out provisions will help support the removal of “legacy”
chemicals stored in these areas, as well as the re-location and
re-distribution of unwanted materials which are still suitable for
re-use in other laboratories via the chemical stock rooms (Commenter No.
81). Three commenters stated that simplicity, inclusiveness and high
environmental performance will result if colleges and universities are
able to take advantage of the clean-out provisions for rooms that are
ancillary to laboratories (Commenter Nos. 11, 25, 54). The commenters
stated that college and university laboratories vary widely in their
configuration and design, and unused reagents are often stored in these
ancillary rooms and transferred to the laboratories on an as-needed
basis.  They stated that laboratory workers generally oversee these
ancillary rooms and control access to them.  One commenter stated that,
because of the relative high cost of chemicals and chemical demand being
highly dependent upon the research direction, chemical stock programs
may be reluctant to dispose of unused chemicals (Commenter No. 14). 
Allowing the flexibility of stock rooms to take advantage of clean-out
incentives would likely improve the management of chemicals in those
areas.  

Response:  We agree with the commenters and we have revised the
definition of laboratory so that these ancillary spaces would be
considered laboratories, whether they support individual laboratories or
the laboratories of a department, and thus they would be eligible to
take advantage of the laboratory clean-out provisions.  In fact, since
these ancillary areas typically store chemicals for use by nearby or
surrounding laboratories, we believe the clean-out provisions are
especially important for these ancillary areas.

Comment:  We heard from one commenter noting that some colleges and
universities will likely not adopt the Subpart K provisions for whatever
reason (Commenter No. 72).  The commenter noted that such colleges and
universities may nonetheless want to partake of the benefits of the
rule’s beneficial aspects, including the clean-out incentives and
container management standards.  The commenter encouraged EPA to amend
the existing RCRA regulations to integrate these specific provisions
from the proposed rule.  The commenter suggested that EPA could do this
in addition to finalizing Subpart K. 

Response:  We view Subpart K as a holistic approach for the management
of hazardous wastes generated in laboratories and we do not anticipate
extending only certain portions of the rule to eligible academic
entities or to other generators.  

	12.3	12-Month Interval Between Laboratory Clean-outs

Comment: We heard from eight commenters expressing support for the
12-month interval required for clean-outs to be eligible for the
rule’s counting exemption (Commenter Nos. 8, 17, 51, 74, 79, 81, 84,
99).  

Response:  We thank the commenters for their support.  We are
finalizing, as proposed, that a laboratory may only take advantage of
the laboratory clean-out incentives provided in Section 262.213 once per
12-month period.  We stress, however, that laboratories may conduct
laboratory clean-outs more frequently than once per 12-months.  

Comment: We heard from one commenter expressing its belief that the
12-month interval should be tied to a certain space and principal
investigator (Commenter 8).  As an example, the commenter stated that,
if room ABC is vacated by Dr. X and a clean-out is conducted, the new
occupant should not be precluded from conducting a clean-out for a
period of twelve months.  We heard from another commenter objecting to
the 12-month internal (Commenter No. 24).  The commenter believes
colleges and universities should be encouraged to conduct clean-outs
more frequently.  

Response:  We agree with the commenters.  We emphasize that we are not
limiting the number of laboratory clean-outs an eligible academic entity
may conduct, only the frequency with which it may take advantage of the
clean-out incentives.  If a laboratory has conducted a clean-out within
the past 12 months, EPA does not typically expect a subsequent
laboratory clean-out to yield an excess of 55 gallons of unwanted
materials.  However, if a laboratory conducts a subsequent laboratory
clean-out within the same 12-month period as the first laboratory
clean-out and generates an excess of 55 gallons of unwanted materials,
the laboratory may not take advantage of the clean-out incentives. 
Therefore, the unwanted materials would have to be removed from the
laboratory within 10 calendar days, in conformance with the requirements
for exceeding 55 gallons on a routine basis and that amount would have
to be counted in determining the generator status of the eligible
academic entity.

Comment: We heard from one commenter stating that it is unclear whether
the intent is once per 12 months for the whole university to conduct one
clean-out of every laboratory, or once per 12 months for each individual
laboratory (Commenter No. 79).  The commenter stated that further
clarification is necessary for this definition in the rule as it would
be impractical and burdensome for a large university to conduct one
clean-out of all labs at once.  

Response:  We agree with the commenter that it would be impractical for
a large university to conduct one clean-out for all of its laboratories
at once.  However, we disagree with the commenter that EPA’s intent is
unclear in its regulation and that further clarification is necessary.
We believe that EPA’s regulation is clear as written and therefore, we
are finalizing, as proposed, that each individual laboratory at an
eligible academic entity may take advantage of the laboratory clean-out
incentives once per 12-month period.  

Comment: We heard from two commenters clarifying that the clean-out
interval should be an “academic year” (i.e., 11 to 13 months)
(Commenter Nos. 11, 25)

Response:  We disagree with the commenters.  We believe that
implementing a clean-out interval on the basis of an “academic year”
could be confusing, because it varies from institution to institution
and even varies from year to year within an institution.  Therefore, we
have retained the provision, as proposed, that a laboratory may take
advantage of the laboratory clean-out incentives once per 12-month
period.

Comment: We heard from two commenters expressing concerns about the
12-month interval required for clean-outs to be eligible for the
rule’s counting exemption (Commenter Nos. 60 and 101).  These
commenters stated that there should be no such limitation.  One of the
commenters stated that the space constraints faced by colleges and
universities lead to the need for optimizing the efficiency of
laboratory space, including the assignment of laboratories as “swing
space” for periods of less than one year and the use of academic
laboratories for different courses and purposes in each academic
semester (Commenter No. 60).  The commenter stated that it is likely
that many colleges and universities would benefit from conducting a
clean-out of the same laboratory room(s) more than once in a 12-month
period.  To encourage timely removal of unwanted chemicals from the
laboratory, the commenter asked EPA to allow for more than one lab
clean-out per 12-month period per laboratory.  Another commenter noted
that EPA acknowledges in the preamble that academic laboratories
generate a minor fraction of the nation's hazardous waste (Commenter No.
101).  The commenter therefore suggested that EPA refrain from
restricting colleges and universities from access to the clean-out
exemption more often than annually for the purposes of determining
generator status by differentiating between "clean out" waste and
"process" waste. The commenter stated that the former creates the
greatest risk of generator status shift, while the latter represents the
majority, by mass, of hazardous waste that laboratories generate.

Response:  We agree with the commenter that laboratory clean-outs are
distinct from regularly scheduled removals of routinely generated
unwanted materials.  We have changed the provision of the laboratory
clean-out incentive so that only laboratory clean-out hazardous wastes
that are unused commercial chemical products are not counted toward the
eligible academic entity’s generator status.  We intend for routinely
generated unwanted materials (i.e., “process” waste) to be removed
from the laboratory during regularly scheduled removals, and we expect
that the bulk of these routinely generated unwanted materials will be
used chemicals.  We do not consider these used, routinely generated
unwanted materials to be laboratory clean-out wastes and thus they must
be counted toward the eligible academic entity’s generator status. 
Therefore, we have revised the regulatory language to be consistent with
our intent and to safeguard against the potential for abuse of the
laboratory clean-out incentive.  This change will also emphasize that
the purpose of the laboratory clean-outs is to remove unneeded or
unuseable chemicals from the laboratory’s inventory in order to
increase safety within the laboratory.

We disagree, however, with the commenter’s view that a 12-month
interval for eligibility for the lab clean-out counting exemption is an
inappropriate limitation.  To further safeguard against the potential
for abuse, the laboratory clean-out incentives (i.e., having 30 days to
conduct a laboratory clean-out and not counting toward the eligible
academic entity’s generator status the hazardous waste that consists
of unused commercial chemical products) remain limited to once per
laboratory per 12 month period.

Comment:  We heard from one commenter that laboratory clean-outs should
be treated as an exception rather than the rule (Commenter No. 88).  The
commenter stated that the term should be used to indicate events that
occur once in many years, i.e. actual lab clean-outs such as upon the
death or retirement of a faculty member or significant remodeling of a
building or lab suite, or the relocation of lab groups. It stated that
clean-outs should be encouraged but the definition should not include
recurring activities (e.g. every semester) to remove waste that should
have been picked up routinely.  

Response:  We disagree with the commenter that laboratory clean-outs
should be treated as an exception rather than the rule.  On the
contrary, we believe that laboratories should conduct laboratory
clean-outs on a regular basis to remove any unwanted, unneeded or
expired chemicals from their inventories.  Without regular laboratory
clean-outs of chemical inventories, we are concerned that a laboratory
would accrue a large number of unused chemicals in its inventory, some
of which can become dangerous over time, developing the potential to
cause significant harm.  It has been our observation that it is unusual
for laboratories to remove unused chemicals from their inventories on
any regular basis.  We have developed the laboratory clean-out
provisions to provide incentives for laboratories to assess their
inventory and remove chemicals from the laboratory that are either
dangerous or have the potential to become dangerous, or are unlikely to
be used in the future, regardless of the reason.  We anticipate that
many eligible academic entities will take advantage of the laboratory
clean-out provisions when a researcher or faculty member retires or
moves, or when a building is renovated.  However, we are not limiting
the use of the laboratory clean-out provisions to these events because
we would like to encourage laboratories to develop the practice of more
frequent reviews and removals of their unneeded or unuseable chemicals. 


	12.4	Compulsory Laboratory Clean-outs

	

Comment: We heard from four commenters expressing support for the
alternative of requiring lab clean-outs (Commenter Nos. 52, 84, 102,
105).  One of the commenters stated that mandatory clean-outs will
increase protection of human health and the environment (Commenter No.
84).  Another commenter stated that, in its experience, many college or
university laboratories have endangered human health and the environment
by allowing many dangerous unwanted chemicals (such as peroxide formers)
to accumulate without much use (Commenter No. 102). The accumulation of
peroxide formers is especially dangerous since these chemicals can form
crystals which become shock sensitive and can explode. The commenter
recommended that all college and university laboratories conduct
mandatory evaluations of their chemical inventories to determine if
there are any "unwanted materials and to ensure that non-essential
chemicals or expired chemicals (especially potentially dangerous
peroxide formers) are removed from the chemical inventory and properly
managed.  

Response:  We agree with the commenter that because college and
universities have sometimes allowed dangerous chemicals to accumulate in
laboratories without much use laboratory clean-outs will increase
protection of human health and the environment.  However, we believe
that the laboratory clean-out provisions are attractive enough to
eligible academic entities such that they will avail themselves of the
clean-out provisions without EPA forcing them to do so through a
mandate.

Nevertheless, we have incorporated the commenter’s suggestion
regarding potentially dangerous chemicals (such as peroxide formers)
into a new required element of the LMP.  Because of the threat some
chemicals may pose, the final rule requires that the seventh element of
Part II of the LMP includes a list of chemicals that the eligible
academic entity has or is likely to have that can degrade over time and
become more dangerous with age; the list of chemicals is intended to
facilitate the removal of these chemicals before a problem develops. 
The third sub-element requires eligible academic entities to develop
procedures to dispose of these chemicals safely.

Comment: We heard from 12 commenters expressing opposition to required
lab clean-outs (Commenter Nos. 8, 11, 14, 25, 29, 54, 60, 76, 79, 81,
107, 108).  These commenters believe the proposed clean-out provisions
should be kept as flexible and performance-based as possible.  Four of
these commenters stated that there are many laboratories for which
regular removals under section 262.208 will sufficiently promote safe
laboratory chemical management and prevent accumulation of excessive
unwanted materials (Commenter Nos. 11, 25, 54, 79).  The commenters
stated that the non-mandatory nature of the clean-out provision allows
individual institutions the flexibility to decide how to best minimize
the accumulation of unused and no longer needed chemicals based on such
factors as available storage space, laboratory worker turnover and class
schedules.  Another commenter stated that required clean-outs could
become a disincentive for laboratories to submit their waste in a timely
fashion as it is generated and instead hold waste until the next
required clean-out time (Commenter No. 14).  Another commenter stated
that performance-based protocols for clean-outs could be described in
section 262.214(a)(10) of the Laboratory Management Plan (Commenter No.
76). For academic laboratories, the commenter believes it would be most
appropriate for clean-outs to be based upon chemical inventory updates,
a change in activities or lab move, and/or routine health and safety
surveys of laboratories.  Two commenters stated that clean-outs should
not be required because they are need-driven (Commenter Nos. 8, 29).

Response:  We agree with the commenters that the laboratory clean-out
provisions should not be mandatory.  First, we believe that the
provisions are attractive enough to eligible academic entities such that
they will avail themselves of the clean-out provisions without EPA
forcing them to do so through a mandate.  Second, we do not want to add
requirements that may deter eligible academic entities from opting into
Subpart K.  Third, we believe that eligible academic entities should
have the flexibility to focus their resources on the laboratories that
are most in need of conducting laboratory clean-outs, rather than
mandating that all laboratories must conduct clean-outs regardless of
the volume or hazards of the chemicals in its laboratories.

In the final rule we have retained the requirement that an eligible
academic entity must describe in its LMP its best practices for
conducting and documenting laboratory clean-outs.  This element must be
addressed in Part II of the LMP.

13.0	Laboratory Management Plan

	13.1	General

Comment: We heard from 30 commenters expressing support for combining
performance-based standards with a requirement for a lab management plan
(LMP) (Commenter Nos. 7, 8, 10, 11, 14, 20, 24, 25, 30, 44, 49, 51, 52,
53,  54, 60, 61, 71, 76, 77, 79, 80, 81, 82, 84, 87, 89, 95, 99 and
108).  These commenters support a performance-based approach and believe
the LMP will help colleges and universities to better achieve
environmental goals, such as regulatory compliance, pollution prevention
and environmental awareness.  One commenter suggested that EPA should
extend this approach to non-academic laboratories (Commenter No. 84).

Response:  EPA agrees with the commenters that the LMP will complement
the performance-based standards by providing a tool that requires
eligible academic entities to thoughtfully plan how they will implement
Subpart K in their laboratories.  We also believe that the LMP will help
eligible academic entities to better achieve environmental goals such as
regulatory compliance, pollution prevention and environmental awareness.
 This is why EPA has finalized Subpart K with a requirement that
eligible academic entities must develop an LMP containing nine required
elements that are meaningfully addressed.  While EPA believes that
non-academic laboratories would certainly benefit from developing LMPs,
we are not expanding the scope of the rule to allow non-academic
laboratories to opt into Subpart K because they do not fit all of the
rationale for today’s rule.  

Comment: We heard from one commenter expressing concern that the LMP
must be developed from scratch or by inclusion in another document
(Commenter No. 19).  

Response:  While EPA understands the commenter’s concern, we believe
that we are providing flexibility to eligible academic entities
regarding the development of the LMP.  By allowing an eligible academic
entity to decide for itself whether to develop its LMP from scratch or
by integrating it with another planning documents, EPA is giving
eligible academic entities the ability to decide what is best for their
laboratories.  

Comment: We heard from one commenter stating its belief that, under the
performance-based approach, colleges and universities would be able to
include laboratories located on non-contiguous properties so that waste
could be brought to an accumulation area that may not be “on-site, but
that is under the same management system and personnel as the rest of
the campus (Commenter No. 10).  

Response:  The commenter’s belief is incorrect.  Even though an
eligible academic entity may develop one LMP for non-continuous sites
(i.e. facilities that are off-site from one another), EPA has not
altered the RCRA hazardous waste manifest regulations (40 CFR 262.20). 
The hazardous waste manifest regulations state that a generator who
transports or offers for transport a hazardous waste for off-site
treatment, storage, or disposal must manifest the hazardous waste to a
permitted facility.  Unless the non-contiguous sites the commenter is
referring to are permitted to treat, store, or dispose of hazardous
waste, the generator cannot send hazardous waste there regardless of
whether they have an accumulation area.

Comment: We heard from one commenter stating its intent to develop a
model LMP that offers a range of options to meet local needs (Commenter
No. 11).  

Response:  EPA supports the commenter’s intent to develop a model LMP
and strongly encourages it.  We believe this is reduce the burden on
eligible academic entities and help provide a starting point for
entities developing LMPs.  

Comment: We heard from one commenter expressing concern that each lab
would be required to develop a performance-based waste management plan
that outlines how that lab will manage its hazardous waste under the new
Subpart K regulations (Commenter No. 48).  The commenter stated that the
plan would need to be updated as systems, experiments and generation
processes change and made available to inspectors upon request. 
Laboratory staff would need to be re-trained in the waste management
plan.  The commenter was concerned that these provisions would require
redundant documentation when considering that all labs are already under
a regulatory mandate to have a chemical hygiene plan that contains
similar information. 

Response:  The concern that each lab would be required to develop an LMP
is not the case at all.  Rather, EPA intended and finalized the rule so
that the eligible academic entity – a college or university, or
non-profit research institute or teaching hospital that is owned by or
has a formal written affiliation agreement with a college or university
– would create one LMP for all its laboratories that are operating
under Subpart K.  In addition, if an eligible academic entity has
multiple EPA Identification Numbers or sites, then it can develop one
LMP to cover operations for all laboratories at all sites operating
under the Subpart K requirements.  Further, we disagree with the
commenter that the provisions of the LMP are redundant with the chemical
hygiene plan.  As the proposal clearly explained, a college or
university (and now eligible academic entities) can take an existing
plan, such as the Chemical Hygiene Plan and revise it to include the
additional necessary information or procedures required by today’s
rule.  In addition, since the LMP is a document to plan how an eligible
academic entity will meet the performance-based standards of Subpart K,
EPA requires the LMP to be reviewed and updated, as needed, so that it
is current with the waste management practices at the eligible academic
entity’s laboratories.  Thus, the commenter is correct in that the LMP
would need to be updated as systems, waste management, or other
processes that are required provisions change.  And, the LMP is required
to be made available to anyone requesting the LMP at the eligible
academic entity again confirming the commenter’s statement. 

Comment:  The following are suggested specific edits to the regulatory
text. Three commenters suggested that EPA revise section 262.214(a)(9)
to change “laboratory” to “laboratories” (Commenter Nos. 11, 25,
54).  The commenters stated that, for the purposes of the laboratory
management plan, a single emergency procedure is sufficient for all
laboratories at most colleges and universities.

Response:  EPA intends for an eligible academic entity to use its LMP
for all of the laboratories it owns once it has opted into Subpart K. 
While we did not change the regulatory text from laboratory to
laboratories, the word laboratory in this part of the regulatory text is
used in the general sense to indicate the types of hazards that occur in
the laboratory.  In preceding regulatory language, it is made clear that
an eligible academic entity may write one Laboratory Management Plan for
all the laboratories owned by the eligible academic entity that have
opted in to this subpart, even if the laboratories are located at sites
with different EPA Identification Numbers.  Thus, changing the word
laboratory to laboratories in this instant would not clarify the
meaning.  Further, EPA provides flexibility for eligible academic
entities in Part II of the LMP which is where the emergency procedure
element is located.  This flexibility allows eligible academic entities
to decide what is right for their facilities, i.e. whether one emergency
procedure is sufficient for all their laboratories or whether they want
to establish various emergency procedures.

Comment: We heard from one commenter stating that EPA should ensure that
college or university lab performance does not slip below existing
levels by requiring LQGs to have an adequate and active Environmental
Management Systems and an LMP that is an integral part of the EMS
(Commenter No. 82).

Response:  EPA agrees with the commenter that Environmental Management
Systems can be useful tools in monitoring performance of laboratories
and increasing environmental management.  However, the EPA did not
propose this requirement and therefore it is beyond the scope of this
final rulemaking.

Comment: We heard from one commenter in regard to a potential benefit of
allowing colleges and universities to integrate the LMP into the
chemical hygiene plan (Commenter No. 99).  The commenter stated that one
way for the EPA to ensure the site is indeed a lab is to check its OSHA
hazard communication compliance. If the site uses a chemical hygiene
plan then it is a laboratory, if the site follows the hazard
communication standard then the site would, presumably, not be a
laboratory. By placing the requirements for the LMP in the chemical
hygiene plan, then the control processes are covered in one document.

Response:  EPA agrees with the commenter that allowing the LMP to be
integrated into an existing plan such as the chemical hygiene plan
provides the eligible academic entity the ability to consolidate and
coordinate all its planning and implementation into one document.  In
addition by providing this option both in the proposal and final rule,
EPA has given eligible academic entities the flexibility to individually
determine the best way to meet the planning requirements of Subpart K. 
While we do not require that the LMP be integrated with another plan, we
do believe integrating planning documents may potentially provide
additional benefits as suggested by this comment.  Finally, EPA
recognizes that if an eligible academic entity has a chemical hygiene
plan, then it would be a laboratory.  However, EPA does not plan to use
this as a verification method.  Subpart K defines the term laboratory
and any space that does not meet this definition cannot operate under
the requirements of Subpart K.

Comment: We heard from 12 commenters suggesting that a new section be
added to the LMP to address the timely characterization of unknown
material, among other things (Commenter Nos. 7, 11, 15, 25, 49, 54, 61,
69, 72, 86, 91, 100).  The following language was suggested for
inclusion at section 262.214(a)(10): “Develop procedures to safely
manage all laboratory materials, including: materials that become more
hazardous as they degrade, the timely characterization of unknowns,
materials that exceed their expiration dates, materials stored for
future use, surplus materials, and deciding that a material is
unwanted.”  

Response:  EPA agrees with the commenters that this new section is
important in terms of emergency prevention and added some of the above
concepts to the emergency prevention element in the LMP.  Specifically,
EPA added three sub-elements to element 7 of Part II of the LMP, the
emergency prevention element.  The sub-elements we added to address the
above comment is for an eligible academic entity to describe its
intended best practices for emergency prevention, including (1) a list
of chemicals that the eligible academic entity has, or is likely to
have, that become more dangerous when they exceed their expiration date
and/or as they degrade, (2) procedures to safely dispose of chemicals
that become more dangerous when they exceed their expiration date and/or
as they degrade, and (3) procedures for the timely characterization of
unknown chemicals.  Thus, EPA appreciates this comment and has
incorporated the suggestion into Subpart K as these are challenges faced
in many laboratories in being prepared for emergencies.

Comment: We heard from one commenter stating that “expired
materials” is a subjective concept (Commenter No. 60).  The commenter
recommended that each college or university should define the procedure
for determining which materials are expired in its performance-based
Laboratory Management Plan.  

Response:  EPA did address the concept of expired materials but in a
different way than the commenter suggested.  Comments above informed the
EPA that laboratories face issues with chemicals that expire and/or
become dangerous as they degrade.  A good example of this is picric
acid, which becomes explosive if it becomes dehydrated/crystallized. 
Because of the threat some chemicals may pose, the final rule requires
that the seventh element of Part II of the LMP includes a list of
chemicals that the eligible academic entity has or is likely to have
that can degrade over time and become more dangerous with age; the list
of chemicals is intended to facilitate the removal of these chemicals
before a problem develops.  It is these expired dangerous chemicals in
particular that have caused enforcement issues in the past.  By creating
a list of these chemicals, EPA expects that eligible academic entities
may find the concept of expired chemicals, less “subjective”.

Comment: We heard from two commenters stating that EPA should include
procedures whereby RCRA-trained staff can create a one-time written
documentation that specific waste streams are not considered hazardous
waste (Commenter Nos. 7 and 61).

Response: The authority to determine which waste streams or materials
are considered hazardous waste is held at the federal level and the
state level in RCRA authorized states.  It would be unlawful for the EPA
to allow RCRA-trained staff at eligible academic entities to create
documentation determining certain waste streams are not hazardous
wastes.  If the commenter was implying that lists of typical
non-hazardous wastes be shared with faculty and students, EPA would find
this practice acceptable.  However, the generator continues to have the
responsibility under 40 CFR 262.11 to make a hazardous waste
determination.

Comment: We heard from eight commenters suggesting that college or
university LMPs should explain or define which of their labs are
participating under Subpart K (Commenter Nos. 10, 11, 25, 54, 62, 81,
102, 110, 112).  These commenters stated that there could be wide
interpretations by colleges and universities of which labs should be
covered under Subpart K, because of the many different situations in
which college or university labs operate (e.g., college or university
labs in which students, faculty and staff work in a laboratory
side-by-side with workers employed by the state or Federal government or
private research institutions), and colleges and universities should be
allowed to determine which of their labs may participate under Subpart K
and describe this in the LMP.

Response:  If multiple sites with separate EPA Identification Numbers
operate under one LMP, the LMP must identify which sites are covered by
the LMP.  However, there is no requirement to identify each laboratory
within each site, as all laboratories at a participating eligible
academic entity within that site or covered by an EPA Identification
Number must operate under Subpart K.  The reason for this is that EPA
believes it would difficult for an eligible academic entity to keep
track of which set of generator regulations apply to which laboratory or
group of laboratories.  Moreover, it would be extremely difficult, if
not impossible, for the States or Regions to keep track of the
applicable set of regulations if, within a single EPA Identification
Number, different laboratories were choosing to be regulated under
different requirements.  Thus, EPA continues to require that all
laboratories owned by the eligible academic entity within one EPA
Identification Number must comply with the same set of regulations. 
Nevertheless, should an eligible academic entity choose to list all its
laboratories that are participating in Subpart K, it could be a valuable
tool to manage removals of unwanted material, as well as assist EPA and
State inspectors in determining compliance with the Subpart K
requirements.

Comment: We heard from two commenters that EPA should include a
requirement for EPA or authorized State to review and approve each LMP
(e.g., before it is implemented) (Commenter Nos. 44 and 102).  One of
the commenters stated that review of the LMP is needed to ensure that
the LMP includes all the necessary information for compliance with
Subpart K (Commenter No. 102).  The other commenter stated that the
RCRA-trained person’s qualifications should be reviewed as part of
this LMP review (Commenter No. 44).

Response:  EPA did not propose a requirement for the EPA or authorized
State to review and approve each LMP not for a RCRA-trained person’s
qualifications to be reviewed.  Thus these comments are beyond the scope
of this rulemaking

Comment: We heard from one commenter that a failure to meet the
performance standards of the Subpart K may indicate a deficiency in the
LMP or of its implementation.  The commenter believes that EPA should
amend the requirement of 262.24(c) to say the LMP must be reviewed and
revised necessary whenever it is discovered that the performance
standards are not being met (Commenter No. 24).

Response:  EPA thanks you for your comment.  However, we believe that
the performance-based standard of reviewing and revising the LMP when
necessary is sufficient to ensure that the LMP is kept current with the
hazardous waste management practices being used at the eligible academic
entity.  EPA anticipates that this standard as written will ensure that
the LMP will be revised should an eligible academic entity fail to meet
a standard and thus updates their practices.  We also expect that when
an EPA or state inspector visits an eligible academic entity that he/she
will review the LMP especially, Part I of the LMP.  Thus, EPA does not
agree that the commenter’s additional prescriptive standard is
necessary for it will not be more environmentally protective than the
standard as written.

Comment: We heard from one commenter that EPA amend the proposed
regulations to include the option that EPA has the right to deny any
college or university access to the Subpart K if EPA finds the
university or college is not meeting the intent of Subpart K and has a
history of non-compliance (Commenter No. 74).

Response:  EPA thanks you for your comment.  However, the commenter’s
option was not proposed and thus is beyond the scope of this rulemaking.

Comment: We heard from one commenter recommending that EPA add to items
to the list of requirements for LMPs:  1) Executive Commitment - Clearly
call out the need for an institution to have an executive commitment and
for the clear communication of that commitment to everyone in the
institution; and 2) Pollution Prevention (Commenter No. 76)

Response:  EPA thanks you for your comment.  However, the commenter’s
option was not proposed and thus is beyond the scope of this rulemaking.


Comment:  We heard from one commenter stating that EPA should clarify if
CESQGs adopting the rule would need to develop a Lab Management Plan
(LMP) under section 262.213 (Commenter No. 10).

Response:  A CESQG site at an eligible academic entity or an eligible
academic entity that is itself a CESQG must opt into Subpart K in its
entirety and follow the management standards for unwanted materials in
the laboratories.  This would include the development of an LMP for
stand-alone CESQGs such as small colleges or universities.  However, if
a CESQG site is part of a larger eligible academic entity, then the
eligible academic entity can develop one LMP to cover operations for all
laboratories at all sites operating under the Subpart K requirements. 
EPA intends that the eligible academic entity – a college or
university, or non-profit research institute or teaching hospital that
is owned by or has a formal written affiliation agreement with a college
or university – would create one LMP for all its laboratories that are
operating under Subpart K regardless of generator status.

Comment: We heard from one commenter stating that the Howard Hughes
Medical Institute (HMMI) Consensus Best Practices 4, 5, 8, and 14 are
applicable to the clean-out process that colleges and universities will
describe in their LMP (Commenter No. 60). 

Response:  In Part II of the LMP, there is a requirement to describe the
procedures for conducting and document laboratory clean-outs.  An
eligible academic entity is free to incorporate HHMI's consensus best
practices as part of this requirement.

Comment: We heard from one commenter recommending that EPA include an
additional requirement at section 262.214(a) for the LMP to address
pollution prevention and waste minimization methods (Commenter No. 74). 
The commenter suggested the following language for the additional
requirement: “Examine their waste generation and waste management
practices with a particular eye toward finding opportunities for waste
minimization and pollution prevention.  Practices that should be
included in the LMP are the identification of opportunities to
redistribute and reuse unwanted materials throughout the institution.
Examples of waste minimization processes which would be appropriate for
laboratories at colleges and universities are the use of micro-scale
techniques for sample analysis and experimentation.”  

Response:  Under the final rule, the LMP must be comprised of two parts
with a total of nine elements as specified in 40 CFR § 262.214.  The
specific contents in Part I of the LMP are enforceable, while the
specific contents in Part II of the LMP are not enforceable.  While
waste minimization and pollution prevention methods are not a required
element, the commenter is free to develop methods for Part II of its
LMP.  In fact, we envision Part II will comprise eligible academic
entities’ best management practices (BMPs) which could certainly
include waste minimization and pollution prevention practices

13.2	Enforceability of LMP

Comment: We heard from eight commenters that the LMP should be an
enforceable document (Commenter Nos. 40, 41, 51, 66, 74, 82, 99, and
105).  These commenters stated that an enforceable LMP would encourage
and hold colleges and universities accountable for developing and
implementing a responsible waste management approach, and facilitate
enforcement and compliance activities.  One of these commenters
suggested that the specific requirements of the rule be included in the
LMP and that it be enforceable (Commenter No. 66).  

Response:  EPA agrees with the commenters’ reasoning about how an
enforceable LMP holds the eligible academic entity accountable. 
Reviewing the Agency’s reasons for proposing the requirement for an
LMP, EPA wanted colleges and universities to give careful thought
regarding the management of unwanted materials and hazardous waste
generated in their laboratories.  Moreover, we wanted to encourage
colleges or universities to go above and beyond the regulations and to
think holistically about waste management on campus by planning and
developing best management practices (BMPs) in the LMP.  We continue to
believe strongly that the LMP is necessary in order to provide the
planning component for implementing the provisions of this rule.  Based
on our views regarding the purpose of the LMP and the comments we
received both above and below, we have decided to split the LMP into two
parts - with the contents of one part enforceable and the contents of
the other part not enforceable, although in order to be in compliance
with Subpart K, an eligible academic entity must reasonably address all
nine elements in its LMP.  As a way to incorporate more flexibility into
the regulations and give eligible academic entities more options, while
maintaining the accountability (as commenters suggested) in this
Subpart, the contents of Part I of the LMP are enforceable.  This part
of the LMP contains necessary information for inspectors and other
officials about what options within Subpart K the eligible academic
entity is exercising.  EPA believes that by designating the contents of
Part I of the LMP enforceable, we are achieving the positive comments
above such as encouraging a responsible waste management approach.  

Comment: We heard from 30 commenters that the LMP should not be an
enforceable document (Commenter Nos. 2, 8, 11, 14, 15, 24, 25, 30, 31,
37, 47, 53, 54, 61, 70, 71, 73, 76, 78, 80, 81, 84, 87, 89, 92, 96, 100,
107, 108, 110, 114).  These commenters expressed concern that an
enforceable LMP is contrary to a performance-based approach, and would
exacerbate college or university lab performance (e.g., because college
or university labs would be compelled to develop minimum procedures),
discourage participation in Subpart K, and increase compliance problems.
 One of the commenters suggested that the performance standards need to
be written in the LMP so that not addressing the minimum amount of
activity required by the regulations to promote the protection of human
health and environment (e.g., frequency of disposal, training, labeling
containers, hazardous waste determinations, locations and removal
schedules etc.), as described in the LMP, would mean that the
performance standards have not been met (Commenter No. 114).  The
commenter believes that the LMP should only be used for enforcement if
the performance standards have not been met.  The commenter noted that
some LMPs may include more aggressive management procedures than
required in the rule.  The commenter stated that deviations from the LMP
that are not considered by state or Federal authorities to compromise
the integrity of the college or university’s hazardous materials
management program and are in compliance with the regulations as far as
addressing the required elements should not be considered violations
that warrant enforcement action.

Response:  EPA also agrees with the commenters’ reasoning about how an
enforceable LMP could inadvertently lead eligible academic entities to
develop weak LMPs in order to avoid compliance and enforcement issues. 
Reviewing the Agency’s reasons for proposing the requirement for an
LMP, EPA wanted colleges and universities to give careful thought
regarding the management of unwanted materials and hazardous waste
generated in their laboratories.  Moreover, we wanted to encourage
colleges or universities to go above and beyond the regulations and to
think holistically about waste management on campus by planning and
developing best management practices (BMPs) in the LMP.  We continue to
believe strongly that the LMP is necessary in order to provide the
planning component for implementing the provisions of this rule.  Based
on our views regarding the purpose of the LMP and the comments we
received both above and below, we have decided to split the LMP into two
parts - with the contents of one part enforceable and the contents of
the other part not enforceable, although in order to be in compliance
with Subpart K, an eligible academic entity must address all nine
elements in its LMP.  EPA envisions that eligible academic entities will
use Part II of the LMP to capture BMPs for holistic waste management
within laboratories.  In order to encourage the development of BMPs, the
specific contents of Part II of the LMP are not enforceable, but the
eligible academic entity must reasonably address the seven required
elements.  By splitting the LMP, EPA anticipates that eligible academic
entities will go beyond the regulation and fully think through their
hazardous waste management practices.

Comment: We heard from one commenter indicating that there could some
uncertainty if the LMP is not enforceable (Commenter No. 44).  The
commenter noted several areas in the preamble that showed some
indecision as to different options being considered in implementing the
regulation. 

Response:  EPA agrees with the commenter that some uncertainty could
exist if parts of the LMP are not enforceable.  This is why for the
final rule, we split the LMP into two parts - with the contents of one
part enforceable and the contents of the other part not enforceable.  As
a way to incorporate more flexibility into the regulations and give
eligible academic entities more options, while maintaining the
accountability in this Subpart, the contents of Part I of the LMP are
enforceable.  This part of the LMP contains necessary information for
inspectors and other officials about what options within Subpart K the
eligible academic entity is exercising.  In Part II of the LMP, EPA
envisions that eligible academic entities will use this section to
capture BMPs for holistic waste management within laboratories.  In
order to encourage the development of BMPs, the specific contents of
Part II of the LMP are not enforceable, but the eligible academic entity
must reasonably address the seven required elements.  Finally, the
preamble to the proposed rule explained and solicited comments on
various options the EPA was proposing and considering which may have
lead the commenter to misinterpret this as indecision.

13.3	Adding an Element to the LMP about Procedures for Unknowns

Comment: We heard from 18 commenters asking EPA to consider the
particular needs of colleges and universities in handling and
characterizing unknowns (i.e., an unknown is an unwanted laboratory
material for which information on its identity, properties and/or
heritage is insufficient to make a hazardous waste determination and/or
assign a waste code) (Commenter Nos. 7, 11, 15, 25, 49, 52, 54, 60, 61,
68, 69, 73, 76, 91, 100, 102, 107, 108).  Eleven of these commenters
asked EPA to include a new section in the LMP provisions for colleges
and universities to develop procedures to safely manage all laboratory
materials, including: materials that become more hazardous as they
degrade, the timely characterization of unknowns, materials that exceed
their expiration dates, materials stored for future use, surplus
materials, and deciding that a material is unwanted (Commenter Nos. 7,
11, 15, 25, 49, 54, 61, 69, 76, 91, 100). 

Response:  EPA agrees with the commenters that this new section is
important in terms of emergency prevention and added some of the above
concepts to the emergency prevention element in the LMP.  Specifically,
EPA added three sub-elements to element 7 of Part II of the LMP, the
emergency prevention element.  The sub-elements we added to address the
above comment is for an eligible academic entity to describe its
intended best practices for emergency prevention, including (1) a list
of chemicals that the eligible academic entity has, or is likely to
have, that become more dangerous when they exceed their expiration date
and/or as they degrade, (2) procedures to safely dispose of chemicals
that become more dangerous when they exceed their expiration date and/or
as they degrade, and (3) procedures for the timely characterization of
unknown chemicals.  Thus, EPA appreciates this comment and has
incorporated the suggestion into Subpart K since many laboratories may
face these challenges in preparing for emergencies.

Comment: We heard from one commenter recommending that sampling and
interim storage pending analysis be allowed while still in the
laboratory (Commenter No. 107). The commenter reasoned that the
material/waste’s composition must be known before it can be moved to
the on-site central accumulation area or on-site TSDF in order to ensure
that the facility’s safety basis is not compromised.  In addition, the
commenter stated that some provision is needed for allowing extra time
(beyond the proposed 4-day limit) for assignment of waste codes and for
making waste determinations when wastes require sampling and analysis. 
Given that a typical analytical laboratory turn around time is 28 days,
the commenter stated that the laboratory’s subject matter experts may
need 40 to 45 days to conduct the sampling, obtain results, and evaluate
the results.  In these cases, wastes could be labeled as “wastes (or
materials) pending analysis” or equivalent terms.  Similarly, the
commenter suggested that, if an unknown or poorly documented unwanted
material is found or is generated in a laboratory late in the 6-month
pick up cycle, it may not be fully characterized and suitable for
transfer to the on-site collection area with the other unwanted
materials.  Hence, provisions for management of laboratory
wastes/materials pending analysis in the laboratory, central
accumulation area or TSDF, is needed and increased flexibility in
scheduling pick ups is needed.

Response:  EPA has expanded the emergency prevention element of the
non-enforceable section (Part II) of the LMP to include the development
of procedures to characterize unknown unwanted materials in a timely
manner.  We anticipate that this element will allow eligible academic
entities to put into place procedures so that unknown unwanted materials
are identified quickly.  To further address the comment of additional
time necessary beyond the 4 days to add the HW codes, we have changed
the 4 day provision for the HW codes.  The eligible academic entity must
still initially determine whether the unwanted materials is hazardous
waste (rather than non-hazardous waste) and, if so, add the words
“hazardous waste” within 4 days of the arrival of unwanted materials
at an on-site central accumulation area or on-site TSDF.  But, the
specific hazardous waste codes may be added to the container’s
associated label before it is taken off-site allowing eligible academic
entities the additional time to determine the hazardous waste codes
while the container is safely stored.  

Comment: We heard from one commenter encouraging EPA to consider use of
guidance or some form of regulatory action to enable disposal facilities
to handle experimental materials (i.e., materials for which sufficient
hazard data do not exist) in the same manner as “samples” (Commenter
No. 87).  

Response:  We appreciate the comment about experimental materials;
however since we did not propose amendments to regulations for disposal
facilities, this comment is beyond the scope of this rulemaking.

Comment: We heard from one commenter offering language to account for
unwanted material that requires analysis to complete a waste
determination (Commenter No. 88).  The commenter suggested adding
language to the effect that “Unwanted material brought from a
laboratory to a central accumulation area for which there is not
sufficient information to make a waste determination and for which
analytical testing will be required, will be labeled in a manner to
indicate that analysis is pending and the waste determination must be
made prior to disposal within the applicable time limits for
accumulation.”  

Response:  While we thank the commenter for his language suggestion, we
added a similar concept to Subpart K through another avenue.  To address
the comment of  additional time necessary to make the hazardous waste
determination, we have changed the 4 day provision for the HW codes. 
The eligible academic entity must still make the initial hazardous waste
determination and add the words “hazardous waste” within 4 days of
the arrival of unwanted materials at an on-site central accumulation
area or on-site TSDF.  But, the hazardous waste codes may be added to
the container’s associated label before it is taken off-site allowing
eligible academic entities the additional time to determine the
hazardous waste codes while the container is safely stored.

Comment: We heard from one commenter that a problem associated with
unknowns is that they generally get labeled as "'most hazardous" simply
because they are not identified specifically (Commenter No. 1). The
commenter stated that the generator generally knows what the general
level of hazard of these materials, because of the nature of the work
done in his/her lab, but does not know specifically the type of waste. 
The commenter stated that a “serious” category of unknowns is
"empty" steel lecture bottles (less than 5 pounds if liquefied) of gases
which have lost labels because of age; the disposal of these is very
onerous and needs some relief.

Response:  EPA thanks you for your comment.  However, this is out of the
scope of this rulemaking.

14.0	Recordkeeping Requirements

Comment: We heard from seven commenters in response to EPA’s request
for comment on the need for additional recordkeeping or reporting
(Commenter Nos. 7, 8, 11, 25, 54, 71, 81), stating that no additional
recordkeeping or reporting is needed.  Four commenters stated that the
required recordkeeping is more than sufficient for purposes of Subpart
K, in light of the existing recordkeeping requirements at 40 CFR 262.34
to which CAAs would also be subject (Commenters 11, 25, 54, 71).  One of
the commenters stated that the recordkeeping requirements should be as
performance-based as possible to ensure colleges and universities have
flexibility to tailor them to their operations (Commenter No. 81). 
Refer to other sections of this document for comments on specific
recordkeeping and reporting requirements in the rule. 

Response:  We thank the commenters for their responses.  In general, we
agree with commenters that no additional recordkeeping or reporting,
beyond records for training and use of the RCRA Site ID form to notify,
is needed as a requirement under Subpart K. The only recordkeeping we
have added under the final rule is due to the expansion of scope of the
rule.  Specifically, an eligible academic entity that is not college or
university must maintain a copy of its formal written affiliation
agreements with a college or university.  We believe the
performance-based nature of Subpart K does not preclude eligible
academic entities from developing site-specific records as they deem
fit, provided the specific recordkeeping requirements of this rule are
met.

	14.1	Retention of Label Information

Comment: We heard from five commenters who said that records of
container maintenance or label information (e.g., accumulation and
removal dates) should not be retained because it would be burdensome and
unnecessary (Commenter Nos. 11, 25, 54, 71, and 77).  Three of these
commenters stated their belief that a record of routine pickups and
pickup offers, which they have recommended, obviates the need to both
date containers and retain labels (Commenter Nos. 11, 25, 54).  We heard
from one commenter that suggested that records regarding container
labels be kept to assure that proper treatment and disposal have been
accomplished for waste laboratory chemicals (Commenter No. 66).  

Response:  We thank the commenters for their responses.  The information
on the label associated with containers, such as the accumulation start
date and information sufficient to make a hazardous waste determination,
was assumed to be either electronic, via spreadsheets and bar codes, or
written logs and in the proposed rule EPA considered requiring that this
information be retained on file as a record.  We agree with the
commenters and believe that other recordkeeping requirements
sufficiently document the information necessary for inspections of
laboratories at eligible academic entities.  Therefore, the final rule
does not require that records be kept for labeling information
associated with containers, beyond the time that a hazardous waste
determination is made for the contents.  

	14.2	Training Records

Comment: We heard from ten commenters stating that colleges and
universities should be able to provide evidence of training, in lieu of
training records (Commenter Nos. 11, 25, 31 54, 61, 68, 71, 73, 96,
100).  The commenters indicated that the proposed recordkeeping
requirements for training are too burdensome and that, as an
alternative, training can be evidenced (e.g., by staff knowledge based
on observed work practices, interviews, point-of-use training material
being posted at the work site, staff meeting minutes, or a formal
practice of reviewing waste disposal and management at the onset of each
laboratory learning exercise).  We heard from one commenter stating that
training records for RCRA trained persons or laboratory workers should
be maintained (Commenter No. 66). 

Response:  We received comments advocating for both the required
retention of training records and the elimination of a requirement for
eligible academic entities to keep training records.  After careful
consideration, we continue to believe it is appropriate that eligible
academic entities that are LQGs under Subpart K retain the records for
training of laboratory workers in order to best demonstrate that the
individual received the necessary training.    The training records that
LQGs must retain for laboratory workers are the same kinds of records
that LQGs must retain for trained professionals under existing generator
regulations, so EPA does not believe that this requirement in Subpart K
is overly burdensome.  The rule provides flexibility in the types of
records or documentation sufficient to determine whether laboratory
workers have been trained.  Documentation demonstrating training can
include, but is not limited to, sign-in or attendance sheet(s) for
training session(s), syllabi for training session(s), certificate(s) of
completion, or test results.  However, EPA disagrees that merely a
posted sign or other non-documented source that does not directly
correspond to training received by the individual would be sufficient to
determine whether individual(s) have been trained

Comment: We heard from four commenters stating that the proposed
recordkeeping requirements should be deleted because they are more
burdensome than the existing requirements, which do not require
documented training for personnel at satellite accumulation areas
(Commenter No. 7, 8, 60, 77).  One of the commenters stated that a
better approach might be to allow the college or university to state in
the LMP how training goals are achieved, thereby allowing each entity
the flexibility to design an appropriate program for their institution
(Commenter No. 7).  Another commenter stated that colleges and
universities are not currently set up to identify, track and train all
lab workers (Commenter No. 8).  Another commenter stated that the number
of individual records at a college or university could be voluminous and
such wide-scale recordkeeping is not merited given the turnover among
those defined as "lab workers" (Commenter No. 77).  The commenter
believes it is sufficient to document that training programs are in
place and to develop a lab management plan that ensures that each worker
receives an appropriate level of training given their duties within the
lab.

Response:    The Agency recognizes that the satellite accumulation area
regulations do not require documented training for personnel. However,
we believe it is appropriate that eligible academic entities that are
LQGs retain the records for training of laboratory workers in order to
best demonstrate that the laboratory worker received the necessary
training.  Additionally, we do not believe the recordkeeping
requirements of this rule are overly burdensome as the Agency is not
requiring retention of training records for all laboratory workers. 
Subpart K does not require SQGs to retain training records  for students
in the laboratory, laboratory workers, or trained professionals.  The
training records that LQGs must retain for laboratory workers are the
same kinds of records that LQGs must retain for trained professionals
under current generator regulations, so EPA does not believe that this
requirement in Subpart K is overly burdensome.  However, we agree with
commenters and believe it is important that Subpart K contain provisions
for an LMP that includes flexibility for a participating academic entity
to plan for and develop training programs.   Therefore, § 262.214
requires participating entities to describe in Part II of its Laboratory
Management Plan (LMP) their intended best practices for providing
training to students and laboratory workers commensurate with their
duties, and for ensuring safe transportation of unwanted materials and
hazardous wastes on-site by trained professionals.

Comment: We heard from one commenter stating that, instead of retaining
training records, each college or university should establish learning
goals in its LMP, as well as a method of measuring the effectiveness of
knowledge transference; in this way, the training will be tailored for
institutional needs, and results will be measurable (Commenter No. 68). 


Response:  We thank the commenter for providing this alternative
suggestion.  The Agency believes that the requirement that LQGs retain
training records for trained professionals and laboratory workers in
conjunction with the LMP requirement to describe its intended best
practices for training students and laboratory workers is appropriate. 
Additionally, we believe the blend of more traditional and
performance-based requirements of this rule provides eligible academic
entities the opportunities and flexibility to develop training programs
tailored to their institutional needs which may enhance development of
learning goals and effective measuring methods while assuring that the
requirements of this rule are met. 

  

Comment: We heard from five commenters stating that the maintenance of
training records for RCRA-trained or laboratory workers at small
quantity generators is unnecessary (Commenter Nos. 8, 11, 25, 54, 81). 
Four of the commenters stated that this is particularly true if evidence
of training or other more flexible approach is used instead (Commenter
Nos. 8, 11, 25, 54). 

Response:  We agree with these commenters.  Therefore, Subpart K does
not require maintenance of training records for trained professions
(“RCRA-Trained in the proposal) or laboratory workers at SQGs.

Comment: We heard from one commenter stating that, assuming certain
small quantity generator universities will benefit from the regulatory
relief provided by Subpart K, it is reasonable to expect in exchange
that EPA include in its final rule a requirement that training records
for designated RCRA-trained individuals be developed and retained by
participating university laboratories (Commenter No. 53).  

Response:  We thank the commenter for this comment.  The scope of the
final rule is expanded to include SGQs.  We received comments advocating
for the required retention of training records as well as comments
advocating for the elimination of this requirement.  After careful
consideration of all the related comments we believe that a trained
professional (RCRA-trained individual in the proposal) must be a
“trained professional” according to the definition in § 262.200,
which requires that the individual complete the applicable RCRA training
requirements of § 265.16 for LQGs, or § 262.34(d)(5)(iii) for SQGs and
CESQGs.   LQG training requirements require training records while SQG
requirements do not.  We believe that recordkeeping requirements under
current RCRA generator training requirements are appropriate under
Subpart K.  Therefore, the final rule does not require SGQs to retain
training records. 

Comment: We heard from one commenter stating that there should be a
written record in the LMP to show the student was actually in class to
receive the necessary instruction dealing with RCRA compliance and other
relevant health and safety issues (Commenter No. 84).

Response:  We thank the commenter for this suggestion.  Subpart K is a
performance-based approach to regulations.  The final rule requires that
training for laboratory workers and students must be commensurate with
their duties so they understand the requirements in this subpart and can
implement them.  While this rule does not preclude compliance with other
relevant requirements (e.g., OSHA) Subpart K does not require that a
student receive training in full RCRA compliance.  Additionally, under
this performance-based approach we do not believe it is necessary to
require a written record documenting student training.  Training for
students (as well as laboratory workers) must be in direct correlation
with their assigned duties and the level of involvement in unwanted
materials management.  For students this may be familiarization with
this rule in order to meet the requirements of proper unwanted materials
management (e.g., students in a supervised classroom setting should be
trained to place the products of experiments in the appropriate
containers of unwanted materials).  Given the student’s degree of
involvement with unwanted materials management we believe a requirement
to describe in an eligible academic entity’s LMP their intended best
practices for training students commensurate with their duties provides
sufficient documentation of planned training.

15.0	Enforcement and Compliance under Proposed Rule	

Comment:  We heard from five commenters that performance-based
regulations are easier for colleges and universities to comply with and
for regulators to monitor and enforce (Commenter Nos. 11, 25, 54, 60,
61).  One of these commenters stated that, in its experience, inspectors
with experience in conducting RCRA inspections should be able to quickly
gain an effective understanding of how the new rule is implemented on a
particular campus and evaluate conformance with core standards (e.g.,
labeling, training) articulated in the institution’s LMP (Commenter
No. 60).

Response:  EPA thanks the commenters for their support of Subpart K’s
performance- based standards.  

Comment:  We heard from one commenter that the effect of inconsistent
application of the Subpart K rule is unclear (Commenter No. 12).  The
commenter stated, for example, that the compliance implications are
unclear if some faculty at the college or university follow Subpart
K/LMP while others do not (e.g., because they are unaware of it).  The
commenter wondered if this would invalidate the LMP and render everyone
following it to be in violation.

Response:  Eligible academic entities managing their laboratory
hazardous wastes under Subpart K must provide training for laboratory
workers and students, and training must provide sufficient information
so that laboratory workers and students can understand and implement the
requirements of Subpart K, commensurate with their duties.  Thus, staff,
faculty, EH&S staff should all be trained to be able to carry out their
duties under Subpart K.  Because of this provision, EPA does not believe
that Subpart K will have inconsistent application.  Further, all
laboratories owned by the eligible academic entity within one EPA
Identification Number must comply with the same set of regulations.  In
other words, the alternative approach can not be applied to only one or
a few laboratories within that EPA Identification Number, but rather
must apply to all laboratories or no laboratories.  Once an eligible
academic entity chooses to opt into Subpart K, the same hazardous waste
management requirements apply to all laboratories covered by the same
Site ID number leading to a consistent application of the Subpart K
requirements.  

Comment: We heard from one commenter recommending that EPA and the
college and university sector establish a collaborative initiative to
develop guidance that will be helpful to colleges and universities who
have opted to comply with Subpart K and for  EPA and State regulators
who will have responsibility for inspecting for compliance with Subpart
K. (Commenter No. 60).  The commenter stated that experiences of
colleges and universities in developing the initial Laboratory
Management Plans will be a valuable source of information.  Another
commenter suggested that EPA engage in a new study of the appropriate
enforcement of performance-based standards, because the commenter
believes enforcement for this rule could be problematic (Commenter No.
92).

Response:  EPA plans to work closely with the Regions, States, and the
academic sector to assist the adoption and the implementation of Subpart
K.  We hope to visit Regions and invite states and eligible academic
entities in order to provide training on the rule.  

Comment: We heard from one commenter noting that the performance-based
regulations are optional standards that may be viewed as less stringent
than the existing regulations (Commenter No. 65).  The commenter
expressed concern about the potential difficulty of ensuring compliance
with a college or university policy that is more stringent than the
underlying requirement.  

Response:  EPA disagrees that Subpart K’s performance-based approach
for management of unwanted materials in the laboratory with a
requirement for the eligible academic entity to develop and implement an
LMP is less stringent than the existing regulations.  In fact, Subpart K
requires training of students commensurate with their duties unlike the
non-existent training requirements for student under the existing SAA
regulations. We believe that a performance-based approach will allow
eligible academic entities greater flexibility by allowing them to
tailor their laboratory waste management program with respect to
container labeling, container management, and training, while ensuring
the necessary environmental protection.  Inspectors will be able to
determine compliance with Subpart K at eligible academic entities. 
Areas of the performance- based regulations that provide more
flexibility are countered by being included in the Part I of the LMP. 
Part I of the LMP contains necessary information for inspectors and
other officials about what options within Subpart K the eligible
academic entity is exercising and the contents of Part I of the LMP are
enforceable.

Comment: We heard from one commenter that expressed concern that that
the rule could be seen as the new “baseline” for compliance
(Commenter No. 88).  The commenter stated that a college or university
that is operating under the existing RCRA regulations may be viewed as
out of compliance by regulators (Commenter No. 88).

Response:  EPA disagrees with the commenters concern.  The final rule
establishes a set of alternative generator regulations for laboratories
owned by eligible academic entities under a new Subpart K in 40 CFR part
262.  Eligible academic entities may choose to be subject to Subpart K
in lieu of the existing generator requirements for the management of the
hazardous waste generated in the laboratories that they own.  We
recognize that the details of hazardous waste management operations vary
widely among campuses and some eligible academic entities have developed
programs consistent with the existing generator regulations that have
proven to be successful.  Thus, these institutions may be reluctant to
change from the generator regulations under which they are currently
operating.  Therefore the final rule, like the proposal, remains an
optional, alternative set of requirements to the existing generator
regulations and eligible academic entities may continue to manage their
laboratory hazardous wastes under the current hazardous waste generator
regulations.  Eligible academic entities may choose according to which
set of generator regulations they will manage their laboratory hazardous
wastes.

16.0	Issues that are Outside the Purview of this Rulemaking

	16.1	Treatment in Labs

Comment: We heard from 18 commenters that EPA should clarify that
colleges and universities can conduct non-thermal treatment/hazard
reduction in their labs under Subpart K in order to minimize waste
and/or  risks to human health and the environment (Commenter Nos. 2, 7,
11, 16, 25, 39, 54, 64, 73, 74, 75, 76, 77, 85, 87, 91, 107, 109). 
Eight of these commenters stated that EPA should further clarify that
non-thermal hazard reduction procedures on unwanted materials in Subpart
K laboratories do not constitute “treatment” in the regulatory
sense; do not require a RCRA hazardous waste permit; are not subject to
in-container treatment standards that require containers to be closed at
all times except when waste is	added or removed; and are not subject to
Land Disposal Restriction (LDR) requirements, including LDR requirements
for recordkeeping, certification and preparing an analysis plan
(Commenter Nos. 7, 11, 25, 54, 75, 85, 91, 109).   

Response:  In the proposal to Subpart K, the Agency did not specifically
identify a regulatory approach for the treatment of hazardous waste by
generators in laboratories.  Therefore, because the Agency did not
provide notice and an opportunity for public comment on this subject, it
is outside the scope of this rulemaking and EPA does not intend to add
any such provisions to the final rule.  While today’s final rule does
not specifically address the treatment of hazardous waste in
laboratories, it also does not change EPA’s interpretation of existing
regulations.

Comment: We heard from one commenters asking if it was EPA’s intent to
clarify treatment in labs under the rule (Commenter No. 114).

Response:  In the proposal to Subpart K, the Agency did not specifically
identify a regulatory approach for the treatment of hazardous waste by
generators in laboratories.  Therefore, because the Agency did not
provide notice and an opportunity for public comment on this subject, it
is outside the scope of this rulemaking and EPA does not intend to add
any such provisions to the final rule.  While today’s final rule does
not specifically address the treatment of hazardous waste in
laboratories, it also does not change EPA’s interpretation of existing
regulations.

Comment: We heard from one commenter recommending that the final rule
clarify that non-thermal risk reduction treatment of small amounts of
material resulting from laboratory experiments can be done as a
continuation of the lab experiment, since the material is not yet
“unwanted” (Commenter No. 39). 

Response:  In the proposal to Subpart K, the Agency did not specifically
identify a regulatory approach for the treatment of hazardous waste by
generators in laboratories.  Therefore, because the Agency did not
provide notice and an opportunity for public comment on this subject, it
is outside the scope of this rulemaking and EPA does not intend to add
any such provisions to the final rule.  While today’s final rule does
not specifically address the treatment of hazardous waste in
laboratories, it also does not change EPA’s interpretation of existing
regulations.

Comment: We heard from one commenter asking EPA to clarify that
treatment by the generator may be conducted by the lab worker and not
just EH&S staff (Commenter No. 76).  

Response:  In the proposal to Subpart K, the Agency did not specifically
identify a regulatory approach for the treatment of hazardous waste by
generators in laboratories.  Therefore, because the Agency did not
provide notice and an opportunity for public comment on this subject, it
is outside the scope of this rulemaking and EPA does not intend to add
any such provisions to the final rule.  While today’s final rule does
not specifically address the treatment of hazardous waste in
laboratories, it also does not change EPA’s interpretation of existing
regulations.

Comment: We heard from one commenter expressing concern that evaporating
solvents under laboratory hoods, as a method of hazardous waste
treatment or disposal, may still be done in some laboratories (Commenter
No. 45).  The commenter suggested that EPA clarify the specific
circumstances under which such evaporation would be allowed to take
place within the context of Subpart K.  The commenter also noted that
the preamble to the proposed rule stated that “generators who treat
hazardous waste on site to meet a treatment standard must prepare a
waste analysis plan if treatment occurs in units that do not require a
RCRA permit (see 40 CFR Part 262.34(a)(4) for LQGs, and 40 CFR Part
262.34(d)(4) for SQGs).”  The commenter stated that this is not true
when treatment occurs in wastewater treatment units or elementary
neutralization units, since the section 268.7(a)(5) requirement is only
for tanks and containers managed under section 262.34, and wastewater
treatment units and elementary neutralization units are not regulated
under section 262.34.

Response:  In the proposal to Subpart K, the Agency did not specifically
identify a regulatory approach for the treatment of hazardous waste by
generators in laboratories.  Therefore, because the Agency did not
provide notice and an opportunity for public comment on this subject, it
is outside the scope of this rulemaking and EPA does not intend to add
any such provisions to the final rule.  While today’s final rule does
not specifically address the treatment of hazardous waste in
laboratories, it also does not change EPA’s interpretation of existing
regulations.

	16.2	One EPA ID Number per Campus

Comment: We heard from eight commenters regarding their concerns that
some contiguous sites have received multiple EPA identification (ID)
numbers, which can cause confusion, burden and inefficiency (Commenter
Nos. 7, 11, 25, 31, 37, 54 80, and 97).  These commenters encouraged EPA
to resolve this problem by allowing one ID number per contiguous campus
as part of the final Subpart K rule.

Response:  We did not specifically identify in the proposal to Subpart K
a regulatory approach for allowing one EPA Identification Number per
campus.  Therefore, because the Agency did not provide notice and an
opportunity for public comment on this subject, it is outside the scope
of this rulemaking and EPA does not intend to add any such provisions to
the final rule.

Eliminate Acutely Hazardous Waste

Comment: We heard from one commenter stating that EPA should eliminate
entirely the threat of generator status shifts caused by acute hazardous
waste  (Commenter No. 101). The commenter stated that generator status
does not indicate relative risk of a facility to the environment or
community.  The commenter stated that sorting generators into tiers by
status eliminates any risk differentiation. The commenter suggested an
alternative, i.e., generation intensity, where waste management programs
depend on normalizing waste generation with some measure of area (square
footage, property size, etc). The commenter believes this approach would
sort the chemical plants from the colleges in a meaningful way for
assessment of relative risk from hazardous waste generation.

Response:  We disagree with the commenter.  In fact, acutely hazardous
wastes are designated as acutely hazardous wastes because they pose a
risk to human health and the environment regardless of how they are
managed (see 45 FR 33106).  Furthermore, the commenter’s suggested
alternative would require a complete revision of the existing RCRA
regulations for hazardous waste listings, which is outside the scope of
this rulemaking.

Comment: We heard from three commenters noting that, under 40 CFR
261.5(e)(1) of the current regulations, generation of 1 kg of an acute
hazardous waste (P-listed) in a calendar month triggers large quantity
generator status, and asking for EPA to address this issue under Subpart
K (Commenter Nos. 11, 25, 31).  Two of the commenters stated that
commercial chemical products on the P-list are rarely found except in
laboratories; hence, laboratories disproportionately and unfairly bear
the burden of this threshold, especially since so many academic
laboratories are small quantity and conditionally exempt small quantity
generators (Commenter Nos. 11 and 25).  The commenters stated their
belief that the 1 kilogram threshold is arbitrary and unnecessarily
complex, and does not relate generator status to waste hazard in a
meaningful way.  All of the commenters urged EPA to waive the 1-kg
P-list large quantity generator threshold for Subpart K.  

Response:  We disagree with the commenter.  In fact, acutely hazardous
wastes are designated as acutely hazardous wastes because they pose a
risk to human health and the environment regardless of how they are
managed (see 45 FR 33106) and therefore warrant a lower threshold for
triggering LQG status.  Furthermore, the commenter’s suggested
alternative would require a complete revision of the RCRA regulations
for hazardous waste listings, which is outside the scope of this
rulemaking.

Other Issues that are Outside the Purview of this Rulemaking

Comment: We heard from three commenters that discussed the benefits of
greater generator flexibility over their waste management (Commenter
Nos. 54, 64 and 87).  The commenters asked EPA to enable colleges and
universities to consolidate their offsite waste at a centralized
non-permitted location.  The commenters believe this would result in
greater environmental performance and increased college or university
participation rates under Subpart K.

Response:  We did not specifically identify in the proposal to Subpart K
a regulatory approach for allowing off-site consolidation at a
centralized non-permitted facility.  Therefore, because the Agency did
not provide notice and an opportunity for public comment on this
subject, it is outside the scope of this rulemaking and EPA does not
intend to add any such provisions to the final rule.

Comment:  We heard from six commenters that expressed concern about the
varying and potentially conflicting regulatory interpretations of
satellite accumulation areas (SAAs) (Commenter Nos. 5, 43, 46, 56, 87,
88):  

One of the commenters stated its belief that the various interpretations
of SAAs and other accumulation areas (e.g., where wastes must be held
and the timeframes) are a source of problems for college or university
labs in managing their unwanted materials (Commenter No. 5).  The
commenter stated, for example, that some people believe that a bottle of
unused or partly used acetone that is no longer wanted but not beyond
its expiration date is an unwanted material and cannot be sent to
another location for redistribution.  The commenter stated it belief
that this is an incorrect interpretation, because such material can be
sent back to the manufacturer without regulatory intervention.  The
commenter stated that the person responsible for making a hazardous
waste determination needs to see the entire picture (e.g., site-wide),
not simply the perspective of a single lab at the site.  

Another commenter noted that the preamble refers to labs as “SAAs”
and it stated that the term “SAA” is in wide use but has no
regulatory basis, and can be misleading because it implies that there is
a “central” accumulation area at the site, which may not be true
(Commenter No. 43).  The commenter stated that it would be preferable to
establish "waste accumulation areas" which could serve as either
"satellite" or "super-satellite" areas.  

Another commenter stated that each lab should be considered a point
source, and the location where any waste is placed prior to removal and
storage in a Main Accumulation Area should be designated an SAA
(Commenter No. 46).  

Two commenters expressed concern about some of the language in the
preamble/rule on SAAs (e.g., that the hazardous waste determination
needs to be made at the SAA; that “under the control of the
generators” means that the generator can hit the containers with a
Frisbee) (Commenter Nos. 56 and 88).  The commenters suggested that EPA
consider revising and clarifying the satellite accumulation provision
for all generators instead of creating a unique rule for just university
and college laboratories. One of the commenters suggested that the
Agency should consider flexible labeling requirements for SAAs
(Commenter No. 88).  

Another commenter stated that there is confusion about the amount of
waste that may be accumulated in laboratories (Commenter No. 87).  The
commenter stated that EPA should provide further discussion on how to
implement the satellite accumulation provisions in various “real
world” settings; in addition, EPA should issue guidance acknowledging
that accumulation limits in each laboratory should be based upon the
specific types of waste streams being generated, recognizing that
combining certain types of waste streams may be hazardous or may
complicate subsequent management of the resulting mixture.  The
commenter stated that EPA also should clarify how to comply with SAA
requirements (e.g., ways to comply with the requirement for closed
containers).  

Response:  Because most laboratories operate under the RCRA satellite
accumulation area regulations of 40 CFR 262.34, Subpart K was crafted to
provide an alternative to the satellite accumulation area regulations. 
We did not specifically identify in the proposal to Subpart K an
approach for revising the SAA regulations themselves or interpretations
pertaining to SAAs.  Therefore, it is outside the scope of this
rulemaking and EPA does not intend to add any such provisions to the
final rule.

Comment:  We heard from three commenters asking for clarification of the
existing RCRA regulations applicable to sink discharges of chemicals
(Commenter Nos. 38, 45, 107).  One of the commenters asked EPA to take
the occasion of addressing Subpart K amendments to define with clarity
the relationship between RCRA and the Clean Water Act (CWA) for the
benefit of institutions with laboratory operations (Commenter No. 38). 
The commenter discussed the problems and hazards associated with the
handling and accumulation of lab packs and stated that adoption of a de
minimis rule for sink disposal of waste would encourage elimination of
such hazards from the workplace immediately in an environmentally sound
manner.  Another commenter noted that the presence of drains (“...
laboratory hood, a contained area equipped with ventilation and
drainage...”) is alluded to, but the possibility of a student using
the sink drain as a waste disposal route, either inadvertently or
deliberately, is not mentioned (Commenter No. 45). The commenter asked
to see more specific information regarding this issue.

Response:  We did not specifically identify in the proposal to Subpart K
an approach for revising the regulations or interpretations pertaining
to sink discharges of laboratory chemicals.  Therefore, because the
Agency did not provide notice and an opportunity for public comment on
this subject, it is outside the scope of this rulemaking and EPA does
not intend to add any such provisions to the final rule. 

Comment: We heard from one commenter stating that EPA should restructure
the hazardous waste regulations away from lists and towards
scientifically determined and internationally recognized hazards of
materials (Commenter No. 101).  The commenter noted that the
Occupational Safety and Health Administration is considering adopting
the Global Harmonized System of Classifying and Labeling Chemicals
(GHS).  The commenter suggested that EPA begin to reconsider hazardous
waste generation in the United States along similar lines.

Response:  Implementing the commenter’s suggestion would require a
complete revision of the RCRA regulations for hazardous waste listings
and characteristics.  We did not specifically identify in the proposal
to Subpart K a regulatory approach for revising the hazardous waste
listings and characteristics.  Therefore, because the Agency did not
provide notice and an opportunity for public comment on this subject, it
is outside the scope of this rulemaking and EPA does not intend to add
any such provisions to the final rule.

Comment: We heard from one commenter stating that research laboratories
often collaborate with each other, or with colleges and universities,
and send samples to other laboratories for study or analysis (Commenter
No. 87).  The commenter stated that, once the work has been completed,
the recipients of the samples frequently want to send the remaining
material back to the originator, indicating that disposal of these
materials should be the "owner's" responsibility; however, these
laboratories voice concerns about the regulatory burden associated with
receipt of the remaining material.  The laboratory that originally sent
out the sample usually will not accept a return of the material, fearing
that the sample may not have further value and may be considered a
hazardous waste, triggering a RCRA violation. The commenter suggested
that EPA should issue guidance allowing (but not necessarily requiring)
the originating facility to accept returns of their samples for
evaluation and possible reuse.  The commenter also stated unwillingness
of TSDFs to accept experimental compounds for which there is a lack of
hazard data.  The commenter asked EPA to issue guidance or take
regulatory action to enable these facilities to handle this waste as
“samples.”

Response:   We did not specifically identify in the proposal to Subpart
K a regulatory approach for enabling eligible academic entities to
accept leftover samples from other institutions with which they
collaborate.  Therefore, because the Agency did not provide notice and
an opportunity for public comment on this subject, it is outside the
scope of this rulemaking and EPA does not intend to add any such
provisions to the final rule.

Comment:  We heard from one commenter expressing concern that some
research and development laboratories face economic costs because of the
storage limits set by the 90-day rule (Commenter No. 87). Because the
90-day “clock” for the accumulation time limit begins when the
oldest container is placed into a drum, research and development
laboratories generating small numbers of lab packs are often unable to
fill a drum within that 90-day period.  As a result, many laboratories
have to ship partially full drums to get the waste off-site before 90
days has elapsed, resulting in significant inefficiencies and excess
costs.  The commenter noted that these high costs could be reduced if
research and development laboratories were allowed to accumulate these
types of wastes on-site for a longer period of time and hence were able
to accumulate sufficient material to ship full drums to off-site
disposal facilities.  The commenter recommended that EPA consider
extending the 90-day accumulation period to at least 180 days for wastes
generated from research and development laboratories in order to address
this concern. 

Response:  We did not specifically identify in the proposal to Subpart K
a regulatory approach for extending the accumulation period for LQGs. 
Therefore, because the Agency did not provide notice and an opportunity
for public comment on this subject, it is outside the scope of this
rulemaking and EPA does not intend to add any such provisions to the
final rule.

17.0	Miscellaneous Comments

Comment: We heard from one commenter encouraging EPA to develop guidance
and additional materials that establish realistic expectations regarding
the waste minimization challenges that are unique to laboratories
(Commenter No. 87).  The commenter believes it would be helpful if EPA
were to provide guidance for inspectors that acknowledge that only
limited opportunities for waste minimization may exist at most labs and
encourage inspectors to look for a good faith effort to identify waste
minimization opportunities in laboratories, rather than expecting a very
specific plan with targeted volume/hazard reductions.

Response:  We recognize the need identified by the commenter for
developing guidance regarding waste minimization at laboratories. 
However, that is outside the scope of this current rulemaking and would
require a separate effort by EPA to provide such guidance in the future.

Comment: We heard from one commenter stating that the proposed rule and
preamble are silent on whether college or university hazardous waste
management facilities opting to be covered by Subpart K would be
required to obtain a permit modification (Commenter No. 14).  The
commenter recommended that the final rule include guidance on how the
Subpart K rules would impact existing hazardous waste permits.  The
commenter believes it is reasonable that facility hazardous waste
permits should be consistent with the Subpart K rules for those parts of
the facility’s operations regulated under Subpart K.  To encourage
states to adopt the rule, the commenter recommends that the modification
of existing permits for facilities opting for coverage under the new
rules be considered a Class 1 permit modification under 40 CFR 270.42.

Response:  We agree with the commenter that an eligible academic entity
that has a permit and opts into Subpart K may be required to obtain a
permit modification.  It would be up to the State that issued the permit
to decide whether a permit modification would be required and which type
of permit modification would be necessary.

Comment: We heard from two commenters recommending that EPA should
include the HHMI Consensus Best Practices as a non-mandatory Appendix to
Subpart K (Commenter Nos. 60, 98).  One of the commenters stated that
the 14 Best Practices would provide helpful guidance for colleges and
universities who are developing performance-based environmental systems
to manage hazardous waste programs (Commenter No. 60).   

Response:  We believe that including the HHMI Consensus Best Practices
as a non-mandatory Appendix to the regulations of Subpart K would be
confusing.  OSHA included a non-mandatory appendix that consisted of an
example Chemical Hygiene Plan in its Laboratory Standard (29 CFR
1910.140), and EPA has often been told that it has led to confusion
about whether laboratories need to have a CHP.  Therefore, we are not
including the HHMI Consensus Best Practices as a non-mandatory appendix
to Subpart K.

Eligible academic entities may choose to refer to the HHMI Consensus
Best Practices in EPA’s 2002 Report to Congress on the HHMI initiative
when developing their LMPs (entitled Evaluating the Consensus Best
Practices Developed through the Howard Hughes Medical Institute’s
Collaborative Hazardous Waste Management Demonstration Project and the
Need for Regulatory Changes to Carry Out Project Recommendations; Report
to Congress and available at
http://www.epa.gov/epawaste/hazard/generation/labwaste/r02008.pdf)

Comment:  We heard from one commenter urging EPA to approve the final
rule in a timely manner that will allow participants under the New
England Universities Academic Laboratories XL (Project XL) to move from
waste management under Project XL to waste management under the new
rule, without having to return to RCRA in the labs (Commenter No. 95). 
The commenter also asked EPA to provide enough flexibility in the new
Subpart K language to allow for Project XL participants to continue
those successful components within the approved regulatory framework of
Project XL.  

Response:  The final rule will be finalized by the time the New England
Universities Academic Laboratories XL expires on April 15, 2009. 
However, the final rule will not be effective in Massachusetts and
Vermont until those states adopt the rule.  EPA Region I plans to work
with Massachusetts and Vermont to help the states adopt the final rule
as quickly as possible and minimize the disruption to the three
universities involved in Project XL.

Comment:  We heard from one commenter suggesting that EPA establish a
requirement for a college or university to set up a "pharmacy" or
"redistribution facility" that will redistribute unused chemicals to
laboratories that need them (Commenter No. 102).  The commenter believes
the pharmacy and redistribution concept is a method to reduce the amount
of hazardous waste generated and to prevent the stockpiling of chemicals
at laboratories that may not have the proper facilities to store
accumulated unwanted materials that another laboratory on campus may
need. The commenter stated that there should be a maximum storage time
limit for the unwanted chemicals in the pharmacy or redistribution
facility that extends at least until the expiration date of the
chemical, to prevent stockpiling.

Response:  We agree with the commenter that the pharmacy and
redistribution facility concept is a method to promote the reuse of
chemicals rather than discarding them.  We disagree with the commenter
that Subpart K should include a requirement to establish a pharmacy or
redistribution facility.  First, we have heard from many stakeholders
over the years that they have had limited success in redistributing
chemicals amongst laboratories because of concerns about the purity of
chemicals.  Second, some eligible academic entities lack the space and
resources to establish and operate such a facility.  Therefore, we are
not requiring eligible academic entities that opt into Subpart K to
establish pharmacy or chemical redistribution facilities.

Comment:  We heard from one commenter suggesting that EPA establish a
requirement for a RCRA-trained person at a college or university to
inspect its college or university’s laboratories (Commenter No. 102). 
The commenter stated that, in its experience, self-inspections can be
beneficial to the college or university in increasing its compliance
rate.  The commenter urged EPA to establish an inspection frequency of
no less than semi-annually for each lab at the college or university.

Response:  We do not believe it is necessary to require inspections of
laboratories by trained professionals.  This is because Subpart K
already requires regularly scheduled removals of unwanted materials from
laboratories and trained professional must accompany all transfers of
unwanted materials outside the laboratory.  Therefore, a trained
professional will be in each laboratory on a regular basis and be able
to observe conditions in the laboratory.

Nevertheless, an eligible academic entity may choose to include in Part
II of its LMP an element indicating that it will conduct inspections of
its laboratories.

Comment:  We heard from one commenter suggesting that laboratory
chemical reviews should be required and recorded once per year which
will encourage good inventory management and waste minimization
(Commenter No. 66).  The commenter stated that laboratory chemical
reviews should be required and recorded in chemical stockrooms that are
related to labs.

Response:  We agree with the commenter that it is a good practice to
maintain an inventory of laboratory chemicals.  Therefore, we have added
an element to Part II of the LMP requiring that an eligible academic
entity must develop a list of chemicals that the eligible academic
entity has, or is likely to have, that become more dangerous when they
exceed their expiration date and/or as they degrade, as well as
procedures to safely dispose of chemicals that become more dangerous
when they exceed their expiration date and/or as they degrade.  We
realize that keeping a complete inventory of all laboratory chemicals
can be burdensome and we believe it is a better use of resources to
focus the inventory on the most dangerous chemicals.  Of course, an
eligible academic entity may choose to go beyond the requirement and
maintain a complete inventory of all laboratory chemicals.

Comment:  We heard from one commenter noting the need for colleges and
universities to prepare for emergency responses (Commenter No. 95).  The
commenter stated that offsite emergency responders may not enter a
building or lab unless an onsite person can provide relevant information
about the hazards.  The commenter urged EPA to allow universities to
develop specific performance-based emergency response plans. 

Response:  We agree with the commenter and have included in Part II of
the LMP, a requirement for an eligible academic entity to describe its
intended best practices for emergency prevention, including:

Procedures for emergency prevention, notification, and response,
appropriate to the hazards in the laboratory, and

A list of chemicals that the eligible academic entity has, or is likely
to have, that become more dangerous when they exceed their expiration
date and/or as they degrade, and  

 Procedures to safely dispose of chemicals that become more dangerous
when they exceed their expiration date and/or as they degrade, and

 Procedures for the timely characterization of unknown chemicals.

In addition, LQGs and SQGs are subject to the emergency response
requirements included in 40 CFR 262.34(a) and 262.34(d), respectively.

	

Comment:  We heard from one commenter stating that varying
interpretations of the solid waste definition have occasionally led to a
requirement that surplus chemicals, even unopened materials, must be
managed as wastes (Commenter No. 68).  The commenter suggested that EPA
create a new definition for the term “surplus chemicals” and an
explicit regulatory exclusion for these materials at section
261.4(a)(22).  The commenter offered specific language for the
definition and exclusion.  The commenter believes this could help to
remedy a long-standing confusion about the regulatory status of
chemicals not wanted in one lab but perfectly useable in others.   We
heard from another commenter expressing concern the existing RCRA
regulations do not include sufficient mechanisms to enable labs to
remove recoverable chemicals from the hazardous waste stream once they
are removed from a lab destined for disposal (Commenter No. 46).  The
commenter stated that there should be a completely different set of
waste characterization processes for laboratories, which would allow
energy/resource recovery, as RCRA was originally intended, and yet allow
truly waste-like chemicals with no recoverable value to be declared
hazardous waste under the existing RCRA regulations.

Response:  It has always been the case under existing RCRA regulations,
and continues to be the case under Subpart K, that chemicals that are
fit for continued use are not solid or hazardous wastes (see §
261.2(e)(1)) and can be transferred between SAAs, laboratories, and
chemical stockrooms.  Under Subpart K, we realize that some chemicals
that are initially identified as unwanted materials will turn out not to
be solid or hazardous wastes.  If, for example, an unwanted material is
brought to an on-site CAA or TSDF for a hazardous waste determination,
and it is determined that such unwanted material can be reused, then it
is not a solid or hazardous waste and is not subject to Subpart K or the
Subtitle C hazardous waste regulations, once the determination is made. 
That is, if a chemical is initially labeled as an unwanted material and
then it is subsequently discovered that it can continue to be used, the
chemical can be returned to a laboratory or chemical stockroom for
redistribution.  EPA selected the term “unwanted material” over
“laboratory waste,” in part to indicate that the material may still
be useable.

Comment: We heard from one commenter stating that EPA needs to address
point of generation issues and management of containers associated with
high performance liquid chromatography (HPLC) and other automated lab
equipment in guidance or regulations (Commenter No. 99).

Response:  As we stated in a memo regarding satellite accumulation
areas, dated March 17, 2004 (Springer to Regions), 

“The container(s) attached to such equipment [i.e., HPLCs and other
automated lab equipment] is a point of generation.”

The same would be true under Subpart K.  That is, the discharges from
HPLCs and other in-line equipment would be considered unwanted materials
and the containers must be labeled in accordance with the Subpart K
labeling requirements.  Under the container management standards of
Subpart K, in-line containers may be vented when it’s required for the
operation of the equipment.

Comment: We heard from one commenter stating that EPA officials stated
that the Generator Initiative will address items of interest to colleges
and universities that are not included in the proposed rule (Commenter
No. 89).  The commenter encouraged EPA to proceed with the initiative as
soon as feasible.

Response:  We thank the commenter for his support.  We continue to work
on items of concern identified during the Generator Initiative public
meetings.  

Appendix I: Organizations Commenting on Proposed Rule

The table below identifies each organization that commented on the
proposed rule and its commenter number, as used in this Response to
Comment Document; and document ID number, as used in the docket for the
Rule.  

Commenter Number	Document

ID Number	Commenter Name

1	0069	University of Tennessee

2	0070	Temple University

3	0132	Children's Hospital Boston

4	0071

0071.1	National Aeronautics and Space Administration (NASA)

5	0072	U.S. Army Medical Research Institute of Infectious Diseases
(USAMRIID) – Fort Detrick, Maryland

6	0073	Clemson University

7	0074

0074.1	American Chemical Society (ACS)

8	0075	University of Nebraska - Lincoln

9	0076	Worcester Polytechnic Institute

10	0077

0077.1	Vermont Educational Safety Committee (VESCO)

11	0078

0078.1	National Safety Council (NSC)/Campus Safety Health and
Environmental Management Association (CSHEMA)

12	0079	Missouri Department of Natural Resources

13	0080	Utah State University

14	0081

0081.1	National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH)

15	0082

0082.1	University of North Carolina - Chapel Hill

16	0083	Williams College

17	0084	Medical College of Georgia

18	0085	Michigan Technological University

19	0086

0086.1	Florida Atlantic University

20	0087	South Dakota State University

21	0088	University of Nebraska at Omaha

22	0089

0089.1	Eastern Virginia Medical School

23	0090	Elon University Chemistry Department

24	0091

0091.1	Oklahoma Department of Environmental Quality

25	0092	University of Utah

26	0093	N/A - FR Notice:  Extension of Comment Period

27	0094	N/A - Incomplete Submission, Resubmitted as 0116

28	0095	East Virginia Medical School

29	0096

0096.1	Iowa State University

30	0097

0097.1	American Council of Education, the National Association of
College and University Business Officers, American Association of
Medical Colleges, American Association of State Colleges and
Universities, Association of American Universities, National Association
of State Universities and Land-Grant Colleges

31	0098	University of Central Florida

32	0099	Vanderbilt University

33	0100

0100.1	U.S. Department of Energy

34	0101

0101.1	Johns Hopkins University School of Medicine

35	0102

0102.1	University of North Carolina

36	0103

0103.1	Northwestern University

37	0104

0104.1	Ohio State University

38	0105

0105.1-4	Concerned Citizen

39	0106

0106.1	Novartis Corporation

40	0107	Concerned Citizen

41	0108	Minnesota Pollution Control Agency

42	0109	Northeastern State University

43	0110	Georgia Institute of Technology

44	0111	Louisiana Department of Environmental Quality

45	0112	New York State Department of Environmental Conservation

46	0113	Private Citizen

47	0114	University of Alabama-Birmingham

48	0115

0115.1	University of Michigan

49	0116

0116.1	University of Vermont

50	0117	N/A – Duplicate Submission of 0113

51	0118	Boehringer Ingelheim Pharmaceuticals, Inc

52	0119	Private Citizen

53	0120	Massachusetts Department of Environmental Protection

54	0121	University of Rochester

55	0122	Private Citizen

56	0123

0123.1	Ohio Environmental Protection Agency

57	0124	University of Cincinnati

58	0125	Nebraska Department of Environmental Quality

59	0126	Pennsylvania Department of Environmental Protection

60	0127

0127.1-2	Howard Hughes Medical Institute (HMMI)

61	0128

0128.1	Campus Consortium for Environmental Excellence (C2E2)

62	0129

0129.1	Council on Governmental Relations (COGR)

63	0130

0130.1	N/A – Comment on Manifest Rule that was incorrectly submitted
to Labs Rule

64	0131

0131.1	University of Delaware

65	0133	University of Arkansas - Fayetteville

66	0134	Idaho Department of Environmental Quality

67	0135

0135.1	Fred Hutchinson Cancer Research Center

68	0136

0136.1	Stanford University

69	0137

0137.1	University of Minnesota

70	0138

0138.1	University of Pittsburgh

71	0139

0139.1	Brigham Young University

72	0140

0140.1-2	Northeastern University

73	0141

0141.1	Walla Walla College

74	0142

0142.1	State of Washington DEC

75	0143

0143.1	Rockefeller University

76	0144

0144.1	University of Washington

77	0145

0145.1	University of California

78	0146	University of Texas System

79	0147

0147.1	Emory University

80	0148

0148.1	Washington University in St. Louis

81	0149

0149.1	Cornell University

82	0150	Private Citizen

83	0151	Washington State University

84	0152

0152.1	Environmental Technology Council (ETC)

85	0153

0153.1	University of Wisconsin System Administration (UWSA)

86	0154

0154.1	University of Illinois at Chicago

87	0155

0155.1	Synthetic Organic Chemical Manufacturers Association

88	0156

0156.1	University of Texas at Austin

89	0157

0157.1	University of Wisconsin – Madison

90	0158

0158.1	Louisiana State University at Baton Rouge

91	0159

0159.1	University of Missouri - Columbia

92	0160	Private Citizen

93	0161	Association of American Medical Colleges (AAMC)

94	0162	Association of Independent Research Institutes (AIRI)

95	0163	Boston College

96	0164	Boston University

97	0165	Otterbein College

98	0166

0166.1	University of Pennsylvania

99	0167

0167.1	The Pharmaceutical Research and Manufacturers of America (PhRMA)

100	0168

0168.1	St. John’s University

101	0169	Colorado College

102	0170	Georgia Department of Natural Resources

103	0171

0171.1	N/A – Incorrect Submission, Removed from Docket

Resubmitted as 0181

104	0172	Indiana University – Purdue University Indianapolis (IUPUI)

105	0173

0173.1	North Carolina Department of Environment and Natural Resources

106	0174	University of Louisville

107	0175

0175.1	Oak Ridge National Laboratory

108	0176

0176.1	Yale University

109	0177	University of Wisconsin – Madison

110	0178	Harvard University

111	0179	Utility Solid Waste Activities Group (USWAG)

112	0180	University of Alabama

113	0181	RCRAInfo Change Management Process Site Identification Program
Group

114	0182

0182.1-2	Texas Commission on Environmental Quality

115	0183	State of Maine Department of Environmental Protection

116	0185	U.S. Department of Agriculture, Agricultural Research Service



Appendix II:  Organizations Whose Comments Received Support from Other
Organizations

A number of organizations that submitted comments on the proposed rule
expressed general support for the comments submitted by another
organization.  In total, six commenters received the support of other
organizations.  These six commenters (and their respective commenter
number) include:

American Chemical Society (Commenter No. 7; Docket No. 0074/0074.1);

American Council of Education, the National Association of College and
University Business Officers, American Association of Medical Colleges,
American Association of State Colleges and Universities, Association of
American Universities, National Association of State Universities and
Land-Grant Colleges (Commenter No. 30; Docket No. 0097/0097.1);

Campus Consortium for Environmental Excellence (Commenter No. 61; Docket
No. 0128/0128.1);

Council on Governmental Relations (Commenter No. 62; Docket No.
0129/0129.1);

Howard Hughes Medical Institute (Commenter No. 60; Docket No.
0127/0127.1-2); and

National Safety Council/Campus Safety Health and Environmental 
Management Association (Commenter No. 11; Docket No. 0078/0078.1).

The table below lists these six organizations. Below each, the table
identifies the commenters that expressed support, by commenter number,
document ID number and name.

Commenter Number	Document ID Number	Commenter Name

American Chemical Society

86	0154

0154.1	University of Illinois at Chicago

96	0164	Boston University

American Council of Education, the National Association of College and
University Business Officers, American Association of Medical Colleges,
American Association of State Colleges and Universities, Association of
American Universities, National Association of State Universities and
Land-Grant Colleges

93	0161	Association of American Medical Colleges (AAMC)

Campus Consortium for Environmental Excellence

95	0163	Boston College

101	0169	Colorado College

Council on Governmental Relations

77	0145

0145.1	University of California

112	0180	University of Alabama

Howard Hughes Medical Institute

75	0143

0143.1	Rockefeller University

76	0144

0144.1	University of Washington

80	0148

0148.1	Washington University in St. Louis

89	0157

0157.1	University of Wisconsin – Madison

National Safety Council/Campus Safety Health and Environmental 
Management Association

8	0075	University of Nebraska - Lincoln

9	0076	Worcester Polytechnic Institute

15	0082

0082.1	University of North Carolina - Chapel Hill

17	0084	Medical College of Georgia

18	0085	Michigan Technological University

20	0087	South Dakota State University

21	0088	University of Nebraska at Omaha

22	0089

0089.1	Eastern Virginia Medical School

23	0090	Elon University Chemistry Department

25	0092	University of Utah

30	0097

0097.1	American Council of Education, the National Association of
College and University Business Officers, American Association of
Medical Colleges, American Association of State Colleges and
Universities, Association of American Universities, National Association
of State Universities and Land-Grant Colleges

31	0098	University of Central Florida

34	0101

0101.1	Johns Hopkins University School of Medicine

35	0102

0102.1	University of North Carolina

36	0103

0103.1	Northwestern University

37	0104

0104.1	Ohio State University

49	0116

0116.1	University of Vermont

54	0121	University of Rochester

61	0128

0128.1	Campus Consortium for Environmental Excellence

62	0129

0129.1	Council on Governmental Relations (COGR)

64	0131

0131.1	University of Delaware

65	0133	University of Arkansas - Fayetteville

68	0136

0136.1	Stanford University

69	0137

0137.1	University of Minnesota

72	0140

0140.1-2	Northeastern University

73	0141

0141.1	Walla Walla College

77	0145

0145.1	University of California

78	0146	University of Texas System

80	0148

0148.1	Washington University in St. Louis

85	0153

0153.1	University of Wisconsin System Administration (UWSA)

86	0154

0154.1	University of Illinois at Chicago

89	0157

0157.1	University of Wisconsin – Madison

90	0158

0158.1	Louisiana State University at Baton Rouge

95	0163	Boston College

96	0164	Boston University

97	0165	Otterbein College

100	0168	St. John’s University

101	0169	Colorado College

104	0172	Indiana University – Purdue University Indianapolis (IUPUI)

106	0174	University of Louisville

109	0177	University of Wisconsin – Madison

110	0178	Harvard University

112	0180	University of Alabama



 EPA identified commenter support based on either a commenter’s
statement of support or a request by the commenter for the rule to apply
to its organization or industry sector.

 The ACGME defines these terms in the “Glossary of Terms” that
appears on its website at   HYPERLINK
"http://acgme.org/acWebsite/about/ab_ACGMEglossary.pdf" 
http://acgme.org/acWebsite/about/ab_ACGMEglossary.pdf .  The ACGME also
describes these documents in more detail in a document called Frequently
Asked Questions Related to Master Affiliation Agreements and Program
Letters of Agreement that appears on its website at
http://acgme.org/acWebsite/about/ab_FAQAgreement.pdf.

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 The Agency has recently issued a memo clarifying that the scope of the
P042 listing does not include epinephrine salts (see memo from Hale to
EPA Regions, October 15, 2007, RCRA Online #14778).

 It appears Commenter No. 81 has provided comments supporting both
approaches.

 PAGE   

	 

	   PAGE  ii 

NOVEMBER 12, 2008                        

	   PAGE  162 

NOVEMBER 12, 2008                        

