SUPPORTING STATEMENT FOR 

INFORMATION COLLECTION REQUEST NUMBER 2317.01

“GENERATOR STANDARDS APPLICABLE TO LABORATORIES OWNED BY ELIGIBLE
ACADEMIC ENTITIES”

July 14, 2008

Office of Solid Waste

United States Environmental Protection Agency

Washington, D.C. 20460

TABLE OF CONTENTS

  TOC \o "1-3" \h \z    HYPERLINK \l "_Toc203723099"  1.	IDENTIFICATION
OF THE INFORMATION COLLECTION	  PAGEREF _Toc203723099 \h  1  

  HYPERLINK \l "_Toc203723100"  1(a)	Title and Number of the Information
Collection	  PAGEREF _Toc203723100 \h  1  

  HYPERLINK \l "_Toc203723101"  1(b)	Short Characterization	  PAGEREF
_Toc203723101 \h  1  

  HYPERLINK \l "_Toc203723102"  2.	NEED FOR AND USE OF THE COLLECTION	 
PAGEREF _Toc203723102 \h  8  

  HYPERLINK \l "_Toc203723103"  2(a)	Need and Authority for the
Collection	  PAGEREF _Toc203723103 \h  8  

  HYPERLINK \l "_Toc203723104"  2(b)	Practical Utility and Users of the
Data	  PAGEREF _Toc203723104 \h  11  

  HYPERLINK \l "_Toc203723105"  3.	NONDUPLICATION, CONSULTATIONS, AND
OTHER COLLECTION CRITERIA	  PAGEREF _Toc203723105 \h  14  

  HYPERLINK \l "_Toc203723106"  3(a)	Nonduplication	  PAGEREF
_Toc203723106 \h  14  

  HYPERLINK \l "_Toc203723107"  3(b)	Public Notice	  PAGEREF
_Toc203723107 \h  14  

  HYPERLINK \l "_Toc203723108"  3(c)	Consultations	  PAGEREF
_Toc203723108 \h  14  

  HYPERLINK \l "_Toc203723109"  3(d)	Effects of Less Frequent Collection
  PAGEREF _Toc203723109 \h  15  

  HYPERLINK \l "_Toc203723110"  3(e)	General Guidelines	  PAGEREF
_Toc203723110 \h  16  

  HYPERLINK \l "_Toc203723111"  3(f)	Confidentiality	  PAGEREF
_Toc203723111 \h  16  

  HYPERLINK \l "_Toc203723112"  3(g)	Sensitive Questions	  PAGEREF
_Toc203723112 \h  16  

  HYPERLINK \l "_Toc203723113"  4.	THE RESPONDENTS AND THE INFORMATION
REQUESTED	  PAGEREF _Toc203723113 \h  17  

  HYPERLINK \l "_Toc203723114"  4(a)	Respondents and NAICS Codes	 
PAGEREF _Toc203723114 \h  17  

  HYPERLINK \l "_Toc203723115"  4(b)	Information Requested	  PAGEREF
_Toc203723115 \h  17  

  HYPERLINK \l "_Toc203723116"  5.	THE INFORMATION COLLECTED:  AGENCY
ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT	  PAGEREF
_Toc203723116 \h  29  

  HYPERLINK \l "_Toc203723117"  5(a)	Agency Activities	  PAGEREF
_Toc203723117 \h  29  

  HYPERLINK \l "_Toc203723118"  5(b)	Collection Methodology and
Management	  PAGEREF _Toc203723118 \h  30  

  HYPERLINK \l "_Toc203723119"  5(c)	Small Entity Flexibility	  PAGEREF
_Toc203723119 \h  30  

  HYPERLINK \l "_Toc203723120"  5(d)	Collection Schedule	  PAGEREF
_Toc203723120 \h  30  

  HYPERLINK \l "_Toc203723121"  6.	ESTIMATING THE HOUR AND COST BURDEN
OF THE COLLECTION	  PAGEREF _Toc203723121 \h  35  

  HYPERLINK \l "_Toc203723122"  6(a)	Estimating Respondent Burden Hours	
 PAGEREF _Toc203723122 \h  35  

  HYPERLINK \l "_Toc203723123"  6(b)	Estimating Respondent Costs	 
PAGEREF _Toc203723123 \h  35  

  HYPERLINK \l "_Toc203723124"  6(c)	Estimating Agency Hour and Cost
Burden	  PAGEREF _Toc203723124 \h  36  

  HYPERLINK \l "_Toc203723125"  6(d)	Estimating the Annual Respondent
Universe and Total Hour and Cost Burden	  PAGEREF _Toc203723125 \h  36  

  HYPERLINK \l "_Toc203723126"  6(e)	Bottom Line Hour and Cost Burden	 
PAGEREF _Toc203723126 \h  45  

  HYPERLINK \l "_Toc203723127"  6(f)	Reasons for Change In Burden	 
PAGEREF _Toc203723127 \h  46  

  HYPERLINK \l "_Toc203723128"  6(g)	Public Burden Statement	  PAGEREF
_Toc203723128 \h  46  

 

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a)	Title and Number of琠敨䤠普牯慭楴湯䌠汯敬瑣潩൮

This Information Collection Request (ICR) is entitled “Generator
Standards Applicable to Laboratories Owned by Eligible Academic
Entities,” EPA ICR Number 2317.01.

1(b)	Short Characterization

The U.S. Environmental Protection Agency (EPA) has finalized an
alternative set of generator requirements applicable to laboratories
owned by eligible academic entities, as defined in the final rule.  The
rule, which establishes a new Subpart K within 40 CFR Part 262, provides
a flexible and protective set of regulations that address the specific
nature of hazardous waste generation and accumulation in laboratories
owned by colleges and universities, and teaching hospitals and
non-profit research institutes that are either owned by or formally
affiliated with a college or university.  In addition, the final rule
allows colleges and universities and these other eligible academic
entities formally affiliated with a college or university the discretion
to determine the most appropriate and effective method of compliance
with these requirements by allowing them the choice of managing their
hazardous wastes in accordance with the new alternative regulations as
set forth in Subpart K or remaining subject to the existing generator
regulations.

In Sections 1 through 5 of this document, EPA presents a comprehensive
description of the information collection requirements in the final
rule.  In Section 6, EPA estimates the total annual hour and cost burden
to respondents associated with these new paperwork requirements.  In
addition, EPA estimates the total annual burden impacts to respondents
for being relieved of some existing requirements.

In the following paragraphs, EPA describes the information collection
requirements in the final rule.

(1)	Notification of Intent to Comply with Subpart K and Recordkeeping of
Agreements

	40 CFR 262.203(a) provides that an eligible academic entity must notify
the appropriate EPA Regional Administrator in writing, using the RCRA
Subtitle C Site Identification Form (EPA Form 8700-12), that it is
electing to be subject to the requirements of Subpart K for all the
laboratories owned by the eligible academic entity under the same EPA
Identification Number.  An eligible academic entity that is a
conditionally exempt small quantity generator and does not have an EPA
Identification Number must notify that it is electing to be subject to
the requirements of Subpart K for all the laboratories owned by the
eligible academic entity that are on-site.  An eligible academic entity
must submit a separate notification (Site Identification Form) for each
EPA Identification Number (or site, for conditionally exempt small
quantity generators) that is electing to be subject to the requirements
of Subpart K.

When submitting the Site Identification Form, the eligible academic
entity must, at a minimum, fill out the fields on the form that are
specified at section 262.203(b)(1)-(11).

Section 262.203(c) provides that an eligible academic entity must keep a
copy of the notification on file at the eligible academic entity for as
long as its laboratories are subject to Subpart K.

Section 262.203(d) provides that a teaching hospital that is not owned
by a college or university must keep a copy of its formal written
affiliation agreement with a college or university on file at the
teaching hospital for as long as its laboratories are subject to Subpart
K.

	Section 262.203(e) provides that a non-profit research institute that
is not owned by a college or university must keep a copy of its formal
written affiliation agreement with a college or university on file at
the non-profit research institute for as long as its laboratories are
subject to Subpart K.

(2)	Notification of Withdrawal from Subpart K

	40 CFR 262.204(a) provides that an eligible academic entity must notify
the appropriate EPA Regional Administrator in writing, using the RCRA
Subtitle C Site Identification Form (EPA Form 8700-12), that it is
electing to no longer be subject to the requirements of Subpart K for
all the laboratories owned by the eligible academic entity under the
same EPA Identification Number.  An eligible academic entity that is a
conditionally exempt small quantity generator and does not have an EPA
Identification Number must notify that it is withdrawing from the
requirements of Subpart K for all the laboratories owned by the eligible
academic entity that are on-site.  An eligible academic entity must
submit a separate notification (Site Identification Form) for each EPA
Identification Number (or site, for conditionally exempt small quantity
generators) that is withdrawing from the requirements of Subpart K.

When submitting the Site Identification Form, the eligible academic
entity must, at a minimum, fill out the fields on the form that are
specified at section 262.204(b)(1)-(11).

	Section 262.204(c) provides that an eligible academic entity must keep
a copy of the withdrawal notice on file at the eligible academic entity
for three years from the date of the notification.

(3)	Labeling of Containers of Unwanted Material in the Laboratory

40 CFR 262.206 provides that an eligible academic entity must label and
manage containers of unwanted material while in the laboratory in
accordance with the requirements in section 262.206.  

Section 262.206(a)(1) requires that the following information must be
affixed or attached to the container: the words ”unwanted material”
or another equally effective term that is to be used consistently by the
eligible academic entity and that is identified in Part I of the
Laboratory Management Plan (262.206(a)(1)(i)), and sufficient
information to alert emergency responders to the contents of the
container (262.206(a)(1)(ii)).

Section 262.206(a)(2) provides that the following information may be
affixed or attached to the container, but must at a minimum associated
with the container: the date that the unwanted material first began
accumulating in the container (262.206(a)(2)(i)) and information
sufficient to allow a trained professional to properly identify whether
an unwanted material is a solid and hazardous waste and to assign the
proper hazardous waste code(s), pursuant to section 262.11
(262.206(a)(2)(ii)). 

(4)	Training

40 CFR 262.207 provides that an eligible academic entity must provide
training to all individuals working in a laboratory at that eligible
academic entity, as specified.  

Section 262.207(a) requires that training for laboratory workers and
students must be commensurate with their duties so they understand the
requirements in Subpart K and can implement them.  

Section 262.207(b) provides that an eligible academic entity can provide
training for laboratory workers and students in a variety of ways (e.g.,
instruction by the professor or laboratory manager before or during an
experiment, formal classroom training, electronic/written training).

Section 262.207(c) provides that an eligible academic entity that is a
large quantity generator must maintain documentation demonstrating
training for all laboratory workers.  Section 262.207(c) also requires
that the information must be sufficient to determine whether laboratory
workers have been trained and must be retained for the durations
specified in section 265.16(e).  Sections 262.207(c)(1)-(4) provide
examples of documentation demonstrating training. 

(5)	Removing Containers of Unwanted Material from the Laboratory

40 CFR 262.208(a) establishes standards for removing containers of
unwanted material on a regular schedule.  An eligible academic entity
must either:  remove all containers of unwanted material from each
laboratory on a regular interval, not to exceed 6 months
(262.208(a)(1)); or remove containers of unwanted material from each
laboratory within 6 months of each container’s accumulation start date
(262.208(a)(2)). 

	Section 262.208(b) requires that the eligible academic entity must
specify in Part I of its Laboratory Management Plan whether it will
comply with section 262.208(a)(1) or (a)(2) for the regular removal of
unwanted material from its laboratories.  

Section 262.208(c) requires that the eligible academic entity must
specify in Part II of its Laboratory Management Plan how it will comply
with section 262.208(a)(1) or (a)(2) and develop a schedule for regular
removals of unwanted material from its laboratories.  

	Section 262.208(d) establishes standards for removing containers of
unwanted material when maximum volumes are exceeded.  Section
262.208(d)(1) provides that, if a laboratory accumulates more than 55
gallons of unwanted material (including reactive acutely hazardous
unwanted material) before the regularly scheduled removal, the eligible
academic entity must ensure that all containers of unwanted material
(including reactive acutely hazardous unwanted material): must have the
date that 55 gallons is exceeded on the label that is associated with
the container (262.208(d)(1)(i)); and are removed from the laboratory
within 10 calendar days of the date that 55 gallons was exceeded, or at
the next regularly scheduled removal, whichever comes first
(262.208(d)(1)(ii)).

	Section 262.208(d)(2) provides that, if a laboratory accumulates more
than 1 quart of reactive acutely hazardous unwanted material before the
regularly scheduled removal, then the eligible academic entity must
ensure that all containers of reactive acutely hazardous unwanted
material: must have the date that 1 quart is exceeded on the label that
is associated with the container (262.208(d)(2)(i)); and are removed
from the laboratory within 10 calendar days of the date that 1 quart was
exceeded, or at the next regularly scheduled removal, whichever comes
first (262.208(d)(2)(ii)).

(6)	Where and When to Make the Hazardous Waste Determination and Where
to Send Containers of Unwanted Material

40 CFR 262.209(a) establishes standards for when and where large
quantity generators and small quantity generators may make the hazardous
waste determination.  An eligible academic entity must ensure that a
trained professional makes a hazardous waste determination, pursuant to
section 262.11, for unwanted material in any of the following areas:

In the laboratory before the unwanted material is removed from the
laboratory, in accordance with section 262.210. 

Within 4 calendar days of arriving at an on-site central accumulation
area, in accordance with section 262.211. 

Within 4 calendar days of arriving at an on-site treatment, storage or
disposal facility, in accordance with section 262.212.

 

Section 262.209(b) establishes standards for when and where
conditionally exempt small quantity generators may make hazardous waste
determinations.  An eligible academic entity must ensure that a trained
professional makes a hazardous waste determination, pursuant to section
262.11, for unwanted material in the laboratory before the unwanted
material is removed from the laboratory, in accordance with 262.210. 

(7)	Making the Hazardous Waste Determination in the Laboratory

40 CFR 262.210 provides that, if an eligible academic entity makes the
hazardous waste determination, pursuant to section 262.11, for unwanted
material in the laboratory before the unwanted material is removed from
the laboratory, it must comply with the specified requirements. 

	Section 262.210(a) requires that a trained professional must make the
hazardous waste determination, pursuant to section 262.11, before the
unwanted material is removed from the laboratory.

	Section 262.210(b) provides that, if an unwanted material is a
hazardous waste, the eligible academic entity must write: the words
“hazardous waste” on the container label that is affixed or attached
to the container, before the hazardous waste may be removed from the
laboratory (262.210(b)(1)) and the appropriate hazardous waste codes(s)
on the label that is associated with the container (or on the label that
is affixed or attached to the container, if that is preferred) before
the hazardous waste may be transported off-site (262.210(b)(2)).  [Note:
 OMB guidance indicates that, if a person is requested or directed to
post a label disclosing information completely defined by a Federal
agency, the information collection is exempted from OMB review and
approval.  For this reason, in this ICR, the addition of the words
“hazardous waste” to the container label is not considered an
information collection and thus is not examined in the remainder of this
document.]  

(8)	Making the Hazardous Waste Determination in an On-site Central
Accumulation Area

	40 CFR 262.211 provides that, if an eligible academic entity makes the
hazardous waste determination, pursuant to section 262.11, for unwanted
material at an on-site central accumulation area, it must comply with
requirements in 262.211:

	Section 262.211(d) requires that a trained professional must determine,
pursuant to §262.11, if the unwanted material is a hazardous waste
within 4 calendar days of the unwanted materials’ arrival at the
on-site central accumulation area.

	Section 262.211(e) provides that, if the unwanted material is a
hazardous waste, the eligible academic entity must write the words
”hazardous waste” on the container label that is affixed or attached
to the container, within 4 calendar days of arriving at the on-site
central accumulation area and before the hazardous waste may be removed
from the on-site central accumulation area (262.211(e)(1)) and write the
appropriate hazardous waste code(s) on the container label that is
associated with the container (or on the label that is affixed or
attached to the container, if that is preferred) before the hazardous
waste may be treated or disposed on-site or transported off-site
(262.211(e)(2)).  [Note:  OMB guidance indicates that, if a person is
requested or directed to post a label disclosing information completely
defined by a Federal agency, the information collection is exempted from
OMB review and approval.  For this reason, in this ICR, the addition of
the words “hazardous waste” to the container label is not considered
an information collection and thus is not examined in the remainder of
this document.]  

(9)	Making the Hazardous Waste Determination at an On-site Interim
Status or Permitted Treatment, Storage, or Disposal Facility

40 CFR 262.212 provides that, if an eligible academic entity makes the
hazardous waste determination, pursuant to section 262.11, for unwanted
material at an on-site interim status or permitted treatment, storage or
disposal facility, it must comply with the requirements in section
262.212.

	Section 262.212(d) requires that a trained professional must determine,
pursuant to section 262.11, if the unwanted material is a hazardous
waste within 4 calendar days of the unwanted materials’ arrival at an
on-site interim status/permitted treatment, storage or disposal
facility.

	Section 262.212(e) provides that, if the unwanted material is a
hazardous waste, the eligible academic entity must write the words
”hazardous waste” on the container label that is affixed or attached
to the container within 4 calendar days of arriving at the on-site
interim status or permitted treatment, storage or disposal facility and
before the hazardous waste may be removed from the on-site interim
status or permitted treatment, storage or disposal facility
(262.212(e)(1)) and write the appropriate hazardous waste code(s) on the
container label that is associated with the container (or on the label
that is affixed or attached to the container, if that is preferred)
before the hazardous waste may be treated or disposed on-site or
transported off-site (262.212(e)(2)).  [Note:  OMB guidance indicates
that, if a person is requested or directed to post a label disclosing
information completely defined by a Federal agency, the information
collection is exempted from OMB review and approval.  For this reason,
in this ICR, the addition of the words “hazardous waste” to the
container label is not considered an information collection and thus is
not examined in the remainder of this document.]  

(10)	Laboratory Clean-outs

	40 CFR 262.213(a) provides that one time per 12 month period per
laboratory, an eligible academic entity may opt to conduct a laboratory
clean-out that is subject to all the applicable requirements of Subpart
K, except as specified otherwise in section 262.213(a). 

	Section 262.213(a)(4) requires that an eligible academic entity must
document the activities of the laboratory clean-out, as specified.  The
eligible academic entity must maintain the records for a period of three
years from the date the clean-out ends.

(11)	Laboratory Management Plan

	40 CFR 262.214 provides that an eligible academic entity must develop
and retain a written Laboratory Management Plan, or revise an existing
written plan.  The Laboratory Management Plan is a site-specific
document that describes how the eligible academic entity will manage
unwanted materials in compliance with this subpart.  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.  

	The Laboratory Management Plan must contain two parts with a total of
nine elements identified in paragraphs (a) and (b) of this section.  In
Part I of its Laboratory Management Plan, an eligible academic entity
must describe its procedures for each of the elements listed in
paragraph (a) of this section.  An eligible academic entity must
implement and comply with the specific provisions that it develops to
address the elements in Part I of the Laboratory Management Plan.

	In Part II of its Laboratory Management Plan, an eligible academic
entity must describe its best management practices for each of the
elements listed in paragraph (b) of this section.  The specific actions
taken by an eligible academic entity to implement each element in Part
II of its Laboratory Management Plan may vary from the procedures
described in the eligible academic entity’s Laboratory Management
Plan, without constituting a violation of this subpart.  An eligible
academic entity may include additional elements and best management
practices in Part II of its Laboratory Management Plan if it chooses.

	Section 262.214(c) provides that an eligible academic entity must make
its Laboratory Management Plan available to laboratory workers,
students, or any others at the eligible academic entity who request it.

	Section 262.214(d) requires that an eligible academic entity must
review and revise its Laboratory Management Plan, as needed.

2.	NEED FOR AND USE OF THE COLLECTION

2(a)	Need and Authority for the Collection

The final regulations are promulgated under the authority of Sections
2002, 3001, 3002, and 3004 of the Solid Waste Disposal Act (SWDA) of
1970, as amended by the Resource Conservation and Recovery Act (RCRA) of
1976, as amended by the Hazardous and Solid Waste Amendments of 1984
(HSWA).

EPA believes there is a clear need for the final rule.  The Agency has
identified four primary differences between laboratory operations at
colleges, universities, and other eligible academic entities and typical
industrial production facilities.  These differences provide the
rationale for the rule.  First, laboratories owned by colleges,
universities and, teaching hospitals and non-profit research institutes
that are either owned by or formally affiliated with a college or
university have a large number of points of generation (i.e., points
where waste is originally generated) such as multiple laboratory
benchtops within a single laboratory and laboratories located at several
areas on a single campus.  Second, these laboratories tend to generate
relatively small volumes of each hazardous waste at each of these points
of generation.  Third, the hazardous wastes generated in these
laboratories tend to vary over time, as areas of research change.  In
contrast, industrial generators tend to generate a relatively smaller
number of predictable wastestreams in large quantities at relatively few
generation points.  Fourth, and of particular note, is that most
individuals involved in hazardous waste generation activities at
eligible academic entity laboratories are students.  Students are
inherently transient, which makes it more difficult to train them.  This
fourth difference sets eligible academic entity laboratories apart not
only from typical production facilities, but also from non-academic,
commercial laboratories.  At industrial production facilities and
non-academic, commercial laboratories, employees who generate hazardous
waste are professionally trained in managing hazardous wastes and are
held accountable due to their employee status.

	

(1)	Notification of Intent to Comply with Subpart K and Recordkeeping of
Agreements

	Because the rule provides eligible academic entities the option to
manage their hazardous wastes from laboratories under the existing
hazardous waste generator regulations or their laboratories’ unwanted
materials under Subpart K, it is important that EPA, or the authorized
State, know which set of regulations apply to an eligible academic
entity’s laboratories.  Therefore, the rule requires that an eligible
academic entity choosing to manage its unwanted materials in compliance
with the alternative set of generator requirements of Subpart K to
submit a Site Identification Form on a one-time basis to the appropriate
EPA Regional Administrator or, when appropriate, State Director in
authorized States that have adopted the final rule.   Should an eligible
academic entity decide not to opt into Subpart K, it will continue to
operate under existing regulations and it does not need to notify.

	EPA believes the Site Identification Form will simplify this
notification process in comparison with other types of notification
methods.  Regulated entities and authorized States are already familiar
with the form because it must be submitted under other RCRA provisions
(e.g., RCRA 3010 Notifications, Hazardous Waste Report).  Further, some
eligible academic entities may have retained a copy that they had
completed and submitted under another provision.  A pre-populated form
will greatly ease the process of completing the form to opt into Subpart
K.

(2)	Notification of Withdrawal from Subpart K

	It is possible that after an eligible academic entity has chosen to
manage its unwanted materials under the Subpart K regulations and has
gained some experience with the program, it may decide that this
approach is not meeting its needs, and that it would prefer to return to
regulation under the standard 40 CFR Part 262 applicable generator
regulations.  Under the final rule, an eligible academic entity that
chooses to end its participation in the Subpart K program will be
required to submit another Site Identification Form to the EPA Regional
Administrator or State Director in authorized States checking the box
for withdrawing from 40 CFR Part 262, Subpart K.  Then, the eligible
academic entity’s laboratories will no longer be subject to Subpart K
and would be subject to the existing applicable generator regulations.

(3)	Labeling of Containers of Unwanted Material in the Laboratory

Eligible academic entities must label containers of unwanted materials
managed in a laboratory, as specified.  These labeling requirements are
necessary to demonstrate compliance with the rule and alert anyone
handling the containers of unwanted materials of what is enclosed in the
container so that proper handling may occur.  The labeling requirements
also would assist trained professionals in properly identifying whether
an unwanted material is a hazardous waste and to assign the appropriate
hazardous waste code(s).

(4)	Training

Eligible academic entities must train all individuals working in a
laboratory commensurate with their duties.  This training is necessary
to ensure that individuals perform their duties in a way that ensures
compliance with the Subpart K requirements.  It also will enable
individuals to manage unwanted materials safely and in an
environmentally sound manner, while in the laboratory.

	In addition, eligible academic entities that are large quantity
generators (LQGs) must maintain training records for laboratory workers.
 These records are necessary to ensure compliance with the Subpart K
training requirements.

 (5)	Removing Containers of Unwanted Material from the Laboratory

Eligible academic entities must label containers with the date the 55
gallons of unwanted material, or the 1 quart of acutely reactive
unwanted material, is exceeded.  This information is needed for
enforcement and monitoring purposes.

(6)	Where and When to Make the Hazardous Waste Determination and Where
to Send Containers of Unwanted Material

The rule specifies three on-site locations at which a hazardous waste
determination can be made: 

In the laboratory before the unwanted material is removed from the
laboratory, in accordance with section 262.210. 

Within 4 calendar days of arriving at an on-site central accumulation
area, in accordance with section 262.211. 

Within 4 calendar days of arriving at an on-site interim status or
permitted treatment, storage or disposal facility, in accordance with
section 262.212.

 	This provision is needed to clarify where and when the hazardous waste
determination must be made.  Without time limits, EPA would not be able
to ensure that eligible academic entities were making their
determinations in a timely manner and managing their hazardous waste in
accordance with the hazardous waste regulations. 

(7)	Making the Hazardous Waste Determination in the Laboratory

As provided at section 262.210, if an unwanted material meets the
definition of hazardous waste per 40 CFR 261.3, the appropriate
hazardous waste code(s) must be placed on the container label that is
associated with the container.  This information is needed to alert
anyone handling the container that hazardous waste is enclosed in the
container so that proper handling may occur.

(8)	Making the Hazardous Waste Determination in an On-site Central
Accumulation Area

As provided at section 262.211, if an unwanted material meets the
definition of hazardous waste per 40 CFR 261.3, the appropriate
hazardous waste code(s) must be placed on the container label that is
associated with the container.  This information is needed to alert
anyone handling the container that hazardous waste is enclosed in the
container so that proper handling may occur.

(9)	Making the Hazardous Waste Determination at an On-site Interim
Status or Permitted Treatment, Storage, or Disposal Facility

As provided at section 262.212, if an unwanted material meets the
definition of hazardous waste per 40 CFR 261.3, the appropriate
hazardous waste code(s) must be placed on the container label that is
associated with the container.  This information is needed to alert
anyone handling the container that hazardous waste is enclosed in the
container so that proper handling may occur.

(10)	Laboratory Clean-outs

Eligible academic entities must develop and maintain documentation on
laboratory clean-outs.  This information is needed to ensure compliance
with the laboratory clean-out requirements.  For example, the
documentation must show the dates when the clean-out began and ended. 
This information will hold the eligible academic entity accountable for
adhering to the 30-day clean-out time limit, as well as other
stipulations in the final rule.

(11)	Laboratory Management Plan

Performance-based standards set the framework for managing unwanted
materials generated in laboratories owned by eligible academic entities.
 The Laboratory Management Plan required under 40 CFR 262.214 is the
mechanism for implementing the alternative program.  This plan is needed
to ensure that eligible academic entities seeking flexibility in
managing the unwanted materials from their laboratories will do so in a
thoughtful manner by documenting their practices.

2(b)	Practical Utility and Users of the Data

(1)	Notification of Intent to Comply with Subpart K and Recordkeeping of
Agreements

	Because the rule establishes an alternative set of generator
requirements that is self-implementing, EPA has determined that it is
necessary to require eligible academic entities to submit a one-time
notification to the appropriate EPA Regional Administrator or State
Director indicating that they are electing to be subject to the Subpart
K requirements as specified.  EPA and States will use this information
to identify the entities and sites subject to the Subpart K requirements
and ensure that all of these sites are managing their unwanted materials
in a manner that is protective of human health and the environment.

(2)	Notification of Withdrawal from Subpart K

	Eligible academic entities that elected to comply with the Subpart K
requirements may elect, at any time, to withdraw from the Subpart K
program.  Because a site’s withdrawal would be self-implementing
(i.e., done at its own discretion), EPA has determined that it is
necessary to require entities to submit a one-time withdrawal
notification to the appropriate EPA Regional Administrator indicating
that they will again begin to manage their hazardous waste pursuant to
section 262.34(c) (or section 261.5 for conditionally exempt small
quantity generators).  EPA and States will use this information to
identify the sites subject to the Subpart K requirements and ensure that
all of these sites are managing their unwanted materials in a manner
that is protective of human health and the environment.

(3)	Labeling of Containers of Unwanted Material in the Laboratory

The labeling requirements are necessary to alert anyone handling the
containers of unwanted materials of what is enclosed in the containers
so that proper handling or inspection may occur.  The labeling
requirements also assist trained professionals in properly identifying
whether an unwanted material is a hazardous waste and to assign the
appropriate hazardous waste code(s).

(4)	Training

	Eligible academic entities must train all individuals working in a
laboratory commensurate with their duties.  This training will enable
individuals to manage unwanted materials safely and in an
environmentally sound manner, while in the laboratory.

	In addition, LQGs must maintain training records for laboratory
workers.  Entities will use this information to demonstrate compliance
with the Subpart K requirements.  EPA will use the information during
inspections and for enforcement purposes.

 (5)	Removing Containers of Unwanted Material from the Laboratory

	Eligible academic entities will use the information on the date the 55
gallons of unwanted material, or the 1 quart of acutely reactive
unwanted material, was exceeded to maintain compliance with Subpart K. 
EPA will use the information during inspections and for enforcement
purposes.

(6)	Where and When to Make the Hazardous Waste Determination and Where
to Send Containers of Unwanted Material

	The rule clarifies where the hazardous waste determinations can be
made, as well as the timing of them.  Eligible academic entities will
follow these procedures to ensure that they are making their
determinations in a timely manner and managing their hazardous wastes in
accordance with the hazardous waste regulations.  

(7)	Making the Hazardous Waste Determination in the Laboratory

Eligible academic entities will use the hazardous waste code information
to ensure that the hazardous waste is managed in a manner that is
protective of human health and the environment.

(8)	Making the Hazardous Waste Determination in an On-site Central
Accumulation Area

Eligible academic entities will use the hazardous waste code information
to ensure that the hazardous waste is managed in a manner that is
protective of human health and the environment.

(9)	Making the Hazardous Waste Determination at an On-site Interim
Status or Permitted Treatment, Storage, or Disposal Facility

Eligible academic entities will use the hazardous waste code information
to ensure that the hazardous waste is managed in a manner that is
protective of human health and the environment.

(10)	Laboratory Clean-outs

Eligible academic entities must develop and maintain documentation on
laboratory clean-outs.  They will use this information to demonstrate
compliance with the Subpart K requirements.  EPA will use the
information during inspections and for enforcement purposes.

(11)	Laboratory Management Plan

	Eligible academic entities must develop and retain a written Laboratory
Management Plan.  They will use the Laboratory Management Plan to
document their practices for complying with the performance-based
requirements of Subpart K.

3.	NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA	

3(a)	Nonduplication

None of the information required by the final rule is duplicative with
any information required by the existing Federal regulations.

3(b)	Public Notice

On May 23, 2006, EPA proposed alternative generator requirements
applicable to college and university laboratories (71 FR 29712).  To
assist the public in commenting on the proposal, EPA raised a number of
issues in the preamble to the proposed rule and asked for the public to
comment on them.  EPA received 111 comments in response to the proposal.
  At the end of the comment period, EPA reviewed the public comments
received and addressed the comments in finalizing the rule and
supporting documents, as appropriate.  

3(c)	Consultations

	EPA has worked with colleges, universities and affiliated entities
since the early 1980s to more fully understand the difficulties they
face in complying with the existing RCRA hazardous waste regulations. 
Projects such as the Howard Hughes Medical Institute pilot program and
the 1999 XL pilot project, which provide flexibility to colleges and
universities, have focused on how hazardous wastes are generated and
accumulated in laboratories.  EPA has met with stakeholders, held public
meetings, and attended meetings and conferences with associations
representing various colleges, universities and affiliated entities. 
Through these various activities EPA has developed a good understanding
of their operational practices in laboratories and the challenges they
face in complying with the RCRA hazardous waste requirements.  In the
following paragraphs, EPA discusses some of its most recent
outreach/consultation efforts. 

	In 2002, EPA conducted a series of outreach activities to generators of
hazardous waste with laboratories to obtain information regarding the
differences between how hazardous waste is generated and managed at
academic laboratory operations as compared with production operations of
industrial generators and other non-college/university laboratory
generators.  The information collected by the Agency indicates that
differences exist between academic laboratory operations and those of
both industrial laboratories and industrial production facilities that
generate hazardous waste, warranting development of an alternative set
of regulations for laboratories of colleges, universities and affiliated
entities.  These differences include the number of points of generation,
the relative small volume of hazardous waste generated at each point of
generation, and the fact that many of the persons involved in hazardous
waste generation activities are students, rather than paid employees.  

	In June 2003, EPA held a public meeting in order to solicit input from
stakeholders on approaches to addressing issues concerning hazardous
waste management in academic laboratories.  Topics discussed at the
meetings included:  where and when to make the hazardous waste
determination; waste labeling requirements; personnel training
requirements; satellite area accumulation; and types of treatment
performed in laboratories.	

	As a parallel effort, in 2003, colleges and universities were selected
to become a new partner in EPA’s Sector Strategies Program.  The
Sector Strategies Program seeks industry-wide environmental gains
through innovative actions taken with a number of manufacturing and
service sectors.  EPA has worked with six College and University Sector
Program Partners to develop sector-specific approaches to assist
colleges and universities advance the use of environmental management
systems, reduce regulatory performance barriers, and measure
environmental progress.

	In May, June, and August 2004, the Colleges and Universities Sector
Program Partners shared their thoughts in a series of proposals
suggesting alternative approaches for developing a RCRA program that
addresses the unique problems faced by college and university
laboratories.  Their suggested changes to existing requirements focused
on tailoring new regulations for college and university laboratories
that are different from the standards required of other generators and
operators of treatment, storage, and disposal facilities (TSDFs),
similar to the current “satellite accumulation area” regulations. 
They suggested changes for providing flexibility for the point at which
the hazardous waste identification is made, training of laboratory
workers, labeling, container management standards, and provisions for
bench scale treatment of waste in the laboratory.

	Since then, EPA has continued to research the laboratory operations and
needs of colleges, universities and other entities.  

	Through the above efforts, EPA has gained a good understanding of the
operations and compliance activities of laboratories at colleges,
universities, and other entities.  EPA used this knowledge in developing
this ICR. 

3(d)	Effects of Less Frequent Collection

EPA has carefully considered the information collection burden imposed
by the final rule.  EPA is confident that those activities required of
respondents are necessary, and to the extent possible, the Agency has
attempted to minimize the burden imposed.  A number of the required
activities, for example, will be performed once (e.g., one-time
notifications).  EPA believes strongly that, if the minimum information
collection requirements of the rule are not met, EPA will not be able to
ensure that the unwanted material generated in laboratories is being
properly managed and do not pose a threat to human health and the
environment.

3(e)	General Guidelines

This ICR adheres to the guidelines stated in the Paperwork Reduction Act
of 1995, OMB’s implementing regulations, EPA’s ICR Handbook, and
other applicable OMB guidance.

3(f)	Confidentiality

EPA does not expect to deem any information collected under the rule to
be CBI (Confidential Business Information).  If such a claim were
asserted, EPA must and will treat the information in accordance with the
applicable regulations (e.g., 40 CFR Part 2, Subpart B).  EPA also will
assure that this information collection complies with the Privacy Act of
1974 and OMB Circular 108.

3(g)	Sensitive Questions

No questions of a sensitive nature are included in the information
collection requirements associated with the rule.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a)	Respondents and NAICS Codes

The following is a list of North American Industry Classification System
(NAICS) codes associated with industries most likely affected by the
information collection requirements covered in this ICR.

NAICS Codes of Entities Potentially Affected by this Final Rule

Description of NAICS Code	NAICS Codes

Colleges and Universities

Junior Colleges	6112, 61121, 611210

Colleges, Universities, and Professional Schools 	6113, 61131, 611310

Technical and Trade Schools 	6115, 61151

Other Technical and Trade Schools 	611519

Fine Arts Schools	61161, 611610

Teaching Hospitals

Veterinary Services (Animal Hospitals)	54194, 541940

Hospitals	622

General Medical and Surgical Hospitals	6221, 62211, 622110

Psychiatric and Substance Abuse Hospitals	6222, 62221, 622210

Specialty (except Psychiatric and Substance Abuse) Hospitals	6223,
62231, 622310

Non-Profit Research Institutes

Research and Development in the Physical, Engineering, and Life Sciences
5417, 54171, 541710

Research and Development in the Social Sciences and Humanities	54172,
541720

4(b)	Information Requested

(1)	Notification of Intent to Comply with Subpart K and Recordkeeping of
Agreements

	40 CFR 262.203(a) provides that an eligible academic entity must notify
the appropriate EPA Regional Administrator in writing, using the RCRA
Subtitle C Site Identification Form (EPA Form 8700-12), that it is
electing to be subject to the requirements of Subpart K for all the
laboratories owned by the eligible academic entity under the same EPA
Identification Number.  An eligible academic entity that is a
conditionally exempt small quantity generator and does not have an EPA
Identification Number must notify that it is electing to be subject to
the requirements of Subpart K for all the laboratories owned by the
eligible academic entity that are on-site.  An eligible academic entity
must submit a separate notification (Site Identification Form) for each
EPA Identification Number (or site, for conditionally exempt small
quantity generators) that is electing to be subject to the requirements
of Subpart K.

When submitting the Site Identification Form, the eligible academic
entity must, at a minimum, fill out the fields on the form that are
specified at section 262.203(b)(1)-(11).

Section 262.203(c) provides that an eligible academic entity must keep a
copy of the notification on file at the eligible academic entity while
its laboratories are subject to Subpart K.

Section 262.203(d) provides that a teaching hospital that is not owned
by a college or university must keep a copy of its formal written
affiliation agreement with a college or university on file at the
teaching hospital while its laboratories are subject to Subpart K.

	Section 262.203(e) provides that a non-profit research institute that
is not owned by a college or university must keep a copy of its formal
written affiliation agreement with a college or university on file at
the non-profit research institute while its laboratories are subject to
Subpart K.

	(i)	Data Items:

A Site Identification Form with the following fields filled out, at a
minimum:

--	Reason for Submittal;

--	Site EPA Identification Number (except for conditionally exempt small
quantity generators);

--	Site Name;

--	Site Location Information;

--	Site Land Type;

--	North American Industry Classification System (NAICS) Code(s) for the
Site;

--	Site Mailing Address;

--	Site Contact Person;

--	Operator and Legal Owner of the Site;

--	Type of Regulated Waste Activity; and

--	Certification.

A copy of the formal written affiliation agreement with a college or
university , as specified under section 262.203(d). 

A copy of the formal written affiliation agreement with a college or
university, as specified under section 262.203(e). 

	(ii)	Respondent Activities:

Eligible academic entities electing to be subject to the requirements of
Subpart K must perform the following:

--	Prepare and submit Site Identification Form; and

--	Keep a copy of the notification on file.

Teaching hospitals that are not owned by a college or university must
keep a copy of their formal written affiliation agreement with college
or university on file while its laboratories are subject to Subpart K. 

Non-profit research institutes that are not owned by a college or
university must keep a copy of the formal written affiliation agreement
with a college or university on file at the non-profit research
institute while its laboratories are subject to Subpart K.

(2)	Notification of Withdrawal from Subpart K

	40 CFR 262.204(a) provides that an eligible academic entity must notify
the appropriate EPA Regional Administrator in writing, using the RCRA
Subtitle C Site Identification Form (EPA Form 8700-12), that it is
electing to no longer be subject to the requirements of Subpart K for
all the laboratories owned by the eligible academic entity under the
same EPA Identification Number.  An eligible academic entity that is a
conditionally exempt small quantity generator and does not have an EPA
Identification Number must notify that it is withdrawing from the
requirements of Subpart K for all the laboratories owned by the eligible
academic entity that are on-site.  An eligible academic entity must
submit a separate notification (Site Identification Form) for each EPA
Identification Number (or site, for conditionally exempt small quantity
generators) that is withdrawing from the requirements of Subpart K.

When submitting the Site Identification Form, the eligible academic
entity must, at a minimum, fill out the fields on the form that are
specified at section 262.204(b)(1)-(11).

	Section 262.204(c) provides that an eligible academic entity must keep
a copy of the withdrawal notice on file at the eligible academic entity
for three years from the date of the notification.

	(i)	Data Items:

A Site Identification Form with the following fields filled out, at a
minimum:

--	Reason for Submittal;

--	Site EPA Identification Number (except for conditionally exempt small
quantity generators);

--	Site Name;

--	Site Location Information;

--	Site Land Type;

--	North American Industry Classification System (NAICS) Code(s) for the
Site;

--	Site Mailing Address;

--	Site Contact Person;

--	Operator and Legal Owner of the Site;

--	Type of Regulated Waste Activity; and

--	Certification.

(ii)	Respondent Activities:

Prepare and submit Site Identification Form; and

Keep a copy of the withdrawal notice on file.

(3)	Labeling of Containers of Unwanted Material in the Laboratory

40 CFR 262.206 provides that an eligible academic entity must label and
manage containers of unwanted material while in the laboratory in
accordance with the requirements in section 262.206.  

Section 262.206(a)(1) requires that the following information must be
affixed or attached to the container: the words ”unwanted material”
or another equally effective term that is to be used consistently by the
eligible academic entity and that is identified in Part I of the
Laboratory Management Plan (262.206(a)(1)(i)), and sufficient
information to alert emergency responders to the contents of the
container (262.206(a)(1)(ii)).

Section 262.206(a)(2) provides that the following information may be
affixed or attached to the container, but must at least be associated
with the container: the date that the unwanted material first began
accumulating in the container (262.206(a)(2)(i)) and information
sufficient to allow a trained professional to properly identify whether
an unwanted material is a solid and hazardous waste and to assign the
proper hazardous waste code(s), pursuant to section 262.11
(262.206(a)(2)(ii)). 

	(i)	Data Items:

Information that is affixed or attached to the container, including: 

--  	Words ”unwanted material” or another equally effective term
that is to be used consistently by the eligible academic entity and that
is identified in Part I of the Laboratory Management Plan; and 

-- 	Sufficient information to alert emergency responders to the contents
of the container.  Examples of information that would be sufficient to
alert emergency responders to the contents of the container include, but
are not limited to, the following:

-	Name of the chemical(s).

-	Type or class of chemical, such as organic solvents or halogenated
organic solvents.

Information that may be affixed or attached to the container, but that
must at least be associated with the container, including: 

--	Date that the unwanted material first began accumulating in the
container; and

--	Information sufficient to allow a trained professional to properly
identify whether an unwanted material is a solid and hazardous waste and
to assign the proper hazardous waste code(s), pursuant to section
262.11.  For example, the following information may be associated with
the container:

-	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;

- 	A description of the manner in which the chemical was processed, if
applicable.

(ii)	Respondent Activities:

Label the containers as specified.

(4)	Training

40 CFR 262.207 provides that an eligible academic entity must provide
training to all individuals working in a laboratory at that eligible
academic entity, as specified.  

Section 262.207(a) requires that training for laboratory workers and
students must be commensurate with their duties so they understand the
requirements in Subpart K and can implement them.  

Section 262.207(b) provides that an eligible academic entity can provide
training for laboratory workers and students in a variety of ways (e.g.,
instruction by the professor or laboratory manager before or during an
experiment, formal classroom training, electronic/written training).

Section 262.207(c) provides that an eligible academic entity that is a
large quantity generator must maintain documentation demonstrating
training for all laboratory workers.  Section 262.207(c) also requires
that the information must be sufficient to determine whether laboratory
workers have been trained and for the durations specified in section
265.16(e).  Sections 262.207(c)(1)-(4) provide examples of documentation
demonstrating training. 

(i)	Data Items:

Documentation demonstrating training for all laboratory workers. 
Examples of documentation demonstrating training can include, but are
not limited to, the following:

--	Sign-in/attendance sheet(s) for training session(s); or

--	Syllabus for training session; or

--	Certificate of training completion; or

--	Test results.

(ii)	Respondent Activities:

Provide training to all individuals working in a laboratory.

Maintain documentation demonstrating training for all laboratory workers
(LQGs only).

(5)	Removing Containers of Unwanted Material from the Laboratory

40 CFR 262.208(a) establishes standards for removing containers of
unwanted material on a regular schedule.  An eligible academic entity
must either:  remove all containers of unwanted material from each
laboratory on a regular interval, not to exceed 6 months
(262.208(a)(1)); or remove containers of unwanted material from each
laboratory within 6 months of each container’s accumulation start date
(262.208(a)(2)). 

	Section 262.208(b) requires that the eligible academic entity must
specify in Part I of its Laboratory Management Plan whether it will
comply with section 262.208(a)(1) or (a)(2) for the regular removal of
unwanted material from its laboratories.  Section 262.208(c) requires
that the eligible academic entity must specify in Part II of its
Laboratory Management Plan how it will comply with section 262.208(a)(1)
or (a)(2) and develop a schedule for regular removals of unwanted
material from its laboratories.  [Note:  The data items and respondent
activities associated with these requirements are presented under
“Laboratory Management Plan.”]

	Section 262.208(d) establishes standards for removing containers of
unwanted material when maximum volumes are exceeded.  Section
262.208(d)(1) provides that, if a laboratory accumulates more than 55
gallons of unwanted material before the regularly-scheduled removal, the
eligible academic entity must ensure that all containers of unwanted
material (including reactive acutely hazardous unwanted material): must
have the date that 55 gallons is exceeded on the label that is
associated with the container (262.208(d)(1)(i)); and are removed from
the laboratory within 10 calendar days of the date that 55 gallons was
exceeded, or at the next regularly scheduled removal, whichever comes
first (262.208(d)(1)(ii)).

	Section 262.208(d)(2) provides that, if a laboratory accumulates more
than 1 quart of reactive acutely hazardous unwanted material before the
regularly scheduled removal, then the eligible academic entity must
ensure that all containers of reactive acutely hazardous unwanted
material: must have the date that 1 quart is exceeded on the label that
is associated with the container (262.208(d)(2)(i)); and are removed
from the laboratory within 10 calendar days of the date that 1 quart was
exceeded, or at the next regularly scheduled removal, whichever comes
first (262.208(d)(2)(ii)).

(i)	Data Items:

Date that the laboratory accumulated more than 55 gallons of unwanted
material.

Date that the laboratory accumulated more than 1 quart of reactive
acutely hazardous unwanted material.

(ii)	Respondent Activities:

Ensure that containers of unwanted material that exceed volume limits
have the date of the exceedence on the label.

(6)	Where and When to Make the Hazardous Waste Determination and Where
to Send Containers of Unwanted Material

40 CFR 262.209(a) establishes standards for where and when large
quantity generators and small quantity generators may make hazardous
waste determinations.  An eligible academic entity must ensure that a
trained professional makes a hazardous waste determination, pursuant to
section 262.11, for unwanted material in any of the following areas:

In the laboratory before the unwanted material is removed from the
laboratory, in accordance with section 262.210.  [Note:  The data items
and respondent activities associated with this requirement are presented
in “Making the Hazardous Waste Determination in the Laboratory.”]

Within 4 calendar days of arriving at an on-site central accumulation
area, in accordance with section 262.211.  [Note:  The data items and
respondent activities associated with this requirement are presented in
“Making the Hazardous Waste Determination in an On-site Central
Accumulation Area.”]

Within 4 calendar days of arriving at an on-site treatment, storage or
disposal facility, in accordance with section 262.212.  [Note:  The data
items and respondent activities associated with this requirement are
presented in “Making the Hazardous Waste Determination at an On-site
Interim Status or Permitted Treatment, Storage, or Disposal
Facility.”]

Section 262.209(b) establishes standards for where and when
conditionally exempt small quantity generators may make hazardous waste
determinations.  An eligible academic entity must ensure that a trained
professional makes a hazardous waste determination, pursuant to section
262.11, for unwanted material in the laboratory before the unwanted
material is removed from the laboratory, in accordance with 262.210. 
[Note:  The data items and respondent activities associated with this
requirement are presented in “Making the Hazardous Waste Determination
in the Laboratory.”]

(7)	Making the Hazardous Waste Determination in the Laboratory

40 CFR 262.210 provides that, if an eligible academic entity makes the
hazardous waste determination, pursuant to section 262.11, for unwanted
material in the laboratory before the unwanted material is removed from
the laboratory, it must comply with the requirements in section 262.210.


	Section 262.210(a) requires that a trained professional must make the
hazardous waste determination, pursuant to section 262.11, before the
unwanted material is removed from the laboratory.

	Section 262.210(b)(2) provides that, if an unwanted material is a
hazardous waste, the eligible academic entity must write the appropriate
hazardous waste codes(s) on the label that is associated with the
container before the hazardous waste may be transported off-site.  

(i)	Data Items:

Hazardous waste determination.

EPA Hazardous waste codes on the label.

(ii)	Respondent Activities:

Make the hazardous waste determination; and

Write hazardous waste codes on the container label.

(8)	Making the Hazardous Waste Determination in an On-site Central
Accumulation Area

	40 CFR 262.211 provides that, if an eligible academic entity makes the
hazardous waste determination, pursuant to section 262.11, for unwanted
material at an on-site central accumulation area, it must comply with
requirements in 262.211.

	Section 262.211(d) requires that a trained professional must determine,
pursuant to section 262.11, if the unwanted material is a hazardous
waste within 4 calendar days of the unwanted materials’ arrival at the
on-site central accumulation area.

	Section 262.211(e)(2) provides that, if the unwanted material is a
hazardous waste, the eligible academic entity must write the appropriate
hazardous waste code(s) on the container label that is associated with
the container before the hazardous waste may be treated or disposed
on-site or transported off-site.

(i)	Data Items:

Hazardous waste determination.

EPA Hazardous waste codes on the label.

(ii)	Respondent Activities:

Make the hazardous waste determination; and

Write hazardous waste codes on the container label.

(9)	Making the Hazardous Waste Determination at an On-site Interim
Status or Permitted Treatment, Storage, or Disposal Facility

40 CFR 262.212 provides that, if an eligible academic entity makes the
hazardous waste determination, pursuant to section 262.11, for unwanted
material at an on-site interim status or permitted treatment, storage or
disposal facility, it must comply with the requirements in section
262.212.

	Section 262.212(d) requires that a trained professional must determine,
pursuant to section 262.11, if the unwanted material is a hazardous
waste within 4 calendar days of the unwanted materials’ arrival at an
on-site interim status or permitted treatment, storage or disposal
facility.

	Section 262.212(e)(2) provides that, if the unwanted material is a
hazardous waste, the eligible academic entity must write the appropriate
hazardous waste code(s) on the container label that is associated with
the container before the hazardous waste may be treated or disposed
on-site or transported off-site.

(i)	Data Items:

Hazardous waste determination.

EPA Hazardous waste codes on the label.

(ii)	Respondent Activities:

Make the hazardous waste determination; and

Write hazardous waste codes on the container label.

(10)	Laboratory Clean-outs

	40 CFR 262.213(a) provides that one time per 12 month period per
laboratory, an eligible academic entity may opt to conduct a laboratory
clean-out that is subject to all the applicable requirements of Subpart
K, except as specified otherwise in section 262.213(a). 

	Section 262.213(a)(4) requires that an eligible academic entity must
document the activities of the laboratory clean-out, as specified.  The
eligible academic entity must maintain the records for a period of three
years from the date the clean-out ends.

(i)	Data Items:

Documentation that, at a minimum, identifies the laboratory being
cleaned out, the date the laboratory clean-out begins and ends, and the
volume of hazardous waste generated during the laboratory clean-out. 

(ii)	Respondent Activities:

Document the activities of the laboratory clean-out; and

Maintain records of the clean-out.

(11)	Laboratory Management Plan

	40 CFR 262.214 provides that an eligible academic entity must develop
and retain a written Laboratory Management Plan, or revise an existing
written plan.  The Laboratory Management Plan is a site-specific
document that describes how the eligible academic entity will manage
unwanted materials in compliance with this subpart.  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.  

The Laboratory Management Plan must contain two parts with a total of
nine elements identified in paragraphs (a) and (b) of this section.  In
Part I of its Laboratory Management Plan, an eligible academic entity
must describe its procedures for each of the elements listed in
paragraph (a) of this section.  An eligible academic entity must
implement and comply with the specific provisions that it develops to
address the elements in Part I of the Laboratory Management Plan.

In Part II of its Laboratory Management Plan, an eligible academic
entity must describe its best management practices for each of the
elements listed in paragraph (b) of this section.  The specific actions
taken by an eligible academic entity to implement each element in Part
II of its Laboratory Management Plan may vary from the procedures
described in the eligible academic entity’s Laboratory Management
Plan, without constituting a violation of this subpart.  An eligible
academic entity may include additional elements and best management
practices in Part II of its Laboratory Management Plan if it chooses.

	Section 262.214(c) provides that an eligible academic entity must make
its Laboratory Management Plan available to laboratory workers,
students, or any others at the eligible academic entity who request it.

	Section 262.214(d) requires that an eligible academic entity must
review and revise its Laboratory Management Plan, as needed.

(i)	Data Items:

A Laboratory Management Plan that includes Part I and II.  The eligible
academic entity must implement and comply with the specific provisions
of Part I of its Laboratory Management Plan.  In Part I of its
Laboratory Management Plan, an eligible academic entity must:

--	Describe procedures for container labeling in accordance with section
262.206(a), including:

-	Identifying whether the eligible academic entity will use the term
“unwanted material” on the containers in the laboratory.  If not,
identify the equally effective term that will be used in lieu of
“unwanted material” and consistently by the eligible academic
entity.  The equally effective term, if used, has the same meaning and
is subject to the same requirements as “unwanted material.”

-	Identifying the manner in which information that is “associated with
the container” will be imparted.

--	Identify whether the eligible academic entity will comply with
section 262.208(a)(1) or section 262.208(a)(2) for regularly scheduled
removals of unwanted material from the laboratory.

In Part II of the Laboratory Management Plan, an eligible academic
entity must:

--	Describe its intended best practices for container labeling and
management, including how the eligible academic entity will manage
containers used for in-line collection of unwanted materials, such as
with high performance liquid chromatograph and other laboratory
equipment.

--	Describe its intended best practices for providing training for
laboratory workers and students commensurate with their duties.

-- 	Describe its intended best practices for providing training to
ensure safe on-site transfers of unwanted material and hazardous waste
by trained professionals.

--	Describe its intended best practices for removing unwanted material
from the laboratory, including:

-	For regularly scheduled removals - Develop a regular schedule for
identifying and removing unwanted materials from its laboratories.

-	For removals when maximum volumes are exceeded:

-	Describe its intended best practices for removing unwanted materials
from the laboratory within 10 calendar days when unwanted materials have
exceeded their maximum volumes.

-	Describe its intended best practices for communicating that unwanted
materials have exceeded their maximum volumes.

--	Describe its intended best practices for making hazardous waste
determinations, including specifying the duties of the individuals
involved in the process.

-- 	Describe its intended best practices for laboratory clean-outs, if
the eligible academic entity plans to use the incentives for laboratory
clean-outs provided in § 262.213, including:

-	Procedures for conducting laboratory clean-outs; and

-	Procedures for documenting laboratory clean-outs

--	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.

(ii)	Respondent Activities:

Develop a Laboratory Management Plan or revise an existing written plan;

Retain, review and revise the Laboratory Management Plan; and

Make Laboratory Management Plan available to laboratory workers,
students, or any others at the eligible academic entity who request it.

5.	THE INFORMATION COLLECTED:  AGENCY ACTIVITIES, COLLECTION
METHODOLOGY, AND INFORMATION MANAGEMENT

5(a)	Agency Activities

(1)	Notification of Intent to Comply with Subpart K and Recordkeeping of
Agreements

Under 40 CFR 262.203(a), the Agency will conduct the following
activities:

Review and process Site Identification Forms.

(2)	Notification of Withdrawal from Subpart K

	Under 40 CFR 262.204(a), the Agency will conduct the following
activities: 

Review and process Site Identification Forms.

(3)	Labeling of Containers of Unwanted Material in the Laboratory

There is no Agency activity under 40 CFR 262.206.

(4)	Training

There is no Agency activity under 40 CFR 262.207.

(5)	Removing Containers of Unwanted Material from the Laboratory

There is no Agency activity under 40 CFR 262.208.

(6)	Where and When to Make the Hazardous Waste Determination and Where
to Send Containers of Unwanted Material

There is no Agency activity under 40 CFR 262.209.

(7)	Making the Hazardous Waste Determination in the Laboratory

There is no Agency activity under 40 CFR 262.210.

(8)	Making the Hazardous Waste Determination in an On-site Central
Accumulation Area

There is no Agency activity under 40 CFR 262.211.

(9)	Making the Hazardous Waste Determination at an On-site Interim
Status or Permitted Treatment, Storage, or Disposal Facility

There is no Agency activity under 40 CFR 262.212.

(10)	Laboratory Clean-outs

There is no Agency activity under 40 CFR 262.213.

(11)	Laboratory Management Plan

There is no Agency activity under 40 CFR 262.214.

5(b)	Collection Methodology and Management

In collecting and analyzing the information associated with this ICR,
EPA and authorized States may use a telephone system, personal
computers, and applicable database software.  They will ensure the
accuracy and completeness of collected information by reviewing the
submittals.  They will keep records of this information in file cabinets
and/or computer systems.

5(c)	Small Entity Flexibility

The final rule allows eligible academic entities the flexibility to
tailor their laboratory operations to meet their individual
circumstances, and remain protective of human health and the
environment.  Performance-based standards for management of hazardous
wastes generated in laboratories provide a better opportunity for them
to evaluate their overall hazardous waste management program, and tailor
it in such a way that facilitates the efficient and safe management of
hazardous waste and minimizes burden, while at the same time maintaining
a high standard of protection of human health and the environment.  The
alternative approach will help each eligible academic entity centralize
and coordinate its chemical management practices and achieve sound
environmental performance. 

	In addition, eligible academic entities have the choice to manage their
hazardous waste in accordance with the alternative set of regulations or
remain subject to the existing generator regulations in 40 CFR 262.34(c)
(or section 261.5 for conditionally exempt small quantity generators). 
Thus, they have the option to comply with the set of regulations that
best suits their circumstances.

	5(d)	Collection Schedule

(1)	Notification of Intent to Comply with Subpart K and Recordkeeping of
Agreements

Under 40 CFR 262.203(a), an eligible academic entity must notify the
appropriate EPA Regional Administrator in writing, using the RCRA
Subtitle C Site Identification Form (EPA Form 8700-12), that it is
electing to be subject to the requirements of Subpart K for all the
laboratories owned by the eligible academic entity under the same EPA
Identification Number.  An eligible academic entity that is a
conditionally exempt small quantity generator and does not have an EPA
Identification Number must notify for all the laboratories owned by the
eligible academic entity that are on-site.  An eligible academic entity
must submit a separate notification (Site Identification Form) for each
EPA Identification Number (or site, for conditionally exempt small
quantity generators) that is electing to be subject to the requirements
of Subpart K.  This is a one-time notification.

Section 262.203(c) provides that an eligible academic entity must keep a
copy of the notification on file at the eligible academic entity while
its laboratories are subject to Subpart K.  

Section 262.203(d) provides that a teaching hospital that is not owned
by a college or university must keep a copy of its formal written
affiliation agreement with a college or university on file at the
teaching hospital while its laboratories are subject to Subpart K.  

	Section 262.203(e) provides that a non-profit research institute that
is not owned by a college or university must keep a copy of the formal
written affiliation agreement with a college or university on file at
the non-profit research institute while its laboratories are subject to
Subpart K.

(2)	Notification of Withdrawal from Subpart K

Under 40 CFR 262.204(a), an eligible academic entity must notify the
appropriate EPA Regional Administrator in writing, using the RCRA
Subtitle C Site Identification Form (EPA Form 8700-12), that it is
electing to no longer be subject to the requirements of Subpart K for
all the laboratories owned by the eligible academic entity under the
same EPA Identification Number.  An eligible academic entity that is a
conditionally exempt small quantity generator and does not have an EPA
Identification Number must notify for all the laboratories owned by the
eligible academic entity that are on-site.  An eligible academic entity
must submit a separate notification (Site Identification Form) for each
EPA Identification Number (or site, for conditionally exempt small
quantity generators) that is withdrawing from the requirements of
Subpart K.  This is a one-time notification.

	Section 262.204(c) provides that an eligible academic entity must keep
a copy of the withdrawal notice on file at the eligible academic entity
for three years from the date of the notification.

(3)	Labeling of Containers of Unwanted Material in the Laboratory

40 CFR 262.206(a) requires that specified information must be affixed or
attached to, or otherwise associated with, the container while in the
laboratory.

(4)	Training

40 CFR 262.207 provides that an eligible academic entity must provide
training to all individuals working in a laboratory at that eligible
academic entity, as specified.  

Section 262.207(c) provides that an eligible academic entity that is a
large quantity generator must maintain documentation demonstrating
training for all laboratory workers.  The information must be retained
for the durations specified in section 265.16(e).  [Note: Existing 40
CFR 265.16(e) requires that training records on current personnel must
be kept until closure of the facility.  Training records on former
employees must be kept for at least three years from the date the
employee last worked at the facility.  Personnel training records may
accompany personnel transferred within the same company.]

(5)	Removing Containers of Unwanted Material from the Laboratory

40 CFR 262.208(d)(1)(i) provides that, if a laboratory accumulates more
than 55 gallons of unwanted material before the regularly scheduled
removal, the eligible academic entity must ensure that all containers of
unwanted material (including reactive acutely hazardous unwanted
material) have the date that 55 gallons is exceeded on the label that is
associated with the container.

	Section 262.208(d)(2)(i) provides that, if a laboratory accumulates
more than 1 quart of reactive acutely hazardous unwanted material before
the regularly scheduled removal, then the eligible academic entity must
ensure that all containers of reactive acutely hazardous unwanted
material have the date that 1 quart is exceeded on the label that is
associated with the container.

(6)	Where and When to Make the Hazardous Waste Determination and Where
to Send Containers of Unwanted Material

40 CFR 262.209(a) establishes standards for where and when large
quantity generators and small quantity generators may make hazardous
waste determinations.  An eligible academic entity must ensure that a
trained professional makes a hazardous waste determination, pursuant to
section 262.11, for unwanted material in any of the following areas:

In the laboratory before the unwanted material is removed from the
laboratory, in accordance with section 262.210. 

Within 4 calendar days of arriving at an on-site central accumulation
area, in accordance with section 262.211. 

Within 4 calendar days of arriving at an on-site treatment, storage or
disposal facility, in accordance with section 262.212. 

Section 262.209(b) establishes standards for where and when
conditionally exempt small quantity generators may make hazardous waste
determinations.  An eligible academic entity must ensure that a trained
professional makes a hazardous waste determination, pursuant to section
262.11, for unwanted material in the laboratory before the unwanted
material is removed from the laboratory, in accordance with 262.210.  

(7)	Making the Hazardous Waste Determination in the Laboratory

40 CFR 262.210(a) requires that a trained professional must make the
hazardous waste determination, pursuant to section 262.11, before the
unwanted material is removed from the laboratory.

	Section 262.210(b)(2) provides that, if an unwanted material is a
hazardous waste, the eligible academic entity must write the appropriate
hazardous waste codes(s) on the label that is associated with the
container before the hazardous waste may be transported off-site.  

(8)	Making the Hazardous Waste Determination in an On-site Central
Accumulation Area

	40 CFR 262.211(d) requires that a trained professional must determine,
pursuant to section 262.11, if the unwanted material is a hazardous
waste within 4 calendar days of the unwanted materials’ arrival at the
on-site central accumulation area.

	Section 262.211(e)(2) provides that, if the unwanted material is a
hazardous waste, the eligible academic entity must write the appropriate
hazardous waste code(s) on the container label that is associated with
the container before the hazardous waste may be treated or disposed
on-site or transported off-site.

(9)	Making the Hazardous Waste Determination at an On-site Interim
Status or Permitted Treatment, Storage, or Disposal Facility

40 CFR 262.212(d) requires that a trained professional must determine,
pursuant to section 262.11, if the unwanted material is a hazardous
waste within 4 calendar days of the unwanted materials’ arrival at an
on-site interim status or permitted treatment, storage or disposal
facility.

	Section 262.212(e)(2) provides that, if the unwanted material is a
hazardous waste, the eligible academic entity must write the appropriate
hazardous waste code(s) on the container label that is associated with
the container before the hazardous waste may be treated or disposed
on-site or transported off-site.

(10)	Laboratory Clean-outs

	40 CFR 262.213(a) provides that one time per 12 month period per
laboratory, an eligible academic entity may opt to conduct a laboratory
clean-out that is subject to all the applicable requirements of Subpart
K, except as specified otherwise in section 262.213(a). 

	Section 262.213(a)(4) requires that an eligible academic entity must
document the activities of the laboratory clean-out, as specified (a
clean-out may last up to 30 calendar days, as specified).  The eligible
academic entity must maintain the records for a period of three years
from the date the clean-out ends.

(11)	Laboratory Management Plan

	40 CFR 262.214 provides that an eligible academic entity must develop
and retain a written Laboratory Management Plan, or revise an existing
written plan.  

	Section 262.214(c) provides that an eligible academic entity must make
its Laboratory Management Plan available to laboratory workers,
students, or any others at the eligible academic entity who request it.

	Section 262.214(d) requires that an eligible academic entity must
review and revise its Laboratory Management Plan as needed.

6.	ESTIMATING THE HOUR AND COST BURDEN OF THE COLLECTION

6(a)	Estimating Respondent Burden Hours

Exhibit 1 provides estimates of the respondent hourly burden associated
with the rule’s paperwork requirements.  Exhibit 1 includes burden
hours (total and by labor type) per respondent, as well as the overall
burden hours for all respondents.

6(b)	Estimating Respondent Costs

Exhibit 1 provides estimates of the annual respondent costs associated
with the rule’s paperwork requirements.  These costs are based on the
cost of labor, capital, and operation and maintenance (O&M). 

(1)	Labor Costs 

The labor wage rates used to estimate costs to respondents were obtained
from EPA’s impact assessment developed for this rulemaking.  EPA
estimates an average loaded respondent hourly labor rate of $116.58 for
legal staff, $63.72 for managerial staff, $35.14 for technical staff,
and $26.50 for clerical staff.  Labor rates were determined using the
“National Compensation Survey: Occupational Earnings in the United
States, June 2006.”  Fringe benefit and overhead rates were estimated
using “United States Department of Labor, Bureau of Labor Statistics,
Employer Costs for Employee Compensation - December 2007,” March 12,
2008, and “OMB Circular No. A-76 - Table C,” May 29, 2003,
respectively.  The fringe benefits were estimated as 42 percent of the
base labor rate.  The overhead rate was estimated as 12 percent of the
base and fringe benefit labor rate.  The labor rates were based on the
hourly pay of a full-time annual civilian salaried employee.  The labor
rates were inflated from 2006 dollars to 2008 dollars using an inflation
factor of 4.1 percent.  

Using the total burden hours discussed in Section 6(a) and the hourly
wage rates outlined in this section, Exhibit 1 estimates the labor costs
associated with the information collection requirements covered in this
ICR. 

(2)	Capital Costs

Capital costs usually include any produced physical good needed to
provide the needed information, such as machinery, computers, and other
equipment.  EPA does not anticipate that respondents will incur capital
costs in carrying out the information collection requirements covered in
this ICR.

(3)	Operation & Maintenance Costs

O&M costs are those costs associated with a paperwork requirement
incurred continually over the life of the ICR.  This ICR includes O&M
costs for postage (i.e., $2.72 for certified mail) and envelope (i.e.,
$0.01).  The ICR includes $0.13 per container label.

6(c)	Estimating Agency Hour and Cost Burden

The final rule will be administered by RCRA-authorized State government
regulatory programs.  Unloaded hourly labor wage rates for States’
activities were taken from “Table 2-3. State and Local Government:
Mean Hourly Earnings and Weekly Hours by Full-time and Part-time Workers
for Selected Occupations, National Compensation Survey, June 2005.” 
The table is found in the “National Compensation Survey: Occupational
Wages in the United States, June 2005,” U.S. Department of Labor,
Bureau of Labor Statistics, August 2006, Bulletin 8521.  EPA updated
these rates to 2008 levels based on the Employment Cost Index, then
multiplied the rates by the fringe benefits and overhead factor of 1.45.
 Based on this, EPA estimated the following average loaded hourly wage
rates for government labor: $54.41 per hour for legal staff, $47.75 per
hour for managerial staff, $35.80 per hour for technical staff, and
$23.04 per hour for clerical staff.  Hour and cost burden to the Agency
is estimated in Exhibit 3.

6(d)	Estimating the Annual Respondent Universe and Total Hour and Cost
Burden

In this section, EPA first describes the estimated respondent universe
under the rule.  EPA then estimates the annual burden to respondents
under the rule’s paperwork requirements.  Finally, EPA estimates the
burden impacts to respondents under the existing RCRA generator
paperwork standards.  

EPA obtained most of the data and assumptions for the burden
calculations in this ICR from EPA’s impact assessment developed for
this rulemaking.  The impact assessment is entitled, “Assessment of
Potential Costs, Benefits and Other Impacts For the Revised Standards
Applicable to Generators of Hazardous Waste; Subpart K - Laboratories
Owned by Eligible Academic Entities, Final Rule” (June 30, 2008).

(1)	Respondent Universe

Table 1 presents the total number of sites at eligible academic entities
that are expected to opt into Subpart K during the three-year period
covered by this ICR.  The table shows the number of large quantity
generators (LQGs), small quantity generators (SQGs), and conditionally
exempt small quantity generators (CESQGs).  It also shows the number of
sites with and without an on-site central accumulation area (CAA).  

In total, EPA expects eligible academic entities to opt in for 112 of
their sites.  Of these, EPA estimates that 25 will be LQGs and 87 will
be SQGs.  EPA does not expect any CESQGs to opt into Subpart K.  EPA
estimates that 10 sites will have a CAA and 102 will not have a CAA. 
These 102 sites without a CAA will ship their hazardous waste off-site
directly from the laboratories.  

	Table 2 presents the average number of laboratories per site and the
average annual number of containers of unwanted material per laboratory.
 Information is presented only for those sites expected to opt into
Subpart K, as shown in Table 1.  Table 2 shows, for example, that each
large SQG is estimated to have 181 laboratories on average.  Each
laboratory is expected to generate five containers of unwanted material,
on average, per year.

	Table 3 presents the total aggregate annual number of containers of
unwanted material generated at sites expected to opt into Subpart K. 
The table is based on the data presented in Tables 1 and 2. 
Specifically, EPA multiplied the total number of sites opting into
Subpart K (see Table 1) by each site’s average number of laboratories
and containers of unwanted materials per laboratory (see Table 2).  This
produced the total aggregate number of containers of unwanted materials
expected to be generated annually under Subpart K. 

	In total, EPA estimates that 352,788 containers of unwanted materials
will be generated in laboratories under Subpart K annually.  Of these,
EPA estimates that 9,000 containers will be generated by sites with CAAs
and 343,788 will be generated by sites without CAAs.  

	EPA used the above data to estimate the annual respondent burden in
this ICR.

(2)	Annual Respondent Burden under Final Rule

Based on the respondent universe data presented in Tables 1 through 3,
EPA estimates the annual incremental hour and cost burden to respondents
under the final rule in Exhibit 1.  A discussion of the assumptions used
in the development of these burden estimates is presented in the
following subsections.  

(a)	Reading the Regulations	

EPA estimates that eligible academic entities will opt in for 112 of
their sites (i.e., 25 LQGs + 87 SQGs) during the three-year life of this
ICR.  EPA expects that employees at these sites will read the Subpart K
regulations once during the three-year life of this ICR.  In estimating
the annual incremental burden to respondents over the three-year period
covered by this ICR, EPA annualized the burden of this one-time activity
by dividing the number of respondents by three.  Thus, EPA estimates
that, on average, 37 sites (i.e., 112 sites / 3 years) will read the
regulations each year.

Table 1

Total Number of Sites at Eligible Academic Entities Opting into Subpart
K

During Three-Year Life of ICRa

Size	LQGs	SQGs	CESQGs	Total

	with CAA	without CAA	Total	with CAA	without CAA	Total	with CAA	without
CAA	Total	with CAA	without CAA	Total

4-Year Colleges and Universities and Non-Profit Research Institutes

Largeb	0	12	12	0	15	15	0	0	0	0	27	27

Smallc	4	0	4	0	51	51	0	0	0	4	51	55

Subtotal	4	12	16	0	66	66	0	0	0	4	78	82

2-Year Colleges and Universities

Largeb	0	0	0	0	4	4	0	0	0	0	4	4

Smallc	0	0	0	0	14	14	0	0	0	0	14	14

Subtotal	0	0	0	0	18	18	0	0	0	0	18	18

Vocation Schools

Largeb	0	0	0	0	1	1	0	0	0	0	1	1

Smallc	0	0	0	0	2	2	0	0	0	0	2	2

Subtotal	0	0	0	0	3	3	0	0	0	0	3	3

Teaching Hospitals

Very Larged	0	2	2	0	0	0	0	0	0	0	2	2

Largee	6	1	7	0	0	0	0	0	0	6	1	7

Smallf	0	0	0	0	0	0	0	0	0	0	0	0

Very Smallg	0	0	0	0	0	0	0	0	0	0	0	0

Subtotal	6	3	9	0	0	0	0	0	0	6	3	9

Total	10	15	25	0	87	87	0	0	0	10	102	112

a. Data obtained from EPA’s impact assessment for this rulemaking. See
“Table 5-2. Number of Facilities Expected to Adopt the Final Rule by
Institution Type, Lab System Size, Generator Status, and CAA
Operation.”

b. Defined as sites with more than 50 labs, more than 5 studios.

c. Defined as sites with less than 50 labs, less than 5 studios.

d. Defined as sites with more than 50 labs.

e. Defined as sites with 15 labs.

f. Defined as sites with 6 labs.

g. Defined as sites with 2 labs.

Table 2

Number of Laboratories Per Site and Number 

of Unwanted Material Containers Per Laboratory

(Data are presented only for sites opting into Subpart Ka)

Size	LQG	SQG	CESQG

	With CAA	Without CAA

	With CAA	Without CAA

	With CAA	Without CAA



4-Year Colleges and Universities and Non-Profit Research Institutes

Largeb	*	525 labs and

45 containers / lab	*	181 labs and

5 containers / lab	*	*

Smallc	25 labs and  

45 containers / lab	*	*	22 labs and

5 containers / lab	*	*

2-Year Colleges and Universities

Largeb	*	*	*	181 labs and

5 containers / lab	*	*

Smallc	*	*	*	22 labs and

5 containers / lab	*	*

Vocational Schools

Largeb	*	*	*	181 labs and

5 containers / lab	*	*

Smallc	*	*	*	22 labs and

5 containers / lab	*	*

Teaching Hospitals

Very Larged	*	501 labs and 

34 containers / lab	*	*	*	*

Largee	15 labs and 

50 containers / lab	15 labs and 

50 containers / lab	*	*	*	*

Smallf	*	*	*	*	*	*

Very Smallg	*	*	*	*	*	*

a. Data obtained from EPA’s impact assessment for this rulemaking. 
See “Table B-1. Annual Number of Waste Containers Generated by
Institution Type, Laboratory System Size, Generator Status, and Central
Accumulation Area (CAA) Operation.”  Data are presented only for sites
opting into Subpart K.  See Table 1 of this supporting statement for the
number of sites opting into Subpart K.  

b. Defined as sites with more than 50 labs, more than 5 studios.

c. Defined as sites with less than 50 labs, less than 5 studios.

d. Defined as sites with more than 50 labs.

e. Defined as sites with 15 labs.

f. Defined as sites with 6 labs.

g. Defined as sites with 2 labs.

Table 3

Total Annual Number of Containers of Unwanted Material

Generated at Sites Opting into Subpart Ka

Size	LQGs	SQGs	CESQGs	Total

	with CAA	without CAA	Total	with CAA	without CAA	Total	with CAA	without
CAA	Total	with CAA	without CAA	Total

4-Year Colleges and Universities and Non-Profit Research Institutes

Largeb	0	283,500	283,500	0	13,575	13,575	0	0	0	0	297,075	297,075

Smallc	4,500	0	4,500	0	5,610	5,610	0	0	0	4,500	5,610	10,110

Subtotal	4,500	283,500	288,000	0	19,185	19,185	0	0	0	4,500	302,685
307,185

2-Year Colleges and Universities

Largeb	0	0	0	0	3,620	3,620	0	0	0	0	3,620	3,620

Smallc	0	0	0	0	1,540	1,540	0	0	0	0	1,540	1,540

Subtotal	0	0	0	0	5,160	5,160	0	0	0	0	5,160	5,160

Vocational Schools

Largeb	0	0	0	0	905	905	0	0	0	0	905	905

Smallc	0	0	0	0	220	220	0	0	0	0	220	220

Subtotal	0	0	0	0	1,125	1,125	0	0	0	0	1,125	1,125

Teaching Hospitals

Very Larged	0	34,068	34,068	0	0	0	0	0	0	0	34,068	34,068

Largee	4,500	750	5,250	0	0	0	0	0	0	4,500	750	5,250

Smallf	0	0	0	0	0	0	0	0	0	0	0	0

Very Smallg	0	0	0	0	0	0	0	0	0	0	0	0

Subtotal	4,500	34,818	39,318	0	0	0	0	0	0	4,500	34,818	39,318

Total	9,000	318,318	327,318	0	25,470	25,470	0	0	0	9,000	343,788	352,788

a. Numbers in the table are based on the data in Tables 1 and 2.

b. Defined as sites with more than 50 labs, more than 5 studios.

c. Defined as sites with less than 50 labs, less than 5 studios.

d. Defined as sites with more than 50 labs.

e. Defined as sites with 15 labs.

f. Defined as sites with 6 labs.

g. Defined as sites with 2 labs.(b)	Notification of Intent to Comply
with Subpart K and Recordkeeping of Agreements

An eligible academic entity must submit the Site Identification Form to
notify EPA or the authorized State that it is electing to be subject to
Subpart K for all laboratories owned by the eligible academic entity
under the same EPA Identification Number.  An eligible academic entity
that is a conditionally exempt small quantity generator and does not
have an EPA Identification Number must notify for all laboratories that
are owned or operated by the eligible academic entity that are on-site. 
In estimating the annual incremental burden to respondents over the
three-year period covered by this ICR, EPA annualized the burden of this
one-time activity by dividing the number of Site Identification Forms by
three.  Thus, EPA estimates that, each year, 37 forms (i.e., 112 forms/3
years) will be prepared, submitted, and retained.

Teaching hospitals opting into Subpart K must keep a copy of their
formal written affiliation agreement with a college or university on
file if they are not owned by a college or university.  EPA has made the
simplifying assumption that 50 percent of teaching hospitals opting into
Subpart K (5 sites) are not owned by a college or university and must
keep these agreements on file.  In estimating the annual incremental
burden to them over the three-year period covered by this ICR, EPA
annualized the burden of this one-time activity by dividing the number
of respondents by three.  Thus, EPA estimates that, each year, two sites
(i.e., 5 sites/3 years) will retain the agreements on file.

	Non-profit research institutes not owned by a college or university
opting into Subpart K must keep a copy of the formal written affiliation
agreement with a college or university on file.  The impact assessment
developed for this rulemaking does not estimate the number of non-profit
research institutes opting into Subpart K separately from four-year
colleges and universities that are opting in.  Rather, it estimates the
combined number of sites at four-year colleges and universities and
non-profit research institutes opting into Subpart K (i.e., 82 sites in
total).  For purposes of this ICR, EPA has made the simplifying
assumption that five percent of these sites are non-profit research
institutes (i.e., 4 sites).  In estimating the annual incremental burden
to them over the three-year period covered by this ICR, EPA annualized
the burden of this one-time activity by dividing the number of
respondents by three.  Thus, EPA estimates that, each year, one site
(i.e., 4 sites/3 years) will retain the agreement on file.

(c)	Notification of Withdrawal from Subpart K

	EPA does not expect any eligible academic entity to submit a withdrawal
notification during the three-year period covered by this ICR.

(d)	Labeling of Containers of Unwanted Material in the Laboratory

As shown in Table 3, EPA estimates that eligible academic entities
subject to Subpart K will generate a total of 352,788 containers of
unwanted materials each year.  They must label the containers as
specified at section 262.206.

(e)	Training

Under section 262.207, individuals working in a laboratory at the 112
sites must be trained commensurate with their duties.  In addition, LQGs
must maintain training records for laboratory workers.  EPA’s impact
assessment estimates that 14 of the 25 LQGs opting into Subpart K will
shift in generator status to SQGs because of the laboratory clean-out
incentives.  Hence, 11 LQGs will be subject to the recordkeeping
provision.  

Note: EPA believes that, under existing regulations (e.g., OSHA and EPA
regulations) and standard industry practices, a variety of training is
provided to individuals that use and/or manage chemicals, hazardous
materials, and hazardous wastes as part of their job responsibilities. 
EPA has found, for example, that the predominant practice by colleges
and universities currently is to provide training to students regarding
proper laboratory and waste management.  In addition,
contractors/consultants that provide support services to eligible
academic entities (e.g., brokers that provide hazardous waste management
support to CESQGs) must train their employees, as applicable.  

Thus, EPA believes that the training requirements under the rule do not
impose incremental burden on respondents.

(f)	Removing Containers of Unwanted Material from the Laboratory

EPA assumes that all eligible academic entities under Subpart K will
remove their containers of unwanted material and reactive acutely
hazardous unwanted materials from each laboratory on a regular basis. 
Because of this, EPA anticipates that none of the laboratories will
accumulate more than 55 gallons of unwanted material or 1 quart of
acutely reactive unwanted material before the regularly scheduled
removal.  As a result, EPA estimates that none of the entities will need
to label any of its containers with the date the 55 gallons or the 1
quart of unwanted material is exceeded.

(g)	Making the Hazardous Waste Determination in the Laboratory

EPA estimates that 102 sites under Subpart K will not have an on-site
CAA.  Rather, they will make their hazardous waste determinations in the
laboratory.  EPA expects that a hazardous waste determination will be
made for each container of unwanted material in these laboratories. 
Based on the data in Table 3, EPA estimates that, each year, hazardous
waste determinations will be made in the laboratory for 343,788
containers of unwanted materials.  EPA assumes that unwanted materials
in all of these containers will be determined to be hazardous waste, and
thus, the appropriate hazardous waste code(s) will be added to the label
that is associated with the containers.

	EPA notes that, for purposes of this analysis, only the addition of the
appropriate hazardous waste code(s) to the container labels is
considered incremental burden.  Under existing regulations (40 CFR
262.11), generators must determine if their waste is hazardous per 40
CFR 261.3.  Thus, the hazardous waste determination does not impose
incremental burden on respondents.

(h)	Making the Hazardous Waste Determination in an On-site Central
Accumulation Area

EPA estimates that 10 sites under Subpart K will have an on-site CAA at
which they will make their hazardous waste determinations.  EPA expects
that a hazardous waste determination will be made for each container of
unwanted material at the CAAs.  Based on the data in Table 3, EPA
estimates that, each year, hazardous waste determinations will be made
at CAAs for 9,000 containers of unwanted materials.  EPA assumes that
unwanted materials in all of these containers will be determined to be
hazardous waste and thus, the appropriate hazardous waste code(s) will
be added to the label that is associated with the containers.

	EPA notes that, for purposes of this analysis, only the addition of the
appropriate hazardous waste code(s) to the container labels is
considered incremental burden.  Under existing regulations (40 CFR
262.11), generators must determine if their waste is hazardous.  Thus,
the hazardous waste determination does not impose incremental burden on
respondents.	

(i)	Making the Hazardous Waste Determination at an On-site Interim
Status or Permitted Treatment, Storage, or Disposal Facility

EPA expects that no hazardous waste determinations will be made at an
on-site interim status or permitted TSDF during the three-year period
covered by this ICR.

(j)	Laboratory Clean-outs

EPA estimates that 20 percent of the laboratories at each site under
Subpart K will conduct a laboratory clean-out annually.  In addition,
EPA estimates that 10 percent of all of the containers of unwanted
material generated by these laboratories during the year will originate
from their laboratory clean-out.  Hence, EPA multiplied the total number
of containers in Table 3 by 20 percent and 10 percent, to estimate that
7,056 containers will originate from laboratory clean-outs annually
(i.e., 352,788 x 20% x 10% = 7,056).  EPA estimates that personnel will
spend two minutes per container to document the clean-out and two
minutes per container to maintain documentation of the clean-out.

(k)	Laboratory Management Plan

	

Eligible academic entities are required to develop a Laboratory
Management Plan or modify an existing plan for their sites under Subpart
K.  For purposes of this ICR, EPA assumes that they will revise an
existing plan (e.g., Chemical Hygiene Plan) to comply with the
Laboratory Management Plan requirement.  In estimating the annual
incremental burden to respondents over the three-year period covered by
this ICR, EPA annualized the burden of this one-time activity by
dividing the number of Laboratory Management Plans by three.  Thus, EPA
estimates that, on average, eligible academic entities will prepare 37
Laboratory Management Plans per year (i.e., 112 Plans / 3 years). 

	EPA also estimates that each site will review, revise, and keep records
of its Laboratory Management Plan each year.  

	Finally, the eligible academic entities must make the Laboratory
Management Plan available to others (e.g., laboratory workers,
students).  

(3)	Annual Respondent Hour and Cost Impacts under Existing Paperwork
Requirements

Some eligible academic entities may be relieved of some of the existing
generator standards under the rule, e.g., if they shift downward in
generator status under Subpart K.  The impact assessment developed by
EPA for this rulemaking estimates that 14 LQGs will shift to SQGs and 7
SQGs will shift to CESQGs because of Subpart K’s laboratory clean-out
incentives.  As a result, these sites will see some burden relief from
the existing paperwork requirements.

	

Exhibit 2 presents the total annual burden under the final rule’s
paperwork requirements, as well as the annual burden impacts (i.e.,
burden relief) under the existing paperwork requirements.  The burden
relief under the existing requirements is presented according to the
approved ICR in which the requirements are addressed.  Below is a brief
discussion of these ICRs, along with a description of relevant capital
and O&M costs affected:

								

Requirements for Generators, Transporters, and Waste Management
Facilities under the RCRA Hazardous Waste Manifest System (EPA ICR
Number 801).  EPA estimates that some eligible academic entities will
see some efficiencies in the movement of their hazardous waste under the
final rule, resulting in fewer manifests being prepared.  In addition,
EPA estimates that sites that drop in generator status (e.g., change
from LQG to SQG) will need to prepare fewer manifests because they will
not need to ship their waste offsite as often as under the baseline. 
There are annual capital cost savings of $244 for fewer file cabinets
needed to keep records of manifests.  There are annual O&M cost savings
of $998 for fewer transmittals of manifests by mail.

Hazardous Waste Generator Standards (EPA ICR Number 820).  EPA estimates
that sites that drop in generator status under Subpart K will see
savings from reduced generator requirements.  There are no capital cost
savings.  There are annual savings in O&M costs of $19.  These savings
are associated with the photocopying and transmittal of fewer records.

The 2007 Hazardous Waste Report (EPA ICR Number 976).  EPA estimates
that LQGs that drop in generator status to SQGs under Subpart K will see
savings for no longer preparing/submitting a Hazardous Waste Report. 
There are no capital cost savings.  There are annual savings in O&M
costs of $14.  These savings are associated with the transmittal and
recordkeeping of fewer forms.

6(e)	Bottom Line Hour and Cost Burden

(1)	Respondent Tally

	As shown in Exhibit 2, EPA estimates the total annual burden to
respondents under the new paperwork requirements to be 14,459 hours and
$562,079.  Taking into account the annual burden relief to respondents
under the existing paperwork requirements, the total net annual burden
to respondents is estimated to be 12,557 hours and $461,632.  The
bottom-line burden over three years is estimated to be 37,671 hours and
$1,384,896.

(2)	Agency Tally

	As shown in Exhibit 3, EPA estimates the total annual burden to the
government under the new paperwork requirements to be 28 hours and $757.
 The bottom-line burden over three years is estimated to be 84 hours and
$2,271.

6(f)	Reasons for Change In Burden

In establishing Subpart K, EPA has established some information
collection requirements to ensure that the hazardous wastes at eligible
academic entities are managed in a manner that is protective of human
health and the environment.  EPA believes these requirements are
justified because the Subpart K regulations allow eligible academic
entities flexibility to tailor their laboratory operations to meet their
individual circumstances, and remain protective of human health and the
environment.  Performance-based standards for the management of
hazardous wastes generated in laboratories provide a better opportunity
for eligible academic entities to evaluate their overall hazardous waste
management program, and tailor it in such a way that facilitates
efficient and safe management of hazardous waste and minimizes burden,
while at the same time maintaining a high standard of protection of
human health and the environment.  The alternative approach will help
them centralize and coordinate their chemical management practices and
achieve sound environmental performance.

6(g)	Public Burden Statement

The hourly reporting burden associated with the final rule is estimated
to be 10 minutes per respondent.  This includes time for preparing and
submitting a Site Identification Form to opt into Subpart K.  The hourly
recordkeeping burden associated with the final rule is estimated to be
approximately 130 hours per respondent.  This includes time for reading
the regulations, labeling containers, and preparing and maintaining
specified documents (e.g., Laboratory Management Plan).

To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket under Docket ID Number
EPA-HQ-RCRA-2003-0012, which is available for online viewing at
www.regulations.gov, or in person viewing at the Resource Conservation
and Recovery Act (RCRA) Docket in the EPA Docket Center (EPA/DC), EPA
West, Room B102, 1301 Constitution Avenue, NW, Washington, D.C.  The EPA
Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal holidays.  The telephone number
for the Reading Room is (202) 566-1744, and the telephone number for the
Resource Conservation and Recovery Act (RCRA) Docket is 202-566-0270. 
An electronic version of the public docket is available at
http://www.regulations.gov.  This site can be used to submit or view
public comments, access the index listing of the contents of the public
docket, and to access those documents in the public docket that are
available electronically.  When in the system, select "search," then key
in the Docket ID Number identified above.  Also, you can send comments
to the Office of Information and Regulatory Affairs, Office of
Management and Budget, 725 17th Street, NW, Washington, D.C. 20503,
Attention: Desk Officer for EPA.  Please include the EPA Docket ID
Number EPA-HQ-RCRA-2003-0012, and OMB Control Number 2050-new in any
correspondence.

3

‘

ù

Y

°

 

-

.

/

0

1

2

3

4

5

Q

R

S

T

X

Y

o

p

q

‹

Œ

Ž

‘

’

“

¯

°

±

²

´

µ

×

Ø

Ù

ó

,ó

ô

õ

ö

÷

ø

ù

ú

û

6

7

8

R

S

T

V

W

X

Y

Z

[

w

x

y

z

~



Ž

©

ª

«



®

¯

°

±

²

Î

Ï

Ð

Ñ

Õ

Ö

ã

ä

å

ÿ

,ÿ

j¸

j;

j¬

j/

j

„Ð`„Ð

„Ð`„Ð

>*

â

â

ã

4

5

E

F

„@

„0ý^„@

„@

„0ý^„@

$

萑ɶ葠ɶ

$

	M

Ff

@

	 

	À

؀Ĥ

$

$

Assessment of Potential Costs, Benefits and Other Impacts for the
Revised Standards Applicable to Generators of Hazardous Waste; Subpart K
- Laboratories Owned by Eligible Academic Entities,” June 30, 2008.

.  Source: The 1.45 fringe and overhead multiplier factor represents
32.85% full fringe benefits factor plus 12% overhead cost factor.  See
OMB Circular No. A-76, Attachment C, May 29, 2003: Calculating
Public-Private Competition Costs, Figure C1 Table of Standard A-76
Costing Factors.  The document can be found at: 
http://www.whitehouse.gov/omb/circulars/a076/a76_incl_tech_correction.pd
f.

. To derive this 5-percent estimate, EPA referred to the impact
assessment to obtain the total number of college and university sites
(1,256 sites) and non-profit research sites (61 sites) that are eligible
for Subpart K.  EPA then calculated the percentage of non-profit
research sites from the combined total of 1,317 sites (i.e., 61 sites /
1,317 = 5%).  EPA applied this 5-percent estimate to the 82 sites, to
estimate that 4 are non-profit research sites.

.  See “Table 5-2. Number of Facilities Expected to Adopt the Final
Rule by Institution Type, Lab System Size, Generator Status, and CAA
Operation.” (p. 64) of EPA’s impact assessment

.  See pages 55 and 56 of EPA’s impact assessment for an additional
discussion of EPA’s rationale.

.  See page 46 of EPA’s impact assessment for an additional discussion
of EPA’s assumptions.

. EPA’s impact assessment estimates that eligible academic entities
will spend 4 hours every 3 years to maintain and update the Laboratory
Management Plan (p. 47).  In preparing this ICR, EPA annualized the 4
hours over three years, to estimate that eligible academic entities will
spend 1.33 hours per year to review, revise and keep records of each of
the 112 Laboratory Management Plans.

.  See page 64 of EPA’s impact assessment for additional information
(i.e., “Table 5-2. Number of Facilities Expected to Adopt the Final
Rule by Institution Type, Lab System Size, Generator Status, and CAA
Operation.”).

 PAGE  i 

 PAGE   

 PAGE   21 

