
[Federal Register: December 1, 2008 (Volume 73, Number 231)]
[Rules and Regulations]               
[Page 72911-72960]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01de08-16]                         


[[Page 72911]]

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Part II





Environmental Protection Agency





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40 CFR Parts 261 and 262



Standards Applicable to Generators of Hazardous Waste; Alternative 
Requirements for Hazardous Waste Determination and Accumulation of 
Unwanted Material at Laboratories Owned by Colleges and Universities 
and Other Eligible Academic Entities Formally Affiliated With Colleges 
and Universities; Final Rule


[[Page 72912]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 261 and 262

[EPA-HQ-RCRA-2003-0012; FRL-8743-9]
RIN 2050-AG18

 
Standards Applicable to Generators of Hazardous Waste; 
Alternative Requirements for Hazardous Waste Determination and 
Accumulation of Unwanted Material at Laboratories Owned by Colleges and 
Universities and Other Eligible Academic Entities Formally Affiliated 
With Colleges and Universities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA or the Agency) is 
finalizing an alternative set of generator requirements applicable to 
laboratories owned by eligible academic entities, as defined in this 
final rule. The rule provides a flexible and protective set of 
regulations that address the specific nature of hazardous waste 
generation and accumulation in laboratories at colleges and 
universities, as well as other eligible academic entities formally 
affiliated with colleges and universities. This final rule is optional 
and colleges and universities and other eligible academic entities 
formally affiliated with a college or university have the choice of 
managing their hazardous wastes in accordance with the new alternative 
regulations as set forth in this final regulation or remaining subject 
to the existing generator regulations.

DATES: This final rule is effective December 31, 2008.

ADDRESSES: EPA has established a docket for this action under Docket ID 
No. RCRA-2003-0012. All documents in the docket are listed on the 
http://www.regulations.gov Web site. Although listed in the index, some 
information is not publicly available, i.e., Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. Certain other material, such as copyrighted material, is 
not placed on the Internet and will be publicly available only in hard 
copy form. Publicly available docket materials are available either 
electronically through http://www.regulations.gov or in hard copy at 
the EPA RCRA Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution 
Ave., NW., Washington, DC. The 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 Public Reading Room is (202) 566-1744, and the 
telephone number for the RCRA Docket is (202) 566-0270.

FOR FURTHER INFORMATION CONTACT: For further information regarding 
specific aspects of this notice, contact Kristin Fitzgerald, Office of 
Solid Waste, (703) 308-8286, Fitzgerald.Kristin@epa.gov; Patricia 
Mercer, Office of Solid Waste, (703) 308-8408, Mercer.Patricia@epa.gov; 
or Jessica Biegelson, Office of Solid Waste, (703) 308-0026, 
Biegelson.Jessica@epa.gov. Mail inquiries may be directed to the Office 
of Solid Waste, (5304P), 1200 Pennsylvania Avenue NW., Washington, DC 
20460.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Entities Potentially Affected by This Rule

    The rule establishes a new Subpart K within 40 CFR part 262. 
Entities potentially affected by this final action are colleges and 
universities; non-profit research institutes that are either owned by 
or have a formal written affiliation agreement with a college or 
university; and teaching hospitals that are either owned by or have a 
formal written affiliation agreement with a college or university, that 
generate hazardous waste in laboratories. Today's final rule refers to 
these collectively as ``eligible academic entities.'' This final action 
is optional for eligible academic entities. That is, eligible academic 
entities that are large quantity generators (LQGs), small quantity 
generators (SQGs), or conditionally exempt small quantity generators 
(CESQGs) may choose to have their laboratories be subject to 40 CFR 
part 262, Subpart K in lieu of the existing generator regulations. In 
States authorized to implement the RCRA program, Subpart K would only 
be available as an option once it has been adopted by the State in 
which the eligible academic entity is located.
    Only eligible academic entities can participate under Subpart K for 
the laboratories they own. The following are examples of entities that 
are not eligible because they do not satisfy the definition of 
``eligible academic entity:'' government facilities; commercial 
research and development (R&D) facilities; non-profit research 
institutes that are not owned by nor have a formal written affiliation 
agreement with a college or university; non-teaching hospitals; and 
teaching hospitals that are not owned by nor have a formal written 
affiliation agreement with a college or university. To determine 
whether the laboratories owned by an eligible academic entity are 
covered by this action, interested parties should examine 40 CFR part 
262, Subpart K carefully. If there are questions regarding the 
applicability of the rule to a particular entity, consult your State, 
EPA Regional office, or the person(s) listed in the section of this 
preamble entitled, FOR FURTHER INFORMATION CONTACT.

     NAICS Codes of Entities Potentially Affected by This Final Rule
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              NAICS codes                   Description of NAICS code
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                         Colleges & Universities
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6112, 61121, 611210....................  Junior Colleges.
6113, 61131, 611310....................  Colleges, Universities, and
                                          Professional Schools.
6115, 61151............................  Technical and Trade Schools.
611519.................................  Other Technical and Trade
                                          Schools.
61161, 611610..........................  Fine Arts Schools.
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                           Teaching Hospitals
------------------------------------------------------------------------
54194, 541940..........................  Veterinary Services (Animal
                                          Hospitals).
622....................................  Hospitals.
6221, 62211, 622110....................  General Medical and Surgical
                                          Hospitals.
6222, 62221, 622210....................  Psychiatric and Substance Abuse
                                          Hospitals.
6223, 62231, 622310....................  Specialty (except Psychiatric
                                          and Substance Abuse)
                                          Hospitals.
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                     Non-profit Research Institutes
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5417, 54171, 541710....................  Research and Development in the
                                          Physical, Engineering, and
                                          Life Sciences.
54172, 541720..........................  Research and Development in the
                                          Social Sciences and
                                          Humanities.
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                            List of Acronyms
------------------------------------------------------------------------

------------------------------------------------------------------------
APA..........................................  Administrative Procedures
                                                Act.
ACE..........................................  American Council on
                                                Education.
AAMC.........................................  Association of American
                                                Medical Colleges.
AIRI.........................................  Association of
                                                Independent Research
                                                Institutes.
BR...........................................  Biennial Report.
BMPs.........................................  Best Management
                                                Practices.
CAA..........................................  Central Accumulation
                                                Area.
CAS..........................................  Chemical Abstract
                                                Service.
CESQG........................................  Conditionally Exempt
                                                Small Quantity
                                                Generator.
CFR..........................................  Code of Federal
                                                Regulations.
C2E2.........................................  Campus Consortium for
                                                Environmental
                                                Excellence.
CSHEMA.......................................  Campus Safety Health and
                                                Environmental Management
                                                Association.
EH&S.........................................  Environmental Health and
                                                Safety.
HHMI.........................................  Howard Hughes Medical
                                                Institute.
HSWA.........................................  Hazardous and Solid Waste
                                                Amendments of 1984.
ICR..........................................  Information Collection
                                                Request.
LDR..........................................  Land Disposal
                                                Restrictions.
LMP..........................................  Laboratory Management
                                                Plan.
LQG..........................................  Large Quantity Generator.
NACUBO.......................................  National Association of
                                                College and University
                                                Business Officers.
NTTAA........................................  National Technology
                                                Transfer Advancement
                                                Act.
OMB..........................................  Office of Management and
                                                Budget.
OSHA.........................................  Occupational Safety and
                                                Health Administration.
PRA..........................................  Paperwork Reduction Act.
Project XL...................................  eXcellence and
                                                Leadership.
R&D..........................................  Research and Development.
RCRA.........................................  Resource Conservation and
                                                Recovery Act.
RFA..........................................  Regulatory Flexibility
                                                Act.
SAA..........................................  Satellite Accumulation
                                                Area.
SQG..........................................  Small Quantity Generator.
SWDA.........................................  Solid Waste Disposal Act.
TSDF.........................................  Treatment, Storage or
                                                Disposal Facility.
UMRA.........................................  Unfunded Mandates Reform
                                                Act.
------------------------------------------------------------------------

Outline

I. Statutory Authority
II. Background
    A. History and Summary of the Proposed Rule
    B. Rationale of the Final Rule
    C. Summary of the Final Rule
    D. Effective Date of the Final Rule
III. Detailed Discussion of the Final Rule
    A. Scope of Eligible Academic Entities Covered Under the Final 
Rule
    1. Hazardous Waste Generation Data
    2. Laboratories Owned by Teaching Hospitals
    3. Laboratories Owned by Non-profit Research Institutes
    4. Laboratories Owned by Eligible Academic Entities that are 
Conditionally Exempt Small Quantity Generators (CESQGs)
    5. Facilities with Laboratories Not Eligible to Participate in 
Subpart K
    a. Government Research Laboratories
    b. Commercial R&D Laboratories
    6. Non-laboratory Facilities at Eligible Academic Entities
    B. Discussion of Definitions
    1. Definitions that Have Not Changed from the Proposed Rule
    2. Definitions that Have Changed from the Proposed Rule
    3. Definitions that Are New
    C. Specific Requirements of the Alternative Regulations
    1. Notification
    2. Labeling Standards
    3. Container Standards
    4. Training Requirements
    5. Removal Frequency of Unwanted Materials
    a. Reactive Acutely Hazardous Unwanted Materials
    b. Transferring Unwanted Materials or Hazardous Wastes from the 
Laboratory to an On-site CAA or On-site TSDF
    c. On-site Consolidation Areas
    6. Making the Hazardous Waste Determination
    7. Laboratory Clean-outs
    a. Summary of the Proposed Laboratory Clean-out Provisions
    b. Changes Made to the Laboratory Clean-out Provisions
    c. Changes Not Made to the Laboratory Clean-out Provisions
    d. Clarifications About the Laboratory Clean-out Provisions
    8. Laboratory Management Plan
    a. Part I of the LMP
    b. Part II of the LMP
    9. How CESQGs Comply with Subpart K and How They Differ from 
LQGs and SQGs
    10. Off-site Consolidation
    a. Off-site Consolidation by CESQGs
    b. Off-site Consolidation by CESQGs, SQGs, and LQGs
    11. Topics that Are Outside the Purview of this Rulemaking
    D. Reporting and Recordkeeping
    1. Reporting to the Biennial Report for Eligible Academic 
Entities that are LQGs
    2. Recordkeeping
    E. Implementation and Enforcement
IV. State Authorization
    A. Applicability of Rules in Authorized States
    B. Effect on State Authorization
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    1. Introduction to the Economic Assessment for the Final Rule

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    2. Baseline Specification
    3. Analytical Methodology, Primary Data Sources, and Key 
Assumptions
    4. Key Analytical Limitations
    5. Findings
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination with 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children from 
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions that Significantly Affect 
Energy Supply, Distribution, or Usage
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations
    K. Congressional Review Act

I. Statutory Authority

    These regulations are promulgated under the authority of Sec. Sec.  
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), 42 U.S.C. 6921, 6922, 6923, and 6924.

II. Background

A. History and Summary of the Proposed Rule

    This rulemaking is a culmination of many years of investigation and 
participation by EPA in efforts designed to better understand the 
challenges that the academic community faces when managing hazardous 
wastes generated in laboratories under the hazardous waste regulations. 
As discussed at length in the preamble to the proposed rule (see 71 FR 
29715), these efforts include two Reports to Congress; a project under 
EPA's eXcellence and Leadership program (Project XL) with three 
colleges and universities in New England; a pilot project led by the 
Howard Hughes Medical Institute (HHMI) to develop and implement a 
performance-based approach to the management of laboratory waste at ten 
colleges and universities; and a public meeting on June 18, 2003, 
sponsored by EPA to discuss the management of hazardous waste in 
research and/or academic laboratories. (See the announcement of the 
public meeting at 68 FR 33121, June 3, 2003. The comments submitted to 
EPA in response to the public meeting are included in the docket for 
today's rulemaking.)
    As a result of these and other efforts, on May 23, 2006, EPA 
proposed alternative generator requirements applicable to college and 
university laboratories that generate hazardous waste (71 FR 29712 \1\ 
). This preamble will refer to the alternative generator requirements 
as ``Subpart K,'' because it establishes a new Subpart K of 40 CFR part 
262. The proposed rule provided a flexible and protective set of 
regulations that addressed the specific nature of hazardous waste 
generation and accumulation in college and university laboratories. The 
proposed rule was optional and colleges and universities had the choice 
of managing their hazardous wastes in accordance with the proposed 
alternative Subpart K requirements or remaining subject to the existing 
generator regulations. Although the applicability of the proposed rule 
was limited to colleges and universities, the Agency requested comment 
on whether it would be appropriate to expand the applicability of the 
final rule to other organizations that also have research or teaching 
laboratories. In addition, since the Agency assumed that CESQGs would 
not want to be subject to the increased burden of Subpart K, the 
proposed rule was limited to colleges and universities that are SQGs 
and LQGs. However, we solicited comments on whether CESQGs should be 
allowed to be subject to Subpart K.
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    \1\ Please see page 29716 of the preamble to the proposed rule 
for information on other EPA efforts to improve hazardous waste 
management at colleges and universities through compliance 
assistance centers and more.
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    Throughout the years of working with academic institutions, EPA has 
heard consistently that the greatest challenge that academic 
institutions face in managing their laboratory hazardous wastes under 
the existing generator regulations is making the RCRA hazardous waste 
determination at the point of generation pursuant to 40 CFR 262.11 
(i.e., determining whether their solid waste is hazardous waste and 
assigning the proper hazardous waste code(s) in the laboratory at the 
time the hazardous waste is generated). This is largely because the 
individuals in the laboratory generating the hazardous waste and other 
materials are students, who are often not trained to make a hazardous 
waste determination. We, therefore, proposed to remove the 
responsibility for the hazardous waste determination from the students 
in the laboratory and place it in the hands of trained environmental 
health and safety (EH&S) professionals. While the hazardous waste 
remains in the laboratory, we proposed that it would be referred to as 
``unwanted material,'' since the hazardous waste determination had not 
yet been made and some portion of the unwanted materials may be unused 
and therefore still usable, or may not be hazardous waste when 
discarded. We proposed that while in the laboratory, the P-listed 
commercial chemical products that were listed for reactivity would be 
referred to as ``reactive acutely hazardous unwanted materials.'' In 
lieu of making the hazardous waste determination at the point of 
generation, the Agency proposed that the hazardous waste determination 
must be made prior to removing the unwanted materials from the 
laboratory (but not at the time the unwanted materials are first 
generated), or within four calendar days of arriving at an on-site 
central accumulation area (CAA) or on-site interim status or permitted 
treatment, storage, or disposal facility (TSDF).
    The Agency also proposed that the unwanted materials would be 
regulated in the laboratory by performance-based container labeling and 
container management standards. These performance-based standards for 
the management of unwanted materials in the laboratory were coupled 
with a requirement for a Laboratory Management Plan (LMP). This 
combination provided flexibility by allowing the college or university 
to specify in its LMP how it would comply with the performance-based 
standards. The Agency co-proposed two options regarding the 
enforceability of the contents of the individual LMPs that colleges and 
universities developed. One option was that the contents of the LMP 
would be enforceable; the second option was that the contents of the 
LMP would not be enforceable.
    Additionally, we proposed that all containers of unwanted materials 
would have to be removed from the laboratory on a regular basis, not to 
exceed six months. However, if a laboratory accumulated more than 55 
gallons of unwanted material before the regularly scheduled removal, 
then all containers of unwanted material would have to be removed from 
the laboratory within ten calendar days. Likewise, if a laboratory 
accumulated more than 1 quart of reactive acutely hazardous unwanted 
material prior to the regularly scheduled removal, then the reactive 
acutely hazardous unwanted materials would have to be removed from the 
laboratory within ten calendar days.
    Finally, to address the problem of laboratories keeping old, 
unneeded, or expired chemicals (i.e., ``legacy chemicals''), the Agency 
proposed regulatory provisions that would give colleges and 
universities incentives for conducting laboratory clean-outs: a

[[Page 72915]]

laboratory clean-out could occur over a 30 day period, even if the 55-
gallon limit of unwanted material was exceeded; and the hazardous waste 
generated during a laboratory clean-out would not have to be counted 
toward the college or university's generator status. However, we 
proposed that colleges and universities could only utilize the clean-
out incentives once per 12 months per laboratory.
    The comment period for the proposed rule was originally due to 
close on August 21, 2006. However, EPA received a request from the 
National Association of College and University Business Officers 
(NACUBO), on behalf of the American Council on Education (ACE), the 
Campus Safety Health and Environmental Management Association (CSHEMA), 
and the Campus Consortium for Environmental Excellence (C2E2) to extend 
the comment period for 45 days. On August 21, 2006, EPA extended the 
public comment period by 30 days (see 71 FR 48500). The comment period 
for the proposed rule closed on September 20, 2006.
    The Agency received 111 comments on the proposed rule. 
Approximately two-thirds of the comments were from colleges and 
universities, or trade groups that represent colleges and universities. 
In general, colleges and universities were very supportive of the 
Agency's effort to address the challenges they face in complying with 
the RCRA hazardous waste regulations in their laboratories. However, 
many of these commenters also suggested specific changes to the rule. 
Thirteen States also submitted comments. Some States expressed support 
for the rule, while others were very skeptical of the need for the 
rule. Most of the rest of the comments were from organizations that 
were not eligible to participate in Subpart K, as proposed. These 
commenters, which included non-profit research organizations, 
commercial companies that conduct research and manufacture 
pharmaceuticals and other products, as well as several Federal 
governmental agencies, requested that the Agency expand the scope of 
the final rule to allow them to be subject to Subpart K. The more 
significant comments on the proposal are addressed later in this 
preamble, in section III, but all are addressed in the Response to 
Comments Document for today's final rule found in the docket at http://
www.regulations.gov (EPA-HQ-RCRA-2003-0012).

B. Rationale of the Final Rule

    In the proposal, the Agency discussed how the hazardous waste 
generation and management practices at college and university 
laboratories differ from both industrial production and industrial 
laboratory operations in several meaningful ways (see 71 FR 29714). 
These differences, which were confirmed by many of the commenters, 
provide the rationale for today's final rule.
    Specifically, the Agency identified four primary differences 
between laboratory operations at colleges and universities and typical 
industrial production facilities. First, laboratories at colleges and 
universities 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 have a different hazardous 
waste generation pattern; they tend to generate a 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 
college and university laboratories are students. Students are 
inherently transient, which makes it more difficult to train them. This 
fourth difference sets college and university laboratories apart not 
only from typical industrial production facilities, but also from non-
academic, government and commercial R&D laboratories. At both 
industrial production facilities and non-college or university, 
commercial laboratories, employees who generate hazardous waste are 
professionally trained in managing hazardous wastes and are held 
accountable due to their employee status.
    The proposal addressed challenges faced by colleges and 
universities that result from these differences, and proposed to 
establish a new, optional Subpart K under 40 CFR part 262 for making 
the hazardous waste determination, and accumulating and removing 
unwanted materials from laboratories at colleges and universities. 
Comments from colleges and universities and their trade associations 
confirm EPA's conclusion that differences in hazardous waste generation 
and management activities at laboratories at academic institutions 
warrant this alternative set of requirements. Because of these 
differences, the alternative generator requirements found in Subpart K 
are directed at the management of unwanted materials in the laboratory 
and not in other areas on the same site where hazardous waste may be 
generated or managed.
    Therefore, today EPA is finalizing an alternative set of generator 
regulations for the management of hazardous waste generated in 
laboratories at specific types of academic facilities (i.e., eligible 
academic entities). Based on comments received on the proposed rule, as 
well as additional analysis, the Agency is finalizing the rule with 
some changes from the proposal. The Agency believes that today's final 
rule is better suited to the circumstances specific to these 
laboratories, and that it promotes environmental protection and public 
health through safer management of laboratory hazardous wastes.

C. Summary of the Final Rule

    This section provides a brief overview of today's final rule and 
describes the major ways in which today's rule differs from the 
proposal. For a detailed description and justification of the changes 
in today's final rule, see Section III of today's preamble.
    The final rule establishes a set of alternative generator 
regulations for laboratories owned by eligible academic entities under 
a new Subpart K in 40 CFR part 262. Eligible academic entities may 
choose to be subject to Subpart K in lieu of the existing generator 
requirements for the management of the hazardous waste generated in the 
laboratories that they own. Laboratories operating under Subpart K must 
comply with the performance-based standards, while the unwanted 
materials remain in the laboratory. The eligible academic entity also 
must develop an LMP that reasonably addresses the nine elements that 
are required to be part of the LMP and that describes how the eligible 
academic entity will comply with the performance-based standards. The 
final rule also provides incentives for eligible academic entities to 
conduct laboratory clean-outs of old, unneeded chemicals.
    One of the major changes from the proposed rule found in today's 
final action is the Agency's decision to expand the applicability of 
the rule. Specifically, the scope of the final rule includes colleges 
and universities, non-profit research institutes that are owned by or 
have a formal written affiliation agreement with a college or 
university, and teaching hospitals that are owned by or have a formal 
written affiliation agreement with a college or university.
    In addition, although the proposed rule specifically precluded 
laboratories

[[Page 72916]]

at colleges or universities that are CESQGs from choosing to be subject 
to Subpart K, the final rule allows laboratories that are owned by 
eligible academic entities that are CESQGs, SQGs or LQGs to operate 
under Subpart K. We also have modified the definition of laboratory, so 
that additional areas within an eligible academic entity, such as photo 
laboratories, field laboratories, and art studios are considered 
laboratories. In addition, chemical stockrooms and preparatory 
laboratories and other areas that provide a support function to 
research and teaching laboratories, are allowed to operate under 
Subpart K.
    EPA recognizes that the details of hazardous waste management 
operations vary widely among campuses and some eligible academic 
entities have developed programs consistent with the existing generator 
regulations that have proven to be successful. Thus, these institutions 
may be reluctant to change from the generator regulations under which 
they are currently operating. Therefore, today's final rule, like the 
proposal, remains an optional, alternative set of requirements to the 
existing generator regulations and eligible academic entities may 
continue to manage their laboratory hazardous wastes under the current 
hazardous waste generator regulations. Eligible academic entities that 
would like the additional flexibility of today's rule may choose to 
manage their laboratory hazardous wastes according to the set of 
generator regulations we are finalizing today.
    Public comments received on the proposed rule confirmed that the 
primary difficulty with managing laboratory hazardous wastes under 
current regulations is making the hazardous waste determination at the 
point of generation. As with the proposal, the final rule addresses 
this challenge by providing flexibility with regard to where and when 
the hazardous waste determination can be made (i.e., in the laboratory 
before it is removed from the laboratory, or within four calendar days 
of arriving at an on-site CAA, or on-site TSDF), provided all unwanted 
materials (as defined by the rule) that are generated in the laboratory 
are managed according to the requirements promulgated in today's rule.
    EPA continues to stress that today's final rule does not alter or 
move the point of generation of any hazardous waste, but merely allows 
the hazardous waste determination to be made at an on-site CAA or on-
site TSDF; or in the laboratory, but at a point in time after the 
initial generation of the waste. The point of generation of the 
hazardous waste continues to be the location and time at which the 
hazardous waste is first generated. Therefore, the applicability of the 
land disposal restrictions (LDRs) to hazardous wastes generated in the 
laboratory are not affected by today's rule and continue to ``attach'' 
at the point of generation of the hazardous waste. In addition, RCRA's 
statutory inspection and enforcement authorities continue to apply in 
the laboratory, even though under Subpart K the hazardous wastes are 
referred to as ``unwanted materials,'' while they remain in the 
laboratory.
    Today's final rule maintains the proposed requirement that unwanted 
materials must be removed from the laboratory primarily on a time 
basis, and secondarily on a volume basis. That is, we are requiring 
that eligible academic entities conduct removals of unwanted materials 
from the laboratory on a regular basis, not to exceed six months, 
although we have included some additional flexibility. If a laboratory 
accumulates more than 55 gallons of unwanted material (including 
reactive acutely hazardous unwanted material) before the regularly 
scheduled removal, then all unwanted materials (including reactive 
acutely hazardous unwanted material) must be removed within ten 
calendar days. And if a laboratory accumulates more than 1 quart of 
reactive acutely hazardous unwanted material before the regularly 
scheduled removal, then the reactive acutely hazardous unwanted 
material must be removed from the laboratory within ten calendar days.
    Another key issue identified by the academic community that we 
addressed in the proposal focused on incentives for discarding unneeded 
or expired chemicals that can accumulate in college and university 
laboratories and chemical store rooms. The academic community contends 
that the existing generator regulations result in discouraging 
laboratory clean-outs (because the increased quantities of hazardous 
waste generated can change the eligible academic entity's generator 
status) and therefore, laboratories often hold on to expired chemicals, 
some of which become dangerous over time. EPA believes that revising 
the regulations to encourage laboratories to remove legacy chemicals 
will result in greater protection of human health and the environment, 
as well as increased environmental compliance. Thus, an important part 
of this final rule is the laboratory clean-out provisions: once per 12 
months per laboratory, a laboratory will have 30 days to conduct a 
clean-out and will not have to count the hazardous waste that consists 
of unused commercial chemical products (either listed or 
characteristic) generated during those 30 days towards the eligible 
academic entity's generator status.
    As in the proposed rule, today's final rule pairs a performance-
based approach for management of unwanted materials in the laboratory 
with a requirement for the eligible academic entity to develop and 
implement an LMP. We believe that a performance-based approach will 
allow eligible academic entities greater flexibility by allowing them 
to tailor their laboratory waste management program with respect to 
container labeling, container management, and training, while ensuring 
better environmental results. Like the proposal, under today's final 
rule, the LMP must describe how an eligible academic entity will meet 
the required provisions (i.e., the performance-based standards) by 
reasonably addressing all the required elements. However, unlike the 
proposal, the LMP under today's final rule must include two distinct 
parts (Parts I and II). The eligible academic entity must comply with 
the specific contents it includes in Part I of its LMP, while Part II 
will comprise the institution's best management practices (BMPs). Thus, 
EPA and authorized States may take enforcement action against an 
institution if it fails to meet the specifics of Part I of its LMP. 
However, EPA and authorized States may not take enforcement action if 
an institution's actions vary from the specific procedures contained in 
Part II of its LMP, but may take enforcement action if the institution 
fails to reasonably address all the required elements in Part II of its 
LMP.
    In summary, the Agency believes that today's rule will lead to the 
safe management of unwanted materials and greater environmental 
protection by requiring that the RCRA hazardous waste determination be 
performed by trained personnel, rather than by untrained students. We 
also believe that today's final rule will promote the protection of 
human health and the environment by ensuring that all unwanted 
materials which may, in whole or in part, be RCRA hazardous wastes, are 
safely managed while in the laboratory prior to the time that the 
hazardous waste determination is made. In addition, EPA believes that 
the requirement to develop and implement an LMP will improve the 
coordination and integration of hazardous waste management procedures 
and enhance environmental awareness among researchers and students at 
eligible

[[Page 72917]]

academic entities, leading to a transfer of good environmental 
management practices to the larger community.

D. Effective Date of the Final Rule

    This final rule is effective on December 31, 2008 section 3010(b) 
of RCRA allows EPA to promulgate a rule with an effective date shorter 
than six months where the Administrator finds that the regulated 
community does not need additional time to come into compliance with 
the rule. This rule is optional for those eligible academic entities 
that choose to follow it. For those entities, this rule provides an 
alternative set of requirements that are intended to provide them 
flexibility from current applicable regulations. Therefore, the Agency 
finds that the regulatory community does not need six months to come 
into compliance.

III. Detailed Discussion of the Final Rule

    Today, EPA is publishing a final rule establishing alternative 
regulations (40 CFR part 262, Subpart K) for the management of unwanted 
materials generated in laboratories in eligible academic entities. This 
section discusses in detail the major features of the final rule and 
the rationale for the changes made from the proposal to today's final 
rule.
    In today's final rule and preamble, we introduce and use several 
new terms. We are including here a brief description of how we will use 
the terminology in today's preamble. First, we will use the terms 
``choose to become subject to,'' ``participate under,'' ``operate 
under'' and ``opt in'' to Subpart K interchangeably. Second, the 
regulations require that in order to be eligible to opt into Subpart K, 
a non-profit research institute must be owned by or have a formal 
written affiliation agreement with a college or university, and a 
teaching hospital must be owned by or have a formal written affiliation 
agreement with a college and university. In the preamble, we will 
generally refer to eligible academic entities other than colleges and 
universities as non-profit research institutes and teaching hospitals 
that are owned by or formally affiliated with a college or university.
    Third, many eligible academic entities have multiple EPA 
Identification Numbers for different sections of the same ``campus,'' 
typically because the sections of the eligible academic entity are 
separated by public roads. When referring to the individual sections of 
an eligible academic entity, we will use the term ``site'' or ``EPA 
Identification Number.'' When referring collectively to all the 
sections of the eligible academic entity, we will use the term, 
``campus,'' or ``eligible academic entity,'' or ``institution.'' As an 
example, when an eligible academic entity opts into Subpart K for its 
laboratories, it must notify the Agency for each EPA Identification 
Number on a campus that is opting in.

A. Scope of Eligible Academic Entities Covered Under the Final Rule

    EPA proposed that this alternative set of generator regulations 
would apply only to laboratories at colleges and universities. As 
discussed in section II.A of today's preamble, EPA has had a long 
history of interaction with colleges and universities. From these 
interactions, the Agency has learned about the unique hazardous waste 
generation pattern in teaching and research laboratories at colleges 
and universities. However, EPA recognized that there may be additional 
types of facilities with laboratories that may fit the rationale for 
Subpart K. Thus, while the proposal was limited to colleges and 
universities, EPA solicited comment on whether to expand the scope of 
the final rule to other institutions that fit the rationale of Subpart 
K.
    Public comments from trade groups, such as the Association of 
American Medical Colleges (AAMC), the Association of Independent 
Research Institutes (AIRI), the Campus Safety Health and Environmental 
Management Association (CSHEMA), and individual comments submitted by 
non-profit research institutes, teaching hospitals, private research 
and development companies, governmental research laboratories, and 
colleges and universities with teaching hospitals and/or non-profit 
research institutes all asserted that their research laboratories fit 
the hazardous waste generation pattern rationale of today's rule. That 
is, these commenters assert that given the nature of research, research 
laboratories share the same hazardous waste generation patterns, 
regardless of what type of institution they are found in. In addition, 
EPA has conducted site visits in various research laboratories at 
teaching hospitals and private R&D companies, among others, and has 
seen similar hazardous waste generation patterns and activities of 
these laboratories.
    Based on the comments EPA received and additional research by EPA 
regarding the presence of students in laboratories at institutions 
other than colleges and universities, we have expanded the scope of the 
final rule to include specific additional entities that fit all aspects 
of the rationale for this rule. This rationale includes not only a 
hazardous waste generation pattern that is similar to that found at 
college and university laboratories, but also a significant student 
population. EPA did not expand the scope of the final rule to include 
certain entities because they did not fit all aspects of the rationale 
for this rule. Therefore, today's final rule allows colleges and 
universities, teaching hospitals that are owned by or have a formal 
written affiliation agreement with a college or university, and non-
profit research institutes that are owned by or have a formal written 
affiliation agreement with a college or university, to opt into Subpart 
K. This expansion includes laboratories at facilities that we and many 
commenters believe are closely integrated with laboratories at colleges 
and universities. Collectively, we are calling the entities that are 
eligible to opt into today's final rule, ``eligible academic 
entities.'' Details on these entities are contained in the following 
sections. (For information regarding changes to the definition of 
laboratory, see section III.B.2 and Sec.  262.200.)
1. Hazardous Waste Generation Data
    In the preamble to the proposed rule, we stated that 9% of the 
hazardous waste generated at college and university LQGs was from 
laboratories. We received several comments from colleges and 
universities asserting that we erred in our estimates and that at their 
campuses, laboratory hazardous waste constituted a much higher 
percentage of their total hazardous waste. The Agency sent follow-up 
letters to several commenters requesting additional information in 
support of their comments. In response to our inquiries, many of the 
commenters supplied detailed information about their hazardous waste 
generation and one commenter provided a detailed analysis of our 
methodology for determining the percentage of laboratory hazardous 
waste, including specific suggestions on how to improve the methodology 
for the final rule. The follow-up letters and the responses are all 
included in the docket for today's rule.
    As a result of these comments, EPA has significantly revised the 
methodology used in the proposal to determine the total quantity of 
hazardous waste and laboratory hazardous waste. Specifically, in the 
proposal, we used key-word searches of the description field on 
Biennial Report (BR) forms to identify laboratory hazardous waste as a 
percent of the total hazardous waste generated. Our revised methodology 
uses three source codes

[[Page 72918]]

from the BR to identify which hazardous wastes are from laboratories:
    (1) G11--Discarding off-specification or out-of-date chemicals or 
products (unused chemicals or products--corresponds to P and U 
hazardous waste codes);
    (2) G22--Laboratory analytical wastes (used chemicals from 
laboratory operations), and
    (3) G09--Other production or service-related processes from which 
the waste is a direct outflow or result. (Because hazardous waste from 
the source code G09 could also be generated in non-laboratory 
operations, these wastes were only considered laboratory wastes if the 
waste form codes indicated it was shipped in a lab pack (i.e., waste 
form codes W001 or W004)).
    Additional laboratory wastes were identified using key-word 
searches of the description field. This revised method resulted in a 
much higher estimate for laboratory hazardous waste as a percent of 
total hazardous waste at colleges and universities--73% under the 
revised methodology, compared to 9% under the original methodology used 
in the proposed rule. This revised methodology was used to calculate 
the amount of laboratory hazardous waste generated as a percent of the 
total hazardous waste generated for colleges and universities, as well 
as for other types of facilities with laboratories that we considered 
including in today's final rule: teaching hospitals, non-profit 
research institutes, governmental research laboratories, and commercial 
R&D laboratories. For a full explanation of the methodology used to 
determine the amounts of total hazardous waste and laboratory hazardous 
waste generated at colleges and universities, teaching hospitals, and 
non-profit research institutes, see the memo entitled, Lab Rule Data 
Analyses, from ICF International to Patricia Mercer, May 1, 2008; and 
for hazardous waste information for LQG government research 
laboratories and LQG commercial R&D laboratories see the memo entitled, 
Final Analyses of College and University Laboratory Hazardous Waste, 
from ICF International to Patricia Mercer, August 17, 2007. Copies of 
both memos are in today's docket.
    Below is a table of the hazardous waste data for eligible academic 
entities (i.e., those entities eligible to opt into Subpart K) that are 
LQGs. Using the revised methodology, we now estimate that for college 
and university LQGs, 73% of their total hazardous waste is from 
laboratories. The percent of hazardous waste coming from laboratories 
at teaching hospitals and non-profit research institutes is even 
higher--81% and 92%, respectively. Further, with all three types of 
eligible academic entities, nearly all LQGs generate laboratory 
hazardous waste.

----------------------------------------------------------------------------------------------------------------
                                                                                                    Non-profit
                                                                   Colleges and      Teaching        research
                                                                   universities    hospitals \1\  institutes \2\
----------------------------------------------------------------------------------------------------------------
 LQGs generating laboratory hazardous waste............             286             104               8
 LQGs generating hazardous waste.......................             293             109               8
% that generate laboratory hazardous waste......................              98              95             100
Tons of laboratory hazardous waste..............................           6,530           1,712             119
Tons of all hazardous waste \3\.................................           8,951           2,119             130
% of hazardous waste that is laboratory hazardous waste.........              73              81              92
----------------------------------------------------------------------------------------------------------------
\1\ To be eligible to opt into Subpart K, a teaching hospital must be owned by or have a formal written
  affiliation agreement with a college or university
\2\ To be eligible to opt into Subpart K, a non-profit research institute must be owned by or have a formal
  written affiliation agreement with a college or university
\3\ Excludes remediation wastes because remediation wastes are not regularly generated hazardous wastes, but
  rather are hazardous wastes generated only when a clean-up or remediation project takes place.

    As discussed above, based on EPA's observations, as well as 
comments that we have received and given the nature of teaching and 
research, activities conducted at teaching and research laboratories in 
colleges, universities, teaching hospitals, and non-profit research 
institutes are comparable and therefore share similar hazardous waste 
generation patterns. EPA identified challenges associated with the 
specific hazardous waste generation patterns, such as difficulty making 
hazardous waste determinations with a large variety of wastestreams. 
These difficulties, along with the difficulties associated with the 
presence of a significant student population, form the basis of this 
rule. Even at proposal, when we estimated that 9% of a college or 
university's hazardous waste was generated in the laboratory, we 
believed that these challenges were sufficient to warrant the 
development of Subpart K. With the revised estimates indicating that 
the percentage of hazardous waste generated in laboratories by eligible 
academic entities being much higher, these specific challenges are 
shown to be even more pervasive and support the need for the 
flexibility offered by Subpart K for these particular entities.
    Given that these types of organizations with research and teaching 
laboratories share similar hazardous waste generation patterns, we 
focused on the extent to which these entities had a significant student 
presence, which is a very important basis of today's rule. Because 
students are inherently transient, and generally have less 
accountability than professionals employed in laboratories, it is 
unlikely that they will make a proper hazardous waste determination 
which requires detailed knowledge of RCRA. The following discussion of 
which entities are and are not eligible to opt into today's rule 
focuses on whether there is a significant student presence. However, 
there are limited data readily available about the number of students 
in laboratories even at colleges and universities much less for 
entities, such as teaching hospitals and non-profit research 
institutes. Thus, we used certain factors as indications that the 
organization did indeed have students in the laboratories. Examples of 
factors indicating student presence include programs for high school, 
undergraduate, or graduate students to conduct laboratory research, 
presence of medical residents/interns, co-sponsored degree programs 
with colleges or universities, or classes offered independent of the 
college or university.
2. Laboratories Owned by Teaching Hospitals
    In the proposal, EPA specifically requested comment on whether 
laboratories in hospitals affiliated with colleges or universities 
should be included in the final rule. Previously, information about 
hospital laboratories led EPA to believe that their wastestreams are 
fairly routine and they

[[Page 72919]]

did not have the same challenges faced by college or university 
laboratories in training their workers. Through comments, EPA learned 
that many teaching hospitals owned by or formally affiliated with a 
college or university have research and teaching laboratories in 
addition to diagnostic laboratories dedicated to patient care. As 
stated earlier, research laboratories at teaching hospitals have 
similar hazardous waste generation patterns as research laboratories on 
a college or university campus. In addition, such teaching hospitals 
have students working in the laboratories to learn how to run various 
tests, how to operate equipment, or to conduct research with 
professors.
    In fact, one commenter asserted that, ``these types of laboratories 
[laboratories at college or university affiliated hospitals and other 
similar locations such as dental colleges, clinics and associated 
laboratories] are very similar to instructional and research 
laboratories. They are used by a large number of students; they are 
used for instructional and research purposes; while some processes are 
static and predictable, others are not; large numbers of different 
wastestreams are produced, but in relatively small quantities.'' 
Another commenter wrote, ``Research labs in a hospital are essentially 
the same as a research lab in a college or university and have similar 
waste generation patterns.''
    Based on these comments, EPA conducted additional research into the 
types of laboratories that are present at teaching hospitals that are 
owned by or formally affiliated with a college or university. In 
particular, EPA identified three types of laboratories: (1) Clinical 
diagnostic laboratories that conduct typical laboratory tests related 
to patient care, (2) applied research laboratories that conduct 
clinical trials and (3) research laboratories that conduct basic 
medical research. While strictly speaking, clinical diagnostic 
laboratories may not exhibit the hazardous waste generation pattern 
identified in the rationale for this rule, we found that the setup in 
teaching hospitals makes it difficult to draw hard distinctions between 
the various types of laboratories. That is, each teaching hospital 
divides its laboratory space differently and oftentimes a single 
laboratory serves multiple functions, such as both diagnostic testing 
and research. Furthermore, in some cases, laboratory personnel perform 
multiple functions within a laboratory and are involved with both 
diagnostic and research activities. Thus, EPA has determined that it 
would be extremely difficult to implement a rule that made a 
distinction between the various types of laboratories at such teaching 
hospitals.
    The Agency also analyzed data from the BR which are sent to the 
Agency every other year by LQGs and housed in EPA's RCRAInfo database, 
to find out more about the universe of non-teaching and teaching 
hospitals owned by or formally affiliated with a college or university 
and their hazardous waste generation patterns. Notably, one of the main 
differences between the hazardous waste generation patterns at LQG 
teaching hospitals owned by or formally affiliated with a college or 
university and non-teaching hospitals is in the amount of laboratory 
hazardous waste as a percentage of the total amount of hazardous waste 
generated. Specifically, teaching hospitals showed approximately 80% of 
the total quantity of hazardous waste generated coming from 
laboratories, while non-teaching hospitals only had 13% of the total 
quantity of hazardous waste generated coming from laboratories. EPA 
attributes this disparity to be the result of the greater amount of 
research generally occurring in teaching hospitals owned by or formally 
affiliated with a college or university.
    In terms of the transient students, EPA has learned from its 
research that teaching hospitals instruct a variety of students--
interns, residents, nursing students, laboratory technicians, and more, 
in the hospital. Instruction of these students includes work in the 
laboratories to learn about the processes and tests conducted there, 
introducing similar difficulties as those encountered at colleges and 
universities in teaching and training transient students and making the 
hazardous waste determination. In fact, one commenter asserted that, 
``the amount of time a student spends at a teaching hospital is 
comparable to that of a graduate student in another laboratory 
discipline.'' Also, medical research at a college and university 
oftentimes is shared between the college and university laboratories 
and teaching hospital laboratories. One commenter pointed out that 
professors, graduate students, and undergraduate students often go back 
and forth between laboratories at colleges and universities, and at 
teaching hospitals, to conduct research.
    EPA recognizes that a teaching hospital that is owned by a college 
or university will instruct students from its medical school. However, 
due to the complex healthcare system, many times medical students or 
residents from a medical school will train in a teaching hospital that 
is affiliated with a college or university, but not owned by the 
college or university. We do not want to preclude these teaching 
hospitals that are training students and have a significant transient 
student population from participating in Subpart K. Therefore, EPA 
looked for a way to define the concept of ``affiliated teaching 
hospital.'' We discovered that the Accreditation Council for Graduate 
Medical Education (ACGME) defines two types of agreements between a 
medical school and a teaching hospital: A master affiliation agreement 
and a program letter of agreement.\2\ EPA has determined that the 
presence of both these agreements indicates that a teaching hospital is 
formally affiliated with a college or university.
---------------------------------------------------------------------------

    \2\ The ACGME defines these terms in the ``Glossary of Terms'' 
that appears on its Web site at http://acgme.org/acWebsite/about/
ab_ACGMEglossary.pdf. The ACGME also describes these documents in 
more detail in a document called Frequently Asked Questions Related 
to Master Affiliation Agreements and Program Letters of Agreement 
that appears on its Web site at  http://acgme.org/acWebsite/about/
ab_FAQAgreement.pdf.
---------------------------------------------------------------------------

    Based on the evidence provided by commenters and additional EPA 
research, we have concluded that teaching hospitals owned by or 
formally affiliated with a college or university fit within all aspects 
of the rationale of today's final rule: many hazardous wastes that vary 
over time are generated in small quantities at many points of 
generation, and there is a significant and transient student population 
that is not familiar with the RCRA hazardous waste requirements. 
Therefore, EPA is allowing teaching hospitals, as defined in this final 
rule that are either owned by or have a formal written affiliation 
agreement with a college or university, to opt into Subpart K for their 
laboratories. (See section III.B.3 for a discussion of the definition 
of teaching hospital and formal written affiliation agreement or Sec.  
262.200.)
3. Laboratories Owned by Non-profit Research Institutes
    EPA received many comments from representatives of non-profit 
research institutes, colleges and universities, and trade groups 
stressing the similarities between college and university laboratories 
and the laboratories at non-profit research institutes in terms of the 
hazardous waste generation pattern rationale identified in the rule and 
the student presence in the laboratories. As indicated above, a 
research laboratory at a non-profit research institute that is owned by 
or has a formal written affiliation agreement with a college or 
university shares the same hazardous waste generation pattern.

[[Page 72920]]

    In terms of the presence of a significant transient student 
population, one commenter explained that as a non-profit research 
institute, it has close ties with the local university; they 
collaborate with the university on projects and faculty hold joint 
appointments. The commenter added that students and researchers often 
travel between the non-profit's laboratories and the local university's 
laboratories and that because the hazardous waste management 
requirements at both institutions are the same under the existing 
generator regulations, currently there are minimal differences in 
hazardous waste management for the students and researchers to learn 
when working at both institutions. Thus, the commenter requested that 
EPA add non-profit research institutes to the final rule in order to 
minimize confusion and training challenges under Subpart K.
    In response to these comments, EPA conducted additional research 
and identified from the BR information housed in the RCRAInfo database, 
nine non-profit research institutes that are LQGs (see section III.A.1 
for information on their hazardous waste generation). For all nine LGG 
non-profit research institutes, we were able to obtain readily 
available information on student populations and programs, as well as 
substantial evidence that non-profit research institutes are similar to 
colleges and universities in that they sometimes grant degrees of their 
own, co-sponsor degrees with colleges and universities, teach classes, 
and share faculty, funding sources, and laboratory space with colleges 
and universities. We determined that the information obtained is 
generally representative of the universe of laboratories at non-profit 
research institutes, because among the non-profits we researched, we 
found that their hazardous waste generation patterns and student 
programs were remarkably homogenous.
    One commenter wrote, ``* * * the distinction between a research 
laboratory in a college and university and a research laboratory in an 
institution that is not a college and university has blurred 
considerably over the last decade.'' As EPA conducted additional study 
into non-profit research institutes, it was difficult for the Agency to 
draw a hard line between college and universities and non-profit 
research institutes. For example, Memorial Sloan-Kettering Cancer 
Center (MSKCC) is a non-profit cancer research institute, a teaching 
hospital, a graduate school in biomedical sciences, and is in 
partnership with the Weill Cornell Graduate School of Medical Sciences 
and Cornell University to train students in research and patient care. 
MSKCC also partners with New York-Presbyterian Hospital, the Hospital 
for Special Surgery, and the Rockefeller University. Via these 
partnerships, the majority of the faculty of the Weill Cornell Medical 
Graduate School of Medical Sciences has their research laboratories and 
other facilities located within the Weill Cornell Medical College-New 
York-Presbyterian Hospital Complex and the MSKCC's research laboratory 
buildings. Another outgrowth of this partnership is that MSKCC jointly 
administers a Ph.D. program with Cornell and Weill Medical College in 
computational biology and medicine. Finally, besides its own graduate 
school of biomedical sciences, MSKCC offers two certificate programs 
for students to learn cytotechnology and radiation therapy.
    As shown in the example above, a non-profit research institute 
owned or formally affiliated with a college or university may be so 
closely associated with the college and university that excluding them 
will prevent colleges and universities from establishing one laboratory 
waste management system, introducing confusion among researchers 
working in laboratories at both institutions. In this situation, such 
non-profit research institutes are virtually identical to a college and 
university and their hazardous waste generation patterns and student 
presence fit within the rationale of this rule. This information made 
it clear to us that non-profit research institutes often are 
``academic'' and should be eligible to opt into today's final rule, 
when they are owned by or formally affiliated with a college or 
university.
    One commenter recommended that EPA expand the scope of the rule to 
any institution that has a formal affiliation with a college or 
university. While the Agency does not believe it should expand the 
scope of the rule to all institutions that have any kind of an 
affiliation with a college or university, we do believe it is 
appropriate to allow those non-profit research institutes that have a 
formal written affiliation agreement with a college or university to 
opt into Subpart K. In order to ensure that the formal written 
affiliation agreement between the two entities represents an 
affiliation that is longstanding, we believe that the affiliation must 
be at the institutional level, as opposed to an agreement between staff 
or professors at the two eligible academic entities. Of the nine non-
profit research institutes that are identified as LQGs in the BR, we 
determined that eight had formal affiliations with colleges and 
universities on an institutional level. For example, the Burnham 
Institute not only administers its own graduate program, it also has an 
institutional affiliation with the University of California at San 
Diego by participating in a joint graduate training program in 
molecular pathology (where approximately 30 graduate students a year 
obtain their primary scientific training at the Institute).
    The reason we are requiring a formal written affiliation agreement 
at the institutional level is because having a formal affiliation at 
the institutional level with a college or university seemed to increase 
the likelihood that the non-profit research institutes would have 
students in their laboratories. The presence of a significant transient 
student presence is an important rationale of today's rule. Typically, 
a formal affiliation at the institutional level allows students at a 
college or university to conduct thesis research at the non-profit 
research institute, use non-profit researchers as mentors, and at 
times, take some of their degree classes at the non-profit research 
institute. Further, requiring a formal written affiliation agreement 
between the non-profit research institute and a college or university 
will assist the implementing agency verify that an affiliation at the 
institutional level exists. Thus, for these reasons, we decided to 
limit today's rule to those non-profit research institutes that have a 
formal written affiliation at the institutional level with a college or 
university. For a discussion of the definition of ``formal written 
affiliation agreement,'' see section III.B.3 of this preamble or Sec.  
262.200.
4. Laboratories Owned by Eligible Academic Entities That Are 
Conditionally Exempt Small Quantity Generators (CESQGs)
    EPA recognizes that laboratories at eligible academic entities that 
are CESQGs share the same hazardous waste generation patterns as 
laboratories at larger generators, except the eligible academic 
entities that are CESQGs generate smaller quantities of hazardous 
waste. However, while laboratories at CESQGs fit within the rationale 
used to define the scope of this rule, the proposal did not allow them 
to opt in. At the time of the proposal, we had thought CESQGs would not 
want to opt into Subpart K since they currently are not subject to the 
controls that apply to satellite accumulation areas (SAAs) and do not 
have to comply with most of the other requirements that apply to LQGs 
and SQGs. In fact, many of the

[[Page 72921]]

provisions in today's final rule would be more stringent than those to 
which they are currently subject under Sec.  261.5. At proposal, we 
solicited comment on whether the final rule should include laboratories 
at CESQGs.
    Numerous commenters indicated that we should provide CESQGs with 
the same opportunity as SQGs and LQGs to assess which set of generator 
regulations is most appropriate for their laboratories and that we 
should not prohibit them from opting into Subpart K. Additionally, many 
comments from colleges and universities indicated that laboratory 
management would improve if their CESQG sites with laboratories could 
operate under this rule and follow the required LMP. Further, 
commenters explained that since colleges and universities often have 
CESQG sites, as part of a larger campus, a college or university may 
want to be able to manage all of its laboratories under one management 
system and that EPA should allow CESQGs to participate in Subpart K. 
This issue is particularly pertinent for urban college and university 
campuses that are divided by public roads. One campus can potentially 
include many separate generator sites, some LQGs, some SQGs, and some 
CESQGs. In light of the comments received, EPA agrees that it makes 
sense that at least some CESQGs would want to opt into Subpart K. Thus, 
EPA is allowing eligible academic entities to opt into Subpart K for 
their CESQG sites and is allowing stand-alone CESQGs to opt into 
Subpart K, as well. CESQG sites at an eligible academic entity may 
include field laboratories and small laboratories separated from the 
main campus by public roadways. In addition, we expect that some 
eligible academic entities that are themselves CESQGs (i.e., stand-
alone CESQGs), such as small non-profit research institutes, may choose 
to opt into the rule to take advantage of the clean-out provisions.
    Other commenters argued that the rule would encourage better 
environmental performance by extending the laboratory clean-out 
provisions to eligible academic entities that are themselves CESQGs or 
have CESQG sites without requiring them to comply with the rest of the 
Subpart K requirements. EPA agrees that stand-alone CESQGs and CESQG 
sites that are part of a larger eligible academic entity will benefit 
by removing legacy chemicals from the laboratory by taking advantage of 
the clean-out incentives of today's rule. However, EPA is not allowing 
a stand-alone eligible academic entity or a CESQG site that is part of 
a larger eligible academic entity to partake only in the laboratory 
clean-out provisions and not the other Subpart K requirements because 
this would prevent CESQGs from taking advantage of the two main 
benefits of today's final rule. That is, if a CESQG site only 
participated in the laboratory clean-out provisions, it would not be 
able to take advantage of the flexibility in where and when to make the 
hazardous waste determination. Second, if a CESQG site that is part of 
a larger eligible academic entity only participated in the laboratory 
clean-out provisions, it would be unable to establish one hazardous 
waste management system in all the laboratories at the eligible 
academic entity. The ability to establish a unified hazardous waste 
management system for all laboratories is one of the priorities cited 
by academic commenters. Therefore, in order for a CESQG site at an 
eligible academic entity or an eligible academic entity that is itself 
a CESQG to take part in the laboratory clean-out incentives, the 
eligible academic entity must opt into Subpart K in its entirety and 
follow the management standards for unwanted materials in the 
laboratories.
5. Facilities With Laboratories Not Eligible To Participate in Subpart 
K
    As explained above, EPA solicited comment on whether to expand the 
scope of the rule beyond laboratories at colleges and universities to 
laboratories at other types of facilities. Many commenters supported 
expansion of the scope of the rule. We received comments from both 
government research laboratories and commercial R&D laboratories 
requesting to be included in this rulemaking. Overall, from the 
information available at this time, it appears that laboratories at 
both of these types of facilities have hazardous waste generation 
patterns similar to laboratories at colleges and universities--
generating small quantities of many types of waste that vary over time 
at many points of generation--since they are research laboratories. 
However, information about the other key aspect of the rationale for 
today's rule, that is, significant student presence, has led EPA to 
determine that, at this time, laboratories at government research and 
commercial R&D facilities are not eligible to participate in Subpart K.
    (a) Government Research Laboratories: We received comments from a 
number of governmental organizations that have research laboratories 
requesting that they be allowed to participate in (or opt into) Subpart 
K. These commenters, all from the Federal government, asserted that 
they fit the hazardous waste generation pattern explained by EPA as 
part of the rationale for Subpart K. In addition to the public 
comments, EPA collected readily available information on hazardous 
waste generation patterns and student presence in government research 
laboratories. From EPA's BR on hazardous waste generated by LQGs, we 
identified 39 LQG government research laboratories. In addition, in its 
comments on the proposal, one Federal agency provided student numbers 
for ten of its laboratories, three of which we have identified as LQGs. 
We also acquired aggregated student numbers or estimates for three 
other Federal agencies. We were unable to obtain student population 
data at laboratories at the remaining government research laboratories, 
including State and local governmental laboratories. Based on this lack 
of available information, EPA has decided to defer our decision on 
government research laboratories and therefore, government research 
laboratories are not included in this final rulemaking. Rather, in 
2009, EPA expects to prepare a Federal Register Notice soliciting 
additional information about government research laboratories, 
particularly the presence of students at such research laboratories in 
order to make a more informed decision regarding whether or not to 
allow them to opt into Subpart K in the future.
    (b) Commercial R&D Laboratories: EPA requested comment on whether 
private laboratories fit within the rationale of Subpart K and received 
comments from pharmaceutical companies, engineering companies, and a 
utility solid waste activity group, all requesting to be included in 
Subpart K because their laboratories fit within the rationale of the 
hazardous waste generation pattern. Based on these comments and 
responses to follow-up letters to commercial research and development 
laboratories (copies of which are in today's docket), it appears that 
there is a similar hazardous waste generation pattern (i.e., small 
amounts of many different types of waste generated at multiple points 
of generation) as at laboratories at colleges and universities. 
However, there is little evidence of student presence in these 
laboratories as indicated in the follow-up responses from commenters 
and EPA's own research. Without the presence of students, commercial 
R&D laboratories do not have the same challenges in making hazardous 
waste determinations for their laboratory hazardous wastes and in 
training their laboratory personnel. Having similar hazardous waste 
generation patterns is

[[Page 72922]]

only one element in determining which entities should be eligible to 
opt into Subpart K. EPA believes that having a significant student 
presence in the laboratories (which increases the difficulty in 
training and in making hazardous waste determinations) is extremely 
important. Therefore, without meeting the rationale that a significant 
number of students must be present, EPA has decided not to allow 
commercial R&D laboratories to opt into Subpart K.
6. Non-Laboratory Facilities at Eligible Academic Entities
    The Agency received many comments requesting that the rule address 
all types of facilities at a college or university where hazardous 
waste is generated, rather than limiting the rule to teaching and 
research laboratories. Commenters requested that non-laboratory areas, 
such as vehicle maintenance shops, machine shops, maintenance shops, 
fabrication units, athletic departments, power plants/energy generation 
units, print shops, and facilities operations be included in the scope 
of the final rule. Some commenters suggested that we include these 
areas by modifying the definition of laboratory to include them. Other 
commenters stated that creating a dual regulatory system for hazardous 
waste management on college or university campuses would hinder their 
participation in Subpart K and ultimately be confusing.
    While the Agency understands the concerns raised by the commenters, 
we also believe that the Subpart K requirements were developed to 
address specific concerns raised by the academic community as they 
relate to hazardous wastes generated in their laboratories--that is, 
the situations and challenges that exist in teaching and research 
laboratories are unique (e.g., having to identify which of the 
potentially hundreds of different wastestreams meet the definition of 
hazardous waste). The academic community has not raised such concerns 
about the hazardous wastes generated outside of the laboratories. For 
this reason, we believe it is inappropriate to expand the scope of the 
rule beyond laboratories at eligible academic entities.

B. Discussion of Definitions

    All of the definitions that appear in today's final rule are only 
for the purposes of 40 CFR part 262, Subpart K. Therefore, the 
definitions are relevant only to the eligible academic entities that 
have laboratories and choose to be subject to the provisions of today's 
final rule. This section discusses: (1) Those definitions that were 
proposed and have not changed since the proposal; (2) those definitions 
that were proposed, but have been modified based on comments received 
on the proposal; and (3) any new definitions that are being added, 
based on modifications to the final rule or comments on the proposed 
rule.
1. Definitions That Have Not Changed From the Proposed Rule
    The following definitions have not been changed from the proposal. 
In general, we received few comments on these definitions and the 
comments we received on these definitions were supportive. Refer to the 
preamble from the proposed rule for a detailed discussion of these 
definitions (71 FR 29722).
    College/University means a private or public, post-secondary, 
degree--granting, academic institution, that is accredited by an 
accrediting agency listed annually by the U.S. Department of Education.
    Laboratory clean-out means an evaluation of the inventory of 
chemicals and other materials in a laboratory that are no longer needed 
or that have expired and the subsequent removal of those chemicals or 
other unwanted materials from the laboratory. A clean-out may occur for 
several reasons. It may be on a routine basis (e.g., at the end of a 
semester or academic year) or as a result of a renovation, relocation, 
or change in laboratory supervisor/occupant. A regularly scheduled 
removal of unwanted material as required by Sec.  262.208 does not 
qualify as a laboratory clean-out.
    Laboratory worker means a person who handles chemicals and/or 
unwanted material in a laboratory and may include, but is not limited 
to, faculty, staff, post-doctoral fellows, interns, researchers, 
technicians, supervisors/managers, and principal investigators. A 
person does not need to be paid or otherwise compensated for his/her 
work in the laboratory to be considered a laboratory worker. 
Undergraduate and graduate students in a supervised classroom setting 
are not laboratory workers.
    Commenters pointed out that the definition of ``laboratory worker'' 
in the preamble to the proposed rule differed slightly from the 
definition in the proposed regulatory text. In the definition included 
the regulatory text, the last sentence of the definition included the 
words ``Undergraduate and graduate'' when referring to students. 
However, the definition included in the preamble discussion omitted the 
words ``Undergraduate and graduate.'' Today, we are finalizing the 
definition, as it was proposed, so that the final sentence reads, 
``Undergraduate and graduate students in a supervised classroom setting 
are not laboratory workers.''
    It is worth noting that EPA would consider undergraduate or 
graduate students in an unsupervised research setting to be laboratory 
workers. Additionally, any student performing duties of a trained 
professional, such as transferring unwanted materials and hazardous 
wastes outside of a laboratory, would be considered a trained 
professional, rather than a student.
2. Definitions That Have Changed From the Proposed Rule
    This section discusses comments on the definitions that were 
included in the proposed rule, as well as the changes that have been 
made to these definitions in today's final rule.
    Central accumulation area--The Agency proposed to define ``central 
accumulation area'' as: an on-site hazardous waste accumulation area 
subject to either Sec.  262.34(a) of this Part (large quantity 
generators) or Sec.  262.34(d) of this Part (small quantity 
generators). A central accumulation area at a college or university 
that chooses to be subject to this subpart must also comply with Sec.  
262.211 when accumulating unwanted material.
    The Agency has made three minor changes to the proposed definition 
of central accumulation area (CAA). First, we added a reference to the 
hazardous waste accumulation area regulations that are applicable to 
Performance Track members. There are currently three Performance Track 
members that would likely qualify as eligible academic entities (the MD 
Anderson Cancer Center, the University of Texas Medical Branch, and 
Washington State University), and we did not intend to imply that these 
eligible academic entities could not opt into Subpart K when we omitted 
a reference to the hazardous waste accumulation area regulations of 
Sec.  262.34 that pertain to them.
    The second change is to make more complete the reference to the 
hazardous waste accumulation area regulations for SQGs. The proposed 
definition referred only to Sec.  262.34(d), which among other things, 
allows 180 days or less for the on-site accumulation of hazardous 
waste. However, SQGs also have the option of complying with Sec.  
262.34(e), which allows them to accumulate hazardous waste on-site for 
270 days or less, if they must send their hazardous waste more than 200 
miles for treatment, storage or disposal. In

[[Page 72923]]

addition, SQGs are subject to Sec.  262.34(f), which states that if 
more than a total of 6000 kg of hazardous waste is accumulated on-site, 
the generator is a storage facility that is subject to the requirements 
for TSDFs. The third change was made to reflect the expansion of the 
applicability of the final rule beyond colleges and universities to 
eligible academic entities.
    The definition of ``central accumulation area'' in the final rule 
is:

an on-site hazardous waste accumulation area subject to either Sec.  
262.34(a) (or 262.34(j) and (k) for Performance Track members) of 
this part (large quantity generators); or Sec.  262.34(d)-(f) of 
this part (small quantity generators). A central accumulation area 
at an eligible academic entity that chooses to be subject to this 
subpart must also comply with Sec.  262.211 when accumulating 
unwanted material and/or hazardous waste.

    Laboratory--The Agency proposed to define ``laboratory'' as:

    an area within a college or university where relatively small 
quantities of chemicals and other substances are used on a non-
production basis for teaching or research purposes and are stored 
and used in containers that are easily manipulated by one person. An 
area where the same hazardous wastes are routinely generated, such 
as photo processing, is not a laboratory.

    In response to comments and as a result of the expansion of scope 
of the final rule, the Agency has made several changes to the 
definition of laboratory. Specifically, the Agency has made two changes 
to reflect the expansion of scope, as discussed in section III.A of 
today's preamble. The first is to change the phrase ``colleges and 
universities'' to the phrase ``eligible academic entities.'' The second 
change is to indicate that clinical diagnostic laboratories at teaching 
hospitals are included within the scope of the final rule, as well as 
teaching and research laboratories at all eligible academic entities. 
This change is being made due to the expansion of the scope to include 
teaching hospitals.
    As discussed in section III.A.2 of today's preamble, the Agency 
believes, and commenters have supported the conclusion, that it is the 
research laboratories at a teaching hospital that are most similar to 
laboratories at colleges and universities in their hazardous waste 
generation patterns. However, we realize that it would be confusing and 
difficult for institutions to implement today's rule if the research 
laboratories at a teaching hospital were allowed to operate under 
Subpart K, but diagnostic laboratories at the same teaching hospital 
were not allowed to operate under Subpart K. In fact, some commenters 
have indicated that in many cases at teaching hospitals, it is not 
possible to distinguish a research laboratory from a clinical 
laboratory because they share physical space and staff. Therefore, the 
Agency has amended the definition of laboratory to include clinical 
diagnostic laboratories at teaching hospitals so that unwanted 
materials from all of the laboratories at a teaching hospital can be 
managed under the same management standards.
    In addition, in response to numerous comments, the Agency has 
deleted the last sentence from the proposed definition of laboratory: 
``An area where the same hazardous wastes are routinely generated, such 
as photo processing, is not a laboratory.'' The reason the Agency 
originally included this statement in the proposed definition is that 
part of our basis for proposing this rule is that laboratories at 
colleges and universities, unlike other types of hazardous waste 
generators, generate many different types of wastes that vary over 
time. However, based on the comments received, we believe it is no 
longer appropriate to include this sentence for the following reasons. 
First, comments indicated that some photo laboratories do, in fact, 
generate many wastestreams that vary over time--this is especially true 
when the photo laboratories are art studios where students may be 
experimenting with different photographic techniques, such as 
daguerreotype and calotype finishing.
    Second, commenters pointed out that it is not unusual for an 
individual research laboratory to generate the same hazardous waste 
routinely for lengthy periods of time, as it focuses on a single area 
of research. Additionally, commenters pointed out that teaching 
laboratories can have an experiment that is part of the ongoing 
curriculum and that generates the same hazardous wastes each semester. 
We did not intend to create a system whereby some laboratories at the 
eligible academic entity would be eligible and some would not, based on 
the hazardous waste generation pattern of each individual laboratory. 
To the contrary, for ease of implementation and enforcement, if the 
eligible academic entity chooses to be subject to Subpart K, the Agency 
is requiring that all laboratories covered under an individual EPA 
Identification Number must operate under those provisions. Therefore, 
we believe that it is sufficient that an eligible academic entity's 
laboratories, as a category, rather than each laboratory, generate many 
different wastes every day.
    Third, based on comments and follow-up discussion, we now 
understand that in many cases photo processing takes place alongside 
teaching and research and that it would be difficult to regulate 
differently the various laboratory operations, as the same students and 
laboratory workers operate in both areas. Therefore, we have revised 
the definition of laboratory to include photo laboratories.
    The Agency also received many comments suggesting that the 
definition of laboratory should include chemical stockrooms, 
preparatory laboratories and other areas ancillary to the laboratory. 
EPA agrees with these commenters that the definition of laboratory 
should include chemical stockrooms and preparatory laboratories and 
other areas that provide a support function to teaching or research 
laboratories (or diagnostic laboratories at teaching hospitals). The 
reason for this change is that the operation of these areas is well 
integrated with the operation of the laboratories; that is, they are 
often in close proximity to the laboratories, and share laboratory 
personnel, and thus should properly be viewed as part of the 
laboratory. Chemical stockrooms that are not associated with laboratory 
operations would not, however, be eligible to operate under Subpart K. 
For example, a chemical stockroom that stores cleaning chemicals or 
pesticides for maintenance at the facility would not be providing a 
support function to a laboratory and would not be considered a 
laboratory that is allowed to operate under Subpart K.
    The Agency also agrees with commenters that field laboratories 
should be considered laboratories because we agree that field 
laboratories, like other laboratories under this rule, exhibit similar 
hazardous waste generation patterns. By considering field laboratories 
as laboratories, laboratory workers would thus only need to operate 
under one set of hazardous waste regulations. However, if the field 
laboratory is off-site and/or has a separate EPA Identification Number 
from the rest of the campus, the eligible academic entity must notify 
separately that the field laboratory will be subject to Subpart K. In 
the proposal, we stated that we expected many field laboratories to be 
CESQGs, which under the proposal were not eligible to opt into Subpart 
K. Commenters confirmed that many field laboratories are, indeed, 
CESQGs. Therefore, with the modifications that the Agency is making in 
today's rule regarding the eligibility of CESQGs and the definition of 
``laboratory,'' field laboratories, whether they are located on-site or 
off-site from the rest of the eligible academic entity, would be 
allowed to operate under the

[[Page 72924]]

Subpart K requirements. See Section III.C.9 regarding the 
implementation of Subpart K at CESQG sites.
    Furthermore, a number of commenters agreed with the Agency's 
position that art studios at eligible academic entities should be 
considered laboratories, despite the fact that they are rarely referred 
to as laboratories. These commenters confirmed that art studios have 
similar hazardous waste generation patterns as scientific laboratories, 
and, like other classroom settings, have students generating much of 
the hazardous waste. Therefore, the definition has been changed to 
clarify that the Agency considers art studios to be laboratories for 
the purposes of Subpart K.
    Finally, we proposed that a ``laboratory'' is ``an area within a 
college or university * * *'' We received comments suggesting that we 
modify the definition of laboratory to be ``an area under the 
administrative or managerial control of a college or university * * *'' 
However, this terminology is not currently used or defined under RCRA. 
The Agency agrees that the definition should be more specific and we 
have incorporated into today's definition of ``laboratory'' a similar 
concept as suggested by the commenters. However, we have relied on 
terminology that is already used and defined in RCRA. Specifically, 
under today's final rule, a laboratory is ``an area that is owned by an 
eligible academic entity * * *'' Therefore, in today's preamble and 
final rule, when we use the term laboratory, we are referring to 
laboratories that are owned by an eligible academic entity.
    To be eligible to opt into today's final rule, an institution first 
must meet the definition of ``eligible academic entity.'' That is, it 
must be a college or university, or a non-profit research institute or 
teaching hospital that is owned by or has a formal written affiliation 
agreement with a college or university, as these terms are defined in 
today's rule. Second, an eligible academic entity may opt into Subpart 
K for the laboratories that it owns. Therefore, government facilities 
with laboratories that are operated by colleges and universities (such 
as many of the Department of Energy's laboratories) would not be 
eligible to opt into Subpart K, because the government facility is not 
an eligible academic entity and the laboratories are not owned by an 
eligible academic entity.
    For the reasons discussed above, today's final rule defines 
``laboratory'' as follows:

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

    Reactive acutely hazardous unwanted material--The Agency proposed 
to define ``reactive acutely hazardous unwanted material'' as:

    an unwanted material that is one of the acutely hazardous 
commercial chemical products listed in Sec.  261.33(e) for 
reactivity and toxicity.

    At proposal, the Agency intended to maintain more stringent 
regulations in the laboratory for the ``P-listed'' commercial chemical 
products that are listed for reactivity because of their high potential 
for causing immediate harm. In the preamble to the proposed rule, we 
provided a list of seven commercial chemical products that we believed 
met this definition:
    (1) P006 (CAS Number: 20859-73-8) Aluminum phosphide;
    (2) P009 (CAS Number: 131-74-8) Ammonium picrate; Pheno, 2,4,6-
trinitro-, ammonium salt;
    (3) P042 (CAS Number: 51-43-4) 1,2-Benzenediol, 4-[1-hydroxy-2-
(methylamino)ethyl];
    (4) P065 (CAS Number: 628-86-4) Fulminic Acid, mercury(2+) salt; 
Mercury fulminate;
    (5) P081 (CAS Number: 55-63-0) Nitroglycerine; 1,2,3-Propanetriol, 
trinitrate;
    (6) P112 (CAS Number: 509-14-8) Methane, tetranitro-; 
Tetranitromethane; and
    (7) P122 (CAS Number: 1314-84-7) Zinc phosphide 
Zn3P2 when present at concentrations greater than 
10%.
    Many commenters correctly pointed out that P042 (CAS Number 51-43-
4) 1,2-Benzenediol, 4-[1-hydroxy-2-(methylamino)ethyl]-, which is 
actually Benzenediol, 4-[1-hydroxy-2-(methylamino)ethyl]-, (R)-, (and 
is also known as epinephrine) is not listed on the ``P-list'' because 
of reactivity. They pointed out that the (R)- following the listing for 
P042 refers to the R enantiomer of the chemical and does not refer to 
the reactivity characteristic. The Agency acknowledges that the 
commenters are, indeed, correct, and if epinephrine were an unwanted 
material in a laboratory, it would not meet the definition of reactive 
acutely hazardous unwanted material. EPA's acknowledgment is simply a 
matter of clarification and does not affect the definition as 
proposed.\3\
---------------------------------------------------------------------------

    \3\ The Agency has recently issued a memo clarifying that the 
scope of the P042 listing does not include epinephrine salts (see 
memo from Hale to EPA Regions, October 15, 2007, RCRA Online 
 14778).
---------------------------------------------------------------------------

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

    an unwanted material that is one of the acutely hazardous 
commercial chemical products listed in Sec.  261.33(e) for 
reactivity.

    Trained professional--The Agency proposed to define a ``RCRA-
trained individual'' as:

    a person who has completed the applicable RCRA training 
requirements of Sec.  265.16 for large quantity generators, or Sec.  
262.34(d)(5)(iii) for small quantity generators. A RCRA-trained 
individual may be an employee of the college/university or may be a 
contractor or vendor.

    The Agency is replacing the term ``RCRA-trained individual'' with 
``trained professional.'' This does not affect the substance of the 
definition, but is merely a change in terminology since Subpart K is 
part of the RCRA hazardous waste regulations and including ``RCRA'' as 
part of the term is unnecessary and may, in fact, imply that anyone who 
is trained under Subpart K is not ``RCRA'' trained.
    In addition, because the final rule has been expanded to include 
eligible academic entities that include CESQG sites or that are 
themselves CESQGs, we have added to the definition of ``trained 
professional'' a requirement that a trained professional at an eligible 
academic entity that is a CESQG must be trained in accordance with the 
SQG training requirements of

[[Page 72925]]

Sec.  262.34(d)(5)(iii). As discussed in more detail in Section III.C.4 
of today's preamble, the hazardous waste determination and on-site 
transfers of unwanted materials outside the laboratory must be 
performed by trained professionals (also see Sec.  262.207). The 
proposed definition of ``RCRA-trained individual'' (which is re-named 
``trained professional'' in today's final rule) relied on references to 
the existing generator training requirements, which vary based on 
generator status. The existing CESQG regulations, however, do not 
include training requirements. It would be counter to the intent of 
today's rule to allow CESQGs opting into Subpart K to have untrained 
personnel making the hazardous waste determination and transferring 
unwanted materials outside the laboratory. Therefore, today's final 
rule requires that trained professionals at eligible academic entities 
that are CESQGs must be trained in accordance with the SQG training 
requirements.
    Finally, because the applicability of the final rule has been 
broadened beyond colleges and universities, the Agency has modified the 
definition of ``trained professional'' accordingly, as follows:

    a person who has completed the applicable RCRA training 
requirements of Sec.  265.16 for large quantity generators, or is 
knowledgeable about normal operations and emergencies in accordance 
with Sec.  262.34(d)(5)(iii) for small quantity generators and 
conditionally exempt small quantity generators. A trained 
professional may be an employee of the eligible academic entity or 
may be a contractor or vendor who meets the requisite training 
requirements.

    Unwanted material--The Agency proposed to define ``unwanted 
material'' as:

    means any chemical, mixtures of chemicals, products of 
experiments or other material from a laboratory that are no longer 
needed, wanted or usable in the laboratory and that are destined for 
hazardous waste determination by a RCRA-trained individual. Unwanted 
material includes reactive acutely hazardous unwanted materials. 
Unwanted material includes material that may eventually be 
determined not to be solid waste pursuant to Sec.  261.2 or a 
hazardous waste, pursuant to Sec.  261.3.

    The Agency has made two changes to the definition of unwanted 
material. The first is to reflect the change from the term ``RCRA-
trained individual'' to ``trained professional.'' The second change is 
to reflect the additional flexibility that we have added to the final 
rule that allows an eligible academic entity the option of using 
another ``equally effective term'' in lieu of the term ``unwanted 
material.'' In the preamble and the regulations, the Agency continues 
to use the term, ``unwanted material,'' but an eligible academic entity 
that opts into Subpart K may use another term if it chooses, provided 
the term is used consistently and is identified in its LMP. Regardless 
of the term that is used, however, it will have the same meaning as 
found in the definition for unwanted material, and it will be subject 
to the same requirements under Subpart K. This additional flexibility 
allowed for using another term in lieu of ``unwanted material'' is 
discussed in more detail in preamble section III.C.2 (also see Sec.  
262.206).
    For the reasons discussed above, today's final rule defines 
``unwanted material'' as:

    any chemical, mixtures of chemicals, products of experiments or 
other material from a laboratory that is no longer needed, wanted or 
usable in the laboratory and that is destined for hazardous waste 
determination by a trained professional. Unwanted materials include 
reactive acutely hazardous unwanted materials and materials that may 
eventually be determined not to be solid waste pursuant to Sec.  
261.2, or a hazardous waste pursuant to Sec.  261.3. If an eligible 
academic entity elects to use another equally effective term in lieu 
of ``unwanted material,'' as allowed by Sec.  262.206(a)(1)(i), the 
equally effective term has the same meaning and is subject to the 
same requirements as ``unwanted material'' under this subpart.

3. Definitions That Are New
    The definitions discussed in this section of today's preamble are 
those definitions that have been developed and added since the 
proposal. All new definitions, except one, pertain to the expansion of 
the scope to other eligible academic entities.
    Eligible academic entity--Today's final rule defines ``eligible 
academic entity'' as:

    a college or university, or a non-profit research institute that 
is owned by or has a formal written affiliation agreement with a 
college or university, or a teaching hospital that is owned by or 
has a formal written affiliation agreement with a college or 
university.

    Since we have expanded the scope of the final rule to allow non-
profit research institutes and teaching hospitals that are either owned 
by or have a formal written affiliation agreement with a college or 
university to opt into Subpart K, we believe it is appropriate to add a 
new term to refer to these types of institutions collectively.
    Incorporated in the definition above is the concept that teaching 
hospitals and non-profit research institutes must be either owned by or 
have a formal written affiliation agreement with a college or 
university. As explained in section III.A. of today's preamble, we are 
requiring a formal written affiliation agreement with a college or 
university because the affiliation indicates that an entity is 
integrated with the college or university and that the entity has a 
significant transient student presence. Our research also demonstrated 
that in some instances, a teaching hospital or non-profit research 
institute is owned by a college or university. We assume that if a non-
profit research institute is owned by a college or university it would 
not have a formal written affiliation agreement. Similarly for teaching 
hospitals, we assume that a formal written affiliation agreement, 
defined below for teaching hospitals as a master affiliation agreement 
and program letter of agreement, would not exist when the teaching 
hospital is owned by the college or university. Thus, this definition 
allows teaching hospitals and non-profit research institutes that are 
located on-campus or off-campus to opt into this rule, provided they 
are owned by or have a formal written affiliation agreement with a 
college or university.
    Formal written affiliation agreement--Today's final rule defines 
``formal written affiliation agreement'' as:

for a non-profit research institute means a written document that 
establishes a relationship between institutions for the purposes of 
research and/or education and is signed by authorized 
representatives, as defined by Sec.  260.10, from each institution. 
A relationship on a project-by-project or grant-by-grant basis is 
not considered a formal written affiliation agreement. A formal 
written affiliation agreement for a teaching hospital means a master 
affiliation agreement and program letter of agreement, as defined by 
the Accreditation Council for Graduate Medical Education, with an 
accredited medical program or medical school.

    For non-profit research institutes, ``formal written affiliation 
agreement'' is defined in a manner to reflect the importance of having 
an official legal written agreement documenting the affiliation, 
partnership, collaboration, or association between the non-profit 
research institute and a college or university. In order for a non-
profit research institute to be eligible to opt into Subpart K, it must 
have this documentation.
    The Agency is requiring that this agreement be signed by authorized 
representatives with the authority to obligate the institution as a 
whole. The term ``authorized representative'' is already defined in 40 
CFR 260.10 as ``the person responsible for the overall

[[Page 72926]]

operation of a facility or an operational unit (i.e., part of a 
facility), e.g., the plant manager, superintendent, or person of 
equivalent responsibility.'' The Director or Chief Executive Officer 
(CEO) of a non-profit research institute and the President or Dean of a 
college or university, among others, would be considered authorized 
representatives.
    The Agency also stresses that the formal written affiliation 
agreement must be between the institutions: The non-profit research 
institute and the college or university. This agreement is intended to 
represent a long-standing collaboration between the two institutions 
rather than simply a relationship between two principal investigators 
or researchers, working jointly for the duration of a particular 
project or grant. An example of what we would consider to be an 
affiliation at the institutional level includes being a member of a 
research consortium with colleges and universities. For instance, the 
Southwest Research Institute is a member of the Southwest Research 
Consortium which combines the research capabilities of nine research 
and educational organizations, including the University of Texas at San 
Antonio, Trinity University, and St. Mary's University. Another example 
of what we would consider an institutional-level affiliation agreement 
is when there are joint faculty appointments on a departmental or other 
large-scale basis. For instance, Seattle Biomedical Research and the 
University of Washington have a formal affiliation where all 
researchers at Seattle Biomedical Research are also faculty members at 
the University of Washington. A third example of what we would consider 
an institutional-level affiliation agreement is when a non-profit co-
sponsors degrees with a college or university. For instance, Fred 
Hutchinson Cancer Research Center and the University of Washington 
jointly administer or co-sponsor a Ph.D. program in Molecular and 
Cellular Biology. Thus, EPA developed this definition to be broad to 
encompass the various working situations that we understand to be 
currently in existence.
    For the definition of formal written affiliation agreement for 
teaching hospitals, EPA researched definitions and terms to describe 
the concept of ``affiliated teaching hospitals,'' such as ``academic 
health centers,'' ``major teaching hospital,'' and ``university 
teaching hospital.'' We quickly discovered that an industry-wide 
standard term for referring to teaching hospitals affiliated with 
colleges and universities does not exist. Without a standard 
definition, we looked into how college or university medical schools 
are linked with hospitals. We learned that the ACGME has established a 
mechanism for medical schools to send residents to hospitals that are 
not part of the medical school. In such cases, ACGME requires a master 
affiliation agreement and a program letter of agreement between the 
medical school and the teaching hospital. Since the ACGME defines these 
two types of agreements and requires them in certain arrangements 
between teaching hospitals and colleges and universities, and since the 
industry already follows and understands these agreements, we have 
decided to refer to these agreements in the definition of ``formal 
written affiliation agreement'' for teaching hospitals in this rule.
    Non-profit research institute--Today's final rule defines ``non-
profit research institute'' as:

an organization that conducts research as its primary function and 
files as a non-profit organization under the tax code of 26 U.S.C. 
501(c)(3).

    EPA's definition, which refers to a well-known, existing definition 
under the tax code of 26 U.S.C. 501(c)(3), is intended to make the 
definition as clear as possible, as well as easy for implementers and 
inspectors to verify. We are emphasizing through this definition that 
not every non-profit organization is eligible to opt into the Subpart K 
requirements. Rather, the non-profit must conduct research as its 
primary function. We require this because, as explained in sections 
II.B and III.A of this preamble, research laboratories, as a category 
of laboratories, have a hazardous waste generation pattern that fits 
within the rationale of today's final rule. Further, as discussed 
above, the non-profit research institute must either be owned by a 
college or university or have a formal written affiliation agreement 
with a college or university in order to be eligible to opt into this 
rule.
    Teaching hospital--Today's final rule defines ``teaching hospital'' 
as:

a hospital that trains students to become physicians, nurses or 
other health or laboratory personnel.

    EPA believes it is important to capture the basic purpose of a 
teaching hospital in this definition: training students in medicine. A 
teaching hospital will train nursing students, medical residents, 
technicians, and others in the laboratories at the hospital's 
facilities ensuring that teaching hospitals fit within a key aspect of 
the rationale of today's rule: a significant transient student presence 
in the laboratories. In addition, the teaching hospital must either be 
owned by a college or university or have a formal written affiliation 
agreement with a college or university in order to be eligible to opt 
into this rule.
    Working container--The Agency did not include a definition of 
``working container'' in the proposed rule. In the preamble to the 
proposed rule, however, we did discuss a possible definition for 
working container and solicited comment on whether the final rule 
should include such a provision. The definition of ``working 
container'' in the preamble to the proposed rule was:

A small container (of one gallon or less), managed under the control 
of a laboratory worker and used at a bench or work station, whose 
contents are emptied into a container of unwanted material at the 
end of the procedure.

    There generally was broad support among commenters for including a 
definition of working container in the final rule. A number of 
commenters suggested, however, that the Agency increase the maximum 
size limit of a working container to five gallons. Since one gallon is 
equal to 3.78 liters, the one-gallon limit discussed in the preamble to 
the proposed rule would have precluded the use of four-liter solvent 
bottles as working containers. The Agency believes that a 5-gallon 
limit for working container is too large to be appropriate despite 
suggestions from commenters. Given that water weighs 8.34 pounds per 
gallon, a full 5-gallon container would weigh in excess of 40 pounds, 
which may be pushing the limits of what can be easily manipulated by 
one person (without the aid of equipment or other devices). This is 
especially true considering that the contents of many working 
containers will be transferred to other containers for disposal.
    Nevertheless, the Agency does agree that since 4-liter solvent 
bottles are commonly used as collection containers in laboratories and 
are easily manipulated by one person, even if full, the Agency believes 
a two-gallon limit for working containers is more appropriate. 
Furthermore, two gallons is consistent with an interpretive letter 
signed by both Region I and the State of Massachusetts (September 2004; 
a copy of which is in today's docket), that originally introduced the 
concept of a working container under RCRA. Therefore, in response to 
these comments, the Agency has increased the maximum size of a working 
container to two gallons. The Agency is not limiting the type of 
containers that can be used as working containers. Thus, the types of 
containers that we would expect to be

[[Page 72927]]

used as working containers are beakers, flasks, bottles, and other 
types of containers typically used in a teaching or research 
laboratory.
    The Agency also has deleted from the definition of working 
container that appeared in the preamble to the proposed rule the 
requirement for the contents of a working container to be emptied into 
a container of unwanted material at the end of a procedure. We believe 
it is more appropriate to include any management standards for working 
containers in Sec.  262.206(b), which addresses the management 
standards for all containers.
    Finally, the Agency has added to the definition that working 
containers are those that are used to collect ``unwanted material.'' 
The Agency believes that this modification is necessary in order to 
distinguish ``working containers'' from other containers used during an 
experiment or procedure that may contain product and are not subject to 
the RCRA Subtitle C regulations. See section III.C.3 of today's 
preamble for a detailed discussion of the container management 
standards that apply to working containers (also see Sec.  262.206).
    The definition of ``working container'' in today's final rule is:

    a small container (i.e., two gallons or less) that is in use at 
a laboratory bench, hood, or other work station, to collect unwanted 
material from a laboratory experiment or procedure.

C. Specific Requirements of the Alternative Regulations

    Today's final Subpart K regulations will allow laboratories at 
eligible academic entities to send unwanted materials that are 
generated in the laboratory to an on-site CAA or an on-site TSDF before 
making the hazardous waste determination for the unwanted materials, or 
to make the hazardous waste determination in the laboratory prior to 
its removal. However, the eligible academic entity must meet certain 
requirements such as notifying, complying with performance-based 
standards in the laboratory, and developing and implementing an LMP 
with nine required elements as described in the sections below.
1. Notification
    Because today's final rule provides eligible academic entities the 
option to manage their hazardous wastes from laboratories under the 
existing generator regulations or their laboratories' unwanted 
materials under today's provisions, it is important that EPA, or the 
authorized State, know to which set of regulations an eligible academic 
entity's laboratories are subject. Therefore, this rule requires that 
an eligible academic entity choosing to manage its unwanted materials 
in compliance with the alternative set of generator requirements being 
promulgated today submit a one-time notification 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 the existing generator regulations and there is no need 
to notify.
    EPA proposed that the notification be provided by letter, but 
requested comment on whether the RCRA Subtitle C Site Identification 
Form (EPA Form 8700-12; or Site Identification Form) should be used to 
provide this notice, and whether the form should be modified to include 
a checkbox to indicate that a college or university is choosing to be 
subject to Subpart K. One commenter pointed out the advantage to using 
a letter would be to allow a college or university to submit one notice 
for several sites with different EPA Identification Numbers. However, 
most commenters supported the option of using the Site Identification 
Form to notify EPA (or the authorized State) regarding their decision 
to manage laboratory hazardous waste under the Subpart K requirements. 
The commenters noted that the regulated community is already familiar 
with this form and the form requires much of the necessary information 
required by the notification requirement that was proposed under 
Subpart K, such as name of the facility, address, and EPA 
Identification Number. Further, most commenters agreed that by using 
the Site Identification Form, there would be increased consistency in 
reporting. When eligible academic entities notify by Site 
Identification Form, the information is included in the RCRAInfo 
database, which provides an additional benefit of being able to monitor 
the extent to which eligible academic entities are taking advantage of 
this new Subpart.
    Based on these comments, EPA is requiring the use of the Site 
Identification Form for notification of opting into, as well as 
withdrawing from Subpart K. In order to use this form for this purpose, 
we will be modifying the Site Identification Form to include a checkbox 
for an eligible academic entity to indicate what type of entity it is 
(i.e., a college or university, or a teaching hospital or a non-profit 
research institute that is either owned by or has a formal written 
affiliation agreement with a college or university) and that it is 
choosing to be subject to the 40 CFR part 262, Subpart K 
requirements.\4\ There is also a checkbox for an eligible academic 
entity to indicate that it is withdrawing from the Subpart K 
requirements, if after having decided to be subject to Subpart K, it 
determines it would prefer to be regulated under the existing hazardous 
waste generator standards.
---------------------------------------------------------------------------

    \4\ If an eligible academic entity chooses to opt into Subpart K 
prior to the completion of the revisions to the Site Identification 
Form (8700-12), it should indicate in the comment field of the form 
what type of eligible academic entity it is and that it is opting 
into Part 262 Subpart K.
---------------------------------------------------------------------------

    Since we are requiring the use of the Site Identification Form, an 
eligible academic entity will have to submit one Site Identification 
form for each EPA Identification Number, or site as defined by RCRA.\5\ 
Thus, if the eligible academic entity is composed of multiple sites 
(i.e., it has multiple EPA Identification Numbers) and all its sites 
will operate under Subpart K, separate Site Identification Forms must 
be submitted for each site. For example, if an urban college or 
university composed of multiple sites divided by public roads wants all 
of its laboratories to operate under Subpart K, the college or 
university must notify the appropriate authority that each of its sites 
is going to be subject to 40 CFR part 262, Subpart K by submitting a 
Site Identification Form for each distinct site (i.e., EPA 
Identification Number) opting into today's rule.
---------------------------------------------------------------------------

    \5\ RCRA 40 CFR part 260.10 defines, ``on-site'' to mean the 
same or geographically contiguous property which may be divided by 
public or private right-of-way provided the entrance and exit 
between the properties is at a cross-roads intersection, and access 
is by crossing as opposed to going along, the right-of-way. Non-
contiguous properties owned by the same person, but connected by a 
right-of-way which he controls and to which the public does not have 
access, is also considered on-site property. For further 
interpretations, see Memo, Shapiro to Wojdyla; May 1, 1996, (RCRA 
Online 14031), a copy of which is in today's docket.
---------------------------------------------------------------------------

    As indicated in the example above, an eligible academic entity can 
be composed of multiple sites because of the way RCRA defines ``on-
site.'' We believe that where this is the case, the eligible academic 
entity will choose to have all its sites at a single campus opt into 
Subpart K. This would allow eligible academic entities to have a 
unified institution-wide hazardous waste management system for all its 
laboratories on campus, which is one of the highest priorities for 
Subpart K cited by the academic community in their public comments. 
However, since a campus or institution opts in for each individual 
site, via EPA Identification Number, there is nothing in today's rule

[[Page 72928]]

that requires an eligible academic entity to have all of its separate 
sites opt into the Subpart K requirements. Thus, by not requiring that 
all the sites with different EPA Identification Numbers at an eligible 
academic entity opt into this rule together, we are providing 
additional flexibility for the eligible academic entity to determine 
the best hazardous waste management practices for its facility.
    Teaching hospitals and non-profit research institutes, as defined 
in this rule, may be located on a college or university campus or 
located nearby. In rare instances, they may even be located in a 
separate State from the college or university with which they are 
affiliated. Since eligible academic entities opt in by filling out the 
Site Identification Form, a teaching hospital or non-profit research 
institute that has a separate EPA Identification Number from a college 
or university must decide independently whether it wants to opt into 
today's final rule. When a teaching hospital or non-profit research 
institute is owned by or formally affiliated with a college or 
university and located on campus, it does not have to opt in when the 
college or university opts in, if it is a separate site or has a 
separate EPA Identification Number, although, as noted above, we 
believe that teaching hospitals and non-profit research institutes will 
likely opt into Subpart K, if the colleges or universities with which 
they are affiliated opt in, to create a more integrated laboratory 
waste management system on campus.
    As explained above, while not all the sites of an eligible academic 
entity must choose to be subject to today's rule, we continue to stress 
that all laboratories owned by the eligible academic entity within one 
EPA Identification Number must comply with the same set of regulations. 
In other words, the alternative approach cannot be applied to only one 
or a few laboratories within that EPA Identification Number, but rather 
must apply to all laboratories or no laboratories. The reason for this 
is that EPA believes it would be difficult for an eligible academic 
entity to keep track of which set of generator regulations apply to 
which laboratory or group of laboratories. Moreover, it would be 
extremely difficult, if not impossible, for the States or Regions to 
keep track of the applicable set of regulations if, within a single EPA 
Identification Number, different laboratories were choosing to be 
regulated under different requirements. No mechanism currently exists 
at EPA or the States to track such distinctions.
    The required notice must be submitted to the appropriate EPA 
Regional Administrator (or State Director in authorized States that 
adopt the final rule). At all times, an eligible academic entity's 
laboratories must comply with either the existing hazardous waste 
generator regulations or the Subpart K regulations. Once an eligible 
academic entity notifies by Site Identification Form that it is opting 
into Subpart K, EPA expects that the site will be in compliance with 
the Subpart K requirements. Therefore, we strongly suggest that an 
eligible academic entity prepare its LMP and ready its facilities for 
the Subpart K laboratory hazardous waste management system before it 
submits a Site Identification Form to the EPA Regional Authority (or 
State Director in authorized States). Further, an eligible academic 
entity may, for example, want to train its employees in the Subpart K 
labeling requirements and container management standards before 
notifying. In addition, an eligible academic entity may want to contact 
its hazardous waste vendors to prepare the vendor for the eligible 
academic entity's switch to Subpart K.
    It is also 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 now existing applicable generator 
regulations, 40 CFR part 262 (or 40 CFR 261.5 for CESQGs). Under this 
final rule, an eligible academic entity that chooses to end its 
participation in the Subpart K program would 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 would no longer be subject to Subpart K and would be 
subject to the existing applicable generator regulations. Once the 
Agency receives the Site Identification Form from the eligible academic 
entity indicating that it is withdrawing from the Subpart K program, 
the Agency expects that the eligible academic entity will be in 
compliance with the 40 CFR part 262 applicable generator requirements 
(or 40 CFR 261.5 for CESQGs).
    Finally, EPA sought comment on whether the Regional Administrator 
(or State Director in authorized States) should provide the eligible 
academic entity with a written receipt of the one-time notice before it 
could manage its unwanted materials in accordance with the Subpart K 
requirements. Most commenters did not want to wait for EPA or the State 
to provide a written receipt of the one-time notice before managing 
their unwanted materials under these alternative generator 
requirements; they argued that it would cause delay and confusion. 
Other commenters pointed out that many States already respond in 
writing when the Site Identification Form is received. Therefore, we 
are not requiring that the Regional Administrator (or State Director in 
authorized States) provide a written receipt of the one-time notice 
before the eligible academic entity can manage its unwanted materials 
under the Subpart K requirements. (For more information on how CESQGs 
notify, see section III.C.9 and Sec.  262.203.)
2. Labeling Standards
    Because today's rule provides laboratories owned by eligible 
academic entities with flexibility in where and when to make the 
hazardous waste determination, labeling requirements for unwanted 
materials in the laboratory are needed. For example, labeling is 
critical to ensure that non-laboratory personnel, such as firefighters 
can quickly ascertain the hazardous materials that are in the 
laboratory in case of an emergency. In order to provide the necessary 
information to laboratory personnel, EH&S staff, inspectors, emergency 
responders, and others, today's rule includes performance-based 
labeling requirements that are informative, yet flexible to fit the 
varying situations at eligible academic entities.
    The labeling requirements in the proposed rule consisted of two 
sets of performance-based labels. First, the proposal required that a 
label be affixed to or physically accompany the container of unwanted 
material. This label was intended to convey the most essential 
information that one needs to know about the contents of the container 
in an emergency situation. It also was intended to convey the notion 
that ``unwanted material'' was no longer wanted in the laboratory. 
Thus, the proposal required that this label include the words 
``unwanted material,'' as well as sufficient information to alert 
emergency response personnel to the container's hazards or contents.
    The second part of the proposed labeling requirements provided 
flexibility by allowing information to be ``associated with the 
container.'' We proposed that this label contain sufficient information 
for the RCRA-trained professional (which has been changed to trained 
professional in today's final rule) to make the hazardous waste 
determination. At a minimum, the information ``associated'' with 
containers of unwanted materials

[[Page 72929]]

was intended to ensure that a hazardous waste determination of the 
contents can be made by a trained professional. Additionally, the 
proposal required that the date when the unwanted materials first began 
accumulating in the container be associated with the container, so that 
EH&S staff or other trained professionals would know when to remove the 
containers of unwanted materials from the laboratory. The preamble to 
the proposed rule indicated that the accumulation start date and 
information sufficient to make a hazardous waste determination could be 
on the label that is affixed to or physically accompanies the 
container, but must, at a minimum, be associated with the container.
    In the preamble to the proposed rule, we discussed examples of how 
the required information might be ``associated'' with a container. One 
example is that laboratory personnel could number containers of 
unwanted material and create an accompanying spreadsheet containing 
sufficient information to identify the material for each numbered 
container of unwanted material that would be given to the trained 
professional to make the hazardous waste determination. Another example 
is that laboratories could affix a bar code to each container of 
unwanted material that when scanned would provide the necessary 
information to make the hazardous waste determination of the unwanted 
material. Alternatively, laboratory personnel might choose to include a 
printed inventory of the unwanted materials and the associated 
information for each container that would provide the necessary 
information for a trained professional to make the hazardous waste 
determination.
    The Agency received a large number of comments from academia in 
support of the performance-based labeling requirements in lieu of 
prescriptive requirements. In keeping with the original intent of the 
rulemaking, today's final rule maintains the performance-based two-
tiered labeling structure; however, we have revised the labeling 
requirements to take into account public comments received on the 
proposal.
    Specifically, we have revised the proposed labeling requirements in 
today's final rule to clarify that the first part of the labeling 
requirement requires the label to be ``affixed or attached to'' the 
container of unwanted material rather than be ``affixed to or 
physically accompany'' the container. We believe this modified language 
provides clarity and ensures that, during the accumulation period in 
the laboratory or during on-site transfer, the identifying information 
will not be inadvertently separated from a container of unwanted 
material and thus the contents of any container can be quickly 
identified in an emergency situation. Examples of labels that are 
``affixed or attached to'' containers of unwanted materials are 
stickers that have been affixed on the container by adhesive, or labels 
that are attached to a small container of unwanted material (i.e., too 
small for an adhesive label) by wire or a piece of tape.
    Many commenters expressed concern about the proposed requirement to 
label containers with the words ``unwanted material,'' preferring a 
more flexible labeling requirement. As one commenter stated, ``The 
purpose of adding an additional label [unwanted material] to a reagent 
chemical container, for instance, is to differentiate it from others 
that a lab still wants or needs in their work so that the pickup crew 
or contractor knows which containers to take. The exact terminology is 
not important to meeting this goal.'' In response to this and other 
similar comments, in the final rule, we are requiring that containers 
be labeled with the words ``unwanted material'' or another ``equally 
effective term'' that is used consistently by the eligible academic 
entity and is identified in Part I of the eligible academic entity's 
LMP. Examples of an ``equally effective term'' include, but are not 
limited to, ``laboratory waste'' or ``chemical lab waste.'' We believe 
this approach is responsive to the comments in that it provides each 
eligible academic entity with flexibility, yet conveys the basic 
information that the material is no longer needed or wanted in the 
laboratory. To this end, if an eligible academic entity elects to use 
another equally effective term in lieu of ``unwanted materials,'' that 
term must address and have the same meaning as ``unwanted material,'' 
and is subject to the same requirements in Subpart K for ``unwanted 
material.'' Additionally, if an eligible academic entity chooses to use 
an equally effective term instead of ``unwanted materials,'' the 
eligible academic entity must use the term consistently in all its 
laboratories that are covered by its LMP. It would not be acceptable 
for each laboratory at an eligible academic entity to be free to use 
its own term of choice because the use of different terms at the same 
eligible academic entity would cause confusion for implementers and 
enforcers.
    A number of commenters opposed the proposed requirement that the 
label that is ``affixed to or physically accompany'' the container 
provide sufficient information to alert emergency responders to the 
contents or the hazards of the container, arguing that the requirement 
is unnecessary and burdensome.\6\ EPA disagrees with these comments and 
believes that maintaining this information is necessary to protect the 
safety of workers, students, emergency responders, and others that may 
come into contact with containers of unwanted materials. For safety 
purposes, emergency responders need to have a quick way to assess the 
contents of a container. However, we understand that at least part of 
the concern was the use of the term ``hazards,'' in that it caused some 
confusion among commenters, many of whom thought that the Agency was 
proposing to require Department of Transportation (DOT) hazard classes 
or National Fire Protection Agency (NFPA) chemical hazard labels to be 
on the label that must be ``affixed to or attached to'' the container. 
This was not the Agency's intent. To address this misunderstanding in 
today's final rule, we have clarified the requirement that the label 
contain sufficient information to alert emergency responders to the 
contents of the container. This performance-based standard could be met 
by including information, such as the name of the chemical(s) in the 
container or, alternatively, a descriptive phrase, such as ``inorganic 
solvents,'' ``halogenated organic solvents,'' or ``water reactive 
chemicals.'' This requirement is flexible, yet provides sufficient 
information to emergency responders in an easily understandable manner 
that would allow them to ascertain the potential dangers associated 
with the contents of containers in the laboratory, while being 
protective of health and safety.
---------------------------------------------------------------------------

    \6\ As discussed previously, the requirement that the label be 
``affixed to or physically accompany'' the container has been 
changed in the final rule to that the label must be ``affixed or 
attached to'' the container.
---------------------------------------------------------------------------

    As proposed, today's final rule requires that each container of 
unwanted material must have associated with the container the date that 
the unwanted material begins accumulating and information sufficient to 
make a hazardous waste determination. We are allowing this information 
to be ``associated with'' the container, as opposed to requiring that 
it be ``affixed or attached to'' the container, in order to facilitate 
the use of technology in conveying this information. This could be done 
using an electronic spreadsheet, a bar code, or some other printed 
inventory of containers (see previous examples of ``affixed or attached 
to'' or

[[Page 72930]]

``associated'' labels). We also point out that this labeling 
requirement maintains the flexibility of the proposed rule, such that 
an eligible academic entity can use the container labeling approach 
that works best for the institution. That is, while it is acceptable to 
have the accumulation start date and information sufficient to make a 
hazardous waste determination ``associated with'' the container, some 
eligible academic entities may prefer to have all required container 
labeling information in a single place. Therefore, it is also 
acceptable to place the accumulation start date and the information 
sufficient to make a hazardous waste determination on the label that is 
``affixed or attached to'' the container. We have reworded the 
container labeling regulations accordingly to reflect the intended 
flexibility and to indicate that, at a minimum, the accumulation start 
date and information sufficient to make a hazardous waste determination 
must be ``associated with'' the container, but that it can be on the 
label that is ``affixed or attached'' to the container, if that is 
preferred.
    Many commenters had concerns about the burden imposed by the 
requirement to associate the accumulation start date with containers of 
unwanted material because it is not required in the current satellite 
accumulation area regulations. We maintain that this requirement is 
necessary to ensure that accumulation time limits in the laboratory are 
complied with for containers of unwanted material. Some commenters 
argued that alternatively, EPA should add a requirement to log regular 
removals from each laboratory in lieu of the container ``dating'' 
requirement. We disagree with this comment because we believe that the 
suggested method would not provide the information necessary to verify 
that a particular container had not been accumulating unwanted material 
for more than six months in the laboratory and, therefore, would not 
allow EPA or an authorized State to determine whether the laboratory 
was in compliance with Subpart K. Therefore, the dating requirement for 
each container of unwanted material has been retained in today's final 
rule.
    Finally, we have retained the requirement from the proposal that 
the label associated with the container must contain information 
sufficient to make a hazardous waste determination. As discussed above, 
this requirement provides flexibility to eligible academic entities in 
that this information can be on the label that is ``affixed or attached 
to'' the container, but it must at least be on the label that is 
``associated with'' the container. However, we stress that 
``information sufficient'' to make a hazardous waste determination, 
whether that information is ``associated with'' or ``affixed or 
attached to'' containers of unwanted materials, must ensure that a 
hazardous waste determination of the contents can be made. Examples of 
information sufficient to make a hazardous waste determination include, 
but are not limited to: the name and/or description of the chemical 
contents or composition of the unwanted material, or, if known, the 
product of the chemical reaction, whether the unwanted material has 
been used or is unused, and a description of the manner in which the 
chemical was processed, if applicable.
    In summary, today's rule finalizes the proposed performance-based 
two-tiered labeling structure, but has modified it to address a number 
of comments received on the proposal. The first part of the final 
labeling requirement consists of information that must be ``affixed or 
attached to'' the container. The information must consist of the words 
``unwanted material'' or another equally effective term that is used 
consistently by the eligible academic entity and is identified in Part 
I of the eligible academic entity's LMP. Additionally, the label must 
contain sufficient information to alert emergency responders to the 
contents of the container. The second part of the final labeling 
requirement consists of information that must be ``associated with'' 
the container in some manner, which could include affixing or attaching 
it to the container. The information required includes the date that 
unwanted material first begins accumulating in the container, and 
information sufficient to allow trained professionals to determine 
whether the unwanted material is a solid and hazardous waste, as well 
as assign the proper hazardous waste code(s), pursuant to Sec.  262.11. 
For more detail on specific labeling requirements for when volume 
limits are exceeded in the laboratory and after hazardous waste 
determinations are made, see section III.C.5, Removal Frequency of 
Unwanted Materials and Section III.C.6, Making the Hazardous Waste 
Determination, respectively.
3. Container Standards
    When accumulating unwanted materials in the laboratory, proper 
container management is essential to protect human health and the 
environment. We proposed performance-based container management 
standards, requiring that the containers be stored to prevent leaks, 
spills, emissions to the air, adverse chemical reactions, and to avoid 
dangerous situations that may result in harm to human health and the 
environment. The proposed container management standards also included 
two specific standards as a means to achieve these goals: (1) 
Containers must be kept in good condition and damaged containers must 
be replaced; and (2) containers must be compatible with their contents.
    In the preamble to the proposed rule, we solicited comment on two 
alternative approaches for container management. First, we requested 
comment as to whether the rule should include more specific container 
management requirements in the regulations, potentially going beyond 
what was proposed. In the preamble, we included some examples of 
specific requirements we were considering, such as secondary 
containment and imposing a minimum safe distance for the storage of 
incompatibles. Another example that was discussed in the preamble was 
requiring that containers of unwanted material always be closed during 
storage, except for cases of in-line collection. An in-line collection 
system is a piece of laboratory equipment, such as a high performance 
liquid chromatograph (HPLC) that is directly connected to a container 
that collects unwanted material, including hazardous waste, typically 
by tubing. The tube carries the waste from the equipment directly into 
the container.
    The second alternative approach for container management that we 
requested comment on was the concept of a ``working container.'' In the 
preamble to the proposal, a working container was defined as a small 
container (one gallon or less), managed under the control of a 
laboratory worker and used at a bench or work station, whose contents 
are emptied into a container of unwanted material at the end of the 
procedure. Similar to the previous alternative, we indicated that if we 
added ``working container'' to the final rule, we would also add a more 
specific requirement that any container of unwanted material that does 
not fit the definition of working container, be closed at all times, 
except when necessary to add or remove unwanted materials.
    We received many comments on the proposed container management 
standards. Most commenters were supportive of the performance-based 
container management standards in lieu of the more prescriptive 
standards. Commenters argued that performance-based container 
management standards

[[Page 72931]]

would allow them the flexibility to tailor the standards to laboratory-
specific operations. On the other hand, a few State commenters 
preferred more prescriptive container management standards as they 
found them easier to enforce than performance-based standards. However, 
we decided to maintain the performance-based container standards 
because we believe they are protective of human health and the 
environment, while providing flexibility to eligible academic entities.
    Today's rule finalizes the proposed container management standards 
with one minor change and adds a new requirement. The requirement that 
eligible academic entities must properly manage containers of unwanted 
material to assure safe storage of the unwanted materials, to prevent 
leaks, spills, emissions to the air, adverse chemical reactions, and 
dangerous situations that may result in harm to human health or the 
environment has remained the same from proposal. Similarly, containers 
must be compatible with their contents. A minor clarification was added 
to the requirement that damaged containers be replaced. Several 
commenters requested that the Agency add language clarifying that 
replacing damaged or degraded containers is not the only method of 
reducing their threat. We agree and have added the requirement in the 
final rule that damaged or degraded containers be replaced, overpacked, 
or repaired, in order to prevent releases of the container's contents 
into the environment. An example of overpacking a container is taking a 
damaged container of unwanted materials and placing it into a second 
container in good condition and then packing the second container with 
absorbent filler similar to the practice of lab-packing. An example of 
repairing a damaged container would be if a small leak appears in the 
cap of a container of unwanted material, and a laboratory worker 
covered the broken cap with a polymer film.
    Many commenters also provided comments in support of the concept of 
a ``working container,'' although a few commenters were opposed to 
allowing a ``working container'' in the final rule. Opponents believed 
that the approach is not protective of the environment, while 
supporters felt that the prescriptive requirement that containers be 
kept closed, except when adding or removing waste, which we said would 
be added if a working container provision were added to the final rule, 
is easier to enforce. In addition, commenters in support of adding a 
working container wrote that this concept ``recognizes the fact that 
many unwanted laboratory materials are actively accumulated in small 
containers at a bench, work station, or fume hood.'' Academic and State 
commenters supported the inclusion of a working container provision 
because it allows containers that are in use for collecting unwanted 
materials to be open while the experiment is running, while at the same 
time it provides protection by requiring that non-working containers be 
closed at all times, except when adding, removing, or consolidating 
unwanted materials.
    After evaluating all of the comments, we have decided to include a 
provision in the final rule allowing laboratories to use ``working 
containers.'' As discussed in the definition section above (section 
III.B.3), a working container is defined in the final rule as a small 
container (i.e., two gallons or less) that is used at a laboratory 
bench, hood, or other work station in order to collect unwanted 
material from a laboratory experiment or procedure. We have added to 
the container management standards a requirement that a working 
container may be open until the end of the procedure or work shift, or 
until it is full, whichever comes first, at which time it must either 
be closed or the contents must be emptied into a container that is 
closed after the contents of the working container are added.
    In reference to the other containers of unwanted materials in the 
laboratory (i.e., non-working containers), several commenters opposed 
the requirement that these non-working containers remain closed, except 
to add or remove unwanted material. We disagree with these commenters. 
We believe that the requirement that containers remain closed, except 
when adding, removing, or consolidating unwanted material is 
straightforward and is protective of human health and the environment. 
Requiring that containers remain closed, except in certain instances, 
will prevent or mitigate accidents in the laboratory that could 
otherwise lead to spills or releases.
    Commenters identified two additional situations (besides working 
containers) where they believed a requirement to keep containers closed 
is problematic. One commenter stated, ``* * * tightly capping 
containers after addition of waste is sometimes impractical and 
dangerous. Capping systems should be allowed which preclude excessive 
evaporation while providing for displacement of air while filling from 
in-line systems such as an HPLC or allow pressure relief from wastes 
which have not fully reacted.'' The comment about ``in-line'' 
collection of unwanted materials is consistent with what the Agency has 
heard over the years through our Project XL with the three New England 
colleges and universities, as well as through public meetings. In many 
cases, automated laboratory equipment will shut down if air is not able 
to escape from an in-line collection system because of a build-up of 
pressure. Another commenter stated, ``* * * that the closed container 
rule may also have a negative effect by creating a compromised 
container in certain situations. Chemical reaction residues may react 
slowly over several days, thus building up pressure in a container. The 
semiconductor etching solution known as ``piranha solution'' is one 
example. Proper management of these solutions requires that the 
container be able to safely vent the excess pressure.''
    In response to the two public comments above, we have modified the 
container management regulations to add these two additional situations 
(besides working containers) in which containers are not required to be 
completely closed, because in these two situations keeping a container 
of unwanted materials closed may be problematic. Specifically, the 
final rule allows containers to be vented when it is necessary (1) for 
the operation of laboratory equipment, such as in-line collection, and 
(2) to avoid dangerous situations, such as the build-up of extreme 
pressure. Thus, as we have explained, we have determined that a 
combination of both performance-based and prescriptive approaches (as 
it relates to whether containers must be kept closed) is more 
protective of human health and the environment than performance-based 
requirements alone. The Agency believes it is preferable to maintain 
the requirement that containers remain closed, except when adding, 
removing or consolidating unwanted material in most instances, while 
allowing for a few specific instances in which it is not appropriate, 
rather than to eliminate the requirement for closed containers 
altogether. This is because such an approach provides the flexibility 
in specific situations where commenters have shown that requiring 
closed containers is inappropriate and does not compromise protection 
for all the other containers of unwanted materials that have no cause 
to be open. Furthermore, this approach is simpler for an eligible 
academic entity to implement and is more easily enforceable.
    In summary, today's final rule contains container management 
standards that require that containers be managed to assure the safe 
storage of the

[[Page 72932]]

unwanted material to prevent leaks, spills, emissions to the air, 
adverse chemical reactions, and dangerous situations that may result in 
harm to human health or the environment. Specifically, today's final 
rule requires that containers be maintained and kept in good condition 
and that damaged containers be replaced, overpacked, or repaired. 
Additionally, containers must be compatible with their contents to 
avoid reactions between the contents and the container and must be made 
of, or lined with, material that is compatible with the unwanted 
material so that the container's integrity is not impaired. Finally, 
containers of unwanted material must be kept closed at all times, with 
three exceptions: (1) When adding, removing or consolidating unwanted 
material, (2) when using working containers, which may be open until 
the end of the procedure or work shift, or until they are full, 
whichever comes first, and (3) allowing containers to be vented if 
necessary for the proper operation of laboratory equipment, such as 
with in-line collection, or to prevent dangerous situations, such as 
build-up of extreme pressure.
4. Training Requirements
    The Agency intends to provide flexibility in the content and method 
of training for laboratory workers and students, while ensuring that 
unwanted materials are properly managed and that an eligible academic 
entity is in full compliance with the Subpart K requirements. Thus, EPA 
has included performance-based standards in today's final rule for 
training of laboratory workers and students.
    EPA proposed that under Subpart K a college or university be 
required to provide training or instruction to all individuals working 
in the laboratory. Specifically, the proposal required that laboratory 
workers be trained commensurate with their duties so they understand 
the requirements of Subpart K and can implement them to ensure the 
laboratories' compliance with the requirements of the rule. In 
addition, we proposed that students in a laboratory where unwanted 
material is generated must receive instruction relevant to their 
activities in the laboratory. We proposed that instruction may include 
proper container labeling, collection procedures for unwanted material, 
and emergency response procedures. Further, the proposal required that 
on-site transfers of unwanted materials (which ultimately may prove to 
be hazardous wastes) and the hazardous waste determination could only 
be conducted by RCRA-trained individuals (called ``trained 
professionals'' in the final rule). The proposal indicated that a 
college or university could provide training and instruction for 
laboratory workers and students in a variety of ways, including, but 
not limited to, instruction by the professor or laboratory manager 
before or during an experiment, formal classroom training, electronic 
or written training, on-the-job training, or written or oral exams. 
Finally, the proposal required that a college or university that is an 
LQG must maintain training records for the laboratory workers that are 
sufficient to determine whether such workers have been trained.
    Many commenters expressed general or partial support for the 
proposed performance-based training and instruction requirements, in 
lieu of prescriptive training requirements. However, many commenters 
requested that the training requirements be made more performance-based 
and include greater flexibility in training approaches (e.g., use of 
postings and signs). In contrast, a few commenters expressed support 
for a more prescriptive approach to training and instruction, including 
a clear and concise required curriculum for RCRA training in order to 
make the Subpart K requirements more meaningful.
    We maintain that performance-based training requirements are 
appropriate for laboratory workers and students. Eligible academic 
entities should have the flexibility to offer training to laboratory 
workers and students through their choice of an effective method, 
provided the information is sufficient and thorough enough to ensure 
proper management of the unwanted materials by laboratory personnel in 
order to avoid dangerous situations. However, EPA disagrees that merely 
posting a sign would adequately instruct laboratory workers and 
students on the proper and safe management of unwanted materials, 
believing that some active training is necessary to ensure that all 
laboratory personnel fully comprehend their duties and assignments with 
respect to unwanted materials management. As stipulated in the proposal 
and supported by comments, today's final rule maintains that training 
methods may consist of a variety of approaches, including formal 
classroom or electronic on-line training, on-the-job training, or 
instruction by a professor or manager. Use of postings or signs may 
supplement and serve as a reminder of the more formal training, but 
does not itself constitute ``training'' for the purposes of today's 
final rule. While we do not believe the use of postings or signs alone 
constitute ``training,'' EPA believes that the use of signs and 
postings to supplement and reinforce the knowledge gained from the 
required training program would be beneficial. Training must be 
sufficient to enable individual laboratory workers and students in the 
laboratory to conduct their duties in an environmentally safe manner 
and in accordance with all applicable regulations.
    Many commenters stated that all training and instruction should be 
commensurate with the duties and activities of the personnel, 
irrespective of their status as students or laboratory workers. We 
concur with these commenters and thus the final rule has been modified 
to reflect that principle. Therefore, as opposed to the proposed rule, 
which distinguished between training for laboratory workers and 
instruction for students, today's final rule requires that both 
laboratory workers and students be trained commensurate with their 
duties. Therefore, commensurate training constitutes training aligned 
with an individual's assigned duties and the degree of involvement with 
the management of the unwanted materials. EPA believes that training 
commensurate with ones duties should correspond with the level of 
knowledge or practical application needed by individuals to perform 
their assigned functions or fulfill their job or enrollment 
classification (i.e., professor, researcher, graduate student, 
undergraduate student) within an eligible academic entity.
    We believe that training commensurate with the duties for students 
constitutes familiarization or transference of knowledge to perform 
tasks and assignments in the laboratory in a safe and environmentally 
sound manner for unwanted materials handling, in accordance with the 
Subpart K requirements. Specifically, students conducting experiments 
will come in contact with and use a variety of chemicals which may 
potentially become hazardous waste following experimentation or may 
react adversely if incorrectly stored or managed. Students in a 
supervised classroom setting generally would require less training than 
students in a research setting. In a teaching laboratory, containers 
for the unwanted materials that are generated during an experiment are 
typically pre-labeled by the laboratory instructor. Therefore, students 
in a supervised classroom setting should be trained to place the 
products of experiments in the appropriate containers of unwanted 
materials. On the other hand, students conducting research where such

[[Page 72933]]

containers are not provided should be trained to store unwanted 
materials in containers to minimize risk and label containers with the 
words ``unwanted materials,'' or another equally effective term, so 
that EH&S staff know that the containers are not longer wanted, as well 
as the contents of the container and the accumulation start date. There 
is also the potential for dangerous or hazardous situations, such as 
explosions, fires, spills, or other hazards from mishandling chemicals 
of unwanted materials which would require emergency response actions by 
qualified personnel. It is not necessary that students have the 
capability of an emergency response coordinator or other qualified 
individual to respond and perform emergency procedures and other 
remedial actions. Rather, it is sufficient for students to know how to 
correctly handle and manage unwanted materials to avoid dangerous or 
hazardous situations and in case of an emergency, know the correct 
information or procedures to follow, such as how to contact emergency 
responders and when to evacuate the laboratory.
    Training commensurate with the duties for laboratory workers and 
graduate students working as laboratory workers may be more formalized 
or technical instruction whereby upon completion of training, personnel 
are qualified to perform the functions of their job descriptions or 
assigned duties. For the purpose of Subpart K, laboratory workers must 
receive training or technical instruction in direct correlation to 
their individual job description or assignments. Under Subpart K, the 
definition of ``laboratory worker'' includes a broad array of job 
classifications with different duties, such as supervisor or manager of 
a laboratory, faculty, staff, researcher, post-doctoral fellows, 
interns, technicians and principal investigators. Examples of training 
for laboratory workers commensurate with ones duties include, but are 
not limited to, training to perform their duties to comply with the 
Subpart K labeling and container management standards, supervising 
students in the laboratory, preparing containers for transport, 
emergency response duties, and/or other duties, as appropriate.
    Several commenters expressed concern about the requirement that 
personnel conducting on-site transfers of unwanted materials be RCRA-
trained. The commenters stated that this requirement is unnecessary and 
does not recognize that these entities have been safely transferring 
hazardous waste on-site for years and that a person can safely transfer 
unwanted materials with appropriate safety training. In contrast, the 
Agency heard from one commenter stating that students and non-RCRA 
trained staff should not transfer hazardous wastes outside of the 
laboratory. We believe that the person transferring unwanted materials 
on-site must be a ``trained professional'' according to the definition 
in Sec.  262.200, which requires that the individual complete the 
applicable RCRA training requirements of Sec.  265.16 for LQGs, or 
Sec.  262.34(d)(5)(iii) for SQGs and CESQGs. Despite the fact that 
commenters stated otherwise, this requirement is consistent with the 
Agency's existing interpretation for on-site transfers of hazardous 
waste (see memo March 17, 2004, Springer to Regions, RCRA Online 
14703). Furthermore, we believe that this level of training is 
``commensurate'' with the duties of the individual transferring the 
unwanted materials on-site, which are to transfer the materials safely, 
to avoid spills or releases, and to respond properly to any releases, 
among other things. Specifically, we believe that the on-site transfer 
of unwanted materials outside of the laboratory should be conducted by 
an individual who has received the full complement of RCRA training in 
accordance with the eligible academic entity's generator status, to 
ensure that that individual is knowledgeable about the RCRA 
requirements, especially with regard to the compatibility of chemicals, 
spill prevention, and emergency response. This is especially important 
considering that the unwanted materials from many individual 
laboratories will often be collected together during the on-site 
collection and transfer of those materials.
    We also heard from two commenters who emphasized the importance of 
training for personnel who make the hazardous waste determination at an 
eligible academic entity. We agree with the commenters, and, as 
proposed, require in today's final rule that the individual making the 
hazardous waste determination, whether it is in the laboratory, at the 
on-site CAA or on-site TSDF, be a trained professional who has the full 
complement of RCRA training in accordance with the eligible academic 
entity's generator status (SQG status for CESQGs). Individuals making 
the hazardous waste determination must be aware of all applicable RCRA 
requirements in order to complete their duties, which are to classify 
the unwanted materials properly as solid and/or hazardous wastes and to 
apply the correct hazardous waste code(s). Thus, we are continuing to 
require that the person making the hazardous waste determination be a 
``trained professional'' according to the definition set out in Sec.  
262.200.
    Therefore, today's final rule maintains the requirement that 
trained professionals make the hazardous waste determination and 
transfer unwanted materials (or hazardous wastes, if the hazardous 
waste determination is made in the laboratory) outside the laboratory 
and that the trained professionals must meet the existing RCRA 
generator training requirements applicable to the eligible academic 
entity's generator status. In addition, today's final rule has added 
the requirement that trained professionals at CESQGs must receive RCRA 
training in accordance with the training requirements for SQGs, at a 
minimum (see definition of ``trained professional'' in Section III.B.2 
of today's preamble, as well as Sec.  262.200).
    Several commenters described other regulatory bodies (e.g., DOT; 
U.S. Nuclear Regulatory Commission (NRC); Occupational Safety and 
Health Administration (OSHA)) that require training on hazardous 
chemicals, emphasizing that Subpart K's training requirements should 
avoid redundancy with other required training. Some of these commenters 
stated that they would use OSHA training to satisfy the proposed 
Subpart K training requirements. In contrast, we heard from one 
commenter expressing concern that there are no other appropriate 
regulatory requirements for training specific enough to be appropriate 
for RCRA because they do not effectively cover the RCRA hazardous waste 
determination. The Agency believes that neither the ``traditional'' 
RCRA generator regulations nor Subpart K prohibits the use of other 
training programs to satisfy the training requirements of Subpart K, 
provided the other training program(s) address the relevant RCRA 
requirements for trained professionals, and the relevant Subpart K 
requirements to train laboratory workers and students commensurate with 
their duties.
    Several commenters argued that eligible academic entities should be 
able to provide evidence of training, in lieu of training records, 
which they believe are too burdensome to keep. Furthermore, a few 
commenters advocated eliminating the proposed recordkeeping 
requirements for LQGs, arguing that such requirements would be more 
burdensome than the existing requirements for satellite accumulation 
areas, which do not require documented training for personnel. The 
Agency recognizes that the satellite

[[Page 72934]]

accumulation area regulations do not require documented training for 
personnel and is not requiring that records be retained for training of 
students in the laboratory. However, we believe it is appropriate that 
eligible academic entities that are LQGs retain the records for 
training of laboratory workers in order to demonstrate that the 
laboratory worker received the necessary training. The records that are 
required for laboratory workers at LQGs are the same that are required 
for trained professionals at eligible academic entities that are LQGs 
(and which they are subject to today), both of which reference the 
current LQG training regulations in Sec.  265.16.
    Finally, we heard from a few commenters who stated that the 
maintenance of training records for trained professionals or laboratory 
workers at SQGs is unnecessary. We did not propose to require such 
recordkeeping for training of laboratory workers or trained 
professionals at SQGs, nor has the Agency included such a requirement 
in today's final rulemaking.
    In summary, under today's final rule, eligible academic entities 
managing their laboratory hazardous wastes under Subpart K must provide 
training for laboratory workers and students, and the training must 
provide sufficient information so that laboratory workers and students 
can understand and implement the requirements of Subpart K, 
commensurate with their duties. An eligible academic entity can provide 
training and instruction for laboratory workers and students in a 
variety of ways, including, but not limited to, instruction by the 
professor/manager before or during an experiment, formal classroom 
training, electronic/written training, on-the-job training, or written 
or oral exams. LQGs managing their laboratory waste under Subpart K 
must maintain documentation demonstrating that the training has been 
provided to laboratory workers and trained professionals. Documentation 
demonstrating training can include, but is not limited to, sign-in or 
attendance sheet(s) for training session(s), syllabi for training 
session(s), certificate(s) of completion, or test results. Finally, the 
training requirements in today's final rule restrict who may conduct 
certain activities under Subpart K. Specifically, only ``trained 
professionals,'' as defined in Sec.  262.200, may transfer unwanted 
materials on-site and make the hazardous waste determination, pursuant 
to Sec.  262.11, for unwanted material.
5. Removal Frequency of Unwanted Materials
    Currently, most laboratories operate under what is commonly 
referred to as the satellite accumulation area (SAA) regulations (see 
40 CFR 262.34(c)). At SAAs, removal of hazardous waste is dependent on 
the volume of hazardous waste that is accumulated in each SAA. That is, 
once more than 55 gallons of hazardous waste (or more than 1 quart of 
acutely hazardous waste) is accumulated in an SAA, a generator has 
three days to remove the excess of 55 gallons (or excess of 1 quart of 
acutely hazardous waste) from the SAA and transfer it to an on-site CAA 
or TSDF, or transport it off-site.
    In large part because colleges and universities explained to us 
that they rarely accumulate 55 gallons of hazardous waste in a 
laboratory, except during a laboratory clean-out, in Subpart K we 
proposed to require the removal of unwanted materials from laboratories 
based primarily on time, and secondarily by the volume of unwanted 
materials. Specifically, we proposed that all unwanted materials, 
including reactive acutely hazardous unwanted materials (as defined in 
the proposal), generated in laboratories must be removed from the 
laboratory at a regular interval that is specified in the entity's LMP, 
and that such interval for routine removals must not exceed six months. 
College and university representatives had told EPA that tying the 
removal of laboratory wastes with the academic calendar would 
facilitate removal of laboratory wastes that accumulate during the 
course of the semester with a minimum of disruption. Therefore, the 
Agency believed that six months was an appropriate length of time to 
allow colleges and universities to schedule routine removals of 
unwanted materials at the end of each semester.
    We also proposed that if a laboratory accumulates more than 55 
gallons of unwanted materials (including reactive acutely hazardous 
unwanted materials) prior to the regularly scheduled removal specified 
in the entity's LMP, then all of the unwanted materials, including the 
reactive acutely hazardous unwanted materials, must be removed from the 
laboratory within ten calendar days of exceeding 55 gallons, or at the 
next regularly scheduled removal, whichever occurs first. For reactive 
acutely hazardous unwanted materials, we proposed that if a laboratory 
accumulates more than 1 quart prior to the regularly scheduled removal, 
then the reactive acutely hazardous unwanted materials would have to be 
removed from the laboratory within ten calendar days of exceeding 1 
quart, or at the next regularly scheduled removal, whichever occurs 
first. The Agency proposed that the reactive acutely hazardous unwanted 
materials be subject to the 1-quart volume limit for accumulation in 
the laboratory, instead of the 55-gallon limit, because when these 
reactive chemicals are stored for long periods, they can become 
unstable, posing an extreme danger because these reactive chemicals 
have the potential to cause significant harm to laboratory personnel 
and property.
    Many commenters generally supported the shift to the time-driven 
removal of unwanted materials from laboratories. However, they also 
requested that the maximum time between regularly scheduled removals be 
lengthened from six months to a year, or an ``academic year,'' which 
commenters defined as ``the 11-13 month period that corresponds to a 
college or university's annual teaching and research activities.'' Some 
commenters argued that six months was too frequent because some 
laboratories generate very small quantities of unwanted material in 
that time period. While some laboratories may generate small quantities 
of unwanted material, we have determined, based on all the available 
information, to keep six months as the maximum time between regularly 
scheduled removals.
    We have retained six months as the maximum time between regularly 
scheduled removals of unwanted materials from the laboratory for 
several reasons. First, we believe that implementing regular removals 
on the basis of an ``academic year'' could be confusing. Second, as we 
indicated in the preamble to the proposed rule, our goal is to have 
unwanted materials removed from laboratories at least once each 
semester. One commenter indicated that a schedule that allows removals 
on a semester basis is preferred by stating, ``colleges and 
universities generally use the semester's end to encourage laboratory 
workers and students to have unwanted materials removed from their 
laboratories before leaving campus. This practice reduces the risk that 
unknown materials will be left behind by a student or laboratory worker 
who does not return the following semester. Also it limits the amount 
of waste material stored in laboratories during the break, when fewer 
people are around to monitor or be aware of the conditions in the 
laboratory.'' Finally, as discussed in the proposal, we do not believe 
that allowing unwanted materials to accumulate for longer than six 
months

[[Page 72935]]

would reduce risk to laboratory personnel and provide the benefits to 
human health and the environment to the same extent and therefore the 
anticipated benefits from moving to a time-driven rather than a volume-
driven approach would be diminished.
    We realize that some laboratories will not generate any unwanted 
materials during a six month period and we do not intend for EH&S 
personnel or other staff or contractors to make a trip to the 
laboratory if they know that the laboratory does not have any unwanted 
materials. The eligible academic entity must describe in Part II of its 
LMP how it will determine whether a removal of unwanted material is 
necessary at each individual laboratory. For example, a form or an e-
mail could be sent to each laboratory asking whether the laboratory has 
any unwanted material accumulating and the EH&S could respond 
accordingly. Eligible academic entities have flexibility with respect 
to how they intend to comply with the requirements for regular removals 
of unwanted materials. However, each eligible academic entity is 
responsible for ensuring that it meets the time-driven requirement 
(i.e., every six months) for the method it has selected for removing 
unwanted materials from the laboratory. The accumulation start date 
associated with each container (or affixed or attached to each 
container, if that is preferred) of unwanted material is intended to be 
used as the mechanism for determining compliance with regularly 
scheduled removals. Of course, unwanted materials may always be picked 
up with greater frequency than specified in either the regulations or 
the eligible academic entity's LMP.
    A number of commenters expressed concern over the requirement to 
remove ``all'' containers of unwanted materials from the laboratory 
either during a regularly scheduled removal or when the volumes have 
been exceeded, because this would require partially-filled containers 
to be removed from the laboratory, which could require the use of more 
containers. Many of these commenters requested that EPA modify the 
requirement to remove ``all'' unwanted material from the laboratory to 
require that only full containers of unwanted material have to be 
removed from the laboratory.
    We recognize the commenters' concerns regarding the requirement to 
remove ``all'' unwanted materials from the laboratory during regularly 
scheduled removals or when volumes have been exceeded. However, we do 
not consider the alternative suggested by commenters--to require that 
only full containers of unwanted material have to be removed from the 
laboratory--to be practical. It would be easy to circumvent the intent 
of the regulations for regular systematic removals of unwanted 
materials from the laboratory by simply not completely filling 
containers of unwanted materials. In this scenario, the removal of 
unwanted materials from the laboratory would be based primarily on 
volume, rather than based on EPA's preferred approach of time. We 
prefer the time-driven approach, with the maximum volumes as a backup 
because, for most laboratories, it is rare to accumulate 55 gallons of 
unwanted material. Without a time limit, unwanted materials could 
remain in the laboratory for extended periods of time. As for the 
concern about using too many containers, consolidation of compatible 
materials is allowed within in a laboratory, as well as at an on-site 
CAA or on-site TSDF, which could then return some or most of the 
reusable containers for use in collecting unwanted material.
    One commenter suggested adopting a system that mirrors the 
Universal Waste system for tracking the amount of time that unwanted 
materials remain in the laboratory. This commenter suggested that a 
laboratory should be allowed to demonstrate the length of time that 
each container has been accumulating unwanted material and that EPA 
should base the removal on how long each container is in the 
laboratory. We also heard from many commenters that we should be more 
flexible in the removal provisions.
    In response to these comments, there are now two alternative 
approaches allowed for regular removals of unwanted materials. The 
first approach is the one that was proposed. That is, all containers of 
unwanted material must be removed from the laboratory on a regular 
basis, not to exceed six months. Under this approach, however, it is 
possible that a container that began accumulating unwanted materials 
the day before the regularly scheduled removal would be required to be 
removed. This approach is easy to implement, as all containers of 
unwanted material would be removed from the laboratory, regardless of 
when they began accumulating unwanted materials.
    The second alternative being added today allows the removal of 
containers of unwanted material using a ``rolling'' six months 
approach. That is, no individual container of unwanted material could 
remain in the laboratory for more than six months. We believe this 
alternative approach provides additional flexibility that many 
commenters sought by adding a choice of implementation methods for the 
removal of unwanted materials, while maintaining the intent of the 
regulations by requiring regular, systematic, time-driven removals of 
unwanted materials. Since there is already a requirement that all 
containers have an accumulation start date associated with them, this 
approach would rely on checking the dates associated with each 
container in order to determine which containers would have to be 
removed from the laboratory. Individual containers could potentially 
remain in the laboratory longer than under the other alternative 
approach and therefore, would be more likely to be full or nearly full. 
On the other hand, this approach would likely require more frequent 
removals from the laboratory to ensure that no container accumulating 
unwanted materials remains in the laboratory longer than six months.
    Each eligible academic entity choosing to be subject to Subpart K 
must select and identify in Part I of its LMP, the approach it chooses 
for complying with regular removals of unwanted materials from the 
laboratory. In Part II of its LMP, the eligible academic entity must 
describe how it plans to comply with the approach it has chosen for 
regular removal of unwanted materials from the laboratory.
    Under the SAA regulations of Sec.  262.34(c), if the maximum 
volumes are exceeded, the excess of 55 gallons of hazardous waste (or 1 
quart of acutely hazardous waste) must be removed from the area within 
three days. We have frequently heard that the three-day time limit was 
problematic, especially during long weekends and holidays. Under 
Subpart K, we proposed to extend from three days to ten calendar days 
the removal of unwanted materials from the laboratory when the maximum 
volumes are exceeded. Many commenters supported this change, although a 
few commenters believed that three days was sufficient. One State 
commenter suggested that laboratories should remove their unwanted 
materials before the maximum volumes are reached, which would remove 
the need for providing additional time for the removal of unwanted 
materials from the laboratory. We have decided to retain ten calendar 
days for removing unwanted materials from the laboratory when the 
maximum volumes are exceeded. We believe that ten calendar days will 
provide sufficient flexibility to respond to the occasions when 55 
gallons of unwanted material (or 1 quart of reactive acutely hazardous 
unwanted material) is exceeded, while maintaining protection to human 
health and the environment.

[[Page 72936]]

    With regard to which unwanted materials must be removed from the 
laboratory when maximum volumes are exceeded, we proposed that when a 
laboratory exceeds 55 gallons of unwanted material, it must remove all 
unwanted materials--including the reactive acutely hazardous materials. 
This is because all reactive acutely hazardous materials are unwanted 
materials and should be considered in calculating whether the 55 
gallons has been exceeded. On the other hand, we proposed that when a 
laboratory exceeds 1 quart of acutely reactive unwanted material, it 
must remove only the reactive acutely hazardous unwanted material, not 
all containers of unwanted material, because not all unwanted materials 
are reactive acutely hazardous unwanted materials, and therefore should 
not be subject to the lower accumulation limits in the laboratory. We 
have retained these requirements in today's final rule, with some minor 
rewording to clarify our intent. Of course, in the case where a 
laboratory exceeds 1 quart of reactive acutely hazardous unwanted 
material, an eligible academic entity may choose to remove all unwanted 
materials from the laboratory. If a trained professional has to make a 
trip to the laboratory to remove reactive acutely hazardous unwanted 
materials in excess of 1 quart, it may be more efficient to remove all 
unwanted materials at the same time, even if they are not required to 
be removed at that time.
    We proposed that if a laboratory accumulates more than 55 gallons 
of unwanted material, then all containers of unwanted materials 
(including reactive acutely hazardous unwanted materials) must be dated 
with the date the 55 gallons is exceeded. We also proposed that if a 
laboratory accumulates more than 1 quart of reactive acutely hazardous 
unwanted material, then all containers of reactive acutely hazardous 
unwanted materials must be dated with the date the 1 quart is exceeded. 
This date is necessary to determine whether the ten calendar days had 
elapsed and, therefore, when the containers must be removed from the 
laboratory. In the proposed regulations, we did not specify which label 
this date must go on--the label that is ``affixed to or physically 
accompanies'' (which has been changed to ``affixed or attached to'' in 
the final rule) the container, or the label that is ``associated with'' 
the container. However, in the preamble to the proposed rule, we did 
indicate that, as with the requirement to date containers with their 
accumulation start date, this date may be included on either label--the 
label that is ``affixed or physically accompanies'' the container, or 
the label that is ``associated with'' the container (see 71 FR 29730). 
In today's final rule, we have revised the regulatory text to be 
consistent with the preamble discussion from the proposed rule. 
Therefore, when 55 gallons of unwanted material (or 1 quart of reactive 
acutely hazardous unwanted material) is exceeded in a laboratory, the 
date that the maximum volume is exceeded may be added to either type of 
label. That is, it may be added to the label that is ``affixed or 
attached to'' the container, but at a minimum it must be added to the 
label that is ``associated with'' the container.
    One commenter pointed out that if an eligible academic entity does 
not have an on-site CAA and one of its laboratories exceeds the 
specified volume limits, the generator must be prepared to have a 
vendor ship the unwanted materials from the laboratory to an off-site 
TSDF within 10 calendar days. We agree with the commenter's assessment 
and point out that this is an increase in the time allowed under the 
current SAA regulations, under which the same generator would have only 
three days in which to ship the hazardous waste off-site (or come into 
compliance with the requirements for 90/180/270-day generator 
accumulation areas).
    One commenter suggested that in order to be consistent with the SAA 
regulations, the 55-gallon limit should be on a ``per wastestream'' 
basis, rather than a ``total volume'' basis. We disagree with the 
commenter and find the commenter's interpretation of the SAA 
regulations to be incorrect. To the contrary, EPA has consistently 
interpreted the SAA regulations such that 55 gallons is based on a 
total volume of all wastestreams combined (see memo from Robert 
Springer, Director, OSW to EPA Regional Directors, March 17, 2004, RCRA 
Online 14703). Thus, Subpart K is consistent with the SAA 
regulations with respect to this provision.
a. Reactive Acutely Hazardous Unwanted Materials
    Under the SAA regulations of Sec.  262.34(c), if more than 1 quart 
of an acutely hazardous waste listed in Sec.  261.33(e) is accumulated, 
the excess of 1 quart must be removed from the SAA within three days 
and taken either to an on-site CAA or TSDF, or transported off-site. 
Section 261.33(e), which is commonly referred to as the ``P list'' of 
hazardous wastes, currently comprises 124 chemicals. The P-list is a 
list of commercial chemical products that are considered acutely 
hazardous waste when discarded because they are considered hazardous 
even when managed in small quantities. Under Subpart K, the Agency is 
reducing the number of chemicals that are subject to removal from the 
laboratory at the 1-quart threshold from all 124 chemicals on the P-
list to the six chemicals that are on the P-list because they are 
reactive. We focused on the reactive chemicals on the P-list because, 
as reactive chemicals, they have the potential to cause significant and 
immediate harm to individuals and property. We are finalizing this 
provision as proposed, along with the change to the definition of 
reactive acutely hazardous unwanted material that was previously 
discussed in section III.B.2 of today's preamble (also see Sec.  
262.200).
    We also would like to clarify that this regulatory revision--that 
is, the number of P-listed chemicals that are subject to removal from 
the laboratory if they exceed the 1-quart threshold--does not impact 
other aspects of the hazardous waste regulations. That is, we have not 
changed the regulations with respect to which chemicals are identified 
as acutely hazardous wastes or the 1 kg/month threshold for becoming an 
LQG. Therefore, the entire P-list must be considered when a trained 
professional makes the hazardous waste determination for unwanted 
materials. If an eligible academic entity generates more than 1 kg/
month of acutely hazardous waste, it is an LQG for that calendar month, 
except if the acutely hazardous waste is from a laboratory clean-out 
conducted in accordance with Sec.  262.213 of today's rule, in which 
case it need not be counted toward the eligible academic entity's 
generator status. See section III.C.7 of today's preamble for a 
discussion of the laboratory clean-out provisions, as well as Sec.  
262.213.
b. Transferring Unwanted Materials or Hazardous Wastes From the 
Laboratory to an On-site CAA or On-site TSDF
    To ensure that unwanted materials removed from the laboratory are 
brought promptly to their next destination, such as an on-site CAA or 
TSDF, the Agency proposed to require that when unwanted materials (or 
hazardous wastes, if the hazardous waste determination was made in the 
laboratory) are removed from a laboratory, they must be brought 
``directly'' from the laboratory(ies) to an on-site CAA or TSDF. We 
sought comment on whether it was necessary to define ``directly'' or to 
replace it with a more specific time-frame, such as a same day 
requirement.

[[Page 72937]]

    We received several comments in support of defining the term 
``directly.'' Other commenters, however, stated that it was not 
necessary to define the term, especially given our preamble discussion 
in the proposed rule. In reviewing the comments, we have decided not to 
add a regulatory definition of ``directly'' and will simply reiterate 
and expand upon the preamble discussion from the proposed rule.
    In general, if the unwanted material is sent from the laboratory or 
laboratories to the on-site CAA or TSDF within the same work day, this 
would meet the intent of the regulation. We realize that many eligible 
academic entities will collect unwanted materials from many 
laboratories at a time, in series, and will deliver all the unwanted 
materials to an on-site CAA or TSDF at the end of the collection 
process. This would be an acceptable practice under today's 
regulations, provided the unwanted materials are in continuous custody 
of the trained professional that is collecting and transferring the 
unwanted materials and they are delivered to the on-site CAA or TSDF at 
the end of the work shift. It is not necessary to bring the unwanted 
material from each individual laboratory directly to the on-site CAA or 
TSDF and then in a separate trip bring the unwanted materials from the 
next laboratory. Such an arrangement would only increase the amount of 
time that trained professionals would spend in removing unwanted 
materials from laboratories and that unwanted materials would spend in 
transport, with no benefit. On the other hand, if unwanted materials 
were left on a cart in the hallway overnight, this would not be an 
acceptable practice and would not meet the intent of the regulation.
c. On-site Consolidation Areas
    Under the existing regulations, generators may accumulate hazardous 
waste in two types of areas without having a permit or interim status: 
(1) An SAA or (2) an on-site generator accumulation area (<=90, <=180 
or <=270 day areas).\7\ Under Subpart K, eligible academic entities 
also may accumulate unwanted materials and hazardous wastes in two 
types of areas without having a permit or interim status: (1) 
Laboratories (in lieu of SAAs) and (2) an on-site CAA (``CAA'' is a 
term that has been defined under Subpart K, but is the same as what has 
sometimes been called ``generator accumulation areas'' or ``90/180/270-
day areas'').
---------------------------------------------------------------------------

    \7\ LQGs may accumulate hazardous waste for 90 days or less on-
site without a permit or interim status, provided the provisions of 
Sec.  262.34(a) (or Sec.  262.34(g)-(i) for F006 recyclers; or Sec.  
262.34(j)-(k) for Performance Track members) are met. SQGs may 
accumulate hazardous waste for 180 days or less on-site without a 
permit or interim status, provided the provisions of Sec.  262.34(d) 
and (f) are met. SQGs that must send their hazardous waste more than 
200 miles for off-site treatment, storage, or disposal are allowed 
to accumulate hazardous waste for 270 days or less on-site without a 
permit or interim status, provided the provisions of Sec.  262.34(d) 
and (f) are met (see Sec.  262.34(e)).
---------------------------------------------------------------------------

    At proposal, we solicited comment on whether an additional 
accumulation area beyond what is already allowed in the rules should be 
created to allow for the consolidation of unwanted materials after they 
have been removed from the laboratory. We received many comments in 
favor of establishing a consolidation area as a new type of area for 
the accumulation of unwanted materials after such material has been 
removed from the laboratory. Some commenters even included suggested 
regulatory text for how these new consolidation areas would be 
regulated, including specific requirements for labeling/dating, 
container management, training, removal frequency, hazardous waste 
determinations, inspections, spill response, signage, and documentation 
in the LMP. A few commenters, however, opposed the creation of another 
type of accumulation area, primarily because they were concerned that 
the addition of another accumulation area would cause confusion.
    After analyzing the comments and considering the flexibility that 
is already provided in the regulations, we have decided not to 
establish a ``consolidation area'' as another type of accumulation area 
for unwanted materials. We agree with the commenters that argued that 
adding another type of accumulation area with another set of standards 
would be confusing for implementers and enforcers with little, if any, 
benefit. We believe that the flexibility that is already in Subpart K 
can provide the benefits of a consolidation area, without establishing 
a new regulatory category for them.
    It has been EPA's regulatory interpretation that hazardous wastes 
can not be moved from one SAA to another (see memo from Robert 
Springer, Director, OSW, to EPA Regional Directors; March 17, 2004, 
RCRA Online 14703). One reason for this prohibition is that it 
would be easy to circumvent the 55-gallon limit in an SAA by moving 
hazardous wastes from one SAA to another SAA and thus remain below the 
volume limits, allowing hazardous wastes to remain in the SAA 
indefinitely.
    In today's rule, however, the removal of unwanted materials is 
based on time primarily, and volume secondarily. Containers must be 
marked with the date that unwanted materials first begin to accumulate. 
This requirement is necessary in order to verify that unwanted 
materials are being removed from the laboratory on a regular basis. The 
requirement for a date to be associated with each container provides 
laboratories with additional flexibility that does not exist in SAAs. 
That is, under Subpart K, unwanted materials can be safely consolidated 
within an on-site laboratory, such as in a chemical stockroom. As with 
all on-site transfers of unwanted material outside of a laboratory, the 
transfer of unwanted materials between laboratories must be accompanied 
by a trained professional. Further, any laboratory in which unwanted 
materials are consolidated from other laboratories is subject to the 
time and volume limits for all laboratories that are subject to Subpart 
K (i.e., if the laboratory accumulates more than 55 gallons of unwanted 
material (or 1 quart of reactive acutely hazardous unwanted material), 
the unwanted material must be removed from the laboratory within 10 
calendar days). In addition, the date that an unwanted material first 
begins to accumulate in a container would remain the same, regardless 
of where the container is moved. In other words, no re-dating of a 
container would be permitted if it were moved to another laboratory or 
chemical stockroom. If the contents of two or more containers with 
compatible materials are combined into one container; however, the 
earliest date associated with the original containers must be used. The 
date that is associated with each container will allow inspectors to 
verify that containers are being removed from the laboratory on a 
routine basis not to exceed six months, as required. The 55-gallon 
volume limit will ensure that large quantities of unwanted materials 
are not consolidated without the additional protections required at 
CAAs.
    We envision this flexibility to be particularly useful for eligible 
academic entities that do not have on-site CAAs. Commenters have 
indicated that by consolidating their unwanted materials in a 
laboratory or chemical stockroom themselves prior to a vendor's 
arrival, they can save money because the vendor will be able to collect 
unwanted materials from fewer laboratories, thus spending less time on-
site. In such a situation, if an eligible academic entity (or the 
vendor) makes the hazardous waste determination in the laboratory, the 
eligible academic entity does not have to make the hazardous waste

[[Page 72938]]

determination when the unwanted material is removed from the first 
laboratory. Rather, the hazardous waste determination may be made when 
the unwanted material is removed from the final laboratory where the 
unwanted materials are consolidated, before it is sent off-site. 
Consolidating unwanted materials from multiple laboratories will 
provide another opportunity to consolidate unwanted materials that are 
compatible with one another, thereby allowing containers to be reused. 
We emphasize that trained professionals must transfer unwanted 
materials between laboratories and that any laboratory where unwanted 
materials are consolidated also is subject to the Subpart K 
requirements, including the time and volume limits.
6. Making the Hazardous Waste Determination
    One of the primary benefits that Subpart K provides over the 
existing generator regulations is flexibility in where and when to make 
the hazardous waste determination. The Agency has consistently 
interpreted the existing generator regulations to require that the 
hazardous waste determination be made at the point of generation. We 
now recognize that making the hazardous waste determination at the 
point of generation is difficult and impractical in teaching and 
research laboratories, because of the high number of individual wastes, 
the variability in such wastes, and the transient nature of those 
generating many of the wastes, namely students. Therefore, in Subpart 
K, we proposed to allow the hazardous waste determination to be made in 
the laboratory before the unwanted materials are removed from the 
laboratory, or within four calendar days of arriving at an on-site CAA 
or interim status or permitted TSDF. We proposed that when the 
hazardous waste determination is made in the laboratory, it does not 
have to be made at the initial time that the hazardous waste is 
generated, as is required under the existing generator regulations, 
only that it must be made before the unwanted materials are removed 
from the laboratory. This alternative approach ensures that the 
hazardous waste determination is made by a trained professional, rather 
than by students, who would likely lack the necessary training, and 
allows much greater flexibility in where and when to make the hazardous 
waste determination.
    In general, we received favorable comments about the flexibility 
provided by Subpart K with regard to making the hazardous waste 
determination. Today, we are finalizing the regulations pertaining to 
where and when the hazardous waste determination must be made with some 
minor changes to address the expansion of the applicability of the 
final rule to include eligible academic entities that are CESQGs. 
Eligible academic entities that are LQGs or SQGs will continue to have 
the choice of making the hazardous waste determination in the 
laboratory before the unwanted material is removed from the laboratory, 
or within four calendar days of arriving at an on-site CAA or interim 
status or permitted TSDF. Because CESQGs would not have an on-site CAA 
or TSDF, CESQGs are required to make the hazardous waste determination 
in the laboratory before the unwanted material is removed from the 
laboratory. See section III.C.9 of today's preamble for further 
discussion of how Subpart K is implemented at CESQGs.
    At the time of the proposal, the Agency was aware that many smaller 
eligible academic entities contract with outside vendors to make the 
hazardous waste determination on their behalf. We expected that the 
smaller eligible academic entities, which do not have on-site CAAs or 
on-site TSDFs, would be relying on vendors to make the hazardous waste 
determination in the laboratory(ies) prior to the hazardous waste being 
brought off-site. As proposed, the regulations of Subpart K, 
specifically Sec.  262.210, allowed for this scenario.
    From comments, we learned that even eligible academic entities with 
on-site CAAs contract with vendors to make and/or confirm their 
hazardous waste determinations. Thus, we received many comments arguing 
against the requirement that the hazardous waste code(s) be placed on 
the container within four days of arriving at the on-site CAA because 
this essentially would preclude these entities from using vendors to 
make the hazardous waste determinations for them. These commenters 
believe that placing the words ``hazardous waste'' on the container is 
sufficient to indicate that a hazardous waste determination has been 
made and that they should be allowed to delay putting the hazardous 
waste code(s) on the container until the vendor comes to ship the 
hazardous wastes off-site.
    We agree with these commenters that the practice of using vendors 
to make the hazardous waste determination should not be limited to 
those eligible academic entities that make the hazardous waste 
determination in the laboratory. Eligible academic entities that make 
the hazardous waste determination in an on-site CAA or interim status 
or permitted TSDF also should be able to use vendors to assist them 
with their hazardous waste determination. In today's final rule, 
therefore, the hazardous waste determination must still be made within 
four calendar days of arriving at an on-site CAA or TSDF, and for those 
unwanted materials that are hazardous waste, the words ``hazardous 
waste'' still must be added to the label that is affixed or attached to 
the container within those four calendar days. However, the Agency is 
amending the final rule so that eligible academic entities may delay 
assigning the hazardous waste code(s) until immediately prior to 
shipping the hazardous waste(s) off-site. When containers of unwanted 
materials arrive at an on-site CAA, they are subject to the CAA 
regulations appropriate to the site's generator status, including 
dating of the containers to calculate the 90/180/270 days that the 
containers may be accumulated on-site, and the container management 
standards. Likewise, when containers of unwanted materials arrive at an 
on-site TSDF, the unwanted material becomes subject to the terms of the 
facility's hazardous waste permit or interim status, as soon as it 
arrives. Therefore, since the containers must be managed as hazardous 
waste upon arriving at an on-site CAA or TSDF, we believe there is no 
decrease in protection of human health and the environment by delaying 
the addition of the hazardous waste code(s). The hazardous waste 
code(s) are necessary for determining the LDR regulations that apply to 
the hazardous wastes, but do not provide additional protection while 
the hazardous wastes are being accumulated on-site. We emphasize that, 
in all cases, regardless of generator status, or where the eligible 
academic entity chooses to make the hazardous waste determination, the 
hazardous waste determination must be made on-site before the unwanted 
material can be treated at an on-site CAA, or treated or disposed at an 
on-site TSDF, or sent off-site.
    Many commenters stated that four calendar days was not sufficient 
to make the hazardous waste determination in an on-site CAA or TSDF. 
However, given that (1) the hazardous waste determination is usually 
required to be made at the point of generation and that the Agency is 
providing considerable flexibility in Subpart K for where and when to 
make the hazardous waste determination and (2) the initial hazardous 
waste determination should be more straightforward without the addition 
of the hazardous waste code(s),

[[Page 72939]]

we are not providing additional time. Thus, under today's final rule, 
the hazardous waste determination must be made within four calendar 
days of arriving at an on-site CAA or TSDF. Commenters also gave 
various suggestions for changing ``calendar'' days to ``working'' or 
``business'' days. We believe that this would be confusing because not 
everyone shares the same ``working'' or ``business'' days. By relying 
on ``calendar'' days, we are providing consistency and clarity in 
calculating the timeframes within the rule.
    The Agency solicited comment on whether the four calendar days 
should be included within the 90/180/270 day timeframe allowed for 
accumulation in an on-site CAA or whether it should be separate from 
these timeframes. Most commenters preferred the proposed option of 
including the four calendar days for making the hazardous waste 
determination as part of the 90/180/270 days allowed for the on-site 
accumulation of hazardous wastes. They expressed this preference, in 
large part, to avoid additional dating of containers that would be 
necessary if the four days were separate from, and additional to, the 
90/180/270 days of accumulation time. Therefore, under today's final 
rule, a container's date of arrival at an on-site CAA will be used for 
two purposes: (1) Calculating the four calendar days allotted for 
making the hazardous waste determination and (2) calculating the 
maximum accumulation time in the CAA.
    Many commenters objected to the proposed requirement that the 
hazardous waste code(s) be placed on the label that is affixed to or 
physically accompanies the container (as previously discussed, today's 
final rule changes this requirement so that the label must be ``affixed 
or attached'' to the container). They pointed out that the majority of 
hazardous wastes generated in a laboratory are lab-packed when they are 
transported off-site and that putting the hazardous waste code(s) on 
the label that is affixed to the container, then placing the container 
inside of a lab pack is of no value because the hazardous waste code(s) 
would not be able to be seen. The commenters suggested allowing the 
hazardous waste code(s) to be placed on the label that is ``associated 
with the container'' rather than the label that is ``affixed or 
physically accompanies the container.'' We had proposed that, as part 
of the hazardous waste determination, the hazardous waste code(s) must 
be placed on the containers within four days of arriving at an on-site 
CAA or interim status or permitted TSDF. In this instance, the 
hazardous waste code(s) on the container label would have been visible 
during accumulation in an on-site CAA or storage in an on-site TSDF. 
However, since the final regulations have been revised so that the 
hazardous waste code(s) do not need to be added until just before the 
hazardous waste is transported off-site and since most containers will 
be lab-packed, we agree that placing the hazardous waste code(s) on the 
container label that is affixed or attached to the container provides 
no value. Therefore, we have revised the regulatory language in 
Sec. Sec.  262.210(b)(2), 262.211(e)(2), and 262.212(e)(2) to allow the 
appropriate hazardous waste code(s) to be placed on the container label 
that is associated with the container. This will allow the practice of 
putting hazardous waste code(s) on a packing slip or inventory list for 
a lab pack to continue.
    One commenter expressed concern about the statement in the preamble 
to the proposed rule (see 71 FR 29735) that, ``* * * regardless of 
whether an employee or non-employee makes the hazardous waste 
determination, the college or university could (emphasis added) still 
be responsible if the hazardous waste determination is not made 
correctly and for any mismanagement of hazardous waste.'' The commenter 
was concerned ``that such wording could be used to contradict current 
RCRA requirements that the generator is always responsible for the 
proper waste determination regardless of who does the actual 
designation.'' We did not intend this language to suggest the potential 
interpretation for which the commenter expressed concern. Indeed, we 
agree with the commenter that making the proper hazardous waste 
determination is, and always has been, the responsibility of the 
generator (as described in 40 CFR 262.11), which in this case, would be 
the eligible academic entity, and did not intend to suggest otherwise.
    Another commenter requested that the Agency clarify that the 
hazardous waste determination can be made in ``any'' of the three 
areas, rather than in ``one'' of the three areas identified in Sec.  
262.209(a). We agree with the commenter and have changed the regulatory 
language to reflect the comment. For LQGs and SQGs, it is not necessary 
for the eligible academic entity to limit itself to making the 
hazardous waste determination in the same place all the time. We 
realize that this could change depending upon circumstances. For 
instance, during typical operations, an eligible academic entity may 
choose to make the hazardous waste determination in its on-site CAA. 
However, during a laboratory clean-out, the hazardous waste 
determination might be made in the laboratory. Eligible academic 
entities that are CESQGs, however, are limited by regulation to making 
the hazardous waste determination in the laboratory before the unwanted 
materials are removed from the laboratory and sent off-site.
    Several commenters requested that the Agency clarify the status of 
chemicals or unwanted materials that can be redistributed to other 
laboratories. It has always been the case under existing RCRA 
regulations, and continues to be the case under Subpart K, that 
chemicals that are fit for continued use are not solid or hazardous 
wastes (see Sec.  261.2(e)(1)) and can be transferred between SAAs, 
laboratories, and chemical stockrooms. Under Subpart K, we realize that 
some chemicals that are initially identified as unwanted materials will 
turn out not to be solid or hazardous wastes. If, for example, an 
unwanted material is brought to an on-site CAA or TSDF for a hazardous 
waste determination, and it is determined that such unwanted material 
can be reused, then it is not a solid or hazardous waste and is not 
subject to Subpart K or the Subtitle C hazardous waste regulations, 
once the determination is made. That is, if a chemical is initially 
labeled as an unwanted material and then it is subsequently discovered 
that it can continue to be used, the chemical can be returned to a 
laboratory or chemical stockroom for redistribution. EPA selected the 
term ``unwanted material'' over ``laboratory waste,'' in part to 
indicate that the material may still be useable.
    Sometimes laboratories end up discarding chemicals for which little 
or no identifying information is available. We recognize that, in some 
cases, chemicals will be managed in the laboratory and that when those 
chemicals are eventually disposed, it may not be possible to identify 
the chemicals. This sometimes happens when a researcher retires and 
leaves unlabeled chemicals behind. In addition, some laboratories 
synthesize new compounds as part of their research. When these 
``unknowns'' are disposed of, it may not be possible to make a 
hazardous waste determination without analysis. A few commenters 
requested that the Agency address more specifically how to handle the 
hazardous waste determination for such unknown chemicals. As a result, 
we have added a requirement that an eligible academic entity must 
develop,

[[Page 72940]]

in Part II of its LMP, procedures for the timely and reliable 
characterization of unknown chemicals. See section III.C.8, of today's 
preamble for more detail, as well as Sec.  262.214.
7. Laboratory Clean-outs
a. Summary of the Proposed Laboratory Clean-out Provisions
    EPA inspections and enforcement cases have revealed that used and 
unused chemicals that are clearly no longer useable, have in some cases 
remained in laboratories at academic institutions for years and even 
decades. Sometimes these chemicals have not been discarded because the 
eligible academic entity did not want to change its RCRA generator 
status. In fact, one of EPA's goals in promulgating Subpart K has been 
to provide incentives for eligible academic entities to remove such 
``legacy'' chemicals from their laboratories. We proposed to provide 
two incentives for conducting voluntary laboratory clean-outs. First, 
we proposed that a college or university would have 30 days to conduct 
a laboratory clean-out. It is during a laboratory clean-out that a 
laboratory is most likely to accumulate more than 55 gallons of 
unwanted material (or 1 quart of reactive acutely hazardous unwanted 
material). If a laboratory accumulates more than 55 gallons, the 
current SAA regulations require that the excess of 55 gallons of 
hazardous waste (or 1 quart of acutely hazardous waste) be removed 
within three days. Under Subpart K, we proposed that if a laboratory 
accumulates more than 55 gallons of unwanted material, all unwanted 
material, including reactive acutely hazardous unwanted material, must 
be removed within ten calendar days, and if a laboratory accumulates 
more than 1 quart of reactive acutely hazardous unwanted material then 
all reactive acutely hazardous unwanted material must be removed from 
the laboratory within ten calendar days. In a laboratory clean-out 
conducted under Subpart K, however, a laboratory has 30 days from the 
starting date of the laboratory clean-out to complete the laboratory 
clean-out without being required to remove the assembled unwanted 
materials from the laboratory, even if the laboratory exceeds 55 
gallons of unwanted material (or 1 quart of reactive acutely hazardous 
unwanted material). This incentive provides flexibility by giving an 
extension in the time allowed for removal of the unwanted material over 
the three days allowed in the satellite accumulation area regulations, 
as well as the ten days allowed in Subpart K for unwanted materials 
that are routinely generated.
    Second, we proposed that unwanted materials that are generated 
during the 30 days of a laboratory clean-out and that are hazardous 
wastes do not need to be counted toward the facility's generator 
status. However, with this ``no counting'' incentive, we were and 
remain concerned about inadvertently encouraging eligible academic 
entities to retain unwanted materials that are generated in the 
laboratory on a routine basis and to remove them only during a 
laboratory clean-out, thereby improperly manipulating their generator 
status. Two provisions in the proposal were intended to safeguard 
against this. First was the proposed requirement for the college or 
university to identify the start date of the laboratory clean-out in 
its records. This, in combination with the proposed labeling 
requirement for each container to have an accumulation start date 
associated with it, provides a method of verification to ensure that 
any container of unwanted material that has a date that pre-dates the 
onset of the laboratory clean-out would not be considered to be from 
the laboratory clean-out and the unwanted material would have to be 
counted toward calculating the facility's generator status, assuming it 
is determined to be hazardous waste. The second safeguard that was 
proposed was that each laboratory at an eligible academic entity could 
take advantage of the laboratory clean-out incentives only once per 12 
month period. Given that each laboratory is required to have a 
regularly scheduled removal of unwanted material at least every six 
months, this was intended to ensure that each laboratory would have at 
least one regularly scheduled removal during a calendar year between 
laboratory clean-outs.
    We received a large number of comments, covering all aspects of the 
laboratory clean-out provisions. In general, there was overwhelming 
support for the concept of the laboratory clean-out incentives, 
although there was opposition expressed by some commenters, as well. 
Based on these comments, in today's final rule, we have made some 
revisions to the proposed laboratory clean-out provisions. Below, we 
discuss the revisions to the proposed laboratory clean-out provisions, 
as well as the aspects of the laboratory clean-out provisions that are 
being finalized as proposed, and we provide clarifications regarding 
the laboratory clean-out provisions.
b. Changes Made to the Laboratory Clean-Out Provisions
    Many commenters expressed support for the laboratory clean-out 
incentive that allowed them not to count their laboratory clean-out 
hazardous wastes toward their generator status. On the other hand, 
several commenters expressed concern that the Agency was creating a 
system that would encourage laboratories to hold onto their routinely 
generated unwanted materials until a laboratory clean-out, in order to 
manipulate their generator status. We share the commenters' concerns 
and have changed the provision of the laboratory clean-out incentive so 
that only laboratory clean-out hazardous wastes that are unused 
commercial chemical products are not counted toward the eligible 
academic entity's generator status. Unused commercial chemical products 
include chemicals that are discarded P- or U-listed commercial chemical 
products, and unused discarded chemicals that are hazardous waste 
because they exhibit one or more characteristics. Any unwanted material 
that has been used and is a hazardous waste must be counted toward the 
eligible academic entities generator status, even if it is removed 
during the 30-day period of a laboratory clean-out. We intend for 
routinely generated unwanted materials to be removed from the 
laboratory during regularly scheduled removals, and we expect that the 
bulk of these routinely generated unwanted materials will be used 
chemicals. We do not consider these used, routinely generated unwanted 
materials to be laboratory clean-out wastes and thus, they must be 
counted toward the eligible academic entity's generator status. 
Therefore, we have revised the regulatory language to be consistent 
with our intent and to safeguard against the potential for abuse of the 
laboratory clean-out incentive. This change will also emphasize that 
the purpose of the laboratory clean-out is to remove unneeded or 
unusable chemicals from the laboratory's inventory in order to increase 
safety within the laboratory.
    We will rely on existing regulations and guidance for defining what 
is considered a used or unused commercial chemical product. For 
example, the P- or U-listings of Sec.  261.33(e) and (f) apply only to 
unused commercial chemical products. Therefore, a P- or U-listed 
hazardous waste generated during a laboratory clean-out would not have 
to be counted toward the eligible academic entity's generator status, 
because, by definition, it would be unused. An unused

[[Page 72941]]

chemical that is a hazardous waste because it exhibits one or more 
characteristics also would not have to be counted toward the eligible 
academic entity's generator status if it were generated during a 
laboratory clean-out. In a memo dated June 14, 1990, (Bussard to 
Wilson, RCRA Online 11523), the Agency answered a series of 
specific questions relating to the definition of ``used.'' In summary, 
the memo states that dissolving or diluting P- or U-listed chemicals in 
water, acids, bases, preservatives, or solvents to make laboratory 
standards (in lieu of buying such solutions) does not constitute use of 
these chemicals. In addition, any unused, leftover chemical (either P- 
or U-listed, or characteristic) in an original container, either 
unopened or opened, or that has been transferred to another container, 
such as a squirt bottle, for use would also be considered unused.
    Some commenters were concerned about the possibility that as a 
result of the laboratory clean-out provision that allows some hazardous 
waste not to count toward the eligible academic entity's generator 
status, some eligible academic entities that are typically CESQGs but 
would become either SQGs or LQGs as a result of a laboratory clean-out 
(absent Subpart K), would be able to maintain their CESQG status. If 
this were the case, the commenter was concerned that hazardous wastes 
that should normally be managed as hazardous waste would be eligible to 
be disposed of in a municipal solid waste landfill, which is allowed 
under the CESQG regulations of Sec.  261.5. The Agency shares the 
commenter's concern. In fact, in the preamble to the proposed rule we 
stated, ``any hazardous waste that is not counted toward generator 
status during a laboratory clean-out is still a hazardous waste and is 
subject to all applicable regulations, including the land disposal 
regulations, and the regulations for on-site and off-site management, 
transportation, and treatment and disposal of hazardous waste. The 
incentive that the Agency is proposing to provide for hazardous wastes 
generated during a laboratory clean-out affects only the length of time 
that hazardous wastes are stored on-site and other associated 
regulations of 40 CFR 262.34 pertaining to generator status, such as 
biennial reporting and contingency plans'' (see 71 FR 29739).
    Nevertheless, we believe that for clarity it is appropriate to 
revise the regulatory language of Sec.  262.213 to reflect the intent 
of the rule as stated in the preamble to the proposed rule. This is 
made all the more necessary by the expansion of the final rule to 
include eligible academic entities that are CESQGs. If an SQG avoided 
LQG status as the result of a laboratory clean-out incentive, the 
hazardous waste would still be regulated as hazardous waste once it is 
taken off-site, since both SQGs and LQGs must comply with the same 
transportation and disposal regulations. With the inclusion of CESQGs 
into the final rule, however, if a CESQG avoided becoming an SQG or LQG 
as the result of a laboratory clean-out incentive, then potentially 
regulated hazardous waste would be allowed to be disposed of at a 
municipal solid waste landfill. Therefore, we are modifying the 
language of Sec.  262.213(a)(2) to indicate that the effect of not 
counting hazardous wastes that are unused commercial chemical products 
toward the eligible academic entity's generator status is limited to 
the on-site accumulation of the hazardous waste. In tandem, we also are 
including a new paragraph, Sec.  262.213(a)(3), to indicate that for 
the purposes of off-site management, if an eligible academic entity 
generates more than the monthly CESQG limits (i.e., >1 kg of acutely 
hazardous waste, or >100 kg of hazardous waste), then the eligible 
academic entity must manage its hazardous waste according to all 
applicable hazardous waste regulations for SQGs and LQGs. When 
determining whether these monthly limits have been exceeded, the 
eligible academic entity must count all of its hazardous wastes, 
including those generated during laboratory clean-outs. In other words, 
even when hazardous wastes are not counted toward the site's generator 
status, if they are generated in excess of the CESQG monthly limits, 
they are regulated as hazardous waste when they are transported, 
treated, stored or disposed of off-site. EPA intended to create an 
incentive to conduct laboratory clean-outs by relieving the generator 
of some of the additional burden that would be incurred by changing 
generator status. However, we did not intend to allow regulated 
hazardous waste in excess of the CESQG monthly limits to be disposed of 
in municipal solid waste landfills.
    We illustrate how this would work by providing an example of a 
likely scenario. An eligible academic entity that is normally a CESQG 
conducts a laboratory clean-out. As a result of the laboratory clean-
out, the eligible academic entity generates 5 kg of P-listed hazardous 
waste. Because P-listed hazardous wastes are all acute hazardous 
wastes, the eligible academic entity generates more than 1 kg of acute 
hazardous waste that month. Normally, this would mean that the eligible 
academic entity would become subject to the LQG regulations for that 
month. However, because the laboratory clean-out provisions allow the 
eligible academic entity not to count the 5-kg of P-listed hazardous 
waste from the laboratory clean-out toward its generator status, the 
eligible academic entity will remain a CESQG under Sec.  261.5 for the 
purposes of on-site accumulation of its hazardous waste, including the 
acute hazardous waste. However, once the hazardous waste is sent off-
site, the eligible academic entity would not be allowed to send its 
hazardous waste to a non-hazardous waste facility, such as a municipal 
solid waste landfill, as allowed by the CESQG regulations of Sec.  
261.5. Instead, because the eligible academic entity generated acute 
hazardous waste in excess of the CESQG monthly limits (i.e., >1 kg 
acute hazardous waste), the hazardous waste would have to be managed as 
hazardous wastes when sent off-site. This means, for example, that the 
hazardous waste would have to be manifested, comply with the LDRs, and 
be either recyled or treated and disposed of at a hazardous waste TSDF.
    A number of commenters expressed support for extending the 
laboratory clean-out incentives to ancillary spaces, such as stockrooms 
and laboratory preparatory rooms. As discussed in the preceding section 
on the definition of laboratory (see Section III.B.2 and Sec.  
262.200), these ancillary spaces would be considered laboratories, 
whether they support individual laboratories or the laboratories of a 
department, and thus would be eligible to take advantage of the 
laboratory clean-out provisions. In fact, since these ancillary areas 
typically store chemicals for use by nearby or surrounding 
laboratories, we believe the clean-out provisions are especially 
important for these ancillary areas.
    Two commenters pointed out an inconsistency between the preamble 
and the regulatory text with respect to how long records of laboratory 
clean-outs must be kept. The preamble to the proposed rule stated that 
records must be kept ``for as long as the college or university 
operates under this new subpart'' (see 71 FR 29739), while the proposed 
regulatory text stated that records pertaining to laboratory clean-outs 
must be kept ``for a period of three years from the date the clean-out 
ends.'' The proposed regulatory text reflects what we intended for 
record retention pertaining to laboratory clean-outs. Thus, the final 
rule makes clear that records for laboratory clean-outs must be kept 
for three years from the date the clean-out ends.

[[Page 72942]]

c. Changes Not Made to the Laboratory Clean-Out Provisions
    Many commenters expressed support for the 30-day timeframe for 
conducting laboratory clean-outs, believing that 30 days is sufficient 
time to conduct a laboratory clean-out. About the same number of 
commenters, however, requested a longer timeframe for conducting 
laboratory clean-outs. Suggestions ranged from 60 days to 180 days. One 
commenter indicated that ``60 days is a more reasonable length of time 
to arrange for and mobilize a hazardous waste contractor for on-site 
lab-packing services, especially if the clean-out was unexpected or the 
institution is in a remote location.'' We anticipate that in most 
instances, laboratory clean-outs will be planned events. Therefore, we 
continue to believe that 30 days is sufficient time to conduct a 
thorough laboratory clean-out and we are finalizing the time limit for 
laboratory clean-outs, as proposed.
    Commenters asked the Agency when the 30 days of a laboratory clean-
out would begin--while the inventory of laboratory chemicals is being 
sorted or when they are discarded? The definition of ``laboratory 
clean-out'' in today's final rule is:

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

Therefore, the 30 days of a laboratory clean-out starts when a trained 
professional or laboratory personnel begins sorting through and 
evaluating the inventory of laboratory chemicals, making decisions 
about whether they are unwanted materials or not. Once it has been 
determined that a chemical is, indeed, an unwanted material, as opposed 
to a chemical or other material that can be kept in the laboratory for 
further use, then the unwanted material becomes subject to the 
requirements of Subpart K. We realize that a laboratory clean-out can 
involve considerable planning before the laboratory clean-out begins. 
Advanced planning for a laboratory clean-out prior to sorting and 
evaluating a laboratory's chemical inventory is not considered the 
start of the 30 days allowed for a laboratory clean-out.
    At the conclusion of the laboratory clean-out, all unwanted 
materials (or hazardous waste, if the hazardous waste determination is 
made in the laboratory) must be removed from the laboratory. Note that, 
as with routinely generated unwanted materials, unwanted materials from 
a laboratory clean-out can be taken to an on-site CAA or TSDF to make 
the hazardous waste determination. Eligible academic entities without 
an on-site CAA, or on-site interim status or permitted TSDF will have 
to make the hazardous waste determination for unwanted materials 
generated during a laboratory clean-out in the laboratory before they 
are removed from the laboratory and will have to be prepared to send 
the hazardous wastes off-site at the conclusion of the 30-day clean-
out.
    Finally, although a few commenters suggested that the Agency 
require that eligible academic entities conduct laboratory clean-outs, 
the Agency has decided not to do so. Rather, we believe that the 
laboratory clean-out provisions are attractive enough to eligible 
academic entities such that they will avail themselves of the clean-out 
provisions without EPA forcing them to do so through a mandate.
d. Clarifications About the Laboratory Clean-Out Provisions
    The Agency wants to reiterate the point that we view laboratory 
clean-outs to be distinct from routine, regularly scheduled removals of 
unwanted materials. In the course of normal laboratory operations, many 
chemicals are used and will become unwanted materials and ultimately 
may be determined to be hazardous wastes. This can occur as a result of 
teaching or research activities or, in the case of teaching hospitals, 
as a result of clinical or diagnostic activities. We expect that these 
routinely generated wastestreams will comprise the bulk of the unwanted 
materials that are removed from the laboratory during regularly 
scheduled removals. On the other hand, a laboratory often can accrue a 
large number of unused chemicals in its inventory, some of which can 
become dangerous over time, developing the potential to cause 
significant harm. It has been our observation that it is unusual for 
laboratories to remove unused chemicals from their inventories on any 
regular basis. We have developed the laboratory clean-out provisions to 
provide incentives for laboratories to assess their inventory and 
remove chemicals from the laboratory that are either dangerous or have 
the potential to become dangerous, or are unlikely to be used in the 
future, regardless of the reason. We anticipate that many eligible 
academic entities will take advantage of the laboratory clean-out 
provisions when a researcher or faculty member retires or moves, or 
when a building is renovated. However, we are not limiting the use of 
the laboratory clean-out provisions to these events because we would 
like to encourage laboratories to develop the practice of more frequent 
reviews and removals of their unneeded or unusable chemicals. However, 
the laboratory clean-out incentives (i.e., having 30 days to conduct a 
laboratory clean-out and not counting toward the eligible academic 
entity's generator status the hazardous waste that consists of unused 
commercial chemical products) is still limited to once per laboratory 
per 12 month period.
    Two commenters asked for clarification about the labeling and 
container management standards that apply to laboratory clean-out 
wastes. During the course of a laboratory clean-out, some chemicals 
will be considered unwanted materials and ultimately hazardous wastes, 
while others will not. Those laboratory clean-out chemicals that become 
unwanted materials are subject to all the same labeling and container 
management standards--as well as all other applicable requirements of 
Subpart K--as any other unwanted material in the laboratory, with the 
exceptions noted in Sec.  262.213(a)(1)-(4). On the other hand, those 
chemicals that can continue to be used in the same laboratory would be 
considered products, not unwanted materials, and would not be subject 
to the labeling and container management standards of Subpart K. If a 
clean-out chemical from one laboratory can be used in a different 
laboratory, we can envision two probable scenarios. If the 
determination is made in the laboratory that a chemical can be used in 
another laboratory, it would not be considered an unwanted material; 
rather, it would be considered a product and thus not regulated under 
RCRA. If, on the other hand, the determination that the chemical can be 
used in another laboratory is made after it is removed from the 
laboratory, in an on-site CAA or TSDF, the clean-out chemical would be 
regulated as an unwanted material until it is redistributed from the 
CAA to another laboratory for further use.
    Several commenters were concerned that if hazardous wastes 
generated as a result of a laboratory clean-out do not have to be 
counted toward the eligible academic entity's generator status, fewer 
generators will have to submit a BR and the result would be under-
reporting of hazardous wastes from those eligible academic entities 
that choose to be subject to the Subpart K requirements.

[[Page 72943]]

We acknowledge that there may be fewer generators reporting hazardous 
waste generation as a result of the laboratory clean-out provisions not 
to count hazardous waste that consists of unused commercial chemical 
products toward the eligible academic entity's generator status because 
under the Federal regulations, only LQGs have to submit the BR. 
Nevertheless, we anticipate that even after subtracting laboratory 
clean-out wastes when calculating their generator status, many eligible 
academic entities will still generate enough hazardous waste to be 
LQGs, based on their routinely generated laboratory waste, as well as 
their non-laboratory hazardous wastes, in which case they will still be 
required to submit the BR. Moreover, some States require SQGs to submit 
a BR. For information on how to submit the BR with respect to hazardous 
wastes generated during laboratory clean-outs, see Section III.D.1.
8. Laboratory Management Plan
    Today's final rule requires that eligible academic entities 
choosing to be subject to the Subpart K requirements must develop an 
LMP. As EPA explained in the preamble to the proposed rule, the goal of 
the LMP is for a college or university to plan carefully how it is 
going to implement Subpart K's performance-based requirements for 
safely managing the unwanted materials generated in laboratories. We 
believe that the LMP provides a necessary supplement to the flexibility 
provided in this rule and will ultimately work to increase 
environmental performance and protection. EPA received positive 
feedback from commenters about requiring the LMP. Many commenters 
explained that requiring an LMP along with a performance-based approach 
will help make it possible for eligible academic entities to achieve 
their environmental goals, such as regulatory compliance, pollution 
prevention and laboratory safety.
    Some commenters misinterpreted EPA's intent for the LMP. One 
commenter believed that each laboratory within a college or university 
had to develop an LMP. That is not the case at all. Rather, EPA 
intended that the eligible academic entity--a college or university, or 
non-profit research institute or teaching hospital that is owned by or 
has a formal written affiliation agreement with a college or 
university--would create one LMP for all its laboratories that are 
operating under Subpart K. In addition, if an eligible academic entity 
has multiple EPA Identification Numbers or sites, then it can develop 
one LMP to cover operations for all laboratories at all sites operating 
under the Subpart K requirements. Also, a number of commenters 
suggested that an eligible academic entity should list in its LMP which 
laboratories would be covered under Subpart K and its LMP. The 
commenters go on to state that each eligible academic entity should be 
allowed to determine which of its laboratories will operate under 
Subpart K and document this in its LMP. In response, and as described 
earlier in the preamble, if multiple sites with separate EPA 
Identification Numbers operate under one LMP, the LMP must identify 
which sites are covered by the LMP. However, there is no requirement to 
identify each laboratory within each site, as all laboratories at a 
participating eligible academic entity within that site or covered by 
an EPA Identification Number must operate under Subpart K (see section 
III.C.1, Notification and Sec.  262.203). Nevertheless, should an 
eligible academic entity choose to list all its laboratories that are 
participating in Subpart K, it could be a valuable tool to manage 
removals of unwanted material, as well as assist EPA and State 
inspectors in determining compliance with the Subpart K requirements.
    Another commenter argued that requiring an LMP would be redundant 
documentation since laboratories are required to have a Chemical 
Hygiene Plan under OSHA's Laboratory Standard. We disagree. As the 
proposal clearly explained, a college or university (and now eligible 
academic entities) can take an existing plan, such as the Chemical 
Hygiene Plan and revise it to include the additional necessary 
information or procedures required by today's rule.
    Two requirements for the LMP are remaining the same in today's 
final rule. First, an eligible academic entity must make its LMP 
``available'' to laboratory workers, students, and anyone requesting 
the LMP at the eligible academic entity. Examples may include, but are 
not limited to, posting the LMP on the Web site of the participating 
eligible academic entity or keeping a copy of the LMP at each 
individual site of the eligible academic entity that is participating 
in Subpart K. Second, since the LMP is a document to plan how an 
eligible academic entity will meet the performance-based standards of 
Subpart K, EPA requires the LMP to be reviewed and updated, as needed, 
so that it is current with the waste management practices at the 
eligible academic entity's laboratories.
    Most of the comments received about the LMP centered on the two 
options EPA co-proposed regarding the enforceability of the contents of 
the LMP. Both proposed options required development of an LMP that 
addressed how the college or university would achieve the performance-
based standards of the rule. The difference between the two options was 
in the enforceability of the contents of the LMP. Under one proposed 
option, compliance with the performance-based regulations was 
enforceable, but the contents of the LMP were not enforceable. In the 
other proposed option, the contents of the LMP were enforceable, as 
well as compliance with the performance-based regulations.
    EPA received comments supporting both options. There was a strong 
belief from some commenters that if the EPA did not make the LMP's 
contents enforceable, then the LMP would not be a meaningful document 
and would not be followed. On the other side, commenters argued that 
the LMP should not be enforceable; these commenters believed that an 
enforceable LMP would compel colleges or universities to develop vague, 
minimum procedures and that an enforceable LMP would be contrary to the 
goals of a performance-based regulation.
    Reviewing the Agency's reasons for proposing the requirement for an 
LMP, EPA wanted colleges and universities to give careful thought 
regarding the management of unwanted materials and hazardous waste 
generated in their laboratories. Moreover, we wanted to encourage 
colleges or universities to go above and beyond the regulations and to 
think holistically about waste management on campus by planning and 
developing best management practices (BMPs) in the LMP. We continue to 
believe strongly that the LMP is necessary in order to provide the 
planning component for implementing the provisions of this rule. Based 
on our views regarding the purpose of the LMP and the comments we 
received, we have decided to split the LMP into two parts--with the 
contents of one part enforceable and the contents of the other part not 
enforceable, although in order to be in compliance with Subpart K, an 
eligible academic entity must address all nine elements in its LMP.
    Thus, under the final rule, the LMP must be comprised of two parts 
with a total of nine elements as specified in 40 CFR 262.214. The 
specific contents in Part I of the LMP are enforceable, while the 
specific contents in Part II of the LMP are not enforceable. Below is a 
discussion of the required elements in the two Parts of the LMP. If an 
element has remained the same as proposed, it is simply enumerated 
without discussion.

[[Page 72944]]

a. Part I of the LMP
    As a way to incorporate more flexibility into the regulations, 
while maintaining the accountability in this Subpart, the contents of 
Part I of the LMP are enforceable. This part of the LMP contains 
necessary information for inspectors and other officials about what 
options within Subpart K the eligible academic entity is exercising. 
The two elements of Part I of the LMP are explained here:

    1. Describe procedures for container labeling in accordance with 
Sec.  262.206(a), including
    i. 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.''
    ii. Identifying the manner in which information that is 
``associated with the container'' will be imparted.

    The first sub-element allows flexibility in using different 
terminology other than ``unwanted materials.'' Many commenters wrote 
that they disliked the term ``unwanted materials'' because it was 
overbroad and would cause confusion. While we do not necessarily agree 
with these commenters, EPA does not object to including additional 
flexibility concerning the terminology that can be used in the 
laboratory instead of ``unwanted materials.'' \8\ However, in order for 
an eligible academic entity to take advantage of this option, it must 
identify another equally effective term (e.g., laboratory waste) in the 
first element of Part I of its LMP. This equally effective term must be 
used consistently in all of its laboratories operating under Subpart K 
(see Section III.C.2 and Sec.  262.206(a)(1)(i)).
---------------------------------------------------------------------------

    \8\ If an eligible academic entity elects to use another equally 
effective term in lieu of ``unwanted material,'' in compliance with 
Sec.  262.206(a)(1)(i), the equally effective term will have the 
same meaning as ``unwanted material.'' In addition, the equally 
effective term shall be subject to all of the same requirements in 
this rule that apply to unwanted materials.
---------------------------------------------------------------------------

    The second sub-element of the first element of Part I of the LMP in 
today's final rule requires eligible academic entities to describe the 
manner in which information associated with the container will be 
provided. For example, if an eligible academic entity chooses to use 
barcodes and a computer tracking system to meet the requirement to have 
information associated with a container, it must describe this in the 
enforceable Part I of the LMP, so that inspectors know where the 
associated container information resides.
    2. Identify whether the eligible academic entity will comply with 
Sec.  262.208(a)(1) or Sec.  262.208(a)(2) for regularly scheduled 
removals of unwanted material from the laboratory.
    In the second element of Part I of the LMP, an eligible academic 
entity must describe which method it will exercise for the removal of 
unwanted materials. Today's final rule adds another option for the 
removal of unwanted materials, as described in Section III.C.5 of 
today's preamble, in order to increase the flexibility for eligible 
academic entities. However, with the added flexibility, we require that 
the eligible academic entity documents which removal method it chooses 
to use. For example, if an eligible academic entity elects to comply 
with 40 CFR 262.208(a)(2), where it must remove containers of unwanted 
material from each laboratory within six months of each container's 
accumulation start date, then the eligible academic entity must record 
this choice in Part I of the LMP. If the eligible academic entity 
elects to comply with the other approach, that must be documented in 
Part I of the LMP.
b. Part II of the LMP
    As with Part I of the LMP, Part II of the LMP is required and must 
reasonably address the seven required elements. EPA envisions that 
eligible academic entities will use this section to capture BMPs for 
holistic waste management within laboratories. In order to encourage 
the development of BMPs, the specific contents of Part II of the LMP 
are not enforceable. For example, should an eligible academic entity 
explain that it will train students commensurate with their duties by 
showing a video, but instead provides classroom instruction because the 
video is broken, then the eligible academic entity is not in violation 
of its LMP. The following are the seven elements that an eligible 
academic entity must address in Part II of its LMP; discussed in the 
order in which they appear in the regulations.
     The first three elements of Part II of the LMP are 
essentially the same as proposed.
    The second element includes a minor change that was necessary 
because of the change in the training and instruction requirements for 
laboratory workers and students. Under the proposed rule, training was 
required for laboratory workers, while instruction was required for 
students. Today's final rule requires that for both laboratory workers 
and students, training be commensurate with their duties. Elements one, 
two, and three of Part II of the LMP are below:

    1. Describe its intended best practices for container labeling 
and management standards, including how the eligible academic entity 
will manage containers used for in-line collection of unwanted 
materials, such as with high performance liquid chromatographs and 
other laboratory equipment (see the required standards at Sec.  
262.206).
    2. Describe its intended best practices for providing training 
for laboratory workers and students commensurate with their duties 
(see the required standard at Sec.  262.207(a)).
    3. Describe its intended best practices for providing training 
to ensure safe on-site transfers of unwanted material by trained 
professionals (see the required standard at Sec.  262.207(d)(1)).

     The fourth element of Part II of the LMP has changed since 
proposal.
    The fourth element of Part II of the LMP concerns the procedures of 
regularly removing unwanted materials from the laboratory. While EPA is 
not adding anything to this element, the regulatory language has been 
modified to clarify what the Agency intends as part of this element. 
That is, we have included two different types of removals of unwanted 
materials from laboratories--regularly scheduled removals, and removals 
when maximum volumes are exceeded--because they require different 
procedures. This clarification will ensure that an eligible academic 
entity develops a method to communicate with EH&S personnel or vendors 
when laboratories exceed the maximum volume and a pickup of the 
unwanted materials is needed. See the fourth element below:

    4. Describe its intended best practices for removing unwanted 
material from the laboratory, including:
    a. For regularly scheduled removals--Develop a regular schedule 
for identifying and removing unwanted materials from its 
laboratories (see the required standards at Sec.  262.208(a)(1) and 
Sec.  262.208(a)(2)).
    b. For removals when maximum volumes are exceeded
    A. Describe its intended best practices for removing unwanted 
materials from the laboratory within 10 calendar days when unwanted 
materials have exceeded their maximum volumes (see the required 
standards at Sec.  262.208(d)).
    B. Describe its intended best practices for communicating that 
unwanted materials have exceeded their maximum volumes.

     The fifth and sixth elements of Part II of the LMP have 
remained essentially the same as proposed. The second part of element 
six reflects one minor change. In the preamble to the proposed rule and 
as finalized today, one of the requirements for a laboratory clean-out 
is that an eligible academic entity must document its clean-out 
activities (see section III.D.2 or Sec.  261.213(a)(4)). Because we are 
not mandating that an

[[Page 72945]]

eligible academic entity document its laboratory clean-out in a 
particular format or media, we are requiring that an eligible academic 
entity develop procedures for documenting it as part of element six of 
Part II of the LMP. See elements five and six below:

    5. Describe its intended best practices for making hazardous 
waste determinations, including specifying the duties of the 
individuals involved in the process (see the required standards at 
Sec.  262.11 and Sec. Sec.  262.209-262.212).
    6. 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 Sec.  262.213, including:
    a. Procedures for conducting laboratory clean-outs (see the 
required standards at Sec.  262.213(a)(1)-(3)) and
    b. Procedures for documenting laboratory clean-outs (see the 
required standards at Sec.  262.213(a)(4)).

     The seventh element of Part II of the LMP has changed 
since proposal.
    The seventh element has been expanded in the final rule based on 
several comments about the characterization of unknown chemicals and 
chemicals that degrade over time. The proposed rule required colleges 
and universities to develop emergency prevention, notification, and 
response procedures appropriate to the hazards in the laboratory, and 
the final rule keeps this requirement as the first sub-element of 
element seven. In comments, however, we were informed that laboratories 
face issues with chemicals that expire and/or become dangerous as they 
degrade. A good example of this is picric acid, which becomes explosive 
if it becomes dehydrated/crystallized. Because of the threat some 
chemicals may pose, the final rule requires that the seventh element of 
Part II of the LMP includes a list of chemicals that the eligible 
academic entity has or is likely to have that can degrade over time and 
become more dangerous with age; the list of chemicals is intended to 
facilitate the removal of these chemicals before a problem develops. 
The third sub-element requires eligible academic entities to develop 
procedures to dispose of these chemicals safely.
    Finally, a number of commenters suggested that eligible academic 
entities should develop procedures in their LMPs for identifying and 
characterizing unknown chemicals in a timely manner. Since transporters 
and TSDFs often will not accept unknown chemicals, the unknown 
chemicals tend to remain on-site for extended periods. We agree with 
the commenters and believe this requirement will assist in the timely 
removal of these unknown chemicals and in emergency prevention for 
laboratories. Thus, we have added it as the fourth sub-element of the 
seventh element of Part II of the LMP. See the seventh element below:

    7. Describe its intended best practices for emergency 
prevention, including:
    a. Procedures for emergency prevention, notification, and 
response, appropriate to the hazards in the laboratory, and
    b. 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
    c. Procedures to safely dispose of chemicals that become more 
dangerous when they exceed their expiration date and/or as they 
degrade, and
    d. Procedures for the timely characterization of unknown 
chemicals.

    In summary, an eligible academic entity must develop an LMP with 
two parts covering a total of nine elements. The contents of the two 
elements in Part I of the LMP are enforceable. Part II of the LMP is 
intended to encourage eligible academic entities to develop BMPs for 
their laboratories. While the contents of Part II of the LMP are not 
enforceable, eligible academic entities must reasonably address the 
seven required elements.
9. How CESQGs Comply With Subpart K and How They Differ From LQGs and 
SQGs
    In most respects, an eligible academic entity that opts into 
Subpart K is regulated the same, regardless of whether the eligible 
academic entity is a CESQG, SQG, or LQG. However, because CESQGs are 
regulated differently than SQGs and LQGs under the existing generator 
regulations, we have had to tailor some sections of the Subpart K 
requirements to reflect their inclusion. This section discusses how the 
Subpart K requirements will be implemented for CESQGs.
    Specifically, Subpart K provides an alternative set of requirements 
for generators of laboratory hazardous waste. For SQGs and LQGs, 
Subpart K provides an alternative to Sec. Sec.  262.11 and 262.34(c) 
(the SAA regulations). For CESQGs, however, the Subpart K requirements 
provide an alternative to the conditional exemption in Sec.  261.5(b), 
which exempts hazardous waste from regulation under 40 CFR Parts 124, 
262-266, 268, 270, and the notification requirements of RCRA section 
3010, provided the CESQG complies with the conditions of the exemption. 
Thus, by choosing to become subject to Subpart K, an eligible academic 
entity relinquishes its conditionally exempt status and becomes subject 
to the requirements of 40 CFR part 262, Subpart K, while managing its 
unwanted materials and hazardous wastes in its laboratories. However, a 
CESQG also will be able to take advantage of the two main benefits of 
the alternative standards: Making the hazardous waste determination 
before the unwanted materials are removed from the laboratory (but at a 
time after the initial generation) and the laboratory clean-out 
provisions.
    As with other eligible academic entities, an eligible academic 
entity that is a CESQG and that opts into Subpart K must notify EPA of 
its intended participation using the Site Identification Form (EPA Form 
8700-12). One of the fields on the Site Identification Form asks for 
the site's EPA Identification Number. We realize that most CESQGs will 
not have EPA Identification Numbers when they submit their 
notifications for Subpart K and they are not required to apply for one, 
although some States may choose to assign an Identification Number once 
a Site Identification Form is submitted. If an eligible academic entity 
that opts into Subpart K is a CESQG and does not have an EPA 
Identification Number, all of the laboratories owned by the eligible 
academic entity and that are on-site (as opposed to under the same EPA 
Identification Number) will be subject to Subpart K.
    Many college and university commenters informed the Agency that 
they have multiple EPA Identification Numbers (or sites) within a 
single campus. When a campus is divided into numerous sites, each site 
has its own generator status, based on its monthly generation of 
hazardous waste. Therefore, a single campus may be comprised of sites 
that are CESQGs, SQGs, and LQGs. Some other commenters also indicated 
that they have field laboratories, which may not be on campus, that are 
typically CESQGs, and which may not be on campus, but that laboratory 
personnel often work in both the campus laboratories and the field 
laboratories. Commenters requesting that CESQGs be allowed to be 
subject to Subpart K argued that it would be to their benefit to have 
the same management standards for the hazardous wastes generated in all 
of their laboratories. The Agency agrees and is clarifying that when 
eligible academic entities that are CESQGs choose to be subject to the 
Subpart K requirements, their laboratories must follow the same 
container labeling, container management, training requirements and all 
other management standards for the management of their unwanted 
materials in the laboratory as other generators operating under Subpart 
K.

[[Page 72946]]

    Since CESQGs will not have an on-site CAA or TSDF, CESQGs must make 
the hazardous waste determination in the laboratory before the unwanted 
materials may be removed from the laboratory (but at a time after the 
initial generation of the unwanted materials). We realize that a CESQG 
may be part of a larger ``main'' campus that has a CAA and that the 
eligible academic entity may want to bring the unwanted materials from 
the CESQG site to the main campus's CAA to make the hazardous waste 
determination. However, today's rule does not allow for this and all 
hazardous waste determinations must be made on-site before the unwanted 
material may be treated or disposed of on-site or transported off-site. 
Today's rule does not allow for off-site consolidation of unwanted 
materials or hazardous wastes, with two exceptions that are discussed 
in section III.C.10 of today's preamble. As discussed previously, 
eligible academic entities, including CESQGs, may consolidate unwanted 
materials on-site in another laboratory (see section III.C.5.c of 
today's preamble for more detail).
    Once the hazardous waste determination is made in accordance with 
Sec.  262.11, the eligible academic entity must count the unwanted 
materials that are hazardous wastes toward calculating its monthly 
generator status and it must remove the hazardous waste from the 
laboratory directly. If the total quantity of hazardous waste for the 
month for the site is below the CESQG limits (i.e., <1 kg of acutely 
hazardous waste and <100 kg of hazardous waste), the hazardous waste 
may be managed as CESQG hazardous waste when removed from the 
laboratory. That is, the hazardous waste may be managed at any of the 
types of facilities listed in Sec.  261.5(f)(3) for acute hazardous 
waste, or Sec.  261.5(g)(3) for hazardous waste:
    (i) Permitted under 40 CFR part 270.
    (ii) In interim status under 40 CFR parts 265 and 270.
    (iii) Authorized to manage hazardous waste by a State with a 
hazardous waste management program approved under 40 CFR part 271.
    (iv) Licensed, registered or permitted by the State to manage 
municipal solid waste, and if managed in a solid waste landfill is 
subject to 40 CFR part 258.
    (v) Licensed, registered or permitted by the State to manage non-
municipal non-hazardous waste, and if managed in a non-municipal non-
hazardous waste disposal unit is subject to 40 CFR 257.5-257.30.
    (vi) Beneficially uses, reuses, legitimately recycles or reclaims 
its waste; or treats its waste prior to beneficial use, reuse, 
legitimate recycling or reclamation, or
    (vii) For universal waste, a universal waste handler or destination 
facility subject to the requirements of 40 CFR part 273.
    Eligible academic entities that are CESQGs or have CESQG sites also 
will be able to take advantage of the laboratory clean-out provisions 
in the final rule. That is, CESQGs can have up to 30 days to conduct a 
laboratory clean-out and not be required to count hazardous wastes that 
are unused commercial chemical products and that are generated during a 
laboratory clean-out toward calculating their generator status. Thus, 
we believe that the laboratory clean-out incentives will now provide a 
considerable benefit to generators that are typically CESQGs, but 
become LQGs on an episodic or periodic basis when they discard unused 
commercial chemical products (either listed or characteristic) from 
their laboratories. As discussed in section III.B.7 of today's 
preamble, even if the laboratory clean-out incentives allow an eligible 
academic entity to maintain its conditionally exempt status, if the 
eligible academic entity generates hazardous waste in quantities in 
excess of the CESQG monthly limits, the hazardous waste is fully 
regulated as hazardous waste when it is transported, treated, stored or 
disposed of off-site (also see Sec.  262.213).
10. Off-site Consolidation
a. Off-site Consolidation by CESQGs
    Several commenters suggested that the Agency allow the off-site 
consolidation of unwanted materials at a centralized, off-site 
location. These commenters generally suggested this as part of their 
request to expand the applicability of the final rule to include 
CESQGs. The current generator regulations, for any generator status, 
provide limited opportunities for a generator to accept off-site 
shipments of another generator's hazardous waste. Under both the 
existing generator regulations, as well as under today's final rule, 
there are two situations that allow for a generator to receive 
hazardous waste from another, off-site generator.
    The first situation applies to the off-site consolidation of 
hazardous waste generated only by CESQGs. Under Sec.  261.5, in order 
to qualify as a CESQG, a CESQG must ensure delivery of its acute 
hazardous waste and hazardous waste to one of the seven types of 
facilities listed in Sec.  261.5(f)(3) and 261.5(g)(3):
    (i) Permitted under 40 CFR part 270.
    (ii) In interim status under 40 CFR Parts 265 and 270.
    (iii) Authorized to manage hazardous waste by a State with a 
hazardous waste management program approved under 40 CFR part 271.
    (iv) Licensed, registered or permitted by the State to manage 
municipal solid waste, and if managed in a solid waste landfill is 
subject to 40 CFR part 258.
    (v) Licensed, registered or permitted by the State to manage non-
municipal non-hazardous waste, and if managed in a non-municipal non-
hazardous waste disposal unit is subject to 40 CFR 257.5 through 
257.30.
    (vi) Beneficially uses, reuses, legitimately recycles or reclaims 
its waste; or treats its waste prior to beneficial use, reuse, 
legitimate recycling or reclamation, or
    (vii) For universal waste, a universal waste handler or destination 
facility subject to the requirements of 40 CFR part 273.
    If a CESQG that generates hazardous waste wants to send its 
hazardous waste to an off-site consolidation area for centralized 
collection, it must send its hazardous waste to a collection site that 
would qualify as one of the above mentioned facilities in order to 
still qualify as a CESQG. Thus, a receiving generator could be an 
acceptable collection site if it qualified as one of the seven 
categories of facilities above. For example, a CESQG could send its 
hazardous waste to an eligible academic entity if such receiving entity 
was an interim status or permitted TSDF or was authorized by the State 
to manage hazardous waste under the State approved program. If the 
CESQG that generates hazardous waste sends it to another generator that 
does not qualify as one of the facilities specified above, the 
generating CESQG would not meet the conditions of the CESQG exemption 
and would be subject to the applicable generator regulations of 40 CFR 
part 262 (see Q&A dated April 4, 1987; RCRA Online 12894).
b. Off-site Consolidation by CESQGs, SQGs, and LQGs
    The second situation applies to all generator categories. A 
generator can send its hazardous waste to another generator's site if 
the receiving site qualifies as a transfer facility (see Q&A dated 
April 4, 1987; RCRA Online 12894). Under Sec.  263.12, 
hazardous waste may be stored in containers at a transfer facility for 
ten days or less without requiring interim status or a permit. A 
transfer facility is defined in 40 CFR 260.10 as `` * * * any 
transportation related facility including loading docks, parking areas, 
storage

[[Page 72947]]

areas, and other similar areas where shipments of hazardous waste are 
held during the normal course of transportation.'' It is possible that 
a generator may qualify as a transfer facility, as long as the 
hazardous waste it receives is not stored on-site for more than ten 
days. As stated previously, the hazardous waste determination must be 
made for all unwanted materials prior to transporting them off-site, 
regardless of whether the off-site transportation includes a stop at a 
transfer facility.
11. Topics That Are Outside the Purview of This Rulemaking
    EPA has consistently interpreted our existing hazardous waste 
regulations to allow generators to non-thermally treat the hazardous 
waste they generate on-site in their accumulation tanks and containers, 
without needing to obtain a RCRA permit or having interim status (51 FR 
10168, March 24, 1986). Examples of treatment that may be conducted in 
accumulation tanks and containers without a permit or interim status 
include precipitating heavy metals from solutions and oxidation/
reduction reactions. A permit or interim status would be required to 
store and/or treat hazardous waste that is consolidated from off-site 
locations or if the treatment was thermal treatment.
    Many commenters suggested that the Subpart K requirements should 
specifically address treatment of hazardous waste by generators in 
laboratories. In the proposal to Subpart K, the Agency did not 
specifically identify a regulatory approach for the treatment of 
hazardous waste by generators in laboratories. Therefore, because the 
Agency did not provide notice and an opportunity for public comment on 
this subject, it is outside the scope of this rulemaking and EPA does 
not intend to add any such provisions to the final rule. While today's 
final rule does not specifically address the treatment of hazardous 
waste in laboratories, it also does not change EPA's interpretation of 
its existing regulations.
    We have also often been informed, and commenters confirmed, that it 
is not uncommon for an eligible academic entity to have numerous EPA 
Identification Numbers per ``campus.'' Typically, this is because the 
campus is intersected by public roads so that not all areas of the 
campus are considered ``on-site,'' as defined by RCRA. We received 
several comments encouraging EPA to allow a single EPA Identification 
Number per campus. We did not specifically identify in the proposal to 
Subpart K a regulatory approach for allowing one EPA Identification 
Number per campus. Therefore, because the Agency did not provide notice 
and an opportunity for public comment on this subject, it is outside 
the scope of this rulemaking and EPA does not intend to add any such 
provisions to the final rule.

D. Reporting and Recordkeeping

1. Reporting to the Biennial Report for Eligible Academic Entities That 
Are LQGs
    Under the existing generator regulations, LQGs are required to 
submit information about their hazardous waste generation and 
management activities in the BR. The data are prepared and submitted to 
the EPA Regions (or authorized States) in even-numbered years (e.g., 
2006) and must include waste information from the previous, odd-
numbered year (e.g., 2005). The data submitted for the BR is retained 
in the RCRAInfo System. When developing rulemakings, the Agency often 
relies on data submitted for the BR to inform us about various aspects 
of the hazardous waste activities, such as identifying generators of 
hazardous wastes and waste generation and management activities (i.e., 
number of hazardous waste generators and volume of hazardous waste 
being generated and managed). When analyzing data in the RCRAInfo 
System to support the development of this rulemaking, it became clear 
to the Agency that there are a variety of ways in which similar 
entities with similar hazardous waste generation patterns report data 
for the BR. The Agency recognizes the differences in reporting may be 
situational; however, we offer suggestions here for reporting future 
laboratory hazardous waste activities to the BR that will assist the 
Agency in analyzing data in a more consistent and accurate manner.
    On the Generation and Management (GM) form of the BR, we suggest 
the use of the Source Code G22 (Laboratory analytical wastes (used 
chemicals from laboratory operations)) would be appropriate in most 
cases for hazardous wastes that are generated in the laboratory and 
that are not from a laboratory clean-out. When G22 is not applicable, 
but the hazardous wastes are generated in a laboratory, the generator 
should indicate in the comment field (when provided by the State) that 
the hazardous waste originated in a laboratory. In addition, the Form 
Codes W001 (Lab packs from any source not containing acute hazardous 
waste) and W004 (Lab packs from any source containing acute hazardous 
waste) should be used when applicable.
    If an eligible academic entity submits a BR that includes hazardous 
waste from laboratory clean-outs, the Agency's guidance on preparing 
the GM Form of the BR is to use the Source Code G11, for the discarding 
of off-specification or out-of-date chemicals or products. If the 
State's version of the GM form provides a comment section, we suggest 
the eligible academic entity indicate that the hazardous waste is from 
a Subpart K laboratory clean-out.
2. Recordkeeping
    Today's final rule requires that eligible academic entities 
choosing to comply with the Subpart K requirements maintain certain 
records. Specifically, eligible academic entities must maintain the 
following records: (1) Notification(s) to the appropriate EPA Regional 
Administrator (or State Director, in authorized States) of its 
participation in or subsequent withdrawal from Subpart K (using the EPA 
Site Identification Form (EPA Form 8700-12)); (2) non-profit research 
institutes and teaching hospitals that are not owned by a college or 
university must keep the formal written affiliation agreement on file; 
(3) training records for laboratory workers defined in 40 CFR 262.200 
of this Subpart at participating LQG eligible academic entities; (4) 
documentation of laboratory clean-out activities identifying the 
laboratory being cleaned out, the date the clean-out begins and is 
completed, and the volume of hazardous waste generated during the 
clean-out that is conducted in accordance with Sec.  262.213; and (5) 
an LMP (an existing plan may be modified to address the specific 
requirements of this alternative regulation).
    EPA is not requiring that a participating eligible academic entity 
keep all required records, such as notifications, training records, 
formal written affiliation agreements and the LMP together. However, 
EPA believes filing all required records together, if practicable, may 
enhance the ease of accessibility by those individuals needing access 
to the records at any given time. Additionally, having the records 
located in one central location may help increase efficiency of 
inspections by reducing the amount of time expended to locate records 
that may be kept in several different locations at a participating 
institution (e.g., training records might normally be filed with 
personnel files and the LMP might normally be kept at the EH&S 
department).
    EPA is requiring that an eligible academic entity maintain a copy 
of its notification to participate in this

[[Page 72948]]

Subpart on file in-house (i.e., at the participating eligible academic 
entity) for the duration that the institution remains subject to the 
Subpart K requirements. Additionally, an eligible academic entity must 
maintain a copy of its notification to withdraw from Subpart K on file 
for three years from the date of the notification of withdrawal from 
the Subpart K requirements.
    Because of the expansion in scope of today's final rule, the Agency 
has added recordkeeping for teaching hospitals and non-profit research 
institutes, as defined in the final rule. In order to document that a 
non-profit research institute or a teaching hospital is eligible to opt 
into Subpart K, the non-profit research institute or teaching hospital 
must keep on file for the duration that the institution remains subject 
to the Subpart K requirements a copy of the formal written affiliation 
agreement that it has with the college or university. For a teaching 
hospital, the formal written affiliation agreement must consist of a 
master affiliation agreement and program letter of agreement with the 
medical college or school with which it is affiliated.
    We reiterate that today's final rule does not change the existing 
recordkeeping requirements for documenting training of trained 
professionals at LQGs. Under the existing hazardous waste generator 
regulations, LQGs must comply with the recordkeeping requirements found 
at 40 CFR 265.16(e). Since this rule simply refers to the existing 
applicable training requirements pertaining to an eligible academic 
entity's generator status, training records for trained professionals 
(i.e., individuals conducting the hazardous waste determination or 
transferring unwanted materials on-site) must be maintained at LQGs. 
SQG training requirements at 40 CFR 262.34(d)(5)(iii) do not require 
retention of training records; therefore, Subpart K does not require 
training records to be kept for trained professionals at SQGs. 
Likewise, training records are not required for trained professionals 
at CESQGs. Furthermore, training records for students are not required 
for LQGs, SQGs or CESQGs.
    In addition, as proposed, today's final rule requires that LQG 
eligible academic entities maintain documentation that demonstrates 
that laboratory workers have been trained commensurate with their 
duties. As with trained professionals, these records must be kept for 
the duration specified in Sec.  265.16(e). Thus, these training records 
must be kept until the institution closes or for three years after the 
departure of a trained professional or laboratory worker.
    Additionally, as proposed, today's final rule includes a 
recordkeeping provision for laboratory clean-out events at 
participating eligible academic entities. Section 262.213(a)(4) of 
today's rule requires eligible academic entities to document their 
clean-out activities. EPA is not mandating a particular record format 
or media. Instead, participating institutions may determine the most 
appropriate type of record that best suits their individual 
capabilities and recordkeeping systems (e.g., filed hard copy, 
electronic copy). However, the documentation must contain certain 
information and be retained at the eligible academic entity for three 
years from the date the laboratory clean-out ends. Specifically, this 
documentation must identify the particular laboratory that is being 
cleaned out, the date the clean-out began and ended, and the volume of 
hazardous waste generated during the clean-out. This documentation is 
particularly relevant since a laboratory may only utilize the 
laboratory clean-out provision incentives (i.e., not counting hazardous 
wastes that are unused commercial chemical products toward its 
generator status and the 30-day allowance for removal) once per 12-
month period per laboratory.
    Also, EPA is requiring that a copy of a participating eligible 
academic entity's LMP be retained on file at the participating 
institution for the duration that it is regulated under 40 CFR part 
262, Subpart K. Furthermore, we recommend that the LMP be dated. While 
EPA is not requiring that a copy of the LMP at a participating eligible 
academic entity be kept at each individual site with a unique EPA 
Identification Number that has opted in, we do require that the LMP is 
``available'' by anyone involved in the management of unwanted 
materials (e.g., students in the laboratory, faculty, inspectors and 
other relevant regulatory authorities). The participating eligible 
academic entity will determine how best to meet the requirements of 
making the LMP available since EPA envisions that an LMP will be 
revised periodically. Examples of ``available'' may include, but are 
not limited to, posting the LMP on the participating eligible academic 
entities Web site or other universally accessible electronic system, or 
keeping a copy of the LMP at each individual site that has opted in.
    Today's rule strives to reduce or minimize additional recordkeeping 
requirements on eligible academic entities participating in Subpart K. 
As an example, we believe some participating eligible academic entities 
will revise their current required planning documents, such as the 
Chemical Hygiene Plan (CHP), which is required by OSHA's Laboratory 
Standard regulations at 29 CFR 1910.1450. In such cases, there would be 
minimal additional recordkeeping associated with an LMP. However, we 
also understand that this may not be true in all cases. When planning 
documents don't already exist, an additional recordkeeping requirement 
would be associated with maintaining an LMP since eligible academic 
entities will need to develop this document to comply with this 
Subpart.
    We solicited comment on whether there should be a requirement to 
retain records of the labels associated with containers. The 
information on the label associated with containers, such as the 
accumulation start date and information sufficient to make a hazardous 
waste determination, was assumed to be either electronic, via 
spreadsheets and bar codes, or written logs and in the proposed rule 
EPA considered requiring that this information be retained on file as a 
record. However, commenters noted that records of container labels 
should not be retained because it would be too burdensome and 
unnecessary. We agree with the commenters and believe that other 
recordkeeping requirements sufficiently document the information 
necessary for inspections of laboratories at eligible academic 
entities. Therefore, the final rule does not require that records be 
kept for labeling information associated with containers, beyond the 
time that a hazardous waste determination is made for the contents.
    EPA also solicited comment in the proposal on whether maintenance 
of any other records or reporting requirements should be required under 
today's Subpart K regulations for purposes of improving implementation, 
compliance monitoring and assistance by the relevant regulatory 
authority or for program implementation. Comments submitted by the 
academic community stated, ``do not add recordkeeping.'' These comments 
noted that the proposed recordkeeping or documentation requirements for 
notification, labeling, laboratory clean-outs and the LMP are 
sufficient to ensure compliance and measure success. We agree with 
these commenters that additional recordkeeping or reporting 
requirements beyond what was included in the proposal are unnecessary 
to ensure compliance with today's rule. Therefore, in today's final 
rule, we are not including any new or additional

[[Page 72949]]

recordkeeping or reporting requirements to the final rule.

E. Implementation and Enforcement

    Subpart K blends traditional regulatory requirements with 
performance-based standards to maximize flexibility and enable better 
environmental compliance at eligible academic entities. Subpart K also 
offers greater flexibility in implementation than the existing 
generator requirements. As such, we are highlighting some points on 
compliance for a few of the more flexible requirements of Subpart K.
    First, only eligible academic entities, as defined in this final 
rule, may participate in Subpart K. As this rule is optional, eligible 
academic entities must at all times comply with either the existing 
generator regulations or with today's Subpart K requirements. 
Specifically, under today's final rule, an eligible academic entity 
must decide under which set of standards (existing generator standards 
or Subpart K) it will operate all of its laboratories that are covered 
by the same EPA Identification Number (or that are on-site) and notify 
EPA if it chooses to opt into Subpart K. Eligible academic entities may 
have several sites with unique EPA Identification Numbers, and each 
site may have laboratories. It is important to note that eligible 
academic entities operating laboratories with different EPA 
Identification Numbers may elect which laboratories will opt into or 
withdraw from Subpart K on a site-by-site basis.
    Second, since this rule is for laboratories only, it is likely that 
participating eligible academic entities will be subject to two 
different sets of requirements for hazardous waste management: 40 CFR 
part 262, Subpart K for unwanted materials generated in its 
laboratories, and existing generator requirements for all other 
hazardous wastes generated at these institutions. As a result, 
implementers (eligible academic entities and compliance and enforcement 
individuals) will need to determine whether the laboratories at an 
eligible academic entity are operating under Subpart K (i.e., under 
different generator regulations) from the remainder of the site for 
compliance monitoring and assistance.
    Third, because the enforcement of the contents of the LMP differs 
for Part I and Part II, and participating entities may modify an 
existing plan to meet the LMP requirements, we reiterate the 
requirements relating to the different parts below (see preamble 
section III.C.8 or Sec.  262.214 of today's final rule for all 
requirements related to the LMP). We also remind eligible academic 
entities that if they choose to modify an existing plan in order to 
meet the LMP requirements under Subpart K, today's rule does not 
supersede or otherwise affect the requirements related to that existing 
plan.
    For Part I of the LMP, the eligible academic entity must implement 
and comply with the specific contents for all the elements they develop 
for Part I. For example, if an eligible academic entity chooses to use 
another ``equally effective term'' for ``unwanted material,'' then it 
must identify the term in Part I of its LMP and must use this equally 
effective term consistently. In addition, the equally effective term is 
subject to all requirements of this rule that apply to unwanted 
materials. If the eligible academic entity uses another term, but fails 
to identify the equally effective term in Part I of its LMP, or uses a 
different term not identified in Part I of its LMP, then the eligible 
academic entity would be considered in violation of Subpart K.
    While an eligible academic entity's LMP must include, and 
reasonably address, the required elements in Part II of its LMP, if the 
eligible academic entity does not meet or implement the specific 
contents of the elements in Part II of its LMP, an enforcement action 
would not be brought against it for such deviations. For example, an 
eligible academic entity must describe in Part II of its LMP how it 
will provide training for laboratory workers and students commensurate 
with their duties. If the institution describes a training program that 
specifies the number of hours of classroom training for laboratory 
workers or students in its LMP, but they receive either a different 
number of hours, or a different type of training, such as video 
instruction, the participating institution would not be in violation of 
Subpart K, provided the laboratory workers and students are trained 
commensurate with their duties.
    Finally, today's rule would not affect a participating eligible 
academic entity's obligation to respond promptly to any releases of 
hazardous wastes that may occur, including releases of unwanted 
materials in the laboratory. Any management of released unwanted 
material not in compliance with applicable Federal and State hazardous 
waste requirements could result in an enforcement action. For example, 
if a spill or release of hazardous waste occurred and was not 
immediately cleaned up, the participating eligible academic entity 
could potentially be subject to enforcement for illegal disposal of the 
hazardous waste. In addition, solid and hazardous waste releases could 
potentially be addressed through enforcement orders, such as orders 
under RCRA sections 3013 and 7003.

IV. State Authorization

A. Applicability of Rules in Authorized States

    Under section 3006 of RCRA, EPA may authorize a qualified State to 
administer its own hazardous waste programs within the State in lieu of 
the Federal program. Following authorization, EPA retains enforcement 
authority under Sections 3008, 3013, and 7003 of RCRA, although 
authorized States have primary enforcement responsibility. The 
standards and requirements for State authorization are found at 40 CFR 
part 271.
    Prior to enactment of the Hazardous and Solid Waste Amendments of 
1984 (HSWA), a State with final RCRA authorization administered its 
hazardous waste program entirely in lieu of EPA administering the 
Federal program in that State. The Federal requirements no longer 
applied in the authorized State, and EPA could not issue permits for 
any facilities in that State, since only the State was authorized to 
issue RCRA permits. When new, more stringent Federal requirements were 
promulgated, the State was obligated to enact equivalent authorities 
within specified time frames. However, the new Federal requirements did 
not take effect in an authorized State until the State adopted the 
Federal requirements as State law.
    In contrast, under RCRA section 3006(g) (42 U.S.C. 6926(g)), which 
was added by HSWA, new requirements and prohibitions imposed under HSWA 
authority take effect in authorized States at the same time that they 
take effect in unauthorized States. EPA is directed by the statute to 
implement these requirements and prohibitions in authorized States, 
including the issuance of permits, until the State is granted 
authorization to do so. While States must still adopt HSWA related 
provisions as State law to retain final authorization, EPA implements 
the HSWA provisions in authorized States until the States do so.
    Authorized States are required to modify their programs only when 
EPA enacts Federal requirements that are more stringent or broader in 
scope than the existing Federal requirements. RCRA section 3009 allows 
the States to impose standards more stringent than those in the Federal 
program (see also 40 CFR 271.1). Therefore, authorized States may, but 
are not required to, adopt Federal regulations, both HSWA

[[Page 72950]]

and non-HSWA, that are considered less stringent than previous Federal 
regulations.

B. Effect on State Authorization

    Today's rule finalizes regulations that are not being promulgated 
under the authority of HSWA. Thus, the standards finalized today would 
be applicable on the effective date only in those States that do not 
have final authorization of their base RCRA programs. Moreover, 
authorized States are required to modify their programs only when EPA 
promulgates Federal regulations that are more stringent or broader in 
scope than the authorized State regulations. For those changes that are 
less stringent or reduce the scope of the Federal program, States are 
not required to modify their program. This is a result of section 3009 
of RCRA, which allows States to impose more stringent regulations than 
the Federal program. However, today's final rule is considered to be 
neither more nor less stringent than the current standards. Therefore, 
authorized States would not be required to modify their programs to 
adopt regulations consistent with and equivalent to today's standards. 
Nevertheless, because EPA believes that today's rule will increase the 
ability of eligible academic entities to comply with the RCRA hazardous 
waste generator regulations which would likely lead to greater 
environmental protection, EPA strongly encourages States to adopt 
today's rule. Eligible academic entities located in authorized States 
wishing to be subject to Subpart K do not have this option until their 
State has adopted the final rule.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993), 
this action is a ``significant regulatory action'' since this action 
may raise novel legal or policy issues [3(f)(4)]. Accordingly, EPA 
submitted this action to the Office of Management and Budget (OMB) for 
review under EO 12866. Any changes made in response to OMB 
recommendations have been documented in the docket for this action.
    This rule is projected to result in benefits to society in the form 
of cost savings. The aggregate cost savings for all eligible academic 
entities that are projected to take advantage of the final rule is 
estimated to be $396,000 per year. This figure is significantly below 
the $100 million threshold \9\ established under part 3(f)(1) of the 
Order. Thus, this rule is not considered to be an ``economically 
significant action.'' However, in an effort to comply with the spirit 
of the Executive Order, we have prepared an economic assessment in 
support of today's action. This document 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. This document is otherwise 
referred to as the ``Economic Assessment.'' The docket established for 
today's rulemaking maintains a copy of this Economic Assessment for 
public review. For a more detailed discussion regarding the comments 
received on the economic assessment for the proposed rule, refer to the 
Response to Comments Document which can be found in the docket for 
today's final rule.
---------------------------------------------------------------------------

    \9\ The $100 million threshold applies to both costs, and cost 
savings.
---------------------------------------------------------------------------

1. Introduction to the Economic Assessment for the Final Rule
    The value of any regulatory action is traditionally measured by the 
net change in social welfare that it generates. The Agency's economic 
assessment conducted as part of EPA's obligations under Executive Order 
12866 evaluates costs, cost savings (benefits), waste quantities 
affected, and other impacts, such as environmental justice, children's 
health, unfunded mandates, regulatory takings, and small entity 
impacts. To conduct this analysis, we prepared a baseline 
characterization, developed and implemented a methodology for examining 
impacts, and followed appropriate guidelines and procedures for 
examining equity considerations, children's health, and other impacts.
2. Baseline Specification
    Proper baseline specification is vital to the accurate assessment 
of incremental costs, benefits, and other economic impacts associated 
with any rulemaking. The baseline essentially describes the world 
absent today's final rulemaking. The incremental impacts of today's 
final rule are evaluated by assessing anticipated post-rule responses 
with respect to baseline conditions and actions. The baseline, as 
applied in this analysis, reflects the practices and requirements of 
eligible academic entities under the existing hazardous waste generator 
regulations. A full discussion of the baseline specification is 
presented in the Economic Assessment.
3. Analytical Methodology, Primary Data Sources, and Key Assumptions
    The first step in the methodology for the economic assessment of 
today's final rule was to use data from EPA's 2005 National Biennial 
Report database and other sources to estimate the number of eligible 
academic entities that generate laboratory hazardous wastes and may be 
affected by the final rule. Several of the comments submitted to EPA 
expressed concern that in the proposed rule, EPA underestimated the 
fraction of hazardous waste generated in teaching and research 
laboratories at colleges and universities compared to total hazardous 
waste generated at colleges and universities. In contrast to the 9 
percent estimate used by EPA for its economic analysis for the proposed 
rule, these commenters stated that in their experience, laboratory 
hazardous waste represents a much larger portion (60 to 95 percent) of 
a college or university's total hazardous waste stream. Several 
commenters provided detailed data on their hazardous waste generation 
especially laboratory hazardous waste. To address this concern, a more 
refined methodology for estimating the quantity of hazardous waste 
generated by laboratories at eligible academic entities was developed. 
For more details about the methodology changes, see section III.A.1 of 
today's preamble or the economic assessment for today's final rule.
    Since today's final rule is equally as stringent as the existing 
Federal hazardous waste regulations, authorized States are not required 
to adopt Subpart K. Thus, once the number of eligible academic entities 
was determined, for purposes of the rule's Economic Assessment, EPA 
estimated how many States would adopt Subpart K. EPA assumed that 
States which have historically adopted at least 85 percent of RCRA's 
rule changes over a five-year period will adopt Subpart K. Thus, 29 
States and Puerto Rico are projected to adopt today's final rule, while 
21 States are assumed to not adopt today's rule.
    In order to model the various scenarios at eligible academic 
entities, we employed four factors to categorize eligible academic 
entities: institution type, laboratory system size, hazardous waste 
generator status, and whether an eligible academic entity operates a 
CAA. Using these categorizations, the Economic Assessment examines the 
costs and savings of this rule's new requirements, such as 
recordkeeping, reporting, training, laboratory clean-outs, etc., 
compared to the existing

[[Page 72951]]

hazardous waste generator requirements, to determine the net overall 
cost or cost savings of Subpart K which includes all of these factors.
    Finally, a specific annualized before-tax cost analysis was 
conducted for each affected entity. Before-tax incremental compliance 
costs were used because they represent a resource or social cost of the 
rulemaking. A discount rate (real rate of return) of 7 percent was used 
covering the estimated period of service or life of the product. All 
costs are adjusted to year 2008 dollars using the Implicit Price 
Deflator for Gross Domestic Product.
4. Key Analytical Limitations
    The Agency was not able to complete a formal RCRA Section 3007 
survey of laboratories at colleges and universities, and non-profit 
research institutes and teaching hospitals that are either owned by or 
have a formal written affiliation agreement with a college or 
university. Consequently, for this assessment, it was necessary to rely 
on publicly available data. The key analytical limitations associated 
with these data are briefly summarized in the bullets below. Additional 
limitations and assumptions related to the economic analysis are 
discussed in more detail in the Economic Assessment.
     The analysis relies heavily on information generated in 
2005 through a survey by NACUBO and, while this survey represents the 
best available source of data, the facilities captured by the survey 
may not be representative of the colleges and universities impacted by 
the rule.
     This analysis relies on BR data which includes hazardous 
waste quantity data for a limited number of SQGs and CESQGs. Thus, the 
number of entities within the universe of potentially eligible academic 
entities is uncertain.
     Data were not available to estimate the number of 
laboratories at non-profit research institutes and teaching hospitals. 
College and university data and Web-based internet information were 
used to estimate the number of laboratories at these sites.
     The cost impact analysis is very sensitive to the number 
and size of containers requiring labeling in the laboratory. The 
analysis assumes that one-third of the containers are pint-size, one-
third are quart-size and one-third are gallon-size.
     An eligible academic entity can develop a single LMP that 
can cover all its laboratories regardless of whether they are located 
in sites with separate EPA Identification Numbers. Data limitations 
prevented us from determining which sites generating laboratory 
hazardous waste may choose to operate under the same LMP.
5. Findings
    The findings presented here reflect a number of analytical 
assumptions and limitations, as touched on above, and as described in 
more detail in the Economic Assessment. Furthermore, we have analyzed 
additional scenarios and conducted sensitivity analyses that are not 
presented in today's preamble. Readers wanting to gain a full 
understanding of our analytical methodology, data, findings, 
assumptions, and limitations are encouraged to read the Economic 
Assessment document prepared in support of this final rule.
    In summary, we have identified a total of 1,580 facilities in 
operation in the U.S., which generate laboratory hazardous wastes and 
are eligible academic entities as defined under today's rulemaking. Of 
this total, 397 are LQGs, 759 are SQGs, and the remaining 424 are 
CESQGs. However as stated above, we assume the States which have 
historically adopted at least 85 percent of RCRA's rule changes over a 
five-year period will adopt Subpart K; thus the universe of eligible 
academic entities located in these States is 169 LQGs, 323 SQGs and 181 
CESQGs (673 facilities in total). Out of this number of eligible 
academic entities located in the States that adopt Subpart K, we 
assumed for this analysis that eligible academic entities that 
experience cost savings by opting into Subpart K will be the only 
eligible academic entities that participate in the final rule. Thus, 
the final rule would provide annual aggregate net cost savings of 
approximately $396,000. These savings would be realized by the 
estimated 112 eligible academic entities that we project would choose 
to operate under Subpart K. The greatest savings would accrue to the 25 
LQGs projected to elect to be regulated under Subpart K; the analysis 
estimates average annual cost savings of approximately $12,200 per LQG 
opting into the rule. Lesser savings would be realized by the 87 SQGs 
that are projected to elect to be regulated under Subpart K; for each 
SQG opting into Subpart K, we estimate average annual cost savings of 
approximately $1,000. Under this Economic Assessment, all CESQG 
eligible academic entities demonstrated cost increases by operating 
under Subpart K, so we assumed that CESQGs would not opt into the final 
rule. Overall, average annual savings for eligible academic entities 
operating under Subpart K are estimated at approximately $3,500 per 
entity.
    An important benefit of Subpart K for some eligible academic 
entities will be the opportunity to maintain their typical RCRA 
generator status because of today's rule's laboratory clean-out 
provisions (see Sec.  262.213). Eligible academic entities that are 
able to maintain their normal generator status rather than episodically 
increasing their generator status by generating laboratory clean-out 
waste can realize savings in reporting, planning, and overall 
administrative costs when operating under Subpart K. Another 
significant portion of the cost savings achieved reflects a reduction 
in the number of off-site hazardous waste shipments, thereby reducing 
shipment costs, particularly among colleges, universities, and research 
institutes that are able to maintain their typical generator status 
from LQG to SQG as a result of the laboratory clean-out provisions. 
Such a change allows for longer accumulation times and increased 
efficiencies in the number of laboratories visited per day for entities 
without CAAs, in order to remove unwanted materials. In addition to 
reduced shipments, much of the benefits of the rule include reduced 
costs for on-site travel. This largely reflects the stipulation that a 
hazardous waste determination for unwanted material in the laboratory 
may occur at any time before it is removed from the laboratory or 
within four days of arrival at an on-site CAA or TSDF, unlike the 
existing generator regulations that stipulate that the hazardous waste 
determination must be made at the point of generation.
    The overall goal of today's action is to promote environmental 
protection and public health through safer management of laboratory 
hazardous waste at eligible academic entities. The Agency has not 
monetized or quantitatively estimated the human health or environmental 
benefits. However, this rule is expected to result in numerous 
environmental benefits. The structured nature of the LMP is expected to 
result in safer laboratory practices and increased awareness of 
hazardous waste management. This will minimize exposure of humans and 
the environment to hazardous wastes. Ultimately, LMPs are expected to 
improve the way eligible academic entities coordinate and integrate 
their hazardous waste management activities and enhance awareness about 
proper laboratory waste handling techniques. In addition to the LMP, 
the rule specifies streamlined, yet cost-neutral training requirements 
that are expected to increase awareness of waste hazards

[[Page 72952]]

and so reduce the potential for mismanagement of the hazardous waste 
generated in laboratories. Also, the Agency included incentives in 
today's final rule to encourage more frequent laboratory clean-outs of 
unwanted and unused reagents, thus reducing the potential for 
accidental releases of these chemicals into the environment. Further, 
EPA expects to see a benefit from allowing CESQGs to opt into the rule, 
because those hazardous wastes generated above CESQGs' monthly volume 
limits during a laboratory clean-out will be managed within the 
Subtitle C system, as opposed to being managed as a non-hazardous 
waste. Finally, we anticipate additional non-quantified economic gains 
through improved hazardous waste management practices, waste 
minimization, and waste coordination activities.

B. Paperwork Reduction Act

    The information collection requirements in this final rule have 
been submitted for approval to the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The 
Information Collection Request (ICR) document prepared by EPA has been 
assigned EPA ICR Number 2317.01.
    The Paperwork Reduction Act requires that EPA estimate the burden 
(time, effort, financial resources) on respondents to comply with all 
actions that involve the collection of information, such as 
recordkeeping, reporting, or disclosure requirements or other 
information collection activities required by this rulemaking. Below is 
a description of the information collection activities required by 
today's rulemaking.
    Since this rule establishes an alternative set of hazardous waste 
generator requirements for eligible academic entities' laboratories, it 
is important that EPA or the authorized States know to which set of 
regulations an eligible academic entity is subject. Therefore, EPA has 
determined at 40 CFR 262.203 and 262.204 that it is necessary to 
require an eligible academic entity to submit a notification to the EPA 
Regional Administrator (or State Director in authorized States) 
indicating that it is electing to be subject to or withdrawing from 
Subpart K for all laboratories under the same EPA Identification Number 
(or on the same site, in the absence of an EPA Identification Number). 
The Site Identification Form must be used by eligible academic entities 
to notify the appropriate authority of its participation in or 
withdrawal from Subpart K. Under 40 CFR 262.206, 262.208, 262.10, 
262.11, and 262.12 of Subpart K, an eligible academic entity must label 
containers of unwanted materials, as specified. These labeling 
requirements are necessary to: Demonstrate compliance with Subpart K, 
alert individuals handling the containers of their contents to ensure 
proper management, assist trained professionals in making the hazardous 
waste determination and assigning the appropriate hazardous code(s), 
ensure emergency responders can quickly ascertain and assess the 
contents of a container in case of an emergency, and utilize for 
enforcement and monitoring purposes.
    Part 40 CFR 262.207 of Subpart K requires training, commensurate 
with duties, for all students and laboratory workers working in a 
laboratory. This training is necessary to ensure that unwanted 
materials are handled safely and in an environmentally sound manner and 
in compliance with Subpart K. In addition, eligible academic entities 
that are LQGs must maintain the training records for laboratory 
workers.
    Under 40 CFR 262.313, eligible academic entities must develop and 
maintain documentation of laboratory clean-outs to ensure compliance 
with Subpart K. Also under 40 CFR 262.214, eligible academic entities 
are required to develop, implement and maintain an LMP to document 
their practices for complying with the performance-based requirements 
of Subpart K.
    Section 3007(b) of RCRA and 40 CFR part 2, Subpart B, defines EPA's 
general policy on public disclosure of information, and contains 
provisions for confidentiality. However, the Agency does not anticipate 
that eligible academic entities will assert any claims of 
confidentiality in association with the final rule. If such a claim 
were asserted, EPA must and will treat the information in accordance 
with the regulations cited above. EPA also will assure that this 
information collection complies with the Privacy Act of 1974 and OMB 
Circular 108.
    According to the estimates provided in the ICR for this final rule, 
the average annual incremental burden of new paperwork requirements to 
respondents as a result of today's final rule is approximately 12,557 
hours and $461,632. These estimates are a total net burden to 
respondents meaning that the burden relief to eligible academic 
entities under the existing regulations was subtracted from the new 
paperwork requirements of Subpart K. Burden means the total time, 
effort, or financial resources expended by persons to generate, 
maintain, retain, or disclose or provide information to or for a 
Federal agency. This includes the time needed to review instructions; 
develop, acquire, install, and utilize technology and systems for the 
purposes of collecting, validating, and verifying information, 
processing and maintaining information, and disclosing and providing 
information; adjust the existing ways to comply with any previously 
applicable instructions and requirements; train personnel to respond to 
a collection of information; search data sources; complete and review 
the collection of information; and transmit or otherwise disclose the 
information.
    The Agency received one consolidated comment representing six 
commenters on the ICR for the proposed rule. The comment on burden 
estimates focused on the notification requirement for Subpart K. In 
general, the commenters believe the burden estimates for notifying the 
appropriate authority of an eligible academic entity's decision to opt 
into or out of Subpart K (see Sec. Sec.  262.203 and 262.204) were 
fairly accurate and supported use of the Site Identification Form as 
the mechanism to be used for notification. The comment specifically 
stated, ``* * * burden for the college to notify appears to be accurate 
and would be the same regardless of whether a letter or Site 
Identification Form is used. However, the burden for the implementer 
for clerical time should be cut in half, from 0.5 to 0.25.'' In 
addition the comment stated, `` * * * the proposed notification 
requirement discussed on Federal Register notice page 29727 under 
section B.3 could be met by using the Site Identification Form (EPA 
form 8700-12).'' A vast majority of the comments received supported the 
use of the Site Identification Form over the use of a letter for 
notification purposes. Thus, the Agency has chosen to finalize the 
requirement for eligible academic entities to use the Site 
Identification Form for notification.
    An agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in 40 CFR are listed in 40 CFR part 9. When this ICR is 
approved by OMB, the Agency will publish a technical amendment to 40 
CFR part 9 in the Federal Register to display the OMB control number 
for the approved information collection requirements contained in this 
final rule.

[[Page 72953]]

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency 
to prepare a regulatory flexibility analysis of any rule subject to 
notice and comment rulemaking requirements under the Administrative 
Procedure Act, or any other statute, unless the agency certifies that 
the rule will not have a significant economic impact on a substantial 
number of small entities. Small entities include small businesses, 
small organizations, and small governmental jurisdictions.
    The RFA provides default definitions for each type of small entity. 
Small entities are defined as: (1) A small business as defined by the 
Small Business Administration's (SBA) regulations at 13 CFR 121.201; 
(2) a small governmental jurisdiction that is a government of a city, 
county, town, school district or special district with a population of 
less than 50,000; and (3) a small organization that is any not-for-
profit enterprise which is independently owned and operated and is not 
dominant in its field. After considering the economic impacts of 
today's final rule on small entities, I certify that this action will 
not have a significant economic impact on a substantial number of small 
entities. Under the final rule, no small eligible academic entities are 
projected to adopt the regulation unless they expect to experience a 
net decrease in costs associated with managing their laboratory 
hazardous waste. Based on these findings, we do not believe that this 
rule will result in significant economic impacts on a substantial 
number of small entities.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, Local, and Tribal 
governments and the private sector. Under Sec.  202 of the UMRA, EPA 
generally must prepare a written statement, including a cost-benefit 
analysis, for proposed and final rules with ``Federal mandates'' that 
may result in expenditures to State, Local, and Tribal governments, in 
the aggregate, or to the private sector, of $100 million or more in any 
one year. Before promulgating an EPA rule for which a written statement 
is needed, Section 205 of the UMRA generally requires EPA to identify 
and consider a reasonable number of regulatory alternatives and adopt 
the least costly, most cost-effective or least burdensome alternative 
that achieves the objectives of the rule. The provisions of section 205 
do not apply when they are inconsistent with applicable law. Moreover, 
section 205 allows EPA to adopt an alternative other than the least 
costly, most cost-effective or least burdensome alternative if the 
Administrator publishes with the final rule an explanation why that 
alternative was not adopted. Before EPA establishes any regulatory 
requirements that may significantly or uniquely affect small 
governments, including Tribal governments, it must have developed under 
section 203 of the UMRA a small government agency plan. The plan must 
provide for notifying potentially affected small governments, enabling 
officials of affected small governments to have meaningful and timely 
input in the development of EPA regulatory proposals with significant 
Federal intergovernmental mandates, and informing, educating, and 
advising small governments on compliance with the regulatory 
requirements.
    Today's final rule contains no Federal mandates (under the 
regulatory provisions of Title II of the UMRA) for State, Local, or 
Tribal governments or the private sector. The UMRA generally excludes 
from the definition of ``Federal intergovernmental mandate,'' duties 
that arise from participation in a voluntary Federal program. This rule 
is a voluntary program because the States are not required to adopt 
these requirements as a condition of authorization (or otherwise). 
Furthermore, EPA has determined that this rule does not contain a 
Federal mandate that may result in expenditures of $100 million or more 
for State, Local, and Tribal governments, in the aggregate, or the 
private sector in any one year. The total net benefits (cost savings) 
of this action are estimated to be $396,000 per year. Finally, EPA has 
determined that this rule contains no regulatory requirements that 
might significantly or uniquely affect small governments.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 
10, 1999), requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and Local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' are defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.''
    Today's rule does not have federalism implications. It will not 
have substantial direct effects on the States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government, 
as specified in the Order. The rule focuses on a set of alternative 
generator requirements for eligible academic entities generating 
laboratory hazardous wastes, without affecting the relationships 
between Federal and State governments. Thus, Executive Order 13132 does 
not apply to this rule.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination 
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000), 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by Tribal officials in the development of regulatory 
policies that have Tribal implications.'' This final rule does not have 
Tribal implications, as specified in Executive Order 13175. EPA has 
concluded that this rule may have Tribal implications only to the 
extent that qualifying academic institutions could be affected if they 
have laboratories that are in some way affiliated with Tribal lands. 
However, this rule will neither impose substantial direct compliance 
costs on Tribal governments nor preempt Tribal law.
    EPA did not consult directly with representatives of Tribal 
governments in the process of developing this rule. However, EPA did 
conduct an extensive outreach process with States and potentially 
affected entities. Furthermore, we received no comments from any Tribal 
governments on the proposed rule. Thus, we believe we have captured the 
concerns that would have been expressed by representatives of Tribal 
governments.

G. Executive Order 13045: Protection of Children From Environmental 
Health and Safety Risks

    Executive Order 13045: ``Protection of Children from Environmental 
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies 
to any rule that: (1) Is determined to be ``economically significant'' 
as defined under Executive Order 12866, and (2) concerns an 
environmental health or safety risk that EPA has reason to believe may 
have a disproportionate effect on children. If the regulatory action 
meets both criteria,

[[Page 72954]]

the Agency must evaluate the environmental health or safety effects of 
the planned rule on children, and explain why the planned regulation is 
preferable to other potentially effective and reasonably feasible 
alternatives considered by the Agency.
    Today's final rule is not subject to the Executive Order because it 
is not economically significant and because the Agency does not have 
reason to believe the environmental health or safety risks addressed by 
this action present a disproportionate risk to children.

H. Executive Order 13211: Actions That Significantly Affect Energy 
Supply, Distribution, or Usage

    This rule is not subject to Executive Order 13211, ``Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use'' (66 FR 28355 (May 22, 2001)) because it is not 
an economically significant action under Executive Order 12866. This 
rule will not seriously disrupt energy supply, distribution patterns, 
prices, imports or exports. Furthermore, this rule is designed to 
improve economic efficiency by streamlining the management of 
laboratory hazardous wastes.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (``NTTAA''), Public Law 104-113, section 12(d) (15 U.S.C. 
272 note) directs EPA to use voluntary consensus standards in its 
regulatory activities unless to do so would be inconsistent with 
applicable law or otherwise impractical. Voluntary consensus standards 
are technical standards (e.g., materials specifications, test methods, 
sampling procedures, and business practices) that are developed or 
adopted by voluntary consensus standards bodies. NTTAA directs EPA to 
provide Congress, through OMB, explanations when the Agency decides not 
to use available and applicable voluntary consensus standards.
    This action does not involve technical standards. Therefore, EPA 
did not consider the use of any voluntary consensus standards.

J. Executive Order 12898: Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes 
Federal executive policy on environmental justice. Its main provision 
directs Federal agencies, to the greatest extent practicable and 
permitted by law, to make environmental justice part of their mission 
by identifying and addressing, as appropriate, disproportionately high 
and adverse human health or environmental effects of their programs, 
policies, and activities on minority populations and low-income 
populations in the United States.
    EPA has determined that this final rule will not have 
disproportionately high and adverse human health or environmental 
effects on minority or low-income populations. This final action is 
designed to ensure more effective and efficient management of 
laboratory hazardous wastes.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. A Major rule cannot 
take effect until 60 days after it is published in the Federal 
Register. This action is not a ``major rule'' as defined by 5 U.S.C. 
804(2). This rule will be effective December 31, 2008.

List of Subjects

40 CFR Part 261

    Environmental protection, Hazardous waste, Recycling, Reporting and 
recordkeeping requirements.

40 CFR Part 262

    Environmental protection, Exports, Hazardous materials 
transportation, Hazardous waste, Imports, Labeling, Packaging and 
containers, Reporting and recordkeeping requirements.

    Dated: November 18, 2008.
Stephen L. Johnson,
Administrator.

0
For the reasons set out in the preamble, Parts 261 and 262 of title 40, 
chapter I of the Code of Federal Regulations are amended as follows:

PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE

0
1. The authority citation for part 261 continues to read as follows:

    Authority: 42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y), and 
6938.


0
2. Section 261.5 is amended by removing the period at the end of 
paragraph (c)(6) and adding in its place a ``semicolon'' and by adding 
paragraph (c)(7) to read as follows:


Sec.  261.5  Special requirements for hazardous waste generated by 
conditionally exempt small quantity generators.

* * * * *
    (c) * * *
    (7) Is a hazardous waste that is an unused commercial chemical 
product (listed in 40 CFR part 261, subpart D or exhibiting one or more 
characteristics in 40 CFR part 261, subpart C) that is generated solely 
as a result of a laboratory clean-out conducted at an eligible academic 
entity pursuant to Sec.  262.213. For purposes of this provision, the 
term eligible academic entity shall have the meaning as defined in 
Sec.  262.200 of Part 262.
* * * * *

PART 262--STANDARDS APPLICABLE TO GENERATORS OF HAZARDOUS WASTE


0
3. The authority citation for part 262 continues to read as follows:

    Authority: 42 U.S.C. 6906, 6912, 6922-6925, 6937, and 6938.

Subpart A--General

0
4. Section 262.10 is amended by adding paragraph (l) to read as 
follows:


Sec.  262.10  Purpose, scope, and applicability.

* * * * *
    (l) The laboratories owned by an eligible academic entity that 
chooses to be subject to the requirements of Subpart K of this part are 
not subject to (for purposes of this paragraph, the terms 
``laboratory'' and ``eligible academic entity'' shall have the meaning 
as defined in Sec.  262.200 of Subpart K of this part).:
    (1) The requirements of Sec.  262.11 or Sec.  262.34(c), for large 
quantity generators and small quantity generators, except as provided 
in Subpart K, and
    (2) The conditions of Sec.  261.5(b), for conditionally exempt 
small quantity generators, except as provided in Subpart K.

0
5. Part 262 is amended by adding Subpart K to read as follows:
Subpart K--Alternative Requirements for Hazardous Waste Determination 
and Accumulation of Unwanted Material for Laboratories Owned by 
Eligible Academic Entities
Sec.
262.200 Definitions for this subpart.
262.201 Applicability of this subpart.
262.202 This subpart is optional.

[[Page 72955]]

262.203 How an eligible academic entity indicates it will be subject 
to the requirements of this subpart.
262.204 How an eligible academic entity indicates it will withdraw 
from the requirements of this subpart.
262.205 Summary of the requirements of this subpart.
262.206 Labeling and management standards for containers of unwanted 
material in the laboratory.
262.207 Training.
262.208 Removing containers of unwanted material from the 
laboratory.
262.209 Where and when to make the hazardous waste determination and 
where to send containers of unwanted material upon removal from the 
laboratory.
262.210 Making the hazardous waste determination in the laboratory 
before the unwanted material is removed from the laboratory.
262.211 Making the hazardous waste determination at an on-site 
central accumulation area.
262.212 Making the hazardous waste determination at an on-site 
interim status or permitted treatment, storage or disposal facility.
262.213 Laboratory clean-outs.
262.214 Laboratory management plan.
262.215 Unwanted material that is not solid or hazardous waste.
262.216 Non-laboratory hazardous waste generated at an eligible 
academic entity.

Subpart K--Alternative Requirements for Hazardous Waste 
Determination and Accumulation of Unwanted Material for 
Laboratories Owned by Eligible Academic Entities


Sec.  262.200  Definitions for this subpart.

    The following definitions apply to this subpart:
    Central accumulation area means an on-site hazardous waste 
accumulation area subject to either Sec.  262.34(a) (or 262.34(j) and 
(k) for Performance Track members) of this part (large quantity 
generators); or Sec.  262.34(d)-(f) of this part (small quantity 
generators). A central accumulation area at an eligible academic entity 
that chooses to be subject to this subpart must also comply with Sec.  
262.211 when accumulating unwanted material and/or hazardous waste.
    College/University means a private or public, post-secondary, 
degree-granting, academic institution, that is accredited by an 
accrediting agency listed annually by the U.S. Department of Education.
    Eligible academic entity means a college or university, or a non-
profit research institute that is owned by or has a formal written 
affiliation agreement with a college or university, or a teaching 
hospital that is owned by or has a formal written affiliation agreement 
with a college or university.
    Formal written affiliation agreement for a non-profit research 
institute means a written document that establishes a relationship 
between institutions for the purposes of research and/or education and 
is signed by authorized representatives, as defined by Sec.  260.10, 
from each institution. A relationship on a project-by-project or grant-
by-grant basis is not considered a formal written affiliation 
agreement. A formal written affiliation agreement for a teaching 
hospital means a master affiliation agreement and program letter of 
agreement, as defined by the Accreditation Council for Graduate Medical 
Education, with an accredited medical program or medical school.
    Laboratory means an area owned by an eligible academic entity where 
relatively small quantities of chemicals and other substances are used 
on a non-production basis for teaching or research (or diagnostic 
purposes at a teaching hospital) and are stored and used in containers 
that are easily manipulated by one person. Photo laboratories, art 
studios, and field laboratories are considered laboratories. Areas such 
as chemical stockrooms and preparatory laboratories that provide a 
support function to teaching or research laboratories (or diagnostic 
laboratories at teaching hospitals) are also considered laboratories.
    Laboratory clean-out means an evaluation of the inventory of 
chemicals and other materials in a laboratory that are no longer needed 
or that have expired and the subsequent removal of those chemicals or 
other unwanted materials from the laboratory. A clean-out may occur for 
several reasons. It may be on a routine basis (e.g., at the end of a 
semester or academic year) or as a result of a renovation, relocation, 
or change in laboratory supervisor/occupant. A regularly scheduled 
removal of unwanted material as required by Sec.  262.208 does not 
qualify as a laboratory clean-out.
    Laboratory worker means a person who handles chemicals and/or 
unwanted material in a laboratory and may include, but is not limited 
to, faculty, staff, post-doctoral fellows, interns, researchers, 
technicians, supervisors/managers, and principal investigators. A 
person does not need to be paid or otherwise compensated for his/her 
work in the laboratory to be considered a laboratory worker. 
Undergraduate and graduate students in a supervised classroom setting 
are not laboratory workers.
    Non-profit research institute means an organization that conducts 
research as its primary function and files as a non-profit organization 
under the tax code of 26 U.S.C. 501(c)(3).
    Reactive acutely hazardous unwanted material means an unwanted 
material that is one of the acutely hazardous commercial chemical 
products listed in Sec.  261.33(e) for reactivity.
    Teaching hospital means a hospital that trains students to become 
physicians, nurses or other health or laboratory personnel.
    Trained professional means a person who has completed the 
applicable RCRA training requirements of Sec.  265.16 for large 
quantity generators, or is knowledgeable about normal operations and 
emergencies in accordance with Sec.  262.34(d)(5)(iii) for small 
quantity generators and conditionally exempt small quantity generators. 
A trained professional may be an employee of the eligible academic 
entity or may be a contractor or vendor who meets the requisite 
training requirements.
    Unwanted material means any chemical, mixtures of chemicals, 
products of experiments or other material from a laboratory that is no 
longer needed, wanted or usable in the laboratory and that is destined 
for hazardous waste determination by a trained professional. Unwanted 
materials include reactive acutely hazardous unwanted materials and 
materials that may eventually be determined not to be solid waste 
pursuant to Sec.  261.2, or a hazardous waste pursuant to Sec.  261.3. 
If an eligible academic entity elects to use another equally effective 
term in lieu of ``unwanted material,'' as allowed by Sec.  
262.206(a)(1)(i), the equally effective term has the same meaning and 
is subject to the same requirements as ``unwanted material'' under this 
subpart.
    Working container means a small container (i.e., two gallons or 
less) that is in use at a laboratory bench, hood, or other work 
station, to collect unwanted material from a laboratory experiment or 
procedure.


Sec.  262.201  Applicability of this subpart.

    (a) Large quantity generators and small quantity generators. This 
subpart provides alternative requirements to the requirements in 
Sec. Sec.  262.11 and 262.34(c) for the hazardous waste determination 
and accumulation of hazardous waste in laboratories owned by eligible 
academic entities that choose to be subject to this subpart, provided 
that they complete the notification requirements of Sec.  262.203.
    (b) Conditionally exempt small quantity generators. This subpart 
provides alternative requirements to the conditional exemption in Sec.  
261.5(b) for

[[Page 72956]]

the accumulation of hazardous waste in laboratories owned by eligible 
academic entities that choose to be subject to this subpart, provided 
that they complete the notification requirements of Sec.  262.203.


Sec.  262.202  This subpart is optional.

    (a) Large quantity generators and small quantity generators: 
Eligible academic entities have the option of complying with this 
subpart with respect to its laboratories, as an alternative to 
complying with the requirements of Sec. Sec.  262.11 and 262.34(c).
    (b) Conditionally exempt small quantity generators. Eligible 
academic entities have the option of complying with this subpart with 
respect to its laboratories, as an alternative to complying with the 
conditional exemption of Sec.  261.5(b).


Sec.  262.203  How an eligible academic entity indicates it will be 
subject to the requirements of this subpart.

    (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 this subpart 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 
this subpart for all the laboratories owned by the eligible academic 
entity that are on-site, as defined by Sec.  260.10. 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 this subpart, and must submit the Site 
Identification Form before it begins operating under this subpart.
    (b) When submitting the Site Identification Form, the eligible 
academic entity must, at a minimum, fill out the following fields on 
the form:
    (1) Reason for Submittal.
    (2) Site EPA Identification Number (except for conditionally exempt 
small quantity generators).
    (3) Site Name.
    (4) Site Location Information.
    (5) Site Land Type.
    (6) North American Industry Classification System (NAICS) Code(s) 
for the Site.
    (7) Site Mailing Address.
    (8) Site Contact Person.
    (9) Operator and Legal Owner of the Site.
    (10) Type of Regulated Waste Activity.
    (11) Certification.
    (c) 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 this subpart.
    (d) 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 this subpart.
    (e) 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 this 
subpart.


Sec.  262.204  How an eligible academic entity indicates it will 
withdraw from the requirements of this subpart.

    (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 this subpart for all the 
laboratories owned by the eligible academic entity under the same EPA 
Identification Number and that it will comply with the requirements of 
Sec. Sec.  262.11 and 262.34(c) for small quantity generators and large 
quantity generators. 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 this subpart for all the laboratories owned by the 
eligible academic entity that are on-site and that it will comply with 
the conditional exemption in Sec.  261.5(b). 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 
this subpart and must submit the Site Identification Form before it 
begins operating under the requirements of Sec. Sec.  262.11 and 
262.34(c) for small quantity generators and large quantity generators, 
or Sec.  261.5(b) for conditionally exempt small quantity generators.
    (b) When submitting the Site Identification Form, the eligible 
academic entity must, at a minimum, fill out the following fields on 
the form:
    (1) Reason for Submittal.
    (2) Site EPA Identification Number (except for conditionally exempt 
small quantity generators).
    (3) Site Name.
    (4) Site Location Information.
    (5) Site Land Type.
    (6) North American Industry Classification System (NAICS) Code(s) 
for the Site.
    (7) Site Mailing Address.
    (8) Site Contact Person.
    (9) Operator and Legal Owner of the Site.
    (10) Type of Regulated Waste Activity.
    (11) Certification.
    (c) 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.


Sec.  262.205  Summary of the requirements of this subpart.

    An eligible academic entity that chooses to be subject to this 
subpart is not required to have interim status or a RCRA Part B permit 
for the accumulation of unwanted material and hazardous waste in its 
laboratories, provided the laboratories comply with the provisions of 
this subpart and the eligible academic entity has a Laboratory 
Management Plan (LMP) in accordance with Sec.  262.214 that describes 
how the laboratories owned by the eligible academic entity will comply 
with the requirements of this subpart.


Sec.  262.206  Labeling and management standards for containers of 
unwanted material in the laboratory.

    An eligible academic entity must manage containers of unwanted 
material while in the laboratory in accordance with the requirements in 
this section.
    (a) Labeling: Label unwanted material as follows:
    (1) The following information must be affixed or attached to the 
container:
    (i) 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, and
    (ii) 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:
    (A) The name of the chemical(s),
    (B) The type or class of chemical, such as organic solvents or 
halogenated organic solvents.
    (2) The following information may be affixed or attached to the 
container, but

[[Page 72957]]

must at a minimum be associated with the container:
    (i) The date that the unwanted material first began accumulating in 
the container, and
    (ii) 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 
Sec.  262.11. Examples of information that would allow a trained 
professional to properly identify whether an unwanted material is a 
solid or hazardous waste include, but are not limited to:
    (A) The name and/or description of the chemical contents or 
composition of the unwanted material, or, if known, the product of the 
chemical reaction,
    (B) Whether the unwanted material has been used or is unused,
    (C) A description of the manner in which the chemical was produced 
or processed, if applicable.
    (b) Management of Containers in the Laboratory: An eligible 
academic entity must properly manage containers of unwanted material in 
the laboratory to assure safe storage of the unwanted material, to 
prevent leaks, spills, emissions to the air, adverse chemical 
reactions, and dangerous situations that may result in harm to human 
health or the environment. Proper container management must include the 
following:
    (1) Containers are maintained and kept in good condition and 
damaged containers are replaced, overpacked, or repaired, and
    (2) Containers are compatible with their contents to avoid 
reactions between the contents and the container; and are made of, or 
lined with, material that is compatible with the unwanted material so 
that the container's integrity is not impaired, and
    (3) Containers must be kept closed at all times, except:
    (i) When adding, removing or consolidating unwanted material, or
    (ii) A working container may be open until the end of the procedure 
or work shift, or until it is full, whichever comes first, at which 
time the working container must either be closed or the contents 
emptied into a separate container that is then closed, or
    (iii) When venting of a container is necessary.
    (A) For the proper operation of laboratory equipment, such as with 
in-line collection of unwanted materials from high performance liquid 
chromatographs, or
    (B) To prevent dangerous situations, such as build-up of extreme 
pressure.


Sec.  262.207  Training.

    An eligible academic entity must provide training to all 
individuals working in a laboratory at the eligible academic entity, as 
follows:
    (a) Training for laboratory workers and students must be 
commensurate with their duties so they understand the requirements in 
this subpart and can implement them.
    (b) An eligible academic entity can provide training for laboratory 
workers and students in a variety of ways, including, but not limited 
to:
    (1) Instruction by the professor or laboratory manager before or 
during an experiment; or
    (2) Formal classroom training; or
    (3) Electronic/written training; or
    (4) On-the-job training; or
    (5) Written or oral exams.
    (c) An eligible academic entity that is a large quantity generator 
must maintain documentation for the durations specified in Sec.  
265.16(e) demonstrating training for all laboratory workers that is 
sufficient to determine whether laboratory workers have been trained. 
Examples of documentation demonstrating training can include, but are 
not limited to, the following:
    (1) Sign-in/attendance sheet(s) for training session(s); or
    (2) Syllabus for training session; or
    (3) Certificate of training completion; or
    (4) Test results.
    (d) A trained professional must:
    (1) Accompany the transfer of unwanted material and hazardous waste 
when the unwanted material and hazardous waste is removed from the 
laboratory, and
    (2) Make the hazardous waste determination, pursuant to Sec.  
262.11, for unwanted material.


Sec.  262.208  Removing containers of unwanted material from the 
laboratory.

    (a) Removing containers of unwanted material on a regular schedule. 
An eligible academic entity must either:
    (1) Remove all containers of unwanted material from each laboratory 
on a regular interval, not to exceed 6 months; or
    (2) Remove containers of unwanted material from each laboratory 
within 6 months of each container's accumulation start date.
    (b) The eligible academic entity must specify in Part I of its 
Laboratory Management Plan whether it will comply with paragraph (a)(1) 
or (a)(2) of this section for the regular removal of unwanted material 
from its laboratories.
    (c) The eligible academic entity must specify in Part II of its 
Laboratory Management Plan how it will comply with paragraph (a)(1) or 
(a)(2) of this section and develop a schedule for regular removals of 
unwanted material from its laboratories.
    (d) Removing containers of unwanted material when volumes are 
exceeded.
    (1) If a laboratory accumulates a total volume of unwanted material 
(including reactive acutely hazardous unwanted material) in excess of 
55 gallons before the regularly scheduled removal, the eligible 
academic entity must ensure that all containers of unwanted material in 
the laboratory (including reactive acutely hazardous unwanted 
material):
    (i) Are marked 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) with the date that 55 gallons is exceeded; and
    (ii) 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.
    (2) 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:
    (i) Are marked 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) with the date that 1 quart is exceeded; and
    (ii) 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.


Sec.  262.209  Where and when to make the hazardous waste determination 
and where to send containers of unwanted material upon removal from the 
laboratory.

    (a) Large quantity generators and small quantity generators--an 
eligible academic entity must ensure that a trained professional makes 
a hazardous waste determination, pursuant to Sec.  262.11, for unwanted 
material in any of the following areas:
    (1) In the laboratory before the unwanted material is removed from 
the laboratory, in accordance with Sec.  262.210;
    (2) Within 4 calendar days of arriving at an on-site central 
accumulation area, in accordance with Sec.  262.211; and
    (3) Within 4 calendar days of arriving at an on-site interim status 
or permitted treatment, storage or disposal facility, in accordance 
with Sec.  262.212.
    (b) Conditionally exempt small quantity generators--an eligible 
academic entity must ensure that a trained professional makes a 
hazardous

[[Page 72958]]

waste determination, pursuant to Sec.  262.11, for unwanted material in 
the laboratory before the unwanted material is removed from the 
laboratory, in accordance with Sec.  262.210.


Sec.  262.210  Making the hazardous waste determination in the 
laboratory before the unwanted material is removed from the laboratory.

    If an eligible academic entity makes the hazardous waste 
determination, pursuant to Sec.  262.11, for unwanted material in the 
laboratory, it must comply with the following:
    (a) A trained professional must make the hazardous waste 
determination, pursuant to Sec.  262.11, before the unwanted material 
is removed from the laboratory.
    (b) If an unwanted material is a hazardous waste, the eligible 
academic entity must:
    (1) 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; and
    (2) Write the appropriate hazardous waste code(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 is transported off-site.
    (3) Count the hazardous waste toward the eligible academic entity's 
generator status, pursuant to Sec.  261.5(c) and (d), in the calendar 
month that the hazardous waste determination was made.
    (c) A trained professional must accompany all hazardous waste that 
is transferred from the laboratory(ies) to an on-site central 
accumulation area or on-site interim status or permitted treatment, 
storage or disposal facility.
    (d) When hazardous waste is removed from the laboratory:
    (1) Large quantity generators and small quantity generators must 
ensure it is taken directly from the laboratory(ies) to an on-site 
central accumulation area, or on-site interim status or permitted 
treatment, storage or disposal facility, or transported off-site.
    (2) Conditionally exempt small quantity generators must ensure it 
is taken directly from the laboratory(ies) to any of the types of 
facilities listed in Sec.  261.5(f)(3) for acute hazardous waste, or 
Sec.  261.5(g)(3) for hazardous waste.
    (e) An unwanted material that is a hazardous waste is subject to 
all applicable hazardous waste regulations when it is removed from the 
laboratory.


Sec.  262.211  Making the hazardous waste determination at an on-site 
central accumulation area.

    If an eligible academic entity makes the hazardous waste 
determination, pursuant to Sec.  262.11, for unwanted material at an 
on-site central accumulation area, it must comply with the following:
    (a) A trained professional must accompany all unwanted material 
that is transferred from the laboratory(ies) to an on-site central 
accumulation area.
    (b) All unwanted material removed from the laboratory(ies) must be 
taken directly from the laboratory(ies) to the on-site central 
accumulation area.
    (c) The unwanted material becomes subject to the generator 
accumulation regulations of Sec.  262.34(a) (or Sec.  262.34(j) and (k) 
for Performance Track members) for large quantity generators or Sec.  
262.34(d)-(f) for small quantity generators as soon as it arrives in 
the central accumulation area, except for the ``hazardous waste'' 
labeling requirements of Sec.  262.34(a)(3) (or Sec.  262.34(j)(6) for 
Performance Track members).
    (d) A trained professional must determine, pursuant to Sec.  
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.
    (e) If the unwanted material is a hazardous waste, the eligible 
academic entity must:
    (1) 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, and
    (2) 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 of on-site or transported 
off-site, and
    (3) Count the hazardous waste toward the eligible academic entity's 
generator status, pursuant to Sec.  261.5(c) and (d) in the calendar 
month that the hazardous waste determination was made, and
    (4) Manage the hazardous waste according to all applicable 
hazardous waste regulations.


Sec.  262.212  Making the hazardous waste determination at an on-site 
interim status or permitted treatment, storage or disposal facility.

    If an eligible academic entity makes the hazardous waste 
determination, pursuant to Sec.  262.11, for unwanted material at an 
on-site interim status or permitted treatment, storage or disposal 
facility, it must comply with the following:
    (a) A trained professional must accompany all unwanted material 
that is transferred from the laboratory(ies) to an on-site interim 
status or permitted treatment, storage or disposal facility.
    (b) All unwanted material removed from the laboratory(ies) must be 
taken directly from the laboratory(ies) to the on-site interim status 
or permitted treatment, storage or disposal facility.
    (c) The unwanted material becomes subject to the terms of the 
eligible academic entity's hazardous waste permit or interim status as 
soon as it arrives in the on-site treatment, storage or disposal 
facility.
    (d) A trained professional must determine, pursuant to Sec.  
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.
    (e) If the unwanted material is a hazardous waste, the eligible 
academic entity must:
    (1) Write the words ``hazardous waste'' on the container label that 
is affixed or attached to the container (or on the label that is 
affixed or attached to the container, if that is preferred) 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, and
    (2) 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, and
    (3) Count the hazardous waste toward the eligible academic entity's 
generator status, pursuant to Sec.  261.5(c) and (d) in the calendar 
month that the hazardous waste determination was made, and
    (4) Manage the hazardous waste according to all applicable 
hazardous waste regulations.


Sec.  262.213  Laboratory clean-outs.

    (a) One time per 12 month period for each laboratory, an eligible 
academic entity may opt to conduct a laboratory clean-out that is 
subject to all the applicable requirements of this subpart, except 
that:
    (1) If the volume of unwanted material in the laboratory exceeds 55 
gallons (or 1 quart of reactive acutely hazardous unwanted material), 
the eligible academic entity is not required to remove all unwanted 
materials from the laboratory within 10 calendar days

[[Page 72959]]

of exceeding 55 gallons (or 1 quart of reactive acutely hazardous 
unwanted material), as required by Sec.  262.208. Instead, the eligible 
academic entity must remove all unwanted materials from the laboratory 
within 30 calendar days from the start of the laboratory clean-out; and
    (2) For the purposes of on-site accumulation, an eligible academic 
entity is not required to count a hazardous waste that is an unused 
commercial chemical product (listed in 40 CFR part 261, subpart D or 
exhibiting one or more characteristics in 40 CFR part 261, subpart C) 
generated solely during the laboratory clean-out toward its hazardous 
waste generator status, pursuant to Sec.  261.5(c) and (d). An unwanted 
material that is generated prior to the beginning of the laboratory 
clean-out and is still in the laboratory at the time the laboratory 
clean-out commences must be counted toward hazardous waste generator 
status, pursuant to Sec.  261.5(c) and (d), if it is determined to be 
hazardous waste; and
    (3) For the purposes of off-site management, an eligible academic 
entity must count all its hazardous waste, regardless of whether the 
hazardous waste was counted toward generator status under paragraph 
(a)(2) of this section, and if it generates more than 1 kg/month of 
acute hazardous waste or more than 100 kg/month of hazardous waste 
(i.e., the conditionally exempt small quantity generator limits of 
Sec.  261.5), the hazardous waste is subject to all applicable 
hazardous waste regulations when it is transported off-site; and
    (4) An eligible academic entity must document the activities of the 
laboratory clean-out. The documentation must, at a minimum, identify 
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. The eligible academic entity must maintain the 
records for a period of three years from the date the clean-out ends; 
and
    (b) For all other laboratory clean-outs conducted during the same 
12-month period, an eligible academic entity is subject to all the 
applicable requirements of this subpart, including, but not limited to:
    (1) The requirement to remove all unwanted materials from the 
laboratory within 10 calendar days of exceeding 55 gallons (or 1 quart 
of reactive acutely hazardous unwanted material), as required by Sec.  
262.208; and
    (2) The requirement to count all hazardous waste, including unused 
hazardous waste, generated during the laboratory clean-out toward its 
hazardous waste generator status, pursuant to Sec.  261.5(c) and (d).


Sec.  262.214  Laboratory management plan.

    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 into 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.
    (a) 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:
    (1) Describe procedures for container labeling in accordance with 
Sec.  262.206(a), including:
    (i) Identifying whether the eligible academic entity will use the 
term ``unwanted material'' on the containers in the laboratory. If not, 
identify an 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.''
    (ii) Identifying the manner in which information that is 
``associated with the container'' will be imparted.
    (2) Identify whether the eligible academic entity will comply with 
Sec.  262.208(a)(1) or (a)(2) for regularly scheduled removals of 
unwanted material from the laboratory.
    (b) In Part II of its Laboratory Management Plan, an eligible 
academic entity must:
    (1) 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 chromatographs and other laboratory 
equipment (see the required standards at Sec.  262.206).
    (2) Describe its intended best practices for providing training for 
laboratory workers and students commensurate with their duties (see the 
required standards at Sec.  262.207(a)).
    (3) Describe its intended best practices for providing training to 
ensure safe on-site transfers of unwanted material and hazardous waste 
by trained professionals (see the required standards at Sec.  
262.207(d)(1)).
    (4) Describe its intended best practices for removing unwanted 
material from the laboratory, including:
    (i) For regularly scheduled removals--Develop a regular schedule 
for identifying and removing unwanted materials from its laboratories 
(see the required standards at Sec.  262.208(a)(1) and (a)(2)).
    (ii) For removals when maximum volumes are exceeded:
    (A) Describe its intended best practices for removing unwanted 
materials from the laboratory within 10 calendar days when unwanted 
materials have exceeded their maximum volumes (see the required 
standards at Sec.  262.208(d)).
    (B) Describe its intended best practices for communicating that 
unwanted materials have exceeded their maximum volumes.
    (5) Describe its intended best practices for making hazardous waste 
determinations, including specifying the duties of the individuals 
involved in the process (see the required standards at Sec.  262.11 and 
Sec. Sec.  262.209 through 262.212).
    (6) 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 Sec.  262.213, including:
    (i) Procedures for conducting laboratory clean-outs (see the 
required standards at Sec.  262.213(a)(1) through (3)); and

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    (ii) Procedures for documenting laboratory clean-outs (see the 
required standards at Sec.  262.213(a)(4)).
    (7) Describe its intended best practices for emergency prevention, 
including:
    (i) Procedures for emergency prevention, notification, and 
response, appropriate to the hazards in the laboratory; and
    (ii) 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
    (iii) Procedures to safely dispose of chemicals that become more 
dangerous when they exceed their expiration date and/or as they 
degrade; and
    (iv) Procedures for the timely characterization of unknown 
chemicals.
    (c) 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.
    (d) An eligible academic entity must review and revise its 
Laboratory Management Plan, as needed.


Sec.  262.215  Unwanted material that is not solid or hazardous waste.

    (a) If an unwanted material does not meet the definition of solid 
waste in Sec.  261.2, it is no longer subject to this subpart or to the 
RCRA hazardous waste regulations.
    (b) If an unwanted material does not meet the definition of 
hazardous waste in Sec.  261.3, it is no longer subject to this subpart 
or to the RCRA hazardous waste regulations, but must be managed in 
compliance with any other applicable regulations and/or conditions.


Sec.  262.216  Non-laboratory hazardous waste generated at an eligible 
academic entity.

    An eligible academic entity that generates hazardous waste outside 
of a laboratory is not eligible to manage that hazardous waste under 
this subpart; and
    (a) Remains subject to the generator requirements of Sec. Sec.  
262.11 and 262.34(c) for large quantity generators and small quantity 
generators (if the hazardous waste is managed in a satellite 
accumulation area), and all other applicable generator requirements of 
40 CFR part 262, with respect to that hazardous waste; or
    (b) Remains subject to the conditional exemption of Sec.  261.5(b) 
for conditionally exempt small quantity generators, with respect to 
that hazardous waste.

[FR Doc. E8-27863 Filed 11-28-08; 8:45 am]

BILLING CODE 6560-50-P
