[Federal Register: December 1, 2008 (Volume 73, Number 231)]
[Rules and Regulations]
[Page 72911-72960]
[DOCID:fr01de08-16]

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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

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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<PHONE_NUMBER>, and the
telephone number for the RCRA Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For further information regarding
specific aspects of this notice, contact Kristin Fitzgerald, Office of
Solid Waste,<PHONE_NUMBER><EMAIL_ADDRESS>Patricia
Mercer, Office of Solid Waste,<PHONE_NUMBER><EMAIL_ADDRESS>
or Jessica Biegelson, Office of Solid Waste,<PHONE_NUMBER>,
<EMAIL_ADDRESS>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
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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
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------------------------------------------------------------------------
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

    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

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

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

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

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

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.

    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

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

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

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

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

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

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

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.
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    \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.
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    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.
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    \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.
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    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

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