[Federal Register Volume 73, Number 231 (Monday, December 1, 2008)]
[Rules and Regulations]
[Pages 72912-72960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-27863]
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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
Federal Register / Vol. 73, No. 231 / Monday, December 1, 2008 /
Rules and Regulations
[[Page 72912]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 261 and 262
[EPA-HQ-RCRA-2003-0012; FRL-8743-9]
RIN 2050-AG18
Standards Applicable to Generators of Hazardous Waste;
Alternative Requirements for Hazardous Waste Determination and
Accumulation of Unwanted Material at Laboratories Owned by Colleges and
Universities and Other Eligible Academic Entities Formally Affiliated
With Colleges and Universities
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: The Environmental Protection Agency (EPA or the Agency) is
finalizing an alternative set of generator requirements applicable to
laboratories owned by eligible academic entities, as defined in this
final rule. The rule provides a flexible and protective set of
regulations that address the specific nature of hazardous waste
generation and accumulation in laboratories at colleges and
universities, as well as other eligible academic entities formally
affiliated with colleges and universities. This final rule is optional
and colleges and universities and other eligible academic entities
formally affiliated with a college or university have the choice of
managing their hazardous wastes in accordance with the new alternative
regulations as set forth in this final regulation or remaining subject
to the existing generator regulations.
DATES: This final rule is effective December 31, 2008.
ADDRESSES: EPA has established a docket for this action under Docket ID
No. RCRA-2003-0012. All documents in the docket are listed on the
http://www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, i.e., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
electronically through http://www.regulations.gov or in hard copy at
the EPA RCRA Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is (202) 566-1744, and the
telephone number for the RCRA Docket is (202) 566-0270.
FOR FURTHER INFORMATION CONTACT: For further information regarding
specific aspects of this notice, contact Kristin Fitzgerald, Office of
Solid Waste, (703) 308-8286, [email protected]; Patricia
Mercer, Office of Solid Waste, (703) 308-8408, [email protected];
or Jessica Biegelson, Office of Solid Waste, (703) 308-0026,
[email protected]. 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.
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Outline
I. Statutory Authority
II. Background
A. History and Summary of the Proposed Rule
B. Rationale of the Final Rule
C. Summary of the Final Rule
D. Effective Date of the Final Rule
III. Detailed Discussion of the Final Rule
A. Scope of Eligible Academic Entities Covered Under the Final
Rule
1. Hazardous Waste Generation Data
2. Laboratories Owned by Teaching Hospitals
3. Laboratories Owned by Non-profit Research Institutes
4. Laboratories Owned by Eligible Academic Entities that are
Conditionally Exempt Small Quantity Generators (CESQGs)
5. Facilities with Laboratories Not Eligible to Participate in
Subpart K
a. Government Research Laboratories
b. Commercial R&D Laboratories
6. Non-laboratory Facilities at Eligible Academic Entities
B. Discussion of Definitions
1. Definitions that Have Not Changed from the Proposed Rule
2. Definitions that Have Changed from the Proposed Rule
3. Definitions that Are New
C. Specific Requirements of the Alternative Regulations
1. Notification
2. Labeling Standards
3. Container Standards
4. Training Requirements
5. Removal Frequency of Unwanted Materials
a. Reactive Acutely Hazardous Unwanted Materials
b. Transferring Unwanted Materials or Hazardous Wastes from the
Laboratory to an On-site CAA or On-site TSDF
c. On-site Consolidation Areas
6. Making the Hazardous Waste Determination
7. Laboratory Clean-outs
a. Summary of the Proposed Laboratory Clean-out Provisions
b. Changes Made to the Laboratory Clean-out Provisions
c. Changes Not Made to the Laboratory Clean-out Provisions
d. Clarifications About the Laboratory Clean-out Provisions
8. Laboratory Management Plan
a. Part I of the LMP
b. Part II of the LMP
9. How CESQGs Comply with Subpart K and How They Differ from
LQGs and SQGs
10. Off-site Consolidation
a. Off-site Consolidation by CESQGs
b. Off-site Consolidation by CESQGs, SQGs, and LQGs
11. Topics that Are Outside the Purview of this Rulemaking
D. Reporting and Recordkeeping
1. Reporting to the Biennial Report for Eligible Academic
Entities that are LQGs
2. Recordkeeping
E. Implementation and Enforcement
IV. State Authorization
A. Applicability of Rules in Authorized States
B. Effect on State Authorization
V. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
1. Introduction to the Economic Assessment for the Final Rule
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2. Baseline Specification
3. Analytical Methodology, Primary Data Sources, and Key
Assumptions
4. Key Analytical Limitations
5. Findings
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination with
Indian Tribal Governments
G. Executive Order 13045: Protection of Children from
Environmental Health and Safety Risks
H. Executive Order 13211: Actions that Significantly Affect
Energy Supply, Distribution, or Usage
I. National Technology Transfer and Advancement Act
J. Executive Order 12898: Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations
K. Congressional Review Act
I. Statutory Authority
These regulations are promulgated under the authority of Sec. Sec.
2002, 3001, 3002, and 3004 of the Solid Waste Disposal Act (SWDA) of
1970, as amended by the Resource Conservation and Recovery Act (RCRA)
of 1976, as amended by the Hazardous and Solid Waste Amendments of 1984
(HSWA), 42 U.S.C. 6921, 6922, 6923, and 6924.
II. Background
A. History and Summary of the Proposed Rule
This rulemaking is a culmination of many years of investigation and
participation by EPA in efforts designed to better understand the
challenges that the academic community faces when managing hazardous
wastes generated in laboratories under the hazardous waste regulations.
As discussed at length in the preamble to the proposed rule (see 71 FR
29715), these efforts include two Reports to Congress; a project under
EPA's eXcellence and Leadership program (Project XL) with three
colleges and universities in New England; a pilot project led by the
Howard Hughes Medical Institute (HHMI) to develop and implement a
performance-based approach to the management of laboratory waste at ten
colleges and universities; and a public meeting on June 18, 2003,
sponsored by EPA to discuss the management of hazardous waste in
research and/or academic laboratories. (See the announcement of the
public meeting at 68 FR 33121, June 3, 2003. The comments submitted to
EPA in response to the public meeting are included in the docket for
today's rulemaking.)
As a result of these and other efforts, on May 23, 2006, EPA
proposed alternative generator requirements applicable to college and
university laboratories that generate hazardous waste (71 FR 29712 \1\
). This preamble will refer to the alternative generator requirements
as ``Subpart K,'' because it establishes a new Subpart K of 40 CFR part
262. The proposed rule provided a flexible and protective set of
regulations that addressed the specific nature of hazardous waste
generation and accumulation in college and university laboratories. The
proposed rule was optional and colleges and universities had the choice
of managing their hazardous wastes in accordance with the proposed
alternative Subpart K requirements or remaining subject to the existing
generator regulations. Although the applicability of the proposed rule
was limited to colleges and universities, the Agency requested comment
on whether it would be appropriate to expand the applicability of the
final rule to other organizations that also have research or teaching
laboratories. In addition, since the Agency assumed that CESQGs would
not want to be subject to the increased burden of Subpart K, the
proposed rule was limited to colleges and universities that are SQGs
and LQGs. However, we solicited comments on whether CESQGs should be
allowed to be subject to Subpart K.
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\1\ Please see page 29716 of the preamble to the proposed rule
for information on other EPA efforts to improve hazardous waste
management at colleges and universities through compliance
assistance centers and more.
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Throughout the years of working with academic institutions, EPA has
heard consistently that the greatest challenge that academic
institutions face in managing their laboratory hazardous wastes under
the existing generator regulations is making the RCRA hazardous waste
determination at the point of generation pursuant to 40 CFR 262.11
(i.e., determining whether their solid waste is hazardous waste and
assigning the proper hazardous waste code(s) in the laboratory at the
time the hazardous waste is generated). This is largely because the
individuals in the laboratory generating the hazardous waste and other
materials are students, who are often not trained to make a hazardous
waste determination. We, therefore, proposed to remove the
responsibility for the hazardous waste determination from the students
in the laboratory and place it in the hands of trained environmental
health and safety (EH&S) professionals. While the hazardous waste
remains in the laboratory, we proposed that it would be referred to as
``unwanted material,'' since the hazardous waste determination had not
yet been made and some portion of the unwanted materials may be unused
and therefore still usable, or may not be hazardous waste when
discarded. We proposed that while in the laboratory, the P-listed
commercial chemical products that were listed for reactivity would be
referred to as ``reactive acutely hazardous unwanted materials.'' In
lieu of making the hazardous waste determination at the point of
generation, the Agency proposed that the hazardous waste determination
must be made prior to removing the unwanted materials from the
laboratory (but not at the time the unwanted materials are first
generated), or within four calendar days of arriving at an on-site
central accumulation area (CAA) or on-site interim status or permitted
treatment, storage, or disposal facility (TSDF).
The Agency also proposed that the unwanted materials would be
regulated in the laboratory by performance-based container labeling and
container management standards. These performance-based standards for
the management of unwanted materials in the laboratory were coupled
with a requirement for a Laboratory Management Plan (LMP). This
combination provided flexibility by allowing the college or university
to specify in its LMP how it would comply with the performance-based
standards. The Agency co-proposed two options regarding the
enforceability of the contents of the individual LMPs that colleges and
universities developed. One option was that the contents of the LMP
would be enforceable; the second option was that the contents of the
LMP would not be enforceable.
Additionally, we proposed that all containers of unwanted materials
would have to be removed from the laboratory on a regular basis, not to
exceed six months. However, if a laboratory accumulated more than 55
gallons of unwanted material before the regularly scheduled removal,
then all containers of unwanted material would have to be removed from
the laboratory within ten calendar days. Likewise, if a laboratory
accumulated more than 1 quart of reactive acutely hazardous unwanted
material prior to the regularly scheduled removal, then the reactive
acutely hazardous unwanted materials would have to be removed from the
laboratory within ten calendar days.
Finally, to address the problem of laboratories keeping old,
unneeded, or expired chemicals (i.e., ``legacy chemicals''), the Agency
proposed regulatory provisions that would give colleges and
universities incentives for conducting laboratory clean-outs: a
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laboratory clean-out could occur over a 30 day period, even if the 55-
gallon limit of unwanted material was exceeded; and the hazardous waste
generated during a laboratory clean-out would not have to be counted
toward the college or university's generator status. However, we
proposed that colleges and universities could only utilize the clean-
out incentives once per 12 months per laboratory.
The comment period for the proposed rule was originally due to
close on August 21, 2006. However, EPA received a request from the
National Association of College and University Business Officers
(NACUBO), on behalf of the American Council on Education (ACE), the
Campus Safety Health and Environmental Management Association (CSHEMA),
and the Campus Consortium for Environmental Excellence (C2E2) to extend
the comment period for 45 days. On August 21, 2006, EPA extended the
public comment period by 30 days (see 71 FR 48500). The comment period
for the proposed rule closed on September 20, 2006.
The Agency received 111 comments on the proposed rule.
Approximately two-thirds of the comments were from colleges and
universities, or trade groups that represent colleges and universities.
In general, colleges and universities were very supportive of the
Agency's effort to address the challenges they face in complying with
the RCRA hazardous waste regulations in their laboratories. However,
many of these commenters also suggested specific changes to the rule.
Thirteen States also submitted comments. Some States expressed support
for the rule, while others were very skeptical of the need for the
rule. Most of the rest of the comments were from organizations that
were not eligible to participate in Subpart K, as proposed. These
commenters, which included non-profit research organizations,
commercial companies that conduct research and manufacture
pharmaceuticals and other products, as well as several Federal
governmental agencies, requested that the Agency expand the scope of
the final rule to allow them to be subject to Subpart K. The more
significant comments on the proposal are addressed later in this
preamble, in section III, but all are addressed in the Response to
Comments Document for today's final rule found in the docket at http://www.regulations.gov (EPA-HQ-RCRA-2003-0012).
B. Rationale of the Final Rule
In the proposal, the Agency discussed how the hazardous waste
generation and management practices at college and university
laboratories differ from both industrial production and industrial
laboratory operations in several meaningful ways (see 71 FR 29714).
These differences, which were confirmed by many of the commenters,
provide the rationale for today's final rule.
Specifically, the Agency identified four primary differences
between laboratory operations at colleges and universities and typical
industrial production facilities. First, laboratories at colleges and
universities have a large number of points of generation (i.e., points
where waste is originally generated), such as multiple laboratory
benchtops within a single laboratory and laboratories located at
several areas on a single campus. Second, these laboratories tend to
generate relatively small volumes of each hazardous waste at each of
these points of generation. Third, the hazardous wastes generated in
these laboratories tend to vary over time, as areas of research change.
In contrast, industrial generators tend to have a different hazardous
waste generation pattern; they tend to generate a smaller number of
predictable wastestreams in large quantities at relatively few
generation points. Fourth, and of particular note, is that most
individuals involved in hazardous waste generation activities at
college and university laboratories are students. Students are
inherently transient, which makes it more difficult to train them. This
fourth difference sets college and university laboratories apart not
only from typical industrial production facilities, but also from non-
academic, government and commercial R&D laboratories. At both
industrial production facilities and non-college or university,
commercial laboratories, employees who generate hazardous waste are
professionally trained in managing hazardous wastes and are held
accountable due to their employee status.
The proposal addressed challenges faced by colleges and
universities that result from these differences, and proposed to
establish a new, optional Subpart K under 40 CFR part 262 for making
the hazardous waste determination, and accumulating and removing
unwanted materials from laboratories at colleges and universities.
Comments from colleges and universities and their trade associations
confirm EPA's conclusion that differences in hazardous waste generation
and management activities at laboratories at academic institutions
warrant this alternative set of requirements. Because of these
differences, the alternative generator requirements found in Subpart K
are directed at the management of unwanted materials in the laboratory
and not in other areas on the same site where hazardous waste may be
generated or managed.
Therefore, today EPA is finalizing an alternative set of generator
regulations for the management of hazardous waste generated in
laboratories at specific types of academic facilities (i.e., eligible
academic entities). Based on comments received on the proposed rule, as
well as additional analysis, the Agency is finalizing the rule with
some changes from the proposal. The Agency believes that today's final
rule is better suited to the circumstances specific to these
laboratories, and that it promotes environmental protection and public
health through safer management of laboratory hazardous wastes.
C. Summary of the Final Rule
This section provides a brief overview of today's final rule and
describes the major ways in which today's rule differs from the
proposal. For a detailed description and justification of the changes
in today's final rule, see Section III of today's preamble.
The final rule establishes a set of alternative generator
regulations for laboratories owned by eligible academic entities under
a new Subpart K in 40 CFR part 262. Eligible academic entities may
choose to be subject to Subpart K in lieu of the existing generator
requirements for the management of the hazardous waste generated in the
laboratories that they own. Laboratories operating under Subpart K must
comply with the performance-based standards, while the unwanted
materials remain in the laboratory. The eligible academic entity also
must develop an LMP that reasonably addresses the nine elements that
are required to be part of the LMP and that describes how the eligible
academic entity will comply with the performance-based standards. The
final rule also provides incentives for eligible academic entities to
conduct laboratory clean-outs of old, unneeded chemicals.
One of the major changes from the proposed rule found in today's
final action is the Agency's decision to expand the applicability of
the rule. Specifically, the scope of the final rule includes colleges
and universities, non-profit research institutes that are owned by or
have a formal written affiliation agreement with a college or
university, and teaching hospitals that are owned by or have a formal
written affiliation agreement with a college or university.
In addition, although the proposed rule specifically precluded
laboratories
[[Page 72916]]
at colleges or universities that are CESQGs from choosing to be subject
to Subpart K, the final rule allows laboratories that are owned by
eligible academic entities that are CESQGs, SQGs or LQGs to operate
under Subpart K. We also have modified the definition of laboratory, so
that additional areas within an eligible academic entity, such as photo
laboratories, field laboratories, and art studios are considered
laboratories. In addition, chemical stockrooms and preparatory
laboratories and other areas that provide a support function to
research and teaching laboratories, are allowed to operate under
Subpart K.
EPA recognizes that the details of hazardous waste management
operations vary widely among campuses and some eligible academic
entities have developed programs consistent with the existing generator
regulations that have proven to be successful. Thus, these institutions
may be reluctant to change from the generator regulations under which
they are currently operating. Therefore, today's final rule, like the
proposal, remains an optional, alternative set of requirements to the
existing generator regulations and eligible academic entities may
continue to manage their laboratory hazardous wastes under the current
hazardous waste generator regulations. Eligible academic entities that
would like the additional flexibility of today's rule may choose to
manage their laboratory hazardous wastes according to the set of
generator regulations we are finalizing today.
Public comments received on the proposed rule confirmed that the
primary difficulty with managing laboratory hazardous wastes under
current regulations is making the hazardous waste determination at the
point of generation. As with the proposal, the final rule addresses
this challenge by providing flexibility with regard to where and when
the hazardous waste determination can be made (i.e., in the laboratory
before it is removed from the laboratory, or within four calendar days
of arriving at an on-site CAA, or on-site TSDF), provided all unwanted
materials (as defined by the rule) that are generated in the laboratory
are managed according to the requirements promulgated in today's rule.
EPA continues to stress that today's final rule does not alter or
move the point of generation of any hazardous waste, but merely allows
the hazardous waste determination to be made at an on-site CAA or on-
site TSDF; or in the laboratory, but at a point in time after the
initial generation of the waste. The point of generation of the
hazardous waste continues to be the location and time at which the
hazardous waste is first generated. Therefore, the applicability of the
land disposal restrictions (LDRs) to hazardous wastes generated in the
laboratory are not affected by today's rule and continue to ``attach''
at the point of generation of the hazardous waste. In addition, RCRA's
statutory inspection and enforcement authorities continue to apply in
the laboratory, even though under Subpart K the hazardous wastes are
referred to as ``unwanted materials,'' while they remain in the
laboratory.
Today's final rule maintains the proposed requirement that unwanted
materials must be removed from the laboratory primarily on a time
basis, and secondarily on a volume basis. That is, we are requiring
that eligible academic entities conduct removals of unwanted materials
from the laboratory on a regular basis, not to exceed six months,
although we have included some additional flexibility. If a laboratory
accumulates more than 55 gallons of unwanted material (including
reactive acutely hazardous unwanted material) before the regularly
scheduled removal, then all unwanted materials (including reactive
acutely hazardous unwanted material) must be removed within ten
calendar days. And if a laboratory accumulates more than 1 quart of
reactive acutely hazardous unwanted material before the regularly
scheduled removal, then the reactive acutely hazardous unwanted
material must be removed from the laboratory within ten calendar days.
Another key issue identified by the academic community that we
addressed in the proposal focused on incentives for discarding unneeded
or expired chemicals that can accumulate in college and university
laboratories and chemical store rooms. The academic community contends
that the existing generator regulations result in discouraging
laboratory clean-outs (because the increased quantities of hazardous
waste generated can change the eligible academic entity's generator
status) and therefore, laboratories often hold on to expired chemicals,
some of which become dangerous over time. EPA believes that revising
the regulations to encourage laboratories to remove legacy chemicals
will result in greater protection of human health and the environment,
as well as increased environmental compliance. Thus, an important part
of this final rule is the laboratory clean-out provisions: once per 12
months per laboratory, a laboratory will have 30 days to conduct a
clean-out and will not have to count the hazardous waste that consists
of unused commercial chemical products (either listed or
characteristic) generated during those 30 days towards the eligible
academic entity's generator status.
As in the proposed rule, today's final rule pairs a performance-
based approach for management of unwanted materials in the laboratory
with a requirement for the eligible academic entity to develop and
implement an LMP. We believe that a performance-based approach will
allow eligible academic entities greater flexibility by allowing them
to tailor their laboratory waste management program with respect to
container labeling, container management, and training, while ensuring
better environmental results. Like the proposal, under today's final
rule, the LMP must describe how an eligible academic entity will meet
the required provisions (i.e., the performance-based standards) by
reasonably addressing all the required elements. However, unlike the
proposal, the LMP under today's final rule must include two distinct
parts (Parts I and II). The eligible academic entity must comply with
the specific contents it includes in Part I of its LMP, while Part II
will comprise the institution's best management practices (BMPs). Thus,
EPA and authorized States may take enforcement action against an
institution if it fails to meet the specifics of Part I of its LMP.
However, EPA and authorized States may not take enforcement action if
an institution's actions vary from the specific procedures contained in
Part II of its LMP, but may take enforcement action if the institution
fails to reasonably address all the required elements in Part II of its
LMP.
In summary, the Agency believes that today's rule will lead to the
safe management of unwanted materials and greater environmental
protection by requiring that the RCRA hazardous waste determination be
performed by trained personnel, rather than by untrained students. We
also believe that today's final rule will promote the protection of
human health and the environment by ensuring that all unwanted
materials which may, in whole or in part, be RCRA hazardous wastes, are
safely managed while in the laboratory prior to the time that the
hazardous waste determination is made. In addition, EPA believes that
the requirement to develop and implement an LMP will improve the
coordination and integration of hazardous waste management procedures
and enhance environmental awareness among researchers and students at
eligible
[[Page 72917]]
academic entities, leading to a transfer of good environmental
management practices to the larger community.
D. Effective Date of the Final Rule
This final rule is effective on December 31, 2008 section 3010(b)
of RCRA allows EPA to promulgate a rule with an effective date shorter
than six months where the Administrator finds that the regulated
community does not need additional time to come into compliance with
the rule. This rule is optional for those eligible academic entities
that choose to follow it. For those entities, this rule provides an
alternative set of requirements that are intended to provide them
flexibility from current applicable regulations. Therefore, the Agency
finds that the regulatory community does not need six months to come
into compliance.
III. Detailed Discussion of the Final Rule
Today, EPA is publishing a final rule establishing alternative
regulations (40 CFR part 262, Subpart K) for the management of unwanted
materials generated in laboratories in eligible academic entities. This
section discusses in detail the major features of the final rule and
the rationale for the changes made from the proposal to today's final
rule.
In today's final rule and preamble, we introduce and use several
new terms. We are including here a brief description of how we will use
the terminology in today's preamble. First, we will use the terms
``choose to become subject to,'' ``participate under,'' ``operate
under'' and ``opt in'' to Subpart K interchangeably. Second, the
regulations require that in order to be eligible to opt into Subpart K,
a non-profit research institute must be owned by or have a formal
written affiliation agreement with a college or university, and a
teaching hospital must be owned by or have a formal written affiliation
agreement with a college and university. In the preamble, we will
generally refer to eligible academic entities other than colleges and
universities as non-profit research institutes and teaching hospitals
that are owned by or formally affiliated with a college or university.
Third, many eligible academic entities have multiple EPA
Identification Numbers for different sections of the same ``campus,''
typically because the sections of the eligible academic entity are
separated by public roads. When referring to the individual sections of
an eligible academic entity, we will use the term ``site'' or ``EPA
Identification Number.'' When referring collectively to all the
sections of the eligible academic entity, we will use the term,
``campus,'' or ``eligible academic entity,'' or ``institution.'' As an
example, when an eligible academic entity opts into Subpart K for its
laboratories, it must notify the Agency for each EPA Identification
Number on a campus that is opting in.
A. Scope of Eligible Academic Entities Covered Under the Final Rule
EPA proposed that this alternative set of generator regulations
would apply only to laboratories at colleges and universities. As
discussed in section II.A of today's preamble, EPA has had a long
history of interaction with colleges and universities. From these
interactions, the Agency has learned about the unique hazardous waste
generation pattern in teaching and research laboratories at colleges
and universities. However, EPA recognized that there may be additional
types of facilities with laboratories that may fit the rationale for
Subpart K. Thus, while the proposal was limited to colleges and
universities, EPA solicited comment on whether to expand the scope of
the final rule to other institutions that fit the rationale of Subpart
K.
Public comments from trade groups, such as the Association of
American Medical Colleges (AAMC), the Association of Independent
Research Institutes (AIRI), the Campus Safety Health and Environmental
Management Association (CSHEMA), and individual comments submitted by
non-profit research institutes, teaching hospitals, private research
and development companies, governmental research laboratories, and
colleges and universities with teaching hospitals and/or non-profit
research institutes all asserted that their research laboratories fit
the hazardous waste generation pattern rationale of today's rule. That
is, these commenters assert that given the nature of research, research
laboratories share the same hazardous waste generation patterns,
regardless of what type of institution they are found in. In addition,
EPA has conducted site visits in various research laboratories at
teaching hospitals and private R&D companies, among others, and has
seen similar hazardous waste generation patterns and activities of
these laboratories.
Based on the comments EPA received and additional research by EPA
regarding the presence of students in laboratories at institutions
other than colleges and universities, we have expanded the scope of the
final rule to include specific additional entities that fit all aspects
of the rationale for this rule. This rationale includes not only a
hazardous waste generation pattern that is similar to that found at
college and university laboratories, but also a significant student
population. EPA did not expand the scope of the final rule to include
certain entities because they did not fit all aspects of the rationale
for this rule. Therefore, today's final rule allows colleges and
universities, teaching hospitals that are owned by or have a formal
written affiliation agreement with a college or university, and non-
profit research institutes that are owned by or have a formal written
affiliation agreement with a college or university, to opt into Subpart
K. This expansion includes laboratories at facilities that we and many
commenters believe are closely integrated with laboratories at colleges
and universities. Collectively, we are calling the entities that are
eligible to opt into today's final rule, ``eligible academic
entities.'' Details on these entities are contained in the following
sections. (For information regarding changes to the definition of
laboratory, see section III.B.2 and Sec. 262.200.)
1. Hazardous Waste Generation Data
In the preamble to the proposed rule, we stated that 9% of the
hazardous waste generated at college and university LQGs was from
laboratories. We received several comments from colleges and
universities asserting that we erred in our estimates and that at their
campuses, laboratory hazardous waste constituted a much higher
percentage of their total hazardous waste. The Agency sent follow-up
letters to several commenters requesting additional information in
support of their comments. In response to our inquiries, many of the
commenters supplied detailed information about their hazardous waste
generation and one commenter provided a detailed analysis of our
methodology for determining the percentage of laboratory hazardous
waste, including specific suggestions on how to improve the methodology
for the final rule. The follow-up letters and the responses are all
included in the docket for today's rule.
As a result of these comments, EPA has significantly revised the
methodology used in the proposal to determine the total quantity of
hazardous waste and laboratory hazardous waste. Specifically, in the
proposal, we used key-word searches of the description field on
Biennial Report (BR) forms to identify laboratory hazardous waste as a
percent of the total hazardous waste generated. Our revised methodology
uses three source codes
[[Page 72918]]
from the BR to identify which hazardous wastes are from laboratories:
(1) G11--Discarding off-specification or out-of-date chemicals or
products (unused chemicals or products--corresponds to P and U
hazardous waste codes);
(2) G22--Laboratory analytical wastes (used chemicals from
laboratory operations), and
(3) G09--Other production or service-related processes from which
the waste is a direct outflow or result. (Because hazardous waste from
the source code G09 could also be generated in non-laboratory
operations, these wastes were only considered laboratory wastes if the
waste form codes indicated it was shipped in a lab pack (i.e., waste
form codes W001 or W004)).
Additional laboratory wastes were identified using key-word
searches of the description field. This revised method resulted in a
much higher estimate for laboratory hazardous waste as a percent of
total hazardous waste at colleges and universities--73% under the
revised methodology, compared to 9% under the original methodology used
in the proposed rule. This revised methodology was used to calculate
the amount of laboratory hazardous waste generated as a percent of the
total hazardous waste generated for colleges and universities, as well
as for other types of facilities with laboratories that we considered
including in today's final rule: teaching hospitals, non-profit
research institutes, governmental research laboratories, and commercial
R&D laboratories. For a full explanation of the methodology used to
determine the amounts of total hazardous waste and laboratory hazardous
waste generated at colleges and universities, teaching hospitals, and
non-profit research institutes, see the memo entitled, Lab Rule Data
Analyses, from ICF International to Patricia Mercer, May 1, 2008; and
for hazardous waste information for LQG government research
laboratories and LQG commercial R&D laboratories see the memo entitled,
Final Analyses of College and University Laboratory Hazardous Waste,
from ICF International to Patricia Mercer, August 17, 2007. Copies of
both memos are in today's docket.
Below is a table of the hazardous waste data for eligible academic
entities (i.e., those entities eligible to opt into Subpart K) that are
LQGs. Using the revised methodology, we now estimate that for college
and university LQGs, 73% of their total hazardous waste is from
laboratories. The percent of hazardous waste coming from laboratories
at teaching hospitals and non-profit research institutes is even
higher--81% and 92%, respectively. Further, with all three types of
eligible academic entities, nearly all LQGs generate laboratory
hazardous waste.
----------------------------------------------------------------------------------------------------------------
Non-profit
Colleges and Teaching research
universities hospitals \1\ institutes \2\
----------------------------------------------------------------------------------------------------------------
LQGs generating laboratory hazardous waste............ 286 104 8
LQGs generating hazardous waste....................... 293 109 8
% that generate laboratory hazardous waste...................... 98 95 100
Tons of laboratory hazardous waste.............................. 6,530 1,712 119
Tons of all hazardous waste \3\................................. 8,951 2,119 130
% of hazardous waste that is laboratory hazardous waste......... 73 81 92
----------------------------------------------------------------------------------------------------------------
\1\ To be eligible to opt into Subpart K, a teaching hospital must be owned by or have a formal written
affiliation agreement with a college or university
\2\ To be eligible to opt into Subpart K, a non-profit research institute must be owned by or have a formal
written affiliation agreement with a college or university
\3\ Excludes remediation wastes because remediation wastes are not regularly generated hazardous wastes, but
rather are hazardous wastes generated only when a clean-up or remediation project takes place.
As discussed above, based on EPA's observations, as well as
comments that we have received and given the nature of teaching and
research, activities conducted at teaching and research laboratories in
colleges, universities, teaching hospitals, and non-profit research
institutes are comparable and therefore share similar hazardous waste
generation patterns. EPA identified challenges associated with the
specific hazardous waste generation patterns, such as difficulty making
hazardous waste determinations with a large variety of wastestreams.
These difficulties, along with the difficulties associated with the
presence of a significant student population, form the basis of this
rule. Even at proposal, when we estimated that 9% of a college or
university's hazardous waste was generated in the laboratory, we
believed that these challenges were sufficient to warrant the
development of Subpart K. With the revised estimates indicating that
the percentage of hazardous waste generated in laboratories by eligible
academic entities being much higher, these specific challenges are
shown to be even more pervasive and support the need for the
flexibility offered by Subpart K for these particular entities.
Given that these types of organizations with research and teaching
laboratories share similar hazardous waste generation patterns, we
focused on the extent to which these entities had a significant student
presence, which is a very important basis of today's rule. Because
students are inherently transient, and generally have less
accountability than professionals employed in laboratories, it is
unlikely that they will make a proper hazardous waste determination
which requires detailed knowledge of RCRA. The following discussion of
which entities are and are not eligible to opt into today's rule
focuses on whether there is a significant student presence. However,
there are limited data readily available about the number of students
in laboratories even at colleges and universities much less for
entities, such as teaching hospitals and non-profit research
institutes. Thus, we used certain factors as indications that the
organization did indeed have students in the laboratories. Examples of
factors indicating student presence include programs for high school,
undergraduate, or graduate students to conduct laboratory research,
presence of medical residents/interns, co-sponsored degree programs
with colleges or universities, or classes offered independent of the
college or university.
2. Laboratories Owned by Teaching Hospitals
In the proposal, EPA specifically requested comment on whether
laboratories in hospitals affiliated with colleges or universities
should be included in the final rule. Previously, information about
hospital laboratories led EPA to believe that their wastestreams are
fairly routine and they
[[Page 72919]]
did not have the same challenges faced by college or university
laboratories in training their workers. Through comments, EPA learned
that many teaching hospitals owned by or formally affiliated with a
college or university have research and teaching laboratories in
addition to diagnostic laboratories dedicated to patient care. As
stated earlier, research laboratories at teaching hospitals have
similar hazardous waste generation patterns as research laboratories on
a college or university campus. In addition, such teaching hospitals
have students working in the laboratories to learn how to run various
tests, how to operate equipment, or to conduct research with
professors.
In fact, one commenter asserted that, ``these types of laboratories
[laboratories at college or university affiliated hospitals and other
similar locations such as dental colleges, clinics and associated
laboratories] are very similar to instructional and research
laboratories. They are used by a large number of students; they are
used for instructional and research purposes; while some processes are
static and predictable, others are not; large numbers of different
wastestreams are produced, but in relatively small quantities.''
Another commenter wrote, ``Research labs in a hospital are essentially
the same as a research lab in a college or university and have similar
waste generation patterns.''
Based on these comments, EPA conducted additional research into the
types of laboratories that are present at teaching hospitals that are
owned by or formally affiliated with a college or university. In
particular, EPA identified three types of laboratories: (1) Clinical
diagnostic laboratories that conduct typical laboratory tests related
to patient care, (2) applied research laboratories that conduct
clinical trials and (3) research laboratories that conduct basic
medical research. While strictly speaking, clinical diagnostic
laboratories may not exhibit the hazardous waste generation pattern
identified in the rationale for this rule, we found that the setup in
teaching hospitals makes it difficult to draw hard distinctions between
the various types of laboratories. That is, each teaching hospital
divides its laboratory space differently and oftentimes a single
laboratory serves multiple functions, such as both diagnostic testing
and research. Furthermore, in some cases, laboratory personnel perform
multiple functions within a laboratory and are involved with both
diagnostic and research activities. Thus, EPA has determined that it
would be extremely difficult to implement a rule that made a
distinction between the various types of laboratories at such teaching
hospitals.
The Agency also analyzed data from the BR which are sent to the
Agency every other year by LQGs and housed in EPA's RCRAInfo database,
to find out more about the universe of non-teaching and teaching
hospitals owned by or formally affiliated with a college or university
and their hazardous waste generation patterns. Notably, one of the main
differences between the hazardous waste generation patterns at LQG
teaching hospitals owned by or formally affiliated with a college or
university and non-teaching hospitals is in the amount of laboratory
hazardous waste as a percentage of the total amount of hazardous waste
generated. Specifically, teaching hospitals showed approximately 80% of
the total quantity of hazardous waste generated coming from
laboratories, while non-teaching hospitals only had 13% of the total
quantity of hazardous waste generated coming from laboratories. EPA
attributes this disparity to be the result of the greater amount of
research generally occurring in teaching hospitals owned by or formally
affiliated with a college or university.
In terms of the transient students, EPA has learned from its
research that teaching hospitals instruct a variety of students--
interns, residents, nursing students, laboratory technicians, and more,
in the hospital. Instruction of these students includes work in the
laboratories to learn about the processes and tests conducted there,
introducing similar difficulties as those encountered at colleges and
universities in teaching and training transient students and making the
hazardous waste determination. In fact, one commenter asserted that,
``the amount of time a student spends at a teaching hospital is
comparable to that of a graduate student in another laboratory
discipline.'' Also, medical research at a college and university
oftentimes is shared between the college and university laboratories
and teaching hospital laboratories. One commenter pointed out that
professors, graduate students, and undergraduate students often go back
and forth between laboratories at colleges and universities, and at
teaching hospitals, to conduct research.
EPA recognizes that a teaching hospital that is owned by a college
or university will instruct students from its medical school. However,
due to the complex healthcare system, many times medical students or
residents from a medical school will train in a teaching hospital that
is affiliated with a college or university, but not owned by the
college or university. We do not want to preclude these teaching
hospitals that are training students and have a significant transient
student population from participating in Subpart K. Therefore, EPA
looked for a way to define the concept of ``affiliated teaching
hospital.'' We discovered that the Accreditation Council for Graduate
Medical Education (ACGME) defines two types of agreements between a
medical school and a teaching hospital: A master affiliation agreement
and a program letter of agreement.\2\ EPA has determined that the
presence of both these agreements indicates that a teaching hospital is
formally affiliated with a college or university.
---------------------------------------------------------------------------
\2\ The ACGME defines these terms in the ``Glossary of Terms''
that appears on its Web site at http://acgme.org/acWebsite/about/ab_ACGMEglossary.pdf. The ACGME also describes these documents in
more detail in a document called Frequently Asked Questions Related
to Master Affiliation Agreements and Program Letters of Agreement
that appears on its Web site at http://acgme.org/acWebsite/about/ab_FAQAgreement.pdf.
---------------------------------------------------------------------------
Based on the evidence provided by commenters and additional EPA
research, we have concluded that teaching hospitals owned by or
formally affiliated with a college or university fit within all aspects
of the rationale of today's final rule: many hazardous wastes that vary
over time are generated in small quantities at many points of
generation, and there is a significant and transient student population
that is not familiar with the RCRA hazardous waste requirements.
Therefore, EPA is allowing teaching hospitals, as defined in this final
rule that are either owned by or have a formal written affiliation
agreement with a college or university, to opt into Subpart K for their
laboratories. (See section III.B.3 for a discussion of the definition
of teaching hospital and formal written affiliation agreement or Sec.
262.200.)
3. Laboratories Owned by Non-profit Research Institutes
EPA received many comments from representatives of non-profit
research institutes, colleges and universities, and trade groups
stressing the similarities between college and university laboratories
and the laboratories at non-profit research institutes in terms of the
hazardous waste generation pattern rationale identified in the rule and
the student presence in the laboratories. As indicated above, a
research laboratory at a non-profit research institute that is owned by
or has a formal written affiliation agreement with a college or
university shares the same hazardous waste generation pattern.
[[Page 72920]]
In terms of the presence of a significant transient student
population, one commenter explained that as a non-profit research
institute, it has close ties with the local university; they
collaborate with the university on projects and faculty hold joint
appointments. The commenter added that students and researchers often
travel between the non-profit's laboratories and the local university's
laboratories and that because the hazardous waste management
requirements at both institutions are the same under the existing
generator regulations, currently there are minimal differences in
hazardous waste management for the students and researchers to learn
when working at both institutions. Thus, the commenter requested that
EPA add non-profit research institutes to the final rule in order to
minimize confusion and training challenges under Subpart K.
In response to these comments, EPA conducted additional research
and identified from the BR information housed in the RCRAInfo database,
nine non-profit research institutes that are LQGs (see section III.A.1
for information on their hazardous waste generation). For all nine LGG
non-profit research institutes, we were able to obtain readily
available information on student populations and programs, as well as
substantial evidence that non-profit research institutes are similar to
colleges and universities in that they sometimes grant degrees of their
own, co-sponsor degrees with colleges and universities, teach classes,
and share faculty, funding sources, and laboratory space with colleges
and universities. We determined that the information obtained is
generally representative of the universe of laboratories at non-profit
research institutes, because among the non-profits we researched, we
found that their hazardous waste generation patterns and student
programs were remarkably homogenous.
One commenter wrote, ``* * * the distinction between a research
laboratory in a college and university and a research laboratory in an
institution that is not a college and university has blurred
considerably over the last decade.'' As EPA conducted additional study
into non-profit research institutes, it was difficult for the Agency to
draw a hard line between college and universities and non-profit
research institutes. For example, Memorial Sloan-Kettering Cancer
Center (MSKCC) is a non-profit cancer research institute, a teaching
hospital, a graduate school in biomedical sciences, and is in
partnership with the Weill Cornell Graduate School of Medical Sciences
and Cornell University to train students in research and patient care.
MSKCC also partners with New York-Presbyterian Hospital, the Hospital
for Special Surgery, and the Rockefeller University. Via these
partnerships, the majority of the faculty of the Weill Cornell Medical
Graduate School of Medical Sciences has their research laboratories and
other facilities located within the Weill Cornell Medical College-New
York-Presbyterian Hospital Complex and the MSKCC's research laboratory
buildings. Another outgrowth of this partnership is that MSKCC jointly
administers a Ph.D. program with Cornell and Weill Medical College in
computational biology and medicine. Finally, besides its own graduate
school of biomedical sciences, MSKCC offers two certificate programs
for students to learn cytotechnology and radiation therapy.
As shown in the example above, a non-profit research institute
owned or formally affiliated with a college or university may be so
closely associated with the college and university that excluding them
will prevent colleges and universities from establishing one laboratory
waste management system, introducing confusion among researchers
working in laboratories at both institutions. In this situation, such
non-profit research institutes are virtually identical to a college and
university and their hazardous waste generation patterns and student
presence fit within the rationale of this rule. This information made
it clear to us that non-profit research institutes often are
``academic'' and should be eligible to opt into today's final rule,
when they are owned by or formally affiliated with a college or
university.
One commenter recommended that EPA expand the scope of the rule to
any institution that has a formal affiliation with a college or
university. While the Agency does not believe it should expand the
scope of the rule to all institutions that have any kind of an
affiliation with a college or university, we do believe it is
appropriate to allow those non-profit research institutes that have a
formal written affiliation agreement with a college or university to
opt into Subpart K. In order to ensure that the formal written
affiliation agreement between the two entities represents an
affiliation that is longstanding, we believe that the affiliation must
be at the institutional level, as opposed to an agreement between staff
or professors at the two eligible academic entities. Of the nine non-
profit research institutes that are identified as LQGs in the BR, we
determined that eight had formal affiliations with colleges and
universities on an institutional level. For example, the Burnham
Institute not only administers its own graduate program, it also has an
institutional affiliation with the University of California at San
Diego by participating in a joint graduate training program in
molecular pathology (where approximately 30 graduate students a year
obtain their primary scientific training at the Institute).
The reason we are requiring a formal written affiliation agreement
at the institutional level is because having a formal affiliation at
the institutional level with a college or university seemed to increase
the likelihood that the non-profit research institutes would have
students in their laboratories. The presence of a significant transient
student presence is an important rationale of today's rule. Typically,
a formal affiliation at the institutional level allows students at a
college or university to conduct thesis research at the non-profit
research institute, use non-profit researchers as mentors, and at
times, take some of their degree classes at the non-profit research
institute. Further, requiring a formal written affiliation agreement
between the non-profit research institute and a college or university
will assist the implementing agency verify that an affiliation at the
institutional level exists. Thus, for these reasons, we decided to
limit today's rule to those non-profit research institutes that have a
formal written affiliation at the institutional level with a college or
university. For a discussion of the definition of ``formal written
affiliation agreement,'' see section III.B.3 of this preamble or Sec.
262.200.
4. Laboratories Owned by Eligible Academic Entities That Are
Conditionally Exempt Small Quantity Generators (CESQGs)
EPA recognizes that laboratories at eligible academic entities that
are CESQGs share the same hazardous waste generation patterns as
laboratories at larger generators, except the eligible academic
entities that are CESQGs generate smaller quantities of hazardous
waste. However, while laboratories at CESQGs fit within the rationale
used to define the scope of this rule, the proposal did not allow them
to opt in. At the time of the proposal, we had thought CESQGs would not
want to opt into Subpart K since they currently are not subject to the
controls that apply to satellite accumulation areas (SAAs) and do not
have to comply with most of the other requirements that apply to LQGs
and SQGs. In fact, many of the
[[Page 72921]]
provisions in today's final rule would be more stringent than those to
which they are currently subject under Sec. 261.5. At proposal, we
solicited comment on whether the final rule should include laboratories
at CESQGs.
Numerous commenters indicated that we should provide CESQGs with
the same opportunity as SQGs and LQGs to assess which set of generator
regulations is most appropriate for their laboratories and that we
should not prohibit them from opting into Subpart K. Additionally, many
comments from colleges and universities indicated that laboratory
management would improve if their CESQG sites with laboratories could
operate under this rule and follow the required LMP. Further,
commenters explained that since colleges and universities often have
CESQG sites, as part of a larger campus, a college or university may
want to be able to manage all of its laboratories under one management
system and that EPA should allow CESQGs to participate in Subpart K.
This issue is particularly pertinent for urban college and university
campuses that are divided by public roads. One campus can potentially
include many separate generator sites, some LQGs, some SQGs, and some
CESQGs. In light of the comments received, EPA agrees that it makes
sense that at least some CESQGs would want to opt into Subpart K. Thus,
EPA is allowing eligible academic entities to opt into Subpart K for
their CESQG sites and is allowing stand-alone CESQGs to opt into
Subpart K, as well. CESQG sites at an eligible academic entity may
include field laboratories and small laboratories separated from the
main campus by public roadways. In addition, we expect that some
eligible academic entities that are themselves CESQGs (i.e., stand-
alone CESQGs), such as small non-profit research institutes, may choose
to opt into the rule to take advantage of the clean-out provisions.
Other commenters argued that the rule would encourage better
environmental performance by extending the laboratory clean-out
provisions to eligible academic entities that are themselves CESQGs or
have CESQG sites without requiring them to comply with the rest of the
Subpart K requirements. EPA agrees that stand-alone CESQGs and CESQG
sites that are part of a larger eligible academic entity will benefit
by removing legacy chemicals from the laboratory by taking advantage of
the clean-out incentives of today's rule. However, EPA is not allowing
a stand-alone eligible academic entity or a CESQG site that is part of
a larger eligible academic entity to partake only in the laboratory
clean-out provisions and not the other Subpart K requirements because
this would prevent CESQGs from taking advantage of the two main
benefits of today's final rule. That is, if a CESQG site only
participated in the laboratory clean-out provisions, it would not be
able to take advantage of the flexibility in where and when to make the
hazardous waste determination. Second, if a CESQG site that is part of
a larger eligible academic entity only participated in the laboratory
clean-out provisions, it would be unable to establish one hazardous
waste management system in all the laboratories at the eligible
academic entity. The ability to establish a unified hazardous waste
management system for all laboratories is one of the priorities cited
by academic commenters. Therefore, in order for a CESQG site at an
eligible academic entity or an eligible academic entity that is itself
a CESQG to take part in the laboratory clean-out incentives, the
eligible academic entity must opt into Subpart K in its entirety and
follow the management standards for unwanted materials in the
laboratories.
5. Facilities With Laboratories Not Eligible To Participate in Subpart
K
As explained above, EPA solicited comment on whether to expand the
scope of the rule beyond laboratories at colleges and universities to
laboratories at other types of facilities. Many commenters supported
expansion of the scope of the rule. We received comments from both
government research laboratories and commercial R&D laboratories
requesting to be included in this rulemaking. Overall, from the
information available at this time, it appears that laboratories at
both of these types of facilities have hazardous waste generation
patterns similar to laboratories at colleges and universities--
generating small quantities of many types of waste that vary over time
at many points of generation--since they are research laboratories.
However, information about the other key aspect of the rationale for
today's rule, that is, significant student presence, has led EPA to
determine that, at this time, laboratories at government research and
commercial R&D facilities are not eligible to participate in Subpart K.
(a) Government Research Laboratories: We received comments from a
number of governmental organizations that have research laboratories
requesting that they be allowed to participate in (or opt into) Subpart
K. These commenters, all from the Federal government, asserted that
they fit the hazardous waste generation pattern explained by EPA as
part of the rationale for Subpart K. In addition to the public
comments, EPA collected readily available information on hazardous
waste generation patterns and student presence in government research
laboratories. From EPA's BR on hazardous waste generated by LQGs, we
identified 39 LQG government research laboratories. In addition, in its
comments on the proposal, one Federal agency provided student numbers
for ten of its laboratories, three of which we have identified as LQGs.
We also acquired aggregated student numbers or estimates for three
other Federal agencies. We were unable to obtain student population
data at laboratories at the remaining government research laboratories,
including State and local governmental laboratories. Based on this lack
of available information, EPA has decided to defer our decision on
government research laboratories and therefore, government research
laboratories are not included in this final rulemaking. Rather, in
2009, EPA expects to prepare a Federal Register Notice soliciting
additional information about government research laboratories,
particularly the presence of students at such research laboratories in
order to make a more informed decision regarding whether or not to
allow them to opt into Subpart K in the future.
(b) Commercial R&D Laboratories: EPA requested comment on whether
private laboratories fit within the rationale of Subpart K and received
comments from pharmaceutical companies, engineering companies, and a
utility solid waste activity group, all requesting to be included in
Subpart K because their laboratories fit within the rationale of the
hazardous waste generation pattern. Based on these comments and
responses to follow-up letters to commercial research and development
laboratories (copies of which are in today's docket), it appears that
there is a similar hazardous waste generation pattern (i.e., small
amounts of many different types of waste generated at multiple points
of generation) as at laboratories at colleges and universities.
However, there is little evidence of student presence in these
laboratories as indicated in the follow-up responses from commenters
and EPA's own research. Without the presence of students, commercial
R&D laboratories do not have the same challenges in making hazardous
waste determinations for their laboratory hazardous wastes and in
training their laboratory personnel. Having similar hazardous waste
generation patterns is
[[Page 72922]]
only one element in determining which entities should be eligible to
opt into Subpart K. EPA believes that having a significant student
presence in the laboratories (which increases the difficulty in
training and in making hazardous waste determinations) is extremely
important. Therefore, without meeting the rationale that a significant
number of students must be present, EPA has decided not to allow
commercial R&D laboratories to opt into Subpart K.
6. Non-Laboratory Facilities at Eligible Academic Entities
The Agency received many comments requesting that the rule address
all types of facilities at a college or university where hazardous
waste is generated, rather than limiting the rule to teaching and
research laboratories. Commenters requested that non-laboratory areas,
such as vehicle maintenance shops, machine shops, maintenance shops,
fabrication units, athletic departments, power plants/energy generation
units, print shops, and facilities operations be included in the scope
of the final rule. Some commenters suggested that we include these
areas by modifying the definition of laboratory to include them. Other
commenters stated that creating a dual regulatory system for hazardous
waste management on college or university campuses would hinder their
participation in Subpart K and ultimately be confusing.
While the Agency understands the concerns raised by the commenters,
we also believe that the Subpart K requirements were developed to
address specific concerns raised by the academic community as they
relate to hazardous wastes generated in their laboratories--that is,
the situations and challenges that exist in teaching and research
laboratories are unique (e.g., having to identify which of the
potentially hundreds of different wastestreams meet the definition of
hazardous waste). The academic community has not raised such concerns
about the hazardous wastes generated outside of the laboratories. For
this reason, we believe it is inappropriate to expand the scope of the
rule beyond laboratories at eligible academic entities.
B. Discussion of Definitions
All of the definitions that appear in today's final rule are only
for the purposes of 40 CFR part 262, Subpart K. Therefore, the
definitions are relevant only to the eligible academic entities that
have laboratories and choose to be subject to the provisions of today's
final rule. This section discusses: (1) Those definitions that were
proposed and have not changed since the proposal; (2) those definitions
that were proposed, but have been modified based on comments received
on the proposal; and (3) any new definitions that are being added,
based on modifications to the final rule or comments on the proposed
rule.
1. Definitions That Have Not Changed From the Proposed Rule
The following definitions have not been changed from the proposal.
In general, we received few comments on these definitions and the
comments we received on these definitions were supportive. Refer to the
preamble from the proposed rule for a detailed discussion of these
definitions (71 FR 29722).
College/University means a private or public, post-secondary,
degree--granting, academic institution, that is accredited by an
accrediting agency listed annually by the U.S. Department of Education.
Laboratory clean-out means an evaluation of the inventory of
chemicals and other materials in a laboratory that are no longer needed
or that have expired and the subsequent removal of those chemicals or
other unwanted materials from the laboratory. A clean-out may occur for
several reasons. It may be on a routine basis (e.g., at the end of a
semester or academic year) or as a result of a renovation, relocation,
or change in laboratory supervisor/occupant. A regularly scheduled
removal of unwanted material as required by Sec. 262.208 does not
qualify as a laboratory clean-out.
Laboratory worker means a person who handles chemicals and/or
unwanted material in a laboratory and may include, but is not limited
to, faculty, staff, post-doctoral fellows, interns, researchers,
technicians, supervisors/managers, and principal investigators. A
person does not need to be paid or otherwise compensated for his/her
work in the laboratory to be considered a laboratory worker.
Undergraduate and graduate students in a supervised classroom setting
are not laboratory workers.
Commenters pointed out that the definition of ``laboratory worker''
in the preamble to the proposed rule differed slightly from the
definition in the proposed regulatory text. In the definition included
the regulatory text, the last sentence of the definition included the
words ``Undergraduate and graduate'' when referring to students.
However, the definition included in the preamble discussion omitted the
words ``Undergraduate and graduate.'' Today, we are finalizing the
definition, as it was proposed, so that the final sentence reads,
``Undergraduate and graduate students in a supervised classroom setting
are not laboratory workers.''
It is worth noting that EPA would consider undergraduate or
graduate students in an unsupervised research setting to be laboratory
workers. Additionally, any student performing duties of a trained
professional, such as transferring unwanted materials and hazardous
wastes outside of a laboratory, would be considered a trained
professional, rather than a student.
2. Definitions That Have Changed From the Proposed Rule
This section discusses comments on the definitions that were
included in the proposed rule, as well as the changes that have been
made to these definitions in today's final rule.
Central accumulation area--The Agency proposed to define ``central
accumulation area'' as: an on-site hazardous waste accumulation area
subject to either Sec. 262.34(a) of this Part (large quantity
generators) or Sec. 262.34(d) of this Part (small quantity
generators). A central accumulation area at a college or university
that chooses to be subject to this subpart must also comply with Sec.
262.211 when accumulating unwanted material.
The Agency has made three minor changes to the proposed definition
of central accumulation area (CAA). First, we added a reference to the
hazardous waste accumulation area regulations that are applicable to
Performance Track members. There are currently three Performance Track
members that would likely qualify as eligible academic entities (the MD
Anderson Cancer Center, the University of Texas Medical Branch, and
Washington State University), and we did not intend to imply that these
eligible academic entities could not opt into Subpart K when we omitted
a reference to the hazardous waste accumulation area regulations of
Sec. 262.34 that pertain to them.
The second change is to make more complete the reference to the
hazardous waste accumulation area regulations for SQGs. The proposed
definition referred only to Sec. 262.34(d), which among other things,
allows 180 days or less for the on-site accumulation of hazardous
waste. However, SQGs also have the option of complying with Sec.
262.34(e), which allows them to accumulate hazardous waste on-site for
270 days or less, if they must send their hazardous waste more than 200
miles for treatment, storage or disposal. In
[[Page 72923]]
addition, SQGs are subject to Sec. 262.34(f), which states that if
more than a total of 6000 kg of hazardous waste is accumulated on-site,
the generator is a storage facility that is subject to the requirements
for TSDFs. The third change was made to reflect the expansion of the
applicability of the final rule beyond colleges and universities to
eligible academic entities.
The definition of ``central accumulation area'' in the final rule
is:
an on-site hazardous waste accumulation area subject to either Sec.
262.34(a) (or 262.34(j) and (k) for Performance Track members) of
this part (large quantity generators); or Sec. 262.34(d)-(f) of
this part (small quantity generators). A central accumulation area
at an eligible academic entity that chooses to be subject to this
subpart must also comply with Sec. 262.211 when accumulating
unwanted material and/or hazardous waste.
Laboratory--The Agency proposed to define ``laboratory'' as:
an area within a college or university where relatively small
quantities of chemicals and other substances are used on a non-
production basis for teaching or research purposes and are stored
and used in containers that are easily manipulated by one person. An
area where the same hazardous wastes are routinely generated, such
as photo processing, is not a laboratory.
In response to comments and as a result of the expansion of scope
of the final rule, the Agency has made several changes to the
definition of laboratory. Specifically, the Agency has made two changes
to reflect the expansion of scope, as discussed in section III.A of
today's preamble. The first is to change the phrase ``colleges and
universities'' to the phrase ``eligible academic entities.'' The second
change is to indicate that clinical diagnostic laboratories at teaching
hospitals are included within the scope of the final rule, as well as
teaching and research laboratories at all eligible academic entities.
This change is being made due to the expansion of the scope to include
teaching hospitals.
As discussed in section III.A.2 of today's preamble, the Agency
believes, and commenters have supported the conclusion, that it is the
research laboratories at a teaching hospital that are most similar to
laboratories at colleges and universities in their hazardous waste
generation patterns. However, we realize that it would be confusing and
difficult for institutions to implement today's rule if the research
laboratories at a teaching hospital were allowed to operate under
Subpart K, but diagnostic laboratories at the same teaching hospital
were not allowed to operate under Subpart K. In fact, some commenters
have indicated that in many cases at teaching hospitals, it is not
possible to distinguish a research laboratory from a clinical
laboratory because they share physical space and staff. Therefore, the
Agency has amended the definition of laboratory to include clinical
diagnostic laboratories at teaching hospitals so that unwanted
materials from all of the laboratories at a teaching hospital can be
managed under the same management standards.
In addition, in response to numerous comments, the Agency has
deleted the last sentence from the proposed definition of laboratory:
``An area where the same hazardous wastes are routinely generated, such
as photo processing, is not a laboratory.'' The reason the Agency
originally included this statement in the proposed definition is that
part of our basis for proposing this rule is that laboratories at
colleges and universities, unlike other types of hazardous waste
generators, generate many different types of wastes that vary over
time. However, based on the comments received, we believe it is no
longer appropriate to include this sentence for the following reasons.
First, comments indicated that some photo laboratories do, in fact,
generate many wastestreams that vary over time--this is especially true
when the photo laboratories are art studios where students may be
experimenting with different photographic techniques, such as
daguerreotype and calotype finishing.
Second, commenters pointed out that it is not unusual for an
individual research laboratory to generate the same hazardous waste
routinely for lengthy periods of time, as it focuses on a single area
of research. Additionally, commenters pointed out that teaching
laboratories can have an experiment that is part of the ongoing
curriculum and that generates the same hazardous wastes each semester.
We did not intend to create a system whereby some laboratories at the
eligible academic entity would be eligible and some would not, based on
the hazardous waste generation pattern of each individual laboratory.
To the contrary, for ease of implementation and enforcement, if the
eligible academic entity chooses to be subject to Subpart K, the Agency
is requiring that all laboratories covered under an individual EPA
Identification Number must operate under those provisions. Therefore,
we believe that it is sufficient that an eligible academic entity's
laboratories, as a category, rather than each laboratory, generate many
different wastes every day.
Third, based on comments and follow-up discussion, we now
understand that in many cases photo processing takes place alongside
teaching and research and that it would be difficult to regulate
differently the various laboratory operations, as the same students and
laboratory workers operate in both areas. Therefore, we have revised
the definition of laboratory to include photo laboratories.
The Agency also received many comments suggesting that the
definition of laboratory should include chemical stockrooms,
preparatory laboratories and other areas ancillary to the laboratory.
EPA agrees with these commenters that the definition of laboratory
should include chemical stockrooms and preparatory laboratories and
other areas that provide a support function to teaching or research
laboratories (or diagnostic laboratories at teaching hospitals). The
reason for this change is that the operation of these areas is well
integrated with the operation of the laboratories; that is, they are
often in close proximity to the laboratories, and share laboratory
personnel, and thus should properly be viewed as part of the
laboratory. Chemical stockrooms that are not associated with laboratory
operations would not, however, be eligible to operate under Subpart K.
For example, a chemical stockroom that stores cleaning chemicals or
pesticides for maintenance at the facility would not be providing a
support function to a laboratory and would not be considered a
laboratory that is allowed to operate under Subpart K.
The Agency also agrees with commenters that field laboratories
should be considered laboratories because we agree that field
laboratories, like other laboratories under this rule, exhibit similar
hazardous waste generation patterns. By considering field laboratories
as laboratories, laboratory workers would thus only need to operate
under one set of hazardous waste regulations. However, if the field
laboratory is off-site and/or has a separate EPA Identification Number
from the rest of the campus, the eligible academic entity must notify
separately that the field laboratory will be subject to Subpart K. In
the proposal, we stated that we expected many field laboratories to be
CESQGs, which under the proposal were not eligible to opt into Subpart
K. Commenters confirmed that many field laboratories are, indeed,
CESQGs. Therefore, with the modifications that the Agency is making in
today's rule regarding the eligibility of CESQGs and the definition of
``laboratory,'' field laboratories, whether they are located on-site or
off-site from the rest of the eligible academic entity, would be
allowed to operate under the
[[Page 72924]]
Subpart K requirements. See Section III.C.9 regarding the
implementation of Subpart K at CESQG sites.
Furthermore, a number of commenters agreed with the Agency's
position that art studios at eligible academic entities should be
considered laboratories, despite the fact that they are rarely referred
to as laboratories. These commenters confirmed that art studios have
similar hazardous waste generation patterns as scientific laboratories,
and, like other classroom settings, have students generating much of
the hazardous waste. Therefore, the definition has been changed to
clarify that the Agency considers art studios to be laboratories for
the purposes of Subpart K.
Finally, we proposed that a ``laboratory'' is ``an area within a
college or university * * *'' We received comments suggesting that we
modify the definition of laboratory to be ``an area under the
administrative or managerial control of a college or university * * *''
However, this terminology is not currently used or defined under RCRA.
The Agency agrees that the definition should be more specific and we
have incorporated into today's definition of ``laboratory'' a similar
concept as suggested by the commenters. However, we have relied on
terminology that is already used and defined in RCRA. Specifically,
under today's final rule, a laboratory is ``an area that is owned by an
eligible academic entity * * *'' Therefore, in today's preamble and
final rule, when we use the term laboratory, we are referring to
laboratories that are owned by an eligible academic entity.
To be eligible to opt into today's final rule, an institution first
must meet the definition of ``eligible academic entity.'' That is, it
must be a college or university, or a non-profit research institute or
teaching hospital that is owned by or has a formal written affiliation
agreement with a college or university, as these terms are defined in
today's rule. Second, an eligible academic entity may opt into Subpart
K for the laboratories that it owns. Therefore, government facilities
with laboratories that are operated by colleges and universities (such
as many of the Department of Energy's laboratories) would not be
eligible to opt into Subpart K, because the government facility is not
an eligible academic entity and the laboratories are not owned by an
eligible academic entity.
For the reasons discussed above, today's final rule defines
``laboratory'' as follows:
an area owned by an eligible academic entity where relatively
small quantities of chemicals and other substances are used on a
non-production basis for teaching or research (or diagnostic
purposes at a teaching hospital) and are stored and used in
containers that are easily manipulated by one person. Photo
laboratories, art studios, and field laboratories are considered
laboratories. Areas such as chemical stockrooms and preparatory
laboratories that provide a support function to teaching or research
laboratories (or diagnostic laboratories at teaching hospitals) are
also considered laboratories.
Reactive acutely hazardous unwanted material--The Agency proposed
to define ``reactive acutely hazardous unwanted material'' as:
an unwanted material that is one of the acutely hazardous
commercial chemical products listed in Sec. 261.33(e) for
reactivity and toxicity.
At proposal, the Agency intended to maintain more stringent
regulations in the laboratory for the ``P-listed'' commercial chemical
products that are listed for reactivity because of their high potential
for causing immediate harm. In the preamble to the proposed rule, we
provided a list of seven commercial chemical products that we believed
met this definition:
(1) P006 (CAS Number: 20859-73-8) Aluminum phosphide;
(2) P009 (CAS Number: 131-74-8) Ammonium picrate; Pheno, 2,4,6-
trinitro-, ammonium salt;
(3) P042 (CAS Number: 51-43-4) 1,2-Benzenediol, 4-[1-hydroxy-2-
(methylamino)ethyl];
(4) P065 (CAS Number: 628-86-4) Fulminic Acid, mercury(2+) salt;
Mercury fulminate;
(5) P081 (CAS Number: 55-63-0) Nitroglycerine; 1,2,3-Propanetriol,
trinitrate;
(6) P112 (CAS Number: 509-14-8) Methane, tetranitro-;
Tetranitromethane; and
(7) P122 (CAS Number: 1314-84-7) Zinc phosphide
Zn3P2 when present at concentrations greater than
10%.
Many commenters correctly pointed out that P042 (CAS Number 51-43-
4) 1,2-Benzenediol, 4-[1-hydroxy-2-(methylamino)ethyl]-, which is
actually Benzenediol, 4-[1-hydroxy-2-(methylamino)ethyl]-, (R)-, (and
is also known as epinephrine) is not listed on the ``P-list'' because
of reactivity. They pointed out that the (R)- following the listing for
P042 refers to the R enantiomer of the chemical and does not refer to
the reactivity characteristic. The Agency acknowledges that the
commenters are, indeed, correct, and if epinephrine were an unwanted
material in a laboratory, it would not meet the definition of reactive
acutely hazardous unwanted material. EPA's acknowledgment is simply a
matter of clarification and does not affect the definition as
proposed.\3\
---------------------------------------------------------------------------
\3\ The Agency has recently issued a memo clarifying that the
scope of the P042 listing does not include epinephrine salts (see
memo from Hale to EPA Regions, October 15, 2007, RCRA Online
14778).
---------------------------------------------------------------------------
Many commenters also correctly pointed out that three of the
chemicals on the list above are listed only for reactivity (P009, P081,
P112), and not for toxicity and, therefore, do not meet the definition
of reactive acutely hazardous unwanted material, as proposed. While the
commenters are correct that P009, P081, and P112 are listed only for
reactivity, we believe that the proposal was clear as to the Agency's
intent--that a ``reactive acutely hazardous unwanted material''
includes those chemicals included on the P-list for reactivity, and
that some of those chemicals were listed for toxicity, as well. The
wording of the proposed definition, however, did not convey that
clearly. Therefore, we are revising the definition of ``reactive
acutely hazardous unwanted material'' to be consistent with the intent
discussed in the preamble, by omitting the reference to toxicity, as
follows:
an unwanted material that is one of the acutely hazardous
commercial chemical products listed in Sec. 261.33(e) for
reactivity.
Trained professional--The Agency proposed to define a ``RCRA-
trained individual'' as:
a person who has completed the applicable RCRA training
requirements of Sec. 265.16 for large quantity generators, or Sec.
262.34(d)(5)(iii) for small quantity generators. A RCRA-trained
individual may be an employee of the college/university or may be a
contractor or vendor.
The Agency is replacing the term ``RCRA-trained individual'' with
``trained professional.'' This does not affect the substance of the
definition, but is merely a change in terminology since Subpart K is
part of the RCRA hazardous waste regulations and including ``RCRA'' as
part of the term is unnecessary and may, in fact, imply that anyone who
is trained under Subpart K is not ``RCRA'' trained.
In addition, because the final rule has been expanded to include
eligible academic entities that include CESQG sites or that are
themselves CESQGs, we have added to the definition of ``trained
professional'' a requirement that a trained professional at an eligible
academic entity that is a CESQG must be trained in accordance with the
SQG training requirements of
[[Page 72925]]
Sec. 262.34(d)(5)(iii). As discussed in more detail in Section III.C.4
of today's preamble, the hazardous waste determination and on-site
transfers of unwanted materials outside the laboratory must be
performed by trained professionals (also see Sec. 262.207). The
proposed definition of ``RCRA-trained individual'' (which is re-named
``trained professional'' in today's final rule) relied on references to
the existing generator training requirements, which vary based on
generator status. The existing CESQG regulations, however, do not
include training requirements. It would be counter to the intent of
today's rule to allow CESQGs opting into Subpart K to have untrained
personnel making the hazardous waste determination and transferring
unwanted materials outside the laboratory. Therefore, today's final
rule requires that trained professionals at eligible academic entities
that are CESQGs must be trained in accordance with the SQG training
requirements.
Finally, because the applicability of the final rule has been
broadened beyond colleges and universities, the Agency has modified the
definition of ``trained professional'' accordingly, as follows:
a person who has completed the applicable RCRA training
requirements of Sec. 265.16 for large quantity generators, or is
knowledgeable about normal operations and emergencies in accordance
with Sec. 262.34(d)(5)(iii) for small quantity generators and
conditionally exempt small quantity generators. A trained
professional may be an employee of the eligible academic entity or
may be a contractor or vendor who meets the requisite training
requirements.
Unwanted material--The Agency proposed to define ``unwanted
material'' as:
means any chemical, mixtures of chemicals, products of
experiments or other material from a laboratory that are no longer
needed, wanted or usable in the laboratory and that are destined for
hazardous waste determination by a RCRA-trained individual. Unwanted
material includes reactive acutely hazardous unwanted materials.
Unwanted material includes material that may eventually be
determined not to be solid waste pursuant to Sec. 261.2 or a
hazardous waste, pursuant to Sec. 261.3.
The Agency has made two changes to the definition of unwanted
material. The first is to reflect the change from the term ``RCRA-
trained individual'' to ``trained professional.'' The second change is
to reflect the additional flexibility that we have added to the final
rule that allows an eligible academic entity the option of using
another ``equally effective term'' in lieu of the term ``unwanted
material.'' In the preamble and the regulations, the Agency continues
to use the term, ``unwanted material,'' but an eligible academic entity
that opts into Subpart K may use another term if it chooses, provided
the term is used consistently and is identified in its LMP. Regardless
of the term that is used, however, it will have the same meaning as
found in the definition for unwanted material, and it will be subject
to the same requirements under Subpart K. This additional flexibility
allowed for using another term in lieu of ``unwanted material'' is
discussed in more detail in preamble section III.C.2 (also see Sec.
262.206).
For the reasons discussed above, today's final rule defines
``unwanted material'' as:
any chemical, mixtures of chemicals, products of experiments or
other material from a laboratory that is no longer needed, wanted or
usable in the laboratory and that is destined for hazardous waste
determination by a trained professional. Unwanted materials include
reactive acutely hazardous unwanted materials and materials that may
eventually be determined not to be solid waste pursuant to Sec.
261.2, or a hazardous waste pursuant to Sec. 261.3. If an eligible
academic entity elects to use another equally effective term in lieu
of ``unwanted material,'' as allowed by Sec. 262.206(a)(1)(i), the
equally effective term has the same meaning and is subject to the
same requirements as ``unwanted material'' under this subpart.
3. Definitions That Are New
The definitions discussed in this section of today's preamble are
those definitions that have been developed and added since the
proposal. All new definitions, except one, pertain to the expansion of
the scope to other eligible academic entities.
Eligible academic entity--Today's final rule defines ``eligible
academic entity'' as:
a college or university, or a non-profit research institute that
is owned by or has a formal written affiliation agreement with a
college or university, or a teaching hospital that is owned by or
has a formal written affiliation agreement with a college or
university.
Since we have expanded the scope of the final rule to allow non-
profit research institutes and teaching hospitals that are either owned
by or have a formal written affiliation agreement with a college or
university to opt into Subpart K, we believe it is appropriate to add a
new term to refer to these types of institutions collectively.
Incorporated in the definition above is the concept that teaching
hospitals and non-profit research institutes must be either owned by or
have a formal written affiliation agreement with a college or
university. As explained in section III.A. of today's preamble, we are
requiring a formal written affiliation agreement with a college or
university because the affiliation indicates that an entity is
integrated with the college or university and that the entity has a
significant transient student presence. Our research also demonstrated
that in some instances, a teaching hospital or non-profit research
institute is owned by a college or university. We assume that if a non-
profit research institute is owned by a college or university it would
not have a formal written affiliation agreement. Similarly for teaching
hospitals, we assume that a formal written affiliation agreement,
defined below for teaching hospitals as a master affiliation agreement
and program letter of agreement, would not exist when the teaching
hospital is owned by the college or university. Thus, this definition
allows teaching hospitals and non-profit research institutes that are
located on-campus or off-campus to opt into this rule, provided they
are owned by or have a formal written affiliation agreement with a
college or university.
Formal written affiliation agreement--Today's final rule defines
``formal written affiliation agreement'' as:
for a non-profit research institute means a written document that
establishes a relationship between institutions for the purposes of
research and/or education and is signed by authorized
representatives, as defined by Sec. 260.10, from each institution.
A relationship on a project-by-project or grant-by-grant basis is
not considered a formal written affiliation agreement. A formal
written affiliation agreement for a teaching hospital means a master
affiliation agreement and program letter of agreement, as defined by
the Accreditation Council for Graduate Medical Education, with an
accredited medical program or medical school.
For non-profit research institutes, ``formal written affiliation
agreement'' is defined in a manner to reflect the importance of having
an official legal written agreement documenting the affiliation,
partnership, collaboration, or association between the non-profit
research institute and a college or university. In order for a non-
profit research institute to be eligible to opt into Subpart K, it must
have this documentation.
The Agency is requiring that this agreement be signed by authorized
representatives with the authority to obligate the institution as a
whole. The term ``authorized representative'' is already defined in 40
CFR 260.10 as ``the person responsible for the overall
[[Page 72926]]
operation of a facility or an operational unit (i.e., part of a
facility), e.g., the plant manager, superintendent, or person of
equivalent responsibility.'' The Director or Chief Executive Officer
(CEO) of a non-profit research institute and the President or Dean of a
college or university, among others, would be considered authorized
representatives.
The Agency also stresses that the formal written affiliation
agreement must be between the institutions: The non-profit research
institute and the college or university. This agreement is intended to
represent a long-standing collaboration between the two institutions
rather than simply a relationship between two principal investigators
or researchers, working jointly for the duration of a particular
project or grant. An example of what we would consider to be an
affiliation at the institutional level includes being a member of a
research consortium with colleges and universities. For instance, the
Southwest Research Institute is a member of the Southwest Research
Consortium which combines the research capabilities of nine research
and educational organizations, including the University of Texas at San
Antonio, Trinity University, and St. Mary's University. Another example
of what we would consider an institutional-level affiliation agreement
is when there are joint faculty appointments on a departmental or other
large-scale basis. For instance, Seattle Biomedical Research and the
University of Washington have a formal affiliation where all
researchers at Seattle Biomedical Research are also faculty members at
the University of Washington. A third example of what we would consider
an institutional-level affiliation agreement is when a non-profit co-
sponsors degrees with a college or university. For instance, Fred
Hutchinson Cancer Research Center and the University of Washington
jointly administer or co-sponsor a Ph.D. program in Molecular and
Cellular Biology. Thus, EPA developed this definition to be broad to
encompass the various working situations that we understand to be
currently in existence.
For the definition of formal written affiliation agreement for
teaching hospitals, EPA researched definitions and terms to describe
the concept of ``affiliated teaching hospitals,'' such as ``academic
health centers,'' ``major teaching hospital,'' and ``university
teaching hospital.'' We quickly discovered that an industry-wide
standard term for referring to teaching hospitals affiliated with
colleges and universities does not exist. Without a standard
definition, we looked into how college or university medical schools
are linked with hospitals. We learned that the ACGME has established a
mechanism for medical schools to send residents to hospitals that are
not part of the medical school. In such cases, ACGME requires a master
affiliation agreement and a program letter of agreement between the
medical school and the teaching hospital. Since the ACGME defines these
two types of agreements and requires them in certain arrangements
between teaching hospitals and colleges and universities, and since the
industry already follows and understands these agreements, we have
decided to refer to these agreements in the definition of ``formal
written affiliation agreement'' for teaching hospitals in this rule.
Non-profit research institute--Today's final rule defines ``non-
profit research institute'' as:
an organization that conducts research as its primary function and
files as a non-profit organization under the tax code of 26 U.S.C.
501(c)(3).
EPA's definition, which refers to a well-known, existing definition
under the tax code of 26 U.S.C. 501(c)(3), is intended to make the
definition as clear as possible, as well as easy for implementers and
inspectors to verify. We are emphasizing through this definition that
not every non-profit organization is eligible to opt into the Subpart K
requirements. Rather, the non-profit must conduct research as its
primary function. We require this because, as explained in sections
II.B and III.A of this preamble, research laboratories, as a category
of laboratories, have a hazardous waste generation pattern that fits
within the rationale of today's final rule. Further, as discussed
above, the non-profit research institute must either be owned by a
college or university or have a formal written affiliation agreement
with a college or university in order to be eligible to opt into this
rule.
Teaching hospital--Today's final rule defines ``teaching hospital''
as:
a hospital that trains students to become physicians, nurses or
other health or laboratory personnel.
EPA believes it is important to capture the basic purpose of a
teaching hospital in this definition: training students in medicine. A
teaching hospital will train nursing students, medical residents,
technicians, and others in the laboratories at the hospital's
facilities ensuring that teaching hospitals fit within a key aspect of
the rationale of today's rule: a significant transient student presence
in the laboratories. In addition, the teaching hospital must either be
owned by a college or university or have a formal written affiliation
agreement with a college or university in order to be eligible to opt
into this rule.
Working container--The Agency did not include a definition of
``working container'' in the proposed rule. In the preamble to the
proposed rule, however, we did discuss a possible definition for
working container and solicited comment on whether the final rule
should include such a provision. The definition of ``working
container'' in the preamble to the proposed rule was:
A small container (of one gallon or less), managed under the control
of a laboratory worker and used at a bench or work station, whose
contents are emptied into a container of unwanted material at the
end of the procedure.
There generally was broad support among commenters for including a
definition of working container in the final rule. A number of
commenters suggested, however, that the Agency increase the maximum
size limit of a working container to five gallons. Since one gallon is
equal to 3.78 liters, the one-gallon limit discussed in the preamble to
the proposed rule would have precluded the use of four-liter solvent
bottles as working containers. The Agency believes that a 5-gallon
limit for working container is too large to be appropriate despite
suggestions from commenters. Given that water weighs 8.34 pounds per
gallon, a full 5-gallon container would weigh in excess of 40 pounds,
which may be pushing the limits of what can be easily manipulated by
one person (without the aid of equipment or other devices). This is
especially true considering that the contents of many working
containers will be transferred to other containers for disposal.
Nevertheless, the Agency does agree that since 4-liter solvent
bottles are commonly used as collection containers in laboratories and
are easily manipulated by one person, even if full, the Agency believes
a two-gallon limit for working containers is more appropriate.
Furthermore, two gallons is consistent with an interpretive letter
signed by both Region I and the State of Massachusetts (September 2004;
a copy of which is in today's docket), that originally introduced the
concept of a working container under RCRA. Therefore, in response to
these comments, the Agency has increased the maximum size of a working
container to two gallons. The Agency is not limiting the type of
containers that can be used as working containers. Thus, the types of
containers that we would expect to be
[[Page 72927]]
used as working containers are beakers, flasks, bottles, and other
types of containers typically used in a teaching or research
laboratory.
The Agency also has deleted from the definition of working
container that appeared in the preamble to the proposed rule the
requirement for the contents of a working container to be emptied into
a container of unwanted material at the end of a procedure. We believe
it is more appropriate to include any management standards for working
containers in Sec. 262.206(b), which addresses the management
standards for all containers.
Finally, the Agency has added to the definition that working
containers are those that are used to collect ``unwanted material.''
The Agency believes that this modification is necessary in order to
distinguish ``working containers'' from other containers used during an
experiment or procedure that may contain product and are not subject to
the RCRA Subtitle C regulations. See section III.C.3 of today's
preamble for a detailed discussion of the container management
standards that apply to working containers (also see Sec. 262.206).
The definition of ``working container'' in today's final rule is:
a small container (i.e., two gallons or less) that is in use at
a laboratory bench, hood, or other work station, to collect unwanted
material from a laboratory experiment or procedure.
C. Specific Requirements of the Alternative Regulations
Today's final Subpart K regulations will allow laboratories at
eligible academic entities to send unwanted materials that are
generated in the laboratory to an on-site CAA or an on-site TSDF before
making the hazardous waste determination for the unwanted materials, or
to make the hazardous waste determination in the laboratory prior to
its removal. However, the eligible academic entity must meet certain
requirements such as notifying, complying with performance-based
standards in the laboratory, and developing and implementing an LMP
with nine required elements as described in the sections below.
1. Notification
Because today's final rule provides eligible academic entities the
option to manage their hazardous wastes from laboratories under the
existing generator regulations or their laboratories' unwanted
materials under today's provisions, it is important that EPA, or the
authorized State, know to which set of regulations an eligible academic
entity's laboratories are subject. Therefore, this rule requires that
an eligible academic entity choosing to manage its unwanted materials
in compliance with the alternative set of generator requirements being
promulgated today submit a one-time notification to the appropriate EPA
Regional Administrator or, when appropriate, State Director in
authorized States that have adopted the final rule. Should an eligible
academic entity decide not to opt into Subpart K, it will continue to
operate under the existing generator regulations and there is no need
to notify.
EPA proposed that the notification be provided by letter, but
requested comment on whether the RCRA Subtitle C Site Identification
Form (EPA Form 8700-12; or Site Identification Form) should be used to
provide this notice, and whether the form should be modified to include
a checkbox to indicate that a college or university is choosing to be
subject to Subpart K. One commenter pointed out the advantage to using
a letter would be to allow a college or university to submit one notice
for several sites with different EPA Identification Numbers. However,
most commenters supported the option of using the Site Identification
Form to notify EPA (or the authorized State) regarding their decision
to manage laboratory hazardous waste under the Subpart K requirements.
The commenters noted that the regulated community is already familiar
with this form and the form requires much of the necessary information
required by the notification requirement that was proposed under
Subpart K, such as name of the facility, address, and EPA
Identification Number. Further, most commenters agreed that by using
the Site Identification Form, there would be increased consistency in
reporting. When eligible academic entities notify by Site
Identification Form, the information is included in the RCRAInfo
database, which provides an additional benefit of being able to monitor
the extent to which eligible academic entities are taking advantage of
this new Subpart.
Based on these comments, EPA is requiring the use of the Site
Identification Form for notification of opting into, as well as
withdrawing from Subpart K. In order to use this form for this purpose,
we will be modifying the Site Identification Form to include a checkbox
for an eligible academic entity to indicate what type of entity it is
(i.e., a college or university, or a teaching hospital or a non-profit
research institute that is either owned by or has a formal written
affiliation agreement with a college or university) and that it is
choosing to be subject to the 40 CFR part 262, Subpart K
requirements.\4\ There is also a checkbox for an eligible academic
entity to indicate that it is withdrawing from the Subpart K
requirements, if after having decided to be subject to Subpart K, it
determines it would prefer to be regulated under the existing hazardous
waste generator standards.
---------------------------------------------------------------------------
\4\ If an eligible academic entity chooses to opt into Subpart K
prior to the completion of the revisions to the Site Identification
Form (8700-12), it should indicate in the comment field of the form
what type of eligible academic entity it is and that it is opting
into Part 262 Subpart K.
---------------------------------------------------------------------------
Since we are requiring the use of the Site Identification Form, an
eligible academic entity will have to submit one Site Identification
form for each EPA Identification Number, or site as defined by RCRA.\5\
Thus, if the eligible academic entity is composed of multiple sites
(i.e., it has multiple EPA Identification Numbers) and all its sites
will operate under Subpart K, separate Site Identification Forms must
be submitted for each site. For example, if an urban college or
university composed of multiple sites divided by public roads wants all
of its laboratories to operate under Subpart K, the college or
university must notify the appropriate authority that each of its sites
is going to be subject to 40 CFR part 262, Subpart K by submitting a
Site Identification Form for each distinct site (i.e., EPA
Identification Number) opting into today's rule.
---------------------------------------------------------------------------
\5\ RCRA 40 CFR part 260.10 defines, ``on-site'' to mean the
same or geographically contiguous property which may be divided by
public or private right-of-way provided the entrance and exit
between the properties is at a cross-roads intersection, and access
is by crossing as opposed to going along, the right-of-way. Non-
contiguous properties owned by the same person, but connected by a
right-of-way which he controls and to which the public does not have
access, is also considered on-site property. For further
interpretations, see Memo, Shapiro to Wojdyla; May 1, 1996, (RCRA
Online 14031), a copy of which is in today's docket.
---------------------------------------------------------------------------
As indicated in the example above, an eligible academic entity can
be composed of multiple sites because of the way RCRA defines ``on-
site.'' We believe that where this is the case, the eligible academic
entity will choose to have all its sites at a single campus opt into
Subpart K. This would allow eligible academic entities to have a
unified institution-wide hazardous waste management system for all its
laboratories on campus, which is one of the highest priorities for
Subpart K cited by the academic community in their public comments.
However, since a campus or institution opts in for each individual
site, via EPA Identification Number, there is nothing in today's rule
[[Page 72928]]
that requires an eligible academic entity to have all of its separate
sites opt into the Subpart K requirements. Thus, by not requiring that
all the sites with different EPA Identification Numbers at an eligible
academic entity opt into this rule together, we are providing
additional flexibility for the eligible academic entity to determine
the best hazardous waste management practices for its facility.
Teaching hospitals and non-profit research institutes, as defined
in this rule, may be located on a college or university campus or
located nearby. In rare instances, they may even be located in a
separate State from the college or university with which they are
affiliated. Since eligible academic entities opt in by filling out the
Site Identification Form, a teaching hospital or non-profit research
institute that has a separate EPA Identification Number from a college
or university must decide independently whether it wants to opt into
today's final rule. When a teaching hospital or non-profit research
institute is owned by or formally affiliated with a college or
university and located on campus, it does not have to opt in when the
college or university opts in, if it is a separate site or has a
separate EPA Identification Number, although, as noted above, we
believe that teaching hospitals and non-profit research institutes will
likely opt into Subpart K, if the colleges or universities with which
they are affiliated opt in, to create a more integrated laboratory
waste management system on campus.
As explained above, while not all the sites of an eligible academic
entity must choose to be subject to today's rule, we continue to stress
that all laboratories owned by the eligible academic entity within one
EPA Identification Number must comply with the same set of regulations.
In other words, the alternative approach cannot be applied to only one
or a few laboratories within that EPA Identification Number, but rather
must apply to all laboratories or no laboratories. The reason for this
is that EPA believes it would be difficult for an eligible academic
entity to keep track of which set of generator regulations apply to
which laboratory or group of laboratories. Moreover, it would be
extremely difficult, if not impossible, for the States or Regions to
keep track of the applicable set of regulations if, within a single EPA
Identification Number, different laboratories were choosing to be
regulated under different requirements. No mechanism currently exists
at EPA or the States to track such distinctions.
The required notice must be submitted to the appropriate EPA
Regional Administrator (or State Director in authorized States that
adopt the final rule). At all times, an eligible academic entity's
laboratories must comply with either the existing hazardous waste
generator regulations or the Subpart K regulations. Once an eligible
academic entity notifies by Site Identification Form that it is opting
into Subpart K, EPA expects that the site will be in compliance with
the Subpart K requirements. Therefore, we strongly suggest that an
eligible academic entity prepare its LMP and ready its facilities for
the Subpart K laboratory hazardous waste management system before it
submits a Site Identification Form to the EPA Regional Authority (or
State Director in authorized States). Further, an eligible academic
entity may, for example, want to train its employees in the Subpart K
labeling requirements and container management standards before
notifying. In addition, an eligible academic entity may want to contact
its hazardous waste vendors to prepare the vendor for the eligible
academic entity's switch to Subpart K.
It is also possible that after an eligible academic entity has
chosen to manage its unwanted materials under the Subpart K regulations
and has gained some experience with the program, it may decide that
this approach is not meeting its needs, and that it would prefer to
return to regulation under the now existing applicable generator
regulations, 40 CFR part 262 (or 40 CFR 261.5 for CESQGs). Under this
final rule, an eligible academic entity that chooses to end its
participation in the Subpart K program would be required to submit
another Site Identification Form to the EPA Regional Administrator (or
State Director in authorized States) checking the box for withdrawing
from 40 CFR part 262, Subpart K. Then, the eligible academic entity's
laboratories would no longer be subject to Subpart K and would be
subject to the existing applicable generator regulations. Once the
Agency receives the Site Identification Form from the eligible academic
entity indicating that it is withdrawing from the Subpart K program,
the Agency expects that the eligible academic entity will be in
compliance with the 40 CFR part 262 applicable generator requirements
(or 40 CFR 261.5 for CESQGs).
Finally, EPA sought comment on whether the Regional Administrator
(or State Director in authorized States) should provide the eligible
academic entity with a written receipt of the one-time notice before it
could manage its unwanted materials in accordance with the Subpart K
requirements. Most commenters did not want to wait for EPA or the State
to provide a written receipt of the one-time notice before managing
their unwanted materials under these alternative generator
requirements; they argued that it would cause delay and confusion.
Other commenters pointed out that many States already respond in
writing when the Site Identification Form is received. Therefore, we
are not requiring that the Regional Administrator (or State Director in
authorized States) provide a written receipt of the one-time notice
before the eligible academic entity can manage its unwanted materials
under the Subpart K requirements. (For more information on how CESQGs
notify, see section III.C.9 and Sec. 262.203.)
2. Labeling Standards
Because today's rule provides laboratories owned by eligible
academic entities with flexibility in where and when to make the
hazardous waste determination, labeling requirements for unwanted
materials in the laboratory are needed. For example, labeling is
critical to ensure that non-laboratory personnel, such as firefighters
can quickly ascertain the hazardous materials that are in the
laboratory in case of an emergency. In order to provide the necessary
information to laboratory personnel, EH&S staff, inspectors, emergency
responders, and others, today's rule includes performance-based
labeling requirements that are informative, yet flexible to fit the
varying situations at eligible academic entities.
The labeling requirements in the proposed rule consisted of two
sets of performance-based labels. First, the proposal required that a
label be affixed to or physically accompany the container of unwanted
material. This label was intended to convey the most essential
information that one needs to know about the contents of the container
in an emergency situation. It also was intended to convey the notion
that ``unwanted material'' was no longer wanted in the laboratory.
Thus, the proposal required that this label include the words
``unwanted material,'' as well as sufficient information to alert
emergency response personnel to the container's hazards or contents.
The second part of the proposed labeling requirements provided
flexibility by allowing information to be ``associated with the
container.'' We proposed that this label contain sufficient information
for the RCRA-trained professional (which has been changed to trained
professional in today's final rule) to make the hazardous waste
determination. At a minimum, the information ``associated'' with
containers of unwanted materials
[[Page 72929]]
was intended to ensure that a hazardous waste determination of the
contents can be made by a trained professional. Additionally, the
proposal required that the date when the unwanted materials first began
accumulating in the container be associated with the container, so that
EH&S staff or other trained professionals would know when to remove the
containers of unwanted materials from the laboratory. The preamble to
the proposed rule indicated that the accumulation start date and
information sufficient to make a hazardous waste determination could be
on the label that is affixed to or physically accompanies the
container, but must, at a minimum, be associated with the container.
In the preamble to the proposed rule, we discussed examples of how
the required information might be ``associated'' with a container. One
example is that laboratory personnel could number containers of
unwanted material and create an accompanying spreadsheet containing
sufficient information to identify the material for each numbered
container of unwanted material that would be given to the trained
professional to make the hazardous waste determination. Another example
is that laboratories could affix a bar code to each container of
unwanted material that when scanned would provide the necessary
information to make the hazardous waste determination of the unwanted
material. Alternatively, laboratory personnel might choose to include a
printed inventory of the unwanted materials and the associated
information for each container that would provide the necessary
information for a trained professional to make the hazardous waste
determination.
The Agency received a large number of comments from academia in
support of the performance-based labeling requirements in lieu of
prescriptive requirements. In keeping with the original intent of the
rulemaking, today's final rule maintains the performance-based two-
tiered labeling structure; however, we have revised the labeling
requirements to take into account public comments received on the
proposal.
Specifically, we have revised the proposed labeling requirements in
today's final rule to clarify that the first part of the labeling
requirement requires the label to be ``affixed or attached to'' the
container of unwanted material rather than be ``affixed to or
physically accompany'' the container. We believe this modified language
provides clarity and ensures that, during the accumulation period in
the laboratory or during on-site transfer, the identifying information
will not be inadvertently separated from a container of unwanted
material and thus the contents of any container can be quickly
identified in an emergency situation. Examples of labels that are
``affixed or attached to'' containers of unwanted materials are
stickers that have been affixed on the container by adhesive, or labels
that are attached to a small container of unwanted material (i.e., too
small for an adhesive label) by wire or a piece of tape.
Many commenters expressed concern about the proposed requirement to
label containers with the words ``unwanted material,'' preferring a
more flexible labeling requirement. As one commenter stated, ``The
purpose of adding an additional label [unwanted material] to a reagent
chemical container, for instance, is to differentiate it from others
that a lab still wants or needs in their work so that the pickup crew
or contractor knows which containers to take. The exact terminology is
not important to meeting this goal.'' In response to this and other
similar comments, in the final rule, we are requiring that containers
be labeled with the words ``unwanted material'' or another ``equally
effective term'' that is used consistently by the eligible academic
entity and is identified in Part I of the eligible academic entity's
LMP. Examples of an ``equally effective term'' include, but are not
limited to, ``laboratory waste'' or ``chemical lab waste.'' We believe
this approach is responsive to the comments in that it provides each
eligible academic entity with flexibility, yet conveys the basic
information that the material is no longer needed or wanted in the
laboratory. To this end, if an eligible academic entity elects to use
another equally effective term in lieu of ``unwanted materials,'' that
term must address and have the same meaning as ``unwanted material,''
and is subject to the same requirements in Subpart K for ``unwanted
material.'' Additionally, if an eligible academic entity chooses to use
an equally effective term instead of ``unwanted materials,'' the
eligible academic entity must use the term consistently in all its
laboratories that are covered by its LMP. It would not be acceptable
for each laboratory at an eligible academic entity to be free to use
its own term of choice because the use of different terms at the same
eligible academic entity would cause confusion for implementers and
enforcers.
A number of commenters opposed the proposed requirement that the
label that is ``affixed to or physically accompany'' the container
provide sufficient information to alert emergency responders to the
contents or the hazards of the container, arguing that the requirement
is unnecessary and burdensome.\6\ EPA disagrees with these comments and
believes that maintaining this information is necessary to protect the
safety of workers, students, emergency responders, and others that may
come into contact with containers of unwanted materials. For safety
purposes, emergency responders need to have a quick way to assess the
contents of a container. However, we understand that at least part of
the concern was the use of the term ``hazards,'' in that it caused some
confusion among commenters, many of whom thought that the Agency was
proposing to require Department of Transportation (DOT) hazard classes
or National Fire Protection Agency (NFPA) chemical hazard labels to be
on the label that must be ``affixed to or attached to'' the container.
This was not the Agency's intent. To address this misunderstanding in
today's final rule, we have clarified the requirement that the label
contain sufficient information to alert emergency responders to the
contents of the container. This performance-based standard could be met
by including information, such as the name of the chemical(s) in the
container or, alternatively, a descriptive phrase, such as ``inorganic
solvents,'' ``halogenated organic solvents,'' or ``water reactive
chemicals.'' This requirement is flexible, yet provides sufficient
information to emergency responders in an easily understandable manner
that would allow them to ascertain the potential dangers associated
with the contents of containers in the laboratory, while being
protective of health and safety.
---------------------------------------------------------------------------
\6\ As discussed previously, the requirement that the label be
``affixed to or physically accompany'' the container has been
changed in the final rule to that the label must be ``affixed or
attached to'' the container.
---------------------------------------------------------------------------
As proposed, today's final rule requires that each container of
unwanted material must have associated with the container the date that
the unwanted material begins accumulating and information sufficient to
make a hazardous waste determination. We are allowing this information
to be ``associated with'' the container, as opposed to requiring that
it be ``affixed or attached to'' the container, in order to facilitate
the use of technology in conveying this information. This could be done
using an electronic spreadsheet, a bar code, or some other printed
inventory of containers (see previous examples of ``affixed or attached
to'' or
[[Page 72930]]
``associated'' labels). We also point out that this labeling
requirement maintains the flexibility of the proposed rule, such that
an eligible academic entity can use the container labeling approach
that works best for the institution. That is, while it is acceptable to
have the accumulation start date and information sufficient to make a
hazardous waste determination ``associated with'' the container, some
eligible academic entities may prefer to have all required container
labeling information in a single place. Therefore, it is also
acceptable to place the accumulation start date and the information
sufficient to make a hazardous waste determination on the label that is
``affixed or attached to'' the container. We have reworded the
container labeling regulations accordingly to reflect the intended
flexibility and to indicate that, at a minimum, the accumulation start
date and information sufficient to make a hazardous waste determination
must be ``associated with'' the container, but that it can be on the
label that is ``affixed or attached'' to the container, if that is
preferred.
Many commenters had concerns about the burden imposed by the
requirement to associate the accumulation start date with containers of
unwanted material because it is not required in the current satellite
accumulation area regulations. We maintain that this requirement is
necessary to ensure that accumulation time limits in the laboratory are
complied with for containers of unwanted material. Some commenters
argued that alternatively, EPA should add a requirement to log regular
removals from each laboratory in lieu of the container ``dating''
requirement. We disagree with this comment because we believe that the
suggested method would not provide the information necessary to verify
that a particular container had not been accumulating unwanted material
for more than six months in the laboratory and, therefore, would not
allow EPA or an authorized State to determine whether the laboratory
was in compliance with Subpart K. Therefore, the dating requirement for
each container of unwanted material has been retained in today's final
rule.
Finally, we have retained the requirement from the proposal that
the label associated with the container must contain information
sufficient to make a hazardous waste determination. As discussed above,
this requirement provides flexibility to eligible academic entities in
that this information can be on the label that is ``affixed or attached
to'' the container, but it must at least be on the label that is
``associated with'' the container. However, we stress that
``information sufficient'' to make a hazardous waste determination,
whether that information is ``associated with'' or ``affixed or
attached to'' containers of unwanted materials, must ensure that a
hazardous waste determination of the contents can be made. Examples of
information sufficient to make a hazardous waste determination include,
but are not limited to: the name and/or description of the chemical
contents or composition of the unwanted material, or, if known, the
product of the chemical reaction, whether the unwanted material has
been used or is unused, and a description of the manner in which the
chemical was processed, if applicable.
In summary, today's rule finalizes the proposed performance-based
two-tiered labeling structure, but has modified it to address a number
of comments received on the proposal. The first part of the final
labeling requirement consists of information that must be ``affixed or
attached to'' the container. The information must consist of the words
``unwanted material'' or another equally effective term that is used
consistently by the eligible academic entity and is identified in Part
I of the eligible academic entity's LMP. Additionally, the label must
contain sufficient information to alert emergency responders to the
contents of the container. The second part of the final labeling
requirement consists of information that must be ``associated with''
the container in some manner, which could include affixing or attaching
it to the container. The information required includes the date that
unwanted material first begins accumulating in the container, and
information sufficient to allow trained professionals to determine
whether the unwanted material is a solid and hazardous waste, as well
as assign the proper hazardous waste code(s), pursuant to Sec. 262.11.
For more detail on specific labeling requirements for when volume
limits are exceeded in the laboratory and after hazardous waste
determinations are made, see section III.C.5, Removal Frequency of
Unwanted Materials and Section III.C.6, Making the Hazardous Waste
Determination, respectively.
3. Container Standards
When accumulating unwanted materials in the laboratory, proper
container management is essential to protect human health and the
environment. We proposed performance-based container management
standards, requiring that the containers be stored to prevent leaks,
spills, emissions to the air, adverse chemical reactions, and to avoid
dangerous situations that may result in harm to human health and the
environment. The proposed container management standards also included
two specific standards as a means to achieve these goals: (1)
Containers must be kept in good condition and damaged containers must
be replaced; and (2) containers must be compatible with their contents.
In the preamble to the proposed rule, we solicited comment on two
alternative approaches for container management. First, we requested
comment as to whether the rule should include more specific container
management requirements in the regulations, potentially going beyond
what was proposed. In the preamble, we included some examples of
specific requirements we were considering, such as secondary
containment and imposing a minimum safe distance for the storage of
incompatibles. Another example that was discussed in the preamble was
requiring that containers of unwanted material always be closed during
storage, except for cases of in-line collection. An in-line collection
system is a piece of laboratory equipment, such as a high performance
liquid chromatograph (HPLC) that is directly connected to a container
that collects unwanted material, including hazardous waste, typically
by tubing. The tube carries the waste from the equipment directly into
the container.
The second alternative approach for container management that we
requested comment on was the concept of a ``working container.'' In the
preamble to the proposal, a working container was defined as a small
container (one gallon or less), managed under the control of a
laboratory worker and used at a bench or work station, whose contents
are emptied into a container of unwanted material at the end of the
procedure. Similar to the previous alternative, we indicated that if we
added ``working container'' to the final rule, we would also add a more
specific requirement that any container of unwanted material that does
not fit the definition of working container, be closed at all times,
except when necessary to add or remove unwanted materials.
We received many comments on the proposed container management
standards. Most commenters were supportive of the performance-based
container management standards in lieu of the more prescriptive
standards. Commenters argued that performance-based container
management standards
[[Page 72931]]
would allow them the flexibility to tailor the standards to laboratory-
specific operations. On the other hand, a few State commenters
preferred more prescriptive container management standards as they
found them easier to enforce than performance-based standards. However,
we decided to maintain the performance-based container standards
because we believe they are protective of human health and the
environment, while providing flexibility to eligible academic entities.
Today's rule finalizes the proposed container management standards
with one minor change and adds a new requirement. The requirement that
eligible academic entities must properly manage containers of unwanted
material to assure safe storage of the unwanted materials, to prevent
leaks, spills, emissions to the air, adverse chemical reactions, and
dangerous situations that may result in harm to human health or the
environment has remained the same from proposal. Similarly, containers
must be compatible with their contents. A minor clarification was added
to the requirement that damaged containers be replaced. Several
commenters requested that the Agency add language clarifying that
replacing damaged or degraded containers is not the only method of
reducing their threat. We agree and have added the requirement in the
final rule that damaged or degraded containers be replaced, overpacked,
or repaired, in order to prevent releases of the container's contents
into the environment. An example of overpacking a container is taking a
damaged container of unwanted materials and placing it into a second
container in good condition and then packing the second container with
absorbent filler similar to the practice of lab-packing. An example of
repairing a damaged container would be if a small leak appears in the
cap of a container of unwanted material, and a laboratory worker
covered the broken cap with a polymer film.
Many commenters also provided comments in support of the concept of
a ``working container,'' although a few commenters were opposed to
allowing a ``working container'' in the final rule. Opponents believed
that the approach is not protective of the environment, while
supporters felt that the prescriptive requirement that containers be
kept closed, except when adding or removing waste, which we said would
be added if a working container provision were added to the final rule,
is easier to enforce. In addition, commenters in support of adding a
working container wrote that this concept ``recognizes the fact that
many unwanted laboratory materials are actively accumulated in small
containers at a bench, work station, or fume hood.'' Academic and State
commenters supported the inclusion of a working container provision
because it allows containers that are in use for collecting unwanted
materials to be open while the experiment is running, while at the same
time it provides protection by requiring that non-working containers be
closed at all times, except when adding, removing, or consolidating
unwanted materials.
After evaluating all of the comments, we have decided to include a
provision in the final rule allowing laboratories to use ``working
containers.'' As discussed in the definition section above (section
III.B.3), a working container is defined in the final rule as a small
container (i.e., two gallons or less) that is used at a laboratory
bench, hood, or other work station in order to collect unwanted
material from a laboratory experiment or procedure. We have added to
the container management standards a requirement that a working
container may be open until the end of the procedure or work shift, or
until it is full, whichever comes first, at which time it must either
be closed or the contents must be emptied into a container that is
closed after the contents of the working container are added.
In reference to the other containers of unwanted materials in the
laboratory (i.e., non-working containers), several commenters opposed
the requirement that these non-working containers remain closed, except
to add or remove unwanted material. We disagree with these commenters.
We believe that the requirement that containers remain closed, except
when adding, removing, or consolidating unwanted material is
straightforward and is protective of human health and the environment.
Requiring that containers remain closed, except in certain instances,
will prevent or mitigate accidents in the laboratory that could
otherwise lead to spills or releases.
Commenters identified two additional situations (besides working
containers) where they believed a requirement to keep containers closed
is problematic. One commenter stated, ``* * * tightly capping
containers after addition of waste is sometimes impractical and
dangerous. Capping systems should be allowed which preclude excessive
evaporation while providing for displacement of air while filling from
in-line systems such as an HPLC or allow pressure relief from wastes
which have not fully reacted.'' The comment about ``in-line''
collection of unwanted materials is consistent with what the Agency has
heard over the years through our Project XL with the three New England
colleges and universities, as well as through public meetings. In many
cases, automated laboratory equipment will shut down if air is not able
to escape from an in-line collection system because of a build-up of
pressure. Another commenter stated, ``* * * that the closed container
rule may also have a negative effect by creating a compromised
container in certain situations. Chemical reaction residues may react
slowly over several days, thus building up pressure in a container. The
semiconductor etching solution known as ``piranha solution'' is one
example. Proper management of these solutions requires that the
container be able to safely vent the excess pressure.''
In response to the two public comments above, we have modified the
container management regulations to add these two additional situations
(besides working containers) in which containers are not required to be
completely closed, because in these two situations keeping a container
of unwanted materials closed may be problematic. Specifically, the
final rule allows containers to be vented when it is necessary (1) for
the operation of laboratory equipment, such as in-line collection, and
(2) to avoid dangerous situations, such as the build-up of extreme
pressure. Thus, as we have explained, we have determined that a
combination of both performance-based and prescriptive approaches (as
it relates to whether containers must be kept closed) is more
protective of human health and the environment than performance-based
requirements alone. The Agency believes it is preferable to maintain
the requirement that containers remain closed, except when adding,
removing or consolidating unwanted material in most instances, while
allowing for a few specific instances in which it is not appropriate,
rather than to eliminate the requirement for closed containers
altogether. This is because such an approach provides the flexibility
in specific situations where commenters have shown that requiring
closed containers is inappropriate and does not compromise protection
for all the other containers of unwanted materials that have no cause
to be open. Furthermore, this approach is simpler for an eligible
academic entity to implement and is more easily enforceable.
In summary, today's final rule contains container management
standards that require that containers be managed to assure the safe
storage of the
[[Page 72932]]
unwanted material to prevent leaks, spills, emissions to the air,
adverse chemical reactions, and dangerous situations that may result in
harm to human health or the environment. Specifically, today's final
rule requires that containers be maintained and kept in good condition
and that damaged containers be replaced, overpacked, or repaired.
Additionally, containers must be compatible with their contents to
avoid reactions between the contents and the container and must be made
of, or lined with, material that is compatible with the unwanted
material so that the container's integrity is not impaired. Finally,
containers of unwanted material must be kept closed at all times, with
three exceptions: (1) When adding, removing or consolidating unwanted
material, (2) when using working containers, which may be open until
the end of the procedure or work shift, or until they are full,
whichever comes first, and (3) allowing containers to be vented if
necessary for the proper operation of laboratory equipment, such as
with in-line collection, or to prevent dangerous situations, such as
build-up of extreme pressure.
4. Training Requirements
The Agency intends to provide flexibility in the content and method
of training for laboratory workers and students, while ensuring that
unwanted materials are properly managed and that an eligible academic
entity is in full compliance with the Subpart K requirements. Thus, EPA
has included performance-based standards in today's final rule for
training of laboratory workers and students.
EPA proposed that under Subpart K a college or university be
required to provide training or instruction to all individuals working
in the laboratory. Specifically, the proposal required that laboratory
workers be trained commensurate with their duties so they understand
the requirements of Subpart K and can implement them to ensure the
laboratories' compliance with the requirements of the rule. In
addition, we proposed that students in a laboratory where unwanted
material is generated must receive instruction relevant to their
activities in the laboratory. We proposed that instruction may include
proper container labeling, collection procedures for unwanted material,
and emergency response procedures. Further, the proposal required that
on-site transfers of unwanted materials (which ultimately may prove to
be hazardous wastes) and the hazardous waste determination could only
be conducted by RCRA-trained individuals (called ``trained
professionals'' in the final rule). The proposal indicated that a
college or university could provide training and instruction for
laboratory workers and students in a variety of ways, including, but
not limited to, instruction by the professor or laboratory manager
before or during an experiment, formal classroom training, electronic
or written training, on-the-job training, or written or oral exams.
Finally, the proposal required that a college or university that is an
LQG must maintain training records for the laboratory workers that are
sufficient to determine whether such workers have been trained.
Many commenters expressed general or partial support for the
proposed performance-based training and instruction requirements, in
lieu of prescriptive training requirements. However, many commenters
requested that the training requirements be made more performance-based
and include greater flexibility in training approaches (e.g., use of
postings and signs). In contrast, a few commenters expressed support
for a more prescriptive approach to training and instruction, including
a clear and concise required curriculum for RCRA training in order to
make the Subpart K requirements more meaningful.
We maintain that performance-based training requirements are
appropriate for laboratory workers and students. Eligible academic
entities should have the flexibility to offer training to laboratory
workers and students through their choice of an effective method,
provided the information is sufficient and thorough enough to ensure
proper management of the unwanted materials by laboratory personnel in
order to avoid dangerous situations. However, EPA disagrees that merely
posting a sign would adequately instruct laboratory workers and
students on the proper and safe management of unwanted materials,
believing that some active training is necessary to ensure that all
laboratory personnel fully comprehend their duties and assignments with
respect to unwanted materials management. As stipulated in the proposal
and supported by comments, today's final rule maintains that training
methods may consist of a variety of approaches, including formal
classroom or electronic on-line training, on-the-job training, or
instruction by a professor or manager. Use of postings or signs may
supplement and serve as a reminder of the more formal training, but
does not itself constitute ``training'' for the purposes of today's
final rule. While we do not believe the use of postings or signs alone
constitute ``training,'' EPA believes that the use of signs and
postings to supplement and reinforce the knowledge gained from the
required training program would be beneficial. Training must be
sufficient to enable individual laboratory workers and students in the
laboratory to conduct their duties in an environmentally safe manner
and in accordance with all applicable regulations.
Many commenters stated that all training and instruction should be
commensurate with the duties and activities of the personnel,
irrespective of their status as students or laboratory workers. We
concur with these commenters and thus the final rule has been modified
to reflect that principle. Therefore, as opposed to the proposed rule,
which distinguished between training for laboratory workers and
instruction for students, today's final rule requires that both
laboratory workers and students be trained commensurate with their
duties. Therefore, commensurate training constitutes training aligned
with an individual's assigned duties and the degree of involvement with
the management of the unwanted materials. EPA believes that training
commensurate with ones duties should correspond with the level of
knowledge or practical application needed by individuals to perform
their assigned functions or fulfill their job or enrollment
classification (i.e., professor, researcher, graduate student,
undergraduate student) within an eligible academic entity.
We believe that training commensurate with the duties for students
constitutes familiarization or transference of knowledge to perform
tasks and assignments in the laboratory in a safe and environmentally
sound manner for unwanted materials handling, in accordance with the
Subpart K requirements. Specifically, students conducting experiments
will come in contact with and use a variety of chemicals which may
potentially become hazardous waste following experimentation or may
react adversely if incorrectly stored or managed. Students in a
supervised classroom setting generally would require less training than
students in a research setting. In a teaching laboratory, containers
for the unwanted materials that are generated during an experiment are
typically pre-labeled by the laboratory instructor. Therefore, students
in a supervised classroom setting should be trained to place the
products of experiments in the appropriate containers of unwanted
materials. On the other hand, students conducting research where such
[[Page 72933]]
containers are not provided should be trained to store unwanted
materials in containers to minimize risk and label containers with the
words ``unwanted materials,'' or another equally effective term, so
that EH&S staff know that the containers are not longer wanted, as well
as the contents of the container and the accumulation start date. There
is also the potential for dangerous or hazardous situations, such as
explosions, fires, spills, or other hazards from mishandling chemicals
of unwanted materials which would require emergency response actions by
qualified personnel. It is not necessary that students have the
capability of an emergency response coordinator or other qualified
individual to respond and perform emergency procedures and other
remedial actions. Rather, it is sufficient for students to know how to
correctly handle and manage unwanted materials to avoid dangerous or
hazardous situations and in case of an emergency, know the correct
information or procedures to follow, such as how to contact emergency
responders and when to evacuate the laboratory.
Training commensurate with the duties for laboratory workers and
graduate students working as laboratory workers may be more formalized
or technical instruction whereby upon completion of training, personnel
are qualified to perform the functions of their job descriptions or
assigned duties. For the purpose of Subpart K, laboratory workers must
receive training or technical instruction in direct correlation to
their individual job description or assignments. Under Subpart K, the
definition of ``laboratory worker'' includes a broad array of job
classifications with different duties, such as supervisor or manager of
a laboratory, faculty, staff, researcher, post-doctoral fellows,
interns, technicians and principal investigators. Examples of training
for laboratory workers commensurate with ones duties include, but are
not limited to, training to perform their duties to comply with the
Subpart K labeling and container management standards, supervising
students in the laboratory, preparing containers for transport,
emergency response duties, and/or other duties, as appropriate.
Several commenters expressed concern about the requirement that
personnel conducting on-site transfers of unwanted materials be RCRA-
trained. The commenters stated that this requirement is unnecessary and
does not recognize that these entities have been safely transferring
hazardous waste on-site for years and that a person can safely transfer
unwanted materials with appropriate safety training. In contrast, the
Agency heard from one commenter stating that students and non-RCRA
trained staff should not transfer hazardous wastes outside of the
laboratory. We believe that the person transferring unwanted materials
on-site must be a ``trained professional'' according to the definition
in Sec. 262.200, which requires that the individual complete the
applicable RCRA training requirements of Sec. 265.16 for LQGs, or
Sec. 262.34(d)(5)(iii) for SQGs and CESQGs. Despite the fact that
commenters stated otherwise, this requirement is consistent with the
Agency's existing interpretation for on-site transfers of hazardous
waste (see memo March 17, 2004, Springer to Regions, RCRA Online
14703). Furthermore, we believe that this level of training is
``commensurate'' with the duties of the individual transferring the
unwanted materials on-site, which are to transfer the materials safely,
to avoid spills or releases, and to respond properly to any releases,
among other things. Specifically, we believe that the on-site transfer
of unwanted materials outside of the laboratory should be conducted by
an individual who has received the full complement of RCRA training in
accordance with the eligible academic entity's generator status, to
ensure that that individual is knowledgeable about the RCRA
requirements, especially with regard to the compatibility of chemicals,
spill prevention, and emergency response. This is especially important
considering that the unwanted materials from many individual
laboratories will often be collected together during the on-site
collection and transfer of those materials.
We also heard from two commenters who emphasized the importance of
training for personnel who make the hazardous waste determination at an
eligible academic entity. We agree with the commenters, and, as
proposed, require in today's final rule that the individual making the
hazardous waste determination, whether it is in the laboratory, at the
on-site CAA or on-site TSDF, be a trained professional who has the full
complement of RCRA training in accordance with the eligible academic
entity's generator status (SQG status for CESQGs). Individuals making
the hazardous waste determination must be aware of all applicable RCRA
requirements in order to complete their duties, which are to classify
the unwanted materials properly as solid and/or hazardous wastes and to
apply the correct hazardous waste code(s). Thus, we are continuing to
require that the person making the hazardous waste determination be a
``trained professional'' according to the definition set out in Sec.
262.200.
Therefore, today's final rule maintains the requirement that
trained professionals make the hazardous waste determination and
transfer unwanted materials (or hazardous wastes, if the hazardous
waste determination is made in the laboratory) outside the laboratory
and that the trained professionals must meet the existing RCRA
generator training requirements applicable to the eligible academic
entity's generator status. In addition, today's final rule has added
the requirement that trained professionals at CESQGs must receive RCRA
training in accordance with the training requirements for SQGs, at a
minimum (see definition of ``trained professional'' in Section III.B.2
of today's preamble, as well as Sec. 262.200).
Several commenters described other regulatory bodies (e.g., DOT;
U.S. Nuclear Regulatory Commission (NRC); Occupational Safety and
Health Administration (OSHA)) that require training on hazardous
chemicals, emphasizing that Subpart K's training requirements should
avoid redundancy with other required training. Some of these commenters
stated that they would use OSHA training to satisfy the proposed
Subpart K training requirements. In contrast, we heard from one
commenter expressing concern that there are no other appropriate
regulatory requirements for training specific enough to be appropriate
for RCRA because they do not effectively cover the RCRA hazardous waste
determination. The Agency believes that neither the ``traditional''
RCRA generator regulations nor Subpart K prohibits the use of other
training programs to satisfy the training requirements of Subpart K,
provided the other training program(s) address the relevant RCRA
requirements for trained professionals, and the relevant Subpart K
requirements to train laboratory workers and students commensurate with
their duties.
Several commenters argued that eligible academic entities should be
able to provide evidence of training, in lieu of training records,
which they believe are too burdensome to keep. Furthermore, a few
commenters advocated eliminating the proposed recordkeeping
requirements for LQGs, arguing that such requirements would be more
burdensome than the existing requirements for satellite accumulation
areas, which do not require documented training for personnel. The
Agency recognizes that the satellite
[[Page 72934]]
accumulation area regulations do not require documented training for
personnel and is not requiring that records be retained for training of
students in the laboratory. However, we believe it is appropriate that
eligible academic entities that are LQGs retain the records for
training of laboratory workers in order to demonstrate that the
laboratory worker received the necessary training. The records that are
required for laboratory workers at LQGs are the same that are required
for trained professionals at eligible academic entities that are LQGs
(and which they are subject to today), both of which reference the
current LQG training regulations in Sec. 265.16.
Finally, we heard from a few commenters who stated that the
maintenance of training records for trained professionals or laboratory
workers at SQGs is unnecessary. We did not propose to require such
recordkeeping for training of laboratory workers or trained
professionals at SQGs, nor has the Agency included such a requirement
in today's final rulemaking.
In summary, under today's final rule, eligible academic entities
managing their laboratory hazardous wastes under Subpart K must provide
training for laboratory workers and students, and the training must
provide sufficient information so that laboratory workers and students
can understand and implement the requirements of Subpart K,
commensurate with their duties. An eligible academic entity can provide
training and instruction for laboratory workers and students in a
variety of ways, including, but not limited to, instruction by the
professor/manager before or during an experiment, formal classroom
training, electronic/written training, on-the-job training, or written
or oral exams. LQGs managing their laboratory waste under Subpart K
must maintain documentation demonstrating that the training has been
provided to laboratory workers and trained professionals. Documentation
demonstrating training can include, but is not limited to, sign-in or
attendance sheet(s) for training session(s), syllabi for training
session(s), certificate(s) of completion, or test results. Finally, the
training requirements in today's final rule restrict who may conduct
certain activities under Subpart K. Specifically, only ``trained
professionals,'' as defined in Sec. 262.200, may transfer unwanted
materials on-site and make the hazardous waste determination, pursuant
to Sec. 262.11, for unwanted material.
5. Removal Frequency of Unwanted Materials
Currently, most laboratories operate under what is commonly
referred to as the satellite accumulation area (SAA) regulations (see
40 CFR 262.34(c)). At SAAs, removal of hazardous waste is dependent on
the volume of hazardous waste that is accumulated in each SAA. That is,
once more than 55 gallons of hazardous waste (or more than 1 quart of
acutely hazardous waste) is accumulated in an SAA, a generator has
three days to remove the excess of 55 gallons (or excess of 1 quart of
acutely hazardous waste) from the SAA and transfer it to an on-site CAA
or TSDF, or transport it off-site.
In large part because colleges and universities explained to us
that they rarely accumulate 55 gallons of hazardous waste in a
laboratory, except during a laboratory clean-out, in Subpart K we
proposed to require the removal of unwanted materials from laboratories
based primarily on time, and secondarily by the volume of unwanted
materials. Specifically, we proposed that all unwanted materials,
including reactive acutely hazardous unwanted materials (as defined in
the proposal), generated in laboratories must be removed from the
laboratory at a regular interval that is specified in the entity's LMP,
and that such interval for routine removals must not exceed six months.
College and university representatives had told EPA that tying the
removal of laboratory wastes with the academic calendar would
facilitate removal of laboratory wastes that accumulate during the
course of the semester with a minimum of disruption. Therefore, the
Agency believed that six months was an appropriate length of time to
allow colleges and universities to schedule routine removals of
unwanted materials at the end of each semester.
We also proposed that if a laboratory accumulates more than 55
gallons of unwanted materials (including reactive acutely hazardous
unwanted materials) prior to the regularly scheduled removal specified
in the entity's LMP, then all of the unwanted materials, including the
reactive acutely hazardous unwanted materials, must be removed from the
laboratory within ten calendar days of exceeding 55 gallons, or at the
next regularly scheduled removal, whichever occurs first. For reactive
acutely hazardous unwanted materials, we proposed that if a laboratory
accumulates more than 1 quart prior to the regularly scheduled removal,
then the reactive acutely hazardous unwanted materials would have to be
removed from the laboratory within ten calendar days of exceeding 1
quart, or at the next regularly scheduled removal, whichever occurs
first. The Agency proposed that the reactive acutely hazardous unwanted
materials be subject to the 1-quart volume limit for accumulation in
the laboratory, instead of the 55-gallon limit, because when these
reactive chemicals are stored for long periods, they can become
unstable, posing an extreme danger because these reactive chemicals
have the potential to cause significant harm to laboratory personnel
and property.
Many commenters generally supported the shift to the time-driven
removal of unwanted materials from laboratories. However, they also
requested that the maximum time between regularly scheduled removals be
lengthened from six months to a year, or an ``academic year,'' which
commenters defined as ``the 11-13 month period that corresponds to a
college or university's annual teaching and research activities.'' Some
commenters argued that six months was too frequent because some
laboratories generate very small quantities of unwanted material in
that time period. While some laboratories may generate small quantities
of unwanted material, we have determined, based on all the available
information, to keep six months as the maximum time between regularly
scheduled removals.
We have retained six months as the maximum time between regularly
scheduled removals of unwanted materials from the laboratory for
several reasons. First, we believe that implementing regular removals
on the basis of an ``academic year'' could be confusing. Second, as we
indicated in the preamble to the proposed rule, our goal is to have
unwanted materials removed from laboratories at least once each
semester. One commenter indicated that a schedule that allows removals
on a semester basis is preferred by stating, ``colleges and
universities generally use the semester's end to encourage laboratory
workers and students to have unwanted materials removed from their
laboratories before leaving campus. This practice reduces the risk that
unknown materials will be left behind by a student or laboratory worker
who does not return the following semester. Also it limits the amount
of waste material stored in laboratories during the break, when fewer
people are around to monitor or be aware of the conditions in the
laboratory.'' Finally, as discussed in the proposal, we do not believe
that allowing unwanted materials to accumulate for longer than six
months
[[Page 72935]]
would reduce risk to laboratory personnel and provide the benefits to
human health and the environment to the same extent and therefore the
anticipated benefits from moving to a time-driven rather than a volume-
driven approach would be diminished.
We realize that some laboratories will not generate any unwanted
materials during a six month period and we do not intend for EH&S
personnel or other staff or contractors to make a trip to the
laboratory if they know that the laboratory does not have any unwanted
materials. The eligible academic entity must describe in Part II of its
LMP how it will determine whether a removal of unwanted material is
necessary at each individual laboratory. For example, a form or an e-
mail could be sent to each laboratory asking whether the laboratory has
any unwanted material accumulating and the EH&S could respond
accordingly. Eligible academic entities have flexibility with respect
to how they intend to comply with the requirements for regular removals
of unwanted materials. However, each eligible academic entity is
responsible for ensuring that it meets the time-driven requirement
(i.e., every six months) for the method it has selected for removing
unwanted materials from the laboratory. The accumulation start date
associated with each container (or affixed or attached to each
container, if that is preferred) of unwanted material is intended to be
used as the mechanism for determining compliance with regularly
scheduled removals. Of course, unwanted materials may always be picked
up with greater frequency than specified in either the regulations or
the eligible academic entity's LMP.
A number of commenters expressed concern over the requirement to
remove ``all'' containers of unwanted materials from the laboratory
either during a regularly scheduled removal or when the volumes have
been exceeded, because this would require partially-filled containers
to be removed from the laboratory, which could require the use of more
containers. Many of these commenters requested that EPA modify the
requirement to remove ``all'' unwanted material from the laboratory to
require that only full containers of unwanted material have to be
removed from the laboratory.
We recognize the commenters' concerns regarding the requirement to
remove ``all'' unwanted materials from the laboratory during regularly
scheduled removals or when volumes have been exceeded. However, we do
not consider the alternative suggested by commenters--to require that
only full containers of unwanted material have to be removed from the
laboratory--to be practical. It would be easy to circumvent the intent
of the regulations for regular systematic removals of unwanted
materials from the laboratory by simply not completely filling
containers of unwanted materials. In this scenario, the removal of
unwanted materials from the laboratory would be based primarily on
volume, rather than based on EPA's preferred approach of time. We
prefer the time-driven approach, with the maximum volumes as a backup
because, for most laboratories, it is rare to accumulate 55 gallons of
unwanted material. Without a time limit, unwanted materials could
remain in the laboratory for extended periods of time. As for the
concern about using too many containers, consolidation of compatible
materials is allowed within in a laboratory, as well as at an on-site
CAA or on-site TSDF, which could then return some or most of the
reusable containers for use in collecting unwanted material.
One commenter suggested adopting a system that mirrors the
Universal Waste system for tracking the amount of time that unwanted
materials remain in the laboratory. This commenter suggested that a
laboratory should be allowed to demonstrate the length of time that
each container has been accumulating unwanted material and that EPA
should base the removal on how long each container is in the
laboratory. We also heard from many commenters that we should be more
flexible in the removal provisions.
In response to these comments, there are now two alternative
approaches allowed for regular removals of unwanted materials. The
first approach is the one that was proposed. That is, all containers of
unwanted material must be removed from the laboratory on a regular
basis, not to exceed six months. Under this approach, however, it is
possible that a container that began accumulating unwanted materials
the day before the regularly scheduled removal would be required to be
removed. This approach is easy to implement, as all containers of
unwanted material would be removed from the laboratory, regardless of
when they began accumulating unwanted materials.
The second alternative being added today allows the removal of
containers of unwanted material using a ``rolling'' six months
approach. That is, no individual container of unwanted material could
remain in the laboratory for more than six months. We believe this
alternative approach provides additional flexibility that many
commenters sought by adding a choice of implementation methods for the
removal of unwanted materials, while maintaining the intent of the
regulations by requiring regular, systematic, time-driven removals of
unwanted materials. Since there is already a requirement that all
containers have an accumulation start date associated with them, this
approach would rely on checking the dates associated with each
container in order to determine which containers would have to be
removed from the laboratory. Individual containers could potentially
remain in the laboratory longer than under the other alternative
approach and therefore, would be more likely to be full or nearly full.
On the other hand, this approach would likely require more frequent
removals from the laboratory to ensure that no container accumulating
unwanted materials remains in the laboratory longer than six months.
Each eligible academic entity choosing to be subject to Subpart K
must select and identify in Part I of its LMP, the approach it chooses
for complying with regular removals of unwanted materials from the
laboratory. In Part II of its LMP, the eligible academic entity must
describe how it plans to comply with the approach it has chosen for
regular removal of unwanted materials from the laboratory.
Under the SAA regulations of Sec. 262.34(c), if the maximum
volumes are exceeded, the excess of 55 gallons of hazardous waste (or 1
quart of acutely hazardous waste) must be removed from the area within
three days. We have frequently heard that the three-day time limit was
problematic, especially during long weekends and holidays. Under
Subpart K, we proposed to extend from three days to ten calendar days
the removal of unwanted materials from the laboratory when the maximum
volumes are exceeded. Many commenters supported this change, although a
few commenters believed that three days was sufficient. One State
commenter suggested that laboratories should remove their unwanted
materials before the maximum volumes are reached, which would remove
the need for providing additional time for the removal of unwanted
materials from the laboratory. We have decided to retain ten calendar
days for removing unwanted materials from the laboratory when the
maximum volumes are exceeded. We believe that ten calendar days will
provide sufficient flexibility to respond to the occasions when 55
gallons of unwanted material (or 1 quart of reactive acutely hazardous
unwanted material) is exceeded, while maintaining protection to human
health and the environment.
[[Page 72936]]
With regard to which unwanted materials must be removed from the
laboratory when maximum volumes are exceeded, we proposed that when a
laboratory exceeds 55 gallons of unwanted material, it must remove all
unwanted materials--including the reactive acutely hazardous materials.
This is because all reactive acutely hazardous materials are unwanted
materials and should be considered in calculating whether the 55
gallons has been exceeded. On the other hand, we proposed that when a
laboratory exceeds 1 quart of acutely reactive unwanted material, it
must remove only the reactive acutely hazardous unwanted material, not
all containers of unwanted material, because not all unwanted materials
are reactive acutely hazardous unwanted materials, and therefore should
not be subject to the lower accumulation limits in the laboratory. We
have retained these requirements in today's final rule, with some minor
rewording to clarify our intent. Of course, in the case where a
laboratory exceeds 1 quart of reactive acutely hazardous unwanted
material, an eligible academic entity may choose to remove all unwanted
materials from the laboratory. If a trained professional has to make a
trip to the laboratory to remove reactive acutely hazardous unwanted
materials in excess of 1 quart, it may be more efficient to remove all
unwanted materials at the same time, even if they are not required to
be removed at that time.
We proposed that if a laboratory accumulates more than 55 gallons
of unwanted material, then all containers of unwanted materials
(including reactive acutely hazardous unwanted materials) must be dated
with the date the 55 gallons is exceeded. We also proposed that if a
laboratory accumulates more than 1 quart of reactive acutely hazardous
unwanted material, then all containers of reactive acutely hazardous
unwanted materials must be dated with the date the 1 quart is exceeded.
This date is necessary to determine whether the ten calendar days had
elapsed and, therefore, when the containers must be removed from the
laboratory. In the proposed regulations, we did not specify which label
this date must go on--the label that is ``affixed to or physically
accompanies'' (which has been changed to ``affixed or attached to'' in
the final rule) the container, or the label that is ``associated with''
the container. However, in the preamble to the proposed rule, we did
indicate that, as with the requirement to date containers with their
accumulation start date, this date may be included on either label--the
label that is ``affixed or physically accompanies'' the container, or
the label that is ``associated with'' the container (see 71 FR 29730).
In today's final rule, we have revised the regulatory text to be
consistent with the preamble discussion from the proposed rule.
Therefore, when 55 gallons of unwanted material (or 1 quart of reactive
acutely hazardous unwanted material) is exceeded in a laboratory, the
date that the maximum volume is exceeded may be added to either type of
label. That is, it may be added to the label that is ``affixed or
attached to'' the container, but at a minimum it must be added to the
label that is ``associated with'' the container.
One commenter pointed out that if an eligible academic entity does
not have an on-site CAA and one of its laboratories exceeds the
specified volume limits, the generator must be prepared to have a
vendor ship the unwanted materials from the laboratory to an off-site
TSDF within 10 calendar days. We agree with the commenter's assessment
and point out that this is an increase in the time allowed under the
current SAA regulations, under which the same generator would have only
three days in which to ship the hazardous waste off-site (or come into
compliance with the requirements for 90/180/270-day generator
accumulation areas).
One commenter suggested that in order to be consistent with the SAA
regulations, the 55-gallon limit should be on a ``per wastestream''
basis, rather than a ``total volume'' basis. We disagree with the
commenter and find the commenter's interpretation of the SAA
regulations to be incorrect. To the contrary, EPA has consistently
interpreted the SAA regulations such that 55 gallons is based on a
total volume of all wastestreams combined (see memo from Robert
Springer, Director, OSW to EPA Regional Directors, March 17, 2004, RCRA
Online 14703). Thus, Subpart K is consistent with the SAA
regulations with respect to this provision.
a. Reactive Acutely Hazardous Unwanted Materials
Under the SAA regulations of Sec. 262.34(c), if more than 1 quart
of an acutely hazardous waste listed in Sec. 261.33(e) is accumulated,
the excess of 1 quart must be removed from the SAA within three days
and taken either to an on-site CAA or TSDF, or transported off-site.
Section 261.33(e), which is commonly referred to as the ``P list'' of
hazardous wastes, currently comprises 124 chemicals. The P-list is a
list of commercial chemical products that are considered acutely
hazardous waste when discarded because they are considered hazardous
even when managed in small quantities. Under Subpart K, the Agency is
reducing the number of chemicals that are subject to removal from the
laboratory at the 1-quart threshold from all 124 chemicals on the P-
list to the six chemicals that are on the P-list because they are
reactive. We focused on the reactive chemicals on the P-list because,
as reactive chemicals, they have the potential to cause significant and
immediate harm to individuals and property. We are finalizing this
provision as proposed, along with the change to the definition of
reactive acutely hazardous unwanted material that was previously
discussed in section III.B.2 of today's preamble (also see Sec.
262.200).
We also would like to clarify that this regulatory revision--that
is, the number of P-listed chemicals that are subject to removal from
the laboratory if they exceed the 1-quart threshold--does not impact
other aspects of the hazardous waste regulations. That is, we have not
changed the regulations with respect to which chemicals are identified
as acutely hazardous wastes or the 1 kg/month threshold for becoming an
LQG. Therefore, the entire P-list must be considered when a trained
professional makes the hazardous waste determination for unwanted
materials. If an eligible academic entity generates more than 1 kg/
month of acutely hazardous waste, it is an LQG for that calendar month,
except if the acutely hazardous waste is from a laboratory clean-out
conducted in accordance with Sec. 262.213 of today's rule, in which
case it need not be counted toward the eligible academic entity's
generator status. See section III.C.7 of today's preamble for a
discussion of the laboratory clean-out provisions, as well as Sec.
262.213.
b. Transferring Unwanted Materials or Hazardous Wastes From the
Laboratory to an On-site CAA or On-site TSDF
To ensure that unwanted materials removed from the laboratory are
brought promptly to their next destination, such as an on-site CAA or
TSDF, the Agency proposed to require that when unwanted materials (or
hazardous wastes, if the hazardous waste determination was made in the
laboratory) are removed from a laboratory, they must be brought
``directly'' from the laboratory(ies) to an on-site CAA or TSDF. We
sought comment on whether it was necessary to define ``directly'' or to
replace it with a more specific time-frame, such as a same day
requirement.
[[Page 72937]]
We received several comments in support of defining the term
``directly.'' Other commenters, however, stated that it was not
necessary to define the term, especially given our preamble discussion
in the proposed rule. In reviewing the comments, we have decided not to
add a regulatory definition of ``directly'' and will simply reiterate
and expand upon the preamble discussion from the proposed rule.
In general, if the unwanted material is sent from the laboratory or
laboratories to the on-site CAA or TSDF within the same work day, this
would meet the intent of the regulation. We realize that many eligible
academic entities will collect unwanted materials from many
laboratories at a time, in series, and will deliver all the unwanted
materials to an on-site CAA or TSDF at the end of the collection
process. This would be an acceptable practice under today's
regulations, provided the unwanted materials are in continuous custody
of the trained professional that is collecting and transferring the
unwanted materials and they are delivered to the on-site CAA or TSDF at
the end of the work shift. It is not necessary to bring the unwanted
material from each individual laboratory directly to the on-site CAA or
TSDF and then in a separate trip bring the unwanted materials from the
next laboratory. Such an arrangement would only increase the amount of
time that trained professionals would spend in removing unwanted
materials from laboratories and that unwanted materials would spend in
transport, with no benefit. On the other hand, if unwanted materials
were left on a cart in the hallway overnight, this would not be an
acceptable practice and would not meet the intent of the regulation.
c. On-site Consolidation Areas
Under the existing regulations, generators may accumulate hazardous
waste in two types of areas without having a permit or interim status:
(1) An SAA or (2) an on-site generator accumulation area (<=90, <=180
or <=270 day areas).\7\ Under Subpart K, eligible academic entities
also may accumulate unwanted materials and hazardous wastes in two
types of areas without having a permit or interim status: (1)
Laboratories (in lieu of SAAs) and (2) an on-site CAA (``CAA'' is a
term that has been defined under Subpart K, but is the same as what has
sometimes been called ``generator accumulation areas'' or ``90/180/270-
day areas'').
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\7\ LQGs may accumulate hazardous waste for 90 days or less on-
site without a permit or interim status, provided the provisions of
Sec. 262.34(a) (or Sec. 262.34(g)-(i) for F006 recyclers; or Sec.
262.34(j)-(k) for Performance Track members) are met. SQGs may
accumulate hazardous waste for 180 days or less on-site without a
permit or interim status, provided the provisions of Sec. 262.34(d)
and (f) are met. SQGs that must send their hazardous waste more than
200 miles for off-site treatment, storage, or disposal are allowed
to accumulate hazardous waste for 270 days or less on-site without a
permit or interim status, provided the provisions of Sec. 262.34(d)
and (f) are met (see Sec. 262.34(e)).
---------------------------------------------------------------------------
At proposal, we solicited comment on whether an additional
accumulation area beyond what is already allowed in the rules should be
created to allow for the consolidation of unwanted materials after they
have been removed from the laboratory. We received many comments in
favor of establishing a consolidation area as a new type of area for
the accumulation of unwanted materials after such material has been
removed from the laboratory. Some commenters even included suggested
regulatory text for how these new consolidation areas would be
regulated, including specific requirements for labeling/dating,
container management, training, removal frequency, hazardous waste
determinations, inspections, spill response, signage, and documentation
in the LMP. A few commenters, however, opposed the creation of another
type of accumulation area, primarily because they were concerned that
the addition of another accumulation area would cause confusion.
After analyzing the comments and considering the flexibility that
is already provided in the regulations, we have decided not to
establish a ``consolidation area'' as another type of accumulation area
for unwanted materials. We agree with the commenters that argued that
adding another type of accumulation area with another set of standards
would be confusing for implementers and enforcers with little, if any,
benefit. We believe that the flexibility that is already in Subpart K
can provide the benefits of a consolidation area, without establishing
a new regulatory category for them.
It has been EPA's regulatory interpretation that hazardous wastes
can not be moved from one SAA to another (see memo from Robert
Springer, Director, OSW, to EPA Regional Directors; March 17, 2004,
RCRA Online 14703). One reason for this prohibition is that it
would be easy to circumvent the 55-gallon limit in an SAA by moving
hazardous wastes from one SAA to another SAA and thus remain below the
volume limits, allowing hazardous wastes to remain in the SAA
indefinitely.
In today's rule, however, the removal of unwanted materials is
based on time primarily, and volume secondarily. Containers must be
marked with the date that unwanted materials first begin to accumulate.
This requirement is necessary in order to verify that unwanted
materials are being removed from the laboratory on a regular basis. The
requirement for a date to be associated with each container provides
laboratories with additional flexibility that does not exist in SAAs.
That is, under Subpart K, unwanted materials can be safely consolidated
within an on-site laboratory, such as in a chemical stockroom. As with
all on-site transfers of unwanted material outside of a laboratory, the
transfer of unwanted materials between laboratories must be accompanied
by a trained professional. Further, any laboratory in which unwanted
materials are consolidated from other laboratories is subject to the
time and volume limits for all laboratories that are subject to Subpart
K (i.e., if the laboratory accumulates more than 55 gallons of unwanted
material (or 1 quart of reactive acutely hazardous unwanted material),
the unwanted material must be removed from the laboratory within 10
calendar days). In addition, the date that an unwanted material first
begins to accumulate in a container would remain the same, regardless
of where the container is moved. In other words, no re-dating of a
container would be permitted if it were moved to another laboratory or
chemical stockroom. If the contents of two or more containers with
compatible materials are combined into one container; however, the
earliest date associated with the original containers must be used. The
date that is associated with each container will allow inspectors to
verify that containers are being removed from the laboratory on a
routine basis not to exceed six months, as required. The 55-gallon
volume limit will ensure that large quantities of unwanted materials
are not consolidated without the additional protections required at
CAAs.
We envision this flexibility to be particularly useful for eligible
academic entities that do not have on-site CAAs. Commenters have
indicated that by consolidating their unwanted materials in a
laboratory or chemical stockroom themselves prior to a vendor's
arrival, they can save money because the vendor will be able to collect
unwanted materials from fewer laboratories, thus spending less time on-
site. In such a situation, if an eligible academic entity (or the
vendor) makes the hazardous waste determination in the laboratory, the
eligible academic entity does not have to make the hazardous waste
[[Page 72938]]
determination when the unwanted material is removed from the first
laboratory. Rather, the hazardous waste determination may be made when
the unwanted material is removed from the final laboratory where the
unwanted materials are consolidated, before it is sent off-site.
Consolidating unwanted materials from multiple laboratories will
provide another opportunity to consolidate unwanted materials that are
compatible with one another, thereby allowing containers to be reused.
We emphasize that trained professionals must transfer unwanted
materials between laboratories and that any laboratory where unwanted
materials are consolidated also is subject to the Subpart K
requirements, including the time and volume limits.
6. Making the Hazardous Waste Determination
One of the primary benefits that Subpart K provides over the
existing generator regulations is flexibility in where and when to make
the hazardous waste determination. The Agency has consistently
interpreted the existing generator regulations to require that the
hazardous waste determination be made at the point of generation. We
now recognize that making the hazardous waste determination at the
point of generation is difficult and impractical in teaching and
research laboratories, because of the high number of individual wastes,
the variability in such wastes, and the transient nature of those
generating many of the wastes, namely students. Therefore, in Subpart
K, we proposed to allow the hazardous waste determination to be made in
the laboratory before the unwanted materials are removed from the
laboratory, or within four calendar days of arriving at an on-site CAA
or interim status or permitted TSDF. We proposed that when the
hazardous waste determination is made in the laboratory, it does not
have to be made at the initial time that the hazardous waste is
generated, as is required under the existing generator regulations,
only that it must be made before the unwanted materials are removed
from the laboratory. This alternative approach ensures that the
hazardous waste determination is made by a trained professional, rather
than by students, who would likely lack the necessary training, and
allows much greater flexibility in where and when to make the hazardous
waste determination.
In general, we received favorable comments about the flexibility
provided by Subpart K with regard to making the hazardous waste
determination. Today, we are finalizing the regulations pertaining to
where and when the hazardous waste determination must be made with some
minor changes to address the expansion of the applicability of the
final rule to include eligible academic entities that are CESQGs.
Eligible academic entities that are LQGs or SQGs will continue to have
the choice of making the hazardous waste determination in the
laboratory before the unwanted material is removed from the laboratory,
or within four calendar days of arriving at an on-site CAA or interim
status or permitted TSDF. Because CESQGs would not have an on-site CAA
or TSDF, CESQGs are required to make the hazardous waste determination
in the laboratory before the unwanted material is removed from the
laboratory. See section III.C.9 of today's preamble for further
discussion of how Subpart K is implemented at CESQGs.
At the time of the proposal, the Agency was aware that many smaller
eligible academic entities contract with outside vendors to make the
hazardous waste determination on their behalf. We expected that the
smaller eligible academic entities, which do not have on-site CAAs or
on-site TSDFs, would be relying on vendors to make the hazardous waste
determination in the laboratory(ies) prior to the hazardous waste being
brought off-site. As proposed, the regulations of Subpart K,
specifically Sec. 262.210, allowed for this scenario.
From comments, we learned that even eligible academic entities with
on-site CAAs contract with vendors to make and/or confirm their
hazardous waste determinations. Thus, we received many comments arguing
against the requirement that the hazardous waste code(s) be placed on
the container within four days of arriving at the on-site CAA because
this essentially would preclude these entities from using vendors to
make the hazardous waste determinations for them. These commenters
believe that placing the words ``hazardous waste'' on the container is
sufficient to indicate that a hazardous waste determination has been
made and that they should be allowed to delay putting the hazardous
waste code(s) on the container until the vendor comes to ship the
hazardous wastes off-site.
We agree with these commenters that the practice of using vendors
to make the hazardous waste determination should not be limited to
those eligible academic entities that make the hazardous waste
determination in the laboratory. Eligible academic entities that make
the hazardous waste determination in an on-site CAA or interim status
or permitted TSDF also should be able to use vendors to assist them
with their hazardous waste determination. In today's final rule,
therefore, the hazardous waste determination must still be made within
four calendar days of arriving at an on-site CAA or TSDF, and for those
unwanted materials that are hazardous waste, the words ``hazardous
waste'' still must be added to the label that is affixed or attached to
the container within those four calendar days. However, the Agency is
amending the final rule so that eligible academic entities may delay
assigning the hazardous waste code(s) until immediately prior to
shipping the hazardous waste(s) off-site. When containers of unwanted
materials arrive at an on-site CAA, they are subject to the CAA
regulations appropriate to the site's generator status, including
dating of the containers to calculate the 90/180/270 days that the
containers may be accumulated on-site, and the container management
standards. Likewise, when containers of unwanted materials arrive at an
on-site TSDF, the unwanted material becomes subject to the terms of the
facility's hazardous waste permit or interim status, as soon as it
arrives. Therefore, since the containers must be managed as hazardous
waste upon arriving at an on-site CAA or TSDF, we believe there is no
decrease in protection of human health and the environment by delaying
the addition of the hazardous waste code(s). The hazardous waste
code(s) are necessary for determining the LDR regulations that apply to
the hazardous wastes, but do not provide additional protection while
the hazardous wastes are being accumulated on-site. We emphasize that,
in all cases, regardless of generator status, or where the eligible
academic entity chooses to make the hazardous waste determination, the
hazardous waste determination must be made on-site before the unwanted
material can be treated at an on-site CAA, or treated or disposed at an
on-site TSDF, or sent off-site.
Many commenters stated that four calendar days was not sufficient
to make the hazardous waste determination in an on-site CAA or TSDF.
However, given that (1) the hazardous waste determination is usually
required to be made at the point of generation and that the Agency is
providing considerable flexibility in Subpart K for where and when to
make the hazardous waste determination and (2) the initial hazardous
waste determination should be more straightforward without the addition
of the hazardous waste code(s),
[[Page 72939]]
we are not providing additional time. Thus, under today's final rule,
the hazardous waste determination must be made within four calendar
days of arriving at an on-site CAA or TSDF. Commenters also gave
various suggestions for changing ``calendar'' days to ``working'' or
``business'' days. We believe that this would be confusing because not
everyone shares the same ``working'' or ``business'' days. By relying
on ``calendar'' days, we are providing consistency and clarity in
calculating the timeframes within the rule.
The Agency solicited comment on whether the four calendar days
should be included within the 90/180/270 day timeframe allowed for
accumulation in an on-site CAA or whether it should be separate from
these timeframes. Most commenters preferred the proposed option of
including the four calendar days for making the hazardous waste
determination as part of the 90/180/270 days allowed for the on-site
accumulation of hazardous wastes. They expressed this preference, in
large part, to avoid additional dating of containers that would be
necessary if the four days were separate from, and additional to, the
90/180/270 days of accumulation time. Therefore, under today's final
rule, a container's date of arrival at an on-site CAA will be used for
two purposes: (1) Calculating the four calendar days allotted for
making the hazardous waste determination and (2) calculating the
maximum accumulation time in the CAA.
Many commenters objected to the proposed requirement that the
hazardous waste code(s) be placed on the label that is affixed to or
physically accompanies the container (as previously discussed, today's
final rule changes this requirement so that the label must be ``affixed
or attached'' to the container). They pointed out that the majority of
hazardous wastes generated in a laboratory are lab-packed when they are
transported off-site and that putting the hazardous waste code(s) on
the label that is affixed to the container, then placing the container
inside of a lab pack is of no value because the hazardous waste code(s)
would not be able to be seen. The commenters suggested allowing the
hazardous waste code(s) to be placed on the label that is ``associated
with the container'' rather than the label that is ``affixed or
physically accompanies the container.'' We had proposed that, as part
of the hazardous waste determination, the hazardous waste code(s) must
be placed on the containers within four days of arriving at an on-site
CAA or interim status or permitted TSDF. In this instance, the
hazardous waste code(s) on the container label would have been visible
during accumulation in an on-site CAA or storage in an on-site TSDF.
However, since the final regulations have been revised so that the
hazardous waste code(s) do not need to be added until just before the
hazardous waste is transported off-site and since most containers will
be lab-packed, we agree that placing the hazardous waste code(s) on the
container label that is affixed or attached to the container provides
no value. Therefore, we have revised the regulatory language in
Sec. Sec. 262.210(b)(2), 262.211(e)(2), and 262.212(e)(2) to allow the
appropriate hazardous waste code(s) to be placed on the container label
that is associated with the container. This will allow the practice of
putting hazardous waste code(s) on a packing slip or inventory list for
a lab pack to continue.
One commenter expressed concern about the statement in the preamble
to the proposed rule (see 71 FR 29735) that, ``* * * regardless of
whether an employee or non-employee makes the hazardous waste
determination, the college or university could (emphasis added) still
be responsible if the hazardous waste determination is not made
correctly and for any mismanagement of hazardous waste.'' The commenter
was concerned ``that such wording could be used to contradict current
RCRA requirements that the generator is always responsible for the
proper waste determination regardless of who does the actual
designation.'' We did not intend this language to suggest the potential
interpretation for which the commenter expressed concern. Indeed, we
agree with the commenter that making the proper hazardous waste
determination is, and always has been, the responsibility of the
generator (as described in 40 CFR 262.11), which in this case, would be
the eligible academic entity, and did not intend to suggest otherwise.
Another commenter requested that the Agency clarify that the
hazardous waste determination can be made in ``any'' of the three
areas, rather than in ``one'' of the three areas identified in Sec.
262.209(a). We agree with the commenter and have changed the regulatory
language to reflect the comment. For LQGs and SQGs, it is not necessary
for the eligible academic entity to limit itself to making the
hazardous waste determination in the same place all the time. We
realize that this could change depending upon circumstances. For
instance, during typical operations, an eligible academic entity may
choose to make the hazardous waste determination in its on-site CAA.
However, during a laboratory clean-out, the hazardous waste
determination might be made in the laboratory. Eligible academic
entities that are CESQGs, however, are limited by regulation to making
the hazardous waste determination in the laboratory before the unwanted
materials are removed from the laboratory and sent off-site.
Several commenters requested that the Agency clarify the status of
chemicals or unwanted materials that can be redistributed to other
laboratories. It has always been the case under existing RCRA
regulations, and continues to be the case under Subpart K, that
chemicals that are fit for continued use are not solid or hazardous
wastes (see Sec. 261.2(e)(1)) and can be transferred between SAAs,
laboratories, and chemical stockrooms. Under Subpart K, we realize that
some chemicals that are initially identified as unwanted materials will
turn out not to be solid or hazardous wastes. If, for example, an
unwanted material is brought to an on-site CAA or TSDF for a hazardous
waste determination, and it is determined that such unwanted material
can be reused, then it is not a solid or hazardous waste and is not
subject to Subpart K or the Subtitle C hazardous waste regulations,
once the determination is made. That is, if a chemical is initially
labeled as an unwanted material and then it is subsequently discovered
that it can continue to be used, the chemical can be returned to a
laboratory or chemical stockroom for redistribution. EPA selected the
term ``unwanted material'' over ``laboratory waste,'' in part to
indicate that the material may still be useable.
Sometimes laboratories end up discarding chemicals for which little
or no identifying information is available. We recognize that, in some
cases, chemicals will be managed in the laboratory and that when those
chemicals are eventually disposed, it may not be possible to identify
the chemicals. This sometimes happens when a researcher retires and
leaves unlabeled chemicals behind. In addition, some laboratories
synthesize new compounds as part of their research. When these
``unknowns'' are disposed of, it may not be possible to make a
hazardous waste determination without analysis. A few commenters
requested that the Agency address more specifically how to handle the
hazardous waste determination for such unknown chemicals. As a result,
we have added a requirement that an eligible academic entity must
develop,
[[Page 72940]]
in Part II of its LMP, procedures for the timely and reliable
characterization of unknown chemicals. See section III.C.8, of today's
preamble for more detail, as well as Sec. 262.214.
7. Laboratory Clean-outs
a. Summary of the Proposed Laboratory Clean-out Provisions
EPA inspections and enforcement cases have revealed that used and
unused chemicals that are clearly no longer useable, have in some cases
remained in laboratories at academic institutions for years and even
decades. Sometimes these chemicals have not been discarded because the
eligible academic entity did not want to change its RCRA generator
status. In fact, one of EPA's goals in promulgating Subpart K has been
to provide incentives for eligible academic entities to remove such
``legacy'' chemicals from their laboratories. We proposed to provide
two incentives for conducting voluntary laboratory clean-outs. First,
we proposed that a college or university would have 30 days to conduct
a laboratory clean-out. It is during a laboratory clean-out that a
laboratory is most likely to accumulate more than 55 gallons of
unwanted material (or 1 quart of reactive acutely hazardous unwanted
material). If a laboratory accumulates more than 55 gallons, the
current SAA regulations require that the excess of 55 gallons of
hazardous waste (or 1 quart of acutely hazardous waste) be removed
within three days. Under Subpart K, we proposed that if a laboratory
accumulates more than 55 gallons of unwanted material, all unwanted
material, including reactive acutely hazardous unwanted material, must
be removed within ten calendar days, and if a laboratory accumulates
more than 1 quart of reactive acutely hazardous unwanted material then
all reactive acutely hazardous unwanted material must be removed from
the laboratory within ten calendar days. In a laboratory clean-out
conducted under Subpart K, however, a laboratory has 30 days from the
starting date of the laboratory clean-out to complete the laboratory
clean-out without being required to remove the assembled unwanted
materials from the laboratory, even if the laboratory exceeds 55
gallons of unwanted material (or 1 quart of reactive acutely hazardous
unwanted material). This incentive provides flexibility by giving an
extension in the time allowed for removal of the unwanted material over
the three days allowed in the satellite accumulation area regulations,
as well as the ten days allowed in Subpart K for unwanted materials
that are routinely generated.
Second, we proposed that unwanted materials that are generated
during the 30 days of a laboratory clean-out and that are hazardous
wastes do not need to be counted toward the facility's generator
status. However, with this ``no counting'' incentive, we were and
remain concerned about inadvertently encouraging eligible academic
entities to retain unwanted materials that are generated in the
laboratory on a routine basis and to remove them only during a
laboratory clean-out, thereby improperly manipulating their generator
status. Two provisions in the proposal were intended to safeguard
against this. First was the proposed requirement for the college or
university to identify the start date of the laboratory clean-out in
its records. This, in combination with the proposed labeling
requirement for each container to have an accumulation start date
associated with it, provides a method of verification to ensure that
any container of unwanted material that has a date that pre-dates the
onset of the laboratory clean-out would not be considered to be from
the laboratory clean-out and the unwanted material would have to be
counted toward calculating the facility's generator status, assuming it
is determined to be hazardous waste. The second safeguard that was
proposed was that each laboratory at an eligible academic entity could
take advantage of the laboratory clean-out incentives only once per 12
month period. Given that each laboratory is required to have a
regularly scheduled removal of unwanted material at least every six
months, this was intended to ensure that each laboratory would have at
least one regularly scheduled removal during a calendar year between
laboratory clean-outs.
We received a large number of comments, covering all aspects of the
laboratory clean-out provisions. In general, there was overwhelming
support for the concept of the laboratory clean-out incentives,
although there was opposition expressed by some commenters, as well.
Based on these comments, in today's final rule, we have made some
revisions to the proposed laboratory clean-out provisions. Below, we
discuss the revisions to the proposed laboratory clean-out provisions,
as well as the aspects of the laboratory clean-out provisions that are
being finalized as proposed, and we provide clarifications regarding
the laboratory clean-out provisions.
b. Changes Made to the Laboratory Clean-Out Provisions
Many commenters expressed support for the laboratory clean-out
incentive that allowed them not to count their laboratory clean-out
hazardous wastes toward their generator status. On the other hand,
several commenters expressed concern that the Agency was creating a
system that would encourage laboratories to hold onto their routinely
generated unwanted materials until a laboratory clean-out, in order to
manipulate their generator status. We share the commenters' concerns
and have changed the provision of the laboratory clean-out incentive so
that only laboratory clean-out hazardous wastes that are unused
commercial chemical products are not counted toward the eligible
academic entity's generator status. Unused commercial chemical products
include chemicals that are discarded P- or U-listed commercial chemical
products, and unused discarded chemicals that are hazardous waste
because they exhibit one or more characteristics. Any unwanted material
that has been used and is a hazardous waste must be counted toward the
eligible academic entities generator status, even if it is removed
during the 30-day period of a laboratory clean-out. We intend for
routinely generated unwanted materials to be removed from the
laboratory during regularly scheduled removals, and we expect that the
bulk of these routinely generated unwanted materials will be used
chemicals. We do not consider these used, routinely generated unwanted
materials to be laboratory clean-out wastes and thus, they must be
counted toward the eligible academic entity's generator status.
Therefore, we have revised the regulatory language to be consistent
with our intent and to safeguard against the potential for abuse of the
laboratory clean-out incentive. This change will also emphasize that
the purpose of the laboratory clean-out is to remove unneeded or
unusable chemicals from the laboratory's inventory in order to increase
safety within the laboratory.
We will rely on existing regulations and guidance for defining what
is considered a used or unused commercial chemical product. For
example, the P- or U-listings of Sec. 261.33(e) and (f) apply only to
unused commercial chemical products. Therefore, a P- or U-listed
hazardous waste generated during a laboratory clean-out would not have
to be counted toward the eligible academic entity's generator status,
because, by definition, it would be unused. An unused
[[Page 72941]]
chemical that is a hazardous waste because it exhibits one or more
characteristics also would not have to be counted toward the eligible
academic entity's generator status if it were generated during a
laboratory clean-out. In a memo dated June 14, 1990, (Bussard to
Wilson, RCRA Online 11523), the Agency answered a series of
specific questions relating to the definition of ``used.'' In summary,
the memo states that dissolving or diluting P- or U-listed chemicals in
water, acids, bases, preservatives, or solvents to make laboratory
standards (in lieu of buying such solutions) does not constitute use of
these chemicals. In addition, any unused, leftover chemical (either P-
or U-listed, or characteristic) in an original container, either
unopened or opened, or that has been transferred to another container,
such as a squirt bottle, for use would also be considered unused.
Some commenters were concerned about the possibility that as a
result of the laboratory clean-out provision that allows some hazardous
waste not to count toward the eligible academic entity's generator
status, some eligible academic entities that are typically CESQGs but
would become either SQGs or LQGs as a result of a laboratory clean-out
(absent Subpart K), would be able to maintain their CESQG status. If
this were the case, the commenter was concerned that hazardous wastes
that should normally be managed as hazardous waste would be eligible to
be disposed of in a municipal solid waste landfill, which is allowed
under the CESQG regulations of Sec. 261.5. The Agency shares the
commenter's concern. In fact, in the preamble to the proposed rule we
stated, ``any hazardous waste that is not counted toward generator
status during a laboratory clean-out is still a hazardous waste and is
subject to all applicable regulations, including the land disposal
regulations, and the regulations for on-site and off-site management,
transportation, and treatment and disposal of hazardous waste. The
incentive that the Agency is proposing to provide for hazardous wastes
generated during a laboratory clean-out affects only the length of time
that hazardous wastes are stored on-site and other associated
regulations of 40 CFR 262.34 pertaining to generator status, such as
biennial reporting and contingency plans'' (see 71 FR 29739).
Nevertheless, we believe that for clarity it is appropriate to
revise the regulatory language of Sec. 262.213 to reflect the intent
of the rule as stated in the preamble to the proposed rule. This is
made all the more necessary by the expansion of the final rule to
include eligible academic entities that are CESQGs. If an SQG avoided
LQG status as the result of a laboratory clean-out incentive, the
hazardous waste would still be regulated as hazardous waste once it is
taken off-site, since both SQGs and LQGs must comply with the same
transportation and disposal regulations. With the inclusion of CESQGs
into the final rule, however, if a CESQG avoided becoming an SQG or LQG
as the result of a laboratory clean-out incentive, then potentially
regulated hazardous waste would be allowed to be disposed of at a
municipal solid waste landfill. Therefore, we are modifying the
language of Sec. 262.213(a)(2) to indicate that the effect of not
counting hazardous wastes that are unused commercial chemical products
toward the eligible academic entity's generator status is limited to
the on-site accumulation of the hazardous waste. In tandem, we also are
including a new paragraph, Sec. 262.213(a)(3), to indicate that for
the purposes of off-site management, if an eligible academic entity
generates more than the monthly CESQG limits (i.e., >1 kg of acutely
hazardous waste, or >100 kg of hazardous waste), then the eligible
academic entity must manage its hazardous waste according to all
applicable hazardous waste regulations for SQGs and LQGs. When
determining whether these monthly limits have been exceeded, the
eligible academic entity must count all of its hazardous wastes,
including those generated during laboratory clean-outs. In other words,
even when hazardous wastes are not counted toward the site's generator
status, if they are generated in excess of the CESQG monthly limits,
they are regulated as hazardous waste when they are transported,
treated, stored or disposed of off-site. EPA intended to create an
incentive to conduct laboratory clean-outs by relieving the generator
of some of the additional burden that would be incurred by changing
generator status. However, we did not intend to allow regulated
hazardous waste in excess of the CESQG monthly limits to be disposed of
in municipal solid waste landfills.
We illustrate how this would work by providing an example of a
likely scenario. An eligible academic entity that is normally a CESQG
conducts a laboratory clean-out. As a result of the laboratory clean-
out, the eligible academic entity generates 5 kg of P-listed hazardous
waste. Because P-listed hazardous wastes are all acute hazardous
wastes, the eligible academic entity generates more than 1 kg of acute
hazardous waste that month. Normally, this would mean that the eligible
academic entity would become subject to the LQG regulations for that
month. However, because the laboratory clean-out provisions allow the
eligible academic entity not to count the 5-kg of P-listed hazardous
waste from the laboratory clean-out toward its generator status, the
eligible academic entity will remain a CESQG under Sec. 261.5 for the
purposes of on-site accumulation of its hazardous waste, including the
acute hazardous waste. However, once the hazardous waste is sent off-
site, the eligible academic entity would not be allowed to send its
hazardous waste to a non-hazardous waste facility, such as a municipal
solid waste landfill, as allowed by the CESQG regulations of Sec.
261.5. Instead, because the eligible academic entity generated acute
hazardous waste in excess of the CESQG monthly limits (i.e., >1 kg
acute hazardous waste), the hazardous waste would have to be managed as
hazardous wastes when sent off-site. This means, for example, that the
hazardous waste would have to be manifested, comply with the LDRs, and
be either recyled or treated and disposed of at a hazardous waste TSDF.
A number of commenters expressed support for extending the
laboratory clean-out incentives to ancillary spaces, such as stockrooms
and laboratory preparatory rooms. As discussed in the preceding section
on the definition of laboratory (see Section III.B.2 and Sec.
262.200), these ancillary spaces would be considered laboratories,
whether they support individual laboratories or the laboratories of a
department, and thus would be eligible to take advantage of the
laboratory clean-out provisions. In fact, since these ancillary areas
typically store chemicals for use by nearby or surrounding
laboratories, we believe the clean-out provisions are especially
important for these ancillary areas.
Two commenters pointed out an inconsistency between the preamble
and the regulatory text with respect to how long records of laboratory
clean-outs must be kept. The preamble to the proposed rule stated that
records must be kept ``for as long as the college or university
operates under this new subpart'' (see 71 FR 29739), while the proposed
regulatory text stated that records pertaining to laboratory clean-outs
must be kept ``for a period of three years from the date the clean-out
ends.'' The proposed regulatory text reflects what we intended for
record retention pertaining to laboratory clean-outs. Thus, the final
rule makes clear that records for laboratory clean-outs must be kept
for three years from the date the clean-out ends.
[[Page 72942]]
c. Changes Not Made to the Laboratory Clean-Out Provisions
Many commenters expressed support for the 30-day timeframe for
conducting laboratory clean-outs, believing that 30 days is sufficient
time to conduct a laboratory clean-out. About the same number of
commenters, however, requested a longer timeframe for conducting
laboratory clean-outs. Suggestions ranged from 60 days to 180 days. One
commenter indicated that ``60 days is a more reasonable length of time
to arrange for and mobilize a hazardous waste contractor for on-site
lab-packing services, especially if the clean-out was unexpected or the
institution is in a remote location.'' We anticipate that in most
instances, laboratory clean-outs will be planned events. Therefore, we
continue to believe that 30 days is sufficient time to conduct a
thorough laboratory clean-out and we are finalizing the time limit for
laboratory clean-outs, as proposed.
Commenters asked the Agency when the 30 days of a laboratory clean-
out would begin--while the inventory of laboratory chemicals is being
sorted or when they are discarded? The definition of ``laboratory
clean-out'' in today's final rule is:
an evaluation of the inventory of chemicals and other materials in a
laboratory that are no longer needed or that have expired and the
subsequent removal of those chemicals or other unwanted materials
from the laboratory. A clean-out may occur for several reasons. It
may be on a routine basis (e.g., at the end of a semester or
academic year) or as a result of a renovation, relocation, or change
in laboratory supervisor/occupant. A regularly scheduled removal of
unwanted material as required by Sec. 262.208 does not qualify as a
laboratory clean-out.
Therefore, the 30 days of a laboratory clean-out starts when a trained
professional or laboratory personnel begins sorting through and
evaluating the inventory of laboratory chemicals, making decisions
about whether they are unwanted materials or not. Once it has been
determined that a chemical is, indeed, an unwanted material, as opposed
to a chemical or other material that can be kept in the laboratory for
further use, then the unwanted material becomes subject to the
requirements of Subpart K. We realize that a laboratory clean-out can
involve considerable planning before the laboratory clean-out begins.
Advanced planning for a laboratory clean-out prior to sorting and
evaluating a laboratory's chemical inventory is not considered the
start of the 30 days allowed for a laboratory clean-out.
At the conclusion of the laboratory clean-out, all unwanted
materials (or hazardous waste, if the hazardous waste determination is
made in the laboratory) must be removed from the laboratory. Note that,
as with routinely generated unwanted materials, unwanted materials from
a laboratory clean-out can be taken to an on-site CAA or TSDF to make
the hazardous waste determination. Eligible academic entities without
an on-site CAA, or on-site interim status or permitted TSDF will have
to make the hazardous waste determination for unwanted materials
generated during a laboratory clean-out in the laboratory before they
are removed from the laboratory and will have to be prepared to send
the hazardous wastes off-site at the conclusion of the 30-day clean-
out.
Finally, although a few commenters suggested that the Agency
require that eligible academic entities conduct laboratory clean-outs,
the Agency has decided not to do so. Rather, we believe that the
laboratory clean-out provisions are attractive enough to eligible
academic entities such that they will avail themselves of the clean-out
provisions without EPA forcing them to do so through a mandate.
d. Clarifications About the Laboratory Clean-Out Provisions
The Agency wants to reiterate the point that we view laboratory
clean-outs to be distinct from routine, regularly scheduled removals of
unwanted materials. In the course of normal laboratory operations, many
chemicals are used and will become unwanted materials and ultimately
may be determined to be hazardous wastes. This can occur as a result of
teaching or research activities or, in the case of teaching hospitals,
as a result of clinical or diagnostic activities. We expect that these
routinely generated wastestreams will comprise the bulk of the unwanted
materials that are removed from the laboratory during regularly
scheduled removals. On the other hand, a laboratory often can accrue a
large number of unused chemicals in its inventory, some of which can
become dangerous over time, developing the potential to cause
significant harm. It has been our observation that it is unusual for
laboratories to remove unused chemicals from their inventories on any
regular basis. We have developed the laboratory clean-out provisions to
provide incentives for laboratories to assess their inventory and
remove chemicals from the laboratory that are either dangerous or have
the potential to become dangerous, or are unlikely to be used in the
future, regardless of the reason. We anticipate that many eligible
academic entities will take advantage of the laboratory clean-out
provisions when a researcher or faculty member retires or moves, or
when a building is renovated. However, we are not limiting the use of
the laboratory clean-out provisions to these events because we would
like to encourage laboratories to develop the practice of more frequent
reviews and removals of their unneeded or unusable chemicals. However,
the laboratory clean-out incentives (i.e., having 30 days to conduct a
laboratory clean-out and not counting toward the eligible academic
entity's generator status the hazardous waste that consists of unused
commercial chemical products) is still limited to once per laboratory
per 12 month period.
Two commenters asked for clarification about the labeling and
container management standards that apply to laboratory clean-out
wastes. During the course of a laboratory clean-out, some chemicals
will be considered unwanted materials and ultimately hazardous wastes,
while others will not. Those laboratory clean-out chemicals that become
unwanted materials are subject to all the same labeling and container
management standards--as well as all other applicable requirements of
Subpart K--as any other unwanted material in the laboratory, with the
exceptions noted in Sec. 262.213(a)(1)-(4). On the other hand, those
chemicals that can continue to be used in the same laboratory would be
considered products, not unwanted materials, and would not be subject
to the labeling and container management standards of Subpart K. If a
clean-out chemical from one laboratory can be used in a different
laboratory, we can envision two probable scenarios. If the
determination is made in the laboratory that a chemical can be used in
another laboratory, it would not be considered an unwanted material;
rather, it would be considered a product and thus not regulated under
RCRA. If, on the other hand, the determination that the chemical can be
used in another laboratory is made after it is removed from the
laboratory, in an on-site CAA or TSDF, the clean-out chemical would be
regulated as an unwanted material until it is redistributed from the
CAA to another laboratory for further use.
Several commenters were concerned that if hazardous wastes
generated as a result of a laboratory clean-out do not have to be
counted toward the eligible academic entity's generator status, fewer
generators will have to submit a BR and the result would be under-
reporting of hazardous wastes from those eligible academic entities
that choose to be subject to the Subpart K requirements.
[[Page 72943]]
We acknowledge that there may be fewer generators reporting hazardous
waste generation as a result of the laboratory clean-out provisions not
to count hazardous waste that consists of unused commercial chemical
products toward the eligible academic entity's generator status because
under the Federal regulations, only LQGs have to submit the BR.
Nevertheless, we anticipate that even after subtracting laboratory
clean-out wastes when calculating their generator status, many eligible
academic entities will still generate enough hazardous waste to be
LQGs, based on their routinely generated laboratory waste, as well as
their non-laboratory hazardous wastes, in which case they will still be
required to submit the BR. Moreover, some States require SQGs to submit
a BR. For information on how to submit the BR with respect to hazardous
wastes generated during laboratory clean-outs, see Section III.D.1.
8. Laboratory Management Plan
Today's final rule requires that eligible academic entities
choosing to be subject to the Subpart K requirements must develop an
LMP. As EPA explained in the preamble to the proposed rule, the goal of
the LMP is for a college or university to plan carefully how it is
going to implement Subpart K's performance-based requirements for
safely managing the unwanted materials generated in laboratories. We
believe that the LMP provides a necessary supplement to the flexibility
provided in this rule and will ultimately work to increase
environmental performance and protection. EPA received positive
feedback from commenters about requiring the LMP. Many commenters
explained that requiring an LMP along with a performance-based approach
will help make it possible for eligible academic entities to achieve
their environmental goals, such as regulatory compliance, pollution
prevention and laboratory safety.
Some commenters misinterpreted EPA's intent for the LMP. One
commenter believed that each laboratory within a college or university
had to develop an LMP. That is not the case at all. Rather, EPA
intended that the eligible academic entity--a college or university, or
non-profit research institute or teaching hospital that is owned by or
has a formal written affiliation agreement with a college or
university--would create one LMP for all its laboratories that are
operating under Subpart K. In addition, if an eligible academic entity
has multiple EPA Identification Numbers or sites, then it can develop
one LMP to cover operations for all laboratories at all sites operating
under the Subpart K requirements. Also, a number of commenters
suggested that an eligible academic entity should list in its LMP which
laboratories would be covered under Subpart K and its LMP. The
commenters go on to state that each eligible academic entity should be
allowed to determine which of its laboratories will operate under
Subpart K and document this in its LMP. In response, and as described
earlier in the preamble, if multiple sites with separate EPA
Identification Numbers operate under one LMP, the LMP must identify
which sites are covered by the LMP. However, there is no requirement to
identify each laboratory within each site, as all laboratories at a
participating eligible academic entity within that site or covered by
an EPA Identification Number must operate under Subpart K (see section
III.C.1, Notification and Sec. 262.203). Nevertheless, should an
eligible academic entity choose to list all its laboratories that are
participating in Subpart K, it could be a valuable tool to manage
removals of unwanted material, as well as assist EPA and State
inspectors in determining compliance with the Subpart K requirements.
Another commenter argued that requiring an LMP would be redundant
documentation since laboratories are required to have a Chemical
Hygiene Plan under OSHA's Laboratory Standard. We disagree. As the
proposal clearly explained, a college or university (and now eligible
academic entities) can take an existing plan, such as the Chemical
Hygiene Plan and revise it to include the additional necessary
information or procedures required by today's rule.
Two requirements for the LMP are remaining the same in today's
final rule. First, an eligible academic entity must make its LMP
``available'' to laboratory workers, students, and anyone requesting
the LMP at the eligible academic entity. Examples may include, but are
not limited to, posting the LMP on the Web site of the participating
eligible academic entity or keeping a copy of the LMP at each
individual site of the eligible academic entity that is participating
in Subpart K. Second, since the LMP is a document to plan how an
eligible academic entity will meet the performance-based standards of
Subpart K, EPA requires the LMP to be reviewed and updated, as needed,
so that it is current with the waste management practices at the
eligible academic entity's laboratories.
Most of the comments received about the LMP centered on the two
options EPA co-proposed regarding the enforceability of the contents of
the LMP. Both proposed options required development of an LMP that
addressed how the college or university would achieve the performance-
based standards of the rule. The difference between the two options was
in the enforceability of the contents of the LMP. Under one proposed
option, compliance with the performance-based regulations was
enforceable, but the contents of the LMP were not enforceable. In the
other proposed option, the contents of the LMP were enforceable, as
well as compliance with the performance-based regulations.
EPA received comments supporting both options. There was a strong
belief from some commenters that if the EPA did not make the LMP's
contents enforceable, then the LMP would not be a meaningful document
and would not be followed. On the other side, commenters argued that
the LMP should not be enforceable; these commenters believed that an
enforceable LMP would compel colleges or universities to develop vague,
minimum procedures and that an enforceable LMP would be contrary to the
goals of a performance-based regulation.
Reviewing the Agency's reasons for proposing the requirement for an
LMP, EPA wanted colleges and universities to give careful thought
regarding the management of unwanted materials and hazardous waste
generated in their laboratories. Moreover, we wanted to encourage
colleges or universities to go above and beyond the regulations and to
think holistically about waste management on campus by planning and
developing best management practices (BMPs) in the LMP. We continue to
believe strongly that the LMP is necessary in order to provide the
planning component for implementing the provisions of this rule. Based
on our views regarding the purpose of the LMP and the comments we
received, we have decided to split the LMP into two parts--with the
contents of one part enforceable and the contents of the other part not
enforceable, although in order to be in compliance with Subpart K, an
eligible academic entity must address all nine elements in its LMP.
Thus, under the final rule, the LMP must be comprised of two parts
with a total of nine elements as specified in 40 CFR 262.214. The
specific contents in Part I of the LMP are enforceable, while the
specific contents in Part II of the LMP are not enforceable. Below is a
discussion of the required elements in the two Parts of the LMP. If an
element has remained the same as proposed, it is simply enumerated
without discussion.
[[Page 72944]]
a. Part I of the LMP
As a way to incorporate more flexibility into the regulations,
while maintaining the accountability in this Subpart, the contents of
Part I of the LMP are enforceable. This part of the LMP contains
necessary information for inspectors and other officials about what
options within Subpart K the eligible academic entity is exercising.
The two elements of Part I of the LMP are explained here:
1. Describe procedures for container labeling in accordance with
Sec. 262.206(a), including
i. Identifying whether the eligible academic entity will use the
term ``unwanted material'' on the containers in the laboratory. If
not, identify the equally effective term that will be used in lieu
of ``unwanted material'' and consistently by the eligible academic
entity. The equally effective term, if used, has the same meaning
and is subject to the same requirements as ``unwanted material.''
ii. Identifying the manner in which information that is
``associated with the container'' will be imparted.
The first sub-element allows flexibility in using different
terminology other than ``unwanted materials.'' Many commenters wrote
that they disliked the term ``unwanted materials'' because it was
overbroad and would cause confusion. While we do not necessarily agree
with these commenters, EPA does not object to including additional
flexibility concerning the terminology that can be used in the
laboratory instead of ``unwanted materials.'' \8\ However, in order for
an eligible academic entity to take advantage of this option, it must
identify another equally effective term (e.g., laboratory waste) in the
first element of Part I of its LMP. This equally effective term must be
used consistently in all of its laboratories operating under Subpart K
(see Section III.C.2 and Sec. 262.206(a)(1)(i)).
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\8\ If an eligible academic entity elects to use another equally
effective term in lieu of ``unwanted material,'' in compliance with
Sec. 262.206(a)(1)(i), the equally effective term will have the
same meaning as ``unwanted material.'' In addition, the equally
effective term shall be subject to all of the same requirements in
this rule that apply to unwanted materials.
---------------------------------------------------------------------------
The second sub-element of the first element of Part I of the LMP in
today's final rule requires eligible academic entities to describe the
manner in which information associated with the container will be
provided. For example, if an eligible academic entity chooses to use
barcodes and a computer tracking system to meet the requirement to have
information associated with a container, it must describe this in the
enforceable Part I of the LMP, so that inspectors know where the
associated container information resides.
2. Identify whether the eligible academic entity will comply with
Sec. 262.208(a)(1) or Sec. 262.208(a)(2) for regularly scheduled
removals of unwanted material from the laboratory.
In the second element of Part I of the LMP, an eligible academic
entity must describe which method it will exercise for the removal of
unwanted materials. Today's final rule adds another option for the
removal of unwanted materials, as described in Section III.C.5 of
today's preamble, in order to increase the flexibility for eligible
academic entities. However, with the added flexibility, we require that
the eligible academic entity documents which removal method it chooses
to use. For example, if an eligible academic entity elects to comply
with 40 CFR 262.208(a)(2), where it must remove containers of unwanted
material from each laboratory within six months of each container's
accumulation start date, then the eligible academic entity must record
this choice in Part I of the LMP. If the eligible academic entity
elects to comply with the other approach, that must be documented in
Part I of the LMP.
b. Part II of the LMP
As with Part I of the LMP, Part II of the LMP is required and must
reasonably address the seven required elements. EPA envisions that
eligible academic entities will use this section to capture BMPs for
holistic waste management within laboratories. In order to encourage
the development of BMPs, the specific contents of Part II of the LMP
are not enforceable. For example, should an eligible academic entity
explain that it will train students commensurate with their duties by
showing a video, but instead provides classroom instruction because the
video is broken, then the eligible academic entity is not in violation
of its LMP. The following are the seven elements that an eligible
academic entity must address in Part II of its LMP; discussed in the
order in which they appear in the regulations.
The first three elements of Part II of the LMP are
essentially the same as proposed.
The second element includes a minor change that was necessary
because of the change in the training and instruction requirements for
laboratory workers and students. Under the proposed rule, training was
required for laboratory workers, while instruction was required for
students. Today's final rule requires that for both laboratory workers
and students, training be commensurate with their duties. Elements one,
two, and three of Part II of the LMP are below:
1. Describe its intended best practices for container labeling
and management standards, including how the eligible academic entity
will manage containers used for in-line collection of unwanted
materials, such as with high performance liquid chromatographs and
other laboratory equipment (see the required standards at Sec.
262.206).
2. Describe its intended best practices for providing training
for laboratory workers and students commensurate with their duties
(see the required standard at Sec. 262.207(a)).
3. Describe its intended best practices for providing training
to ensure safe on-site transfers of unwanted material by trained
professionals (see the required standard at Sec. 262.207(d)(1)).
The fourth element of Part II of the LMP has changed since
proposal.
The fourth element of Part II of the LMP concerns the procedures of
regularly removing unwanted materials from the laboratory. While EPA is
not adding anything to this element, the regulatory language has been
modified to clarify what the Agency intends as part of this element.
That is, we have included two different types of removals of unwanted
materials from laboratories--regularly scheduled removals, and removals
when maximum volumes are exceeded--because they require different
procedures. This clarification will ensure that an eligible academic
entity develops a method to communicate with EH&S personnel or vendors
when laboratories exceed the maximum volume and a pickup of the
unwanted materials is needed. See the fourth element below:
4. Describe its intended best practices for removing unwanted
material from the laboratory, including:
a. For regularly scheduled removals--Develop a regular schedule
for identifying and removing unwanted materials from its
laboratories (see the required standards at Sec. 262.208(a)(1) and
Sec. 262.208(a)(2)).
b. For removals when maximum volumes are exceeded
A. Describe its intended best practices for removing unwanted
materials from the laboratory within 10 calendar days when unwanted
materials have exceeded their maximum volumes (see the required
standards at Sec. 262.208(d)).
B. Describe its intended best practices for communicating that
unwanted materials have exceeded their maximum volumes.
The fifth and sixth elements of Part II of the LMP have
remained essentially the same as proposed. The second part of element
six reflects one minor change. In the preamble to the proposed rule and
as finalized today, one of the requirements for a laboratory clean-out
is that an eligible academic entity must document its clean-out
activities (see section III.D.2 or Sec. 261.213(a)(4)). Because we are
not mandating that an
[[Page 72945]]
eligible academic entity document its laboratory clean-out in a
particular format or media, we are requiring that an eligible academic
entity develop procedures for documenting it as part of element six of
Part II of the LMP. See elements five and six below:
5. Describe its intended best practices for making hazardous
waste determinations, including specifying the duties of the
individuals involved in the process (see the required standards at
Sec. 262.11 and Sec. Sec. 262.209-262.212).
6. Describe its intended best practices for laboratory clean-
outs if the eligible academic entity plans to use the incentives for
laboratory clean-outs provided in Sec. 262.213, including:
a. Procedures for conducting laboratory clean-outs (see the
required standards at Sec. 262.213(a)(1)-(3)) and
b. Procedures for documenting laboratory clean-outs (see the
required standards at Sec. 262.213(a)(4)).
The seventh element of Part II of the LMP has changed
since proposal.
The seventh element has been expanded in the final rule based on
several comments about the characterization of unknown chemicals and
chemicals that degrade over time. The proposed rule required colleges
and universities to develop emergency prevention, notification, and
response procedures appropriate to the hazards in the laboratory, and
the final rule keeps this requirement as the first sub-element of
element seven. In comments, however, we were informed that laboratories
face issues with chemicals that expire and/or become dangerous as they
degrade. A good example of this is picric acid, which becomes explosive
if it becomes dehydrated/crystallized. Because of the threat some
chemicals may pose, the final rule requires that the seventh element of
Part II of the LMP includes a list of chemicals that the eligible
academic entity has or is likely to have that can degrade over time and
become more dangerous with age; the list of chemicals is intended to
facilitate the removal of these chemicals before a problem develops.
The third sub-element requires eligible academic entities to develop
procedures to dispose of these chemicals safely.
Finally, a number of commenters suggested that eligible academic
entities should develop procedures in their LMPs for identifying and
characterizing unknown chemicals in a timely manner. Since transporters
and TSDFs often will not accept unknown chemicals, the unknown
chemicals tend to remain on-site for extended periods. We agree with
the commenters and believe this requirement will assist in the timely
removal of these unknown chemicals and in emergency prevention for
laboratories. Thus, we have added it as the fourth sub-element of the
seventh element of Part II of the LMP. See the seventh element below:
7. Describe its intended best practices for emergency
prevention, including:
a. Procedures for emergency prevention, notification, and
response, appropriate to the hazards in the laboratory, and
b. A list of chemicals that the eligible academic entity has, or
is likely to have, that become more dangerous when they exceed their
expiration date and/or as they degrade, and
c. Procedures to safely dispose of chemicals that become more
dangerous when they exceed their expiration date and/or as they
degrade, and
d. Procedures for the timely characterization of unknown
chemicals.
In summary, an eligible academic entity must develop an LMP with
two parts covering a total of nine elements. The contents of the two
elements in Part I of the LMP are enforceable. Part II of the LMP is
intended to encourage eligible academic entities to develop BMPs for
their laboratories. While the contents of Part II of the LMP are not
enforceable, eligible academic entities must reasonably address the
seven required elements.
9. How CESQGs Comply With Subpart K and How They Differ From LQGs and
SQGs
In most respects, an eligible academic entity that opts into
Subpart K is regulated the same, regardless of whether the eligible
academic entity is a CESQG, SQG, or LQG. However, because CESQGs are
regulated differently than SQGs and LQGs under the existing generator
regulations, we have had to tailor some sections of the Subpart K
requirements to reflect their inclusion. This section discusses how the
Subpart K requirements will be implemented for CESQGs.
Specifically, Subpart K provides an alternative set of requirements
for generators of laboratory hazardous waste. For SQGs and LQGs,
Subpart K provides an alternative to Sec. Sec. 262.11 and 262.34(c)
(the SAA regulations). For CESQGs, however, the Subpart K requirements
provide an alternative to the conditional exemption in Sec. 261.5(b),
which exempts hazardous waste from regulation under 40 CFR Parts 124,
262-266, 268, 270, and the notification requirements of RCRA section
3010, provided the CESQG complies with the conditions of the exemption.
Thus, by choosing to become subject to Subpart K, an eligible academic
entity relinquishes its conditionally exempt status and becomes subject
to the requirements of 40 CFR part 262, Subpart K, while managing its
unwanted materials and hazardous wastes in its laboratories. However, a
CESQG also will be able to take advantage of the two main benefits of
the alternative standards: Making the hazardous waste determination
before the unwanted materials are removed from the laboratory (but at a
time after the initial generation) and the laboratory clean-out
provisions.
As with other eligible academic entities, an eligible academic
entity that is a CESQG and that opts into Subpart K must notify EPA of
its intended participation using the Site Identification Form (EPA Form
8700-12). One of the fields on the Site Identification Form asks for
the site's EPA Identification Number. We realize that most CESQGs will
not have EPA Identification Numbers when they submit their
notifications for Subpart K and they are not required to apply for one,
although some States may choose to assign an Identification Number once
a Site Identification Form is submitted. If an eligible academic entity
that opts into Subpart K is a CESQG and does not have an EPA
Identification Number, all of the laboratories owned by the eligible
academic entity and that are on-site (as opposed to under the same EPA
Identification Number) will be subject to Subpart K.
Many college and university commenters informed the Agency that
they have multiple EPA Identification Numbers (or sites) within a
single campus. When a campus is divided into numerous sites, each site
has its own generator status, based on its monthly generation of
hazardous waste. Therefore, a single campus may be comprised of sites
that are CESQGs, SQGs, and LQGs. Some other commenters also indicated
that they have field laboratories, which may not be on campus, that are
typically CESQGs, and which may not be on campus, but that laboratory
personnel often work in both the campus laboratories and the field
laboratories. Commenters requesting that CESQGs be allowed to be
subject to Subpart K argued that it would be to their benefit to have
the same management standards for the hazardous wastes generated in all
of their laboratories. The Agency agrees and is clarifying that when
eligible academic entities that are CESQGs choose to be subject to the
Subpart K requirements, their laboratories must follow the same
container labeling, container management, training requirements and all
other management standards for the management of their unwanted
materials in the laboratory as other generators operating under Subpart
K.
[[Page 72946]]
Since CESQGs will not have an on-site CAA or TSDF, CESQGs must make
the hazardous waste determination in the laboratory before the unwanted
materials may be removed from the laboratory (but at a time after the
initial generation of the unwanted materials). We realize that a CESQG
may be part of a larger ``main'' campus that has a CAA and that the
eligible academic entity may want to bring the unwanted materials from
the CESQG site to the main campus's CAA to make the hazardous waste
determination. However, today's rule does not allow for this and all
hazardous waste determinations must be made on-site before the unwanted
material may be treated or disposed of on-site or transported off-site.
Today's rule does not allow for off-site consolidation of unwanted
materials or hazardous wastes, with two exceptions that are discussed
in section III.C.10 of today's preamble. As discussed previously,
eligible academic entities, including CESQGs, may consolidate unwanted
materials on-site in another laboratory (see section III.C.5.c of
today's preamble for more detail).
Once the hazardous waste determination is made in accordance with
Sec. 262.11, the eligible academic entity must count the unwanted
materials that are hazardous wastes toward calculating its monthly
generator status and it must remove the hazardous waste from the
laboratory directly. If the total quantity of hazardous waste for the
month for the site is below the CESQG limits (i.e., <1 kg of acutely
hazardous waste and <100 kg of hazardous waste), the hazardous waste
may be managed as CESQG hazardous waste when removed from the
laboratory. That is, the hazardous waste may be managed at any of the
types of facilities listed in Sec. 261.5(f)(3) for acute hazardous
waste, or Sec. 261.5(g)(3) for hazardous waste:
(i) Permitted under 40 CFR part 270.
(ii) In interim status under 40 CFR parts 265 and 270.
(iii) Authorized to manage hazardous waste by a State with a
hazardous waste management program approved under 40 CFR part 271.
(iv) Licensed, registered or permitted by the State to manage
municipal solid waste, and if managed in a solid waste landfill is
subject to 40 CFR part 258.
(v) Licensed, registered or permitted by the State to manage non-
municipal non-hazardous waste, and if managed in a non-municipal non-
hazardous waste disposal unit is subject to 40 CFR 257.5-257.30.
(vi) Beneficially uses, reuses, legitimately recycles or reclaims
its waste; or treats its waste prior to beneficial use, reuse,
legitimate recycling or reclamation, or
(vii) For universal waste, a universal waste handler or destination
facility subject to the requirements of 40 CFR part 273.
Eligible academic entities that are CESQGs or have CESQG sites also
will be able to take advantage of the laboratory clean-out provisions
in the final rule. That is, CESQGs can have up to 30 days to conduct a
laboratory clean-out and not be required to count hazardous wastes that
are unused commercial chemical products and that are generated during a
laboratory clean-out toward calculating their generator status. Thus,
we believe that the laboratory clean-out incentives will now provide a
considerable benefit to generators that are typically CESQGs, but
become LQGs on an episodic or periodic basis when they discard unused
commercial chemical products (either listed or characteristic) from
their laboratories. As discussed in section III.B.7 of today's
preamble, even if the laboratory clean-out incentives allow an eligible
academic entity to maintain its conditionally exempt status, if the
eligible academic entity generates hazardous waste in quantities in
excess of the CESQG monthly limits, the hazardous waste is fully
regulated as hazardous waste when it is transported, treated, stored or
disposed of off-site (also see Sec. 262.213).
10. Off-site Consolidation
a. Off-site Consolidation by CESQGs
Several commenters suggested that the Agency allow the off-site
consolidation of unwanted materials at a centralized, off-site
location. These commenters generally suggested this as part of their
request to expand the applicability of the final rule to include
CESQGs. The current generator regulations, for any generator status,
provide limited opportunities for a generator to accept off-site
shipments of another generator's hazardous waste. Under both the
existing generator regulations, as well as under today's final rule,
there are two situations that allow for a generator to receive
hazardous waste from another, off-site generator.
The first situation applies to the off-site consolidation of
hazardous waste generated only by CESQGs. Under Sec. 261.5, in order
to qualify as a CESQG, a CESQG must ensure delivery of its acute
hazardous waste and hazardous waste to one of the seven types of
facilities listed in Sec. 261.5(f)(3) and 261.5(g)(3):
(i) Permitted under 40 CFR part 270.
(ii) In interim status under 40 CFR Parts 265 and 270.
(iii) Authorized to manage hazardous waste by a State with a
hazardous waste management program approved under 40 CFR part 271.
(iv) Licensed, registered or permitted by the State to manage
municipal solid waste, and if managed in a solid waste landfill is
subject to 40 CFR part 258.
(v) Licensed, registered or permitted by the State to manage non-
municipal non-hazardous waste, and if managed in a non-municipal non-
hazardous waste disposal unit is subject to 40 CFR 257.5 through
257.30.
(vi) Beneficially uses, reuses, legitimately recycles or reclaims
its waste; or treats its waste prior to beneficial use, reuse,
legitimate recycling or reclamation, or
(vii) For universal waste, a universal waste handler or destination
facility subject to the requirements of 40 CFR part 273.
If a CESQG that generates hazardous waste wants to send its
hazardous waste to an off-site consolidation area for centralized
collection, it must send its hazardous waste to a collection site that
would qualify as one of the above mentioned facilities in order to
still qualify as a CESQG. Thus, a receiving generator could be an
acceptable collection site if it qualified as one of the seven
categories of facilities above. For example, a CESQG could send its
hazardous waste to an eligible academic entity if such receiving entity
was an interim status or permitted TSDF or was authorized by the State
to manage hazardous waste under the State approved program. If the
CESQG that generates hazardous waste sends it to another generator that
does not qualify as one of the facilities specified above, the
generating CESQG would not meet the conditions of the CESQG exemption
and would be subject to the applicable generator regulations of 40 CFR
part 262 (see Q&A dated April 4, 1987; RCRA Online 12894).
b. Off-site Consolidation by CESQGs, SQGs, and LQGs
The second situation applies to all generator categories. A
generator can send its hazardous waste to another generator's site if
the receiving site qualifies as a transfer facility (see Q&A dated
April 4, 1987; RCRA Online 12894). Under Sec. 263.12,
hazardous waste may be stored in containers at a transfer facility for
ten days or less without requiring interim status or a permit. A
transfer facility is defined in 40 CFR 260.10 as `` * * * any
transportation related facility including loading docks, parking areas,
storage
[[Page 72947]]
areas, and other similar areas where shipments of hazardous waste are
held during the normal course of transportation.'' It is possible that
a generator may qualify as a transfer facility, as long as the
hazardous waste it receives is not stored on-site for more than ten
days. As stated previously, the hazardous waste determination must be
made for all unwanted materials prior to transporting them off-site,
regardless of whether the off-site transportation includes a stop at a
transfer facility.
11. Topics That Are Outside the Purview of This Rulemaking
EPA has consistently interpreted our existing hazardous waste
regulations to allow generators to non-thermally treat the hazardous
waste they generate on-site in their accumulation tanks and containers,
without needing to obtain a RCRA permit or having interim status (51 FR
10168, March 24, 1986). Examples of treatment that may be conducted in
accumulation tanks and containers without a permit or interim status
include precipitating heavy metals from solutions and oxidation/
reduction reactions. A permit or interim status would be required to
store and/or treat hazardous waste that is consolidated from off-site
locations or if the treatment was thermal treatment.
Many commenters suggested that the Subpart K requirements should
specifically address treatment of hazardous waste by generators in
laboratories. In the proposal to Subpart K, the Agency did not
specifically identify a regulatory approach for the treatment of
hazardous waste by generators in laboratories. Therefore, because the
Agency did not provide notice and an opportunity for public comment on
this subject, it is outside the scope of this rulemaking and EPA does
not intend to add any such provisions to the final rule. While today's
final rule does not specifically address the treatment of hazardous
waste in laboratories, it also does not change EPA's interpretation of
its existing regulations.
We have also often been informed, and commenters confirmed, that it
is not uncommon for an eligible academic entity to have numerous EPA
Identification Numbers per ``campus.'' Typically, this is because the
campus is intersected by public roads so that not all areas of the
campus are considered ``on-site,'' as defined by RCRA. We received
several comments encouraging EPA to allow a single EPA Identification
Number per campus. We did not specifically identify in the proposal to
Subpart K a regulatory approach for allowing one EPA Identification
Number per campus. Therefore, because the Agency did not provide notice
and an opportunity for public comment on this subject, it is outside
the scope of this rulemaking and EPA does not intend to add any such
provisions to the final rule.
D. Reporting and Recordkeeping
1. Reporting to the Biennial Report for Eligible Academic Entities That
Are LQGs
Under the existing generator regulations, LQGs are required to
submit information about their hazardous waste generation and
management activities in the BR. The data are prepared and submitted to
the EPA Regions (or authorized States) in even-numbered years (e.g.,
2006) and must include waste information from the previous, odd-
numbered year (e.g., 2005). The data submitted for the BR is retained
in the RCRAInfo System. When developing rulemakings, the Agency often
relies on data submitted for the BR to inform us about various aspects
of the hazardous waste activities, such as identifying generators of
hazardous wastes and waste generation and management activities (i.e.,
number of hazardous waste generators and volume of hazardous waste
being generated and managed). When analyzing data in the RCRAInfo
System to support the development of this rulemaking, it became clear
to the Agency that there are a variety of ways in which similar
entities with similar hazardous waste generation patterns report data
for the BR. The Agency recognizes the differences in reporting may be
situational; however, we offer suggestions here for reporting future
laboratory hazardous waste activities to the BR that will assist the
Agency in analyzing data in a more consistent and accurate manner.
On the Generation and Management (GM) form of the BR, we suggest
the use of the Source Code G22 (Laboratory analytical wastes (used
chemicals from laboratory operations)) would be appropriate in most
cases for hazardous wastes that are generated in the laboratory and
that are not from a laboratory clean-out. When G22 is not applicable,
but the hazardous wastes are generated in a laboratory, the generator
should indicate in the comment field (when provided by the State) that
the hazardous waste originated in a laboratory. In addition, the Form
Codes W001 (Lab packs from any source not containing acute hazardous
waste) and W004 (Lab packs from any source containing acute hazardous
waste) should be used when applicable.
If an eligible academic entity submits a BR that includes hazardous
waste from laboratory clean-outs, the Agency's guidance on preparing
the GM Form of the BR is to use the Source Code G11, for the discarding
of off-specification or out-of-date chemicals or products. If the
State's version of the GM form provides a comment section, we suggest
the eligible academic entity indicate that the hazardous waste is from
a Subpart K laboratory clean-out.
2. Recordkeeping
Today's final rule requires that eligible academic entities
choosing to comply with the Subpart K requirements maintain certain
records. Specifically, eligible academic entities must maintain the
following records: (1) Notification(s) to the appropriate EPA Regional
Administrator (or State Director, in authorized States) of its
participation in or subsequent withdrawal from Subpart K (using the EPA
Site Identification Form (EPA Form 8700-12)); (2) non-profit research
institutes and teaching hospitals that are not owned by a college or
university must keep the formal written affiliation agreement on file;
(3) training records for laboratory workers defined in 40 CFR 262.200
of this Subpart at participating LQG eligible academic entities; (4)
documentation of laboratory clean-out activities identifying the
laboratory being cleaned out, the date the clean-out begins and is
completed, and the volume of hazardous waste generated during the
clean-out that is conducted in accordance with Sec. 262.213; and (5)
an LMP (an existing plan may be modified to address the specific
requirements of this alternative regulation).
EPA is not requiring that a participating eligible academic entity
keep all required records, such as notifications, training records,
formal written affiliation agreements and the LMP together. However,
EPA believes filing all required records together, if practicable, may
enhance the ease of accessibility by those individuals needing access
to the records at any given time. Additionally, having the records
located in one central location may help increase efficiency of
inspections by reducing the amount of time expended to locate records
that may be kept in several different locations at a participating
institution (e.g., training records might normally be filed with
personnel files and the LMP might normally be kept at the EH&S
department).
EPA is requiring that an eligible academic entity maintain a copy
of its notification to participate in this
[[Page 72948]]
Subpart on file in-house (i.e., at the participating eligible academic
entity) for the duration that the institution remains subject to the
Subpart K requirements. Additionally, an eligible academic entity must
maintain a copy of its notification to withdraw from Subpart K on file
for three years from the date of the notification of withdrawal from
the Subpart K requirements.
Because of the expansion in scope of today's final rule, the Agency
has added recordkeeping for teaching hospitals and non-profit research
institutes, as defined in the final rule. In order to document that a
non-profit research institute or a teaching hospital is eligible to opt
into Subpart K, the non-profit research institute or teaching hospital
must keep on file for the duration that the institution remains subject
to the Subpart K requirements a copy of the formal written affiliation
agreement that it has with the college or university. For a teaching
hospital, the formal written affiliation agreement must consist of a
master affiliation agreement and program letter of agreement with the
medical college or school with which it is affiliated.
We reiterate that today's final rule does not change the existing
recordkeeping requirements for documenting training of trained
professionals at LQGs. Under the existing hazardous waste generator
regulations, LQGs must comply with the recordkeeping requirements found
at 40 CFR 265.16(e). Since this rule simply refers to the existing
applicable training requirements pertaining to an eligible academic
entity's generator status, training records for trained professionals
(i.e., individuals conducting the hazardous waste determination or
transferring unwanted materials on-site) must be maintained at LQGs.
SQG training requirements at 40 CFR 262.34(d)(5)(iii) do not require
retention of training records; therefore, Subpart K does not require
training records to be kept for trained professionals at SQGs.
Likewise, training records are not required for trained professionals
at CESQGs. Furthermore, training records for students are not required
for LQGs, SQGs or CESQGs.
In addition, as proposed, today's final rule requires that LQG
eligible academic entities maintain documentation that demonstrates
that laboratory workers have been trained commensurate with their
duties. As with trained professionals, these records must be kept for
the duration specified in Sec. 265.16(e). Thus, these training records
must be kept until the institution closes or for three years after the
departure of a trained professional or laboratory worker.
Additionally, as proposed, today's final rule includes a
recordkeeping provision for laboratory clean-out events at
participating eligible academic entities. Section 262.213(a)(4) of
today's rule requires eligible academic entities to document their
clean-out activities. EPA is not mandating a particular record format
or media. Instead, participating institutions may determine the most
appropriate type of record that best suits their individual
capabilities and recordkeeping systems (e.g., filed hard copy,
electronic copy). However, the documentation must contain certain
information and be retained at the eligible academic entity for three
years from the date the laboratory clean-out ends. Specifically, this
documentation must identify the particular laboratory that is being
cleaned out, the date the clean-out began and ended, and the volume of
hazardous waste generated during the clean-out. This documentation is
particularly relevant since a laboratory may only utilize the
laboratory clean-out provision incentives (i.e., not counting hazardous
wastes that are unused commercial chemical products toward its
generator status and the 30-day allowance for removal) once per 12-
month period per laboratory.
Also, EPA is requiring that a copy of a participating eligible
academic entity's LMP be retained on file at the participating
institution for the duration that it is regulated under 40 CFR part
262, Subpart K. Furthermore, we recommend that the LMP be dated. While
EPA is not requiring that a copy of the LMP at a participating eligible
academic entity be kept at each individual site with a unique EPA
Identification Number that has opted in, we do require that the LMP is
``available'' by anyone involved in the management of unwanted
materials (e.g., students in the laboratory, faculty, inspectors and
other relevant regulatory authorities). The participating eligible
academic entity will determine how best to meet the requirements of
making the LMP available since EPA envisions that an LMP will be
revised periodically. Examples of ``available'' may include, but are
not limited to, posting the LMP on the participating eligible academic
entities Web site or other universally accessible electronic system, or
keeping a copy of the LMP at each individual site that has opted in.
Today's rule strives to reduce or minimize additional recordkeeping
requirements on eligible academic entities participating in Subpart K.
As an example, we believe some participating eligible academic entities
will revise their current required planning documents, such as the
Chemical Hygiene Plan (CHP), which is required by OSHA's Laboratory
Standard regulations at 29 CFR 1910.1450. In such cases, there would be
minimal additional recordkeeping associated with an LMP. However, we
also understand that this may not be true in all cases. When planning
documents don't already exist, an additional recordkeeping requirement
would be associated with maintaining an LMP since eligible academic
entities will need to develop this document to comply with this
Subpart.
We solicited comment on whether there should be a requirement to
retain records of the labels associated with containers. The
information on the label associated with containers, such as the
accumulation start date and information sufficient to make a hazardous
waste determination, was assumed to be either electronic, via
spreadsheets and bar codes, or written logs and in the proposed rule
EPA considered requiring that this information be retained on file as a
record. However, commenters noted that records of container labels
should not be retained because it would be too burdensome and
unnecessary. We agree with the commenters and believe that other
recordkeeping requirements sufficiently document the information
necessary for inspections of laboratories at eligible academic
entities. Therefore, the final rule does not require that records be
kept for labeling information associated with containers, beyond the
time that a hazardous waste determination is made for the contents.
EPA also solicited comment in the proposal on whether maintenance
of any other records or reporting requirements should be required under
today's Subpart K regulations for purposes of improving implementation,
compliance monitoring and assistance by the relevant regulatory
authority or for program implementation. Comments submitted by the
academic community stated, ``do not add recordkeeping.'' These comments
noted that the proposed recordkeeping or documentation requirements for
notification, labeling, laboratory clean-outs and the LMP are
sufficient to ensure compliance and measure success. We agree with
these commenters that additional recordkeeping or reporting
requirements beyond what was included in the proposal are unnecessary
to ensure compliance with today's rule. Therefore, in today's final
rule, we are not including any new or additional
[[Page 72949]]
recordkeeping or reporting requirements to the final rule.
E. Implementation and Enforcement
Subpart K blends traditional regulatory requirements with
performance-based standards to maximize flexibility and enable better
environmental compliance at eligible academic entities. Subpart K also
offers greater flexibility in implementation than the existing
generator requirements. As such, we are highlighting some points on
compliance for a few of the more flexible requirements of Subpart K.
First, only eligible academic entities, as defined in this final
rule, may participate in Subpart K. As this rule is optional, eligible
academic entities must at all times comply with either the existing
generator regulations or with today's Subpart K requirements.
Specifically, under today's final rule, an eligible academic entity
must decide under which set of standards (existing generator standards
or Subpart K) it will operate all of its laboratories that are covered
by the same EPA Identification Number (or that are on-site) and notify
EPA if it chooses to opt into Subpart K. Eligible academic entities may
have several sites with unique EPA Identification Numbers, and each
site may have laboratories. It is important to note that eligible
academic entities operating laboratories with different EPA
Identification Numbers may elect which laboratories will opt into or
withdraw from Subpart K on a site-by-site basis.
Second, since this rule is for laboratories only, it is likely that
participating eligible academic entities will be subject to two
different sets of requirements for hazardous waste management: 40 CFR
part 262, Subpart K for unwanted materials generated in its
laboratories, and existing generator requirements for all other
hazardous wastes generated at these institutions. As a result,
implementers (eligible academic entities and compliance and enforcement
individuals) will need to determine whether the laboratories at an
eligible academic entity are operating under Subpart K (i.e., under
different generator regulations) from the remainder of the site for
compliance monitoring and assistance.
Third, because the enforcement of the contents of the LMP differs
for Part I and Part II, and participating entities may modify an
existing plan to meet the LMP requirements, we reiterate the
requirements relating to the different parts below (see preamble
section III.C.8 or Sec. 262.214 of today's final rule for all
requirements related to the LMP). We also remind eligible academic
entities that if they choose to modify an existing plan in order to
meet the LMP requirements under Subpart K, today's rule does not
supersede or otherwise affect the requirements related to that existing
plan.
For Part I of the LMP, the eligible academic entity must implement
and comply with the specific contents for all the elements they develop
for Part I. For example, if an eligible academic entity chooses to use
another ``equally effective term'' for ``unwanted material,'' then it
must identify the term in Part I of its LMP and must use this equally
effective term consistently. In addition, the equally effective term is
subject to all requirements of this rule that apply to unwanted
materials. If the eligible academic entity uses another term, but fails
to identify the equally effective term in Part I of its LMP, or uses a
different term not identified in Part I of its LMP, then the eligible
academic entity would be considered in violation of Subpart K.
While an eligible academic entity's LMP must include, and
reasonably address, the required elements in Part II of its LMP, if the
eligible academic entity does not meet or implement the specific
contents of the elements in Part II of its LMP, an enforcement action
would not be brought against it for such deviations. For example, an
eligible academic entity must describe in Part II of its LMP how it
will provide training for laboratory workers and students commensurate
with their duties. If the institution describes a training program that
specifies the number of hours of classroom training for laboratory
workers or students in its LMP, but they receive either a different
number of hours, or a different type of training, such as video
instruction, the participating institution would not be in violation of
Subpart K, provided the laboratory workers and students are trained
commensurate with their duties.
Finally, today's rule would not affect a participating eligible
academic entity's obligation to respond promptly to any releases of
hazardous wastes that may occur, including releases of unwanted
materials in the laboratory. Any management of released unwanted
material not in compliance with applicable Federal and State hazardous
waste requirements could result in an enforcement action. For example,
if a spill or release of hazardous waste occurred and was not
immediately cleaned up, the participating eligible academic entity
could potentially be subject to enforcement for illegal disposal of the
hazardous waste. In addition, solid and hazardous waste releases could
potentially be addressed through enforcement orders, such as orders
under RCRA sections 3013 and 7003.
IV. State Authorization
A. Applicability of Rules in Authorized States
Under section 3006 of RCRA, EPA may authorize a qualified State to
administer its own hazardous waste programs within the State in lieu of
the Federal program. Following authorization, EPA retains enforcement
authority under Sections 3008, 3013, and 7003 of RCRA, although
authorized States have primary enforcement responsibility. The
standards and requirements for State authorization are found at 40 CFR
part 271.
Prior to enactment of the Hazardous and Solid Waste Amendments of
1984 (HSWA), a State with final RCRA authorization administered its
hazardous waste program entirely in lieu of EPA administering the
Federal program in that State. The Federal requirements no longer
applied in the authorized State, and EPA could not issue permits for
any facilities in that State, since only the State was authorized to
issue RCRA permits. When new, more stringent Federal requirements were
promulgated, the State was obligated to enact equivalent authorities
within specified time frames. However, the new Federal requirements did
not take effect in an authorized State until the State adopted the
Federal requirements as State law.
In contrast, under RCRA section 3006(g) (42 U.S.C. 6926(g)), which
was added by HSWA, new requirements and prohibitions imposed under HSWA
authority take effect in authorized States at the same time that they
take effect in unauthorized States. EPA is directed by the statute to
implement these requirements and prohibitions in authorized States,
including the issuance of permits, until the State is granted
authorization to do so. While States must still adopt HSWA related
provisions as State law to retain final authorization, EPA implements
the HSWA provisions in authorized States until the States do so.
Authorized States are required to modify their programs only when
EPA enacts Federal requirements that are more stringent or broader in
scope than the existing Federal requirements. RCRA section 3009 allows
the States to impose standards more stringent than those in the Federal
program (see also 40 CFR 271.1). Therefore, authorized States may, but
are not required to, adopt Federal regulations, both HSWA
[[Page 72950]]
and non-HSWA, that are considered less stringent than previous Federal
regulations.
B. Effect on State Authorization
Today's rule finalizes regulations that are not being promulgated
under the authority of HSWA. Thus, the standards finalized today would
be applicable on the effective date only in those States that do not
have final authorization of their base RCRA programs. Moreover,
authorized States are required to modify their programs only when EPA
promulgates Federal regulations that are more stringent or broader in
scope than the authorized State regulations. For those changes that are
less stringent or reduce the scope of the Federal program, States are
not required to modify their program. This is a result of section 3009
of RCRA, which allows States to impose more stringent regulations than
the Federal program. However, today's final rule is considered to be
neither more nor less stringent than the current standards. Therefore,
authorized States would not be required to modify their programs to
adopt regulations consistent with and equivalent to today's standards.
Nevertheless, because EPA believes that today's rule will increase the
ability of eligible academic entities to comply with the RCRA hazardous
waste generator regulations which would likely lead to greater
environmental protection, EPA strongly encourages States to adopt
today's rule. Eligible academic entities located in authorized States
wishing to be subject to Subpart K do not have this option until their
State has adopted the final rule.
V. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993),
this action is a ``significant regulatory action'' since this action
may raise novel legal or policy issues [3(f)(4)]. Accordingly, EPA
submitted this action to the Office of Management and Budget (OMB) for
review under EO 12866. Any changes made in response to OMB
recommendations have been documented in the docket for this action.
This rule is projected to result in benefits to society in the form
of cost savings. The aggregate cost savings for all eligible academic
entities that are projected to take advantage of the final rule is
estimated to be $396,000 per year. This figure is significantly below
the $100 million threshold \9\ established under part 3(f)(1) of the
Order. Thus, this rule is not considered to be an ``economically
significant action.'' However, in an effort to comply with the spirit
of the Executive Order, we have prepared an economic assessment in
support of today's action. This document is entitled: Assessment of
Potential Costs, Benefits and Other Impacts for the Revised Standards
Applicable to Generators of Hazardous Waste; Subpart K--Laboratories
Owned by Eligible Academic Entities. This document is otherwise
referred to as the ``Economic Assessment.'' The docket established for
today's rulemaking maintains a copy of this Economic Assessment for
public review. For a more detailed discussion regarding the comments
received on the economic assessment for the proposed rule, refer to the
Response to Comments Document which can be found in the docket for
today's final rule.
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\9\ The $100 million threshold applies to both costs, and cost
savings.
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1. Introduction to the Economic Assessment for the Final Rule
The value of any regulatory action is traditionally measured by the
net change in social welfare that it generates. The Agency's economic
assessment conducted as part of EPA's obligations under Executive Order
12866 evaluates costs, cost savings (benefits), waste quantities
affected, and other impacts, such as environmental justice, children's
health, unfunded mandates, regulatory takings, and small entity
impacts. To conduct this analysis, we prepared a baseline
characterization, developed and implemented a methodology for examining
impacts, and followed appropriate guidelines and procedures for
examining equity considerations, children's health, and other impacts.
2. Baseline Specification
Proper baseline specification is vital to the accurate assessment
of incremental costs, benefits, and other economic impacts associated
with any rulemaking. The baseline essentially describes the world
absent today's final rulemaking. The incremental impacts of today's
final rule are evaluated by assessing anticipated post-rule responses
with respect to baseline conditions and actions. The baseline, as
applied in this analysis, reflects the practices and requirements of
eligible academic entities under the existing hazardous waste generator
regulations. A full discussion of the baseline specification is
presented in the Economic Assessment.
3. Analytical Methodology, Primary Data Sources, and Key Assumptions
The first step in the methodology for the economic assessment of
today's final rule was to use data from EPA's 2005 National Biennial
Report database and other sources to estimate the number of eligible
academic entities that generate laboratory hazardous wastes and may be
affected by the final rule. Several of the comments submitted to EPA
expressed concern that in the proposed rule, EPA underestimated the
fraction of hazardous waste generated in teaching and research
laboratories at colleges and universities compared to total hazardous
waste generated at colleges and universities. In contrast to the 9
percent estimate used by EPA for its economic analysis for the proposed
rule, these commenters stated that in their experience, laboratory
hazardous waste represents a much larger portion (60 to 95 percent) of
a college or university's total hazardous waste stream. Several
commenters provided detailed data on their hazardous waste generation
especially laboratory hazardous waste. To address this concern, a more
refined methodology for estimating the quantity of hazardous waste
generated by laboratories at eligible academic entities was developed.
For more details about the methodology changes, see section III.A.1 of
today's preamble or the economic assessment for today's final rule.
Since today's final rule is equally as stringent as the existing
Federal hazardous waste regulations, authorized States are not required
to adopt Subpart K. Thus, once the number of eligible academic entities
was determined, for purposes of the rule's Economic Assessment, EPA
estimated how many States would adopt Subpart K. EPA assumed that
States which have historically adopted at least 85 percent of RCRA's
rule changes over a five-year period will adopt Subpart K. Thus, 29
States and Puerto Rico are projected to adopt today's final rule, while
21 States are assumed to not adopt today's rule.
In order to model the various scenarios at eligible academic
entities, we employed four factors to categorize eligible academic
entities: institution type, laboratory system size, hazardous waste
generator status, and whether an eligible academic entity operates a
CAA. Using these categorizations, the Economic Assessment examines the
costs and savings of this rule's new requirements, such as
recordkeeping, reporting, training, laboratory clean-outs, etc.,
compared to the existing
[[Page 72951]]
hazardous waste generator requirements, to determine the net overall
cost or cost savings of Subpart K which includes all of these factors.
Finally, a specific annualized before-tax cost analysis was
conducted for each affected entity. Before-tax incremental compliance
costs were used because they represent a resource or social cost of the
rulemaking. A discount rate (real rate of return) of 7 percent was used
covering the estimated period of service or life of the product. All
costs are adjusted to year 2008 dollars using the Implicit Price
Deflator for Gross Domestic Product.
4. Key Analytical Limitations
The Agency was not able to complete a formal RCRA Section 3007
survey of laboratories at colleges and universities, and non-profit
research institutes and teaching hospitals that are either owned by or
have a formal written affiliation agreement with a college or
university. Consequently, for this assessment, it was necessary to rely
on publicly available data. The key analytical limitations associated
with these data are briefly summarized in the bullets below. Additional
limitations and assumptions related to the economic analysis are
discussed in more detail in the Economic Assessment.
The analysis relies heavily on information generated in
2005 through a survey by NACUBO and, while this survey represents the
best available source of data, the facilities captured by the survey
may not be representative of the colleges and universities impacted by
the rule.
This analysis relies on BR data which includes hazardous
waste quantity data for a limited number of SQGs and CESQGs. Thus, the
number of entities within the universe of potentially eligible academic
entities is uncertain.
Data were not available to estimate the number of
laboratories at non-profit research institutes and teaching hospitals.
College and university data and Web-based internet information were
used to estimate the number of laboratories at these sites.
The cost impact analysis is very sensitive to the number
and size of containers requiring labeling in the laboratory. The
analysis assumes that one-third of the containers are pint-size, one-
third are quart-size and one-third are gallon-size.
An eligible academic entity can develop a single LMP that
can cover all its laboratories regardless of whether they are located
in sites with separate EPA Identification Numbers. Data limitations
prevented us from determining which sites generating laboratory
hazardous waste may choose to operate under the same LMP.
5. Findings
The findings presented here reflect a number of analytical
assumptions and limitations, as touched on above, and as described in
more detail in the Economic Assessment. Furthermore, we have analyzed
additional scenarios and conducted sensitivity analyses that are not
presented in today's preamble. Readers wanting to gain a full
understanding of our analytical methodology, data, findings,
assumptions, and limitations are encouraged to read the Economic
Assessment document prepared in support of this final rule.
In summary, we have identified a total of 1,580 facilities in
operation in the U.S., which generate laboratory hazardous wastes and
are eligible academic entities as defined under today's rulemaking. Of
this total, 397 are LQGs, 759 are SQGs, and the remaining 424 are
CESQGs. However as stated above, we assume the States which have
historically adopted at least 85 percent of RCRA's rule changes over a
five-year period will adopt Subpart K; thus the universe of eligible
academic entities located in these States is 169 LQGs, 323 SQGs and 181
CESQGs (673 facilities in total). Out of this number of eligible
academic entities located in the States that adopt Subpart K, we
assumed for this analysis that eligible academic entities that
experience cost savings by opting into Subpart K will be the only
eligible academic entities that participate in the final rule. Thus,
the final rule would provide annual aggregate net cost savings of
approximately $396,000. These savings would be realized by the
estimated 112 eligible academic entities that we project would choose
to operate under Subpart K. The greatest savings would accrue to the 25
LQGs projected to elect to be regulated under Subpart K; the analysis
estimates average annual cost savings of approximately $12,200 per LQG
opting into the rule. Lesser savings would be realized by the 87 SQGs
that are projected to elect to be regulated under Subpart K; for each
SQG opting into Subpart K, we estimate average annual cost savings of
approximately $1,000. Under this Economic Assessment, all CESQG
eligible academic entities demonstrated cost increases by operating
under Subpart K, so we assumed that CESQGs would not opt into the final
rule. Overall, average annual savings for eligible academic entities
operating under Subpart K are estimated at approximately $3,500 per
entity.
An important benefit of Subpart K for some eligible academic
entities will be the opportunity to maintain their typical RCRA
generator status because of today's rule's laboratory clean-out
provisions (see Sec. 262.213). Eligible academic entities that are
able to maintain their normal generator status rather than episodically
increasing their generator status by generating laboratory clean-out
waste can realize savings in reporting, planning, and overall
administrative costs when operating under Subpart K. Another
significant portion of the cost savings achieved reflects a reduction
in the number of off-site hazardous waste shipments, thereby reducing
shipment costs, particularly among colleges, universities, and research
institutes that are able to maintain their typical generator status
from LQG to SQG as a result of the laboratory clean-out provisions.
Such a change allows for longer accumulation times and increased
efficiencies in the number of laboratories visited per day for entities
without CAAs, in order to remove unwanted materials. In addition to
reduced shipments, much of the benefits of the rule include reduced
costs for on-site travel. This largely reflects the stipulation that a
hazardous waste determination for unwanted material in the laboratory
may occur at any time before it is removed from the laboratory or
within four days of arrival at an on-site CAA or TSDF, unlike the
existing generator regulations that stipulate that the hazardous waste
determination must be made at the point of generation.
The overall goal of today's action is to promote environmental
protection and public health through safer management of laboratory
hazardous waste at eligible academic entities. The Agency has not
monetized or quantitatively estimated the human health or environmental
benefits. However, this rule is expected to result in numerous
environmental benefits. The structured nature of the LMP is expected to
result in safer laboratory practices and increased awareness of
hazardous waste management. This will minimize exposure of humans and
the environment to hazardous wastes. Ultimately, LMPs are expected to
improve the way eligible academic entities coordinate and integrate
their hazardous waste management activities and enhance awareness about
proper laboratory waste handling techniques. In addition to the LMP,
the rule specifies streamlined, yet cost-neutral training requirements
that are expected to increase awareness of waste hazards
[[Page 72952]]
and so reduce the potential for mismanagement of the hazardous waste
generated in laboratories. Also, the Agency included incentives in
today's final rule to encourage more frequent laboratory clean-outs of
unwanted and unused reagents, thus reducing the potential for
accidental releases of these chemicals into the environment. Further,
EPA expects to see a benefit from allowing CESQGs to opt into the rule,
because those hazardous wastes generated above CESQGs' monthly volume
limits during a laboratory clean-out will be managed within the
Subtitle C system, as opposed to being managed as a non-hazardous
waste. Finally, we anticipate additional non-quantified economic gains
through improved hazardous waste management practices, waste
minimization, and waste coordination activities.
B. Paperwork Reduction Act
The information collection requirements in this final rule have
been submitted for approval to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document prepared by EPA has been
assigned EPA ICR Number 2317.01.
The Paperwork Reduction Act requires that EPA estimate the burden
(time, effort, financial resources) on respondents to comply with all
actions that involve the collection of information, such as
recordkeeping, reporting, or disclosure requirements or other
information collection activities required by this rulemaking. Below is
a description of the information collection activities required by
today's rulemaking.
Since this rule establishes an alternative set of hazardous waste
generator requirements for eligible academic entities' laboratories, it
is important that EPA or the authorized States know to which set of
regulations an eligible academic entity is subject. Therefore, EPA has
determined at 40 CFR 262.203 and 262.204 that it is necessary to
require an eligible academic entity to submit a notification to the EPA
Regional Administrator (or State Director in authorized States)
indicating that it is electing to be subject to or withdrawing from
Subpart K for all laboratories under the same EPA Identification Number
(or on the same site, in the absence of an EPA Identification Number).
The Site Identification Form must be used by eligible academic entities
to notify the appropriate authority of its participation in or
withdrawal from Subpart K. Under 40 CFR 262.206, 262.208, 262.10,
262.11, and 262.12 of Subpart K, an eligible academic entity must label
containers of unwanted materials, as specified. These labeling
requirements are necessary to: Demonstrate compliance with Subpart K,
alert individuals handling the containers of their contents to ensure
proper management, assist trained professionals in making the hazardous
waste determination and assigning the appropriate hazardous code(s),
ensure emergency responders can quickly ascertain and assess the
contents of a container in case of an emergency, and utilize for
enforcement and monitoring purposes.
Part 40 CFR 262.207 of Subpart K requires training, commensurate
with duties, for all students and laboratory workers working in a
laboratory. This training is necessary to ensure that unwanted
materials are handled safely and in an environmentally sound manner and
in compliance with Subpart K. In addition, eligible academic entities
that are LQGs must maintain the training records for laboratory
workers.
Under 40 CFR 262.313, eligible academic entities must develop and
maintain documentation of laboratory clean-outs to ensure compliance
with Subpart K. Also under 40 CFR 262.214, eligible academic entities
are required to develop, implement and maintain an LMP to document
their practices for complying with the performance-based requirements
of Subpart K.
Section 3007(b) of RCRA and 40 CFR part 2, Subpart B, defines EPA's
general policy on public disclosure of information, and contains
provisions for confidentiality. However, the Agency does not anticipate
that eligible academic entities will assert any claims of
confidentiality in association with the final rule. If such a claim
were asserted, EPA must and will treat the information in accordance
with the regulations cited above. EPA also will assure that this
information collection complies with the Privacy Act of 1974 and OMB
Circular 108.
According to the estimates provided in the ICR for this final rule,
the average annual incremental burden of new paperwork requirements to
respondents as a result of today's final rule is approximately 12,557
hours and $461,632. These estimates are a total net burden to
respondents meaning that the burden relief to eligible academic
entities under the existing regulations was subtracted from the new
paperwork requirements of Subpart K. Burden means the total time,
effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a
Federal agency. This includes the time needed to review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements; train personnel to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
The Agency received one consolidated comment representing six
commenters on the ICR for the proposed rule. The comment on burden
estimates focused on the notification requirement for Subpart K. In
general, the commenters believe the burden estimates for notifying the
appropriate authority of an eligible academic entity's decision to opt
into or out of Subpart K (see Sec. Sec. 262.203 and 262.204) were
fairly accurate and supported use of the Site Identification Form as
the mechanism to be used for notification. The comment specifically
stated, ``* * * burden for the college to notify appears to be accurate
and would be the same regardless of whether a letter or Site
Identification Form is used. However, the burden for the implementer
for clerical time should be cut in half, from 0.5 to 0.25.'' In
addition the comment stated, `` * * * the proposed notification
requirement discussed on Federal Register notice page 29727 under
section B.3 could be met by using the Site Identification Form (EPA
form 8700-12).'' A vast majority of the comments received supported the
use of the Site Identification Form over the use of a letter for
notification purposes. Thus, the Agency has chosen to finalize the
requirement for eligible academic entities to use the Site
Identification Form for notification.
An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9. When this ICR is
approved by OMB, the Agency will publish a technical amendment to 40
CFR part 9 in the Federal Register to display the OMB control number
for the approved information collection requirements contained in this
final rule.
[[Page 72953]]
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act, or any other statute, unless the agency certifies that
the rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
The RFA provides default definitions for each type of small entity.
Small entities are defined as: (1) A small business as defined by the
Small Business Administration's (SBA) regulations at 13 CFR 121.201;
(2) a small governmental jurisdiction that is a government of a city,
county, town, school district or special district with a population of
less than 50,000; and (3) a small organization that is any not-for-
profit enterprise which is independently owned and operated and is not
dominant in its field. After considering the economic impacts of
today's final rule on small entities, I certify that this action will
not have a significant economic impact on a substantial number of small
entities. Under the final rule, no small eligible academic entities are
projected to adopt the regulation unless they expect to experience a
net decrease in costs associated with managing their laboratory
hazardous waste. Based on these findings, we do not believe that this
rule will result in significant economic impacts on a substantial
number of small entities.
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, Local, and Tribal
governments and the private sector. Under Sec. 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, Local, and Tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, Section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including Tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
Today's final rule contains no Federal mandates (under the
regulatory provisions of Title II of the UMRA) for State, Local, or
Tribal governments or the private sector. The UMRA generally excludes
from the definition of ``Federal intergovernmental mandate,'' duties
that arise from participation in a voluntary Federal program. This rule
is a voluntary program because the States are not required to adopt
these requirements as a condition of authorization (or otherwise).
Furthermore, EPA has determined that this rule does not contain a
Federal mandate that may result in expenditures of $100 million or more
for State, Local, and Tribal governments, in the aggregate, or the
private sector in any one year. The total net benefits (cost savings)
of this action are estimated to be $396,000 per year. Finally, EPA has
determined that this rule contains no regulatory requirements that
might significantly or uniquely affect small governments.
E. Executive Order 13132: Federalism
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and Local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' are defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
Today's rule does not have federalism implications. It will not
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in the Order. The rule focuses on a set of alternative
generator requirements for eligible academic entities generating
laboratory hazardous wastes, without affecting the relationships
between Federal and State governments. Thus, Executive Order 13132 does
not apply to this rule.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by Tribal officials in the development of regulatory
policies that have Tribal implications.'' This final rule does not have
Tribal implications, as specified in Executive Order 13175. EPA has
concluded that this rule may have Tribal implications only to the
extent that qualifying academic institutions could be affected if they
have laboratories that are in some way affiliated with Tribal lands.
However, this rule will neither impose substantial direct compliance
costs on Tribal governments nor preempt Tribal law.
EPA did not consult directly with representatives of Tribal
governments in the process of developing this rule. However, EPA did
conduct an extensive outreach process with States and potentially
affected entities. Furthermore, we received no comments from any Tribal
governments on the proposed rule. Thus, we believe we have captured the
concerns that would have been expressed by representatives of Tribal
governments.
G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks
Executive Order 13045: ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that: (1) Is determined to be ``economically significant''
as defined under Executive Order 12866, and (2) concerns an
environmental health or safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria,
[[Page 72954]]
the Agency must evaluate the environmental health or safety effects of
the planned rule on children, and explain why the planned regulation is
preferable to other potentially effective and reasonably feasible
alternatives considered by the Agency.
Today's final rule is not subject to the Executive Order because it
is not economically significant and because the Agency does not have
reason to believe the environmental health or safety risks addressed by
this action present a disproportionate risk to children.
H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Usage
This rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355 (May 22, 2001)) because it is not
an economically significant action under Executive Order 12866. This
rule will not seriously disrupt energy supply, distribution patterns,
prices, imports or exports. Furthermore, this rule is designed to
improve economic efficiency by streamlining the management of
laboratory hazardous wastes.
I. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, section 12(d) (15 U.S.C.
272 note) directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. NTTAA directs EPA to
provide Congress, through OMB, explanations when the Agency decides not
to use available and applicable voluntary consensus standards.
This action does not involve technical standards. Therefore, EPA
did not consider the use of any voluntary consensus standards.
J. Executive Order 12898: Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations. This final action is
designed to ensure more effective and efficient management of
laboratory hazardous wastes.
K. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A Major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective December 31, 2008.
List of Subjects
40 CFR Part 261
Environmental protection, Hazardous waste, Recycling, Reporting and
recordkeeping requirements.
40 CFR Part 262
Environmental protection, Exports, Hazardous materials
transportation, Hazardous waste, Imports, Labeling, Packaging and
containers, Reporting and recordkeeping requirements.
Dated: November 18, 2008.
Stephen L. Johnson,
Administrator.
0
For the reasons set out in the preamble, Parts 261 and 262 of title 40,
chapter I of the Code of Federal Regulations are amended as follows:
PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE
0
1. The authority citation for part 261 continues to read as follows:
Authority: 42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y), and
6938.
0
2. Section 261.5 is amended by removing the period at the end of
paragraph (c)(6) and adding in its place a ``semicolon'' and by adding
paragraph (c)(7) to read as follows:
Sec. 261.5 Special requirements for hazardous waste generated by
conditionally exempt small quantity generators.
* * * * *
(c) * * *
(7) Is a hazardous waste that is an unused commercial chemical
product (listed in 40 CFR part 261, subpart D or exhibiting one or more
characteristics in 40 CFR part 261, subpart C) that is generated solely
as a result of a laboratory clean-out conducted at an eligible academic
entity pursuant to Sec. 262.213. For purposes of this provision, the
term eligible academic entity shall have the meaning as defined in
Sec. 262.200 of Part 262.
* * * * *
PART 262--STANDARDS APPLICABLE TO GENERATORS OF HAZARDOUS WASTE
0
3. The authority citation for part 262 continues to read as follows:
Authority: 42 U.S.C. 6906, 6912, 6922-6925, 6937, and 6938.
Subpart A--General
0
4. Section 262.10 is amended by adding paragraph (l) to read as
follows:
Sec. 262.10 Purpose, scope, and applicability.
* * * * *
(l) The laboratories owned by an eligible academic entity that
chooses to be subject to the requirements of Subpart K of this part are
not subject to (for purposes of this paragraph, the terms
``laboratory'' and ``eligible academic entity'' shall have the meaning
as defined in Sec. 262.200 of Subpart K of this part).:
(1) The requirements of Sec. 262.11 or Sec. 262.34(c), for large
quantity generators and small quantity generators, except as provided
in Subpart K, and
(2) The conditions of Sec. 261.5(b), for conditionally exempt
small quantity generators, except as provided in Subpart K.
0
5. Part 262 is amended by adding Subpart K to read as follows:
Subpart K--Alternative Requirements for Hazardous Waste Determination
and Accumulation of Unwanted Material for Laboratories Owned by
Eligible Academic Entities
Sec.
262.200 Definitions for this subpart.
262.201 Applicability of this subpart.
262.202 This subpart is optional.
[[Page 72955]]
262.203 How an eligible academic entity indicates it will be subject
to the requirements of this subpart.
262.204 How an eligible academic entity indicates it will withdraw
from the requirements of this subpart.
262.205 Summary of the requirements of this subpart.
262.206 Labeling and management standards for containers of unwanted
material in the laboratory.
262.207 Training.
262.208 Removing containers of unwanted material from the
laboratory.
262.209 Where and when to make the hazardous waste determination and
where to send containers of unwanted material upon removal from the
laboratory.
262.210 Making the hazardous waste determination in the laboratory
before the unwanted material is removed from the laboratory.
262.211 Making the hazardous waste determination at an on-site
central accumulation area.
262.212 Making the hazardous waste determination at an on-site
interim status or permitted treatment, storage or disposal facility.
262.213 Laboratory clean-outs.
262.214 Laboratory management plan.
262.215 Unwanted material that is not solid or hazardous waste.
262.216 Non-laboratory hazardous waste generated at an eligible
academic entity.
Subpart K--Alternative Requirements for Hazardous Waste
Determination and Accumulation of Unwanted Material for
Laboratories Owned by Eligible Academic Entities
Sec. 262.200 Definitions for this subpart.
The following definitions apply to this subpart:
Central accumulation area means an on-site hazardous waste
accumulation area subject to either Sec. 262.34(a) (or 262.34(j) and
(k) for Performance Track members) of this part (large quantity
generators); or Sec. 262.34(d)-(f) of this part (small quantity
generators). A central accumulation area at an eligible academic entity
that chooses to be subject to this subpart must also comply with Sec.
262.211 when accumulating unwanted material and/or hazardous waste.
College/University means a private or public, post-secondary,
degree-granting, academic institution, that is accredited by an
accrediting agency listed annually by the U.S. Department of Education.
Eligible academic entity means a college or university, or a non-
profit research institute that is owned by or has a formal written
affiliation agreement with a college or university, or a teaching
hospital that is owned by or has a formal written affiliation agreement
with a college or university.
Formal written affiliation agreement for a non-profit research
institute means a written document that establishes a relationship
between institutions for the purposes of research and/or education and
is signed by authorized representatives, as defined by Sec. 260.10,
from each institution. A relationship on a project-by-project or grant-
by-grant basis is not considered a formal written affiliation
agreement. A formal written affiliation agreement for a teaching
hospital means a master affiliation agreement and program letter of
agreement, as defined by the Accreditation Council for Graduate Medical
Education, with an accredited medical program or medical school.
Laboratory means an area owned by an eligible academic entity where
relatively small quantities of chemicals and other substances are used
on a non-production basis for teaching or research (or diagnostic
purposes at a teaching hospital) and are stored and used in containers
that are easily manipulated by one person. Photo laboratories, art
studios, and field laboratories are considered laboratories. Areas such
as chemical stockrooms and preparatory laboratories that provide a
support function to teaching or research laboratories (or diagnostic
laboratories at teaching hospitals) are also considered laboratories.
Laboratory clean-out means an evaluation of the inventory of
chemicals and other materials in a laboratory that are no longer needed
or that have expired and the subsequent removal of those chemicals or
other unwanted materials from the laboratory. A clean-out may occur for
several reasons. It may be on a routine basis (e.g., at the end of a
semester or academic year) or as a result of a renovation, relocation,
or change in laboratory supervisor/occupant. A regularly scheduled
removal of unwanted material as required by Sec. 262.208 does not
qualify as a laboratory clean-out.
Laboratory worker means a person who handles chemicals and/or
unwanted material in a laboratory and may include, but is not limited
to, faculty, staff, post-doctoral fellows, interns, researchers,
technicians, supervisors/managers, and principal investigators. A
person does not need to be paid or otherwise compensated for his/her
work in the laboratory to be considered a laboratory worker.
Undergraduate and graduate students in a supervised classroom setting
are not laboratory workers.
Non-profit research institute means an organization that conducts
research as its primary function and files as a non-profit organization
under the tax code of 26 U.S.C. 501(c)(3).
Reactive acutely hazardous unwanted material means an unwanted
material that is one of the acutely hazardous commercial chemical
products listed in Sec. 261.33(e) for reactivity.
Teaching hospital means a hospital that trains students to become
physicians, nurses or other health or laboratory personnel.
Trained professional means a person who has completed the
applicable RCRA training requirements of Sec. 265.16 for large
quantity generators, or is knowledgeable about normal operations and
emergencies in accordance with Sec. 262.34(d)(5)(iii) for small
quantity generators and conditionally exempt small quantity generators.
A trained professional may be an employee of the eligible academic
entity or may be a contractor or vendor who meets the requisite
training requirements.
Unwanted material means any chemical, mixtures of chemicals,
products of experiments or other material from a laboratory that is no
longer needed, wanted or usable in the laboratory and that is destined
for hazardous waste determination by a trained professional. Unwanted
materials include reactive acutely hazardous unwanted materials and
materials that may eventually be determined not to be solid waste
pursuant to Sec. 261.2, or a hazardous waste pursuant to Sec. 261.3.
If an eligible academic entity elects to use another equally effective
term in lieu of ``unwanted material,'' as allowed by Sec.
262.206(a)(1)(i), the equally effective term has the same meaning and
is subject to the same requirements as ``unwanted material'' under this
subpart.
Working container means a small container (i.e., two gallons or
less) that is in use at a laboratory bench, hood, or other work
station, to collect unwanted material from a laboratory experiment or
procedure.
Sec. 262.201 Applicability of this subpart.
(a) Large quantity generators and small quantity generators. This
subpart provides alternative requirements to the requirements in
Sec. Sec. 262.11 and 262.34(c) for the hazardous waste determination
and accumulation of hazardous waste in laboratories owned by eligible
academic entities that choose to be subject to this subpart, provided
that they complete the notification requirements of Sec. 262.203.
(b) Conditionally exempt small quantity generators. This subpart
provides alternative requirements to the conditional exemption in Sec.
261.5(b) for
[[Page 72956]]
the accumulation of hazardous waste in laboratories owned by eligible
academic entities that choose to be subject to this subpart, provided
that they complete the notification requirements of Sec. 262.203.
Sec. 262.202 This subpart is optional.
(a) Large quantity generators and small quantity generators:
Eligible academic entities have the option of complying with this
subpart with respect to its laboratories, as an alternative to
complying with the requirements of Sec. Sec. 262.11 and 262.34(c).
(b) Conditionally exempt small quantity generators. Eligible
academic entities have the option of complying with this subpart with
respect to its laboratories, as an alternative to complying with the
conditional exemption of Sec. 261.5(b).
Sec. 262.203 How an eligible academic entity indicates it will be
subject to the requirements of this subpart.
(a) An eligible academic entity must notify the appropriate EPA
Regional Administrator in writing, using the RCRA Subtitle C Site
Identification Form (EPA Form 8700-12), that it is electing to be
subject to the requirements of this subpart for all the laboratories
owned by the eligible academic entity under the same EPA Identification
Number. An eligible academic entity that is a conditionally exempt
small quantity generator and does not have an EPA Identification Number
must notify that it is electing to be subject to the requirements of
this subpart for all the laboratories owned by the eligible academic
entity that are on-site, as defined by Sec. 260.10. An eligible
academic entity must submit a separate notification (Site
Identification Form) for each EPA Identification Number (or site, for
conditionally exempt small quantity generators) that is electing to be
subject to the requirements of this subpart, and must submit the Site
Identification Form before it begins operating under this subpart.
(b) When submitting the Site Identification Form, the eligible
academic entity must, at a minimum, fill out the following fields on
the form:
(1) Reason for Submittal.
(2) Site EPA Identification Number (except for conditionally exempt
small quantity generators).
(3) Site Name.
(4) Site Location Information.
(5) Site Land Type.
(6) North American Industry Classification System (NAICS) Code(s)
for the Site.
(7) Site Mailing Address.
(8) Site Contact Person.
(9) Operator and Legal Owner of the Site.
(10) Type of Regulated Waste Activity.
(11) Certification.
(c) An eligible academic entity must keep a copy of the
notification on file at the eligible academic entity for as long as its
laboratories are subject to this subpart.
(d) A teaching hospital that is not owned by a college or
university must keep a copy of its formal written affiliation agreement
with a college or university on file at the teaching hospital for as
long as its laboratories are subject to this subpart.
(e) A non-profit research institute that is not owned by a college
or university must keep a copy of its formal written affiliation
agreement with a college or university on file at the non-profit
research institute for as long as its laboratories are subject to this
subpart.
Sec. 262.204 How an eligible academic entity indicates it will
withdraw from the requirements of this subpart.
(a) An eligible academic entity must notify the appropriate EPA
Regional Administrator in writing, using the RCRA Subtitle C Site
Identification Form (EPA Form 8700-12), that it is electing to no
longer be subject to the requirements of this subpart for all the
laboratories owned by the eligible academic entity under the same EPA
Identification Number and that it will comply with the requirements of
Sec. Sec. 262.11 and 262.34(c) for small quantity generators and large
quantity generators. An eligible academic entity that is a
conditionally exempt small quantity generator and does not have an EPA
Identification Number must notify that it is withdrawing from the
requirements of this subpart for all the laboratories owned by the
eligible academic entity that are on-site and that it will comply with
the conditional exemption in Sec. 261.5(b). An eligible academic
entity must submit a separate notification (Site Identification Form)
for each EPA Identification Number (or site, for conditionally exempt
small quantity generators) that is withdrawing from the requirements of
this subpart and must submit the Site Identification Form before it
begins operating under the requirements of Sec. Sec. 262.11 and
262.34(c) for small quantity generators and large quantity generators,
or Sec. 261.5(b) for conditionally exempt small quantity generators.
(b) When submitting the Site Identification Form, the eligible
academic entity must, at a minimum, fill out the following fields on
the form:
(1) Reason for Submittal.
(2) Site EPA Identification Number (except for conditionally exempt
small quantity generators).
(3) Site Name.
(4) Site Location Information.
(5) Site Land Type.
(6) North American Industry Classification System (NAICS) Code(s)
for the Site.
(7) Site Mailing Address.
(8) Site Contact Person.
(9) Operator and Legal Owner of the Site.
(10) Type of Regulated Waste Activity.
(11) Certification.
(c) An eligible academic entity must keep a copy of the withdrawal
notice on file at the eligible academic entity for three years from the
date of the notification.
Sec. 262.205 Summary of the requirements of this subpart.
An eligible academic entity that chooses to be subject to this
subpart is not required to have interim status or a RCRA Part B permit
for the accumulation of unwanted material and hazardous waste in its
laboratories, provided the laboratories comply with the provisions of
this subpart and the eligible academic entity has a Laboratory
Management Plan (LMP) in accordance with Sec. 262.214 that describes
how the laboratories owned by the eligible academic entity will comply
with the requirements of this subpart.
Sec. 262.206 Labeling and management standards for containers of
unwanted material in the laboratory.
An eligible academic entity must manage containers of unwanted
material while in the laboratory in accordance with the requirements in
this section.
(a) Labeling: Label unwanted material as follows:
(1) The following information must be affixed or attached to the
container:
(i) The words ``unwanted material'' or another equally effective
term that is to be used consistently by the eligible academic entity
and that is identified in Part I of the Laboratory Management Plan, and
(ii) Sufficient information to alert emergency responders to the
contents of the container. Examples of information that would be
sufficient to alert emergency responders to the contents of the
container include, but are not limited to:
(A) The name of the chemical(s),
(B) The type or class of chemical, such as organic solvents or
halogenated organic solvents.
(2) The following information may be affixed or attached to the
container, but
[[Page 72957]]
must at a minimum be associated with the container:
(i) The date that the unwanted material first began accumulating in
the container, and
(ii) Information sufficient to allow a trained professional to
properly identify whether an unwanted material is a solid and hazardous
waste and to assign the proper hazardous waste code(s), pursuant to
Sec. 262.11. Examples of information that would allow a trained
professional to properly identify whether an unwanted material is a
solid or hazardous waste include, but are not limited to:
(A) The name and/or description of the chemical contents or
composition of the unwanted material, or, if known, the product of the
chemical reaction,
(B) Whether the unwanted material has been used or is unused,
(C) A description of the manner in which the chemical was produced
or processed, if applicable.
(b) Management of Containers in the Laboratory: An eligible
academic entity must properly manage containers of unwanted material in
the laboratory to assure safe storage of the unwanted material, to
prevent leaks, spills, emissions to the air, adverse chemical
reactions, and dangerous situations that may result in harm to human
health or the environment. Proper container management must include the
following:
(1) Containers are maintained and kept in good condition and
damaged containers are replaced, overpacked, or repaired, and
(2) Containers are compatible with their contents to avoid
reactions between the contents and the container; and are made of, or
lined with, material that is compatible with the unwanted material so
that the container's integrity is not impaired, and
(3) Containers must be kept closed at all times, except:
(i) When adding, removing or consolidating unwanted material, or
(ii) A working container may be open until the end of the procedure
or work shift, or until it is full, whichever comes first, at which
time the working container must either be closed or the contents
emptied into a separate container that is then closed, or
(iii) When venting of a container is necessary.
(A) For the proper operation of laboratory equipment, such as with
in-line collection of unwanted materials from high performance liquid
chromatographs, or
(B) To prevent dangerous situations, such as build-up of extreme
pressure.
Sec. 262.207 Training.
An eligible academic entity must provide training to all
individuals working in a laboratory at the eligible academic entity, as
follows:
(a) Training for laboratory workers and students must be
commensurate with their duties so they understand the requirements in
this subpart and can implement them.
(b) An eligible academic entity can provide training for laboratory
workers and students in a variety of ways, including, but not limited
to:
(1) Instruction by the professor or laboratory manager before or
during an experiment; or
(2) Formal classroom training; or
(3) Electronic/written training; or
(4) On-the-job training; or
(5) Written or oral exams.
(c) An eligible academic entity that is a large quantity generator
must maintain documentation for the durations specified in Sec.
265.16(e) demonstrating training for all laboratory workers that is
sufficient to determine whether laboratory workers have been trained.
Examples of documentation demonstrating training can include, but are
not limited to, the following:
(1) Sign-in/attendance sheet(s) for training session(s); or
(2) Syllabus for training session; or
(3) Certificate of training completion; or
(4) Test results.
(d) A trained professional must:
(1) Accompany the transfer of unwanted material and hazardous waste
when the unwanted material and hazardous waste is removed from the
laboratory, and
(2) Make the hazardous waste determination, pursuant to Sec.
262.11, for unwanted material.
Sec. 262.208 Removing containers of unwanted material from the
laboratory.
(a) Removing containers of unwanted material on a regular schedule.
An eligible academic entity must either:
(1) Remove all containers of unwanted material from each laboratory
on a regular interval, not to exceed 6 months; or
(2) Remove containers of unwanted material from each laboratory
within 6 months of each container's accumulation start date.
(b) The eligible academic entity must specify in Part I of its
Laboratory Management Plan whether it will comply with paragraph (a)(1)
or (a)(2) of this section for the regular removal of unwanted material
from its laboratories.
(c) The eligible academic entity must specify in Part II of its
Laboratory Management Plan how it will comply with paragraph (a)(1) or
(a)(2) of this section and develop a schedule for regular removals of
unwanted material from its laboratories.
(d) Removing containers of unwanted material when volumes are
exceeded.
(1) If a laboratory accumulates a total volume of unwanted material
(including reactive acutely hazardous unwanted material) in excess of
55 gallons before the regularly scheduled removal, the eligible
academic entity must ensure that all containers of unwanted material in
the laboratory (including reactive acutely hazardous unwanted
material):
(i) Are marked on the label that is associated with the container
(or on the label that is affixed or attached to the container, if that
is preferred) with the date that 55 gallons is exceeded; and
(ii) Are removed from the laboratory within 10 calendar days of the
date that 55 gallons was exceeded, or at the next regularly scheduled
removal, whichever comes first.
(2) If a laboratory accumulates more than 1 quart of reactive
acutely hazardous unwanted material before the regularly scheduled
removal, then the eligible academic entity must ensure that all
containers of reactive acutely hazardous unwanted material:
(i) Are marked on the label that is associated with the container
(or on the label that is affixed or attached to the container, if that
is preferred) with the date that 1 quart is exceeded; and
(ii) Are removed from the laboratory within 10 calendar days of the
date that 1 quart was exceeded, or at the next regularly scheduled
removal, whichever comes first.
Sec. 262.209 Where and when to make the hazardous waste determination
and where to send containers of unwanted material upon removal from the
laboratory.
(a) Large quantity generators and small quantity generators--an
eligible academic entity must ensure that a trained professional makes
a hazardous waste determination, pursuant to Sec. 262.11, for unwanted
material in any of the following areas:
(1) In the laboratory before the unwanted material is removed from
the laboratory, in accordance with Sec. 262.210;
(2) Within 4 calendar days of arriving at an on-site central
accumulation area, in accordance with Sec. 262.211; and
(3) Within 4 calendar days of arriving at an on-site interim status
or permitted treatment, storage or disposal facility, in accordance
with Sec. 262.212.
(b) Conditionally exempt small quantity generators--an eligible
academic entity must ensure that a trained professional makes a
hazardous
[[Page 72958]]
waste determination, pursuant to Sec. 262.11, for unwanted material in
the laboratory before the unwanted material is removed from the
laboratory, in accordance with Sec. 262.210.
Sec. 262.210 Making the hazardous waste determination in the
laboratory before the unwanted material is removed from the laboratory.
If an eligible academic entity makes the hazardous waste
determination, pursuant to Sec. 262.11, for unwanted material in the
laboratory, it must comply with the following:
(a) A trained professional must make the hazardous waste
determination, pursuant to Sec. 262.11, before the unwanted material
is removed from the laboratory.
(b) If an unwanted material is a hazardous waste, the eligible
academic entity must:
(1) Write the words ``hazardous waste'' on the container label that
is affixed or attached to the container, before the hazardous waste may
be removed from the laboratory; and
(2) Write the appropriate hazardous waste code(s) on the label that
is associated with the container (or on the label that is affixed or
attached to the container, if that is preferred) before the hazardous
waste is transported off-site.
(3) Count the hazardous waste toward the eligible academic entity's
generator status, pursuant to Sec. 261.5(c) and (d), in the calendar
month that the hazardous waste determination was made.
(c) A trained professional must accompany all hazardous waste that
is transferred from the laboratory(ies) to an on-site central
accumulation area or on-site interim status or permitted treatment,
storage or disposal facility.
(d) When hazardous waste is removed from the laboratory:
(1) Large quantity generators and small quantity generators must
ensure it is taken directly from the laboratory(ies) to an on-site
central accumulation area, or on-site interim status or permitted
treatment, storage or disposal facility, or transported off-site.
(2) Conditionally exempt small quantity generators must ensure it
is taken directly from the laboratory(ies) to any of the types of
facilities listed in Sec. 261.5(f)(3) for acute hazardous waste, or
Sec. 261.5(g)(3) for hazardous waste.
(e) An unwanted material that is a hazardous waste is subject to
all applicable hazardous waste regulations when it is removed from the
laboratory.
Sec. 262.211 Making the hazardous waste determination at an on-site
central accumulation area.
If an eligible academic entity makes the hazardous waste
determination, pursuant to Sec. 262.11, for unwanted material at an
on-site central accumulation area, it must comply with the following:
(a) A trained professional must accompany all unwanted material
that is transferred from the laboratory(ies) to an on-site central
accumulation area.
(b) All unwanted material removed from the laboratory(ies) must be
taken directly from the laboratory(ies) to the on-site central
accumulation area.
(c) The unwanted material becomes subject to the generator
accumulation regulations of Sec. 262.34(a) (or Sec. 262.34(j) and (k)
for Performance Track members) for large quantity generators or Sec.
262.34(d)-(f) for small quantity generators as soon as it arrives in
the central accumulation area, except for the ``hazardous waste''
labeling requirements of Sec. 262.34(a)(3) (or Sec. 262.34(j)(6) for
Performance Track members).
(d) A trained professional must determine, pursuant to Sec.
262.11, if the unwanted material is a hazardous waste within 4 calendar
days of the unwanted materials' arrival at the on-site central
accumulation area.
(e) If the unwanted material is a hazardous waste, the eligible
academic entity must:
(1) Write the words ``hazardous waste'' on the container label that
is affixed or attached to the container, within 4 calendar days of
arriving at the on-site central accumulation area and before the
hazardous waste may be removed from the on-site central accumulation
area, and
(2) Write the appropriate hazardous waste code(s) on the container
label that is associated with the container (or on the label that is
affixed or attached to the container, if that is preferred) before the
hazardous waste may be treated or disposed of on-site or transported
off-site, and
(3) Count the hazardous waste toward the eligible academic entity's
generator status, pursuant to Sec. 261.5(c) and (d) in the calendar
month that the hazardous waste determination was made, and
(4) Manage the hazardous waste according to all applicable
hazardous waste regulations.
Sec. 262.212 Making the hazardous waste determination at an on-site
interim status or permitted treatment, storage or disposal facility.
If an eligible academic entity makes the hazardous waste
determination, pursuant to Sec. 262.11, for unwanted material at an
on-site interim status or permitted treatment, storage or disposal
facility, it must comply with the following:
(a) A trained professional must accompany all unwanted material
that is transferred from the laboratory(ies) to an on-site interim
status or permitted treatment, storage or disposal facility.
(b) All unwanted material removed from the laboratory(ies) must be
taken directly from the laboratory(ies) to the on-site interim status
or permitted treatment, storage or disposal facility.
(c) The unwanted material becomes subject to the terms of the
eligible academic entity's hazardous waste permit or interim status as
soon as it arrives in the on-site treatment, storage or disposal
facility.
(d) A trained professional must determine, pursuant to Sec.
262.11, if the unwanted material is a hazardous waste within 4 calendar
days of the unwanted materials' arrival at an on-site interim status or
permitted treatment, storage or disposal facility.
(e) If the unwanted material is a hazardous waste, the eligible
academic entity must:
(1) Write the words ``hazardous waste'' on the container label that
is affixed or attached to the container (or on the label that is
affixed or attached to the container, if that is preferred) within 4
calendar days of arriving at the on-site interim status or permitted
treatment, storage or disposal facility and before the hazardous waste
may be removed from the on-site interim status or permitted treatment,
storage or disposal facility, and
(2) Write the appropriate hazardous waste code(s) on the container
label that is associated with the container (or on the label that is
affixed or attached to the container, if that is preferred) before the
hazardous waste may be treated or disposed on-site or transported off-
site, and
(3) Count the hazardous waste toward the eligible academic entity's
generator status, pursuant to Sec. 261.5(c) and (d) in the calendar
month that the hazardous waste determination was made, and
(4) Manage the hazardous waste according to all applicable
hazardous waste regulations.
Sec. 262.213 Laboratory clean-outs.
(a) One time per 12 month period for each laboratory, an eligible
academic entity may opt to conduct a laboratory clean-out that is
subject to all the applicable requirements of this subpart, except
that:
(1) If the volume of unwanted material in the laboratory exceeds 55
gallons (or 1 quart of reactive acutely hazardous unwanted material),
the eligible academic entity is not required to remove all unwanted
materials from the laboratory within 10 calendar days
[[Page 72959]]
of exceeding 55 gallons (or 1 quart of reactive acutely hazardous
unwanted material), as required by Sec. 262.208. Instead, the eligible
academic entity must remove all unwanted materials from the laboratory
within 30 calendar days from the start of the laboratory clean-out; and
(2) For the purposes of on-site accumulation, an eligible academic
entity is not required to count a hazardous waste that is an unused
commercial chemical product (listed in 40 CFR part 261, subpart D or
exhibiting one or more characteristics in 40 CFR part 261, subpart C)
generated solely during the laboratory clean-out toward its hazardous
waste generator status, pursuant to Sec. 261.5(c) and (d). An unwanted
material that is generated prior to the beginning of the laboratory
clean-out and is still in the laboratory at the time the laboratory
clean-out commences must be counted toward hazardous waste generator
status, pursuant to Sec. 261.5(c) and (d), if it is determined to be
hazardous waste; and
(3) For the purposes of off-site management, an eligible academic
entity must count all its hazardous waste, regardless of whether the
hazardous waste was counted toward generator status under paragraph
(a)(2) of this section, and if it generates more than 1 kg/month of
acute hazardous waste or more than 100 kg/month of hazardous waste
(i.e., the conditionally exempt small quantity generator limits of
Sec. 261.5), the hazardous waste is subject to all applicable
hazardous waste regulations when it is transported off-site; and
(4) An eligible academic entity must document the activities of the
laboratory clean-out. The documentation must, at a minimum, identify
the laboratory being cleaned out, the date the laboratory clean-out
begins and ends, and the volume of hazardous waste generated during the
laboratory clean-out. The eligible academic entity must maintain the
records for a period of three years from the date the clean-out ends;
and
(b) For all other laboratory clean-outs conducted during the same
12-month period, an eligible academic entity is subject to all the
applicable requirements of this subpart, including, but not limited to:
(1) The requirement to remove all unwanted materials from the
laboratory within 10 calendar days of exceeding 55 gallons (or 1 quart
of reactive acutely hazardous unwanted material), as required by Sec.
262.208; and
(2) The requirement to count all hazardous waste, including unused
hazardous waste, generated during the laboratory clean-out toward its
hazardous waste generator status, pursuant to Sec. 261.5(c) and (d).
Sec. 262.214 Laboratory management plan.
An eligible academic entity must develop and retain a written
Laboratory Management Plan, or revise an existing written plan. The
Laboratory Management Plan is a site-specific document that describes
how the eligible academic entity will manage unwanted materials in
compliance with this subpart. An eligible academic entity may write one
Laboratory Management Plan for all the laboratories owned by the
eligible academic entity that have opted into this subpart, even if the
laboratories are located at sites with different EPA Identification
Numbers. The Laboratory Management Plan must contain two parts with a
total of nine elements identified in paragraphs (a) and (b) of this
section. In Part I of its Laboratory Management Plan, an eligible
academic entity must describe its procedures for each of the elements
listed in paragraph (a) of this section. An eligible academic entity
must implement and comply with the specific provisions that it develops
to address the elements in Part I of the Laboratory Management Plan. In
Part II of its Laboratory Management Plan, an eligible academic entity
must describe its best management practices for each of the elements
listed in paragraph (b) of this section. The specific actions taken by
an eligible academic entity to implement each element in Part II of its
Laboratory Management Plan may vary from the procedures described in
the eligible academic entity's Laboratory Management Plan, without
constituting a violation of this subpart. An eligible academic entity
may include additional elements and best management practices in Part
II of its Laboratory Management Plan if it chooses.
(a) The eligible academic entity must implement and comply with the
specific provisions of Part I of its Laboratory Management Plan. In
Part I of its Laboratory Management Plan, an eligible academic entity
must:
(1) Describe procedures for container labeling in accordance with
Sec. 262.206(a), including:
(i) Identifying whether the eligible academic entity will use the
term ``unwanted material'' on the containers in the laboratory. If not,
identify an equally effective term that will be used in lieu of
``unwanted material'' and consistently by the eligible academic entity.
The equally effective term, if used, has the same meaning and is
subject to the same requirements as ``unwanted material.''
(ii) Identifying the manner in which information that is
``associated with the container'' will be imparted.
(2) Identify whether the eligible academic entity will comply with
Sec. 262.208(a)(1) or (a)(2) for regularly scheduled removals of
unwanted material from the laboratory.
(b) In Part II of its Laboratory Management Plan, an eligible
academic entity must:
(1) Describe its intended best practices for container labeling and
management, including how the eligible academic entity will manage
containers used for in-line collection of unwanted materials, such as
with high performance liquid chromatographs and other laboratory
equipment (see the required standards at Sec. 262.206).
(2) Describe its intended best practices for providing training for
laboratory workers and students commensurate with their duties (see the
required standards at Sec. 262.207(a)).
(3) Describe its intended best practices for providing training to
ensure safe on-site transfers of unwanted material and hazardous waste
by trained professionals (see the required standards at Sec.
262.207(d)(1)).
(4) Describe its intended best practices for removing unwanted
material from the laboratory, including:
(i) For regularly scheduled removals--Develop a regular schedule
for identifying and removing unwanted materials from its laboratories
(see the required standards at Sec. 262.208(a)(1) and (a)(2)).
(ii) For removals when maximum volumes are exceeded:
(A) Describe its intended best practices for removing unwanted
materials from the laboratory within 10 calendar days when unwanted
materials have exceeded their maximum volumes (see the required
standards at Sec. 262.208(d)).
(B) Describe its intended best practices for communicating that
unwanted materials have exceeded their maximum volumes.
(5) Describe its intended best practices for making hazardous waste
determinations, including specifying the duties of the individuals
involved in the process (see the required standards at Sec. 262.11 and
Sec. Sec. 262.209 through 262.212).
(6) Describe its intended best practices for laboratory clean-outs,
if the eligible academic entity plans to use the incentives for
laboratory clean-outs provided in Sec. 262.213, including:
(i) Procedures for conducting laboratory clean-outs (see the
required standards at Sec. 262.213(a)(1) through (3)); and
[[Page 72960]]
(ii) Procedures for documenting laboratory clean-outs (see the
required standards at Sec. 262.213(a)(4)).
(7) Describe its intended best practices for emergency prevention,
including:
(i) Procedures for emergency prevention, notification, and
response, appropriate to the hazards in the laboratory; and
(ii) A list of chemicals that the eligible academic entity has, or
is likely to have, that become more dangerous when they exceed their
expiration date and/or as they degrade; and
(iii) Procedures to safely dispose of chemicals that become more
dangerous when they exceed their expiration date and/or as they
degrade; and
(iv) Procedures for the timely characterization of unknown
chemicals.
(c) An eligible academic entity must make its Laboratory Management
Plan available to laboratory workers, students, or any others at the
eligible academic entity who request it.
(d) An eligible academic entity must review and revise its
Laboratory Management Plan, as needed.
Sec. 262.215 Unwanted material that is not solid or hazardous waste.
(a) If an unwanted material does not meet the definition of solid
waste in Sec. 261.2, it is no longer subject to this subpart or to the
RCRA hazardous waste regulations.
(b) If an unwanted material does not meet the definition of
hazardous waste in Sec. 261.3, it is no longer subject to this subpart
or to the RCRA hazardous waste regulations, but must be managed in
compliance with any other applicable regulations and/or conditions.
Sec. 262.216 Non-laboratory hazardous waste generated at an eligible
academic entity.
An eligible academic entity that generates hazardous waste outside
of a laboratory is not eligible to manage that hazardous waste under
this subpart; and
(a) Remains subject to the generator requirements of Sec. Sec.
262.11 and 262.34(c) for large quantity generators and small quantity
generators (if the hazardous waste is managed in a satellite
accumulation area), and all other applicable generator requirements of
40 CFR part 262, with respect to that hazardous waste; or
(b) Remains subject to the conditional exemption of Sec. 261.5(b)
for conditionally exempt small quantity generators, with respect to
that hazardous waste.
[FR Doc. E8-27863 Filed 11-28-08; 8:45 am]
BILLING CODE 6560-50-P