[Federal Register Volume 64, Number 187 (Tuesday, September 28, 1999)]
[Rules and Regulations]
[Pages 52380-52396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25137]
[[Page 52379]]
_______________________________________________________________________
Part II
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 262
Project XL Site-specific Rulemaking for University Laboratories at the
University of Massachusetts Boston, Boston, MA, the Boston College,
Chestnut Hill, MA, and the University of Vermont, Burlington, VT;
Hazardous Waste Management System; Final Rule
Federal Register / Vol. 64, No. 187 / Tuesday, September 28, 1999 /
Rules and Regulations
[[Page 52380]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 262
[FRL-6444-8]
Project XL Site-specific Rulemaking for University Laboratories
at the University of Massachusetts Boston, Boston MA, the Boston
College, Chestnut Hill, MA, and the University of Vermont, Burlington,
VT; Hazardous Waste Management System
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: Today's rule provides regulatory flexibility under the
Resource Conservation and Recovery Act (RCRA), as amended. It allows
the participating laboratories at the University of Massachusetts-
Boston, Boston, MA, Boston College, Chestnut Hill, MA and the
University of Vermont, Burlington, VT (the Universities) to replace
certain existing requirements for hazardous waste generators with a
comprehensive Laboratory Environmental Management Plan (EMP) designed
for each University. EPA is promulgating this rule to implement an XL
project for the laboratories at the Universities. The terms of the XL
project are defined in the Final Project Agreement (FPA) which is
scheduled to be signed by the parties on September 28, 1999. The FPA
explains the project in detail, while the promulgation of this federal
rule will enable Massachusetts Department of Environmental Protection
(MADEP) and Vermont Department of Environmental Conservation (VTDEC) to
implement portions of the project requiring regulatory changes. The
requirements of this rule will not take effect in Massachusetts and
Vermont until they adopt the requirements as state law. For the sake of
simplicity, the remainder of this preamble refers to the effects of
this rule, although it will be the corresponding state law change that
will actually govern this XL project.
In order to qualify for the flexibility that the rule provides, the
Universities must implement environmental management plans for the
participating laboratories and comply with minimum performance criteria
for managing laboratory waste. EPA expects this XL project to result in
superior environmental performance in Massachusetts and Vermont, while
providing waste minimization opportunities to the participating
Universities.
DATES: This final rule is effective September 28, 1999.
ADDRESSES: A docket containing public comments and supporting materials
is available for public inspection and copying at the RCRA Information
Center (RIC), located at Crystal Gateway, 1235 Jefferson Davis Highway,
First Floor, Arlington, Virginia. The RIC is open from 9:00 am to 4:00
pm Monday through Friday, excluding federal holidays. The public is
encouraged to phone in advance to review docket materials. Appointments
can be scheduled by phoning the Docket Office at (703) 603-9230. Refer
to RCRA docket number F-1999-NEUP-FFFFF. The public may copy a maximum
of 100 pages from any regulatory docket at no charge. Additional copies
cost 15 cents per page.
A duplicate copy of the docket is available for inspection and
copying at U.S. EPA, Region 1, 1 Congress Street, Suite 1100 (LIB),
Boston, MA 02114-2023 during normal business hours. Persons wishing to
view the duplicate docket at the Boston location are encouraged to
contact Ms. Gina Snyder or Mr. George Frantz in advance, by telephoning
(617) 918-1837 or (617) 918-1883. Information is also available on the
world wide web at http://www.epa.gov/ProjectXL.
FOR FURTHER INFORMATION CONTACT: Ms. Gina Snyder or Mr. George Frantz,
U.S. Environmental Protection Agency, Region I (SPE), Assistance and
Pollution Prevention Division, 1 Congress Street, Suite 1100, Boston,
MA 02114-2023. Ms. Snyder can be reached at (617) 918-1837 and Mr.
Frantz can be reached at (617) 918-1883.
SUPPLEMENTARY INFORMATION:
Outline of Today's Document
The information presented in this preamble is organized as follows:
I. Authority
II. Background
A. Overview of Project XL
B. Overview of the New England University Laboratories XL
Project
1. Introduction
2. Description of the New England University Laboratories XL
Project
3. What Are the Environmental Benefits of the Project?
4. What Are the Economic Benefits and Paperwork Reduction
Deriving from the Project?
5. Stakeholder Involvement
6. What is the Project Duration and Completion Date?
C. Rule Description
1. Summary of Rule
2. Changes to the Proposed Rule
III. Response to Significant Public Comments
IV. What is the Effective Date of This Rule?
V. Additional Information
A. How Does This Rule Comply with Executive Order 12866?
B. Is a Regulatory Flexibility Analysis Required?
C. Is EPA required to Submit a Rule Report Under the
Congressional Review Act?
D. Is an Information Collection Request Required for This
Project Under the Paperwork Reduction Act?
E. Does This Project Trigger the Requirements of the Unfunded
Mandates Reform Act?
F. RCRA/HSWA
1. Applicability of Rules in Authorized States
2. Effect on Massachusetts and Vermont Authorization
G. How Does This Rule Comply With Executive Order 13045:
Protection of Children from Environmental Health Risks and Safety
Risks?
H. How Does This Rule Comply with Executive Orders on
Federalism?
I. How Does This Rule Comply with Executive Order 13084:
Consultation and Coordination With Indian Tribal Governments?
J. Does This Rule Comply with National Technology Transfer and
Advancement Act?
I. Authority
EPA is publishing this regulation under the authority of sections
2002, 3001, 3002, 3003, 3006, 3010, and 7004 of the Solid Waste
Disposal Act of 1970, as amended by the Resource Conservation and
Recovery Act, as amended (42 U.S.C. 6912, 6921, 6922, 6923, 6926, 6930,
and 6974).
II. Background
A. Overview of Project XL
Each Project XL project is implemented with a Final Project
Agreement (FPA). For this Project XL, the FPA sets forth the intentions
of EPA and the Universities with regard to a project developed under
Project XL, an EPA initiative to allow regulated entities to achieve
better environmental results at less cost. The regulation will
facilitate implementation of the project. Project XL--``eXcellence and
Leadership'' was announced on March 16, 1995, as a central part of the
National Performance Review and the EPA's effort to reinvent
environmental protection. See 60 FR 27282 (May 23, 1995). Project XL
provides a limited number of private and public regulated entities an
opportunity to develop their own pilot projects to provide regulatory
flexibility that will result in environmental protection that is
superior to what would be achieved through compliance with current and
reasonably anticipated future regulations. These efforts are crucial to
EPA's ability to test new strategies that reduce the regulatory burden
and promote economic growth while achieving better environmental and
public health protection. EPA
[[Page 52381]]
intends to evaluate the results of this and other XL projects to
determine which specific elements of the project(s), if any, should be
more broadly applied to other regulated entities for the benefit of
both the economy and the environment.
Under Project XL, participants in four categories--facilities,
industry sectors, governmental agencies and communities--are offered
the flexibility to develop common sense, cost-effective strategies that
will replace or modify specific regulatory requirements, on the
condition that they produce and demonstrate superior environmental
performance. To participate in Project XL, applicants must develop
alternative pollution reduction strategies pursuant to eight criteria:
superior environmental performance; cost savings and paperwork
reduction; local stakeholder involvement and support; test of an
innovative strategy; transferability; feasibility; identification of
monitoring, reporting and evaluation methods; and avoidance of shifting
the risk burden. They must have full support of affected federal, state
and tribal agencies to be selected.
For more information about the XL criteria, readers should refer to
the two descriptive documents published in the Federal Register (60 FR
27282, May 23, 1995 and 62 FR 19872, April 23, 1997), and the December
1, 1995 ``Principles for Development of Project XL Final Project
Agreements'' document. For further discussion as to how the New England
University Laboratories XL project addresses the XL criteria, readers
should refer to the Final Project Agreement and fact sheet that are
available from the docket for this action (see ADDRESSES section of
today's preamble) and the Federal Register notice publishing the
proposed rule (64 FR 40696, July 27, 1999).
Project XL is intended to allow the EPA to experiment with untried,
potentially promising regulatory approaches, both to assess whether
they provide benefits at the specific facility affected, and whether
they should be considered for wider application. Such pilot projects
allow the EPA to proceed more quickly than would be possible when
undertaking changes on a nationwide basis. EPA may modify rules, on a
site- or state-specific basis, that represent one of several possible
policy approaches within a more general statutory directive, so long as
the alternative being used is permissible under the statute. Adoption
of such alternative approaches or interpretations in the context of a
given XL project does not, however, signal EPA's willingness to adopt
that interpretation as a general matter, or even in the context of
other XL projects. It would be inconsistent with the forward-looking
nature of these pilot projects to adopt such innovative approaches
prematurely on a widespread basis without first determining whether or
not they are viable in practice and successful for the particular
projects that embody them. Furthermore, as EPA indicated in announcing
the XL program, it expects to adopt only a limited number of carefully
selected projects. These pilot projects are not intended to be a means
for piecemeal revision of entire programs. Depending on the results in
these projects, EPA may or may not be willing to consider adopting the
alternative approach or interpretation again, either generally or for
other specific facilities.
EPA believes that adopting alternative policy approaches and/or
interpretations, on a limited, site- or state-specific basis and in
connection with a carefully selected pilot project, is consistent with
the expectations of Congress about EPA's role in implementing the
environmental statutes (so long as EPA acts within the discretion
allowed by the statute). Congress' recognition that there is a need for
experimentation and research, as well as ongoing reevaluation of
environmental programs, is reflected in a variety of statutory
provisions, e.g., section 8001 of RCRA.
B. Overview of the New England University Laboratories XL Project
1. Introduction
On July 27, 1999, the Environmental Protection Agency proposed a
rule to implement a Project XL that would provide regulatory
flexibility under the Resource Conservation and Recovery Act (RCRA) for
the participating laboratories at the University of Massachusetts-
Boston, Boston, MA, Boston College, Chestnut Hill, MA and the
University of Vermont, Burlington, VT (the Universities). Specifically,
the Agency proposed to allow participating laboratories at the
Universities to replace existing requirements for hazardous waste
generators with a comprehensive Environmental Management Standard that
would identify a plan for the effective management of laboratory wastes
and the minimum performance requirements for handling such waste in a
laboratory (64 FR 40696). Today's final rule promulgates regulations
that are very similar to the July 27, 1999 proposal. Readers of this
notice are encouraged to refer to the July 27, 1999 (64 FR 40696)
notice for a more detailed description of the problems today's rule is
intended to address and a more detailed explanation of how the Agency
expects the Environmental Management Standard to work.
Today's rule will facilitate implementation of the FPA (the
document that embodies EPA's intent to implement this project) that has
been developed by EPA, Massachusetts Department of Environmental
Protection (MADEP), Vermont Department of Environmental Conservation
(VTDEC), the Universities, and other stakeholders. EPA, MADEP, VTDEC
and the Universities are scheduled to sign the final FPA on September
28, 1999. The FPA is available for review in the docket for today's
action and on the world wide web at http://www.epa.gov/ProjectXL. The
FPA addresses the eight Project XL criteria, and the expectation of EPA
that this XL project will meet those criteria. Those criteria are: (1)
Environmental performance superior to what would be achieved through
compliance with current and reasonably anticipated future regulations;
(2) cost savings or economic opportunity, and/or decreased paperwork
burden; (3) stakeholder support; (4) test of innovative strategies for
achieving environmental results; (5) approaches that could be evaluated
for future broader application; (6) technical and administrative
feasibility; (7) mechanisms for monitoring, reporting, and evaluation;
and (8) consistency with Executive Order 12898 on Environmental Justice
(avoidance of shifting of risk burden). The FPA specifically addresses
the manner in which the project is expected to produce superior
environmental benefits.
EPA is promulgating today's rule to implement the provisions of
this Project XL initiative that require regulatory changes. However, as
discussed in Section IV.F. below, both Massachusetts and Vermont have
received authority to administer hazardous waste standards for
generators that are equivalent to, or more stringent than, the federal
program. Therefore, the requirements outlined in today's rule will not
take effect in these States until each State adopts equivalent
requirements as State law, and EPA will not be the primary regulatory
agency responsible for implementing the requirements of this rule.
Although today's rule references ``EPA,'' for Massachusetts, ``MADEP'',
and for Vermont, ``VTDEC'' will be substituted for ``EPA'' when the
States adopt these requirements as State law. For this reason, this
preamble discussion will use the term ``regulatory agency'' when
referring to the ``EPA'' responsibilities identified in today's
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rule. In addition, for the sake of simplicity, the remainder of this
preamble refers to the effects of this rule, although it will be the
corresponding State law change that will actually govern this XL
project.
2. Description of the New England University Laboratories XL Project
Integrated Performance-Based System.
The University Laboratory XL project tests the effectiveness of an
integrated, flexible, performance-based system for managing hazardous
wastes in laboratories which (1) results in pollution prevention and
streamlined procedures for managing hazardous wastes and hazardous
chemicals at universities, (2) meets the objectives of both the RCRA
and OSHA regulatory programs combined and (3) is at least as protective
of human health and the environment as the current system.
This project pilots an alternative approach to hazardous waste
management in university laboratories which is more systematic and more
centralized than the approach implemented by universities under the
current system. At the same time, the pilot integrates some of the
current RCRA hazardous waste regulations with current Occupational
Safety and Health Act (OSHA) regulations by requiring that the
Universities develop a plan similar to the OSHA required Chemical
Hygiene Plan (CHP). The plan required by the alternative system
outlined in this site-specific final rule is to be designed for the
management of environmental aspects of their activities to facilitate
the creation of an integrated and consistent system for managing
laboratory waste in laboratories. As a result of the efficiencies
gained from the harmonization of the OSHA CHP and the RCRA-oriented
Laboratory Environmental Management Plan, the new system is expected to
provide a better management approach for laboratories and to result in
increased pollution prevention while still ensuring protection of human
health and the environment.
To achieve this objective, the Universities will follow the
regulatory model of a Laboratory Environmental Management Standard
(EMS) that identifies both the elements for the effective management of
laboratory wastes, and the minimum performance requirements for
handling wastes in each individual laboratory. The Laboratory EMS sets
out all the requirements for the alternative system of managing
laboratory waste. First and foremost, the Laboratory EMS includes
Minimum Performance Criteria for the management of laboratory wastes
within the laboratory and en route to the on-site hazardous waste
accumulation area. These criteria are similar to the requirements of 40
CFR 262.34(c). The Minimum Performance Criteria are a set of measurable
requirements that are similar to the current RCRA requirements. Each of
the elements of the Minimum Performance Criteria is briefly explained
below. In addition, the Laboratory EMS also requires the development of
a Laboratory Environmental Management Plan (EMP). The EMP is written by
each University to document its specific procedures for how it will
conform with the Laboratory EMS. The EMP describes the procedures each
laboratory must follow in order to meet the Minimum Performance
Criteria.
Laboratory Environmental Management Standard (EMS). Today's final
rule creates a new subpart to 40 CFR part 262, Subpart J, called the
``Laboratory Environmental Management Standard.'' It includes a
definition section (40 CFR 262.102) that sets out the definitions
applicable to the requirements in the new Subpart J, the requirements
for waste management in the laboratory, or the Minimum Performance
Criteria, (40 CFR 262.104) and the specific requirement that each
University develop a Laboratory Environmental Management Plan (40 CFR
262.105). Subpart J also contains requirements detailing the
organizational responsibilities and the training requirements of each
participating University laboratory (40 CFR 262.105). The Laboratory
EMS provides the umbrella framework for an effective system for the
management of university laboratory waste. It contains all the
elements, from definitions through waste determination requirements (40
CFR 262.106), that make up the new systematic approach for the
University laboratories. The Laboratory EMS was originally modeled
after the general structure and format of the OSHA ``Occupational
Exposure to Hazardous Chemicals in Laboratories'' standard which
requires a Chemical Hygiene Plan.
Laboratory Environmental Management Plan (EMP). The Laboratory EMS
requires the development of a Laboratory EMP which is the mechanism
through which each University's EMS is put into practice at each
University. The Laboratory EMP, modeled on OSHA's Chemical Hygiene
Plan, is a comprehensive plan to be developed by each University. The
EMP documents the procedures, practices and programs to (a) manage
laboratory waste in a manner that is protective of human health and the
environment and (b) ensure implementation to achieve compliance with
the requirements of the Laboratory EMS and the Minimum Performance
Criteria. It is through the Laboratory EMP that the Universities have
the opportunity and the obligation to design a performance-based system
to complement the OSHA requirements, to encourage waste minimization,
and the redistribution and reuse of laboratory waste. The Laboratory
EMP identifies specific elements to be implemented by each University,
including requirements for pollution prevention policies and
procedures.
One of the objectives of the EMP and the overall XL project is to
erase the distinction between unused chemicals and waste chemicals in
the laboratory setting, so that the value in reusing chemicals can be
realized. This is to be accomplished by defining laboratory waste to
include hazardous chemicals that result from laboratory scale
activities and which may or may not constitute RCRA hazardous wastes.
In the rule, laboratory waste is defined as ``a hazardous chemical that
results from laboratory scale activities and includes the following:
excess or unused hazardous chemicals that may or may not be reused
outside their laboratory of origin; hazardous chemicals determined to
be RCRA hazardous waste as defined in 40 CFR Part 261; and hazardous
chemicals that will be determined not to be RCRA hazardous waste
pursuant to 40 CFR 262.106.'' Thus, all ``laboratory waste'' is managed
under a single standard while in the laboratory. The determination that
a laboratory waste could not be reused and would be a RCRA solid waste,
and as to whether such solid waste would be a RCRA hazardous waste,
will be made at a centralized area, by Environmental Health and Safety
professionals.
Minimum Performance Criteria. The requirements for the laboratory
EMP include a requirement that the EMP include procedures to assure
compliance with Minimum Performance Criteria (MPC) specified in the
regulation. The Minimum Performance Criteria set forth minimum
requirements for the management of laboratory waste and have been
designed to ensure that laboratory waste will be managed in a manner
protective of human health and the environment. The requirements in the
Minimum Performance Criteria include provisions which are consistent
with current RCRA requirements, including labeling and container
management. The criteria have a wider application than current RCRA
requirements because the definition of
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laboratory waste includes some materials that are not RCRA hazardous
waste.
The New System. Currently, there are two potential impediments to
the centralization and coordination facilitated by this rule. The first
is the hazardous waste determination requirement under 40 CFR 262.11.
If this determination is made in the individual laboratory, decisions
with regard to reuse are inevitably decentralized since the hazardous
waste determination necessitates a prior solid waste determination. To
the extent that these decisions are made by laboratory workers who do
not have a complete sense of the chemical needs of the entire
university, such decisions are often premature and do not maximize the
potential for re-use. The second potential impediment under the current
system is the requirement under 40 CFR 262.34(c) that hazardous waste
in excess of 55-gallons be removed within three days of reaching the
55-gallon limit. Such a time constraint results in constant, unplanned,
episodic pick-ups which are in themselves, time-consuming. In contrast,
the extended time period of 30 days allows for a more coordinated and
efficient pick-up and delivery system which frees up staff time, and
allows for the development of infrastructure and training designed to
increase waste minimization and an organized and coordinated campus-
wide chemical reuse system.
3. What Are the Environmental Benefits of the Project?
This Laboratory XL project is expected to achieve superior
environmental performance beyond that which is achieved by the current
RCRA regulatory system, in the three key areas of:
Setting of Environmental Objectives and Targets and
Pollution Prevention: The systematic approach to environmental
management will set the stage for better tracking, control, goal
setting and pollution prevention.
Streamlining the Regulatory Process: By coordinating RCRA
and OSHA regulatory compliance, the project will streamline the overall
regulatory process for University laboratories.
Environmental Awareness. The implementation and continuous
improvement of the Laboratory EMS will enhance environmental awareness
among laboratory workers.
These three areas are described more fully below:
In the setting of environmental objectives and targets and
pollution prevention, this XL project in the requirements for the
Laboratory Environmental Management Plan, is a significant improvement
in that it makes explicit to the research community that there is an
institutional commitment in the form of a policy to prevent pollution,
a procedure for conducting an annual survey of hazardous chemicals of
concern and a better system to reduce the potential for hazardous
chemicals to accumulate on laboratory shelves and become wastes. Each
XL Participant's Laboratory Environmental Management Plan must include
or reference:
A pollution prevention plan.
Defined procedures for conducting an annual survey of
laboratories that potentially store hazardous chemicals of concern
(``HCOC'').
Defined procedures for conducting laboratory
decommissionings (e.g., cleanouts).
Defined procedures for the timely removal of laboratory
wastes from the laboratory.
To increase reuse of laboratory waste and laboratory waste
reduction: The current regulatory framework does little to encourage
researchers to identify hazardous chemicals on the shelf as hazardous
waste or to identify institutional opportunities for reuse of such
chemicals. One targeted area for the demonstration of superior
environmental performance will be enhanced management and reuse of
laboratory hazardous chemicals. For example, chemicals that are no
longer of sufficient purity for research use may be reused or recycled
into teaching laboratories. Additionally, waste reduction will occur as
a result of better systems to exchange and reuse hazardous chemicals
throughout each university. According to a 1996 survey of approximately
100 academic institutions by the Campus, Safety, Health and
Environmental Management Association, nearly 95% of respondents
reported that they redistributed or recycled less than 1% of the
hazardous chemical waste otherwise destined for disposal. This
Laboratory XL Project commits the Universities to achieve better
results, with the goals of 10% reduction in waste (from the baseline)
and 20% increase in reuse or redistribution of chemicals from measured
baseline.
In addition, the EMP includes a requirement that each University
define a list of ``hazardous chemicals of concern'' (``HCOC'') and
annually conduct a risk evaluation survey of these chemicals in the
laboratory. This list will be generated by EHS professionals at each
University based on regulatory concerns, risk concerns and potential
chemical reactions. The criteria at each University includes:
Chemicals given an expiration date by the manufacturer due
to safety considerations (e.g., peroxide forming chemicals, etc.).
Chemicals which meet the RCRA definitions of reactive or
corrosive (flammables are covered by fire department restrictions; in
general, toxics are hazardous during their use, not during storage) and
have been determined by professional judgment to present a risk to non-
lab workers or the environment.
Poison Inhalation Hazard designation by DOT (covers
serious toxics).
Other chemicals as determined by professional judgment to
present a risk to non-lab workers or the environment.
Chemicals may be removed from the HCOC list if there are
insufficient quantities to pose a risk.
The HCOC list will be developed on a university-by-university
basis, because the types of hazardous chemicals at a particular
university will vary with the type of research work performed there.
This list will be reviewed on an annual basis and updated.
The annual survey directly addresses the problems associated with
the accumulation of old hazardous chemicals on the shelf. Federal EPA
and state inspectors have indicated that this problem is a priority
concern. This University Laboratory XL Project goes beyond the
``waste'' management regulations prescribed in RCRA by addressing this
particular ``upstream'' issue at its source. By providing regular and
consistent data on chemicals and chemical storage, such surveys will
support university-wide chemical redistribution and/or the timely
disposal of hazardous chemicals that are approaching or have exceeded
their shelf life. The survey will also document that HCOC's that remain
on the shelf have been assessed for product integrity.
In addition, evaluations and audits will be performed to help
assure conformance with the University's EMP. Together with the
enhanced environmental awareness training, internal audits/corrective
actions will provide a way to continually improve the Laboratory EMS
and help achieve improved environmental protection.
Another focus of this project is to streamline regulatory
requirements: As demonstrated by the effort to develop the Integrated
Contingency Plan, Federal agencies have placed high value on
coordination between regulatory programs. Laboratories in most states
are already regulated by the
[[Page 52384]]
requirements of OSHA's 29 CFR 1910.1450 (Occupational Exposure to
Hazardous Chemicals in Laboratories) which requires the development of
a Chemical Hygiene Plan (CHP) to ensure the health and safety of
laboratory workers handling hazardous chemicals. In this project, the
requirement to define and implement laboratory waste management
policies and procedures will effectively manage laboratory wastes at
every stage of their handling and disposition, including full
compliance with current RCRA requirements once laboratory waste is
received at the on-site hazardous waste accumulation area. The Minimum
Performance Criteria and the procedures for complying with the minimum
performance criteria which will be included in each University's
Laboratory EMP ensure that enforceable safeguards will be in place.
Moreover, the effect of a hazardous chemical survey and other
procedures defined in the Laboratory EMP will be to minimize hazardous
waste by shifting the focus to upstream sources of waste. The result
will be performance that will exceed that prompted by the current RCRA
program requirements as the focus of the university environmental
departments can broaden from the current narrow focus on the issues
associated with waste pick-up and handling to include pollution
prevention and the attendant issues of chemical substitution and reuse.
Environmental benefits will also result from increased
environmental awareness: Training, defined policies and procedures,
enhanced audit programs and pollution prevention strategies are key
management elements leading to superior environmental performance.
Under the current system, these elements often receive less attention
than they should because EH&S staff are focused on less pro-active
issues such as managing laboratories as satellite accumulation areas.
By allowing the institutional EH&S staff to schedule routine pick-ups
of laboratory wastes at more suitable intervals (e.g., 3-4 weeks rather
than 3-days under the satellite accumulation rule, but limiting the
satellite accumulation to a maximum quantity of 55 gallons per
laboratory, plus an ``excess'' of 55 gallons), the XL Participants will
be able to more pro-actively focus limited resources on training and
audit/corrective action programs and the establishment and
administration of waste-exchange and hazardous chemical redistribution
programs.
Under this project, laboratory workers will receive enhanced
hazardous chemical training with respect to laboratory waste, pollution
prevention and the environmental management practices at the
university. The training requirements are outlined in the Environmental
Management Standard (40 CFR part 262, Subpart J). The training will
also result in benefits for students who were laboratory workers as
they graduate and pursue their careers equipped with an increased
environmental awareness and respect for the environmental aspects of
their jobs.
4. What Are the Economic Benefits and Paperwork Reduction Deriving From
the Project?
Laboratory waste management currently accounts for the most
substantial expense for environmental, health and safety programs at
the XL Participants. This University Laboratory XL Project will allow
academic institutions to more effectively promote and implement waste
minimization programs in laboratories. This will result in reduced
waste disposal costs and reduced chemical purchasing costs without
diminishing the level of environmental protection associated with the
proper handling and/or disposal of hazardous laboratory wastes. The
opportunity to develop a systematic, planned procedure for the pickup,
consolidation and disposal of laboratory wastes will also enable
participating institutions to more effectively utilize their EH&S staff
for proactive activities. However, since existing RCRA record keeping
and reporting requirements will remain in full effect at the
institutional level, the XL Participants do not expect to significantly
reduce the paperwork associated with compliance.
5. Stakeholder Involvement
MADEP, VTDEC and EPA have been involved in the development of this
project, and support it. From the beginning of the Laboratory XL
process, there has been a high priority on having diverse stakeholders
review and support this project so that both national and local
stakeholders have been involved in the development of the Laboratory
Environmental Management Standard. This activity is described below and
additional information, such as a listing of national stakeholders and
letters of support are included in the docket supporting this
rulemaking.
The initial stakeholder group was a national assembly of experts in
laboratory chemical and environmental safety. The purpose of this group
was twofold: (a) to assure that the University Laboratory XL Proposal
reflected state of the art thinking with regard to controlling the
potential impacts of laboratory chemicals; and (b) to ensure that the
Laboratory Environmental Management Standard developed by the XL
Participants could reasonably apply to a broad spectrum of small,
medium and large institutions.
In addition to the stakeholder group, XL Participants made
presentations and gave workshops at the Campus Safety, Health and
Environmental Management Association meeting in New Orleans in July,
1998, sponsored a panel of presentations at the American Chemical
Society meeting in Boston in August, 1998, gave a presentation at the
EPA-New England sponsored workshop on compliance at universities March
24, 1999, and continue to speak to national forums and workshops in
order to reach national stakeholders on a continuing basis.
6. What Is the Project Duration and Completion Date?
As with all XL projects testing alternative environmental
protection strategies, the term of the New England University
Laboratories XL project is one of limited duration. The duration of the
regulatory relief provided by this rule is anticipated to be four (4)
years from the effective date of this rule. However, a participating
University may be terminated or suspended at any time for failure to
comply with any of the requirements of the rule.
C. Rule Description
1. Summary of Rule
The rule amends 40 CFR 262.10 to add a paragraph (j) that states
that the participating University laboratories are not subject to the
requirements of 40 CFR 262.11 and 40 CFR 262.34(c) as long as the
Universities comply with all the requirements of 40 CFR part 262,
Subpart J. This rule also adds a new section to the Standards
Applicable to Generators of Hazardous Waste, 40 CFR part 262, Subpart
J. Section 262.100 of the rule specifies which organizations are
covered by this site-specific rule (University of Massachusetts Boston,
Boston MA, the Boston College, Chestnut Hill MA and the University of
Vermont, Burlington VT). Section 262.101 outlines what is in Subpart J.
Subpart J provides a framework for a new management system for wastes
that are generated in university laboratories. This framework is called
the Laboratory Environmental Management Standard. The standard includes
some specific definitions that apply to the University laboratories,
specific requirements for how to handle laboratory waste, and
[[Page 52385]]
requirements for developing and implementing an environmental
management plan. Subpart J outlines the responsibilities of the
management staff of each participating university and identifies
requirements for training people who will work in the laboratories or
manage laboratory waste. Section 262.102 of the rule defines terms used
in the new rule. The definition of laboratory waste is of particular
interest because of its importance in the implementation of the
regulation. Section 262.103 defines the scope of the rule and makes it
clear that the Laboratory Environmental Management Standard does not
affect or supercede any legal requirements other than those described
in Sec. 262.10(j). Section 262.104 includes the requirements that a
University and participating laboratory will comply with in order to
continue to participate in this project, called the Minimum Performance
Criteria. Section 262.105 specifies the requirements for the laboratory
environmental management plan (EMP). Section 262.106 specifies when a
hazardous waste determination must be made for laboratory waste.
Section 262.107 includes a termination provision, in addition to
EPA's usual enforcement options 1, which authorizes EPA to
remove from this XL project any University that does not comply with
the Laboratory Environmental Management Standard as described in the
rule. In the event of such removal, the temporary conditional deferral
would be revoked and the Universities would be required to submit to
EPA an implementation schedule setting forth how the Universities would
plan to come into full compliance regulations within 90 days from such
notice. The schedule would reflect the Universities' intent to use
their best efforts to come into compliance as quickly as practicable
within the 90 day transition period. During this 90 day transition
period, the provisions of this proposed rule and the University's
Environmental Management Plan would apply in full. At the conclusion of
the 90 day period, the applicable RCRA regulations would again apply to
the Universities in full. For further discussion, see the preamble to
the proposed rule and the Final Project Agreement.
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\1\ As noted in the proposed rule (64 FR 40696) EPA retains its
full range of enforcement options under today's rule. The
enforcement response on the part of EPA will vary depending upon the
actual performance of each University and the severity of any
violation. So that EPA can continue to evaluate this XL project,
each University will be evaluated by EPA Region I through regular
state and/or federal inspections based on four criteria outlined in
both the preamble to the proposed rule and the Final Project
Agreement.
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The final paragraph of the rule, section 262.108, sets forth the
expiration date of the rule, September 30, 2003.
2. Changes to the Proposed Rule
EPA has made several changes to the proposed rule in response to
comments. First, EPA has modified the rule in response to comments on
the training requirements at 40 CFR 262.105(d). As proposed,
Sec. 262.105(d) required each participating university, in general, to
``provide laboratory workers with information and training so that they
can understand and can implement the elements of each University's
Environmental Management Plan that are relevant to the laboratory
worker's responsibilities.'' Similarly, Sec. 262.104(j) required that
each university must ``provide laboratory workers with information and
training so that they can implement and comply with [the] Minimum
Performance Criteria.'' One commenter was concerned that these
requirements did not recognize that a laboratory worker may receive
training outside of the University and that the University should not
have to provide (nor should the lab worker have to receive) training
which is merely duplicative. EPA agrees with this commenter that, as
proposed, these requirements may lead to duplicative training. As
discussed at proposal, the goal of these training requirements is for
the University to ensure that all laboratory workers have been trained
to understand the hazards of laboratory waste and to take measures to
protect human health and the environment. EPA did not intend to
preclude appropriate reliance on any relevant training received from
outside the University. Thus, EPA is modifying Secs. 262.104(j) and
262.105(d) to require that the participating Universities must
``ensure'' that laboratory workers have received training regarding the
minimum performance criteria and the EMP. This change clarifies that
the participating Universities have the flexibility to consider whether
a laboratory worker has received sufficient training outside the
University. For example, if a newly assigned laboratory worker has
already had other training that enables him/her to implement and comply
with the MPC, the training that the University will have to provide may
be minimized for that worker.
Also regarding training, another commenter pointed out that, with
respect to Sec. 262.105(d)(2), the requirement that laboratory workers
must be trained when they are first assigned to a work area is more
stringent than under current RCRA requirements, and large universities
may find it difficult to provide training upon first assignment to a
work area especially at the beginning of an academic year. EPA agrees
that this may be a difficult standard to meet for the Universities. As
discussed above, the main purpose of the university training
requirements was to ensure that all laboratory workers would be trained
irrespective of their particular status (e.g., ``student,''
``employee'') within the laboratory. EPA's intent was not that
particular training requirements would be more stringent than required
under current RCRA requirements. EPA believes it is appropriate to
allow the participating Universities the same flexibility regarding
when a newly assigned lab worker will have to be trained as they would
have under current RCRA requirements. Thus, EPA has modified
Sec. 262.105(d)(2) to read: ``(i) Each University must provide the
information to each laboratory worker when he/she is first assigned to
a work area where laboratory wastes may be generated. (ii) Each
University must ensure that each laboratory worker has been trained
within six months of when he/she is first assigned to a work area where
laboratory wastes may be generated and must retrain a laboratory worker
when a laboratory waste poses a new or unique hazard for which the
laboratory worker has not received prior training and as frequently as
needed to maintain knowledge of the procedures of the Environmental
Management Plan.''
Second, EPA has slightly modified the container labeling
requirements. As proposed, Sec. 262.104(a) required that all laboratory
waste be labeled with ``the chemical name and general hazard class.''
One commenter was concerned that this requirement did not allow enough
discretion for the Universities, while another commenter expressed
concern that this requirement did nothing to clarify the confusion
resulting from current RCRA labeling requirements. The container
labeling requirements included in the proposed rule were part of the
University participants' proposal to the Agency. In particular, the
participants included both the ``hazard class'' and the chemical
contents on the label as an attempt to integrate OSHA and RCRA by
including information relevant under both programs. This is an aspect
of the project that EPA will be evaluating to determine how it compares
to current requirements. EPA did not intend, however, that laboratories
should have less flexibility in how they identify
[[Page 52386]]
chemical contents. EPA's intent in modifying the existing RCRA
container labeling requirements was simply to replace the term
``hazardous waste'' because not all laboratory waste will necessarily
be ``hazardous waste.'' Thus, EPA has modified Sec. 262.104(a) to
require that laboratory waste containers be labeled ``with the general
hazard class and either the words ``laboratory waste'' or with the
chemical name of the contents.'' This requirement operates in
conjunction with the Environmental Management Plan (EMP) that each
University must develop. Section 262.105(b) requires each University to
write, implement and comply with an Environmental Management Plan that
includes the following specific requirement to address container
labeling in subparagraph (9) of that section: ``The criteria that
laboratory workers must comply with for managing, containing and
labeling laboratory wastes * * *'' Therefore, each University must
designate the system for identifying the hazard class (for example, if
the system that would work best were RCRA, it would utilize the terms
ignitible, corrosive, reactive or EP toxic; if an OSHA-type system
worked better for a university, it would include flammable rather than
ignitible, and would probably include radioactive and biohazard or
infectious classes of waste). The chemical name must either include the
actual name of the chemical in the container or identify it as
``laboratory waste.'' EPA expects this requirement to be less confusing
than current requirements and, when combined with requirements in the
EMP (see 40 CFR 262.105(b)(9)), we expect participants to be able to
develop labeling protocols that will provide sufficient information to
characterize the contents of containers containing laboratory waste.
Finally, one commenter pointed out that the rule, as proposed,
would preclude a university from sending laboratory waste directly to a
treatment, storage, or disposal (TSD) facility rather than first
sending it to the hazardous waste accumulation area. The commenter felt
that such an option may be necessary in unusual circumstances. EPA
agrees that there may be unusual circumstances when a university would
need the flexibility to transfer laboratory wastes from a laboratory
directly to a permitted TSD facility, for example, if a laboratory
generated a reactive waste where the most protective management of the
waste might include minimizing the movement of the waste. Rather than
moving the waste to the on-site hazardous waste accumulation area, the
University might feel that it is more prudent to ship it directly to
the TSD. Therefore EPA has modified Sec. 262.104(i) and other relevant
provisions in the rule to clarify that laboratory waste may also be
sent to a TSD facility permitted to handle the waste under 40 CFR part
270 or in interim status under 40 CFR parts 265 and 270 (or authorized
to handle the waste by a state with a hazardous waste management
program approved under 40 CFR part 271) if it is determined in the
laboratory by the individuals identified in the EMP to be responsible
for waste management decisions that the waste is a hazardous waste and
that it is prudent to transfer it directly to a treatment, storage, and
disposal facility.
Laboratory waste that will be sent directly to a TSD facility
rather than to a hazardous waste accumulation area is still subject to
the 30-day limit (Sec. 262.104(c)), and therefore, solid and hazardous
waste determinations must be made in the laboratory by the appropriate
personnel prior to the 30-day deadline for removing the waste from the
laboratory. Whether sent to a hazardous waste accumulation area or
directly to a TSD facility, all laboratory waste that is determined to
be hazardous waste is no longer subject to the provisions of today's
rule and must be managed in accordance with all applicable RCRA
requirements (Sec. 262.106(c)). For example, waste sent from the
laboratory to an off-site TSD facility will have to be accompanied by a
manifest.
III. Response to Significant Public Comments
The following presents responses to significant public comments (in
addition to those comments already discussed at Section C.2.) received
during the public comment period. For EPA's responses to all the
comments received during the public comment period regarding the
proposal see the ADDRESSES section of this preamble to determine where
you can obtain a copy, or follow the links to this project on EPA's
world wide web Project XL website at http:/www.epa.gov/ProjectXL.
EPA received 9 comment letters during the public comment period
from: the California State University, Los Angeles Department of
Chemistry and Biochemistry, the University of Wisconsin-Madison
(Assistant Vice Chancellor), the American Chemical Society, Boston
University, the Howard Hughes Medical Institute, Cynthia Salisbury, the
American Council on Education, the University of Wisconsin System
Administration--Environmental/Occupational Health & Safety Section, and
Harvard University.
(1) Many of the commenters supported EPA's proposed rule and agreed
that the proposed rule should result in superior environmental
performance and significant cost savings to universities while being
protective of human health and the environment but also noted that the
rulemaking should not be a model for all universities as this may not
be the best approach at all educational institutions.
EPA Response: EPA does not consider this XL project to be a model
for all universities, but rather a pilot designed to test one possible
approach to the management of hazardous waste within university
laboratories. One of the purposes of implementing this XL project, as
with all XL projects, is to assess whether it should be considered for
wider application. It would be inconsistent with the forward-looking
nature of these pilot projects to adopt such innovative approaches
prematurely on a widespread basis without first determining whether or
not they are viable in practice and successful in the particular
projects that embody them. Although EPA hopes that today's rule will
result in a successful innovative new system for universities and other
research organizations, we recognize that this regulatory approach may
not be appropriate at all such institutions.
(2) Several commenters noted that because participating
Universities may designate only certain departments to participate in
the project, there would be duplicate systems regulating their
hazardous waste.
EPA Response: Although this rule does not pilot a strictly
performance-based system, nonetheless, each University may design their
environmental management plan in the way that most suits their
structure and needs. This includes each University having the option
not to include all departments operating pursuant to the alternative
standard's in today's rule. As several of the comment letters noted,
this could result in two sets of rules being applicable at a single
institution. EPA would like to stress that it is up to each University
to decide, based on its own needs, what departments will be
participating in this XL project. If, for example, certain departments
determined that the EMP would work well with their Chemical Hygiene
Plan, while other departments did not want to implement an EMP, then
two sets of requirements for managing hazardous wastes in the
laboratories would be applicable at that institution.
[[Page 52387]]
(3) Several commenters commented on the definition of
``laboratory,'' indicating that EPA was considering the laboratory
process unit or laboratory management unit concept and that the
proposal does not specifically delineate what constitutes a laboratory,
questioning whether, for example, a photo lab or clinical lab would be
a laboratory.
Response: The definition of laboratory, under new Subpart J, is
``an area within a facility where the laboratory use of hazardous
chemicals occurs. It is a workplace where relatively small quantities
of hazardous chemicals are used on a non-production basis. The physical
extent of individual laboratories within an organization will be
defined by the Environmental Management Plan. A laboratory may include
more than a single room if the rooms are in the same building and under
the common supervision of a laboratory supervisor.'' This definition
operates in concert with the definition of ``Laboratory Scale'' which
is defined as ``work with substances in which containers used for
reactions, transfers and other handling of substances are designed to
be safely and easily manipulated by one person.'' ``Laboratory Scale''
excludes ``those workplaces whose function is to produce commercial
quantities of chemicals.'' These definitions are another example of how
this rule parallels the current OSHA Laboratory Standard, as these
definitions follow the definitions in the OSHA standard.
Any area on a campus that is designated in the Environmental
Management Plan as a laboratory and that meets these definitions will
be considered a laboratory for the purpose of this pilot project.
However, it would be rare that a typical photographic laboratory would
meet the criterion of non-production. For example if a university had a
photographic facility on the campus that processed film for students,
that would be operating on a production basis and would not be
considered eligible under this rule. However, EPA understands that
photographic laboratories may also be laboratory scale and could be
eligible to participate under this rule, examples would include, labs
used to support research and teaching, such as a small photo lab
developing X-rays as part of medical research or a small photo lab
developing satellite photographs as part of geologic or environmental
research. Key factors that would limit the participation of a
laboratory include consideration of the scale of the activities and
whether they could be viewed as operating as a production process as
opposed to the varied small-scale activities described in the proposed
rule for teaching and research. EPA did not intend for this rule to be
available to production operations. This rule applies to laboratory
scale activities as defined in the definitions section at 40 CFR
262.102.
(4) Several commenters suggested that Sec. 262.105(b)(6) of the
proposed rule is duplicative since the EMP must include a ``a pollution
prevention plan, including, but not limited to, roles and
responsibilities, training, pollution prevention activities, and
performance evaluation.'' The commenter noted further that an EMP
should be an integral part of every pollution prevention plan, or visa
versa and ``generic pollution prevention principles'' should not be
applied to automatically prevent the use of chemicals essential to
research or to require the use of less effective substitutes.
Response: The rule requires each University to write, implement and
comply with their EMP. Although the EMP must include a pollution
prevention plan there are many elements that the EMP must include in
addition to a pollution prevention plan. If a University already has a
pollution prevention plan in place, this plan can be incorporated into
or referenced by the EMP. There is no requirement for the plans to
address or adopt generic solutions. The intent of the regulation is
simply for each University to individually develop pollution prevention
methods to ensure waste minimization and to document their intended
actions or methods. The proposal attempts to recognize the unique
activities of university laboratories, many of which, as the comment
notes, are conducting innovative research that may lead to the
improvement of the quality of life. It is the hope of EPA and the
project sponsors that this XL project, once implemented and
operational, will create a system that effectively and efficiently
supports that research.
Furthermore, if the existing pollution prevention plan had ``an
environmental policy, or environmental, health and safety policy,
signed by the University's senior management, including commitments to
regulatory compliance, waste minimization, risk reduction and continual
improvement of the environmental management system'' as required by
Sec. 262.105(b)(1), then the EMP could simply incorporate the pollution
prevention plan to meet this requirement. There is no requirement to
create a new pollution prevention plan and, therefore, the requirement
is not duplicative. The project envisions that through annual reviews
and continuous improvement, each university will determine whether
separate plans or combined plans work best.
(5) The comment suggests that the proposed rule makes no provision
for recycling of chemicals between nearby laboratories, which is an
efficient waste minimization practice that precedes RCRA; everything
that is waste from a laboratory must go to the central accumulation
area for evaluation and recycling.
Response: Centralizing the solid and hazardous waste determination
is one function that is being piloted with this XL project. The intent
of the new alternative is to centralize waste re-use decisions within
the EH&S department, which has knowledge of campus-wide re-use
opportunities. A participating University may demonstrate that this
precludes some internal re-use opportunities, and provide documentation
as part of this pilot. Alternatively, if laboratories are working
closely together and would like to share used chemicals, the definition
of ``laboratory'' allows a participating University to define them as a
single laboratory for the purposes of their Environmental Management
Plan.
(6) The comment encourages EPA to make a change in the Minimum
Performance Criteria with respect to Sec. 262.104--that senior
management should be granted authority to make changes in performance
criteria.
Response: The minimum performance criteria have been developed as
the minimum set of requirements that EPA believes are necessary to
protect human health and the environment. Senior management may adopt
more stringent criteria, as long as such criteria still comply with the
requirements in today's rule.
(7) The comment suggests that Sec. 262.104(b) and (d) be changed to
provide some discretion to exceed the amounts when approved by senior
management. An example is given that a university may want to describe
a laboratory to mean all modules under control of a single researcher.
Response: For the purposes of this pilot, EPA will not be allowing
additional flexibility in the amount of waste that can be temporarily
held in a laboratory although EPA agrees that it might be useful to
gather data on the need for additional flexibility on the amount of
laboratory waste that can be temporarily held in the laboratory,
especially in view of the fact that some laboratories may currently
contain numerous points of generation resulting in limits far beyond
the 110 gallons
[[Page 52388]]
currently imposed by this proposal. EPA expects the participating
universities to indicate in their reports whenever such limits result
in less than optimal implementation of the new rule. The rule currently
includes the flexibility for the participating universities to identify
the laboratories in their individual EMPs. In the process of continuous
improvement and periodic reviews conducted by the universities during
this project, the configuration of participating laboratories as
identified in the EMP may be changed. Additionally, the Final Project
Agreement (FPA) does envision that other participants may come forward
with new proposals to pilot test these concepts.
(8) The comment suggests that the ``in-line waste collection'' at
Sec. 262.104(e)(1) interpretation augment the closed container rule for
certain repetitive manual operations, under the discretion of senior
management.
Response: EPA disagrees that discretion is appropriate in this
area. EPA believes the requirements in the rule are necessary to
protect human health and the environment. In the discussions during
development of the rule, EPA considered the possibility of manual
operations in terms of ``in-line waste collection'' and concluded that
under such operations waste would be being added to the container under
the control of the operator of the process and therefore would fit
under the requirements as they are written at Sec. 262.104(e):
``containers of laboratory wastes must be: (1) closed at all times
except when wastes are being added. . . .'' EPA understands that
repetitive manual operations such as a pipetting process where a
researcher takes a supernatant from a beaker and pours it into a waste
container could be interpreted as ``wastes being added to the
container.'' EPA was not provided with specific scenarios to describe
repetitive manual operations where a container would be left open to
add waste and yet would not meet the requirement that ``containers must
be closed at all times except when wastes are being added or removed.''
Thus, EPA sees no need to augment the closed container rule for manual
operations where there is an operator of the process present.
(9) The comment suggests eliminating the inspection requirements at
Secs. 262.104(e)(4) and 262.105(b)(15) (the latter which specifically
requires a regular inspection of each laboratory) since such
requirements do not seem feasible for a large university that has
thousands of laboratories.
Response: EPA does not agree that the inspection requirement should
be removed at Sec. 262.104(e)(4) as it performs an important function.
Under current RCRA requirements, Sec. 262.34(c) requires satellite
accumulation containers to be ``at or near any point of generation
where waste initially accumulates which is under the control of the
operator of the process generating the waste.'' This requirement helps
ensure that containers in satellite accumulation areas will be
naturally subject to inspection. Under today's rule, containers holding
laboratory waste may not always be (and are not required to be) located
at an area which is similarly subject to such naturally occurring
inspections. Thus, EPA believes it is necessary to include a
requirement that inspections of containers in laboratories be conducted
on a regular (at least annual) basis to ensure that they meet the
minimum performance criteria for container management.
40 CFR 262.105(b)(15) requires the EMP to include, ``the procedures
for regularly inspecting a laboratory to assess conformance with the
requirements of the Environmental Management Plan.'' Based on the
proposal submitted, EPA expects that this is a feasible requirement and
is not unduly burdensome. (The New Hampshire state RCRA program, for
example, already has such a requirement in place.) Nonetheless, this
pilot will test the feasibility of the requirement. In this pilot, each
University is expected to develop a system that will work within the
constraints of their campus systems, and to define the personnel to
perform the inspections and the timetable for these inspections, which
may vary for each laboratory. For example, one participant currently
utilizes a ``peer review'' type process for inspecting laboratories
which has the added advantage of networking and the potential to create
a system of informal exchange of best practices.
(10) The comment questions how university laboratories are
accumulating 55 gallons of hazardous waste at the point of generation
and whether this is a realistic problem for university laboratories.
Response: The project embodied in today's rule focuses on the
approach that the University participants believe to be a common sense,
cost effective approach for managing laboratory waste. EPA has
determined that this particular XL project is beneficial to human
health and the environment and is worth evaluating as an alternative to
the existing system. The proposed rule was developed in view of current
Federal RCRA regulations for satellite accumulation areas that require
that any hazardous waste accumulated at any point of generation in
excess of 55 gallons (or one quart of acutely hazardous laboratory
waste) be removed within three days. Current regulations do not limit
the number of points of generation within an individual laboratory as
long as hazardous waste is accumulated in accordance with all the
requirements of 40 CFR 262.34(c). Thus, a given laboratory could
potentially accumulate well over 55 gallons under the current rules.
However, under the proposed rule, the Universities would be limited to
temporarily holding 55 gallons of laboratory waste per laboratory, and
no matter how many points of generation there are within a laboratory,
any laboratory would be limited to 110 gallons. EPA noted in the
preamble to the proposed rule (64 FR 40703) that ``while this proposed
restriction may prove to be more restrictive than the current system,
this approach represents an experiment to be tested under this XL
project.''
The size of laboratory waste streams varies greatly, and although
many laboratories do not produce large quantities of waste, there are
some activities and some laboratories that may generate larger amounts
on a discontinuous basis, making it difficult to schedule pick-ups.
(11) The comment addressed the regulatory implications of
commingling RCRA regulated lab wastes and non-RCRA laboratory wastes
(e.g., nonhazardous wastes). The comment noted that the commingling of
RCRA regulated laboratory wastes and non-RCRA laboratory wastes would
result in the entire mixture being designated a RCRA hazardous waste
(assuming the laboratory waste is a determined to be a RCRA waste) due
to the mixture rule (see 40 CFR 261.3(a)(2)), and thus would result in
an increase in hazardous waste generation. Likewise, the scenario would
be the same for the commingling of RCRA acutely hazardous wastes (e.g.,
P-listed hazardous wastes) and acutely hazardous laboratory wastes
(AHLW), only the impact could be more substantial because of the ``1
kilogram of acute hazardous waste/month'' definition of a Large
Quantity Generator (LQG). The commenter went further to say that the
only way to prevent this scenario would be if the laboratory workers
identify which laboratory wastes are RCRA hazardous wastes and keep
those wastes segregated from the non-RCRA wastes. The comment concludes
with the statement that a primary objective of this XL project is to
take the waste determination out of the
[[Page 52389]]
hands of laboratory workers; however, to efficiently implement the
proposal, these laboratory workers must continue to make these waste
determinations (presumably in order to segregate RCRA hazardous wastes
from non-RCRA wastes). The commenter believes this would have the
effect of creating ``another layer in the waste determination scheme--
and a layer that will likely result in consternation at the central
accumulation area.''
Response: EPA believes the commenter misunderstands the objective
of this rule. It is not the goal of the XL project to take all waste
determinations out of the hands of the laboratory workers, but rather
to centralize the point at which RCRA hazardous waste determinations
are made within the university such that more effective and informed
determinations are made with regard to whether the chemicals in
question are truly wastes that require further management as solid and
hazardous waste or whether they may be reused within the university
and, thus, are not wastes.
While EPA acknowledges that the commenter is correct in that the
mixture rule does apply and could have the regulatory effect described
in the comment, the Agency does not believe that the applicability of
the mixture rule to such commingling scenarios is a regulatory
impediment. A ``superior environmental benefit'' of this project is to
encourage and increase the reuse of laboratory wastes. Since the
commingling of these chemicals (i.e., laboratory wastes) would likely
result in rendering such chemicals unusable and thus precluding reuse
opportunities, the Agency believes a regulatory change that would
encourage such commingling would be counter to the goal of this XL
project.
In EPA's experience under this project, laboratories do not
commonly mingle acutely hazardous and hazardous waste. Additionally,
under this project, the specific concern of the comment should be
addressed by two of the requirements of the EMP working together. Under
the EMP, the laboratories will be required to include (see
Sec. 262.105(b)(6)) a pollution prevention plan, including, but not
limited to, roles and responsibilities and training as well as (see
Sec. 262.105(b)(9)) ``the criteria that laboratory workers must comply
with for managing, containing and labeling laboratory wastes,
including: an evaluation of the need for and the use of any special
containers or labeling circumstances, and the use of laboratory wastes
secondary containers including packaging, bottles, or test tube
racks.'' Each EMP must address the labeling and containing of wastes
and ensure that laboratory workers are trained to implement the EMP
(see 40 CFR 262.104(j) and 262.105(d)(1)).
EPA does not agree that today's rule will, in effect, impose a
second (and complicating) layer of waste determinations. Rather, the
regulatory modifications being promulgated in today's rule recognize
that while laboratory workers may have specific knowledge of the
chemicals in question, they may not have access to information
pertinent to whether the chemical is also a solid waste under RCRA
(e.g., information regarding potential reuse of a chemical in another
part of the university). The Agency also notes that today's rule
provides the flexibility for specific procedures (including procedures
regarding the commingling of these materials) to be set by the
laboratory (e.g., in the environmental management plan (EMP)). To the
extent that RCRA regulations discourage the commingling of laboratory
wastes, encourage the segregation of RCRA acutely hazardous wastes (a
designation that assumes the chemicals are discarded rather than
reused), and that these regulatory considerations are reflected in the
EMP or standardized laboratory procedures, EPA considers this a benefit
of the current regulatory framework.
(12) The comment questions the need for a deferral of the
requirements of 40 CFR 262.34(c) within the laboratory because that
deferral would follow as a direct consequence of deferring the
Sec. 262.11 hazardous waste determination.
Response: The deferral of the Sec. 262.11 hazardous waste
determination does not mean that laboratories are not handling
hazardous waste; the effect of the ``deferral'' is only to identify
with precision the point at which these Universities will be held
responsible for their solid and hazardous waste determinations. For
this reason, EPA has explicitly deferred those portions of 40 CFR Part
262 that could otherwise have applied within the laboratory to the
handling of material that was later determined to be hazardous waste.
(13) The comment makes the statement that Clean Water Act
notification may no longer apply to any laboratory waste discharged
down the drain by participating institutions.
Response: The proposal specifically addresses releases of hazardous
constituents as noted at 64 FR 40703-40704 of the preamble: ``Today's
proposed rule would contain a statement that laboratory waste
management must not result in the release of hazardous constituents
into the land, air and water where such release would be prohibited by
federal law.'' The rule itself includes two provisions to prevent such
releases, including Sec. 262.103 (the scope of the laboratory
environmental management standard) and Sec. 262.104(e). The Laboratory
Environmental Management Standard will not affect or supersede any
legal requirements other than those described in Sec. 262.10(j). The
requirements that continue to apply include, but are not limited to,
OSHA, Fire Codes, wastewater permit limitations, emergency response
notification provisions, and other legal requirements applicable to
University laboratories. Also, the rule states at Sec. 262.104(f) ``the
management of laboratory waste must not result in the release of
hazardous constituents into the land, air and water where such release
is prohibited under federal law.'' Additionally, with respect to
regulations concerning POTW's, local limits as specified under 40 CFR
403.5 would continue to apply.
(14) The comment expresses concern over the scope of wastes covered
under the definition of ``laboratory wastes'' in the rule and questions
how the definition applies to such waste products as broken labware,
towels, bench coverings, gels and protective equipment that have come
into contact with chemicals.
Response: Today's rule requires that the EMP include (see
Sec. 262.105(b)(9)) ``the criteria laboratory workers must comply with
for managing, containing and labeling laboratory wastes, including: an
evaluation of the need for and the use of any special containers or
labeling circumstances.'' The EMP must identify how such waste products
as broken labware, towels, bench coverings, gels and protective
equipment that have come into contact with chemicals would be managed,
contained and labeled when they are appropriately considered to be
laboratory waste. The determination of the status of such material will
depend on the characterization of the waste. This is no different than
current RCRA requirements. As noted in response to a previous comment,
it is not the goal of the XL project to take all waste determinations
out of the hands of the laboratory workers, but rather to centralize
the point at which RCRA hazardous waste determinations are made within
the University such that more effective and informed determinations are
made with regard to whether the chemicals in question are truly wastes
that require further
[[Page 52390]]
management as solid and/or hazardous waste.
(15) The comment notes that Sec. 262.106 requires a hazardous waste
determination ``as soon as the laboratory waste reaches the
University's Hazardous Waste Accumulation Area,'' and believes that the
words ``as soon as'' should be replaced with ``at the first
opportunity'' to allow waste management personnel adequate time to
characterize containers when many are received.
Response: In developing the rule, EPA considered several
alternatives for this provision. EPA feels that ``at the first
opportunity'' would be too vague and subject to interpretation of when
the appropriate ``opportunity'' arose. The intent of the regulation is
that waste be characterized as soon as it arrives. EPA understands that
waste characterization is a process, and in some cases that process
could require that a sample be sent out to confirm the contents of a
container. EPA also acknowledges that there could, at times, be a large
number of containers that will take some effort to characterize. The
intent of the regulation is not to impose an impossible standard, but
to ensure that the process of characterizing the waste will commence as
soon as the waste reaches the accumulation area.
IV. What Is the Effective Date of This Rule?
This rule is effective immediately. Section 3010(b) of RCRA
generally requires that EPA's hazardous waste regulations and revisions
thereto take effect within six months after their promulgation. The
purpose of this requirement is to allow persons handling hazardous
wastes sufficient lead time to prepare to comply with new regulatory
requirements. The Hazardous and Solid Waste Amendments of 1984 amended
section 3010 of RCRA to allow rules to become effective in less than
six months when the regulated entities do not need the six-month period
to come into compliance. That is the case here. This rule will not take
effect in the relevant states unless and until it is adopted as state
law. In addition, the rule itself does not require immediate
compliance. Once adopted as state law, its effect will be to exempt
certain entities from identified RCRA regulations so long as the
entities comply with the requirements in this rule (i.e., it is up to
the regulated entities to determine when they want to take advantage of
the exemption). These reasons also provide a basis for making this rule
effective immediately, upon publication, under the Administrative
Procedure Act, pursuant to 5 U.S.C. 553(d).
V. Additional Information
A. How Does This Rule Comply With Executive Order 12866?
Because this rule affects only three specific universities, it is
not a rule of general applicability and, therefore, is not subject to
OMB review and Executive Order 12866. In addition, OMB has agreed that
review of site-specific rules under Project XL is not necessary.
B. Is a Regulatory Flexibility Analysis Required?
The Regulatory Flexibility Act (RFA) generally requires an Agency
to conduct a Regulatory Flexibility analysis of any rule subject to
notice and comment rulemaking requirements 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 not-for-profit enterprises, and small governmental
jurisdictions. EPA has concluded that this rule will not have a
significant impact on a substantial number of small entities because it
affects only three entities: the University of Massachusetts-Boston,
Boston, Massachusetts, Boston College, Chestnut Hill, Massachusetts,
and the University of Vermont, Burlington, Vermont. These Universities
are not small entities. Therefore, EPA certifies that today's rule will
not have a significant economic impact on a substantial number of small
entities.
C. Is EPA Required To Submit a Rule Report Under the 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 the Comptroller General of the United
States. Section 804, however, exempts from Section 801 the following
types of rules: rules of particular applicability, rules relating to
agency management or personnel, and rules of agency organization,
procedure, or practice that do not substantially affect the rights or
obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required
to submit a rule report regarding today's action under Section 801
because this is a rule of particular applicability.
D. Is an Information Collection Request Required for This Project Under
the Paperwork Reduction Act?
This action applies only to three universities, and therefore
requires no information collection activities subject to the Paperwork
Reduction Act, and therefore no information collection request (ICR)
will be submitted to OMB for review in compliance with the Paperwork
Reduction Act, 44 U.S.C. 3501, et seq.
E. Does This Project Trigger the Requirements of the 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 section 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 of 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.
As noted above, this rule is applicable only to the three
Universities. The EPA has determined that this rule does not contain a
Federal mandate that may
[[Page 52391]]
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. Thus, today's rule is not subject to the requirements of sections
202 and 205 of the UMRA. EPA has also determined that this rule
contains no regulatory requirements that might significantly or
uniquely affect small governments.
F. RCRA/HSWA
1. Applicability of Rules in Authorized States
Under section 3006 of RCRA, EPA may authorize qualified States to
administer and enforce the RCRA program for hazardous waste within the
State. (See 40 CFR part 271 for the standards and requirements for
authorization.) States with final authorization administer their own
hazardous waste programs in lieu of the federal program. Following
authorization, EPA retains enforcement authority under sections 3008,
7003 and 3013 of RCRA.
After authorization, rules written under RCRA provisions that
predate the Hazardous and Solid Waste Amendments of 1984 (HSWA) no
longer apply in the authorized State. New Federal requirements imposed
by those rules do not take effect in an authorized state until the
state adopts the requirements as state law.
In contrast, under section 3006(g) of RCRA, new requirements and
prohibitions imposed by HSWA take effect in authorized States at the
same time they take effect in nonauthorized States. EPA is directed to
carry out those requirements and prohibitions in authorized States
until the state is granted authorization to do so.
2. Effect on Massachusetts and Vermont Authorization
Today's rule is promulgated pursuant to RCRA provisions that
predate HSWA. Massachusetts and Vermont have received authority to
administer most of the RCRA program; thus, authorized provisions of the
States' hazardous waste program are administered in lieu of the Federal
program. Massachusetts and Vermont have received authority to
administer hazardous waste standards for generators. As a result,
today's rule will not be effective in Massachusetts and Vermont until
the States adopt equivalent requirements as State law. It is EPA's
understanding that subsequent to the promulgation of this rule,
Massachusetts and Vermont intend to propose rules containing equivalent
provisions. EPA may not enforce these requirements until it approves
the State requirements as a revision to each of the authorized State
programs.
G. How Does This Rule Comply With Executive Order 13045: Protection of
Children From Environmental Health Risks and Safety Risks?
The 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, 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.
This rule is not subject to Executive Order 13045 because it is not
economically significant as defined in Executive Order 12866, 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. How Does This Rule Comply With Executive Orders on Federalism?
Under Executive Order 12875, EPA may not issue a regulation that is
not required by statute and that creates a mandate upon a State, local
or tribal government, unless the Federal government provides the funds
necessary to pay the direct compliance costs incurred by those
governments or EPA consults with those governments. If EPA complies by
consulting, Executive Order 12875 requires EPA to provide to the Office
of Management and Budget a description of the extent of EPA's prior
consultation with representatives of affected State, local and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create a mandate on State, local or tribal
governments. The rule does not impose any enforceable duties on these
entities. Accordingly, the requirements of section 1(a) of Executive
Order 12875 do not apply to this rule.
On August 4, 1999, President Clinton issued a new executive order
on Federalism, Executive Order 13132 (64 FR 43255 (August 10, 1999))
which will take effect on November 2, 1999. In the interim, the current
Executive Order 12612 (52 FR 41685 (October 30, 1987)) on federalism
still applies. This rule will not have a substantial direct effect on
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 Executive Order 12612.
I. How Does This Rule Comply With Executive Order 13084: Consultation
and Coordination With Indian Tribal Governments?
Under Executive Order 13084, EPA may not issue a regulation that is
not required by statute, that significantly or uniquely affects the
communities of Indian tribal governments, and that imposes substantial
direct compliance costs on those communities, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by the tribal governments or EPA consults with those
governments. If EPA complies by consulting, Executive Order 13084
requires EPA to provide to the Office of Management and Budget, in a
separately identified section of the preamble to the rule, a
description of the extent of EPA's prior consultation with
representatives of affected tribal governments, a summary of the nature
of their concerns, and a statement supporting the need to issue the
regulation. In addition, Executive Order 13084 requires EPA to develop
an effective process permitting elected officials and other
representatives of Indian tribal governments ``to provide meaningful
and timely input in the development of regulatory policies on matters
that significantly or uniquely affect their communities.'' Today's rule
does not significantly or uniquely affect the communities of Indian
tribal governments. Accordingly, the requirements of section 3(b) of
Executive Order 13084 do not apply to this rule. There are no
communities of Indian tribal governments located in the vicinity of the
University laboratories.
J. Does This Rule Comply With National Technology Transfer and
Advancement Act?
As noted in the proposed rule, section 12(d) of the National
Technology Transfer and Advancement Act of 1995
[[Page 52392]]
(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. The NTTAA directs EPA to provide Congress,
through OMB, explanations when the Agency decides not to use available
and applicable voluntary consensus standards. This rulemaking does not
involve technical standards. Therefore, EPA did not consider the use of
any voluntary consensus standards.
List of Subjects in 40 CFR Part 262
Environmental protection, Hazardous waste.
Dated: September 22, 1999.
Carol M. Browner,
Administrator.
For the reasons set forth in the preamble, part 262 of title 40,
chapter I of the Code of Federal Regulations is amended as follows:
PART 262--STANDARDS APPLICABLE TO GENERATORS OF HAZARDOUS WASTE
1. 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
2. Section 262.10 is amended by adding paragraph (j) to read as
follows:
Sec. 262.10 Purpose, scope, and applicability.
* * * * *
(j) (1) Universities that are participating in the Laboratory XL
project are the University of Massachusetts Boston in Boston,
Massachusetts, Boston College in Chestnut Hill, Massachusetts, and the
University of Vermont in Burlington, Vermont (``Universities''). The
Universities generate laboratory wastes (as defined in Sec. 262.102),
some of which will be hazardous wastes. As long as the Universities
comply with all the requirements of subpart J of this part the
Universities' laboratories that are participating in the University
Laboratories XL Project as identified in Table 1 of this section, are
not subject to the provisions of Secs. 262.11, 262.34(c), 40 CFR Parts
264 and 265, and the permit requirements of 40 CFR Part 270 with
respect to said laboratory wastes.
Table 1.--Laboratory XL Project Participant Information
----------------------------------------------------------------------------------------------------------------
Approx.
Institution number of Departments participating Location of current hazardous
labs waste accumulation areas
----------------------------------------------------------------------------------------------------------------
Boston College, Chestnut Hill, MA..... 120 Chemistry, Biology, Geology, Merkert Chemistry Building,
Physics, Psychology. 2609 Beacon St., Boston, MA,
Higgins Building, 140
Commonwealth Ave., Chestnut
Hill, MA.
University of Massachusetts Boston, 150 Chemistry, Biology, Science Building (Bldg.
Boston, MA. Psychology, Anthropology, #080); McCormack Building
Geology and Earth Sciences, (Bldg. #020); and Wheatley
and Environmental, Coastal Building (Bldg. #010), 100
and Ocean Sciences. Morrissey Blvd., Boston, MA.
University of Vermont, Burlington, VT. 400 Colleges of: Agriculture and Given Bunker, 89 Beaumont
Life Sciences, Arts and Ave., Burlington, VT.
Sciences, Medicine, and
Engineering and Mathematics;
and Schools of: Nursing,
Allied Heath Sciences, and
Natural Resources.
----------------------------------------------------------------------------------------------------------------
(2) Each University shall have the right to change its respective
departments or the on-site location of its hazardous waste accumulation
areas listed in Table 1 of this section upon written notice to the
Regional Administrator for EPA-Region I and the appropriate state
agency. Such written notice will be provided at least ten days prior to
the effective date of any such changes.
3. Part 262 is amended by adding Subpart J to read as follows:
Subpart J--University Laboratories XL Project--Laboratory Environmental
Management Standard
Sec.
262.100 To what organizations does this subpart apply?
262.101 What is in this subpart?
262.102 What special definitions are included in this subpart?
262.103 What is the scope of the laboratory environmental
management standard?
262.104 What are the minimum performance criteria?
262.105 What must be included in the laboratory environmental
management plan?
262.106 When must a hazardous waste determination be made?
262.107 Under what circumstances will a university's participation
in this environmental management standard pilot be terminated?
262.108 When will this subpart expire?
Sec. 262.100 To what organizations does this subpart apply?
This subpart applies to an organization that meets all three of the
following conditions:
(a) It is one of the three following academic institutions: The
University of Massachusetts Boston in Boston, Massachusetts, Boston
College in Chestnut Hill, Massachusetts, or the University of Vermont
in Burlington, Vermont (``Universities''); and
(b) It is a laboratory at one of the Universities (identified
pursuant to Sec. 262.105(c)(2)(ii)) where laboratory scale activities,
as defined in Sec. 262.102, result in laboratory waste; and
(c) It complies with all the requirements of this subpart.
Sec. 262.101 What is in this subpart?
This subpart provides a framework for a new management system for
wastes that are generated in University laboratories. This framework is
called the Laboratory Environmental Management Standard. The standard
includes some specific definitions that apply to the University
laboratories. It contains specific requirements for how to handle
laboratory waste that are called Minimum Performance Criteria. The
standard identifies the requirements for developing and implementing an
environmental management plan. It outlines the responsibilities of the
management staff of each participating university. Finally, the
standard identifies requirements for training people who will work in
the
[[Page 52393]]
laboratories or manage laboratory waste. This Subpart contains
requirements for RCRA solid and hazardous waste determination, and
circumstances for termination and expiration of this pilot.
Sec. 262.102 What special definitions are included in this subpart?
For purposes of this subpart, the following definitions apply:
Acutely Hazardous Laboratory Waste means a laboratory waste,
defined in the Environmental Management Plan as posing significant
potential hazards to human health or the environment and which must
include RCRA ``P'' wastes, and may include particularly hazardous
substances as designated in a University's Chemical Hygiene Plan under
OSHA, or Extremely Hazardous Substances under the Emergency Planning
and Community Right to Know Act.
Emergency means any occurrence such as, but not limited to,
equipment failure, rupture of containers or failure of control
equipment which results in the potential uncontrolled release of a
hazardous chemical into the environment and which requires agency or
fire department notification and/or reporting.
Environmental Management Plan (EMP) means a written program
developed and implemented by the university which sets forth standards
and procedures, responsibilities, pollution control equipment,
performance criteria, resources and work practices that both protect
human health and the environment from the hazards presented by
laboratory wastes within a laboratory and between a laboratory and the
hazardous waste accumulation area, and satisfies the plan requirements
defined elsewhere in this Subpart. Certain requirements of this plan
are satisfied through the use of the Chemical Hygiene Plan (see, 29 CFR
1910.1450), or equivalent, and other relevant plans, including a waste
minimization plan. The elements of the Environmental Management Plan
must be easily accessible, but may be integrated into existing plans,
incorporated as an attachment, or developed as a separate document.
Environmental Objective means an overall environmental goal of the
organization which is verifiable.
Environmental Performance means results of the data collected
pursuant to implementation of the Environmental Management Plan as
measured against policy, objectives and targets.
Environmental Target means an environmental performance requirement
of the organization which is quantifiable, where practicable,
verifiable and designed to be achieved within a specified time frame.
Hazardous Chemical means any chemical which is a physical hazard or
a health hazard. A physical hazard means a chemical for which there is
scientifically valid evidence that it is a combustible liquid, a
compressed gas, explosive, flammable, an organic peroxide, an oxidizer,
pyrophoric, unstable (reactive) or water-reactive. A health hazard
means a chemical for which there is statistically significant evidence
based on at least one study conducted in accordance with established
scientific principles that acute or chronic health effects may occur in
exposed employees. The term ``health hazard'' includes chemicals which
are carcinogens, toxic or highly toxic agents, reproductive toxins,
irritants, corrosives, sensitizers, hepatotoxins, nephrotoxins,
neurotoxins, agents which act on the hematopoietic system and agents
which damage the lungs, skin, eyes or mucous membranes.
Hazardous Chemical of Concern means a chemical that the
organization has identified as having the potential to be of
significant risk to human health or the environment if not managed in
accordance with procedures or practices defined by the organization.
Hazardous Waste Accumulation Area means the on-site area at a
University where the University will make a solid and hazardous waste
determination with respect to laboratory wastes.
In-Line Waste Collection means a system for the automatic
collection of laboratory waste which is directly connected to or part
of a laboratory scale activity and which is constructed or operated in
a manner which prevents the release of any laboratory waste therein
into the environment during collection.
Laboratory means, for the purpose of this Subpart, an area within a
facility where the laboratory use of hazardous chemicals occurs. It is
a workplace where relatively small quantities of hazardous chemicals
are used on a non-production basis. The physical extent of individual
laboratories within an organization will be defined by the
Environmental Management Plan. A laboratory may include more than a
single room if the rooms are in the same building and under the common
supervision of a laboratory supervisor.
Laboratory Clean-Out means an evaluation of the chemical inventory
of a laboratory as a result of laboratory renovation, relocation or a
change in laboratory supervision that may result in the transfer of
laboratory wastes to the hazardous waste accumulation area.
Laboratory Environmental Management Standard means the provisions
of this Subpart and includes the requirements for preparation of
Environmental Management Plans and the inclusion of Minimum Performance
Criteria within each Environmental Management Plan.
Laboratory Scale means work with substances in which containers
used for reactions, transfers and other handling of substances are
designed to be safely and easily manipulated by one person.
``Laboratory Scale'' excludes those workplaces whose function is to
produce commercial quantities of chemicals.
Laboratory Waste means a hazardous chemical that results from
laboratory scale activities and includes the following: excess or
unused hazardous chemicals that may or may not be reused outside their
laboratory of origin; hazardous chemicals determined to be RCRA
hazardous waste as defined in 40 CFR Part 261; and hazardous chemicals
that will be determined not to be RCRA hazardous waste pursuant to
Sec. 262.106.
Laboratory Worker means a person who is assigned to handle
hazardous chemicals in the laboratory and may include researchers,
students or technicians.
Legal and Other Requirements means requirements imposed by, or as a
result of, governmental permits, governmental laws and regulations,
judicial and administrative enforcement orders, non-governmental
legally enforceable contracts, research grants and agreements,
certification specifications, formal voluntary commitments and
organizational policies and standards.
Senior Management means senior personnel with overall
responsibility, authority and accountability for managing laboratory
activities within the organization.
Universities means the following academic institutions; University
of Vermont, Boston College, and the University of Massachusetts Boston,
which are participants in this Laboratory XL project and which are
subject to the requirements set forth in this Subpart J.
Sec. 262.103 What is the scope of the laboratory environmental
management standard?
The Laboratory Environmental Management Standard will not affect or
supersede any legal requirements other than those described in
Sec. 262.10(j). The requirements that continue to apply include, but
are not limited to, OSHA, Fire Codes, wastewater permit limitations,
emergency response notification provisions, or other legal
[[Page 52394]]
requirements applicable to University laboratories.
Sec. 262.104 What are the minimum performance criteria?
The Minimum Performance Criteria that each University must meet in
managing its Laboratory Waste are:
(a) Each University must label all laboratory waste with the
general hazard class and either the words ``laboratory waste'' or with
the chemical name of the contents. If the container is too small to
hold a label, the label must be placed on a secondary container.
(b) Each University may temporarily hold up to 55 gallons of
laboratory waste or one quart of acutely hazardous laboratory waste, or
weight equivalent, in each laboratory, but upon reaching these
thresholds, each University must mark that laboratory waste with the
date when this threshold requirement was met (by dating the
container(s) or secondary container(s)).
(c) Each university must remove all of the dated laboratory waste
from the laboratory for delivery to a location identified in paragraph
(i) of this section within 30 days of reaching the threshold amount
identified in paragraph (b) of this section.
(d) In no event shall the excess laboratory waste that a laboratory
temporarily holds before dated laboratory waste is removed exceed an
additional 55 gallons of laboratory waste (or one additional quart of
acutely hazardous laboratory waste). No more than 110 gallons of
laboratory waste total (or no more than two quarts of acutely hazardous
laboratory waste total) may be temporarily held in a laboratory at any
one time. Excess laboratory waste must be dated and removed in
accordance with the requirements of paragraphs (b) and (c) of this
section.
(e) Containers of laboratory wastes must be:
(1) Closed at all times except when wastes are being added to
(including during in-line waste collection) or removed from the
container;
(2) Maintained in good condition and stored in the laboratory in a
manner to avoid leaks;
(3) Compatible with their contents to avoid reactions between the
waste and its container; and must be made of, or lined with, materials
which are compatible with the laboratory wastes to be temporarily held
in the laboratory so that the container is not impaired; and
(4) Inspected regularly (at least annually) to ensure that they
meet requirements for container management.
(f) The management of laboratory waste must not result in the
release of hazardous constituents into the land, air and water where
such release is prohibited under federal law.
(g) The requirements for emergency response are:
(1) Each University must post notification procedures, location of
emergency response equipment to be used by laboratory workers and
evacuation procedures;
(2) Emergency response equipment and procedures for emergency
response must be appropriate to the hazards in the laboratory such that
hazards to human health and the environment will be minimized in the
event of an emergency;
(3) In the event of a fire, explosion or other release of
laboratory waste which could threaten human health or the environment,
the laboratory worker must follow the notification procedures under
paragraph (g)(1) of this section.
(h) Each University must investigate, document, and take actions to
correct and prevent future incidents of hazardous chemical spills,
exposures and other incidents that trigger a reportable emergency or
that require reporting under paragraph (g) of this section.
(i) Each University may only transfer laboratory wastes from a
laboratory:
(1) directly to an on-site designated hazardous waste accumulation
area. Notwithstanding 40 CFR 263.10(a), each University must comply
with requirements for transporters set forth in 40 CFR 263.30 and
263.31 in the event of a discharge of laboratory waste en route from a
laboratory to an on-site hazardous waste accumulation area; or
(2) to a treatment, storage or disposal (TSD) facility permitted to
handle the waste under 40 CFR part 270 or in interim status under 40
CFR parts 265 and 270 (or authorized to handle the waste by a state
with a hazardous waste management program approved under 40 CFR part
271) if it is determined in the laboratory by the individuals
identified in Sec. 262.105(b)(3) to be responsible for waste management
decisions that the waste is a hazardous waste and that it is prudent to
transfer it directly to a treatment, storage, and disposal facility
rather than an on-site accumulation area.
(j) Each University must ensure that laboratory workers receive
training and are provided with information so that they can implement
and comply with these Minimum Performance Criteria.
Sec. 262.105 What must be included in the laboratory environmental
management plan?
(a) Each University must include specific measures it will take to
protect human health and the environment from hazards associated with
the management of laboratory wastes and from the reuse, recycling or
disposal of such materials outside the laboratory.
(b) Each University must write, implement and comply with an
Environmental Management Plan that includes the following:
(1) The specific procedures to assure compliance with each of the
Minimum Performance Criteria set forth in Sec. 262.104.
(2) An environmental policy, or environmental, health and safety
policy, signed by the University's senior management, which must
include commitments to regulatory compliance, waste minimization, risk
reduction and continual improvement of the environmental management
system.
(3) A description of roles and responsibilities for the
implementation and maintenance of the Laboratory Environmental
Management Plan.
(4) A system for identifying and tracking legal and other
requirements applicable to laboratory waste, including the procedures
for providing updates to laboratory supervisors.
(5) Criteria for the identification of physical and chemical
hazards and the control measures to reduce the potential for releases
of laboratory wastes to the environment, including engineering
controls, the use of personal protective equipment and hygiene
practices, containment strategies and other control measures.
(6) A pollution prevention plan, including, but not limited to,
roles and responsibilities, training, pollution prevention activities,
and performance review.
(7) A system for conducting and updating annual surveys of
hazardous chemicals of concern and procedures for identifying acutely
hazardous laboratory waste.
(8) The procedures for conducting laboratory clean-outs with regard
to the safe management and disposal of laboratory wastes.
(9) The criteria that laboratory workers must comply with for
managing, containing and labeling laboratory wastes, including: an
evaluation of the need for and the use of any special containers or
labeling circumstances, and the use of laboratory wastes secondary
containers including packaging, bottles, or test tube racks.
(10) The procedures relevant to the safe and timely removal of
laboratory wastes from the laboratory.
(11) The emergency preparedness and response procedures to be
implemented for laboratory waste.
[[Page 52395]]
(12) Provisions for information dissemination and training,
provided for in paragraph (d) of this section.
(13) The procedures for the development and approval of changes to
the Environmental Management Plan.
(14) The procedures and work practices for safely transferring or
moving laboratory wastes from a laboratory to a location identified in
Sec. 262.104(i).
(15) The procedures for regularly inspecting a laboratory to assess
conformance with the requirements of the Environmental Management Plan.
(16) The procedures for the identification of environmental
management plan noncompliance, and the assignment of responsibility,
timelines and corrective actions to prevent their reoccurrence.
(17) The record keeping requirements to document conformance with
this Plan.
(c) Organizational responsibilities for each university. Each
University must:
(1) Develop and oversee implementation of its Laboratory
Environmental Management Plan.
(2) Identify the following:
(i) Annual environmental objectives and targets;
(ii) Those laboratories covered by the requirements of the
Laboratory Environmental Management Plan.
(3) Assign roles and responsibilities for the effective
implementation of the Environmental Management Plan.
(4) Determine whether laboratory wastes are solid wastes under RCRA
and, if so, whether they are hazardous.
(5) Develop, implement, and maintain:
(i) Policies, procedures and practices governing its compliance
with the Environmental Management Plan and applicable federal and state
hazardous waste regulations.
(ii) Procedures to monitor and measure relevant conformance and
environmental performance data for the purpose of supporting continual
improvement of the Environmental Management Plan.
(iii) Policies and procedures for managing environmental documents
and records applicable to this Environmental Management Standard.
(6) Ensure that:
(i) Its Environmental Management Plan is available to laboratory
workers, vendors, employee representatives, visitors, on-site
contractors, and upon request, to governmental representatives.
(ii) Personnel designated by each University to handle laboratory
wastes and RCRA hazardous waste receive appropriate training.
(iii) The Environmental Management Plan is reviewed at least
annually by senior management to ensure its continuing suitability,
adequacy and effectiveness. The reviews may include, but not be limited
to, a consideration of monitoring and measuring information, Laboratory
Environmental Management Standard performance data, assessment and
audit results and other relevant information and data.
(d) What are the Information and Training Requirements for Each
University?
(1) Each University must ensure that laboratory workers receive
training and are provided with the information to understand and
implement the elements of each University's Environmental Management
Plan that are relevant to the laboratory workers' responsibilities.
(2) When must each University ensure that laboratory workers
receive training and information?
(i) Each University must provide the information to each laboratory
worker when he/she is first assigned to a work area where laboratory
wastes may be generated.
(ii) Each University must ensure that each laboratory worker has
had training within six months of when he/she is first assigned to a
work area where laboratory wastes may be generated. Each University
must retrain a laboratory worker when a laboratory waste poses a new or
unique hazard for which the laboratory worker has not received prior
training and as frequently as needed to maintain knowledge of the
procedures of the Environmental Management Plan.
(3) Each University must provide an outline of training and specify
who is to receive training in its Environmental Management Plan.
(4) Each University must ensure that laboratory workers are
informed of:
(i) The contents of this Subpart and the Laboratory Environmental
Management Plan(s) for the laboratory(ies) in which they will be
performing work;
(ii) The location and availability of the Environmental Management
Plan;
(iii) Emergency response measures applicable to laboratories;
(iv) Signs and indicators of a hazardous substance release;
(v) The location and availability of known reference materials
relevant to implementation of the Environmental Management Plan; and
(vi) Environmental training requirements applicable to laboratory
workers.
(5) Each University must ensure that Laboratory workers have
received training in:
(i) Methods and observations that may be used to detect the
presence or release of a hazardous substance;
(ii) The chemical and physical hazards associated with laboratory
wastes in their work area;
(iii) The relevant measures a laboratory worker can take to protect
human health and the environment; and
(iv) Details of the Environmental Management Plan sufficient to
ensure they manage laboratory waste in accordance with the requirements
of this Subpart.
(6) Requirements pertaining to Laboratory visitors:
(i) Laboratory visitors, such as on-site contractors or
environmental vendors, that require information and training under this
standard must be identified in the Environmental Management Plan.
(ii) Laboratory visitors identified in the Environmental Management
Plan must be informed of the existence and location of the
Environmental Management Plan.
(iii) Laboratory visitors identified in the Environmental
Management Plan must be informed of relevant policies, procedures or
work practices to ensure compliance with the requirements of the
Environmental Management Plan.
(7) Each University must define methods of providing objective
evidence and records of training and information dissemination in its
Environmental Management Plan.
Sec. 262.106 When must a hazardous waste determination be made?
(a) For laboratory waste sent from a laboratory to an on-site
hazardous waste accumulation area, each University must evaluate the
laboratory wastes to determine whether they are solid wastes under RCRA
and, if so, determine pursuant to Sec. 262.11 (a) through (d) whether
they are hazardous wastes, as soon as the laboratory wastes reach the
University's Hazardous Waste Accumulation area(s). At this point each
University must determine whether the laboratory waste will be reused
or whether it must be managed as RCRA solid or hazardous waste.
(b) For laboratory waste that will be sent from a laboratory to a
TSD facility permitted to handle the waste, each University must
evaluate such laboratory wastes to determine whether they are solid
wastes under RCRA and, if so, determine pursuant to Sec. 262.11 (a)
through (d) whether they are hazardous wastes, prior to the 30-day
deadline for removing dated laboratory waste from the laboratory.
(c) Laboratory waste that is determined to be hazardous waste is no
longer subject to the provisions of this
[[Page 52396]]
subpart and must be managed in accordance with all applicable
provisions of 40 CFR Parts 260 through 270.
Sec. 262.107 Under what circumstances will a university's
participation in this environmental management standard pilot be
terminated?
(a) EPA retains the right to terminate a University's participation
in this Laboratory XL project if the University:
(1) Is in non-compliance with the Minimum Performance Criteria in
Sec. 262.104; or
(2) Has actual environmental management practices in the laboratory
that do not conform to its Environmental Management Plan; or
(3) Is in non-compliance with the Hazardous Waste Determination
requirements of Sec. 262.106.
(b) In the event of termination, EPA will provide the University
with 15 days written notice of its intent to terminate. During this
period, which commences upon receipt of the notice, the University will
have the opportunity to come back into compliance with the Minimum
Performance Criteria, its Environmental Management Plan, or the
requirements for making a hazardous waste determination at Sec. 262.106
or to provide a written explanation as to why it was not in compliance
and how it intends to return to compliance. If, upon review of the
University's written explanation, EPA then re-issues a written notice
terminating the University from this XL Project, the provisions of
paragraph (c) of this section will immediately apply and the University
shall have 90 days to come into compliance with the applicable RCRA
requirements deferred by Sec. 262.10(j). During the 90-day transition
period, the provisions of this subpart shall continue to apply to the
University.
(c) If a University withdraws from this XL project, or receives a
notice of termination pursuant to this section, it must submit to EPA
and the state a schedule for returning to full compliance with RCRA
requirements at the laboratory level. The schedule must show how the
University will return to full compliance with RCRA within 90 days from
the date of the notice of termination or withdrawal.
Sec. 262.108 When will this subpart expire?
This subpart will expire on September 30, 2003.
[FR Doc. 99-25137 Filed 9-27-99; 8:45 am]
BILLING CODE 6560-50-U
