[Federal Register Volume 64, Number 143 (Tuesday, July 27, 1999)]
[Proposed Rules]
[Pages 40696-40715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19123]
[[Page 40695]]
_______________________________________________________________________
Part VI
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;
Proposed Rule
Federal Register / Vol. 64, No. 143 / Tuesday, July 27, 1999 /
Proposed Rules
[[Page 40696]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 262
[FRL-6408-4]
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
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule; request for comments and draft final project
agreement.
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SUMMARY: The Environmental Protection Agency (EPA) today is proposing
this rule to implement a project under the Project XL program that
would provide regulatory flexibility under the Resource Conservation
and Recovery Act (RCRA), as amended for the University of
Massachusetts-Boston, Boston, MA, Boston College, Chestnut Hill, MA and
the University of Vermont, Burlington, VT (the Universities). The
principal objective of this Laboratory XL Project is to pilot a
flexible, performance-based system for managing laboratory waste. To
achieve this, today's proposed rule would provide regulatory
flexibility to allow the participating laboratories at the Universities
to replace existing requirements for hazardous waste generators with a
comprehensive Laboratory Environmental Management Plan designed for
each University. The terms of the overall XL project are contained in
the draft Final Project Agreement (FPA) on which EPA is also requesting
comments. The draft Final Project Agreement (FPA) is available for
public review and comment at the EPA Docket in Washington DC, in the
EPA Region I library, at the Universities, and on the world wide web at
http://www.epa.gov/projectxl/. Following a review of the public
comments and appropriate changes, the FPA would be signed by delegates
from the EPA, the Massachusetts Department of Environmental Protection
(MADEP), the Vermont Department of Environmental Conservation (VTDEC)
and the Universities.
DATES: Public Comments: Comments on the proposed rule and/or FPA must
be received on or before August 26, 1999. All comments should be
submitted in writing to the address listed below.
Public Hearing: Commenters may request a public hearing by August
10, 1999 during the public comment period. Commenters requesting a
public hearing should specify the basis for their request. If EPA
determines that there is sufficient reason to hold a public hearing, it
will do so by August 17, 1999, during the last week of the public
comment period. Requests for a public hearing should be submitted to
the address below. If a public hearing is scheduled, the date, time,
and location will be available through a Federal Register notice or by
contacting Ms. Gina Snyder or Mr. George Frantz at the Region 1 office.
ADDRESSES: Request to Speak at Hearing: Requests for a hearing should
be mailed to the RCRA Information Center Docket Clerk (5305G), U.S.
Environmental Protection Agency, 401 M Street, S.W., Washington, D.C.
20460. Please send an original and two copies of all comments, and
refer to Docket Number F-1999-NEUP-FFFFF. A copy should also be sent to
Ms. Gina Snyder at U.S. EPA Region I. Ms. Gina Snyder may be contacted
at the following address: U.S. Environmental Protection Agency, Region
I (SPE), 1 Congress St., Suite 1100, Boston, MA, 02114, (617) 918-1837.
Comments: Written comments should be mailed to the RCRA Information
Center Docket Clerk (5305W), U.S. Environmental Protection Agency, 401
M Street, S.W., Washington, D.C. 20460. Please send an original and two
copies of all comments, and refer to Docket Number F-1999-NEUP-FFFFF.
Viewing Project Materials: A docket containing the proposed rule,
draft Final Project Agreement, supporting materials, and public
comments 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. Project materials are
also available for review for today's action on the world wide web at
http://www.epa.gov/projectxl/.
A duplicate copy of the docket is available for inspection and
copying at U.S. EPA, Region I, 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.
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. Further information on today's
action may also be obtained on the world wide web at http://
www.epa.gov/projectxl/.
SUPPLEMENTARY INFORMATION: The development and implementation of an
Environmental Management Plan would be piloted at these three
Universities in their laboratories at areas that are currently managed
as satellite accumulation areas (see 40 CFR 262.34(c)). Hazardous waste
managed at all other areas of each University would continue to be
subject to current RCRA regulations. This pilot is intended to test the
effectiveness of an integrated, flexible, performance-based approach
for managing hazardous waste in university laboratories to determine
whether this approach promotes better management of laboratory wastes
than the current standards.
In an effort to more efficiently manage hazardous waste and
minimize the volume of waste generated in the university laboratory
setting, the proposed rule would provide for a ``temporary conditional
deferral'' from two specific RCRA requirements that apply to generators
of hazardous waste, 40 CFR 262.11--Hazardous Waste Determination, and
262.34(c)--Satellite Accumulation, which includes requirements for
container management. Instead, laboratory waste would be managed in
accordance with a Laboratory Environmental Management Plan until it
reaches each University's on-site hazardous waste accumulation area
where a determination would be made by Environmental Health and Safety
personnel as to whether the waste can be redistributed and reused at
the University or whether it must be managed as a RCRA hazardous waste.
The proposed rule would define laboratory waste 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
[[Page 40697]]
hazardous waste pursuant to the new proposed rule at 40 CFR 262.106.
Making a solid and hazardous waste determination at a central location
would allow professionals within the Universities' Environmental,
Health and Safety program to more easily manage the laboratory waste
and to increase reuse opportunities.
The deferral of specified RCRA requirements is ``temporary.'' It
remains in effect only for the four-year term of this Laboratory XL
project. The four-year term is based upon the date of promulgation of
the final rule when the Universities will commence the development of
their Laboratory Environmental Management Plans (EMP). Following review
of its EMP, each University would notify the applicable state agency
and EPA in writing of the date on which it intends to implement its
EMP. The proposed rule would become effective in the designated
participating laboratories only after such written notification.
Section III.D.2. and IV.F.1. discuss the aspects of state
implementation of the proposed rule.
The deferral of the specified RCRA requirements is also
``conditional.'' It is conditioned upon each University's
implementation and compliance with the Laboratory Environmental
Management Standard set forth in 40 CFR part 262, subpart J of this
proposed rule. The Laboratory Environmental Management Standard
includes specific requirements for the management of laboratory waste
that ensure protection of human health and the environment while
providing some flexibility to encourage chemical reuse and waste
minimization. These requirements are termed Minimum Performance
Criteria. They are enforceable in the same way as current RCRA
standards are enforceable to ensure that handling of laboratory waste
would be protective of human health and the environment. During this XL
project, the proposed requirements set forth in the proposed Subpart J
(including the Environmental Management Plan requirements) would also
be enforceable under RCRA section 3008.
The Environmental Management Standard (EMS) in subpart J contains
requirements for each University to create and implement an
Environmental Management Plan (EMP) to cover all of its participating
laboratories. The elements of the EMP in the proposed rule are expected
to function as an outline of the procedures that must be in place to
manage laboratory waste in order to both minimize the amount of waste
generated, while allowing for the maximum reuse of the waste that is
generated. Although the EMP must describe how each laboratory will
comply with the specific Minimum Performance Criteria, the Minimum
Performance Criteria are requirements that stand on their own. The
proposed deferral of the hazardous waste determination is conditioned
on compliance with all of the requirements of the EMS, including the
Minimum Performance Criteria. These criteria ensure that the handling
of laboratory waste would be protective of human health and the
environment by establishing how laboratory waste would be managed
within the laboratory, and in transit to the on-site hazardous waste
accumulation area for each University.
EPA has agreed to allow the Universities to undertake this XL
project with the requested regulatory flexibility to determine if the
proposed performance-based Environmental Management Plan approach would
result in superior environmental performance and significant cost
savings to the universities.
Today's proposed rulemaking, and the state actions described in
section IV.F.1. of this preamble that parallel today's action, will not
in any way affect the provisions or applicability of any other existing
or future regulations.
EPA is soliciting comments on this rulemaking. EPA will publish
responses to comments in a subsequent final rule. The XL Project will
enter the implementation phase when, in addition to promulgation of the
final rule, all signatories to the XL Project sign the Final Project
Agreement. Implementation of the Environmental Management Plan(s) will
occur after the individual EMPs have been developed by each university,
and reviewed by EPA and the appropriate State agency to ensure
adherence to the Environmental Management Standard, prior to
commencement of the new system.
Outline of Today's Document
The information presented in this preamble is organized as follows:
I. Authority
II. Overview of Project XL
III. Overview of the University Laboratory XL Project Pilot
A. To What Laboratories Would the Proposed Rule Apply?
B. What Problems Have the University Laboratories Identified?
C. What Solutions Are Proposed by the University Laboratory XL
Project?
1. A New Integrated Performance-Based System
2. Laboratory Environmental Management Standard (EMS)
3. Laboratory Environmental Management Plan (EMP)
4. Minimum Performance Criteria
5. How the New System Would Work
6. Comparison of the Minimum Performance Criteria with Current
RCRA Regulations
7. Comparison of the Proposed Rule with Current OSHA and RCRA
Regulatory Requirements
8. How the Laboratory XL Project Will Result in Superior
Environmental Performance
D. What Regulatory Changes will be Necessary to Implement this
Project?
1. Federal Regulatory Changes
2. State Regulatory Changes
E. Why is EPA Supporting this New Approach to Laboratory Waste
Management?
F. How Have Various Stakeholders Been Involved in this Project?
G. How Will this Project Result in Cost Savings and Paperwork
Reduction?
H. How Will EPA Ensure the Integrity and Comprehensiveness of
Each University's Laboratory Environmental Management Plan?
I. How Will the Terms of the Laboratory XL Project and Proposed
Rule be Enforced?
J. How Long Will this Project Last and When Will it be Complete?
IV. Additional Information
A. How to Request a Public Hearing
B. How Does this Rule Comply With Executive Order 12866?
C. Is a Regulatory Flexibility Analysis Required?
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 & Hazardous and Solid Waste Amendments of 1984
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. Does this Rule Comply with Executive Order 12875: Enhancing
Intergovernmental Partnerships?
I. How Does this Rule Comply with Executive Order 13084:
Consultation and Coordination with Indian Tribal Governments?
J. Does this Rule Comply with the National Technology Transfer
and Advancement Act?
I. Authority
EPA is publishing this proposed 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,
6937, 6938, and 6974).
[[Page 40698]]
II. Overview of Project XL
The draft 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 proposed regulation would 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 regulatory burden and promote economic growth
while achieving better environmental and public health protection. EPA
intends to evaluate the results of this and other Project 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.
The XL program is intended to allow EPA to experiment with
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 EPA to proceed more quickly than would be possible when
undertaking changes on a nationwide basis. As part of this
experimentation, the EPA may try out approaches or legal
interpretations that depart from or are even inconsistent with
longstanding Agency practice, so long as those interpretations are
within the broad range of discretion enjoyed by the Agency in
interpreting statutes that it implements. The EPA may also modify
rules, on a site-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 in the
particular projects that embody them. Furthermore, as EPA indicated in
announcing the XL program, EPA 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 interpretation again, either
generally or for other specific facilities.
EPA believes that adopting alternative policy approaches and
interpretations, on a limited, site-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 (provided that the Agency acts within the
discretion allowed by the statute). Congress' recognition that there is
a need for experimentation and research, as well as ongoing re-
evaluation of environmental programs, is reflected in a variety of
statutory provisions, such as section 8001 of RCRA.
XL Criteria
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 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 University
Laboratories XL project addresses the XL criteria, readers should refer
to the Final Project Agreement available from the EPA RCRA docket or
Region 1 library for this action (see ADDRESSES section of today's
preamble).
XL Program Phases
The Project XL program is compartmentalized into four basic phases:
the initial pre-proposal phase where the project sponsor comes up with
an innovative concept that they would like to consider as an XL pilot,
the second phase where the project sponsor works with EPA and
interested stakeholders in developing an XL proposal, the third phase
where EPA, local regulatory agencies, and other interested stakeholders
review the XL proposal, the fourth phase where the project sponsor
works with EPA, local regulatory agencies, and interested stakeholders
in developing a Final Project Agreement and legal mechanism. After
promulgation of the final rule (or other legal mechanism) for the XL
pilot, and after the Final Project Agreement has been signed by all
designated parties, the XL pilot proceeds into the implementation phase
and evaluation phase.
Final Project Agreement
The Final Project Agreement (FPA) is a written agreement between
the project sponsor and regulatory agencies. The FPA contains a
detailed description of the proposed pilot project. It addresses the
eight Project XL criteria, and the expectation of the Agency that this
XL project will meet those criteria. The Final Project Agreement
identifies performance goals and indicators (monitoring schedule) which
will enable the laboratories to clearly illustrate the baseline
quantities. The draft FPA specifically addresses the manner in which
the project is expected to produce superior environmental benefits. The
FPA also discusses the administration of the agreement, including
dispute resolution and termination. The Final Project Agreement is
available for review in the docket for today's action, and also is
available on the world wide web at http://www.epa.gov/projectxl/.
III. Overview of the University Laboratories XL Project
EPA is today requesting comments on the draft FPA and proposed rule
to implement key provisions of this Project XL initiative. Today's
proposed rule would facilitate implementation of the draft FPA (the
document that embodies EPA's intent to implement this project) that has
been developed by EPA, Massachusetts Department of
[[Page 40699]]
Environmental Protection (MADEP), Vermont Department of Environmental
Conservation (VTDEC), the Universities, and other stakeholders. After
comments on the draft FPA have been considered, EPA, MADEP, VTDEC, and
the three Universities expect to sign a final FPA. Today's proposed
rule would not be effective in Massachusetts and Vermont until those
states have made conforming changes.
A. To What Laboratories Would the Proposed Rule Apply?
The Proposed Rule would apply only to participating laboratories at
the following three Universities:
University of Massachusetts Boston, Boston, MA
Boston College, Chestnut Hill, MA
University of Vermont, Burlington, VT
Boston College is classified as a Small Quantity Generator (SQG).
The University of Massachusetts Boston and the University of Vermont
are classified as Large Quantity Generators (LQG). The University of
Massachusetts Boston is an LQG solely as a generator of acute wastes in
excess of the one kilogram per month threshold. Additionally, the
University of Vermont operates a part B permitted facility for the
storage of hazardous wastes. Participating laboratories at all the
Universities currently generate and manage hazardous waste and the
Universities fully expect that some of the laboratory wastes that would
be generated and managed under the Environmental Management Plans would
meet the definition of a RCRA hazardous waste.
The University laboratories that would be affected by this project
are used for research and teaching purposes. A breakdown of the
individual Universities' laboratories is shown in Table 1 below. The
table also identifies each Universities' on-site hazardous waste
accumulation areas which would continue to be regulated under existing
federal and state RCRA regulation:
Table 1.--Laboratory XL Project Participant Information
----------------------------------------------------------------------------------------------------------------
Location of current
Institution Student Number of Departments participating hazardous waste
body labs accumulation areas \1\
----------------------------------------------------------------------------------------------------------------
Boston College Chestnut Hill, MA. 14,000 120 Chemistry, Biology, Merkert Chemistry
Geology, Physics, Building, 2609 Beacon
Psychology. St., Boston MA; Higgins
Building, 140
Commonwealth Ave.,
Chestnut Hill MA.
University of Massachusetts 13,000 150 Chemistry, Biology, Science Building (Bldg.
Boston Boston, MA. Psychology, #080); McCormack
Anthropology, Geology Building (Bldg. #020);
and Earth Sciences, and and Wheatley Building
Environmental, Coastal (Bldg. #010) 100
and Ocean Sciences. Morrissey Blvd., Boston
MA
University of Vermont Burlington, 10,000 400 Colleges of: Agriculture Given Bunker, 89
VT. and Life Sciences; Arts Beaumont Ave.,
and Sciences; Medicine; Burlington VT.
and Engineering and
Mathematics; and Schools
of: Nursing; Allied
Heath Sciences; and
Natural Resources.
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\1\ Note: These accumulation areas would still be fully covered by the current federal and state RCRA
regulations. This XL project, for example, would not allow any increased air emissions that would otherwise be
controlled under the current RCRA regulations such as the subpart CC hazardous waste organic air emission
standards that apply to large quantity generators who accumulate hazardous waste on-site.
B. What Problems Have the University Laboratories Identified?
To understand the problems faced by the Universities and the
purpose behind the proposed rule, it is necessary to understand the
context in which the proposed rule has arisen and to consider the
experience of university laboratories as regulated entities under both
the Occupational Safety and Health Act (OSHA) and RCRA. While both
statutes have the common objective of protecting human health, RCRA
makes a clear distinction between hazardous waste and hazardous
chemicals in a laboratory setting. There are specific handling and
management requirements for ``hazardous wastes'' under RCRA which do
not apply to the larger universe of ``hazardous chemicals'' regulated
by the Occupational Safety and Health Administration. Researchers are
familiar with the specialized system developed for laboratory work by
OSHA, which includes the requirement to develop and implement a
Chemical Hygiene Plan (CHP). This systematic approach, incorporating a
specific plan, can also be applied to the management of hazardous waste
that sometimes results from the use of hazardous chemicals in the
laboratory. However, under the current system, laboratories are
required to implement and to track two parallel, and not always
consistent chemical management systems within the laboratory setting.
The Universities have proposed streamlining the management of
chemicals in the laboratory by having a single system addressing
hazardous chemicals that will result in both better management and a
reduction in the quantity of laboratory wastes that have to be
disposed. This streamlining will result in a number of changes, which
when combined in a single systematic approach to chemical management,
are expected to provide results that are superior to those provided by
the current regulatory framework.
An example of one area that will be streamlined is the process for
training laboratory workers. OSHA's chemical standard requires that the
employer provide employees with information and training on the hazards
of chemicals present in their area. RCRA requires large quantity
generators to ensure that facility personnel complete classroom
instruction or on-the-job training that teaches them to perform their
duties in a way that ensures the facility's compliance with applicable
requirements. RCRA requires small quantity generators to ensure that
all employees are familiar with proper waste handling and emergency
procedures relevant to their responsibilities. The new system proposed
in this rule would require the same standardized training for all
laboratory workers, including: students, personnel in positions related
to hazardous waste management, and laboratory employees. This
systematic training approach can cover both safety
[[Page 40700]]
and environmental concerns when performed through the integration of
chemical hygiene planning and environmental management planning. This
is expected not only to streamline but also to upgrade existing
training, and to provide students--the laboratory workers of the
future--with a better understanding of the environmental impacts of
their work and how to minimize those impacts.
The university laboratory setting is decentralized, with various
departments funding diverse types of research. The university community
is also diverse and subject to the regular turnover of students and
researchers. This decentralized setting, when combined with rules that
vary from state to state (as discussed in sections D.2. and E., below)
and between federal RCRA and federal OSHA standards, often leads to the
unnecessary and premature disposal of chemicals after an individual
laboratory has no use for them. This is true even for unused chemicals
that may be reusable elsewhere at the University. A more centralized
system should result in more effective decision making with regard to
chemical disposition and should result in increased chemical reuse.
Therefore, one of the larger changes to result from this proposed
project would be the centralization of the system for managing chemical
wastes. This would allow decisions regarding chemical disposition to
more easily occur at a centralized area where knowledge of campus-wide
needs for chemicals can be factored into decisions as to whether unused
or used chemicals (formerly disposed as waste) can be reused within the
University.
The implementation of the current system is further complicated by
the structure of university laboratories which is different from
industrial settings where RCRA has been quite effective. Industrial
settings commonly have ongoing processes which generate a single waste
at a fairly regular rate of generation. With potentially hundreds of
small laboratories within one university, each producing small amounts
of multiple wastes on a noncontinuous basis, the overall management of
hazardous wastes becomes more difficult. For example, it can be
difficult for universities to comply with the current requirements that
result in 3 day removal timeframes for hazardous waste in excess of 55
gallons at their satellite areas (managed under 40 CFR 262.34(c) or
equivalent state provisions). Waste generation in manufacturing
settings is generally more uniform and continuous than it is in
university research laboratories where the rate of waste generated is
often unpredictable. This uncertainty makes it difficult for a
university to predict when satellite accumulation limits may be
exceeded and to arrange for removal of the waste within the required
amount of time. This proposed alternative system for university
laboratories attempts to address their atypical circumstances by
allowing them to set up a monthly pick-up schedule for laboratory
waste. With the ability to be proactive in setting up schedules for
waste pickups, EH&S professionals at the Universities would be able to
avoid a reactive mode of operation, to proactively develop a systematic
approach for re-use of chemicals on-site, and to operate that system
based on the schedule they could develop under this proposal.
The difficulty of managing laboratory wastes has been the subject
of nation-wide discussions within the university and research community
throughout the past decade. Many organizations including the Campus
Safety, Health and Environmental Management Association, the National
Research Council, and the American Chemical Society have all sought a
better way to properly manage and handle hazardous chemicals in the
laboratory, and to comply with the requirements of both OSHA and RCRA.
In the New England area, the Laboratory Consortium for Environmental
Excellence (LCEE) was formed to explore viable alternatives to the
current parallel regulatory scheme and to promote best management
practices for laboratories. As a result of exhaustive reviews and
interviews with universities and research organizations across the
country, a consensus was reached regarding the need to harmonize the
RCRA and OSHA regulatory systems through a performance-based management
system that would actively promote prudent practices, encourage
chemical reuse and recycling, minimize costs, and increase efficiency.
The central purpose of this Laboratory XL project is to test the
effectiveness of an integrated, performance-based environmental
management system which is consistent with the objectives of RCRA and
which would complement the applicable OSHA regulations.
C. What Solutions Are Proposed by the University Laboratory XL Project?
1. A New Integrated Performance-Based System
The University Laboratory XL project proposes to test the
effectiveness of an integrated, flexible, performance-based system for
managing hazardous wastes in laboratories which (1) would result in
pollution prevention and streamlined procedures for managing hazardous
wastes and hazardous chemicals at universities, (2) would meet the
objectives of both the RCRA and OSHA regulatory programs combined and
(3) would be at least as protective of human health and the environment
as the current system.
This project would pilot 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 OSHA regulations
by proposing that universities develop a plan similar to the CHP but
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 would like to pursue a
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 proposed Laboratory
EMS sets out all the requirements for the proposed alternative system
of managing laboratory waste. First and foremost, the Laboratory EMS
would include 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 the requirements
that would be an alternative to 40 CFR 262.34(c) in the laboratory. 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 described in full in today's
proposed rule and is briefly explained below. In addition, the
Laboratory EMS would also require the development of a Laboratory
Environmental Management Plan (EMP). The EMP would be written by each
University to document its specific procedures for how it would
[[Page 40701]]
conform with the Laboratory EMS. The EMP would also describe the
procedures each laboratory would follow in order to meet the Minimum
Performance Criteria. The elements of the EMP are summarized below in
Table 2.
2. Laboratory Environmental Management Standard (EMS)
Today's proposed rule is called the ``Laboratory Environmental
Management Standard''. It would include a definition section (40 CFR
262.102), 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). Proposed 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 would provide the umbrella framework
for an effective system for the management of university laboratory
waste. It would contain all the elements, from definitions through
waste determination requirements (40 CFR 262.106), that would make up
the new systematic approach proposed for university laboratories. The
proposed 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.
3. Laboratory Environmental Management Plan (EMP)
The Laboratory EMS would require the development of a Laboratory
EMP which would be the mechanism through which the Laboratory EMS is
put into practice at each University. The Laboratory EMP, modeled on
OSHA's Chemical Hygiene Plan, would be a comprehensive plan to be
developed by each University. The EMP would document the procedures,
practices and programs to (a) manage laboratory waste in a manner that
is protective of human health and the environment and (b) that would be
implemented to achieve compliance with the requirements of the
Laboratory EMS and the Minimum Performance Criteria. It is through the
Laboratory EMP that the Universities would 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 would identify
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 would 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 proposal, 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'' would be 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, would be made at a centralized
area, by Environmental Health and Safety professionals.
4. Minimum Performance Criteria
The proposed requirements for the laboratory EMP include a
requirement that the EMP include procedures to assure compliance with
certain Minimum Performance Criteria (MPC) specified in the proposed
regulation. The proposed 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 laboratory waste includes some
materials that are not RCRA hazardous waste.
5. How the New System Would Work
This new proposed system would help each University to centralize
and coordinate its chemical management practices and demonstrate
environmental performance beyond what would likely be achieved under
the existing system.
Currently, there are two potential impediments to such
centralization and coordination. 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
accumulation period of 30 days should allow for a more coordinated and
efficient pick-up and delivery system which would free up staff time,
and allow for the development of infrastructure and training designed
to increase waste minimization and an organized and coordinated campus-
wide chemical reuse system.
The EMP and the Minimum Performance Criteria would work together to
form the alternative system for the management of laboratory waste. The
following outline presents a step-by-step overview of how the
Laboratory Environmental Management Standard would work once this rule
is finalized and conforming changes are adopted by Vermont and
Massachusetts.
Development of the Environmental Management Plan
Step 1: Within six months, each University would develop its
Environmental Management Plan (EMP) addressing all the elements
required by 40 CFR 262.105, summarized in Table 2, below. Applicable
RCRA requirements would remain in full effect in the laboratories prior
to the EMP being written, reviewed, and implemented. For the purpose of
this Laboratory XL project, each University would consult with EPA, and
the state of Massachusetts (DEP) or Vermont (DEC) in the development of
its EMP. The centerpiece of the new system would be the individual
Laboratory Environmental Management Plan. The EMP would include
detailed specific elements that would have to be
[[Page 40702]]
included and implemented by each University. Each University would be
expected to craft an Environmental Management Plan that is tailored to
the structure and individual needs of the University and its
laboratories. A summary of the elements in the Environmental Management
Plans is outlined in Table 2. These are more fully detailed in the
proposed rule at 40 CFR 262.105.
Step 2: Once completed, the EMP would be made available on each
University's web site. So that EPA can continue to evaluate this XL
project, EPA-Region I would review each EMP to confirm that it meets
all of the requirements of 40 CFR 262.105. The relevant state agencies
may also review the EMP. Each University would also be working on how
it will implement its EMP, which would include training laboratory
workers with regard to the requirements of the Minimum Performance
Criteria pursuant to the procedures contained in the Environmental
Management Plan.
Table 2.--Summary of Major Elements Required in Laboratory Environmental
Management Plans
------------------------------------------------------------------------
-------------------------------------------------------------------------
General:
The EMP must include a description of specific measures a University
will take to protect human health and the environment from hazards
associated with the management of laboratory wastes.
Administration:
1. An environmental policy, including commitments to regulatory
compliance, waste minimization, risk reduction and continual
improvement of the environmental management system.
2. A description of roles and responsibilities for the
implementation and maintenance of the Laboratory Environmental
Management Plan.
3. A pollution prevention plan.
4. Provisions for information dissemination and training.
5. Procedures for the development and approval of changes to the
EMP.
Waste Management and Conformance Review:
6. Criteria that laboratory workers shall comply with for managing,
containing and labeling laboratory wastes.
7. Procedures for inspecting a laboratory to assess conformance with
the requirements of the Environmental Management Plan.
8. Procedures to assure compliance with the Minimum Performance
Criteria (MPC).
9. Procedures for the identification of environmental management
plan noncompliance and the assignment of responsibility, timelines
and corrective actions to prevent their reoccurrence.
10. Criteria for the identification of physical and chemical hazards
and the control measures to reduce the potential for releases to
the environment of laboratory wastes.
Reporting/Recordkeeping:
11. The University's system for identifying and tracking legal and
other requirements applicable to the management and disposal of
designated laboratory wastes.
12. The University's system for conducting annual surveys of
hazardous chemicals of concern.
13. The recordkeeping requirements to document conformance with the
EMP.
Removal of Waste:
14. Procedures relevant to the timely and safe removal of laboratory
wastes.
15. Procedures and work practices for safely transporting or moving
laboratory wastes.
Maintenance:
16. Procedures for conducting laboratory clean-outs.
Emergency:
17. Emergency preparedness and response procedures.
------------------------------------------------------------------------
Step 3: Following review of its EMP, each University would notify
the relevant state agency in writing of the date on which it intends to
implement its EMP. For purposes of this XL project, each University
would also notify EPA Region I. The proposed rule would become
effective in the laboratories only after such written notification.
Implementation of the Environmental Management Plan Including
Procedures for Meeting the Minimum Performance Criteria
The EMP would cover the management requirements for laboratory
waste until that waste reaches the designated on-site hazardous waste
accumulation area, including emergency response requirements in the
Minimum Performance Criteria while the waste is in transit to the
accumulation area. The following steps outline procedures at a
laboratory once the EMP would be in place and operational:
Step 4: Information and training would have been provided to
laboratory workers to comply with the Minimum Performance Criteria as
well as OSHA per the University's Laboratory Environmental Management
Plan. Hazardous chemicals would be received at the University,
distributed to the laboratory and placed in storage in the laboratory
in accordance with any and all requirements imposed by OSHA, Fire Codes
and/or building permits. If those chemicals pose a new or unique hazard
for which a worker has not received prior training, the worker would
receive new information and training so that they could understand and
implement the relevant elements of the EMP.
Step 5: Hazardous chemicals would be used in the research or
teaching laboratory under the direction of a trained individual, and
laboratory waste would be generated from those laboratory scale
activities.
Step 6: The laboratory waste would be managed in accordance with
the Minimum Performance Criteria and the University's specific
Laboratory EMP which would include the University-specific procedures
for meeting those criteria. These procedures would include ensuring
that the laboratory waste generated as a result of laboratory scale
activities in Step 5 is placed in containers and labeled with a
chemical name and hazard warning as per the Minimum Performance
Criteria and the procedures for meeting those criteria as outlined in
the Environmental Management Plan. For example, the Laboratory EMP may
specify the type of label the University requires for each type of
laboratory waste and how that label must be filled out.
Step 7: Each laboratory would be able to temporarily hold up to 55-
gallons of laboratory waste (or up to 1 quart of acutely hazardous
laboratory waste) prior to having to put a date on the waste. Upon
reaching the 55 gallon or 1 quart limit in the laboratory, the
laboratory waste container(s) would be marked with the date. Any
laboratory waste held in excess of these limits before the dated
laboratory waste is
[[Page 40703]]
removed would also be managed as described in Step 6, and the excess
would be limited in quantity to an additional 55 gallons (or an
additional 1 quart of acutely hazardous laboratory waste). Excess waste
accumulated before dated laboratory waste is removed would also have to
be marked with the date it reaches the 55 gallon or 1 quart limit and
would subsequently be removed from the laboratory as described in Step
8.
Step 8: Once laboratory waste is dated, the University EH&S staff
would be immediately informed that the laboratory waste would have to
be removed to the on-site hazardous waste accumulation area within 30
days of the label date.
Step 9: The laboratory waste referred to in Step 8 would be picked
up (within thirty days of the dates referred to in Step 8) by EH&S
department representatives and directly transferred to a designated on-
site hazardous waste accumulation area (as defined in the definitions
at proposed 40 CFR 262.102). Current hazardous waste accumulation areas
at each of the Universities are shown in Table 1. Designated hazardous
waste accumulation areas would be listed in the EMP.
Step 10: As soon as the laboratory waste is received at the on-site
hazardous waste accumulation area, the University EH&S staff or
designated trained professionals, would make a determination as to
whether it is a solid waste under RCRA, and if it is a solid waste, the
staff would determine whether it is a hazardous waste in accordance
with 40 CFR 262.11, as required by proposed 40 CFR 262.106. Once the
laboratory waste is received at the on-site hazardous waste
accumulation area, the proposed ``temporary conditional deferral''
would no longer apply, and the laboratory waste that is determined to
be hazardous waste would be managed in accordance with current RCRA
requirements.
Step 11: If the laboratory waste could be reused, the University
EH&S staff would arrange for its redistribution and reuse within the
University. If EH&S staff determine that the laboratory waste is a
solid waste and it is hazardous, it would be managed in accordance with
all applicable RCRA requirements.
6. Comparison of Minimum Performance Criteria with Current RCRA
Regulations
EPA intends that laboratory waste be managed safely. The Minimum
Performance Criteria contained in proposed 40 CFR 262.104 have been
developed by the University laboratories and EPA to ensure that
laboratory waste is managed in a manner that is protective of human
health and the environment. The following discussion demonstrates how
specific provisions in the Minimum Performance Criteria would compare
with RCRA provisions currently in effect. EPA is describing the current
RCRA provisions as a point of comparison for the requirements proposed
today, but is not proposing any changes to these current RCRA
provisions.
(i) Labeling: Current RCRA regulations require that containers of
hazardous waste in satellite accumulation areas be labeled either with
the words ``hazardous waste'' or with other words that identify the
contents. Today's rule would contain a requirement that laboratory
waste would have to be labeled or tagged with the chemical name and
general hazard class. Where a laboratory container is too small to be
effectively labeled or where containers of like wastes are
consolidated, such as where test tubes are stored in a rack or where
similar wastes are being consolidated in a lab-pack shipping container,
the secondary container (e.g. the rack containing the test tubes or the
DOT shipping container) would have to be labeled. The Environmental
Management Plan would include specific procedures that lab workers
would have to follow to carry out the MPC requirements for labeling in
the laboratories.
(ii) Quantity Limitations: Current federal RCRA regulations for
satellite accumulation areas 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. 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. Although
this approach could result in a limit that is considerably less than
what a laboratory might be allowed to accumulate under current law,
today's proposed rule would grant the Universities flexibility on the
amount of time allowed to remove excess waste from the laboratory. (See
(iv) below.)
(iii) Quantity Limitation for Excess Laboratory Waste: Current RCRA
regulations do not place specific limits on the amount of ``excess''
hazardous waste, beyond 55 gallons, that a generator may accumulate in
satellite areas during the three days prior to removal of such excess.
Today's proposed rule specifically limits such excess in the laboratory
setting to an additional 55 gallons of laboratory waste (or an
additional 1 quart of acutely hazardous laboratory waste). Thus, the
maximum amount of laboratory waste which may be held in a University
laboratory at any time under today's proposed rule would be 110 gallons
(or two quarts of acutely hazardous laboratory waste). While this
requirement may prove to be more restrictive than the current system,
this approach represents an experiment to be tested under this XL
project, and it would ensure that there would not be excessive
quantities of waste in the laboratories during the 30-day timeframe
discussed below.
(iv) Timing Limitations: Current RCRA regulations state that a
generator may accumulate up to 55 gallons of hazardous waste (or one
quart of acutely hazardous waste) under 40 CFR 262.34(c) and within
three days of exceeding that 55 gallons must comply with the
requirements of 40 CFR 262.34(a) or other applicable requirements with
respect to the excess over 55 gallons (or one quart). Under the
proposed rule, all laboratory waste that has reached threshold amounts
would have to be removed from the lab within 30 days, instead of three
days. EPA is granting flexibility on the timing of removal to allow for
a more efficient pick-up schedule which will in turn allow University
staff to devote additional resources to make centralized decisions
about the reuse of laboratory waste. As noted above, to ensure that
large quantities of waste are not held in laboratories, today's
proposal limits the excess to an additional 55 gallons of laboratory
waste (or one additional quart of acutely hazardous laboratory waste).
(v) Dating and Removal Requirements: Current RCRA regulations
require that a generator mark the container holding hazardous waste in
excess of 55 gallons of hazardous waste (or one quart of acutely
hazardous waste) with the date the excess amount began accumulating.
Today's proposed rule would contain a requirement that
[[Page 40704]]
when laboratory waste reaches the threshold of 55 gallons (or one quart
of acutely hazardous laboratory waste) it must be dated. Once
laboratory waste is dated, the laboratory would have 30 days to remove
it from the laboratory to the on-site hazardous waste accumulation
area.
(vi) Hazardous Waste Accumulation Areas: Once satellite
accumulation quantity limits are met, current RCRA regulations require
generators to comply (within 3 days) with 40 CFR 262.34(a) or other
applicable provisions. Under today's proposed rule, the accumulated
laboratory waste would be directly transferred to a designated on-site
hazardous waste accumulation area. Once the laboratory waste is
received at the on-site hazardous waste accumulation area, the proposed
``temporary conditional deferral'' would no longer apply, and the
laboratory waste that is determined to be hazardous waste would be
managed in accordance with Sec. 262.34(a) or other applicable RCRA
requirements. In this regard, the proposed alternative system is meant
to work in the same way as the current system.
(vii) Container Management: Current RCRA regulations set forth at
40 CFR 265.173(a), as referenced by Sec. 262.34(c)(1)(i), require that
containers of hazardous wastes be closed at all times, except when it
is necessary to add or remove wastes. Today's proposed rule would
contain the same requirement but allows the University to make
exceptions for in-line waste collection containers. Some experiments
use a process for the ``in-line collection'' of waste, which is a
system that automatically collects waste while an experiment is
running. Such systems may collect waste through a physically connected
apparatus, such as, for example, gas chromatographs. Gas chromatographs
commonly carry the chemical sample through the instrument using tubing
that leads from the instrument to waste collection bottles on the back
of the instrument. Each tube commonly runs through a stopper set into
each small collection bottle. Other types of equipment use in-line
collection systems that, while not physically connected, are
nevertheless a necessary part of the apparatus as a means to collect
waste, such as distillation equipment. In these types of systems, the
waste is collected in an otherwise uncovered container (e.g., waste
drips from a tube into the container) while the experiment is running--
although the entire apparatus would be covered or hooded to prevent the
release of volatile hazardous vapors or fumes. The apparatus set-up
provides the physical control otherwise provided by the laboratory
worker, who ensures during an experiment that containers are closed,
except when he or she needs to add or remove a chemical. The proposed
rule for this XL project proposes that such systems for the in-line
collection of waste would be a circumstance in which waste may be
added, consistent with the requirement that containers containing waste
be kept closed (i.e., when a container is permissibly ``open'' for the
adding of waste). To be considered as in-line waste collection, the
University would describe this arrangement for in-line waste collection
in their EMP. This part of the proposed rule addresses the need for
flexibility around the diverse conditions of research and
experimentation that constitute the work of the University
laboratories, while at the same time minimizing the potential for
release. (Note that this rule does not change the meaning of
``release'' under RCRA.) This flexibility is limited to specific
circumstances in order to address the unique configuration of some
research and laboratory instrumentation such as gas chromatographs and
DNA synthesizers. The flexibility is being proposed for in-line waste
collection due to laboratory scale experimentation.
Today's proposed rule also specifies that containers be compatible
with their contents, and be in good condition. These requirements are
equivalent to the current requirements at 40 CFR 262.34(c)1(i) which
reference section 265.171 and section 265.172 regulating the condition
of containers and compatibility of waste in satellite accumulation
areas.
(viii) Inspections: Current RCRA regulations require that satellite
accumulation areas (those areas regulated by 40 CFR 262.34(c), at or
near any point of generation where wastes accumulate) be under the
control of the operator of the process. Although in each laboratory,
laboratory waste could only be generated under the control of the
trained laboratory workers, today's proposed rule would also contain a
requirement for regular inspections of containers of laboratory wastes
within the laboratory to ensure that the containers are meeting
requirements for container management. The frequency of these
inspections would be at least once per year and would otherwise be
based on laboratory practices. Specific inspection schedules would be
specified in the Environmental Management Plan.
Other Minimum Performance Criteria include
(ix) Posting of Emergency Notification Procedures: Today's proposed
rule would contain a requirement that includes posting of emergency
notification procedures and evacuation procedures for laboratory
workers. Current RCRA regulations require facilities to include such
information in a contingency plan (large quantity generators) or to
ensure that all employees are thoroughly familiar with emergency
procedures (small quantity generators). Today's proposed rule makes no
changes to those requirements. Emergency response and notification
procedures, under the proposed rule, would be required for
participating laboratories that otherwise could be regulated under 40
CFR 262.34(c), and the EMPs must address all aspects of laboratory
waste management, including emergencies (see Table 2 for an outline of
EMP requirements and the proposed rule at 40 CFR 262.105).
(x) Emergency Response: Today's proposed rule would contain a
requirement that emergency response equipment and procedures for
emergency response be appropriate to the hazards in the laboratory.
Current RCRA regulations require equipment appropriate to the hazards
presented at a facility and specify procedures that must be followed
for particular emergencies. The proposal also includes a requirement to
comply with spill response provisions set forth in 40 CFR 263.30 and
263.31 for spills of laboratory waste that may occur while it is en
route to the on-site hazardous waste accumulation area.
(xi) Training Requirements: Today's proposed rule would contain a
requirement that laboratory workers receive training so that they can
implement and comply with the Minimum Performance Criteria. Training
under the EMP is required when a laboratory worker is first assigned to
a laboratory and when a laboratory waste poses a new or unique hazard
for which the worker has not received prior training.
(xii) General Compliance: 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.
As noted in Table 2, above, additional requirements for
laboratories under this proposed system would be included in
[[Page 40705]]
the Environmental Management Plan (EMP).
As previously mentioned, the proposed Minimum Performance Criteria
described above would only apply to the management of laboratory waste
within laboratories and while en route to an on-site hazardous waste
accumulation area. Once received at an on-site hazardous waste
accumulation area, the laboratory waste would be subject to all
applicable RCRA requirements. A participating University could, for
example, accumulate any laboratory waste that is determined to be
hazardous waste at the hazardous waste accumulation area in accordance
with the current requirements of 40 CFR 262.34 (for 90 or 180 day on-
site accumulation). EPA is not proposing any changes to the
requirements Universities would have to meet in order to accumulate
waste on-site for 90 (large quantity generators) or 180 days (small
quantity generators).
7. Comparison of the Proposed Rule With Current OSHA and RCRA
Regulatory Requirements
The following discussion demonstrates how specific provisions in
the proposal compare with current OSHA and RCRA requirements. EPA is
describing the current RCRA provisions as a point of comparison for the
requirements proposed today, but is not proposing any changes to these
current RCRA provisions.
The OSHA Chemical Hygiene Plan (CHP) set forth at 29 CFR
1910.1450(e)(3) requires that the CHP address: (i) standard operating
procedures, (ii) criteria used to determine when to implement control
measures, (iii) fume hood functioning, (iv) employee training, (v)
circumstances requiring prior approval, (vi) provisions for medical
consultation, (vii) designation of responsible personnel, (viii)
provisions for protection for work with particularly hazardous
substances and (ix) annual review of the plan and its effectiveness.
Although current OSHA regulations may require a Chemical Hygiene
Plan for laboratories, there is no parallel requirement under RCRA. No
regulations currently require the Universities to implement a
Laboratory Environmental Management Plan as would be required by
today's proposed rule. Moreover, while many of the Minimum Performance
Criteria delineated in the proposed requirements would be similar to
current RCRA requirements for satellite accumulation of hazardous waste
(in the laboratory areas which are currently regulated under 40 CFR
262.34(c)), some limitations have been proposed beyond what current
RCRA requirements allow, such as limiting each laboratory to 55 gallons
of laboratory waste.
Existing RCRA requirements for satellite accumulation (under 40 CFR
262.34(c)) require that containers: (i) be at or near the point of
generation, (ii) be under the control of the operator, (iii) be marked
with the words ``hazardous waste'' or the contents, (iv) be in good
condition, (v) be compatible with their contents, and (vi) be kept
closed except as necessary to add or remove waste. In addition,
accumulation is limited to 55 gallons of hazardous waste per point of
generation. Any excess waste over 55 gallons must within three days
comply with 262.34(a) or other applicable provisions. Existing RCRA
regulations also require that a generator make a hazardous waste
determination. The current federal regulations do not require
management plans for these areas.
The proposed Laboratory Environmental Management Standard has been
drafted in an attempt to align RCRA requirements that would apply to
hazardous wastes in laboratories with the OSHA requirements for
hazardous chemical handling in laboratories, in order to provide for
the more efficient management of laboratory waste. This would be
accomplished by the crafting of an Environmental Management Plan that
would implement standard operating procedures for managing laboratory
waste, just as the CHP requires standard operating procedures relevant
to safety and health considerations when working with hazardous
chemicals.
While the Laboratory Environmental Management Plan proposed in this
project is intended to function in the same way as the OSHA CHP, the
requirements of the Laboratory Environmental Management Standard would
be more effective at managing laboratory wastes. For example, the
Laboratory Environmental Management Standard would require procedures
for an annual review of high hazard chemicals (defined in the
Environmental Management Standard under ``hazardous chemicals of
concern'') in the laboratory, while no such requirement currently
exists under RCRA or OSHA. In addition, the Laboratory Environmental
Management Standard would require an institutional process that is not
required by current regulations for (i) setting environmental
objectives and targets, and (ii) the promotion of pollution prevention
and environmental improvements.
The current RCRA system allows generators to accumulate hazardous
waste at satellite accumulation areas under 40 CFR 262.34(c). The
requirements under 40 CFR 262.34(c) set specific requirements for
container management, labeling, and accumulation times. No written
plans are currently required for a facility to set forth and document
the procedures that they will use to comply with the requirements of
Sec. 262.34(c). In today's proposed rule, the Universities would be
required not only to comply with proposed requirements on container
management, labeling and holding times pursuant to proposed
Sec. 262.104, which offers some flexibility but still ensures
protection of human health and the environment, they would also have to
specifically document the procedures they will use to comply with
proposed Sec. 262.104. In addition, to documenting the procedures for
complying with the Minimum Performance Criteria of Sec. 262.104, the
Universities would also have to develop and document the procedures for
all of the elements in Table 2, i.e.: (i) their environmental policy,
(ii) roles and responsibilities, (iii) a pollution prevention plan,
(iv) their system for tracking requirements applicable to laboratory
waste, (v) criteria for identifying physical and chemical hazards and
control measures to reduce releases, (vi) a system for conducting
surveys of hazardous chemicals of concern, (vii) procedures for
cleaning out laboratories, (viii) criteria with which laboratory
workers would be required to comply in managing laboratory waste
according to the Minimum Performance Criteria, (ix) procedures for safe
and timely removal of wastes from laboratories, (x) procedures for
emergencies, (xi) procedures for training, (xii) procedures for safe
transfer of waste to the accumulation areas, (xiii) procedures for
regularly inspecting a laboratory to assess conformance with the
requirements of the EMP, (xiv) procedures for identifying environmental
management plan nonconformances and corrective actions, (xv)
recordkeeping requirements to document conformance with their EMP. This
Laboratory Environmental Management Plan would be an entirely new
requirement imposed upon the Universities. (This proposed requirement
doesn't change existing institutional RCRA requirements. For example
any University that is currently required to have a Contingency Plan
would still be required to have a Contingency Plan).
EPA envisions a three-part compliance assurance program to ensure
that this proposed system
[[Page 40706]]
adequately protects human health and the environment. First, because
EPA expects the Minimum Performance Criteria to operate as an
equivalent, alternative system to the current RCRA requirements in 40
CFR 262.34(c), EPA expects the first level of assurance to be similar
to the inspection system currently in place. Thus, at the laboratory
level, the first level: the management of laboratory waste would have
to be in conformance with the Minimum Performance Criteria. The second
level would be the documentation of procedures: the Laboratory EMP
would have to be written in conformance with the requirements of the
standard proposed at 40 CFR 262.105. The third level would be
operational: the operations ongoing in all the laboratories that are
participating would have to be in conformance with the procedures
described in the EMP. Thus, this proposal provides two additional
levels of review for satellite storage of hazardous waste, while
allowing the Universities to be more centralized in their operations
and to adopt a more coherent approach to management of laboratory
wastes.
8. How the Laboratory XL Project Will Result in Superior Environmental
Performance
The Laboratory XL Project is designed to achieve environmental
results that are superior to what is currently achieved by the current
RCRA regulatory system. The aim of the proposal is to enable the
Universities to more easily manage all hazardous chemicals under a
logical, integrated scheme. Under the proposed model, environmental
professionals at the Universities would, at on-site hazardous waste
accumulation areas, determine whether there are any opportunities,
throughout the University, for reuse of laboratory waste or whether the
laboratory waste is hazardous waste.
As a result, the Laboratory XL project is expected first and
foremost to result in increased pollution prevention. In a 1996 survey
of approximately 100 academic institutions conducted by the Campus
Safety Health and Environmental Management Association, nearly 95
percent of respondents reported that they reused or recycled less than
one percent of the hazardous chemical waste otherwise destined for
disposal. In the FPA, the Universities have committed themselves to
increased hazardous waste reduction. The Universities have set specific
pollution prevention goals including (i) a 10 percent reduction in the
overall amount of hazardous waste generated from participating
laboratories (from baseline) and (ii) a 20 percent increase (from
baseline) in reuse of laboratory waste over the life of the project. In
accordance with the FPA for this project, the Universities
participating in this XL project would report each year on their
progress in meeting these goals.
Second, under this proposed rule, each University would implement
their procedures for an annual assessment of those hazardous chemicals
that they believe pose significant risks (based on physical or health
hazards, or defined shelf-life) in an effort to minimize risks to human
health and the environment and to monitor materials that might
otherwise accumulate on the shelf or require disposal.
In addition, this XL project would promote the following:
Setting of Environmental Objectives and Targets and
Pollution Prevention: The systematic approach to environmental
management would enable the University to organize waste management
functions to achieve goal setting, better tracking, pollution
prevention, and control. This process is outlined in more detail in the
Final Project Agreement.
Streamlining of the Regulatory Process: By setting up a
complementary system that essentially attempts to integrate EPA and
OSHA requirements, the project would streamline the overall regulatory
process for laboratories, reducing the burden on the Universities and
resulting in a more efficient and protective approach to chemical
management.
Increased Environmental Awareness: The implementation and
continuous improvement of the Laboratory Environmental Management
Standard for laboratories would enhance environmental awareness among
researchers and students leading to a transfer of good environmental
management practices to the larger community.
Finally, the implementation of the Laboratory Environmental
Management Standard would achieve superior environmental performance
because criteria would be set for the systematic management of all
laboratory wastes. Some of the laboratory wastes would otherwise not be
managed under the requirements of RCRA (such as ethidium bromide wastes
and virgin or unused chemicals on the shelf and that haven't
consistently been defined as hazardous waste.)
D. What Regulatory Changes Will Be Necessary to Implement This Project?
1. Federal Regulatory Changes
Today's proposal would provide the Universities with a temporary
conditional deferral from two specific RCRA regulations: Hazardous
Waste Determination: 40 CFR 262.11, and the Satellite Accumulation
Provisions: 40 CFR 262.34(c). The site-specific rule necessary to allow
for the temporary conditional deferral, and being proposed by EPA
today, would add a paragraph (j) to 40 CFR 262.10 to clarify that the
temporary holding of laboratory wastes within the participating
University laboratories would be covered by a new section to 40 CFR
part 262, subpart J. Proposed subpart J would fully describe the
conditions to be met for each University's management of laboratory
waste and by its Laboratory Environmental Management Plan as outlined
above, in the sections C.2., C.3. and C.4 of this preamble.
(i) Hazardous Waste Determination: 40 CFR 262.11: Current
regulation requires that generators make a determination as to whether
a solid waste is a RCRA hazardous waste. The proposed rule would
identify the specific point at which the Universities would make this
determination. Under the proposed rule, the Universities would not make
a hazardous waste determination until the laboratory waste is received
at the on-site Hazardous Waste Accumulation Areas identified in Table 1
above. These areas would be the point where decisions would be made as
to whether the laboratory waste would be reused within the University,
accumulated for up to 90- or 180-days pursuant to 40 CFR 262.34, or
sent to a RCRA permitted (or interim status) treatment, storage or
disposal facility.
Because universities have such small and diverse waste streams and
have large numbers of small laboratories, EPA recognizes the resource
efficiency in making the hazardous waste determination at the on-site
hazardous waste accumulation area. This approach would enable the
university to determine whether laboratory waste can be reused on site
at a central area, where the connections between departments and
laboratories on a university-wide basis can be better made by the
institution's professional environmental health and safety personnel.
EPA also recognizes that while laboratory wastes remain in the
laboratory, they would be managed pursuant to the Laboratory
Environmental Management Standard as embodied in the proposed subpart J
which includes Minimum Performance Criteria to ensure that they would
be
[[Page 40707]]
managed in a manner protective of human health and the environment.
(ii) Satellite Accumulation Provisions: 40 CFR 262.34(c): This
regulation governs the satellite accumulation of hazardous waste. It
states in paragraph (1) that a generator may accumulate as much as 55
gallons of hazardous waste or one quart of acutely hazardous waste in
containers at or near any point of generation where wastes initially
accumulate, which is under the control of the operator of the process
generating the waste, without complying with paragraph 262.34(a)
provided the generator: (i) complies with sections 265.171, 265.172 and
265.173(a); and (ii) marks the containers with the words ``Hazardous
Waste'' or with other words that identify the contents. Paragraph (2)
states that a generator that accumulates in excess of the amounts in
paragraph (1) must, with respect to the excess amount, comply within
three days with 40 CFR 262.34(a) or other applicable provisions. This
paragraph also requires that the generator must mark the container
holding the excess accumulation with the date the excess began
accumulating.
This proposed rule would allow the Universities to manage hazardous
waste in the laboratories without complying with Sec. 262.34(c).
Specifically, the Universities would not be required to comply with the
3-day accumulation time limit that applies to hazardous waste in excess
of 55 gallons. Instead, under the proposed rule, Universities would be
allowed to take 30 calendar days to remove the waste in their
laboratories once the 55 gallon (or one quart of acutely hazardous
laboratory waste) threshold is reached, while complying with their
Environmental Management Plans. The extension from 3 to 30 days would
allow for University environmental, health and safety professionals to
collect and remove laboratory wastes during planned, systematic and
scheduled intervals rather than the current reactive and episodic pick-
ups which, in an institution with over a hundred laboratories, can be
extremely inefficient, diverting environmental, health and safety
department staff time from more proactive measures. By providing
additional time for waste pickups to be carefully scheduled, this
proposed rule should enable university environmental professionals to
provide additional training to students and other laboratory workers
and to develop waste minimization, reuse and recycling opportunities
for chemicals from the university laboratories. In addition, while
laboratory waste is being held in the laboratory, the Universities
would have to manage it in compliance with minimum performance
criteria.
Thus, the result of today's rule is that 40 CFR 262.34(c) would no
longer be the only alternative available to manage waste in the
individual laboratories at the Universities. Another system would be
available under the proposed rule at 40 CFR part 262, subpart J, which
sets forth the requirements of the Laboratory Environmental Management
Plan (proposed Sec. 262.105), and the Minimum Performance Criteria
(proposed Sec. 262.104).
Proposed subpart J would only apply within the Universities'
laboratories and while the laboratory waste is en route to an on-site
hazardous waste accumulation area. Once the laboratory waste is
received at the on-site hazardous waste accumulation area, subpart J
would no longer apply and laboratory waste that is determined to be
hazardous waste would be subject to all applicable RCRA requirements.
2. State Regulatory Changes
The state of Vermont and the Commonwealth of Massachusetts are
authorized under section 3006 of RCRA to implement the federal RCRA
program. Thus, these state programs operate in lieu of the federal
program. Moreover, Vermont and Massachusetts hazardous waste management
regulations, codified in Code of Vermont Regulations and 310 Code of
Massachusetts Regulations (CMR) 30.00, respectively, contain equivalent
or more stringent, requirements as compared to the Federal regulations
at 40 CFR 262.10 and 262.34(c). The Universities are subject to the
Vermont (for the University of Vermont) and the Massachusetts (for the
University of Massachusetts Boston and Boston College) state
regulations, which would include requirements that the hazardous waste
in laboratories be handled according to the accumulation provisions of
RCRA. Therefore, conforming state regulatory changes or legal
mechanisms must be implemented in addition to the proposed federal
changes to undertake this new system.
E. Why Is EPA Supporting This New Approach to Laboratory Waste
Management?
EPA is supporting the regulatory model contained in today's rule
because it provides for a degree of environmental protection that is at
least as protective as that which existing RCRA regulations would
provide for the participating laboratories. The model also promotes
systemic, integrated cost-effective compliance which should increase
opportunities for waste minimization through the centralization of
waste determinations. EPA and the Universities anticipate that
chemicals which would have been disposed of as waste should be
redistributed and reused through the centralized hazardous waste
determination process. In addition, by providing the Universities the
flexibility to schedule regular waste pickups, professional resources
can be redirected from reactive waste management to proactive waste
management.
EPA hopes that this proposed rule will result in a successful
innovative pilot of a new system for universities and research
organizations as unique workplaces where researchers and students often
move from one jurisdiction to another throughout the country. If this
pilot is successful, EPA hopes that this system could be translated
into a national program, to address the confusion regarding the RCRA
rules that has been reported by the universities. By implementing a
standard system for universities, laboratory workers would remain
cognizant of the requirements for managing chemicals, and in
particular, waste chemicals, no matter where in the U.S. they are
performing their research. EPA recognizes that the proposed new system
may not be appropriate or necessary for some institutions such as small
colleges but may, at some point, depending on the results of this XL
project, consider the possibility of offering it as a regulatory
option.
Finally, for this pilot, the Universities would be implementing
continuous improvement systems which would include training, planning,
and self-inspections in ways that have never been tested before.
F. How Have Various Stakeholders Been Involved in This Project?
Stakeholder involvement during the project development stage was
encouraged in several ways. The methods included communicating through
the media (newspaper, e-mails, and the LCEE website); directly
contacting interested parties and offering an educational program
regarding the regulatory requirements impacted by the XL project.
Stakeholders have been kept informed on the project status via mailing
lists, newspaper articles, public meetings and the establishment of a
website at URL: http://esf.uvm.edu/LabXL.
Representatives from Second Nature and Ecologia, national
environmental interest groups (with members participating in the
ISO14000 standard setting process), and the Tellus Institute (a
nationally recognized nonprofit
[[Page 40708]]
corporation providing research on, among other issues, environmental
management performance and reporting) have participated in conference
calls and meetings with the Project XL team and provided comments
during the development of the proposed Final Project Agreement. A
representative of the national environmental group, the Environmental
Defense Fund, has also been a participant in commenting on this
proposal. These representatives continue to be notified of project
meetings and activities.
The university and research community is a diverse and busy one.
Each University has held individual local stakeholder meetings in an
effort to engage their surrounding communities. However, few local
stakeholders other than employees of the facilities have expressed
interest in actively participating in the development of the project.
Copies of all comment letters, as well as EPA's response to comment
letters, will be located in the rulemaking Docket (see the ADDRESSES
section of today's preamble).
As this XL project continues to be implemented, the stakeholder
involvement program would shift its focus to ensure that: (1)
Stakeholders are apprised of the status of project implementation and
(2) Stakeholders have access to information sufficient to judge the
success of this Project XL initiative. Anticipated stakeholder
involvement during the term of the project will likely include other
general public meetings to present periodic status reports,
availability of data and other information generated. In addition to
the EPA, VTDEC, and MADEP reporting requirements of today's rulemaking,
the FPA includes provisions whereby the University Laboratories will
make copies of interim project reports available to all interested
parties. A public file on this XL project has been maintained at the
website http://esf.uvm.edu/labxl throughout project development, and
the Universities have committed to continue to update it as the project
is implemented. Additional information is available at EPA's website at
http://www.epa.gov/projectxl.
A detailed description of this program and the stakeholder support
for this project is included in the Final Project Agreement, which is
available through the docket or through EPA's Project XL site on the
Internet (see ADDRESSES section of this preamble).
G. How Will This Project Result in Cost Savings and Paperwork
Reduction?
Laboratory waste management currently accounts for the most
substantial expense for environmental, health and safety programs at
the participating Universities. This XL Project would allow academic
institutions to more effectively promote and implement waste
minimization programs in laboratories which would reduce waste disposal
costs and minimize chemical purchasing costs. The opportunity to
develop a systematic, planned procedure for the pickup of laboratory
wastes and centralization of waste management decisions would also
enable Environmental Health and Safety Departments to more effectively
utilize staff on proactive activities such as training and implementing
chemical reuse and waste minimization programs.
Additionally, a certain amount of paperwork associated with RCRA
compliance is likely to be reduced in the long term, while in the short
term the requirement to write Environmental Management Plans would add
additional paperwork. Once the Laboratory EMP is written, the annual
review of the Chemical Hygiene Plans required by OSHA, and the review
of the Environmental Management Plan could be accomplished in one step.
The Universities do not expect significant paperwork reduction gains
given the fact that the RCRA requirements would still be fully
applicable once the laboratory waste reaches the on-site hazardous
waste accumulation areas.
H. How Will EPA Ensure the Integrity and Comprehensiveness of Each
University's Laboratory Environmental Management Plan?
EPA, along with MA DEP and VT DEC and designated stakeholders would
have sufficient opportunity to review and comment on the Laboratory
EMP's as they are being developed by the Universities. In this pilot
project, once its Laboratory EMP is complete, each University would
formally submit their own Laboratory EMP to EPA and the applicable
state for a final review of its conformance with the requirements of
the Laboratory Environmental Management Standard. Because the
Universities would be working with the agencies in developing their
EMP, it is expected that they would be able to respond quickly to any
possible comments or concerns raised by the agencies.
I. How Will the Terms of the Laboratory XL Project and Proposed Rule Be
Enforced?
All XL projects must include a legally enforceable mechanism to
ensure accountability and superior environmental performance. EPA
retains its full range of enforcement options under the proposed rule.
The enforcement response on the part of EPA would 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 would be evaluated by EPA Region I through regular
inspections based on the following four criteria:
1. Does the University have an Environmental Management Plan as
required by the Laboratory Environmental Management Standard?
2. Does the University's Environmental Management Plan include the
required policy and procedural elements specified in the Laboratory
Environmental Management Standard?
3. Is the University in compliance with the Minimum Performance
Criteria as set forth in the Laboratory Environmental Management
Standard at 40 CFR 262.104?
4. To what degree do the University's environmental management
practices in the laboratory conform to its Environmental Management
Plan?
Today's proposed rule includes a termination provision, in addition
to EPA's usual enforcement options, 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.
The rationale for the 90-day transition period is to allow
sufficient time for the Universities to reinstate the operational and
administrative infrastructure
[[Page 40709]]
necessary for proper RCRA compliance. Such a transition will likely
require the dismantling of the Environmental Management Plan and its
component parts. Retraining and reverting to the implementation of the
current RCRA system would include, among other things, (1) the re-
establishment of 3-day pick-ups of hazardous waste from the University
laboratories, (2) making early hazardous waste determinations in the
laboratories, and (3) the re-training of hundreds of laboratory
workers. Most importantly, this transition might require the
acquisition of funding and resources which were unnecessary under the
streamlined Environmental Management Plan. For example, additional
funding might be needed for the re-negotiation of contract terms with
hazardous waste contractors who might be needed for additional
hazardous waste pick-ups. Finally, the Universities may receive such a
revocation notice during the summer or during a semester break when
staff and graduate students are less available for re-training. For all
of these reasons, and given the fact that the proposed rule and
Environmental Management Plan would be fully applicable during this
time, EPA is confident that the 90-day time frame is reasonable.
J. How Long Will This Project Last and When Will It Be Complete?
As with all XL projects testing alternative environmental
protection strategies, the term of the University Laboratory XL project
is one of limited duration. Today's proposed rule would set the term of
the XL Project at four years after the effective date of this rule.
Because Project XL is a voluntary and experimental program, today's
proposed rule contains provisions that allow the project to conclude
prior to the end of the four years in the event that it is desirable or
necessary to do so. For example, an early conclusion would be warranted
if the project's environmental benefits do not meet the Project XL
requirement for the achievement of superior environmental results. In
addition, new laws or regulations may become applicable to the
Universities' laboratories during the project term which might render
the project impractical, or might contain regulatory requirements that
supersede the superior environmental benefits that the University
Laboratories are achieving under this project. Similarly, the
Universities may also request that the temporary conditional deferral
be revoked prior to the four years if the experimental project does not
provide sufficient benefits for the Universities to justify continued
participation.
If an early conclusion to the project is determined to be
appropriate, today's rule provides a mechanism for EPA to legally
conclude the project prior to the four years, through a notice of
termination, which would trigger the 90-day transitional period
described above in this preamble discussion. While EPA, the state
environmental agencies and the Universities have broad discretion and
latitude to initiate an early conclusion of the project, both expect to
exercise their good faith and judgment in determining whether
exercising this option is appropriate.
EPA reserves the discretion to terminate a project and an FPA in
the event a University fails to comply with or meet its obligations in
the proposed rule, or its supplementary commitments contained in the
FPA. The FPA and the site specific rule also provide for the project
sponsor's return to compliance with existing regulatory requirements
following termination.
IV. Additional Information
A. How To Request a Public Hearing
A public hearing will be held, if requested, to provide opportunity
for interested persons to make oral presentations regarding this
regulation in accordance with 40 CFR part 25. Persons wishing to make
an oral presentation on the site specific rule to implement the
University Laboratory XL project should contact Ms. Gina Snyder or Mr.
George Frantz of the Region I EPA office, at the address given in the
ADDRESSES section of this document. Any member of the public may file a
written statement before the hearing, or after the hearing, to be
received by EPA no later than August 10, 1999. Written statements
should be sent to EPA at the addresses given in the ADDRESSES section
of this document. If a public hearing is held, a verbatim transcript of
the hearing, and written statements provided at the hearing will be
available for inspection and copying during normal business hours at
the EPA addresses for docket inspection given in the ADDRESSES section
of this preamble.
B. How Does This Rule Comply With Executive Order 12866?
Under Executive Order 12866 (58 FR 51735, October 4, 1993) the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to Office of Management and Budget (OMB) review
and the requirements of the Executive Order. The Order defines
``significant regulatory action'' as one that is likely to result in a
rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety in State, local, or tribal governments or communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlement, grants,
user fees, or loan programs of the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
Because the annualized cost of this final rule will be
significantly less than $100 million and will not meet any of the other
criteria specified in the Executive Order, it has been determined that
this rule is not a ``significant regulatory action'' under the terms of
Executive Order 12866, and is therefore not subject to OMB review.
Executive Order 12866 also encourages agencies to provide a
meaningful public comment period, and suggests that in most cases the
comment period should be 60 days. However, in consideration of the very
limited scope of today's rulemaking and the considerable public
involvement in the development of the proposed Final Project Agreement,
the EPA considers 30 days to be sufficient in providing a meaningful
public comment period for today's action.
C. Is a Regulatory Flexibility Analysis Required?
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq,
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. This rule will not
have a significant impact on a substantial number of small entities
because it only affects three institutions, the University of
Massachusetts in Boston, Massachusetts, Boston College in Boston,
Massachusetts, and the University of Vermont in Burlington, Vermont.
These universities are not small entities. Therefore, EPA certifies
that this action will not have a significant economic impact on a
substantial number of small entities.
[[Page 40710]]
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 in Massachusetts and Vermont. The EPA has determined that
this rule contains no regulatory requirements that might significantly
or uniquely affect small governments. EPA has also determined that this
rule does not contain a Federal mandate that may result in expenditures
of $100 million or more for State, local, and tribal governments, in
the aggregate, or the private sector in any one year. Thus, today's
rule is not subject to the requirements of sections 202 and 205 of the
UMRA.
F. RCRA and Hazardous and Solid Waste Amendments of 1984
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, federal rules written under RCRA (non-HSWA),
no longer apply in the authorized state except for those issued
pursuant to the Hazardous and Solid Waste Act Amendments of 1984
(HSWA). 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 HSWA requirements and prohibitions in authorized states until
the state is granted authorization to do so.
2. Effect on Massachusetts and Vermont Authorization
Today's proposed rule, if finalized, would be promulgated pursuant
to non-HSWA authority, rather than HSWA. Massachusetts and Vermont have
received authority to administer most of the RCRA program; thus,
authorized provisions of each State's 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, if today's proposed rule is finalized, it
would not be effective in Massachusetts and Vermont until the State
adopts equivalent legal mechanisms or requirements as state law. It is
EPA's understanding that subsequent to the promulgation of this rule,
Massachusetts and Vermont intend to propose rules or other legal
mechanisms containing equivalent provisions. EPA may not enforce these
requirements until it approves the State requirements as a revision to
the authorized State program.
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
an economically significant rule, as defined by Executive Order 12866,
and because it does not involve decisions based on environmental health
or safety risks.
H. Does This Rule Comply With Executive Order 12875: Enhancing
Intergovernmental Partnerships?
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. If the mandate is unfunded, EPA must 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.
[[Page 40711]]
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.
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. If the mandate is unfunded,
EPA must 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 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. There
are no communities of Indian tribal governments located in the vicinity
of the university laboratories. Accordingly, the requirements of
section 3(b) of Executive Order 13084 do not apply to this rule.
J. Does This Rule Comply With the National Technology Transfer and
Advancement Act?
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, section 12(d) (15 U.S.C.
272 note) directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standard. This
proposed rulemaking does not involve technical standards. Therefore,
EPA is not considering the use of any voluntary consensus standards.
EPA welcomes comments on this aspect of the proposed rulemaking and,
specifically, invites the public to identify potentially-applicable
voluntary consensus standards and to explain why such standards should
be used in this regulation.
List of Subjects in 40 CFR Part 262
Environmental protection, Accumulation time, Hazardous waste, Waste
determination.
Dated: July 21, 1999.
Carol M. Browner,
Administrator.
For the reasons set forth in the preamble, part 262 of Chapter I of
title 40 of the Code of Federal Regulations is proposed to be 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
1. 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 40 CFR 262.102)
some of which will be hazardous wastes. As long as the Universities
comply with all the requirements of 40 CFR Part 262, Subpart J, the
Universities' laboratories that are participating in the University
Laboratories XL Project as identified in Table 1, are not subject to
the provisions of 40 CFR 262.11, 262.34(c), 40 CFR Part 264, 40 CFR
Part 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 upon written notice to the Regional
Administrator for EPA--Region I and the appropriate state agency. Such
written notice will be
[[Page 40712]]
provided at least ten days prior to the effective date of any such
changes.
2. 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 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
Sec. 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
[[Page 40713]]
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 40
CFR 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 I.
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 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
chemical name and general hazard class. 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 direct delivery to the hazardous waste
accumulation area 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 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.
(j) Each University must provide laboratory workers with
information and training 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
[[Page 40714]]
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.
(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 hazardous waste
accumulation area.
(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 recordkeeping 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 received at a hazardous
waste accumulation area 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 provide laboratory workers with
information and training so that they understand and can implement the
elements of each University's Environmental Management Plan that are
relevant to the laboratory workers' responsibilities.
(2) Each University must provide the information and training to
each laboratory worker 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 train Laboratory workers 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.
[[Page 40715]]
(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?
Each University must evaluate all laboratory wastes to determine
whether they are solid wastes under RCRA and, if so, determine pursuant
to 40 CFR 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. Laboratory waste that is
determined to be hazardous waste is no longer subject to the provisions
of this Subpart and must be managed in accordance with all applicable
RCRA requirements.
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
Sec. 262.107(c) 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 [INSERT DATE 4 YEARS FROM EFFECTIVE
DATE OF FINAL RULE].
[FR Doc. 99-19123 Filed 7-26-99; 8:45 am]
BILLING CODE 6560-50-P
