[Federal Register Volume 64, Number 187 (Tuesday, September 28, 1999)]
[Rules and Regulations]
[Pages 52380-52396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25137]



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Part II





Environmental Protection Agency





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40 CFR Part 262



Project XL Site-specific Rulemaking for University Laboratories at the 
University of Massachusetts Boston, Boston, MA, the Boston College, 
Chestnut Hill, MA, and the University of Vermont, Burlington, VT; 
Hazardous Waste Management System; Final Rule

  Federal Register / Vol. 64, No. 187 / Tuesday, September 28, 1999 / 
Rules and Regulations  

[[Page 52380]]



ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 262

[FRL-6444-8]


Project XL Site-specific Rulemaking for University Laboratories 
at the University of Massachusetts Boston, Boston MA, the Boston 
College, Chestnut Hill, MA, and the University of Vermont, Burlington, 
VT; Hazardous Waste Management System

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: Today's rule provides regulatory flexibility under the 
Resource Conservation and Recovery Act (RCRA), as amended. It allows 
the participating laboratories at the University of Massachusetts-
Boston, Boston, MA, Boston College, Chestnut Hill, MA and the 
University of Vermont, Burlington, VT (the Universities) to replace 
certain existing requirements for hazardous waste generators with a 
comprehensive Laboratory Environmental Management Plan (EMP) designed 
for each University. EPA is promulgating this rule to implement an XL 
project for the laboratories at the Universities. The terms of the XL 
project are defined in the Final Project Agreement (FPA) which is 
scheduled to be signed by the parties on September 28, 1999. The FPA 
explains the project in detail, while the promulgation of this federal 
rule will enable Massachusetts Department of Environmental Protection 
(MADEP) and Vermont Department of Environmental Conservation (VTDEC) to 
implement portions of the project requiring regulatory changes. The 
requirements of this rule will not take effect in Massachusetts and 
Vermont until they adopt the requirements as state law. For the sake of 
simplicity, the remainder of this preamble refers to the effects of 
this rule, although it will be the corresponding state law change that 
will actually govern this XL project.
    In order to qualify for the flexibility that the rule provides, the 
Universities must implement environmental management plans for the 
participating laboratories and comply with minimum performance criteria 
for managing laboratory waste. EPA expects this XL project to result in 
superior environmental performance in Massachusetts and Vermont, while 
providing waste minimization opportunities to the participating 
Universities.

DATES: This final rule is effective September 28, 1999.

ADDRESSES: A docket containing public comments and supporting materials 
is available for public inspection and copying at the RCRA Information 
Center (RIC), located at Crystal Gateway, 1235 Jefferson Davis Highway, 
First Floor, Arlington, Virginia. The RIC is open from 9:00 am to 4:00 
pm Monday through Friday, excluding federal holidays. The public is 
encouraged to phone in advance to review docket materials. Appointments 
can be scheduled by phoning the Docket Office at (703) 603-9230. Refer 
to RCRA docket number F-1999-NEUP-FFFFF. The public may copy a maximum 
of 100 pages from any regulatory docket at no charge. Additional copies 
cost 15 cents per page.
    A duplicate copy of the docket is available for inspection and 
copying at U.S. EPA, Region 1, 1 Congress Street, Suite 1100 (LIB), 
Boston, MA 02114-2023 during normal business hours. Persons wishing to 
view the duplicate docket at the Boston location are encouraged to 
contact Ms. Gina Snyder or Mr. George Frantz in advance, by telephoning 
(617) 918-1837 or (617) 918-1883. Information is also available on the 
world wide web at http://www.epa.gov/ProjectXL.

FOR FURTHER INFORMATION CONTACT: Ms. Gina Snyder or Mr. George Frantz, 
U.S. Environmental Protection Agency, Region I (SPE), Assistance and 
Pollution Prevention Division, 1 Congress Street, Suite 1100, Boston, 
MA 02114-2023. Ms. Snyder can be reached at (617) 918-1837 and Mr. 
Frantz can be reached at (617) 918-1883.

SUPPLEMENTARY INFORMATION:

Outline of Today's Document

    The information presented in this preamble is organized as follows:

I. Authority
II. Background
    A. Overview of Project XL
    B. Overview of the New England University Laboratories XL 
Project
    1. Introduction
    2. Description of the New England University Laboratories XL 
Project
    3. What Are the Environmental Benefits of the Project?
    4. What Are the Economic Benefits and Paperwork Reduction 
Deriving from the Project?
    5. Stakeholder Involvement
    6. What is the Project Duration and Completion Date?
    C. Rule Description
    1. Summary of Rule
    2. Changes to the Proposed Rule
III. Response to Significant Public Comments
IV. What is the Effective Date of This Rule?
V. Additional Information
    A. How Does This Rule Comply with Executive Order 12866?
    B. Is a Regulatory Flexibility Analysis Required?
    C. Is EPA required to Submit a Rule Report Under the 
Congressional Review Act?
    D. Is an Information Collection Request Required for This 
Project Under the Paperwork Reduction Act?
    E. Does This Project Trigger the Requirements of the Unfunded 
Mandates Reform Act?
    F. RCRA/HSWA
    1. Applicability of Rules in Authorized States
    2. Effect on Massachusetts and Vermont Authorization
    G. How Does This Rule Comply With Executive Order 13045: 
Protection of Children from Environmental Health Risks and Safety 
Risks?
    H. How Does This Rule Comply with Executive Orders on 
Federalism?
    I. How Does This Rule Comply with Executive Order 13084: 
Consultation and Coordination With Indian Tribal Governments?
    J. Does This Rule Comply with National Technology Transfer and 
Advancement Act?

I. Authority

    EPA is publishing this regulation under the authority of sections 
2002, 3001, 3002, 3003, 3006, 3010, and 7004 of the Solid Waste 
Disposal Act of 1970, as amended by the Resource Conservation and 
Recovery Act, as amended (42 U.S.C. 6912, 6921, 6922, 6923, 6926, 6930, 
and 6974).

II. Background

A. Overview of Project XL

    Each Project XL project is implemented with a Final Project 
Agreement (FPA). For this Project XL, the FPA sets forth the intentions 
of EPA and the Universities with regard to a project developed under 
Project XL, an EPA initiative to allow regulated entities to achieve 
better environmental results at less cost. The regulation will 
facilitate implementation of the project. Project XL--``eXcellence and 
Leadership'' was announced on March 16, 1995, as a central part of the 
National Performance Review and the EPA's effort to reinvent 
environmental protection. See 60 FR 27282 (May 23, 1995). Project XL 
provides a limited number of private and public regulated entities an 
opportunity to develop their own pilot projects to provide regulatory 
flexibility that will result in environmental protection that is 
superior to what would be achieved through compliance with current and 
reasonably anticipated future regulations. These efforts are crucial to 
EPA's ability to test new strategies that reduce the regulatory burden 
and promote economic growth while achieving better environmental and 
public health protection. EPA

[[Page 52381]]

intends to evaluate the results of this and other XL projects to 
determine which specific elements of the project(s), if any, should be 
more broadly applied to other regulated entities for the benefit of 
both the economy and the environment.
    Under Project XL, participants in four categories--facilities, 
industry sectors, governmental agencies and communities--are offered 
the flexibility to develop common sense, cost-effective strategies that 
will replace or modify specific regulatory requirements, on the 
condition that they produce and demonstrate superior environmental 
performance. To participate in Project XL, applicants must develop 
alternative pollution reduction strategies pursuant to eight criteria: 
superior environmental performance; cost savings and paperwork 
reduction; local stakeholder involvement and support; test of an 
innovative strategy; transferability; feasibility; identification of 
monitoring, reporting and evaluation methods; and avoidance of shifting 
the risk burden. They must have full support of affected federal, state 
and tribal agencies to be selected.
    For more information about the XL criteria, readers should refer to 
the two descriptive documents published in the Federal Register (60 FR 
27282, May 23, 1995 and 62 FR 19872, April 23, 1997), and the December 
1, 1995 ``Principles for Development of Project XL Final Project 
Agreements'' document. For further discussion as to how the New England 
University Laboratories XL project addresses the XL criteria, readers 
should refer to the Final Project Agreement and fact sheet that are 
available from the docket for this action (see ADDRESSES section of 
today's preamble) and the Federal Register notice publishing the 
proposed rule (64 FR 40696, July 27, 1999).
    Project XL is intended to allow the EPA to experiment with untried, 
potentially promising regulatory approaches, both to assess whether 
they provide benefits at the specific facility affected, and whether 
they should be considered for wider application. Such pilot projects 
allow the EPA to proceed more quickly than would be possible when 
undertaking changes on a nationwide basis. EPA may modify rules, on a 
site- or state-specific basis, that represent one of several possible 
policy approaches within a more general statutory directive, so long as 
the alternative being used is permissible under the statute. Adoption 
of such alternative approaches or interpretations in the context of a 
given XL project does not, however, signal EPA's willingness to adopt 
that interpretation as a general matter, or even in the context of 
other XL projects. It would be inconsistent with the forward-looking 
nature of these pilot projects to adopt such innovative approaches 
prematurely on a widespread basis without first determining whether or 
not they are viable in practice and successful for the particular 
projects that embody them. Furthermore, as EPA indicated in announcing 
the XL program, it expects to adopt only a limited number of carefully 
selected projects. These pilot projects are not intended to be a means 
for piecemeal revision of entire programs. Depending on the results in 
these projects, EPA may or may not be willing to consider adopting the 
alternative approach or interpretation again, either generally or for 
other specific facilities.
    EPA believes that adopting alternative policy approaches and/or 
interpretations, on a limited, site- or state-specific basis and in 
connection with a carefully selected pilot project, is consistent with 
the expectations of Congress about EPA's role in implementing the 
environmental statutes (so long as EPA acts within the discretion 
allowed by the statute). Congress' recognition that there is a need for 
experimentation and research, as well as ongoing reevaluation of 
environmental programs, is reflected in a variety of statutory 
provisions, e.g., section 8001 of RCRA.

B. Overview of the New England University Laboratories XL Project

1. Introduction
    On July 27, 1999, the Environmental Protection Agency proposed a 
rule to implement a Project XL that would provide regulatory 
flexibility under the Resource Conservation and Recovery Act (RCRA) for 
the participating laboratories at the University of Massachusetts-
Boston, Boston, MA, Boston College, Chestnut Hill, MA and the 
University of Vermont, Burlington, VT (the Universities). Specifically, 
the Agency proposed to allow participating laboratories at the 
Universities to replace existing requirements for hazardous waste 
generators with a comprehensive Environmental Management Standard that 
would identify a plan for the effective management of laboratory wastes 
and the minimum performance requirements for handling such waste in a 
laboratory (64 FR 40696). Today's final rule promulgates regulations 
that are very similar to the July 27, 1999 proposal. Readers of this 
notice are encouraged to refer to the July 27, 1999 (64 FR 40696) 
notice for a more detailed description of the problems today's rule is 
intended to address and a more detailed explanation of how the Agency 
expects the Environmental Management Standard to work.
    Today's rule will facilitate implementation of the FPA (the 
document that embodies EPA's intent to implement this project) that has 
been developed by EPA, Massachusetts Department of Environmental 
Protection (MADEP), Vermont Department of Environmental Conservation 
(VTDEC), the Universities, and other stakeholders. EPA, MADEP, VTDEC 
and the Universities are scheduled to sign the final FPA on September 
28, 1999. The FPA is available for review in the docket for today's 
action and on the world wide web at http://www.epa.gov/ProjectXL. The 
FPA addresses the eight Project XL criteria, and the expectation of EPA 
that this XL project will meet those criteria. Those criteria are: (1) 
Environmental performance superior to what would be achieved through 
compliance with current and reasonably anticipated future regulations; 
(2) cost savings or economic opportunity, and/or decreased paperwork 
burden; (3) stakeholder support; (4) test of innovative strategies for 
achieving environmental results; (5) approaches that could be evaluated 
for future broader application; (6) technical and administrative 
feasibility; (7) mechanisms for monitoring, reporting, and evaluation; 
and (8) consistency with Executive Order 12898 on Environmental Justice 
(avoidance of shifting of risk burden). The FPA specifically addresses 
the manner in which the project is expected to produce superior 
environmental benefits.
    EPA is promulgating today's rule to implement the provisions of 
this Project XL initiative that require regulatory changes. However, as 
discussed in Section IV.F. below, both Massachusetts and Vermont have 
received authority to administer hazardous waste standards for 
generators that are equivalent to, or more stringent than, the federal 
program. Therefore, the requirements outlined in today's rule will not 
take effect in these States until each State adopts equivalent 
requirements as State law, and EPA will not be the primary regulatory 
agency responsible for implementing the requirements of this rule. 
Although today's rule references ``EPA,'' for Massachusetts, ``MADEP'', 
and for Vermont, ``VTDEC'' will be substituted for ``EPA'' when the 
States adopt these requirements as State law. For this reason, this 
preamble discussion will use the term ``regulatory agency'' when 
referring to the ``EPA'' responsibilities identified in today's

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rule. In addition, for the sake of simplicity, the remainder of this 
preamble refers to the effects of this rule, although it will be the 
corresponding State law change that will actually govern this XL 
project.
2. Description of the New England University Laboratories XL Project
    Integrated Performance-Based System.
    The University Laboratory XL project tests the effectiveness of an 
integrated, flexible, performance-based system for managing hazardous 
wastes in laboratories which (1) results in pollution prevention and 
streamlined procedures for managing hazardous wastes and hazardous 
chemicals at universities, (2) meets the objectives of both the RCRA 
and OSHA regulatory programs combined and (3) is at least as protective 
of human health and the environment as the current system.
    This project pilots an alternative approach to hazardous waste 
management in university laboratories which is more systematic and more 
centralized than the approach implemented by universities under the 
current system. At the same time, the pilot integrates some of the 
current RCRA hazardous waste regulations with current Occupational 
Safety and Health Act (OSHA) regulations by requiring that the 
Universities develop a plan similar to the OSHA required Chemical 
Hygiene Plan (CHP). The plan required by the alternative system 
outlined in this site-specific final rule is to be designed for the 
management of environmental aspects of their activities to facilitate 
the creation of an integrated and consistent system for managing 
laboratory waste in laboratories. As a result of the efficiencies 
gained from the harmonization of the OSHA CHP and the RCRA-oriented 
Laboratory Environmental Management Plan, the new system is expected to 
provide a better management approach for laboratories and to result in 
increased pollution prevention while still ensuring protection of human 
health and the environment.
    To achieve this objective, the Universities will follow the 
regulatory model of a Laboratory Environmental Management Standard 
(EMS) that identifies both the elements for the effective management of 
laboratory wastes, and the minimum performance requirements for 
handling wastes in each individual laboratory. The Laboratory EMS sets 
out all the requirements for the alternative system of managing 
laboratory waste. First and foremost, the Laboratory EMS includes 
Minimum Performance Criteria for the management of laboratory wastes 
within the laboratory and en route to the on-site hazardous waste 
accumulation area. These criteria are similar to the requirements of 40 
CFR 262.34(c). The Minimum Performance Criteria are a set of measurable 
requirements that are similar to the current RCRA requirements. Each of 
the elements of the Minimum Performance Criteria is briefly explained 
below. In addition, the Laboratory EMS also requires the development of 
a Laboratory Environmental Management Plan (EMP). The EMP is written by 
each University to document its specific procedures for how it will 
conform with the Laboratory EMS. The EMP describes the procedures each 
laboratory must follow in order to meet the Minimum Performance 
Criteria.
    Laboratory Environmental Management Standard (EMS). Today's final 
rule creates a new subpart to 40 CFR part 262, Subpart J, called the 
``Laboratory Environmental Management Standard.'' It includes a 
definition section (40 CFR 262.102) that sets out the definitions 
applicable to the requirements in the new Subpart J, the requirements 
for waste management in the laboratory, or the Minimum Performance 
Criteria, (40 CFR 262.104) and the specific requirement that each 
University develop a Laboratory Environmental Management Plan (40 CFR 
262.105). Subpart J also contains requirements detailing the 
organizational responsibilities and the training requirements of each 
participating University laboratory (40 CFR 262.105). The Laboratory 
EMS provides the umbrella framework for an effective system for the 
management of university laboratory waste. It contains all the 
elements, from definitions through waste determination requirements (40 
CFR 262.106), that make up the new systematic approach for the 
University laboratories. The Laboratory EMS was originally modeled 
after the general structure and format of the OSHA ``Occupational 
Exposure to Hazardous Chemicals in Laboratories'' standard which 
requires a Chemical Hygiene Plan.
    Laboratory Environmental Management Plan (EMP). The Laboratory EMS 
requires the development of a Laboratory EMP which is the mechanism 
through which each University's EMS is put into practice at each 
University. The Laboratory EMP, modeled on OSHA's Chemical Hygiene 
Plan, is a comprehensive plan to be developed by each University. The 
EMP documents the procedures, practices and programs to (a) manage 
laboratory waste in a manner that is protective of human health and the 
environment and (b) ensure implementation to achieve compliance with 
the requirements of the Laboratory EMS and the Minimum Performance 
Criteria. It is through the Laboratory EMP that the Universities have 
the opportunity and the obligation to design a performance-based system 
to complement the OSHA requirements, to encourage waste minimization, 
and the redistribution and reuse of laboratory waste. The Laboratory 
EMP identifies specific elements to be implemented by each University, 
including requirements for pollution prevention policies and 
procedures.
    One of the objectives of the EMP and the overall XL project is to 
erase the distinction between unused chemicals and waste chemicals in 
the laboratory setting, so that the value in reusing chemicals can be 
realized. This is to be accomplished by defining laboratory waste to 
include hazardous chemicals that result from laboratory scale 
activities and which may or may not constitute RCRA hazardous wastes. 
In the rule, laboratory waste is defined as ``a hazardous chemical that 
results from laboratory scale activities and includes the following: 
excess or unused hazardous chemicals that may or may not be reused 
outside their laboratory of origin; hazardous chemicals determined to 
be RCRA hazardous waste as defined in 40 CFR Part 261; and hazardous 
chemicals that will be determined not to be RCRA hazardous waste 
pursuant to 40 CFR 262.106.'' Thus, all ``laboratory waste'' is managed 
under a single standard while in the laboratory. The determination that 
a laboratory waste could not be reused and would be a RCRA solid waste, 
and as to whether such solid waste would be a RCRA hazardous waste, 
will be made at a centralized area, by Environmental Health and Safety 
professionals.
    Minimum Performance Criteria. The requirements for the laboratory 
EMP include a requirement that the EMP include procedures to assure 
compliance with Minimum Performance Criteria (MPC) specified in the 
regulation. The Minimum Performance Criteria set forth minimum 
requirements for the management of laboratory waste and have been 
designed to ensure that laboratory waste will be managed in a manner 
protective of human health and the environment. The requirements in the 
Minimum Performance Criteria include provisions which are consistent 
with current RCRA requirements, including labeling and container 
management. The criteria have a wider application than current RCRA 
requirements because the definition of

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laboratory waste includes some materials that are not RCRA hazardous 
waste.
    The New System. Currently, there are two potential impediments to 
the centralization and coordination facilitated by this rule. The first 
is the hazardous waste determination requirement under 40 CFR 262.11. 
If this determination is made in the individual laboratory, decisions 
with regard to reuse are inevitably decentralized since the hazardous 
waste determination necessitates a prior solid waste determination. To 
the extent that these decisions are made by laboratory workers who do 
not have a complete sense of the chemical needs of the entire 
university, such decisions are often premature and do not maximize the 
potential for re-use. The second potential impediment under the current 
system is the requirement under 40 CFR 262.34(c) that hazardous waste 
in excess of 55-gallons be removed within three days of reaching the 
55-gallon limit. Such a time constraint results in constant, unplanned, 
episodic pick-ups which are in themselves, time-consuming. In contrast, 
the extended time period of 30 days allows for a more coordinated and 
efficient pick-up and delivery system which frees up staff time, and 
allows for the development of infrastructure and training designed to 
increase waste minimization and an organized and coordinated campus-
wide chemical reuse system.
3. What Are the Environmental Benefits of the Project?
    This Laboratory XL project is expected to achieve superior 
environmental performance beyond that which is achieved by the current 
RCRA regulatory system, in the three key areas of:
     Setting of Environmental Objectives and Targets and 
Pollution Prevention: The systematic approach to environmental 
management will set the stage for better tracking, control, goal 
setting and pollution prevention.
     Streamlining the Regulatory Process: By coordinating RCRA 
and OSHA regulatory compliance, the project will streamline the overall 
regulatory process for University laboratories.
     Environmental Awareness. The implementation and continuous 
improvement of the Laboratory EMS will enhance environmental awareness 
among laboratory workers.
    These three areas are described more fully below:
    In the setting of environmental objectives and targets and 
pollution prevention, this XL project in the requirements for the 
Laboratory Environmental Management Plan, is a significant improvement 
in that it makes explicit to the research community that there is an 
institutional commitment in the form of a policy to prevent pollution, 
a procedure for conducting an annual survey of hazardous chemicals of 
concern and a better system to reduce the potential for hazardous 
chemicals to accumulate on laboratory shelves and become wastes. Each 
XL Participant's Laboratory Environmental Management Plan must include 
or reference:
     A pollution prevention plan.
     Defined procedures for conducting an annual survey of 
laboratories that potentially store hazardous chemicals of concern 
(``HCOC'').
     Defined procedures for conducting laboratory 
decommissionings (e.g., cleanouts).
     Defined procedures for the timely removal of laboratory 
wastes from the laboratory.
    To increase reuse of laboratory waste and laboratory waste 
reduction: The current regulatory framework does little to encourage 
researchers to identify hazardous chemicals on the shelf as hazardous 
waste or to identify institutional opportunities for reuse of such 
chemicals. One targeted area for the demonstration of superior 
environmental performance will be enhanced management and reuse of 
laboratory hazardous chemicals. For example, chemicals that are no 
longer of sufficient purity for research use may be reused or recycled 
into teaching laboratories. Additionally, waste reduction will occur as 
a result of better systems to exchange and reuse hazardous chemicals 
throughout each university. According to a 1996 survey of approximately 
100 academic institutions by the Campus, Safety, Health and 
Environmental Management Association, nearly 95% of respondents 
reported that they redistributed or recycled less than 1% of the 
hazardous chemical waste otherwise destined for disposal. This 
Laboratory XL Project commits the Universities to achieve better 
results, with the goals of 10% reduction in waste (from the baseline) 
and 20% increase in reuse or redistribution of chemicals from measured 
baseline.
    In addition, the EMP includes a requirement that each University 
define a list of ``hazardous chemicals of concern'' (``HCOC'') and 
annually conduct a risk evaluation survey of these chemicals in the 
laboratory. This list will be generated by EHS professionals at each 
University based on regulatory concerns, risk concerns and potential 
chemical reactions. The criteria at each University includes:
     Chemicals given an expiration date by the manufacturer due 
to safety considerations (e.g., peroxide forming chemicals, etc.).
     Chemicals which meet the RCRA definitions of reactive or 
corrosive (flammables are covered by fire department restrictions; in 
general, toxics are hazardous during their use, not during storage) and 
have been determined by professional judgment to present a risk to non-
lab workers or the environment.
     Poison Inhalation Hazard designation by DOT (covers 
serious toxics).
     Other chemicals as determined by professional judgment to 
present a risk to non-lab workers or the environment.
     Chemicals may be removed from the HCOC list if there are 
insufficient quantities to pose a risk.
    The HCOC list will be developed on a university-by-university 
basis, because the types of hazardous chemicals at a particular 
university will vary with the type of research work performed there. 
This list will be reviewed on an annual basis and updated.
    The annual survey directly addresses the problems associated with 
the accumulation of old hazardous chemicals on the shelf. Federal EPA 
and state inspectors have indicated that this problem is a priority 
concern. This University Laboratory XL Project goes beyond the 
``waste'' management regulations prescribed in RCRA by addressing this 
particular ``upstream'' issue at its source. By providing regular and 
consistent data on chemicals and chemical storage, such surveys will 
support university-wide chemical redistribution and/or the timely 
disposal of hazardous chemicals that are approaching or have exceeded 
their shelf life. The survey will also document that HCOC's that remain 
on the shelf have been assessed for product integrity.
    In addition, evaluations and audits will be performed to help 
assure conformance with the University's EMP. Together with the 
enhanced environmental awareness training, internal audits/corrective 
actions will provide a way to continually improve the Laboratory EMS 
and help achieve improved environmental protection.
    Another focus of this project is to streamline regulatory 
requirements: As demonstrated by the effort to develop the Integrated 
Contingency Plan, Federal agencies have placed high value on 
coordination between regulatory programs. Laboratories in most states 
are already regulated by the

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requirements of OSHA's 29 CFR 1910.1450 (Occupational Exposure to 
Hazardous Chemicals in Laboratories) which requires the development of 
a Chemical Hygiene Plan (CHP) to ensure the health and safety of 
laboratory workers handling hazardous chemicals. In this project, the 
requirement to define and implement laboratory waste management 
policies and procedures will effectively manage laboratory wastes at 
every stage of their handling and disposition, including full 
compliance with current RCRA requirements once laboratory waste is 
received at the on-site hazardous waste accumulation area. The Minimum 
Performance Criteria and the procedures for complying with the minimum 
performance criteria which will be included in each University's 
Laboratory EMP ensure that enforceable safeguards will be in place. 
Moreover, the effect of a hazardous chemical survey and other 
procedures defined in the Laboratory EMP will be to minimize hazardous 
waste by shifting the focus to upstream sources of waste. The result 
will be performance that will exceed that prompted by the current RCRA 
program requirements as the focus of the university environmental 
departments can broaden from the current narrow focus on the issues 
associated with waste pick-up and handling to include pollution 
prevention and the attendant issues of chemical substitution and reuse.
    Environmental benefits will also result from increased 
environmental awareness: Training, defined policies and procedures, 
enhanced audit programs and pollution prevention strategies are key 
management elements leading to superior environmental performance. 
Under the current system, these elements often receive less attention 
than they should because EH&S staff are focused on less pro-active 
issues such as managing laboratories as satellite accumulation areas. 
By allowing the institutional EH&S staff to schedule routine pick-ups 
of laboratory wastes at more suitable intervals (e.g., 3-4 weeks rather 
than 3-days under the satellite accumulation rule, but limiting the 
satellite accumulation to a maximum quantity of 55 gallons per 
laboratory, plus an ``excess'' of 55 gallons), the XL Participants will 
be able to more pro-actively focus limited resources on training and 
audit/corrective action programs and the establishment and 
administration of waste-exchange and hazardous chemical redistribution 
programs.
    Under this project, laboratory workers will receive enhanced 
hazardous chemical training with respect to laboratory waste, pollution 
prevention and the environmental management practices at the 
university. The training requirements are outlined in the Environmental 
Management Standard (40 CFR part 262, Subpart J). The training will 
also result in benefits for students who were laboratory workers as 
they graduate and pursue their careers equipped with an increased 
environmental awareness and respect for the environmental aspects of 
their jobs.
4. What Are the Economic Benefits and Paperwork Reduction Deriving From 
the Project?
    Laboratory waste management currently accounts for the most 
substantial expense for environmental, health and safety programs at 
the XL Participants. This University Laboratory XL Project will allow 
academic institutions to more effectively promote and implement waste 
minimization programs in laboratories. This will result in reduced 
waste disposal costs and reduced chemical purchasing costs without 
diminishing the level of environmental protection associated with the 
proper handling and/or disposal of hazardous laboratory wastes. The 
opportunity to develop a systematic, planned procedure for the pickup, 
consolidation and disposal of laboratory wastes will also enable 
participating institutions to more effectively utilize their EH&S staff 
for proactive activities. However, since existing RCRA record keeping 
and reporting requirements will remain in full effect at the 
institutional level, the XL Participants do not expect to significantly 
reduce the paperwork associated with compliance.
5. Stakeholder Involvement
    MADEP, VTDEC and EPA have been involved in the development of this 
project, and support it. From the beginning of the Laboratory XL 
process, there has been a high priority on having diverse stakeholders 
review and support this project so that both national and local 
stakeholders have been involved in the development of the Laboratory 
Environmental Management Standard. This activity is described below and 
additional information, such as a listing of national stakeholders and 
letters of support are included in the docket supporting this 
rulemaking.
    The initial stakeholder group was a national assembly of experts in 
laboratory chemical and environmental safety. The purpose of this group 
was twofold: (a) to assure that the University Laboratory XL Proposal 
reflected state of the art thinking with regard to controlling the 
potential impacts of laboratory chemicals; and (b) to ensure that the 
Laboratory Environmental Management Standard developed by the XL 
Participants could reasonably apply to a broad spectrum of small, 
medium and large institutions.
    In addition to the stakeholder group, XL Participants made 
presentations and gave workshops at the Campus Safety, Health and 
Environmental Management Association meeting in New Orleans in July, 
1998, sponsored a panel of presentations at the American Chemical 
Society meeting in Boston in August, 1998, gave a presentation at the 
EPA-New England sponsored workshop on compliance at universities March 
24, 1999, and continue to speak to national forums and workshops in 
order to reach national stakeholders on a continuing basis.
6. What Is the Project Duration and Completion Date?
    As with all XL projects testing alternative environmental 
protection strategies, the term of the New England University 
Laboratories XL project is one of limited duration. The duration of the 
regulatory relief provided by this rule is anticipated to be four (4) 
years from the effective date of this rule. However, a participating 
University may be terminated or suspended at any time for failure to 
comply with any of the requirements of the rule.

C. Rule Description

1. Summary of Rule
    The rule amends 40 CFR 262.10 to add a paragraph (j) that states 
that the participating University laboratories are not subject to the 
requirements of 40 CFR 262.11 and 40 CFR 262.34(c) as long as the 
Universities comply with all the requirements of 40 CFR part 262, 
Subpart J. This rule also adds a new section to the Standards 
Applicable to Generators of Hazardous Waste, 40 CFR part 262, Subpart 
J. Section 262.100 of the rule specifies which organizations are 
covered by this site-specific rule (University of Massachusetts Boston, 
Boston MA, the Boston College, Chestnut Hill MA and the University of 
Vermont, Burlington VT). Section 262.101 outlines what is in Subpart J. 
Subpart J provides a framework for a new management system for wastes 
that are generated in university laboratories. This framework is called 
the Laboratory Environmental Management Standard. The standard includes 
some specific definitions that apply to the University laboratories, 
specific requirements for how to handle laboratory waste, and

[[Page 52385]]

requirements for developing and implementing an environmental 
management plan. Subpart J outlines the responsibilities of the 
management staff of each participating university and identifies 
requirements for training people who will work in the laboratories or 
manage laboratory waste. Section 262.102 of the rule defines terms used 
in the new rule. The definition of laboratory waste is of particular 
interest because of its importance in the implementation of the 
regulation. Section 262.103 defines the scope of the rule and makes it 
clear that the Laboratory Environmental Management Standard does not 
affect or supercede any legal requirements other than those described 
in Sec. 262.10(j). Section 262.104 includes the requirements that a 
University and participating laboratory will comply with in order to 
continue to participate in this project, called the Minimum Performance 
Criteria. Section 262.105 specifies the requirements for the laboratory 
environmental management plan (EMP). Section 262.106 specifies when a 
hazardous waste determination must be made for laboratory waste.
    Section 262.107 includes a termination provision, in addition to 
EPA's usual enforcement options 1, which authorizes EPA to 
remove from this XL project any University that does not comply with 
the Laboratory Environmental Management Standard as described in the 
rule. In the event of such removal, the temporary conditional deferral 
would be revoked and the Universities would be required to submit to 
EPA an implementation schedule setting forth how the Universities would 
plan to come into full compliance regulations within 90 days from such 
notice. The schedule would reflect the Universities' intent to use 
their best efforts to come into compliance as quickly as practicable 
within the 90 day transition period. During this 90 day transition 
period, the provisions of this proposed rule and the University's 
Environmental Management Plan would apply in full. At the conclusion of 
the 90 day period, the applicable RCRA regulations would again apply to 
the Universities in full. For further discussion, see the preamble to 
the proposed rule and the Final Project Agreement.
---------------------------------------------------------------------------

    \1\ As noted in the proposed rule (64 FR 40696) EPA retains its 
full range of enforcement options under today's rule. The 
enforcement response on the part of EPA will vary depending upon the 
actual performance of each University and the severity of any 
violation. So that EPA can continue to evaluate this XL project, 
each University will be evaluated by EPA Region I through regular 
state and/or federal inspections based on four criteria outlined in 
both the preamble to the proposed rule and the Final Project 
Agreement.
---------------------------------------------------------------------------

    The final paragraph of the rule, section 262.108, sets forth the 
expiration date of the rule, September 30, 2003.
2. Changes to the Proposed Rule
    EPA has made several changes to the proposed rule in response to 
comments. First, EPA has modified the rule in response to comments on 
the training requirements at 40 CFR 262.105(d). As proposed, 
Sec. 262.105(d) required each participating university, in general, to 
``provide laboratory workers with information and training so that they 
can understand and can implement the elements of each University's 
Environmental Management Plan that are relevant to the laboratory 
worker's responsibilities.'' Similarly, Sec. 262.104(j) required that 
each university must ``provide laboratory workers with information and 
training so that they can implement and comply with [the] Minimum 
Performance Criteria.'' One commenter was concerned that these 
requirements did not recognize that a laboratory worker may receive 
training outside of the University and that the University should not 
have to provide (nor should the lab worker have to receive) training 
which is merely duplicative. EPA agrees with this commenter that, as 
proposed, these requirements may lead to duplicative training. As 
discussed at proposal, the goal of these training requirements is for 
the University to ensure that all laboratory workers have been trained 
to understand the hazards of laboratory waste and to take measures to 
protect human health and the environment. EPA did not intend to 
preclude appropriate reliance on any relevant training received from 
outside the University. Thus, EPA is modifying Secs. 262.104(j) and 
262.105(d) to require that the participating Universities must 
``ensure'' that laboratory workers have received training regarding the 
minimum performance criteria and the EMP. This change clarifies that 
the participating Universities have the flexibility to consider whether 
a laboratory worker has received sufficient training outside the 
University. For example, if a newly assigned laboratory worker has 
already had other training that enables him/her to implement and comply 
with the MPC, the training that the University will have to provide may 
be minimized for that worker.
    Also regarding training, another commenter pointed out that, with 
respect to Sec. 262.105(d)(2), the requirement that laboratory workers 
must be trained when they are first assigned to a work area is more 
stringent than under current RCRA requirements, and large universities 
may find it difficult to provide training upon first assignment to a 
work area especially at the beginning of an academic year. EPA agrees 
that this may be a difficult standard to meet for the Universities. As 
discussed above, the main purpose of the university training 
requirements was to ensure that all laboratory workers would be trained 
irrespective of their particular status (e.g., ``student,'' 
``employee'') within the laboratory. EPA's intent was not that 
particular training requirements would be more stringent than required 
under current RCRA requirements. EPA believes it is appropriate to 
allow the participating Universities the same flexibility regarding 
when a newly assigned lab worker will have to be trained as they would 
have under current RCRA requirements. Thus, EPA has modified 
Sec. 262.105(d)(2) to read: ``(i) Each University must provide the 
information to each laboratory worker when he/she is first assigned to 
a work area where laboratory wastes may be generated. (ii) Each 
University must ensure that each laboratory worker has been trained 
within six months of when he/she is first assigned to a work area where 
laboratory wastes may be generated and must retrain a laboratory worker 
when a laboratory waste poses a new or unique hazard for which the 
laboratory worker has not received prior training and as frequently as 
needed to maintain knowledge of the procedures of the Environmental 
Management Plan.''
    Second, EPA has slightly modified the container labeling 
requirements. As proposed, Sec. 262.104(a) required that all laboratory 
waste be labeled with ``the chemical name and general hazard class.'' 
One commenter was concerned that this requirement did not allow enough 
discretion for the Universities, while another commenter expressed 
concern that this requirement did nothing to clarify the confusion 
resulting from current RCRA labeling requirements. The container 
labeling requirements included in the proposed rule were part of the 
University participants' proposal to the Agency. In particular, the 
participants included both the ``hazard class'' and the chemical 
contents on the label as an attempt to integrate OSHA and RCRA by 
including information relevant under both programs. This is an aspect 
of the project that EPA will be evaluating to determine how it compares 
to current requirements. EPA did not intend, however, that laboratories 
should have less flexibility in how they identify

[[Page 52386]]

chemical contents. EPA's intent in modifying the existing RCRA 
container labeling requirements was simply to replace the term 
``hazardous waste'' because not all laboratory waste will necessarily 
be ``hazardous waste.'' Thus, EPA has modified Sec. 262.104(a) to 
require that laboratory waste containers be labeled ``with the general 
hazard class and either the words ``laboratory waste'' or with the 
chemical name of the contents.'' This requirement operates in 
conjunction with the Environmental Management Plan (EMP) that each 
University must develop. Section 262.105(b) requires each University to 
write, implement and comply with an Environmental Management Plan that 
includes the following specific requirement to address container 
labeling in subparagraph (9) of that section: ``The criteria that 
laboratory workers must comply with for managing, containing and 
labeling laboratory wastes * * *'' Therefore, each University must 
designate the system for identifying the hazard class (for example, if 
the system that would work best were RCRA, it would utilize the terms 
ignitible, corrosive, reactive or EP toxic; if an OSHA-type system 
worked better for a university, it would include flammable rather than 
ignitible, and would probably include radioactive and biohazard or 
infectious classes of waste). The chemical name must either include the 
actual name of the chemical in the container or identify it as 
``laboratory waste.'' EPA expects this requirement to be less confusing 
than current requirements and, when combined with requirements in the 
EMP (see 40 CFR 262.105(b)(9)), we expect participants to be able to 
develop labeling protocols that will provide sufficient information to 
characterize the contents of containers containing laboratory waste.
    Finally, one commenter pointed out that the rule, as proposed, 
would preclude a university from sending laboratory waste directly to a 
treatment, storage, or disposal (TSD) facility rather than first 
sending it to the hazardous waste accumulation area. The commenter felt 
that such an option may be necessary in unusual circumstances. EPA 
agrees that there may be unusual circumstances when a university would 
need the flexibility to transfer laboratory wastes from a laboratory 
directly to a permitted TSD facility, for example, if a laboratory 
generated a reactive waste where the most protective management of the 
waste might include minimizing the movement of the waste. Rather than 
moving the waste to the on-site hazardous waste accumulation area, the 
University might feel that it is more prudent to ship it directly to 
the TSD. Therefore EPA has modified Sec. 262.104(i) and other relevant 
provisions in the rule to clarify that laboratory waste may also be 
sent to a TSD facility permitted to handle the waste under 40 CFR part 
270 or in interim status under 40 CFR parts 265 and 270 (or authorized 
to handle the waste by a state with a hazardous waste management 
program approved under 40 CFR part 271) if it is determined in the 
laboratory by the individuals identified in the EMP to be responsible 
for waste management decisions that the waste is a hazardous waste and 
that it is prudent to transfer it directly to a treatment, storage, and 
disposal facility.
    Laboratory waste that will be sent directly to a TSD facility 
rather than to a hazardous waste accumulation area is still subject to 
the 30-day limit (Sec. 262.104(c)), and therefore, solid and hazardous 
waste determinations must be made in the laboratory by the appropriate 
personnel prior to the 30-day deadline for removing the waste from the 
laboratory. Whether sent to a hazardous waste accumulation area or 
directly to a TSD facility, all laboratory waste that is determined to 
be hazardous waste is no longer subject to the provisions of today's 
rule and must be managed in accordance with all applicable RCRA 
requirements (Sec. 262.106(c)). For example, waste sent from the 
laboratory to an off-site TSD facility will have to be accompanied by a 
manifest.

III. Response to Significant Public Comments

    The following presents responses to significant public comments (in 
addition to those comments already discussed at Section C.2.) received 
during the public comment period. For EPA's responses to all the 
comments received during the public comment period regarding the 
proposal see the ADDRESSES section of this preamble to determine where 
you can obtain a copy, or follow the links to this project on EPA's 
world wide web Project XL website at http:/www.epa.gov/ProjectXL.
    EPA received 9 comment letters during the public comment period 
from: the California State University, Los Angeles Department of 
Chemistry and Biochemistry, the University of Wisconsin-Madison 
(Assistant Vice Chancellor), the American Chemical Society, Boston 
University, the Howard Hughes Medical Institute, Cynthia Salisbury, the 
American Council on Education, the University of Wisconsin System 
Administration--Environmental/Occupational Health & Safety Section, and 
Harvard University.
    (1) Many of the commenters supported EPA's proposed rule and agreed 
that the proposed rule should result in superior environmental 
performance and significant cost savings to universities while being 
protective of human health and the environment but also noted that the 
rulemaking should not be a model for all universities as this may not 
be the best approach at all educational institutions.
    EPA Response: EPA does not consider this XL project to be a model 
for all universities, but rather a pilot designed to test one possible 
approach to the management of hazardous waste within university 
laboratories. One of the purposes of implementing this XL project, as 
with all XL projects, is to assess whether it should be considered for 
wider application. It would be inconsistent with the forward-looking 
nature of these pilot projects to adopt such innovative approaches 
prematurely on a widespread basis without first determining whether or 
not they are viable in practice and successful in the particular 
projects that embody them. Although EPA hopes that today's rule will 
result in a successful innovative new system for universities and other 
research organizations, we recognize that this regulatory approach may 
not be appropriate at all such institutions.
    (2) Several commenters noted that because participating 
Universities may designate only certain departments to participate in 
the project, there would be duplicate systems regulating their 
hazardous waste.
    EPA Response: Although this rule does not pilot a strictly 
performance-based system, nonetheless, each University may design their 
environmental management plan in the way that most suits their 
structure and needs. This includes each University having the option 
not to include all departments operating pursuant to the alternative 
standard's in today's rule. As several of the comment letters noted, 
this could result in two sets of rules being applicable at a single 
institution. EPA would like to stress that it is up to each University 
to decide, based on its own needs, what departments will be 
participating in this XL project. If, for example, certain departments 
determined that the EMP would work well with their Chemical Hygiene 
Plan, while other departments did not want to implement an EMP, then 
two sets of requirements for managing hazardous wastes in the 
laboratories would be applicable at that institution.

[[Page 52387]]

    (3) Several commenters commented on the definition of 
``laboratory,'' indicating that EPA was considering the laboratory 
process unit or laboratory management unit concept and that the 
proposal does not specifically delineate what constitutes a laboratory, 
questioning whether, for example, a photo lab or clinical lab would be 
a laboratory.
    Response: The definition of laboratory, under new Subpart J, is 
``an area within a facility where the laboratory use of hazardous 
chemicals occurs. It is a workplace where relatively small quantities 
of hazardous chemicals are used on a non-production basis. The physical 
extent of individual laboratories within an organization will be 
defined by the Environmental Management Plan. A laboratory may include 
more than a single room if the rooms are in the same building and under 
the common supervision of a laboratory supervisor.'' This definition 
operates in concert with the definition of ``Laboratory Scale'' which 
is defined as ``work with substances in which containers used for 
reactions, transfers and other handling of substances are designed to 
be safely and easily manipulated by one person.'' ``Laboratory Scale'' 
excludes ``those workplaces whose function is to produce commercial 
quantities of chemicals.'' These definitions are another example of how 
this rule parallels the current OSHA Laboratory Standard, as these 
definitions follow the definitions in the OSHA standard.
    Any area on a campus that is designated in the Environmental 
Management Plan as a laboratory and that meets these definitions will 
be considered a laboratory for the purpose of this pilot project. 
However, it would be rare that a typical photographic laboratory would 
meet the criterion of non-production. For example if a university had a 
photographic facility on the campus that processed film for students, 
that would be operating on a production basis and would not be 
considered eligible under this rule. However, EPA understands that 
photographic laboratories may also be laboratory scale and could be 
eligible to participate under this rule, examples would include, labs 
used to support research and teaching, such as a small photo lab 
developing X-rays as part of medical research or a small photo lab 
developing satellite photographs as part of geologic or environmental 
research. Key factors that would limit the participation of a 
laboratory include consideration of the scale of the activities and 
whether they could be viewed as operating as a production process as 
opposed to the varied small-scale activities described in the proposed 
rule for teaching and research. EPA did not intend for this rule to be 
available to production operations. This rule applies to laboratory 
scale activities as defined in the definitions section at 40 CFR 
262.102.
    (4) Several commenters suggested that Sec. 262.105(b)(6) of the 
proposed rule is duplicative since the EMP must include a ``a pollution 
prevention plan, including, but not limited to, roles and 
responsibilities, training, pollution prevention activities, and 
performance evaluation.'' The commenter noted further that an EMP 
should be an integral part of every pollution prevention plan, or visa 
versa and ``generic pollution prevention principles'' should not be 
applied to automatically prevent the use of chemicals essential to 
research or to require the use of less effective substitutes.
    Response: The rule requires each University to write, implement and 
comply with their EMP. Although the EMP must include a pollution 
prevention plan there are many elements that the EMP must include in 
addition to a pollution prevention plan. If a University already has a 
pollution prevention plan in place, this plan can be incorporated into 
or referenced by the EMP. There is no requirement for the plans to 
address or adopt generic solutions. The intent of the regulation is 
simply for each University to individually develop pollution prevention 
methods to ensure waste minimization and to document their intended 
actions or methods. The proposal attempts to recognize the unique 
activities of university laboratories, many of which, as the comment 
notes, are conducting innovative research that may lead to the 
improvement of the quality of life. It is the hope of EPA and the 
project sponsors that this XL project, once implemented and 
operational, will create a system that effectively and efficiently 
supports that research.
    Furthermore, if the existing pollution prevention plan had ``an 
environmental policy, or environmental, health and safety policy, 
signed by the University's senior management, including commitments to 
regulatory compliance, waste minimization, risk reduction and continual 
improvement of the environmental management system'' as required by 
Sec. 262.105(b)(1), then the EMP could simply incorporate the pollution 
prevention plan to meet this requirement. There is no requirement to 
create a new pollution prevention plan and, therefore, the requirement 
is not duplicative. The project envisions that through annual reviews 
and continuous improvement, each university will determine whether 
separate plans or combined plans work best.
    (5) The comment suggests that the proposed rule makes no provision 
for recycling of chemicals between nearby laboratories, which is an 
efficient waste minimization practice that precedes RCRA; everything 
that is waste from a laboratory must go to the central accumulation 
area for evaluation and recycling.
    Response: Centralizing the solid and hazardous waste determination 
is one function that is being piloted with this XL project. The intent 
of the new alternative is to centralize waste re-use decisions within 
the EH&S department, which has knowledge of campus-wide re-use 
opportunities. A participating University may demonstrate that this 
precludes some internal re-use opportunities, and provide documentation 
as part of this pilot. Alternatively, if laboratories are working 
closely together and would like to share used chemicals, the definition 
of ``laboratory'' allows a participating University to define them as a 
single laboratory for the purposes of their Environmental Management 
Plan.
    (6) The comment encourages EPA to make a change in the Minimum 
Performance Criteria with respect to Sec. 262.104--that senior 
management should be granted authority to make changes in performance 
criteria.
    Response: The minimum performance criteria have been developed as 
the minimum set of requirements that EPA believes are necessary to 
protect human health and the environment. Senior management may adopt 
more stringent criteria, as long as such criteria still comply with the 
requirements in today's rule.
    (7) The comment suggests that Sec. 262.104(b) and (d) be changed to 
provide some discretion to exceed the amounts when approved by senior 
management. An example is given that a university may want to describe 
a laboratory to mean all modules under control of a single researcher.
    Response: For the purposes of this pilot, EPA will not be allowing 
additional flexibility in the amount of waste that can be temporarily 
held in a laboratory although EPA agrees that it might be useful to 
gather data on the need for additional flexibility on the amount of 
laboratory waste that can be temporarily held in the laboratory, 
especially in view of the fact that some laboratories may currently 
contain numerous points of generation resulting in limits far beyond 
the 110 gallons

[[Page 52388]]

currently imposed by this proposal. EPA expects the participating 
universities to indicate in their reports whenever such limits result 
in less than optimal implementation of the new rule. The rule currently 
includes the flexibility for the participating universities to identify 
the laboratories in their individual EMPs. In the process of continuous 
improvement and periodic reviews conducted by the universities during 
this project, the configuration of participating laboratories as 
identified in the EMP may be changed. Additionally, the Final Project 
Agreement (FPA) does envision that other participants may come forward 
with new proposals to pilot test these concepts.
    (8) The comment suggests that the ``in-line waste collection'' at 
Sec. 262.104(e)(1) interpretation augment the closed container rule for 
certain repetitive manual operations, under the discretion of senior 
management.
    Response: EPA disagrees that discretion is appropriate in this 
area. EPA believes the requirements in the rule are necessary to 
protect human health and the environment. In the discussions during 
development of the rule, EPA considered the possibility of manual 
operations in terms of ``in-line waste collection'' and concluded that 
under such operations waste would be being added to the container under 
the control of the operator of the process and therefore would fit 
under the requirements as they are written at Sec. 262.104(e): 
``containers of laboratory wastes must be: (1) closed at all times 
except when wastes are being added. . . .'' EPA understands that 
repetitive manual operations such as a pipetting process where a 
researcher takes a supernatant from a beaker and pours it into a waste 
container could be interpreted as ``wastes being added to the 
container.'' EPA was not provided with specific scenarios to describe 
repetitive manual operations where a container would be left open to 
add waste and yet would not meet the requirement that ``containers must 
be closed at all times except when wastes are being added or removed.'' 
Thus, EPA sees no need to augment the closed container rule for manual 
operations where there is an operator of the process present.
    (9) The comment suggests eliminating the inspection requirements at 
Secs. 262.104(e)(4) and 262.105(b)(15) (the latter which specifically 
requires a regular inspection of each laboratory) since such 
requirements do not seem feasible for a large university that has 
thousands of laboratories.
    Response: EPA does not agree that the inspection requirement should 
be removed at Sec. 262.104(e)(4) as it performs an important function. 
Under current RCRA requirements, Sec. 262.34(c) requires satellite 
accumulation containers to be ``at or near any point of generation 
where waste initially accumulates which is under the control of the 
operator of the process generating the waste.'' This requirement helps 
ensure that containers in satellite accumulation areas will be 
naturally subject to inspection. Under today's rule, containers holding 
laboratory waste may not always be (and are not required to be) located 
at an area which is similarly subject to such naturally occurring 
inspections. Thus, EPA believes it is necessary to include a 
requirement that inspections of containers in laboratories be conducted 
on a regular (at least annual) basis to ensure that they meet the 
minimum performance criteria for container management.
    40 CFR 262.105(b)(15) requires the EMP to include, ``the procedures 
for regularly inspecting a laboratory to assess conformance with the 
requirements of the Environmental Management Plan.'' Based on the 
proposal submitted, EPA expects that this is a feasible requirement and 
is not unduly burdensome. (The New Hampshire state RCRA program, for 
example, already has such a requirement in place.) Nonetheless, this 
pilot will test the feasibility of the requirement. In this pilot, each 
University is expected to develop a system that will work within the 
constraints of their campus systems, and to define the personnel to 
perform the inspections and the timetable for these inspections, which 
may vary for each laboratory. For example, one participant currently 
utilizes a ``peer review'' type process for inspecting laboratories 
which has the added advantage of networking and the potential to create 
a system of informal exchange of best practices.
    (10) The comment questions how university laboratories are 
accumulating 55 gallons of hazardous waste at the point of generation 
and whether this is a realistic problem for university laboratories.
    Response: The project embodied in today's rule focuses on the 
approach that the University participants believe to be a common sense, 
cost effective approach for managing laboratory waste. EPA has 
determined that this particular XL project is beneficial to human 
health and the environment and is worth evaluating as an alternative to 
the existing system. The proposed rule was developed in view of current 
Federal RCRA regulations for satellite accumulation areas that require 
that any hazardous waste accumulated at any point of generation in 
excess of 55 gallons (or one quart of acutely hazardous laboratory 
waste) be removed within three days. Current regulations do not limit 
the number of points of generation within an individual laboratory as 
long as hazardous waste is accumulated in accordance with all the 
requirements of 40 CFR 262.34(c). Thus, a given laboratory could 
potentially accumulate well over 55 gallons under the current rules. 
However, under the proposed rule, the Universities would be limited to 
temporarily holding 55 gallons of laboratory waste per laboratory, and 
no matter how many points of generation there are within a laboratory, 
any laboratory would be limited to 110 gallons. EPA noted in the 
preamble to the proposed rule (64 FR 40703) that ``while this proposed 
restriction may prove to be more restrictive than the current system, 
this approach represents an experiment to be tested under this XL 
project.''
    The size of laboratory waste streams varies greatly, and although 
many laboratories do not produce large quantities of waste, there are 
some activities and some laboratories that may generate larger amounts 
on a discontinuous basis, making it difficult to schedule pick-ups.
    (11) The comment addressed the regulatory implications of 
commingling RCRA regulated lab wastes and non-RCRA laboratory wastes 
(e.g., nonhazardous wastes). The comment noted that the commingling of 
RCRA regulated laboratory wastes and non-RCRA laboratory wastes would 
result in the entire mixture being designated a RCRA hazardous waste 
(assuming the laboratory waste is a determined to be a RCRA waste) due 
to the mixture rule (see 40 CFR 261.3(a)(2)), and thus would result in 
an increase in hazardous waste generation. Likewise, the scenario would 
be the same for the commingling of RCRA acutely hazardous wastes (e.g., 
P-listed hazardous wastes) and acutely hazardous laboratory wastes 
(AHLW), only the impact could be more substantial because of the ``1 
kilogram of acute hazardous waste/month'' definition of a Large 
Quantity Generator (LQG). The commenter went further to say that the 
only way to prevent this scenario would be if the laboratory workers 
identify which laboratory wastes are RCRA hazardous wastes and keep 
those wastes segregated from the non-RCRA wastes. The comment concludes 
with the statement that a primary objective of this XL project is to 
take the waste determination out of the

[[Page 52389]]

hands of laboratory workers; however, to efficiently implement the 
proposal, these laboratory workers must continue to make these waste 
determinations (presumably in order to segregate RCRA hazardous wastes 
from non-RCRA wastes). The commenter believes this would have the 
effect of creating ``another layer in the waste determination scheme--
and a layer that will likely result in consternation at the central 
accumulation area.''
    Response: EPA believes the commenter misunderstands the objective 
of this rule. It is not the goal of the XL project to take all waste 
determinations out of the hands of the laboratory workers, but rather 
to centralize the point at which RCRA hazardous waste determinations 
are made within the university such that more effective and informed 
determinations are made with regard to whether the chemicals in 
question are truly wastes that require further management as solid and 
hazardous waste or whether they may be reused within the university 
and, thus, are not wastes.
    While EPA acknowledges that the commenter is correct in that the 
mixture rule does apply and could have the regulatory effect described 
in the comment, the Agency does not believe that the applicability of 
the mixture rule to such commingling scenarios is a regulatory 
impediment. A ``superior environmental benefit'' of this project is to 
encourage and increase the reuse of laboratory wastes. Since the 
commingling of these chemicals (i.e., laboratory wastes) would likely 
result in rendering such chemicals unusable and thus precluding reuse 
opportunities, the Agency believes a regulatory change that would 
encourage such commingling would be counter to the goal of this XL 
project.
    In EPA's experience under this project, laboratories do not 
commonly mingle acutely hazardous and hazardous waste. Additionally, 
under this project, the specific concern of the comment should be 
addressed by two of the requirements of the EMP working together. Under 
the EMP, the laboratories will be required to include (see 
Sec. 262.105(b)(6)) a pollution prevention plan, including, but not 
limited to, roles and responsibilities and training as well as (see 
Sec. 262.105(b)(9)) ``the criteria that laboratory workers must comply 
with for managing, containing and labeling laboratory wastes, 
including: an evaluation of the need for and the use of any special 
containers or labeling circumstances, and the use of laboratory wastes 
secondary containers including packaging, bottles, or test tube 
racks.'' Each EMP must address the labeling and containing of wastes 
and ensure that laboratory workers are trained to implement the EMP 
(see 40 CFR 262.104(j) and 262.105(d)(1)).
    EPA does not agree that today's rule will, in effect, impose a 
second (and complicating) layer of waste determinations. Rather, the 
regulatory modifications being promulgated in today's rule recognize 
that while laboratory workers may have specific knowledge of the 
chemicals in question, they may not have access to information 
pertinent to whether the chemical is also a solid waste under RCRA 
(e.g., information regarding potential reuse of a chemical in another 
part of the university). The Agency also notes that today's rule 
provides the flexibility for specific procedures (including procedures 
regarding the commingling of these materials) to be set by the 
laboratory (e.g., in the environmental management plan (EMP)). To the 
extent that RCRA regulations discourage the commingling of laboratory 
wastes, encourage the segregation of RCRA acutely hazardous wastes (a 
designation that assumes the chemicals are discarded rather than 
reused), and that these regulatory considerations are reflected in the 
EMP or standardized laboratory procedures, EPA considers this a benefit 
of the current regulatory framework.
    (12) The comment questions the need for a deferral of the 
requirements of 40 CFR 262.34(c) within the laboratory because that 
deferral would follow as a direct consequence of deferring the 
Sec. 262.11 hazardous waste determination.
    Response: The deferral of the Sec. 262.11 hazardous waste 
determination does not mean that laboratories are not handling 
hazardous waste; the effect of the ``deferral'' is only to identify 
with precision the point at which these Universities will be held 
responsible for their solid and hazardous waste determinations. For 
this reason, EPA has explicitly deferred those portions of 40 CFR Part 
262 that could otherwise have applied within the laboratory to the 
handling of material that was later determined to be hazardous waste.
    (13) The comment makes the statement that Clean Water Act 
notification may no longer apply to any laboratory waste discharged 
down the drain by participating institutions.
    Response: The proposal specifically addresses releases of hazardous 
constituents as noted at 64 FR 40703-40704 of the preamble: ``Today's 
proposed rule would contain a statement that laboratory waste 
management must not result in the release of hazardous constituents 
into the land, air and water where such release would be prohibited by 
federal law.'' The rule itself includes two provisions to prevent such 
releases, including Sec. 262.103 (the scope of the laboratory 
environmental management standard) and Sec. 262.104(e). The Laboratory 
Environmental Management Standard will not affect or supersede any 
legal requirements other than those described in Sec. 262.10(j). The 
requirements that continue to apply include, but are not limited to, 
OSHA, Fire Codes, wastewater permit limitations, emergency response 
notification provisions, and other legal requirements applicable to 
University laboratories. Also, the rule states at Sec. 262.104(f) ``the 
management of laboratory waste must not result in the release of 
hazardous constituents into the land, air and water where such release 
is prohibited under federal law.'' Additionally, with respect to 
regulations concerning POTW's, local limits as specified under 40 CFR 
403.5 would continue to apply.
    (14) The comment expresses concern over the scope of wastes covered 
under the definition of ``laboratory wastes'' in the rule and questions 
how the definition applies to such waste products as broken labware, 
towels, bench coverings, gels and protective equipment that have come 
into contact with chemicals.
    Response: Today's rule requires that the EMP include (see 
Sec. 262.105(b)(9)) ``the criteria laboratory workers must comply with 
for managing, containing and labeling laboratory wastes, including: an 
evaluation of the need for and the use of any special containers or 
labeling circumstances.'' The EMP must identify how such waste products 
as broken labware, towels, bench coverings, gels and protective 
equipment that have come into contact with chemicals would be managed, 
contained and labeled when they are appropriately considered to be 
laboratory waste. The determination of the status of such material will 
depend on the characterization of the waste. This is no different than 
current RCRA requirements. As noted in response to a previous comment, 
it is not the goal of the XL project to take all waste determinations 
out of the hands of the laboratory workers, but rather to centralize 
the point at which RCRA hazardous waste determinations are made within 
the University such that more effective and informed determinations are 
made with regard to whether the chemicals in question are truly wastes 
that require further

[[Page 52390]]

management as solid and/or hazardous waste.
    (15) The comment notes that Sec. 262.106 requires a hazardous waste 
determination ``as soon as the laboratory waste reaches the 
University's Hazardous Waste Accumulation Area,'' and believes that the 
words ``as soon as'' should be replaced with ``at the first 
opportunity'' to allow waste management personnel adequate time to 
characterize containers when many are received.
    Response: In developing the rule, EPA considered several 
alternatives for this provision. EPA feels that ``at the first 
opportunity'' would be too vague and subject to interpretation of when 
the appropriate ``opportunity'' arose. The intent of the regulation is 
that waste be characterized as soon as it arrives. EPA understands that 
waste characterization is a process, and in some cases that process 
could require that a sample be sent out to confirm the contents of a 
container. EPA also acknowledges that there could, at times, be a large 
number of containers that will take some effort to characterize. The 
intent of the regulation is not to impose an impossible standard, but 
to ensure that the process of characterizing the waste will commence as 
soon as the waste reaches the accumulation area.

IV. What Is the Effective Date of This Rule?

    This rule is effective immediately. Section 3010(b) of RCRA 
generally requires that EPA's hazardous waste regulations and revisions 
thereto take effect within six months after their promulgation. The 
purpose of this requirement is to allow persons handling hazardous 
wastes sufficient lead time to prepare to comply with new regulatory 
requirements. The Hazardous and Solid Waste Amendments of 1984 amended 
section 3010 of RCRA to allow rules to become effective in less than 
six months when the regulated entities do not need the six-month period 
to come into compliance. That is the case here. This rule will not take 
effect in the relevant states unless and until it is adopted as state 
law. In addition, the rule itself does not require immediate 
compliance. Once adopted as state law, its effect will be to exempt 
certain entities from identified RCRA regulations so long as the 
entities comply with the requirements in this rule (i.e., it is up to 
the regulated entities to determine when they want to take advantage of 
the exemption). These reasons also provide a basis for making this rule 
effective immediately, upon publication, under the Administrative 
Procedure Act, pursuant to 5 U.S.C. 553(d).

V. Additional Information

A. How Does This Rule Comply With Executive Order 12866?

    Because this rule affects only three specific universities, it is 
not a rule of general applicability and, therefore, is not subject to 
OMB review and Executive Order 12866. In addition, OMB has agreed that 
review of site-specific rules under Project XL is not necessary.

B. Is a Regulatory Flexibility Analysis Required?

    The Regulatory Flexibility Act (RFA) generally requires an Agency 
to conduct a Regulatory Flexibility analysis of any rule subject to 
notice and comment rulemaking requirements unless the agency certifies 
that the rule will not have a significant economic impact on a 
substantial number of small entities. Small entities include small 
businesses, small not-for-profit enterprises, and small governmental 
jurisdictions. EPA has concluded that this rule will not have a 
significant impact on a substantial number of small entities because it 
affects only three entities: the University of Massachusetts-Boston, 
Boston, Massachusetts, Boston College, Chestnut Hill, Massachusetts, 
and the University of Vermont, Burlington, Vermont. These Universities 
are not small entities. Therefore, EPA certifies that today's rule will 
not have a significant economic impact on a substantial number of small 
entities.

C. Is EPA Required To Submit a Rule Report Under the Congressional 
Review Act?

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and the Comptroller General of the United 
States. Section 804, however, exempts from Section 801 the following 
types of rules: rules of particular applicability, rules relating to 
agency management or personnel, and rules of agency organization, 
procedure, or practice that do not substantially affect the rights or 
obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required 
to submit a rule report regarding today's action under Section 801 
because this is a rule of particular applicability.

D. Is an Information Collection Request Required for This Project Under 
the Paperwork Reduction Act?

    This action applies only to three universities, and therefore 
requires no information collection activities subject to the Paperwork 
Reduction Act, and therefore no information collection request (ICR) 
will be submitted to OMB for review in compliance with the Paperwork 
Reduction Act, 44 U.S.C. 3501, et seq.

E. Does This Project Trigger the Requirements of the Unfunded Mandates 
Reform Act?

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, and tribal 
governments and the private sector. Under section 202 of the UMRA, EPA 
generally must prepare a written statement, including a cost-benefit 
analysis, for proposed and final rules with ``Federal mandates'' that 
may result in expenditures to State, local, and tribal governments, in 
the aggregate, or to the private sector, of $100 million or more in any 
one year. Before promulgating an EPA rule for which a written statement 
is needed, section 205 of the UMRA generally requires EPA to identify 
and consider a reasonable number of regulatory alternatives and adopt 
the least costly, most cost-effective or least burdensome alternative 
that achieves the objectives of the rule. The provisions of section 205 
do not apply when they are inconsistent with applicable law. Moreover, 
section 205 allows EPA to adopt an alternative other than the least 
costly, most cost-effective or least burdensome alternative if the 
Administrator publishes with the final rule an explanation of why that 
alternative was not adopted. Before EPA establishes any regulatory 
requirements that may significantly or uniquely affect small 
governments, including tribal governments, it must have developed under 
section 203 of the UMRA a small government agency plan. The plan must 
provide for notifying potentially affected small governments, enabling 
officials of affected small governments to have meaningful and timely 
input in the development of EPA regulatory proposals with significant 
Federal intergovernmental mandates, and informing, educating, and 
advising small governments on compliance with the regulatory 
requirements.
    As noted above, this rule is applicable only to the three 
Universities. The EPA has determined that this rule does not contain a 
Federal mandate that may

[[Page 52391]]

result in expenditures of $100 million or more for State, local, and 
tribal governments, in the aggregate, or the private sector in any one 
year. Thus, today's rule is not subject to the requirements of sections 
202 and 205 of the UMRA. EPA has also determined that this rule 
contains no regulatory requirements that might significantly or 
uniquely affect small governments.

F. RCRA/HSWA

1. Applicability of Rules in Authorized States
    Under section 3006 of RCRA, EPA may authorize qualified States to 
administer and enforce the RCRA program for hazardous waste within the 
State. (See 40 CFR part 271 for the standards and requirements for 
authorization.) States with final authorization administer their own 
hazardous waste programs in lieu of the federal program. Following 
authorization, EPA retains enforcement authority under sections 3008, 
7003 and 3013 of RCRA.
    After authorization, rules written under RCRA provisions that 
predate the Hazardous and Solid Waste Amendments of 1984 (HSWA) no 
longer apply in the authorized State. New Federal requirements imposed 
by those rules do not take effect in an authorized state until the 
state adopts the requirements as state law.
    In contrast, under section 3006(g) of RCRA, new requirements and 
prohibitions imposed by HSWA take effect in authorized States at the 
same time they take effect in nonauthorized States. EPA is directed to 
carry out those requirements and prohibitions in authorized States 
until the state is granted authorization to do so.
2. Effect on Massachusetts and Vermont Authorization
    Today's rule is promulgated pursuant to RCRA provisions that 
predate HSWA. Massachusetts and Vermont have received authority to 
administer most of the RCRA program; thus, authorized provisions of the 
States' hazardous waste program are administered in lieu of the Federal 
program. Massachusetts and Vermont have received authority to 
administer hazardous waste standards for generators. As a result, 
today's rule will not be effective in Massachusetts and Vermont until 
the States adopt equivalent requirements as State law. It is EPA's 
understanding that subsequent to the promulgation of this rule, 
Massachusetts and Vermont intend to propose rules containing equivalent 
provisions. EPA may not enforce these requirements until it approves 
the State requirements as a revision to each of the authorized State 
programs.

G. How Does This Rule Comply With Executive Order 13045: Protection of 
Children From Environmental Health Risks and Safety Risks?

    The Executive Order 13045, ``Protection of Children from 
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 
1997) applies to any rule that (1) is determined to be ``economically 
significant'' as defined under Executive Order 12866, and (2) concerns 
an environmental health or safety risk that EPA has reason to believe 
may have a disproportionate effect on children. If the regulatory 
action meets both criteria, the Agency must evaluate the environmental 
health or safety effects of the planned rule on children and explain 
why the planned regulation is preferable to other potentially effective 
and reasonably feasible alternatives considered by the Agency.
    This rule is not subject to Executive Order 13045 because it is not 
economically significant as defined in Executive Order 12866, and 
because the Agency does not have reason to believe the environmental 
health or safety risks addressed by this action present a 
disproportionate risk to children.

H. How Does This Rule Comply With Executive Orders on Federalism?

    Under Executive Order 12875, EPA may not issue a regulation that is 
not required by statute and that creates a mandate upon a State, local 
or tribal government, unless the Federal government provides the funds 
necessary to pay the direct compliance costs incurred by those 
governments or EPA consults with those governments. If EPA complies by 
consulting, Executive Order 12875 requires EPA to provide to the Office 
of Management and Budget a description of the extent of EPA's prior 
consultation with representatives of affected State, local and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.'' 
Today's rule does not create a mandate on State, local or tribal 
governments. The rule does not impose any enforceable duties on these 
entities. Accordingly, the requirements of section 1(a) of Executive 
Order 12875 do not apply to this rule.
    On August 4, 1999, President Clinton issued a new executive order 
on Federalism, Executive Order 13132 (64 FR 43255 (August 10, 1999)) 
which will take effect on November 2, 1999. In the interim, the current 
Executive Order 12612 (52 FR 41685 (October 30, 1987)) on federalism 
still applies. This rule will not have a substantial direct effect on 
States, on the relationship between the national government and the 
States or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 12612.

I. How Does This Rule Comply With Executive Order 13084: Consultation 
and Coordination With Indian Tribal Governments?

    Under Executive Order 13084, EPA may not issue a regulation that is 
not required by statute, that significantly or uniquely affects the 
communities of Indian tribal governments, and that imposes substantial 
direct compliance costs on those communities, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by the tribal governments or EPA consults with those 
governments. If EPA complies by consulting, Executive Order 13084 
requires EPA to provide to the Office of Management and Budget, in a 
separately identified section of the preamble to the rule, a 
description of the extent of EPA's prior consultation with 
representatives of affected tribal governments, a summary of the nature 
of their concerns, and a statement supporting the need to issue the 
regulation. In addition, Executive Order 13084 requires EPA to develop 
an effective process permitting elected officials and other 
representatives of Indian tribal governments ``to provide meaningful 
and timely input in the development of regulatory policies on matters 
that significantly or uniquely affect their communities.'' Today's rule 
does not significantly or uniquely affect the communities of Indian 
tribal governments. Accordingly, the requirements of section 3(b) of 
Executive Order 13084 do not apply to this rule. There are no 
communities of Indian tribal governments located in the vicinity of the 
University laboratories.

J. Does This Rule Comply With National Technology Transfer and 
Advancement Act?

    As noted in the proposed rule, section 12(d) of the National 
Technology Transfer and Advancement Act of 1995

[[Page 52392]]

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

List of Subjects in 40 CFR Part 262

    Environmental protection, Hazardous waste.

    Dated: September 22, 1999.
Carol M. Browner,
Administrator.

    For the reasons set forth in the preamble, part 262 of title 40, 
chapter I of the Code of Federal Regulations is amended as follows:

PART 262--STANDARDS APPLICABLE TO GENERATORS OF HAZARDOUS WASTE

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

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

Subpart A--General

    2. Section 262.10 is amended by adding paragraph (j) to read as 
follows:


Sec. 262.10  Purpose, scope, and applicability.

* * * * *
    (j) (1) Universities that are participating in the Laboratory XL 
project are the University of Massachusetts Boston in Boston, 
Massachusetts, Boston College in Chestnut Hill, Massachusetts, and the 
University of Vermont in Burlington, Vermont (``Universities''). The 
Universities generate laboratory wastes (as defined in Sec. 262.102), 
some of which will be hazardous wastes. As long as the Universities 
comply with all the requirements of subpart J of this part the 
Universities' laboratories that are participating in the University 
Laboratories XL Project as identified in Table 1 of this section, are 
not subject to the provisions of Secs. 262.11, 262.34(c), 40 CFR Parts 
264 and 265, and the permit requirements of 40 CFR Part 270 with 
respect to said laboratory wastes.

                             Table 1.--Laboratory XL Project Participant Information
----------------------------------------------------------------------------------------------------------------
                                         Approx.
              Institution               number of     Departments participating    Location of current hazardous
                                           labs                                       waste accumulation areas
----------------------------------------------------------------------------------------------------------------
Boston College, Chestnut Hill, MA.....        120  Chemistry, Biology, Geology,    Merkert Chemistry Building,
                                                    Physics, Psychology.            2609 Beacon St., Boston, MA,
                                                                                    Higgins Building, 140
                                                                                    Commonwealth Ave., Chestnut
                                                                                    Hill, MA.
University of Massachusetts Boston,           150  Chemistry, Biology,             Science Building (Bldg.
 Boston, MA.                                        Psychology, Anthropology,       #080); McCormack Building
                                                    Geology and Earth Sciences,     (Bldg. #020); and Wheatley
                                                    and Environmental, Coastal      Building (Bldg. #010), 100
                                                    and Ocean Sciences.             Morrissey Blvd., Boston, MA.
University of Vermont, Burlington, VT.        400  Colleges of: Agriculture and    Given Bunker, 89 Beaumont
                                                    Life Sciences, Arts and         Ave., Burlington, VT.
                                                    Sciences, Medicine, and
                                                    Engineering and Mathematics;
                                                    and Schools of: Nursing,
                                                    Allied Heath Sciences, and
                                                    Natural Resources.
----------------------------------------------------------------------------------------------------------------

    (2) Each University shall have the right to change its respective 
departments or the on-site location of its hazardous waste accumulation 
areas listed in Table 1 of this section upon written notice to the 
Regional Administrator for EPA-Region I and the appropriate state 
agency. Such written notice will be provided at least ten days prior to 
the effective date of any such changes.
    3. Part 262 is amended by adding Subpart J to read as follows:

Subpart J--University Laboratories XL Project--Laboratory Environmental 
Management Standard

Sec.
262.100  To what organizations does this subpart apply?
262.101  What is in this subpart?
262.102  What special definitions are included in this subpart?
262.103  What is the scope of the laboratory environmental 
management standard?
262.104  What are the minimum performance criteria?
262.105  What must be included in the laboratory environmental 
management plan?
262.106  When must a hazardous waste determination be made?
262.107  Under what circumstances will a university's participation 
in this environmental management standard pilot be terminated?
262.108  When will this subpart expire?


Sec. 262.100  To what organizations does this subpart apply?

    This subpart applies to an organization that meets all three of the 
following conditions:
    (a) It is one of the three following academic institutions: The 
University of Massachusetts Boston in Boston, Massachusetts, Boston 
College in Chestnut Hill, Massachusetts, or the University of Vermont 
in Burlington, Vermont (``Universities''); and
    (b) It is a laboratory at one of the Universities (identified 
pursuant to Sec. 262.105(c)(2)(ii)) where laboratory scale activities, 
as defined in Sec. 262.102, result in laboratory waste; and
    (c) It complies with all the requirements of this subpart.


Sec. 262.101  What is in this subpart?

    This subpart provides a framework for a new management system for 
wastes that are generated in University laboratories. This framework is 
called the Laboratory Environmental Management Standard. The standard 
includes some specific definitions that apply to the University 
laboratories. It contains specific requirements for how to handle 
laboratory waste that are called Minimum Performance Criteria. The 
standard identifies the requirements for developing and implementing an 
environmental management plan. It outlines the responsibilities of the 
management staff of each participating university. Finally, the 
standard identifies requirements for training people who will work in 
the

[[Page 52393]]

laboratories or manage laboratory waste. This Subpart contains 
requirements for RCRA solid and hazardous waste determination, and 
circumstances for termination and expiration of this pilot.


Sec. 262.102  What special definitions are included in this subpart?

    For purposes of this subpart, the following definitions apply:
    Acutely Hazardous Laboratory Waste means a laboratory waste, 
defined in the Environmental Management Plan as posing significant 
potential hazards to human health or the environment and which must 
include RCRA ``P'' wastes, and may include particularly hazardous 
substances as designated in a University's Chemical Hygiene Plan under 
OSHA, or Extremely Hazardous Substances under the Emergency Planning 
and Community Right to Know Act.
    Emergency means any occurrence such as, but not limited to, 
equipment failure, rupture of containers or failure of control 
equipment which results in the potential uncontrolled release of a 
hazardous chemical into the environment and which requires agency or 
fire department notification and/or reporting.
    Environmental Management Plan (EMP) means a written program 
developed and implemented by the university which sets forth standards 
and procedures, responsibilities, pollution control equipment, 
performance criteria, resources and work practices that both protect 
human health and the environment from the hazards presented by 
laboratory wastes within a laboratory and between a laboratory and the 
hazardous waste accumulation area, and satisfies the plan requirements 
defined elsewhere in this Subpart. Certain requirements of this plan 
are satisfied through the use of the Chemical Hygiene Plan (see, 29 CFR 
1910.1450), or equivalent, and other relevant plans, including a waste 
minimization plan. The elements of the Environmental Management Plan 
must be easily accessible, but may be integrated into existing plans, 
incorporated as an attachment, or developed as a separate document.
    Environmental Objective means an overall environmental goal of the 
organization which is verifiable.
    Environmental Performance means results of the data collected 
pursuant to implementation of the Environmental Management Plan as 
measured against policy, objectives and targets.
    Environmental Target means an environmental performance requirement 
of the organization which is quantifiable, where practicable, 
verifiable and designed to be achieved within a specified time frame.
    Hazardous Chemical means any chemical which is a physical hazard or 
a health hazard. A physical hazard means a chemical for which there is 
scientifically valid evidence that it is a combustible liquid, a 
compressed gas, explosive, flammable, an organic peroxide, an oxidizer, 
pyrophoric, unstable (reactive) or water-reactive. A health hazard 
means a chemical for which there is statistically significant evidence 
based on at least one study conducted in accordance with established 
scientific principles that acute or chronic health effects may occur in 
exposed employees. The term ``health hazard'' includes chemicals which 
are carcinogens, toxic or highly toxic agents, reproductive toxins, 
irritants, corrosives, sensitizers, hepatotoxins, nephrotoxins, 
neurotoxins, agents which act on the hematopoietic system and agents 
which damage the lungs, skin, eyes or mucous membranes.
    Hazardous Chemical of Concern means a chemical that the 
organization has identified as having the potential to be of 
significant risk to human health or the environment if not managed in 
accordance with procedures or practices defined by the organization.
    Hazardous Waste Accumulation Area means the on-site area at a 
University where the University will make a solid and hazardous waste 
determination with respect to laboratory wastes.
    In-Line Waste Collection means a system for the automatic 
collection of laboratory waste which is directly connected to or part 
of a laboratory scale activity and which is constructed or operated in 
a manner which prevents the release of any laboratory waste therein 
into the environment during collection.
    Laboratory means, for the purpose of this Subpart, an area within a 
facility where the laboratory use of hazardous chemicals occurs. It is 
a workplace where relatively small quantities of hazardous chemicals 
are used on a non-production basis. The physical extent of individual 
laboratories within an organization will be defined by the 
Environmental Management Plan. A laboratory may include more than a 
single room if the rooms are in the same building and under the common 
supervision of a laboratory supervisor.
    Laboratory Clean-Out means an evaluation of the chemical inventory 
of a laboratory as a result of laboratory renovation, relocation or a 
change in laboratory supervision that may result in the transfer of 
laboratory wastes to the hazardous waste accumulation area.
    Laboratory Environmental Management Standard means the provisions 
of this Subpart and includes the requirements for preparation of 
Environmental Management Plans and the inclusion of Minimum Performance 
Criteria within each Environmental Management Plan.
    Laboratory Scale means work with substances in which containers 
used for reactions, transfers and other handling of substances are 
designed to be safely and easily manipulated by one person. 
``Laboratory Scale'' excludes those workplaces whose function is to 
produce commercial quantities of chemicals.
    Laboratory Waste means a hazardous chemical that results from 
laboratory scale activities and includes the following: excess or 
unused hazardous chemicals that may or may not be reused outside their 
laboratory of origin; hazardous chemicals determined to be RCRA 
hazardous waste as defined in 40 CFR Part 261; and hazardous chemicals 
that will be determined not to be RCRA hazardous waste pursuant to 
Sec. 262.106.
    Laboratory Worker means a person who is assigned to handle 
hazardous chemicals in the laboratory and may include researchers, 
students or technicians.
    Legal and Other Requirements means requirements imposed by, or as a 
result of, governmental permits, governmental laws and regulations, 
judicial and administrative enforcement orders, non-governmental 
legally enforceable contracts, research grants and agreements, 
certification specifications, formal voluntary commitments and 
organizational policies and standards.
    Senior Management means senior personnel with overall 
responsibility, authority and accountability for managing laboratory 
activities within the organization.
    Universities means the following academic institutions; University 
of Vermont, Boston College, and the University of Massachusetts Boston, 
which are participants in this Laboratory XL project and which are 
subject to the requirements set forth in this Subpart J.


Sec. 262.103  What is the scope of the laboratory environmental 
management standard?

    The Laboratory Environmental Management Standard will not affect or 
supersede any legal requirements other than those described in 
Sec. 262.10(j). The requirements that continue to apply include, but 
are not limited to, OSHA, Fire Codes, wastewater permit limitations, 
emergency response notification provisions, or other legal

[[Page 52394]]

requirements applicable to University laboratories.


Sec. 262.104  What are the minimum performance criteria?

    The Minimum Performance Criteria that each University must meet in 
managing its Laboratory Waste are:
    (a) Each University must label all laboratory waste with the 
general hazard class and either the words ``laboratory waste'' or with 
the chemical name of the contents. If the container is too small to 
hold a label, the label must be placed on a secondary container.
    (b) Each University may temporarily hold up to 55 gallons of 
laboratory waste or one quart of acutely hazardous laboratory waste, or 
weight equivalent, in each laboratory, but upon reaching these 
thresholds, each University must mark that laboratory waste with the 
date when this threshold requirement was met (by dating the 
container(s) or secondary container(s)).
    (c) Each university must remove all of the dated laboratory waste 
from the laboratory for delivery to a location identified in paragraph 
(i) of this section within 30 days of reaching the threshold amount 
identified in paragraph (b) of this section.
    (d) In no event shall the excess laboratory waste that a laboratory 
temporarily holds before dated laboratory waste is removed exceed an 
additional 55 gallons of laboratory waste (or one additional quart of 
acutely hazardous laboratory waste). No more than 110 gallons of 
laboratory waste total (or no more than two quarts of acutely hazardous 
laboratory waste total) may be temporarily held in a laboratory at any 
one time. Excess laboratory waste must be dated and removed in 
accordance with the requirements of paragraphs (b) and (c) of this 
section.
    (e) Containers of laboratory wastes must be:
    (1) Closed at all times except when wastes are being added to 
(including during in-line waste collection) or removed from the 
container;
    (2) Maintained in good condition and stored in the laboratory in a 
manner to avoid leaks;
    (3) Compatible with their contents to avoid reactions between the 
waste and its container; and must be made of, or lined with, materials 
which are compatible with the laboratory wastes to be temporarily held 
in the laboratory so that the container is not impaired; and
    (4) Inspected regularly (at least annually) to ensure that they 
meet requirements for container management.
    (f) The management of laboratory waste must not result in the 
release of hazardous constituents into the land, air and water where 
such release is prohibited under federal law.
    (g) The requirements for emergency response are:
    (1) Each University must post notification procedures, location of 
emergency response equipment to be used by laboratory workers and 
evacuation procedures;
    (2) Emergency response equipment and procedures for emergency 
response must be appropriate to the hazards in the laboratory such that 
hazards to human health and the environment will be minimized in the 
event of an emergency;
    (3) In the event of a fire, explosion or other release of 
laboratory waste which could threaten human health or the environment, 
the laboratory worker must follow the notification procedures under 
paragraph (g)(1) of this section.
    (h) Each University must investigate, document, and take actions to 
correct and prevent future incidents of hazardous chemical spills, 
exposures and other incidents that trigger a reportable emergency or 
that require reporting under paragraph (g) of this section.
    (i) Each University may only transfer laboratory wastes from a 
laboratory:
    (1) directly to an on-site designated hazardous waste accumulation 
area. Notwithstanding 40 CFR 263.10(a), each University must comply 
with requirements for transporters set forth in 40 CFR 263.30 and 
263.31 in the event of a discharge of laboratory waste en route from a 
laboratory to an on-site hazardous waste accumulation area; or
    (2) to a treatment, storage or disposal (TSD) facility permitted to 
handle the waste under 40 CFR part 270 or in interim status under 40 
CFR parts 265 and 270 (or authorized to handle the waste by a state 
with a hazardous waste management program approved under 40 CFR part 
271) if it is determined in the laboratory by the individuals 
identified in Sec. 262.105(b)(3) to be responsible for waste management 
decisions that the waste is a hazardous waste and that it is prudent to 
transfer it directly to a treatment, storage, and disposal facility 
rather than an on-site accumulation area.
    (j) Each University must ensure that laboratory workers receive 
training and are provided with information so that they can implement 
and comply with these Minimum Performance Criteria.


Sec. 262.105  What must be included in the laboratory environmental 
management plan?

    (a) Each University must include specific measures it will take to 
protect human health and the environment from hazards associated with 
the management of laboratory wastes and from the reuse, recycling or 
disposal of such materials outside the laboratory.
    (b) Each University must write, implement and comply with an 
Environmental Management Plan that includes the following:
    (1) The specific procedures to assure compliance with each of the 
Minimum Performance Criteria set forth in Sec. 262.104.
    (2) An environmental policy, or environmental, health and safety 
policy, signed by the University's senior management, which must 
include commitments to regulatory compliance, waste minimization, risk 
reduction and continual improvement of the environmental management 
system.
    (3) A description of roles and responsibilities for the 
implementation and maintenance of the Laboratory Environmental 
Management Plan.
    (4) A system for identifying and tracking legal and other 
requirements applicable to laboratory waste, including the procedures 
for providing updates to laboratory supervisors.
    (5) Criteria for the identification of physical and chemical 
hazards and the control measures to reduce the potential for releases 
of laboratory wastes to the environment, including engineering 
controls, the use of personal protective equipment and hygiene 
practices, containment strategies and other control measures.
    (6) A pollution prevention plan, including, but not limited to, 
roles and responsibilities, training, pollution prevention activities, 
and performance review.
    (7) A system for conducting and updating annual surveys of 
hazardous chemicals of concern and procedures for identifying acutely 
hazardous laboratory waste.
    (8) The procedures for conducting laboratory clean-outs with regard 
to the safe management and disposal of laboratory wastes.
    (9) The criteria that laboratory workers must comply with for 
managing, containing and labeling laboratory wastes, including: an 
evaluation of the need for and the use of any special containers or 
labeling circumstances, and the use of laboratory wastes secondary 
containers including packaging, bottles, or test tube racks.
    (10) The procedures relevant to the safe and timely removal of 
laboratory wastes from the laboratory.
    (11) The emergency preparedness and response procedures to be 
implemented for laboratory waste.

[[Page 52395]]

    (12) Provisions for information dissemination and training, 
provided for in paragraph (d) of this section.
    (13) The procedures for the development and approval of changes to 
the Environmental Management Plan.
    (14) The procedures and work practices for safely transferring or 
moving laboratory wastes from a laboratory to a location identified in 
Sec. 262.104(i).
    (15) The procedures for regularly inspecting a laboratory to assess 
conformance with the requirements of the Environmental Management Plan.
    (16) The procedures for the identification of environmental 
management plan noncompliance, and the assignment of responsibility, 
timelines and corrective actions to prevent their reoccurrence.
    (17) The record keeping requirements to document conformance with 
this Plan.
    (c) Organizational responsibilities for each university. Each 
University must:
    (1) Develop and oversee implementation of its Laboratory 
Environmental Management Plan.
    (2) Identify the following:
    (i) Annual environmental objectives and targets;
    (ii) Those laboratories covered by the requirements of the 
Laboratory Environmental Management Plan.
    (3) Assign roles and responsibilities for the effective 
implementation of the Environmental Management Plan.
    (4) Determine whether laboratory wastes are solid wastes under RCRA 
and, if so, whether they are hazardous.
    (5) Develop, implement, and maintain:
    (i) Policies, procedures and practices governing its compliance 
with the Environmental Management Plan and applicable federal and state 
hazardous waste regulations.
    (ii) Procedures to monitor and measure relevant conformance and 
environmental performance data for the purpose of supporting continual 
improvement of the Environmental Management Plan.
    (iii) Policies and procedures for managing environmental documents 
and records applicable to this Environmental Management Standard.
    (6) Ensure that:
    (i) Its Environmental Management Plan is available to laboratory 
workers, vendors, employee representatives, visitors, on-site 
contractors, and upon request, to governmental representatives.
    (ii) Personnel designated by each University to handle laboratory 
wastes and RCRA hazardous waste receive appropriate training.
    (iii) The Environmental Management Plan is reviewed at least 
annually by senior management to ensure its continuing suitability, 
adequacy and effectiveness. The reviews may include, but not be limited 
to, a consideration of monitoring and measuring information, Laboratory 
Environmental Management Standard performance data, assessment and 
audit results and other relevant information and data.
    (d) What are the Information and Training Requirements for Each 
University?
    (1) Each University must ensure that laboratory workers receive 
training and are provided with the information to understand and 
implement the elements of each University's Environmental Management 
Plan that are relevant to the laboratory workers' responsibilities.
    (2) When must each University ensure that laboratory workers 
receive training and information?
    (i) Each University must provide the information to each laboratory 
worker when he/she is first assigned to a work area where laboratory 
wastes may be generated.
    (ii) Each University must ensure that each laboratory worker has 
had training within six months of when he/she is first assigned to a 
work area where laboratory wastes may be generated. Each University 
must retrain a laboratory worker when a laboratory waste poses a new or 
unique hazard for which the laboratory worker has not received prior 
training and as frequently as needed to maintain knowledge of the 
procedures of the Environmental Management Plan.
    (3) Each University must provide an outline of training and specify 
who is to receive training in its Environmental Management Plan.
    (4) Each University must ensure that laboratory workers are 
informed of:
    (i) The contents of this Subpart and the Laboratory Environmental 
Management Plan(s) for the laboratory(ies) in which they will be 
performing work;
    (ii) The location and availability of the Environmental Management 
Plan;
    (iii) Emergency response measures applicable to laboratories;
    (iv) Signs and indicators of a hazardous substance release;
    (v) The location and availability of known reference materials 
relevant to implementation of the Environmental Management Plan; and
    (vi) Environmental training requirements applicable to laboratory 
workers.
    (5) Each University must ensure that Laboratory workers have 
received training in:
    (i) Methods and observations that may be used to detect the 
presence or release of a hazardous substance;
    (ii) The chemical and physical hazards associated with laboratory 
wastes in their work area;
    (iii) The relevant measures a laboratory worker can take to protect 
human health and the environment; and
    (iv) Details of the Environmental Management Plan sufficient to 
ensure they manage laboratory waste in accordance with the requirements 
of this Subpart.
    (6) Requirements pertaining to Laboratory visitors:
    (i) Laboratory visitors, such as on-site contractors or 
environmental vendors, that require information and training under this 
standard must be identified in the Environmental Management Plan.
    (ii) Laboratory visitors identified in the Environmental Management 
Plan must be informed of the existence and location of the 
Environmental Management Plan.
    (iii) Laboratory visitors identified in the Environmental 
Management Plan must be informed of relevant policies, procedures or 
work practices to ensure compliance with the requirements of the 
Environmental Management Plan.
    (7) Each University must define methods of providing objective 
evidence and records of training and information dissemination in its 
Environmental Management Plan.


Sec. 262.106  When must a hazardous waste determination be made?

    (a) For laboratory waste sent from a laboratory to an on-site 
hazardous waste accumulation area, each University must evaluate the 
laboratory wastes to determine whether they are solid wastes under RCRA 
and, if so, determine pursuant to Sec. 262.11 (a) through (d) whether 
they are hazardous wastes, as soon as the laboratory wastes reach the 
University's Hazardous Waste Accumulation area(s). At this point each 
University must determine whether the laboratory waste will be reused 
or whether it must be managed as RCRA solid or hazardous waste.
    (b) For laboratory waste that will be sent from a laboratory to a 
TSD facility permitted to handle the waste, each University must 
evaluate such laboratory wastes to determine whether they are solid 
wastes under RCRA and, if so, determine pursuant to Sec. 262.11 (a) 
through (d) whether they are hazardous wastes, prior to the 30-day 
deadline for removing dated laboratory waste from the laboratory.
    (c) Laboratory waste that is determined to be hazardous waste is no 
longer subject to the provisions of this

[[Page 52396]]

subpart and must be managed in accordance with all applicable 
provisions of 40 CFR Parts 260 through 270.


Sec. 262.107  Under what circumstances will a university's 
participation in this environmental management standard pilot be 
terminated?

    (a) EPA retains the right to terminate a University's participation 
in this Laboratory XL project if the University:
    (1) Is in non-compliance with the Minimum Performance Criteria in 
Sec. 262.104; or
    (2) Has actual environmental management practices in the laboratory 
that do not conform to its Environmental Management Plan; or
    (3) Is in non-compliance with the Hazardous Waste Determination 
requirements of Sec. 262.106.
    (b) In the event of termination, EPA will provide the University 
with 15 days written notice of its intent to terminate. During this 
period, which commences upon receipt of the notice, the University will 
have the opportunity to come back into compliance with the Minimum 
Performance Criteria, its Environmental Management Plan, or the 
requirements for making a hazardous waste determination at Sec. 262.106 
or to provide a written explanation as to why it was not in compliance 
and how it intends to return to compliance. If, upon review of the 
University's written explanation, EPA then re-issues a written notice 
terminating the University from this XL Project, the provisions of 
paragraph (c) of this section will immediately apply and the University 
shall have 90 days to come into compliance with the applicable RCRA 
requirements deferred by Sec. 262.10(j). During the 90-day transition 
period, the provisions of this subpart shall continue to apply to the 
University.
    (c) If a University withdraws from this XL project, or receives a 
notice of termination pursuant to this section, it must submit to EPA 
and the state a schedule for returning to full compliance with RCRA 
requirements at the laboratory level. The schedule must show how the 
University will return to full compliance with RCRA within 90 days from 
the date of the notice of termination or withdrawal.


Sec. 262.108  When will this subpart expire?

    This subpart will expire on September 30, 2003.

[FR Doc. 99-25137 Filed 9-27-99; 8:45 am]
BILLING CODE 6560-50-U