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

SUMMARY: The Environmental Protection Agency (EPA) today is proposing

this rule to implement a project under the Project XL program that

would provide regulatory flexibility under the Resource Conservation

and Recovery Act (RCRA), as amended for the University of

Massachusetts-Boston, Boston, MA, Boston College, Chestnut Hill, MA and

the University of Vermont, Burlington, VT (the Universities). The

principal objective of this Laboratory XL Project is to pilot a

flexible, performance-based system for managing laboratory waste. To

achieve this, today's proposed rule would provide regulatory

flexibility to allow the participating laboratories at the Universities

to replace existing requirements for hazardous waste generators with a

comprehensive Laboratory Environmental Management Plan designed for

each University. The terms of the overall XL project are contained in

the draft Final Project Agreement (FPA) on which EPA is also requesting

comments. The draft Final Project Agreement (FPA) is available for

public review and comment at the EPA Docket in Washington DC, in the

EPA Region I library, at the Universities, and on the world wide web at

http://www.epa.gov/projectxl/. Following a review of the public

comments and appropriate changes, the FPA would be signed by delegates

from the EPA, the Massachusetts Department of Environmental Protection

(MADEP), the Vermont Department of Environmental Conservation (VTDEC)

and the Universities.

DATES: Public Comments: Comments on the proposed rule and/or FPA must

be received on or before August 26, 1999. All comments should be

submitted in writing to the address listed below.

Public Hearing: Commenters may request a public hearing by August

10, 1999 during the public comment period. Commenters requesting a

public hearing should specify the basis for their request. If EPA

determines that there is sufficient reason to hold a public hearing, it

will do so by August 17, 1999, during the last week of the public

comment period. Requests for a public hearing should be submitted to

the address below. If a public hearing is scheduled, the date, time,

and location will be available through a Federal Register notice or by

contacting Ms. Gina Snyder or Mr. George Frantz at the Region 1 office.

ADDRESSES: Request to Speak at Hearing: Requests for a hearing should

be mailed to the RCRA Information Center Docket Clerk (5305G), U.S.

Environmental Protection Agency, 401 M Street, S.W., Washington, D.C.

20460. Please send an original and two copies of all comments, and

refer to Docket Number F-1999-NEUP-FFFFF. A copy should also be sent to

Ms. Gina Snyder at U.S. EPA Region I. Ms. Gina Snyder may be contacted

at the following address: U.S. Environmental Protection Agency, Region

I (SPE), 1 Congress St., Suite 1100, Boston, MA, 02114, (617) 918-1837.

Comments: Written comments should be mailed to the RCRA Information

Center Docket Clerk (5305W), U.S. Environmental Protection Agency, 401

M Street, S.W., Washington, D.C. 20460. Please send an original and two

copies of all comments, and refer to Docket Number F-1999-NEUP-FFFFF.

Viewing Project Materials: A docket containing the proposed rule,

draft Final Project Agreement, supporting materials, and public

comments is available for public inspection and copying at the RCRA

Information Center (RIC), located at Crystal Gateway, 1235 Jefferson

Davis Highway, First Floor, Arlington, Virginia. The RIC is open from

9:00 am to 4:00 pm Monday through Friday, excluding federal holidays.

The public is encouraged to phone in advance to review docket

materials. Appointments can be scheduled by phoning the Docket Office

at (703) 603-9230. Refer to RCRA docket number F-1999-NEUP-FFFFF. The

public may copy a maximum of 100 pages from any regulatory docket at no

charge. Additional copies cost 15 cents per page. Project materials are

also available for review for today's action on the world wide web at

http://www.epa.gov/projectxl/.

A duplicate copy of the docket is available for inspection and

copying at U.S. EPA, Region I, 1 Congress Street, Suite 1100 (LIB),

Boston, MA 02114-2023 during normal business hours. Persons wishing to

view the duplicate docket at the Boston location are encouraged to

contact Ms. Gina Snyder or Mr. George Frantz in advance, by telephoning

(617) 918-1837 or (617) 918-1883.

FOR FURTHER INFORMATION CONTACT: Ms. Gina Snyder or Mr. George Frantz,

U.S. Environmental Protection Agency, Region I (SPE), Assistance and

Pollution Prevention Division, 1 Congress Street, Suite 1100, Boston,

MA 02114-2023. Ms. Snyder can be reached at (617) 918-1837 and Mr.

Frantz can be reached at (617) 918-1883. Further information on today's

action may also be obtained on the world wide web at http://

www.epa.gov/projectxl/.

SUPPLEMENTARY INFORMATION: The development and implementation of an

Environmental Management Plan would be piloted at these three

Universities in their laboratories at areas that are currently managed

as satellite accumulation areas (see 40 CFR 262.34(c)). Hazardous waste

managed at all other areas of each University would continue to be

subject to current RCRA regulations. This pilot is intended to test the

effectiveness of an integrated, flexible, performance-based approach

for managing hazardous waste in university laboratories to determine

whether this approach promotes better management of laboratory wastes

than the current standards.

In an effort to more efficiently manage hazardous waste and

minimize the volume of waste generated in the university laboratory

setting, the proposed rule would provide for a ``temporary conditional

deferral'' from two specific RCRA requirements that apply to generators

of hazardous waste, 40 CFR 262.11--Hazardous Waste Determination, and

262.34(c)--Satellite Accumulation, which includes requirements for

container management. Instead, laboratory waste would be managed in

accordance with a Laboratory Environmental Management Plan until it

reaches each University's on-site hazardous waste accumulation area

where a determination would be made by Environmental Health and Safety

personnel as to whether the waste can be redistributed and reused at

the University or whether it must be managed as a RCRA hazardous waste.

The proposed rule would define laboratory waste as a hazardous chemical

that results from laboratory scale activities and includes the

following: excess or unused hazardous chemicals that may or may not be

reused outside their laboratory of origin; hazardous chemicals

determined to be RCRA hazardous waste as defined in 40 CFR part 261;

and hazardous chemicals that will be determined not to be RCRA

[[Page 40697]]

hazardous waste pursuant to the new proposed rule at 40 CFR 262.106.

Making a solid and hazardous waste determination at a central location

would allow professionals within the Universities' Environmental,

Health and Safety program to more easily manage the laboratory waste

and to increase reuse opportunities.

The deferral of specified RCRA requirements is ``temporary.'' It

remains in effect only for the four-year term of this Laboratory XL

project. The four-year term is based upon the date of promulgation of

the final rule when the Universities will commence the development of

their Laboratory Environmental Management Plans (EMP). Following review

of its EMP, each University would notify the applicable state agency

and EPA in writing of the date on which it intends to implement its

EMP. The proposed rule would become effective in the designated

participating laboratories only after such written notification.

Section III.D.2. and IV.F.1. discuss the aspects of state

implementation of the proposed rule.

The deferral of the specified RCRA requirements is also

``conditional.'' It is conditioned upon each University's

implementation and compliance with the Laboratory Environmental

Management Standard set forth in 40 CFR part 262, subpart J of this

proposed rule. The Laboratory Environmental Management Standard

includes specific requirements for the management of laboratory waste

that ensure protection of human health and the environment while

providing some flexibility to encourage chemical reuse and waste

minimization. These requirements are termed Minimum Performance

Criteria. They are enforceable in the same way as current RCRA

standards are enforceable to ensure that handling of laboratory waste

would be protective of human health and the environment. During this XL

project, the proposed requirements set forth in the proposed Subpart J

(including the Environmental Management Plan requirements) would also

be enforceable under RCRA section 3008.

The Environmental Management Standard (EMS) in subpart J contains

requirements for each University to create and implement an

Environmental Management Plan (EMP) to cover all of its participating

laboratories. The elements of the EMP in the proposed rule are expected

to function as an outline of the procedures that must be in place to

manage laboratory waste in order to both minimize the amount of waste

generated, while allowing for the maximum reuse of the waste that is

generated. Although the EMP must describe how each laboratory will

comply with the specific Minimum Performance Criteria, the Minimum

Performance Criteria are requirements that stand on their own. The

proposed deferral of the hazardous waste determination is conditioned

on compliance with all of the requirements of the EMS, including the

Minimum Performance Criteria. These criteria ensure that the handling

of laboratory waste would be protective of human health and the

environment by establishing how laboratory waste would be managed

within the laboratory, and in transit to the on-site hazardous waste

accumulation area for each University.

EPA has agreed to allow the Universities to undertake this XL

project with the requested regulatory flexibility to determine if the

proposed performance-based Environmental Management Plan approach would

result in superior environmental performance and significant cost

savings to the universities.

Today's proposed rulemaking, and the state actions described in

section IV.F.1. of this preamble that parallel today's action, will not

in any way affect the provisions or applicability of any other existing

or future regulations.

EPA is soliciting comments on this rulemaking. EPA will publish

responses to comments in a subsequent final rule. The XL Project will

enter the implementation phase when, in addition to promulgation of the

final rule, all signatories to the XL Project sign the Final Project

Agreement. Implementation of the Environmental Management Plan(s) will

occur after the individual EMPs have been developed by each university,

and reviewed by EPA and the appropriate State agency to ensure

adherence to the Environmental Management Standard, prior to

commencement of the new system.

Outline of Today's Document

The information presented in this preamble is organized as follows:

I. Authority

II. Overview of Project XL

III. Overview of the University Laboratory XL Project Pilot

A. To What Laboratories Would the Proposed Rule Apply?

B. What Problems Have the University Laboratories Identified?

C. What Solutions Are Proposed by the University Laboratory XL

Project?

1. A New Integrated Performance-Based System

2. Laboratory Environmental Management Standard (EMS)

3. Laboratory Environmental Management Plan (EMP)

4. Minimum Performance Criteria

5. How the New System Would Work

6. Comparison of the Minimum Performance Criteria with Current

RCRA Regulations

7. Comparison of the Proposed Rule with Current OSHA and RCRA

Regulatory Requirements

8. How the Laboratory XL Project Will Result in Superior

Environmental Performance

D. What Regulatory Changes will be Necessary to Implement this

Project?

1. Federal Regulatory Changes

2. State Regulatory Changes

E. Why is EPA Supporting this New Approach to Laboratory Waste

Management?

F. How Have Various Stakeholders Been Involved in this Project?

G. How Will this Project Result in Cost Savings and Paperwork

Reduction?

H. How Will EPA Ensure the Integrity and Comprehensiveness of

Each University's Laboratory Environmental Management Plan?

I. How Will the Terms of the Laboratory XL Project and Proposed

Rule be Enforced?

J. How Long Will this Project Last and When Will it be Complete?

IV. Additional Information

A. How to Request a Public Hearing

B. How Does this Rule Comply With Executive Order 12866?

C. Is a Regulatory Flexibility Analysis Required?

D. Is an Information Collection Request Required for this

Project Under the Paperwork Reduction Act?

E. Does This Project Trigger the Requirements of the Unfunded

Mandates Reform Act?

F. RCRA & Hazardous and Solid Waste Amendments of 1984

1. Applicability of Rules in Authorized States

2. Effect on Massachusetts and Vermont Authorization

G. How Does this Rule Comply with Executive Order 13045:

Protection of Children from Environmental Health Risks and Safety

Risks?

H. Does this Rule Comply with Executive Order 12875: Enhancing

Intergovernmental Partnerships?

I. How Does this Rule Comply with Executive Order 13084:

Consultation and Coordination with Indian Tribal Governments?

J. Does this Rule Comply with the National Technology Transfer

and Advancement Act?

I. Authority

EPA is publishing this proposed regulation under the authority of

sections 2002, 3001, 3002, 3003, 3006, 3010, and 7004 of the Solid

Waste Disposal Act of 1970, as amended by the Resource Conservation and

Recovery Act, as amended (42 U.S.C. 6912, 6921, 6922, 6923, 6926, 6930,

6937, 6938, and 6974).

[[Page 40698]]

II. Overview of Project XL

The draft FPA sets forth the intentions of EPA and the Universities

with regard to a project developed under Project XL, an EPA initiative

to allow regulated entities to achieve better environmental results at

less cost. The proposed regulation would facilitate implementation of

the project. Project XL--``eXcellence and Leadership''--was announced

on March 16, 1995, as a central part of the National Performance Review

and the EPA's effort to reinvent environmental protection. See 60 FR

27282 (May 23, 1995). Project XL provides a limited number of private

and public regulated entities an opportunity to develop their own pilot

projects to provide regulatory flexibility that will result in

environmental protection that is superior to what would be achieved

through compliance with current and reasonably anticipated future

regulations. These efforts are crucial to EPA's ability to test new

strategies that reduce regulatory burden and promote economic growth

while achieving better environmental and public health protection. EPA

intends to evaluate the results of this and other Project XL projects

to determine which specific elements of the project(s), if any, should

be more broadly applied to other regulated entities for the benefit of

both the economy and the environment.

Under Project XL, participants in four categories--facilities,

industry sectors, governmental agencies and communities--are offered

the flexibility to develop common sense, cost-effective strategies that

will replace or modify specific regulatory requirements, on the

condition that they produce and demonstrate superior environmental

performance.

The XL program is intended to allow EPA to experiment with

potentially promising regulatory approaches, both to assess whether

they provide benefits at the specific facility affected, and whether

they should be considered for wider application. Such pilot projects

allow EPA to proceed more quickly than would be possible when

undertaking changes on a nationwide basis. As part of this

experimentation, the EPA may try out approaches or legal

interpretations that depart from or are even inconsistent with

longstanding Agency practice, so long as those interpretations are

within the broad range of discretion enjoyed by the Agency in

interpreting statutes that it implements. The EPA may also modify

rules, on a site-specific basis, that represent one of several possible

policy approaches within a more general statutory directive, so long as

the alternative being used is permissible under the statute.

Adoption of such alternative approaches or interpretations in the

context of a given XL project does not, however, signal EPA's

willingness to adopt that interpretation as a general matter, or even

in the context of other XL projects. It would be inconsistent with the

forward-looking nature of these pilot projects to adopt such innovative

approaches prematurely on a widespread basis without first determining

whether or not they are viable in practice and successful in the

particular projects that embody them. Furthermore, as EPA indicated in

announcing the XL program, EPA expects to adopt only a limited number

of carefully selected projects. These pilot projects are not intended

to be a means for piecemeal revision of entire programs. Depending on

the results in these projects, EPA may or may not be willing to

consider adopting the alternative interpretation again, either

generally or for other specific facilities.

EPA believes that adopting alternative policy approaches and

interpretations, on a limited, site-specific basis and in connection

with a carefully selected pilot project, is consistent with the

expectations of Congress about EPA's role in implementing the

environmental statutes (provided that the Agency acts within the

discretion allowed by the statute). Congress' recognition that there is

a need for experimentation and research, as well as ongoing re-

evaluation of environmental programs, is reflected in a variety of

statutory provisions, such as section 8001 of RCRA.

XL Criteria

To participate in Project XL, applicants must develop alternative

pollution reduction strategies pursuant to eight criteria: superior

environmental performance; cost savings and paperwork reduction; local

stakeholder involvement and support; test of an innovative strategy;

transferability; feasibility; identification of monitoring, reporting

and evaluation methods; and avoidance of shifting risk burden. They

must have full support of affected Federal, state and tribal agencies

to be selected.

For more information about the XL criteria, readers should refer to

the two descriptive documents published in the Federal Register (60 FR

27282, May 23, 1995 and 62 FR 19872, April 23, 1997), and the December

1, 1995 ``Principles for Development of Project XL Final Project

Agreements'' document. For further discussion as to how the University

Laboratories XL project addresses the XL criteria, readers should refer

to the Final Project Agreement available from the EPA RCRA docket or

Region 1 library for this action (see ADDRESSES section of today's

preamble).

XL Program Phases

The Project XL program is compartmentalized into four basic phases:

the initial pre-proposal phase where the project sponsor comes up with

an innovative concept that they would like to consider as an XL pilot,

the second phase where the project sponsor works with EPA and

interested stakeholders in developing an XL proposal, the third phase

where EPA, local regulatory agencies, and other interested stakeholders

review the XL proposal, the fourth phase where the project sponsor

works with EPA, local regulatory agencies, and interested stakeholders

in developing a Final Project Agreement and legal mechanism. After

promulgation of the final rule (or other legal mechanism) for the XL

pilot, and after the Final Project Agreement has been signed by all

designated parties, the XL pilot proceeds into the implementation phase

and evaluation phase.

Final Project Agreement

The Final Project Agreement (FPA) is a written agreement between

the project sponsor and regulatory agencies. The FPA contains a

detailed description of the proposed pilot project. It addresses the

eight Project XL criteria, and the expectation of the Agency that this

XL project will meet those criteria. The Final Project Agreement

identifies performance goals and indicators (monitoring schedule) which

will enable the laboratories to clearly illustrate the baseline

quantities. The draft FPA specifically addresses the manner in which

the project is expected to produce superior environmental benefits. The

FPA also discusses the administration of the agreement, including

dispute resolution and termination. The Final Project Agreement is

available for review in the docket for today's action, and also is

available on the world wide web at http://www.epa.gov/projectxl/.

III. Overview of the University Laboratories XL Project

EPA is today requesting comments on the draft FPA and proposed rule

to implement key provisions of this Project XL initiative. Today's

proposed rule would facilitate implementation of the draft FPA (the

document that embodies EPA's intent to implement this project) that has

been developed by EPA, Massachusetts Department of

[[Page 40699]]

Environmental Protection (MADEP), Vermont Department of Environmental

Conservation (VTDEC), the Universities, and other stakeholders. After

comments on the draft FPA have been considered, EPA, MADEP, VTDEC, and

the three Universities expect to sign a final FPA. Today's proposed

rule would not be effective in Massachusetts and Vermont until those

states have made conforming changes.

A. To What Laboratories Would the Proposed Rule Apply?

The Proposed Rule would apply only to participating laboratories at

the following three Universities:

University of Massachusetts Boston, Boston, MA

Boston College, Chestnut Hill, MA

University of Vermont, Burlington, VT

Boston College is classified as a Small Quantity Generator (SQG).

The University of Massachusetts Boston and the University of Vermont

are classified as Large Quantity Generators (LQG). The University of

Massachusetts Boston is an LQG solely as a generator of acute wastes in

excess of the one kilogram per month threshold. Additionally, the

University of Vermont operates a part B permitted facility for the

storage of hazardous wastes. Participating laboratories at all the

Universities currently generate and manage hazardous waste and the

Universities fully expect that some of the laboratory wastes that would

be generated and managed under the Environmental Management Plans would

meet the definition of a RCRA hazardous waste.

The University laboratories that would be affected by this project

are used for research and teaching purposes. A breakdown of the

individual Universities' laboratories is shown in Table 1 below. The

table also identifies each Universities' on-site hazardous waste

accumulation areas which would continue to be regulated under existing

federal and state RCRA regulation:

Table 1.--Laboratory XL Project Participant Information

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

Location of current

Institution Student Number of Departments participating hazardous waste

body labs accumulation areas \1\

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

Boston College Chestnut Hill, MA. 14,000 120 Chemistry, Biology, Merkert Chemistry

Geology, Physics, Building, 2609 Beacon

Psychology. St., Boston MA; Higgins

Building, 140

Commonwealth Ave.,

Chestnut Hill MA.

University of Massachusetts 13,000 150 Chemistry, Biology, Science Building (Bldg.

Boston Boston, MA. Psychology, #080); McCormack

Anthropology, Geology Building (Bldg. #020);

and Earth Sciences, and and Wheatley Building

Environmental, Coastal (Bldg. #010) 100

and Ocean Sciences. Morrissey Blvd., Boston

MA

University of Vermont Burlington, 10,000 400 Colleges of: Agriculture Given Bunker, 89

VT. and Life Sciences; Arts Beaumont Ave.,

and Sciences; Medicine; Burlington VT.

and Engineering and

Mathematics; and Schools

of: Nursing; Allied

Heath Sciences; and

Natural Resources.

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

\1\ Note: These accumulation areas would still be fully covered by the current federal and state RCRA

regulations. This XL project, for example, would not allow any increased air emissions that would otherwise be

controlled under the current RCRA regulations such as the subpart CC hazardous waste organic air emission

standards that apply to large quantity generators who accumulate hazardous waste on-site.

B. What Problems Have the University Laboratories Identified?

To understand the problems faced by the Universities and the

purpose behind the proposed rule, it is necessary to understand the

context in which the proposed rule has arisen and to consider the

experience of university laboratories as regulated entities under both

the Occupational Safety and Health Act (OSHA) and RCRA. While both

statutes have the common objective of protecting human health, RCRA

makes a clear distinction between hazardous waste and hazardous

chemicals in a laboratory setting. There are specific handling and

management requirements for ``hazardous wastes'' under RCRA which do

not apply to the larger universe of ``hazardous chemicals'' regulated

by the Occupational Safety and Health Administration. Researchers are

familiar with the specialized system developed for laboratory work by

OSHA, which includes the requirement to develop and implement a

Chemical Hygiene Plan (CHP). This systematic approach, incorporating a

specific plan, can also be applied to the management of hazardous waste

that sometimes results from the use of hazardous chemicals in the

laboratory. However, under the current system, laboratories are

required to implement and to track two parallel, and not always

consistent chemical management systems within the laboratory setting.

The Universities have proposed streamlining the management of

chemicals in the laboratory by having a single system addressing

hazardous chemicals that will result in both better management and a

reduction in the quantity of laboratory wastes that have to be

disposed. This streamlining will result in a number of changes, which

when combined in a single systematic approach to chemical management,

are expected to provide results that are superior to those provided by

the current regulatory framework.

An example of one area that will be streamlined is the process for

training laboratory workers. OSHA's chemical standard requires that the

employer provide employees with information and training on the hazards

of chemicals present in their area. RCRA requires large quantity

generators to ensure that facility personnel complete classroom

instruction or on-the-job training that teaches them to perform their

duties in a way that ensures the facility's compliance with applicable

requirements. RCRA requires small quantity generators to ensure that

all employees are familiar with proper waste handling and emergency

procedures relevant to their responsibilities. The new system proposed

in this rule would require the same standardized training for all

laboratory workers, including: students, personnel in positions related

to hazardous waste management, and laboratory employees. This

systematic training approach can cover both safety

[[Page 40700]]

and environmental concerns when performed through the integration of

chemical hygiene planning and environmental management planning. This

is expected not only to streamline but also to upgrade existing

training, and to provide students--the laboratory workers of the

future--with a better understanding of the environmental impacts of

their work and how to minimize those impacts.

The university laboratory setting is decentralized, with various

departments funding diverse types of research. The university community

is also diverse and subject to the regular turnover of students and

researchers. This decentralized setting, when combined with rules that

vary from state to state (as discussed in sections D.2. and E., below)

and between federal RCRA and federal OSHA standards, often leads to the

unnecessary and premature disposal of chemicals after an individual

laboratory has no use for them. This is true even for unused chemicals

that may be reusable elsewhere at the University. A more centralized

system should result in more effective decision making with regard to

chemical disposition and should result in increased chemical reuse.

Therefore, one of the larger changes to result from this proposed

project would be the centralization of the system for managing chemical

wastes. This would allow decisions regarding chemical disposition to

more easily occur at a centralized area where knowledge of campus-wide

needs for chemicals can be factored into decisions as to whether unused

or used chemicals (formerly disposed as waste) can be reused within the

University.

The implementation of the current system is further complicated by

the structure of university laboratories which is different from

industrial settings where RCRA has been quite effective. Industrial

settings commonly have ongoing processes which generate a single waste

at a fairly regular rate of generation. With potentially hundreds of

small laboratories within one university, each producing small amounts

of multiple wastes on a noncontinuous basis, the overall management of

hazardous wastes becomes more difficult. For example, it can be

difficult for universities to comply with the current requirements that

result in 3 day removal timeframes for hazardous waste in excess of 55

gallons at their satellite areas (managed under 40 CFR 262.34(c) or

equivalent state provisions). Waste generation in manufacturing

settings is generally more uniform and continuous than it is in

university research laboratories where the rate of waste generated is

often unpredictable. This uncertainty makes it difficult for a

university to predict when satellite accumulation limits may be

exceeded and to arrange for removal of the waste within the required

amount of time. This proposed alternative system for university

laboratories attempts to address their atypical circumstances by

allowing them to set up a monthly pick-up schedule for laboratory

waste. With the ability to be proactive in setting up schedules for

waste pickups, EH&S professionals at the Universities would be able to

avoid a reactive mode of operation, to proactively develop a systematic

approach for re-use of chemicals on-site, and to operate that system

based on the schedule they could develop under this proposal.

The difficulty of managing laboratory wastes has been the subject

of nation-wide discussions within the university and research community

throughout the past decade. Many organizations including the Campus

Safety, Health and Environmental Management Association, the National

Research Council, and the American Chemical Society have all sought a

better way to properly manage and handle hazardous chemicals in the

laboratory, and to comply with the requirements of both OSHA and RCRA.

In the New England area, the Laboratory Consortium for Environmental

Excellence (LCEE) was formed to explore viable alternatives to the

current parallel regulatory scheme and to promote best management

practices for laboratories. As a result of exhaustive reviews and

interviews with universities and research organizations across the

country, a consensus was reached regarding the need to harmonize the

RCRA and OSHA regulatory systems through a performance-based management

system that would actively promote prudent practices, encourage

chemical reuse and recycling, minimize costs, and increase efficiency.

The central purpose of this Laboratory XL project is to test the

effectiveness of an integrated, performance-based environmental

management system which is consistent with the objectives of RCRA and

which would complement the applicable OSHA regulations.

C. What Solutions Are Proposed by the University Laboratory XL Project?

1. A New Integrated Performance-Based System

The University Laboratory XL project proposes to test the

effectiveness of an integrated, flexible, performance-based system for

managing hazardous wastes in laboratories which (1) would result in

pollution prevention and streamlined procedures for managing hazardous

wastes and hazardous chemicals at universities, (2) would meet the

objectives of both the RCRA and OSHA regulatory programs combined and

(3) would be at least as protective of human health and the environment

as the current system.

This project would pilot an alternative approach to hazardous waste

management in University laboratories which is more systematic and more

centralized than the approach implemented by Universities under the

current system. At the same time, the pilot integrates some of the

current RCRA hazardous waste regulations with current OSHA regulations

by proposing that universities develop a plan similar to the CHP but

designed for the management of environmental aspects of their

activities to facilitate the creation of an integrated and consistent

system for managing laboratory waste in laboratories. As a result of

the efficiencies gained from the harmonization of the OSHA CHP and the

RCRA-oriented Laboratory Environmental Management Plan, the new system

is expected to provide a better management approach for laboratories

and to result in increased pollution prevention while still ensuring

protection of human health and the environment.

To achieve this objective, the Universities would like to pursue a

regulatory model of a Laboratory Environmental Management Standard

(EMS) that identifies both the elements for the effective management of

laboratory wastes, and the minimum performance requirements for

handling wastes in each individual laboratory. The proposed Laboratory

EMS sets out all the requirements for the proposed alternative system

of managing laboratory waste. First and foremost, the Laboratory EMS

would include Minimum Performance Criteria for the management of

laboratory wastes within the laboratory and en route to the on-site

hazardous waste accumulation area. These criteria are the requirements

that would be an alternative to 40 CFR 262.34(c) in the laboratory. The

Minimum Performance Criteria are a set of measurable requirements that

are similar to the current RCRA requirements. Each of the elements of

the Minimum Performance Criteria is described in full in today's

proposed rule and is briefly explained below. In addition, the

Laboratory EMS would also require the development of a Laboratory

Environmental Management Plan (EMP). The EMP would be written by each

University to document its specific procedures for how it would

[[Page 40701]]

conform with the Laboratory EMS. The EMP would also describe the

procedures each laboratory would follow in order to meet the Minimum

Performance Criteria. The elements of the EMP are summarized below in

Table 2.

2. Laboratory Environmental Management Standard (EMS)

Today's proposed rule is called the ``Laboratory Environmental

Management Standard''. It would include a definition section (40 CFR

262.102), the requirements for waste management in the laboratory, or

the Minimum Performance Criteria, (40 CFR 262.104) and the specific

requirement that each University develop a Laboratory Environmental

Management Plan (40 CFR 262.105). Proposed subpart J also contains

requirements detailing the organizational responsibilities and the

training requirements of each participating University laboratory (40

CFR 262.105). The Laboratory EMS would provide the umbrella framework

for an effective system for the management of university laboratory

waste. It would contain all the elements, from definitions through

waste determination requirements (40 CFR 262.106), that would make up

the new systematic approach proposed for university laboratories. The

proposed Laboratory EMS was originally modeled after the general

structure and format of the OSHA ``Occupational Exposure to Hazardous

Chemicals in Laboratories'' standard which requires a Chemical Hygiene

Plan.

3. Laboratory Environmental Management Plan (EMP)

The Laboratory EMS would require the development of a Laboratory

EMP which would be the mechanism through which the Laboratory EMS is

put into practice at each University. The Laboratory EMP, modeled on

OSHA's Chemical Hygiene Plan, would be a comprehensive plan to be

developed by each University. The EMP would document the procedures,

practices and programs to (a) manage laboratory waste in a manner that

is protective of human health and the environment and (b) that would be

implemented to achieve compliance with the requirements of the

Laboratory EMS and the Minimum Performance Criteria. It is through the

Laboratory EMP that the Universities would have the opportunity and the

obligation to design a performance-based system to complement the OSHA

requirements, to encourage waste minimization, and the redistribution

and reuse of laboratory waste. The Laboratory EMP would identify

specific elements to be implemented by each University, including

requirements for pollution prevention policies and procedures.

One of the objectives of the EMP and the overall XL project is to

erase the distinction between unused chemicals and waste chemicals in

the laboratory setting, so that the value in reusing chemicals can be

realized. This would be accomplished by defining laboratory waste to

include hazardous chemicals that result from laboratory scale

activities and which may or may not constitute RCRA hazardous wastes.

In the proposal, laboratory waste is defined as ``a hazardous chemical

that results from laboratory scale activities and includes the

following: excess or unused hazardous chemicals that may or may not be

reused outside their laboratory of origin; hazardous chemicals

determined to be RCRA hazardous waste as defined in 40 CFR part 261;

and hazardous chemicals that will be determined not to be RCRA

hazardous waste pursuant to 40 CFR 262.106.'' Thus, all ``laboratory

waste'' would be managed under a single standard while in the

laboratory. The determination that a laboratory waste could not be

reused and would be a RCRA solid waste, and as to whether such solid

waste would be a RCRA hazardous waste, would be made at a centralized

area, by Environmental Health and Safety professionals.

4. Minimum Performance Criteria

The proposed requirements for the laboratory EMP include a

requirement that the EMP include procedures to assure compliance with

certain Minimum Performance Criteria (MPC) specified in the proposed

regulation. The proposed Minimum Performance Criteria set forth minimum

requirements for the management of laboratory waste and have been

designed to ensure that laboratory waste will be managed in a manner

protective of human health and the environment. The requirements in the

Minimum Performance Criteria include provisions which are consistent

with current RCRA requirements, including labeling and container

management. The criteria have a wider application than current RCRA

requirements because the definition of laboratory waste includes some

materials that are not RCRA hazardous waste.

5. How the New System Would Work

This new proposed system would help each University to centralize

and coordinate its chemical management practices and demonstrate

environmental performance beyond what would likely be achieved under

the existing system.

Currently, there are two potential impediments to such

centralization and coordination. The first is the hazardous waste

determination requirement under 40 CFR 262.11. If this determination is

made in the individual laboratory, decisions with regard to reuse are

inevitably decentralized since the hazardous waste determination

necessitates a prior solid waste determination. To the extent that

these decisions are made by laboratory workers who do not have a

complete sense of the chemical needs of the entire university, such

decisions are often premature and do not maximize the potential for re-

use. The second potential impediment under the current system is the

requirement under 40 CFR 262.34(c) that hazardous waste in excess of 55

gallons be removed within three days of reaching the 55-gallon limit.

Such a time constraint results in constant, unplanned, episodic pick-

ups which are in themselves, time-consuming. In contrast, the extended

accumulation period of 30 days should allow for a more coordinated and

efficient pick-up and delivery system which would free up staff time,

and allow for the development of infrastructure and training designed

to increase waste minimization and an organized and coordinated campus-

wide chemical reuse system.

The EMP and the Minimum Performance Criteria would work together to

form the alternative system for the management of laboratory waste. The

following outline presents a step-by-step overview of how the

Laboratory Environmental Management Standard would work once this rule

is finalized and conforming changes are adopted by Vermont and

Massachusetts.

Development of the Environmental Management Plan

Step 1: Within six months, each University would develop its

Environmental Management Plan (EMP) addressing all the elements

required by 40 CFR 262.105, summarized in Table 2, below. Applicable

RCRA requirements would remain in full effect in the laboratories prior

to the EMP being written, reviewed, and implemented. For the purpose of

this Laboratory XL project, each University would consult with EPA, and

the state of Massachusetts (DEP) or Vermont (DEC) in the development of

its EMP. The centerpiece of the new system would be the individual

Laboratory Environmental Management Plan. The EMP would include

detailed specific elements that would have to be

[[Page 40702]]

included and implemented by each University. Each University would be

expected to craft an Environmental Management Plan that is tailored to

the structure and individual needs of the University and its

laboratories. A summary of the elements in the Environmental Management

Plans is outlined in Table 2. These are more fully detailed in the

proposed rule at 40 CFR 262.105.

Step 2: Once completed, the EMP would be made available on each

University's web site. So that EPA can continue to evaluate this XL

project, EPA-Region I would review each EMP to confirm that it meets

all of the requirements of 40 CFR 262.105. The relevant state agencies

may also review the EMP. Each University would also be working on how

it will implement its EMP, which would include training laboratory

workers with regard to the requirements of the Minimum Performance

Criteria pursuant to the procedures contained in the Environmental

Management Plan.

Table 2.--Summary of Major Elements Required in Laboratory Environmental

Management Plans

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

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

General:

The EMP must include a description of specific measures a University

will take to protect human health and the environment from hazards

associated with the management of laboratory wastes.

Administration:

1. An environmental policy, including commitments to regulatory

compliance, waste minimization, risk reduction and continual

improvement of the environmental management system.

2. A description of roles and responsibilities for the

implementation and maintenance of the Laboratory Environmental

Management Plan.

3. A pollution prevention plan.

4. Provisions for information dissemination and training.

5. Procedures for the development and approval of changes to the

EMP.

Waste Management and Conformance Review:

6. Criteria that laboratory workers shall comply with for managing,

containing and labeling laboratory wastes.

7. Procedures for inspecting a laboratory to assess conformance with

the requirements of the Environmental Management Plan.

8. Procedures to assure compliance with the Minimum Performance

Criteria (MPC).

9. Procedures for the identification of environmental management

plan noncompliance and the assignment of responsibility, timelines

and corrective actions to prevent their reoccurrence.

10. Criteria for the identification of physical and chemical hazards

and the control measures to reduce the potential for releases to

the environment of laboratory wastes.

Reporting/Recordkeeping:

11. The University's system for identifying and tracking legal and

other requirements applicable to the management and disposal of

designated laboratory wastes.

12. The University's system for conducting annual surveys of

hazardous chemicals of concern.

13. The recordkeeping requirements to document conformance with the

EMP.

Removal of Waste:

14. Procedures relevant to the timely and safe removal of laboratory

wastes.

15. Procedures and work practices for safely transporting or moving

laboratory wastes.

Maintenance:

16. Procedures for conducting laboratory clean-outs.

Emergency:

17. Emergency preparedness and response procedures.

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

Step 3: Following review of its EMP, each University would notify

the relevant state agency in writing of the date on which it intends to

implement its EMP. For purposes of this XL project, each University

would also notify EPA Region I. The proposed rule would become

effective in the laboratories only after such written notification.

Implementation of the Environmental Management Plan Including

Procedures for Meeting the Minimum Performance Criteria

The EMP would cover the management requirements for laboratory

waste until that waste reaches the designated on-site hazardous waste

accumulation area, including emergency response requirements in the

Minimum Performance Criteria while the waste is in transit to the

accumulation area. The following steps outline procedures at a

laboratory once the EMP would be in place and operational:

Step 4: Information and training would have been provided to

laboratory workers to comply with the Minimum Performance Criteria as

well as OSHA per the University's Laboratory Environmental Management

Plan. Hazardous chemicals would be received at the University,

distributed to the laboratory and placed in storage in the laboratory

in accordance with any and all requirements imposed by OSHA, Fire Codes

and/or building permits. If those chemicals pose a new or unique hazard

for which a worker has not received prior training, the worker would

receive new information and training so that they could understand and

implement the relevant elements of the EMP.

Step 5: Hazardous chemicals would be used in the research or

teaching laboratory under the direction of a trained individual, and

laboratory waste would be generated from those laboratory scale

activities.

Step 6: The laboratory waste would be managed in accordance with

the Minimum Performance Criteria and the University's specific

Laboratory EMP which would include the University-specific procedures

for meeting those criteria. These procedures would include ensuring

that the laboratory waste generated as a result of laboratory scale

activities in Step 5 is placed in containers and labeled with a

chemical name and hazard warning as per the Minimum Performance

Criteria and the procedures for meeting those criteria as outlined in

the Environmental Management Plan. For example, the Laboratory EMP may

specify the type of label the University requires for each type of

laboratory waste and how that label must be filled out.

Step 7: Each laboratory would be able to temporarily hold up to 55-

gallons of laboratory waste (or up to 1 quart of acutely hazardous

laboratory waste) prior to having to put a date on the waste. Upon

reaching the 55 gallon or 1 quart limit in the laboratory, the

laboratory waste container(s) would be marked with the date. Any

laboratory waste held in excess of these limits before the dated

laboratory waste is

[[Page 40703]]

removed would also be managed as described in Step 6, and the excess

would be limited in quantity to an additional 55 gallons (or an

additional 1 quart of acutely hazardous laboratory waste). Excess waste

accumulated before dated laboratory waste is removed would also have to

be marked with the date it reaches the 55 gallon or 1 quart limit and

would subsequently be removed from the laboratory as described in Step

8.

Step 8: Once laboratory waste is dated, the University EH&S staff

would be immediately informed that the laboratory waste would have to

be removed to the on-site hazardous waste accumulation area within 30

days of the label date.

Step 9: The laboratory waste referred to in Step 8 would be picked

up (within thirty days of the dates referred to in Step 8) by EH&S

department representatives and directly transferred to a designated on-

site hazardous waste accumulation area (as defined in the definitions

at proposed 40 CFR 262.102). Current hazardous waste accumulation areas

at each of the Universities are shown in Table 1. Designated hazardous

waste accumulation areas would be listed in the EMP.

Step 10: As soon as the laboratory waste is received at the on-site

hazardous waste accumulation area, the University EH&S staff or

designated trained professionals, would make a determination as to

whether it is a solid waste under RCRA, and if it is a solid waste, the

staff would determine whether it is a hazardous waste in accordance

with 40 CFR 262.11, as required by proposed 40 CFR 262.106. Once the

laboratory waste is received at the on-site hazardous waste

accumulation area, the proposed ``temporary conditional deferral''

would no longer apply, and the laboratory waste that is determined to

be hazardous waste would be managed in accordance with current RCRA

requirements.

Step 11: If the laboratory waste could be reused, the University

EH&S staff would arrange for its redistribution and reuse within the

University. If EH&S staff determine that the laboratory waste is a

solid waste and it is hazardous, it would be managed in accordance with

all applicable RCRA requirements.

6. Comparison of Minimum Performance Criteria with Current RCRA

Regulations

EPA intends that laboratory waste be managed safely. The Minimum

Performance Criteria contained in proposed 40 CFR 262.104 have been

developed by the University laboratories and EPA to ensure that

laboratory waste is managed in a manner that is protective of human

health and the environment. The following discussion demonstrates how

specific provisions in the Minimum Performance Criteria would compare

with RCRA provisions currently in effect. EPA is describing the current

RCRA provisions as a point of comparison for the requirements proposed

today, but is not proposing any changes to these current RCRA

provisions.

(i) Labeling: Current RCRA regulations require that containers of

hazardous waste in satellite accumulation areas be labeled either with

the words ``hazardous waste'' or with other words that identify the

contents. Today's rule would contain a requirement that laboratory

waste would have to be labeled or tagged with the chemical name and

general hazard class. Where a laboratory container is too small to be

effectively labeled or where containers of like wastes are

consolidated, such as where test tubes are stored in a rack or where

similar wastes are being consolidated in a lab-pack shipping container,

the secondary container (e.g. the rack containing the test tubes or the

DOT shipping container) would have to be labeled. The Environmental

Management Plan would include specific procedures that lab workers

would have to follow to carry out the MPC requirements for labeling in

the laboratories.

(ii) Quantity Limitations: Current federal RCRA regulations for

satellite accumulation areas require that any hazardous waste

accumulated at any point of generation in excess of 55 gallons (or one

quart of acutely hazardous laboratory waste) be removed within three

days. Current regulations do not limit the number of points of

generation within an individual laboratory as long as hazardous waste

is accumulated in accordance with all the requirements of 40 CFR

262.34(c). Thus, a given laboratory could potentially accumulate well

over 55 gallons under the current rules. However, under the proposed

rule, the Universities would be limited to temporarily holding 55

gallons of laboratory waste per laboratory, and no matter how many

points of generation there are within a laboratory, any laboratory

would be limited to 110 gallons. While this proposed restriction may

prove to be more restrictive than the current system, this approach

represents an experiment to be tested under this XL project. Although

this approach could result in a limit that is considerably less than

what a laboratory might be allowed to accumulate under current law,

today's proposed rule would grant the Universities flexibility on the

amount of time allowed to remove excess waste from the laboratory. (See

(iv) below.)

(iii) Quantity Limitation for Excess Laboratory Waste: Current RCRA

regulations do not place specific limits on the amount of ``excess''

hazardous waste, beyond 55 gallons, that a generator may accumulate in

satellite areas during the three days prior to removal of such excess.

Today's proposed rule specifically limits such excess in the laboratory

setting to an additional 55 gallons of laboratory waste (or an

additional 1 quart of acutely hazardous laboratory waste). Thus, the

maximum amount of laboratory waste which may be held in a University

laboratory at any time under today's proposed rule would be 110 gallons

(or two quarts of acutely hazardous laboratory waste). While this

requirement may prove to be more restrictive than the current system,

this approach represents an experiment to be tested under this XL

project, and it would ensure that there would not be excessive

quantities of waste in the laboratories during the 30-day timeframe

discussed below.

(iv) Timing Limitations: Current RCRA regulations state that a

generator may accumulate up to 55 gallons of hazardous waste (or one

quart of acutely hazardous waste) under 40 CFR 262.34(c) and within

three days of exceeding that 55 gallons must comply with the

requirements of 40 CFR 262.34(a) or other applicable requirements with

respect to the excess over 55 gallons (or one quart). Under the

proposed rule, all laboratory waste that has reached threshold amounts

would have to be removed from the lab within 30 days, instead of three

days. EPA is granting flexibility on the timing of removal to allow for

a more efficient pick-up schedule which will in turn allow University

staff to devote additional resources to make centralized decisions

about the reuse of laboratory waste. As noted above, to ensure that

large quantities of waste are not held in laboratories, today's

proposal limits the excess to an additional 55 gallons of laboratory

waste (or one additional quart of acutely hazardous laboratory waste).

(v) Dating and Removal Requirements: Current RCRA regulations

require that a generator mark the container holding hazardous waste in

excess of 55 gallons of hazardous waste (or one quart of acutely

hazardous waste) with the date the excess amount began accumulating.

Today's proposed rule would contain a requirement that

[[Page 40704]]

when laboratory waste reaches the threshold of 55 gallons (or one quart

of acutely hazardous laboratory waste) it must be dated. Once

laboratory waste is dated, the laboratory would have 30 days to remove

it from the laboratory to the on-site hazardous waste accumulation

area.

(vi) Hazardous Waste Accumulation Areas: Once satellite

accumulation quantity limits are met, current RCRA regulations require

generators to comply (within 3 days) with 40 CFR 262.34(a) or other

applicable provisions. Under today's proposed rule, the accumulated

laboratory waste would be directly transferred to a designated on-site

hazardous waste accumulation area. Once the laboratory waste is

received at the on-site hazardous waste accumulation area, the proposed

``temporary conditional deferral'' would no longer apply, and the

laboratory waste that is determined to be hazardous waste would be

managed in accordance with Sec. 262.34(a) or other applicable RCRA

requirements. In this regard, the proposed alternative system is meant

to work in the same way as the current system.

(vii) Container Management: Current RCRA regulations set forth at

40 CFR 265.173(a), as referenced by Sec. 262.34(c)(1)(i), require that

containers of hazardous wastes be closed at all times, except when it

is necessary to add or remove wastes. Today's proposed rule would

contain the same requirement but allows the University to make

exceptions for in-line waste collection containers. Some experiments

use a process for the ``in-line collection'' of waste, which is a

system that automatically collects waste while an experiment is

running. Such systems may collect waste through a physically connected

apparatus, such as, for example, gas chromatographs. Gas chromatographs

commonly carry the chemical sample through the instrument using tubing

that leads from the instrument to waste collection bottles on the back

of the instrument. Each tube commonly runs through a stopper set into

each small collection bottle. Other types of equipment use in-line

collection systems that, while not physically connected, are

nevertheless a necessary part of the apparatus as a means to collect

waste, such as distillation equipment. In these types of systems, the

waste is collected in an otherwise uncovered container (e.g., waste

drips from a tube into the container) while the experiment is running--

although the entire apparatus would be covered or hooded to prevent the

release of volatile hazardous vapors or fumes. The apparatus set-up

provides the physical control otherwise provided by the laboratory

worker, who ensures during an experiment that containers are closed,

except when he or she needs to add or remove a chemical. The proposed

rule for this XL project proposes that such systems for the in-line

collection of waste would be a circumstance in which waste may be

added, consistent with the requirement that containers containing waste

be kept closed (i.e., when a container is permissibly ``open'' for the

adding of waste). To be considered as in-line waste collection, the

University would describe this arrangement for in-line waste collection

in their EMP. This part of the proposed rule addresses the need for

flexibility around the diverse conditions of research and

experimentation that constitute the work of the University

laboratories, while at the same time minimizing the potential for

release. (Note that this rule does not change the meaning of

``release'' under RCRA.) This flexibility is limited to specific

circumstances in order to address the unique configuration of some

research and laboratory instrumentation such as gas chromatographs and

DNA synthesizers. The flexibility is being proposed for in-line waste

collection due to laboratory scale experimentation.

Today's proposed rule also specifies that containers be compatible

with their contents, and be in good condition. These requirements are

equivalent to the current requirements at 40 CFR 262.34(c)1(i) which

reference section 265.171 and section 265.172 regulating the condition

of containers and compatibility of waste in satellite accumulation

areas.

(viii) Inspections: Current RCRA regulations require that satellite

accumulation areas (those areas regulated by 40 CFR 262.34(c), at or

near any point of generation where wastes accumulate) be under the

control of the operator of the process. Although in each laboratory,

laboratory waste could only be generated under the control of the

trained laboratory workers, today's proposed rule would also contain a

requirement for regular inspections of containers of laboratory wastes

within the laboratory to ensure that the containers are meeting

requirements for container management. The frequency of these

inspections would be at least once per year and would otherwise be

based on laboratory practices. Specific inspection schedules would be

specified in the Environmental Management Plan.

Other Minimum Performance Criteria include

(ix) Posting of Emergency Notification Procedures: Today's proposed

rule would contain a requirement that includes posting of emergency

notification procedures and evacuation procedures for laboratory

workers. Current RCRA regulations require facilities to include such

information in a contingency plan (large quantity generators) or to

ensure that all employees are thoroughly familiar with emergency

procedures (small quantity generators). Today's proposed rule makes no

changes to those requirements. Emergency response and notification

procedures, under the proposed rule, would be required for

participating laboratories that otherwise could be regulated under 40

CFR 262.34(c), and the EMPs must address all aspects of laboratory

waste management, including emergencies (see Table 2 for an outline of

EMP requirements and the proposed rule at 40 CFR 262.105).

(x) Emergency Response: Today's proposed rule would contain a

requirement that emergency response equipment and procedures for

emergency response be appropriate to the hazards in the laboratory.

Current RCRA regulations require equipment appropriate to the hazards

presented at a facility and specify procedures that must be followed

for particular emergencies. The proposal also includes a requirement to

comply with spill response provisions set forth in 40 CFR 263.30 and

263.31 for spills of laboratory waste that may occur while it is en

route to the on-site hazardous waste accumulation area.

(xi) Training Requirements: Today's proposed rule would contain a

requirement that laboratory workers receive training so that they can

implement and comply with the Minimum Performance Criteria. Training

under the EMP is required when a laboratory worker is first assigned to

a laboratory and when a laboratory waste poses a new or unique hazard

for which the worker has not received prior training.

(xii) General Compliance: Today's proposed rule would contain a

statement that laboratory waste management must not result in the

release of hazardous constituents into the land, air and water where

such release would be prohibited by federal law.

As noted in Table 2, above, additional requirements for

laboratories under this proposed system would be included in

[[Page 40705]]

the Environmental Management Plan (EMP).

As previously mentioned, the proposed Minimum Performance Criteria

described above would only apply to the management of laboratory waste

within laboratories and while en route to an on-site hazardous waste

accumulation area. Once received at an on-site hazardous waste

accumulation area, the laboratory waste would be subject to all

applicable RCRA requirements. A participating University could, for

example, accumulate any laboratory waste that is determined to be

hazardous waste at the hazardous waste accumulation area in accordance

with the current requirements of 40 CFR 262.34 (for 90 or 180 day on-

site accumulation). EPA is not proposing any changes to the

requirements Universities would have to meet in order to accumulate

waste on-site for 90 (large quantity generators) or 180 days (small

quantity generators).

7. Comparison of the Proposed Rule With Current OSHA and RCRA

Regulatory Requirements

The following discussion demonstrates how specific provisions in

the proposal compare with current OSHA and RCRA requirements. EPA is

describing the current RCRA provisions as a point of comparison for the

requirements proposed today, but is not proposing any changes to these

current RCRA provisions.

The OSHA Chemical Hygiene Plan (CHP) set forth at 29 CFR

1910.1450(e)(3) requires that the CHP address: (i) standard operating

procedures, (ii) criteria used to determine when to implement control

measures, (iii) fume hood functioning, (iv) employee training, (v)

circumstances requiring prior approval, (vi) provisions for medical

consultation, (vii) designation of responsible personnel, (viii)

provisions for protection for work with particularly hazardous

substances and (ix) annual review of the plan and its effectiveness.

Although current OSHA regulations may require a Chemical Hygiene

Plan for laboratories, there is no parallel requirement under RCRA. No

regulations currently require the Universities to implement a

Laboratory Environmental Management Plan as would be required by

today's proposed rule. Moreover, while many of the Minimum Performance

Criteria delineated in the proposed requirements would be similar to

current RCRA requirements for satellite accumulation of hazardous waste

(in the laboratory areas which are currently regulated under 40 CFR

262.34(c)), some limitations have been proposed beyond what current

RCRA requirements allow, such as limiting each laboratory to 55 gallons

of laboratory waste.

Existing RCRA requirements for satellite accumulation (under 40 CFR

262.34(c)) require that containers: (i) be at or near the point of

generation, (ii) be under the control of the operator, (iii) be marked

with the words ``hazardous waste'' or the contents, (iv) be in good

condition, (v) be compatible with their contents, and (vi) be kept

closed except as necessary to add or remove waste. In addition,

accumulation is limited to 55 gallons of hazardous waste per point of

generation. Any excess waste over 55 gallons must within three days

comply with 262.34(a) or other applicable provisions. Existing RCRA

regulations also require that a generator make a hazardous waste

determination. The current federal regulations do not require

management plans for these areas.

The proposed Laboratory Environmental Management Standard has been

drafted in an attempt to align RCRA requirements that would apply to

hazardous wastes in laboratories with the OSHA requirements for

hazardous chemical handling in laboratories, in order to provide for

the more efficient management of laboratory waste. This would be

accomplished by the crafting of an Environmental Management Plan that

would implement standard operating procedures for managing laboratory

waste, just as the CHP requires standard operating procedures relevant

to safety and health considerations when working with hazardous

chemicals.

While the Laboratory Environmental Management Plan proposed in this

project is intended to function in the same way as the OSHA CHP, the

requirements of the Laboratory Environmental Management Standard would

be more effective at managing laboratory wastes. For example, the

Laboratory Environmental Management Standard would require procedures

for an annual review of high hazard chemicals (defined in the

Environmental Management Standard under ``hazardous chemicals of

concern'') in the laboratory, while no such requirement currently

exists under RCRA or OSHA. In addition, the Laboratory Environmental

Management Standard would require an institutional process that is not

required by current regulations for (i) setting environmental

objectives and targets, and (ii) the promotion of pollution prevention

and environmental improvements.

The current RCRA system allows generators to accumulate hazardous

waste at satellite accumulation areas under 40 CFR 262.34(c). The

requirements under 40 CFR 262.34(c) set specific requirements for

container management, labeling, and accumulation times. No written

plans are currently required for a facility to set forth and document

the procedures that they will use to comply with the requirements of

Sec. 262.34(c). In today's proposed rule, the Universities would be

required not only to comply with proposed requirements on container

management, labeling and holding times pursuant to proposed

Sec. 262.104, which offers some flexibility but still ensures

protection of human health and the environment, they would also have to

specifically document the procedures they will use to comply with

proposed Sec. 262.104. In addition, to documenting the procedures for

complying with the Minimum Performance Criteria of Sec. 262.104, the

Universities would also have to develop and document the procedures for

all of the elements in Table 2, i.e.: (i) their environmental policy,

(ii) roles and responsibilities, (iii) a pollution prevention plan,

(iv) their system for tracking requirements applicable to laboratory

waste, (v) criteria for identifying physical and chemical hazards and

control measures to reduce releases, (vi) a system for conducting

surveys of hazardous chemicals of concern, (vii) procedures for

cleaning out laboratories, (viii) criteria with which laboratory

workers would be required to comply in managing laboratory waste

according to the Minimum Performance Criteria, (ix) procedures for safe

and timely removal of wastes from laboratories, (x) procedures for

emergencies, (xi) procedures for training, (xii) procedures for safe

transfer of waste to the accumulation areas, (xiii) procedures for

regularly inspecting a laboratory to assess conformance with the

requirements of the EMP, (xiv) procedures for identifying environmental

management plan nonconformances and corrective actions, (xv)

recordkeeping requirements to document conformance with their EMP. This

Laboratory Environmental Management Plan would be an entirely new

requirement imposed upon the Universities. (This proposed requirement

doesn't change existing institutional RCRA requirements. For example

any University that is currently required to have a Contingency Plan

would still be required to have a Contingency Plan).

EPA envisions a three-part compliance assurance program to ensure

that this proposed system

[[Page 40706]]

adequately protects human health and the environment. First, because

EPA expects the Minimum Performance Criteria to operate as an

equivalent, alternative system to the current RCRA requirements in 40

CFR 262.34(c), EPA expects the first level of assurance to be similar

to the inspection system currently in place. Thus, at the laboratory

level, the first level: the management of laboratory waste would have

to be in conformance with the Minimum Performance Criteria. The second

level would be the documentation of procedures: the Laboratory EMP

would have to be written in conformance with the requirements of the

standard proposed at 40 CFR 262.105. The third level would be

operational: the operations ongoing in all the laboratories that are

participating would have to be in conformance with the procedures

described in the EMP. Thus, this proposal provides two additional

levels of review for satellite storage of hazardous waste, while

allowing the Universities to be more centralized in their operations

and to adopt a more coherent approach to management of laboratory

wastes.

8. How the Laboratory XL Project Will Result in Superior Environmental

Performance

The Laboratory XL Project is designed to achieve environmental

results that are superior to what is currently achieved by the current

RCRA regulatory system. The aim of the proposal is to enable the

Universities to more easily manage all hazardous chemicals under a

logical, integrated scheme. Under the proposed model, environmental

professionals at the Universities would, at on-site hazardous waste

accumulation areas, determine whether there are any opportunities,

throughout the University, for reuse of laboratory waste or whether the

laboratory waste is hazardous waste.

As a result, the Laboratory XL project is expected first and

foremost to result in increased pollution prevention. In a 1996 survey

of approximately 100 academic institutions conducted by the Campus

Safety Health and Environmental Management Association, nearly 95

percent of respondents reported that they reused or recycled less than

one percent of the hazardous chemical waste otherwise destined for

disposal. In the FPA, the Universities have committed themselves to

increased hazardous waste reduction. The Universities have set specific

pollution prevention goals including (i) a 10 percent reduction in the

overall amount of hazardous waste generated from participating

laboratories (from baseline) and (ii) a 20 percent increase (from

baseline) in reuse of laboratory waste over the life of the project. In

accordance with the FPA for this project, the Universities

participating in this XL project would report each year on their

progress in meeting these goals.

Second, under this proposed rule, each University would implement

their procedures for an annual assessment of those hazardous chemicals

that they believe pose significant risks (based on physical or health

hazards, or defined shelf-life) in an effort to minimize risks to human

health and the environment and to monitor materials that might

otherwise accumulate on the shelf or require disposal.

In addition, this XL project would promote the following:

Setting of Environmental Objectives and Targets and

Pollution Prevention: The systematic approach to environmental

management would enable the University to organize waste management

functions to achieve goal setting, better tracking, pollution

prevention, and control. This process is outlined in more detail in the

Final Project Agreement.

Streamlining of the Regulatory Process: By setting up a

complementary system that essentially attempts to integrate EPA and

OSHA requirements, the project would streamline the overall regulatory

process for laboratories, reducing the burden on the Universities and

resulting in a more efficient and protective approach to chemical

management.

Increased Environmental Awareness: The implementation and

continuous improvement of the Laboratory Environmental Management

Standard for laboratories would enhance environmental awareness among

researchers and students leading to a transfer of good environmental

management practices to the larger community.

Finally, the implementation of the Laboratory Environmental

Management Standard would achieve superior environmental performance

because criteria would be set for the systematic management of all

laboratory wastes. Some of the laboratory wastes would otherwise not be

managed under the requirements of RCRA (such as ethidium bromide wastes

and virgin or unused chemicals on the shelf and that haven't

consistently been defined as hazardous waste.)

D. What Regulatory Changes Will Be Necessary to Implement This Project?

1. Federal Regulatory Changes

Today's proposal would provide the Universities with a temporary

conditional deferral from two specific RCRA regulations: Hazardous

Waste Determination: 40 CFR 262.11, and the Satellite Accumulation

Provisions: 40 CFR 262.34(c). The site-specific rule necessary to allow

for the temporary conditional deferral, and being proposed by EPA

today, would add a paragraph (j) to 40 CFR 262.10 to clarify that the

temporary holding of laboratory wastes within the participating

University laboratories would be covered by a new section to 40 CFR

part 262, subpart J. Proposed subpart J would fully describe the

conditions to be met for each University's management of laboratory

waste and by its Laboratory Environmental Management Plan as outlined

above, in the sections C.2., C.3. and C.4 of this preamble.

(i) Hazardous Waste Determination: 40 CFR 262.11: Current

regulation requires that generators make a determination as to whether

a solid waste is a RCRA hazardous waste. The proposed rule would

identify the specific point at which the Universities would make this

determination. Under the proposed rule, the Universities would not make

a hazardous waste determination until the laboratory waste is received

at the on-site Hazardous Waste Accumulation Areas identified in Table 1

above. These areas would be the point where decisions would be made as

to whether the laboratory waste would be reused within the University,

accumulated for up to 90- or 180-days pursuant to 40 CFR 262.34, or

sent to a RCRA permitted (or interim status) treatment, storage or

disposal facility.

Because universities have such small and diverse waste streams and

have large numbers of small laboratories, EPA recognizes the resource

efficiency in making the hazardous waste determination at the on-site

hazardous waste accumulation area. This approach would enable the

university to determine whether laboratory waste can be reused on site

at a central area, where the connections between departments and

laboratories on a university-wide basis can be better made by the

institution's professional environmental health and safety personnel.

EPA also recognizes that while laboratory wastes remain in the

laboratory, they would be managed pursuant to the Laboratory

Environmental Management Standard as embodied in the proposed subpart J

which includes Minimum Performance Criteria to ensure that they would

be

[[Page 40707]]

managed in a manner protective of human health and the environment.

(ii) Satellite Accumulation Provisions: 40 CFR 262.34(c): This

regulation governs the satellite accumulation of hazardous waste. It

states in paragraph (1) that a generator may accumulate as much as 55

gallons of hazardous waste or one quart of acutely hazardous waste in

containers at or near any point of generation where wastes initially

accumulate, which is under the control of the operator of the process

generating the waste, without complying with paragraph 262.34(a)

provided the generator: (i) complies with sections 265.171, 265.172 and

265.173(a); and (ii) marks the containers with the words ``Hazardous

Waste'' or with other words that identify the contents. Paragraph (2)

states that a generator that accumulates in excess of the amounts in

paragraph (1) must, with respect to the excess amount, comply within

three days with 40 CFR 262.34(a) or other applicable provisions. This

paragraph also requires that the generator must mark the container

holding the excess accumulation with the date the excess began

accumulating.

This proposed rule would allow the Universities to manage hazardous

waste in the laboratories without complying with Sec. 262.34(c).

Specifically, the Universities would not be required to comply with the

3-day accumulation time limit that applies to hazardous waste in excess

of 55 gallons. Instead, under the proposed rule, Universities would be

allowed to take 30 calendar days to remove the waste in their

laboratories once the 55 gallon (or one quart of acutely hazardous

laboratory waste) threshold is reached, while complying with their

Environmental Management Plans. The extension from 3 to 30 days would

allow for University environmental, health and safety professionals to

collect and remove laboratory wastes during planned, systematic and

scheduled intervals rather than the current reactive and episodic pick-

ups which, in an institution with over a hundred laboratories, can be

extremely inefficient, diverting environmental, health and safety

department staff time from more proactive measures. By providing

additional time for waste pickups to be carefully scheduled, this

proposed rule should enable university environmental professionals to

provide additional training to students and other laboratory workers

and to develop waste minimization, reuse and recycling opportunities

for chemicals from the university laboratories. In addition, while

laboratory waste is being held in the laboratory, the Universities

would have to manage it in compliance with minimum performance

criteria.

Thus, the result of today's rule is that 40 CFR 262.34(c) would no

longer be the only alternative available to manage waste in the

individual laboratories at the Universities. Another system would be

available under the proposed rule at 40 CFR part 262, subpart J, which

sets forth the requirements of the Laboratory Environmental Management

Plan (proposed Sec. 262.105), and the Minimum Performance Criteria

(proposed Sec. 262.104).

Proposed subpart J would only apply within the Universities'

laboratories and while the laboratory waste is en route to an on-site

hazardous waste accumulation area. Once the laboratory waste is

received at the on-site hazardous waste accumulation area, subpart J

would no longer apply and laboratory waste that is determined to be

hazardous waste would be subject to all applicable RCRA requirements.

2. State Regulatory Changes

The state of Vermont and the Commonwealth of Massachusetts are

authorized under section 3006 of RCRA to implement the federal RCRA

program. Thus, these state programs operate in lieu of the federal

program. Moreover, Vermont and Massachusetts hazardous waste management

regulations, codified in Code of Vermont Regulations and 310 Code of

Massachusetts Regulations (CMR) 30.00, respectively, contain equivalent

or more stringent, requirements as compared to the Federal regulations

at 40 CFR 262.10 and 262.34(c). The Universities are subject to the

Vermont (for the University of Vermont) and the Massachusetts (for the

University of Massachusetts Boston and Boston College) state

regulations, which would include requirements that the hazardous waste

in laboratories be handled according to the accumulation provisions of

RCRA. Therefore, conforming state regulatory changes or legal

mechanisms must be implemented in addition to the proposed federal

changes to undertake this new system.

E. Why Is EPA Supporting This New Approach to Laboratory Waste

Management?

EPA is supporting the regulatory model contained in today's rule

because it provides for a degree of environmental protection that is at

least as protective as that which existing RCRA regulations would

provide for the participating laboratories. The model also promotes

systemic, integrated cost-effective compliance which should increase

opportunities for waste minimization through the centralization of

waste determinations. EPA and the Universities anticipate that

chemicals which would have been disposed of as waste should be

redistributed and reused through the centralized hazardous waste

determination process. In addition, by providing the Universities the

flexibility to schedule regular waste pickups, professional resources

can be redirected from reactive waste management to proactive waste

management.

EPA hopes that this proposed rule will result in a successful

innovative pilot of a new system for universities and research

organizations as unique workplaces where researchers and students often

move from one jurisdiction to another throughout the country. If this

pilot is successful, EPA hopes that this system could be translated

into a national program, to address the confusion regarding the RCRA

rules that has been reported by the universities. By implementing a

standard system for universities, laboratory workers would remain

cognizant of the requirements for managing chemicals, and in

particular, waste chemicals, no matter where in the U.S. they are

performing their research. EPA recognizes that the proposed new system

may not be appropriate or necessary for some institutions such as small

colleges but may, at some point, depending on the results of this XL

project, consider the possibility of offering it as a regulatory

option.

Finally, for this pilot, the Universities would be implementing

continuous improvement systems which would include training, planning,

and self-inspections in ways that have never been tested before.

F. How Have Various Stakeholders Been Involved in This Project?

Stakeholder involvement during the project development stage was

encouraged in several ways. The methods included communicating through

the media (newspaper, e-mails, and the LCEE website); directly

contacting interested parties and offering an educational program

regarding the regulatory requirements impacted by the XL project.

Stakeholders have been kept informed on the project status via mailing

lists, newspaper articles, public meetings and the establishment of a

website at URL: http://esf.uvm.edu/LabXL.

Representatives from Second Nature and Ecologia, national

environmental interest groups (with members participating in the

ISO14000 standard setting process), and the Tellus Institute (a

nationally recognized nonprofit

[[Page 40708]]

corporation providing research on, among other issues, environmental

management performance and reporting) have participated in conference

calls and meetings with the Project XL team and provided comments

during the development of the proposed Final Project Agreement. A

representative of the national environmental group, the Environmental

Defense Fund, has also been a participant in commenting on this

proposal. These representatives continue to be notified of project

meetings and activities.

The university and research community is a diverse and busy one.

Each University has held individual local stakeholder meetings in an

effort to engage their surrounding communities. However, few local

stakeholders other than employees of the facilities have expressed

interest in actively participating in the development of the project.

Copies of all comment letters, as well as EPA's response to comment

letters, will be located in the rulemaking Docket (see the ADDRESSES

section of today's preamble).

As this XL project continues to be implemented, the stakeholder

involvement program would shift its focus to ensure that: (1)

Stakeholders are apprised of the status of project implementation and

(2) Stakeholders have access to information sufficient to judge the

success of this Project XL initiative. Anticipated stakeholder

involvement during the term of the project will likely include other

general public meetings to present periodic status reports,

availability of data and other information generated. In addition to

the EPA, VTDEC, and MADEP reporting requirements of today's rulemaking,

the FPA includes provisions whereby the University Laboratories will

make copies of interim project reports available to all interested

parties. A public file on this XL project has been maintained at the

website http://esf.uvm.edu/labxl throughout project development, and

the Universities have committed to continue to update it as the project

is implemented. Additional information is available at EPA's website at

http://www.epa.gov/projectxl.

A detailed description of this program and the stakeholder support

for this project is included in the Final Project Agreement, which is

available through the docket or through EPA's Project XL site on the

Internet (see ADDRESSES section of this preamble).

G. How Will This Project Result in Cost Savings and Paperwork

Reduction?

Laboratory waste management currently accounts for the most

substantial expense for environmental, health and safety programs at

the participating Universities. This XL Project would allow academic

institutions to more effectively promote and implement waste

minimization programs in laboratories which would reduce waste disposal

costs and minimize chemical purchasing costs. The opportunity to

develop a systematic, planned procedure for the pickup of laboratory

wastes and centralization of waste management decisions would also

enable Environmental Health and Safety Departments to more effectively

utilize staff on proactive activities such as training and implementing

chemical reuse and waste minimization programs.

Additionally, a certain amount of paperwork associated with RCRA

compliance is likely to be reduced in the long term, while in the short

term the requirement to write Environmental Management Plans would add

additional paperwork. Once the Laboratory EMP is written, the annual

review of the Chemical Hygiene Plans required by OSHA, and the review

of the Environmental Management Plan could be accomplished in one step.

The Universities do not expect significant paperwork reduction gains

given the fact that the RCRA requirements would still be fully

applicable once the laboratory waste reaches the on-site hazardous

waste accumulation areas.

H. How Will EPA Ensure the Integrity and Comprehensiveness of Each

University's Laboratory Environmental Management Plan?

EPA, along with MA DEP and VT DEC and designated stakeholders would

have sufficient opportunity to review and comment on the Laboratory

EMP's as they are being developed by the Universities. In this pilot

project, once its Laboratory EMP is complete, each University would

formally submit their own Laboratory EMP to EPA and the applicable

state for a final review of its conformance with the requirements of

the Laboratory Environmental Management Standard. Because the

Universities would be working with the agencies in developing their

EMP, it is expected that they would be able to respond quickly to any

possible comments or concerns raised by the agencies.

I. How Will the Terms of the Laboratory XL Project and Proposed Rule Be

Enforced?

All XL projects must include a legally enforceable mechanism to

ensure accountability and superior environmental performance. EPA

retains its full range of enforcement options under the proposed rule.

The enforcement response on the part of EPA would vary depending upon

the actual performance of each University and the severity of any

violation. So that EPA can continue to evaluate this XL project, each

University would be evaluated by EPA Region I through regular

inspections based on the following four criteria:

1. Does the University have an Environmental Management Plan as

required by the Laboratory Environmental Management Standard?

2. Does the University's Environmental Management Plan include the

required policy and procedural elements specified in the Laboratory

Environmental Management Standard?

3. Is the University in compliance with the Minimum Performance

Criteria as set forth in the Laboratory Environmental Management

Standard at 40 CFR 262.104?

4. To what degree do the University's environmental management

practices in the laboratory conform to its Environmental Management

Plan?

Today's proposed rule includes a termination provision, in addition

to EPA's usual enforcement options, which authorizes EPA to remove from

this XL project any University that does not comply with the Laboratory

Environmental Management Standard as described in the rule. In the

event of such removal, the temporary conditional deferral would be

revoked and the Universities would be required to submit to EPA an

implementation schedule setting forth how the Universities would plan

to come into full compliance regulations within 90 days from such

notice. The schedule would reflect the Universities' intent to use

their best efforts to come into compliance as quickly as practicable

within the 90 day transition period. During this 90 day transition

period, the provisions of this proposed rule and the University's

Environmental Management Plan would apply in full. At the conclusion of

the 90 day period, the applicable RCRA regulations would again apply to

the Universities in full.

The rationale for the 90-day transition period is to allow

sufficient time for the Universities to reinstate the operational and

administrative infrastructure

[[Page 40709]]

necessary for proper RCRA compliance. Such a transition will likely

require the dismantling of the Environmental Management Plan and its

component parts. Retraining and reverting to the implementation of the

current RCRA system would include, among other things, (1) the re-

establishment of 3-day pick-ups of hazardous waste from the University

laboratories, (2) making early hazardous waste determinations in the

laboratories, and (3) the re-training of hundreds of laboratory

workers. Most importantly, this transition might require the

acquisition of funding and resources which were unnecessary under the

streamlined Environmental Management Plan. For example, additional

funding might be needed for the re-negotiation of contract terms with

hazardous waste contractors who might be needed for additional

hazardous waste pick-ups. Finally, the Universities may receive such a

revocation notice during the summer or during a semester break when

staff and graduate students are less available for re-training. For all

of these reasons, and given the fact that the proposed rule and

Environmental Management Plan would be fully applicable during this

time, EPA is confident that the 90-day time frame is reasonable.

J. How Long Will This Project Last and When Will It Be Complete?

As with all XL projects testing alternative environmental

protection strategies, the term of the University Laboratory XL project

is one of limited duration. Today's proposed rule would set the term of

the XL Project at four years after the effective date of this rule.

Because Project XL is a voluntary and experimental program, today's

proposed rule contains provisions that allow the project to conclude

prior to the end of the four years in the event that it is desirable or

necessary to do so. For example, an early conclusion would be warranted

if the project's environmental benefits do not meet the Project XL

requirement for the achievement of superior environmental results. In

addition, new laws or regulations may become applicable to the

Universities' laboratories during the project term which might render

the project impractical, or might contain regulatory requirements that

supersede the superior environmental benefits that the University

Laboratories are achieving under this project. Similarly, the

Universities may also request that the temporary conditional deferral

be revoked prior to the four years if the experimental project does not

provide sufficient benefits for the Universities to justify continued

participation.

If an early conclusion to the project is determined to be

appropriate, today's rule provides a mechanism for EPA to legally

conclude the project prior to the four years, through a notice of

termination, which would trigger the 90-day transitional period

described above in this preamble discussion. While EPA, the state

environmental agencies and the Universities have broad discretion and

latitude to initiate an early conclusion of the project, both expect to

exercise their good faith and judgment in determining whether

exercising this option is appropriate.

EPA reserves the discretion to terminate a project and an FPA in

the event a University fails to comply with or meet its obligations in

the proposed rule, or its supplementary commitments contained in the

FPA. The FPA and the site specific rule also provide for the project

sponsor's return to compliance with existing regulatory requirements

following termination.

IV. Additional Information

A. How To Request a Public Hearing

A public hearing will be held, if requested, to provide opportunity

for interested persons to make oral presentations regarding this

regulation in accordance with 40 CFR part 25. Persons wishing to make

an oral presentation on the site specific rule to implement the

University Laboratory XL project should contact Ms. Gina Snyder or Mr.

George Frantz of the Region I EPA office, at the address given in the

ADDRESSES section of this document. Any member of the public may file a

written statement before the hearing, or after the hearing, to be

received by EPA no later than August 10, 1999. Written statements

should be sent to EPA at the addresses given in the ADDRESSES section

of this document. If a public hearing is held, a verbatim transcript of

the hearing, and written statements provided at the hearing will be

available for inspection and copying during normal business hours at

the EPA addresses for docket inspection given in the ADDRESSES section

of this preamble.

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

Under Executive Order 12866 (58 FR 51735, October 4, 1993) the

Agency must determine whether the regulatory action is ``significant''

and therefore subject to Office of Management and Budget (OMB) review

and the requirements of the Executive Order. The Order defines

``significant regulatory action'' as one that is likely to result in a

rule that may:

(1) Have an annual effect on the economy of $100 million or more or

adversely affect in a material way the economy, a sector of the

economy, productivity, competition, jobs, the environment, public

health or safety in State, local, or tribal governments or communities;

(2) Create a serious inconsistency or otherwise interfere with an

action taken or planned by another agency;

(3) Materially alter the budgetary impact of entitlement, grants,

user fees, or loan programs of the rights and obligations of recipients

thereof; or

(4) Raise novel legal or policy issues arising out of legal

mandates, the President's priorities, or the principles set forth in

the Executive Order.

Because the annualized cost of this final rule will be

significantly less than $100 million and will not meet any of the other

criteria specified in the Executive Order, it has been determined that

this rule is not a ``significant regulatory action'' under the terms of

Executive Order 12866, and is therefore not subject to OMB review.

Executive Order 12866 also encourages agencies to provide a

meaningful public comment period, and suggests that in most cases the

comment period should be 60 days. However, in consideration of the very

limited scope of today's rulemaking and the considerable public

involvement in the development of the proposed Final Project Agreement,

the EPA considers 30 days to be sufficient in providing a meaningful

public comment period for today's action.

C. Is a Regulatory Flexibility Analysis Required?

The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq,

generally requires an agency to conduct a regulatory flexibility

analysis of any rule subject to notice and comment rulemaking

requirements unless the agency certifies that the rule will not have a

significant economic impact on a substantial number of small entities.

Small entities include small businesses, small not-for-profit

enterprises, and small governmental jurisdictions. This rule will not

have a significant impact on a substantial number of small entities

because it only affects three institutions, the University of

Massachusetts in Boston, Massachusetts, Boston College in Boston,

Massachusetts, and the University of Vermont in Burlington, Vermont.

These universities are not small entities. Therefore, EPA certifies

that this action will not have a significant economic impact on a

substantial number of small entities.

[[Page 40710]]

D. Is an Information Collection Request Required for This Project Under

the Paperwork Reduction Act?

This action applies only to three universities, and therefore

requires no information collection activities subject to the Paperwork

Reduction Act, and therefore no information collection request (ICR)

will be submitted to OMB for review in compliance with the Paperwork

Reduction Act, 44 U.S.C. 3501, et seq.

E. Does This Project Trigger the Requirements of the Unfunded Mandates

Reform Act?

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public

Law 104-4, establishes requirements for Federal agencies to assess the

effects of their regulatory actions on State, local, and tribal

governments and the private sector. Under section 202 of the UMRA, EPA

generally must prepare a written statement, including a cost-benefit

analysis, for proposed and final rules with ``Federal mandates'' that

may result in expenditures to State, local, and tribal governments, in

the aggregate, or to the private sector, of $100 million or more in any

one year. Before promulgating an EPA rule for which a written statement

is needed, section 205 of the UMRA generally requires EPA to identify

and consider a reasonable number of regulatory alternatives and adopt

the least costly, most cost-effective or least burdensome alternative

that achieves the objectives of the rule. The provisions of section 205

do not apply when they are inconsistent with applicable law. Moreover,

section 205 allows EPA to adopt an alternative other than the least

costly, most cost-effective or least burdensome alternative if the

Administrator publishes with the final rule an explanation of why that

alternative was not adopted. Before EPA establishes any regulatory

requirements that may significantly or uniquely affect small

governments, including tribal governments, it must have developed under

section 203 of the UMRA a small government agency plan. The plan must

provide for notifying potentially affected small governments, enabling

officials of affected small governments to have meaningful and timely

input in the development of EPA regulatory proposals with significant

Federal intergovernmental mandates, and informing, educating, and

advising small governments on compliance with the regulatory

requirements.

As noted above, this rule is applicable only to the three

universities in Massachusetts and Vermont. The EPA has determined that

this rule contains no regulatory requirements that might significantly

or uniquely affect small governments. EPA has also determined that this

rule does not contain a Federal mandate that may result in expenditures

of $100 million or more for State, local, and tribal governments, in

the aggregate, or the private sector in any one year. Thus, today's

rule is not subject to the requirements of sections 202 and 205 of the

UMRA.

F. RCRA and Hazardous and Solid Waste Amendments of 1984

1. Applicability of Rules in Authorized States

Under section 3006 of RCRA, EPA may authorize qualified states to

administer and enforce the RCRA program for hazardous waste within the

state. (See 40 CFR part 271 for the standards and requirements for

authorization.) States with final authorization administer their own

hazardous waste programs in lieu of the federal program. Following

authorization, EPA retains enforcement authority under sections 3008,

7003 and 3013 of RCRA.

After authorization, federal rules written under RCRA (non-HSWA),

no longer apply in the authorized state except for those issued

pursuant to the Hazardous and Solid Waste Act Amendments of 1984

(HSWA). New federal requirements imposed by those rules do not take

effect in an authorized state until the state adopts the requirements

as state law.

In contrast, under section 3006(g) of RCRA, new requirements and

prohibitions imposed by HSWA take effect in authorized states at the

same time they take effect in nonauthorized states. EPA is directed to

carry out HSWA requirements and prohibitions in authorized states until

the state is granted authorization to do so.

2. Effect on Massachusetts and Vermont Authorization

Today's proposed rule, if finalized, would be promulgated pursuant

to non-HSWA authority, rather than HSWA. Massachusetts and Vermont have

received authority to administer most of the RCRA program; thus,

authorized provisions of each State's hazardous waste program are

administered in lieu of the federal program. Massachusetts and Vermont

have received authority to administer hazardous waste standards for

generators. As a result, if today's proposed rule is finalized, it

would not be effective in Massachusetts and Vermont until the State

adopts equivalent legal mechanisms or requirements as state law. It is

EPA's understanding that subsequent to the promulgation of this rule,

Massachusetts and Vermont intend to propose rules or other legal

mechanisms containing equivalent provisions. EPA may not enforce these

requirements until it approves the State requirements as a revision to

the authorized State program.

G. How Does This Rule Comply With Executive Order 13045: Protection of

Children From Environmental Health Risks and Safety Risks?

The Executive Order 13045, ``Protection of Children from

Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,

1997) applies to any rule that: (1) Is determined to be ``economically

significant,'' as defined under Executive Order 12866; and (2) concerns

an environmental health or safety risk that EPA has reason to believe

may have a disproportionate effect on children. If the regulatory

action meets both criteria, the Agency must evaluate the environmental

health or safety effects of the planned rule on children, and explain

why the planned regulation is preferable to other potentially effective

and reasonably feasible alternatives considered by the Agency.

This rule is not subject to Executive Order 13045 because it is not

an economically significant rule, as defined by Executive Order 12866,

and because it does not involve decisions based on environmental health

or safety risks.

H. Does This Rule Comply With Executive Order 12875: Enhancing

Intergovernmental Partnerships?

Under Executive Order 12875, EPA may not issue a regulation that is

not required by statute and that creates a mandate upon a State, local

or tribal government, unless the Federal government provides the funds

necessary to pay the direct compliance costs incurred by those

governments. If the mandate is unfunded, EPA must provide to the Office

of Management and Budget a description of the extent of EPA's prior

consultation with representatives of affected State, local and tribal

governments, the nature of their concerns, copies of any written

communications from the governments, and a statement supporting the

need to issue the regulation. In addition, Executive Order 12875

requires EPA to develop an effective process permitting elected

officials and other representatives of State, local and tribal

governments to provide meaningful and timely input in the development

of regulatory proposals containing significant unfunded mandates.

[[Page 40711]]

Today's rule does not create a mandate on State, local or tribal

governments. The rule does not impose any enforceable duties on these

entities. Accordingly, the requirements of section 1(a) of Executive

Order 12875 do not apply to this rule.

I. How Does This Rule Comply With Executive Order 13084: Consultation

and Coordination With Indian Tribal Governments?

Under Executive Order 13084, EPA may not issue a regulation that is

not required by statute, that significantly or uniquely affects the

communities of Indian tribal governments, and that imposes substantial

direct compliance costs on those communities, unless the Federal

government provides the funds necessary to pay the direct compliance

costs incurred by the tribal governments. If the mandate is unfunded,

EPA must provide to the Office of Management and Budget, in a

separately identified section of the preamble to the rule, a

description of the extent of EPA's prior consultation with

representatives of affected tribal governments, a summary of the nature

of their concerns, and a statement supporting the need to issue the

regulation. In addition, Executive Order 13084 requires EPA to develop

an effective process permitting elected and other representatives of

Indian tribal governments to provide meaningful and timely input in the

development of regulatory policies on matters that significantly or

uniquely affect their communities. Today's rule does not significantly

or uniquely affect the communities of Indian tribal governments. There

are no communities of Indian tribal governments located in the vicinity

of the university laboratories. Accordingly, the requirements of

section 3(b) of Executive Order 13084 do not apply to this rule.

J. Does This Rule Comply With the National Technology Transfer and

Advancement Act?

Section 12(d) of the National Technology Transfer and Advancement

Act of 1995 (``NTTAA''), Public Law 104-113, section 12(d) (15 U.S.C.

272 note) directs EPA to use voluntary consensus standards in its

regulatory activities unless to do so would be inconsistent with

applicable law or otherwise impractical. Voluntary consensus standards

are technical standards (e.g., materials specifications, test methods,

sampling procedures, and business practices) that are developed or

adopted by voluntary consensus standards bodies. The NTTAA directs EPA

to provide Congress, through OMB, explanations when the Agency decides

not to use available and applicable voluntary consensus standard. This

proposed rulemaking does not involve technical standards. Therefore,

EPA is not considering the use of any voluntary consensus standards.

EPA welcomes comments on this aspect of the proposed rulemaking and,

specifically, invites the public to identify potentially-applicable

voluntary consensus standards and to explain why such standards should

be used in this regulation.

List of Subjects in 40 CFR Part 262

Environmental protection, Accumulation time, Hazardous waste, Waste

determination.

Dated: July 21, 1999.

Carol M. Browner,

Administrator.

For the reasons set forth in the preamble, part 262 of Chapter I of

title 40 of the Code of Federal Regulations is proposed to be amended

as follows:

PART 262--STANDARDS APPLICABLE TO GENERATORS OF HAZARDOUS WASTE

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

follows:

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

Subpart A--General

1. Section 262.10 is amended by adding paragraph (j) to read as

follows:

Sec. 262.10 Purpose, scope, and applicability.

* * * * *

(j)(1) Universities that are participating in the Laboratory XL

project are the University of Massachusetts Boston in Boston,

Massachusetts, Boston College in Chestnut Hill, Massachusetts, and the

University of Vermont in Burlington, Vermont (``Universities''). The

Universities generate laboratory wastes, (as defined in 40 CFR 262.102)

some of which will be hazardous wastes. As long as the Universities

comply with all the requirements of 40 CFR Part 262, Subpart J, the

Universities' laboratories that are participating in the University

Laboratories XL Project as identified in Table 1, are not subject to

the provisions of 40 CFR 262.11, 262.34(c), 40 CFR Part 264, 40 CFR

Part 265, and the permit requirements of 40 CFR Part 270 with respect

to said laboratory wastes.

Table 1.--Laboratory XL Project Participant Information

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

Approx.

Institution number of Departments participating Location of current hazardous

labs waste accumulation areas

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

Boston College, Chestnut Hill, MA.... 120 Chemistry, Biology, Geology, Merkert Chemistry Building,

Physics, Psychology. 2609 Beacon St., Boston MA;

Higgins Building, 140

Commonwealth Ave., Chestnut

Hill, MA.

University of Massachusetts Boston, 150 Chemistry, Biology, Science Building (Bldg.

Boston, MA. Psychology, Anthropology, #080); McCormack Building

Geology and Earth Sciences, (Bldg. #020); and Wheatley

and Environmental, Coastal Building (Bldg. #010), 100

and Ocean Sciences. Morrissey Blvd., Boston, MA.

University of Vermont, Burlington, VT 400 Colleges of: Agriculture and Given Bunker, 89 Beaumont

Life Sciences, Arts and Ave., Burlington, VT.

Sciences, Medicine, and

Engineering and Mathematics;

and Schools of: Nursing,

Allied Heath Sciences, and

Natural Resources.

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

(2) Each University shall have the right to change its respective

departments or the on-site location of its hazardous waste accumulation

areas listed in Table 1 upon written notice to the Regional

Administrator for EPA--Region I and the appropriate state agency. Such

written notice will be

[[Page 40712]]

provided at least ten days prior to the effective date of any such

changes.

2. Part 262 is amended by adding Subpart J to read as follows:

Subpart J--University Laboratories XL Project--Laboratory

Environmental Management Standard

Sec.

262.100 To what organizations does this subpart apply?

262.101 What is in this subpart?

262.102 What special definitions are included in this subpart?

262.103 What is the scope of the laboratory environmental

management standard?

262.104 What are the minimum performance criteria?

262.105 What must be included in the laboratory environmental

management plan?

262.106 When must a hazardous waste determination be made?

262.107 Under what circumstances will a university's participation

in this environmental management standard pilot be terminated?

262.108 When will this subpart expire?

Sec. 262.100 To what organizations does this subpart apply?

This Subpart applies to an organization that meets all three of the

following conditions:

(a) It is one of the three following academic institutions: The

University of Massachusetts Boston in Boston, Massachusetts, Boston

College in Chestnut Hill, Massachusetts, or the University of Vermont

in Burlington, Vermont (``Universities''); and

(b) It is a laboratory at one of the Universities (identified

pursuant to Sec. 262.105(c)(2)(ii)) where laboratory scale activities,

as defined in Sec. 262.102, result in laboratory waste; and

(c) It complies with all the requirements of this Subpart.

Sec. 262.101 What is in this subpart?

This Subpart provides a framework for a new management system for

wastes that are generated in University laboratories. This framework is

called the Laboratory Environmental Management Standard. The standard

includes some specific definitions that apply to the University

laboratories. It contains specific requirements for how to handle

laboratory waste that are called Minimum Performance Criteria. The

standard identifies the requirements for developing and implementing an

environmental management plan. It outlines the responsibilities of the

management staff of each participating university. Finally, the

standard identifies requirements for training people who will work in

the laboratories or manage laboratory waste. This Subpart contains

requirements for RCRA solid and hazardous waste determination, and

circumstances for termination and expiration of this pilot.

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

For purposes of this Subpart, the following definitions apply:

Acutely Hazardous Laboratory Waste means a laboratory waste,

defined in the Environmental Management Plan as posing significant

potential hazards to human health or the environment and which must

include RCRA ``P'' wastes, and may include particularly hazardous

substances as designated in a University's Chemical Hygiene Plan under

OSHA, or Extremely Hazardous Substances under the Emergency Planning

and Community Right to Know Act.

Emergency means any occurrence such as, but not limited to,

equipment failure, rupture of containers or failure of control

equipment which results in the potential uncontrolled release of a

hazardous chemical into the environment and which requires agency or

fire department notification and/or reporting.

Environmental Management Plan (EMP) means a written program

developed and implemented by the university which sets forth standards

and procedures, responsibilities, pollution control equipment,

performance criteria, resources and work practices that both protect

human health and the environment from the hazards presented by

laboratory wastes within a laboratory and between a laboratory and the

hazardous waste accumulation area, and satisfies the plan requirements

defined elsewhere in this Subpart. Certain requirements of this plan

are satisfied through the use of the Chemical Hygiene Plan (see, 29 CFR

Sec. 1910.1450), or equivalent, and other relevant plans, including a

waste minimization plan. The elements of the Environmental Management

Plan must be easily accessible, but may be integrated into existing

plans, incorporated as an attachment, or developed as a separate

document.

Environmental Objective means an overall environmental goal of the

organization which is verifiable.

Environmental Performance means results of the data collected

pursuant to implementation of the Environmental Management Plan as

measured against policy, objectives and targets.

Environmental Target means an environmental performance requirement

of the organization which is quantifiable, where practicable,

verifiable and designed to be achieved within a specified time frame.

Hazardous Chemical means any chemical which is a physical hazard or

a health hazard. A physical hazard means a chemical for which there is

scientifically valid evidence that it is a combustible liquid, a

compressed gas, explosive, flammable, an organic peroxide, an oxidizer,

pyrophoric, unstable (reactive) or water-reactive. A health hazard

means a chemical for which there is statistically significant evidence

based on at least one study conducted in accordance with established

scientific principles that acute or chronic health effects may occur in

exposed employees. The term ``health hazard'' includes chemicals which

are carcinogens, toxic or highly toxic agents, reproductive toxins,

irritants, corrosives, sensitizers, hepatotoxins, nephrotoxins,

neurotoxins, agents which act on the hematopoietic system and agents

which damage the lungs, skin, eyes or mucous membranes.

Hazardous Chemical of Concern means a chemical that the

organization has identified as having the potential to be of

significant risk to human health or the environment if not managed in

accordance with procedures or practices defined by the organization.

Hazardous Waste Accumulation Area means the on-site area at a

University where the University will make a solid and hazardous waste

determination with respect to laboratory wastes.

In-Line Waste Collection means a system for the automatic

collection of laboratory waste which is directly connected to or part

of a laboratory scale activity and which is constructed or operated in

a manner which prevents the release of any laboratory waste therein

into the environment during collection.

Laboratory means, for the purpose of this Subpart, an area within a

facility where the laboratory use of hazardous chemicals occurs. It is

a workplace where relatively small quantities of hazardous chemicals

are used on a non-production basis. The physical extent of individual

laboratories within an organization will be defined by the

Environmental Management Plan. A laboratory may include more than a

single room if the rooms are in the same building and under the common

supervision of a laboratory supervisor.

Laboratory Clean-Out means an evaluation of the chemical inventory

of a laboratory as a result of laboratory renovation, relocation or a

change in laboratory supervision that may result in the transfer of

laboratory wastes to the hazardous waste accumulation area.

Laboratory Environmental Management Standard means the

[[Page 40713]]

provisions of this Subpart and includes the requirements for

preparation of Environmental Management Plans and the inclusion of

Minimum Performance Criteria within each Environmental Management Plan.

Laboratory Scale means work with substances in which containers

used for reactions, transfers and other handling of substances are

designed to be safely and easily manipulated by one person.

``Laboratory Scale'' excludes those workplaces whose function is to

produce commercial quantities of chemicals.

Laboratory Waste means a hazardous chemical that results from

laboratory scale activities and includes the following: excess or

unused hazardous chemicals that may or may not be reused outside their

laboratory of origin; hazardous chemicals determined to be RCRA

hazardous waste as defined in 40 CFR Part 261; and hazardous chemicals

that will be determined not to be RCRA hazardous waste pursuant to 40

CFR 262.106.

Laboratory Worker means a person who is assigned to handle

hazardous chemicals in the laboratory and may include researchers,

students or technicians.

Legal and Other Requirements means requirements imposed by, or as a

result of, governmental permits, governmental laws and regulations,

judicial and administrative enforcement orders, non-governmental

legally enforceable contracts, research grants and agreements,

certification specifications, formal voluntary commitments and

organizational policies and standards.

Senior Management means senior personnel with overall

responsibility, authority and accountability for managing laboratory

activities within the organization.

Universities means the following academic institutions; University

of Vermont, Boston College, and the University of Massachusetts Boston,

which are participants in this Laboratory XL project and which are

subject to the requirements set forth in this Subpart I.

Sec. 262.103 What is the scope of the laboratory environmental

management standard?

The Laboratory Environmental Management Standard will not affect or

supersede any legal requirements other than those described in

Sec. 262.10(j). The requirements that continue to apply include, but

are not limited to, OSHA, Fire Codes, wastewater permit limitations,

emergency response notification provisions, or other legal requirements

applicable to University laboratories.

Sec. 262.104 What are the minimum performance criteria?

The Minimum Performance Criteria that each University must meet in

managing its Laboratory Waste are:

(a) Each University must label all laboratory waste with the

chemical name and general hazard class. If the container is too small

to hold a label, the label must be placed on a secondary container.

(b) Each University may temporarily hold up to 55 gallons of

laboratory waste or one quart of acutely hazardous laboratory waste, or

weight equivalent, in each laboratory, but upon reaching these

thresholds, each University must mark that laboratory waste with the

date when this threshold requirement was met (by dating the

container(s) or secondary container(s)).

(c) Each university must remove all of the dated laboratory waste

from the laboratory for direct delivery to the hazardous waste

accumulation area within 30 days of reaching the threshold amount

identified in paragraph (b) of this section.

(d) In no event shall the excess laboratory waste that a laboratory

temporarily holds before dated laboratory waste is removed exceed an

additional 55 gallons of laboratory waste (or one additional quart of

acutely hazardous laboratory waste). No more than 110 gallons of

laboratory waste total (or no more than two quarts of acutely hazardous

laboratory waste total) may be temporarily held in a laboratory at any

one time. Excess laboratory waste must be dated and removed in

accordance with the requirements of paragraphs (b) and (c) of this

section.

(e) Containers of laboratory wastes must be:

(1) Closed at all times except when wastes are being added to

(including during in-line waste collection) or removed from the

container;

(2) Maintained in good condition and stored in the laboratory in a

manner to avoid leaks;

(3) Compatible with their contents to avoid reactions between the

waste and its container; and must be made of, or lined with, materials

which are compatible with the laboratory wastes to be temporarily held

in the laboratory so that the container is not impaired; and

(4) Inspected regularly (at least annually) to ensure that they

meet requirements for container management.

(f) The management of laboratory waste must not result in the

release of hazardous constituents into the land, air and water where

such release is prohibited under federal law.

(g) The requirements for emergency response are:

(1) Each University must post notification procedures, location of

emergency response equipment to be used by laboratory workers and

evacuation procedures;

(2) Emergency response equipment and procedures for emergency

response must be appropriate to the hazards in the laboratory such that

hazards to human health and the environment will be minimized in the

event of an emergency;

(3) In the event of a fire, explosion or other release of

laboratory waste which could threaten human health or the environment,

the laboratory worker must follow the notification procedures under

paragraph (g)(1) of this section.

(h) Each University must investigate, document, and take actions to

correct and prevent future incidents of hazardous chemical spills,

exposures and other incidents that trigger a reportable emergency or

that require reporting under paragraph (g) of this section.

(i) Each University may only transfer laboratory wastes from a

laboratory directly to an on-site designated hazardous waste

accumulation area. Notwithstanding 40 CFR 263.10(a), each University

must comply with requirements for transporters set forth in 40 CFR

263.30 and 263.31 in the event of a discharge of laboratory waste en

route from a laboratory to an on-site hazardous waste accumulation

area.

(j) Each University must provide laboratory workers with

information and training so that they can implement and comply with

these Minimum Performance Criteria.

Sec. 262.105 What must be included in the laboratory environmental

management plan?

(a) Each University must include specific measures it will take to

protect human health and the environment from hazards associated with

the management of laboratory wastes and from the reuse, recycling or

disposal of such materials outside the laboratory.

(b) Each University must write, implement and comply with an

Environmental Management Plan that includes the following:

(1) The specific procedures to assure compliance with each of the

Minimum Performance Criteria set forth in Sec. 262.104.

(2) An environmental policy, or environmental, health and safety

policy, signed by the University's senior management, which must

include

[[Page 40714]]

commitments to regulatory compliance, waste minimization, risk

reduction and continual improvement of the environmental management

system.

(3) A description of roles and responsibilities for the

implementation and maintenance of the Laboratory Environmental

Management Plan.

(4) A system for identifying and tracking legal and other

requirements applicable to laboratory waste, including the procedures

for providing updates to laboratory supervisors.

(5) Criteria for the identification of physical and chemical

hazards and the control measures to reduce the potential for releases

of laboratory wastes to the environment, including engineering

controls, the use of personal protective equipment and hygiene

practices, containment strategies and other control measures.

(6) A pollution prevention plan, including, but not limited to,

roles and responsibilities, training, pollution prevention activities,

and performance review.

(7) A system for conducting and updating annual surveys of

hazardous chemicals of concern and procedures for identifying acutely

hazardous laboratory waste.

(8) The procedures for conducting laboratory clean-outs with regard

to the safe management and disposal of laboratory wastes.

(9) The criteria that laboratory workers must comply with for

managing, containing and labeling laboratory wastes, including: an

evaluation of the need for and the use of any special containers or

labeling circumstances, and the use of laboratory wastes secondary

containers including packaging, bottles, or test tube racks.

(10) The procedures relevant to the safe and timely removal of

laboratory wastes from the laboratory.

(11) The emergency preparedness and response procedures to be

implemented for laboratory waste.

(12) Provisions for information dissemination and training,

provided for in paragraph (d) of this section.

(13) The procedures for the development and approval of changes to

the Environmental Management Plan.

(14) The procedures and work practices for safely transferring or

moving laboratory wastes from a laboratory to a hazardous waste

accumulation area.

(15) The procedures for regularly inspecting a laboratory to assess

conformance with the requirements of the Environmental Management Plan.

(16) The procedures for the identification of environmental

management plan noncompliance, and the assignment of responsibility,

timelines and corrective actions to prevent their reoccurrence.

(17) The recordkeeping requirements to document conformance with

this Plan.

(c) Organizational responsibilities for each university. Each

University must:

(1) Develop and oversee implementation of its Laboratory

Environmental Management Plan.

(2) Identify the following:

(i) Annual environmental objectives and targets;

(ii) Those laboratories covered by the requirements of the

Laboratory Environmental Management Plan.

(3) Assign roles and responsibilities for the effective

implementation of the Environmental Management Plan.

(4) Determine whether laboratory wastes received at a hazardous

waste accumulation area are solid wastes under RCRA and, if so, whether

they are hazardous.

(5) Develop, implement, and maintain:

(i) Policies, procedures and practices governing its compliance

with the Environmental Management Plan and applicable federal and state

hazardous waste regulations.

(ii) Procedures to monitor and measure relevant conformance and

environmental performance data for the purpose of supporting continual

improvement of the Environmental Management Plan.

(iii) Policies and procedures for managing environmental documents

and records applicable to this Environmental Management Standard.

(6) Ensure that:

(i) Its Environmental Management Plan is available to laboratory

workers, vendors, employee representatives, visitors, on-site

contractors, and upon request, to governmental representatives.

(ii) Personnel designated by each University to handle laboratory

wastes and RCRA hazardous waste receive appropriate training.

(iii) The Environmental Management Plan is reviewed at least

annually by senior management to ensure its continuing suitability,

adequacy and effectiveness. The reviews may include, but not be limited

to, a consideration of monitoring and measuring information, Laboratory

Environmental Management Standard performance data, assessment and

audit results and other relevant information and data.

(d) What are the Information and Training Requirements for Each

University? (1) Each University must provide laboratory workers with

information and training so that they understand and can implement the

elements of each University's Environmental Management Plan that are

relevant to the laboratory workers' responsibilities.

(2) Each University must provide the information and training to

each laboratory worker when he/she is first assigned to a work area

where laboratory wastes may be generated. Each University must retrain

a laboratory worker when a laboratory waste poses a new or unique

hazard for which the laboratory worker has not received prior training

and as frequently as needed to maintain knowledge of the procedures of

the Environmental Management Plan.

(3) Each University must provide an outline of training and specify

who is to receive training in its Environmental Management Plan.

(4) Each University must ensure that laboratory workers are

informed of:

(i) The contents of this Subpart and the Laboratory Environmental

Management Plan(s) for the laboratory(ies) in which they will be

performing work;

(ii) The location and availability of the Environmental Management

Plan;

(iii) Emergency response measures applicable to laboratories;

(iv) Signs and indicators of a hazardous substance release;

(v) The location and availability of known reference materials

relevant to implementation of the Environmental Management Plan; and

(vi) Environmental training requirements applicable to laboratory

workers.

(5) Each University must train Laboratory workers in:

(i) Methods and observations that may be used to detect the

presence or release of a hazardous substance;

(ii) The chemical and physical hazards associated with laboratory

wastes in their work area;

(iii) The relevant measures a laboratory worker can take to protect

human health and the environment; and

(iv) Details of the Environmental Management Plan sufficient to

ensure they manage laboratory waste in accordance with the requirements

of this Subpart.

(6) Requirements pertaining to Laboratory visitors:

(i) Laboratory visitors, such as on-site contractors or

environmental vendors, that require information and training under this

standard must be identified in the Environmental Management Plan.

(ii) Laboratory visitors identified in the Environmental Management

Plan must be informed of the existence and location of the

Environmental Management Plan.

[[Page 40715]]

(iii) Laboratory visitors identified in the Environmental

Management Plan must be informed of relevant policies, procedures or

work practices to ensure compliance with the requirements of the

Environmental Management Plan.

(7) Each University must define methods of providing objective

evidence and records of training and information dissemination in its

Environmental Management Plan.

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

Each University must evaluate all laboratory wastes to determine

whether they are solid wastes under RCRA and, if so, determine pursuant

to 40 CFR 262.11(a) through (d) whether they are hazardous wastes, as

soon as the laboratory wastes reach the University's Hazardous Waste

Accumulation area(s). At this point each University must determine

whether the laboratory waste will be reused or whether it must be

managed as RCRA solid or hazardous waste. Laboratory waste that is

determined to be hazardous waste is no longer subject to the provisions

of this Subpart and must be managed in accordance with all applicable

RCRA requirements.

Sec. 262.107 Under what circumstances will a university's

participation in this environmental management standard pilot be

terminated?

(a) EPA retains the right to terminate a University's participation

in this Laboratory XL project if the University:

(1) Is in non-compliance with the Minimum Performance Criteria in

Sec. 262.104; or

(2) Has actual environmental management practices in the laboratory

that do not conform to its Environmental Management Plan; or

(3) Is in non-compliance with the Hazardous Waste Determination

requirements of Sec. 262.106.

(b) In the event of termination, EPA will provide the University

with 15 days written notice of its intent to terminate. During this

period, which commences upon receipt of the notice, the University will

have the opportunity to come back into compliance with the Minimum

Performance Criteria, its Environmental Management Plan, or the

requirements for making a hazardous waste determination at Sec. 262.106

or to provide a written explanation as to why it was not in compliance

and how it intends to return to compliance. If, upon review of the

University's written explanation, EPA then re-issues a written notice

terminating the University from this XL Project, the provisions of

Sec. 262.107(c) will immediately apply and the University shall have 90

days to come into compliance with the applicable RCRA requirements

deferred by Sec. 262.10(j). During the 90-day transition period, the

provisions of this Subpart shall continue to apply to the University.

(c) If a University withdraws from this XL project, or receives a

notice of termination pursuant to this section, it must submit to EPA

and the state a schedule for returning to full compliance with RCRA

requirements at the laboratory level. The schedule must show how the

University will return to full compliance with RCRA within 90 days from

the date of the notice of termination or withdrawal.

Sec. 262.108 When will this subpart expire?

This Subpart will expire on [INSERT DATE 4 YEARS FROM EFFECTIVE

DATE OF FINAL RULE].

[FR Doc. 99-19123 Filed 7-26-99; 8:45 am]

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