United States      Solid Waste and     EPA530-R-02-008
         Environmental Protection  Emergency Response   March 2002
         Agency	(5305W)	www.epa.gov/osw
SEPA   REPORT TO
         CONGRESS:
         Evaluating the Consensus
         Best Practices Developed
         through the Howard Hughes
         Medical Institute's
         Collaborative Hazardous
         Waste Management
         Demonstration Project and
         the Need for Regulatory
         Changes to Carry Out Project
         Recommendations

-------
                    REPORT TO CONGRESS
     Evaluating the Consensus Best Practices Developed through the
                 Howard Hughes Medical Institute's
Collaborative Hazardous Waste Management Demonstration Project and the
  Need for Regulatory Changes to Carry Out Project Recommendations
                         In Response to
          Senate Report 106-410 and House Report 106-674
                     Accompanying H.R. 4635
                          March 2002
                       Office of Solid Waste
            Office of Solid Waste and Emergency Response
            United States Environmental Protection Agency

-------
                                  EXECUTIVE SUMMARY
       This report discusses a collaborative project initiated by the Howard Hughes Medical Institute
(HHMI) to establish and evaluate a performance-based approach to management of hazardous wastes
in the laboratories of academic research institutions.  Participants in the project included ten academic
research institutions and representatives from state and federal environmental regulatory agencies.  The
Environmental Protection Agency (EPA) commends HHMI, the ten participating academic research
institutions, and other participants on their efforts to improve hazardous waste management in academic
research laboratories through development and demonstration of a robust set of consensus best
practices. EPA recognizes academic research institutions have had difficulty complying with the
Resource Conservation and Recovery Act (RCRA) regulations due largely to their industry-oriented
framework.  Therefore, EPA supports developing effective alternatives for safely managing hazardous
wastes in academic research institutions that meet standards for protection of human health and the
environment. Although EPA believes that the current RCRA regulations are flexible and may allow for
the implementation of the majority of the best practices developed through the  project, it also believes
that in some  cases regulatory changes may be required.  EPA also believes that the regulatory change
process allows the Agency to consider views from diverse stakeholders as well as promotes national
consistency.  EPA plans to issue a guidance memo shortly that will address some concerns of academic
institutions by clarifying existing EPA policy and how it impacts laboratory wastes and operations. At
the same time EPA looks forward to working with HHMI as well as other laboratory associations,
states, EPA Regions, the Occupational Safety and Health Administration, and the public to develop an
approach that builds upon the consensus best practices as well as other ongoing efforts to provide labs
needed flexibility while maintaining effective protection for human health and the environment. EPA
expects to begin a coordinated project this spring that follows up on the recommendations of this report
and integrates other ongoing work addressing related issues.

-------
                                        PART ONE

I.  INTRODUCTION AND BACKGROUND

       In 1999, the Howard Hughes Medical Institute (HHMI) initiated a collaborative project to
establish and evaluate a performance-based approach to the management of hazardous wastes in the
laboratories of academic research institutions. HHMI believed that such an approach coupled with
regulatory flexibility could yield superior compliance and reduce burden under the hazardous waste
regulations of the Resource Conservation and Recovery Act (RCRA).  The HHMI collaborative
project partnered environmental health and safety professionals and biomedical researchers from ten
major academic research institutions and respective state regulatory officials from each of the ten
regions of the U.S. Environmental Protection Agency ("EPA" or "the Agency").  The participants
developed fourteen consensus best practices as guidelines to the new approach for managing hazardous
wastes in academic research institutions.

       During deliberations over the FY 2001 budget, both the House and Senate Committees on
Appropriations included language in reports (House Report 106-674  and Senate Report 106-410)
supporting the Howard Hughes Medical  Institute initiative and asking that EPA provide the maximum
flexibility permissible under the regulatory provisions of RCRA. Since under RCRA, states are
authorized to administer and enforce a hazardous waste program in lieu of the federal program, EPA
encouraged states to provide the maximum flexibility permissible under the regulations. Similarly,
written guidance to RCRA Regional Program administrators encouraged support for the program. (See
Attachment to Part One of this report.)  Also, in response to Congressional requests, EPA has
prepared this Report to Congress.

       Part One of EPA's Report to Congress provides a summary of the RCRA-related challenges
to academic research institutions (Section n), a summary of other initiatives that reflect or address
academic research institution's concerns (Section HI), a description of EPA's role in the HHMI
collaborative project (Section IV), and EPA's evaluation of the consensus best practices and the need
for regulatory changes to carry out initiative recommendations
(Section V).

       Part Two of this report contains the HHMI "Report on Consensus Best Practices for Managing
Hazardous Wastes in Academic Research Institutions," October 2001. The HHMI demonstration
phase report contains detailed information regarding the project and the results and findings of
university-based demonstration projects, which the academic research institutions and HHMI used to
evaluate implementation of the consensus best practices.

H. SUMMARY OF REGULATORY CHALLENGES

        Many academic research institutions are subject to the Resource Conservation and Recovery
Act (RCRA) regulations for managing hazardous wastes. These requirements are designed to protect
human health and the environment from  the mismanagement of hazardous wastes and establish a system
to manage hazardous waste generation, transport, recycling, treatment, storage and disposal.

                                             1

-------
RCRA Overview

       RCRA §3002 requires EPA to promulgate regulations applicable to generators of hazardous
waste as may be necessary to protect human health and the environment. These generator regulations,
codified in 40 Code of Federal Register Part 262, apply to all hazardous waste generators and are the
primary RCRA requirements governing university hazardous waste activities. They apply to hazardous
wastes managed by academic research institutions if an institution generates over 100 kilograms of non-
acute hazardous waste in a calendar month or one or more kilograms of acutely hazardous waste in a
calendar month. Of particular concern to regulated academic research institutions are those regulations
concerning the hazardous waste determination (40 CFR 262.11), generator accumulation time (40
CFR 262.34), satellite accumulation (40 CFR 262.34(c)(l), requirements to keep accumulation
containers closed (40 CFR 262.34(a) and 265.173(a)), container labeling (40 CFR 262.34(a)(3)),
manifesting shipments transported offsite (40 CFR 262.20(a) through (e)), and generator training (40
CFR 262.34 and 265.16).

RCRA-related Challenges
       A number of issues have been identified by academic research institutions as presenting a
challenge to waste management in their laboratories.  These issues, also outlined in EPA-sponsored
New England University Laboratories XL Project, are gathered from both participating and non-
participating institutions and include:

•      Satellite Accumulation. RCRA regulations allow for the accumulation of hazardous wastes at
       "satellite" locations in academic research institutions (§262.34(c)). Although the requirements
       regarding such accumulation are minimal, they can present a logistical challenge for university
       academic research institutions.

       For example, generators may collect up to 55 gallons of hazardous waste where the waste is
       initially generated with no time limitations. However, once the 55 gallon limit is reached, they
       are required to, within 3 days, comply with more stringent requirements for on-site hazardous
       waste accumulation.  Typically, this means the hazardous waste will be moved to a 90-day
       accumulation area and will be accumulated in accordance with §262.34(a). There is no federal
       limit to the number of satellite accumulation areas at a facility.

       Among the problems raised is the difficulty some academic research institutions experience in
       complying with the 3-day time frame once the quantity limit has been reached. Because the
       rate of waste  generated in university laboratories is often unpredictable, academic research
       institutions say that it is difficult to predict when satellite accumulation limits may be exceeded
       and to arrange for removal of the waste within 3 days.

       Collection of hazardous waste is also more challenging when states or academic research
       institutions impose more stringent requirements by reducing the volume of waste that may be
       accumulated or by limiting the amount waste that can be collected to one type. We also
       understand that some academic research institutions prefer to consolidate wastes

        generated in  a single building before moving the waste to a 90-day accumulation area. This

-------
may also present problems if the site is neither a satellite, nor a 90-day accumulation area.

Dual Regulation Under RCRA and Occupational Safety and Health Administration: Many
academic research institutions are required to comply with OSHA regulations for the
management of hazardous chemicals in the laboratory.  Academic research institutions have
often characterized RCRA and OSHA training requirements as duplicative, and indicate a
preference for compliance with the OSHA standards for occupational exposure only, rather
than both OSHA standards for managing hazardous chemicals in the laboratory as well as
RCRA regulations for managing hazardous wastes. They also point to the definitional
differences between RCRA and OSHA as a source of confusion.

OSHA requirements overlap with RCRA requirements in some areas. For example, OSHA
regulations specify that employees must be provided with information and training in the
procedures for safe removal of contaminated waste (29 CFR 1910.1450(e)(3)(viii)(B)).
RCRA regulations for training require that personnel who handle hazardous waste must have
training necessary to ensure safe handling of the wastes and to ensure that personnel are able to
respond effectively in emergency situations.  OSHA regulations, however, are not designed to
protect the environment and do not specifically cover waste management except for removal.
OSHA regulations also do not apply to academic research institutions in many states. States
may develop and operate their own job safety and health programs that are "at least as effective
as" comparable federal standards and there are 23 States and jurisdictions operating complete
State plans (covering both the private sector and State and local government employees).

Decentralized Laboratory Operations: Academic research institutions commonly consist of
many diverse, relatively small individual laboratory operations run by independent researchers.
This distinguishes them from industrial operations that are generally more centralized and
centrally  controlled.  Academic research institutions have said that the large number of
independent waste generation points creates challenges in effectively implementing a uniform
waste management program.

High Staff Turnover: The use of students and independent laboratory researchers creates a
diverse population that is subject to frequent, regular turnover. This high turnover hinders the
continuity of a hazardous waste management plan and the ability to systematically and efficiently
train staff about RCRA-compliant handling of hazardous wastes. Academic research
institutions suggest that qualified permanent Environment Health and Safety (EH&S) staff are
able to more effectively manage hazardous wastes.

Waste Determination: Currently the waste determination usually occurs in the laboratory and
is performed by the person performing the test, experiment, or operation. This person uses his
or her knowledge to assess the nature of the materials remaining after the operation and is most
familiar with the chemicals used and the chemical changes that may have occurred during the
experiment or process.

Academic research institutions indicate a preference for the RCRA hazardous waste
determination to be made by trained and knowledgeable EH&S staff.  EH&S staff in their

-------
       opinion, are aware of the potential reusability of used or opened chemicals. In some cases, they
       would prefer to be able to make this decision after the material has been moved from a
       laboratory to a central location.

       Academic research institutions suggest that one drawback to making the waste determination in
       the laboratory is that it may be more difficult to assess the needs of the entire university for
       further use of certain chemicals. Academic research institutions prefer to have EH&S staff
       make the final hazardous waste determination because these permanent staff have campus-wide
       knowledge and are better able to determine that the material can be used elsewhere on
       campus.

•      Budgetary Constraints: Competing funding priorities can hinder the development and
       adequate support of waste management programs in individual academic research institutions or
       on individual laboratory research projects. Thus appropriate savings in waste management
       costs may result in improved waste management as well as increased funding available for
       research.

•      Inconsistency due to State Variation: Under Section 3006 of RCRA, EPA may authorize a
       qualified state to administer and enforce a hazardous waste program in the state in lieu of the
       federal program.  State authorized programs may impose requirements that are more stringent
       or broader in scope than the federal RCRA program. As a result, there are variations in how
       certain requirements apply across state programs. The impacts of this variability can be
       magnified at academic research institutions by the relatively wide range of types of waste
       materials generated as well as by the relative infrequency and small volumes in which these
       materials are generated. Although EPA cannot mandate consistency among states, it can
       promote it with well-circulated guidance.

Recent RCRA Enforcement and Compliance Assistance Activities at Academic Research Institutions

       Academic institutions are often similar to small cities, with many facilities and activities on their
campuses such as research laboratories, auto repair facilities, power plants, wastewater treatment
plants, hazardous waste management and trash disposal, asbestos management, drinking water supply,
grounds maintenance and incineration. In addition, many operate medical and research facilities which
create an additional set of challenges, some of which have been described in the preceding section of
this report.

       Because academic institutions undertake so many diverse activities, it is important that they
accomplish them in a manner protective of human health and the environment.  EPA is concerned about
the management of hazardous waste because of the potential risk to human health and the environment
and because of the proximity of these institutions to student residences and urban centers. EPA
inspections of academic institutions  have revealed significant noncompliance with a number of the
RCRA (and other environmental) requirements. As a result, EPA has stepped up both its compliance
assistance and enforcement efforts to  deal with the risks to the public and the environment.

       The most common RCRA violations include: failing to mark containers with the words

-------
"hazardous waste," treating, storing or disposing of hazardous waste at a facility without a permit or
interim status, disposing of potentially hazardous waste in solid waste trash bins, failure to provide and
document hazardous waste training, failure to make hazardous waste determinations, and failure to
inspect waste containers on a weekly basis.  All of these violations can present risks to human health
and the environment. Failure to label waste as hazardous increases the potential for mismanaged waste
and injuries. Lack of a permit or interim status poses a danger to employees of the facility and nearby
residents, and could lead to contamination of the soil, air and water.  Placing incompatible wastes
together in a solid waste trash bin could create fire, explosions, or dangerous gases. Failure to properly
determine if a waste is hazardous could mean that it may not be handled safely on site and/or properly
transported off site and disposed of in an appropriate facility.

       EPA found a number of violations in academic research institutions across the country, including
Massachusetts Institute of Technology, Boston University, George Washington University, the
University of Hawaii, University of New Hampshire, and the University of Rhode Island. Violations
ranged from improper transportation of hazardous waste between two universities to the storage of
leaking chemicals in a basement over many years.  One settlement resulting from such violations was
worth as much as $1.6 million. More information on recent enforcement activities can be found in the
July 2000 Enforcement Alert,  (Vol. 3, No. 7, EPA 300-N-00-012) at
http://epa.gov/oeca/ore/enfalert/vol3num7.html.

EPA continues to offer compliance assistance to colleges and universities to help them achieve
compliance with environmental laws. Some of these compliance assistance activities are summarized
below.

       In November 1999, Region 1 hosted a focus group discussion for college and university
       environmental health and safety staff. Region 1 used the information from this dialogue to
       develop an integrated strategy for the college and university sector. The Region's strategy
       includes  1) Basic Regulatory Compliance including an informational web page and compliance
       workshops, 2) Best Management Practices to provide tools to conduct audits and implement
       environmental management systems, and 3) Sustainability, encouraging colleges and universities
       currently involved in activities that go beyond compliance (i.e., green procurement, energy
       efficiency, etc.) to share their experiences with fellow institutions.

•      In 2000,  Region 2 sent letters to 344 colleges and universities encouraging them to take
       advantage of EPA's Audit policy providing incentives to conduct environmental audits and
       voluntarily discover, disclose and correct violations.  The Region has combined this effort with
       supplemental compliance assistance mailings, including self-audit guides, and seminars. New
       York State also conducted compliance assistance in coordination with the Region.

       Region 3 created a questionnaire for college and university presidents to determine what
       elements of a good environmental management system are being implemented on their
       campuses.  Region 3 also participated in three day-long workshops hosted by Baltimore and
       Philadelphia universities.  In June 2001, Region 3 held two workshops for colleges and
       universities with hospitals.

-------
•      In August 2001, Region 7 invited 400 universities to participate in a compliance workshop for
       colleges and universities.  There were presentations on the Audit policy,  waste reduction
       strategies, and environmental management systems.

       In 2000, Region 9 invited Arizona colleges and universities to participate in a RCRA-focused
       Audit policy initiative. In conjunction with this effort, the Arizona Department of Environmental
       Quality sponsored an all-day workshop on RCRA compliance and reinforced the seriousness
       of follow up inspection and enforcement efforts.  Region 9 also developed a compliance self-
       audit project that includes the University of California system. The Region invited several
       campuses and medical schools from the UC system to participate in a voluntary compliance
       self-audit program.

       These Regional initiatives confirm that continued attention needs to be given to academic
research institutions to improve RCRA compliance. Regions and states have worked to devise
methods that improve compliance, and Best Management Practices such as those developed through
the HHMI initiative provide another tool to aid in achieving compliance in academic research
institutions.
HI. EPA PARTICIPATION IN LABORATORY AND RELATED INITIATIVES
       EPA became increasingly aware of the challenges faced by academic research institutions in
complying with the hazardous waste regulations. EPA has actively participated in a number of efforts
not associated with the HHMI project aimed at identifying and addressing issues of concern to
academic research institutions .  The initiatives described in this section include examples of ways EPA
has tried to address concerns raised by academic research institutions. Concerns include requests to
clarify RCRA regulations, examine performance-based approaches to managing hazardous wastes, and
make it easier to move hazardous waste among buildings on university campuses. Many of these issues
are equally evident in the HHMI project, which enables academic research institutions to focus on and
understand hazardous waste management requirements, and continue to experiment with performance
based-approaches to site-specific problems.

EPA Report to Congress on Management of Hazardous Waste in Educational Institutions. On
April 26,1989, EPA submitted a report to Congress entitled "Management of Hazardous Wastes from
Educational Institutions." The report discussed waste management practices at educational institutions,
as well as problems, and possible ways to improve the management of hazardous wastes.

NCCLS Guidelines for Clinical Laboratory Waste Management. EPA also participated in the
National Committee for Clinical Laboratory Standards (NCCLS) subcommittee on Laboratory Waste
to develop "Guidelines for Clinical Laboratory Waste Management." The approved Guideline was first
published in  1993 and is currently available through NCCLS.

Government University Industry Research Roundtable. Beginning in 1994, EPA participated on the
Government University Industry Research Roundtable, sponsored by the National Academy of

-------
Sciences, National Academy of Engineering, and Institute of Medicine.  Participants in the group
identified several areas of the RCRA regulations they believed needed attention, including the waste
determination, treatment of hazardous wastes, reuse of chemicals, generator ID numbers, training, and
expired chemicals.

New England Universities Laboratories Project XL. In June, 1998, EPA's Region I accepted the
New England University Laboratories proposal as an EPA Project XL. This project was proposed by
three New England universities to address many of the issues discussed in Section II of this report. On
September 28, 1999 (64 Federal Register  52380-52396), EPA finalized the New England
Universities Laboratories Project XL. This pilot project provides regulatory flexibility under RCRA for
participating academic research institutions at the University of Massachusetts in Boston, Boston
College, and the University of Vermont.  The New England Universities (NEU) Laboratories XL
Project was approved to enable academic research institutions to test the effectiveness of an integrated,
flexible, performance-based system for managing hazardous wastes in academic research institutions.
This XL project is designed to achieve environmental results superior to those achievable under the
current RCRA system and the HHMI best practices demonstration project is in many ways consistent
with the NEU Project XL.  The XL pilot project has a four year time limit (to September 28, 2003)
during which EPA will evaluate its success and determine whether it should be continued and/or
expanded to other universities through regulatory changes.

       EPA has also worked on other efforts that, although not designed specifically for labs, would
address some laboratory issues. These regulatory initiatives are  described below.

Hazardous Waste Manifest Exemption. In 1997, EPA finalized a rule (February 12, 1997, 62 FR
6621-6657) which exempts from manifest requirements shipments of hazardous waste on right-of-ways
on or between contiguous properties and along the perimeter of contiguous properties controlled by the
same generator. This change enables academic research institutions that are located on large parcels of
land divided by public or private right-of-ways to more easily move hazardous wastes between
university buildings.

Mixed Waste Rule andHWIR On May 16, 2001, EPA finalized rules ( May 16, 2001, 66 FR
27217) providing increased flexibility to generators and facilities that manage low-level mixed waste
(LLMW) and technologically enhanced naturally occurring and/or accelerator-produced radioactive
material (NARM) containing hazardous waste. LLMW is now exempt from some RCRA storage and
treatment regulations, and LLMW or eligible NARM is exempt from RCRA hazardous waste
transportation and disposal regulations provided they meet specified conditions. EPA and HHMI
believe this rule will positively impact academic research institutions handling LLMW.

Standardized Permit. EPA is working to streamline the permit process for facilities who want to store
or manage wastes they generate in tanks, containers and containment buildings. EPA published a
proposed Standardized Permit Rule on October 12, 2001 (66 FR 52192). If finalized, this rule would
simplify the permit process, shorten the time needed to process  permit applications, and reduce the cost
of a permit for routine permits. This change is expected to benefit academic research institutions and
others who would like to store hazardous wastes on site for longer than 90 days.

-------
       In addition to these efforts, there are a number of non-regulatory efforts designed to address
concerns of academic research institutions:

Green Methods for Laboratories. EPA has been working on "Green Methods" for laboratories,
which are designed to minimize the use of hazardous chemicals (such as solvents) in waste analysis
procedures. This project has developed several extraction methods for organic compounds which can
reduce the use of hazardous solvents 90% or more. Green Methods work is ongoing, and is published
in EPA's "SW-846" handbook of analytical methods (available on our website:
http://www.epa.gov/SW-846y

Standard Sampling Methods for Waste Testing. EPA's Office of Solid Waste is working with
American Society  for Testing Materials (ASTM) to develop standard sampling methods for waste
testing.  This cooperative effort has so far produced 19 consensus ASTM standards, with 13 additional
standards in progress. EPA expects these ASTM sampling methods to be incorporated into EPA
technical guidance documents. Our work with ASTM is part of EPA's commitment to using industry-
developed standard practices and specifications in our regulatory programs, whenever appropriate.
IV. EPA ROLE IN HHMI PROJECT
       The HHMI project participants included environmental health and safety professionals and
biomedical researchers from ten major academic research institutions, each in a different U.S. EPA
Region, along with RCRA state regulatory officials from each of the ten Regions, the Office of Solid
Waste, EPA's Safety, Health and Environmental Management Division, and others. EPA participated
as a member of the Project Steering Committee by attending meetings and contributing to discussions
regarding the project. EPA also encouraged RCRA Regional program administrators to support the
demonstration project as indicated in the Appropriations Report language.

       EPA and state RCRA regulators participated in all three phases of the two-year HHMI
collaborative initiative. During phase one, beginning in August 1999, EPA participants joined in
finalizing the project scope, reached a consensus on project objectives and criteria, and identified seven
principal elements of a hazardous waste management plan for academic research institutions. In phase
two, beginning in early 2000, EPA participants joined in identification of fourteen best practices under
the seven principal elements. Phase three ran for a twelve-month period between the Fall of 2000 and
2001. The university participants agreed to demonstrate and measure the effectiveness of the consensus
best practices.

       The consensus best practices and the principal elements under which they fall are listed in the
HHMI Report. HHMI found that many of the best practices have become standard practice at
participating academic research institutions as a result of the project.  In some cases, the academic
research institutions found that it was difficult to show implementation progress during the time period of
the project.  None of the academic research institutions considered it necessary to develop a
demonstration project for Best Practice 8, regarding the collection, transport, and storage of hazardous
wastes by EH&S and for Best Practice 11, regarding developing a plan for emergency response,

-------
because they said they already conduct their programs in accordance with the practices.
V. EVALUATION OF THE HHMI CONSENSUS BEST PRACTICES AND THE NEED
   FOR REGULATORY CHANGES
       Congress requested that EPA evaluate the consensus best practices developed through the the
HHMI initiative and the need for regulatory changes to carry out the recommendations of the initiative.

       The final HHMI report concluded with several recommendations regarding the management of
hazardous wastes as follows:

1.  "That the EPA Administrator should recognize the consensus best practices developed through this
initiative as a performance-based model for achieving RCRA compliance and for promoting
stewardship and responsibility for health, safety, and the environment in academic research institutions.
The Administrator should determine and initiate appropriate methods for implementing a performance-
based model, using the consensus best practices developed through this initiative, for achieving RCRA
compliance in academic institutions."

2. "The U.S. EPA Administrator should promote conformity and consistency among the U.S. EPA
regional offices and state environmental protection agencies in carrying out RCRA assistance and
enforcement programs for academic institutions."

3.  "Academic institutions should adopt the consensus best practices developed through this initiative
as a performance-based model for managing hazardous wastes in their laboratories and for achieving
RCRA compliance."

4.  "Academic institutions should establish dialogue with their regulatory agency officials to plan
cooperatively  their approaches for implementing the consensus best practices developed through this
collaborative initiative."
       EPA recognizes that academic research institutions have had difficulty complying with the
RCRA regulations and supports developing effective alternatives for safely managing hazardous wastes
in academic research institutions that meet standards for protection of human health and the
environment.  EPA has supported the development of the consensus best practices

under this program as well as other innovations that respond to concerns raised by academic research
institutions.

       EPA congratulates Howard Hughes Medical Institute and the ten participating academic
research institutions on their efforts to improve hazardous waste management in their laboratories.  The
ten academic research institutions reported that the initiative provided an opportunity for increased
partnerships with students and faculty in promoting future goals in materials conservation and

-------
environmental protection. The ten academic research institutions also recognized the value and
effectiveness of the 14 consensus best practices and described the positive impact on their programs
and on the commitment to environmental protection. For example, several academic research
institutions did not previously have formal statements of executive commitment to environmental
stewardship, but have now begun the process of establishing these statements because of the program.
EPA is pleased that the best practices have elicited positive responses from executives at the
participating institutions.  Executive commitment helps ensure that there is adequate support for
environmental programs and that there is strong institutional commitment to environmental protection.
The best practices address a wide range of issues, and encourage academic research institutions to
develop thoughtful approaches to managing their hazardous waste.

       EPA also understands that some states and EPA Regions have implemented initiatives  of their
own to address compliance issues at academic research institutions. These  should also be considered,
along with programs at academic research institutions that have not participated in this demonstration
project, in any national effort to formalize best practices for laboratory management of hazardous
wastes.

       In general, EPA believes that the current RCRA regulations are flexible and may allow for the
implementation of many of the best practices identified by HHMI. The consensus best practices are
intended to be implemented differently by each institution depending on site-specific needs. This allows
management practices to be tailored to the needs of the institution. The extent to which an application
of a best practice is fully within RCRA regulations would depend upon the approach chosen to
represent the best practice. In some cases, consensus best practices may be allowable under the
current regulation, depending on the specific measures actually implemented by a university, and in
other situations may require regulatory changes. For example, the HHMI report identifies a need for
flexibility in hazardous waste accumulation time limits.  Such time limits are specifically required (see,
e.g., 40 CFR §262.34(a)), thus a regulatory change would likely be required to implement such a
practice.

       In some cases, EPA and states will need to work with academic partners to determine clearly
whether a best practice would require  a regulatory change.  For example we will need to continue to
work collaboratively to clarify how the HHMI demonstration program best practices  ensure that
containers will be managed to protect  against spills and prevent release. EPA is aware that some
academic research institutions want to leave some waste collection containers open beyond the time
needed to add or remove hazardous wastes. They suggest that the current requirement that containers
be kept closed except when adding or removing wastes is not always practical in the laboratory setting
because commonly used containers such as beakers have an open design.  If the consensus best
practices would not ensure that hazardous waste containers remained closed except when adding or
removing waste, an alternative to the closed container requirement would most likely require a
regulatory change to consistently and unambiguously allow the practice.

       Additionally, the HHMI report recommends that a university's health and safety program make
the RCRA hazardous waste determination. EPA's New England Universities Laboratories Project XL
(discussed in Section in) tests an approach consistent with this recommendation for its potential to
provide improved environmental stewardship, but does so through a regulatory change. Depending on

                                             10

-------
how this recommendation is to be implemented, however, a regulatory change may not be necessary.
EPA commits to work with stakeholders to support the most appropriate implementation of this
recommendation.

       In general, EPA believes promulgation of a regulatory change to specifically address a range of
academic laboratory issues is preferable because it allows the consideration of diverse viewpoints
through the regulatory development and notice and comment processes, as well as provides fair notice
to all concerned. A regulatory change would also allow EPA to work with HHMI, other laboratory
associations, states, EPA Regions, the Occupational  Safety and Health Administration, and the public
to develop an approach that builds upon the consensus best practices as well as other ongoing efforts
such as the New England Labs Project to provide needed flexibility and effective protection of human
health and the environment. Additionally, EPA believes that a regulation is more likely to promote the
national consistency that HHMI seeks from its federal and state regulators and encourages broader
understanding and acceptance of an approach than would guidance or a demonstration project alone.

       It should be noted that state authorized RCRA programs may impose requirements that are
more stringent or broader in  scope than the federal RCRA program. Thus, even where sufficient
flexibility exists in the federal regulations to implement the recommended best practices, authorized
states may still choose to limit such flexibility in administering their state programs. Similarly, even if
EPA promulgates regulatory changes to the federal program, authorized states may choose not to
adopt similar changes to their state programs. A federal rule would, however, provide leadership that
encourages states to conform their regulations and adopt a consistent approach nationally.

       EPA has worked to address the issues raised by academic research institutions in a variety of
forums,  however, we recognize that laboratories still  may have difficulty after these efforts. Using the
best management practices developed through this initiative can further improve the management of
hazardous wastes generated in academic research institutions, however, EPA believes this would best
be achieved by developing regulatory reforms that endorse best management practices and other sound
alternative approaches to achieving RCRA compliance.

       EPA is committed to resolving compliance problems in laboratories at academic research
institutions and expects to continue working with the Howard Hughes Medical Institute and other key
stakeholders to improve the RCRA program as it affects the nation's academic research institutions.
                                             11

-------
             ATTACHMENT TO PART 1

           October 13, 2000 Memorandum to
EPA Regional RCRA Senior Policy Managers and Branch Chiefs
                       12

-------
MEMORANDUM

SUBJECT:    Best Practices for Academic Research Laboratory Waste Management

FROM:       Elizabeth Cotsworth, Director
              Office of Solid Waste

TO:           RCRA Senior Policy Managers
              RCRA Branch Chiefs

DATE:        October 13, 2000

I want to encourage your support, along with that of my office, for an innovative project underway to
promote the development of Best Practices for academic research laboratories' hazardous waste
management procedures. The objective of this collaborative regulatory reform project  is to identify
practices  and procedures that will provide greater flexibility for laboratories in complying with RCRA
regulations coupled with improved environmental stewardship. This project is explicitly directed by
Congress, through reports attached to our 2001 appropriations (attached) and states that:

       "The Committee encourages EPA to participate in this initiative and to provide the maximum
       flexibility permissible under the regulatory provisions of RCRA, as appropriate, in support of
       the initiative.  Within 12 months, EPA is to submit a report to the Congress evaluating the
       consensus best practices developed through the initiative and the need for regulatory changes, if
       any, to carry out its recommendations. In addition, EPA should consider proposing regulatory
       changes based on the consensus approach to best practices for academic research laboratory
       waste management developed under this initiative."

Ten major academic research institutions, along with the Howard Hughes Medical Institute (HHVfl)
and state  regulatory officials from each of the 10 EPA regions have developed a consensus set of "Best
Practices for Academic Research Laboratory Waste Management"and are currently initializing
demonstration projects, as well as developing appropriate performance measures. The project is
intended to show that academic research laboratories can potentially yield superior compliance while
reducing  regulatory burden. The pilot demonstration project should take about 8 months to complete,

-------
during FY 2001, after which EPA must prepare a Report to Congress. Our report to Congress must
evaluate this innovative project and provide recommendations on whether to revise RCRA regulations
to allow flexibility for laboratory waste management.

As the Congressional report indicates, the Agency's support for this project is  critical to its smooth and
effective implementation. Our state partners are working directly and closely with staff of the
participating institutions (see attached list) and need EPA's encouragement and acknowledgment. With
our support, those universities who will be putting the BMP's into operation may prove to be useful to
the Agency in fostering improved RCRA compliance among their fellow academic research institutions.
I strongly encourage your support, and endorsement of this project during FY 2001.  In addition to
general project support to the universities and state partner in your Region, some other ways in which I
feel you could help are:

       provide your expertise to the participants regarding the RCRA regulations
•      help to assist in evaluating the data quality in the final HHVfl report, including what performance
       measures were used for evaluating the best practices
       help to develop the recommendations for the Report to Congress on whether to change the
       RCRA regulations or to allow flexibility.

Please share this information with your staff and colleagues as soon as possible.  Should your staff
have any questions, they should feel free to contact Gail Hansen who is the lead person working on this
issue at (703-308-0463, hansen.gail@epa.gov).
Attachments
cc:     Regional RCRA Enforcement Contacts
       ASTSWMO
       HHMI Project Participants
       Jay Benferado, OPEI
       Betsy Shaw, OPEI
       Lisa Lund, OCSAR
       Betsy Devlin, OECA/ORE
       Caroline Ahearn, OECA/ORE

-------
               University Participant
                                                    State Partner
Region 1
Joseph Griffin
Director, Environmental Health and Safety
Harvard University
46 Oxford Street
Cambridge, MA 02138
Phone:  617-495-2370
E-mail:  joseph_griffin@harvard.edu
James Miller
Chief, Waste Branch
Regulatory Standards Unit
Bureau of Waste Prevention
Massachusetts Department of
   Environmental Protection
1 Winter Street
Boston, MA 02108
Phone: 617-292-5574
E-mail: james.miller@state.ma
Region 2
Amy Wilkerson
Director, Laboratory Safety and Environmental
Health
The Rockefeller University
1230 York Avenue, Box 51
New York, NY 10021-6399
Phone: 212-327-8324
E-mail:  wilkera@rockvax.rockefeller.edu
Mark Moroukian
Environmental Engineer II
Division of Solid & Hazardous Materials
Bureau of Hazardous Waste Management
New York State Department of
   Environmental Conservation
50 Wolf Road
Albany, NY  12233-7521
Phone: 518-485-8988
E-mail:  mmmorouk@gw.dec.state.ny.us
Region 3
Matthew D. Finucane, C.I.H.
Director, Environmental Health and Radiation Safety
University of Pennsylvania
1408 Blockley Hall
Philadelphia, PA  19104-6021
Phone:  215-898-4453
E-mail:  matt@ehrs.upenn.edu
James Roof
Environmental Chemist
Pennsylvania Department of
   Environmental Protection
Division of Hazardous Waste Management
Rachael Carson State Office Building
14th Floor
400 Market Street
Harrisburg, PA  17101
Phone: 717-787-6239
E-mail:  Roof.James@dep.state.pa.us

-------
Region 4       Wayne R. Thomann, Dr. PH.
               Director, Occupational and Environmental Safety
               Duke University Medical Center
               DUMC, Box 3914
               131 Environmental Safety Building
               Durham, NC 27710
               Phone: 919-684-2794
               E-mail: thoma010@mc.duke.edu
Linda Culpepper, M.P.H.
Programs Branch Head
Hazardous Waste Section
Division of Waste Management
State of North Carolina
401 Oberlin Road, Room 150
Raleigh, NC  27605
Phone: 919-733-2178 ext. 220
E-mail: linda.culpepper@ncmail.net
Region 5       David W. Drummond, Ph.D., C.I.H.
               Director, Safety Department
               University of Wisconsin-Madison
               30 North Murray Street
               Madison, WI 53715-2609
               Phone: 608-262-9707
               E-mail: ddrummond@fpm.wisc.edu
Ginger K. Hooper, C.H.M.M.
Hazardous Waste Specialist
West Central Region
Wisconsin Department of Natural Resources
1300 W. Clairemont Avenue
Eau Claire, WI 54701
Phone: 715-839-3759
E-mail: hoopeg@mail01 .dnr.state.wi.us
Region 6       Jose A. Lopez, Ph.D.
               Director, Environmental Health and Safety
               University of Texas Southwestern Medical Center
               5323 Harry Hines Boulevard
               Dallas, TX  75235-9053
               Phone: 214-648-2250
               E-mail: jose.lopez@UTSouthwestern.edu
Minor Hibbs
Strategic Environmental Analysis Group
Texas Natural Resources
   Conservation Commission
Mail Code 206
P.O. Box 13087
Austin, TX 78711-3087
Region 7       Bruce Backus, P.E., C.I.H.
               Director, Environmental Health and Safety
               Washington University  School of Medicine
               Campus Box 8229
               660 South Euclid Avenue
               St. Louis, MO  63110
               Phone:314-362-6816
               E-mail: backusb@msnotes.wustl.edu
Lyle Crocker
Chief, Hazardous Waste Program
Enforcement Section
Division of Environmental Quality
Missouri Department of Natural Resources
P.O. Box 176
Jefferson City, MO 65102-0176
Phone: 573-751-7560

-------
Region 8       Dave W. Wergin
               Director, Environmental Health and Safety
               University of Colorado, Boulder
               Campus Box 375
               Stadium Gate 10, Room 180
               Boulder, CO 80309-0375
               Phone:   303-492-6025
               E-mail: dave.wergin@colorado.edu
Christopher L. Erzinger
Environmental Protection Specialist
Hazardous Materials and
   Waste Management Division
Colorado Department of
   Public Health and Environment
4300 Cherry Creek Drive South
Denver, CO 80246-1530
Phone:  303-692-3344
E-mail:  cerzinge@smtpgate.dphe. state.co.us
Region 9       Lawrence M. Gibbs, C.I.H.
               Associate Vice Provost for Environmental Health and
               Safety
               Stanford University
               640 Oak Road
               Stanford, CA  94305-8007
               Phone:   650-723-7403
               E-mail: lgibbs@leland.stanford.edu
Mike Horner
Department of Toxic Substances Control
400 P Street, 4th Floor
P.O. Box 806
Sacramento, CA
95812-0806
Ph: (916)322-7889
E-mail: mhorner@dtsc.ca.gov
Region 10      Karen A. VanDusen, C.I.H.
               Director, Environmental Health and Safety
               University of Washington
               201 Hall Health Center
               Box 354400
               Seattle, WA  98195-4400
               Phone: 206-616-4146
               E-mail :kav@u.washington.edu
Julie Sellick
Section Supervisor
Northwest Regional Office
Hazardous Waste and
   Toxics Reduction Program
Department of Ecology
3190 160th Avenue, S.W.
Bellevue, WA 98008-5452
Phone:   425-649-7053
E-mail: jsel461@ecy.wa.gov

-------
                       PART TWO (Attachment)



             REPORT ON CONSENSUS BEST PRACTICES

                               FOR

MANAGING HAZARDOUS WASTES IN ACADEMIC RESEARCH INSTITUTIONS
      Prepared by the Howard Hughes Medical Institute of Laboratory Safety
            in Collaboration with the Project's Principal Participants
                            October 2001

-------
                           REPORT ON

                   CONSENSUS BEST PRACTICES

                              FOR

MANAGING HAZARDOUS WASTES IN ACADEMIC RESEARCH INSTITUTIONS
                          Prepared by the
         Howard Hughes Medical Institute Office of Laboratory Safety
           in Collaboration with the Project's Principal Participants
                           October 2001

-------
                                           Report on
                                 Consensus Best Practices for
                Managing Hazardous Wastes in Academic Research Institutions

                                          October 2001
       The Howard Hughes Medical Institute Office of Laboratory Safety prepared this Report in
collaboration with the project's Principal Participants.
Principal Participants

Howard Hughes Medical Institute, Office of Laboratory Safety
    W. Emmett Barkley, Ph.D., Director; Cheryl A. Warfield, Senior Program Manager

Duke University Medical Center, Occupational and Environmental Safety Office
    Wayne R. Thomann, Dr. P.H., Director
    William S. Brewer, Ph.D. and Gary Tencer, C.I.H., Project Managers
Harvard University, Environmental Health and Safety Department
    Joseph Griffin, Director; Mary J. Corrigan, C.I.H. and Sean Reagan, C.H.M.M., Project Managers
Stanford University, Environmental Health and Safety Department
    Lawrence M. Gibbs, C.I.H., Associate Vice Provost
    Craig Barney and Heather Perry, Project Managers
The Rockefeller University, Department of Laboratory Safety and Environmental Health
    Amy Wilkerson, Director; Frank X. Schaefer, Project Manager
University of Colorado at Boulder, Division of Environmental Health and Safety
    Dave W. Wergin, Director; Mike L. Morrison, C.S.P., C.I.H., Project Manager
    Arthur J. Zaug, Ph.D., HHMI Senior Associate
University of Pennsylvania, Office of Environmental Health and Radiation Safety
    Matthew D. Finucane, C.I.H., Director; Kyle Rosato, Project Manager
University of Texas Southwestern Medical Center, Environmental Health and Safety Department
    Jose A. Lopez, Ph.D., Director
University of Washington, Environmental Health and Safety Department
    Karen A. VanDusen, Director; David Lundstrom, Project Manager
University  of Wisconsin-Madison, Safety Department
    David W. Drummond, Ph.D., C.I.H., Director; Ronald Bresell, Project Manager
Washington University School of Medicine, Environmental Health and Safety Department
    Bruce D. Backus, P.E.,  Director; Michael Kershaw, Project Manager

North Carolina Division of Waste Management,  Hazardous Waste Section
    Linda M. Culpepper, M.P.H., Programs Branch Head
Washington State Department of Ecology, Hazardous Waste and Toxics Reduction Program
    Julie Sellick, Section Supervisor

U.S. Environmental Protection Agency, Office of Solid Waste
    Elizabeth A. Cotsworth, Director
    Staff:  Ann M. Codrington, Gail Hansen, Charlotte R. Mooney, Patricia A. Washington

U.S. Environmental Protection Agency,  Division of Safety, Health and Environmental Management
    Howard O. Wilson

-------
Other Participants

California Department of Toxic Substances Control
    Michael Horner, State Regulatory Programs Office
Colorado Department of Public Health and Environment
    Frederick R. Dowsett, Compliance Coordinator
    Christopher L. Erzinger, Environmental Protection Specialist
Duke University Medical Center
    Dwayne Allen, Ph.D., Research Associate
Massachusetts Department of Environmental Protection
    James Miller, Chief, Waste Branch, Bureau of Waste Prevention
Massachusetts Institute of Technology, Office of Environmental Management
    William Van Schalkwyk, C.S.P., Director
Missouri Department of Natural Resources
    Lyle Crocker, Chief, Hazardous Waste Program
National Institutes of Health, Office of Extramural Research
    Anthony Demsey, Ph.D., Senior Advisor for Policy
New England  University Laboratories Project XL
    Boston College, Office of Environmental Health  and Safety
       Suzanne Howard, Director
    University of Massachusetts Boston, Office of Environmental  Health and Safety
       Zehra Schneider-Graham, Manager
    University of Vermont, Environmental Safety Program
       Ralph Stuart, Manager
New York State Department of Environmental Conservation
    Mark Moroukian, Environmental Engineer II
North Carolina Division of Waste Management
    William Meyer, Director (retired)
Pennsylvania  Department of Environmental Protection
    James Roof, Environmental Chemist
Stanford University School of Medicine
    Carol J. Toman, HHMI Research Technician
Texas Natural Resources Conservation Commission
    Minor Hibbs, Strategic Environmental Analysis Group
The Rockefeller University
    Kyungsun Suh, Ph.D., HHMI Research Specialist
University of Texas Southwestern Medical Center
    Donald  E. Carlson, Ph.D., Director (retired), Environmental Health and Safety Department
    Esequiel Barrera and Sally Keenan (retired), Project Managers
    Clive Slaughter, Ph.D., HHMI Senior Associate
University of Washington
    Rolf M.A.  Hahn, Ph.D., C.I.H., Environmental Health Laboratory
University of Wisconsin
    Michael D. Schwartz, Ph.D., HHMI Associate
Wisconsin Department of Natural Resources
    Ginger K. Hooper,  C.H.M.M., Hazardous Waste Specialist

-------
                                          Report on
                                Consensus Best Practices for
               Managing Hazardous Wastes in Academic Research Institutions

                                          Contents
Executive Summary	iv

1.   Introduction	1
     Congressional Interest	1

2.   Framing the RCRA Issue	2
     Introduction to RCRA	2
     Federal Oversight of Environmental Health and Safety in Laboratories	3
     An Example of a Performance-based Regulation	3
     Efforts to Improve RCRA Applicability to Laboratories	4

3.   The Collaborative Initiative	5
     Participants	5
     Project Approach	5

4.   The Consensus Best Practices	7

5.   Results and Findings of Demonstration Projects	11
     By Consensus Best Practice	11
       Executive Commitment	12
       Responsibility and Accountability	13
       Policies and Procedures for Pollution Prevention	14
       Chemical Hygiene Plan	14
       Chemical Waste Management	15
       Container Labeling	16
       Laboratory Protocols to Reduce Hazard	16
       Collection, Transport and Storage by Environmental Health and Safety	17
       Validated Environmental Health and Safety Treatment Protocols for Volume Reduction	17
       RCRA  Determination by Environmental Health and Safety	19
       Emergency Response	20
       Training, Education, Communication	20
       Effective Communication within the Organization	21
       Program Evaluation and Improvement	22
     Qualitative Assessment	23
     Partnership and Collaboration	24
     Conformity and Consistency	25

6.   Discussion	26
     Validation of Best Practices	27
       Treatment	28
       RCRA  Determination	29
     Improving RCRA Applicability to Laboratories	30

7.   Conclusions and Recommendations	31

-------
                                           Report on
                                 Consensus Best Practices for
                Managing Hazardous Wastes in Academic Research Institutions
EXECUTIVE SUMMARY

       The Howard Hughes Medical Institute (HHMI) led a two-year collaborative initiative
beginning in August 1999 to establish consensus best practices for managing hazardous wastes in
academic research institutions and to demonstrate that a performance-based model can be an
effective and practical approach for regulating hazardous wastes in the academic research setting.
The initiative partnered environmental health and safety (EH&S) professionals and biomedical
research scientists from ten major academic research institutions—one from each Environmental
Protection Agency (EPA) region; authorized state regulatory officials from the states of the
participating institutions; and the U.S. EPA Office of Solid Waste. The institutions were Duke
University Medical Center, Harvard University, Stanford University, The Rockefeller University,
University of Colorado at Boulder, University of Pennsylvania, University of Texas Southwestern
Medical Center, University of Washington, University of Wisconsin-Madison, and Washington
University School of Medicine.  A guiding principle of the initiative was a commitment to promote
stewardship and responsibility for health, safety, and the environment as an integral part of the
nation's biomedical research mission.

       The House Committee on Appropriations (House Report 106-674) and the Senate Committee
on Appropriations (Senate Report 106-410) included language in the Departments of Veterans
Affairs and Housing and Urban Development, and Independent Agencies Appropriations Bill, 2001,
supporting the initiative and encouraging the Administrator of EPA to participate and provide the
maximum flexibility permissible under the regulatory provisions of the Resource Conservation and
Recovery Act (RCRA) in support of the initiative. The Committees requested to receive within 12
months (October 2001) a report from the EPA evaluating the initiative's consensus best practices and
the need for regulatory changes, if any, to carry out the recommendations of the initiative.

       The initiative responded to the continuing difficulties academic institutions are experiencing
in applying the industrial-oriented RCRA regulations to the management of hazardous wastes
generated in their laboratories.  An objective was to develop a better regulatory approach to apply
RCRA to academic institutions—one that builds upon the culture of the institutions and recognizes
that laboratories differ from industrial operations in their use and handling of hazardous chemicals.
Other objectives were  to promote cooperation, understanding, and mutual respect among
environmental protection agencies, academic institutions, and the scientific  research community, and
to propose a plan for implementing a performance-based approach for managing hazardous wastes in
academic research institutions.

       The initiative included three phases. In phase one, HHMI sponsored a workshop to  introduce
the initiative; to develop the project scope, objectives, criteria, and approach; and to identify the
principal elements of a hazardous waste management plan for academic research institutions. Seven
elements were identified: executive commitment; a management plan; responsibility and
accountability; policies and procedures to minimize waste; standard operating procedures; training,
education, and communication; and continual evaluation and improvement.  In phase two, 14
consensus best practices for managing hazardous wastes in the academic research setting were
developed. In phase three, plans for demonstrating the consensus best practices and for measuring
                                               IV

-------
their effectiveness at the ten universities were developed.  The demonstrations would continue for
one year, concluding in October 2001; the universities would prepare comprehensive reports
evaluating their demonstrations in June 2001.  These evaluations served as the basis for this report.

        The findings of the initiative support the views of scientists, EH&S professionals, and many
regulators as reported earlier by the National Research Council and other groups, that the extant
application of RCRA to laboratories is inefficient and difficult, and that a performance-based
approach for the application of RCRA to laboratories is a preferred regulatory model. The initiative
found a lack of conformity and consistency nationwide in the application of RCRA to academic
laboratories, particularly in the range of allowable practices for making RCRA determinations.  In
addition, the findings of the initiative reveal that the current regulatory approach for applying RCRA
to laboratories in academic institutions is a disincentive to the promotion of environmental
stewardship, an objective of RCRA. A new regulatory approach for laboratories could improve
RCRA effectiveness and compliance in universities, and become a catalyst to bring about
commitment and action to protect human health and the environment and promote excellence in
environmental stewardship within the academic research community.

        The recommendations of the initiative envision a two-tiered approach for applying RCRA to
universities and their laboratories. It involves the application of a performance-based model, using the
consensus best practices developed in this initiative, for guiding RCRA compliance in laboratories, and
the application of the current provisions of RCRA for guiding RCRA compliance in universities at the
time the universities' EH&S programs assume ownership and responsibility for laboratory waste
materials and make the RCRA hazardous waste determination.  The basis for this approach is the
premise that the EH&S program makes the RCRA hazardous waste determination and conducts any
appropriate generator treatment on behalf of the academic  institution. This initiative found that four of
the ten universities are successfully using this approach, with the concurrence of their state regulatory
agencies, in managing their hazardous waste programs. This experience is significant because it
demonstrates value in this approach as a regulatory model, and indicates that it does not compromise
compliance.

        There are three principal conclusions resulting from this two-year collaborative initiative.

        A performance-based model that has as its core the consensus best practices developed and
demonstrated through this initiative is a workable approach for effective and efficient management of
hazardous waste in academic research institutions. This approach will not compromise RCRA
compliance, and will promote stewardship and  responsibility for health, safety, and the environment while
respecting the culture of an academic institution and the unique characteristics of the laboratory setting.

        Collaboratively, the EH&S professionals, scientifically trained laboratory staff, informed
institutional administrators, and staff from federal and state regulatory agencies who are familiar with the
laboratory and academic setting will identify safe and  practical ways to improve hazardous waste
management programs, and they will do this enthusiastically when the outcome promotes environmental
stewardship.

        The interactions between some of the universities and their corresponding state regulatory
agencies provide evidence that common ground is available within RCRA to adopt both the consensus
best practices and a performance-based approach for compliance. The difficulty of matching specific
requirements of RCRA with the academic laboratory setting stimulated efforts to find this common ground.
Four of the ten universities participating in this initiative operate their hazardous waste  management
programs today with the concurrence of their state regulatory officials on the premise that the EH&S
professionals are the most capable for determining whether used or unused laboratory chemicals are

-------
RCRA hazardous waste and, in this capacity, serve as the RCRA generator for overall compliance
purposes. This operational practice is the cornerstone for a best practices performance-based regulatory
model.

       The Howard Hughes Medical Institute and the ten universities participating in this hazardous
waste management initiative make the following recommendations to the U.S. EPA and to the
nation's academic institutions.

1.      The U.S. EPA Administrator should recognize the consensus best practices developed through
       this initiative as a performance-based model for achieving RCRA compliance and for promoting
       stewardship and responsibility for health, safety, and the environment in academic institutions.
       The Administrator should determine and initiate the appropriate methods for implementing a
       performance-based model, using the consensus best practices developed through this initiative,
       for achieving RCRA compliance in academic institutions.

2.      The U.S. EPA Administrator should promote conformity and consistency among the U.S. EPA
       regional offices and state environmental protection agencies in carrying out RCRA assistance
       and enforcement programs for academic institutions.

3.      Academic institutions should adopt the consensus best practices developed through this initiative
       as a performance-based model for managing hazardous wastes in their laboratories and for
       achieving RCRA compliance.

4.      Academic institutions should  establish dialogue with their regulatory agency officials to plan
       cooperatively their approaches for implementing the consensus best practices developed through
       this collaborative initiative.
                                               VI

-------
                                           Report on
                                 Consensus Best Practices for
                Managing Hazardous Wastes in Academic Research Institutions
1. INTRODUCTION

       The Howard Hughes Medical Institute (HHMI) led a two-year collaborative initiative to
establish consensus best practices for managing hazardous wastes in academic research institutions.
A goal of the initiative was to demonstrate that a performance-based model is an effective approach
for regulating hazardous wastes in the academic research setting.  The initiative partnered
environmental health and safety (EH&S) professionals and biomedical research scientists from ten
major academic research institutions—one from each Environmental Protection Agency (EPA)
region; authorized state regulatory officials from the states of the participating institutions; and the
U.S. EPA Office of Solid Waste.

       HHMI is a scientific and philanthropic organization whose principal purpose is the direct
conduct of biomedical research. Some 350 HHMI investigators carry out their research in
laboratories located throughout the United States at 72 academic medical centers, universities and
other scientific institutions, under long-term research collaboration agreements.  It is the philosophy
of the Institute that research of the highest standards occurs in laboratories where the commitment to
safeguard human health and the environment is exemplary. In collaboration with the EH&S
programs of the 72 host institutions, the HHMI Office of Laboratory Safety provides leadership in
promoting stewardship and responsibility for health, safety, and the environment as an integral part
of the nation's biomedical research mission.

       Annually, HHMI sponsors a two-day conference for the directors  of the EH&S programs of
the 72 host institutions.  The 1999 conference, Healthy Workers—Healthful Environments—Helpful
Regulations, included a presentation by an EPA Region 1 official on the Agency's enforcement and
reinvention programs.  From this talk emerged the idea for a nationwide initiative to evaluate a
performance-based approach for managing hazardous wastes in academic research institutions.

       The HHMI Office of Laboratory Safety drafted a project scope. Key to the proposed project
was the criterion that the initiative would uphold the spirit and intent of current EPA regulations. In
addition, the EPA would provide the maximum flexibility permissible under the regulatory
provisions of the Resource Conservation and Recovery Act of 1976 (RCRA). Since the inception of
RCRA, developed with the industrial setting in mind, the academic research community has
recognized that allowing sensible flexibility within the academic laboratory  setting can potentially
yield superior compliance while reducing regulatory burden and promote excellence in
environmental stewardship.

Congressional Interest

       The U.S. Congress became interested in the collaborative initiative in the summer of 2000.
The House Committee on Appropriations (House Report 106-674) and the Senate Committee on
Appropriations (Senate Report 106-410) included language in the  Departments of Veterans Affairs
and Housing and Urban Development, and Independent Agencies Appropriations Bill, 2001,
supporting the initiative's approach for development of consensus best practices for hazardous waste
management in academic research laboratories, and applauding the initiative's commitment to

-------
minimize the potential for harm to human health and the environment and to promote excellence in
environmental stewardship. Both Committees encouraged the Administrator of EPA to participate in
the initiative and to provide the maximum flexibility permissible under the regulatory provisions of
RCRA in support of the initiative. The Committees requested to receive within 12 months a report
from the EPA evaluating the consensus best practices developed through the initiative and the need
for regulatory changes, if any, to carry out the recommendations of the initiative.
2. FRAMING THE RCRA ISSUE

Introduction to RCRA

       The U.S.  Congress enacted the Resource Conservation and Recovery Act (RCRA) in 1976 to
address the problem of municipal and industrial solid waste disposal and reduction. The goals set by
RCRA are:

       To protect human health and the environment from the hazards posed by waste disposal.

       To conserve energy and natural resources through waste recycling and recovery.

       To reduce or eliminate, as expeditiously as possible, the amount of waste generated,
       including hazardous waste.

       To manage wastes in a manner that is protective of human health and the environment.

       Subtitle C of RCRA establishes a system to control hazardous waste from the time of
generation until its ultimate disposal.  The Act directs EPA to develop and promulgate criteria for
identifying hazardous waste and gives the EPA Administrator the authority to develop specific
requirements governing the generation, transport, treatment, storage, and disposal of hazardous waste
to ensure sound and protective hazardous waste management.  The EPA developed the hazardous
waste regulations  based largely on industrial hazardous waste activities.  However, with limited
exceptions, these regulations apply to academic laboratories that use chemicals, as well as to the
industrial sector.

       The industrial orientation of RCRA regulations creates  difficulty for the laboratory
community in areas of interpretation, application, and compliance.  A laboratory setting is
significantly different from an industrial setting and is not easily adaptable to control measures
appropriate for industry.  In the academic research laboratory,  relatively  small quantities of a large
number of chemicals are in use on a non-production basis. In addition, the chemicals in use vary
often depending on the frequently changing direction of a research endeavor. The potential
environmental risks are of a different magnitude as well. Although the hazard inherent in a small
quantity of a chemical from a laboratory is the same as the hazard inherent in a large quantity of the
same chemical in an industrial process, the overall potential for harm to human health or the
environment can often be less because of the  smaller quantity.  Further, the scientifically trained
laboratory staff generally has a high level of awareness of health, safety, and environmental hazards
associated with working with chemicals.

-------
Federal Oversight of Environmental Health and Safety in Laboratories

       Other federal agencies provide regulatory or advisory oversight of EH&S practices and
programs in academic research laboratories including issuance of regulations and guidelines that
impact waste management.  These are the Occupational Safety and Health Administration (OSHA),
the Department of Health and Human Services (DHHS), the Department of Transportation (DOT),
the Department of Agriculture (USDA), and the Nuclear Regulatory Commission (NRC). For
example, OSHA's Laboratory Standard (29 CFR 1910.1450) requires an employer to establish a
Chemical Hygiene Plan (CHP).  The CHP identifies standard operating procedures (SOP) for
employees to follow that will protect them from the health hazards presented by hazardous chemicals
in use in their laboratories. The Standard's definition for a hazardous chemical includes all materials
RCRA would designate as hazardous waste.  The Preamble to the Standard also provides examples
of work activities that SOPs should cover including emergency response, waste disposal procedures,
and spill clean-up procedures.

       Similarly, DHHS, USDA, and the NRC have requirements that address the handling and
disposal of laboratory waste containing human pathogens, animal pathogens, and radioactive
materials, respectively.  The DOT regulates the shipment of hazardous materials.  The regulatory
model that most of these agencies use, however, differs considerably from the traditional approach
used by the EPA to develop and enforce hazardous waste regulations. For example, the NIH
Guidelines for Research Involving Recombinant Molecules (66 FR  1146: January 5, 2001), presents
three performance-based guidelines as disposal requirements for laboratory wastes from experiments
involving the insertion of recombinant DNA molecules into a serious or lethal pathogen such as
Mycobacterium tuberculosis.

       All  contaminated liquid or solid wastes are decontaminated  before  disposal.

       Contaminated materials that are to be decontaminated at a site away from the laboratory
       are placed in a durable leak-proof container which is closed before being removed from
       the laboratory.

       An autoclave for decontaminating laboratory wastes is available preferably within the
       laboratory.

An Example of a Performance-based Regulation

       The OSHA Laboratory Standard is an example of a performance-based standard. The basis
for this Standard was a determination by the Assistant Secretary of Labor for OSHA that laboratories
typically differ from industrial operations in their use and handling of hazardous chemicals, and that
an approach different from that found in OSHA's substance-specific health standards was warranted
to protect workers. The Standard's definition of a laboratory reads:

       "Laboratory" means 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 Standard also characterizes a laboratory by the term "laboratory-scale." The Standard
reads:

       "Laboratory scale" means work with substances in which the containers used for
       reactions, transfers, and other handling of substances are designed to be easily and

-------
       safely manipulated by one person. "Laboratory-scale" excludes those workplaces whose
       function is to produce commercial quantities of materials.

       To the extent possible, the Standard allows for a large measure of flexibility in compliance
methods. For example, the Standard does not intend to dictate the approach that the employer may
find effective in meeting the objectives of the CHP or the manner in which the employer implements
the approach.  (Preamble to 29 CFR Part 1910.)

Efforts to Improve RCRA Applicability to Laboratories

       In anon-mandatory Appendix to the Laboratory Standard (29 CFR 1910.1450), OSHA offers
guidance to laboratory employers on the development of a CHP.  The recommendations came from
the National Research  Council's report, Prudent Practices for Handling Hazardous Chemicals in
Laboratories, published in 1981.  The recommendations provide an example of a performance-based
standard for hazardous waste management in laboratories.

       The 1981 report also noted that new regulations to control chemical waste were under
development by the EPA.  The regulations became effective on November 19, 1980, shortly before
the report went to press. In less  than six months it became clear that academic,  government, and
industrial laboratories were having substantial difficulties in interpreting and implementing these
regulations.  Over the succeeding 15 years, the National Research Council published several
authoritative studies on the subject of hazardous waste management recommending that EPA change
its approach to regulating laboratories.

       In 1995, the National Research Council Committee on Prudent Practices for Handling,
Storage, and Disposal of Chemicals published Prudent Practices in the Laboratory—Handling and
Disposal  of Chemicals. This report contained further recommendations that EPA change its
approach to regulating laboratories.  Most recommendations made in this and previous reports
remain germane today.  The recommendations made in 1995 by the National Research Council
committee follow.

       The committee recommends that regulations directed to laboratories be performance
       based  and  be structured  to take into account the unique aspects and professional
       expertise within the laboratory.

       The committee recommends that the Environmental Protection Agency extend its permit-
       by-rule provision to allow scientifically sound treatment of small quantities of waste
       generated in laboratories.

       The committee recommends that the Environmental Protection Agency allow storage of
       small quantities of waste in laboratory facilities for periods  longer than the current time
       limitation on storage of hazardous waste.

       The committee recommends that federal, state,  and local lawmakers and regulators
       strive for conformity  and  consistency in the regulations that affect laboratories.

       The committee recommends that the Environmental Protection Agency allow the  use of
       one EPA identification number for all chemical waste generated on a single campus of an
       educational institution. (Note:  The Military Munitions Rule [40 CFR Part  260, effective
       August 12, 1997], generally addressed this recommendation.)

-------
        Other groups have made substantial efforts to encourage the EPA to adopt a performance-
based approach for regulating academic laboratories including the National Research Council's
Government-University-Industry-Research-Roundtable, the American Chemical Society, the
National Institutes of Health, the National Association of College and University Business
Organizations, and the American Council on Education. Studies, reports, and recommendations from
these groups have a common theme:  Sensible regulatory flexibility within the laboratory setting
potentially can yield superior compliance while reducing the regulatory burden that results when
applying an industrial oriented standard to laboratories.

        EPA has recently considered some of the issues addressed by these organizations and groups.
The Storage, Treatment, Transportation, and Disposal of Mixed Wastes; Final Rule (66 FR 27218:
May 16, 2001; effective November 13, 2001), provides increased flexibility to generators and
facilities that manage low-level mixed waste.  This Rule resolves a long-standing problem for
academic research institutions handling such waste in their laboratories.  EPA's approval of the New
England University Laboratories Project XL demonstrates the Agency's recognition that there may
be value in a performance-based approach to regulating academic laboratories.  In addition, the EPA
regional offices have initiated several RCRA compliance assistance programs to aid universities in
their efforts to achieve RCRA compliance such as Web-based guidance and regional conferences.
3. THE COLLABORATIVE INITIATIVE

Participants

        The two-year collaborative initiative led by HHMI to establish consensus best practices for
managing hazardous wastes in academic research institutions occurred in three phases. During each
phase, the participants included the EH&S directors and hazardous waste managers from ten HHMI
host institutions, each from a different EPA region.  These were:

        Duke University Medical Center        University of Pennsylvania
        Harvard University                    University of Texas Southwestern Medical Center
        Stanford University                    University of Washington
        The Rockefeller University             University of Wisconsin-Madison
        University of Colorado at Boulder       Washington University School of Medicine

        Also participating were researchers from the ten HHMI host institutions; authorized state
regulatory officials from the states of the host institutions; the Director and staff,  Office of Solid
Waste, U.S. EPA; staff of the Safety, Health and Environmental Management Division, U.S. EPA;
officials from the NIH Office of Extramural Research responsible for the NIH study on regulatory
burden; the Director, Office of Environmental Management, Massachusetts Institute of Technology;
and the EH&S directors of the three universities involved in the New England University
Laboratories Project XL.

Project Approach

        In August 1999, HHMI sponsored a workshop to introduce and begin phase one.  From the
outset, the participants agreed that the commitment to protect human health and the environment and
to promote excellence in environmental stewardship would govern all discussions. The group
finalized the project scope, reached consensus on the objectives and criteria, devised an approach to

-------
carry out the project, and identified seven principal elements of a hazardous waste management plan
for academic research institutions.

        Scope
        To develop and carry out a broad collaborative initiative to identify and establish
        consensus best practices for managing hazardous wastes in major academic research
        institutions, and develop a proposed regulatory model for implementation at the state or
        federal levels.

        Objectives
        To develop an operational strategy for managing hazardous wastes generated in
        teaching and research laboratories of major academic research institutions that would (1)
        establish consensus best practices that are relevant to laboratory activities, practical to
        carry out, efficient, and cost-effective; and (2) promote excellence in environmental
        stewardship among students, laboratory employees and other workers, and scientists
        and academic leaders.

        To demonstrate the efficacy of the strategy for managing hazardous laboratory wastes.

        To promote cooperation, understanding, and mutual respect among environmental
        protection agencies, academic institutions, and the scientific research community.

        To develop a plan for implementing the best practices approach for managing hazardous
        wastes in academic research institutions.

        Criteria
        Current EPA and state regulations would apply to all  hazardous wastes  leaving academic
        research institutions for  treatment, storage or disposal.

        Current EPA or state regulations would not constrain  the development of best practices
        for managing on-site hazardous wastes generated in teaching and research laboratories.

        The commitment to  minimize the potential of harm to  human health and the environment
        and to promote excellence in environmental stewardship would govern all discussions.

        Seven Principal Elements of a Hazardous Waste Management Plan

        Executive commitment                       Standard operating procedures
        Specific management plan                    Training, education, and communication
        Responsibility and accountability              Continual evaluation and improvement
        Policies and procedures to minimize waste

        Phase  two of the initiative began in March 2000 following a six-month period during which
the ten universities independently identified best practices for managing hazardous wastes in the
academic research setting.  At a second workshop, using the reports prepared by the ten universities,
the group reached consensus on 14 best practices.

        Phase  three of the initiative began in August 2000. At a third workshop, the group
formalized the 14 consensus best practices, devised an implementation plan for  demonstrating and
measuring their effectiveness, and reviewed the maximum regulatory flexibility permissible for each.
The group agreed to demonstrate and measure the effectiveness of the consensus best practices for
one year beginning October 1, 2000, and ending October 1, 2001.

-------
        At the start of the demonstrations, the Director, Office of Solid Waste, U.S. EPA, wrote to all
RCRA senior policy managers and branch chiefs encouraging their support of the demonstration
projects. Also, at the start of the demonstrations, each university performed an extensive self-
assessment of its hazardous waste management program for the 14 consensus best practices and the
roughly 120 sub-elements of those practices.  Each university repeated the same self-assessment at
the conclusion of the demonstrations.
4. THE CONSENSUS BEST PRACTICES

        The consensus best practices are not prescriptive requirements—they are guidelines that give
purpose, direction, and clarity to broad functions that an academic research institution should carry
out in managing the hazardous wastes produced in its laboratories.  Their value is to promote
stewardship and responsibility for health, safety,  and the environment as a performance goal.  The
universities agreed that the best way to meet a performance goal is to develop institutional programs
that reflect the style, culture, and nature of the laboratory activities of the individual universities.  For
this reason, each university could decide how to  interpret and carry out the intent of the best
practices.  In some cases, the universitie s found that their current programs met the intent of one or
more of the best practices and, therefore, chose not to conduct demonstration projects in those areas.
However, all ten universities addressed the first best practice concerning executive commitment:
Each wanted to assure strong executive commitment to their hazardous waste management program.

        The 14 consensus best practices follow.  The information included with each best practice
clarifies intent without prescribing measures for how to develop or manage a quality hazardous waste
management program.

Executive Commitment

1.      The executive leadership of the institution embraces, supports, states, and carries out the
commitment to protect human health and the environment and to promote excellence in environmental
stewardship.

        This commitment presumes a willingness to strive for a level of performance that exceeds
        basic regulatory compliance requirements.  Broad performance goals are set to drive and
        sustain this commitment.

        Executive commitment is the critical element for the success of all institutional activities  that
        collectively promote excellence in occupational safety and health and environmental
        protection, including the management of hazardous wastes. The chief executive officer and
        all institutional governance bodies endorse the commitment. The institution provides
        resources sufficient to enable the implementing programs to lead the institution beyond
        compliance toward a level of excellence in environmental stewardship.  The chief executive
        officer assigns responsibility and authority to senior level managers and  laboratory directors
        for carrying out their program responsibilities.  The chief executive officer also defines and
        assigns responsibility and accountability of all institutional employees, contractors, students,
        and visitors for carrying out this commitment.

        The institution defines its commitment in writing, communicates the written commitment to
        all individuals and groups associated with the institution, and reinforces its commitment

-------
        periodically.  An example statement of commitment is: "Our institution is committed to the
        philosophy that teaching and research are best conducted in laboratories where dedication to
        safety, health, and environmental stewardship is exemplary."

Responsibility and Accountability

2.       All members of the institution's laboratories and environmental health and safety program know
their roles in the institution's chemical waste management program and understand they are accountable
for their performance.

        Responsibilities of individuals and groups are clear, appropriate, and relevant to their work
        and duties.  Individuals and groups are aware of their individual and group performance
        expectations.  The interactions between groups with responsibility are clear.  Mechanisms for
        assuring accountability and correcting identified problems are available. Such mechanisms
        can include peer review, committee oversight, incentive initiatives, criteria in personnel
        evaluations, and procedures for reporting problems without fear of reprisal. The term
        members means employees, students, guests, and contract employees who work in
        laboratories or in the institution's environmental health and safety program.

Policies and Procedures for Pollution Prevention

3.       Policies and procedures for pollution prevention are an integral part of the institution's chemical
waste management program.

        Pollution prevention is a primary goal of environmental stewardship. Pollution prevention
        encompasses such practices as waste minimization, recycling, and reuse. There is a high
        expectation that laboratory scientists with assistance from staff of the institution's
        environmental health and safety program will voluntarily conduct regular project reviews to
        identify and implement better ways to reduce hazardous waste, including ways to reduce or
        eliminate chemical hazards of a protocol waste stream.  Inventory procedures including
        periodic review of current holdings assure the purchasing of minimal chemical quantities and
        container sizes that are appropriate for laboratory use requirements.  Procedures that allow
        for the  voluntary transfer of unused chemicals to other laboratories that can use them are in
        place. Pollution prevention is a consideration in the selection and development of new
        research protocols. Laboratories substitute less hazardous chemicals in existing protocols
        and adopt micro-scale research protocols where appropriate.

Standard Operating Procedures

4.       The provisions of the institution's written Chemical Hygiene Plan apply to all practices involving
the handling, containing, and storing of chemicals in laboratories.

        The Chemical Hygiene Plan is a written program developed and implemented by the
        institution that specifies the procedures, equipment, personal protective equipment, and work
        practices that are capable of protecting people from the health hazards presented by
        hazardous chemicals used in its laboratories.  The Chemical Hygiene Plan is a regulatory
        requirement of the Department of Labor under its Occupational Safety and Health
        Administration Standard on Occupational Exposures to Hazardous Chemicals in
        Laboratories.  The Standard is applicable to all hazardous chemicals in laboratories including

-------
        used and unused chemicals that could potentially present a hazard to human health and the
        environment.

        Institutions that write Chemical Hygiene Plans for individual laboratories provide an
        institutional model to assure consistent practices for handling, containing, and storing used
        and unused chemicals.

        A State institution not under the jurisdiction of the U.S. Occupational Safety and Health
        Administration has a comparable written plan that describes its provisions for the protection
        of human health and the environment.

5.       Standard operating procedures that are necessary to carry out the institution's chemical waste
management program are written and readily available to members of laboratories and the institution's
environmental health and  safety program.

        The institution incorporates the standard operating procedures for laboratories by reference as
        provisions of its Chemical Hygiene Plan or comparable written plan.  The procedures are
        performance-based, clearly stated, easy to follow, specific to laboratory activities and
        quantities of chemicals  handled, and free of extraneous material that is not relevant.  The
        standard operating procedures for activities conducted in laboratories  and in the facilities of
        the environmental health and safety program are based on and tailored to the specific waste
        management functions  and responsibilities of these groups.  The laboratories and
        environmental health and safety program jointly develop the standard operating procedures.

6.       Chemical materials removed from laboratories have labels with  information sufficient to inform the
recipient of potential health or safety hazards, and to enable the environmental  health and safety program
to carry out safely and effectively the institution's  chemical waste management program.

        The label contains qualitative information, such as the identity  of the chemicals present, and
        sufficient quantitative information to permit the institution's environmental health and safety
        program to determine the level of hazard.

7.       Laboratories adapt, validate, and use laboratory protocols, where appropriate, to reduce or
eliminate chemical waste.

        Scientists are encouraged to adapt existing laboratory protocols and to create and validate
        new protocols that reduce  or eliminate chemical waste and the use of hazardous chemicals in
        research protocols.  Such initiatives offer great promise for innovative waste minimization
        processes.

8.       The institution's environmental health and safety program collects used and unused chemicals
from laboratories and transports them to  on-site storage locations. The program selects options
regarding reuse, recycling, consolidating, storage, volume reduction, treatment, or disposal.

        The environmental health  and safety program provides a timely and efficient process for
        responding to requests for collection of used  and unused chemicals  from laboratories. At the
        time of collection, the program verifies chemical information, assures integrity of collection
        containers, and communicates any discrepancies with the chemical  user, laboratory director,
        or other available laboratory personnel.  The  program staff transports acceptable collection
        containers to on-site storage locations in secondary containment to reduce the likelihood of

-------
       release to the environment. Spill control equipment is available on vehicles used to transport
       collection containers between campus facilities. The inter-facility transport of collection
       containers is coordinated with the institution's emergency response program.  Used and
       unused chemicals may be stored temporarily in on-site facilities under the control of the
       environmental health and safety program.

       Environmental health and safety programs that use contractors for collection of used and
       unused chemicals identify chemical materials appropriate for inclusion in on-site waste
       minimization efforts prior to the contractor's characterization of used and unused chemicals
       for off-site management.

9.      The institution's environmental health and safety program uses validated protocols, where
appropriate, to recycle, reduce, or eliminate chemical hazards of laboratory-scale quantities of waste
chemicals including  bulk and consolidated materials.

       The environmental health and safety program is encouraged to develop and validate protocols
       for recycling, reducing, or eliminating hazardous characteristics of waste chemicals collected
       from laboratories. Protocols will not include combustion.  Compliance with the provisions of
       the institution's Chemical Hygiene Plan or comparable written plan assures the protection of
       human health and the environment when conducting these activities.  Such initiatives offer
       great promise for innovative waste minimization processes.

10.     The institution's environmental health and safety program makes the hazardous waste RCRA
determination.

       The environmental health and safety program may accumulate used and unused chemicals it
       collects from laboratories in on-site storage facilities  under its control.  The environmental
       health and safety program makes  or confirms a hazardous waste RCRA determination
       following the institution's standard operating procedures at the time the used and unused
       chemicals are brought to these facilities. Once the environmental health and safety program
       determines a used or unused chemical is a RCRA hazardous waste, it will comply with all
       extant provisions of RCRA regulations for the management of hazardous waste. However,
       flexibility in the accumulation time limit is available to optimize waste management where
       there are limited treatment and disposal options, or it is necessary to minimize  risk to human
       health and the environment.

11.     The institution plans for the appropriate response to chemical emergencies in laboratories and
other locations associated with the institution's chemical waste  management program.

       Members of laboratories know how to respond to emergencies involving hazardous
       chemicals handled in their laboratories. They receive information and training in the
       emergency procedures that the institution has established in its emergency response program
       relevant to work conducted in laboratories.

Training, Education, and Communication

12.     The amount and complexity of training  that members  of laboratories and the environmental health
and safety program receive correspond to the skills and knowledge required to carry out their individual
responsibilities. Performance monitoring documents training effectiveness.
                                                10

-------
       All training relevant to chemical waste management clearly communicates the executive
       commitment to protect human health and the environment and to promote excellence in
       environmental stewardship. Chemical waste management training is an integral part of
       orientation and refresher training in laboratory safety. All persons responsible for hazardous
       waste determination, RCRA waste management, and emergency response receive training
       consistent with applicable regulations. Appropriate members of the institution's
       environmental health and safety program participate in orientation training. Each visit to the
       laboratory by a staff member of the environmental health and safety program provides an
       opportunity for in-service continuing education. A continuing objective is to optimize
       learning methods. Innovative computer-assisted programs  can provide efficient and effective
       training.

13.     A communication system that links the executive leadership, members of laboratories, and
members of the environmental health and safety program is in place to maintain awareness of and
commitment to the goals and  best practices of the institution's chemical waste management program.

       An effective communication process helps individuals stay informed of what they need to
       know to do their part to maintain the quality of the chemical waste management program.
       Open communication where there is no fear of reprisal can accelerate the identification of
       problems, corrective actions, and improvements.  Effective communication is vital to the
       success of any effort to introduce  new requirements or procedures.

Program Evaluation and Improvement

14.     The institution's environmental health and safety program conducts carefully planned program
evaluations to enhance the quality and effectiveness of the institution's chemical waste management
program.

       The value of a program evaluation for improving program performance is dependent on the
       professional skill and experience of the person conducting the evaluation.  Careful studies
       require the selection of appropriate criteria for monitoring and documentation. Performance
       indicators help show measurable improvements.  Environmental audits are an excellent
       means for evaluating program quality and effectiveness and for highlighting areas for
       improvements. Recommended improvements originate through effective interactions
       between members of laboratories,  including laboratory directors, and members of the
       environmental health and safety program. Written reports  and early feedback help the
       adoption of recommended improvements. Periodic evaluations allow the institution to adapt
       easily to changing circumstances.  Environmental health and safety programs consider
       involving the applicable regulatory  agencies as active partners in program evaluations and for
       sharing results of program evaluations with these agencies.
5. RESULTS AND FINDINGS OF DEMONSTRATION PROJECTS

By Consensus Best Practice

       The request by Congress for a report in October 2001 evaluating the consensus best practices
developed through the initiative caused the universities to shorten their demonstration period to eight
months. In this eight-month period the universities made much progress.  Although the
                                               11

-------
demonstration projects will continue until October 1, 2001, most of the best practices are now
standard practices at the ten universities.

        The following describes the results and findings of the projects that the universities
undertook as part of the consensus best practices demonstrations. It does not include information
describing the hazardous waste management programs the universities had in place prior to the start
of this initiative, except  for a few comments to add perspective. The results  and findings reflect the
diversity and creativity that is indicative of the potential value of a performance-based approach for
managing hazardous wastes in academic research institutions.

        Executive Commitment

        At the beginning of the demonstration projects, Harvard University and the University of
Colorado at  Boulder assessed their levels of executive commitment to environmental stewardship as
excellent.  Both universities provide strong support with appropriate resources for their EH&S
programs. At Harvard  University, executive commitment extends from the  President and Deans
down to each faculty and administrative group. The President's delegation of authority demonstrates
a model approach for assuring subordinate leadership commitment to EH&S in academic institutions
having an organizational tradition of decentralization.

        Stanford University and the University of Texas Southwestern Medical Center (UTSMC)
assessed their levels of executive commitment as acceptable. Both universities have written
statements of commitment and appropriate delegations of authority, and resources for their EH&S
programs. At Stanford  University, the issuance of environmental policy is under the authority of the
President. In the University of Texas  System, the Chancellor issues environmental policy to all
University of Texas System presidents including the President of UTSMC.  Stanford University and
UTSMC use a committee system to guide implementation of environmental policy.

        The remaining six universities made substantial progress toward enhancing their levels of
executive commitment to health, safety, and environmental stewardship. Duke University's
Executive Vice  President issued a statement in support of environmental stewardship and plans are
developing to have the Board of Trustees address this issue.  The University committed new
resources that enabled the EH&S program to hire an environmental engineer to develop and carry out
an environmental audit program. The President of The Rockefeller University revised the
University's written executive commitment statement to  affirm support for excellence in
environmental stewardship with regard to hazardous waste management.  Plans are underway to
encourage the Faculty Senate to show its support for this commitment in writing.

        The universities of Pennsylvania, Washington, Wisconsin-Madison, and Washington
University do not have formal statements of executive commitment to environmental stewardship,
however, projects are in progress to establish these statements. The University of Pennsylvania's
Health, Environment, and Safety Committee is currently reviewing a draft statement developed as
part of their  demonstration.  The University of Washington has developed an Environmental
Stewardship Task Force under the auspices of the University's Executive Vice President to develop
an executive commitment policy statement and a strategy of targeted projects to attain policy goals.
Recommendations will  go to the University's President, Executive Vice President, and Provost.  The
Task Force includes faculty, administrators, and students. In addition, the University is updating
existing governance documents.  The  University of Wisconsin-Madison is working to codify policy
on health, safety, and the environment.  The University's executive commitment project has raised
                                                12

-------
sensitivity to the need for written policies, even when the principles are generally accepted.  At
Washington University, the Associate Vice Chancellor for Medical Affairs is drafting language to be
included in the University's mission statement.  The Chancellor will submit the statement to the
Executive Faculty for approval this summer.

        These projects raised executive leadership awareness of and interest in hazardous waste
issues and the role of the universities in promoting environmental stewardship.

        Responsibility and Accountability

        This best practice is standard practice at the ten universities. At the beginning of the
demonstrations, most universities assessed their performance as acceptable.  Harvard University
increased its performance level after finding that an initiative under another best practice—Effective
Communication within an Organization—increased organizational and individual responsibility and
accountability.  During the course of the project, the University of Colorado  at Boulder reassessed its
performance to be at the excellent level

        At Stanford University, the EH&S staff invited several laboratories to participate in a
demonstration project on a pilot basis.  They briefed the laboratories on the project, asked the
research staff to incorporate aspects of the consensus best practices into their daily operations, and
reviewed with them the results of a University-wide baseline assessment of its hazardous waste
program to ensure the results accurately reflected the conditions within the pilot laboratories. During
the demonstrations, the EH&S staff provided extra resources and attention to the laboratories.  A
survey conducted by EH&S several months into the  demonstrations showed that performance had
improved considerably—to the level of excellent. Using qualitative measures of self-assessments,
the EH&S staff found that the members of the pilot laboratories had a better understanding of their
responsibilities, and were more knowledgeable of the practices for which they are held accountable
than did their counterparts in non-pilot laboratories. Although this  increase in performance may be
due in part to the special care provided by the EH&S staff, the pilot laboratories reported that they
were more motivated by a commitment to environmental stewardship, which guided the development
of the project, than by being told to follow strictly administrative compliance activities.

                                       STANFORD UNIVERSITY
                                    ELEMENTS OF BEST PRACTICE 2
                         PERFORMANCE IMPROVEM ENTS IN PILOT LABORATORIES
                    ELEMENT
INCREASE IN PERFORMANCE OVER BASELINE
    Knowledge of hazardous characteristics
                55%
    Knowledge of unusual characteristics
                40%
    Knowledge of handling procedures
                67%
    Knowledge of emergency procedures
                64%
    Investigators convey importance of lab safety
                64%
    Day to day training
                (-2%)
    Follows up on inspections
                50%
        The University of Washington initiated a collaborative demonstration project, that has since
become standard practice, involving auditors from its Prevention and Assessment Office and EH&S
staff.  The group developed a short list of possible hazardous waste deficiencies for the auditors to
use during routine laboratory audits. When deficiencies are observed, the auditors encourage
immediate corrective action.  Where such action is not possible, the auditors notify EH&S.  During
                                                13

-------
the demonstration, there were 19 deficiencies noted in audits of 37 laboratories; the laboratory staffs
immediately corrected the deficiencies.  This same list is included as part of a compliance evaluation
form used by EH&S to note deficiencies during waste collection visits to the laboratories. When
deficiencies are noted, the EH&S staff leaves the form and requests the investigator to return it
within ten days indicating the corrective actions taken.  The EH&S staff left compliance forms
during 34 waste collection visits.  All investigators returned the forms within 10 days.  The EH&S
staff reports no recurring deficiencies on subsequent waste collection visits; the staff credits use of
the compliance forms for decreasing hazardous waste deficiencies and improving performance.

        Policies and Procedures for Pollution Prevention

        Prior to the start of this initiative, the universities had prepared reference guides for
laboratories listing opportunities for pollution prevention and waste minimization.  As part of the
demonstrations, many of the guides were updated and made available on the EH&S Web pages for
easy access by laboratory staff.  The Stanford University EH&S staff distributed information on
specific practices for pollution prevention and waste minimization to their pilot laboratories.  They
report that the pilot laboratories were more likely to improve their chemical inventory methods,
substitute less hazardous chemicals where possible, and adopt micro-scale protocols than were
baseline laboratories. UTSMC is introducing a new environmental compliance audit program that
will gather information to identify pollution prevention opportunities.

        The University of Washington EH&S staff operates an excellent pollution prevention
program. Developed within a five-year Pollution Prevention Plan are performance goals for
treatment, recycling, surplus exchange, and hazardous materials use reduction.  The EH&S staff
tracks and analyzes data annually to identify high volume or high cost wastes that may offer
opportunities for pollution prevention and to revise, as necessary, program goals. Promotion of the
program occurs with incentives.  Laboratories save approximately 60 percent in costs when
purchasing recycled solvents. The  surplus chemical exchange is operated free of charge.  Estimates
are that  University laboratories participating in the program collectively saved more than $10,000 in
the year 2000. The University, under the authority granted by the Washington State Department of
Ecology, also operates a "treatment by generator" program as part of its pollution prevention
program.  Such state authorized programs allow generators to responsibly treat wastes in tanks or
containers without a RCRA permit.  The University of Washington EH&S staff treats over 65,000
pounds of hazardous wastes per year.

        All ten universities are expanding their silver recovery programs and accelerating efforts to
eliminate the use of mercury containing thermometers in clinical and research areas. Most
universities have or will implement this  year a mercury thermometer exchange program. Health and
safety committees and EH&S staffs are  reviewing chemical requisitions and inventories to identify
opportunities for pollution prevention. Redistribution programs for surplus materials are showing
greater promise for intercepting these materials from laboratory waste streams.

        Chemical Hygiene Plan

        The federal Laboratory Standard of OSHA, which mandates a written CHP, applies to seven
of the ten universities. This Standard does not apply to the University of Colorado at Boulder,
UTSMC, or the University of Wisconsin-Madison, which are public institutions in non-OSHA Plan
states. However, these three public universities have or are developing comparable written plans that
describe provisions for protecting human health and the environment.  The University of Wisconsin-
                                                14

-------
Madison EH&S staff is undertaking a project to place greater emphasis on the role of its CHP in
laboratory safety and protection.  The EH&S staff has shifted emphasis from development of
individual laboratory plans to plans that have broader coverage  such as for an academic department
or an entire building.  They expect this shift will increase uniformity, simplify compliance, and
increase administrative involvement in environmental, health, and safety issues.  The University of
Colorado at Boulder and UTSMC are planning projects to evaluate and improve practices for
managing hazardous  chemicals on their campuses.

       The EH&S staffs at The Rockefeller University and Washington University reviewed and
updated their CHPs.  The Rockefeller University's review concluded that this best practice offers the
greatest opportunity for meaningful improvement in waste management in the laboratory because the
CHP addresses the waste at the point of generation and recognizes the difference between a
laboratory and an industrial setting. Further, good laboratory practices assure the safe handling of
wastes in a consistent and efficient manner by appropriate staff.

       The EH&S staff at the University of Pennsylvania revised its CHP to reflect changes in its
chemical waste management program.  This revision increased safety awareness in the laboratories,
particularly with regard to hazardous waste management. The  EH&S staff plans to work with the
laboratories to address the human health and environmental protection issues for unique chemical
waste streams generated in research. The staff believes this collaboration will foster educational
opportunities and increase knowledge in safe and healthful practices.

       Chemical  Waste Management

       Stanford University reports that members of the pilot laboratories had a better understanding
of container segregation and labeling requirements, and considered pollution prevention methods
more often when designing new experiments than did their colleagues in non-pilot laboratories.  The
close interaction between the EH&S staff and the laboratory workers established by this project
contributed to this positive outcome. Members of the pilot laboratories showed only a modest
interest in conducting bench top treatment; they perceive that the regulatory burden is too high.

       The Rockefeller University EH&S staff reviewed the standard operating procedures of its
waste management program.  They revised the procedure for treatment of ethidium bromide and
successfully treated 76 liters of ethidium bromide waste.  The staff evaluated a neutralization
program for acids and bases and concluded that the potential reduction in waste volume did not
justify the use of staff resources. They also identified several improvement projects including the
preparation and distribution of waste guidelines for laboratory workers, a review of waste storage
practices with a goal of eliminating satellite accumulation  areas  within laboratories, and a training
project to improve  container management. An environmental audit by a consulting firm may identify
other opportunities  for improvements.

       The University of Pennsylvania EH&S staff met with investigators, research technicians, and
graduate students to review and critique the guidelines of its hazardous waste management program.
Their goal was to ensure that the guidelines are current and helpful, and reflect input from the
research community. The Washington University EH&S staff  developed a pictorial flow chart for
laboratories in need of special guidance to aid in improving their performance.
                                                15

-------
        Container Labeling

        Stanford University EH&S staff introduced new procedures for labeling containers in its pilot
laboratories. A simplified waste label was developed and given to the pilot laboratories along with
stickers designating a surplus material.  The EH&S staff advised laboratory workers to manage
discarded chemicals as either waste or surplus materials. There was no time limit applied to storage
or accumulation of surplus materials. The staff defined waste as expired, banned, or degraded
materials, and mixtures and solutions typically categorized as hazardous waste.  Laboratory workers
managed only waste materials as hazardous wastes. When the waste materials were received by
EH&S, they were undeclared if necessary, and reclassified  as surplus, retrograde, or recyclable
materials. The staff used surplus, retrograde, or recyclable stickers to identify the reclassified
materials. Product labels provided appropriate identification and hazard warning for materials
reclassified as surplus.  Upon receipt of the laboratories' surplus materials, the EH&S staff entered
the materials into a chemical redistribution program or declared them a hazardous waste and
managed them accordingly.  The laboratory workers were responsive to the simplified labeling
program and mastered the procedures with ease.

        The Rockefeller University EH&S staff found through its laboratory audit program a need to
improve the procedure for identifying container contents. They developed a standard label for
chemical waste accumulation containers, modified the waste guidelines to require use of the label,
and alerted the campus community of the changes.  The staff will highlight use of the label in an
intra-Web training program now in development. This summer, the staff is repeating a campus-wide
educational outreach effort.  Members of EH&S will meet with researchers in their laboratories,
provide additional copies of the labels and updates on waste guidelines, and answer questions on
waste management  issues.

        The University of Pennsylvania EH&S staff revised its Chemical Waste Disposal Procedures
in March 2000 and internal SOPs in December 2000 to reflect changes in the storage, handling, and
identification of chemical waste material in the laboratory.  Large volumes of solvent wastes, for
example, halogenated solvents or non-halogenated solvents,  are identified as hazardous waste while
inside the laboratory. The information on a color-coded tag  includes the waste stream, data, and the
Treatment, Storage,  and Disposal Facility (TSDF) waste stream identification code for the particular
waste stream.  When initially placing waste into a container, it is the responsibility of the laboratory
staff to attach a color-coded tag to the outside of the container. When the container is full, the staff
affixes a chemical disposal label to the upper part of the container identifying the chemical
compounds' corresponding percentages and principal investigator.  Reagents in their original
containers with legible manufacturer's labels require no additional labeling or packaging.

        Laboratory Protocols to Reduce Hazard

        The use of a biodegradable scintillation cocktail in place of the past traditional solvent based
cocktail is an excellent example of this best practice—a laboratory protocol has been adapted to
eliminate a chemical hazard.  Several universities recognized the potential benefits of this best
practice, but the short time allotted for the demonstrations made progress difficult.  The University of
Colorado at Boulder encourages laboratories to adopt post-process treatment protocols that reduce
hazardous wastes. Protocols for treatments other than neutralization of clean acids and bases require
approval of the EH&S program.  The University of Wisconsin-Madison reports that laboratories are
reluctant to incorporate hazard reduction protocols because initially they may require more time to
                                                16

-------
perform since laboratory workers are unfamiliar with the procedures.  Teaching laboratories are
incorporating hazard reduction protocols into procedures as part of the teaching process.

       Collection, Transport, and  Storage by Environmental Health and Safety

       All ten universities conduct their hazardous waste management programs in accordance with
this best practice and, therefore, none considered a demonstration project necessary. Seven
universities report excellent performance in many elements of this best practice; three report
excellent performance in most elements. Both the University of Colorado at Boulder and UTSMC
have authorization under a RCRA Part B Permit to operate a hazardous waste TSDF.  The University
of Wisconsin-Madison is in the final  process of closure to secure its old TSDF. The University built
a new chemical waste facility and in the planning process determined that a RCRA Part B Permit is
not advantageous.  The Rockefeller University is also planning to construct a new waste management
facility; the University will not apply for a RCRA Part B Permit.

       Five universities reported data on the number of incidents occurring during the demonstration
phase involving the collection, transport, and storage of chemical waste.  One reported no incidents,
three reported one incident, and one reported two incidents.  No  chemical waste incidents resulted in
a release to the environment. All universities reported that chemical waste incidents are rare
occurrences. In addition, one university noted that the majority of "unknowns" processed during this
period involved clean-out of historical collections and did not originate from daily collections.

       Validated  Environmental Health and Safety Treatment Protocols for Volume Reduction

       The University of Colorado at Boulder EH&S staff prepared procedures for laboratory
workers to neutralize clean acids  and bases and to dispose of the treated materials as wastewater.
The staff is installing state-of-the-art equipment  in its TSDF to perform silver recovery,
neutralization of bulk acids and bases, and organic waste ozone and ultraviolet oxidation. The
University's RCRA Part B Permit allows certain flexibility to conduct treatment that is not generally
available to universities  with non-permit facilities.

       The University of Washington EH&S staff operates a "treatment by generator" program to
treat hazardous waste on-site. The Washington State Department of Ecology allows generators of
hazardous waste to treat waste in tanks or containers, without a RCRA permit, in an environmentally
responsible manner to reduce the hazard or volume of hazardous waste. This treatment program
treats over 65,000 pounds of hazardous wastes annually. In addition, the EH&S staff operates a
solvent recycling program that distills waste solvents and markets the purified solvents to the
University's laboratories. This program saves disposal costs and reduces the laboratories' cost of
new solvents by over 60 percent.

       The following table shows the results of Duke University's current chemical waste volume
reduction program. The data show a significant  reduction in the  use of halogenated solvents and
major increases in recycling of oil, fluorescent light bulbs, and mercury.  The program also
redistributed through its chemical waste exchange over 1,400 pounds of usable chemicals in the year
2000. The data does not reflect solid waste that goes to a landfill and liquid waste discharged as
wastewater.
                                               17

-------
DUKE UNIVERSITY
CHEMICAL WASTE VOLUM E REDUCTION PROGRAM
DISPOSAL AND TREATMENT METHODS
WASTE STREAM1
Bulk flammable / corrosive
Bulk halogenated solvents
Bulk low solvents
Bulk non-halogenated solvents
Bulk non-regulated solvents
Bulk oil
Bulk photographic fixer
Bulk spill response solid material
Bulkxylene
Fluorescent light bulbs
Labpack corrosive liquid
Labpack flammable liquid
Labpack halogenated solvents
Labpack non-halogenated solvent
Labpack non-regulated poisonous solid ^
Labpack paint flammable °
Labpack not in file4
Mercury
Recyclable wastes5
INCINERATE
1999
-
7534
1120

2014


20



176
92
191
-
314
1584


2000
63
5993
861

3954


1342



223
-
-
252
442
-


FUEL BLENDING
1999



11741















2000



11044















RECYCLE
1999





3928
2302

2313
9739







317
-
2000





7770
2307

1865
30851







623
408
NEUTRALIZE
1999










762








2000










681








1 All the wastes are approximated in pounds.
2 These are incinerated or fuel blended with very little landfilled.
3Can be incinerated or mixed forfuel blending, depending on the chemical make-up.
4 Chemical that is not in the EH&S Chemical Waste Inventory Data Base.
5 Contains waste such as various metals, oxides and empty gas cylinders.
       The Duke University EH&S staff has undertaken a major project to expand the treatment
capabilities of its chemical waste volume reduction program.  The University entered into a
Memorandum of Understanding with a process technology company to conduct a final evaluation of
the cost and risk benefits of employing an innovative chemical waste treatment technology for
oxidation of organic compounds in its chemical waste reduction program.  The Pacific Northwest
National Laboratory developed the fundamentals of the process technology, which is based on
cerium electrochemistry.  The North Carolina Division of Waste Management (DWM) is interested
in Duke University's pursuit of this initiative. The DWM participated in the regulatory evaluation,
and approved Duke University's use of this technology under the provision of the hazardous waste
generator regulations.

       Duke University's Nicholas School of the Environment is participating in the project.  A
graduate student joined the project team to  study which waste streams are candidates for beneficial
treatment using this technology. Current projections suggest that all bulk solvent waste and waste
oil, and approximately 25 percent of the labpack waste are candidate waste streams.  This represents
roughly 75  percent of the waste handled in the chemical waste reduction program, excluding landfill
waste and wastewater.  However, the program will likely continue to recycle bulk oil and xylene, and
use bulk non-halogenated solvents in fuel blending. This would make the beneficial projections
approximately 30 percent, or  12,000 pounds of the consolidated waste streams. The program is also
                                               18

-------
considering introducing a new filtration technology for the treatment of ethidium bromide waste.
This approach could reduce the waste volume by another 150 gallons per year.

        RCRA Determination by Environmental Health and Safety

        Stanford University and Washington University undertook demonstration projects for this
best practice. The EH&S programs at four universities currently make the RCRA determinations;
they assess their performance as excellent. Four other universities chose not to address this best
practice because they perceived that their state regulatory agencies would not grant this flexibility
without specific approval from the EPA.

        The EH&S programs at Duke University, The Rockefeller University, University of
Washington, and University of Wisconsin make RCRA determinations for waste materials collected
from their laboratories with the concurrence of their state regulatory agencies.  The University of
Washington works closely with the Washington State Department of Ecology and receives extensive
guidance in applying regulatory flexibility. The University reports that it achieves improved
compliance and efficiency in following the requirements of RCRA by having its trained EH&S staff
make the RCRA determinations prior to collection and by operating laboratories as satellite
accumulation areas.  This approach reduces errors and inconsistencies in making RCRA
determinations.  Laboratory personnel are able to focus their efforts on container management and
hazard communication.

        The laboratory staffs at Harvard University, Stanford University, UTSMC, and Washington
University are responsible for making the RCRA determinations. Laboratory staffs at the University
of Colorado at Boulder and the University of Pennsylvania also are responsible for making the
RCRA determinations.  However, the EH&S programs at these universities can change the
determinations made by the laboratory staffer modify the process for making RCRA determinations.
For example, at the University of Colorado at Boulder, when the laboratory staffs are unclear as to
whether materials are RCRA hazardous waste, the EH&S staff makes the formal RCRA
determinations.  At the University of Pennsylvania, the EH&S staff makes the RCRA determinations
for waste reagents that are in their original containers with intact labels.

        The following table summarizes the variations in RCRA determination responsibilities.
EXISTING RESPONSIBILITIES
FOR MAKING RCRA DETERMINATIONS
UNIVERSITY
Duke University
Harvard University
Stanford University
The Rockefeller University
University of Colorado, Boulder
University of Pennsylvania
University of Texas S M Center
University of Washington
University of Wisconsin-Madison
Washington University
LABORATORY STAFF
No
Yes
Yes
No
Yes
Yes, for large volume waste
Yes
No
No
Yes
EH&S STAFF
Yes
No
Yes, for surplus reagents
Yes
Can change determination
Yes, for labpack waste
No
Yes
Yes
Yes, for surplus reagents
        Stanford University's EH&S staff discussed their interest in conducting a demonstration
project on this best practice with the California Department of Toxic Substances Control (DTSC).
                                               19

-------
The DTSC agreed to a project that allowed the EH&S staff to collect surplus materials from the pilot
laboratories without the laboratory staffs making a RCRA determination.  The EH&S staff made the
RCRA determinations for the surplus materials collected from the pilot laboratories that were not
suitable for the University's chemical redistribution program.  The laboratory staff and the EH&S
program found this procedure to be practical and efficient.

        The Washington University's EH&S program developed its project in collaboration with the
Missouri Department of Natural Resources.  The demonstration project requires laboratory personnel
to make initial  RCRA determinations. EH&S staff makes the final determinations after the waste
material is brought to its central facility. The evaluation of the project is not complete since it began
toward the  end on the demonstration phase.

        Emergency Response

        All ten universities have plans and procedures for implementing appropriate responses to
emergencies including emergencies in laboratories. All report that incidents relating to the operation
of their hazardous waste management programs are infrequent.  For example, during the past 18
months, Duke  University  has experienced only one chemical waste incident in a laboratory. In
addition, the University  reports that of the 80 responses to chemical spills in laboratories, none
resulted in a release into the environment. The ten universities agreed that this best practice did not
require demonstration projects.

        Training, Education, Communication

        The Duke University EH&S staff revised its Web-based training modules for laboratory
safety to expand emphasis on best practices.  In addition, information on hazardous waste
management was incorporated into a new EH&S module for graduate credit through the Nicholas
School of the Environment.

        Harvard University conducted three projects relating to this best practice. The EH&S staff
revised the  quiz found in its Web-based hazardous waste training program in response to feedback
from trainees and research operational managers.  The quiz now randomly selects nine questions
from a group of 20 specific to laboratory hazardous waste management.  This eliminates repetition
and better tests the trainees' knowledge. The EH&S staff anticipates that this will yield better
compliance with issues  such as labeling and container management, but it is too early to determine
the  quantitative impact.  A second project involved modifying the EH&S  training database to allow
users to search a department's training status for any program.  One of the critical outcomes of this
system is that it places the responsibility for re-training on the trainees and their departments, and not
on the Harvard University EH&S staff. In addition, the staff revised its Training Requirements
Guide to better assist departments in determining the individual training needs.  These improvements
allow EH&S to customize training programs for various groups and helps management staffs develop
better training  plans for their departments. In a third project, a hazardous waste module was
integrated into  a monthly training course that laboratory workers attend to meet their obligations for
training in various EH&S  disciplines. This resulted in a significant savings in time for the EH&S
professionals who previously taught in hazardous waste training sessions, and eliminated confusion
for  trainees who were unsure about what training courses they needed.
                                                20

-------
        The Stanford University EH&S staff led training sessions for the laboratory workers in its
pilot laboratories tailored specifically to the health and safety issues associated with their research;
the laboratory staffs appreciated the relevance of this training. The positive results of this training
initiative were evident in several of the best practices including responsibility and accountability,
policies and procedures for pollution prevention, chemical waste management, chemical labeling,
and communication within the organization.

        The University of Washington undertook a major review of its training programs and
conducted several initiatives as part of this best practice. They assembled a Training Review
Committee of EH&S staff, laboratory personnel, and Washington State Department of Ecology staff.
The Committee reviewed existing training programs, both internal and external to the University,
evaluated the effectiveness of internal programs, and identified key subjects to emphasize in future
training. The group considered Web-based training and video in their review. The Committee
developed an evaluation tool to obtain feedback from trainees on relevance, course presentation, and
value.  Several hundred incoming graduate level science students attending the University's annual
laboratory safety seminar completed the evaluation. Their comments emphasized that training must
be customized to the students, include examples that reflect relevant chemicals and situations, be
concise, to the point, and interactive.  The EH&S staff is incorporating these elements into its 2001
laboratory safety seminar that will be an interactive workshop with smaller class sizes.

        In addition, the EH&S staff evaluated the  capabilities of the Web for hazardous  waste
training. They invited 35 faculty and graduate students from two University departments to evaluate
a prototype Web-based training program.  The content addressed findings from the University's audit
programs, common RCRA violations at academic  institutions, and laboratory feedback.  The staff is
reviewing the evaluations to determine what content should be given emphasis.

        Stanford University, The Rockefeller University, and the universities of Colorado at Boulder,
Pennsylvania, Texas SMC, Washington, and Wisconsin-Madison also found Web-based training to
be an effective method for increasing knowledge and awareness, and for reinforcing prudent
practices in the disciplines of health, safety, and environmental protection.

        Effective Communication within the Organization

        The Harvard University EH&S management system has created effective communication
channels within the University regarding all EH&S matters. The EH&S staff works closely with the
EH&S committee structure, environmental and safety compliance officer network, laboratory safety
and building manager committees, and other university contacts to provide regular, consistent forms
of communications regarding EH&S  matters.  In addition, EH&S dedicates ample resources to the
development and maintenance of its Web site which serves as an excellent means of standard and
consistent communication of complex, technical, and regulatory standards to a diverse audience.

        The Harvard University EH&S staff developed on its Web  site several "toolkit" pages
tailored to specific audiences including researchers, building managers, and students.  The toolkit
concept provides personnel with only that EH&S information pertinent to their operation, thus
eliminating additional links that have no relevance.  The laboratory toolkit, still in its pilot phase,
creates one location on the EH&S Web site where laboratory personnel can get laboratory-specific
EH&S information including hazardous waste resources. The EH&S staff will introduce the
laboratory toolkit to the University community in the next several months.
                                                21

-------
       In addition, the EH&S staff implemented an automated e-mail notification system for
personnel requiring re-training, for example, annual re-training for hazardous waste.  EH&S enters
the names of all personnel receiving training into its Web-accessible training database.
Modifications to this database have made it possible to generate automated e-mail notices to trainees
requiring re-training and notices to designated department administrators for personnel overdue for
re-training. Trainees receive reminder e-mail notices 30 days prior to the re-training date.  Since the
start of this system, several research operations managers have reported a decrease in time necessary
to locate and communicate with delinquent trainees. The system allows designated "Superusers,"
typically department administrators and human resources staff, to run reports on their department's
participation in various training requirements.  They also can receive feedback on their compliance
performance for re-training.  Poor re-training rates may be an indication that communication barriers
exist or of a need to create communication pathways.

       The University of Wisconsin EH&S staff developed a "no reprisal" policy to codify its
current practice. The staff is recommending that the University consider broader adoption of the
policy. Washington University developed plans to conduct an annual meeting for department safety
officers as a means for improving and promoting health, safety, and environmental stewardship.  It is
also considering a project to prepare annual reports for each department that will evaluate the
department's progress in meeting the stewardship goals of the University.

       All EH&S programs are employing multimedia approaches for communicating with their
campus communities.  There is a continuing effort to ensure essential information is  current and
appropriate.  Several programs adapted their laboratory audits to  encourage informal discussions with
laboratory staff concerning health, safety, and environmental issues.

       Program  Evaluation and Improvement

       To focus more on chemical waste management, the Duke University EH&S staff modified an
existing laboratory audit program, which is  an element of its CHP. The auditors now ask laboratory
workers specific questions that address container management and storage as well as other aspects of
the University's chemical waste management program. The following table reports  the results of
roughly 360 annual audits conducted in 2000 and 2001 involving 1,100 laboratories.
DUKE UNIVERSITY
AUDIT RESULTS ON CHEMICAL WASTE MANAGEMENT
YEAR
2001
2000
ALL REGULATED
WASTES COLLECTED
AND SUBMITTED TO
EH&S PROGRAM
Compliant 293
Non-compliant 17
Percent compliant 95
Compliant 282
Non-compliant 21
Percent compliant 93
CHEMICAL WASTES
LABELED
APPROPRIATELY
Compliant 292
Non-compliant 13
Percent compliant 95
Compliant 286
Non-compliant 20
Percent compliant 93
CHEMICAL WASTES
STORED
APPROPRIATELY
Compliant 294
Non-compliant 15
Percent compliant 95
Compliant 290
Non-compliant 21
Percent compliant 93
STAFF AWARE OF
SURPLUS CHEMICAL
EXCHANGE
Compliant 303
Non-compliant 19
Percent compliant 94
Compliant 286
Non-compliant 30
Percent compliant 95
       The Harvard University EH&S staff developed a hazardous waste assessment database that
uses hand held computers for collecting assessment results. A hazardous waste contractor conducts
monthly inspections at over 1,000 satellite accumulation areas in order to provide specific
                                               22

-------
performance data to each department. Assessment criteria consist of the most commonly cited issues
for hazardous waste management—labeling and container management.  Hand held technology
eliminates the paper associated with many assessment programs.  This system allows for fast
collection and download of data to the central hazardous waste assessment database. The EH&S
staff estimates that this system saves  0.5 full-time equivalents through more efficient data collection,
management, and reporting. In addition, once in the database, the data is easier to analyze to identify
problem areas and formulate corrective actions.  Monthly reports are provided via e-mail to
environmental and safety compliance officers and department managers.  Detailed reports, available
upon request, include assessment performance on a room-by-room basis and track each laboratory's
monthly performance. This level of detail allows the environmental and safety compliance officers,
laboratory directors, and others to better determine their department's weaknesses.  An ancillary
impact of these reports is that the consistency in assessment criteria has helped to focus and educate
management personnel on critical management and compliance issues.

       The University of Washington EH&S staff selected an evaluation team to conduct a review
of its hazardous waste management program. The team consisted of the Undergraduate Director of
the Chemistry Department, a research scientist with the Department of Environmental Health, two
staff from the Hazardous Waste Toxics Reduction Program of the Washington State Department of
Ecology, the EH&S Training Manager, and the EH&S Manager of Hazardous Materials and Waste
Management. The team used  a Web-based client survey to collect information. They invited 926
laboratory personnel including investigators, laboratory managers, technicians, and graduate students
to participate; there was a 20 percent response. The survey indicated that most clients are satisfied
with the EH&S hazardous waste management services except for the frequency of waste collections.
The survey helped  raise the awareness of the responders to information on the EH&S Web site about
the hazardous waste management program, particularly the availability of forms and labels. The staff
concluded that use  of the Web  could improve collection efficiencies.

       All EH&S  programs reported that they have existing audit programs for evaluating program
quality and effectiveness and for highlighting areas for improvement. They also reported that they
made significant progress toward improving their waste management programs in the short time
allotted for their demonstration projects.  The new initiatives and evaluation tools developed as part
of this  demonstration will allow progress to continue at an even greater pace.

Qualitative Assessment

       At the beginning of the demonstration phase, the universities performed a qualitative
assessment of their existing hazardous waste  management programs.  The objective was to determine
the extent to which their programs carried out the spirit and intent of the consensus best practices.
The self-assessments enabled the universities to  select demonstration projects that would be of most
benefit to their programs. It is important to note that the assessments were not a review of
compliance performance. The goals  of the consensus best practices transcend the regulatory
expectations for compliance to a set of prescribed practices.  The universities repeated their
assessments at the  end of the eight-month demonstration period. The following table reports the
results of those assessments.
                                              23

-------
PROJECT PERFORMANCE ASSESSMENTS
BY
CONSENSUS BEST PRACTICES
OCTOBER 2000 - JUNE 2001
BEST PRACTICE
1 Executive commitment
2 Responsibility and accountability
3 Pollution prevention
4 SOP: Chemical Hygiene Plan
5 SOP: Chemical waste management
6 SOP: Container labeling
7 SOP: Laboratory protocols to reduce hazard
8 SOP: Collection, transport, and storage
9 SOP: Treatment
10 SOP: RCRA determination by EH&S
11 SOP: Emergency response
12 Training, education, and communication
13 Effective communication
14 Program evaluation and improvement
INITIAL ASSESSMENT
AVERAGE VALUE
1.6
1.7
1.9
2.2
2.6
2.5
1.3
3.4
1.8
2.9
2.6
1.9
1.6
1.6
EIGHT -MONTH ASSESSMENT
AVERAGE VALUE
1.9
2.1
2.1
2.3
3.0
2.6
1.5
3.3
2.1
2.9
2.5
2.2
2.2
2.1
Assessment values:
1 — Marginal performance
2 —Acceptable performance
3 — Excellent performance in many elements
4 — Excellent performance in most elements
Note: One university reassessed its initial assessment of Best Practices 8 and 1 1 from 4 to 3 after re-evaluating its
program during the eight-month demonstration period.
       The assessments support two observations about the existing hazardous waste management
programs of the ten universities. The first is that existing hazardous waste management practices
reflect an institutional commitment to achieve regulatory compliance.  The universities assessed their
initial performance in the best practices that incorporate compliance functions—container labeling;
collection, transport, and storage; emergency preparedness; and RCRA determination—at a high
performance level and they maintained that level throughout the demonstration phase. The second
observation is that efforts to promote stewardship and responsibility for health, safety, and the
environment received less institutional commitment prior to this initiative than did compliance
related practices. The universities assessed their initial performance in the best practices that
enhance stewardship and responsibility—executive commitment, responsibility and accountability,
and program evaluation and improvement—as being much lower than their performance in
compliance related best practices.  These best practices, however, received the greatest attention
during the demonstration phase. The eight-month performance assessments show considerable
progress in applying these best practices to the universities' hazardous waste management programs.

Partnership and Collaboration

       Partnership and collaboration among EH&S professionals, scientists, and officials from the
state and federal environmental protection agencies are positive forces for developing consensus best
practices that are relevant to the laboratory and for promoting environmental stewardship among
scientists.  This was evident in the results of each of the three workshops and during the
demonstration phase.  For example, the University of Washington reports that one of the most
                                                24

-------
valuable outcomes of this collaborative project has been their success in establishing a more
cooperative relationship among researchers, regulators, university administrators, and EH&S staff.
The EH&S staff recognizes this as essential to their program—it was also an underlying goal of this
initiative. The EH&S staff reports that this initiative provided an opportunity to develop a
partnership leading to honest dialogue with regulators  about the challenges facing their University.
In addition, faculty and students came to understand the significant framework that exists to promote
human health and protect the environment while the campus community pursues the goals of
teaching, research, and service.  The staff also reports that administrative programs  at the University
are  seeing new opportunities for increased partnerships with students and faculty in promoting future
goals in conservation and environmental protection.

        Another valuable outcome that resulted from  Stanford University's pilot laboratories project
was confirmation that scientists find performance-based initiatives developed collaboratively by
EH&S staff, scientists, and regulators motivate them to think positively about environmental
stewardship whereas prescriptive regulatory requirements imposed on them with little consideration
of the research laboratory environment negate such thinking.

        One state regulatory official participating in the initiative observed that continuing dialog on
environmental regulations, both within the university, and among the university and the state and
federal regulatory programs, is paramount in building  trust and finding sensible approaches to meet
common goals within a given regulatory structure.  This dialog, it was stated, is essential in
addressing environmental regulations, such as RCRA, that are not well suited for the one-size-fits-all
approach. The official concluded that the dialog promoted by this initiative made it possible to
develop and validate these best practices for managing hazardous waste in academic laboratories.

Conformity and Consistency

        This initiative found a lack of conformity and  consistency nationwide in the application of
RCRA to academic laboratories.  These findings result, in part, from the authority RCRA gives to the
states to promulgate regulations that are more stringent than federal RCRA regulations.  For
example, the Massachusetts Department of Environmental Protection prohibits treatment of
hazardous waste except for certain emergencies and  requires most recycling of hazardous waste to be
a permitted activity.  These types of stringent requirements discourage academic institutions from
developing and adopting recycling or other waste treatment strategies recommended by EPA for
managing hazardous wastes. The expense and effort required for the permit application process and
the  administrative requirements imposed on permitted operations are too great to justify the modest
environmental benefits that are possible for a single university.

        In contrast, the Washington Department of Ecology actively promotes "treatment by
generator" options as a non-permitted activity.  The Department of Ecology has determined that on-
site treatment is a preferred waste reduction option when environmental factors are  equal because "it
minimizes transportation risks, limits the transfer of risk to other communities, and results in the
application of appropriate, waste-specific  technologies." (Hazardous Waste and Toxics Reduction
Program Technical Information Memorandum 96-412: Treatment by Generator; May 1999.)

        These differences in treatment options between Massachusetts and Washington impact
opportunities universities have for  promoting environmental stewardship within their  respective
states.  The University of Washington, working collaboratively with the Department  of Ecology, has
established a "treatment by generator" program that impacts positively the protection of health,
                                                25

-------
safety, and the environment.  The three universities participating in the New England University
Laboratories Project XL, two of which are in Massachusetts, had originally proposed to evaluate the
environmental benefits of several treatment options as a part of their project. They chose not to do
this, however, because the subject of treatment was too contentious among the project stakeholders.

       Differences also exist among the EPA regional offices and state implementing agencies in
areas  of RCRA enforcement practices, the focus of assistance programs, and the interpretation of
RCRA provisions.  The most significant example is the range of allowable practices found among the
universities regarding RCRA determinations (see page 19).  At four of the ten universities
participating in this initiative, the EH&S programs make the RCRA determinations and the
laboratory staffs do not.  At two of the universities, the laboratory staffs make the RCRA
determinations and the EH&S programs do not. At the remaining four universities there is some
leeway for sharing this responsibility between the laboratory staffs and the EH&S programs.  There
is value in having the EH&S staffs make the RCRA determinations because this allows them
opportunities to develop waste management programs that are more efficient and effective than those
developed by the EH&S programs at the universities where laboratory staffs are required to make the
RCRA determinations.

       Inconsistencies in required practices, however, make it difficult to establish a common
understanding among scientists of the value and importance of RCRA compliance.  Waste
management programs at academic institutions reflect the different interpretations, guidance, and
requirements of their regulatory agencies.  This results in significantly different practices at the
laboratory level among universities in different areas.  These inconsistencies suggest to scientists that
RCRA compliance requirements are often more arbitrary than sound practice.  Research protocols
are the same wherever conducted, requiring consistent and precise execution. However, scientists
experience variations in waste handling requirements for identical research protocols frequently since
it is common for scientists to move from one university to another as their careers  advance.  For
example, a review in 1999 showed that assistant investigators at the Howard Hughes Medical
Institute will move, on average, to four  universities in their short careers as assistant investigators;
three  of these universities will be in different EPA regions.

       Conformity and consistency in enforcement practices, technical guidance,  and regulatory
interpretations will encourage the adoption of consensus best practices. This will add value to efforts
for promoting stewardship and responsibility for health, safety, and the environment.
6. DISCUSSION

       Three criteria set the ground rules for the HHMI-led initiative to develop consensus best
practices for managing hazardous wastes in academic research institutions and to demonstrate their
value as a performance-based model for achieving RCRA compliance. The first criterion required
that hazardous wastes prepared for removal from the ten participating universities would comply
fully with all applicable provisions of federal EPA and state RCRA regulations.  The second criterion
focused the development of best practices on broad environmental performance objectives rather
than prescriptive RCRA compliance requirements.  The third criterion set a high standard for the
initiative: Each university agreed that the commitment to minimize the potential for harm to human
health and the environment and to promote excellence in environmental stewardship would be a
fundamental principle of the initiative.  Adherence to these criteria lends credibility to the initiative
and its recommendations.
                                               26

-------
        The 14 consensus best practices developed through this initiative reflect, in most part,
practices currently carried out at the ten universities. The best practices are statements that give
purpose, direction, and clarity to broad functions that a university should adopt when establishing
programs to manage hazardous wastes produced in its laboratories. The information that
accompanies the best practice statements illustrates the means used to attain the intent of the best
practices; they are a composite of the types of thinking, commitment, and creative approaches used
by the ten universities.  The level of emphasis on any single best practice and the means used for
attaining intent can vary in accordance with the style, culture, and nature of the university. This is
the inherent value in a performance-based model for RCRA compliance at academic research
institutions.  This inherent value also could make a consensus  best practices approach universally
applicable to both small and large colleges and universities.

        Collectively, based on their own experiences prior to beginning the demonstration phase, the
ten universities recognized the value and efficacy of the 14 consensus best practices.  They also had
recent histories of favorable to excellent RCRA compliance.  Most of the best practices
demonstrations, therefore, became efforts to improve environmental awareness, processes, tools, and
management systems—efforts to increase efficiency and promote environmental stewardship.

Validation of Best Practices

        This discussion reviews the value found in the demonstration projects for each best practice.
The best practices addressing treatment and RCRA determination receive special emphasis because
they are practices for which the regulatory agencies have not established consistent policies.

        Agreement to participate in this initiative was, in itself, a statement of support of the first best
practice addressing executive commitment, which reads:

        The executive leadership of the institution embraces, supports, states, and carries out the
        commitment to  protect human health and the environment and to promote excellence in
        environmental stewardship.

        This commitment strengthened during the conduct of the initiative.   In September 2000, the
President of HHMI wrote letters to the presidents of the ten universities reading that a goal of the
initiative was "to stimulate new thinking about the role of an academic institution in promoting
excellence in health, safety, and environmental stewardship as a valued part of its broad mission for
teaching, research, scholarship, and service."

        Although strong executive commitment for compliance attainment was evident at the start of
the initiative, six of the ten universities began to explore measures for broadening their commitment
to stewardship and responsibility for health, safety, and the environment. The President from one
university issued a statement promoting excellence in environmental stewardship. Five other
universities are continuing their efforts to explore a role beyond compliance on issues relating to
health, safety, and the environment.  This is evidence that the academic community can be motivated
to seek excellence in environmental health and safety beyond RCRA compliance by values unrelated
to the risk of regulatory enforcement.

        The best practice addressing executive commitment had a positive effect on the best practices
addressing responsibility and accountability, effective communication within the organization, and
program evaluation and improvement.  Several universities provided additional staff and resources or
                                                27

-------
realigned program priorities to establish or augment audit processes for evaluating their multimedia
environmental programs including air, water, and solid waste; to develop new tools and mechanisms
to improve communications; and to provide special guidance to laboratory workers. Performance-
based best practices offer many  opportunities to utilize resources more effectively than do strictly
compliance programs.  It was evident at one university that a shift from attaining only regulatory
compliance to achieving environmental goals could enhance individual responsibility and
accountability. However, because of the enforcement risk, executive leadership would not condone
shifting program priorities toward broad environmental performance goals when the regulatory
approach demands compliance with prescriptive requirements.  In addition, one university reporting
greater than 95 percent compliance with waste management requirements in its laboratories would
not consider changing its annual audit frequency, even though these resources could be better utilized
in other areas of environmental protection.  Their reason—past EPA enforcement efforts focused on
absolute compliance with container management and labeling.

       Best practices addressing policies and procedures for pollution prevention; chemical waste
management; container labeling; collection, transport, and storage by EH&S; and emergency
response specifically address extant RCRA compliance requirements.  These best practices are
standard practices at the ten universities. The universities' EH&S programs generally have
responsibility for carrying out the universities' hazardous waste management programs. Most
universities have devised labeling systems to simplify laboratory procedures and reduce compliance
risks. There is a high level of performance by most of the universities in these best practices as
shown by  their self-assessments and regulatory compliance histories.

       Demonstration projects  relating to the best practice addressing training, education, and
communication emphasized the value of both Web-based training and personal contact by EH&S
staff in improving training and educational programs  and in ensuring effective communication.
Direct interactions between EH&S staff and scientists create positive results and are helpful in
promoting environmental stewardship.   Other demonstration projects such as those relating to
compliance activities and program evaluation and improvement, also took advantage of the power
and efficiencies offered by Web-based technology.

       Treatment

       The best practice addressing laboratory protocols to reduce hazards covers both the selection
of research protocols that involve fewer or less hazardous materials and the treatment of waste in the
laboratory. There is much evidence in scientific publications that scientists will adopt research
protocols that reduce hazards. Micro-scale and automated research protocols result in significant
reductions in the quantities of hazardous materials as compared with their predecessor protocols used
a decade ago. This change resulted from scientific advancements, not from a conscious effort to
develop environmentally friendly methods. Nevertheless, the rapid scientific progress achieved with
efficient micro-scale methods is motivation for researchers to adopt new methods that offer the
corollary benefits for environmental protection.  The  environmental benefits may also provide
encouragement for some laboratory workers to adopt these new methods earlier.

       All but one university conducts some form of treatment for certain hazardous wastes, for
example, simple neutralization.  Most waste treatment at the universitie s is done by the EH&S staff.
This is the preference of several universities because when a trained staff conducts the treatment
methods there is  better quality control and less compliance risk, and there is economy in scale.  There
has been little motivation to do treatment in the laboratories, although several universities encourage
                                                28

-------
this practice.  Laboratory workers are reluctant to treat waste because they are unfamiliar with the
methods, they prefer not using their time in this way, and compliance record keeping is onerous.
One demonstration project, however, found that environmental protection goals could become
valuable motivators for doing waste treatment in laboratories.

        The range of treatment activities varies considerably among the ten universities. One
university is located in a state where a statutory provision prohibits treatment of hazardous waste
except for as an emergency permitted activity. Two universities operate permitted TSDFs. Two
universities have terminated use of permitted TSDFs.  Regulatory complexities and costs are major
reasons why universities choose not to seek or maintain authorization to establish and operate
TSDFs. Two universities have authorization from their state EPA regulatory agencies for the EH&S
staffs to operate "treatment by  generator" programs.  One of these universities is in a state that
promotes "treatment by generator" programs; the other university received its authorization as part of
this demonstration project.

        Treatment by EH&S staffs offers much promise for waste reduction and pollution prevention.
Treatment on-site reduces transportation risks, avoids transferring risks to other communities, and
utilizes the most appropriate treatment technologies for specific laboratory  waste streams.  Using this
treatment approach, however, requires that the EH&S program makes the  RCRA hazardous waste
determination and conducts any appropriate generator treatment on behalf  of the academic
institution. The potential benefit of this treatment approach is substantial. For example, if the
treatment technology that is being evaluated by one university proves successful and is applied at all
ten universities, approximately 740,000 pounds (370 tons) of chemical wastes (most of which is
regulated hazardous waste) that is now collectively incinerated off-site could be treated on-site by  the
EH&S programs.  This quantity of waste would represent more than 50 percent of the total annual
quantities  of chemical wastes generated by these universities.

        RCRA Determination

        The results and findings of the demonstrations show that the level of authority of a
university's EH&S program for making RCRA determinations influences the practices used in
carrying out the university's hazardous waste program. The complexities of working with the
industrial-oriented RCRA regulations require EH&S programs to develop staff who are competent in
the technical issues of RCRA to ensure effective and compliant operation of their hazardous waste
programs. Requiring laboratory staff to acquire this level of expertise is not practical or productive.

        Most of the ten universities prefer to rely on trained EH&S staff for making RCRA
determinations because this increases the accuracy and reliability of the regulatory determinations.
Four state agencies acknowledge that this practice adds value to a university's hazardous waste
program and endorse use of EH&S staff for making RCRA determinations.  Two state agencies do
not allow EH&S staff to make  RCRA determinations because they are not certain that federal EPA
would allow this practice. Two other state agencies were reluctant to authorize the EH&S program
to make such determinations as part of their demonstration projects without specific guidance from
EPA. Four state agencies allow the EH&S programs to change the RCRA determinations made by
laboratory members.  One EH&S program chooses to require laboratory members to label chemical
waste as hazardous waste if the laboratory is  unsure of the proper designation to reduce regulatory
risk of an inaccurate determination.  The inconsistencies in practices have come about as a result of
the combined efforts of EH&S programs and state agencies to adapt an industrial-orientated standard
                                               29

-------
to the unique characteristics of the laboratory setting. In addition, the inconsistencies demonstrate
the lack of conformity on this critical issue nationwide.

       There are many advantages—in addition to increasing accuracy and reliability— to placing
authority for making RCRA determinations within the EH&S programs. The EH&S programs would
have more opportunities to develop innovative waste management strategies that are relevant to
research laboratories.  There would be a greater ability to plan, adopt, and use waste reduction
programs. It would place the operational responsibilities for the details of RCRA compliance within
the organization that has the technical expertise, training, and regulatory understanding necessary to
enable the university to achieve compliance.  Further, removing the complex responsibility for
RCRA determinations from the laboratories would help the EH&S staff promote within the research
community stewardship and responsibility for health, safety, and the environment.

Improving RCRA Applicability to Laboratories

       This initiative supports the long held views of scientists, environmental health and safety
professionals, and many regulators that the extant application of RCRA to laboratories is inefficient
and difficult, and that a performance-based approach for the application of RCRA to laboratories is a
preferred regulatory model.  In addition, this initiative found that the current regulatory approach
could actually constrain efforts within the academic community to promote environmental
stewardship, an objective of RCRA. A new regulatory  approach  for laboratories could improve
RCRA effectiveness and compliance in universities, and become  a catalyst to bring about
commitment and action for promoting stewardship and responsibility for health, safety, and
environment.

       This initiative envisions a two-tiered approach for applying RCRA to universities and their
laboratories. It involves the application of a performance-based model, using the consensus best
practices developed and demonstrated in this initiative, for guiding RCRA compliance in
laboratories, and the application of the current provisions of RCRA for guiding RCRA compliance in
universities at the time the universities' EH&S programs assume ownership and responsibility for
laboratory waste materials and make the RCRA hazardous waste determination. The basis for this
approach is the premise that the EH&S program makes the RCRA hazardous waste determination
and conducts any appropriate generator treatment on behalf of the academic institution.  This
initiative found that four of the ten universities are successfully using this approach, with the
concurrence of their state regulatory agencies, in managing their hazardous waste programs.  This
experience is significant because it demonstrates value in this approach as a regulatory model, and
indicates that it does not compromise compliance.

       Adoption by the EPA Administrator of this approach for achieving RCRA compliance in
academic institutions would allow implementation of the consensus best practices performance-based
model developed in this initiative.  In addition, the EPA Administrator should encourage conformity
and consistency nationwide in the implementation of this approach for applying RCRA to academic
institutions. The Administrator should determine and initiate appropriate methods for implementing
a performance-based regulatory model, using the consensus best practices developed through this
initiative, for achieving RCRA compliance in academic institutions. This should proceed at an
accelerated pace.   The framework used by OSHA for the Laboratory Standard (29 CFR 1910.1450) is
a useful model for implementing a performance-based approach.
                                               30

-------
       Academic institutions that choose to adopt the consensus best practices for managing
hazardous wastes in their laboratories should plan for implementation cooperatively with their state
or federal regulatory officials. This initiative found that the full value of this performance-based
approach is best achieved through partnership and collaboration among state and federal regulatory
officials, and scientists and EH&S professionals of academic institutions.
7. CONCLUSIONS AND RECOMMENDATIONS

       There are three principal conclusions resulting from this two-year collaborative initiative on
consensus best practices for managing hazardous wastes in academic research institutions.

       A performance-based model that has as its core the consensus best practices developed
       and demonstrated through this initiative is a workable approach for effective and efficient
       management of hazardous waste in academic research institutions. This approach will
       not compromise RCRA compliance,  and will promote stewardship and responsibility for
       health, safety, and the environment while respecting the culture of an academic institution
       and the unique characteristics of the laboratory setting.

       Collaboratively, the EH&S professionals, scientifically trained laboratory staff, informed
       institutional administrators, and staff from federal and state regulatory agencies who are
       familiar with the laboratory and academic setting  will identify safe and practical ways to
       improve hazardous waste management programs, and they will do this enthusiastically
       when the outcome promotes environmental stewardship.

       The interactions between some of the universities and their corresponding state regulatory
       agencies provide evidence that common ground is available within RCRA to adopt both
       the consensus best practices and a performance-based approach for compliance. The
       difficulty of matching specific requirements of RCRA with the academic laboratory setting
       stimulated efforts to find this common ground.  Four of the ten universities participating in
       this initiative operate their hazardous waste management programs today with the
       concurrence of their state regulatory officials on the premise that the EH&S professionals
       are the most capable for determining whether used or unused laboratory chemicals are
       RCRA hazardous waste and, in this  capacity, serve as the RCRA generator for overall
       compliance purposes. This operational practice is the cornerstone  for a best practices
       performance-based regulatory model.

       The Howard Hughes Medical Institute and the ten universities participating in the hazardous
waste management initiative make the following recommendations to the U.S. EPA, and to the
nation's academic institutions.

       1.      The U.S. EPA Administrator should recognize the consensus best
               practices developed through this initiative as a  performance-based
               model for achieving RCRA compliance and for promoting stewardship
               and responsibility for health, safety, and the environment in academic
               institutions.  The Administrator should determine and  initiate
               appropriate methods for implementing a  performance-based model,
               using the consensus best practices developed through this initiative,
               for achieving RCRA compliance in academic institutions.

       2.      The U.S. EPA Administrator should promote conformity and
               consistency among the U.S. EPA regional offices and state
               environmental protection agencies in carrying out RCRA assistance
               and enforcement programs for academic  institutions.
                                               31

-------
3.      Academic institutions should adopt the consensus best practices
       developed through this initiative as a performance-based model for
       managing hazardous wastes in their laboratories and for achieving
       RCRA compliance.

4.      Academic institutions should establish dialogue with their
       regulatory agency officials to plan cooperatively their approaches
       for implementing the consensus best practices developed through
       this collaborative initiative.
                                     32

-------