FASEB and AAMC Letter to
OMB on Regulatory Burden
May 16, 2002
John Morrall
Office of Information and Regulatory Affairs
Office of Management and Budget
NEOB, Room 10235
725 17th Street, N.W.
Washington, D.C. 20503
Dear Mr. Morrall:
The Federation of American Societies for Experimental Biology
(FASEB) appreciates the opportunity to comment on the March
28, 2002 Draft Report to Congress on the Costs and Benefits
of Federal Regulation. FASEB is comprised of 21 societies
with more than 60,000 members, making it the largest coalition
of biomedical research associations in the United States.
The mission of FASEB is to enhance the ability of biomedical
and life scientists to improve, through their research, the
health, well-being and productivity of all people.
We are joined in these comments by the Association of American
Medical Colleges (AAMC), representing all 125 U.S. medical
schools, over 400 teaching hospitals, and 98 academic and
medical societies representing over 100,000 faculty.
The investigators and institutions represented by these
two organizations manage and conduct a substantial share of
the nation's publicly supported biomedical research and are
stewards for the safe and responsible conduct of this research.
General Comments
We commend the Office of Management and Budget through the
Office of Information and Regulatory Affairs for its commitment
to approaching regulatory review in an open, transparent and
analytically sound manner.
Standards for Privacy of Individually Identifiable Health
Information
We are particularly appreciative of the proactive role that
OIRA has taken in suggesting regulatory priorities for agency
consideration. In response to suggestions solicited in OMB's
draft version of last year's annual report, OIRA identified
as a high priority review the Department of Health and Human
Services (HHS) Standards for Privacy of Individually Identifiable
Health Information. HHS has since issued guidance clarifying
the requirements of this rule, has publicly committed to making
regulatory changes to certain aspects of the rule and is presently
considering significant modifications.
Data Dissemination Guidelines
On January 3, 2002, OIRA issued government-wide guidelines
implementing Section 515 of P.L. 106-554 to enhance the quality
of information that federal agencies disseminate to the public.
We are pleased that OMB responded to the concerns of the academic
and scientific community in revising the guidelines to explicitly
recognize the objectivity of scientific information and allow
research to be disseminated where "the results have been subject
to formal, independent, external peer review."
OIRA Scientific Advisory Panel
The Draft Report announces that "OIRA is in the process
of forming a scientific advisory panel that will suggest initiatives
to OIRA, evaluate OIRA's ongoing activities, comment on national
and international policy developments of interest to OIRA,
and act as a resource and recruitment mechanism for OIRA staff."
We applaud this effort to solicit input from the scientific
community and we would be pleased to nominate candidates for
this panel. We note that both the National Institutes of Health
Regulatory Burden Advisory Group and the Department of Health
and Human Services Secretary's Advisory Committee on Regulatory
Reform are charged with making recommendations on regulatory
reform. It would be useful to invite at least one member of
the NIH Group and at least one member of the Secretary's Advisory
Committee on Regulatory Reform to participate on the new OIRA
advisory panel to share insights into what work has already
been done and to coordinate future efforts.
Proposals for Reform of Regulations
Resource Conservation and Recovery Act (RCRA)
Chapter IV of the Draft Report invites recommendations from
the public for the reform of Federal rules that, if adopted,
would increase net qualitative and quantitative benefits to
the public. We offer the following comments to the regulatory
provisions of the Resource Conservation and Recovery Act (RCRA),
which is administered by the Environmental Protection Agency
(EPA).
The RCRA was enacted in 1976 to protect human health and
the environment from the hazards posed by waste disposal.
Subtitle C of RCRA establishes a system to control hazardous
waste from the time of generation until its ultimate disposal.
With limited exceptions, many of the hazardous waste regulations
apply to academic laboratories that use chemicals, as well
as to the industrial sector. However, because a laboratory
setting differs dramatically from an industrial setting in
the use of relatively small quantities of a large number of
chemicals on a non-production basis, the RCRA regulations
create difficulty for the laboratory community in the areas
of interpretation, application, and compliance.(2)
Our campuses report that they must contend with elaborate
record keeping, detailed storage requirements for reagents
that are not relevant to their everyday use, and significant
costs for technician time to manage inventory, testing, and
paperwork. Institutional officials emphasize that regulations
ought to be appropriate to the laboratory setting. The hazards
of risks involved in the use of low levels of radionuclides
or toxins in academic research are significantly different
from the use of these materials for industry. These concerns
have been widely noted elsewhere in relation to these and
other regulations.(3)
In recognition of these difficulties, beginning in August
1999 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
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 resulted
in a Report on Consensus Best Practices for Managing Hazardous
Wastes in Academic Research Institutions.(4) (See Attachment
A - Report on Consensus Best Practices)
The House Committee on Appropriations (House Report 106-674)
and the Senate Committee on Appropriations (Senate Report
106-410) supported the initiative and encouraged the Administrator
of EPA to participate in it. The Committees requested 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. In response to the
Committees' request, on March 14, 2002, EPA filed its Report
to Congress, containing its evaluation of the Consensus Best
Practices developed through the Howard Hughes Institute's
Project. EPA praised the HHMI Report and the participating
academic research institutions for their efforts to improve
hazardous waste management in their laboratories, noted that
the best practices recommended by the Report addressed a wide
range of issues, and most importantly encouraged academic
research institutions to develop thoughtful approaches to
managing their hazardous waste and instilling strong institutional
commitment to environmental protection programs.(6) (See
Attachment B - EPA Report to Congress)
FASEB and AAMC strongly recommend that OIRA endorse the
following recommendations developed by the HHMI initiative
for the management of hazardous wastes in academic research:
"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.
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." (7)
Sincerely,
Robert R. Rich, M.D.
President, FASEB
Jordan J. Cohen, M.D.
President, AAMC
2. Report on Consensus Best Practices for Managing Hazardous
Wastes in Academic Research Institutions October 2001, accessed
April 24, 2002 Download
report (PDF, 39 pages)
3. See also, Abelson PH. Impact of regulations on universities.
Science. 1995; 267: 1247, and U.S. Congress, Office
of Technology Assessment, The Regulatory Environment for
Science - A technical Memorandum, OTA-TM-SET-34. Washington,
DC: U.S. Government Printing Office, February 1986.
4. Report on Consensus Best Practices, Executive Summary,
p.5
5. Report to Congress Evaluating the Consensus Best Practices
Developed through the Howard Hughes Medical Collaborative
Hazardous Waste Management Demonstration Project and the Need
for Regulatory Changes to Carry Out Project Recommendations,
March 14, 2002, Office of Solid, Office of Solid Waste and
Emergency Response, United States Environmental Protection
Agency.
6. Report to Congress, p. 10.11.
7. Report on Consensus Best Practices, Conclusions and Recommendations,
pp. 31-32.
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