Public Affairs Report
ASM Responds to Regulations on Biotechnology
and Bioengineering
Premarket Notice Concerning Bioengineered Foods
Draft Guidance for Industry: Voluntary Labeling Indicating Whether
Foods Have or Have Not Been Developed Using Bioengineering
In March, ASM submitted comments to the Food and Drug Administration
(FDA) on its proposed rule that would require food developers to notify
the FDA at least 120 days in advance of their intent to market a food
produced through biotechnology and provide information to demonstrate
that the product is as safe as its conventional counterpart. ASM also
submitted written comments on the FDA draft guidelines on Voluntary
Labeling Indicating Whether Foods Have or Have Not Been Developed Using
Bioengineering.
ASM Meetings with Policymakers
In March, ASM Public and Scientific Affairs
Board Chair Gail Cassell and ASM Public Affairs Director Janet Shoemaker
met with Office of Management and Budget (OMB) Director Mitchell Daniels
to discuss research and public health issues related to the National
Institutes of Health, infectious diseases and global security, and the
need for greater funding for nonmedical life sciences research budgets.
Cassell, Shoemaker, and Ronald Atlas, cochair of the ASM Task Force on
Biological Weapons Control, met with Norman Neureiter, science and
technology adviser to the Secretary of State, to discuss how ASM could
assist the State Department with scientific issues on which the ASM has
expertise. Atlas and Shoemaker also met with Richard Falkenrath,
director of Proliferation Strategy for the National Security Council, to
discuss policy issues related to biological weapons control and
security, including strategies to strengthen the Biological Weapons
Convention and other measures to protect against biological weapons
while protecting scientific research and clinical and diagnostic
medicine. Shoemaker met with NIH Director Ruth Kirschstein on 10 April
to discuss the NIH fiscal year 2003 budget and with Congressman Sherrod
Brown on 7 March to discuss legislative issues involved with antibiotic
resistance.
On 16 March, James Tiedje, PSAB Committee on
Environmental Microbiology chair, and ASM Public Affairs Manager Ted
Cartwright met with officials from the National Science Foundation (NSF)
and the Department of Energy (DOE) to discuss microbiological programs
within both agencies.
ASM Partners with CDC Laboratory Response
Network
James Snyder, University of Louisville,
represented ASM at the Laboratory Response Network's (LRN), Bioterrorism
Working Group meeting on 16 March. The Association of Public Health
Laboratories (APHL) hosted the meeting at its headquarters in
Washington, D.C. Representatives from the Centers for Disease Control
and Prevention (CDC) were also present at the meeting, which was
organized to discuss a strategic direction for public health
laboratories (Level B) to prepare and respond to bioterrorism, in
coordination with clinical laboratories (Level A), local, state, and
federal (Level C) laboratories, and the CDC. The goal of the LRN is to
strengthen emergency preparedness and response among Level A-D
laboratories, through an evaluation of the existing infrastructure to
identify strengths and weaknesses. Ongoing evaluation of the
infrastructure will also take place to identify areas in need of
increased emphasis and resources. Effective communication between the
associations was discussed, including links to ASM's web page, where the
Level A Protocols will be posted in the near future. The Level A
Protocols which are being developed by ASM members Alice Weissfeld, Mary
Gilchrist, James Snyder, Roberta Carey, Dave Saubolle, Susan Sharp,
Peter Gilligan, Mary York, David Welch, and Daniel Shapiro, will assist
Level A laboratory personnel to rule out or detect such microorganisms
in the event of a bioterrorist attack.
ASM Participates in CLMA Staffing Shortage
Forum
On 30-31 March, Alice Weissfeld, chair of PSAB's
Professional Affairs Committee, represented ASM at the Clinical
Laboratory Management Association's Staffing Shortage Forum in
Philadelphia, Pa. The Forum was organized to gather laboratorians from
across the country to meet and discuss solutions regarding laboratory
shortages, to provide examples of career paths available to laboratory
professionals and case studies of programs and strategies that attract
and motivate laboratorians, and to promote discussion among those in the
laboratory industry of ways to improve the retention rate. Weissfeld was
asked to speak in a panel discussion entitled, How Laboratory
Managers, Educators, and Manufacturers Can Work Together To Build and
Maintain a Stronger Laboratory Workforce.
ASM Testimony on FY 2002 R&D Budgets
Testimony
In March and April, ASM submitted written
testimony to the House and Senate Committees on Appropriations in
support of increased funding for the research and education programs
within the National Institutes of Health, the National Science
Foundation, the Department of Agriculture, the Department of Energy's
Life Sciences Office, the Environmental Protection Agency's research and
water programs, the Centers for Disease Control and Prevention, and the
Food and Drug Administration. The following is a brief summary of the president's fiscal year (FY)
2002 budget requests that were submitted to Congress on 9 April.
National Institutes of Health (NIH). The
administration proposed a 13.5% increase for the NIH, for a total budget
request of $23 billion. The FY 2001 enacted level is $20.3 billion for
NIH. The proposed increase for the National Institute of Allergy and
Infectious Diseases is 15.3%.
National Science Foundation. The
President proposed a $4.5 billion budget for the NSF, a $56 million
(1.3%) increase over FY 2001. Within this proposed budget, the
Biological Sciences (BIO) would be funded at $483 million, a $2.3
million decrease from FY 2001. Also included in the NSF budget is $58
million for the Biocomplexity in the Environment (BE) initiative, an
increase of $3 million or 5.9%.
U.S. Department of Agriculture (USDA).
The proposed USDA Research, Education and Economics (REE) budget is $2.1
billion. The budget also proposes to maintain funding at the 2001 level
for the competitive National Research Initiative (NRI) at $106 million
and the Initiative for Future Agriculture and Food Systems (IFAFS) at
$120 million. The FY 2002 budget provides $849 million in program
funding for the Animal Plant Health and Inspection Service (APHIS), up
$174 million over 2001. The budget also strengthens the Agriculture
Quarantine Inspection Program (AQI), by requesting $13 million in
additional program support. The Agricultural Research Service (ARS) is
funded at a proposed $969 million, with $12 million redirected for
research in the prevention and control of exotic diseases and pests,
with special emphasis ($5 million) on bovine spongiform encephalopathy (BSE)
and $7.5 million to support biotechnology.
Department of Energy (DOE). The
administration has proposed a $3.2 billion (0.1% increase) budget for
DOE's Office of Science, which includes $442.9 million (8.2% decrease)
for the Biological and Environmental Research program. The DOE Genomes
to Life program is to be funded at $19.5 million, a $10 million increase
over FY 2001.
Environmental Protection Agency. The
administration's budget proposal cut the Exploratory Grants Program from
$10.4 million in FY 2001 to $10.3 million for FY 2002. The STAR
Fellowship Program received a small increase over FY 2001 levels to $9.7
million for FY 2002. The FY 2002 budget also provides $3.2 billion for
clean and safe water initiatives, a 12.5% decrease from FY 2001.
Centers for Disease Control and Prevention (CDC).
A total of $4.1 billion is proposed for the CDC in FY 2002, a decrease
of $109 million or 3% from FY 2001. Within the administration's budget,
$332 million (a 4% increase) is proposed for infectious diseases, $182
million for bioterrorism preparedness activities, and $150 million for
CDC's buildings and infrastructure.
Food and Drug Administration (FDA).
Focusing on food safety, mad cow disease, protecting human research
subjects, assuring safety of FDA-regulated products, and improving FDA's
physical infrastructure needs, the President proposed a $123 million
increase (8%) for the Food and Drug Administration for a total of $1.4
billion in FY 2002. Of that, $15 million of the FDA's budget is proposed
to prevent the spread of BSE from reaching the United States, to ensure
that proteins from infected animals are not being fed to cattle, to
better educate federal and state inspectors on the regulations for the
production of cattle feeds, and to increase oversight and inspection of
imported dietary supplements and cosmetics that include animal
byproducts. An increase of $15 million, for a total of $124 million, is
proposed for FDA's food safety activities as well as the National
Antibiotic Resistance Monitoring System (NARMS), which tracks emerging
antibiotic resistance in food animals.