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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Draft Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering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. 

Last Modified: June 13, 2001
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