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Public Affairs Report
ASM Participates in State Department Biotechnology Meeting
On 11 July, Anne Vidaver, chair of the Public and Scientific Affairs Board (PSAB) Committee on Agricultural and Food Microbiology, and David Pramer, chair of the PSAB Committee on Industry and Biotechnology, participated as ASM representatives in a meeting of the Biotechnology Working Group of the U.S. Department of State. Although the Department of State does not have regulatory authority over agricultural biotechnology, issues relating to genetically modified organisms and food safety increasingly challenge U.S. foreign and trade policies. A scientific advisory capacity was recently created in the Department of State to assist in international diplomacy, and the Department is working increasingly with relevant national and international associations to advance understanding of biotechnology, and of the opportunities it presents to achieve developmental and humanitarian objectives in the less industrialized regions of the world.
Meeting participants were briefed by panels of experts on various issues related to biotechnology and foods. The Panel on Capacity Building in Developing Countries reported that the U.S. Agency for International Development (USAID) has worked for 10 years to obtain private sector involvement in public technology programs, as an international extension of what has been accomplished in this country by the enactment in 1980 of the Bayh-Dole Act. Working in conjunction with the Institute for International Agriculture at Michigan State University, the USAID has promoted a number of productive private/public partnerships, including that of the Monsanto Company and the Kenyan Agricultural Research Institute to engineer virus-resistant sweet potatoes and that of ICI Seeds and the Egyptian Agricultural Genetic Research Institute to engineer tubermoth-resistant potatoes. Technical successes by these partnerships are at times thwarted by failure to obtain agreement on the terms of technology transfer and rights to intellectual property. However, this experience in developing countries is creating a local awareness of biosafety and marketing issues, and a bottom-up demand for regulation.
The Panel on Food Safety Regulatory Regimes agreed that the position of the European Union (EU) on the importation of products of biotechnology was not a matter of creating trade barriers to protect its own food industry, but rather the result of recent incidents of animal diseases (foot and mouth and mad cow), as well as blood supply and food contamination, plus public demonstrations by the Green Party that have sensitized the people and their representatives to biosafety issues. However, Japan, China, and other countries have been influenced by the EU position. The subject of agricultural biotechnology has become highly politicized. Although there is evidence that the position of the EU is moving closer to that of the U.S., agreement is not likely in the near future, creating a dilemma for developing countries.
The meeting concluded with a brief panel review of recent and upcoming events that include considerations of biotechnology. The Biosafety Protocol chronology was reviewed. It was reported that the Codex Alimentarius Commission of the UN Food and Agriculture Organization (FAO) at a meeting 1-7 July 2001 defeated a request for special labeling of products of biotechnology, and formulated regulations for the safety of biotech foods and genetically modified crops. The FAO and the UN World Health Organization (WHO) is sponsoring a meeting of the Global Forum of Food Safety Regulators 22-24 October 2001 in Morocco. The program will cover the Codex food safety regulations and their implementation, risk management, precaution, capacity building, and consumer information. The forum meeting will be open to regulatory authorities responsible for food safety as well as producer and consumer groups.
ASM Comments on FDA's Draft Guidance Document on Hepatitis C Devices
FDA Guidance Document [PDF]
On 26 July, ASM provided comments to the Food and Drug Administration (FDA) regarding its draft guidance for Industry and FDA on Premarket Approval Applications for In Vitro Diagnostic Devices Pertaining to Hepatitis C Viruses (HCV): Assays Intended for Diagnosis, Prognosis, or Monitoring of HCV Infection, Hepatitis C, or Other HCV-Associated Disease. While ASM commended FDA for the detailed guidance document, stating that the document would offer significant assistance to manufacturers and FDA staff in the preparation and review of premarket approvals (PMAs), it disagreed with the FDA's recommendation to use the strip immunoassay (SIA) in the detection of anti-HCV antibodies. ASM stated that the SIA is not an independent marker of infection because the "SIAs use the same or similar HCV antigens as EIAs." ASM also disagreed with the FDA recommendation that EIAs should be confirmed with repeat duplicate testing, stating that the appropriate confirmatory test for a positive EIA test is "an assay that demonstrates active viral replication; that is, a HCV-RNA assay should be performed."
ASM Signs Onto Coalition Letter Supporting Antibioterrorism Funding
In June, ASM joined with several public health organizations in signing a coalition letter to Congress in support of FY 2002 funding for bioterrorism preparedness and response activities. The coalition is requesting $240 million for bioterrorism preparedness activities implemented by the Centers for Disease Control and Prevention (CDC) and $100 million to build the public health capacity of state and local health departments. In FY 2001, a total of $180.9 million was allocated to the CDC for its bioterrorism preparedness and response efforts. President Bush's FY 2002 budget request includes $181.9 million for CDC bioterrorism preparedness and $1 million for state and local public health capacity building. For a copy of the letter, contact Suzy Leous at sleous@asmusa.org .
ASM Responds to FDA and USDA Proposed Policies for Listeria monocytogenes in Ready-To-Eat Foods
On 13 July, ASM submitted a response to the FDA and USDA Food Safety Inspection Service (FSIS) draft Risk Assessment Document and Risk Management Action Plan for relative risk to public health from foodborne Listeria monocytogenes in ready-to-eat foods. The FDA published the notice in the Federal Register, Vol. 66, in an effort to determine the relative risk of serious illness and death that may be associated with consumption of different types of ready-to-eat foods that may be contaminated with L. monocytogenes. In its letter to the FDA and USDA, ASM stated that the data used in the drafts were based on a paucity of data within several of the food categories and failed to consider the differences in listerial growth rates among foods that were combined into specific categories. Even though several concerns were raised in the comments, ASM supported the goals of the assessment and encouraged the FDA and USDA to continue to improve the model for conducting a qualitative risk assessment of L. monocytogenes in ready-to-eat foods.
New Brochures Published Regarding the Benefits of Animal Research
Foundation for Biomedical Research
Two new brochures have been published by the Foundation for Biomedical Research (FBR) on the benefits of animal research. Animal Research: Fact vs. Myth dispels common misconceptions of the antiresearch elements of the animal rights movement. The Proud Achievements of Animal Research offers an overview of the contributions animal research has made to medical and scientific advances, for human and animal health, in the last century. The brochures are available on the FBR's website and can also be purchased by calling FBR at (202) 457-0654. The FBR is a sister organization of the National Association for Biomedical Research (NABR). ASM is a member of the NABR.
The Microbe Project Report Available Online
A report from the Interagency Working Group on microbial genomics, The Microbe Project, is now available online from the National Science and Technology Council. The Microbe Project is a coordinated Federal effort for microbial genomics. The Working Group, made up of representatives from the National Science Foundation, the National Institutes of Health, the Office of Science and Technology Policy, and the Committee on Science developed a coordinated plan to address research, infrastructure, and human resource gaps. Implementation of the plan will greatly advance discoveries based on microbial genomics research.
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