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FDA Consumer magazine
May-June 2003
Table of Contents
As part of its continuing efforts to ensure the safety and security of the nation's food supply, the Food and Drug Administration has announced the availability of four guidance documents designed to help manufacturers minimize the risk of tampering or other malicious, criminal or terrorist actions. The FDA also has increased surveillance of domestic and imported foods and enhanced collaboration with other government agencies as part of its Liberty Shield initiatives.
Operation Liberty Shield is a multi-department, multi-agency national plan designed to increase protections for America's citizens and infrastructure. Maintaining the free flow of goods and people across U.S. borders with minimal disruption to the nation's economy and way of life is among the goals of the plan.
The FDA's new Liberty Shield initiatives build on Health and Human Services Secretary Tommy G. Thompson's leadership on food security, including new regulations in process to enhance import security and contain outbreaks of foodborne illness; over 800 new inspectors and field personnel; greater laboratory testing and response capabilities; and new use of intelligence information to help guide food security activities. The agency has initiated the following new activities:
"Securing our food supply against terrorist threats is one of our most important public health priorities, especially at a time of heightened alert," says Thompson. "FDA is responsible for 80 percent of what we eat. Americans depend on FDA to keep food safe and secure, and we will keep doing all we can to fulfill this critical mission."
"The guidance documents ... as part of the government-wide Liberty Shield initiative cover each segment of food and cosmetic operations, focusing on practical steps that will improve safety and security," says Mark B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs. "In conjunction with increased surveillance of domestic and imported foods for biological and chemical agents of terrorism, these steps represent a new level of commitment at FDA to keep the food supply secure."
Two of the guidances are revised, final documents, and two are proposed guidances.
The FDA accepts comments on any of these guidance documents at any time and determines whether further revisions are appropriate. However, the FDA is requesting comments on the two draft guidance documents within 60 days of publication. The agency will consider these comments as it develops the final guidance documents, which will be published in the Federal Register. The four documents are:
Docket #01D-0583:
These final documents will help operators of food establishments (for example, firms that produce, process, store, repack, re-label, distribute, or transport food or food ingredients) and operators of food importing establishments, storage warehouses, and customs brokers identify preventive measures to improve the security of their operations.
Docket #03D-0092:
These draft guidances cover food stores and food service establishments such as bakeries, bars, cafeterias, commissaries, convenience stores, fairs, grocery stores, food service for airlines and trains, restaurants, and vending machine operators as well as cosmetic establishments. They also identify preventive measures that operators can take to minimize the security risks to their products.
Written comments on both final and draft guidance documents can be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments can also be sent electronically. It is important to include the docket numbers when providing comments.
The FDA is proposing two regulations that would enhance the agency's ability to monitor and protect the nation's food supply against terrorist acts and other threats. These proposals are important milestones in implementing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
Under one proposal, owners, operators, or agents in charge of a domestic or foreign facility would be required to submit a registration to the FDA that includes basic information about the company, as well as the categories of food the facility handles. Except for specific exemptions, the new regulation would apply to all facilities for all foods and animal feed products regulated by the FDA, including dietary supplements, infant formula, beverages (including alcoholic beverages, which are not regulated by the FDA), and food additives.
All facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States will be required to register. A second proposal would require that prior notice be given to the FDA before food is imported or offered for import in the United States. This would give the FDA advance information of imported food shipments, which would allow the agency to target inspections more effectively and to help ensure the safety of imported food products before they enter domestic commerce.
Under the proposal, the FDA must be notified by noon of the calendar day before the imported food will arrive at the U.S. border crossing or port of entry. This notice would be submitted electronically through an Internet-based system that would be available 24 hours a day, seven days a week. The FDA anticipates it will receive an average of 20,000 of these notices a day. According to the Bioterrorism Act, both of these requirements will come into effect by Dec. 12, 2003, even if the FDA has not issued final regulations.
"Our ability to efficiently and effectively help protect the nation's food supply is a critical part in our agency's counterterrorism mission ... the Bioterrorism Act gives FDA this important new authority," says FDA Commissioner Mark B. McClellan, M.D., Ph.D.