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FDA Issues New Security Guidance as Part of Operation Liberty Shield
To Protect the Food Supply

As part of its continuing efforts to ensure the safety and security of the nation's food supply, the Food and Drug Administration (FDA) today announced the availability of four guidance documents designed to help manufacturers minimize the risk of tampering or other malicious, criminal or terrorist actions. FDA also announced increased surveillance of domestic and imported foods, and enhanced collaboration with other government agencies, as part of its Liberty Shield initiatives.

Operation Liberty Shield (www.dhs.gov) is a comprehensive national plan designed to increase protections for America's citizens and infrastructure while maintaining the free flow of goods and people across our border with minimal disruption to our economy and way of life. Operation Liberty Shield is a multi-department, multi-agency, national team effort, and the Department of Health and Human Services has many critical roles in this effort. With responsibility for the safety and security of 80% of the nation's food supply, the Food and Drug Administration has initiated the following new activities:

• Working with the food industry to reduce threats -- FDA has issued new industry guidance on security measures, and has encouraged specific additional industry security measures in response to the increased threat level.
• Increased surveillance of the domestic food industry -- FDA has increased facility inspections and product sampling.
• Increased monitoring of imported foods -- FDA has increased examinations and sampling of imported foods.
• Enhanced collaboration with other government agencies -- FDA has increased its joint activities with Federal, state, and local partners to help ensure a safe and secure food supply, including work with CDC to ensure that outbreaks of illness or unusual patterns of illness or injury are quickly investigated.

FDA's new Liberty Shield initiatives build on HHS Secretary 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.

"Securing our food supply against terrorist threats is one of our most important public health priorities, especially at a time of heightened alert," said Tommy G. Thompson, Secretary of Health and Human Services. "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 released today 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," said 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 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 improve the security of their operations.

The proposals 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 to minimize the security risks to their products.

FDA's guidance documents are not regulations and are not mandatory. They set forth voluntary recommendations from FDA. They do not create or confer any rights for, or on, any person and do not operate to bind FDA or the public.

FDA has found that developing guidance is the fastest way to get these types of recommendations to the industry, while allowing greater flexibility to alter recommendations as science and intelligence information changes. In matters such as these, industry generally follows FDA's recommendations.

FDA accepts comments on any of these guidance documents at any time and determines whether further revisions are appropriate. However, FDA is requesting comments on the two draft guidance documents within 60 days of publication. FDA will consider these comments as it develops the final guidance documents, which will be published in the Federal Register.

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 be sent electronically to www.fda.gov/dockets/ecomments. It is important to include the docket numbers when providing comments:

Docket #03D-0092: draft guidance

• Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance
• Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance

Docket #01D-0583: final guidance

• Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance
• Importers and Filers: Food Security Preventive Measures Guidance

Requests for single copies of these documents should be submitted to: John Kvenburg, Office of Compliance (HFS-600), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740. A self-addressed adhesive label should be included to help process the request. Copies can be obtained electronically (see web addresses below).

Additional information about provisions of the Bioterrorism Act under FDA's jurisdiction and the agency's implementation plans is available at http://www.fda.gov/oc/bioterrorism/bioact.html. Additional information on other agency bioterrorism activities can be found at the Bioterrorism Home Page.

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Additional Materials

Fact Sheet

Food Security Preventive Guidances Federal Register (PDF)

• Final Guidance--Importers and Filers
• Final Guidance--Food Producers, Processors, and Transporters

Food and Cosmetic Security Guidances Federal Register (PDF)

• Draft Guidance--Retail Food Stores and Food Service Establishments
• Draft Guidance--Cosmetics Processors and Transporters

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