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U.S. Department of Health and Human Services

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FDA Issues Food and Cosmetic Security Preventive Measures Guidance

Guidance for Industry - FDA Issues Food and Cosmetic Security Preventive Measures Guidance

 

March 2003

On March 19, 2003, the Food and Drug Administration has announced the availability of four guidance documents addressing food and cosmetic security preventive measures. Two are revised, final guidance documents; one addresses food producers, processors, and transporters; the other addresses importers and filers. The other two documents are draft guidance; one addresses retail food stores and food service establishments and another addresses cosmetics processors and transporters. This fact sheet provides an overview of the draft and final guidance documents that present the agency's current thinking on appropriate preventive measures that establishments may take to minimize the risk that food or cosmetics under their control will be subject to tampering or other malicious, criminal, or terrorist actions.

The guidance documents take the operators of food and cosmetic establishments through each segment of the system within their control, in order to minimize the risk that the foods or cosmetics under their control are subject to tampering, or other malicious criminal or terrorist actions. Implementation of these measures requires commitment from both management and employees to be successful and, therefore, both should participate in their development and review.

These guidance documents are not regulations and are not mandatory. They set forth voluntary recommendations from FDA, which represent FDA's current thinking on appropriate and flexible food and cosmetic security preventive measures that may be taken by the FDA-regulated industry. 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.

 

Revised, Final Guidance Documents

The two revised, final guidance documents are:

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

The guidance found in these documents is designed as an aid to 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 filers (including customhouse brokers). It identifies the kinds of preventive measures that operators may want to consider taking to minimize the risk that food under their control will be subject to tampering or other malicious, criminal or terrorist actions.

 

Draft Guidance Documents

The two draft guidance documents are:

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

The guidance found in these documents is designed as an aid to operators of retail food stores and food service establishments (for example, bakeries, bars, bed-and-breakfast operations, cafeterias, camps, child and adult day care providers, church kitchens, commissaries, community fund raisers, convenience stores, fairs, food banks, grocery stores, interstate conveyances, meal services for homebound persons, mobile food carts, restaurants, and vending machine operators) and operators of cosmetic establishments. It identifies the kinds of preventive measures that operators may want to consider taking to minimize the risk that food and cosmetics under their control will be subject to tampering or other malicious, criminal or terrorist actions.

 

Copies of Documents Available

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. Include a self-addressed adhesive label to assist that office in processing your request. A copy can be obtained electronically at http://www.cfsan.fda.gov under Food Safety and Terrorism.

 

Opportunities for Public Comment

Comments on guidance documents: 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

 

Related Agency Activities Regarding Food Safety and Bioterrorism

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 www.fda.gov at the Bioterrorism Home Page.

 

Additional Materials

Press Release

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