Food and Cosmetic Security Guidances; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document related to food security entitled “Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance” and a draft guidance document related to cosmetics security entitled “Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance.” The draft guidance document entitled “Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance” is designed as an aid to operators of retail food stores and food service establishments (i.e., 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). It identifies the kinds of preventive measures that operators may take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal or terrorist actions. The draft guidance document entitled “Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance” is designed as an aid to operators of cosmetics establishments (i.e., firms that process, store, repack, relabel, distribute, or transport cosmetics or cosmetics ingredients). It identifies the kinds of preventive measures that operators may take to minimize the risk that cosmetics under their control will be subject to tampering or other malicious, criminal or terrorist actions.

DATES:

Submit written or electronic comments on the draft guidance documents by May 20, 2003, to ensure their adequate consideration in the preparation of revised guidances, if warranted. However, you may submit written or electronic comments at any time.

ADDRESSES:

Submit written requests for single copies of the draft guidance document entitled “Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance,” or “Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance” to John Kvenberg, Center for Food Safety and Applied Nutrition, (HFS-600), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Include a self-addressed adhesive label to assist that office in processing your request. Submit written comments on the draft guidance documents to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance documents.

FOR FURTHER INFORMATION CONTACT:

John Kvenberg, Center for Food Safety and Applied Nutrition (HFS-600), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2359, e-mail: jkvenberg@cfsan.fda.gov or Donald W. Kraemer, Center for Food Safety and Applied Nutrition (HFS-400), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2300, e-mail: dkraemer@cfsan.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Operators of retail food store, food service, and cosmetics establishments are encouraged to review their current security procedures and controls in light of the potential for tampering or other malicious, criminal or terrorist actions and make appropriate improvements.

FDA announced the availability of two guidance documents related to food security in the Federal Register of January 6, 2002 (67 FR 1224). They were entitled “Food Producers, Processors, Transporters, and Retailers: Food Security Preventive Measures Guidance” and “Importers and Filers: Food Security Preventive Measures Guidance.” The agency solicited public comment, but indicated that the two guidance documents would be implemented immediately in accordance with § 10.115(g)(2) (21 CFR 10.115(g)(2)). The two guidance documents were prompted by the tragedies of September 11, 2001, and the resulting scrutiny of, and interest in, food safety and security that followed.

The agency reviewed and evaluated the comments it received (11 written and 5 electronic). A number of the comments urged the agency to issue guidance that was specifically tailored for the retail food store and food service sector. Accordingly, FDA is issuing this draft guidance document entitled “Retail Food Store and Food Service Establishments: Food Security Preventive Measures Guidance.”

The draft guidance document entitled “Retail Food Store and Food Service Establishments: Food Security Preventive Measures Guidance” identifies the kinds of preventive measures that operators of retail food store and food service establishments (i.e., 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) can take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal or terrorist actions.

FDA is also requesting comment on whether the agency's package of food security guidance documents should be expanded to include coverage of cosmetics, in addition to foods. To facilitate such comments, FDA also is announcing the availability of a draft guidance document entitled “Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance.” The draft guidance document entitled “Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance” identifies the kinds of preventive measures that operators of cosmetics establishments can take to minimize the risk that cosmetics under their control will be subject to tampering or other malicious, criminal or terrorist actions. It takes the operator through each segment of the cosmetics production system that is within their control, in order to minimize the risk of tampering or other malicious, criminal or terrorist action at each segment. Implementation of these measures requires commitment from both management and employees to be successful and, therefore, both should participate in their development and review.

Both draft guidance documents are level 1 guidances issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance documents, when finalized, will represent the agency's current thinking on appropriate measures that retail food store, food service, and cosmetics establishments may take to minimize the risk of foods or cosmetics under their control will be subjected to tampering or other malicious, criminal or terrorist actions. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public.

II. Comments

Interested persons may submit to the Dockets Management Branch (see ADDRESSES) written or electronic comments on either draft guidance document at any time. Two copies of any mailed comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The draft guidance documents and received comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Copies of these draft guidance documents also are available on the Internet at http://www.cfsan.fda.gov/guidance.html.