Final Regulation Implementing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002-Establishment and Maintenance of Records for Foods; Notice of Public Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; public meeting on final rule.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a series of domestic public meetings to discuss the final regulation implementing section 306 (Maintenance and Inspection of Records) of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), which is publishing in this issue of Federal Register. The purpose of these public meetings is to provide information on the rule to the public and to provide the public an opportunity to ask questions of clarification.

DATES:

See table 1 of the SUPPLEMENTARY INFORMATION section of this document.

ADDRESSES:

See table 1 of the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:

Marion V. Allen, Center for Food Safety and Applied Nutrition (HFS-32), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1584, FAX: 301-436-2605, e-mail: marion.allen@fda.hhs.gov, for general questions only about the meeting.

SUPPLEMENTARY INFORMATION:

I. Background

The events of September 11, 2001, highlighted the need to enhance the security of the U.S. food supply. Congress responded by passing the Bioterrorism Act (Public Law 107-188), which was signed into law on June 12, 2002.

In this issue of the Federal Register, FDA is publishing the final rule implementing section 306 of the Bioterrorism Act and a draft guidance on records access under the Bioterrorism Act. During the public meetings, FDA will explain this rule and the draft guidance and answer questions of clarification.

Information about the public meetings, contact information, and the provisions of the Bioterrorism Act under FDA's jurisdiction can be accessed at http://www.fda.gov/oc/bioterrorism/bioact.html .

II. Final Rule and Draft Guidance

Section 306 of the Bioterrorism Act directs the Secretary of Health and Human Services (the Secretary) to issue final regulations that establish requirements regarding the establishment and maintenance, for not longer than 2 years, of records by persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food. The records that must be kept by these regulations are those that are needed by the Secretary for inspection to allow the Secretary to identify the immediate previous sources and immediate subsequent recipients of food, including its packaging, in order to address credible threats of serious adverse health consequences or death to humans or animals. This regulation implements the recordkeeping authority in the Bioterrorism Act.

In addition, the Bioterrorism Act provides records inspection authority to FDA such that if FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, and the records are necessary to assist FDA in making such a determination, persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food must provide access to records.

III. Registration for the Public Meetings

Please submit your registration information (including name, title, firm name, address, telephone number, e-mail address, and fax number) at least 5 working days before the public meeting date. For specific site locations, we encourage you to register online at http://www.cfsan.fda.gov/~dms/fsbtac23.html or fax directly to Sharon Barcellos at 202-479-4970. We will accept registration onsite. Space is limited and registration will be closed at each site when maximum seating capacity for that site is reached (between 100 to 200 persons per site). If you need special accommodations due to a disability, please notify the contact person as listed under FOR FURTHER INFORMATION CONTACT in this document at least 7 working days in advance of the meeting. All participants must present valid photo identification when entering a Federal building and parking facility.

IV. Dates, Times, and Addresses of Public Meetings

IV. Transcripts

A transcript will be made of the proceedings of each meeting. You may request a copy of a meeting transcript in writing from FDA's Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 30 working days after the public meetings at a cost of 10 cents per page. The transcript of each public meeting will be available for public examination at the Division of Dockets Management, (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 between 9 a.m. and 4 p.m., Monday through Friday.