E6-19886. Food Defense Workshop; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

SUMMARY:

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in co-sponsorship with the Risk Management Small Business Development Center (RMSBDC), is announcing a public workshop entitled “Food Defense Workshop.” This public workshop is intended to provide information about food defense, the regulations authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and other related subjects to FDA-regulated food facilities (farms, manufacturers, processors, distributors, retailers, and restaurants).

Date and Time: This public workshop will be held on March 29, 2007, from 8 a.m. to 5 p.m.

Location: The public workshop will be held at the Hoblitzelle Auditorium at the Bill Priest Campus of El Centro College, 1402 Corinth St., Dallas, TX 75215.

Contact: David Arvelo, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, Suite 900, Dallas, TX 75204, 214-253-4952, FAX: [phone], or e-mail: [e-mail].

Registration: Registration by March 15, 2007, is encouraged. The RMSBDC has a $20 registration fee to cover the cost of facilities and refreshments. Please submit your registration as soon as possible. Those accepted into the workshop will receive confirmation. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at the site is $25, payable to RMSBDC. If you need special accommodations due to a disability, please contact David Arvelo (see the Contact section of this document) at least 7 days in advance.

Registration Form Instructions: To register, please complete the RMSBDC registration form and submit along with payment to RMSBDC, Attn: Saira Roberts, 1402 Corinth St., Dallas, TX 75215. You may fax the completed registration form to RMSBDC at 214-860-5867. To obtain a copy of the registration form, please call RMSBDC at 214-860-5887 or 214-860-5849. The registration form is also available online at http://www.ntsbdc.org/​.

Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Workshop handouts may be requested through the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page.

SUPPLEMENTARY INFORMATION:

This public workshop is being held in response to the large volume of food defense inquiries from FDA-regulated food facilities (farms, manufacturers, processors, distributors, retailers, and restaurants) originating from the area covered by the FDA Dallas District Office. The SWRO is presenting this workshop to help achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which include working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. This is consistent with the purposes of the Small Business Representative Program, which are in part to respond to industry inquiries, develop educational materials, sponsor workshops and conferences to provide firms, particularly small businesses, with firsthand working knowledge of FDA's guidance, requirements, and compliance policies. This workshop is also consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121) that requires outreach activities by Government agencies directed to small businesses.

The goal of this public workshop is to present information that will enable FDA-regulated food facilities (farms, manufacturers, processors, distributors, retailers, and restaurants) to better understand the regulations authorized by the Bioterrorism Act, and food defense guidance, especially in light of growing concerns about food defense. Information presented will be based on agency position as articulated through regulation, guidance, and information previously made available to the public. Topics to be discussed at the workshop include the following: (1) Food defense awareness, (2) ALERT: The Basics, (3) FDA actions on bioterrorism legislation (food supply), (4) food recalls, (5) crisis management, and other related topics. FDA expects that participation in this public workshop will provide regulated industry with greater understanding of FDA regulations and guidance related to food defense and increase voluntary compliance and food defense awareness.

Dated: November 17, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.