Members Bioterrorism Act
BIOTERRORISM ACT INFORMATION
Interim Final Regulations from the FDA pertaining to the provisions of the Bioterrorism Act (BT) Section 305 Registration of Food Facilities and Section 307 Prior Notice of Import Shipments were released by FDA on October 10, 2003. On October 31, 2008 FDA released the final rule for Section 307 Prior Notice of Import Shipments with an effective date of May 6, 2009. Regulations for Section 303 Detention and Section 306 Records Maintenance were finalized and released during 2004.
Click here to go to the FDA/CFSAN information on the final rule for Prior Notice.
WBFI submitted comment on the proposed regulations for Section 305 Registration prior to the April 4, 2003 deadline. WBFI is pleased to report that FDA has exempted Retailers of Animal Food, including Wild Bird Retail Stores, from the Registration Requirement.
WBFI submitted responses to several of the FDA's questions during the comment period which closed on April 4, 2004.
On March 21, 2003 FDA's Center for Food Safety and Applied Nutrition (CFSAN) released Guidance documents for three business categories. The intention of these FDA Guidance documents is to assist companies to identify the kinds of preventive measures that are expected of them. It is designed to help the industry understand the view of FDA/CFSAN on Food Security Preventive Measures.
The Administrative Detention authority in section 303 of the Bioterrorism Act took effect immediately upon enactment of the Act in 2002. The procedures FDA will follow for administratively detaining food that is specified in the final rule took effect on July 6, 2004, 30 days after the June 4, 2004, Federal Register publication date. The link to the Federal Register to review the final rule is http://www.cfsan.fda.gov/~lrd/fr040604.html.
The final rule on Establishment and Maintenance of Records was issued on December 6, 2004 and took effect 60 days after the Federal Register publication date, or approximately February 6, 2005. WBFI Members are required to maintain records to provide the information covered in the regulations. Click here to go to the information required in the regulations.
Dates of Importance:
October 10, 2003: FDA releases Interim Final Regulations for Section 305 Registration of Food Facilities and Section 307 Prior Notice of Import Shipments
December 12, 2003: Deadline for domestic and foreign companies manufacturing/processing, distributing or holding food for humans or animals in the United States to begin compliance with the provisions of Facility Registration and Prior Notice.
December 24, 2003: End of comment period on Interim Final Regulations for Facility Registration and Prior Notice.
March 2004: FDA additional comment period on Sections 305 Facility Registration and 306 Prior Notice.
July 2004: Rules for Section 303 Administrative Detention took effect.
December 2004: Final Rules for Establishment and Maintenance of Records published in the Federal Register.
February 2005: Final Rules for Establishment and Maintenance of Records take effect.
May 6, 2009: Final Rules for Prior Notice take effect.