fda-regulatory

Bioterrorism Act

Enhance the security of the USA

The events of Sept. 11, 2001, reinforced the need to enhance the security of the United States. Congress responded by passing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which President Bush signed into law June 12, 2002.

Section 305 – Food Facility Registration

Requires the owner, operator, or agent in charge of a USA or non-USA facility to submit a registration to the Secretary. For a foreign facility, the registration must include the name of the U.S. agent for the facility.

Below are the latest registration numbers per country as published by FDA.

Foreign Countries with ≥ 900 Registered FacilitiesNO. Registered Foreign Facilities (212,183 TOTAL)
TOTAL ( 24 countries)99,889 (47% of all foreign)
JAPAN14092
FRANCE10577
ITALY10383
CHINA9918
MEXICO9842
CANADA6871
SPAIN4803
KOREA, REPUBLIC OF4007
INDIA3558
GERMANY2408
CHILE2304
BRAZIL1972
UNITED KINGDOM1935
TAIWAN1778
ARGENTINA1598
COLOMBIA1537
VIET NAM1536
THAILAND1530
PERU1513
RUSSIAN FEDERATION1428
AUSTRALIA1392
ECUADOR1361
NEW ZEALAND1228
GREECE1208
TURKEY1110

Section 307 – Prior Notice of Shipment

Requires a prior notice of imported food shipments. The notice is required to provide the article, the manufacturer and shipper, the grower (if known within the specified time in which notice is required), the country of origin, the country from which the article is shipped, and the anticipated port of entry. If notice is not provided, the article cannot be imported into the USA.

FDA’s Food Protection Plan
The FDA Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4th, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.

FDA will develop new tools to ensure that imported foods meet US standards and are safe for consumers. For example, for the first time, importers will have to verify that their foreign
suppliers have adequate preventive controls in place to ensure safety, and FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with U.S. food safety standards.