The Bioterrorism Act and the Alcohol Beverage Industry
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act, Public Law 107-188) may affect members of the alcohol beverage industry.1 Among its provisions, the Bioterrorism Act authorizes the Secretary of Health and Human Services, acting through the Food and Drug Administration (FDA), to issue regulations to protect the Nation's food and drug supplies against bioterrorism and food-borne illness.
Please note: Under the Bioterrorism Act, the term "food" includes alcohol beverages.
Provisions of the Bioterrorism Act That May Affect You
The following provisions of the Bioterrorism Act and the related FDA regulations may affect members of the alcohol beverage industry.2
- Food Facility Registration: Under the Act, certain domestic and foreign food facilities that manufacture, process, pack, or hold food must register with the FDA by December 12, 2003, or before beginning such activities after that date.3
- Prior Notice of Importation: Importers must provide the FDA with prior notice of food imported or offered for import into the United States after December 12, 2003 (via the Bureau of Customs and Border Protection Automated Broker Interface or the FDA Prior Notice system). 4
- Establishment and Maintenance of Records: Certain domestic and foreign facilities must keep and retain records that identify the immediate previous non-transport sources and the immediate subsequent non-transport recipients of food. The Act also provides the FDA with records inspection authority.5
- Administrative Detention of Food: The Act authorizes the FDA to detain food if there is credible evidence that the food poses a threat of serious illness or death. Food from unregistered facilities or food imported into the U.S. without prior notice is also subject to detention or refusal of entry.
For More Information
View the Bioterrorism Act and read more information about the Bioterrorism Act.
The FDA Industry Systems Web site provides online access to, on information on, the FDA's food facility registration system and its prior notice of importation system.
21 CFR Part 1-General Enforcement Regulations contains the FDA regulations issued under the Bioterrorism Act. Specifically, see Subpart H-Registration of Food Facilities, Subpart I-Prior Notice of Imported Food, Subpart J--Establishment, Maintenance, and Availability of Records, and Subpart K-Administrative Detention of Food for Human or Animal Consumption.
Bureau of Customs and Border Protection Bioterrorism Act Web site (includes information on personal shipments of food into the United States).
TTB comments on FDA's proposed rules issued in 2003 for registration and prior notice and records establishment and maintenance.
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The President signed the Bioterrorism Act into law on June 12, 2002.
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The Bioterrorism Act and the related FDA regulations affect TTB-regulated industry members who are: Bonded wine premises, breweries (including microbreweries and brewpubs that pack any beverages for off-site sale), distilled spirits plants, and alcohol beverage distributors, importers, warehouses, and wholesalers. If you have a question concerning the Bioterrorism Act's applicability to you, contact the FDA.
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Registration Exemptions: In general, private residences, farms, restaurants, retail food outlets, and non-profit food establishments in which food is prepared or served directly to consumers are exempt from the FDA registration requirement. See the FDA Bioterrorism Act Web site for more details.
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Prior Notice Exemptions: In general, you do NOT have to give prior notice of import for: (1) Food purchased by a traveler for personal use or as a gift and that is brought or shipped to the U.S. by that traveler, (2) homemade food shipped by the producer to an individual in the U.S. as a personal gift, (3) food in household goods shipments, (4) food immediately exported from the U.S. from the same port of arrival, and (5) food shipped in diplomatic pouches. See the FDA Bioterrorism Act Web site or the Bureau of Customs and Border Protection Bioterrorism Act Web site for more details.
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Recordkeeping Exemptions: In general, farms, restaurants, retail food outlets, and non-profit food establishments in which food is prepared or served directly to consumers, and foreign facilities that only send food to other non-U.S. facilities for further processing are exempt from this recordkeeping requirement. See the FDA Bioterrorism Act Web site for more details.
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