Signed into law last June 12, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, includes national preparedness plans for bioterrorism, mechanisms to protect the nation’s food and drug supply, and a plan of action to secure drinking water security.
The two newly proposed rules are the last two of four proposed regulations that the Bioterrorism Act calls upon FDA to develop regarding food safety.
The rules (Section 303 and 306 of the Act) mandate that most food firms establish and maintain certain records. It also authorizes the FDA to detain any food the agency believes could present a “a threat of serious adverse health consequences or death to humans or animals.”
The detention of any food must be approved by an official at the district director level or higher, and may not exceed 30 days. In addition, food products may be put on temporary hold at ports of entry for periods of less than 24 hours.
An appeals process will be made available in cases where the FDA has detained food products, with expedited hearings allowed for perishable foods such as fresh produce, fresh fish and fresh seafood products.
Any imported foods that may pose a risk to public may be placed under administrative detention, the Act states.
It also authorizes the secretary of agriculture to have access to the previous two years of company records when there is 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.
“It applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of the food. It excludes farms and restaurants. It also excludes information such as recipes, financial data, personnel data, research data, and sales data, other than shipment data regarding sales,” the FDA rule says.
Within 18 months of the completion of the FDA’s plan to protect the nation’s food, water and drug supply in case of a terrorist attack, the secretary of agriculture is directed to develop a set of regulations for the establishment and maintenance of records needed to determine the immediate previous sources and the immediate subsequent recipients of food, which will vary according to business size.
The proposed rule makes it illegal for a food manufacturer or importer to refuse to permit access to or copying of any required record, or fail to establish or maintain any required record.
For more information on either of the two proposed regulations, visit the FDA Bioterrorism Act web page at http://www.fda.gov/oc/bioterrorism/bioact.html.