FDA issues recordkeeping rule.The U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has issued final regulations on the establishment and maintenance of records to protect the security of the U.S. human and animal food supply in the event of bioterrorism bi·o·ter·ror·ism n. The use of biological agents, such as pathogenic organisms or agricultural pests, for terrorist purposes. Bioterrorism and other threats. The final rule implements section 306 of the Bioterrorism Act, which directs the Health and Human Services Noun 1. Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979 Department of Health and Human Services, HHS secretary to issue regulations requiring people who manufacture, process, pack, transport, distribute, receive, hold, or import food to establish and maintain records. These records will identify the immediate, previous source of all food received as well as the immediate, subsequent recipient of all food released. "These records will be crucial for FDA to deal effectively with food-related emergencies, such as deliberate contamination contamination /con·tam·i·na·tion/ (kon-tam?i-na-shun) 1. the soiling or making inferior by contact or mixture. 2. the deposition of radioactive material in any place where it is not desired. of food by terrorists," said Lester Les´ter n. 1. (Meteor.) A dry sirocco in the Madeira Islands. M. Crawford, acting FDA commissioner. "The ability to trace back will enable us to get to the source of contamination. The records also enable the FDA to trace forward to remove adulterated a·dul·ter·ate tr.v. a·dul·ter·at·ed, a·dul·ter·at·ing, a·dul·ter·ates To make impure by adding extraneous, improper, or inferior ingredients. adj. 1. Spurious; adulterated. 2. Adulterous. food that poses a significant health threat in the food supply. The retention periods for human food records range from six months to two years depending on the shelf life of the food. Records for animal food, including pet food, must be retained for one year. The maximum record retention requirement for transporters of all types of food is one year. To minimize the burden on food companies affected by the rule, the required information may be kept in any format, paper or electronic. All businesses covered by the rule, with the exception of very small companies, must comply within 12 months from the date the rule is published in the Federal Register. When the FDA has a reasonable belief that an article of food is adulterated and presents a serious threat to humans or animals, any records or other information to which the FDA has access must be available for inspection and copying as soon as possible but no later than 24 hours from the time the official request is received. This access authority applies both to records required to be established and maintained by the final rule or any other records a covered entity may keep to comply with federal, state, or local law or as a matter of business practice. The FDA can seek criminal actions in federal court to prosecute To follow through; to commence and continue an action or judicial proceeding to its ultimate conclusion. To proceed against a defendant by charging that person with a crime and bringing him or her to trial. those who fail to establish and maintain records as required by the final rule. |
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