WASHINGTON (CN) - The Food and Drug Administration will be able to access records not only for suspect articles of food, but for any other article of food that is likely to be affected in a similar manner, according to a new rule. The Secretary of Health and Human Services is to make the determination of likeliness based on a "reasonable belief."
The FDA also may access records regarding articles of food with a reasonable probability of causing serious adverse health consequences or death to humans or animals, according to the rule. This also is determined by the secretary, and also applies to food likely to be affected in a similar manner.
The rule, effective March 1, implements amendments to the Federal Food, Drug, and Cosmetic Act made by the FDA Food Safety Modernization Act. The FDA seeks comments on the rule.
The FDA also has released a new guide on the establishment and maintenance of records by those who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States under the Federal Food, Drug, and Cosmetic Act.
Click the document icon for this regulation and others.