Although an interim rule from the Food and Drug Administration regarding its access to food companies’ records goes into effect March 1, the agency is accepting comments on the rule through May 23.
The interim rule, published Feb. 23 in the Federal Register, is the FDA’s response to one of the mandates of the 2011 Food Safety Modernization Act. It broadens FDA’s access to records relating to “suspect” foods, including fresh produce.
Previously the FDA could only demand records related to a “specific suspect article of food.” The interim rule gives the agency access to records related to “any other article of food” that an official “reasonably believes is likely to be affected in a similar manner,” according to the Federal Register notice.
Further, the interim rule allows FDA to access records about food that has not been shown to have any problems. The agency now has authority to demand records on the “belief” that there is “reasonable probability” a food could cause “serious adverse health consequences or death to humans or animals.”
Records must be produced within 24 hours of an official request from FDA. No new records are required to be kept, but the interim rule does specify that records must be maintained for at least two years.
Farms and restaurants are excluded, but many businesses in the fresh produce industry are covered by the rule because it applies to anyone who “manufacturers, processes, packs, distributes, received, holds or imports” food.
The FDA officials stated in the Federal Register notice that they anticipate issuing a final rule one year after the close of the comment period on May 23.
Comments must include the docket number “FDA-2002-N-0153” and the regulatory information number “(RIN) 0910–AG73.” They may be submitted via mail, fax or online. Fax comments to 301–827–6870. Mail comments to: Division of Dockets Management, (HFA–305), FDA, 5630 Fishers Lane, Room 1061, Rockville, Md., 20852.