FDA Proposes Additional Rules to Ensure the Safety of Imported Food

The Food and Drug Administration is issuing a proposed rule covering the use of private sampling services and laboratories in connection with imported food. Once finalized, the rule will strengthen the safety and wholesomeness of the U.S. food supply by helping to assure the integrity and scientific validity of data and results submitted to FDA.

The new regulations would require samples to be properly identified, collected and maintained; mandate that private laboratories use validated or recognized analytical methods; and direct private laboratories to submit the results directly to FDA. The proposal also would require importers to provide notice to FDA about the use of a sampling service or a private laboratory to sample and test food that is subject to an FDA enforcement action.

"This is yet another of the many steps initiated by our agency to protect Americans from food that appears to be adulterated or misbranded," said Dr. Lester M. Crawford, the Acting FDA Commissioner. "When it is finalized, this regulation will add an important building block to the FDA regulatory wall that helps to keep suspect food from harming our consumers."

Imports of food are rapidly rising and last year reached more than 6 million shipments. FDA estimates that importers hire more than 100 private laboratories to generate analytical data in support of claims that imported food products comply with U.S. laws. After questions were raised in mid-1990s about the coordination between these firms and FDA, the agency conducted several meetings with stakeholders that resulted in suggestions that the FDA take the following actions:

Establish consistent and objective national standards for the format and content of analytical data that private laboratories submit to FDA;

Require independent sampling so that FDA may be assured that samples collected and tested by private laboratories are truly representative of a shipment lot and are collected properly to ensure the integrity of any samples that were collected for testing; and

Require private laboratories to report analytical results directly to FDA to assure that the results are reported fairly.

FDA's proposal embodies these recommendations by describing the obligations of persons who use sampling services and/or private laboratories to submit data to FDA, and by establishing requirements for services that collect food samples and for private laboratories that analyze them.

The proposed rule emphasizes the importance of keeping the manner and process of sample collection and analysis free of any unauthorized influence or interference in order to deter manipulation, alteration, or substitution of the tested products.

The proposal, which can be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/oc99264.pdf, is on display today at the Office of the Federal Register. The proposal provides a 90-day period for comments. Comments should be identified by Docket No. 2002N-0085 and submitted using one of the means described in the opening section of the posted document.


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