FDA Proposes New Requirements for Using Sampling Services & Private Laboratories for Imported Food Subject to an Enforcement Action, Etc

(For example, pending an FDA decision to refuse admission to imported food, the owner or consignee of the imported article may wish to engage a sampling service and/or private laboratory to provide evidence that the product does not violate the Federal Food Drug and Cosmetic Act (Act).)

According to the FDA, the proposed requirements would not apply if one collects analyzes, or tests imported food samples for purposes not related to an FDA enforcement action.

FDA Says Proposed Rule Would Shorten Review Time, Reduce Importer Fraud

FDA states that the benefits of this proposed rule are expected to include shortening the time it takes FDA to review private laboratory submissions, as more consistent requirements for laboratories will reduce the number and length of any delays.

In addition, FDA states that the proposed rule is expected to reduce the potential for fraudulent activities by importers, such as banking samples and engaging multiple laboratories to test samples and then choosing the most beneficial results to forward on to FDA, as importers would be required to notify FDA of the laboratory used before submitting samples to it, and the laboratory would be required to report its results directly to FDA.

Proposed Requirements for Those Using Sampling Services and Private Labs

The FDA's proposed rule would set forth the following requirements in Subpart B of a proposed new Part 59 of 21 CFR, for those persons using sampling services and/or private laboratories in connection with imported food (partial list):

Requirement to Notify FDA. If you intend to use a sampling service to collect samples of an imported food and/or a private laboratory to test or analyze samples of an imported food in connection with an FDA enforcement action, FDA proposes that you must notify the FDA district office that is reviewing the entry of your intention.

In this notification, specific contact information for the sampling service and/or private laboratory would have to be provided. Users would also have to state their intention to have the private lab submit the results and supporting data to the FDA. In addition, the reason(s) why the product is being tested and analyzed would have to be specified.

Persons using multiple private laboratories to conduct tests would have to notify all of the private laboratories involved and the FDA. The notice must state how many private laboratories are conducting or will conduct tests or analyses and describe those tests or analyses.

Provide sampling service/private laboratory with entry information. The sampling service and/or private laboratory must be given the U.S. Customs and Border Protection (CBP) entry number, as well as the FDA entry line number (if applicable or available). Sampling services must also be given the location of the lot that will be sampled, sufficient information to identify the lot to be sampled, and the name and address of the private laboratory that will test the sample.

Not influence or interfere. FDA's proposed rule states that those persons using sampling services and/or private laboratories must not influence or interfere with the manner and process in which samples are collected, tested and/or analyzed.

Maintain control of lot. The proposed rule also states that persons using sampling services and/or private laboratories would have to maintain control of the lot from which the sample was taken until they are notified by the FDA that they can release the lot or take other action on the lot.

Requirements for Sampling Services and for Private Laboratories, Etc.

In addition to requirements for persons using sampling services and/or private laboratories, the FDA proposes requirements specific to sampling services and private laboratories, in Subparts C and D, respectively, of proposed new 21 CFR Part 59.

The FDA also states that for those persons who: (1) would collect their own imported food sample and intend to have this sample tested and analyzed, or (2) are a private laboratory and collects samples of an imported food in connection with an FDA enforcement action, the requirements of Subpart C to proposed 21 CFR Part 59 would have to be complied with.

-written/ electronic comments due 07/28/04

-written/electronic comments on the associated information collection(s) due 06/01/04

FDA Contact - Philip Chao (301) 827-3380

FDA Proposed Rule (D/N 2002N-0085, FR Pub 04/29/04) available athttp://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/pdf/04-9699.pdf