FDA's Expedited Review: A Step In The Right Direction For Food Safety

The Food and Drug Administration (FDA) will speed up its review of certain food additive petitions that seek to clear products--including packaging materials--intended to enhance food safety. (See 64 Fed. Reg. 517, Jan. 4, 1999.) The Agency will consider expediting a review when an additive is intended to decrease incidences of food borne illnesses through antimicrobial actions against human pathogens that might be present in food.

You can find FDA's guidance document explaining the new policy at www.fda.gov/cfsan. Written comments on the document "Food Additive Petition Expedited Review Guidance for Industry and Center for Food Safety and Applied Nutrition Staff' may be submitted at any time.

How Fast Is Fast?

"Expedited review" means that the petition will advance to the beginning of the appropriate review queues and be handled ahead of other pending food additive petitions. Otherwise the petition does not receive any special treatment. It will require the same quality and quantity of data as any other petition and will be similarly evaluated for safety.

FDA is also imposing no special deadlines for completing the actual review. By statute, FDA's review of a petition should be concluded within 90 day of the filing date, or 180 days in cases the Agency has determined require additional time. FDA, however, only rarely meets these deadlines.

FDA will use two criteria in selecting petitions for expedited review:

1. Use of the additive as proposed must be intended to significantly decrease human pathogens (for example, e. coli, salmonella, campylobacter, cyclospora or listeria) or their toxins in or on food.

2. The petition must be complete and contain sufficient data and information to support a decision to approve the additive.

At the time of filing, the Director of the Office of Premarket Approval in consultation with Division Directors will decide which petitions warrant expedited review, but, in an appropriate cover letter, tell the Agency that you believe that the petition meets the criteria for expedited review.

FDA will notify petitioners in writing if their petitions have been designated for expedited review and will also publicly disclose such designations on its home page.

FDA hopes that implementing this policy will not adversely affect review times for other petitions and, while periodically monitoring the status of petitions designated for expedited review, will evaluate the affect of the procedure on all petitions.

The Agency also intends to shift workloads within the affected reviewing divisions when necessary, and may also call on scientists from other divisions in FDA to provide support for those petitions that are significantly affected by the policy.

Packaging Examples

Companies seeking FDA approval of additives with antimicrobial properties may well be significant beneficiaries of FDA's new policy. Such substances include those that reduce food borne illnesses by direct addition to food, such as fruit and vegetable washes, as well as treatment technologies, such as the use of radiation. Petitions to clear the use of specific packaging materials for pre-packaged irradiated foods should also be eligible for this expedited consideration, as should petitions for antimicrobials incorporated into food packaging materials that reduce pathogenic organisms.

Other technologies that may be used to reduce pathogens by providing sterile packaging materials may also be considered by FDA under this criteria. Indeed, even some more conventional types of food packaging materials that are intended to protect food products from outside contaminants may possibly be shoe-homed into this program. The important thing is to recognize when the criteria is available for use and to clearly indicate this to the Agency.

Jurisdictional Snag

The benefits that FDA hopes to obtain through this expedited review program may be thwarted by feet-dragging from other government agencies that may exercise concurrent jurisdiction over some of these products or treatment methods, such as the U.S. Environmental Protection Agency (EPA) or Department of Agriculture (USDA).

For example, while FDA exercises jurisdiction over the food safety question for fruit and vegetable washes intended to be used on raw fruits and vegetables in a food processing facility, these products are still subject to EPA registration requirements as pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).

Thus, no matter how quickly FDA finishes its review, the product still cannot be marketed until EPA review is also complete. Indeed, if these products are also intended to be used in the field or in facilities other than a food processing plant, EPA is responsible not only for the registration of the product, but also must determine whether the product meets its (EPA's) food safety criteria. FDA's determination is not binding on EPA (see Regulatory Update, January 1999).

Similar problems exist for antimicrobials intended to be incorporated into food packaging materials.

While FDA exercises jurisdiction over the food safety question, EPA still requires the product to be registered.

Moreover, EPA has exclusive jurisdiction over antimicrobials that are used in permanent and semi-permanent food contact materials, such as conveyor belts and trays. Thus, review of these items by FDA under its expedited procedures will not be available at all.

Although EPA claims to have some expedited programs for antimicrobial pesticides, in fact, review times can often take significantly longer than the parallel FDA review. And EPA often has more stringent data requirements for similar types of products, which, of course, makes preparation of the appropriate submissions more time consuming and expensive.

The same problem exists with USDA for antimicrobials intended for use with or on meat and poultry products. Such additives must be specifically cleared by USDA in most cases, which may not necessarily come quickly.

Take, for example, FDA's approval of the use of radiation for meat products in December of 1997. Although FDA has long completed the heavy lifting necessary for establishing the safety of such treatment methods, prepackaged meats still cannot be subject to radiation because USDA clearance for this treatment (as required by law) is not yet complete!

FDA's new expedited review program is a definite step in the right direction. Let's hope that other government agencies involved with food safety questions follow suit.

By George Misko, Partner, Keller & Heckman Inquiries or comments may be sent to Mr. Misko at 1001 G St., N.W., Suite 500W, Washington, DC 20001; phone (202) 434-4100 or fax (202) 434-4646. E-mail: misko@khlaw.com

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