Expedited Review of Food Additive Petitions

Reports of foodborne illnesses caused by microbial contamination have increased over the past few years. While America’s food supply is among the safest in the world, every year millions of Americans become ill and thousands die as a result of infections caused by foodborne pathogens.

Several human pathogens (e.g., Escherichia coli O157:H7 and Salmonella, Campylobacter, Cyclospora, and Listeria species) have been identified as causing, or have been implicated in, outbreaks of foodborne illnesses over the past few years. The Food and Drug Administration is concerned about this increase in foodborne illness and has undertaken several actions in an attempt to address this issue.

One such action has been to give priority to the review of petitions for food additives that are intended to decrease the incidence of foodborne illness through their antimicrobial action against human pathogens that might be present in food, i.e., to designate such petitions for expedited review.

Designating a petition for expedited review means that the food additive petition is reviewed ahead of other pending petitions; i.e., the petition is placed at the beginning of the appropriate review queues. These expedited petitions still have to meet the same approval standards that are applied to other food additive petitions: the need for valid scientific evidence, including data to support claims made in the petitions, and, most important, the need to meet the safety standard.

Although FDA has traditionally initiated its reviews of all petitions in the order in which they are received, the agency believes that it is in the interest of enhanced public safety to expedite the review of these particular food additive petitions. Examples of petitions that could be designated for expedited review are those that propose the use of sources of radiation or chemicals such as chlorine dioxide intended to reduce harmful bacteria.

The process of expedited review is designed to provide an incentive for manufacturers to develop these critical products and to ensure that such products are available for marketing as soon as possible, while still meeting the safety standard and operating within the process established by law for food additives.

FDA’s Office of Premarket Approval has identified several teams that can be assigned to expedited reviews on a moment’s notice. These teams are coordinated by a Consumer Safety Officer who ensures that the reviews are completed as expeditiously as possible, keeps management informed, communicates with the petitioner, and drafts any regulations that may result from the petition.

The guidelines regarding the expedited review process can be accessed via the Internet at http://vm.cfsan.fda.gov/~dms/ opa-expe.html, and the list of expedited petitions can be accessed at http://vm.cfsan.fda.gov/~dms/opa-expd.html. These documents can also be found via FDA’s home page (www.fda.gov) by clicking on Foods, Food Additives and Premarket Approval, Technical Documents for Industry, and Petitions Expedited. As of the end of April, five petitions have been expedited: four for use of antimicrobial agents and one for use of irradiation.

FDA invites anyone interested in submitting a petition that might be eligible for expedited review to contact us to discuss the petition before submitting it. Several of the petitions that we have received involve other agencies, such as the Environmental Protection Agency or the U.S. Dept. of Agriculture’s Food Safety and Inspection Service. By knowing in advance if other agencies may be involved, we can also help the petitioner contact the appropriate persons in these agencies, thus reducing the overall time needed to reach the marketplace.

Anyone with further questions concerning the expedited review of petitions should visit our Web site or contact us directly (Robert L. Martin, phone 202-418-3074, e-mail [email protected]; Patricia A. Hansen, phone 202-418-3093, e-mail [email protected]).