FDA Issues Guidance on Voluntary Third-Party Certification for Foods and Animal Feeds

According to the FDA, an increasing number of establishments that sell foods to the public, such as retailers and food service providers, are independently requesting, as a condition of doing business, that their suppliers, both foreign and domestic, become certified as meeting safety (and other) standards. In addition, domestic and foreign suppliers are increasingly looking to third-party certification programs to assist them in meeting U.S. regulatory requirements.

Guidance is Step in Future FDA Recognition of Third-Party Certification

FDA's guidance is intended as one of the steps in its future recognition of one or more voluntary third-party certification programs for particular product types. It describes the general attributes FDA believes a certification program should have to provide quality verification of product safety.

Highlights of FDA Recommended Process for Third-Party Certification of Foods

The following are highlights of FDA's recommended process for third-party certification programs for foods:

Application. The certification body should require an application form, signed by a duly authorized representative of the establishment, which should include (partial list):(i) statement on establishment's regulatory standing (whether it has been the subject of FDA legal action, warning letter, Import Alert, etc.); (ii) name, address, and unique facility identification code, if applicable, of the site-specific establishment(s) to be certified for a particular food product it produces, manufactures, processes, packs, or holds; (iii) list of product market forms, packaging, and processes used by the establishment for the product types to be certified; (iv) etc.

Audit. Upon satisfactory completion of the application process, an auditor acting for the certification body should perform an audit of the establishment and records. The audit should provide the certification body with reasonable assurance that the establishment produces, manufactures, processes, packs, or holds foods that are safe and in compliance with certification criteria.¹ The auditor should have access to the relevant parts of the establishment, processes, and product types, and records relating to food safety in order to make this determination.

Certification. A certification body would provide assurance that the establishment conforms to the certification criteria. A decision on certification should be specific to an establishment and processes for particular product types (i.e. it should be possible to be certified for processes for a particular product type and not for other product types).

Recertification. In general, recertification to confirm an establishment's continued conformity with the certification criteria should occur at least once every two years for most products. Higher risk product types, processes, or establishments should be audited at least annually. FDA may provide further guidance on the frequency of recertification when recognizing certification programs in particular product areas.

Compliance and corrective action. The certification body should take appropriate steps when there is non-compliance such as: (i) use a risk-based system to determine when an investigation, follow-up, or re-audit is needed; (ii) evaluate whether the establishment has executed corrective actions that resolve the deviations that would affect certification; and (iii)withdraw certification if the establishment fails to take such corrective actions.

Possible Benefits of Participation in Third-Party Food Certification Programs

According to FDA, whether an establishment participates in such a voluntary food third-party certification program would not affect its rights or obligations, however participation may be beneficial. For example, FDA may:

take into consideration an establishment's product-specific certification by a recognized certification body when determining its inspection priorities, as well as its entry admissibility decisions and field exam and sampling priorities;

take certification into consideration when determining "may proceed²" rates for imported products, which may result in expediting entry for certain product types from particular establishments;

acknowledge certified establishments by developing a publicly accessible database;

more easily and quickly investigate certified establishments and therefore exclude them during a foodborne illness outbreak; and

take such certification into account when considering requests by establishments to have their products removed from an FDA Import Alert that is for Detention Without Physical Examination.

Guidance in Response to Import Safety "Action Plan," FDA Food Protection Plan

FDA states that this guidance is issued in response to the recommendations contained in the Action Plan for Import Safety: A Roadmap for Continual Improvement issued on November 6, 2007, by the Interagency Working Group on Import Safety as well as FDA's Food Protection Plan released on the same date. According to FDA, both those plans emphasize certification as a way to improve FDA's capacity to verify the safety of products from a growing food establishment inventory, both domestic and foreign.

(See ITT's Online Archives or 11/09/07 and 11/14/07 news, 07110910 and 07111415, for BP summaries of the action plan and food protection plan, respectively.)

¹FDA states that the final guidance document differs from its draft version in that the audit section no longer includes detailed criteria on specific safety and security systems.

²The "may proceed" rate means the rate of import entries entered into domestic commerce after electronic review, but without FDA staff review of the entry, including physical examination or sampling. FDA sets this rate based on various considerations, such as product risk and the demonstrated degree of compliance of the commodity/establishment/country.

(See ITT's Online Archives or 07/14/08 and 04/17/08 news, 08071410 and 08040720, for BP summaries of FDA announcements of the draft version of this guidance and a pilot third-party certification program for certain imported shrimp, etc. and FDA seeking comments on voluntary third-party certification programs for food, respectively.)

FDA contact - Sharon Lindan Mayl (301)796-4840

FDA notice (D/N FDA-2008-D-0381, FR Pub 01/16/09) available at http://edocket.access.gpo.gov/2009/pdf/E9-861.pdf

FDA guidance, ''Voluntary Third-Party Certification Programs for Foods and Feeds''(dated January 2009) available at http://www.fda.gov/oc/guidance/thirdpartycert.html