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Issue Number: Council I 030

Title

Food Equipment Certification

Issue you would like the Conference to consider

The 2009 FDA Food Code contains language in Chapter 4 - Equipment, Utensils, and Linens recognizing a single organization for the accreditation of certification programs for food service equipment. Specifically, Section 4-205.10 of the Food Code limits the acceptability of food equipment certification programs to those accredited by the American National Standards Institute (ANSI). ANSI, a private, non-governmental organization, is one of three nationally recognized, U.S. based accreditation bodies that are qualified to accredit product certification programs. The identification of ANSI as the sole (proprietary) source for qualified accreditation providers is unnecessarily restrictive.

Public Health Significance

The reliance on properly accredited third- party certification programs to evaluate food service equipment to nationally recognized standards that address sanitation and safety is a reliable mechanism to establish compliance with Sections 4-1 and 4-2 of the Food Code. The establishment of clear requirements for determining the acceptability of accreditation bodies is consistent with current practice while supporting an open marketplace based on demonstrated compliance.

Both the American National Standards Institute (ANSI) and the International Accreditation Service (IAS) are U.S. domiciled accreditation bodies that are signatory members of the International Accreditation Forum (IAF), meaning both organizations are recognized nationally and internationally as having equivalent levels of confidence for providing accreditation services. Accreditation is increasingly being used by regulators and the market as an impartial, independent and transparent means of assessing the competence of conformity assessment bodies.

Regulators in the United States increasingly rely on an integrated system of accreditation and certification to demonstrate that products and services comply with regulatory requirements. In the United States, examples of the reliance on systems of accreditation and certification include programs administered by the Environmental Protection Agency (EPA), the Department of Energy (DOE) and the Nuclear Regulatory Commission (NRC). The EPA Water Sense® and Energy Star® programs require that manufacturers submit products to an accredited certification agency for testing and evaluation in order to establish compliance with established standards and criteria. Both programs establish qualification criteria for recognition of accreditation bodies based on a framework for accreditation developed by IAF. IAF provides the technical basis for the recognition of the competence of accreditation bodies. IAF conducts an initial onsite evaluation, routine surveillance and periodic re-evaluations of accreditation bodies to determine compliance with the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) Standard 17011 Conformity assessment-General requirements for accreditation bodies accrediting conformity assessment bodies. Accreditation bodies found to be operating accreditation programs that comply with these requirements become signatories to the IAF Multilateral Recognition Arrangement. The criteria for the accreditation of product certifying bodies is detailed in ISO/IEC Guide 65, General requirements for bodies operating product certification systems and the International Accreditation Forum (IAF) Guidance on the Application of ISO/IEC Guide 65.

Recommended Solution: The Conference recommends...

that a letter be sent to the FDA requesting the 2009 Food Code (as modified by the Supplement issued in 2011), Section 4-205.1, be amended as shown below (new language shown with underline and deleted language shown with strike-through):

Acceptability

4-205.10 Food Equipment, Certification and Classification.

Food equipment that is certified or classified for sanitation by an American National Standards Institute (ANSI)-accredited a certification program accredited by a U.S. domiciled accreditation body that is a signatory to the International Accreditation Forum (IAF) Multilateral Recognition Arrangement (MLA) is deemed to comply with Parts 4-1 and 4-2 of this chapter.

Attachments

Submitter Information

Name Ron Coiner
Organization International Accreditation Service
Address 5360 Workman Mill Rd.
Whittier, CA 90601
Telephone (562) 364-8201 ext 3309
Fax (562) 699-8031
Email rcoiner@iasonline.org
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