FDA Proposes New Rules on Oversight of Food Imports

Proposal Envisions Critical Role for Third-Party Accreditation

The U.S. Food and Drug Administration (FDA) recently announced two new proposed rules intended to bolster inspections of food imported into the United States. Now in the midst of a 120-day public comment period, the rules would require food importers to maintain records demonstrating compliance with FDA safety rules and required inspection criteria, bringing their responsibilities in line with requirements scheduled to be implemented for U.S. food producers. In addition, the FDA would increasingly rely on oversight work carried out by accredited third-party certification bodies. Recognized accreditors that follow FDA-approved procedures would assess the competence of the organizations performing food safety inspections and audits being conducted on food imports, as well as broader food safety scopes in supply-chain management.

The proposed rules are related to the implementation of the 2011 Food Safety Modernization Act (FMSA). Under FSMA, the FDA is empowered to take proactive steps to prevent the sale, distribution, and consumption of tainted food products, rather than simply investigating outbreaks of foodborne illness or food-related deaths. About 48 million people are made ill and 3,000 are killed each year in the U.S. by foodborne bacteria, viruses, and pathogens; however, the FDA was only able to inspect 0.4% of imported food in 2011, compared to 6% of domestic food sources. This disparity highlights the importance of finding new ways to increase effective, verifiable inspections by private-sector sources and foreign government agencies.

"These proposed rules demonstrate that the Food and Drug Administration is committed to transforming our nation's food inspection system, and highlight the essential role played by internationally recognized accreditation of third-party certification bodies in food safety assurance and the larger global economy," said S. Joe Bhatia, president and CEO of the American National Standards Institute (ANSI).

In its role as the coordinator of the U.S. voluntary consensus standardization system and as a U.S. representative to the International Accreditation Forum (IAF), ANSI has longstanding involvement in efforts to increase reliance upon accredited third-party certification. The Institute administers a broad portfolio of accreditation programs that recognize the competence of a range of conformity assessment bodies in accordance with guidelines and requirements defined in international standards. These programs are increasingly specified by local, state, and federal governments, and include organizations that certify products, personnel, processes, services, and systems; validate or verify greenhouse gas assertions; and issue education and training certificates.

In 2012, ANSI established a Subcommittee on Food Safety Programs as part of its Accreditation Committee on Product/Process/Services Certification. This group works to further public understanding of food safety issues and to increase awareness about third-party accreditation in this area, including information about best practices and the divide between accredited and non-accredited certification bodies. The subcommittee is currently at work developing ANSI's official comments on the FDA's proposed rules.

"We applaud the FDA's efforts to recognize the value of accredited food safety audits and certifications as part of the solution to the challenges posed by the rapid globalization of the food marketplace," said subcommittee chair Jorge Hernandez, senior vice president for food safety and quality assurance at US Foods. "The use of accredited food safety audits and certifications provides the best and fastest opportunity to bolster the safety of the food supply in the U.S. acting as a force multiplier to the government efforts and making effective use of the each offered by private third party food safety audits."

For more information about the two proposed rules or to access their full text, click here. Comments may be submitted electronically at www.regulations.gov, faxed to 301-827-6870, or mailed to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments must be received by November 26, 2013, in order to be considered.

To submit comments to ANSI regarding the proposed rules, please contact Reinaldo Figueiredo, ANSI senior program director for product and process accreditation, at [email protected].