The FDA Issues Two New Rules Implementing the Food Safety Modernization Act of 2011

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August 6, 2013 - Mujadala Abdul-Majid

On 26 July 2013, the FDA published two proposed rules for purposes of implementing Sections 301 and 307 of the 2011 Food Safety Modernization Act (FSMA). The proposed rules are intended to strengthen global food safety. One proposed rule addresses accreditation of third-party auditors and the other establishes a foreign supplier verification program (FSVP) for importers of food for humans and animals.

3E Analysis

Accreditation of Third-party Auditors

Through an accreditation program, the FDA intends to use accreditation bodies to certify third-party auditors to conduct food safety audits and issue certifications for foreign facilities and under specified programs.

The proposed rule will require accreditation bodies to:

  • Assess third-party auditors for accreditation;
  • Monitor performance of the third-party auditors it accredits and notify the FDA of any change in, or denial of, accreditation;
  • Assess and correct any problems in its own performance;
  • Submit reports and other notifications to the FDA;
  • Protect against conflicts of interest; and
  • Maintain and provide the FDA access to records

The proposed rule will require third-party auditors to:

  • Ensure their audit agents are competent and objective;
  • Conduct rigorous audits;
  • Submit reports of audits used for certification purposes to the FDA;
  • Notify the FDA upon finding of any condition posing a serious risk to the public health;
  • Assess and correct any problems in its own performance;
  • Maintain and provide the FDA access to records

Foreign Supplier Verification Program for Importers

Importers will have to provide identifying information such as names, locations, and Bradstreet Data Universal Numbering System (DUNS) numbers to:

  • Help the agency to evaluate risks presented by imported foods and to target its resources accordingly;
  • Help the FDA “create a comprehensive and up-to-date database that will enable [the Agency] to efficiently and effectively monitor compliance with and enforce the FSVP regulations”; and
  • Maintain on FDA’s website a list of the names, locations, and other information about importers “participating under” the FSVP.

Under the program, all importers must establish and follow an FSVP, unless exempted. The FSVP should include a plan for the following:

  • Compliance status review of the food and potential foreign supplier before importing
  • Hazard analysis associated with each imported food
  • Verification activities that provide adequate assurances that the hazards identified are adequately controlled
  • Corrective actions regarding complaints concerning imported foods
  • Periodic reassessment of the FSVP within three years of establishing the program and within three years of the last assessment
  • Importer identification including a DUNS number
  • Recordkeeping

Comments for both proposed rules are due by 26 November 2013.

Business Impact

The Food Safety Modernization Act was broad-sweeping legislation enacted in 2012 to address quality issues associated with an increasingly global food supply chain. These two proposed rules can be seen as a valuable guide to indicate the FDA’s interpretation of how it intends to regulate controls over foreign suppliers and third-party auditors.

For importers, it will be important to understand if one meets the statutory definition of “importer” to know whether one is required to establish an FSVP. These rules, once confirmed, will place new obligations on importers of food for humans and animals. Obligations such as the compliance status, hazard analysis, verification activities, and recordkeeping may require importers to establish and maintain new information management systems, or to contract for such services with a third party.

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