On July 26, 2013, FDA released two key Proposed Rules as part of the implementation of the Food Safety Modernization Act (FSMA), signed into law in 2011.  The long-awaited Proposed Rules are "Foreign Supplier Verification Programs for Importers of Food for Humans and Animals" and "Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications," implementing sections 301 and 307 of FSMA, respectively.

Both rules will be published in the Federal Register on Monday, July 29, 2013.  The public will have 120 days from the date of its publication to comment –until November 26, 2013 – unless the deadline is extended.  Furthermore, FDA stated its intent to extend for 60 days the comment period for its proposed rules on Produce Safety and Preventive Controls for Human Foods in order to coincide with the ending of the comment period for the rules published today. 

Foreign Supplier Verification Program (FSVP)

The FSVP rule would establish guidelines by which importers must verify that food products being imported from their foreign suppliers meet U.S. food safety standards.  FDA has explained that this program will alleviate the burden of border inspection on FDA and allow for a more preventive approach to food safety, a key aim of FSMA.  All non-exempt importers would be required to develop, maintain, and follow an FSVP for each food it imports.  FSVPs are to consist of the following:

  • a review of the compliance status of the foreign supplier and the food they are purchasing;
  • an analysis of all potential hazards reasonably likely to occur for each food imported;
  • verification activities to ensure such hazards are adequately controlled;
  • corrective actions and periodic reassessments to ensure compliance is maintained;
  • a unique identification number for each importer; and
  • recordkeeping requirements to document the aforementioned components of the FSVP.

The supplier verification requirements are based on the question of who is responsible for the hazards that are reasonably likely to occur with a particular food.  The rule proposes two options for the supplier verification activities for hazards that the foreign supplier will control or that the foreign supplier verifies are being controlled by its raw material or ingredient supplier.  The rule proposes two options:

  • Under Option 1, if the foreign supplier controls the hazard at its establishment and there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals (i.e. the Class I recall standard), the importer would be required to conduct or obtain documentation of onsite auditing of the foreign supplier.
  • Under Option 2 of the proposal, for all hazards that the foreign supplier will either control or verify that its supplier is controlling, importers would need to choose a verification procedure from among onsite auditing, sampling and testing, review of supplier food safety records, or some other appropriate procedure.

Third Party Accreditation

The third party accreditation rule would establish a program to recognize certification bodies that would provide accreditation to third-party auditors to conduct food safety audits and issue certifications of foreign food facilities.  The rule sets eligibility requirements for recognition as an accreditation body as well as for accreditation as a third-party auditor. 

An accreditation body can be a foreign government/agency or a private third-party.  A third-party auditor can be a foreign government, foreign cooperative, or other third-party.  Accredited third-party auditors would audit and issue certifications for foreign facilities and their food products.  Both accreditation bodies and third-party auditors must meet standards for legal authority, competency and capacity, impartiality/objectivity, quality assurance, and records procedures. 

Requirements of accredited third-party auditors would include:

  • ensuring their audit agents are competent and objective;
  • conducting rigorous audits;
  • submitting reports of audits used for certification purposes to FDA;
  • notifying the FDA upon finding any condition posing a serious risk to the public health;
  • assessing and correcting any problems in its own performance;
  • protecting against conflicts of interest; an
  • maintaining and providing FDA access to records.

Effective Dates for Proposed Rules

The FSVP rule would take effect 60 days after the Final Rule is published in the Federal Register and compliance would be required 18 months after that publication date.  Given the comment period and implementation timeline, compliance is unlikely to be required prior to 2015. 

For the third party accreditation rule, FDA indicated only that it intends to implement the program as soon as possible after publication of the Final Rule and the final Model Accreditation Standards.  The latter will be published separately and will specify what qualifications a certification body must have to qualify for accreditation.  The public will have the opportunity to comment on the Model Accreditation Standards under a different docket and comment period than the third party accreditation rule.