On July 23, the US Food and Drug Administration (FDA) issued a proposed rule that will, if finalized, support a new program to help foreign companies affirmatively establish that their imported food meets US food safety requirements (80 Fed. Reg. 43987, July 24, 2015) (the Proposed Rule). The Proposed Rule is authorized under Section 307 of the Food Safety Modernization Act (FSMA) (Pub.L. 111-353). FSMA aims to protect public health through ensuring safety and security in the food supply chain. The Proposed Rule would help to ensure the safety of imported foods, which make up about 15% of the US food supply.

The Proposed Rule would supplement the previously proposed rule “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” (78 Fed. Reg. 45782, July 29, 2013) and establish a user fee program to reimburse the FDA for the services performed in the accreditation of third-party auditors/certification bodies. Additionally, the FDA published draft guidance titled “Draft Guidance for Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards” (the Draft Guidance) as a companion document for the Proposed Rule.

As we stated in a previous blog post, “Voluntary Qualified Importer Program Draft Guidance: Incentivizing Food Import Safety,” the Voluntary Qualified Importer Program (VQIP) will allow foreign food companies—among other benefits—to achieve expedited entry on shipments of food into the United States. In order for foreign food companies to qualify for the VQIP, they must first be audited and certified by either an accredited third-party auditor or a certification body. The Proposed Rule and Draft Guidance establish a program describing how the FDA will allow these entities to perform the audits and certifications of the foreign food importers participating in the VQIP.

The Proposed Rule tentatively concludes that there are four main groups to whom costs should be attributed for the purposes of charging user fees:

  1. Accreditation bodies submitting applications or renewal applications for recognition in the third-party accreditation program
  2. Recognized accreditation bodies in the third-party accreditation program subject to FDA monitoring activities
  3. Certification bodies submitting application or renewal applications for direct accreditation
  4. Accredited certification bodies participating in the third-party accreditation program subject to FDA monitoring activities

Among the fees that the FDA proposed are application fees to fund FDA review of applications and annual fees to support relevant monitoring activities. The FDA estimates that fees for the accreditation of third-party auditors and certification bodies will be approximately $35,850 for the initial application, $18,853 for renewal applications (every three to five years), and between $1,982 and $2,250 for annual FDA monitoring fees. In line with how the FDA releases fee schedules for other FDA-regulated products (e.g., prescription drug user fee rates and medical device user fee rates), the FDA predicts it will release the fee rates in late summer, which is just before the start of the federal fiscal year.

In its Draft Guidance, the FDA creates an industry standard for third-party auditor/certification body qualifications that applicants will be advised to follow.

Comments regarding the Proposed Rule or Draft Guidance may be submitted through www.regulations.gov referencing Docket No. FDA-2011-N-0146. Comments regarding the Proposed Rule are due by October 7, 2015.