Q&A: Food Safety Modernization Act (FSMA) Services

  • Open What is FSMA and what are the requirements?

    The FDA Food Safety Modernization Act looks to establish accountability for proactive identification and control of food safety risks in the U.S. food supply. FSMA also seeks to provide greater safety assurance of imported foods through third-party accreditation certification and the Foreign Supplier Verification Programs (FSVP).

  • Open How is FSMA different from FDA inspection?

    The Food Safety Modernization Act (FSMA) is an FDA regulation and law. The U.S. Food and Drug Administration FDA) is the government authority responsible for enforcement of the law. The FDA conducts inspections to verify compliance with the regulation. The FDA enforces the FSMA regulation and additional FDA regulations that preceded FSMA, such as the Food, Drug, and Cosmetic Act (FD&C Act) and other U.S. FDA regulations.

  • Open What is FSVP and what are the requirements?

    The Foreign Supplier Verification Program is a requirement under FSMA regulations for those who import ingredients that will receive further processing in the U.S..

    Under FSVP supplier approval requirements, importers of foods must analyze the hazards of imported food, evaluate the performance of their foreign suppliers and the risk posed by the foods to be imported, and conduct appropriate verification activities such as on-site auditing, sampling, testing and review of records. NSF’s import supplier certification audit can be used to meet the FSVP supplier on-site audit verification activity requirements.

  • Open What other options are there for supplier verification activities?

    Whether domestic or foreign, the supplier’s control measures, including records review and testing, must be verified by an outside agent. On-site audits can be conducted by the buyer or by a third-party qualified auditor.

    The buyer cannot rely only on the supplier’s own self-assessments or record reviews. The buyer must also take corrective action with the supplier for failures and the buyer must maintain records of these evaluations.

  • Open What NSF services will meet FSVP requirements?

    It is the responsibility of the importer to determine what verification activity meets the needs of their program, including the scope of on-site audits, whether that be a custom audit, a GFSI certification audit or an FDA FSMA-accredited regulatory audit. NSF offers many second- and third-party audit options performed by qualified auditors to fully evaluate all the importer’s compliance requirements.

    • FDA FSMA accredited certification: NSF’s import supplier certification
    • GFSI benchmarked certifications: BRC, IFS, SQF, FSSC, GLOBALG.A.P., CanadaGAP and PrimusGFS
    • FSMA readiness
    • GMP audits
    • HACCP audits
    • Customer-specific audits
  • Open What if my supplier plant is already GFSI certified?

    GFSI programs are an acceptable verification activity if deemed appropriate according to the risk assessment conducted by the importer. Importers may require additional verification activity or be audited against specific FDA regulations to provide greater assurance.

    GFSI programs are not currently accepted by the FDA for VQIP importers or for FDA high-risk import certification.

  • Open What is VQIP and what are the requirements?

    The Voluntary Qualified Importer Program provides expedited entry of products into the U.S. Under VQIP, suppliers must be certified against FDA regulations by an FDA accredited third-party certifier such as NSF. The U.S. importer enrolls with the FDA for VQIP and registers all suppliers and products.

  • Open What is the NSF import supplier certification audit?

    The NSF’s import supplier certification audit meets the FDA FSMA regulations. The audit requires document and record reviews and on-site facility audits annually, performed at the foreign facility.

    This certification, or an acceptable alternative, is required for suppliers to VQIP importers and high-risk imports. It is an option for domestic FSVP import supplier verification.

  • Open What is the duration of the audit?

    The duration of NSF’s import supplier certification audit depends on various factors such as the number of employees, square footage of the facility and the scope of the HACCP plans. The typical audit duration of the accredited program is one to one and a half days. The desk audit duration is set at one day as well as one day for report writing.

  • Open How does NSF’s import supplier certification audit compare to FSMA readiness audits?

    NSF’s import supplier certification for FDA FSMA is accredited and recognized by FDA as a regulatory audit conducted by a qualified individual. No additional verification of auditor qualification and audit methods is required by the importer to assure compliance with FDA FSVP requirements. This assurance is provided through the accreditation process. If the audit is not accredited by the FDA Third-Party Accredited Certification Program, the importer must conduct evaluation of auditor qualifications and audit methods and keep records of this assessment.

  • Open Where can I find the detailed requirements to meet FSVP and VQIP?
  • Open What are considered high-risk items?

    The FDA has identified certain product categories and types as higher risk, which are targeted for focused attention.

    https://www.fda.gov/Food/ComplianceEnforcement/FoodCompliancePrograms/default.htm

    Some foods in the high-risk categories include:

    • Raw produce subject to pathogenic contamination
    • Ready-to-eat (RTE) foods subject to pathogenic contamination
    • Baked goods, custard or cream-filled (egg containing) foods
    • Bovine spongiform encephalitis (BSE) risk foods such as soups, stews, gravies and sauces containing meat

     

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