The U.S. Food and Drug Administration's (FDA) final Food Safety Modernization Act (FSMA) "Foreign Supplier Verification Programs for Importers of Food for Humans and Animals Rule" (FSVP) and "Accreditation of Third-Party Auditors Rule" (3rd Party), were published in November 2015.
The FDA participated in a webinar hosted by PMA and United Fresh in partnership with California Leafy Greens Marketing Agreement, Canadian Produce Marketing Association, Florida Fruit and Vegetable Association, Fresh Produce Association of the Americas, Georgia Fruit and Vegetable Growers Association, Northwest Horticultural Council, Texas International Produce Association, and Western Growers Association.
The presentation provided an overview of these final rules and help industry members understand what they need to do to be compliant.
Useful links for more information on both rules include:
Foreign Supplier Verification Programs (FSVP) Rule
Brian Pendleton, Senior Policy Advisor, Office of Policy in FDA's Office of the Commissioner
The FSVP Rule aims to provide assurances that 1) foreign suppliers produce food using processes and procedures providing the same level of public health protection as FSMA preventive controls or produce safety provisions, and that 2) food is not adulterated or misbranded with respect to allergen labeling, Mr. Pendleton explained.
The key principles of the FSVPA rule are:
- Importers have a responsibility to ensure the safety of imported food
- The FSVP rule is risk based, taking into account different types of hazards, importers and suppliers
- The FSVP rule provides flexibility in meeting requirements to accommodate modern global supply chains to allow importers to rely on assessing activities conducted by others
- The FSVP rule is aligned with preventive controls for human foods rule supply-chain provisions
"FSVP is truly significant because for the first time it requires importers to take specific steps to ensure the safety of the food they import," Pendleton said.
Under FSVP, the "importer" is the U.S. owner or consignee of a food at the time of U.S. entry. If there is no U.S. owner or consignee at entry, the importer is the U.S. agent or representative of the foreign owner or consignee, as confirmed in the signed statement of consent.
Mr. Pendleton noted that importers are deemed in compliance with most of FSVP when they:
- Comply with preventive controls supply-chain provisions
- Implement preventive controls under the preventive controls regulation for hazards in food they import
To provide importers with additional clarification on FSVP requirements, Mr. Pendleton indicated FDA will be developing FSVP draft guidance in the first half of 2016. The Food Safety Preventive Controls Alliance will also be developing training materials for the FSVP regulation.
Accredited Third-Party Certification Rule
Charlotte Christin, Senior Policy Advisor, Office of Foods and Veterinary Medicine
The 3rd Party Rule establishes a voluntary program for the accreditation of third-party auditors, also known as certification bodies, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce, said Ms. Christin.
Importers will not generally be required to obtain certifications. Certifications under this rule, she said, will be used for two purposes:
- Facility certifications will be used by importers to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food.
- Food or facility certifications will be used for admissibility of a food subject to a risk-based determination by FDA.
Accreditation bodies can be a foreign government/agency or a private third-party, and an accreditation body may use documentation of its conformance to ISO/IEC 17011, supplemented as necessary, in meeting FDA requirements, said Ms. Christin.
When performing audits under this rule, accredited third-party certification bodies must:
- Perform facility audits unannounced
- Notify FDA on discovering a condition that could cause or contribute to a serious risk to public health
- Submit regulatory audit reports
- Maintain consultative audit reports in records
Model Accreditation Standards draft guidance — containing recommendations on the qualifications that third-party certification bodies and their agents should follow — and a proposed rule establishing user fees for accreditation and certification bodies were issued in July 2015, with comment periods ending in October 2015. FDA is currently working to finalize these related requirements, and implementation of the 3rd-party Rule will launch after the final user-fee rule takes effect.
