On July 29 2013 the US Food and Drug Administration (FDA) published two significant, long-awaited proposed rules mandated by the Food Safety Modernisation Act, the landmark bipartisan overhaul of the US food safety system that was signed into law on January 4 2011. The proposed rules – the Foreign Supplier Verification Programmes for Importers of Food for Humans and Animals(1) and the Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications(2) – are intended to work with the rules that the FDA proposed on January 4 2013 to establish preventive controls for food manufacturers, harvesting rules for produce and enhanced good manufacturing practice requirements for all foods.(3)
The Foreign Supplier Verification Programmes for Importers of Food for Humans and Animals, which implements Section 301 of the Food Safety Modernisation Act, is intended to ensure that imported foods meet the same high safety standards as those processed or harvested in the United States. Subject to certain exemptions, the regulation would require importers to establish foreign supplier verification programmes to control foreseeable food safety risks through a hazard assessment process. Each verification programme would have to be established and performed by a 'qualified individual', defined as one with the necessary education, training, and experience to comply with the FDA's proposed requirements. In general, each programme would need to consider the following:
- Compliance status review – importers would be required to review the compliance status of the product and the foreign supplier before initially importing the product and periodically thereafter. Such a review would need to include any FDA warning letters, import alerts and requirements for certification issued by the FDA under Section 801(q) of the Food, Drug and Cosmetic Act.
- Hazard analysis – importers would be required to identify the hazards that are reasonably likely to occur for each type of food imported.
- Verification activities: – Importers would be required to provide adequate assurances that the hazards identified as reasonably likely to occur are adequately controlled, including maintaining a written list of foreign suppliers and establishing and following adequate written procedures for conducting verification activities. These activities could include onsite auditing of foreign suppliers; periodic or lot-by-lot sampling and testing of food; periodic review of foreign supplier food safety records; or other appropriate risk-based procedures.
- Periodic reassessment of the verification programme – importers would be required to reassess their programmes every three years.
- Importer identification – importers would be required to obtain a Data Universal Numbering System number for their company and to provide it electronically when filing entries with Customs and Border Protection.
- Recordkeeping – importers would be required to keep certain records, including those that document compliance status reviews, hazard analyses, foreign supplier verification activities, investigations and corrective actions and verification programme reassessments.
The proposed rules are intended to be flexible and vary based on the type of food product and category of importer, meaning that the importer will have some discretion in developing and implementing the verification programme. Furthermore, the procedures focus on foreseeable food safety risks, not all risks covered by the adulteration provisions in the Food, Drug and Cosmetic Act. In addition, 'foreign supplier' is defined as an establishment that manufactures or processes the foreign food without further processing by another establishment. Only a single foreign supplier for any particular shipment need be verified.
With respect to the verification activities, however, the FDA is inviting comment on two different options, one of which is considerably more prescriptive than the other. The first option would require an onsite audit of the foreign supplier or, for foods other than produce, reliance on the inspection results of the FDA or an FDA-sanctioned food safety authority if exposure to a foreseeable hazard would result in serious adverse health consequences or death. For less serious hazards, the importer would have the flexibility to choose appropriate verification activities itself.
The second option would allow the importer discretion to choose from the proposed verification activities for all hazards, regardless of severity, as long as the importer considered the risk presented by the hazard, the probability that exposure to the hazard might result in serious harm and the foreign supplier's compliance with US safety regulations.
The regulation proposes several exceptions for certain types of food and importer, including the following:
- National exemptions – food from a foreign supplier in a country with a food safety system that the FDA has officially recognised as comparable to that of the United States is excluded from most of the standard verification requirements so long as the food is within the scope of FDA's official recognition and the importer determines that the supplier is in good standing with the regulatory body in its home country.
- Dietary supplements – importers of dietary supplement components and dietary supplements subject to further processing that verify their suppliers' compliance with good manufacturing practice regulations need not comply with most of the standard verification requirements, including the verification activities. Importers of finished dietary supplements would have to comply with more of the verification requirements, but would not have to conduct hazard analyses, and their supplier verification activities would focus on verifying good manufacturing practice compliance.
- Small businesses – very small food importers and importers of food from very small foreign suppliers – defined as entities with annual food sales of no more than $500,000 – need only obtain written assurances from foreign suppliers describing the processes and procedures used to ensure the safety of the product. They are not required to conduct hazard analyses.
- Foods subject to Hazard Analysis Critical Control Point (HACCP) regulations – products from juice and seafood facilities that are already subject to, and in compliance with, HACCP regulations are exempt from the verification requirements.
With respect to on-site audits, the FDA would not require such audits to be performed by an FDA-accredited auditor. The only limitation on auditors is that they are "qualified individuals."
Importing a product without a verification programme would be a prohibited act and failure to meet the requirements in the proposed rule would constitute grounds to refuse admission of a food product into the United States.
To comply with Section 307 of the Food Safety Modernisation Act, the FDA proposed rules amending 21 Code of Federal Regulations Parts 1 and 16 to ensure the competence and independence of third-party auditors or certification bodies which will conduct foreign food safety audits. Based on these audits and resulting certifications, the FDA will decide whether imported foods can enter the United States.
The Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications is designed to apply to entities that voluntarily participate in the FDA's accredited third-party audits and certification programme. This includes:
- accreditation bodies seeking recognition under this programme;
- third-party auditors or certification bodies seeking accreditation; and
- eligible entities seeking food safety audits from accredited auditors or certification bodies.
A third-party auditor could be a foreign government, a foreign cooperative or any other third party that the FDA deems appropriate. The FDA will retain complete oversight over imported food by establishing and imposing standards and regulatory obligations on the accreditation bodies, the third-party auditors/certification bodies and the certified/audited foreign food facilities seeking to ship food to the United States. The FDA has the authority to revoke recognition of an accreditation body, which can have significant implications down the chain to the certified food facility, depending on the reason for the revocation.
To qualify for recognition as an accreditation body, an applicant must demonstrate that it can perform assessments of the third party auditors/certification bodies necessary to determine if they are capable of auditing and certifying food facilities and food. These assessments would include reviewing records, conducting on site assessments, performing reassessments or surveillance necessary to monitor compliance, and suspending, withdrawing or reducing the scope of the accreditation. An accreditation body must have personnel with the relevant knowledge, skills and experience to effectively audit for compliance with FDA requirements and industry standards. Accreditation bodies must also perform routine self-assessments and submit reports to the FDA regarding all evaluations performed. Also, the proposed rules require accreditation bodies to establish programmes to safeguard against conflicts of interest that could compromise objectivity and independence. Reports must be filed with the FDA on all determinations, including denials of accreditation.
Similar qualification obligations are proposed for auditors and certification bodies, including self-assessments of compliance. Facility audits performed by accredited bodies can be either consultative or regulatory – but all regulatory audits must be reported to the FDA, even where it does not result in a certification. The FDA proposes regulations prescribing exactly how an audit must be conducted and what must be included in the resulting report. The FDA may require food certifications as a condition for admitting a food into the United States "where necessary based on [FDA's] determination of the risk of the food". The FDA will request food certification under 801(q) at its discretion based on whether there are known safety risks associated with the food or country of origin, or if it finds that food safety standards are not adequate to ensure that a product is as safe as a similar product in the United States.
Agents that have performed a consultative audit of an eligible entity within the preceding 13 months may not conduct a regulatory audit for that same entity unless the FDA grants a waiver. Unannounced audits are crucial to the programme, so the FDA proposes to require accredited auditors first to review an entity's management system before conducting an onsite food safety audit at the facility. Information from accredited auditors or certification bodies can be used to meet the foreign supplier verification programme requirements.
Critically, all auditors must immediately notify the FDA of any condition discovered during a food safety audit that could cause or contribute to a serious risk to the public health.
Comments on both rules are due in by November 26 2013. The rules are intended to take effect six months after the applicable compliance dates of the January 2013 proposed rules.
The president's proposed 2013 budget calls for user fees from food processors to help fund the FDA's food safety programme. The third-party accreditation programme will rely on user fees for processing applications.
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(3) Those rules were the subject of a client alert that Sidley disseminated on January 8, 2013 which can be seen here.