The US Food and Drug Administration (FDA) recently issued two final rules intended to increase the safety of food imported into the United States, furthering one of the main objectives of the Food Safety Modernization Act (FSMA), signed into law in January 2011. The Foreign Supplier Verification Program (FSVP) Final Rule1 and Accredited Third-Party Certification (TPC) Final Rule2 are designed to ensure that food imported into the United States is at least as safe as food produced domestically under the new FSMA preventive controls and the produce safety rules finalized in September and November respectively.3
FSVP Final Rule
Under the FSVP Final Rule, importers are required to establish and follow a plan to conduct supplier verification activities related to the known or reasonably foreseeable hazards for each type of food they import. FSVP regulations require food importers to adopt programs to ensure that the food they import is (i) produced in a manner that provides the same level of public health protection as food produced by domestic food producers (now subject to more rigorous requirements under the preventive controls and produce safety rules); (ii) is not adulterated; and (iii) is not misbranded with regard to allergen labeling.
The rule defines an importer as the US owner or consignee of a food offered for import into the United States. If there is no US owner or consignee, the importer is the US agent of the foreign owner of consignee at the time of entry, as confirmed in a signed statement of consent. This is a change from the Proposed Rule, made on FDA’s own initiative.
The final rule obliges importers to do the following with regard to imported food:
- Conduct Hazard Analysis: An importer must determine the hazards reasonably likely to cause illness or injury with each food. The hazard analysis must consider biological, chemical and physical hazards, hazards that occur naturally or unintentionally and those that are intentionally introduced for economic gain.
- Evaluate Foreign Suppliers: Using the results of the hazard analysis, an importer must evaluate the risks associated with a food, the foreign supplier’s food safety history and other factors, as appropriate. An importer may rely on another entity’s evaluation, so long as the importer reviews and assesses the evaluation and related documentation.
- Approve Suppliers: An importer must approve its own suppliers. However, the importer may rely on another entity’s evaluation when deciding whether to approve a supplier. This provision will be useful when an importer works with a distributor and does not necessarily have much contact with the actual suppliers.
- Determine and Conduct Supplier Verification Activities: An importer must establish written procedures to ensure that it only imports foods from approved suppliers; it must then conduct activities to ensure its approved suppliers continue to produce food in a manner that comports with US food safety standards. Although FDA states that verification activities can be tailored, the agency notes that annual onsite audits are the default verification activity and it advises that decisions to implement alternative activities should be documented along with the rationale. Under certain circumstances, activities entirely outside of supplier verification may be appropriate. For example, when the hazard will be controlled for by a subsequent entity in the distribution chain, an importer would need to obtain written assurances to that effect from that entity. This scenario would also permit minimal verification activities with regard to the supplier.
- Take Corrective Actions: An importer must promptly take corrective actions if the importer determines that a foreign supplier is not producing food that meets US safety standards. This may include ceasing importation of foods from a noncompliant supplier until compliance issues are addressed.
- Maintain Records: Importers must retain records of FSVP activities. As proposed, the Final Rule does not require these records be kept in English. However, the “qualified individual” evaluating the records for FSVP purposes must be able to read and understand them, and an English translation must be provided at FDA’s request.
The Final Rule provides exemptions and modifications in certain circumstances.
- There are modified requirements for (i) very small importers and importers of certain small foreign suppliers and (ii) certain foods from a foreign supplier in a country with a food safety system recognized by FDA to be comparable to the US food safety system.
- Certain foods are not covered by the rule, these are: (i) foods that are subject to, and are in compliance with, FDA’s Hazard Analysis and Critical Control Point (HACCP) regulations for juice, fish and fishery products; (ii) food for research or evaluation; (iii) food for personal consumption; (iv) alcoholic beverages and certain ingredients for use in such beverages; (v) food that is imported for processing and future export; (vi) low-acid canned foods (LACF), and certain ingredients for use in such products, with respect to microbiological hazards covered in LACF regulations; and (vii) certain meat, poultry and egg products that are regulated by the US Department of Agriculture.
- FSVP requirements generally do not apply to importers of dietary supplements when the importer can verify compliance with the dietary supplement Current Good Manufacturing Practice (CGMP) regulations. When the requirements are applicable, verification activities would revolve around the dietary supplement CGMP regulations.
To reduce redundancy and achieve more congruence with the preventive controls produce safety regulations, the Final Rule deems some importers that also are manufacturers/processors to be in compliance with most of the FSVP regulations when certain conditions are met. These conditions center around the importer’s compliance with other regulations or laws that provide reasonable assurances of safety.
In general, FDA made numerous changes to the Final Rule to more closely align FSVP provisions with the preventive control regulations, which were finalized in September 2015. To achieve more consistency between the FSVP and the preventive controls regulations, FDA revised definitions and offered additional exemptions. Where FDA declined to cross-reference or match FSVP regulations with the preventive control regulations, the agency cited differences in scope or purpose that necessitated a different approach or requirement for FSVP.
The final rule could be considered flexible or ambiguous, depending on the level of guidance an importer desires. FDA declined to delineate more-specific standards in many areas of the rule, particularly for the hazard analysis and verification activities. Instead, the agency said it wanted to keep the rule flexible and that an importer may arrive at the same result through a variety of activities. Enhanced flexibility could be an advantage for industry. However, given that compliance will be determined at FDA’s discretion, there is a at least the possibility that this “flexibility” could turn into a lack of direction that results in an importer taking actions that FDA does not consider to be compliant.
The FSVP Final Rule will become effective January 26, 2016, and importers must generally comply by July 26, 2017, however, there are compliance deadline exceptions for certain small importers.
TPC Final Rule
On the same day it issued the FSVP Final Rule, FDA also issued a related final rule on Accredited Third-Party Certification (TPC).4 The TPC rule sets forth the regulatory mechanisms by which foreign food facilities may obtain certifications of their food safety controls. These certifications may be used to facilitate entry of certain foods into the United States.
Under the TPC, FDA will recognize accreditation bodies, which may then go on to accredit third parties to serve as certification bodies (also known as auditors), which may issue certifications for foreign facilities and their foods. Under the TPC, accreditation bodies must assess and monitor certification bodies, as well as maintain records and report to FDA. Certified auditors must undertake unannounced audits, record observed risks to public health to FDA and verify the effectiveness of any corrective actions, as well as maintain records and report to FDA. In addition, accreditation bodies and certification must bodies self-evaluate, self-correct and self-report to FDA.
The certifications may be used in several contexts. First, under certain circumstances, FDA may require a certification to accompany the importation of certain potentially harmful foods. Second, importers may use the certifications to qualify for the Voluntary Qualified Importer Program (VQIP),5 which will provide expedited importation where significant control over the safety of the supply chain is shown.
FDA plans to implement the TPC program as soon as possible after it publishes the forthcoming final Model Accreditation Standards guidance and the final user fee rule. Once these are in place, FDA will begin accepting applications for accreditation bodies. Auditors may apply for certification as soon an FDA-recognized accreditation body begins accepting applications.