15 Feb 2018
FDA Launches Expedited Food Import Programme, Issues New Guidance on FSMA Compliance
The Food and Drug Administration announced on 31 January that it has launched its Voluntary Qualified Importer Program, a fee-based programme that will provide for expedited review and importation of human and animal food by participating importers who achieve and maintain a high level of control over the safety and security of their supply chains. The FDA believes VQIP benefits will incentivise importers to adopt a robust system of supply chain management and allow the agency to focus its resources on examining and sampling food imports that are more likely to present a potential risk to public health.
The VQIP launch was made possible because the FDA has recognised the first accreditation body under the Accredited Third-Party Certification Program, which accredits third-party certification bodies (auditors) to conduct food safety audits of foreign food entities and certify that they and the food they produce meet applicable FDA food safety requirements. These audits and certifications will be used by importers seeking to establish eligibility for the VQIP.
The FDA states that it will expedite entry for all foods included in an approved VQIP application. Specifically, the agency will use its PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting) import screening tool to recognise food shipments that are part of the VQIP programme and, in most cases, immediately release those shipments without further examination and sampling. The agency will limit its examination and/or sampling of approved VQIP food entries to (i) “for cause” situations in which it suspects a potential risk to public health, such as an investigation of an outbreak or illness; (ii) obtain statistically necessary risk-based microbiological samples (when building a product risk profile based on non-biased surveillance sampling); and (iii) audit a small percentage of import shipments covered by VQIP to verify that products declared in a VQIP entry are consistent with products covered in the VQIP application.
When the FDA needs to examine an import entry covered by VQIP it will attempt, to the extent possible, to examine the entry and collect samples at the VQIP food destination or other location preferred by the VQIP importer. In the event the agency collects a sample of a VQIP food import entry, FDA laboratories will prioritise processing of VQIP samples. If import entry to the United States is denied, the FDA will assist in fulfilling an importer’s request to U.S. Customs and Border Protection to export the refused products from the port preferred by the importer.
Meanwhile, the FDA recently issued five guidance documents to help importers and food producers meet key food safety provisions mandated by the Food Safety Modernization Act. The agency states that two of these documents, a draft guidance and a Small Entity Compliance Guide, are meant to help industry meet the requirements of the Foreign Supplier Verification Programs regulation. Under the FSVP importers are responsible for ensuring that their foreign suppliers use processes and procedures that provide at least the same level of public health protection as the FDA’s preventive controls or produce safety regulations, if applicable, and that the suppliers’ food is not adulterated or misbranded with respect to allergen labelling. The draft guidance provides the FDA’s current thinking on how best to comply with these requirements, while the SECG offers specific guidance on the modified procedures allowed for very small importers or importers of food from certain small foreign suppliers.
The draft guidance indicates, among other things, that a U.S. agent or representative of a foreign owner or consignee for FSVP could be, but is not required to be, the same person as the U.S. agent of a foreign food facility named in the facility’s FDA registration under section 415 of the Federal Food, Drug, and Cosmetic Act. The U.S. agent or representative of a foreign owner or consignee for FSVP purposes is responsible for meeting the full breadth of applicable requirements under the FSVP regulation. These requirements include conducting a hazard analysis, performing supplier verification activities and taking other steps to ensure the safety of imported food. These responsibilities are qualitatively different from serving as a communications link with a foreign facility. Therefore, a U.S. agent or representative for FSVP purposes serves a different role than a U.S. agent named in the FDA registration of a foreign food facility. The U.S. agent of a foreign food facility may also serve as the U.S. agent or representative of that facility for FSVP purposes, provided the person has signed a statement of consent to serve as the importer of the food for purposes of the FSVP regulation.
The draft guidance also states that compliance with the FSVP provisions does not exempt a food from the prior notice requirements because, while both the FSVP and prior notice regulations help the FDA ensure the safety of imported foods, each has a distinct purpose. FSVP focuses on ensuring that the food is safe before arrival at U.S. ports of entry while advance notice of import shipments allows the FDA, with the support of CBP, to target import examinations more effectively once food arrives at U.S. ports of entry.
For purposes of the FSVP requirements, the foreign supplier of a food is the establishment that manufactures/processes the food, raises the animal or grows the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labelling or any similar activity of a de minimis nature. As a result, a U.S. importer’s foreign supplier might not be the entity from which that importer directly obtains the food. For example, if a company imports packaged dog food from a foreign distributor who obtains the dog food in its final packaging from the manufacturer, the foreign supplier would be the manufacturer of the dog food. A foreign supplier may or may not be a food facility that is required to register under section 415 of the FD&C Act. For example, an establishment that raises animals or grows food is included in the definition of foreign supplier but may not be required to register as a food facility with the FDA.
The draft guidance adds that while food contact substances are included in the definition of “food” for purposes of the FSVP regulation, the FDA intends to exercise enforcement discretion for imports of these substances with respect to the FSVP requirements. However, importers of food contact substances remain subject to the statutory prohibition against the introduction or delivery for introduction into interstate commerce of adulterated food. In addition, the FDA will consider revising its exercise of enforcement discretion if, for example, new information becomes available regarding safety concerns associated with food contact substances. A food contact substance is any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting or holding food if such use of the substance is not intended to have any technical effect in such food.
The third draft guidance addresses the term “same level of public health protection” used in both the FSVP regulation and the produce safety regulation by providing a framework for determining the adequacy of a process, procedure or other action intended to provide the same level of protection as those required under the FSMA regulations for produce and human or animal food. The fourth draft guidance is designed to help food facilities comply with the supply chain programme requirements of the regulation implementing FSMA requirements for hazard analysis and risk-based preventive controls for human food.
Finally, the FDA has issued a guidance announcing its intention to exercise enforcement discretion with regard to the application of the FSVP regulation for (i) importers of grain raw agricultural commodities that are solely engaged in the storage of grain intended for further distribution or processing and (ii) grain importers that do not take physical possession of the grain they import but instead arrange for its delivery to others for storage, packing or manufacturing/processing (such as certain commodity brokers with respect to the FSVP regulation). Grain RACs imported into the United States include barley, dent- and flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat and oilseeds for oil extraction (e.g., cotton seed, flax seed, rapeseed, soybean, sunflower seed).