Food Safety: Remote Inspections under COVID-19 and Other Key Provisions in the Foreign Supplier Verification Program

By: Olga Torres, Managing Member & Derrick Kyle, Associate & Donna Wedgeworth, Trade Advisor
Date: 07/17/2020

The COVID-19 pandemic has affected nearly all aspects of everyday life, but sometimes it is easy to forget that the U.S. Government must also adjust its operations to be able to meet regulatory requirements during the pandemic.

One aspect of this adjustment includes the manner in which government agencies are confirming industry’s compliance with various regulatory burdens. For importers of human and animal food products, this adjusted practice includes remote inspections by Federal Drug Administration (“FDA”) investigators to confirm compliance with the Foreign Supplier Verification Program (“FSVP”), one of several regulations designed to implement the provisions of the Food Safety Modernization Act of 2011 (“FSMA”).

FSMA amended the existing Food, Drug and Cosmetic Act of 1938 by establishing a risk-based approach that put the emphasis on preventing food hazards in both human and animal food products rather than reacting to detected hazards. The new approach places obligations on parties across the supply chain for avoiding food hazards, from farm to table.

Essentially, the FSVP requires food importers to ensure that their foreign suppliers are producing food in accordance with U.S. food safety standards. The FDA published the final rule making FSVP effective on January 26, 2016; it  included different compliance dates based on the size of the importer, the size of the foreign supplier, and other factors, such as the particular type of food imported. The first of these compliance dates was May 30, 2017, and the final deadline – affecting Very Small Businesses (as defined in 21 CFR 112.3) – will occur this summer on July 27, 2020.

The FSVP rule generally requires food importers to be responsible for:

  • Identifying themselves as the food “Importer” (as defined in 21 CRF Part 1, Subpart L, 1.500 Definitions);
  • Determining known or reasonably foreseeable hazards with each food;
  • Evaluating the risk posed by a food, based on a hazard analysis and the foreign supplier’s performance;
  • Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities;
  • Developing written policies and procedures for supplier verification activities to ensure food imports only come from approved foreign suppliers;
  • Conducting appropriate and prompt corrective actions to protect public health when a food item is adulterated, misbranded, or poses any type of hazard; and
  • Documenting FSVP-related activities and retaining those records for future inspection.

It is important to note that there are multiple exceptions and modifications to the requirements, depending on a variety of factors. For example, an importer of low-acid canned food (“LACF”) whose supplier meets the requirements under 21 CFR 117, “Current Good Manufacturing Practice, Hazard Analysis, And Risk-Based Preventive Controls For Human Food,” is not required to conduct a hazard analysis with respect to microbiological hazards. In addition, an importer of eggs that is properly regulated under the U.S. Department of Agriculture (“USDA”) is not subject to certain portions of the FSVP.

To prevent redundant requirements, importers that import raw materials and ingredients for further processing or manufacturing in the United States, and that are compliant with the relevant food safety authority governing their specific food item (like the preventative controls of the FMSA or other requirements of their supply chain obligations), would be excluded from additional FSVP requirements. These importers must nevertheless be listed as the FSVP Importer in Customs entry documents.

Under FMSA, the FSVP Importer is defined as “the U.S. owner or consignee of an article of food that is being offered for import into the United States.”  The FSVP further defines “U.S. owner or consignee” as “the person in the United States who, at the time of the food's U.S. entry, either owns the food, has purchased the food, or has agreed in writing to purchase the food.” The FSVP Importer may be, but is not necessarily, the importer of record under Customs regulations. Unlike the importer of record, the FSVP Importer must have a financial interest in the food or be designated to conduct supplier verification activities.

Compliance with FSVP requires the preparation of a written FSVP plan, and this plan and other FSVP activities must be performed by a “qualified individual,” which is a defined term in the FDA regulations and means “a person who has the education, training, or experience (or a combination thereof) necessary to perform an activity required” by the FSVP rule, “and can read and understand the language of any records that the person must review in performing this activity.” Many food importers may have an individual on staff who may be well-positioned for appointment as a “qualified individual,” but importers that do not have such an employee may outsource the “qualified individual” role to a third party.

FDA enforcement activities have previously relied primarily upon physical inspections of food manufacturing or processing facilities. Under the FSVP, inspections will be focused more on the importer’s recordkeeping of supplier verification activities. In the preamble of the FSVP rule, FDA states “[o]ur enforcement of FSVP therefore ordinarily will not hinge on the observation of manufacturing/processing, packing, and holding activities. Rather, it ordinarily will be based on whether importers have conducted adequate verification activities, documented those activities, and maintained appropriate records.” 

Although the FDA may perform an onsite inspection of records, generally the request will be for electronic submission of records. As previously mentioned, at the time of publishing, FDA investigators are conducting FSVP audits remotely due to the COVID-19 pandemic. Such audits typically begin with an FDA Form 482 Notice of Inspection requesting specific records of FSVP documents. If significant violations are discovered, FDA notifies the FSVP Importer by issuing a Warning Letter. The Warning Letter identifies the violation and provides a timeline and instructions for the entity to correct the problem.

Because it is a new program, FDA enforcement is in its infancy when it comes to FSVP compliance. Since the first date of required compliance on May 30, 2017, the FDA has issued 26 warning letters related to conduct controlled under the FSVP, with most of those warnings issued in 2020.

If you have any questions about FSVP compliance or other FDA regulations applicable to importers, please do not hesitate to contact the attorneys at Torres Law. Torres Law also employs trade advisors who can act as “qualified individuals” for FSVP companies.