FSMA Regulations from a Food Ingredient Perspective

One interesting and unexpected overlap has resulted between the FDA and the DHS Chemical Facility Anti-Terrorism Standards (CFATS) program for chemical facilities. FDA’s Intentional Adulteration rule shares several elements with CFATS, such as security requirements and background checks for employees. While the first compliance date for FDA’s Intentional Adulteration rule isn’t until July 2019, the chemical community is already discussing how it will implement the requirements and if coordination between FDA and DHS on these regulatory programs is possible.

Recent FDA Activity Under FSMA

In early 2018, FDA announced enforcement discretion for the written assurances provisions of the Preventive Control rules, the Foreign Supplier Verification Program (FSVP), and  the Produce Safety Rule. The agency admitted it did not anticipate the vast impacts that the written assurances requirements would impose on industry and decided to consider alternate rulemaking. It also announced earlier this year that food contact substances would not be required to comply with the FSVP requirements. Additionally, as part of the third-party accreditation rule, FDA recently recognized two accreditation bodies that can conduct food safety audits of foreign facilities and will continue to review applications as they arrive.

FDA Inspections at Non-Traditional Food Facilities

Inspections at chemical distributors are usually conducted in a single day and with minimal involvement compared to a typical food facility. However, many FDA inspectors are not familiar with chemicals and can arrive at a chemical distribution facility unsure of how to do a food inspection at a non-traditional facility. Undoubtedly it is frustrating for an FDA inspector to arrive and realize that he or she doesn’t know how to conduct an inspection, and it can be just as frustrating for companies that spend considerable time and money preparing for an inspection.

Thankfully, FDA recently implemented an initiative called “program alignment” wherein FDA offices will be assigned to facilities based on their expertise instead of the location. Previously, a facility would be inspected by the closest FDA office to its location, which resulted in FDA inspectors having to be experts in every type of facility inspected—food, drugs, devices, biologics, and more. Under program alignment, FDA offices are now divided into one of two categories, “food” or “drugs,” and now food facilities are inspected by the closest FDA food office, which should help concentrate the knowledge about chemical distribution at FDA.

FDA is also in the process of developing a resource library for inspectors that they can access before, during, and after inspections with additional information on the facilities and products that they will be inspecting.

Foreign Suppliers and Food Safety

Many chemical distributors also import food from other countries and must meet FDA’s goal for FSVP: Imported food that meets the same standard of quality as food from the U.S. Importers must verify their suppliers and document the procedures used to ensure a supplier is meeting its obligations under FSVP. In some cases, verification may mean an overseas in-person audit and in other cases it may mean less stringent procedures, such as a thorough review of a foreign facility’s Hazard Analysis and Risk-Based Preventive Controls plan.

Verification of foreign suppliers is expected of all importers and, just as important, documentation of that verification. FSVP allows importers to use the most appropriate method to verify their suppliers. Most chemical distributors are familiar with importing and conducting due diligence of foreign suppliers, however, FSVP has added a unique challenge as distributors try to be aware of the uses of each chemical they are importing.

Food-Grade and Intended Use of Chemicals

The word “food-grade” can be misleading in the chemical world. Chemical distributors frequently purchase food-grade chemicals based on customer demand for selling into industrial or other markets. For example, a customer may wish to purchase food-grade citric acid for use in nutritional supplements, which are regulated by FDA, however not under FSMA.