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FDA shifting from education to enforcement of FSMA requirements

The Food Safety Modernization Act (FSMA) has many rules and new procedures for food and supplement brands, but FDA expects full compliance and is willing to issue citations.

The Food Safety Modernization Act (FSMA) requires most food and beverage facilities that operate in the U.S. or export to the U.S. market to develop and implement written food safety plans using the hazard analysis and risk-based preventive controls (HARPC) method and requires importers to develop foreign supplier verification programs (FSVPs). With the exception of “very small” animal food facilities, the compliance deadlines for covered facilities and importers to follow these rules have passed, and FDA is ramping up enforcement efforts during facility inspections as a response. Any missing component from a facility’s food safety plan or FSVP can lead to a citation that could lead to further regulatory action.

FSMA Requirements

A complete food safety plan contains multiple components; failure to incorporate any of them can result in FDA considering a plan insufficient. A food safety plan must be written by a preventive controls qualified individual (PCQI). This PCQI must either receive training in preventive controls or be otherwise qualified through job experience. A complete food safety plan must identify all potential biological, chemical (including radiological) and physical hazards and then establish controls to prevent, reduce or eliminate the hazards. Written procedures must be established for monitoring, corrective actions and verification of the controls. A supply chain program is required when hazards are controlled solely by a supplier. Procedures on how to approve, monitor and verify a supplier’s controls must be included in the supply chain program. Records on monitoring, corrective actions and verification of controls must be kept for at least two years. Lastly, procedures to follow in case of a food safety related issue must be written in a recall plan.

For FSVP, importers must verify that the food they import follows FDA regulations and provide the same level of public health protection by meeting or exceeding U.S. food safety standards. They must evaluate, approve and monitor the foreign suppliers, and verify that the food is not adulterated or misbranded (in regard to allergens). They are required to write an FSVP for each food from each foreign supplier. It aligns with the requirements of the supply chain program in that they must evaluate the supplier before approval and identify the hazards associated with the food and the controls that their suppliers are applying. Then they must establish and conduct the proper verification. Importers must be or assign a qualified individual to write the FSVP and to conduct all activities related to FSVP. Foreign suppliers must be reevaluated for performance at least once every three years or as needed when an issue arises. Importers must only use suppliers they have approved. Failure to meet the requirements can result in FDA regulatory action, such as warning letters or detentions.

Enforcement to Date

After the first deadlines to have a food safety plan passed, FDA focused on educating facilities during inspections to help them understand the new requirements. Many food facilities were not aware they were under the new rule and had failed to develop a new plan or believed their previous food safety scheme (hazard analysis and critical control point [HACCP], International Organization for Standardization [ISO] 22000, etc.) automatically met all HARPC requirements. The same was done during FSVP inspections. It is the first time FDA has put such responsibility on importers, so FDA checked their FSVPs while also educating.

In 2018, FDA began shifting toward enforcing these rules more actively and more frequently cited FSMA violations during inspections. The most frequently cited inspection violation of that year was failing to develop an FSVP. The number of FSVP violations from 2017 to 2018 more than doubled, going from 108 to 278. FDA also issued 396 citations in 2018 relating to violations of preventive controls rules. Some of these violations included not having a HARPC food safety plan, not identifying all hazards at a facility, failing to establish controls for all potential hazards, not monitoring sanitation or allergen controls, and improper record-keeping. In 2019, FDA has already issued several warning letters to companies for violating FSMA-mandated rules, even mentioning that the compliance dates to have a food safety plan have passed. As time goes on, FDA will likely continue increasing efforts toward enforcing these rules, so it is important for facilities to be prepared.

Being Prepared for an FDA Inspection

When preparing a food safety plan or FSVP, it is critical that the person assigned to develop them fully understands the requirements. Each facility will have hazards and controls that are unique to them and will thus require unique plans. Brands cannot simply follow another facility’s food safety plan. Most of the common violations surrounding food safety plans involve leaving out a component or failing to identify all potential hazards and controls. The plan must be thorough and carefully evaluated to avoid a citation during an inspection.

After the plan is in place, it must be properly implemented and kept up to date. Upon any changes to the food, process, equipment or controls, or if any issue with the food arises (e.g., recall), a reanalysis must be conducted to evaluate if and/or how the changes affect the safety of the food or if any gaps in the plan were initially missed. FDA has issued warning letters to companies for failing to properly implement the controls identified in their plans in 2019. Brands need to integrate the facility’s plan into their standard operating procedures (SOPs) and ensure all employees are trained to understand their responsibilities toward executing it.

Understanding and following all of the new FSMA rules can be overwhelming and getting used to the new operating procedures can take time. However, FDA has begun enforcing the FSMA rules. Now is the time to have a complete and compliant food safety plan and/or FSVP to avoid a citation that can lead to further regulatory action.

Learn more about FDA inspection observations for FSMA violations from Coley Anderson during the “FSMA and Import Requirements for Food and Supplement Brands” session on Wednesday, Oct. 16, 2019 at 9:00 a.m. at SupplySide West in Las Vegas. This session is underwritten Venable.

Coley Anderson (canderson@registrarcorp.com) serves as director of industry and government relations at Registrar Corp, an FDA consulting firm that helps companies comply with FDA regulations. She has been assisting companies since 2004, focusing on educating foreign governments, trade associations, and individual companies about FDA regulations.

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