Food Safety Modernization Act (FSMA)

The Food Safety Modernization Act (FSMA) enlarged FDA’s power to regulate safety procedures, domestically and internationally, for the production, manufacture, packaging, storage, and transportation of food. FSMA also provided FDA with new powers to regulate food imports by increasing FDA’s ability to inspect foreign and domestic facilities, increasing FDA’s enforcement powers, (including broadening FDA’s administrative detention powers and FDA’s ability to obtain information), and granting FDA the authority to issue mandatory recalls. From farmers to manufacturers to importers this act assigns them significant responsibility to prevent food contamination.

FDA issued a series of new regulations, with seven major new rules.

  1. Preventive Control Rule for Human Food
  2. Preventive Control Rule for Animal Food
  3. Standards for Produce Safety
  4. Foreign Supplier Verification Program
  5. Third-Party Certification Program
  6. Sanitary Transportation Rule
  7. Intentional Adulteration Rule

Although FSMA was signed into law in 2011, compliance dates vary, with the vast majority rolled out before 2020. Generally, FDA implemented the new rules for larger businesses first, then smaller ones. Also, FDA typically took the approach of educating businesses about the new rules before moving to enforcement of the rules. There are also a few exemptions for each of the rules.

If you have specific questions about how these complex rules impact your business operations, we can help.

Preventive Controls Rule

The Hazard Analysis and Risk-Based Preventive Controls (aka HARPC, PC Rules, or Preventive Controls) are similar to the better-known Hazard Analysis and Critical Control Point (HACCP) program which applies to seafood and juice. The Preventive Controls require food facilities to identify potential hazards based on the type of food produced and manufacturing processes used, and to implement controls to prevent or minimize these hazards. This applies to nearly all food facilities. Exempt facilities include small or very small businesses with on-farm manufacturing, processing, packing, or holding; facilities subject to Standards of Produce Safety, HACCP, or dietary supplement current Good Manufacturing Practices; or facilities dealing with alcoholic beverages or the storage of raw agricultural commodities (RAC). Low acid canned food facilities are exempt from the microbiological hazards element of HARPC provided they comply with FDA’s LACF regulations (FCE and SID requirements).

Under Preventive Controls, food facilities need to have a written food safety plan including a hazard analysis, preventative controls, a recall plan, and corrective actions procedures. Food safety plans must be prepared or overseen by a preventive controls qualified individual (PCQI). Companies must reanalyze the food safety plan every three years and maintain records of all the steps. In addition, a facility that receives raw material must conduct a hazard analysis for the raw material, to reveal identifiable food safety hazards. The facility must establish and implement a risk-based supply-chain program to ensure that the hazards are significantly minimized or prevented. This includes approving suppliers, conducting appropriate supplier verification activities, and documenting this. Read more about HARPC.

Standards for Produce Safety (aka the Produce Safety Rule)

This regulation established “science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables.” The rule includes many requirements for water quality testing, manure application, employee health and hygiene training, and other activities. Exemptions include produce that is rarely consumed raw and produce that receives specific commercial processing. FDA may also apply enforcement discretion for certain crops.

Foreign Supplier Verification Program

The Foreign Supplier Verification Program (FSVP) is one of the most significant provisions of FSMA with a huge impact on the food industry. FSVP shifted the requirements for food safety onto the importer and their foreign food suppliers.

There are exemptions to FSVP, such as seafood and juice importers (who are subject to HACCP), raw materials for seafood and juice facilities subject to HACCP, and food intended for research and evaluation or personal consumption.

Importers must create and maintain a food safety verification plan that ensures each of their foreign suppliers meet FDA’s food safety standards. Importers must determine possible hazards and evaluate the risks posed by the food. A plan, prepared or reviewed by a PCQI, is needed for each food and supplier. Importers are also required to perform verification activities, depending on the type of hazards determined. Importers must take corrective actions if issues arise. Recordkeeping is a key component of FSVP compliance to document the hazard analyses, risk evaluations, and ongoing supplier verification activities.

Importers must reevaluate their programs at least every 3 years. Learn more about FDA requirements for when to revisit your FSVP. FDA may review FSVP records and conduct on-site inspections as part of any enforcement action. FDA may even put a company on import alert for failing to have a compliant FSVP. Specifically, a company could be placed on Import Alert 99-41 for noncompliance.

Food importers are required to submit (usually through their customs brokers) someone designated as the “FSVP importer.” If there is no U.S. owner or consignee at the time goods are entered, an FSVP agent must be designated. Note this is not the same as a facility’s U.S. agent for facility registration purposes.

Third-Party Certification Program

FDA created an accredited third-party certification program where they recognize accreditation bodies, who then may accredit certification bodies. Certification can establish eligibility for food importers to receive expedited review and release of food shipments under the Voluntary Qualified Importer Program (VQIP). It operates similarly to the Customs-Trade Partnership Against Terrorism (C-TPAT), which relies on the cooperation of major stakeholders in the international supply chain. Those food importers who “achieve and maintain a high level of control over the safety and security of their supply chains,” assure FDA they have a program of ensuring imported food safety and can verify recent history of compliance are candidates for the expedited review and release program. A firm qualifies as a VQIP “importer” even if it is not the Foreign Supplier Verification Program (FSVP) importer or HACCP importer. Any manufacturer, owner, consignee, or importer of record can participate if they meet the criteria. In creating this program, FDA has in mind larger, established importers who have highly valuable or perishable foods such as fresh seafood or produce.

Participating firms enjoy expedited entry of all foods included in the VQIP application, limited examination and sampling of VQIP foods to “for cause” situations, preferred location for necessary testing and sampling, assistance in shipping good which must be exported from a preferred port, expedited lab analysis of “for cause” or audit samples, access to FDA’s VQIP help desk, and the option to have their company’s name posted on a publicly available list of approved VQIP importers.

Sanitary Transportation Rule

This rule looks to provide safeguards for food safety risks related to transportation. These include “failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food.” The requirements apply to shippers, loaders, carriers, and receivers, but exclude transportation by ship or air. There are requirements related to vehicles, temperature controls, contamination, training, and record-keeping.

Intentional Adulteration Rule

This rule is aimed at preventing intentional adulteration of the food supply. It does not target specific hazards but focuses on mitigation strategies for certain registered food facilities. With this rule, FDA is requiring a food defense plan, primarily for large companies with products that get in the hands of many consumers.

Mandatory Recall Authority

FDA now has the authority to order a mandatory recall when it believes there is a reasonable probability that a food is adulterated or misbranded and that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals. Read more about recalls here. 

Inspection-Related Refusal Power

FDA may refuse food that derives from a foreign facility (or government) operator that refuses to permit FDA inspectors to inspect the establishment. For purposes of this provision, the refusal is deemed to have occurred if it is not permitted during the 24-hour period after a request is made, or after such other time period as agreed upon by FDA and the factory.

FSMA was a sweeping reform of US food safety and industry is still learning the finer points of compliance with the many rules. FDA now actively enforces FSMA and will issue warning letters, detain shipments, and put firms on import alert. Our consultants can help you understand your requirements.

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