United States: FDA Publishes Three Major FSMA Final Rules

Last Updated: November 18 2015
Article by Jonathan Berman and Colleen Heisey
Most Read Contributor in United States, September 2019

On November 13, 2015, the U.S. Food and Drug Administration ("FDA") published the three major rules affecting the food industry that it will adopt in 2015. These include final rules on Foreign Supplier Verification Programs ("FSVP"), Accredited Third-Party Certification, and Produce Safety. Two major rules were published in final form this past September, and, together, the five final rules will seriously affect how food producers, both domestic and foreign, do business in the coming years.

The Food Safety Modernization Act ("FSMA") was signed into law on January 6, 2011, and immediately gave FDA a series of powers intended to improve food safety in the U.S. In the four years since the signing of this law, FDA has published various draft rules, held public stakeholder meetings, and accepted and evaluated thousands of comments from industry to develop final rules the Agency feels are effective while not imposing unreasonable burdens on industry. Two of the three newly published final rules focus on imported foods, which constitute 19 percent of the U.S. food supply and 52 percent of fresh fruits consumed by Americans.

Final Rule on Foreign Supplier Verification Programs for Importers of Food for Humans and Animals

The Final Rule on Foreign Supplier Verification Programs for Importers of Food for Humans and Animals will require importers to perform certain risk-based activities to verify that food imported into the U.S. has been produced in a manner consistent with U.S. food safety standards. Importers will have flexibility in determining appropriate verification measures based on the risk level of the food and supplier.

This rule will necessarily create new responsibilities and potential new liabilities for importers of food. For purposes of FSVP, an "importer" is (i) the U.S. owner or consignee of an imported food or, if there is no U.S. owner or consignee, then (ii) the U.S. agency or representative of the foreign owner or consignee at the time of entry. Importer responsibilities will include:

  • Determination of known or foreseeable hazards associated with a food;
  • Evaluation of the risk posed by a food based on hazard analysis and the foreign supplier's performance history;
  • Use of the risk evaluation of a food and supplier's past performance to approve suppliers and to determine appropriate supplier verification activities;
  • Conduct of supplier verification activities; and
  • Undertaking of corrective actions when required. 

Importers will be required to maintain ongoing documentation reflecting implementation of and compliance with FSVP activities. Industry will be required to comply with these rules on or before May 13, 2017 (18 months after publication of the final rule). Companies subject to the Preventive Controls final rules published earlier this year will have an additional six months to comply with the rule.

Final Rule on Accredited Third-Party Certification

The Final Rule on Accredited Third-Party Certification addresses the issues of identifying reliable entities to audit food facilities located outside the U.S. and the actual food exports destined for the U.S. market. The rule establishes a voluntary program for the accreditation of third-party auditors (which the rule calls "certification bodies") to conduct food safety audits and issue certifications of foreign facilities and the foods they produce. These requirements will help ensure the competence and independence of the accreditation bodies and third-party certification bodies participating in the program.

Foreign entities may use the certifications described in the rule for the following purposes:

  • To prevent potentially harmful food from reaching U.S. consumers and
  • For importers to establish eligibility for expedited review and entry of food imports pursuant to the Voluntary Qualified Importer Program, which will be published as a final rule in 2016.  

The complex rule establishes the framework, procedures, and requirements for accreditation bodies seeking recognition by the FDA as well as requirements for third-party auditors seeking accreditation. An accredited third-party auditor under this rule could be either a foreign government or some other third-party entity or individual.

Final Rule on Produce Safety

The Final Rule on Produce Safety establishes science-based standards that must be adopted by foreign or domestic farms growing, harvesting, packing, or holding fresh fruits and vegetables for human consumption. This rule establishes minimum standards for:

  • Agricultural water;
  • Biological soil amendments;
  • Sprouts;
  • Domesticated and wild animals;
  • Worker training and health and hygiene; and
  • Equipment, tools, and buildings.  

The rule will not apply to:

  • Produce that is not a raw agricultural commodity;
  • A list of specific commodities that FDA has established are rarely consumed raw;
  • Most food grains, including barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds;
  • Produce that is used for personal or on-farm consumption; and
  • Farms that have an average annual value of produce sold during the prior three years of $25,000 or less.  

The rule also provides qualified exemptions for smaller farms and farms that sell produce locally. Dates for compliance with the rule will vary according to the magnitude of a farm's sales during the prior three years as follows:

  • Very small farms (between $25,000 and $250,000): four years (from publication of final rule).
  • Small farms (more than $250,000 and less than $500,000): three years.
  • All other farms: two years.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Jonathan Berman
Colleen Heisey
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