United States: The FDA Is Getting PCQI: New FSMA Rules Issued

Last Updated: September 15 2015
Article by Michael A. Walsh

On September 10, 2015, the Food and Drug Administration issued Final Rules on Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and for Animal Food.

The Food Safety Modernization Act (FSMA) was signed into law in January 2011, and is regarded by the FDA as "the most sweeping reform of our food safety laws in more than 70 years." FSMA represents a paradigm shift in the FDA's regulatory oversight from responding to outbreaks to preventing them. Prevention under FSMA places the burden on of compliance on industry and provides the FDA with new oversight and enforcement power.

After the FDA failed to meet the implementation deadlines set by FSMA, a public interest group sued the FDA, culminating in a Consent Decree that set new deadlines to issue final rules on current good manufacturing practice (cGMP), hazard analysis and risk-based preventive controls for human and animal food. The Consent Decree required release of final rules on preventive controls for human and animal food by August 31, 2015. On September 10, 2015, the FDA issued its 930-page Final Rule for human Food and a 660-page Final Rule for animal food. The Final Rules are far too comprehensive for discussion in a single blog, but some of the basic requirements are discussed below. In addition, the FDA has provided fact sheets summarizing the provisions for both Human Food and Animal Food.

The Final Rules amend current regulations in two fundamental ways: first, they attempt to modernize cGMP requirements. Second, domestic and foreign facilities that are subject to registration requirements are required to establish and implement hazard analysis and risk-based preventive controls.

The Final Rules for human and animal food revise certain definitions, attempt to clarify the scope of registration exemptions for "farms" and clarify that domestic and foreign facilities that must register with the FDA are subject to the Final Rules' requirements. The Major Provisions of the Final Rules include requirements for:

  • A written food safety plan;
  • Hazard analysis;
  • Preventive controls including corrective actions and corrections, monitoring and verification;
  • A supply chain program requiring approved suppliers and supplier verification;
  • A recall plan;
  • Current (and updated) Good Manufacturing Practices; and
  • Associated record keeping.

The Final Rule for human food requires a facility to reanalyze its food safety plan as a whole at least once every three years. An important feature of the Final Rule for human food is continuous monitoring. The hazard analysis must consider hazards that occur naturally as well as unintentionally and intentionally introduced hazards. Facilities must identify and implement preventive controls to assure that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed or held by the facility will not be adulterated.

The Rule requires that compliance activities be conducted (or overseen) by a "preventive controls qualified individual." A preventive controls qualified individual is defined in the Final Rule as "a qualified individual who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system."

For human food, larger businesses are expected to comply with cGMP requirements and preventive control requirements by September 19, 2016. Small businesses have until September 18, 2017 to comply and very small businesses have until September 17, 2018. The FDA may allow additional time for compliance with the supply chain program requirements of the rule.

The Final Rule for animal food establishes cGMP provisions including the following major provisions:

  • Personnel;
  • Plant and grounds;
  • Sanitation;
  • Water supply and plumbing;
  • Equipment and utensils;
  • Plant operations;
  • Holding and distribution; and
  • Holding and distribution of human food by-products for use as animal food.

Large animal food businesses are required to comply with cGMP by September 19, 2016, and with preventive control requirements by September 18, 2017. Small businesses have until 2018 and very small businesses until 2019. As with human food, the FDA may provide additional time for supply chain program compliance.

The paradigm shift from response to prevention under FSMA and the Final Rules places important new requirements on the food industry to ensure compliance not only of their own operations but also those of suppliers and others in the supply chain. The new rules represent a significant change in the FDA's oversight and create new challenges and risks of exposure for civil and criminal enforcement as well as new risks of liability to consumers for noncompliance.

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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Michael A. Walsh
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