As of September 17, 2018, food facilities of all sizes are required to be in full or partial compliance with the Preventive Controls for Human Food (PCHF) and Preventive Controls for Animal Food (PCAF) rules.

The PCHF and PCAF rules are part of the Food Safety Modernization Act (FSMA). As such, the rules require food facilities to reduce risks during processing and manufacturing that could cause food to be adulterated or otherwise harmful to consumers and animals. The PCHF and PCAF rules have two main components:

1) Compliance with FDA’s updated current good manufacturing practice regulations (CGMP)

2) Implementation of a food safety plan that analyzes hazards and develops risk-based preventive controls

CGMP regulations provide the most important procedures for protecting the food supply from contamination or spoilage during manufacturing, packing, and storage. The regulations address the general design, construction, and operation of food manufacturing and storage facilities, equipment sanitation, and employee hygienic practices. For example, CGMP regulations require management to ensure that all employees have the necessary combination of education, training, and experience necessary to manufacture, process, pack, or hold food that is clean and safe. Under the PCHF and PCAF, food facilities must consider the unique aspects of the food being produced and decide how best to tailor their work and processes to comply with the CGMP regulations.

A food facility’s food safety plan must include the following:

1) hazard analysis;

2) preventive controls;

3) oversight and management of the preventive controls; and

4) a recall plan.

The plan may also be required to have a supply chain program if an identified hazard requires a preventive control that needs to be implemented outside the facility somewhere else in the supply chain. The PCHF and PCAF rules require all food facilities to conduct proper hazard analysis for biological, chemical, and physical hazards and to stablish corresponding preventive controls so that the facility can mitigate food safety concerns.

Compliance dates for businesses are contingent on the scale of operations.

Small Businesses

  • A business with 500 full time equivalent employees or fewer are to comply with the preventative controls aspect of the PCAF as of September 17, 2018.

Very Small Businesses

  • Businesses which average less than $1 million per year (adjusted for inflation) in both annual sales of human food manufactured, processed, packed or held without sale during the preceding 3- year period.
  • Must comply with the CGMP requirements of the PCAF rule as of September 17, 2018.
  • Must comply with the preventive controls of the PCAF rule by September 17, 2019.
  • Businesses and facilities subject to the Pasteurized Milk Ordinance for Grade “A” milk and milk product must comply with the PCAF rule as of September 17, 2018.

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