The U.S. Food and Drug Administration's (FDA) Food Safety Modernization Act (FSMA) Preventive Controls for Human Food and Preventive Controls for Animal Food final rules were published on Sept. 17, 2016 in the Federal Register. To help produce industry members understand these final rules and the implications on produce businesses, the Produce Marketing Association and United Fresh Produce Association in collaboration with California Leafy Greens Marketing Association, Canadian Produce Marketing Association, Florida Fruit and Vegetable Association, Fresh Produce Association of the Americas, Northwest Horticultural Council, Texas International Produce Association, and Western Growers Association hosted a webinar with FDA subject matter experts on Oct. 2, 2015.
The webinar presentation by FDA subject matter experts highlighted which businesses are covered and which businesses are not covered by these final regulations, and how specific provisions of these regulations may or may not apply to your business.
Useful links for more information regarding FSMA including detailed information on both Preventive Controls rules may be found at:
Watch the full webinar, including Q&A:
Download webinar presentation slides here.
Preventive Controls for Human Food Rule
Jenny Scott, Senior Advisor, Office of Food Safety, FDA Center for Food Safety and Applied Nutrition
Ms. Scott explained the final Preventive Controls for Human Foods Rule revises FDA food safety regulations in four important ways:
- Revises the FDA definition of "farm," which is critically important to the produce industry as the Preventive Controls for Human Food Rule does not cover "farms"
- Updates current Good Manufacturing Practice requirements
- Establishes new requirements for Hazard Analysis and Risk-based Preventive Controls
- Establishes new supply-chain program requirements
This new Preventive Controls for Human Food rule applies to both domestic and international food facilities that manufacture, process, pack or hold human food, that will be offered for sale in the United States.
The Preventive Controls for Human Food rule applies to food facilities required to register with FDA under sec. 415 of the Federal Food, Drug and Cosmetic (FD&C) Act. However, "farms" and "retail food establishments" are not covered by this rule.
Preventive Controls for Animal Food Rule
Jenny Murphy, Consumer Safety Officer, Office of Surveillance and Compliance, FDA Center for Veterinary Medicine
Ms. Murphy explained the Preventive Controls for Animal Food Rule applies to animal food facilities required to register with FDA under the FD&C Act that manufacture, process, pack or hold animal food. The produce industry has a limited role in the animal feed industry, mostly as a provider of by-products (e.g., produce of insufficient quality culled from a harvest or fresh-cut processing operation) that serve as feedstock for animal feed.
The provisions of the Preventive Controls for Animal Food Rule and Preventive Controls for Human Food Rule contain parallel provisions (PCAF § 507.28 and PCHF § 117.95) to provide continuity between the two rules for businesses that may simply be holding and distributing human food by-products for use as animal food. These important provisions in both rules require that firms holding and distributing food by-products for use as animal food do so in a manner that protects food by-products against contamination and trash, requires labeling of the by-products container and mandates the container must be examined before it is used.