On September 17, 2015, the FDA announced two new final rules for the Food Safety Modernization Act (“FSMA”) (Pub. L. 111-353). The two new final rules are: (1) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and (2) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food.

Covered facilities, which exclude farms, must create and implement a food safety systems that includes:

  • Hazard analysis: identification of known or reasonably foreseeable biological, chemical, and physical hazards
  • Preventive controls: measures that assure identified hazards can be minimized or prevented
  • Monitoring, verification, and corrective action plans for use of preventive controls; additionally, each animal food facility with a preventive control in place must develop a recall plan

For animal food facilities, Current Good Manufacturing Practices (“cGMP”) are being established for the first time. The animal food rule contains FDA’s baseline standards for the production of animal food. For human food, the existing cGMPs are updated. Human food cGMPs no longer include nonbinding provisions, meaning that employee qualification provisions will be binding and allergen cross-contact must be addressed in the manufacturing process.

The FDA is currently developing guidance documents on a variety of subjects related to the new rules that will aid with compliance and a variety of training and technical assistance programs will be made available to industry.

The FDA has staggered the compliance dates for both rules based on the size of the business. The compliance dates are:

Human Food

  • Very small business (less than $1m in sales per year): September 17, 2018 (records supporting that a business is a very small business must be submitted by January 1, 2016)
  • Businesses subject to the Pasteurized Milk Ordinance: September 17, 2018
  • Small business (fewer than 500 FTEs): September 17, 2017
  • All other businesses: September 17, 2016

Animal Food

  • Very small business (less than $2.5 in sales per year, (records supporting that a business is a very small business must be submitted by January 1, 2017)
    • cGMP Compliance: September 17, 2018
    • Preventive Control Compliance: September 17, 2019
  • Small business (fewer than 500 FTEs)
    • cGMP Compliance: September 17, 2017
    • Preventive Control Compliance: September 17, 2018
  • All other businesses:
    • cGMP Compliance: September 17, 2016
    • Preventive Control Compliance: September 17, 2017