FSMA UPDATE (Small Business Compliance Guide): Preventive Controls for Human Food and Preventive Controls for Animal Food
The U.S. Food and Drug Administration (FDA) has issued small entity compliance guidances under the FDA Food Safety Modernization Act (FSMA) to assist small and very small businesses with the implementation of the Preventive Controls for Human Food and Preventive Controls for Animal Food rules.
Compliance Dates:
– Business other than small and very small
Current Good Manufacturing Practice Compliance Date: September 19, 2016
Preventive Controls Compliance Date: September 18, 2017
– Small businesses, i.e., a business with fewer than 500 full-time equivalent employees:
Current Good Manufacturing Practice Compliance Date: September 18, 2017
Preventive Controls Compliance Date: September 17, 2018
The rule requires a written food safety plan (21 CFR 507.31). The written plan must be prepared by (or its preparation overseen by) one or more “preventive controls qualified individuals” and must include the following (21 CFR 507.31(c)):
•A hazard analysis
•Preventive controls
•A risk-based supply chain program, if appropriate
•A recall plan, if there is a hazard requiring a preventive control identified for an animal food
•Monitoring procedures
•Corrective action procedures
•Verification Procedures
To find out who is exempt from the requirements for Hazard Analysis and Risk-Based Preventive Controls for Animal Food or Subject to Modified Requirements, we strongly recommend that you read the full Small Entity Compliance Guide for more details:
Thank you,
Flegenheimer Internation Team