FDA has issued two Small Entity Compliance Guides (SECG) to enable domestic and foreign food facilities to better understand and comply with the requirements of two final rules implementing the FDA Food Safety Modernization Act. See generally Food for Animals Small Entity Compliance Guide Availability; Human Food Small Entity Compliance Guide Availability. The final rules that are the subject of each SECG are:
- Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; and
- Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.
The SECGs are:
- Guidance for Industry: Small Entity Compliance Guide: What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507) (Oct. 2016) (available here) ; and
- What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR Part 117): Guidance for Industry: Small Entity Compliance Guide (Oct. 2016).
Comments on these SECGs may be submitted to FDA at any time.
The final rules that are the subject of the SEGs became effective generally on November 16, 2015, but have compliance dates staggered over several years. The SECGs represent the current thinking of FDA on the final rules, but do not establish any rights for any person and are not binding on FDA or the public. A company may use an alternative approach if it satisfies the requirements of the FD&C Act, as amended by FSMA, and implementing regulations. If you want to discuss any alternative approach, contact FDA’s Technical Assistance Network.
