Preventive Controls for Animal Food: Exemptions
General Exemption Information
As with many rules, there are exceptions. The basic rule states that facilities that are required to register under the Bioterrorism Act of 2002 are required to comply with FSMA.
Establishments, including farms, that are not required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) do not need to comply with any part of the rule. The FDA guidance document regarding food facility registration answers many questions regarding that regulation.
What is a farm?
Primary Production Farm
A Primary Production Farm is an operation under one management in one general, but not necessarily contiguous, physical location. It is devoted to growing of crops, harvesting of crops, raising of animals or any combination of these activities and may conduct certain manufacturing, processing, packing or holding activities of animal food, as specified.
Secondary Activities Farm
A Secondary Activities Farm is an operation not located on a primary production farm that is devoted to harvesting, packing and/or holding raw agricultural commodities. The primary production farm(s) that grow, harvest and/or raise the majority of those raw agricultural commodities must own or jointly own a majority interest in the secondary activities farm. They may also pack or hold raw agricultural commodities, or manufacture/process, pack or hold processed foods so long as all such food is consumed on that farm or another farm under the same management or the manufacturing/process falls into limited categories.
What are the exemptions?
Subpart B (CGMP) does not apply to establishments solely engaged in:
- The holding and/or transportation of raw agricultural commodities.
- Hulling, shelling, drying, packing and/or holding nuts and hulls (without manufacturing/processing, such as grinding shells or roasting nuts).
- Cotton ginning (without manufacturing/processing, such as extracting oil from cottonseed).
Subparts C and E
Subparts C and E do not apply to:
- Activities subject to regulations for Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (just those activities, not the whole facility).
- Activities that are subject to Standards for Produce Safety Rule.
- Qualified facilities (must follow modified requirements).
- Small or very small businesses (Qualified facilities) that are farm mixed-type facilities if the only packing or holding activities are specified low-risk packing or holding activity/animal food combinations, even if activities are for distribution into commerce.
- Facilities solely engaged in storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution of processing.