Some manufactured food establishments are exempt from certain subparts of Title 21, Part 117, Code of Federal Regulations (CFR).
The following foods and facilities are exempt from Subpart C (Preventive Controls) and Subpart G (Supply-Chain Program):
Seafood, juice and dietary supplements are only exempt from subparts C and G if the processors are in compliance with the seafood Hazard Analysis Critical Control Points (HACCP), juice HACCP or dietary supplement regulations.
Activities subject to 21 CFR 113 for control of C. botulinum and other microbiological hazards in low-acid canned foods are exempt from subparts C and G. However, control of all other hazards (chemical, physical, formation of heat-stable toxins by pathogenic bacteria before thermal processing) in low-acid canned foods is subject to subparts C and G.
Alcoholic beverages are exempt from subparts C and G if they are at a facility required to register under the Bioterrorism Act and obtain permits from the U.S. Department of Treasury. This exemption at an alcoholic beverage facility also includes prepackaged food if not more than 5% of the overall sales of the facility.
A facility solely engaged in the storage of raw agricultural commodities (e.g., a grain elevator) is also exempt from the Subpart B GMP requirements per 117.5(k)(1)(iii).
A facility solely engaged in the storage of unexposed packaged food is exempt from subparts C and G per 117.7 but is subject to the modified requirements in Subpart D 117.206 for unexposed packaged food that has to be refrigerated for safety.
Any on-farm activities subject to the Produce Rule (Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption — 21 CFR 112) are exempt from subparts C and G.
The following operations are not exempt from subparts C and G:
A farm mixed-type facility engages in:
The farm activities are exempt from 21 CFR 117.
The activities requiring registration that occur at a farm mixed-type facility are subject to 117. However, the farm mixed-type facility may be exempt from subparts C and G depending on the size of operation and products. See 117.5(g)(3) and 117.5(h)(3) for more information.
A qualified facility (defined in 117.3) is a very small business averaging less than $1 million in sales of human food per year during a three-year period (adjusted for inflation). A facility that meets this definition is exempt from subparts C and G if it submits a qualified facility attestation to the U.S. Food and Drug Administration (FDA) under 21 CFR 117 Subpart D, Modified Requirements (21 CFR 117.201).
If a very small business does not submit a qualified facility attestation to FDA, then it is subject to the full requirements of 21 CFR 117, including subparts C and G.
Foods covered by specific regulations are still subject to the requirements of those regulations. These foods include:
Any provisions in product-specific regulations that are the same as, more restrictive, or in addition to the regulations in 21 CFR 117 must be followed. Manufactured food establishments will have to assess how their compliance with such provisions can be incorporated into the preventive control requirements in Subpart C and record requirements in Subpart F.
For example, the acidified food regulation (21 CFR 114) is intended to control microorganisms of public health significance (C. botulinum and other microbiological hazards). An acidified food facility’s food safety plan must include a preventive control program covering C. botulinum and other microorganisms of public health significance, along with any chemical or physical hazards that may require preventive controls. It is acceptable for a facility’s food safety plan to reference and/or incorporate the scheduled processes, operating procedures, and records established and maintained in accordance with 21 CFR 114.