NC State Extension

Exemptions

Structure of the Rule

Based on the size, sales, and/or nature of a facility, the facility might qualify for exemption from specific portions of the Preventive Controls for Human Food (PCHF) Rule. To better understand the exemptions, the structure of the PCHF rule needs to be displayed. The PCHF rule is found in 21 CFR Part 117 and consists of 7 subparts which are:

A. General Provisions

B. Current Good Manufacturing Practices

C. Hazard Analysis and Risk-Based Preventive Controls

D. Modified Requirements

E. Withdrawal of a Qualified Facility Exemption

F. Requirements Applying to Records that Must be Established and Maintained

G. Supply-Chain Program

All FDA regulated facilities are required to be in compliance with subpart B (Good Manufacturing Practices), but may be exempt from subparts C and G.

Types of Exemptions

FACILITIES UNDER ALTERNATIVE REGULATIONS

Some FDA registered facilities that produce specific commodities are regulated under a different structure than the PCHF rule, and are therefore exempt from compliance with specific provisions in the PCHF rule.

Juice Manufacturers:

Those FDA registered facilities that manufacture juice must comply with 21 CFR Part 120, Hazard Analysis and Critical Control Points (HACCP). Since these products are not regulated under the PCHF rule they are exempt from compliance with the provisions given in part 117 subparts C and G. However, the facilities must still comply with good manufacturing practices (GMPs) found in 21 CFR Part 117 Subpart B.

Fish and Fishery Products:

Facilities engaged in the processing and production of fish and fishery products are regulated by the FDA under a HACCP structure found in 21 CFR Part 123. Since these products are not regulated under the PCHF rule they are exempt from compliance with the provisions given in part 117 subparts C and G. However, the facilities must still comply with good manufacturing practices (GMPs) found in 21 CFR Part 117 Subpart B.

Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers:

Facilities that manufacture products that fall under this category are regulated under 21 CFR Part 113. Since these products are not regulated under the PCHF rule they are exempt from compliance with the provisions given in part 117 subparts C and G. However, this exemption only applies to biological hazards. The facility would still be subject to subparts C and G of part 117 as it concerns physical and chemical hazards. The facilities must still comply with good manufacturing practices (GMPs) found in 21 CFR Part 117 Subpart B.

QUALIFIED FACILITY

This type of exemption is based on the size and/or the end consumer of the product produced in a facility. A qualified facility is defined as:

a facility that is a very small business: <$1,000,000/year sales of human food plus the market value of human food manufactured, processed, packed, or held without sale

If a facility meets this definition they are eligible for a qualified exemption. This means that the facility is not required to comply with the provisions given in subparts C and G of the PCHF rule. A qualified facility still has to comply with GMPs (subpart B) as well as the modified requirements given in §117.201.

STORAGE OF UNEXPOSED PACKAGED FOOD

If a facility is solely engaged in the storage of unexposed, packaged food, that facility is not required to comply with the provisions given in subparts C and G of the PCHF rule. A facility solely engaged in the storage of unexposed packaged food still has to comply with GMPs (subpart B) as well as the modified requirements given in §117.206.

Written By

Photo of Currey NoblesCurrey NoblesArea Specialized Agent, Food Safety Serves 50 CountiesBased out of Schaub Hall (Food Science)(919) 515-9520 canobles@ncsu.eduFood, Bioprocessing and Nutrition Science - NC State University
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