Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507 | Guideline Explorer

Description

The purpose of this guidance is to help establishments and facilities subject to Title 21 of the Code of Federal Regulations (21 CFR) part 117 (part 117) or 21 CFR part 507 (part 507) determine whether they are “solely engaged” in certain activities. Establishments and facilities “solely engaged” in certain activities are exempt from some or all requirements in parts 117 or 507.

Scope & Applicability

Product Classes

3

Raw Agricultural Commodity

Sprouts in their raw or natural state

Unexposed Packaged Food

Food that is not exposed to the environment; Packaged foods that are not exposed to the environment

Raw Agricultural Commodities

RACs such as hops, wine grapes, pulse crops, and almonds

Stakeholders

2

Facility

The entity requesting the meeting and implementing CAPAs

Establishment

Entities making donor eligibility determinations

Regulatory Context

Attributes

1

Time/Temperature Control

Requirement for certain packaged foods to maintain safety

Identified Hazards

Hazards

1

Pathogens

Microbiological hazard causing adulteration; Sampling recommendations for detecting contamination

Related CFR Sections (6)

21CFR507.5§ 507.5 Exemptions.
(a) This part does not apply to establishments, including “farms” (as defined in § 1.227 of this chapter ), that are not required to register under section 415 of the Federal Food, Drug, and Cosmetic Act.Read full regulation →
21CFR117.5§ 117.5 Exemptions.
(a) Except as provided by subpart E of this part , subparts C and G of this part do not apply to a qualified facility. Qualified facilities are subject to the modified requirements in § 117.201 .Read full regulation →
21CFR1.227§ 1.227 What definitions apply to this subpart?
The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this subpart. In addition, for the purposes of this subpart:Read full regulation →
21CFR507.10§ 507.10 Applicability of subparts C and E of this part to a facility solely engaged in the storage of unexposed packaged animal food.
(a) Subparts C and E of this part do not apply to a facility solely engaged in the storage of unexposed packaged animal food that does not require time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens.Read full regulation →
21CFR117.7§ 117.7 Applicability of subparts C , D , and G of this part to a facility solely engaged in the storage of unexposed packaged food.
(a) Applicability of subparts C and G. Subparts C and G of this part do not apply to a facility solely engaged in the storage of unexposed packaged food.Read full regulation →
21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →

Related Warning Letters (10)

CGMP/Animal Food/Adulterated
King Farm
2025-12-23
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Compass Group USA
2025-11-11
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Gracie's Kitchens, Inc.
2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Hans Bakery Inc. d/b/a Andersen’s Bakery
2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Tan Nam Corporation
2025-09-30
Foreign Supplier Verification Program (FSVP)
Eurobread Inc. dba First Harvest
2025-08-26
Seafood HACCP/CGMP for Foods/Adulterated
Chaohu Daxin Foodstuffs Co., Ltd.
2025-08-19
CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
J.D. Heiskell Holdings LLC
2025-07-08
CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Lystn LLC dba Answers Pet Food
2025-07-08
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Marin Baking LLC
2025-06-24