Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Application of the Solely Engaged 
Exemptions in Parts 117 and 507: 
Guidance for Industry  
Draft Guidance 
This guidance is being distributed for comment purposes only. 
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to 
ensure that FDA considers your comment on this draft guidance before we begin work on the 
final version of the guidance, submit either electronic or written comments on the draft 
guidance within 180 days of publication in the Federal Register of the notice announcing the 
availability of the draft guidance.  Submit electronic comments to 
https://www.regulations.gov.  Submit written comments to the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852.  All comments should be identified with the docket number 2017-D- 6333 listed in 
the notice of availability that publishes in the Federal Register.  
For questions regarding this draft document as it relates to our regulation entitled Current 
Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for 
Human Food, contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-
402-2166. 
For questions regarding this draft document as it relates to our regulation entitled Current 
Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for 
Food for Animals, contact the Center for Veterinary Medicine (CVM) at 240-402-6246. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine 
October 2017  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Table of Contents 
 
 
I.   Introduction  
 
II.    Background  
 
III.   Discussion  
 
  2  Contains Nonbinding Recommendations 
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Application of the Solely Engaged 
Exemptions in Parts 117 and 507: 
1
Guidance for Industry 
 
    
   
 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration's (FDA or we) on this topic.  It does not establish any rights for any person and is 
not binding on FDA or the public.  You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.  To discuss an alternative approach, 
contact the FDA staff responsible for this guidance as listed on the title page.  
 
 
 
I.  Introduction  
 
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.   
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDA guidances means that something is suggested or 
recommended, but not required.  
 
II.  Background 
 
This guidance concerns two regulations that we have established in 21 CFR as part of our 
implementation of the FDA Food Safety Modernization Act (FSMA; Pub. L. 111353).2  These 
two regulations are part 117 (published in the Federal Register on September 17, 2015, 80 FR 
55907) and part 507 (published in the Federal Register on September 17, 2015, 80 FR 51670). 
                                                 
1 This guidance has been jointly prepared by the Office of Food Safety in the Center for Food Safety and Applied 
Nutrition, the Office of Surveillance and Compliance in the Center for Veterinary Medicine, and the Office of Foods 
and Veterinary Medicine in the Office of the Commissioner at the U.S. Food and Drug Administration. 
 
2 For more information on the Agencys implementation of FSMA, see http://www.fda.gov/fsma. 
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Requirements for establishments3 that manufacture, process, pack, or hold human food to follow 
current good manufacturing practices (CGMPs) are found in subparts A, B, and F of part 117.  
Requirements for domestic and foreign facilities that are required to register under section 415 of 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350d) to conduct a hazard 
analysis and implement risk-based preventive controls for human food (the human food 
preventive controls requirements) are found in subparts A, C, D, E, F, and G of part 117. 
 
For domestic and foreign facilities that are required to register, subparts A, B, and F of part 507 
include animal food CGMP requirements and subparts A, C, D, E and F of part 507 include 
requirements to conduct a hazard analysis and implement risk-based preventive controls for 
animal food (the animal food preventive controls requirements). 
 
Parts 117 and 507 contain exemptions specific to establishments and facilities solely engaged 
in certain activities.  These exemptions refer to the primary subparts that contain CGMP and 
preventive controls requirements:  subpart B (CGMPs), subparts C and G (human preventive 
controls) and subparts C and E (animal food preventive controls).  Exemption from the primary 
subparts necessarily includes exemption from the associated subparts.  For example, when 
subpart B is not applicable, then the associated CGMP requirements in subparts A and F are not 
applicable.   
 
The relevant exemptions are outlined below. 
 
Exemption from human food CGMP requirements 
Part 117, subpart B does not apply to the following: 
  Establishments solely engaged in the holding and/or transportation of one or more raw 
agricultural commodities (RACs) (21 CFR 117.5(k)(1)(iii)) 
  Establishments solely engaged in hulling, shelling, drying, packing, and/or holding nuts 
(without additional manufacturing/processing, such as roasting nuts) (21 CFR 
117.5(k)(1)(v)) 
 
Exemption from human food preventive controls requirements 
Part 117, subparts C and G do not apply to: 
  Facilities that are solely engaged in the storage of RACs (other than fruits and vegetables) 
intended for further distribution or processing (21 CFR 117.5(j)) 
  Facilities solely engaged in the storage of unexposed packaged food (21 CFR 117.7(a)) 
 
Exemption from animal food CGMP requirements 
Part 507, subpart B does not apply to the following: 
  Establishments solely engaged in the holding and/or transportation of one or more RACs  
(21 CFR 507.5(h)(1)) 
                                                 
3 In this guidance we use the term establishments in the context of the CGMP requirements and facilities in the 
context of the preventive controls requirements (or both requirements in some circumstances) to reflect differences 
in the regulatory text.   
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  Establishments solely engaged in hulling, shelling, drying, packing, and/or holding nuts 
and hulls (without manufacturing/processing, such as grinding shells or roasting nuts) (21 
CFR 507.5(h)(2)) 
  Establishments solely engaged in ginning of cotton (without manufacturing/processing, 
such as extracting oil from cottonseed) (21 CFR 507.5(h)(3)) 
 
Exemption from animal food preventive controls requirements 
Part 507, subparts C and E do not apply to: 
  Facilities that are solely engaged in the storage of RACs (other than fruits and vegetables) 
intended for further distribution or processing (21 CFR 507.5(g)) 
  Facilities 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 (21 CFR 507.10(a)) 
 
The terms facility, holding, packing, raw agricultural commodity, unexposed packaged 
food, and unexposed packaged animal food are defined in 21 CFR 117.3 and 507.3. 
 
III.  Discussion  
 
A.  Exemption from CGMP Requirements 
 
The human food CGMP regulations in part 1104 include an exemption for [e]stablishments 
engaged solely in the harvesting, storage, or distribution of one or more raw agricultural 
commodities, as defined in section 201(r) of the [FD&C Act], which are ordinarily cleaned, 
prepared, treated or otherwise processed before being marketed to the consuming public.  (See 
21 CFR 110.19.)  This provision has been called the RAC exemption.  Modified RAC 
exemptions have been codified in parts 117 and 507 (see 21 CFR 117.5(k)(1)(iii) and (v) and 21 
CFR 507.5(h)).  
 
Although the RAC exemption from CGMPs in part 110 is written to apply to establishments that 
are solely engaged in harvesting, storing, or distributing RACs, FDA has long interpreted this 
exemption as applying to establishments that are doing any one or more of these activities (e.g., 
both harvesting and storing).  This interpretation is reflected in the modified RAC exemptions in 
parts 117 and 507 (i.e., holding and/or transportation of RACs; hulling, shelling, drying, packing, 
and/or holding nuts [and, for animal food, hulls]). Note that 21 CFR 117.5(k)(1)(iii) and 21 CFR 
507.5(h)(1) provide an exemption for holding and/or transportation of RACs  but do not refer 
to harvesting, which falls within the farm definition (see 21 CFR 1.227).  Farms, as defined 
in 21 CFR 1.227, are exempt from the human food and animal food CGMP requirements.  (See 
21 CFR 117.5(k)(1)(i) and (iv) and 21 CFR 507.5(a).))  Activities of a farm that is part of a farm 
mixed-type facility need not be considered when determining whether an establishment is solely 
engaged in the activities specified in the exemptions. 
 
An establishment engaged in any combination of the activities listed in 21 CFR 117.5(k)(1)(iii) 
and (v) and 507.5(h), and not engaged in any other activities subject to CGMPs, qualifies for the 
                                                 
4 Part 110, promulgated before FSMA was enacted, will be removed from 21 CFR on September 17, 2018. 
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RAC exemption and is not subject to the CGMP requirements in part 117, subpart B, or part 507, 
subpart B.  However, if an establishment engages in any activity subject to the CGMP 
requirements (e.g., certain manufacturing/processing), in addition to those activities covered by a 
CGMP exemption, then the establishment is subject to the CGMP requirements. 
 
Examples 
1.  An establishment that holds and transports RACs for human and animal food use, 
hulls and shells nuts, and does not engage in any additional activities covered by the 
CGMP requirements is exempt from the CGMP requirements in parts 117 and 507. 
 
2.  An establishment that holds and transports RACs, hulls and shells nuts, and grinds the 
shells, all for animal food use, is not solely engaged in activities exempt from the 
CGMP requirements.  Therefore, the establishment must comply with the CGMP 
requirements in part 507.   
 
B.  Exemption from Preventive Controls Requirements 
 
Section 418(m) of the FD&C Act allows exemptions from the preventive controls requirements 
for facilities that are solely engaged in the storage of RACs (other than fruits and vegetables) 
intended for further processing and distribution, or the storage of packaged foods that are not 
exposed to the environment.  We have issued regulations based on this section in 21 CFR 
117.5(j) and 117.7, and 21 CFR 507.5(g) and 507.10.  We believe it is reasonable to implement  
418(m) and the associated regulations consistent with our well-established implementation of the 
RAC exemption for CGMPs.  This allows a facility that is storing RACs (other than fruits and 
vegetables) intended for further processing and distribution, storing packaged food that is not 
exposed to the environment and does not require time/temperature control, or storing both types 
of food, to be exempt from the preventive controls requirements.  We also note that the relevant 
portions of  418(m) do not distinguish between human and animal food; we interpret this 
section to allow a facility to store both types of food and still qualify for exemptions from the 
preventive controls requirements. 
 
However, as explained in the preamble to the part 117 regulation (80 FR 55907 at 55984-85 and 
55994), if a facility performs any activity subject to preventive controls requirements (such as 
certain manufacturing/processing) in addition to those activities described in the preventive 
controls exemptions, then the activities that would have been subject to the exemptions are no 
longer exempt and the facility is subject to preventive controls requirements. 
 
Examples 
3.  A facility that stores unexposed packaged human and animal food that does not 
require time/temperature control, stores grain RACs intended for further processing and 
distribution, and does not engage in any additional activities covered by the preventive 
controls requirements is exempt from the preventive controls requirements in parts 117 
and 507. 
 
4.  A facility that stores unexposed packaged human food that does not require 
time/temperature control but also cuts vegetables (i.e., manufactures/processes food) is 
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not solely engaged in activities exempt from the preventive controls requirements.  
Therefore, the facility must comply with the preventive controls requirements in part 117.   
 
5.  A facility that stores unexposed packaged human food, including unexposed packaged 
food that requires time/temperature control, but also stores fruits and vegetables for 
human consumption that are exposed to the environment (e.g., stored in vented 
containers) is not solely engaged in activities exempt from the preventive controls 
requirements.  Therefore, the facility must comply with the preventive controls 
requirements in part 117. 
 
C.  Exemption from Both CGMP and Preventive Controls Requirements 
 
A facility can be exempt from both CGMP and preventive controls requirements, for part 117 or 
part 507 or both parts, as long as it is engaged in any combination of activities that are exempt 
from CGMP and preventive controls requirements, and not engaged in activities that would be 
subject to those requirements.  If any part of a facility is engaged in an activity subject to 
CGMPs or preventive controls requirements, then the entire facility is subject to the CGMP 
requirements, the preventive controls requirements, or both. 
 
Examples 
6.  A facility consisting of a grain elevator that holds grain RACs for human and animal 
food use and does not engage in any other activities covered by the CGMP or preventive 
controls requirements is exempt from the CGMP and preventive controls requirements in 
parts 117 and 507. 
 
7.  A facility consisting of both a grain elevator that holds grain RACs for animal food 
use and a feed mill that manufactures animal food is not solely engaged in activities 
exempt from either the CGMP or preventive controls requirements.  Therefore, the 
facility is subject to the CGMP and preventive controls requirements in part 507. 
 
D.  Conclusion 
 
In summary, if all of the activities performed by an establishment are exempt under one or more 
CGMP exemptions, then the establishment is not subject to the part 117 and/or part 507 CGMPs, 
as applicable.  Similarly, if all the activities performed by a facility are exempt under one or 
more preventive controls exemptions, then the facility is not subject to the part 117 and/or part 
507 preventive controls requirements, as applicable.  If all of the activities performed by a 
facility are exempt under one or more CGMP exemptions and one or more preventive controls 
exemptions, then the facility is not subject to the CGMP or preventive controls requirements in 
part 117 and/or part 507, as applicable.  However, if any part of a facility is engaged in an 
activity subject to the CGMP or preventive controls requirements, then the entire facility is 
subject to CGMPs, the preventive control requirements, or both.  This framework is summarized 
in Table 1. 
 
 
 
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Table 1:  Summary of CGMP and Preventive Controls Exemption Framework 
  All Activities Covered by PC  All Activities not Covered by PC 
Exemptions  Exemptions 
All Activities Covered by CGMP  Facility exempt from CGMP and  Facility exempt from CGMP 
Exemptions  PC requirements  requirements only 
All Activities not Covered by  Facility exempt from PC  Facility not exempt from CGMP 
CGMP Exemptions  requirements only  and PC requirements 
 
 
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