Policy Regarding Certain Entities Subject to the 
Current Good Manufacturing Practice and 
Preventive Controls, Produce Safety, and/or 
Foreign Supplier Verification Programs:  
Guidance for Industry 
 
 
You may submit electronic or written comments regarding this guidance at any time. 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 FDA-2017-N-
6908 listed in the notice of availability published in the Federal Register.  
  
For questions regarding this document, you may contact the FSMA Technical Assistance 
Network online at https://www.fda.gov/food/guidanceregulation/fsma/ucm459719.htm, by mail 
at Food and Drug Administration; 5001 Campus Drive; Wiley Building, HFS-009; Attn: FSMA 
Outreach; College Park, MD, 20740, or by phone at 1-888-SAFEFOOD (1-888-723-3366).   
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
Center for Veterinary Medicine 
 
 
 
 
 
 
 
 
 
January 2018   
  Contains Nonbinding Recommendations   
 
Table of Contents 
 
I. Introduction
 
II. Background
 
III. Discussion
   
A.  Enforcement Policy for Specific Facilities Subject to Part 117 and/or 
Part 507 
1.  General 
2.  Facilities that Would Qualify as Secondary Activities Farms Except for the Ownership of the 
Facility 
3.   Facilities that Would Qualify as Farms If They Did Not Color RACs  
4.   Facilities that Would Qualify as Secondary Activities Farms Except that They Pack, Package, 
Label, and/or Hold Processed Food that Consists Only of RACs that Have Been Dried/Dehydrated to 
Create a Distinct Commodity 
5.  Farm Mixed-Type Facilities Making Silage Food for Animals  
B.  Enforcement Policy for the Written Assurances in the Customer 
Provisions in Part 117 and Related Rules 
C.  Enforcement Policy for Importation of Food Contact Substances Under 
the FSVP Regulation 
D. Enforcement Policy for Certain Human Food By-Products for Use as 
Animal Food that is Further Manufactured/Processed   
 
IV. References
   
  
   
2 
  Contains Nonbinding Recommendations   
 
Policy Regarding Certain Entities Subject to the 
Current Good Manufacturing Practice and 
Preventive Controls, Produce Safety, and/or 
Foreign Supplier Verification Programs: 
Guidance for Industry 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA, the Agency, 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 document is to state the intent of the Food and Drug Administration (FDA, 
we, or the Agency) not to enforce certain regulatory requirements as they currently apply to 
certain entities and/or activities. The applicable requirements are established in our regulations 
entitled Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive 
Controls for Human Food (21 CFR part 117); Current Good Manufacturing Practice, Hazard 
Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR part 507); 
Standards for Growing, Harvesting, Packing, or Holding of Produce for Human Consumption 
(21 CFR Part 112); and Foreign Supplier Verification Programs for Importers of Food for 
Humans and Animals (21 CFR Part 1, Subpart L).  
 
We are issuing this guidance consistent with our good guidance practices (GGP) regulation (21 
CFR 10.115). This guidance is immediately effective because FDA has determined that prior 
public participation is not feasible or appropriate (21 CFR 10.115(g)(2)).  
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys 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 Agency guidances means that something is suggested or 
recommended, but not required. 
 
In this guidance, pronouns such as you refer to entities that are covered by this guidance.  
3 
  Contains Nonbinding Recommendations   
 
II. Background  
See Table 1 for information about the rulemakings to establish four regulations as part of our 
implementation of the FDA Food Safety Modernization Act (FSMA; Pub. L. 111-353) and for 
the abbreviations that we use in this document for these regulations (i.e., part 117, part 507, the 
produce safety regulation, and the FSVP regulation). You can access the listed Federal Register 
publications and other information about these regulations from our FSMA website 
(https://www.fda.gov/fsma) and from the Docket No. (listed in Table 1) established for each 
rulemaking (available at https://www.regulations.gov). 
 
Table 1.The Regulations That Are Relevant to This Guidance Document 
Title and Regulatory Citation  Abbreviation  Docket No. and Key Publications in the Federal 
Used in This  Register1 
Document 
Current Good Manufacturing Practice,  part 117    Docket No. FDA2011N0920  
Hazard Analysis, and Risk-Based    Proposed rule: 78 FR 3646, January 16, 2013  
Preventive Controls for Human Food (21    Supplemental notice of proposed 
CFR part 117)  rulemaking: 79 FR 58524, September 29, 2014  
  Final rule: 80 FR 55908, September 17, 2015  
  Final rule; extension and clarification of 
compliance dates for certain provisions: 81 FR 
57784, August 24, 2016 
Current Good Manufacturing Practice,  part 507    Docket No. FDA2011N0922  
Hazard Analysis, and Risk-Based    Proposed rule: 78 FR 64736, October 29, 
Preventive Controls for Food for  2013 
Animals (21 CFR part 507)    Supplemental notice of proposed 
rulemaking: 79 FR 58476, September 29, 2014 
  Final rule: 80 FR 56170, September 17, 2015 
  Final rule; extension and clarification of 
compliance dates for certain provisions: 81 FR 
57784, August 24, 2016 
Standards for the Growing, Harvesting,  produce safety    Docket No. FDA2011N0921 
Packing, and Holding of Produce for  regulation or    Proposed rule: 78 FR 64736, October 29, 
Human Consumption (21 CFR part 112)  part 112  2013 
  Supplemental notice of proposed 
rulemaking: 79 FR 58434, September 29, 2014 
  Final rule: 80 FR 74354, November 27, 2015 
  Final rule; extension and clarification of 
compliance dates for certain provisions: 81 FR 
57784, August 24, 2016 
Foreign Supplier Verification Programs  FSVP    Docket No. FDA2011N0143 
for Importers of Food for Humans and  regulation    Proposed rule: 78 FR 45730, July 29, 2013 
Animals (21 CFR Part 1, Subpart L)     Supplemental notice of proposed 
rulemaking: 79 FR 58574, September 29, 2014 
  Final rule: 80 FR 74226, November 27, 2015 
  Final rule; extension and clarification of 
compliance dates for certain provisions: 81 FR 
57784, August 24, 2016 
1 During each rulemaking listed in Table 1, we also issued several notices extending the comment period or 
announcing a public meeting to discuss the proposed rule. For the complete history of Federal Register publications 
associated with each rulemaking, see the applicable final rule. 
 
4 
  Contains Nonbinding Recommendations   
 
In a final rule published in the Federal Register of August 24, 2016 (81 FR 57784; the 
compliance date final rule), we extended the compliance dates for certain provisions in the 
four FSMA rules listed in the table above, to address concerns about the practicality of 
compliance, consider changes to the regulatory text, and better align compliance dates across the 
rules (81 FR 57784). As relevant to this guidance, we extended the compliance dates for:  
 
  Specific facilities subject to part 117 and/or part 507: 
  Facilities solely engaged in packing and/or holding produce raw agricultural 
o
commodities (RACs) and/or nut hulls and shells that are used in animal food; 
  Facilities that would qualify as secondary activities farms except for the ownership of 
o
the facility; 
  Facilities that would qualify as farms if they did not color RACs under part 117; 
o
  Facilities solely engaged in the ginning of cotton under part 507;  
o
  Written assurances under the customer provisions in part 117 and related rules; and 
  Importation of food contact substances under the FSVP regulation. 
 
As discussed more fully below, we intend to exercise enforcement discretion with regard to these 
facilities or requirements.  In addition, since the compliance date final rule we have become 
aware of additional circumstances in which we now intend to exercise enforcement discretion. 
Those are also described fully below. 
 
In this document we use the term facility to refer to a facility required to register under the 
section 415 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350d) 
registration requirements. A facility that is currently required to register must still do so, 
regardless of whether the facility is covered by the enforcement policy that applies to the 
preventive controls requirements, the CGMP requirements, or both. In addition, we use the 
phrase farm-related activities to refer to activities included within the farm definition if 
performed by a farm.  Farm-related activities include manufacturing/processing activities 
allowed within the farm definition (e.g., drying/dehydrating RACs to create a distinct 
commodity, treating RACs to manipulate ripening, and packaging and labeling RACs and RACs 
that have been dried/dehydrated to create a distinct commodity or treated to manipulate 
ripening). Finally, we use the term farm mixed-type facility to refer to a
n establishment that 
i s a farm but also conducts activities outside the farm definition that require the 
establishment to be registered under section 415. 
5 
  Contains Nonbinding Recommendations   
 
III.  Discussion  
A. Enforcement Policy for Specific Facilities Subject to Part 117 and/or 
Part 507 
1.  General 
a.  Rulemakings to establish part 117, part 507, and revise the farm 
definition 
Among other things, the rulemaking to establish part 117 amended our CGMP regulation for 
manufacturing, packing, or holding human food to modernize it and establish it in new part 117, 
primarily in subpart B, with associated requirements in subparts A and F (the human food CGMP 
requirements). Part 117 also includes new requirements for domestic and foreign facilities that 
are required to register under section 415 to establish and implement hazard analysis and risk-
based preventive controls for human food (the human food preventive controls requirements). 
The human food preventive controls requirements are primarily in subparts C and G, with 
associated requirements in subparts A, D, E, and F. In the preamble of the final rule establishing 
part 117, we stated that the rule is effective November 16, 2015, and provided for compliance 
dates of 1 to 3 years from the date of publication in most cases (see Table 53 in the preamble of 
the final rule establishing part 117, 80 FR 55908 at 56128).  
 
The rulemaking to establish part 117 also amended the farm definition in our regulations 
implementing section 415 of the FD&C Act (the section 415 registration regulations are at 21 
CFR part 1, subpart H). The purpose of the amendment was to clarify the scope of the exemption 
from registration requirements provided for farms and, in so doing, to clarify which human 
food establishments are subject to the human food preventive controls requirements, and which 
human food establishments are exempt from those requirements because they are farms. The 
farm definition also impacts the applicability of the CGMP requirements because farms are 
exempt from CGMPs (21 CFR 117.5(k)(i)). 
 
The rulemaking to establish part 507 included new requirements for CGMPs, primarily in 
subpart B, with associated requirements in subparts A and F (the animal food CGMP 
requirements) and  requirements for hazard analysis and risk-based preventive controls for food 
for animals, primarily in subparts C and E, with associated requirements in subparts A, D, E, and 
F (the animal food preventive controls requirements). The part 507 requirements apply to 
domestic and foreign facilities that are required to register under the section 415 registration 
regulation.  Thus, the farm definition that we amended as part of the rulemaking to establish 
part 117 also clarifies which animal food establishments are subject to the part 507 requirements, 
and which animal food establishments are exempt from those requirements because they are 
farms. In the preamble of the final rule establishing part 507, we stated that the rule is effective 
November 16, 2015 (80 FR 56170). We provided for compliance dates of 1 to 3 years from the 
date of publication in most cases for compliance with the CGMP requirements, with an 
additional year beyond that for compliance with the animal food preventive controls 
requirements. 
6 
  Contains Nonbinding Recommendations   
 
b.  Why the enforcement policy is needed 
As discussed in more detail below, a threshold question to determine whether and how the 
regulatory framework provided by parts 117 and 507 applies to an entity is whether the entity is 
a farm as that term is defined in  1.227 of the section 415 registration regulation. Feedback 
from regulated entities has raised complex questions about factors, such as farm-related activities 
and farm ownership, that impact the determination of whether an entity is a farm. In addition, 
we have previously stated our belief that certain activities conducted on produce RACs are 
similar regardless of where they happen and that an off-farm packinghouse that is subject to the 
human food preventive controls requirements in part 117 will be able to draw from the 
provisions of the produce safety regulation in developing its food safety plan and establishing 
preventive control management components that are appropriate in light of the nature of the 
preventive controls and their role in the facilities food safety system. Feedback from regulated 
entities has emphasized the need for additional regulatory guidance or changes to the regulatory 
text to enable this goal to be achieved. In the compliance date final rule, we described these and 
other questions and extended compliance dates for requirements in part 117 and part 507 as they 
apply to certain facilities and activities, to consider changes to the regulatory text and better align 
compliance dates across the regulations.  
 
FDA intends to initiate a rulemaking that could change the applicability of the preventive 
controls and CGMP requirements to some entities that conduct farm-related activities. In the 
remainder of this guidance, we refer to this rulemaking as the future rulemaking related to farm 
activities. For example, a change to the farm definition could change the status of an entity 
from a facility required to register to a farm. Under the current regulatory framework, a farm is 
not subject to the preventive controls or CGMP requirements but may be subject to the produce 
safety regulation, depending on the food and activities involved. We do not anticipate that 
changes to the regulatory text would result in an entity that currently is a farm becoming 
subject to the preventive controls or CGMP requirements for human or animal food. 
 
To provide sufficient time to pursue the future rulemaking related to farm activities and other 
solutions to the concerns regarding the applicability of parts 117 and 507, we intend to exercise 
enforcement discretion with regard to the preventive controls requirements (and, in some cases, 
the CGMP requirements) of parts 117 and 507 for the facilities identified in sections III.A.2 
through III.A.5 of this guidance until completion of the future rulemaking related to farm 
activities. In sections III.A.2 through III.A.5, we describe the facilities, the activities that they 
conduct, and the specific regulatory requirements for which the enforcement policy for specific 
facilities subject to part 117 and/or part 507 applies. If we adopt any approaches to the concerns 
described in the document that do not require rulemaking, we may announce those approaches, 
and any timeframe for compliance with the applicable requirements, via a communication other 
than the future rulemaking related to farm activities, such as a guidance document.   
 
Regardless of our intent to exercise enforcement discretion, the statutory prohibition against the 
introduction or delivery for introduction into interstate commerce of adulterated food (section 
301(a) of the FD&C Act (21 U.S.C. 331(a)) applies.  For example, under section 402(a)(4) of the 
FD&C Act (21 U.S.C. 342(a)(4)), a food shall be deemed to be adulterated if it has been 
prepared, packed, or held under insanitary conditions whereby it may have become contaminated 
with filth, or whereby it may have been rendered injurious to health. 
7 
  Contains Nonbinding Recommendations   
 
c.  The enforcement policy applies to facilities and mixed-type facilities 
The enforcement policy for part 117 and/or part 507 applies to facilities and farm mixed-type 
facilities.  For example, an operation that is devoted to holding and packing RACs but is not a 
secondary activities farm because it does not meet the ownership requirement is a facility 
addressed in section III.A.2.  An operation that grows and harvest oranges but also colors them is 
a farm mixed-type facility that would be entirely a farm if it did not color RACs and is a facility 
addressed in section III.A.3.   
 
Farm mixed-type facilities that engage in manufacturing/processing activities not within the 
farm definition and not addressed in this guidance remain subject to the compliance dates 
listed in Table 53 of the final rule establishing part 117 (for human food) (80 FR 55908 at 56128) 
and the compliance dates listed in Table 32 of the final rule establishing part 507 (for animal 
food) (80 FR 56170 at 56329) for those activities that require the entity to register.  
d.  The enforcement policy applies to associated requirements 
The enforcement policy in this guidance for the primary subparts for CGMP and preventive 
controls requirements also applies to the associated subparts. Thus, when we state our intent to 
exercise enforcement discretion with regard to the preventive controls requirements, that intent 
also applies to the associated requirements. Likewise, when we state our intent to exercise 
enforcement discretion with regard to the CGMP requirements, that intent also applies to the 
associated requirements. For example, the requirements in  117.4(b)(2) in part 117, subpart A, 
and in  507.4(b)(2) in part 507, subpart A to ensure that all individuals who manufacture, 
process, pack, or hold human or animal food receive training in the principles of food hygiene 
and food safety are part of the CGMP requirements in parts 117 and 507.  We intend to exercise 
enforcement discretion with regard to these training requirements in part 117 or part 507 in those 
circumstances where we state our intent to exercise enforcement discretion with regard to the 
CGMP requirements of part 117 or part 507, respectively.  
e.   The enforcement policy applies even if a facility is subject to two 
categories 
Section III.A. describes four categories of facilities that are subject to FDAs enforcement policy 
for parts 117 and 507.  A facility might not be included in the enforcement policy if each 
category is considered alone but may qualify if two or more of the categories are considered 
together.  For example, FDA intends to exercise enforcement discretion for a human food facility 
that packs, colors, and holds RACs and that would fail to be a secondary activities farm both 
because it does not meet the ownership requirement (section III.A.2) and because it colors RACs 
(section III.A.3).   
f.   Application of the enforcement policy to preventive controls and  CGMP 
requirements 
The enforcement policy for part 117 and part 507 applies to all human and animal food 
preventive controls requirements, all animal food CGMP requirements, and to human food 
CGMP requirements for non-produce RACs.  The enforcement policy for human food CGMPs 
8 
  Contains Nonbinding Recommendations   
 
does not include activities conducted on produce RACs, many of which have long been subject 
to CGMP requirements in part 110.  To the extent the activities on produce RACs were exempt 
from part 110 under  110.19, they continue to be exempt under  117.5(k).  Further, unlike non-
produce RACs, produce RACs on farms are subject to part 112.  Note that some off-farm 
produce packinghouses and warehouses that will continue to be subject to human food CGMPs 
have the option to comply with the human food CGMP requirements or with the applicable 
requirements for packing and holding in the produce safety regulation (see  117.8).     
g.  Facilities that currently are exempt from preventive controls 
requirements or CGMP requirements will continue to be exempt from those 
requirements 
Some facilities currently are exempt from the preventive controls or CGMP requirements or 
both.  Exemptions from the regulations are codified in 21 CFR 117.5 and 507.5.  The 
enforcement policy in this guidance does not affect those exemptions.  For example, 
establishments solely engaged in the holding and/or transportation of one or more RACs and 
establishments solely engaged in hulling, shelling, drying, packing and/or holding nuts are 
exempt from CGMPs (21 CFR 117.5(k)(iii) and (v), 21 CFR 507.5(h)(1) and (2)). 
h.  Summary of the enforcement policy for specific facilities subject to part 
117 and/or part 507  
Tables 2 and 3 summarize the enforcement policy in section III.A as it relates to human and 
animal food, respectively. For a complete description of the enforcement policy, see the 
discussions in sections III.A.2 through III.A.5. 
 
Table 2. Summary of the Enforcement Policy With Regard to Human Food  
Section  Description of Facilities and Activities  Does Enforcement  Does Enforcement 
Conducted by the Facilities  Discretion Apply for  Discretion Apply for 
Human Food Preventive  Human Food 
Controls Requirements?   CGMPs? 
III.A.2  Facilities That Would Qualify as  Yes    No, for farm-
Secondary Activities Farms Except for  related activities 
the Ownership of the Facility  conducted on produce 
RACs.   
  Yes, for farm-
related activities 
conducted on non-
produce RACs.  
III.A.3  Facilities That Would Qualify as Farms  Yes    No, for coloring 
If They Did Not Color RACs  produce RACs.   
  Yes, for coloring 
non-produce RACs. 
III.A.4  Facilities that Would Qualify as  Yes    No, for produce 
Secondary Activities Farms Except that  RACs.   
They Pack, Package, Label, and/or Hold    Yes, for non-
Processed Food That Consists Only of  produce RACs. 
RACs that Have Been Dried/Dehydrated 
to Create a Distinct Commodity 
 
 
9 
  Contains Nonbinding Recommendations   
 
  
Table 3. Summary of the Enforcement Policy With Regard to Animal Food  
Section  Description of Facilities and Activities  Does Enforcement  Does Enforcement 
Conducted by the Facilities  Discretion Apply for  Discretion Apply for 
Animal Food Preventive  Animal Food 
Controls Requirements?   CGMPs? 
III.A.2  Facilities That Would Qualify as  Yes  Yes 
Secondary Activities Farms Except for 
the Ownership of the Facility 
III.A.3  Facilities That Would Qualify as Farms  Yes  Yes 
If They Did Not Color RACs 
III.A.4  Facilities that Would Qualify as  Yes  Yes 
Secondary Activities Farms Except that 
They Pack, Package, Label, and/or Hold 
Processed Food That Consists Only of 
RACs that Have Been Dried/Dehydrated 
to Create a Distinct Commodity 
III.A.5  Farm Mixed-Type Facilities Making    N/A for small and very  Yes 
Silage Food for Animals  small businesses (because 
they are exempt from 
animal food preventive 
controls requirements 
under  507.5(f)(4)) 
  Yes, for businesses that 
are not small or very 
small. 
 
2.  Facilities that Would Qualify as Secondary Activities Farms Except for the 
Ownership of the Facility  
Part 117 and Part 507 
 
The rulemaking to establish part 117 created a secondary activities farm definition within the 
farm definition (in 21 CFR 1.227) to cover certain operations that are not located on a primary 
production farm but are sufficiently related to a primary production farm so that it is appropriate 
to consider the operations to be farms. (See Response 25, 80 FR 55908 at 55928 to 55929.) A 
secondary activities farm is devoted to harvesting, packing, and/or holding of RACs (such as 
produce, grains, and eggs) and may also conduct those additional activities allowed on a primary 
production farm (i.e., farm-related activities). Further, a secondary activities farm must be 
majority-owned (singly or jointly) by the primary production farm(s) that grows, harvests, and/or 
raises the majority of the RACs harvested, packed, and/or held by the secondary activities farm 
( 1.227).  
 
In the compliance date final rule, we explained that we had received multiple questions on 
whether certain operations would qualify as secondary activities farms as defined in  1.227. 
These questions described a variety of business structures that may satisfy our intent with the 
final rule to require a close relationship between primary and secondary activities farms, but the 
business structures did not meet the ownership requirement as codified in the farm definition. 
In the compliance date final rule, we extended the compliance dates for facilities that would 
10 
  Contains Nonbinding Recommendations 
qualify as secondary activities farms except for the ownership of the facility but limited to 
extension to circumstances where the operation was under common ownership with the primary 
production farm(s) that grew, harvested, and/or raised the majority of the RACs harvested, 
packed, and/or held by the operation. (See Table 3, 81 FR 57784 at 57790.) 
To provide sufficient time to pursue the future rulemaking related to farm activities and other 
solutions to address these questions about ownership of secondary activities farms, we intend to 
exercise enforcement discretion for facilities that would be secondary activities farms except for 
the ownership of the facility.  In contrast to the compliance date final rule, our intent to exercise 
enforcement discretion is not contingent upon an operation being under common ownership with 
the primary production farm(s) that grew, harvested, and/or raised the majority of the RACs 
harvested, packed, and/or held by the operation.  As explained in section III.A.1.f, we intend to 
exercise enforcement discretion for this category for all of the human and animal food preventive 
controls requirements, all animal food CGMP requirements, and for human food CGMP 
requirements for non-produce RACs.  
Because of the change regarding ownership, some of the facilities identified separately in the 
compliance date final rule are now included in this category.  Specifically, because our intent to 
exercise enforcement discretion applies to any operation (not located on a primary production 
farm) that is dedicated to harvesting, packing, and/or holding RACs, it applies to facilities solely 
engaged in packing and/or holding activities on produce RACs and/or nut hulls and shells.  For 
similar reasons, it applies to facilities solely engaged in the ginning of cotton.  Listed below are 
examples of the types of facilities likely to fit within this category: 
 Facilities engaged in farm-related activities on produce RACs (e.g., produce
packinghouses and warehouses)
 Facilities engaged in farm-related activities on non-produce RACs (e.g., egg
packinghouses and grain elevators)
 Facilitates engaged in nut hulling/shelling operations
 Facilitates engaged in the ginning of cotton; and
 Facilities engaged in conditioning seed for cultivation that solely pack and hold seed for
use in animal food
3. Facilities that Would Qualify as Farms If They Did Not Color RACs
a. Part 117
The definition of RAC in section 201(r) of the FD&C Act includes fruits that are ... colored ... 
in their unpeeled natural form prior to marketing. (21 U.S.C. 321(r)). As discussed in the 
compliance date final rule (81 FR 57784 at 57791-57792), we previously described coloring a 
RAC as an example of an activity that is manufacturing/processing but does not transform a 
RAC into a processed food (78 FR 3646 at 3678 to 3679, January 16, 2013). Generally, an 
establishment that conducts manufacturing/processing activities other than those specified as 
being within the farm definition is a facility that is required to register and is subject to the 
preventive controls requirements.  
11  Contains Nonbinding Recommendations   
 
Unlike treating RACs to manipulate ripening and packaging and labeling RACs, we did not 
include coloring RACs as a manufacturing/processing activity within the farm definition. 
Therefore, coloring a RAC intended for use in human food brings an operation outside the 
farm definition and triggers the requirements for human food preventive controls and CGMPs 
(except where other exemptions apply). In the compliance date final rule, we extended the 
compliance dates for facilities that would be farms if they did not color RACs for use in human 
food. (See Table 4, 81 FR 57784 at 57791.)  
 
To provide sufficient time to pursue the future rulemaking related to farm activities and other 
solutions that fully consider whether and how coloring RACs could be within the farm 
definition, we intend to exercise enforcement discretion for this category with regard to all of the 
human food preventive controls requirements; as well as the human food CGMP requirements 
for activities conducted on non-produce RACs.   
 
b.  Part 507 
Some facilities that would be farms if they did not color RACs generate by-product for use as 
animal food as a result of their coloring operations.  Some of these facilities simply pack and 
hold the by-product for distribution, while other facilities may further manufacture/process the 
by-product for use as animal food.  These packing, holding, and manufacturing/processing 
activities are subject to part 507, unless an exemption applies.  To provide sufficient time to 
pursue the future rulemaking related to farm activities and other solutions to fully consider 
whether and how coloring RACs could be within the farm definition, we intend to exercise 
enforcement discretion with regard to the animal food preventive controls and CGMP 
requirements for facilities that would be farms if they did not color RACs and that generate by-
product for use as animal food as a result of their coloring operations. 
4.  Facilities that Would Qualify as Secondary Activities Farms Except that 
They Pack, Package, Label, and/or Hold Processed Food that Consists Only of 
RACs that Have Been Dried/Dehydrated to Create a Distinct Commodity 
a.  Part 117 
The farm definition provides for a farm to dry/dehydrate RACs to create a distinct commodity.  
Further, it provides for a farm to pack, package, label, and/or hold the processed food (e.g., 
raisins, dried herbs) resulting from the drying/dehydrating.  An operation that solely packs, 
packages, labels, and/or holds dried/dehydrated RACs that have become a distinct commodity 
cannot be a primary production farm because it is not devoted to growing or harvesting RACs.  
Further, such an operation cannot be a secondary activities farm because it is not devoted to 
harvesting, packing, and/or holding RACs, since the dried/dehydrated RACs are processed food.  
Thus, even though it is solely engaged in farm-related activities, such an operation does not meet 
the definition of a farm.   
 
In addition, since issuing the final rules establishing part 117 and the produce safety regulation, 
our Technical Assistance Network (TAN) has received questions seeking clarification on 
12 
  Contains Nonbinding Recommendations   
 
whether dried beans1 are considered produce RACs. In the preamble to the final rule 
establishing the produce safety regulation, we stated that dried beans are a processed food (i.e., a 
distinct commodity). In addition, in 117.5(g)(2)(i) we referred to dried legumes as a 
processed food product for the purposes of the exemptions in  117.5 (g)(3) and (h)(3) for 
specific low-risk packing/holding manufacturing/processing activity/food combinations 
conducted by small and very small on-farm businesses.  However, in a previous Federal Register 
notice of policy interpretation entitled Legal and Policy Interpretation of the Jurisdiction Under 
the Federal Food, Drug, and Cosmetic Act of the Food and Drug Administration and the 
Environmental Protection Agency Over the Use of Certain Antimicrobial Substances, beans 
were included within a group of commodities (i.e., hay, nuts, rice, beans, corn, other grasses, 
legumes, and grains) that remain RACs even though they may have undergone some drying (63 
FR 54532 at 54542, October 9, 1998).  
 
To provide sufficient time to pursue the future rulemaking related to farm activities and to 
further consider the status of dried beans (which currently are considered a processed food), we 
intend to exercise enforcement discretion with regard to all of the human food preventive 
controls requirements for facilities that would qualify as secondary activities farms except that 
they pack, package, label, and/or hold processed food that consists only of dried/dehydrated 
RACs that have become a distinct commodity until completion of the future rulemaking related 
to farm activities.  In addition, we intend to exercise enforcement discretion for those facilities 
with regard to the human food CGMP requirements for non-produce RACs.   
 
b.  Part 507 
Some facilities that would be secondary activities farms except that they pack, package, label, 
and/or hold processed food that consists only of RACs that have been dried/dehydrated to create 
a distinct commodity may provide the commodity (e.g., dried beans) for use as animal food or 
generate by-product for use as animal food as a result of their operations.  Some of these 
facilities simply pack and hold the by-product for distribution, while other facilities may further 
manufacture/process the by-product for use as animal food.  These packing, holding, and 
manufacturing/processing activities are subject to part 507, unless an exemption applies.  While 
we are pursuing the future rulemaking related to farm activities and resolving the inconsistency 
relating to dried beans, we intend to exercise enforcement discretion with regard to the animal 
food preventive controls and CGMP requirements for facilities that would qualify as secondary 
activities farms if they did not pack, package, label, and/or hold processed food that consists only 
of dried/dehydrated RACs that have become  a distinct commodity, and that generate by-product 
for use as animal food, until completion of the future rulemaking related to farm activities. 
                                                 
1 In the produce safety regulation, we classify several types of beans as produce. Examples of beans that the 
produce safety regulation classifies as produce are black beans, cowpea beans (also called black-eyed peas), great 
northern beans, kidney beans, lima beans, navy beans, pinto beans. (See  112.1(b)(1), 112.2(a)(1), and the 
definition of produce in  112.3.) The produce safety regulation classifies soybeans as a food grain. (See the 
definition of produce in  112.3.)  
13 
  Contains Nonbinding Recommendations   
 
5.  Farm Mixed-Type Facilities Making Silage Food for Animals 
Part 507 
Silage is food for animals made by storing and fermenting green forage plants (e.g., corn stalks, 
bean plants, grass), sometimes in a silo. Silage is primarily made on a farm following harvest. 
When a farm makes silage and the silage is consumed on that farm or another farm under the 
same management, the farm is exempt from part 507. If the silage enters commerce (e.g., is 
donated or sold to another farm or animal food manufacturer), the silage-making farm becomes a 
mixed-type facility (see section III.A.1.c). Mixed-type facilities are required to register under 
section 415 of the FD&C Act and are subject to part 507 for the animal food activities that 
require registration. 
 
A farm that is a mixed-type facility and also a small or very small business is exempt from the 
animal food preventive controls requirements if the farms only manufacturing/processing 
activities fall into specific low-risk manufacturing/processing activity/animal food combinations. 
See  507.5(f). Ensiling, including making silage, is an activity that is exempt from the animal 
food preventive controls requirements when conducted on-farm by a small or very small farm 
mixed-type facility ( 507.5(f)(4)). This exemption is based on our determination that making 
silage for animal food is a low-risk manufacturing/processing activity/animal food combination. 
A farm mixed-type facility making silage for distribution in commerce is subject to the CGMP 
requirements of part 507. 
We have received feedback through the TAN from farmers that they consider making silage to 
be an extension of harvesting and that FDA should consider making silage to be a harvesting 
activity. The harvesting definition includes cutting (or otherwise separating) the edible portion 
of the raw agricultural commodity from the crop plant and removing or trimming part of the raw 
agricultural commodity (e.g. foliage, husks, roots or stems) ( 507.3).  For animals, the crop 
plant, foliage, husks, roots, and stems are also edible. When these parts of the plant are used for 
silage, they are cut and trimmed in the field during harvesting.  
To provide sufficient time to pursue the future rulemaking related to farm activities and other 
solutions  that fully consider whether and how making silage could be within the harvesting 
definition, we intend to exercise enforcement discretion with regard to the animal food CGMP 
requirements for a farm that is a mixed-type facility only because it is making silage that enters 
commerce (i.e., is not fed on the farm or another farm under the same management)  until 
completion of the future rulemaking related to farm activities. A farm mixed-type facility that is 
a small or very small business is exempt from the animal food preventive control requirements 
for its ensiling (see  507.5(f)(4)) and will continue to be exempt.  We intend to exercise 
enforcement discretion with regard to the animal food preventive controls requirements 
applicable to ensiling for farm mixed-type facilities that are not small or very small businesses, 
until completion of the future rulemaking related to farm activities. 
14 
  Contains Nonbinding Recommendations   
 
B. Enforcement Policy for the Written Assurances in the Customer 
Provisions in Part 117 and Related Rules 
Among other requirements, subpart C of part 117 requires a facility that manufactures/processes 
human food to conduct a hazard analysis to determine whether there are any hazards that require 
a preventive control ( 117.130) and identifies several types of possible preventive controls ( 
117.135(c)). In addition, subpart C of part 117 includes several provisions that apply when a 
manufacturer/processor of human food identifies a hazard requiring a preventive control 
(identified hazard), does not control the identified hazard, and relies on an entity in its 
distribution chain to control the identified hazard ( 117.136(a)(2) through (4) and 117.137). A 
manufacturer/processor that complies with these provisions is not required to implement a 
preventive control for the identified hazard before distributing the food. As discussed in the final 
rule to establish part 117 (80 FR 55908 at 56036-56037), the combination of three requirements 
in these provisions was intended to provide assurance that food for further processing will be 
processed to control the identified hazard before it reaches consumers:  
 
  Documentation provided by the manufacturer/processor to its direct customer that the 
food is not processed to control [identified hazard] (the disclosure statement 
requirements; current  117.136(a)(2)(i), (3)(i), and (4)(i));  
  Written assurance provided by the customer to the manufacturer/processor that the 
identified hazard will be controlled (the written assurance requirements; current  
117.136(a)(2)(ii), (3)(ii), and (4)(ii)); and  
  A provision specifying that a facility that provides a written assurance under the customer 
provisions must act consistently with the assurance and document its actions taken to 
satisfy the written assurance (the accountability requirements; current  117.137). 
 
In these provisions, customer means a commercial customer, not a consumer. 
 
Part 117 includes several provisions applicable to records associated with the written assurances 
(the written assurance recordkeeping requirements):  
  Section 117.136(b)(2), (3), and (4) requires that you must document the written 
assurances; and 
  Subpart F of part 117 specifies requirements applying to all records that must be 
established and maintained to comply with part 117 and includes the elements to be 
included in the written assurances required by  117.136(a)(2)(ii), (3)(ii), and (4)(ii). (See 
 117.335(b).)  
 
We refer to the collective provisions of  117.136(a)(2) through (4), 117.136(b)(2) through (4), 
117.137, and 117.335(b) as the customer provisions of part 117.  
 
Among other requirements, subpart C of part 507 requires a facility that manufactures/processes 
food for animals to conduct a hazard analysis to determine whether there are any hazards that 
require a preventive control ( 507.33) and identifies several types of possible preventive 
controls ( 507.34(c)). Subpart F of part 507 specifies requirements applying to all records that 
must be established and maintained to comply with part 507. 
As with part 117, part 507 includes customer provisions as follows: 
15 
  Contains Nonbinding Recommendations   
 
  Subpart C of part 507 includes provisions for disclosure statements and written 
assurances that apply when a manufacturer/processor of food for animals identifies a 
hazard requiring a preventive control, does not control the identified hazard, and relies on 
an entity in its distribution chain to control the hazard ( 507.36(a)(2), (3), and (4), 
507.36(c), 507.36(d), and 507.37). A manufacturer/processor that complies with these 
provisions of part 507 is not required to implement a preventive control for the identified 
hazard. The combination of these requirements was intended to provide assurance that 
the food will be processed to control the identified hazard before it reaches the consumer 
feeding the food to animals. 
  Subpart F of part 507 specifies the elements to be included in the written assurances 
required by  507.36(a)(2)(ii), (3)(ii), and (4)(ii). (See  507.215(b).)  
 
The FSVP regulation includes customer provisions that apply when an importer imports a food 
for which the hazards are controlled after importation ( 1.507). As with the customer provisions 
in part 117 and part 507, the requirements in the customer provisions of the FSVP regulation 
were intended to provide assurance that the food will be processed to control the identified 
hazard before it reaches the humans or animals that would consume the food. 
 
The produce safety regulation applies to covered produce as set forth in  112.1 and 112.2. 
Produce that would otherwise be covered is eligible for an exemption from most of the 
requirements of the produce safety regulation if: (1) The produce receives commercial 
processing that adequately reduces the presence of microorganisms of public health significance 
( 112.2(b)(1)); and (2) certain other conditions are met, including requirements for disclosure 
statements and written assurances analogous to the requirements for disclosure statements and 
written assurances in the customer provisions required by part 117, part 507, and the FSVP 
regulation ( 112.2(b)(2) through (4) and (6)).  
 
FDA has received feedback from industry expressing concern that certain product distribution 
chains would require vastly more written assurances (and consequently resources to comply with 
the requirement) than anticipated by FDA during the rulemaking process (Ref. 1). For example, a 
manufacturing facility may sell food products subject to the customer provisions to a distributor, 
who may sell numerous items requiring assurances to multiple restaurants, cafeterias, 
delicatessens, and other distributors. It is estimated that this could result in hundreds or even 
thousands of written assurances needed by a single distributor (Ref. 1). After considering this 
feedback from industry, we stated our belief that the requirement for written assurance in the 
customer provisions of part 117 significantly exceeds the current practices of even the largest 
facilities; compliance by those facilities by September 19, 2016, may not be feasible; and it is 
appropriate to extend the compliance dates for 2 years for the written assurance requirements for 
part 117, part 507, the FSVP regulation, and the produce safety regulation while we considered 
the best approach to address feasibility concerns (81 FR 57784 at 57786).  
 
FDA intends to initiate a rulemaking that takes into consideration the complex supply chain 
relationships and resource requirements. To provide sufficient time for us to pursue that 
rulemaking, we are exercising enforcement discretion with regard to the written assurance 
requirements of part 117, part 507, part 112, and the FSVP regulation until completion of that 
rulemaking process. In the meantime, entities with disclosure duties under part 117, part 507, 
16 
  Contains Nonbinding Recommendations   
 
part 112, or the FSVP regulation are still required to make necessary disclosures. Subsequent 
entities in the distribution chain will continue to be subject to applicable requirements related to 
food adulteration in Federal and/or state and local laws and regulations, e.g., part 117, part 507, 
and the Retail Food Code. 
C. Enforcement Policy for Importation of Food Contact Substances Under 
the FSVP Regulation 
The FSVP regulation requires food importers to develop, maintain, and follow an FSVP that 
provides adequate assurances that the foreign supplier uses processes and procedures that 
provide the same level of public health protection as those required under the preventive controls 
or produce safety provisions of FSMA (if applicable) and regulations implementing those 
provisions, as well as assurances that the imported food is not adulterated and that human food is 
not misbranded with respect to allergen labeling (21 CFR 1.502(a)). Among other things, the 
FSVP regulation (21 CFR 1.500-1.514) requires most food importers to do the following: 
  Analyze the hazards for the foods they import (21 CFR 1.504);  
  Evaluate the performance of their potential foreign suppliers and the risk posed by the 
foods to be imported (21 CFR 1.505); and 
  Determine and conduct appropriate foreign supplier verification activities, such as onsite 
auditing of foreign suppliers, sampling and testing, and review of supplier food safety 
records (21 CFR 1.506). 
 
The FSVP regulation applies (with certain exceptions) to the importation of food as defined in 
section 201(f) of the FD&C Act (see 21 CFR 1.500). Food contact substances are included in the 
definition of food for purposes of the FSVP regulation (21 CFR 1.500). However, for the 
reasons stated below, we intend to exercise enforcement discretion for importers of food contact 
substances with respect to the FSVP regulation.  
 
A food contact substance is any substance that is intended for use as a component of materials 
used in manufacturing, packing, packaging, transporting, or holding food if such use of the 
substance is not intended to have any technical effect in such food (section 409(h)(6) of the 
FD&C Act (21 U.S.C. 348(h)(6)); 21 CFR 170.3(e)(3)). The term food is defined in section 
201(f)(3) of the FD&C Act to include articles used as components of food. In the preamble to the 
FSVP final rule, we stated that the definition of food for purposes of FSVP includes food 
contact substances that are considered food in section 201(f) of the FD&C Act (80 FR 74225 
at 74233). Therefore, the FSVP regulation applies to importers of food contact substances that 
meet the definition of food in section 201(f).  
 
In the compliance date final rule, we extended the compliance date for the importation of food 
contact substances by 2 years so that we could consider how best to address concerns raised 
about the feasibility of importers of food contact substances meeting the FSVP requirements (81 
FR 57784 at 57792-57793). As a result of this extension, the earliest that an importer would be 
required to comply with FSVP for the importation of food contact substances would be May 28, 
2019.  
 
17 
  Contains Nonbinding Recommendations   
 
Upon consideration of comments and information provided by industry and other interested 
parties and the issues involved, we have concluded that, because of certain characteristics related 
to the nature of food contact substances, FDAs premarket review/oversight of food contact 
substances, and the regulatory framework for such substances, it is appropriate to consider the 
exercise of our enforcement discretion to not require importers of food contact substances to 
meet FSVP requirements. Because by definition food contact substances are not intended to have 
a technical effect in food, food contact substances generally result in relatively low levels of 
migration to food. Consequently, consumer exposure to food contact substances is frequently 
less than exposure to other types of food substances. In addition, FDA has extensive premarket 
review processes for these substances under the food contact notification (FCN) process and the 
food additive petition process. Section 309 of the Food and Drug Administration Modernization 
Act of 1997 (FDAMA) amended section 409 of the FD&C Act to establish the FCN process 
(codified in 21 CFR 170.100 through 170.106) as the primary method by which we regulate food 
additives that are food contact substances. Before FDAMA, many food additives that are now 
authorized through the FCN process required premarket approval by the Agency through the 
submission of food additive petitions and publication of regulations authorizing their intended 
use.  
 
Both the FCN process and the food additive approval process require the notifier or petitioner to 
demonstrate that the intended use of the food contact substance is safe within the meaning of 
section 409(c)(3)(A) of the FD&C Act. If the information in the food additive petition or 
notification does not support the safety of the substance, FDA will act so that this use is not 
authorized: for food additive petitions, we can deny the petition; for FCNs, we can object to the 
notification within 120 days from the date of receipt of the notification so that it does not become 
effective (21 CFR 170.104)(c)). For an authorized use of a food contact substance, the food 
additive regulation or effective notification establishes, among other things, specifications 
(including purity or physical properties) for the substance and any limitations on the conditions 
of use. A substance is not authorized for use in contact with food in the United States unless it 
complies with all such criteria. Further, we note that food contact substances are not subject to 
the supply-chain program requirements in the human food preventive controls regulation. Under 
that regulation, the supply-chain program requirements only apply to hazards requiring a supply-
chain applied control, and FDA has determined that there are no hazards associated with food 
contact substances that are hazards requiring a supply-chain applied control under 21 CFR 
117.405(a)(1). 
 
For the reasons above, we intend to exercise enforcement discretion for these food contact 
substances with regard to the FSVP requirements. However, importers of food contact 
substances remain subject to the statutory prohibition against the introduction or delivery for 
introduction into interstate commerce of adulterated food (section 301(a) of the FD&C Act (21 
U.S.C. 331(a)). In addition, we will consider revising our exercise of enforcement discretion if, 
for example, new information becomes available regarding safety concerns associated with food 
contact substances 
 
18 
  Contains Nonbinding Recommendations   
 
D. Enforcement Policy for Certain Human Food By-Products for Use as 
Animal Food that is Further Manufactured/Processed  
The final rule establishing part 507 included two provisions that streamline the requirements for 
human food facilities subject to and in compliance with part 117 for the manufacturing, 
processing, packing, and holding of human food by-products for use as animal food.   
 
One provision applies to human food facilities subject to and in compliance with part 117, 
subpart B and all applicable human food safety requirements of the FD&C Act that do not 
further manufacture/process their human food by-products for use as animal food after separation 
from the human food (see  507.12).  These facilities are only subject to the limited holding and 
distribution CGMP requirements located in  507.28 and duplicated in  117.95.  The other part 
507 CGMP requirements and the animal food preventive controls requirements do not apply to 
their human food by-products for use as animal food. 
 
The second provision applies to human food facilities subject to part 117 that are further 
manufacturing/processing their human food by-products for use as animal food after separation 
from the human food (see  507.1(d)).  These facilities are subject to all the requirements in part 
507 for their human food by-products for use as animal food unless an exemption applies.  
However, the facility has the choice to comply with the CGMP requirements and the hazard 
analysis and risk-based preventive controls requirements from either part 117 or part 507. 
 
In August 2016, we published Draft Guidance for Industry (GFI) #239, Human Food By-
Products for Use as Animal Food that further explains these streamlined provisions for human 
food by-products for use as animal food.  In the draft guidance, we identified some activities that 
we do not consider to be further manufacturing/processing when determining whether the human 
food facility is subject to just the limited holding and distribution CGMPs, as opposed to the full 
part 507 CGMP and animal food preventive controls requirements.  These activities include:  
  passive dewatering 
  holding by-products at a particular temperature to facilitate transportation (e.g., keeping a 
syrup or oil warm to maintain liquidity or holding frozen blocks of by-product). 
 
After the publication of the final rule establishing part 507 and release of draft GFI #239: Human 
Food By-Products for Use as Animal Food, we were made aware of concerns about how the 
requirements in part 507 apply to certain activities that are frequently performed in part to 
facilitate the storage and transportation of human food by-products for use as animal food, 
including:  combining different ingredients (e.g., vegetable culls and trimmings or liquid juice 
and dairy by-products), drying/dehydrating, evaporating, chopping, mixing, pressing, heating, 
cooling, trimming, and washing (Refs. 2, 3, 4).  For example, some alcoholic beverage 
manufacturers dry spent grains to facilitate transportation of these grains to farms or animal food 
manufacturers a greater distance from the facility.  Some beverage manufacturers have a single 
tank where they commingle liquid by-products from dairy and juice manufacturing to be sent to 
animal food manufacturers or farmers for use as animal food.  Fruit and vegetable processors 
may commingle trimmings and culls from different types of fruits and vegetables that were 
processed at the same time and perform chopping on these fruits and vegetables to reduce bulk 
for storage or transportation.  We note that typically trimming and washing activities are done to 
19 
  Contains Nonbinding Recommendations   
 
the human food before it has been separated from the by-product and thus would not be 
considered further manufacturing/processing of the human food by-product for use as animal 
food. 
 
Generally, we do not expect that these manufacturing/processing activities will change the safety 
profile of human food by-products for use as animal food if they are done in compliance with the 
CGMP requirements in part 507, subpart B or part 117, subpart B.  In contrast, 
manufacturing/processing activities that are more complex activities performed on human food 
by-products, such as heating or cooling to address pathogens, pelleting, extruding, and 
formulating, may introduce hazards or change the animal food safety profile in a way that could 
require the implementation of preventive controls.  We do not intend to exercise enforcement 
discretion for manufacturing/processing activities that may impact safety as described below.    
 
To provide sufficient time to consider the application of animal food preventive controls 
requirements to certain manufacturing/processing activities on human food by-products for use 
as animal food, we intend to exercise enforcement discretion with regard to the animal food 
preventive control requirements for human food facilities meeting the qualifications in  
507.12(a)(1)(i) or (ii), if the manufacturing/processing activities that are performed on the human 
food by-products for use as animal food are limited to the following activities and circumstances:  
  drying/dehydrating, evaporating, pressing, chopping, and similar activities to reduce 
weight, bulk, or volume,  and/or 
  mixing (e.g., combining different vegetable culls and trimmings, combining juice and 
dairy by-products, stirring), centrifuging, and similar activities to combine ingredients 
or separate components (e.g., water and solids), and 
  these activities are not performed to prevent or significantly minimize animal food 
hazards and do not introduce animal food hazards.   
 
This enforcement discretion is being provided because we do not expect that these types of 
activities done for the purposes of reducing weight, bulk, or volume, and/or separating 
components, or combining ingredients will change the food safety profile of the animal food.  
This enforcement discretion does not extend to a human food facility that performs other 
manufacturing/processing activities on its human food by-products for use as animal food. 
 
 
IV.  References 
1. Grocery Manufacturers Association, 21 CFR 117.136. Industry Impacts from Disclosure and 
Written Assurance Requirements, 2016. 
2.  Comment from American Frozen Food Institute to FDA Docket FDA-2016-D-1220. 
3.  Comment from Midwest Food Processors Association to FDA Docket FDA-2016-D-1220. 
4.  Comment from Northwest Food Processors Association to FDA Docket FDA-2016-D-1220. 
 
20