Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Describing a Hazard That Needs Control 
in Documents Accompanying the Food, as 
Required by Four Rules Implementing 
the FDA Food Safety Modernization Act: 
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Draft Guidance
 
This guidance is being distributed for comment purposes only.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that FDA considers your comment on this draft guidance before we begin work on the final 
version of the guidance, submit either electronic or written comments on the draft guidance 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 180days of publication in the Federal Register of the notice announcing the availability of 
the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written 
comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the 
docket number FDA-2016-D-2841 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 and 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 and Hazard Analysis and Risk-Based Preventive Controls for Food for 
Animals, contact the Center for Veterinary Medicine (CVM) at 240-402-6246. 
For questions regarding this draft document as it relates to our regulation entitled Standards for 
the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, contact 
the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-1636. 
For questions regarding this draft document as it relates to our regulation entitled Foreign 
Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals, contact 
the Office of Policy, Food and Drug Administration at 301-796-4576. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
Center for Veterinary Medicine 
Office of Policy 
October, 2016  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
Table of Contents  
 
Table of Contents 
I.  Introduction 
II.  Background on the Four Foundational Rules 
A.  Part 117 
1. Framework of part 117 
2. Disclosure statement required in the customer provisions of part 117 
B.  Part 507 
1. Framework of part 507 
2. Disclosure statement required in the customer provisions of part 507 
C.  Produce Safety Regulation 
1. Framework of the produce safety regulation 
2. Disclosure statement required in the commercial processing exemption of the produce 
safety regulation 
D.  Foreign Supplier Verification Regulation 
1. Framework of the FSVP regulation 
2. Disclosure statement required in the customer provisions of the FSVP regulation 
III.   Discussion 
A.  FDAs Recommendations Regarding the Part 117 Disclosure Statement 
1. How to describe the identified hazard 
2. Documents of the trade 
B.  FDAs Recommendations Regarding the Part 507 Disclosure Statement 
C.  FDAs Recommendations Regarding the Produce Safety Regulation Disclosure 
Statement 
1. How to describe the identified hazard 
2. Documents of the trade 
D.  FDAs Recommendations Regarding the FSVP Regulation Disclosure Statement 
1. How to describe the identified hazard 
2. Documents of the trade 
 
  2  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Describing a Hazard That Needs Control 
in Documents Accompanying the Food, as 
Required by Four Rules Implementing 
the FDA Food Safety Modernization Act: 
1
Guidance for Industry
 
 
 
 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration (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 FDAs Technical Assistance Network by submitting the form available at 
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm.  
 
I.  Introduction  
This guidance concerns four of the seven foundational rules that we have established in Title 21 
of the Code of Federal Regulations (21 CFR) as part of our implementation of the FDA Food 
Safety Modernization Act (FSMA; Pub. L. 111353). Table 1 lists these four rules.  
Table 1. Four Foundational Rules Providing the Framework for Implementing FSMA 
Title  Regulatory  Abbreviation for the  Publication 
Codification  Purpose of This 
Guidance 
Current Good Manufacturing Practice,  21 CFR part 117  Part 117  80 FR 55908, 
Hazard Analysis, and Risk-Based  September 17, 2015 
Preventive Controls for Human Food 
Current Good Manufacturing Practice,  21 CFR part 507  Part 507  80 FR 56170, 
Hazard Analysis, and Risk-Based  September 17, 2015 
Preventive Controls for Food for Animals 
Standards for the Growing, Harvesting,  21 CFR part 112  Produce safety  80 FR 74354, 
Packing, and Holding of Produce for  regulation  November 27, 2015 
Human Consumption 
Foreign Supplier Verification Programs  21 CFR part 1,  FSVP regulation  80 FR 74226, 
(FSVP) for Importers of Food for  subpart L  November 27, 2015 
Humans and Animals 
                                                 
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 Policy 
in the Office of the Commissioner at the U.S. Food and Drug Administration.  
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This guidance is intended for any entity that is subject to certain provisions (in part 117, part 
507, the produce safety regulation, or the FSVP regulation) that require a disclosure statement, in 
documents accompanying food, that certain hazards have not been controlled by that entity. This 
guidance is not intended to address other requirements of part 117, part 507, the produce safety 
regulation, or the FSVP regulation.  
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 on the Four Foundational Rules 
A. Part 117 
1.  Framework of part 117 
In part 117, we have established our regulation entitled Current Good Manufacturing Practice, 
Hazard Analysis, and Risk-Based Preventive Controls for Human Food. Among other things, 
the rulemaking to establish part 117 amended our current good manufacturing practice (CGMP) 
regulation for manufacturing, packing, or holding human food to modernize it and establish it in 
new part 117, subparts A, B, and F. Part 117 also includes new requirements for domestic and 
foreign facilities that are required to register under section 415 of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 350d)2 in subparts A, C, D, E, F, and G 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 in part 117 
implement the provisions of FSMA, established in section 418 of the FD&C Act (21 U.S.C. 
350g), for human food.  
Part 117 includes some exemptions from the CGMP requirements and the human food 
preventive controls requirements. See 21 CFR 117.5 for those exemptions. 
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 (21 CFR 117.130) and identifies several types of possible preventive 
controls, including process controls (21 CFR 117.135(c)(1)), food allergen controls (21 CFR 
117.135(c)(2)), sanitation controls (21 CFR 117.135(c)(3)), and supply-chain controls (21 CFR 
117.135(c)(4). 
                                                 
2 The requirements for domestic and foreign facilities to register under section 415 of the FD&C Act are established 
in 21 CFR part 1, subpart H. In this document, we refer to those requirements as the section 415 registration 
regulation. 
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2.  Disclosure statement required in the customer provisions of part 117 
Subpart C of part 117 includes several provisions (referred to collectively as customer 
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 address the hazard (21 CFR 117.136(a)(2), (3), and 
(4)). A manufacturer/processor that complies with the customer provisions is not required to 
implement a preventive control for the identified hazard. (In these provisions, customer means 
a commercial customer, not a consumer.) 
One aspect of the customer provisions is a requirement for the manufacturer/processor to 
disclose, in documents accompanying the food, in accordance with the practice of the trade, that 
the food is not processed to control [identified hazard] ((21 CFR 117.136(a)(2)(i), (3)(i), and 
(4)(i)). In this guidance, we refer to this required disclosure as the part 117 disclosure 
statement. 
B. Part 507 
1.  Framework of part 507 
In part 507, we have established our regulation entitled Current Good Manufacturing Practice, 
Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals. Among other 
things, the rulemaking to establish part 507 established new requirements for CGMPs in subparts 
A, B, and F (CGMP requirements) and also established requirements for hazard analysis and 
risk-based preventive controls for food for animals in subparts A, C, 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. The animal 
food preventive controls requirements in part 507 implement the provisions of FSMA, 
established in section 418 of the FD&C Act (21 U.S.C. 350g), for animal food. 
Part 507 includes some exemptions from the CGMP requirements and the animal food 
preventive controls requirements. See 21 CFR 507.5 for those exemptions. 
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 (21 CFR 507.33) and identifies several types of possible preventive 
controls, including process controls (21 CFR 507.34(c)(1)), sanitation controls (21 CFR 
507.34(c)(2)), and supply-chain controls (21 CFR 507.34(c)(3)).  
2.  Disclosure statement required in the customer provisions of part 507 
As with part 117, subpart C of part 507 includes customer provisions that apply when a 
manufacturer/processor of food for animals 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 address the hazard (21 CFR 507.36(a)(2), (3), and (4)). A 
manufacturer/processor that complies with the customer provisions is not required to implement 
a preventive control for the identified hazard.  
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As with part 117, one aspect of the customer provisions applicable to manufacturing/processing 
food for animals is a requirement for the manufacturer/processor to disclose, in documents 
accompanying the animal food, in accordance with the practice of the trade, that the animal food 
is not processed to control [identified hazard] ((21 CFR 507.36(a)(2)(i), (3)(i), and (4)(i)). In 
this guidance, we refer to this required disclosure as the part 507 disclosure statement. 
C. Produce Safety Regulation 
1.  Framework of the produce safety regulation  
In part 112 (21 CFR part 112), we have established our regulation entitled Standards for the 
Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. Among other 
things, the rulemaking to establish the produce safety regulation set forth in a new part 112 
procedures, processes, and practices that minimize the risk of serious adverse health 
consequences or death, including those reasonably necessary to prevent the introduction of 
known or reasonably foreseeable biological hazards into or onto produce and to provide 
reasonable assurances that the produce is not adulterated on account of such hazards. The 
produce safety regulation applies to certain produce farms, and does not apply to activities of 
facilities that are subject to part 117 (as established in part 117). The produce safety regulation 
established in part 112 implements the provisions of FSMA established in section 419 of the 
FD&C Act (21 U.S.C. 350h). 
2.  Disclosure statement required in the commercial processing exemption 
of the produce safety regulation 
The produce safety regulation applies to covered produce as set forth in 21 CFR 112.1 and 
112.2. Produce that would otherwise be covered is eligible for an exemption from the 
requirements of the produce safety regulation if it receives commercial processing that 
adequately reduces the presence of microorganisms of public health significance and certain 
other conditions are met, including the disclosure statement that is the subject of this guidance 
document (21 CFR 112.2(b)). Examples of commercial processing that adequately reduces the 
presence of microorganisms of public health significance are processing in accordance with the 
requirements of 21 CFR part 113, 114, or 120; treating with a validated process to eliminate 
spore-forming microorganisms (such as processing to produce tomato paste or shelf-stable 
tomatoes); and processing such as refining, distilling, or otherwise manufacturing/processing 
produce into products such as sugar, oil, spirits, wine, beer or similar products. In this document, 
we refer to this exemption as the commercial processing exemption from the produce safety 
regulation. 
For the commercial processing exemption to be satisfied, the farm that produces the produce 
must, among other things, disclose in documents accompanying the produce, in accordance with 
the practice of the trade, that the food is not processed to adequately reduce the presence of 
microorganisms of public health significance. In this guidance, we refer to this required 
disclosure as the produce safety regulation disclosure statement. 
  6  Contains Nonbinding Recommendations 
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D. Foreign Supplier Verification Regulation 
1.  Framework of the FSVP regulation  
In part 1, subpart L (21 CFR part 1, subpart L), we have established our regulation entitled 
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals. The 
FSVP regulation requires importers to establish foreign supplier verification programs to verify 
that their foreign suppliers are using processes and procedures that provide the same level of 
public health protection as those required under the provisions on hazard analysis and risk-based 
preventive controls and standards for produce safety in the FD&C Act, that the imported food is 
not adulterated, and that food is not misbranded with respect to food allergen labeling. The FSVP 
regulation established in part 1, subpart L implements the provisions of FSMA established in 
section 805 of the FD&C Act (21 U.S.C. 384a.). 
2.  Disclosure statement required in the customer provisions of the FSVP 
regulation  
The FSVP regulation includes customer provisions that apply when an importer imports a food 
that cannot be consumed without the hazards being controlled or for which the hazards are 
controlled after importation (21 CFR 1.507). One aspect of these provisions is a requirement for 
the importer to disclose to customers that the food is not processed to control [identified 
hazard] (21 CFR 1.507(a)(2)(i), (a)(3)(i), and (a)(4)(i)). In this guidance, we refer to this 
required disclosure as the FSVP regulation disclosure statement.  
III.   Discussion  
A. FDAs Recommendations Regarding the Part 117 Disclosure Statement 
1.  How to describe the identified hazard 
We believe that, in practice, the part 117 disclosure statement will be required mostly for 
biological hazards, because the part 117 disclosure statement only applies when a manufacturing/ 
processing facility has identified a hazard requiring a preventive control, but has not applied that 
preventive control. In the case of most chemical and physical hazards, a chemical or physical 
hazard that a manufacturing/processing facility identifies as requiring a preventive control would 
most likely be controlled by the first manufacturing/processing facility in the supply/distribution 
chain. For example, a corn miller that is the first manufacturer/processor could identify the 
chemical hazard aflatoxin in corn that it receives from a supplier and use physical sorting 
techniques to remove aflatoxin-contaminated corn (or moldy, damaged corn that could 
potentially be contaminated) during processing. Therefore, the miller controls the aflatoxin 
hazard and would not pass the chemical hazard on to a subsequent manufacturer/processor for 
control. Likewise, a manufacturing/processing facility that receives produce RACs likely would 
establish and implement a control for physical hazards such as stones that get into the RACs as a 
result of harvesting.  
  7  Contains Nonbinding Recommendations 
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For biological hazards, we will consider a manufacturing/processing facility that describes the 
identified hazard using a general term (e.g., microbial pathogens, microorganisms of public 
health significance) rather than a specific biological hazard (e.g., Salmonella or Listeria 
monocytogenes) to be in compliance with the requirements for the part 117 disclosure statement. 
Such a statement adequately communicates the key safety information.  Regardless of whether 
the establishment that receives food accompanied by such a disclosure statement is subject to the 
CGMP requirements, the human food preventive controls requirements, or both the CGMP and 
human food preventive controls requirements in part 117, that establishment is responsible for 
taking appropriate steps to ensure that biological hazards applicable to that food are controlled 
before the food reaches the consumer. 
For chemical and physical hazards, a manufacturing/processing facility that chooses to not 
control chemical and physical hazards and to rely on its customers to do so, would be subject to 
the requirements of the part 117 disclosure statement. We expect such a facility to describe the 
identified chemical or physical hazard using a specific term (e.g., mycotoxins, aflatoxin, 
stones) that adequately communicates the key safety information regarding the chemical or 
physical hazard that needs to be controlled. Referring to physical or chemical hazards using a 
general term only does not provide a customer with sufficient information to address the hazard.   
2.  Documents of the trade 
The requirements for the part 117 disclosure statement specify that the disclosure must be made 
in documents accompanying the food, in accordance with the practice of the trade. See 21 CFR 
117.136(a)(2)(i), (a)(3)(i), and (a)(4)(i). This allows for the disclosure statement to be provided 
using a wide variety of types of documents that accompany the food, such as labels, labeling, bill 
of lading, shipment-specific certificates of analysis, and other documents or papers associated 
with the shipment that a food safety manager for the customer is likely to read.  
However, it is not sufficient to reference a website in a document of the trade without including 
the disclosure statement, itself, in the document of the trade. It is permissible, for the purposes of 
the requirements of the part 117 disclosure statement, to use labeling that includes a disclosure 
statement such as not processed to control microbial pathogens and then directs the recipient to 
a website for additional information about those microbial pathogens. 
We do not recommend documents such as contractual agreements, letters of guarantee, 
specifications, or terms and conditions be used to communicate the information required in the 
part 117 disclosure statement. Such documents generally are not specific to a particular 
shipment, and some of these documents may not be available to the customers food safety 
manager. 
B. FDAs Recommendations Regarding the Part 507 Disclosure Statement 
See the discussion in section III.A of our recommendations regarding the part 117 disclosure 
statement. The same discussion and recommendations apply to the part 507 disclosure statement. 
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C. FDAs Recommendations Regarding the Produce Safety Regulation 
Disclosure Statement 
1.  How to describe the identified hazard 
Because both part 117 and part 507 define the term pathogen to mean microorganism of 
public health significance, and because some disclosure statements in accordance with the 
requirements of part 117 or the requirements of part 507 likely will use terms such as microbial 
pathogens, we will consider a farm that discloses not processed to adequately reduce the 
presence of microbial pathogens, or similar phrases, to be in compliance with the requirements 
for the produce safety regulation disclosure statement.  
2.  Documents of the trade 
See the discussion in section III.A of our recommendations regarding the part 117 disclosure 
statement. The same discussion and recommendations apply to the produce safety regulation 
disclosure statement. 
D. FDAs Recommendations Regarding the FSVP Regulation Disclosure 
Statement 
1.  How to describe the identified hazard 
We believe that, in practice, the FSVP regulation disclosure statement will be required mostly for 
biological hazards, because the FSVP regulation disclosure statement only applies when an 
importer has identified a hazard requiring a control, but that control has not been applied prior to 
importation, or by the importer if the importer is a manufacturer or processor. In the case of most 
chemical and physical hazards, a chemical or physical hazard that an importer identifies as 
requiring a control would most likely be controlled by the first manufacturing/processing facility 
in the supply/distribution chain. For example, an animal food vitamin pre-mix manufacturer that 
is a foreign supplier could identify the chemical hazard nutrient toxicity in the vitamin 
ingredients it receives from its supplier.  The pre-mix manufacturer would evaluate the potency 
of the individual vitamin ingredients prior to manufacturing the pre-mix, controlling the nutrient 
toxicity hazard by combining the vitamin ingredients at an appropriate ratio.  In this scenario, the 
pre-mix manufacturer would not pass the chemical hazard on to a future customer for 
control.  Likewise, an importer that is a manufacturing/processing facility that receives produce 
RACs from a foreign supplier likely would establish and implement a control for physical 
hazards such as stones that get into the RACs as a result of harvesting.  
 
For biological hazards, we will consider an importer that describes the identified hazard using 
a general term (e.g., microbial pathogens, microorganisms of public health significance) 
rather than a specific biological hazard (e.g., Salmonella or Listeria monocytogenes) to be in 
compliance with the requirements for the FSVP regulation disclosure statement. Such a 
statement adequately communicates the key safety information. Regardless of whether the 
establishment that receives food from the importer accompanied by such a disclosure statement 
is subject to the CGMP requirements, the preventive controls requirements, or both the CGMP 
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and preventive controls requirements in part 117 or part 507, that establishment is responsible for 
taking appropriate steps to ensure that biological hazards applicable to that food are controlled 
before the food reaches the consumer. 
For chemical and physical hazards, an importer that chooses to rely on its customers to control 
chemical and physical hazards (instead of controlling the hazards itself or verifying that the 
hazards have been controlled prior to importation) would be subject to the requirements of the 
FSVP regulation disclosure statement. We expect such an importer to describe the identified 
chemical or physical hazard using a specific term (e.g., mycotoxins, aflatoxin, stones) that 
adequately communicates the key safety information regarding the chemical or physical hazard 
that needs to be controlled. Referring to physical or chemical hazards using a general term only 
does not provide a customer with sufficient information to address the hazard.   
2.  Documents of the trade 
See the discussion in section III.A of our recommendations regarding the part 117 disclosure 
statement. The same discussion and recommendations apply to the FSVP regulation disclosure 
statement. 
 
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