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Application of the Foreign Supplier Verification 
Program Regulation to Importers of Grain Raw 
Agricultural Commodities: 
 
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 Docket No. 
FDA-2017-D-6592 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 
Office of Regulatory Affairs 
Center for Food Safety and Applied Nutrition 
Center for Veterinary Medicine 
Office of Regulatory Affairs 
 
 
 
 
 
January 2018   
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Table of Contents 
 
I. Introduction 
II. Background 
III. Discussion 
 
     
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Application of the Foreign Supplier Verification 
Program Regulation to  
Importers of Grain Raw Agricultural Commodities: 
 
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 Food and Drug Administrations (FDAs) intent to 
exercise enforcement discretion regarding application of the regulation on foreign supplier 
verification programs (FSVPs) to importers of grains imported into the United States as raw 
agricultural commodities (RACs).  For the reasons stated below, we intend to exercise 
enforcement discretion with respect to the FSVP regulation for importers of grain RACs that are 
solely engaged in the storage of grain intended for further distribution or processing and grain 
importers that do not take physical possession of the grain they import but instead arrange for the 
delivery of the grain to others for storage, packing, or manufacturing/processing (such as certain 
commodity brokers with respect to the FSVP regulation). 
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. 
 
This guidance provides information to facilitate understanding of the applicability of the FSVP 
requirements to the importation of grain RACs.  The pronouns I, me, and you are used in 
this guidance to refer to the importer.  Agency and the pronouns we and our are used to 
refer to FDA.   
 
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II. Background  
 
Many RACs that are not fruits or vegetables, including grains, are imported into the United 
States.  Grain RACs imported into the United States include barley, dent- and flint-corn, 
sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds for oil extraction 
(e.g., cotton seed, flax seed, rapeseed, soybean, sunflower seed).  
Mycotoxin contamination is one of the primary hazards associated with grain RACs.  Some 
grains may also contain other hazards, including microbial pathogens such as Salmonella.  
Grains in which microbial pathogens may be present are usually destined for further processing 
(for example, extraction of oil from oilseeds and cooking of rice) such that these hazards are 
controlled.  Most grains are dried in the field (rice being the exception, being dried following 
harvest) and then stored dry, typically in grain elevators, under conditions that minimize fungal 
growth and mycotoxin production.  Although some controls for mycotoxins in grain crops can be 
applied during cultivation, mycotoxins generally cannot be fully controlled on the farm.   
Therefore, other post-harvest mitigation measures are employed.  These measures include 
moisture and temperature controls to prevent fungal growth and mycotoxin production; sorting to 
remove moldy, discolored, and damaged kernels; and milling grains.  Sampling and analytical 
testing are used as a means of segregating lots with higher and lower mycotoxin concentration as 
appropriate for specific uses.  In the United States, most food facilities have programs for 
mycotoxin control in domestic and imported grains, such as safe practices for storage, drying, 
sorting, and testing of grain.  These programs result in low concentrations of mycotoxins in 
finished grain-based foods.  
 
The importation of grain RACs into the United States is subject to certain supplier verification 
requirements established in the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353).  
FSMA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add, among other 
food safety requirements, provisions requiring the verification of the safety of food imported 
from foreign suppliers of that food.  
 
Section 805(c) of the FD&C Act directs FDA to issue regulations on the content of FSVPs.  We 
issued the FSVP final rule on November 27, 2015 (80 FR 74225).  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 and 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).   
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The FSVP regulation applies (with certain exceptions) to the importation of food as defined in 
section 201(f) of the FD&C Act (except that food for FSVP purposes does not include 
pesticides as defined in 7 U.S.C. 136(u)) (see 21 CFR 1.500).  Thus, the FSVP regulation applies 
to importers of RACs, including RACs that are grains.  
 
FSMA also includes provisions (codified in section 418 of the FD&C Act) requiring certain food 
facilities to implement preventive controls to, among other things, provide assurances that 
hazards identified in a hazard analysis will be significantly minimized or prevented.  The 
preventive controls provisions of FSMA include supplier verification activities as one type of 
procedure, practice, or process that food facilities might need to use as a preventive control to 
significantly minimize or prevent hazards arising in the manufacture, processing, packing, or 
holding of food (section 418(o)(3)(G) of the FD&C Act).  FDAs final rules on current good 
manufacturing practice (CGMP), hazard analysis, and risk-based preventive controls for human 
food (80 FR 55908, September 17, 2015) and for animal food (80 FR 56170, September 17, 
2015) include provisions requiring receiving facilities to conduct a hazard analysis and to 
establish and implement supply-chain programs for domestic and imported raw materials and 
other ingredients for which the facility has identified a hazard requiring a supply-chain-applied 
control (21 CFR part 117, subpart G, and 21 CFR part 507, subpart E, respectively).   
 
Under the supply-chain program provisions of the preventive controls regulations, a receiving 
facility is a facility subject to the preventive controls and supply-chain program requirements 
and that manufactures/processes a raw material or other ingredient it receives from a supplier 
(21 CFR 117.3 and 507.3).  A supply-chain-applied control is a preventive control for a hazard 
in a raw material or other ingredient when the hazard is controlled before its receipt (21 CFR 
117.3 and 507.3).  The supply-chain program requirements include, among other things, 
determining and conducting appropriate supplier verification activities (such as onsite auditing, 
sampling and testing, and review of supplier food safety records) to provide assurance that 
hazards requiring a supply-chain-applied control have been significantly minimized or 
prevented.  Importers of grain RACs that manufacture/process the grain are subject to the 
preventive controls requirements, including the supply-chain program provisions.  In addition, 
under 21 CFR 1.502(c), grain RAC importers that are also receiving facilities subject to the 
preventive controls regulations for human or animal food will be deemed in compliance with 
most of the FSVP requirements when they implement preventive controls for the hazards in the 
grain in accordance with 21 CFR 117.135 (for human food) or 507.34 (for animal food). 
The preventive controls requirements, including the supply-chain program provisions, do not 
apply to facilities that are solely engaged in the storage of non-produce RACs (including grain 
RACs) intended for further distribution or processing (21 CFR 117.5(j) and 507.5(g)).  This 
exemption reflects the Agencys finding that outbreaks of foodborne illness have not been traced 
back to storage facilities solely engaged in the storage of non-produce RACs (see 78 FR 3646 at 
3709, January 16, 2013 and 78 FR 64736 at 64764, October 29, 2013).  Consequently, we 
concluded that subjecting facilities that only store non-produce RACs intended for further 
distribution or processing to the preventive controls requirements would provide no significant 
public health benefit.   
However, as stated above, the FSVP regulation applies to all importers of non-produce RACs, 
including importers that are solely engaged in the storage of these RACs intended for further 
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processing.  Unless exempt from FSVP (under other provisions) or importing the grain under 
modified FSVP requirements (e.g., for very small importers), importers of grain RACs such as 
grain elevators, brokers, and manufacturers/processors may be required to conduct the standard 
FSVP activities, including evaluating and approving a foreign supplier (21 CFR 1.505) and   
conducting foreign supplier verification activities (21 CFR 1.506).1  However, as discussed 
above, suppliers of grain RACs (i.e., farmers) generally do not control the hazards in the grain.  
Therefore, the standard FSVP requirements to evaluate potential foreign suppliers and conduct 
verification of the suppliers generally would not apply to importers of grain RACs.    
 
Rather than the standard FSVP requirements, certain modified requirements would apply when 
there is a hazard in the grain and either of the following is applicable:  
  The grain cannot be consumed without application of an appropriate control (e.g., 
soybeans, which require heat treatment to denature a natural toxin found in soybeans) 
(see 21 CFR 1.507(a)(1)).  The importer would need to document its determination that 
the grain cannot be consumed without application of a control. 
  The importers customer or a subsequent entity will control the hazards in the grain.  In 
such cases, the importer would need to disclose that the grain had not been processed to 
control the identified hazards and obtain written assurance from the customer that the 
customer or some subsequent entity will control the hazards (see 21 CFR 1.507(a)(2)-
(4)).  (We have issued guidance for industry entitled Policy Regarding Certain Entities 
Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce 
Safety, and/or Foreign Supplier Verification Programs stating we are exercising 
enforcement discretion with regard to the written assurance requirements to complete 
rulemaking to address feasibility concerns with the provision (83 FR 598, January 5, 
2018).) 
 
III. Discussion 
 
To better align the FSVP regulation with the exemption from preventive controls requirements 
for facilities solely engaged in the storage of non-produce RACs, and because of the nature of 
the hazards associated with grain RACs and how they are generally addressed in the distribution 
chain, we intend to exercise enforcement discretion for importers of grain RACs that are solely 
engaged in the storage of grain intended for further distribution or processing (in accordance 
with 21 CFR 117.5(j) or 507.5(g)) with respect to the FSVP regulation.  This means that we will 
not expect these FSVP importers of grain RACs (i.e., grain elevators and other facilities solely 
engaged in the storage of grain RACs intended for further distribution or processing) to meet any 
of the FSVP requirements.  However, these grain RAC importers 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)).   
                                                 
1 Other FSVP requirements include, but are not limited to, determining whether there are any 
hazards requiring a control in imported foods (21 CFR 1.504), taking corrective actions (when 
appropriate) (21 CFR 1.508), ensuring that the importer is identified at U.S. entry (21 CFR 
1.509), and recordkeeping (21 CFR 1.510). 
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This intent to exercise enforcement discretion with respect to the FSVP regulation also applies to 
grain importers that do not take physical possession of the grain they import but instead arrange 
for the delivery of the grain to others for storage, packing or manufacturing/processing (such as 
certain commodity brokers).  Thus, if a firm that is the FSVP importer (as defined in 21 CFR 
1.500) of a grain RAC arranges for the distribution of the grain without taking physical 
possession of it (e.g., does not engage in storage, packing, or processing of the grain), we intend 
to exercise enforcement discretion for the FSVP requirements. 
This intent to exercise enforcement discretion with respect to the FSVP regulation for certain 
importers of grain RACs does not apply to importers that manufacture/process grain RACs.  
However, as discussed above, we do not expect FSVP to pose a regulatory burden for these 
manufacturers/processors, because of the nature of the hazards in grain RACs and specific 
provisions already included in the preventive controls regulations for human or animal food 
requiring manufacturers/processors to control the hazards that are identified as requiring a 
preventive control.  The only FSVP requirement that the importer that manufactures/processes 
grain RACs and is also a receiving facility will need to meet is to ensure that it is identified as 
the FSVP importer of the grain at U.S. entry (in accordance with 21 CFR 1.509).  Those 
importers that manufacture/process grain RACs and are not receiving facilities will likely be able 
to use the modified provisions in 21 CFR 1.507 rather than perform supplier verification 
activities. 
When a food product under FDA oversight is offered for entry into the United States, the U.S. 
Customs and Border Protection (CBP) Automated Commercial Environment (ACE) system will 
prompt the filer to transmit an entity role code or affirmation of compliance code related to 
FSVP.  The entity role code FSV indicates that the entry line is subject to the FSVP regulation 
and currently subject to FSVP enforcement, so the importer must provide its name, electronic 
mail address, and unique facility identifier recognized as acceptable by FDA (see 21 CFR 1.509).  
If the food entry line is exempt from the requirements of the FSVP regulation, not yet subject to 
the regulation, or eligible for enforcement discretion with respect to the FSVP regulation, the 
filer should transmit the applicable Affirmation of Compliance code.  FSX should be used if 
FDA has provided guidance that the agency intends to exercise enforcement discretion for the 
relevant shipment with respect to the FSVP regulation.  
 
Therefore, importers of grain RACs that are solely engaged in the storage of grain intended for 
further distribution or processing and grain importers that do not take physical possession of the 
grain they import but instead arrange for the delivery of the grain to others for storage, packing, 
or manufacturing/processing should transmit the affirmation of compliance code FSX when 
making entry in the U.S.  For more information on importer identification, consult Guidance for 
Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign 
Supplier Verification Programs Regulation, available at 
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm556661.htm. 
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