This document is scheduled to be published in the
Federal Register on 11/27/2015 and available online at 
http://federalregister.gov/a/2015-28158
, 
and on 
FDsys.gov
   
4164 -01-P 
DEPARTMENT OF HEALTH AND HUMAN SERVICES  
Food and Drug Administration  
21 CFR Part s 1, 11, and 111  
[Docket No. FDA -2011 -N-0143]  
RIN 0910 -AG64  
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals  
AGENCY:  Food and Drug Administration, HHS.  
ACTION:  Final rule.  
SUMMARY:  The Food and Drug Administration (FDA) is adopting a regulation on foreign 
supplier verification programs (FSVPs) for importers  of food for humans and animals.  The 
regulation require s importers to verify  that food they import into the United States is produced in 
compliance with the hazard analysis and risk -based preventive controls and standards for 
produce safety provisions  of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is not 
adulterated, and is not misbranded with respect to food allergen labeling.  We are issuing th is 
regulation in accordance with the FDA Food Safety Modernization Act (FSMA).  The regulation 
will help ensure the safety of imported food . 
DATES :  This rule is effective [ INSERT DATE  60 DAYS AFTER DATE OF PUBLICATION 
IN THE FEDERAL REGISTER ].  For the applicable compliance dates, see “Effective and 
Compliance Dates” in the Supplementary Information  section of this document . 
ADDRESSES:   For access to the docket to read background documents or comments received, 
go to http://www.regulations.gov  and insert the docket number found in brackets in the heading 2 
 
 
 of this final rule into the “Search” box and f ollow the prompts, and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockvi lle, MD 20852.  
FOR FURTHER INFORMATION CONTACT:  Brian Pendleton, Office of Policy, Food and 
Drug Administration, 10903 New Hampshire Ave., Silver Spring,  MD 20993 -0002, 301 -796-
4614; or Domenic Veneziano, Office of Enforcement and Import Operations (ELEM -3108), 
Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element 
Bldg., Rockville, MD 20857, 301 -796-6673.  
SUPPLEMENTARY INF ORMATION:  
Table of Contents  
Executive Summary  
Purpose and Coverage of the Rule  
Summary of the Major Provisions of the Final Rule  
Modified Provisions for Certain Types of Importers  
Costs and Benefits  
I.  Background  
 A.  FDA Food Safety Modernization Act  
 B.  Stages in the FSVP Rulemaking  
 C.  Summary of the Major Provisions of the Proposed Rule  
 D.  Public Comments  
II.  Legal Authority  
III.  Comments on the Proposed Rule and Supplemental Notice of Proposed Rulemaking  
 A.  Definitions  (§ 1.500)  3 
 
 
  B.  Applicability and Exemptions  (§ 1.501 ) 
 C.  Purpose and Scope of FSVP s (§ 1.502 ) 
 D.  Personnel Developing and Performing FSVP Activities  (§ 1.503)  
 E.  Hazard Analysis  (§ 1.504)  
 F.  Evaluation for Foreign Supplier Approval and Verification  (§ 1.505)  
 G.  Foreign Supplier Verification Activities ( § 1.506)  
 H.  Foods That Cannot Be Consumed Without Control of Hazards and Foods Whose Hazards 
Are Controlled After Importation  (§ 1.507)  
 I.  Corrective Actions and Investigations Into FSVP Adequacy (§ 1.508)  
 J.  Identification of Importer at Entry (§ 1.509)  
 K.  Records ( § 1.510 ) 
 L.  Dietary Supplements and Dietary Supplement Components ( § 1.511 ) 
 M.  Very Small Importers  and Importers of Food From Certain Small Foreign Suppliers  
(§ 1.512 ) 
 N.  Importing a Food  From a Foreign Supplier in a Country With  an Officially Recognized or 
 Equivalent Food Safety System ( § 1.513 ) 
 O.  Consequences of Failure to Comply  With FSVP Requirements  (§ 1.514 ) 
 P.  Other Issues  
IV.  Effective and Compliance Dates  
 A.  Effective Date  
 B.  Compliance Dates  
V.  Executive Order 13175  4 
 
 
 VI.  Economic Analysis of Impact s 
VII.  Analysis of Environmental Impact  
VIII.  Paperwork Reduction Act of 1995  
IX.  Federalism  
X.  References  
Executive Summary  
Purpose and Coverage of the Rule  
This rule  is part of FDA’s implementation of the FDA Food Safety Modernization Act 
(FSMA), which intends to better protect public health by, among other things, adopting a 
modern, preventive, and risk -based approach to food safety regulation.  This rule adopts  
provisions  concerning  FSVPs that importers must create and follow to help ensure the safety of 
imported food.  The regulation  is designed to be flexible based on risk, and the requirements vary 
based on the type of food product (such as processed foods, produc e, and dietary supplements) 
and category of importer.  
Congress required importers to perform risk -based foreign supplier verification activities 
and directed FDA to promulgate regulations on the content of FSVPs in section 301 of FSMA, 
codified in section 805 of the FD&C Act.  The rule requires importers to implement FSVPs to 
provide adequate assurances that the importer’s foreign suppliers produce food in compliance 
with processes and procedures, including risk -based preventive controls, that provide the s ame 
level of public health protection as those required under section 418 (concerning hazard analysis 
and preventive controls) or 419 (concerning produce safety) of the FD&C Act, as appropriate, 5 
 
 
 and in  compliance with sections 402 (concerning adulteration)  and 403(w) (concerning 
misbranding regarding allergen labeling) of the FD&C Act.  
This rule is the result of significant stakeholder engagement.  We took this approach to 
help ensure that the rule achieves its public health goal, reflects industry practice , and strikes the 
right balance between flexibility and accountability.   
Summary of the Major Provisions  of the Final Rule  
We are finalizing a flexible, risk -based approach to foreign supplier verification.  The  
FSVP  regulation focus es on known or reasona bly foreseeable food safety hazards, identified  and 
considered  through a hazard analysis and evaluation process, rather than all adulteration covered 
by the adulteration provisions in section 402 of the FD&C Act.  After considering the comments  
on the prop osed rule and the subsequently revised proposal along with  other stakeholder input, 
we continue to believe that hazard a nalysis , which is well accepted and understood throughout 
the international food safety community, provides the most effective way to im plement a risk -
based framework in which importers can evaluate potential products and suppliers and ensure 
that appropriate verification activities occur.  
The FSVP regulation align s with key components of the food safety plans that facilities 
that manufact ure, process, pack, or hold must establish and follow under FDA’s recently issued 
regulations  on current good manufacturing practice (CGMP) and hazard analysis and risk -based 
preventive controls for human food and animal food ( preventive controls regulatio ns).  In 
particular, th e FSVP final  rule is consistent with the supply -chain  program provisions of those 
regulations  to the extent feasible and appropriate.  The general FSVP framework, together with 
the modified requirements applicable to certain importer s and foods , are intended to be 6 
 
 
 sufficiently general and flexible to apply to a variety of circumstances without being unduly 
burdensome or restrictive of trade.   
Although FSVP requirements apply to most imported food under FDA’s regulatory 
jurisdiction, certain categories of imported food are not covered under the FSVP regulation.  
These exemptions include certain juice, fish, and fishery products (which are already subject to 
verification under FDA’s hazard analysis and critical control point ( HACCP ) regulations  for 
those products ), food for research or evaluation, food for personal consumption, alcoholic 
beverages, food that is transshipped, food imported for processing and future export, food 
exported from  and returned to  the U nited States  without m anufacturing/processing in a foreign 
country , and certain meat, poultry, and egg products regulated by the U.S. Department of 
Agriculture (USDA) . 
In the final rule, we have added new provisions to allow greater flexibility with respect to 
certain requireme nts to better reflect modern food supply and distribution chains.  Under the 
FSVP regulation, importers are responsible for:  
1.  Determining the hazards reasonably likely to cause illness or injury  with each food.  
Importers can conduct their own analysis of the potential hazards with a food or review and 
assess  a hazard analysis conducted by another entity.  
2.  Evaluating the risk posed by a food, using the results of the hazard analysis, and 
evaluating the foreign supplier’s performance.  This evaluation  informs the approval of foreign 
suppliers and the determination of appropriate supplier verification activities.  An importer may 
rely on another entity to conduct this evaluation and to determine the appropriate supplier 7 
 
 
 verification activities as long a s the importer reviews and assesses the evaluation, determination, 
or both, as applicable.  An importer must approve its own foreign suppliers.  
3.  Conducting supplier verification activities.  In general, importers must establish and 
follow written proced ures to ensure they only import foods from foreign suppliers they have 
approved.  However, i mporters may import food from unapproved foreign suppliers, on a 
temporary basis when necessary and appropriate, if they subject the  food from these  suppliers  to 
adequate verification activities before importing  it.    
Importers are responsible for determining and documenting foreign supplier verification 
activities  (as well as the frequency with which those activities must be conducted ) that are 
appropriate to provi de assurance that hazards requiring a control in food are significantly 
minimized or prevented .  Importer s must  conduct supplier verification activities for each foreign 
supplier before importing  a food in to the United States and periodically thereafter.  An importer 
may determine, document, and conduct these activities itself  or may  rely on other entities to 
perform those tasks, as long as the importer reviews and assesses the relevant documentation, 
includi ng the results of supplier verification activities.  
The appropriate verification activities and their frequency will vary depending on the 
food, the foreign supplier, and the nature of the control.  Appropriate verification activities 
include:  onsite audi ting, sampling and testing of a food, review of the foreign supplier’s relevant 
food safety records, and other activities that are appropriate based on the evaluation of the risk 
posed by the food and foreign supplier performance.  
When a hazard in a food will be controlled by the foreign supplier and is one for which 
there is a reasonabl e probability that exposure to the hazard will result in serious adverse health 8 
 
 
 consequences or death to humans or animals, the default appropriate verification activity under 
the regulation is an annual onsite audit  of the foreign supplier .  To provide flexibility even in 
these circumstances, the rule allows for the performance  of a different  supplier verification 
activity and/or less frequent onsite auditing provided  an ad equate written determination is made 
that the other approach will meet the public health purpose of supplier verification.  
4.  Performing appropriate activities in other circumstances.  The final rule also adds 
flexibility and recognizes the reality of mod ern distribution chains by not requiring an importer 
to conduct supplier verification (or evaluate the risk posed by a food and the foreign supplier’s 
performance) when the hazard requiring a control in a food will be controlled by a subsequent 
entity in t he distribution chain  in the United States .  For example, if an importer’s customer will 
control the hazard, the importer can rely on its customer to provide written assurance that the 
food will be processed for food safety  and must disclos e that the food has not been processed to 
control the identified hazard .  If the hazard will be controlled by a subsequent entity in the 
distribution chain, the final rule requires  disclosure that the food has not been processed to 
control the identified hazard  as well as  a series of written assurances starting with assurances 
from the customer to the importer and continuing the obligation to provide written assurance of 
processing for food safety  through out the distribution chain.  We also have provided flexibility 
for an importer  to establish, document, and implement an alternative system that ensures 
adequate control, at a later distribution step, of the hazards in a food product distributed by a 
manufacturing/processing facility.  
5.  Conducting corrective actions.  An i mporter must take appropriate corrective actions 
promptly if it determines that a foreign supplier of a food it imports does not produce the food in 9 
 
 
 compliance with the processes and procedures that provide the same level of public health 
protection as tho se required under section 418 or 419 of the FD&C Act, if either is applicable, or 
produces food that is adulterated under section 402 or misbranded under section 403(w) (if 
applicable) of the FD&C Act.  This determination could be based on a review of cons umer, 
customer, or other complaints related to food safety, verification activities, or other information .  
The appropriate corrective actions will depend on the circumstances but could include 
discontinuing use of the foreign supplier until the problem is  resolved.  
6.  Identifying themselves as the importer of the food for each line of food product 
offered for importation into the United States.  
7.  Retaining records of FSVP activities.  
Modified Provisions for Certain Types of Importers  
The rule provides several exceptions to the standard FSVP requirements for certain types 
of importers.  First, for dietary supplements and dietary supplement components, importers who 
establish and verify compliance with certain specifications (concerning dietary supplement  
components  and packaging ) under the dietary supplement CGMP regulations w ill not be required 
to comply with most of the standard FSVP requirements, including hazard analysis and standard 
supplier verification activities.  The same exception would apply to  importers whose customer is 
required to establish such specifications and verify that they are met, except that the importer 
would have to obtain written assurance that its customer is complying with those requirements.  
In contrast, importers of other  dietary supplements would be required to comply with most of the 
standard FSVP requirements but would not have to conduct hazard analyses, and their supplier 
verification activities would focus on verifying that the supplier is in compliance with the dietary  10 
 
 
 supplement CGMP regulation, rather than verifying that hazards requiring a control are 
significantly minimized or prevented, as required under the standard supplier verification activity 
provisions . 
Second, the rule establishes modified FSVP requirements for very small importers and 
importers of food from certain small foreign suppliers.  We have aligned the definition of “very 
small importer ” with the definitions of “very small business ” under the regulations on preventive 
controls for human food and anim al food .  With respect to the importation of human food, the 
definition of very small importer has an annual sales ceiling  of $1,000,000, which is consistent 
with the $1,000,000 annual sales ceiling  for a very small business under the preventive controls 
for human food regulation .  With respect to the importation of animal food, the definition of very 
small importer has an annual sales ceiling  of $2,500,000, which is consistent with the $ 2,500,000 
annual sales ceiling  for a very small business under the pre ventive controls for animal food 
regulation . 
In addition, f ood from three types of small foreign suppliers is not subject to standard 
supplier verification requirements.  Those foreign suppliers are:  (1) qualified facilities under 
either of the preventive  controls regulations , (2) farms that are not “covered farms” under the 
produce safety regulation in part 112 (21 CFR part 112) in accordance with § 112.4(a), or in 
accordance with §§  112.4(b) and 112.5 , and (3) shell egg producers not subject to part 118 (21 
CFR part 118 ) because the shell egg producer has fewer  than 3,000 laying hens.  Each of these 
types of producers is either exempt from their underlying FDA food safety regulation s or subject 
to modified requirements , mostly , and in some cases  entirely , because of the size of these 
producers . 11 
 
 
 The relatively small volume of food imported by and from these entities  should reduce 
consumers’ exposure to, and potential risk from, th is imported  food.  Therefore , we are 
proposing that in these situations the im porter would not be required to conduct a hazard analys is 
and would be able to verify their foreign suppliers by obtaining written assurance of their 
supplier’s compliance with the applicable food safety  regulations  (or, in some cases, the 
supplier’s ackno wledgement that it is subject to the adulteration provisions of the FD&C Act) .  
This policy is similarly reflected in the supply -chain  program provisions of the preventive 
controls regulation s. 
Third, the rule exclude s from most of the standard FSVP requir ements (including hazard 
analysis and verification that identified hazards are significantly minimized or prevented ) certain 
types of food from a foreign supplier in a country whose food safety system FDA has officially 
recognized as comparable or determin ed to be equivalent to that of the United States, provided 
that: 
The food is within the scope of the relevant  official recognition or equivalency 
determination;  
The importer determines that the foreign supplier of the food is in good compliance 
standi ng with the relevant food safety authority; and  
The food is not intended for further processing in the United States, e.g., packaged 
food products and raw agricultural commodities (RACs) that will not be processed 
further before consumption.  
These provisions are consistent with our risk -based approach to foreign supplier 
verification because they enable both importers and FDA to leverage  the regulatory efforts of 12 
 
 
 food safety a uthorities in countries the Agency  has officially determine d to have  food safety 
systems that are comparable or equivalent to that of the United States.  
Costs and Benefits  
 This final rule requires importers of human and animal food to establish foreign supplier 
verification programs.  It includes requirements regarding us e of qualified individuals, evaluation 
of hazards in food and foreign supplier performance , verification of suppliers ( through activities 
such as onsite audits, testing, and records review ), and importer identification at entry.  The total 
annualized costs  of the final rule are estimated to be approximately $435 million p er year under  3 
percent and 7 percent discount rate s over 10  years.  In the proposed rule’s  Preliminary 
Regulatory Impact Analysis ( PRIA ), we calculated costs under three different scenario s 
reflecting different percentages o f importers who, under proposed Option 2  for supplier 
verification requirements , might choose to conduct onsite audit s of their foreign suppliers rather 
than per form different permitted verification activities.  We prese nt the Scenario 1 estimate 
(under which 63 percent  of the importers we estimated would need to conduct mandatory onsite 
audits of their foreign suppliers under proposed Option 1 would conduct onsite audits under the 
final rule ) as the overall estimate to f acilitate comparison with the summary tabl es in the PRIA 
and the Supplemental PRIA; however, the summary table provide s totals costs under all thre e 
scenarios . 
 
Total Annual Cost Summary for All Elements of Final Rule (rounded to nearest million)  
 Total  
Year 1   13 
 
 
 Hiring Qualified Individuals   
Scenario 1  $34 
Scenario 2  $33 
Scenario 3  $32 
Conducting Information Collection and Food and Supplier Evaluations  $89 
Writing and Maintaining Procedures Relating to Verification Requirements  $51 
Following Procedures Relating to Verification Requirements Including 
Establishing, Maintaining, and Following Procedures to Ensure Receipt of Food 
From Approved Suppliers   
Scenario 1  $245  
Scenario 2  $241  
Scenario 3  $237  
Obtaining Written Assurances From Foreign Suppliers, Customers, and Other 
Entities in U.S. Distribution  $31 
Documenting Very Small Importer or Small Supplier Status  $6 
Conducting Corrective Actions  $1 
Importer Identification  $7 
Grand Total Year 1   
Scenario 1  $464  
Scenario 2  $459  
Scenario 3  $456  14 
 
 
 Every Year After Year 1   
Hiring Qualified Individuals   
Scenario 1  $34 
Scenario 2  $33 
Scenario 3  $32 
Conducting Information Collection and Food and Supplier Evaluations  $74 
Writing and Maintaining Procedures Relating to Verification Requirements  $42 
Following Procedures Relating to Verification Requirements Including 
Establishing, Maintaining, and Following Procedures to Ensure Receipt of Food 
From Approved Suppliers   
Scenario 1  $245  
Scenario 2  $241  
Scenario 3  $237  
Obtaining Written Assurances From Foreign Suppliers, Customers, and Other 
Entities in U.S. Distribution  $23 
Documenting Very Small Importer or Small Supplier Status  $6 
Conducting Corrective Actions  $1 
Importer Identification  $7 
Grand Total Every Year After Year 1   
Scenario 1  $431  
Scenario 2  $426  15 
 
 
 Scenario 3  $422  
 
 
Although the FSVP regulation do es not establish safety requirements for food 
manufacturing and processing, it benefit s the public health by helping to ensure that imported 
food is produced in a manner consistent with other applicable food safety regulations.  The 
Regulatory Impact Analyses for the final rules on preventive controls for human food and 
standards for produce  safety consider and analyze the number of illnesses and deaths that those 
regulations are aimed at reducing.  The greater the compliance with those regulations, the greater 
the expected reduction in illnesses and deaths as well as the costs associated wit h them.  The 
FSVP regulation will be an important mechanism for improving and helping to ensur e 
compliance with the above -noted food safety regulations as they apply to imported food.  For 
this reason, and because we do not have sufficient data to determin e the extent to which 
particular regulations might be responsible for the expected reduction in foodborne illnesses 
resulting from the FSMA final rules, we account for the public health benefits of the FSVP 
regulation in the preventive controls, produce sa fety, and other applicable food safety regulations 
instead of in this final rule.  
I.  Background  
A.  FDA Food Safety Modernization Act  
FSMA (Pub. L. 111 -353), signed into law by President Obama on January 4, 2011, is 
intended to allow FDA to better protect public health by helping to ensure the safety and security 
of the food supply.  FSMA enables us to focus more on preventing food safet y problems rather 16 
 
 
 than relying primarily on reacting to problems after they occur.  The law also provides new 
enforcement authorities to help achieve higher rates of compliance with risk -based, prevention -
oriented safety standards and to better respond to problems when they occur.  In addition, the law 
contains important new tools to better ensure the safety of imported foods and encourages 
partnerships with State, local, tribal, and territorial authorities.  A top priority for FDA are those 
FSMA -required r egulations that provide the framework for industry’s implementation of 
preventive controls and enhance our ability to oversee their implementation for both domestic 
and imported food.  To that end, we proposed the seven foundational rules listed in Table 1 and 
requested comments on all aspects of these proposed rules.   
Table 1. Published Foundational Rules for Implementation of FSMA  
Title  Abbreviation  Publication  
Current Good Manufacturing Practice and Hazard 
Analysis and Risk -Based Preventive Controls f or 
Human Food  2013 preventive controls for 
human food proposed rule  78 FR 3646, January 16, 
2013  
Standards for the Growing, Harvesting, Packing, 
and Holding of Produce for Human Consumption  2013 produce safety 
proposed rule  78 FR 3504, January 16, 
2013  
Current Good Manufacturing Practice and Hazard 
Analysis and Risk -Based Preventive Controls for 
Food for Animals  2013 preventive controls for 
animal food proposed rule  78 FR 64736, October 29, 
2013  
Foreign Supplier Verification Programs for 
Importers of Fo od for Humans and Animals  2013 FSVP proposed rule  78 FR 45730, July 29, 
2013  
Accreditation of Third -Party Auditors/Certification 
Bodies to Conduct Food Safety Audits and to Issue 
Certifications  2013 third -party 
certification  proposed rule  78 FR 45782, July 29, 
2013  
Focused Mitigation Strategies to Protect Food 
Against Intentional Adulteration  2013 intentional 
adulteration proposed rule  78 FR 78014, December 
24, 2013  
Sanitary Transportation of Human and Animal 
Food  2014 sanitary transportation 
proposed  rule 79 FR 7006, February 5, 
2014  
 
We also issued a supplemental notice of proposed rulemaking for the rules listed in Table 
2 and requested comments on specific issues identified in each supplemental notice.  
 17 
 
 
 Table 2. Published Supplemental Notices of Proposed Rulemaking for the Foundational Rules for Implementation of 
FSMA  
Title  Abbreviation  Publication  
Current Good Manufacturing Practice and Hazard 
Analysis and Risk -Based Preventive Controls for 
Human Food  2014 preventive controls for 
human food supplemental 
notice  79 FR 58524, September 
29, 2014  
Standards for the Growing, Harvesting, Packing, 
and Holding of Produce for Human Consumption  2014 produce safety 
supplemental notice  79 FR 58434, September 
29, 2014  
Current Good Manufacturing Practice and Hazard 
Analysis and Risk -Based Preventive Controls for 
Food for Animals  2014 preventive controls for 
animal food supplemental 
notice  79 FR 58476, September 
29, 2014  
Foreign Supplier Verification Programs for 
Importers of Food for Humans and Animals  2014 F SVP supplemental 
notice  79 FR 58574, September 
29, 2014  
 
We finalized two of the foundational rulemakings listed in Table 3 in September 2015.  
Table 3. Published Foundational Rules for Implementation of FSMA  
Title  Abbreviation  Publication  
Current Good Manufacturing Practice and Hazard 
Analysis and Risk -Based Preventive Controls for 
Human Food  preventive controls  for 
human food  final rule  80 FR 55908 , September 
17, 2015  
Current Good Manufacturing Practice and Hazard 
Analysis and Risk -Based Preventive Controls for 
Food for Animals  preventive controls for 
animal food final rule  80 FR 56170 , September 
17, 2015  
 
As we finalize these seven foundational rulemakings, we are putting in place a modern 
framework for food safety that brings to bear the most current science on the regulation of  food 
safety, is risk -based and focuses effort s on known or reasonably foreseeable hazards, and is 
flexible and practical given existing  food safety practices.  To achieve this,  we have  engaged in 
extensive  outreach to the stakeholder community to find the right balance of flexibility and 
accountability  in this regulation .   
Since FSMA was enacted in 2011, we have been involved in approximately 600 
engagements on FSMA and the proposed rules, including public  meetings, webinars, listening 
sessions, farm tours, and extensive presentations and meetings with various stakeholder groups 
(Refs. 1-3).  As a result of this stakeholder dialogue, we decided to issue the four supplemental 18 
 
 
 notices of proposed rulemaking t o announce several changes to our proposals, share our current 
thinking on key issues , and get additional stak eholder input on those issues.  As we move 
forward into the next phase of FSMA implementation, we intend to continue this dialogue and 
collaborati on with our stakeholders, through guidance, education, training, and assistance, to 
ensure that everyone understands and engages in their role in food safety.  We believe these 
seven foundational final rules will effectively implement  the paradigm shift to ward prevention 
envisioned in FSMA and be a major step forward for food safety that will help protect consumers 
into the future.   
B.  Stages in the FSVP Rulemaking  
Section 301 of FSMA added section 805 to the FD&C Act (21 U.S.C. 384a) to require 
persons who import food into the United States to perform risk -based foreign supplier 
verification activities.  Section 805(c) of the FD&C Act directs FDA to issue regulations on the 
content of FSVPs.  
We published a proposed rule on FSVPs in 2013  (78 FR 45730, Jul y 29, 2013).  We 
published new and re vised  provisions in a 2014  supplemental notice  of proposed rulemaking 
(Supplemental Notice) (79 FR 58574, September 29, 2014) .  In the Supplemental Notice, we 
reopened the comment period on the proposed rule only with respect to specific proposed 
provisions.  In addition, we emphasized that the re vised  provisions we included in the regulatory 
text were based on a preliminary review of the comments.   
In this document, we use the term s “FSVP proposed regulation s” or “proposed rule” to 
refer to the complete proposed regulatory text, including both the proposed provisions we 
published in the 2013 proposed rule and the new and re vised  provisions we published in the 2014 19 
 
 
 Supplemental Notice.  We use the terms “2013 FSVP proposed rule” and “ Supplemental Notice ” 
to refer to specific text published in those documents .  We use the terms “ FSVP regulation ,” 
“final rule,”  and “this rule” to refer to the regulation we are establishing as a result of this 
rulemaking.  We also  use the term “ preventive controls regulations” to refer to the regulations on 
preventive controls for human food and preventive controls for animal food collectively.  
C.  Summary of the Major Provisions of the Proposed Rule 
 The proposed FSVP regulation , set forth in proposed subpart L of part 1 (21 CFR part 1), 
would require importers of most imported food to take risk -based steps to verify that the food 
they import is produced in compliance with applicable FDA regulatory requirements.  The 
proposed reg ulation w as intended to work in tandem with provisions of FSMA and the FD&C 
Act to create a more seamless system of food safety, applicable to both domestic and imported  
food, that provides appropriate layers of protection for U.S. consumers.  At its core,  FSMA 
establishes a preventive and risk -based approach that assigns to the food industry the primary 
responsibility for food safety.  For example, FSMA requires food facilities that manufacture, 
process, pack, or hold food to implement risk -based preventiv e controls (in section 103 of 
FSMA, codified in section 418 of the FD&C Act  (21 U.S.C. 350g) ), with certain exceptions.  
FSMA also requires FDA to establish science -based, minimum standards for farms that grow, 
harvest, pack, and hold certain produce, also  with certain exceptions (in section 105 of FSMA, 
codified in section 419 of the FD&C Act  (21 U.S.C. 350h) ).  The intent of these requirements is 
to ensure that all segments of the food industry meet their responsibilit ies under the FD& C Act 
to produce safe food.    20 
 
 
 While FSMA grant s FDA additional enforcement tools and directs the Agency  to 
increase its inspections of food facilities, Congress determined that more was needed to 
adequately control the safety risks posed by  import ed food .  Thus, FSMA creates new 
obligations for food import ers.  The FSVP proposed regulation  was intended to ensure that 
importers take responsibility for the safety of the food they import into the United States so no 
food safety gaps exist between foreign produ cers and U.S. consumers.   
Through this and other FSMA regulations, we are  establishing a modern, risk -based food 
safety system designed to hold those in the food safety supply chain accountable for meeting 
their responsibilities.  In doing so, we recogniz e the variability within the food industry  of the 
size of operations and the type and volume of foods produced .  Therefore,  we have  written 
regulations that provide  a flexible approach to food safety, taking into account the risk posed by 
the food  and the size of the regulated business es.  While these regulations establish strong, risk -
based food safety standards, they allow firms  flexibility  in determining how they will meet these 
standards , as appropriate .   
In accordance with FSMA, t he FSVP regulation we  proposed would require food 
importers to adopt programs to ensure that the food they import:  (1) is produced in a manner that 
provides the same level of public health protection as required under  section 418 or 419 of the 
FD& C Act, as appropriate; (2) is not adulterated under section 402 of the FD&C Act  (21 U.S.C. 
342); and (3) is not misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)) 
(concerning allergen labeling).  The proposed rule would require importers to  take the following 
actions as part of their FSVPs:  
Use a qualified individual to perform most FSVP activities ; 21 
 
 
 Analyze known or reasonably foreseeable hazards in foods they import to determine 
if the hazards are significant ; 
Determine and perform ve rification activities for foods they import, based on the 
hazard analysis and an evaluation of supplier risks ; 
Establish and follow procedures to ensure they import foods only from foreign 
suppliers they have approved (except, when necessary and appropri ate, from 
unapproved suppliers on a temporary basis) ;   
Review complaints, conduct investigations of adulterated or misbranded food, take 
corrective actions when appropriate, and modify the FSVP when it is determined to 
be inadequate ; 
Reassess the effe ctiveness of the FSVP ; 
Ensure that information identifying the importer is submitted upon entry of a food 
into the United States ; and  
Maintain records of FSVP procedures and activities.  
In addition to these “standard” FSVP requirements that would apply  to most food 
importers, the proposed rule included modified requirements for the following:  
Importers of dietary supplements and dietary supplement components ; 
Very small importers and importers of food from very small suppliers ; and  
Importers of food from foreign suppliers in countries whose food safety systems FDA 
has officially recognized as comparable or determined to be equivalent to the U.S. 
food safety system.  22 
 
 
 D.  Public Comments  
We received more than 300 public submissions on the 2013  FSVP  proposed rule and 
more than 100 public submissions on the 2014 Supplemental Notice, each containing one or 
more comments  on various aspects of the proposal .  We received submissions from diverse 
members of the public, including  the following:  I mporters; coalitions; trade organizations; 
consulting firms; law firms; academia; public health organizations; public advocacy groups; 
consumers; consumer groups; Congress ; Federal, State, local, and tribal Government Agencies; 
foreign governments; and other organiz ations.  The c omments address virtually every provision 
of the FSVP proposed rule.  In the remainder of this document, we describe these comments, 
respond to them, and explain any changes  we made to the proposed regulation .   
Some comments address issues t hat are outside the scope of this rule making .  For 
example, we received comments asking that we increase the frequency and standardization of 
our inspection of foreign food facilities, improve our entry review procedures, and revise the 
Reportable Food Reg istry.  We do not discuss such comments in this document.  
II.  Legal Authority  
On January 4, 2 011, FSMA was signed into law.  Section 301 of FSMA added section 
805 to the FD&C Act to require persons who import food into the United States to perform risk -
based foreign supplier verification activities for the purpose of verifying the following:  (1) The 
food is produced in compliance with section 418 (concerning hazard analysis and risk -based 
preventive controls) or 419 (concerning standards for the safe prod uction and harvesting of 
certain fruits and vegetables that are RACs) of the FD&C Act, as appropriate; (2) the food is not 
adulterated under section 402 of the FD&C Act; and (3) the food is not misbranded under section 23 
 
 
 403(w) of the FD&C Act (concerning fo od allergen labeling).  Section 805(c) of the FD&C Act 
directs FDA to issue regulations on the content of FSVPs.  Section 805(c)(2)(A) states that these 
regulations must  require that the FSVP of each importer is adequate to provide assurances that 
each of the importer ’s foreign suppliers produces food in compliance with processes and 
procedures, including risk -based preventive controls, that provide the same level of public health 
protection as those required under section 418 or 419 of the FD&C Act, as app ropriate, and in 
compliance with sections 402 and 403(w) of the FD&C Act.  Section 805(c)(2)(B) states that 
these regulations must  include such other requirements as FDA deems necessary and appropriate 
to verify that food imported into the United States is  as safe as food produced and sold within the 
United States.  
Section 805(c)(3) of the FD&C Act directs FDA to, as appropriate, take into account 
differences among importers and types of imported food, including based on the level of risk 
posed by the impor ted food.  Section 805(c)(4) states that verification activities under FSVPs 
may include monitoring records for shipments, lot -by-lot certification of compliance, annual 
onsite inspections, checking the hazard analysis and risk -based preventive control pla ns of 
foreign suppliers, and periodically testing and sampling shipments of imported products.  Section 
805(d) states that records of an importer related to a foreign supplier verification program must  
be maintained for a period of not less than 2 years an d must  be made available promptly to a 
duly authorized representative of the Secretary of the Department of Health and Human Services 
(the Secretary) upon request.  Section 805(g) directs FDA to publish and maintain a list of 
importers participating under section 805 on the Agency ’s Web site.  24 
 
 
 Section 301(b) of FSMA amends section 301 of the FD&C Act (21 U.S.C. 331) by 
adding section 301(zz), which designates as a prohibited act the importation or offering for 
importation of a food if the importer (as define d in section 805 of the FD&C Act) does not have 
in place an FSVP in compliance with section 805.  In addition, section 301(c) of FSMA amends 
section 801(a) of the FD&C Act (21 U.S.C. 381(a)) by stating that an article of food being 
imported or offered for import into the United States must  be refused admission if it appears 
from an examination of a sample of such an article or otherwise that the importer is in violation 
of section 805.  
In addition to the authority specified in section 301 of FSMA to issue t his regulation, 
section 701(a) of the FD&C Act (21 U.S.C. 371(a)) gives us the authority to issue  regulations for 
the efficient enforcement of the FD&C Act.  Also, some aspects of the FSVP regulation are 
supported by section 421(b) of the FD& C Act (21 U.S.C. 350j(b)).   
In addition to the FD&C Act, FDA’s legal authority for some aspects of the regulations 
derives from the Public Health Service Act (PHS Act) to the extent such measures are related to 
communicable disease.  Authority under the P HS Act is derived from the provisions of sections 
311, 361, and 368 (42 U.S.C. 243, 264, and 271) that relate to communicable disease.  The PHS 
Act authorizes the Secretary  to make and enforce such regulations as “are necessary to prevent 
the introduction,  transmission, or spread of communicable diseases from foreign countries into 
the States * * * or from one State *  * * into any other State” (section 361(a) of the PHS Act) ( see 
section 1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. 202 for transfer of authorit y from the Surgeon 
General to the Secretary) .    25 
 
 
 III.  Comments on the Proposed Rule and Supplemental Notice of Proposed Rulemaking  
A.  Definitions (§ 1.500)  
We proposed to codify definitions of several terms that we use in the FSVP regulation.  
As discuss ed in the following paragraphs, we have revised several of the proposed definitions in 
response to comments we received.  The definitions for terms used in the FSVP regulation are 
set forth in § 1.500.  
1.  Definitions Generally  
 (Comment  1)  Some comments suggest that we use the same definition for terms used in 
different FSMA rulemakings.  
 (Response  1)  We agree and have align ed the definitions used in the different regulations 
as much as possible.  However, in some cases the definitions of terms differ be cause of 
differences in the applicable statutory provisions or in the scope or purpose of the regulations.  
2.  Audit  
 We proposed to define “audit” as the systematic, independent, and documented 
examination (through observation, investigation, records revi ew, and, as appropriate, sampling 
and laboratory analysis) to assess a foreign supplier’s food safety processes and procedures.  
 On our own initiative,  we have changed the definition to refer to an “audited entity” 
rather than a “foreign supplier” because in some cases an importer might conduct (or rely on the 
results of) an onsite audit of an entity other than the foreign supplier (such as a foreign sup plier’s 
supplier) to meet FSVP requirements.   In addition, consistent with auditing practice we have 
added discussions with employees of the audited entity to the list of activities that might be 
included in an audit.  26 
 
 
  (Comment  2)  One comment recommends that we interpret an “independent” 
examination as including audits other than third -party audits, such as audits conducted by the 
importer or the importer’s customer.  
 (Response  2)  To the extent the comment is requesting that the definition of the term 
“audit” allow an importer to rely on an audit conducted by the importer itself, we agree.  To the 
extent, however, the comment is requesting that there be no requirements for the independence 
of auditors, we disagree.  Any qualified auditor conducting an aud it relied upon by an importer 
would need to meet the requirements for independence set forth in §  1.506(e)(4), discussed in 
section III. G.7 of this document.  Note, however, that under §  1.506(e)(2)(i) an importer cannot 
rely on a supplier’s self -audit to fulfill the importer’s requirement to conduct supplier 
verification under §  1.506 (because the supplier would  have an inherent  conflict of interest 
regarding the audit results ). 
 (Comment  3)  One comment requests that sampling and laboratory analysis not b e 
specified as a potential component of an audit because they are separate verification activities.  
 (Response  3)  While  sampling and laboratory analysis  might  in some instances be 
conducted instead of an audit or other verification activities, we do not a gree that sampling  and 
laboratory analysis  cannot also be  included as  a component of an audit.  A qualified auditor 
might reasonably determine that it is appropriate to include some sampling and testing of a food 
or raw material or other ingredient as part  of an onsite audit of a foreign supplier.  
3.  Environmental Pathogen  
We proposed to define “environmental pathogen” as a pathogen that is capable of 
surviving and persisting within the manufacturing, processing, packing, or holding environment 27 
 
 
 such that f ood may be contaminated and may result in foodborne illness if that food is consumed 
without treatment to significantly minimize or prevent the environmental pathogen.  The 
proposed definition also specified that environmental pathogens do not include the spores of 
pathogenic sporeformers.  To provide additional clarity, the final rule specifies in the definition 
that examp les of environmental pathogens include Listeria monocytogenes  and Salmonella  spp.  
 (Comment  4)  Some comments suggest that instead of a “pathogen,” the definition of 
environmental pathogen should refer to “pathogenic bacteria” because the latter term is considered 
more relevant to protecting food safety.  
 (Response  4)  We do not agree.  Pathogens other than bacteria might be capable of 
surviving in a manufacturing environment, cause food to be contaminated, and result in 
foodborne illness.  
4.  Farm  
 We are adding a definition of “farm” to the final rule.  A “farm” is a farm as defined in 
§ 1.227 (2 1 CFR 1.227) in the regulation on registration of food facilities.  
5.  Farm Mixed -Type Facility  
 We are adding a definition of “farm mixed -type facility” to the final rule.  A “farm 
mixed -type facilit y” is an establishment that is a farm but that also cond ucts activities  outside the 
farm definition  that require the establishment to be registered under section 415 of the FD&C 
Act (21 U.S.C. 350d) . 28 
 
 
 6.  Food  
We proposed to define “food” as having the meaning given in section 201(f) of the 
FD&C Act  (21 U.S.C. 3 21(f)) , except that food would not include pesticides as defined in 7 
U.S.C. 136(u).  
 (Comment  5)  Several comments request that we exclude food contact substances from 
the definition of food because facilities that manufacture, process, pack, or hold food  contact 
substances are not required to register with FDA and therefore are not subject to the proposed 
regulations on preventive controls.  One comment suggests that we either exclude food 
packaging from the FSVP regulation or establish modified requireme nts for packaging.  
 (Response  5)  We do not agree that it is appropriate to exclude food contact substances 
(including food packaging), as defined in section 409(h)(6) of the FD&C Act (21 U.S.C. 
348(h)(6)), from the definition of “food” for FSVP purposes .  The definition of “food” in 
§ 1.227, for the purposes of food facility registration, excludes food contact substances as 
defined in section 409(h)(6) of the FD&C Act.  Consequently, a facility that 
manufactures/processes, packs, or holds food contact subs tances is not required to be registered. 
Because section 418 of the FD&C Act only applies to establishments that are required to register, 
facilities involved in the manufacturing/processing, packing, and holding of food contact 
substances are not subject to the preventive control regulations implementing section 418.  
Section 805 of the FD&C Act, however, is not similarly limited to facilities that are required to 
register.  Instead, section 805 applies to imports of “food.”  The term “food” is defined in section 
201(f)(3) of the FD&C Act to include articles used as components of food, and the case law 
interpreting the definition makes clear that many substances that meet the definition of food 29 
 
 
 contact substances under section 409(h)(6) of the FD&C Act also  meet the definition of food  
(see, e.g., Natick Paperboard  v. Weinberger , 525 F.2d 1103 (1st Cir . 1975) (paperboard 
containing PCBs intended for food use is adulterated food); U.S. v. Articles of Food 688 Cases 
of Pottery (Cathy Rose) , 370 F. Supp. 371 (E. D. Mi. 1974) (ceramic pottery that leaches lead is 
adulterated food) ).  Further, we do not believe there is any evidence that Congress intended to 
exclude food contact substances from being considered “food” for purposes of section 805 and 
the FSVP regulat ion.  
 (Comment  6)  Several comments request that we add raw materials and other ingredients 
to the definition of food for clarity and for consistency with the definition of food in the 
preventive controls regulations.  
 (Response  6)  We conclude that the suggested change is unnecessary because the 
definition of food in section 201(f) of the FD&C Act, which we are incorporating in the FSVP 
regulation, defines food as including articles used for components of any such food or drink for 
man or animals, which includes raw materials and other ingredients.  
 (Comment  7)  One comment states that chemicals used in processing foods (e.g., 
hydrochloric acid in the production of cheese) that are declared as food -grade most likely will be 
used in food production but so metimes will not be used for such purposes.  The comment asks 
that we provide guidance on how to address such imported chemicals.  
 (Response  7)  As explained in section III.B .9 of this document , substances such as 
chemicals that are capable of food and non -food use are subject to the FSVP regulation if they 
are reasonably likely to be directed to a food use.  In the example provided by the comment, the 
application of the FSVP regulation would no t be based solely on whether a substance is declared 30 
 
 
 as food -grade.  However, we would consider the fact that the chemical is declared as food -grade 
in determining whether the chemical is reasonably likely to be directed to a food use.    
7.  Foreign Suppl ier 
We proposed to define “foreign supplier” as, for an article of food, the establishment that 
manufactures/processes the food, raises the animal, or harvests the food that is exported to the 
United States without further manufacturing/processing by another establishment, except for 
further manufacturing/processing that consists solely of the addition of labeling or any similar 
activity of a de minimis nature.  
In the preamble to the proposed rule, we stated that the proposed definition of foreign 
supp lier was generally consistent with the definition of a foreign facility under the preventive 
controls section (section 418) of the FD&C Act.  However, we stated that the proposed definition 
of foreign supplier did not include firms that only pack or hold f ood, with no or de minimis 
manufacturing/processing (even if the firm is required to register with FDA under section 415 of 
the FD&C Act) because we tentatively concluded that Congress intended the importer to verify a 
single foreign supplier for a particu lar shipment of a food and, when several entities are required 
to register as foreign facilities with respect to this food, excluding a subsequent registered packer 
or holder who does not do any significant manufacturing/processing would be consistent with  
this intent.  We also stated that the proposed exclusion from the definition of foreign supplier of 
any establishment engaging in further manufacturing/processing of a food that consists solely of 
the addition of labeling or any similar activity of a de m inimis nature was consistent with FDA 
regulations on the registration of foreign food facilities  in subpart H of part 1  (see 21 CFR 
1.226(a)).   31 
 
 
  (Comment  8)  Several comments oppose the proposed definition of foreign supplier 
because they believe it would  require importers to go more than “one step back” in the supply 
chain to conduct supplier verification.  The comments maintain this would be inconsistent with 
section 204(d)(1)(L)) of FSMA and the section 414 of the FD&C Act (21 U.S.C. 350c)) .  The 
commen ts assert that, when foods are obtained from entities such as brokers, distributors, and 
consolidators, rather than the entity that manufactured/processed, raised, or harvested the food, it 
would be difficult for the importer to know the identity of the pr oducer because the consolidator 
might refuse to reveal this information due to concern that the importer might decide to buy 
directly from the producer in the future.  The comments also maintain that in these 
circumstances, particularly with consolidated o r commingled RACs, it would be impractical and 
burdensome to have to conduct supplier verification of the original producer of the food and 
could result in multiple audits of the same farm or manufacturer.  Therefore, some comments 
request that we define t he foreign supplier as the immediate previous source of an imported food.   
The comments assert that under this definition, importers would conduct verification activities to 
assess the supplier’s ability to verify that its suppliers (growers or manufacture rs) were 
producing food consistent with U.S. requirements.   
 (Response  8)  Although we understand the concerns related to obtaining food from an 
entity that did not manufacture/process, raise, or harvest the food, such as distributors, 
warehouses, and con solidators of RACs, we decline to revise the definition of foreign supplier as 
suggested.  The other FSMA and FD&C Act  provisions noted by the comments were enacted to 
serve different purposes than the FSVP provisions.  Section 805(c)(2)(A) of the FD&C Act  
specifically directs FDA to adopt regulations requiring that each importer’s FSVP is adequate to 32 
 
 
 provide assurances that “the foreign supplier to the importer produces  the imported food” 
(emphasis added) in compliance with the applicable U.S. standards.  Therefore, we conclude that 
Congress did not intend supplier verification  to be conducted for  entities  that only perform 
activities of a de minimis nature with respect to the imported food.  Consequently, we conclude 
that it would not be appropriate to define “foreign supplier” so that the importer would be 
conducting supplier verification of an entity in the supply chain that did not perform any 
significant processing s tep, such as distributors and some consolidators of RACs.   
 However, we understand that the requirement to perform sup plier verification on the 
establishment  that manufactures/processes, raises, or grows  the imported food could impose a 
greater burden on importers when the foreign supplier is not the immediate source of the 
imported food, such as the case with consolidated RACs.  To address this concern, we have 
revised the provisions on hazard analysis, evaluation for foreign supplier approval and 
verific ation, and supplier verification activit ies to allow an importer of a food to obtain 
information needed to meet certain FSVP requirements from other entities, such as a distributor 
or consolidator of that food.  As discussed in sections III. E.5, III.F.4, and III. G.4 of this 
document, an importer may review and assess hazard analyses, evaluations of the risk posed by a 
food and the foreign supplier’s performance, determinations of appropriate foreign supplier 
verification activities, and results of such acti vities conducted by other entities for an imported 
food to meet its FSVP requirements in these areas.  We anticipate that many importers will be 
able to rely on activities conducted by other entities, which will r educe the need for importers to 
directly ve rify t he compliance of producers from which  the importers did not directly purchase 
the imported food .  We conclude that this approach to foreign supplier verification ensures that 33 
 
 
 the FSVP requirements are consistent with FSMA while limiting the burden th at otherwise might 
be imposed on importers when the foreign supplier of a food is not the importer’s direct source 
for the food.  
 (Comment  9)  One comment states that firms that pack or hold food products (other than 
of de minimis value) could introduce hazards during these operations.  The comment maintains 
that the proposed definition of foreign supplier conflicts with the definition of facility in the 
FD&C Act and appears contrary to the intent of ensuring the safety of imported food.  One 
comment asks  that we revise the definition of foreign supplier to clarify that, in addition to an 
entity that harvests a food, a foreign supplier m ight be the establishment that owns (or owns and 
packs) a harvested food.  
 (Response  9)  We decline to change the definit ion of foreign supplier to include entities 
that only own, pack, or hold food.  We conclude  that defining foreign supplier to include a firm 
that only owns or packs or holds a food would not be consistent with Congressional intent , 
because it would have th e effect of requiring  that importers verify the establishment  that merely 
owns, packs, and/or holds a food --as opposed to the establishment  that “produces” a food.  As 
stated previously, in enacting section 805(c)(2)(A) of the FD&C Act, Congress specifical ly 
directed us to adopt regulations requiring that each importer’s FSVP is adequate to provide 
assurances that “the foreign supplier to the importer produces  the imported food” (emphasis 
added) in compliance with the applicable U.S. standards .  
(Comment  10)  Two comments request that we revise the definition of foreign supplier to 
include an exception for activities conducted on RACs that do not change the RAC into 
processed food.   The comments maintain that farms that grow and harvest produce should not be  34 
 
 
 regarded as foreign suppliers if the produce is sent to a packing operation that is not part of the 
farm before the produce is exported.   The comments assert that because the packing operation is 
a separate entity from the farm, the activities performed a t the packing operation (such as 
washing and grading) should be considered manufacturing/processing by another 
establishment.   The comments ask that we revise the definition of foreign supplier as follows:  
•  Specify that activities with RACs that do not c hange the RAC into processed food 
would not constitute further manufacturing/processing that would make an establishment a 
foreign supplier.  
•  State that when an entity aggregates a RAC from multiple farms without changing the 
RAC into processed food, the  aggregator and the farm that produced the RAC will both be 
considered foreign suppliers.  
 (Response  10)  We decline to revise the definition of foreign supplier as requested.   In 
general, though not always, an entity between the farm and the importer that performs an activity 
that does not change a RAC into processed food would not be the foreign supplier of the RAC 
because, in most but not all cases, that entity would most likely not be manufacturing/processing 
the RAC but would only be packing or holding the RAC.   For example, a packing operation that 
is a separate entity from a farm that only washes and grades produce RACs incidental to packing 
and holding the RACs is not manufacturing/processing the RACs but only packing and holding  
them .     
We also conclude it would not be consistent with FSMA to designate multiple foreign 
suppliers of the same food, which would result by specifying that both the aggregator in the 
example and the farm that grew  the RAC would be foreign suppliers of that RAC.   If an 35 
 
 
 aggregator is merely packing and/or holding RACs, and not performing 
manufacturing/processing (and no othe r foreign entity is doing more than de minimis 
manufacturing/processing of the food before export), then the farm that grew  the RAC would be 
the foreign supplier of the RAC.  
 (Comment  11)  One comment asks that we clarify whether food facilities required t o 
register, such as  off-farm packing houses, are foreign suppliers.  This comment also asks whether 
farms that are not required to register and that have on -farm packing operations  are foreign 
suppliers.   Noting that RACs often are harvested by a contract harvest company, the comment 
also asks us to clarify what is meant by “establishment that harvests a food” and whether, in such 
circumstances, the foreign supplier of the RAC would be the contract harvest company or the 
establishment that owns the crop and  sells it to an importer.  
            (Response  11)  The foreign supplier of a crop that is grown and harvested would either be 
the establishment  that grew the food or, if another foreign entity later manufactured/processed 
the food (performing an activity  of a more than de minimis nature), the foreign supplier would be 
the last entity in a foreign country that performed such a manufacturing/processing activity. 
Because, as previously stated, the definition of foreign supplier does not include firms that on ly 
pack or hold food, off -farm packing houses that solely pack or hold food would not be foreign 
suppliers.  In such cases, assuming that no other foreign entity manufactures/processes the food 
(performing an activity of more than a de minimis nature) afte r it is grown, the farm that grows 
the food is the foreign supplier.   Similarly, provided that no foreign entity 
manufactures/processes the food (performing an activity of more than a de minimis nature) after 36 
 
 
 it is grown, farms that grow food and also have  on-farm packing operations are foreign suppliers 
of the food they grow because they grew the food.   
Our consideration of the comment on contract harvesting, and of comments we received 
on the definition of “farm” in the rulemaking on preventive controls for human food, has led us 
to change the definition of foreign supplier as it relates to farming operations and to make other 
changes to clarify the importer’s responsibilities when multiple entities in its supply chain 
control different hazards in the sam e food.  The definition of “farm” in the proposed rule on 
preventive controls for human food referred to an entity “devoted to the growing and harvesting 
of crops, the raising of animals (including seafood), or both” (78 FR 3646 at 3795 , January 16, 
2013 ) (emphasis added) .  However, as discussed in the preamble to the final rule on preventive 
controls for human food, farming operations can take diverse forms, including those in which 
multiple growers share ownership of a packinghouse and those in which sep arate operations 
grow and harvest a crop  (80 FR 55908 at 55926 to 55927, September 17, 2015) .  Therefore, the 
definition of farm in §  1.227 (which is included in the definitions applicable to the FSVP 
regulation under §  1.500 of the final rule) refers to a  “primary production farm” as an operation 
devoted to the “growing of crops, the harvesting of crops, the raising of animals (including 
seafood), or any combination of these activities.”  This change to the definition of farm 
accommodates business models i n which growing, harvesting, and packing operations --each of 
which requires the application of controls --are conducted by different business entities.   
 When we referred, in the FSVP proposed rule, to an establishment  that “harvests the 
food” as being the  foreign supplier, we assumed that the grower of a food was also the harvester, 
and because harvesting followed growing, it was appropriate to refer to the harvesting, rather 37 
 
 
 than growing, of a food in the definition of foreign supplier.  However, as noted  by the comment 
and discussed in the previous paragraph, a food is not always grown and harvested by the same 
establishment .  Given the possibility that the growing and harvesting of a food might be 
conducted by separate entities, we conclude that, fo r pur poses of the definition of “foreign 
supplier,” it is appropriate to regard the grower of a food, rather than the harvester, as the foreign 
supplier of the food.  Although there are some hazards that must be controlled during harvesting 
(e.g., worker hygien e, water quality), we believe that most people would regard the farm that 
grows a crop as the producer of the food rather than the establishment  that harvests the crop.  
Given the potential complexities associated with different harvesting contractual rela tionships, 
the grower of a crop may be more easily identifiable than the harvester.  In addition, making the 
grower the foreign supplier facilitates onsite auditing of the supplier because there is a clearly 
defined physical location for the farm on which the crop is grown, while the entity conducting 
harvesting might not own or have control over the site at which harvesting occurs (e.g., mobile 
harvesting operations).  
This change in the definition of foreign supplier from the harvester of a food to the 
grower of the food means that, when food is harvested on a farm by a contract harvest company, 
even one that takes ownership of the food, the grower of the food would be the foreign supplier 
(provided that no other foreign entity manufactures/processes the fo od by performing an activity 
of more than a de minimis nature).   
Although the final rule defines the grower of a food, rather than the harvester, as the 
foreign supplier, the importer still must obtain assurances that hazards associated with the 
harvestin g and packing of food are being significantly minimized or prevented .  Without such 38 
 
 
 assurances, we conclude that an importer could not meet its obligation under section 805(a)(1)  of 
the FD&C Act of verifying that imported food is produced in compliance wit h sections 418 and  
419, as app licable, and that such food is not adulterated under section 402 or misbranded with 
respect to allergen labeling under section  403(w) .  We address this issue further in the discussion 
of the determination of appropriate supplier verification activities in section III.G.4 of this 
document.  
  (Comment  12)  One comment asks that we clarify how the definition of foreign supplier 
compares to the definitions of “grower” and “manufacturer” in the prior notice regulation.  The 
comment asks whether the terms grower and manufacturer, collectively, equate to the term 
foreign supplier.  The comment notes that “gr ower ” is defined in the prior notice regulation (21 
CFR part 1, subpart I) in 21 CFR 1.276(b)(7) as a person who engages in growing and harvesting 
or collecting crops (including botanicals), raising animals (including fish, which includes 
seafood), or both; “manufacturer” is defined in § 1.276(b)(9) as the last facility (as defined in 
§ 1.227) that manufactured/processed the fo od.  Under §  1.227, a facility is considered the last 
facility even if the food undergoes further manufacturing/processing that consists of adding 
labeling or any similar activity of a de minimis  nature.   
 (Response  12)  As previously stated, the final ru le defines the foreign supplier of a crop 
as the grower of the food rather than the harvester.  Consequently, with respect to food that is 
grown, the definition of “foreign supplier” for FSVP purposes differs from the definition of 
“grower” under §  1.276(b )(7), which includes both growing and harvesting.  Regardless, 
definitions used in the prior notice regulation do not apply to words or phrases in the FSVP 
regulation, and vice versa.  39 
 
 
  (Comment  13)  One comment asks that the definition of foreign supplier exclude farms 
that grow non -produce botanical, algal, or fungal RACs.  The comment asserts that these 
products have a complicated supply chain that makes it difficult to identify the farms that grow 
them, there are no public health reasons to identify thes e farms, and there are no regulations 
governing the production of these products.   
 (Response  13)  We decline to adopt a different approach for these particular types of 
RACs compared to the previously stated approach to defining the foreign supplier of a  RAC.  
Provided these products are being imported for use as food as defined in 201(f)  of the FD&C 
Act, importers of these products are subject to FSVP.  However, the FSVP regulation d oes not 
require that the importer be the entity to gather information about the farms.  Rather, the 
regulation allow s importers of such RACs to obtain information from other entities in the supply 
chain for the RAC to meet the importers’ FSVP requirements for  these products , provided the 
importer reviews and assesses the information and documents the review and assessment . 
 (Comment  14)  Several comments request that we clarify whether certain activities are 
“de minimis” activities and therefore would mean the  entity performing these activities for a 
food would not be the foreign supplier of the food.   Some comments ask whether waxing, 
cooling, washing, and repacking are de minimis activities.   Some comments maintain that 
sorting, packing, cooling, and holding of produce by packing houses should be regarded as de 
minimis activities, as should farm activities such as waxing, sorting, culling, conveying, storing, 
labeling, packing, packaging, and shipping of RACs.  
 (Response  14)  The foreign supplier is the estab lishment  that manufactures/processes the 
food, raises the animal, or grows  the food that is exported to the United States without further 40 
 
 
 manufacturing/processing except for  the addition of labeling or any similar activity of de 
minimis nature.   This means  that a foreign supplier is not an entity that merely performs de 
minimis manufacturing/processing activities, but, importantly, a foreign supplier also is not an 
entity that only packs or holds a food.    
Whether an activity is harvesting, manufacturing/pr ocessing, packing, or holding can  
depend on the circumstances.   For example, packing, cooling, and holding performed by an off -
farm packing house (that only packs and holds produce and cools the produce incidental to 
packing and holding) would not make the  packing house the foreign supplier, because these 
activities would not be considered manufacturing/processing but only packing and 
holding.   Waxing, sorting, culling, conveying, storing, packing, and shipping of RACs when 
conducted on a farm would general ly be considered harvesting, packing, or holding.   Assuming 
the farm conducting these activities grows  the RACs  and no other entity manufactures/processes 
the food (except de minimis manufacturing/processing) before it enters the United States, the 
farm wo uld be the foreign supplier.    
With regard to the packaging of RACs, packaging is a manufacturing/processing activity 
but is specifically included within the farm definition.  A farm that raises an animal or grows a 
crop and performs packaging operations would be the foreign supplier (assuming that no other 
entity manufacturers/processes the food except for de minimis manufacturing/processing).  
Concerning the comment’s ref erence to re -packing, re-packing is a packing activity  (i.e., 
the definition of packi ng includes re -packing) , not a manufacturing/processing  activit y.  We 
regard w axing and cooling RACs , when done by a packing operation  for purposes of storage or 
transport , to be packing activities rather than manufacturing/processing activities.   41 
 
 
 To help explain FDA’s current thinking on the classification of activities as “harvesting,” 
“packing,” “holding,” or “manufacturing/processing,” we will issue a draft guidance  for industry 
on preventive controls for human food .  We intend for this guidance, when f inalized, to provide 
sufficient examples of activities within each of these definitions to inform both industry and 
regulators of those activities we consider to be within those definitions.   The draft guidance will 
be available for public comment in accor dance with our regulation on good guidance practices  
(see 21 CFR 10.115(g)(1)).   We will consider comments we receive on the draft guidance in 
developing the final guidance.  
 (Comment  15)  One comment, noting that coffee beans are extracted from the cherry  
surrounding the bean by fermentation, washing, and/or drying at a mill, asserts that because these 
activities are more than de minimis in nature, the mill should be regarded as the foreign supplier 
of the coffee beans.   
 (Response  15)  We agree that fermentation, washing, and/or drying of raw coffee cherries 
(or “berries”) would constitute manufacturing/processing that is not of a de minimis nature and 
would make the mill the foreign supplier of the coffee beans (provided no subsequent entity 
conducte d additional manufacturing/processing that is not of a de minimis nature before export  
to the United States ).  We note, however, that under § 1.507(a)(1)  of the final rule , importers of 
foods that cannot be consumed without the application of an appropriat e control, including  RAC s 
like coffee beans, are not subject to the full requirements of the FSVP regulation (s ee the 
discussion in section III.H.1  of this document) .  42 
 
 
  (Comment  16)  One comment asks that we distinguish “further manufacturing/processing 
by another establishment” under the proposed definition of foreign supplier from the concept of 
substantial transformation applied by U.S. Customs and Border Protection ( CBP ). 
  (Response  16)  The concept of “further manufacturing/processing by another 
estab lishment ” in the  definition of “foreign supplier” under the FSVP regulation and the 
definition of “substantial transformation” as used by CBP (i.e., the emergence of an article from 
manufacturing process es as a new and different article, with a distinctive  name, character, or use) 
are used for different purposes and do not necessarily refer to the same processes.  Further 
manufacturing/processing in the context of FSVP involves direct manipulation of a food, but it 
need not result in a new and different article, as it can include activities such as washing and 
freezing.  
8.  Good Compliance Standing With a Foreign Food Safety Authority  
We proposed to define “good compliance standing with a foreign food safety authorit y” 
as meaning the foreign supplier (1) appears on the current version of a list, issued by the food 
safety authority of the country in which the foreign supplier is located and which has regulatory 
oversight of the supplier, of food manufacturers and proce ssors that are in good compliance 
standing with the food safety authority, or (2) has otherwise been designated by such food safety 
authority as being in good compliance standing.   Under §  1.513 of the final rule (discussed in 
section III.N of this documen t), modified FSVP requirements apply , subject to  certain conditions  
and requirements , to importers of certain types of food from foreign suppliers in countries whose 
food safety systems FDA has officially recognized as comparable or determined to be equiva lent 
to the U.S. system.  One of the requirements for eligibility for the modified requirements is that 43 
 
 
 the foreign supplier must be in  good compliance  standing with the food safety authority of a 
country with a comparable or equivalent food safety system.  
On our own initiative, we revised the definition to reference to “food producers” instead 
of “food manufacturers and processors”  because farms might be included among food producers 
designated as being in good compliance standing by a foreign food safety authority .   
 (Comment  17)  One comment questions the need for this term in the FSVP regulation 
given that all U.S. importers of food must ensure the safety of the food they import.  The 
comment maintains that it is unclear whether or to what extent a fore ign supplier’s inclusion on a 
list maintained by a foreign food safety authority will facilitate an importer’s access to a foreign -
supplied food.  The comment also asserts that it is unclear whether any country’s food safety 
authority can be required to de velop and maintain such a list and suggests that there will be 
disparity among countries regarding whether such a list can and will be developed.  
 (Response  17)  The term good compliance standing with a foreign food safety authority is 
used to describe one  of the conditions under which an importer is eligible to import certain types 
of food under the modified requirements in §  1.513 of the final rule.  We conclude it is 
appropriate to condition the use of these modified requirements on the foreign supplier of the 
food being in good compliance standing with the food safety authority of a country whose food 
safety system FDA has officially recognized as comparable or determined to be equivalent to 
that of the United States.  If the foreign supplier is not in g ood compliance standing, we conclude 
that the importer would lack adequate assurances that the foreign supplier is producing the food 
consistent with U.S. requirements.  Although foreign authorities will not be required to designate 44 
 
 
 food producers as being  in good compliance standing, we believe that it is likely that some 
authorities will decide to do so.  
 (Comment  18)  One comment suggests that the official registration or approval of an 
establishment by the relevant competent authority should be considered sufficient to meet the 
requirement of good compliance standing.  The comment asserts that because all food 
establishments in the European Union (EU) are either registered with, or approved by, the 
national authorities, the existence of the recor ds of these actions should be taken into account to 
avoid unnecessary or duplicative work.  
 (Response  18)  We do not agree.  We conclude that the fact that a foreign supplier is 
registered with, or approved to operate by, the food safety authority of the c ountry in which it is 
located would generally not constitute a designation that the foreign supplier was in good 
compliance standing with that authority, absent a determination or designation by a food safety 
authority indicating that the supplier is in go od compliance standing within the meaning in 
§ 1.500.  We believe it is possible a foreign supplier might maintain its registration or approval 
to operate even while it is the subject of an ongoing enforcement action due to significant non -
compliance.  The refore, a foreign supplier cannot be regarded as in good compliance standing 
with a food safety authority unless that authority has affirmatively designated that supplier as 
being in good compliance standing, either through the supplier’s inclusion on a li st of such 
suppliers, a company -specific certification, or some other manner of designation.  
9.  Harvesting   
For clarity and consistency , we are adding a definition of “harvesting” that is consistent 
with the definition in the preventive controls regulatio ns.  Our new definition states that 45 
 
 
 harvesting applies to farms and farm mixed -type facilities and means activities that are 
traditionally performed on farms for the purpose of removing RACs  from the place they were 
grown or raised and preparing them for u se as food.  Harvesting is limited to activities performed 
on RACs  on a farm.  Harvesting does not include activities that transform a RAC  into a 
processed food as defined in section 201(gg) of the F D&C  Act.  Examples of harvesting include 
cutting (or othe rwise separating) the edible portion of a RAC  from the crop plant and removing 
or trimming part of the RAC  (e.g., foliage, husks, roots or stems).  Examples of harvesting also 
include cooling, field coring, filtering, gathering, hulling, removing stems and  husks from, 
shelling, sifting, threshing, trimming outer leaves of, and washing RAC s grown on a farm.  
10.  Hazard  
 We proposed to define “hazard” as any biological, chemical (including radiological), or 
physical agent that is reasonably likely to cause il lness or injury in the absence of its control.  
 On our own initiative, we have deleted “in the absence of its control” from the definition, 
consistent with a corresponding change to the definition of hazard in the preventive controls 
regulations, because the aspect of control of a hazard is addressed unde r the definition of “hazard 
requiring a control.”   
 (Comment  19)  One comment suggests limiting the definition of hazard by referring to an 
agent that is reasonably likely to cause illness or injury “in the intended species” in the absence 
of its control.  
 (Response  19)  We do not believe that the suggested change to the definition of hazard is 
necessary.  We note that under §  1.504(c)(3) of the final rule, in determining whether a hazard is 46 
 
 
 a “hazard requiring a control,” an importer must consider, among other factors, the intended or 
reasonably foreseeable use of the food, includ ing the species for which the food was intended.  
11.  Hazard Requiring a Control  
In the Supplemental Notice, we proposed to adopt the term “significant hazard” and to 
define it a s a known or reasonably foreseeable hazard for which a person knowledgeable about 
the safe manufacturing, processing, packing, or holding of food would, based on the outcome of 
a hazard analysis, establish controls to significantly minimize or prevent the hazard in a food and 
components to manage those controls (such as monitoring, corrections and corrective actions, 
verification, and records) as appropriate to the food, the facility, and the control.  
 (Comment 20)  Some comments request that we use a term other than “significant 
hazard” to refer to a known or reasonably foreseeable hazard for which a knowledgeable person 
would establish a control.  One comment maintains that use of the term “significant hazard” 
could be confusing because the term is used to  refer to hazards addressed in a HACCP plan 
through critical control points.  One comment recommends using the definition of “significant 
hazard” instead of the term itself.  Some comment s recommend using the term “food safety 
hazard” because it has no ass ociation with HACCP principles.  Some comments recommend 
using the term “hazard requiring control.”   
 (Response  20)  To provide more clarity , we agree that  the FSVP regulation should use a 
term other than “significant hazard.”  We conclude it is appropria te to refer to such a hazard as a 
“hazard requiring a control.”  The definition states, in pertinent part, that a “hazard requiring a 
control” is a known or reasonably foreseeable hazard for which a knowledgeable person would 
establish one or more “control s or measures” to significantly minimize or prevent the hazard.  47 
 
 
 The definition refers to controls or measures because the FSVP requirements apply to food that 
is subject to the preventive controls regulations (which require the establishment of preventive  
“controls”), food that is subject to the produce safety regulation (which refer s to safety 
“measures”), and food that is subject to other FDA regulations (e.g., dietary supplement 
CGMPs).  
 (Comment  21)  Some comments recommend replacing the reference to “a person 
knowledgeable about safe manufacturing, processing, packing, or holding food” with “a 
qualified individual” because a  qualified individual will be responsible for conducting a hazard 
analysis.  
 (Response  21)  Although a qualified individual must conduct a hazard analysis for a food, 
we decline to make this change to the definition of “hazard requiring a control” because we 
believe it is appropriate to specify that a person determining whether a known or reasonably 
foreseeable hazard is one for whi ch one or more controls or measures are needed must be 
knowledgeable about the safe manufacturing, processing, packing, or holding of food.  This is 
consistent with the revised definition of “hazard requiring a preventive control” in the preventive 
control s regulations.  
 (Comment 22)  Some comments recommend stating in the definition of “significant 
hazard” (or its replacement term) that a determination of a significant hazard is based on a hazard 
analysis that assesses the severity of the illness or injury  to humans or animals if the hazard were 
to occur and the probability that the hazard will occur in the absence of a control, because 
severity and probability are integral to determining whether a hazard is significant.  48 
 
 
  (Response  22)  We agree with the co mments that this additional language is helpful.  
Consistent with the revised definition of “hazard requiring a preventive control” in the 
preventive controls regulations, this change is incorporated in the definition of “hazard requiring 
a control,” which  under the final rule means a known or reasonably foreseeable hazard for which 
a person knowledgeable about the safe manufacturing, processing, packing, or holding of food 
would, based on the outcome of a hazard analysis (which includes an assessment of th e 
probability that the hazard will occur in the absence of controls or measures and the severity of 
the illness or injury if the hazard were to occur), establish one or more controls or measures to 
significantly minimize or prevent the hazard in a food and  components to manage those controls 
or measures (such as monitoring, corrections or corrective actions, verification, and records) as 
appropriate to the food, the facility, and the nature of the control or measure and its role in the 
facility ’s food safet y system.  
 (Comment 23)  Some comments recommend that the definition of significant hazard 
reflect that components to manage controls should be appropriate not just to the food, the 
facility, and the control, but also to the intended use of the food.  
 (Response  23)  We do not think this change to the definition of hazard requiring control 
is necessary because an importer already must consider the intended or reasonably foreseeable 
use of a food in evaluating the hazards in the food under §  1.504(c)(3) of th e final rule.  
12.  Holding  
On our own initiative, we are adding a definition of “holding” that is consistent with the 
preventive controls regulations.  Our new definition states that holding means storage of food 
and also includes activities performed inci dental to storage of a food (e.g., activities performed 49 
 
 
 for the safe or effective storage of that food, such as fumigating food during storage, and 
drying/dehydrating RAC s when the drying/dehydrating does not create a distinct commodity 
(such as drying/deh ydrating hay or alfalfa) ).  Holding also includes activities performed as a 
practical necessity for the distribution of that food (such as blending of the same RAC  and 
breaking down pallets), but does not include activities that transform a RAC  into a proc essed 
food as defined in section 201(gg) of the F D&C  Act.  Holding facilities could include 
warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.  
13.  Importer  
We proposed to define “importer” as the person in the United States who has purchased 
an article of food that is being offered for import into the United States.  The proposed definition 
further stated that:  
•  If the article of food has not been sold to a person in the United States at the time of 
U.S. entry , the importer is the person in the United States to whom the article has been consigned 
at the time of entry; and  
•  If the article of food has not been sold or consigned to a person in the United States at 
the time of U.S. entry, the importer is the U.S.  agent or representative of the foreign owner or 
consignee at the time of entry.  
We proposed this definition of importer based on  the statutory definition of importer in 
section 805(a)(2) of the FD&C Act, which states that the importer is the U.S. owner o r consignee 
of an article of food at the time of entry of the article into the United States, or if at that time 
there is no U.S. owner or consignee, the importer is the U.S. agent or representative of the 
foreign owner or consignee.   50 
 
 
 On our own initiativ e, we are revising the definition of “importer” to mean the U.S. 
owner or consignee of an article of food that is being offered for import into the United States.  If 
there is no U.S. owner or consignee at the time of U.S. entry, the importer is the U.S. a gent or 
representative of the foreign owner or consignee at the time of entry, as confirmed in a signed 
statement of consent to serve as the importer under the FSVP regulations.  We conclude  that this 
revised definition is more consistent with the statutor y defi nition in section 805(a)(2).  For the 
reasons explained in the following paragraphs, we also conclude  that this change , along with a 
new definition we are adding for “U.S. owner or consignee,” better ensures that  the FSVP 
importer  is a person who has a financial interest in the food and has knowledge and control over 
the food’s supply chain.  We are defining  “U.S. owner or consignee ” to mean  the person in the 
United States who, at the time of entry of a food into the United States, either owns the foo d, has 
purchased the food, or has agreed in writing to purchase the food.   
a.  General . 
 (Comment 24)  Some comments ask that we either define or clarify the term “purchased.”  
One comment states that CBP defines the terms owner and purchaser to include any party with a 
financial interest in a transaction, including, but not limited to, the actual owner of the goods, the 
actual purchaser of the goods, a buying or selling agent, a person or firm who imports for 
exhibition at a trade fair , or a person or fi rm who imports foods for repair or alteration.  One 
comment maintains that in contrast to the proposed rule, the statute does not create different rules 
for U.S. owners and their consignees regarding their FSVP responsibilities and does not define 
the impo rter as the person who purchased an article of food.  The comment asserts that because 51 
 
 
 neither the statute nor the proposed rule defines “purchased,” it is unclear who is responsible for 
ensuring FSVP compliance.  
 (Response  24)  We do not agree that the proposed definition would create different FSVP 
regulations for U.S. owners and consignees, as the proposed rule contained no requirements that 
differed on that basis.  However, to prevent possible confusion regarding the defini tion of 
importer and to align more closely with the statutory text, we have revised the definition of 
importer  to mean the U.S. owner or consignee of an article of food that is being offered for 
import into the United States.  We are further defining “U.S.  owner or consignee” as the person 
in the United States who, at the time of entry of a food into the United States, either owns the 
food, has purchased the food, or has agreed in writing to purchase the food .  Thus, the final rule 
explicitly refers to a U. S. “owner” of a food .  Because there is a wide range of  commercial 
arrangements between foreign owners and U.S. persons, there may be situations  in which 
ownership of imported food  has not transferred from the foreign owner at the time of entry to the 
United States, but a person in the United States has nevertheless purchased or agreed in writing 
to purchase the goods.  We do not agree  it is necessary to define the terms “purchased” or 
“purchase,” but we understand the terms to mean obtain by paying money o r its equivalent.  
 (Comment 25)  Some comments request that we clarify that the FSVP importer of a food 
is not necessarily the importer of record for the food as defined by CBP.  However, some 
comments suggest that instead of creating a new definition of i mporter, we should adopt a 
definition that parallels CBP’s definition of importer of record.  The comments note that under 
19 U.S.C. 1484(2)(B), an “importer of record” is defined as the owner or purchaser of the 
merchandise or, when appropriately designat ed by the owner, purchaser, or consignee of the 52 
 
 
 merchandise, a person holding a valid customs broker license.  The comment s maintain that this 
definition of importer of record is substantially similar to the statutory definition of importer 
under FSMA.  (T he comment s also note that CBP regulations (19 CFR 101.1) define “importer” 
as the person primarily liable for the payment of any duties on the merchandise or an authorized 
agent.)  The comment s maintain that CBP’s definition of importer has been effective in ensuring 
proper enforcement of collection of customs duties and provides certainty by defining a single 
party responsible for entry of a product.    
 (Response  25)  We do not agree  that it i s appropriate to define “importer” for FSVP 
purposes to match CBP’s definition of “importer” or “importer of record. ”  As we stated in the 
preamble to the proposed rule, the importer of a food for FSVP purposes might be, but would not 
necessarily be, the i mporter of record of the food under CBP provisions (i.e., the individual or 
firm responsible for making entry and payment of import duties).  We conclude that, in section 
805(a)(2) of the FD&C Act, Congress adopted a definition of importer that suits the p urposes of 
the FSVP regulation because:  
•  It clearly specifies the person who will be responsible for ensuring that supplier 
verification activities are conducted for each food imported into the United States; and  
•  By specifying the U.S. owner or consig nee, the definition helps to ensure that the 
person responsible for meeting the FSVP requirements has a financial interest in the food and 
has knowledge and control over the food’s supply chain.   
The “U.S. owner or consignee ” of a food , as we have defined  the term,  is more likely to 
have knowledge of food safety practices and control over the supply chain of an imported food 
than a customs broker, who often is the importer of record of a food for CBP purposes.  53 
 
 
 Although the CBP definition of importer may b e effective in ensuring collection of customs 
duties  and otherwise meeting CBP requirements , that is not the purpose of the FSVP regulation.  
Consequently, the final rule adopts a definition of importer that best serves the purposes of the 
FSVP requirement s, consistent with the statutory provisions the FSVP regulation must 
implement.  
 (Comment 26)  Some comments maintain that the importer should be the person who has 
a direct financial interest in the imported food or, alternatively, the last known exporter .  The 
comments assert that the only parties who can ensure the safety of the food supply chain are 
entities who are directly and financially involved in the manufacture, growth, sale, receipt , or 
purchase of the imported food.  
 (Response  26)  As previous ly stated, the definition of importer is intended in part to 
ensure that someone with a financial interest in the imported food, as well as knowledge and 
control over the food’s supply chain, is responsible for meeting the FSVP requirements.  In most 
cases, this will be the U.S. owner or consignee  of the food .  However, under section 805(a)(2) of 
the FD&C Act and §  1.500 of the final rule, the importer for FSVP purposes could not be the 
exporter in the foreign country in which the food was produced.  If there is no U.S. owner or 
consignee of a food at the time of the food’s entry into the United States, the foreign owner or 
consignee of the food must have validly designated a U.S. agent or representative (in accordance 
with § 1.509(b) of the final rule) to s erve as the U.S. importer of the food for purposes of FSVP 
compliance.  We do not agree  that the last known exporter is an appropriate person to serve as 
the FSVP “importer” because such a person exports --as opposed to imports --the food.  54 
 
 
  (Comment 27)  One  comment states that retailers may contract with foreign 
manufacturers to produce private label products bearing the retailer’s name and purchase the 
products from a U.S. firm after the  products  have entered the United States.  The comment asks 
us to clari fy that in this situation, the retailer would not be the importer of the food for FSVP 
purposes.  
 (Response  27)  We agree that provided  a U.S. entity other than the retailer owns the food , 
has purchased the food, or has agreed in writing to purchase the fo od at the time of entry  (i.e., is 
the “U.S. owner or consignee”) , the retailer would not be the FSVP importer of the food.  In this 
situation, the importer is the U.S. firm that owns the product , has purchased the product, or has 
agreed in writing to purch ase the product  when it is offered for import in to the United States and 
the entry documentation is submitted or presented .  It would not be relevant that the retailer was 
the entity that entered into a contract with the foreign manufacturer (as long as  the retailer is not 
the person in the United States that owns the food, has purchased the food, or has agreed in 
writing to purchase the food at the time of entry) .  If, on the other hand, the retailer owns the 
food, has purchased the food, or has agreed in writing to purchase the food at the time of entry 
(and thus is the U.S. owner or consignee ), the retailer would be the FSVP “importer.”  
 (Comment 28)  One comment asks that we clarify that a restaurant owner is not an 
“importer” for FSVP purposes unless it  directly imports a food for its use and chooses to accept 
the responsibilities of the importer.  The comment asserts that failing to do this would place an 
added burden on restaurant owners and operators who will have to make clear to their suppliers 
of foreign materials that the  suppliers  are responsible for compliance with FSVP requirements.  
The comment maintains that adoption of the FSVP regulation might result in a loss of U.S. 55 
 
 
 importers of foreign products due to their unwillingness to assume respons ibility for FSVP 
compliance.  
 (Response  28)  A restaurant located in the United States must comply with the FSVP 
requirements only if it meets the definition of importer under §  1.500 (e.g., because it is the 
“U.S. owner or consignee” of  the food at the time of entry or, if there is no U.S. owner or 
consignee at the time of entry, the foreign owner or consignee designates the restaurant as a U.S. 
agent or representative for purposes of serving as the FSVP “importer”).  If the restaurant  
purchases the food from another U.S. entity, the restaurant would not meet that definition and 
would not be responsible for meeting the FSVP requirements.  However, we have added 
flexibility in the final rule to allow importers, including  restaurants, to me et their FSVP 
obligations by relying on analyses, evaluations, and activities performed by certain other entities, 
provided  those importers review and assess the corresponding documentation  (see sections 
III.E.5, III.F. 4, and III.G.4  of this document) . 
 (Comment 29)  One comment asks that we define the phrase “time of U.S. entry” as used 
in the proposed definition of importer.  
 (Response  29)  Section 805(a)(2)(A) of the FD&C Act provides that for purposes of the 
FSVP regulation, the term “importer” means th e United States owner or consignee of the article 
of food “at the time of entry of such article into the United States.”  The meaning of the phrase 
“at the time of entry of such article into the United States” is ambiguous.   It could mean that the 
importer  is the U.S. owner or consignee at the time of submission of an entry or at the time that 
the article of food physically enters U.S. territ ory.  Given it might not always be clear when an 
imported item physically enters U.S. territory, we conclude  that Con gress intended that the 56 
 
 
 importer be the U.S. owner or consignee at the time of submission of entry 
documents.   Therefore, “t ime of U.S. entry ,” as used in §  1.500,  is the time when an import entry 
is submitted to CBP  either  electronically or in paper  form .  Because we believe that entities 
engaged in the import of food into the United States will understand this term , we do not think it 
is necessary to include  a definition for “time of entry” in th ese regulation s. 
 (Comment 30)  One comment expresses conce rn that the proposed definition of importer 
will create a new layer of middlemen who would assume ownership of food at the time of entry 
into the United States and charge fees for ensuring compliance with the FSVP requirements.  The 
comment contends this m ight result in duplicative foreign supplier verifications.  
 (Response  30)  We do not agree.  We believe it is unlikely that many entities currently 
not food importers will enter the food importing business because of the need to adopt and 
implement the pro cedures required under the FSVP regulation.  Some importers may choose to 
hire employees or outside consultants to assist them in meeting the FSVP requirements, but this 
would not need to involve third parties assuming ownership of imported food or otherwi se 
serving in an importer role solely for the purpose of providing supplier verification services.  
Even if new, FSVP -oriented businesses are created  to conduct supplier verification activities on 
behalf of some importers, we do not see how this would resu lt in duplicative supplier 
verification.  Regardless, the definition of “importer” is consistent with the definition established 
by Congress in secti on 805(a)(2) of the FD&C Act.   
 (Comment 31)  Some comments request that we define the term “consignee” be cause it 
might be confused with a similar term used by CBP.  In addition, some  comments suggest that 
the term “consignee” be restricted to persons with a direct ownership interest in the product.  57 
 
 
  (Response  31)  We agree with the comments to the extent the y are premised on a claim  
that the proposed rule did not clarify the meaning of “consignee.”  Instead of defining the term 
“consignee,” however, we have revised the definition of “importer”  so the FSVP importer is not, 
first, a U.S. owner, and, second, a U .S. consignee.  There is no separate “consignee” category of 
persons who meet the definition of “importer.”  Instead, under the revised definition, the  
“importer” is the “ U.S. owner or consignee ” of an article of food that is being offered for import 
into the United States.  If there is no U.S. owner or consignee at the time of U.S. entry, the 
importer is the U.S. agent or representative of the foreign owner or consignee at the time of 
entry, as c onfirmed in a signed statement of consent to serve as the importer under the FSVP 
regulation.   
At the same time, we are defining “U.S. owner or consignee” to mean the person in the 
United States who, at the time of entry of a food into the United States, either owns the food, has 
purchased the food, or has agreed in writing to purchase the food.  Under the previously 
proposed definition of “importer,” the “consignee” category could have caused  proprietors of the 
U.S. premises to which imported  food is to b e delivered  to be designated as FSVP “importers,” 
even when  such proprietors have no connection to the imported food other than  the physical 
receipt --even temporary receipt --of the food.   Under section 805(a)(2)(B) of the FD&C Act, 
Congress provided that w hen there is no U.S. owner or consignee, the FSVP importer should be 
the U.S. agent or representative of a foreign owner or consignee at the time of entry into the 
United States.  If the consignee for purposes of FSVP included the proprietor of the U.S. 
premises to which the merchandise is to be delivered, we believe it would be unlikely an FSVP 
importer would ever be the U.S. agent or representative of a foreign owner or consignee, as 58 
 
 
 contemplated by section 805(a)(2)(B), because the role of FSVP importer would fall to the 
proprietor of the premises before it would fall to the U.S. agent or representative.  Moreover, we 
believe that a U.S. agent or representative of a foreign owner or consignee is more likely to have 
knowledge and control over the product’s  supply chain, and is therefore more likely to be able to 
perform supplier verification activities , than the proprietor of the U.S. premises to which the 
merchandise is delivered  (in cases where the proprietor of the U.S. premises has no connection to 
the food other than physical receipt) .   
The effect of our change  to the definition of “importer,” in conjunction with the new 
definition of “U.S. owner or consignee,” likely will result in different entities serving as the 
FSVP importer in some circumstances  than those who might have served as the importer under 
the proposed definition .  For instance, in the case of a Canadian company that ships a food 
product to a Montana  warehouse  and for which delivery is made to  the Montana  facility in 
anticipation of pos sible orders from customers in the United States, it is possible, under the 
proposed rule, that the warehouse would have been the FSVP “importer”  because the food might 
be considered to be  consigned to the warehouse at the time of entry  and no one  in the U nited 
States at the time of entry either owned or had purchased the food.  Under the final rule, 
however, the warehouse would not necessarily be the FSVP importer.  Because there is no 
person in t he United States  at the time of entry who owns the food, pur chased the food, or 
promised to purchase the food, there is no “U.S. owner or consignee.”  Therefore, the FSVP 
“importer” would have to be a properly designated U.S. agent or representative.    
As for those comments suggesting that a consignee needs to be a person with a direct 
ownership in the product, we do not agree.  Section 805(a)(2)(A) of the FD&C Act provides that 59 
 
 
 “importer” for purposes of section 805 means the “United States owner or consignee” (emphasis 
added).  Because Congress used the word “or” between “owner” and “consignee,” we believe  
Congress intended the “United States  owner or consignee”  to include person s other than owner s.  
Requiring a U.S. owner or consignee to have direct ow nership over the product would be 
inconsistent with that intent.  We also understand it is possible for U.S. persons to purchase or 
agree in writing to purchase food at the time of entry to the United States, even if they do not yet 
own the products at th at time.  Requiring a U.S. owner or consignee to have direct ownership in 
the product at the time of entry would not account for these types  of commercial arrangements.  
b.  U.S. agent or representative . 
 (Comment 32)  Several comments maintain that the U.S.  agent or representative for 
FSVP purposes should not necessarily be the same person as the U.S. agent for a foreign food 
facility under the FDA food facility registration regulation ( § 1.227) and section 415(a) of the 
FD&C Act.  The comments note that whi le section 805(a)(2) of the FD&C Act describes an 
agent acting for the foreign owner or consignee of an article of imported food at the time of 
entry, section 415(a) describes an agent acting for a food facility.  The comments assert  that 
Congress did not require that the U.S. agent for a foreign food facility also act as the U.S. agent 
for FSVP purposes, and many persons who serve as U.S. agents for facility registration purposes 
might not have the knowledge or ability to meet the FSVP requirements.  The c omments request 
that the FSVP regulation clarify this distinction by referring to the “U.S. FSVP agent or 
representative.”   
 (Response  32)  FDA agrees in part and disagrees in part.  Section 805(a)(2)(B) provides 
that whe n there is no U.S. owner or consignee with respect to an article of food, the term 60 
 
 
 “importer” for FSVP means “the United States agent or representative of a foreign owner or 
consignee of the article of food at the time of entry of such article into the Unit ed States” 
(emphasis added).  Section 805 does not further define the term “United States agent.”  In 
addition, section 415(a)(1)(B) of the FD&C Act provides that foreign food facilities must  submit 
the name of the “United States agent” for the facility as  part of the facility’s registration under 
that section.  FDA’s regulation implementing the food facility registration requirements in 
section 415 of the FD&C Act specifies  that the registration for foreign facilities must include the 
name of the U.S. agen t for the facility (21 CFR 1.232(d)).  The facility registration regulation  
also define s the term U.S. agent to mean a person (as defined in section 201(e) of the FD&C Act) 
residing or maintaining a place of business in the United States whom a foreign fac ility 
designates as its agent for purposes of food facility registration ( § 1.227).  The regulation further 
specif ies that the U.S. agent “acts as a communications link between FDA and the foreign 
facility for both emergency and routine communications”.     
Although  Congress used the term “United States agent” in both section 805(a)(2)(B) and 
section 415(a)(1)(B) of the FD&C Act, we do not interpret the use of the term “Un ited States 
agent” in section 805(a)(2)(B) to mean the U.S. agent for a foreign facility under section 
415(a)(1)(B).  U.S. agents that foreign food facilities must designate for purposes of food facility 
registration perform  a very different role than the “U nited States agent” that a foreign owner or 
consignee may designate under section 805(a)(2)(B) of the FD&C Act to serve as the “importer” 
for purposes of the FSVP regulations.  For food facility registration, the “U.S. agent” acts as a 
communications link.   For FSVP, however, an importer (whether a “United States agent” or 
otherwise) is responsible for the full breadth of supplier verification activities required under the 61 
 
 
 FSVP regulation.  These activities involve ensuring the safety of imported food, whic h is 
qualitatively different from serving as a communications link.  Thus, we agree with the 
comments that urge us to not interpret the use of the term “United States agent” under section 
805(a)(2)(B) to have the same meaning as the U.S. agent that food fa cilities are required to 
designate under section 415(a)(1)(B) and FDA’s food facility registration regulation.    
We note, however, that this interpretation does not prohibit a foreign owner or consignee 
from designating a person who serves as a U.S. agent  under the food facility regulation as the 
“importer” for purposes of FSVP.  To the contrary, under the definition of “importer” in § 1.500, 
in cases in which there is no U.S. owner or consignee, it is up to the foreign owner or consignee 
to determine whic h U.S. agent or other U.S. representative will serve as the FSVP “importer.”  
Whomever the foreign owner or consignee designates also may be listed as a foreign facility’s 
U.S. agent for food facility registration purposes.  We decline to adopt the term “U .S. FSVP 
agent or representative” because doing so is not necessary to prevent the kind of inadvertent or 
otherwise improper designation of FSVP importers contemplated by the comments.   
 (Comment 33)  Some comments ask that we revise the definition of imp orter to specify 
that a person acting as a U.S. agent or representative of a foreign owner or consignee must 
knowingly and explicitly consent to serve as the U.S. agent or representative.  
 (Response  33)  For cases in which a food has not been sold or consi gned to a person in 
the United States at the time of entry, we proposed to required that, before an article of food is 
imported or offered for import into the United States, the foreign owner or consignee of the 
article must designate a U.S. agent or repre sentative as the importer of the food for the purposes 
of the definition of “importer.”  The final rule retains this requirement.  Because we agree a U.S. 62 
 
 
 agent or representative cannot truly function as the FSVP importer without having consented to 
do so,  we are  adding a clarification to the definition of “importer” explain ing that in order for the 
foreign owner or consignee of the article to validly designate a U.S. agent or representative 
(when there is no U.S. owner or consignee) for purposes of the def inition of “importer,” the U.S. 
agent or representative’s role must be confirmed in a signed statement of consent.  The signed 
statement of consent must confirm that the U.S. agent or representative agrees to serve as the 
import er under the FSVP regulation .  Because a signed statement  is an explicit acknowledgment 
of consent, we conclude that a signed statement  is an effective way of ensuring the consent of 
U.S. agents and representatives.  In addition, we will be able to inspect the signed statements, 
should the need arise, allowing us to verify the accuracy of “importer” designations under the 
FSVP regulation.  Being able to verify the accuracy of such designations will allow us to more 
efficiently and ef fectively monitor compliance with , and enforce , section 805 of the FD&C Act.   
 (Comment  34)  Several comments express concern about the manner in which a foreign 
owner or consignee would designate its U.S. agent or representative.  The comments state that  a 
foreign supplier might designate a party in the United States, such as the warehouse where the 
imported food will be stored, without seeking an affirmative acceptance from that party, or the 
foreign supplier of the food might assume the agent listed on its facility registration is also the 
U.S. agent for FSVP purposes.  Some comments note concerns regarding the process for 
verification of U.S. agents of foreign facilities, including the absence of a requirement to obtain 
formal consent from a person to s erve as the agent and FDA’s failure to obtain confirmation of 
consent.  Several comments suggest that, because the U.S. agent’s responsibilities as the 
importer of a food under the FSVP regulation will be substantial, the regulation should require 63 
 
 
 affirmat ive written acceptance by the designated firm for valid designation of a foreign owner or 
consignee’s U.S. agent or representative.   
 (Response  34)  We agree that a person should not be required to serve as the U.S. agent 
or representative of a foreign ow ner or consignee unless the person has agreed to serve in this 
capacity.   As explained in Response 33, we therefore are adding a clarification to the definition 
of “importer” stating  that when the foreign own er or consignee of the article must designate a 
U.S. agent or representative (when there is no U.S. owner or consignee) for the purposes of the 
definition of “importer,” the U.S. agent or representative’s role should be confirmed in a signed 
statement of consent.  The signed statement of consent must co nfirm that the U.S. agent or 
representative agrees to serve as the importer under the FSVP regulation.  In accordance with 
these changes, we also have revised the provisions regarding refusal of admission in proposed 
§ 1.514(a) to specify that if there is no U.S. owner or consignee at the time an article of  food is 
offered for entry into the United States, the article of food may not be imported into the United 
States unless the foreign owner or consignee has appropriately  designated a U.S. agent or 
representative as the importer in accordance with §  1.500.  
 (Comment 35)  One comment states that the requirement for foreign producers to obtain a 
U.S. agent in order for their product to be imported into the United States coul d be considered a 
technical barrier to trade according to the World Trade Organization (WTO).  
 (Response 35)  We do not agree that the regulation require s that foreign producers obtain 
U.S. agents or otherwise impose s a barrier to trade.  To the extent tha t the comment’s reference 
to U.S. agents relates to who may be an FSVP “importer,” the definition of importer in § 1.500 is 
flexible and does not require that the importer be a U.S. agent.  Instead, the FSVP importer is the 64 
 
 
 U.S. owner or consignee of the i mported food.  A U.S. agent or representative functions as the 
FSVP importer of a food only if there is no U.S. owner or consignee of the food at the time of 
entry.  Notably, the importer can be a foreign national residing in the United States and need not  
be a U.S. citizen.  The definition of importer thus serves to identify persons with financial 
interests in the imported food who are likely to be able to ensure the safety of the food, while 
also providing flexibility that does not unduly burden trade.   
(Comment  36)   One comment states that FDA’s explanation of the proposed definition 
of “importer” indicates  the rule implies a regulatory pressure for foreign producers to sell or 
distribute products through U.S. persons  in a manner  inconsistent with U.S. obligations under the 
U.S.-Korea Free Trade Agreement (KORUS).    
 (Response  36)  We do not agree that the definition of “importer” in §  1.500 is 
inconsistent with U.S . obligations u nder the  KORUS .  Under National Treatment and Market 
Access for Goods , Article 2.8.6 to 2.8.8 , neither party may, as a condition for engaging in 
importation or for the importation of a good, require a person of the other party to establish or 
maintain a contractual or other relationship with a “distributor” in its territory.  The term 
“distributor” under the KORUS is defined as a “person of a party” who is responsible for the 
commercial distribution, agency, concession, or representation in the territory of that party of 
goods of the other party.   The term “person of a party” is defined as a national or an enterprise of 
a party to the agreement.   The term “enterprise” means any entity constituted or organized under 
applicable law, whether or not for profit, and whether privately or governmentally owned or 
controlled, including any corporation, trust, partnership, sole proprietorship, joint venture, 
association, or similar organization.  65 
 
 
 The U.S. owner or consignee  need not be a United States “distributor” within the 
meaning of the KORUS  because it  need not be a U.S. national or U .S. enterprise constituted or 
organized under U.S. law responsible for commercial distribution, agency, concession, or 
representation in the United States.   For example,  the U.S. owner or consignee could be  a Korean 
national or enterprise residing or maint aining a place of business in the United States.  
Alternatively, if there is no U.S. owner or consignee of a food at the time of entry, the foreign 
owner or consignee could designate a U.S. agent or representative who is a Korean national (or a 
national of  another country) but who resides or maintains a place of business in the United 
States.  Under those circumstances, such a Korean national or enterprise would be the FSVP 
“importer.”   Consequently, we are  not requiring any person whose imports fall within  the scope 
of the KORUS to establish or maintain a contractual or other relationship with a “distributor” or 
other entity in its territory.   Therefore , the definition of “importer” is not inconsistent with U.S. 
obligations under the KORUS , and we do not be lieve the rule exerts any pressure on foreign 
producers to rely on U.S. persons to distribute food in a manner that is inconsistent with the 
KORUS . 
14.  Known or Reasonably Foreseeable Hazard  
 In the Supplemental Notice, we deleted the proposed term “hazar d reasonably likely to 
occur” and replaced it with the term “known or reasonably foreseeable hazard.”  We proposed to 
define “known or reasonably foreseeable hazard” as a potential biological, chemical (including 
radiological), or physical hazard that is k nown to be, or has the potential to be, associated with a 
food or the facility in which it is manufactured/processed.  66 
 
 
  (Comment 37)  One comment suggests that we use the term “reasonably anticipated 
contaminants” as a phrase that clearly defines all hazards, whether deliberate or accidental, that 
can cause adulteration in the food supply.  
 (Response 37)  We decline to make this change  because “hazard” is a widely understood 
term in food safety and the word “contaminant” might suggest a substance that comes into 
contact with or is added to a food, but not all hazards arise from such contaminants.  As 
discussed in section III. E.3.b  of this document, importers are required to consider hazards that 
occur naturally, may be unintentionally introduced, or may  be intentionally introduced for 
economic gain.  
 (Comment 38)  One comment asks that we delete the reference to “potential” hazards as 
redundant because the proposed definition of “hazard” refers to agents “reasonably likely” to 
cause illness or injury.  
 (Response  38)  We are deleting the word “potential” before the phrase “biological, 
chemical (including radi ological), or physical hazard” because we agree the use of that word is 
redundant.  The remaining portion of the definition of “known or reasonably fo reseeable hazard” 
includes both a hazard that is known to be associated with a food or the facility in which it is 
manufactured/processed, as well as a hazard that “has the potential to be” associated with a food 
or facility.  
 (Comment 39)  One comment re quests that the definition of “known or reasonably 
foreseeable hazard” also refer to hazards that might be associated with the location or type of 
farm on which a food is grown or raised.  The comment cites as an example the potential effect 
on a food of t he agricultural methods used on the farm that produced the food.  67 
 
 
  (Response  39)  We conclude this change is unnecessary because the potential effect of 
the location or type of farm on which a food is grown or raised on whether a hazard requires a 
control w ill be addressed as part of the hazard evaluation conducted under §  1.504(c) of the final 
rule, which considers factors such as those related to the harvesting and raising of the food.   
15.  Lot  
 We proposed to define “lot” as the food produced during a p eriod of time indicated by a 
specific code.  
 (Comment 40)  Several comments request that “lot” be defined by criteria other than 
time.  Some comments assert that the proposed definition appears to ignore other factors such as 
common characteristics (e.g., origin, variety, type of packing) and maintain that mult iple lots can 
be produced during the same time but with different lot designations.  These comments suggest 
that lot be defined as a body of food designated with common characteristics that is separable by 
such characteristics from other bodies of food.  O ne comment asserts  that growers and 
processors define lot differently based on their company practices and the specific characteristics 
of the process and product.  As examples of such definitions, the comment lists the following:  
•  A specific planting bl ock of specified size prepared and planted on a given day, raised 
with common agricultural inputs, and scheduled for harvest on a selected date.  
 •  A quantity of finished product that passes over a processing line during a given period 
of time.  
This comme nt requests that importers be permitted to independently define lot and make the 
definition available to FDA during an inspection.   68 
 
 
 One comment suggests that lot be defined as a batch, or a specified identified portion of a 
batch or, in the case of food p roduced by a continuous process, a specific identified amount of 
food produced during a specified period of time, or in a specified quantity, on a specified 
equipment line.  This comment would define “batch” as a specific quantity of a food produced 
during  a specified time period during a single cycle of manufacture, and it would define “code” 
as a unique and distinctive group of letters, numbers and/or symbols from which the 
manufacturing and packaging history of the associated lot or batch of food can be determined.  
 (Response  40)  We agree that a change to the definition of lot is appropriate, as we 
believe the reference to a period of time indicated by a specific code might be misinterpreted to 
mean that the “specific code” must be based on time  (such as a date ), which was not our intent .  
Although the term “lot” is associated with a period of time, the establishment that produces a 
food has the flexibility to develop its own coding system for lots, with or without any indication 
of time in the code.  F or example, a lot code could be based on a date, time of day, production 
characteristic (such as those mentioned in the comments), combination of date/time/production 
characteristic, or any other characteristics the establishment finds appropriate.  To cla rify that the 
definition of lot would not require that the time of production be “indicated” by the lot code and 
acknowledge the establishment’s flexibility to determine the code, we have revised “period of 
time indicated by a specific code” to “period of time and identified by an establishment’s 
specific code.”      
16.  Manufacturing/Processing  
 We proposed to define “manufacturing/processing” as making food from one or more 
ingredients, or synthesizing, preparing, treating, modifying, or manipulating foo d, including food 69 
 
 
 crops or ingredients.  Examples of manufacturing/processing activities  the definition provided  
include cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, 
freezing, cooling, pasteurizing, homogenizing, m ixing, formulating, bottling, milling, grinding, 
extracting juice, distilling, labeling, or packaging.  The proposed definition stated that f or farms 
and farm mixed -type facilities, manufacturing/processing would not include activities that are 
part of har vesting, packing, or holding.    
We are finalizing the definition of “manufacturing/processing” largely as proposed.  
However, we are adding “boiling” , “canning”, and “evaporating”, and “treating to manipulate 
ripening” to the list of activities that we clas sify as manufacturing/processing, as well as 
drying/dehydrating RACs to create a distinct commodity.  We are also adding “extruding” and 
“pelleting” but limiting the applicability of these activities to the manufacture/processing of 
animal food.  We are ma king these changes so that the definition of manufacturing/processing in 
this regulation aligns with the definition s in the regulation s on preventive controls for human 
food and animal food .  For a discussion of the classification of these and other activi ties, see 
section IV of the preamble to the final rule on preventive controls for human food (80 FR 55908 
at 55924 through 55936).  
 (Comment 41)  Several comments express concern regarding the proposed definition of 
“manufacturing/processing” and what may constitute activities that are a part of harvesting, 
packing, or holding.  One comment asks that we classify the following activities, whether they 
occur on or off the farm, as part of harvesting/post -harvest handling operations because there is 
no substan tial transformation of the produce item into a different product in commerce:  cutting, 
trimming, washing, waxing, cooling, mixing, labeling, and packaging of fresh produce RAC s.  70 
 
 
 One comment requests that coring, artificial ripening, waxing, cutting, labe ling, stickering, 
packaging , and fumigation be included in the definition of “harvesting” and not 
“manufacturing/processing.”  
 (Response  41)  We conclude that the definition of “manufacturing/processing” in §  1.500 
is appropriate because it is consistent with the definition of the term in the regulations on 
preventive controls for human food and for animal food.  With respect to the comments 
regar ding whether particular activities involving produce should be classified as 
manufacturing /processing, as previously stated, the final rule on preventive controls for human 
food addresses the scope of manufacturing/processing  (80 FR 55908 at 55924 through 55936).   
 (Comment 42)  One comment suggests that the definition of “manufacturing/processing” 
refer to making food from one or more “raw materials and/or ingredients” rather than 
“ingredients.”   
 (Response  42)  We do not believe the change is necessary b ecause raw materials in the 
context of the definition of “manufacturing/processing” are food ingredients.  
17.  Pathogen  
We proposed to define “pathogen” as a microorganism of public health significance.  
 (Comment 43)  Some comments assert that, because the  significance of a pathogen for 
public health depends on an organism’s severity and exposure, “pathogen” should be defined as 
a microorganism of such severity and exposure that it would be deemed of public health 
significance.  Some comments suggest that t he definition refer to “human or animal” public 
health significance.  71 
 
 
  (Response  43)  We decline to make these changes because the definition already 
addresses the public health significance of a pathogen and it is unnecessary to indicate that a 
pathogen mi ght affect humans or animals.  The definition’s reference to microorganism s “of 
public health significance” take s into account factors such as the severity of illness and the route 
of exposure.  In addition,  the term “microorganism of public health signifi cance” is broad 
enough to address both  human s and animal s.  
18.  Qualified Auditor  
In the Supplemental Notice, we proposed to add a definition for “qualified auditor,” 
which we proposed to define as a person who is a qualified individual and has technical expertise 
obtained by a combination of training and experience appropriate to perform onsite audits.  We 
further stated that a foreign government employee could be a qualified auditor.  
 (Comment 44)  Some comments ask that we r evise the definition of quali fied auditor to 
include persons who have technical expertise obtained by a combination of training, experience, 
or education appropriate to perform audits.  Some comments ask us to recognize that training 
and/or experience can make a person a qualified aud itor; the comments state that people with 
experience performing audits likely have applicable training but might not have completed a 
specific regimen of courses.  Some comments maintain that a person might be sufficiently 
qualified to conduct an audit thr ough experience only and allowing an individual to be deemed 
qualified through training and/or experience is critical for food additive and generally recognized 
as safe (GRAS) substance facilities.  Some comments maintain that we should recognize the role 
of the education of a potential qualified auditor as well as training and experience to meet the 
criteria.     72 
 
 
 (Response  44)  We agree a qualified auditor might obtain the necessary auditing expertise 
through education, training, or experience, or some com bination of those sources of expertise, 
and we have revised the definition of qualified auditor accordingly.  (As discussed in section 
III.D of this document, the requirement that a qualified auditor have such education, training, 
and/or experience is sepa rately set forth in §  1.503(b) of the final rule.)  However, we believe it 
is likely that a person would need at least some actual experience in auditing (including by 
assisting or observing others in the performance of an audit) to meet the definition of a qualified 
auditor, i.e., it would be difficult to obtain the necessary technical expertise solely through 
education and/or training that does not involve assisting or observing others in the performance 
of an audit.  
 (Comment 45)  Some comments object t o the proposed requirement that a qualified 
auditor must be a qualified individual with certain technical auditing expertise.  One comment 
asserts that a qualified auditor should not be required to have the broader skills of a qualified 
individual.  One co mment maintains that a qualified auditor should not be required to have 
knowledge, skills, and abilities beyond those of a qualified indivi dual; instead, the definition 
should give a qualified individual the discretion to conduct an audit himself/herself o r identify 
someone to perform this function.    
 (Response  45)  We do not agree with the c omments.  For purposes of FSVP, the final rule  
define s a qualified individual as a person with the education, training, or experience (or a 
combination thereof) necessary to perform the activities needed to perform an activity required 
under the FSVP regulations.  (We did not intend that every qualified individual who performs an 
FSVP activity would need to have the education, training, or exp erience needed to perform all 73 
 
 
 FSVP activities --only the activity or activities the person is performing; therefore, we have 
revised the definition of “qualified individual” to refer to the performance of “an activity 
required under this subpart”.)  Thus, w hatever FSVP activity is being conducted, including onsite 
auditing, the individual conducting the activity must have adequate education, training, or 
experience (or some combination thereof) to properly conduct the activity.  However, in the case 
of onsit e auditing, the qualified individual conducting the auditing must have additional 
expertise --specifically, technical expertise that is needed to adequately perform the auditing 
function.  
Further, we conclude  that the person conducting an audit must not onl y have expertise in 
conducting audits but also a broader understanding of food safety processes and procedures.  The 
scope of an audit can be a review of an entire range of food safety processes or procedures or a 
component of an overall system of such pro cesses and procedures.  It is therefore critical that the 
auditor has education, training or experience required of qualified individuals, as well as 
education, training , or experience specific to conducting audits.  The definition of qualified 
auditor doe s not require or prohibit a qualified individual working on the importer’s behalf from 
selecting the person who will conduct an onsite audit.  However, the person selected to conduct 
an onsite audit must meet the definition of a qualified auditor.  
 (Comme nt 46)  One comment asks that we define qualified auditor under the FSVP 
regulation the same way we define qualified auditor under the regulation on preventive controls 
for animal food.  
 (Response  46)  The definitions of qualified auditor in the FSVP and p reventive controls 
for animal food regulations are essentially the same.  Therefore, no change s are needed.  74 
 
 
  (Comment 47)  Some comments ask that we define or provide guidance on the criteria for 
the technical expertise required under the definition of qua lified auditor.  One comment asks that 
we consider training courses that would certify individuals similar to the courses being 
developed to become a qualified individual.  
 (Response  47)  A qualified auditor might acquire the appropriate technical expertis e 
through education, training (including training that results in accreditation under a recognized 
facility auditing or certification scheme), or experience , or some combination of those criteria .  
We intend to provide more information in the FSVP draft gu idance on how persons might obtain 
the necessary expertise to be qualified auditors for FSVP purposes.   
  (Comment 48)  One comment asks how an importer can determine whether a foreign 
government employee has sufficient knowledge of U.S. regulations to serve as a qualified 
auditor, given that such officials often inspect and certify firms according to national 
requiremen ts.  One comment requests guidance on how an importer may rely on audits 
performed by unaccredited foreign government employees and how foreign governments can 
create audit programs to assist firms that export food to the United States.  One comment 
sugges ts that we recognize foreign government employees as qualified auditors after they receive 
training and pass an assessment organized by the foreign government according to U.S. 
regulations.  
 (Response  48)  The standard for being a qualified auditor does no t differ when the audit 
is performed by a foreign government employee.  Auditors often audit against multiple schemes, 
and we see no reason why a foreign government employee with appropriate technical expertise 
obtained by a combination of education, train ing, and /or experience could not audit against 75 
 
 
 FDA’s standards.  There  also is no requirement that audits be performed by accredited auditors 
for the purpose of the FSVP  regulation .  We currently do  not envision establishing a program to 
recognize individu als as meeting the definition of qualified auditor for the purposes of FSVP.   
However, we do intend to conduct outreach, develop training modules, and provide technical 
assistance to facilitate compliance with this rule.  
 (Comment 49)  Some comments ask t hat we include in the definition of qualified auditor 
properly trained Federal auditors and what the comments described as State and private auditors 
operating under contract with the Federal government.  
 (Response  49)  We agree that government employees o f different levels of government 
may be qualified auditors (provided they otherwise meet the definition of qualified auditor).  We 
therefore have revised the definition of qualified auditor to state in part that a government 
employee, including, but not li mited to, a foreign government employee, may be a qualified 
auditor.  As for the comment suggesting that private auditors operating under contract with the 
Federal government may be qualified auditors, we note that nothing in the definition of qualified 
auditor prevents private auditors from serving as qualified auditors (provided they otherwise 
meet the definition of qualified auditor).   
 (Comment 50)  One comment suggests that the definition of qualified auditor should 
include third -party auditors accred ited under FDA’s third -party auditing regulations.  
 (Response  50)  We agree and have revised the definition of qualified auditor to state that 
a qualified auditor could be  an audit agent of a certification body accredited in accordance with 
subpart M of part 1 (the regulations implementing section 808 of the FD&C Act (21 U.S.C. 
384d) ).  (The final rule on the accreditation of third -party certification bodies, published 76 
 
 
 elsewhere in this issue of the Federal Register , refers to third -party aud itors also as “certification 
bodies.”)  As a result of making this change, it is no longer  necessary  to specify in the definition 
of “qualified individual” that a qualified individual includes, but i s not limited to, a third -party 
auditor (certification bo dy) that has been accredited in accordance with section 808 of the FD&C 
Act, as we previously proposed  (because a qualified auditor must also be a qualified individual ).  
(Comment 51)  One comment maintains that in addition to auditors accredited under 
FDA ’s third -party certification  regulations, a qualified auditor could be a qualified individual 
who is not a third -party auditor accredited under those regulations.  However, one comment 
asserts that not requiring the use of accredited auditors or an accredi ted system is not a good idea 
from a food safety perspective, particularly for RACs originating in a part of the world that has a 
history of shipping microbiologically contaminated products to the United States.   
 (Response  51)  We believe that a person need not be an auditor formally accredited under 
the third -party certification  regulations or any other accreditation system to have the technical 
expertise needed to appropriately perform an onsite audit.  Under the definition of qualified 
auditor, a person may obtain the necessary technical expertise through a combination of 
education, training  (including training that is rigorous but does not lead to formal 
“accredit ation”) , and /or experience.  For example, a government employ ee might be less likely 
than a private sector auditor to be accredited, but the government employee might still be a 
qualified auditor and be appropriately suited to conduct onsite audits of foreign suppliers.  
However, importers have the responsibility to  choose qualified auditors even though we are not 
requiring that auditors be formally accredited.    77 
 
 
  (Comment 52)  One comment, stating that it uses its internal auditors to conduct onsite 
audits of its foreign suppliers, suggests that the definition of q ualified auditor be revised to allow 
the use of internal auditors when they have no direct financial interest in the foreign supplier.  
 (Response  52)  Although we agree with the comment, we do not believe that it is 
necessary to change the definition as su ggested.  An importer’s employee could be a qualified 
auditor if he or she has the expertise required under the definition.  In addition, the final rule does 
not prohibit an importer or one of its employees from conducting verification of the supplier.  
19.  Qualified Individual  
We proposed to define “qualified individual” as a person who has the necessary 
education, training, and experience to perform the activities needed to meet the FSVP 
requirements.  The proposed definition states that a qualified indiv idual may be, but is not 
required to be, an employee of the importer.  The proposed definition further states that, 
regarding the performance of verification activities related to preventive controls implemented 
by the foreign supplier in accordance with s ection 418 of the F D&C Act , a qualified individual 
must have successfully completed training in the development and application of risk -based 
preventive controls at least equivalent to that received under a standardized curriculum 
recognized as adequate by  FDA or be otherwise qualified through job experience to develop and 
implement a food safety system.  The proposed definition also states that:  
•  A qualified individual includes, but is not limited to, a third -party auditor that has been 
accredited in acc ordance with section 808 of the F D&C Act; and  
•  A foreign government employee could be a qualified individual.  78 
 
 
  (Comment 53)  One comment asks that we clarify in the definition that a qualified 
individual could have the necessary education, training and experience to perform FSVP 
activities “or a combination thereof.”   
 (Response 53)  We agree and have changed the definition to state that a qualified 
individual must have education, training, or experience (or a combination thereof) necessary to 
perform an FSVP activit y.  (We have separately set forth the requirement that a qualified 
individual have such education, training, an d/or experience in §  1.503(a) of the final rule.)  
  (Comment 54)  One comment asserts that the term “necessary education” in the proposed 
definition is misleading and suggests that the definition require a qualified individual to have 
“skills consistent wi th the requirements.”   
(Response 54)  We have changed the definition of qualified individual so the term 
“necessary education” is not included .  However, we do not agree that the use of the term 
“necessary” in the revised definition is misleading.  The definition of qualified individual makes 
clear that the required education, training, or experience is that which is needed to conduct the 
FSVP activity or activities the person is performing.  
(Comment 55)  One comment, noting “qualified individual” is def ined differently in the 
proposed regulations on preventive controls, asserts that using the same term with different 
meanings in different regulations could lead to confusion.  The comment suggests that the FSVP 
regulation use the term “FSVP qualified indi vidual.”  
 (Response  55)  We decline to make this change.  The definition of “qualified individual” 
in the FSVP regulation makes clear that the necessary qualifications are specific to FSVP 
activities performed by the individual, and the definition of “qual ified individual” in the 79 
 
 
 preventive controls regulations likewise makes clear that the necessary qualifications are specific 
to the activities required under those regulations.  To the extent the comment objects to the 
differences in the definitions for “q ualified individual” across the different regulations, we 
disagree.  Fundamentally, the definition of “qualified individual” in th e FSVP  regulation is 
aligned with the definition of qualified individual in the preventive controls regulations .  In each 
case, a qualified individual means a person who has the education, training, or experience (or a 
combination thereof) necessary to perform activities required under the regulation s.  However, 
the definitions vary as a result of the different activities a quali fied individual must perform 
under each rule.     
  (Comment 56)  Some comments suggest that we establish specific standards or minimum 
qualifications for qualified individuals.  One comment maintains that the definition should 
require an understanding of FDA regulations.  Some comments ask that we provide examples of, 
or guidance regarding, necessary education, training, and experience so that importers can 
determine whether their employees meet the standard.  One comment asks that qualifications not 
be re stricted to a certain type of course or program as this would unnecessarily raise the cost of 
compliance and disqualify well -suited individuals from compliance roles.  
 (Response  56)  We intend to address in guidance what appropriate education, training, 
and experience qualified individuals should have to conduct FSVP activities.  To maximize 
flexibility, persons will not be required to complete a particular course or program to become a 
qualified individual under the FSVP regulations; rather, persons will b e able to obtain the 
necessary education, training, and /or experience through a variety of methods and experiences.  80 
 
 
 The principal concern  is that the education, training, and experience equip them to conduct the 
FSVP activity or activities they are perfor ming.  
 (Comment 57)  One comment requests that we include a requirement for certification 
with specific criteria for competence for performing FSVP activities because merely requiring 
that an individual be knowledgeable in the food process would not adequ ately ensure the 
individual is qualified to perform FSVP activities.   
 (Response  57)  We decline to require that a person obtain a particular certification to act 
as a qualified individual on behalf of an importer.  As stated previously, we want to provide  
flexibility as to how a person can obtain the necessary education, training, and /or experience.  
 (Comment 58)  One comment stresses that the determination as to whether an individual 
is qualified to develop and oversee an importer’s FSVP should be a perfo rmance -based 
evaluation, not a paperwork exercise.  
 (Response  58)  We agree with the comment to the extent that the comment suggests that 
an importer should only use a person to conduct FSVP activities who the importer has 
determined has the education, tra ining, or experience (or a combination thereof) necessary to 
perform those activities.  Whether a person is qualified to perform those activities should be 
determined by the importer on a case -by-case basis.  
 (Comment 59)  One comment suggests that we add to the definition a requirement that 
the qualified individual understands the language of the country in which the foreign supplier is 
located.  
 (Response  59)  We agree a qualified individual must be able to read and understand the 
language of any records that the individual must review in performing FSVP activities.  This 81 
 
 
 would ensure the individual responsible for performing FSVP activities is able to provide 
meaningful supplier verification, and is especially important in the imports context in which  
individuals in the United States must verify suppliers in countries where records may be ke pt in 
languages  other than English .  We  therefore have revised the definition of “qualified individual” 
to specify that a qualified individual must have the ability to read and understand the language of 
any records the person must review in performing FSVP activities  (this requirement is separately 
set forth in §  1.503(a) of the final rule) .  As discussed more fully in section III. K.3.a  of this 
document, we have deleted  the proposed requirement in §  1.510(b) of the proposed rule that all 
FSVP records be maintained in English, and we have added a requirement that, upon Agency 
request, the importer must provide an English translation of a record in another language in a 
reasonable period of time.  
 (Comment 60)  One comment requests that we clarify the statement in the proposed 
definition of qualified individual regarding the “standard curriculum” for training in the 
development and application of risk -based preventive contr ols recognized by FDA as adequate.  
The comment also asks that we explain how a qualified individual could be qualified through job 
experience to develop and implement a food safety system and state whether and how the 
Agency will recognize industry provid ers of training programs.  One comment requests that we 
provide a process by which foreign training in risk -based preventive controls can be recognized 
as equivalent or adequate.  The comment asserts that it would be unreasonable to expect FDA -
recognized t raining to be available in all languages and in all countries exporting food to the 
United States, and it also would be unreasonable to require foreign suppliers to travel to the 
United States to obtain the required training.  82 
 
 
  (Response  60)  As discussed in the preamble to the final rule on preventive controls for 
human food, we are  working to develop general guidance on hazard analysis and preventive 
controls.  We also intend to work with the Food Safety Preventive Controls Alliance (FSPCA ) to 
develop selected sections of model food safety plans for several food types that will provide 
instructional examples .  In addition to the preventive controls curriculum,  we intend to develop a 
curriculum regarding FSVP that will be available as an opt ion for importers and other 
stakeholders.  It will be the responsibility of a person providing training in preventive controls to 
ensure the training is at least equivalent to that provided under a standardized curriculum 
recognized as adequate by FDA.  Tr aining providers will not need to obtain express approval 
from the Agency  to use any particular curriculum.  In addition, t he qualified individuals used by 
importers to perform FSVP activities related to preventive controls will not be required to obtai n 
training in the United States . 
 However, we have concluded it is not necessary to include in the regulation a 
requirement that qualified individuals performing FSVP activities related to a foreign supplier’s 
preventive controls complete a specified training  in preventive controls.  Instead, the draft 
guidance on FSVPs will provide recommendations on the type of training that qualified 
individuals should have, including, for persons who assess foreign supplier s’ preventive controls, 
training in the developmen t and application of preventive controls  available in (or comparable 
to) the curriculum that FDA is developing with the FSPCA .  The draft guidance also will provide 
recommendations for training for individuals who will be conducting verification activities  
regarding suppliers of food that is subject to the produce safety regulations or other FDA food 
safety regulations.  83 
 
 
  (Comment 61)  One comment suggests that we revise the definition of qualified 
individual to refer to a person being qualified to “develop and apply” a food safety program 
rather than “develop and implement” such a program to be consistent with the proposed 
regulations on preventive controls for human food.  
 (Response  61)  Although w e agree that this change would be appropriate, we have 
delet ed the reference to specialized training in preventive controls from the definition of 
qualified individual .  However  we will take this  suggestion  into consideration in developing our 
guidance on appropriate training for qualified individuals.  
 (Comment 62)  One comment suggests that we consider including requirements for 
ongoing training to ensure qualified individuals stay current in the latest developments relevant 
to their credentials.  
 (Response  62)  Because the definition for “qualified individual” al ready requires that 
such individuals be qualified to perform FSVP activities, we do not believe it is necessary to 
establish specific requirements for ongoing training.  If developments over time cause a person ’s 
education, training, and experience to be i nadequate to perform FSVP activities, that person  
would no longer be a qualified individual and the individual might need to obtain additional 
education, training, or experience.   
 (Comment 63)  One comment requests that we specify that to be considered a  qualified 
individual, a foreign government employee should meet the same stringent requirements as those 
who are privately employed.  
 (Response  63)  All persons acting as qualif ied individuals for an importer --whether 
located in the United State s or anoth er country, whether a government of ficial or privately 84 
 
 
 employed --will be required to have the education, training, or experience (or a combination 
thereof) necessary to perform their FSVP activities.  Thus, the standard for being a qualified 
individual doe s not vary depending on whether an individual is a foreign government employee.  
20.  Ready -to-Eat Food  
On our own initiative, we are adding a definition of “ready -to-eat food” that is consistent 
with the preventive controls regulations.  The definition sta tes that ready -to-eat food (RTE food) 
means any food that is normally eaten in its raw state or any food, including a processed food, 
for which it is reasonably foreseeable that the food will be eaten without further processing that 
would significantly min imize biological hazards.  
21.  Receiving Facility  
Also on our own initiative, we are adding a definition of “receiving facility” that is 
consistent with the preventive controls regulations.  The d efinition states that a receiving facility 
means a facility that is subject to subparts C and G of part 117 (21 CFR part 117) (the 
regulations on hazard analysis and risk -based preventive controls and supply -chain  programs  for 
human food ) or subparts C and  E of part 507 (21 CFR part 507) (the corresponding regulations 
for animal food)  and that manufactures/processes a raw material or other ingredient it receives 
from a supplier.   In accordance with the language used in the final regulations on preventive 
controls, we refer to the supplier provisions in those regulations as provisions on  “supply -chain 
programs ” instead of  “supplier programs .”  
22.  Very Small Foreign Supplier  
In the Supplemental Notice, we proposed to define “very small foreign supplier” as a 
foreign supplier, including any subsidiary, affiliate, or subsidiaries or affiliates, collectively, of 85 
 
 
 any entity of which the foreign supplier is a subsidiary or affiliate, whose average annual 
monetary value of sales of food during the pre vious 3 -year period (on a rolling basis) is no more 
than $1 million, adjusted for inflation.    
(Comment 64)  We received many comments on th e proposed  definition  of very small 
foreign supplier .  Some comments support th e definition  while others question th e breadth of the 
definition and the percentage of imported food it would exclude from full FSVP requirements .  
Some comments  suggest different eligibility criteria, such as number of employees.  Some 
comments assert that basing the definition on the U.S. d ollar value of sales would provide an 
unfair advantage to foreign firms compared to American firms of comparable size because many 
foreign suppliers are located in countries with currencies valued much lower than the U.S. dollar.  
Some comments assert that  using a monetary criterion for very small status is impractical 
because of fluctuations in foreign exchange rates and because those rates are not related to any 
risk in food; the comments maintain that using this criterion would jeopardize a foreign 
suppl ier’s predictability of business and have negative effects on international trade.    
Some comments assert that “very small” status should be based on the foreign supplier’ s 
sales of food exports to the United States rather than its total food sales.  One c omment suggests 
that it might be difficult for foreign suppliers to determine their average annual monetary value 
of food sales because many crops can be used for both food and non -food purposes (such as soil 
improvement, planting seed, and b iofuels).   Some comments suggest that the reference to food 
“sales” include returns  received by members of cooperatives for the crops the members provide.  
One comment state s that if a very small foreign supplier is defined on the basis of dollar 
revenues, we should c larify whether the adjustment for inflation is to be based on the U.S. 86 
 
 
 inflation rate or the rate in the supplier’s country.  The comment also suggests that a neutral 
outside s ource such as the World Bank be used to determine the inflation rate rather than  using 
rates estimated by  individual governments .   
(Response  64)  As discussed more fully in section III. M.1 of this document , in response 
to these comments and other comments related to the modified requirements we proposed for 
very small foreign supplie rs, we have deleted the proposed provisions applicable to food  
imported from  “very small foreign supplier s.”  Instead, in alignment with the supply -chain 
program provisions of the preventive controls regulations, § 1.512 of the final rule includes 
modified  requirements for importers of food from certain small foreign manufacturers/processors 
and farms.   The modified requirements include, among other things, the following:  
•  Annually obtain ing written assurance from the importer’s  foreign supplier that the 
supplie r meets the specified criteria as a certain type of small facility or farm under FDA  
regulation s on preventive controls, produce sa fety, or shell egg production , storage, and 
transportation;  
•  Obtaining written assurance  at least every 2 years  that the small supplier is in 
compliance with applicable regulations or (for some small suppliers) that it acknowledges  it is 
subject to the adulteration provisions of the FD&C Act ; 
•  Evaluating the foreign supplier’s compliance his tory and approving suppliers; and  
•  Establishing procedures to ensure the use of approved suppliers .   
As discussed in section III.M .1 of this document, we conclude that these modified 
requirements for food  from certain small foreign suppliers are  appropr iate to align the FSVP and 
preven tive controls provision s to help provide parity in supplier verification requirements for 87 
 
 
 domestic and foreign food producers.   We further conclude that basing eligibility for the 
modified requirements on different criteria , such as the supplier’s sales of fo od to the United 
States, would not be consistent with this approach.   We believe it is appropriate for these 
modified verification requirements to be based on the underlying food safety regulations (i.e., the 
regulations  on preventive controls, produce safety , and shell egg production ) because  those 
regulations themselves provide for modified requirements or exemptions  for these food 
producers .  Because the modified verification provisions for certain small foreign suppli ers are 
based on the underlying food safety regulations, a foreign supplier’s qualification for these 
modif ied requirements or exemptions depends on the eligibility criteria specified  in those 
regulations.  Concerns  regarding the app ropriateness of these eligibility criteria are beyond the 
scope of this rulemaking.  
23.  Very Small Importer  
In the Supplemental Notice, we proposed to define “very small importer” as an importer, 
including any subsidiary, affiliate, or subsidiaries or aff iliates, collectively, of any entity of 
which the importer is a subsidiary or affiliate, whose average annual monetary value of sales of 
food during the previous 3 -year period (on a rolling basis) is no more than $1 million, adjusted 
for inflation.   We sta ted that the proposed annual sales ceiling of $1 million was consistent with 
the definition of “very small business” in the proposed rule on preventive controls for human 
food.   However, we noted that the definition of “very small business” in the proposed  rule on 
preventive controls for animal food included an annual sales ceiling of $2,500,000 and different 
sales ceilings applied to smaller entities subject to (or not covered under) the proposed produce 
safety regulations (i.e., $500,000 in annual produce  sales for “small businesses,” $250,000 in 88 
 
 
 annual produce sales for “very small businesses,” and $25,000 in annual produce sales for certain 
farms not covered under the produce safety regulations), and we sought comment on whether 
and, if so, how we should  take these definitions into account in defining very small importers and 
very small foreign suppliers.  
 (Comment 65)  Some comments support defining “very small importer” consistently with 
the definition of “very small business” in the regulation on preve ntive controls for human 
food.   Other comments support a definition of very small importer for animal food that is 
consistent with the proposed definition of very small business in the preventive controls for 
animal food regulation.  Some comments  assertin g that our proposed definition is inconsistent 
with some other FSMA definitions of small entities nevertheless also express  concern about 
practical challenges of having different annual sales ceilings for different types of imported food.  
Some comments su pport using an annual food sales ceiling of $500,000 as originally proposed.    
 (Response  65)  We agree with the comments that the definition of very small importer 
should be consistent with the definitions of very small business in the preventive controls  
regulation s.  This is particularly important for importers that are also subject to those regulations.  
We believe that defining the terms consistently will contribute to a level playing field between 
domestic and imported food and will help avoid a situa tion in which a facility would be a very 
small business  under the preventive controls regulations but not a very small importer under 
FSVP, or vice versa.   
Given that our very small importer definition was already designed to track the definition 
of very small business in the preventive controls for human food regulation , we are only adding 
new language to address the inconsistency  between the very small importer definition and the 89 
 
 
 very small business definition in the regulation on preventive controls for  animal food.  
Therefore, the final rule states that, with respect to animal food, a very small importer means an 
importer  (including any subsidiar ies and  affiliate s) averag ing less than $2.5 million per year, 
adjusted for inflation, during the 3 -year peri od preceding the applicable calendar year, in  sales of 
animal food combined with the U.S. market value of animal food imported, manufactured, 
processed, packed , or held without sale --as discussed in the following paragraphs).   For 
importers that import bot h human and animal food, the $1 million ceiling  applies to the human 
food imported and the $2.5 million ceiling  applies to the animal food imported.  For example, if 
an importer imports $1.5 million of human food and $1 million of animal food, the importer  
would be a very small importer for the purposes of its animal food (i.e., the importer would be 
subject to modified requirements for this food) but would not be a very small importer for the 
purposes of its human food (i.e., the importer would be subject to the standard  supplier 
verification requirements for th is food).   This is consistent with the way facilities that produce 
both human and animal food domestically are treated under the preventive controls regulations .   
Another change we are making to the very small importer definition to make it more 
consistent with the very small business definitions in the preventive controls regulations is to 
address the circumstance s in which an importer charge s fees for importing fo od.  Because  the 
definition in the Supplemental Notice  concerned  “sales of food,” it was unclear how entities that 
charge fees but do not “sell” food would be treated.  As discussed more fully in section III.M of 
this document , a principal reason that we a re comfortable with modified requirements for food 
imported by very small importers is that these firms are likely to be importing a relatively low 
volume of food into the United States.  As we stated in the preamble to the proposed rule, sales 90 
 
 
 of food is a proxy for volume.  We need a different proxy for importers of food that do not have 
food sales , such as  certain warehouses and repacking facilities .  Therefore, we are clarifying that 
importers that do not have sales of food, per se, should calculate the  U.S. market value of the 
food they import to determine whether they do not exceed the monetary ceiling for being a very 
small importer.  If an importer has some sales of food and conducts some of its food importation 
business in exchange for fees, the imp orter must add the sales of food and the U.S. market value 
of the food imported without sale  to determine whether it is a very small importer . 
 (Comment 66)  One comment finds the phrase “on a rolling basis” in the definition of 
very small importer to be c onfusing.   
 (Response 66)  In response to this comment and to be consistent with the very small 
business definitions in the preventive controls regulations , we are removing the phrase “on a 
rolling basis” from the definition.  Instead, we are specifying th at the average annual sales must 
be calculated, adjusted for inflation, during the 3 -year period preceding the applicable calendar 
year.  
 (Comment 67)  Some comments request that we base annual sales on different 
criteria.   Several comments request that the annual sales ceiling be based on sales to the United 
States rather than worldwide.   Some comments similarly request that the ceiling apply only to the 
value of food imported into the United States rather than an importer’s total annual food sales.  
Some comments assert that it would be difficult for FDA to determine which products are 
intended for export and which are for domestic consumption.   One comment supports an annual 
sales ceiling of $2 million if we decide to base the number on worldwide sales.  91 
 
 
 (Response 67)  We disagree that the annual sales ceiling should be based on sales to the 
United States rather than worldwide or only to the value of food imported as opposed to an 
importer’s total annual food sales.   By establishing modified requirements for very small 
importers, we are providing practical allowances for entities we believe pose a relatively low risk 
of causing harm to consumers .  An importer that sells more than the ceiling  dollar amount poses 
more risk .  We also affirm our tentative conc lusion from the proposed rule that, given the risk to 
overall public health, the modified requirements we put in place are adequate to provide 
assurances that the foreign suppliers to these importers produce food in compliance with 
processes and procedures  that provide the same level of public health protection as those 
required under section 418 or 419 of the FD&C Act  (as applicable ) and in compliance with 
sections 402 and 403(w) of the FD&C Act (as applicable).   This approach is consistent with the 
approach we are taking with respect to very small businesses under the preventive controls 
regulations.    
B.  Applicability and Exemptions (§ 1.501)  
 We proposed to specify (in §  1.501(a)) that the FSVP regulations would apply to all food 
imported or offered for import into the United States and to the importers of such food, except to 
the extent that we set forth proposed exemptions in §  1.501.  In response to comments, we have 
made some changes to the exemptions and added certain  exemption s. 
1.  Exemption for Certain Juice and Seafood Products   
 In accordance with section 805(e) of the FD&C Act, w e proposed to exempt from the 
FSVP regulation juice, fish, and fishery products imported from a foreign supplier that is 
required  to comply with, and is in compliance with, the regulation on juice in part 120 (21 CFR 92 
 
 
 part 120) or the regulation on fish and fishery products in part 123 (21 CFR part 123) (proposed 
§ 1.501(b)).  We further proposed to specify that importers of juice or  fish and fishery products 
that are subject to the  requirements  applicable to importers of those products under §  120.14 or § 
123.12, respectively  (the “HACCP importer regulations”) , must comply with those requirements .  
 (Comment 68)  One comment expresses concern about the proposed exemption for 
seafood products.  The comment maintains that because the seafood HACCP regulation do es not 
require onsite auditing to verify the foreign supplier’s compliance with that regulation, there is 
no assurance of compliance.  The comment contends that the exemption for seafood products is 
not consistent with congressional direction and the stated intent of the FSVP regulation.   
 (Response  68)  We do not agree.  The exemption for fish and fishery pro ducts in 
§ 1.501(b) (1) of the final rule provides that the FSVP regulation do es not apply to products 
imported from a foreign supplier that is required to comply with, and is in compliance with, the 
regulation on fish and fishery products in part 123.  Amo ng other things, part 123 requires 
importers to comply with requirements for imported fish and fishery products, which may 
include implement ing written procedures for ensuring that imported products were processed in 
accordance with the HACCP regulation, i ncluding the use of “affirmative steps” such as 
obtaining continuing lot -specific certificates from an appropriate foreign government inspection 
authority or competent third party, or regularly inspecting foreign processor facilities (see 
§ 123.12).  Thus,  § 1.501(b) (1) makes clear that importers of fish and fishery products are 
responsible for verification, but must do so under the regulation specific to fish and fishery 
products in part 123.  As for the comment that the seafood HACCP exemption is inconsis tent 
with congressional intent, we do not agree.  Section 805(e) of the FD&C Act states that the 93 
 
 
 FSVP requirements “shall not apply to a facility if the owner, operator, or agent in charge of 
such facility is required to comply with, and is in compliance w ith,” the HACCP regulation f or 
seafood (as well as juice).  Thus, Congress specifically exempted facilities that are required to 
comply with, and are in compliance with, the seafood HACCP regulation from the scope of the 
FSVP regulation.  We therefore conc lude that it is consistent with congressional intent to exempt 
from the FSVP regulation the importation of seafood that is required to comply with, and is in 
compliance with, the seafood HACCP regulation in part 123.  
 (Comment  69)  One comment asserts that  the proposed exemption for juice is narrower 
than the statutory exemption because it applies to imported juice products but not ingredients.  
The comment requests that the exemption be applied to all ingredients and raw materials used in 
a facility that i s subject to and in compliance with the juice HACCP regulation provided those 
ingredients will be used in the production of juice products subject to the HACCP regulation.  
(Response 69)  We agree with the comment that we should broaden this exemption.   As 
we stated in the preamble to the FSVP proposed rule, the meaning of the reference to a juice or 
seafood “facility” in  section 805(e) (1) and (e)(2)  of the FD&C Act is subj ect to multiple 
interpretations  (78 FR 45730 at 45745) .  We discussed the possibility that the reference to 
“facility” might be intended to apply to a foreign supplier of juice or seafood or to an importer of 
such food.  We  tentatively concluded that Congress intended that section 805(e) (1) and (e)(2)  
apply to food being imported from forei gn suppliers in compliance with FDA requirements for 
juice or seafood HACCP.   
However, as the comment notes, applyin g section 805(e)(1) and (e)(2) only to food being 
imported from HACCP -compliant foreign facilities would mean that importers that are also juice 94 
 
 
 or seafood facilities would need to conduct supplier verification for the raw materials and other 
ingredients they import for use in juice and seafood products that are processed in accordance 
with the HACCP regulations.  However, i n enacting section 805(e)(1) and (e)(2), we believe that 
Congress intended to exclude food covered by and in compliance with the HACCP requirements 
from section 805 of the FD&C Act.  This exclusion likely reflects a determination that the HACCP 
regulations  in parts 120 and 123 make application of section 805 unnecessary because those 
regulations require processors to adequately address applicable hazards.   
We therefore conclude that a more reasonable interpretation is that Congress intended to 
exempt from the FSVP requirements the activities of a facility that are subject to the juice or seafood 
HACCP regulations in part 120 or 123.  Under this interpretation, the exemption applies not only to 
the importation of food produced by a foreign supplier subject t o and in compliance with those 
regulations, but also to the importation of raw materials or other ingredients by U.S. facilities for use 
in processing juice and seafood products in accordance with the regulations.  We conclude that this 
interpretation woul d fulfill the apparent goal o f section 805(e)(1) and (e)(2) because importers 
that manufacture/process juice or seafood under the HACCP regulations will be addressing all 
the hazards in the raw materials or other ingredients they import in accordance with those 
regulations.  Accordingly, § 1.501(b)(2) of the final rule states the FSVP regulation  does not 
apply with respect to raw materials or other ingredients an importer uses in manufacturing or 
processing juice subject to part 120 or fish and fishery prod ucts subject to part 123, provided the 
importer complies with the relevant regulation when manufacturing or processing the juice or 
seafood product.  95 
 
 
  (Comment 70)  Some  comment s express concern regarding  the statement in the preamble 
to the proposed rule t hat we are considering whether in the future we should initiate a rulemaking 
to revise the HACCP importer regulations in light of the FSVP regulation and FSMA’s increased 
emphasis on importers’ role in ensuring the safety of imported food.  The comment s assert that 
although the HACCP importer regulations do not require onsite audits of foreign suppliers, other 
requirements under the HACCP regulations ensure food safety.   One comment questions whether 
revising the juice HACCP regulation would result in addit ional safety because juice producers 
must process juice to achieve a 5 -log reduction in the pertinent microorganisms for juice, a 
requirement that is not mandated in the FSMA proposed rules.  
 (Response  70)  We agree that the juice and seafood HACCP regulations have 
requirements applicable to importers in § § 120.14 and 123.12, respectively.  At the same time, 
we recognize that section 805 of the FD&C Act and the implementing regulation in this final rule 
set forth a more comprehensive approach to veri fication than the existing juice and seafood 
HACCP regulations.  Consistent with the statement in the preamble to the proposed rule, we 
therefore think it is appropriate to consider whether the Agency should in the future initiate a 
rulemaking to revise th e regulations applicable to importers of juice and seafood.   We believe 
that the comment on the juice HACCP processing requireme nts is misplaced because the FSVP 
regulation concern s verification that the food safety requirements applicable to the 
manu factu ring/processing, growing , or raising of food are met, not the establishment of the food 
safety requirements themselves.  96 
 
 
 2.  Exemption for Food Imported for Research or Ev aluation  
In proposed § 1.501(c), we proposed to exempt from the FSVP regulation  food t hat is 
imported for research or evaluation use, provided that:  
•  The food is not intended for retail sale and is not sold or distributed to the public ; 
•  The food is labeled with the statement “Food for research or evaluation use”; and  
•  When filing en try with CBP, the customs broker or filer for the food provides an 
electronic declaration that the food will be used for research or evaluation purposes and will not 
be sold or distributed to the public.   
 We further proposed to specify that food is impor ted for research or evaluation purposes 
only if it is imported in a small quantity that is consistent with a research, analysis, or quality 
assurance purpose and the entire quantity is used for this purpose.   We proposed this exemption 
from the FSVP requir ements consistent with section 805(f) of the FD&C Act.  
 (Comment 71)  One comment asks that we require that  the statement “Food for research 
or evaluation use” be placed on a permanently affixed  label.  
 (Response  71)  We do not believe that it is necessary to specify that the label be 
permanently affixed to the food covered by this exemption.  However, in proposing to require 
that the food eligible for this exemption be labeled with the statement “Food for research o r 
evaluation use,” we stated that this requirement was intended to help ensure that the food is, in 
fact, not intended for retail sale and is not sold or distributed to the public.  We therefore expect 
that such labels will be securely attached to the food  so they remain on the food until the food is 
used for research or evaluation to ensure that it is not sold or distributed to the public.  97 
 
 
  (Comment 72)  One comment maintains that the regulation should not require the 
importer to declare electronically tha t a food will be used for research and evaluation purposes, 
asserting that the requirement to label the food should be sufficient.  
 (Response  72)  We do not agree.  We stated in the preamble to the proposed rule that the 
intent of requiring this declaratio n at entry was to help ensure that the food is, in fact, not 
intended for retail sale and is not sold or distributed to the public.  The electronic declaration 
requirement also provides an efficient and effective means of determining whether a food is 
exem pt under §  1.501(c).  For example, the electronic declaration will mean that the designation 
for research and evaluation use is readily available to FDA during entry review of the food.  We 
believe that the electronic declaration requirement will allow us to efficiently enforce th is 
exemption  and thus efficiently enforce section 805(f) of the FD&C Act .   
 (Comment 73)  Some comments request that we interpret “small quantity” flexibly to 
allow for variance based on the type of food product, the purpose of th e research or evaluation, 
and other factors.  Some comments suggest that we interpret research and evaluation use on a 
case-by-case basis.  One comment asserts that the amount of food needed for research or 
evaluation varies and is not always a small quant ity; therefore, the comment suggests that we 
remove the term “small quantity” or replace it with a phrase such as “amounts not to exceed the 
amount reasonably sufficient to conduct” the research or evaluation.  Some comments maintain 
that the quantity shou ld not matter as long as the imported food will be used exclusively for 
research or evaluation and will not enter commerce.   
 (Response  73)  We do not agree that we should remove or replace the term “small 
quantity” in § 1.501(c).  In drafting section 805 (f) of the FD&C Act, Congress specif ied that the 98 
 
 
 exemption for research and evaluation purposes is for “small quantities” of food.  Thus, it would 
not be consistent with the intent of the exemption if we removed the s pecification that the 
exemption applies to small quantities of food.  As for replacing the term “small quantity” with a 
term such as “amounts not to exceed the amount reasonably sufficient to conduct” the research 
or evaluation, we decline this request for the same reason; the limitation regard ing “small 
quantities” is consistent with congressional intent.  To the extent the comments take the position 
that some flexibility is needed in administering the “small quantities” limitation, we agree.  
Because we understand that the amount of food used in research can vary based on the type of 
food, the nature of the research, and other factors, we intend to address in the FSVP draft 
guidance the quantity of food that is consistent with the “small quantities” limitation under 
different circumstances.     
 (Comment 74)  One comment suggests that we modify the exemption for food imported 
for research or evaluation to require unused amounts to be properly managed to ensure they do 
not enter commerce.  
 (Response  74)  We agree and have revised the exemption to specify that any unused 
amounts must be properly disposed of.  This requirement will help ensure that all food imported 
under this exemption is in fact used for the intended purpose of the exemption:  research or 
evaluation.  As such, this requirement will assist us in meeting our statutory obligation under 
section 805(f) of the FD&C Act to provide an FSVP exemption for small quantities of food 
imported for research and evaluation purposes.   
 (Comment 75)  Some  comments request an exemption from the FSVP requirements for 
food samples imported for trade shows.  The comments maintain that trade show food samples 99 
 
 
 provide an important marketing opportunity for small and medium companies at the early stage 
of expandi ng their business in the United States, and they contend it would be difficult for such 
companies to comply with the FSVP regulation.   
 (Response  75)  We do not agree that it is appropriate to exempt from the scope of the 
FSVP requirements food samples im ported for consumption at trade shows.  Section 805(f) of 
the FD&C Act directs FDA to establish an exemption  for food imported in small quantities for 
research and evaluation purposes,  “provided that such foods are not intended for retail sale and 
are not sold or distributed to the public.”  Because food imported for consumption at trade shows 
would be sold or distributed to the public  generally (i.e., anyone could attend the trade show) , we 
conclude that exempting such food from the FSVP regulation would b e inconsistent with the 
limitation in section 805(f).  We also believe  such an exemption would b e inconsistent with the 
broader  intent of section 805, which is to help ensure the safety of imported food.   
 (Comment 76)  One comment requests that pet food imported for use in in -home studies 
conducted under contracts with pet owners be exempt from the FSVP requirements.  
 (Response  76)  Provided that food imported for use in such in -home studies is imported 
in small quantities and meets the additional require ments of § 1.501(c), we agree that such food 
would be exempt from the FSVP requirements .  Because the food  would be used as part of a 
defined  study with a discrete set of test subjects for research and evaluation purposes, it does not 
appear that such food would be sold or distributed to the general public.  
 (Comment 77)  One comment asks that we clarify that if materials produced in a research  
and development facility will be used in products that are consumed by the public, such as in 100 
 
 
 market research activities like home -use tests, consumer panels, and sales samples, the facility 
will be subject to the FSVP regulation.  
  (Response  77)  Import ed food that is sold or distributed to the public is not eligible for 
the exemption for food for research and evaluation purposes in § 1.501(c).  Therefore , if the 
comment is referring to a foreign supplier that is a research and development facility but i s 
producing food t o be distributed  or made available  to the public  generally  (rather than provided 
under defined  research conditions  with a discrete  set of test subjects ), that food imported from 
that foreign supplier would not be exempt from FSVP.  If the  comment is referring to an 
importer that is a research and development facility using imported food to produce food 
products to be distributed to the public, the importer will be subject to FSVP for that food.  If the 
importer is also a “facility” under s ection 415 of the FD&C Act and therefore subject to the 
preventive controls regulations, and if the facility has established and implemented supply -chain  
program requirements  for an import ed raw material or other ingredient  in compliance with 
subpart G of part 117 or subpart E of part 507 with respect to the food , the facility would be 
deemed to be in compliance with the FSVP requirements, except for the requirements in § 1.509  
(see § 1.502(c)  of the final rule ). 
 (Comment 78)  One comment suggests that if a facility conducts research and 
development activities on the same site at which food is manufactured or processed, the 
exemption should apply only to the food intended for research or evaluation purposes instead of 
all fo od from the facility.  
 (Response 78)  We agree.  The exemption for food imported for research or evaluation 
applies only to food that meets the requirements for the exemption set forth in §  1.501(c) of the 101 
 
 
 final rule.  Importation of other food from a fore ign supplier that also provides food for research 
or evaluation would not be exempt from the FSVP requirements.  
 (Comment 79)  Some comments request that first shipments of a food imported in to the 
United States be exempt from the FSVP requirements.  Accor ding to the comments, the FSVP 
regulation might prohibit emerging products from entering the United States and hinder 
innovation by foreign suppliers.   
 (Response  79)  We do not agree.  In enacting section 805(f) of the FD&C Act, Congress 
specified that t he exemption for research and evaluation apply only for “food . . . for research 
and evaluation purposes.”  Congress further specified that the exemption applies “provided that 
such foods are not intended for retail sale and are not sold or distributed to the public.”  
Extending the exemption to all “first shipments” of a particular food would not be consistent 
with that limited exemption.   
3.  Exemption for Food Imported for Personal Consumption  
 Consistent with section 805(f) of the FD&C Act, w e proposed  to exempt from the FSVP 
regulation food that is imported for personal consumption, provided  such food is not intended for 
retail sale and is not sold or distributed to the public  (proposed §  1.501(d)) .  We proposed to 
specify that food is imported for per sonal consumption only if it is purchased or otherwise 
acquired by a person in a small quantity that is consistent with a non -commercial purpose and is 
not sold or distributed to the public.   
 (Comment 80)  One comment asserts that the term “small quantity ” is subjective and asks 
whether we will clarify the term.  However, one comment asks that we not define “small 
quantity” because doing so might conflict with other FDA food regulations (e.g., 21 CFR 102 
 
 
 1.277(b)(1) and 1.327(m)) that refer to food for “person al consumption” or “personal use” 
without further elaboration.  This comment suggests that if we do define “small quantity” for 
personal consumption, we should allow importation of a supply of a given food that would 
permit at least a number of years’ wort h of personal consumption (assuming the food item is 
shelf stable).   
 (Response  80)  We conclude it is not appropriate to define “small quantity” for purposes 
of the exemption for food imported for personal consumption.  The determination of what 
quantity  of food is “consistent with a non -commercial purpose” must be made on a case -by-case 
basis and might vary depending on the type of food and other factors.  In some cases, a supply 
that exceeds what one person might consume in a relatively short period of time might suggest a 
commercial purpose (and thus fall outside of the personal consumption exemption for FSVP).  In 
other cases, a small supply that one person might consume over a period of years might be 
consistent with a personal consumption purpose and  therefore might fall within the scope of the 
personal consumption exemption in § 1.501(d) .  However, in all cases the quantity of imported 
food would have to be consistent with a non -commercial purpose and the food could not be sold 
or distributed to the public in order to be subject to the exemption.  
 (Comment 81)  One  comment expresses concern that the exemption for personal 
consumption might be abused.  The comment asserts that foods are often shipped or smuggled 
into the United States purportedly for personal use but are instead sold at ethnic food stores.  The 
comme nt recommends that FDA and State and local agencies share information about such food 
to better control such violations.  103 
 
 
  (Response  81)  We agree it is important that agencies involved in ensuring the safety of 
food imported into the United States share re levant information when possible and permitted by 
law.  We routinely work with our State and local regulatory partners to address activities 
affecting the safety of imported food, and we intend to include implementation of the FSVP 
regulation among these a ctivities.  To the extent we become aware of any abuses of the personal 
consumption exemption in § 1.501(d), we intend to take appropriate action in response.  
4.  Exemption for Alcoholic Beverages  
Under proposed §  1.501(e), we proposed to exempt from the F SVP regulation alcoholic 
beverages that are imported from a foreign supplier that is a facility that meets the following two 
conditions:  
•  Under the Federal Alcohol Administration Act  (FAA A) (27 U.S.C. 201 et seq .) or 
chapter 51 of subtitle E of the Internal Revenue Code of 1986 (26 U.S.C. 5001 et seq .), the 
facility is a foreign facility of a type that, if it were a domestic facility, would require obtaining a 
permit from, registering with, or obtaining approval of a notice or application from the Secretary 
of the Treasury as a condition of doing business in the United States; and  
•  Under section 415 of the FD&C Act , the facility is required to register as a facility 
because it is engaged in manufacturing/process ing one or more alcoholic beverages.  
We also proposed that the FSVP regulation would not apply to food other than alcoholic 
beverages that is imported from a foreign supplier described in § 1.501(e)(1) provided that such 
food:  
(1)  Is in prepackaged form t hat prevents any direct human contact with such food; and  104 
 
 
 (2)  Constitutes not more than 5 percent of the overall sales of the facility, as determined 
by the Secretary of the Treasury.  
 We tentatively concluded that these provisions were consistent with th e provisions on 
alcohol -related facilities in section 116 of FSMA (21 U.S.C. 2206(a)) and the proposed 
regulation on preventive controls for human food.   
 (Comment 82)  Some  comments request that we exempt from the FSVP requirements 
importation of raw mat erials and ingredients (e.g., grapes, grains, hops, flavors) used to produce 
alcoholic beverages.  The comments maintain that such an exemption would be consistent with 
the regulations on preventive controls for human food and accreditation of third -party auditors.  
The comments further assert that such an exemption would ensure  consistency between domestic 
and foreign facilities and be consistent with Congressional intent regarding section 116 of 
FSMA.  
 (Response 82)  For the reasons stated  in the following paragraphs, we agree that some 
importers that import raw materials and other ingredients used to produce alcoholic beverages 
should be exempt from the FSVP  regulation , but only with respect to alcoholic beverages an 
importer manufactures/ processes, packs , or holds at a facility that meets the requirements to be 
exempt from the preventive contro ls regulation under § 117.5(i)  and as further described in the 
following paragraphs.  
We believe  that the context and purpose of FSMA supports this approach.  Section 116(a) 
of FSMA provides that, except as provided by certain listed sections in FSMA, nothing in that 
act, or the amendments made by it, shall be construed to apply to a facility that (1) under the 
FAAA (or chapter 51 of subtitle E of the  Internal Revenue Code of 1986 ) is required to obtain a 105 
 
 
 permit or to register with the Secretary of the Treasury as a condition of doing business in the 
United States; and (2) under section 415 of the FD&C Act is required to register as a facility 
because such facility is engaged in manufacturing, processing, packing, or holding one or more 
alcoholic beverages (with respect to the activities of such facility that relate to the 
manufacturing, processing, packing, or holding of alcoholic beverages).  
The regul ation on preventive controls for human food include s provisions implementing 
section 116 of FSMA.  As reflected  in the final rule on preventive controls for human food , FDA 
has determined that the alcoholic beverage exemption contemplated by section 116 ex empts 
from the preventive controls regulation alcoholic beverages at facilities meeting the two 
specified conditions in section 116.  (The exemption from  the preventive controls regulation also 
applies with respect to food other than alcoholic beverages at  facilities described in the 
exemption, provided such food is in prepackaged form that prevents direct human contact with 
the food and constitutes not more than 5 percent of the overall sales of the facility.)  Notably, we 
interpret the exemption to apply not only to domestic facilities that are required to secure a 
permit, registration, or approval from the Secretary of the Treasury under the relevant statutes, 
but also to foreign facilities of a type that would require such a permit, registration, or appr oval if 
they were domestic facilities.  
In the FSVP proposed rule, we discussed two possible approaches to interpreting section 
116 of FSMA for purposes of the FSVP regulation.  In doing so, we noted that section 116 is 
premised in part on status as a facil ity required to register under section 415 of the FD&C Act 
(section 116(a)(2) of FSMA).  We also noted that under the definition of “importer” in the 
proposed rule, an “importer” under the FSVP regulation might be a registered facility but would 106 
 
 
 not necess arily be one.  Given section 116’s emphasis on status as a facility that is required to 
register unde r section 415 of the FD&C Act, we noted that one approach to implementing section 
116 would be to base an exemption from the FSVP regulation on whether the importer of an 
alcoholic beverage was a registered facility.  The second approach we identified was to focus on 
the foreign supplier and to exempt from the FSVP regulation alcoholic beverages from foreign 
suppliers that would be exempt from the preventive controls regulation.  As explained in the 
proposed rule, we proposed to adopt th e second approach.   
In reaching this tentative conclusion we noted that, under the first approach, firms might 
import the sam e product (e.g., a bottled alcoholic beverage) and one firm would be eligible for 
the alcoholic beverage exemption from the FSVP regulation because it is required to register 
(e.g., it packs or holds the alcoholic beverage), while the other would not be el igible for this 
exemption because it is not required to register (e.g., it is a commodity broker that does not 
manufacture, process, pack, or hold food for consumption in the United States, or it is a 
restaurant or retailer).  The latter importer would nee d to conduct supplier verification under 
section 805 of the FD&C Act while the former would not.  
The second approach of focusing on the foreign supplier, however, tentatively seemed to 
be more consistent with FDA’s approach to alcoholic beverages in the p roposed regulations on 
preventive controls for human food.  Under this approach, if an alcoholic beverage is being 
imported, the foreign supplier would, by definition, be a facility that is required to register  with 
FDA .  Our proposed definition of “foreig n supplier” meant that the supplier would be engaged in 
manufacturing/processing the alcoholic beverage and that this beverage would not undergo 
further manufacturing/processing before being exported to the United States, except for labeling 107 
 
 
 or any similar  activity of a de minimis nature (see § 1.226 regarding foreign facility registration).  
Under this interpretation, whether an imported food is exempt from section 805 of the FD&C 
Act would not depend on who the importer happens to be, but on the nature of  the product being 
imported --whether the foreign supplier and the food in question (i.e., the alcoholic beverage or 
food other than alcoholic beverages) meet the requirements for exemption under section 116 of 
FSMA.  We tentatively concluded that this inte rpretation was consistent with the preventive 
controls proposed regulation because, in considering the two proposals together, if a foreign 
supplier is exempt from section 418 of the FD&C Act by operation of section 116 of FSMA for a 
particular food, then the importer would not be required to conduct verification of the supplier 
for the food under section 805.  
In proposing this second approach, however, we created an unanticipated inconsistency 
with the preventive controls regulation.  Under the proposed F SVP regulation, a facility that 
meets the requirements for the alcoholic beverage exemption under § 117.5(i) of the regulation 
on preventive controls for human food could nevertheless be subject to the FSVP regulation if it 
imports, for example, raw materi als to be used in the manufacture/processing of alcoholic 
beverages.  Because the importer/facility would be exempt from the preventive controls 
regulation under §  117.5(j), it would not be required to establish and implement a risk -based 
supplier program under that regulation.   That would mean that the importer would not be exempt 
from most FSVP requirements under the proposal to deem importers in compliance if they are 
required to establish and implement a risk -based supplier program under the preventive controls 
regulation, and are in compliance with those requirements.   This is  because only importers 
required under the preventive controls regulation to establish and implement such a supplier 108 
 
 
 program could be deemed in compliance under that proposal.   Under the proposed FSVP 
regulation, such an importer would not be exempt from FSVP because the food it imports would 
not be alcoholic beverages from a foreign supplier that meets the proposed requirements for the 
FSVP alcoholic beverage exemption.  For facili ties that meet the requirements for the alcoholic 
beverage exemption under § 117.5(i) and that also import raw materials  for use in the 
manufacture/processing of alcoholic beverages, the result of this proposed approach would be to 
simultaneously exempt su ch facilities from the supplier verification requirements of the 
preventive controls regulation by operation of § 117.5(i), while requiring such facilities to 
conduct supplier verification activities under the FSVP regulation because they import food that 
would not be subject to the FSVP proposed exemption for alcoholic beverages.   
We conclude  that such a result would not be  consistent with the risk -based public health 
principles underlying section 805 of the FD&C Act and FSMA generally.  In  enacting secti on 
116 of FSMA , Congress must have considered it a lower public health priority to apply FSMA’s 
core requirements to the manufacture/processing, packing, and holding of alcoholic beverages.  
Congress may have made such a conclusion in light of the potentia l antimicrobial function of the 
alcohol content in such beverages and the concurrent regulation of alcoholic beverage -related 
facilities by both FDA and the Alcohol and Tobacco Tax and Trade Bureau (TTB).  In this 
context, we concluded that section 116 of FSMA should be interpreted to indicate that the 
manufacturing, processing, packing, or holding of alcoholic beverages at most alcohol -related 
facilities should not be subject to the preventive controls requirements of FSMA.  For that 
reason,  we established  § 117.5(i).  As discussed in the previous paragraphs,  we included supplier 
verification requirements in the preventive control re gulation .  As a result, requiring alcohol -109 
 
 
 related facilities that are exempt from the supplier verification requirements in the preventive 
controls regulation under  § 117.5(i) to nevertheless conduct supplier verification for  imported  
ingredients used in the manufacture/processing of alcoholic beverages would effectively undo 
part of the exemption e stablished by § 117.5(i).   
For these reasons , we conclude that it is appropriate to adjust the scope of the alcoholic 
beverage exemption in the FSVP regulation .  The final rule continues to exempt the alcoholic 
beverages that the proposed rule proposed to  exempt , but also adds an exemption for food used 
in the production of alcoholic beverages that is based on the first approach to interpreting section 
116 of FSMA that we discussed in the proposed rule, with additional limitations.  Specifically, 
the final  rule adds an exemption that only applies to importers required to be registered under 
section 415 of the FD&C Act, whe n such facilities are exempt from the preventive controls 
regulation under § 117.5(i).  This exemption applies  to food , such as grapes, h ops, grains, and 
other ingredients, that is used by the importer in the manufacturing/processing, packing, or 
holding of alcoholic beverages.  
Also in this final rule, we  are clarify ing the exemption for food that is not an alcoholic 
beverage imported from  foreign suppliers described in § 1.501(e)(1) that is in prepackaged form 
prevent ing any direct human contact with the food, whe n such food constitutes not more than 5 
percent of the overall sales of the facility.  Instead of using the term “food other tha n alcoholic 
beverages” to describe the applicability of the exemption, as we proposed, we are now using the 
term “food that is not an alcoholic beverage.”   110 
 
 
 5.  Inapplicability to Food That Is Transshipped or Imported for Further Processing and Export  
We pr oposed that the FSVP regulations would not apply to food that is transshipped 
through the United States to another country or to food that is imported for future export and that 
is neither consumed nor distributed in the United States.  
 (Comment 83)  One c omment expresses concern that the exemptions for transshipped food 
and food imported  for further  processing inappropriately shift the  burden  for ensuring the safety of 
imported food  to the domest ic manufactu rer.  
 (Response  83)  As stated in the preamble to the proposed rule, section 805 of the FD&C 
Act is designed to require importers to take affirmative steps to verify the compliance of the food 
with U.S. safety requirements.  Given that context, we tentatively concluded that se ction 805 is 
not intended to apply to food that is neither consumed nor distributed in the United States and 
that is imported for further processing and export.   We have not received any comments in 
response to the proposed rule that have caused us to chan ge this tentative conclusion.  The final rule 
therefore retains the exemption for transshipped food and for food that is imported for further 
processing and export.  However, we are making several clarifications to these exemptions.  First, we 
are clarifyi ng that the exemption for transshipment  only applies to food that is neither consumed nor 
distributed to the public in the United States.  Second, the exemption for food that is imported for 
export applies when the food is being imported for processing, fo llowed by export.  Third, this 
exemption applies when the food is not consumed or distributed to the public  in the United States.  
(The proposed rule proposed to specify that the exemption would apply when the food is not 
“consumed or distributed” in the United States, but did not explain that distributed means 
“distributed to the public .”)   111 
 
 
 To the extent that the comment suggests that the exemptions place an unfair burden of 
ensuring the safety of imported food on U.S. manufacturers, we do not agree.  By definition, 
U.S. manufacturers are not involved in the manufacturing/processing of transshipped food  and 
thus are not affected by  such food .  We also believe the exemptions are consistent with the intent 
of section 805 of the FD&C Act.   
 (Comme nt 84)  On e comment asks whether the exemption for transshipped food applies 
to all imported food or only food that is bonded by CBP, which permits merchandise to be 
moved from one port to another without the merchandise being appraised or duties imposed.  
 (Response  84)  The exemption for transshipped food applies to all food that is 
transshipped through the United States to another country, provided that the food is not 
consumed or distributed to the public in the United States.  The exemption does not hinge on 
whet her the food is bonded by CBP.  
6.  U.S. Goods Returned  
 (Comment 85)  Several comments asked that the transshipment exemption apply to food 
that is produced in and exported from the United States and is returned  to the exporter after being 
rejected by the  foreign purchaser or a foreign government  (referred to as “U.S. goods returned” 
or “American goods returned”) , sometimes for reasons other than the safety of the food.  
(Several other comments also asked for such an exemption, independent of the transship ment 
exemption.)  One comment maintains that conducting verification for  food that is returned to its 
U.S. producer in its original packaging would not constitute risk -based verification because there 
would be no hazards in such food.  One comment asserts that because entries of U.S. goods 
returned are easily identified by their Harmonized Tariff Schedule (HTS) code, FDA should be 112 
 
 
 able to manage any risks with such food through other mechanisms, including the Predictive 
Risk-based Evaluation for Dynamic Imp ort Compliance Targeting (PREDICT) electronic import 
screening system.  The comments maintain that the FSVP requirements should not apply to U.S. 
goods returned because there is no foreign supplier of the food and the “importer” of the food 
would be conduc ting verification of its own operations.  
 (Response  85)  We agree in part and disagree in part.  Conside ring the context of section 
805 of the FD&C Act, under which the importer must take affirmative steps to verify the 
compliance of imported  food with U.S. safety requirements, we reaffirm our tentative conclusion 
(stated in the preamble to  the proposed rule) that section 805 is not intended to apply to food that 
is neither consumed nor distributed in the United States.  Th erefore , we are fina lizing § 1.501(f) 
with a few minor changes .   
We think that similar considerations make it reasonable to conclude that the FSVP 
requirements do not apply to food that is manufactured/processed, raised, or grown  in the United 
States, exported, and then retu rned to the United States.  Although section 805 of the FD&C Act 
applies to “each importer” and “the food imported by the imp orter or agent of an importer,”  we 
think that section 805 of the FD&C Act is not intended to apply to circumstances in which there 
would not be a true foreign supplier of the food.  Applying FSVP requirements in such 
circumstances would not be consistent with the underlying  purpose  of the FSVP  provisions .  
Section 805(c)(2)(A) states that FDA’s implementing regulations must  require th at the FSVP of 
each importer be adequate to provide assurances that each of the importer’s foreign suppliers 
produces food in compliance with processes and procedures, including risk -based preventive 
controls, that provide the same level of public health p rotection as those required under sections 113 
 
 
 418 or 419 of the FD&C Act, as appropriate, and in compliance with sections 402 and 403(w) of 
the FD&C Act.  Section 805(c)(2)(B) states that these regulations must  include such other 
requirements as FDA  deems nec essary and appropriate to verify that food imported into the 
United States is as safe as food produced and sold within the United States.   Food that is 
originally manufactured/processed, grown, harvested, or raised in the United States is generally 
already  subject to sections 402, 403(w), 418, and 419 of the FD&C Act, as applicable , and is 
therefore already subject to requirements that the food be as safe as other food produced and sold in 
the United States.  Therefore, there is no reason to subject such fo od to the FSVP requirements  and 
doing so would not be consistent with the context and purpose of section 805 .  Consequently , the 
final rule includes a provision, §  1.501(g),  specif ying that the FSVP regulation  does not apply to such 
U.S. foods  returned to the United States.   
7.  Raw Agricultural Commodities  
 (Comment 86)  Some comments request that we exempt commingled or consolidated 
RACs (other than fruits and vegetables) from the FSVP regulations.  Some comments request 
specific exemption for such RACs as dairy products, coffee and cocoa beans, and milled rice, 
canola meal, and cottonseed used for animal food.  The comments maintain that these RACs 
generally are low -risk foods and are further processed at facilities in the United States that are 
required  to register under section 415 of the FD&C Act, and that the U.S. facilities will address 
any hazards in the foods.  The comments assert that, because of the complexity of RAC supply 
chains, it would be prohibitively expensive for importers to conduct supp lier verification for all 
of the farms associated with consolidated shipments of RACs.  The comments maintain that 
RACs may change hands many times between the farm and the foreign port facility and also 114 
 
 
 between the importer and the U.S. facility that manu factures/processes the RAC.  The comments 
also contend that, because distributors may refuse to reveal their suppliers for competitive 
reasons or may not know the identity of the farms where the RACs are grown, it might not be 
possible for the importer to identify the growers.  Some comments assert that exemption  from 
FSVP  is appropriate because FDA has not established standards for growers and traders of RACs 
that are not subject to the produce safety regulation and has limited standards for others in RAC 
supply chains.   
 (Response  86)  We decline to exempt importers of RACs that are not subject to the 
produce safety regulation from the FSVP regulation .  Although we have not established specific 
safety requirements for these RACs under the produce safety r egulation, the requirements for 
FSVP are separate from the requirements for produce safety.  We do not believe that an 
exemption for all RACs oth er than fruits and vegetables --whether com mingled, consolidated, or 
otherwise --is appropriate.  As discussed in  response to other comments, section 805 of the 
FD&C Act applies to “each importer” and “the food imported by the importer or agent of an 
importer.”   Given Congress’ decision to include exemptions for some types of food (e.g., seafood 
and juice products su bject to , and in compliance with,  FDA’s HACCP regulations), but not 
RACs, we believe that Congress intended for FDA to establish FSVP regulations to ensure that 
imported RACs of the type discussed in the comments are as safe as similar RACs produced in 
the United States.  As such, the RACs discussed in the comments are subject to the FSVP 
regulation, and  importers of such RACs generally must conduct supplier verification activities in 
accordance with the FSVP requirements .  However, if an importer determines under §  1.504(f) 
of the final rule that there are no hazards requiring a control in a particular RAC, the importer 115 
 
 
 would not be required to determine what foreign supplier verification and related activities 
would need  to be conduct ed, and the importer would not have to conduct such activities (see 
section III. E.7 of this document).  
In addition, as discussed in more detail in section III.H .2 of this document, under §  1.507 
of the final rule, an importer will not be req uired to conduct the standard supplier verification 
activities when the hazards in a food (including a RAC) will be significantly minimized or 
prevented by the importer’s customer.  Instead, the importer will be required to (1) disclose in 
documents accomp anying the food that the food is not processed to control identified hazards, 
and (2) obtain written assurance that its customer or an entity after its customer is processing the 
food for food safety .  Similar procedures also are available when an entity i n the distribution 
chain after the importer’s immediate customer is  processing the food for food safety .  The final 
rule also would not require compliance with the standard supplier verification requirements  for 
foods that could not be consumed without the  application of an appropriate control (as may be 
the case with some RACs discussed in the comments) or when the importer implements a system 
that ensures control of the hazards in a food at a later distribution step.  
8.  Produce Rarely Consumed Raw  and Food Intended for Commercial Processing  
 (Comment 87)  One comment asks that we exempt from the FSVP requirements produce 
that is rarely consumed raw and produce that is intended for commercial processing  
(presumably, processing that would adequately reduce the presence of pathogens ), asserting  that 
such a n exemption would be consistent with the exemption for such foods from the produce 
safety regulation.  Another comment opposes the exemption of produce rarely consumed raw 116 
 
 
 from the produce safety regulation and asks that these products not be exempt from t he FSVP 
regulation.  
 (Response  87)  The final rule does not exempt from the FSVP regulation produce rarely 
consumed raw or produce intended for commercial processing, whether or not the processing 
would adequately reduce the presence of microorganisms of p ublic health significance.  
Regarding produce rarely consumed raw, we are allowing importers to rely on the provisions in 
§§ 1.505, 1.506, and 1.507 instead of providing an exemption.  For some produce in this 
category, an importer might determine it is ap propriate  is to conduct supplier verification 
activities to ensure that hazards in the food have been significantly minimized or prevented 
before importation.  For other produce in this category , we are establishing requirements in § 
1.507 that we believe are generally more suitable to ensuring the safety of many of these foods  
than the standard FSVP requirements  and that would not require the importer to conduct standard 
supplier verification activities.  As described in section III.H .2 of this document,  the final rule 
provides flexibility for situations in which an entity in the United States that is not the importer 
will control the hazards  in a food .   
 Regarding imported produce intended for commercial processing, under §  1.502(c) of the 
final rule, when the importer itself is a receiving facility as defined in the preventive controls 
regulation s and either (1) implements preventive controls for the hazards in the food , (2) is not 
required to implement a preventive control under §  117.135 or §  507.34,  or (3) has implemented 
a supply -chain  program  for the food in compliance with  the preventive controls regulations,  the 
importer would be deemed in compliance with most of the FSVP requirements (except for the 
requirements in §  1.509).  W hen such processin g is performed by the importer’s customer  or a 117 
 
 
 subsequent entity , the flexibility provided  in § 1.507  would allow the importer to forego supplier 
verification activities provided  it meets certain other requirements to help ensure that the 
processing is ade quately performed before the food is consumed.  
9.  Products Not for Use as Food  
 (Comment 88)  One comment suggests that for a food that may be used for either a food 
or non -food use, FDA should regard each shipment of the product offered for import to be  food 
that is subject to the FSVP regulation unless the statement “Not for food use” is included in the 
commercial documentation accompanying the shipment.  
 (Response  88)  Under FDA’s regulation  implementing the prior notice requirements of 
the Bioterroris m Act , prior notice must be submitted for each article of food that is imported or 
offered for import into the United States (21 CFR 1.281(a)).  In  our interim final rule  on prior 
notice , we explained that we will consider a product as one that will be used for food if any of 
the persons involved in importing or offering the product for import (e.g., submitter, transmitter, 
manufacturer, grower, shipper, importer, owner, ultimate consignee) reasonably believes  that the 
substance is reasonably expected to be directed to a food use (68 FR 58974 at 58987 , October 
10, 2003 ).  In the prior notice final rule, we clarified that we consider a dual use substance to be 
“food” for the purpose of prior notic e if it is reas onably likely to  be directed to a food use (73 FR 
66294 at 66301 , November 7, 2008 ).  Thus, an article of food is subject to the prior notice 
requirements if it is capable of multiple uses, provided that it is reasonably likely to be directed 
to a food use .  We believe  that a similar approach is appropriate with respect to FSVP.  
Therefore, we conclude that a  substance that is capable of multiple uses is subject to the FSVP 
regulation if it is reasonably likely to be directed to a food use.  We believe  this standard is 118 
 
 
 appropriate because it will subject substances that are reasonably likely to be directed to a food 
use to the FSVP regulation, more so than basing  the application  of the FSVP regulation on the 
existence of a “Not for food use” statement that might not necessarily reflect industry practice or 
the likely  use of the substance.   
10.  Food From Foreign Suppliers That Are Part of Same Corporate Structure  
 In the preamble to the proposed rule, we stated that some importers might  obtain food 
from fore ign suppliers who are part of the same corporate structure as the importer and who 
might , along with the importer, be subject to a single, integrated, company -wide approach to 
food safety in which hazards are controlled and verified by a common supply chai n management 
system.  We sought comment on whether such importers should be required to conduct foreign 
supplier verification or should be subject to different FSVP requirements.  
 (Comment 89)  Several comments request that we exempt from the FSVP re gulation s 
food that is imported from a foreign supplier who is part of the same corporate structure as the 
importer.  The comments assert that whe n the importer and the foreign supplier follow the same 
food safety standards and practices, supplier verifica tion is unnecessary.  Some comments 
request that we exempt from the FSVP regulation food that is imported from a foreign supplier 
that is an affiliate of the importer; some comments request that the exemption apply when the 
foreign supplier of a food is un der the same corporate structure as the importer and/or is subject 
to the same integrated, company -wide approach to food safety as the importer.  However, some 
comments express concern that such an exemption might lead to fraudulent schemes to make it 
appe ar as if the importer and the foreign supplier are integrated companies.  119 
 
 
  (Response  89)  We decline to exempt from the FSVP regulation  food an importer obtains 
from a foreign supplier that is part of the same corporate structure as the importer.  We also 
decline to establish an exemption from the FSVP requirements whe n the foreign supplier and 
importer may otherwise be affiliated, and whe n the foreign supplier and importer are part of the 
same company -wide “approach” to food safety.  We conclude that the fa ct that an importer and 
its foreign supplier are affiliated and may be operating within a unified corporate structure or 
food safety system does not necessarily ensure that the foreign supplier is operating in 
compliance with sections 402 and 403(w) of t he FD&C Act (where applicable).   Nor does such a 
relationship necessarily ensure the foreign supplier is operating in compliance with processes and 
procedures that provide the same level of public health protection as the requirements under the 
preventive co ntrols or produce safety regulations, where applicable.  Consequently, importers 
should be required to conduct supplier verification in these circumstances.  However, we agree 
that an importer’s corporate affiliation with its foreign supplier might provide  the importer with 
greater assurance regarding the supplie r’s compliance with applicable requirements under the 
FD&C Act.  Therefore, an importer of a food from a foreign supplier that is part of the same 
corporate structure as the importer and/or is subje ct to the same integrated, corporate approach to 
food safety may take this into account in evaluating the foreign supplier’s performance under 
§ 1.505 of the final rule and determining appropriate supplier verification activities for the 
supplier under §  1.506.    
 (Comment 90)  One comment asserts that requiring supplier verification for imports from 
suppliers with the same corporate parent may increase trade burdens in violation of WTO 
agreements.  The comment provided the example of Company A in San Diego that imports 120 
 
 
 finished packaged cereal from Company A in Tijuana, Mexico.  The comment states that under 
the proposed rule, the company would be required to conduct supplier verification of itself, but 
the company would not be required to conduct supp lier verification if it had manufactured the 
cereal in California.  The comment maintains that without exempting the Tijuana -produced food 
from FSVP, U.S. -produced goods would receive favorable treatment because FSVP would 
impose a paperwork burden for int ra-company imports.  
 (Response 90)  We do not agree.  FSVP would not impose a trade or paperwork burden 
for the intra -company imports described in the comment.  If the company in the example 
manufactured the cereal product in California, the company would be subject to the supply -chain 
program requirements in the preventive controls for human food regulation , and therefore  would  
be required to verify its ingredient suppliers .  It also would be required to review its supply -chain 
program records to determine  whether the program is effective.  Therefore, it is not correct that if 
the company manufactured the cereal product in California, it would not need to conduct 
verification activities with respect to the product.   In addition, FSVP -related verification 
activities for the cereal product manufactured in Tijuana need only be commensurate with the 
risk posed by the cereal, and the importer of the cereal can take the intra -company relationship 
into account in evaluating the foreign supplier and determining appr opriate verification activities.  
Therefore, we do not believe the FSVP regulation increase s trade burdens on importers of 
suppliers with the same corporate parent . 
We also note that  the California facility would be part of a domestic U.S. Integrated Food 
Safety System ( IFSS ) that includes multiple Federal, State, territorial, tribal, and local regulatory 
and public health agencies  (see the discussion of the IFSS in Response 10 5).  Inspections of 121 
 
 
 domestic food facilities (including farms, manufacturing faci lities, and retail facilities) are 
overseen by a mix of Federal, State, local, tribal, and territorial agencies.   When compared to this 
comprehensive system of domestic oversight for food production and distribution from farm to 
retail  (discussed in more d etail in section III.C.1.g of this document) , we believe that the supplier 
verification requirements for imported foods under the FSVP regulation are no more burdensome 
than the oversight and control measures applied to domestic foods.   Consequently, the C alifornia 
facility would be subject to oversight that is no less burdensome than the verification that the 
Tijuana facility would face under FSVP.   
11.  Other Requests for Exemption  
 (Comment 91)  One comment requests an exemption from FSVP based on an agreement 
with the foreign government of the country in which the foreign supplier is located.  One 
comment suggests a product -specific exemption for a foreign supplier who was in compliance 
with t he foreign government’s applicable regulations.   
 (Response  91)  As discussed more fully in section III .N of this document and in the 
preamble to the proposed rule, we are excluding from many of the standard FSVP requirements 
food from foreign suppliers i n countries whose food safety system s FDA has officially 
recognized as comparable or determined to be equivalent to that of the United States, provided 
that the importer documents that certain conditions are met.  These modified FSVP requirements 
are set f orth in § 1.51 3 of the final rule.   Depending on the scope of the official recognition or 
equivalence determination regarding a foreign food safety authority, these modified FSVP 
requirements might apply to all foods from suppliers in the relevant country  or only certain 
products or commodities.  122 
 
 
  (Comment 92)  One comment suggests that exemptions from the FSVP regulation be 
based on factors such as the size of the company, the type of food, and the risk posed by the 
food.  
 (Response  92)  As discussed previ ously, the final rule contains exemptions or partial 
exemptions for several types of foods  consistent with exemptions provided under section 805(e) 
of the FD&C Act .  These include exemptions for juice and seafood  products  and thermally 
processed low-acid f oods  packaged in hermetically sealed containers (“low -acid canned foods” 
or LACF)  (discussed in section III.C.2 of this document), subject to certain conditions.  Although 
the final rule does not exempt very small importers from the FSVP requirements, it contains 
modified provisions  for these importers that will significantly reduce the number of FSVP 
requirements they must meet  (see § 1.512 of the final rule and section III. M of this document).   
In addition, the FSVP regulation take s into account the risk posed by foods in several ways (e.g., 
no verification activities required when there are no hazards in a food, certain supplier 
verification activity provisions  for foods with hazards that can result in serious adverse health 
consequences or death to humans or animals ( SAHCODHA) .  These provisions of the rule 
adequately address the different risks posed by different foods and business es of different sizes.   
(Comment 93)  One comment states that cattle, poultry meat, and egg products should be 
exempt from the FSVP regulations because they are subject to regulation by the USDA’s Food 
Safety and Inspection Service (FSIS).  One comment ask s whether the FSVP regulation appl ies 
to live animals intended for consumption, specifically cattle.  The comment asserts that for live 
cattle imported from Canada, the Canadian government and USDA’s Animal and Plant Health 
Inspection Service ( APHIS ) and F SIS share responsibility for verifying safety (with respect to 123 
 
 
 bovine spongiform encephalopathy (BSE)), and it would be duplicative to require the importer to 
comply with the FSVP regulation with respect to such cattle.  
 (Response  93)  We agree that an exe mption is appropriate with respect to cattle, poultry, 
and egg products , but not live animals.  The final rule adds § 1.501(h), which states that the 
FSVP regulation  does not apply to meat, poultry, and egg products that at the time of importation 
are subj ect to the requirements of the USDA under the Federal Meat Inspection Act (FMIA) (21 
U.S.C. 601 et seq.), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq .), or the 
Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 et seq .).  We conclude t hat this provision is 
consistent with the context and purpose of FSMA generally, and with section 805 of the FD&C 
Act in particular.  In enacting section 805, Congress intended to ensure that food imported into 
the United States is produced in a manner con sistent with U.S. standards.  At the same time 
Congress enacted section 805, it also enacted section 403 of FSMA (21 U.S.C. 2251), entitled 
“Rule of Construction,” which states that nothing in FSMA must be construed to alter or limit 
the jurisdiction of the Secretary of the Department of Agriculture.  For many decades, USDA has 
exercised authority and responsibility over the import of such meat, poultry, and egg products, 
and has adopted detailed regulati ons and procedures implementing this authority.  In light of 
USDA’s role with respect to the importation of these products, and also in light of section 403 of 
FSMA, we conclude that Congress did not intend the FSVP regulation to apply to meat, poultry, 
and egg products that at the time of importation are subject to USDA requirements under the 
MPIA, P PIA, and EPIA, respectively.  We therefore conclude  that §  1.501(h) is consistent with 
Congress’ intent in promulgating section 403 of FSMA and section 805 of the FD&C Act.   124 
 
 
  However, we do not agree that the FSVP regulation should not apply to live animals, 
including cattle, intended for consumption.   Live animals raised for food, even though not in 
their final, edible form, are considered to be food under the  FD&C Act (see United States  v. 
Tomahara Enterprises Ltd. , Food Drug Cosm. L. Rep. (CCH) 38,217 (N.D.N.Y. 1983) (live 
calves intended as veal are food); United States v. Tuente Livestock, 888 F. Supp. 1416 (S.D. 
Ohio 1995) (live hogs are food)).   Further, live animals, such as poultry and cattle, are not 
subject to the USDA requirements under the FMIA or PPIA at the time of importatio n.  Indeed, 
FDA has exercised authority and responsibility  over the importation of live food animals.   For 
example, FDA’s fin al rule on prior notice requirements specifically includes live animals that are 
imported for food use (see 73 FR 66294 at 66306).   Only food that is subject to the requirements 
of the USDA under the FMIA, the PPIA, or the EPIA at the time of importation a re excluded 
from the scope of the FSVP regulation under § 1.501(h).    
However, w ith respect to live animals that are eventually processed at FSIS -inspected 
slaughter and production plants or inspected by States under cooperative agreements with FSIS,  
we ex pect that importers likely will determine , in accordance with §  1.507 of the final rule,  that 
the live animals could not be consumed without application of an appropriate control in the 
supply or distribution chain , so that the importers will not be requir ed to conduct an evaluation 
under § 1.505 or supplier verification activities  under §  1.506 .  The principal hazards for such 
live animals are chemical hazards such as unlawful drug residues and BSE.   FSIS and APHIS 
have comprehensive regulatory requirement s that control  these hazards, including HACCP 
requirements.   FSIS -regulated meat and poultry establishments are required to conduct a hazard 
analysis and consider the food safety hazards that might be expected to arise from, for example, 125 
 
 
 drug residues, and  are also required to develop systems to guard against these hazards.  In 
addition, FSIS oversees the requirements related to the identification and control of hazards , and 
collects samples of meat, poultry, and egg products and analyzes the samples at FSI S 
laboratories for chemical residues of veterinary drugs, among other contaminants.   Thus, when 
USDA -regulated establishments are in compliance with the USDA -administered HACCP and 
other requirements, the hazards associated with the live animals processed at such establishments 
ordinarily would be controlled  and the live animals could not be consumed without such 
controls .   
However, importers of  live animals of species such as bison and elk that are not 
processed at USDA -regulated slaughter and production plants under HACCP requirements might 
determine that there are drug residue s or other hazards requiring control.   Importers of such live 
animal s might therefore be required to conduct supplier verification for the foreign supplier that 
raised the animals.  
C.  Purpose and Scope of FSVP s (§ 1.502)  
 In § 1.502 of the proposed rule, we proposed that importers be required to have an FSVP 
for each food  they import that would provide adequate assurances that the standard of food 
safety set forth in section 805 of the FD&C Act would be met.  We included a modification of 
that proposed requirement with respect to microbiological hazards in thermally proces sed low -
acid foods packaged in hermetically sealed containers (low -acid canned foods or LACF).  In the 
Supplemental Notice, we revised proposed § 1.502 to include provisions under which importers 
who were in compliance with the supplier program provisions of the preventive controls 
regulations (or whose customers were in compliance with those provisions) would be deemed in 126 
 
 
 compliance with most of the FSVP requirements.  As discussed in the following paragraphs, the 
final rule includes several changes to pro posed §  1.502 in response to comments and on our own 
initiative.  
1.  Requirement to Develop and Follow an FSVP  
We proposed to require importer s to develop, maintain, and follow an FSVP for each 
food imported that provides adequate assurances that the forei gn supplier is producing the food 
in compliance with processes and procedures that provide the same level of public health 
protection as those required under section 418 (regarding hazard analysis and risk -based 
preventive controls for certain foods) or 41 9 (regarding standards for produce safety), if either 
was applicable, and was producing the food in compliance with sections 402 (regarding 
adulteration) and 403(w) (regarding misbranding with respect to labeling for the presence of 
major food allergens) o f the FD&C Act.   
On our own initiative, to clarify the relevant requirements, we have revised §  1.502(a) to 
refer not only to sections 418 and 419 of the FD&C Act but also to “the implementing 
regulations” for those sections, i.e., the preventive controls  and produce safety regulations, 
respectively.  In addition, because we are interpreting section 403(w) of the FD&C Act regarding 
misbranding with respect to allergen labeling to be inapplicable to animal food, we have revised 
§ 1.502(a) to specify that an  importer’s FSVP must provide assurance that a foreign supplier is 
producing a food in compliance with section 403(w) “ if applicable.”  We have made 
corresponding changes to other provisions in the FSVP regulation citing  this FSMA standard for 
FSVPs.  
 a.  Meaning of “for each food.”  127 
 
 
  (Comment 94)  Several comments ask that we clarify the meaning of proposed §  1.502(a) 
with respect to having an FSVP “for each food.”  For example, the comments ask whether 
importers would be required to have a different FSVP f or each of similar foods (e.g., red and 
green grapes) or even different package sizes (e.g., 9 -count and 12 -count) of the same food 
product.  The comments maintain that having to develop an FSVP for each individual food 
product would be burdensome without contributing to food safety.  Some comments ask that 
importers be allowed to have an FSVP for foods that are of the same “type.”  Some comments 
suggest that importers be permitted to include foods in similar commodity groups (e.g., different 
types of squas h and zucchini) in the same FSVP.  Some comments suggest that importers be 
allowed to have one FSVP for produce grown, harvested, and packed under the same conditions.  
 (Response  94)  We decline to make th e suggested change s.  Section 805(c)(2)(A) of the 
FD&C Act requires that the FSVP of each importer be adequate to provide assurances that each 
foreign supplier to the importer produces “the imported food” in compliance with the standard 
set forth in that provision; it does not state that an importer’s FSVP  would be for a “type of food” 
from a foreign supplier.  However, we agree with the comments that an importer should not be 
required to establish separate FSVPs for different versions of the same food when the differences 
in the products will not impact th e safety of the food.  For example, it might be appropriate for 
an importer to develop a single FSVP covering several different packaging sizes or formats for a 
particular food, provided that these packaging differences do not pose different hazards that n eed 
to be controlled by the foreign supplier and addressed in supplier verification activities.  We 
intend to provide additional examples of what constitutes the same food for purposes of 
establishing an FSVP for the importation of the food in the FSVP dra ft guidance.  128 
 
 
 Although an importer must have an FSVP for each food it imports from each foreign 
supplier, we conclude (as discussed more fully in section III.E.2 of this document) that it might 
be appropriate to conduct a hazard analysis for a “type” of fo od, such as different varieties of the 
same fruit or vegetable, provided all aspects of the hazard analysis are applicable to all foods that 
the importer regards as being of the same type.  However, it would not be appropriate to use the 
same hazard analys is for foods that, though very similar, have different hazards requiring 
control.  For example, even if two foods were grown, harvested, and packed under the same 
conditions, it would not be appropriate to use the same hazard analysis for both foods if one  food 
was susceptible to certain microbiological hazards but the other food was not.   
It is also important to note that importers must establish an FSVP for each foreign 
supplier of a food.  Thus, if an importer obtains a particular food from multiple for eign suppliers, 
the importer must have a separate FSVP for each supplier.  This is appropriate because the FSVP 
regulation require s importers to consider not just hazards inherent in the foods they import, but 
also the performance history and characteristi cs of the foreign suppliers of the food, and to 
conduct supplier verification activities that are tailored to the particular food and foreign 
supplier.   However, as discussed elsewhere in this document, importers may be able to rely on 
foreign supplier eva luations and verification activities conducted by other entities in meeting 
these requirements.  
 (Comment 95)  Some comments request that we provide guidance on appropriate 
processes for safely producing products that fall into similar categories.  
 (Response  95)  The FSVP regulation do es not establish requirements for the safe 
production of food; those requirements are set forth in other FDA regulations, including those on 129 
 
 
 produce safety and preventive controls for human and animal food.  However, as  stated 
previously, the FSVP draft guidance will provide additional examples regarding what importers 
may regard as the same food that can be addressed in a particular FSVP.  
b.  Role of importer’s corporate headquarters . 
 (Comment 96)  Several comments sta te that §  1.502(a) should acknowledge that an 
importer’s corporate headquarters might establish or develop the importer’s FSVP for a food and 
might do the same for a contract manufacturer.  The comments add that FDA should conduct its 
inspections of import ers accordingly.  
 (Response  96)  The requirements to develop FSVPs and keep records  apply to importers 
as defined in §  1.500 of the final rule, and §  1.502(a) accordingly does not refer to a particular 
“facility” but to the importer.  For purposes of FDA i nspection of importers, the importer’s 
location is where the importer conducts business.  This might be, but is not required to be, the 
place where the importer retains its FSVP records.  For some importers that import food into the 
United States through multiple ports, the importers’ FSVPs for the foods they import might be 
developed and maintained at a single location, such as a corporate headquarters.  However, while 
entities other than the importer may conduct activities to satisfy various FSVP requirements  
(provided that the importer reviews and assesses results of those activities, among other things) , 
an importer of a food is responsible for maintaining and administering its FSVP.  Th erefore, if a 
contract manufacturer for a U.S. food facility is the importer of a food under §  1.500, the 
contract manufacturer would be required to maintain and administer the FSVP for the food.   
 c.  Entity controlling the hazards . 130 
 
 
  (Commen t 97)  One co mment states that the requirement to have an FSVP for an 
imported food should be limited to a food that a hazard analysis indicates may contain a 
significant hazard that is addressed by a foreign supplier , because sometimes the importer, not 
the foreign su pplier, will control the hazards in the food.  
 (Response  97)  We agree that it will not be necessary for an importer that is also a food 
facility under section 415 of the FD&C Act and is controlling hazards under the preventive 
controls regulations  to comp ly with the majority of the  provisions of this rule.  As discussed in 
section III. C.3 of this document, under §  1.502(c) of the final rule, if an importer is a receiving 
facility that implements preventive controls for the hazards in a food in accordance w ith 
§ 117.13 5 or § 507.3 4 for a food it imports, the receiving facility is deemed to be in compliance 
with the requirements of the FSVP regulation, except for the requirements in §  1.509.  For these 
reasons, it is not necessary to change §  1.502(a) as suggested . 
d.  Adequate assurances of foreign supplier’s adherence to food safety standards . 
 (Commen t 98)  Some comments suggest that we explain what constitutes “adequate 
assurances” that foreign suppliers are producing food in accordance with the standa rd specified 
in § 1.502(a).  One comment suggests that when considering whether adequate assurances exist, 
the importer should consider issues such as whether the foreign supplier has an adequate food 
safety plan that accounts for all hazards in a food.  O ne comment asks that we specify what kind 
of assurance of compliance importers need from their suppliers (e.g., certification with the 
International Standards Organization (ISO), HACCP compliance, reports of FDA inspections), 
adding that the requirements s hould be the same for both domestic and foreign establishments.  131 
 
 
 One comment states that the need to provide adequate assurance of compliance with the relevant 
standards elevates the importance of clear definitions of those standards.   
 (Response  98)  Importers must obtain a dequate assurances of foreign supplier compliance 
with the applicable standards stated in §  1.502(a) primarily through foreign supplier verification 
activities conducted under §  1.506 of the final rule, which must reflect the evaluation  of the food 
and foreign supplier conducted under §  1.505.  Section 1.506(c) states that foreign supplier 
verification activities must  provide the adequate assurance  that the hazards requiring a control in 
imported foods have been significantly minimized o r prevented (because such control of hazards 
provides assurance that the standard  specified in §  1.502(a)  is met).  Section 1.506 specifies the 
foreign supplier verification activities that are appropriate under different circumstances for 
providing adequa te assurances of compliance.   
For foreign suppliers subject to the preventive controls or produce safety regulations, the 
adequate assurances that importers must obtain through their FSVPs primarily will be that the 
supplier is producing the food in a man ner that provides the same level of public health 
protection as the applicable regulations.  For foreign suppliers subject to the preventive controls 
regulations, adequate assurance of compliance would include, as the comments suggest, a 
consideration of t he adequacy of the supplier’s food safety plan as well as other elements of the 
preventive controls regulations and whether the supplier’s processes and procedures provide the 
same level of public health protection as the processes and procedures required under those 
regulations.  As such, the processes and procedures used by foreign farms and facilities covered 
by the produce safety and preventive controls regulations are expected to provide no more --and 
no less --public health protection  than those used by  domestic farms and facilities .  Section 132 
 
 
 III.G.4 of this document addresses the specific information that importers must  review under 
§ 1.506 of the final rule when conducting supplier verification activities to assess whether the 
supplier is producing food in accordance with U.S. standard s. 
e.  Same level of public health protection . 
 (Comment 99)  Several comments request  that we provide clarity regarding the nature of 
processes and procedures that will provide the same level of public health protection as those 
required under the preventive controls or produce safety regulations.  Some comments express 
concern that permit ting use of the “same level of public health protection” standard raises 
questions about whether there will be a level playing field for domestic and foreign producers . 
Some comments state that we must apply the same food safety standards (in particular th e 
produce safety regulation) to domestic and foreign producers .  Some comments assert that we 
should also require verification of foreign supplier compliance with USDA requirements 
concerning fertilizers, herbicides, pesticides, and fumigants .   
One commen t states that the “same level of public health protection” language appears to 
allow foreign suppliers to establish alternative standards to preventive controls and produce 
safety requirements within the FSVP regulations, even though there is no process fo r adopting 
alternative procedures under the preventive controls regulations and the ability to adopt 
alternative procedures under the produce safety regulation is limited.  Some comments ask that 
we specify how importers should determine whether use of an alternative procedure results in the 
same level of public health protection and which entity is permitted to make a determination 
regarding the same level of public health protection.  One comment recommends that we allow a 
flexible approach for meeting th e same level of public health protection standard because of 133 
 
 
 issues raised by the application of preventive controls requirements to foreign facilities.  One 
comment requests that the regulation specify the standards that verification activities must meet 
to demonstrate an equivalent level of public health protection, but adds that if these standards are 
instead to be set forth in guidance, it should be a level 1 guidance and the Agency should hold 
public meetings and advisory committee meetings.   One comme nt suggests that we include a 
requirement for importers to identify when a foreign supplier is using an alternative procedure if 
use of alternative procedures is not an option for domestic firms under the applicable food safety 
regulations.   
 (Response  99)  As the comments note, FSMA itself (section 805(c)(2)(A) of the FD&C 
Act) directs FDA to establish regulations that require importers to obtain assurances that their 
foreign suppliers are using processes and procedures that provide the same level of publ ic health 
protection as those required under the preventive controls or produce safety regulations, as 
appropriate.   Importers must determine whether particular processes and procedures used by 
foreign suppliers that differ from those required under the pr eventive controls or produce safety 
regulations nevertheless provide the same level of public health protection, although FDA will be 
able to review such determinations as part of records reviews  of importers for compliance with 
the FSVP requirements.  
The produce safety regulation include s provisions ( § 112.12) permitting the use of 
alternatives to certain requirements in th e regulation provided the producer of the food (the farm) 
has adequate scientific data or information to support a conclusion that the alternative would 
provide the same level of public health protection as the applicable provision  and would not 
increase the likelihood that the produce was adulterated.  The produce safety regulation also 134 
 
 
 include s provisions ( subpart P of part 112)  under w hich States , tribes, and foreign countries may 
request a variance from the produce safety requirements when the State , tribe, or foreign country 
determines that the variance is necessary in light of local growing  conditions and the procedures, 
processes, and practices to be followed under the variance are reasonably likely to ensure that the 
produce is not adulterated and to provide the same level of public health protection .  Although 
the preventive controls regulations do not include similar alternative or variance procedures, 
those regulations are designed to allow facilities the flexibility to tailor their processes and 
procedures in a manner that is appropriate to the food and the facility, with management 
components that are appropriate to the food, t he facility, and the nature of the preventive controls  
and their role in the facility’s food safety system . 
To the extent that the comment is suggesting that § 1.502 include a requirement that 
importers document each procedure used by a foreign supplier th at differs from the preventive 
controls or produce safety regulations, we conclude it is not necessary to do so.  However, where 
such use of such alternative procedures is relevant to an importer’s evaluation of a foreign 
supplier’s performance under §  1.505 or the results of foreign supplier verification activities 
under §  1.506, information about the alternative procedures must  be included in the 
documentation for these FSVP requirements.  With respect to the variance provisions under the 
produce safety r egulations for States, tribes, and foreign countries,  there may be circumstances in 
which approved  variances are relevant to determining whether a particular foreign supplier’s 
processes and procedures provide the same level of public health protection as the requirements 
under section 419 of the FD&C Act.  Audits of suppliers foll owing procedures, processes, or  
practices specified in an approved varian ce from the produce safety regulation conducted for the 135 
 
 
 purpose of FSVP compliance may consider that  FDA , in granting the variance, determined that 
those procedures, processes, or  practices are reasonably likely to ensure that the produce is not 
adulterated under section 402 of the FD&C Act and to provide the same level of public health 
protection as the requi rements under section 419.  
We conclude  it is not necessary to state in the regulation specific actions that importers 
must take in evaluating whether alternative procedures used by foreign suppliers provide the 
same level of public health protection as pr ocedures required in the regulations implementing 
sections 418 and 419 of the FD&C Act.   
 (Comment 100)  One comment maintains that food safety regulations in the EU, and 
particularly in France, provide the same level of public health protection as the FSMA standards 
and urges that we recognize these standards.  
 (Response 100)  We do not have sufficient information at this time to determine whether 
the food safety re gulations in particular countr ies or region s provide the same level of public 
health protection as U.S. standards.  However, importers may find that compliance with the laws 
of France and other EU countries is relevant to determining whether foods are bein g produced 
using processes and procedures that provide the same level of public health protection as those 
required under FDA’s regulations.  In addition, as discussed in section III.N of this document, 
FDA has established a systems recognition initiative,  under which we are conduct ing 
comprehensive assessments of foreign food safety systems to determine whether they provide 
similar protections to those offered under the U.S. system and a similar level of oversight and 
monitoring.  As discussed in more deta il in section III.N, the systems recognition program is 
based on the principle that foreign food producers can meet U.S. food safety requirements by 136 
 
 
 providing assurances that these foods are produced according to the food safety standards of a 
country whos e food safety system we have found to be comparable.  Under §  1.513 of the final 
rule, o nce we have made a determination that a foreign food safety system is comparable to ours, 
certain foods within the scope of such a determination may be imported under m odified FSVP 
requirements (provided that certain conditions are met).  These provisions will allow the 
importation of such food without being subject to most of th e standard FSVP requirements.   
 (Comment 101)  Some comments state that, to ensure that the concept of “same level of 
public health protection” is applied consistently, FDA must conduct risk assessments of foods to 
formulate an appropriate risk matrix that can be applied domestically and internationally.  The 
comments request that, before we issu e the final rules on produce safety and FSVPs, we issue for 
public comment the risk model that we intend to use for evaluating requests for variances under 
the produce safety proposed regulation.  
 (Response  101)  We do not agree.  This rule establishes a flexible, risk -based approach to 
foreign supplier verification based in significant part on a requirement that importers understand 
the hazards in the foods they import so they can take appropriate steps to verify that their 
suppliers have adequately contr olled these hazards .  We believe that a system of hazard analysis, 
control, and verification is well accepted and understood throughout the international food safety 
community and  provides the most effective way to implement a risk -based f ramework for 
foreign supplier verification.  W e have confidence that import ers will be  able to implement 
FSVPs based on their own hazard analyses or their review of analyses conducted by others , 
without our having  to conduct risk a ssessments for all foods to generate a  risk matrix that all 
food producers would use.  As stated previously, we  intend to issue guidance to assist importers 137 
 
 
 and foreign and  domestic producers in complying with the new regulations that we are adopting 
under FSMA, including  guidance on the analy sis of hazards in food.  With respect to variances 
under  the produce safety regulation , we note that the final rule adopting th at regulation  published 
elsewhere in this issue of the Federal Register  addresses how FDA will  evalu ate requests for 
variances su bmitted in accordance with  subpart P of part 112.  
f.  Relevant statutory requirements . 
 (Comment 102)  One comment states that FSVPs should be limited to verifying foreign 
supplier compliance with the preventive controls or produce safety regulations.  One  comment 
states that the FSVP regulation should not impose any additional obligations on foreign suppliers 
beyond those required under other FDA regulations, and should be based on relevant 
international standards and conform to U.S. international obligati ons. 
 (Response  102)  The purpose and scope of importers’ FSVPs, as set forth in § 1.502(a) of 
the final rule, implements the standard mandated in FSMA for FSVPs.  Consequently, it requires 
importers to take steps to ensure that their foreign suppliers are  producing food in a manner 
consistent with the preventive controls or produce safety regulations, to the extent that those 
regulations apply to the foreign supplier’s production of a food, and to ensure that the food from 
the supplier is not adulterated a nd is not misbranded with respect to allergen labeling, if 
applicable.  The FSVP regulation do es not impose on foreign suppliers any requirements that 
they are not already subject to under the FD&C Act and implementing regulations, including the 
regulation s on preventive controls and produce safety.  In addition, the FSVP regulation is 
drafted to be consistent with U.S. obligations under international agreements.  138 
 
 
  (Comment 103)  One comment suggests that the phrase “if either is applicable” when 
referring t o the preventive controls and produce safety provisions be interpreted to mean that if a 
type of produce is covered by section 419 (and the produce safety regulation), it must be in 
compl iance  with section 419, rather than meaning that any imported “produc e” would be subject 
to section 419. 
 (Response  103)  We agree.  If an imported item of produce is not subject to the produce 
safety regulation, the importer would not be required to verify that the produce was grown in 
accordance with th at regulation.  
 (Comment 104)  One comment suggests that the requirement to have an FSVP be limited 
to problems that “cause a risk to the public health,” which the comment maintains would be 
consistent with the statement in the preamble to the proposed rule that the regulati on should 
focus on foreseeable food safety risks identified through hazard assessment rather than all risks 
covered by the adulteration provisions.  The comment contends that not all adulterants cause a 
food safety risk and many forms of adulteration are n ot amenable to discovery by the importer.  
 (Response  104)  We do not believe that  the proposed change is necessary.  The 
importance of the existence of a risk to public health is incorporated in the definition of 
“hazard,” meaning any biological, chemical,  or physical agent that is reasonably likely to cause 
illness or injury.  Except as specified otherwise, each importer would need to have an FSVP for 
each food that it imports from each foreign supplier and to conduct a hazard analysis for each 
type of foo d in accordance with §  1.504 of the final rule.  However, under §  1.504(f), if an 
importer determines there are no hazards requiring a control in a food, the importer would not be 139 
 
 
 required to conduct an evaluation of the risk posed by the food and the fore ign supplier’s 
performance and would not be required to conduct supplier verification activities.  
 g.  U.S. international obligations . 
 (Comment 105)  One comment notes that domestic farms supplying foods directly to 
retailers are not subject to supplier verification requirements because the supplying entity (i.e., 
the farm) and receiving entity (i.e., the retailer)  are not subject to the regulations on preventive 
controls, which contai n supplier program provisions.  The comment asks that we  revise the 
FSVP  provisions regarding produce to ensure that there are no differences in treatment between 
domestic and foreign suppliers with  respect to the obligations of the WTO Agreement on the 
Application of Sanitary and Phytosanitary Measures ( SPS Ag reement ) (Ref. 4) .   
(Response 105)  The FSVP regulation  align s with the supply -chain program provisions of 
the preventive controls regulations by requiring importers to verify that their suppliers have 
systems in place to significantly minimize or prevent  the hazards associated with the foods they 
are supplying and that their suppliers meet or provide the same level of public health protection 
as required under applicable FDA safety standards.   In addition, an importer conducting supplier 
verification unde r the preventive controls regulations for imported raw materials or other 
ingredients would be deemed in compliance with most of the FSVP requirements.    
Nevertheless, the supply -chain program provisions of the preventive controls regulations 
do not apply to certain domestic entities, including restaurants or retail food establishments.   
However, this does not mean that farms that supply produce to such entities are subject to 
different or lesser safety standards than foreign farms that supply produce to U. S. importers  140 
 
 
 subject to the FSVP regulation .  To the contrary, the requirements in the produce safety 
regulation apply with equal force to domestic and foreign farms.    
Under the food safety system envisioned by FSMA, supplier verification of imported 
produce to be sold by U.S. retailers is needed to ensure a consistent level of oversight and 
protection for domestic and imported food.  Consistent with  other provisions of FSMA, FDA is 
taking several steps to establish a more comprehensive, effective, risk -based approach to 
domestic food safety oversight and enforcement.  We are working through the Partnership for 
Food Protection (PFP), a group of dedicated professionals from Federal, State, local, tribal, and 
territorial governments with roles in protecting t he food supply and public health, to develop and 
implement a national Integrated Food Safety System (IFSS) for domestic compliance oversight  
(Ref. 5) .  We are also adopting a new domestic inspection paradigm, stemming from our 
authority to inspect under se ction 704 of the FD&C Act (21 U.S.C. 374), focused on whether 
firms are implementing systems that effectively prevent or significantly minimize food 
contamination in compliance with the new FSMA regulations, including those on preventive 
controls and produ ce safety.  This new paradigm involves a major reorientation and retraining of 
more than 2,000 FDA inspectors, compliance officers, and other staff involved in food safety 
activities, as well as thousands of State, local, and tribal inspectors.   
In additi on, section 201 of FSMA (section 421 of the FD&C Act (21 U.S.C. 350j)) 
mandates that we inspect domestic high -risk facilities not less than once every 3 years.  We are 
currently meeting this mandate and we intend to significantly exceed it as part of our s trategy to 
implement the new food safety standards.  We intend there to be an FDA or State inspection of 141 
 
 
 every dom estic high -risk human food facility annually to verify compliance with the new 
regulations.  
Our implementation of the final rule on produce sa fety (published elsewhere in this issue 
of the Federal Register ) will entail a broad, collaborative effort to foster awareness and 
compliance domestically.  Our strategy includes guidance, education, technical assistance, and 
verification.  Verification wi ll be achieved through the actions of multiple public and private 
entities, including inspections by FDA and partner agencies, USDA audits, marketing 
agreements, and private audits required by commercial purchasers.  In keeping with this broad 
vision, we i ntend to focus our domestic efforts on several important activities, including the 
following:  
•  Supporting and collaborating with public and private parties involved in audits and 
other accountability and verification activities;  
•  Conducting targeted do mestic on -farm surveys and risk -based inspections to 
understand current practices and identify gaps in compliance; and  
•  Taking administrative compliance and enforcement action when needed to correct 
problems that put consumers at risk.  
We have the author ity to inspect farms subject to the produce safety regulation under 
section 704 of the FD&C Act.  We will target our inspections on the basis of risk.  We intend to 
rely heavily on the States to conduct a large proportion of the routine inspections of farm s, and 
we are committed to working closely with the States to verify compliance with the new FSMA 
requirements.  In addition to FDA and State inspections, we will leverage third -party audits 142 
 
 
 conducted by USDA and others with a goal of annual verification o f all domestic farms subject 
to the produce safety rule.  
In contrast, we expect to have a far less robust system of direct public oversight of 
foreign food facilities and farms that are subject to the new FSMA regulations.  We have less 
ability to physica lly inspect and take enforcement actions against those who produce food abroad 
for export to the United States due to legal and practical limitations.  For example, diplomatic 
and practical logistics associated with conducting foreign inspections in most c ountries 
complicate, and in some cases make impossible, the kind of routine unannounced inspections of 
establishments that we conduct in the United States.  As a result, neither we nor our IFSS 
partners can rely on unannounced inspections abroad in the sam e way as we can domestically.   
We also face challenges in conducting “for cause” inspections of foreign facilities when 
we have evidence of a compliance problem.  Domestically, we can respond to a refusal to permit 
inspection or a refusal to permit access  to or copying of records by obtaining inspection warrants 
in the federal courts.   For foreign inspections, however, we do not have the same access to the 
courts, and it can be challenging to compel inspections and access to records when needed.  We 
also f ace diplomatic and logistical challenges in conducting foreign civil and criminal 
investigations and prosecutions when violations occur  that do not hinder our domestic 
enforcement efforts.  In addition to legal issues related to extraterritoriality, practical and 
operational challenges to our foreign enforcement activities include obtaining visas and official 
travel documents, finding qua lified translators, procuring foreign travel authorizations, 
difficulties in coordinating with foreign authorities, and extradition.   143 
 
 
 Because of these challenges , we largely rely on the cooperation of foreign governments 
when conducting inspections in for eign countries and bringing enforcement actions against 
foreign businesses and individuals.  Today, our main approach to oversight of imported food is 
reactive, involving sampling and testing food at ports of entry.  However, with the increased 
volume of i mported foods coming across U.S. borders and limited resources, we are able to 
physically examine less than 2 percent of food offered for import each year.  
Given the difficulties in conducting direct FDA regulatory oversight of foreign producers, 
FSMA requ ires importers to share responsibility for verifying the safety of imported food.  The 
FSVP regulation  require s that U.S. importers, who are domestic entities under direct legal 
jurisdiction, take action to ensure the safety of the food they import by perf orming risk -based 
supplier verification activities.  Combined with FDA’s foreign inspections and enforcement 
efforts, the FSVP requirements will help ensure that imported food is subject to the same level of 
risk-based oversight and accountability that app lies to domestic food under our comprehensive, 
integrated domestic food safety system.  
In establishing  these requirements for supplier verification by importers, we are 
integrating practices that industry has adopted in the last two decades to ensure that imported 
food is produced under modern food safety standards.  Global industry best practices include not 
only risk -based, prevention -oriented standards for producing safe food but also verification 
measures to ensure that those standards are being met, including supplier verification and other 
supply -chain management activities.  These oversight and verif ication approaches also are 
recognized by the Codex Alimentarius Commission (Codex) and are consistent with the 
approach of export oversight agencies in governments of countries with w hich the United States 144 
 
 
 trades  (see the discussion of Codex and relevant Codex standards and guidelines in Response 
106).  Therefore, in  relying on the FSVP regulation  to help ensure that oversight of imported 
food matches the level of domestic oversight made possible under FSMA, we are relying on 
mechanisms that are consistent  with internationally recognized standards.    
Our goal is for our domestic implementation strategy, including outreach, inspection 
frequencies, and other mechanisms to achieve compliance, to be operational on a schedule that 
corresponds with the dates by which domestic food producers are required to comply with the 
new FSMA standards.  We have designed the compliance dates for importers under this final rule 
in a parallel fashion.  As described in section IV.B of this guidance, an FSVP importer whose 
forei gn supplier is subject to new FSMA requirements will not have to comply with the FSVP 
regulation until after its supplier is required to comply with its new requirements.   
(Comment 106)  Some comments assert that assigning responsibility for ensuring food  
safety to importers could result in events that might breach WTO agreements, such as importer -
specific supplier verification lists, different importers imposing different verification criteria on 
the same foreign supplier, and additional and more frequent  onsite auditing.  Some comments 
maintain that oversight of foreign suppliers is best left to the private sector, and imposing 
requirements on importers might be inconsistent with WTO obligations.  
(Response 106)  We do not agree.  Supplier verification of imported food is needed to 
ensure a consistent level of oversight and protection for domestic and imported food.  Requiring 
importers to share responsibility for ensuring that imported food is safe is consistent with 
industry practice, principles of Codex,  and the approaches of export oversight agencies of many 
U.S. trading partners.  145 
 
 
 As a member of the WTO trade agreements, the United States has assumed international 
obligations including those set out in the SPS Agreement.   The SPS Agreement requires that 
measures adopted by WTO members to protect human or animal health be risk -based and that 
such measures are not more trade -restrictive than required to achieve their appropriate level of 
sanitary or phytosanitary protection, taking into account technical an d economic feasibility.     
Codex was formed in 1963 by the Food and Agriculture Organization and the World 
Health Organization of the United Nations to develop food standards, guidelines, and related 
texts such as codes of practice, and is recognized unde r the SPS Agreement as the international 
standards organization for food safety.  In describing the general characteristics of food import 
control systems, the Guidelines for Food Import Control Systems (CAC/GL 47 –2003) (Food 
Import Guidelines)  issued by t he Codex Committee on Food Import and Export Inspection a nd 
Certification Systems (Ref. 6) note the importance of clearly defined legislation on import 
control systems and recognize the value of importer verification systems.   The Food Import 
Guidelines re cognize the need for importing countries to perform inspections and audits where 
appropriate in exporting countries, and also acknowledge the utility of additional activities in 
ensuring that imported foods are safe.   The Guidelines recommend that standard s should be 
based on risk and, as far as possible, applied equally to imported and domestic food.      
The FSVP regulation  contain s requirements to ensure that imported foods are produced in 
compliance with processes and procedures that provide the same lev el of public health protection 
as those required under the preventive controls and produce safety regulations, and in 
compliance with sections 402 (regarding adulteration) and 403(w) (regarding misbranding with 
respect to labeling for the presence of major  food allergens) of the FD&C Act.  These underlying 146 
 
 
 preventive controls regulations are based on and conform to scientific evidence and international 
food safety standards, including the HACCP Annex to the Codex General Principles of Food 
Hygiene (Annex to  CAC/RCP 1 -1969 (Rev. 4 --2003)) (HACCP Annex) (Ref. 7).  In developing 
these re gulations , we also considered the recommendations of the Codex Code of Hygienic 
Practice for Fresh Fruits and Vegetables (CAC/RCP 53 –2003) (the Codex Code)  (Ref. 8).  
Similarly,  components of the FSVP regulation , including the hazard analysis requirements, are 
consistent with principles in  the HACCP Annex  that require private sector food producers to play 
a role in implementing HACCP by conducting hazard identification, evaluatio n, and subsequent 
control operations .  In addition, certain FSVP requirements correlate with Codex codes and 
principles on food safety relating to the basic definition of food safety standards and to the 
Codex standards for labeling of allergens in prepack aged food s (Ref s. 7, 9 ). 
Many countries have adopted similar food safety regulations mandating that certain 
principles and conditions be applied to food manufacturing and food importation.  These include 
mandatory HACCP programs for seafood and other foods .   
In addition to aligning with Codex standards an d guidance, the FSVP regulation  
incorporate s a risk -based approach to food safety that allows importers the flexibility to tailor the 
supplier verification activities they conduct so that they provide adeq uate assurance that hazards 
in the food they import have been significantly minimized or prevented.  The regulations are also 
designed to require verification that imported food meets the same standards that apply to 
domestic food (including the preventive  controls and produce safety regulations) and align with 
the supplier verification provisions that apply to food from domestic suppliers under the 
preventive controls regulations.  147 
 
 
 Regarding the comments’ ass ertion that the FSVP regulation  will result in mo re onsite 
auditing of foreign suppliers, we n ote that the FSVP regulation does  not require importers to 
conduct onsite audits of foreign suppliers.   Instead, applying risk -based principles, importers are 
required to determine appropriate supplier verificat ion activities based on the risks associated 
with the food being imported and the capabilities of the foreign supplier of the food.   Because the 
FSVP requirements are flexible and not prescriptive, we do not agree that the FSVP regulations 
will significant ly increase costs or impede trade.  
With respect to the possibility that different importers might subject the same foreign 
supplier to different verification activities, we believe it is unlikely that different importers would 
identify significantly differ ent hazards requiring control for the same food from the same foreign 
supplier.  We do not expect that to happen because all importers likely will be considering 
similar information on hazards associated with particular foods that is available from food 
producers, consultants, trade associations, industry -related publications, and regulatory agencies.  
Therefore, we anticipate that different importers are likely to conduct (or obtain documentation 
of) similar supplier verification activities for particular types of food.   In addition, the final rule 
allows importers to rely on verification activities conducted by other importers for the same food 
imported from the same foreign supplier.   This flexibility reduces the potential extent to which 
foreign supplier s might be subject to different verification activities by different importers.   We 
also note that, to the extent private food safety audit scheme owners and benchmarking 
organizations continue to develop tools to verify that foreign suppliers produce food  consistent 
with FDA food safety standards, importers could rely on such audit schemes to help meet FSVP 
requirements.   If this were to occur, multiple importers of the same food from the same foreign 148 
 
 
 supplier might choose to rely on the same supplier audi t conducted in accordance with such a 
scheme.  
(Comment 107)  One comment maintains that, to satisfy WTO obligations, we need to 
ensure that domestic and foreign supplier verification requirements are aligned, and therefore 
need to require that domestic foo d facilities conduct supplier verification with respect to RACs 
(if RACs are subject to the FSVP regulation as proposed).  
 (Response 107)  The regulations on preventive controls for human and animal foods 
include supply -chain program requirements that are  closely aligned with the FSVP supplier 
verification requirements, which we believe, for the reasons previously stated, are consistent 
with our WTO obligations.  Raw materials and other ingredients such as RACs that are 
manufactured/processed at domestic U .S. receiving facilities (as well as at foreign receiving 
facilities) are within the scope of the supply -chain program requirements in the FSVP and 
preventive controls  regulations.  
2.  Low -Acid Canned Foods  
In accordance with section 805(e)(3) of the FD&C Act, w e proposed that, with respect to 
those microbiological hazards that are controlled by the LACF regulation set forth in part 113 
(21 CFR part 113), the importer of an LACF would be required to verify and document that the 
food was produced in accordan ce with part 113.  For all matters not controlled by part 113 (e.g., 
hazards other than microbiological hazards addressed under part 113), the importer would be 
required to have an FSVP as specified in proposed §  1.502(a).  In the pr eamble to the proposed 
rule, we  noted that an LACF importer would not know if it was importing the food from a 
foreign supplier whose facility was in compliance with part 113 unless it conducted some 149 
 
 
 appropriate form of verification, such as auditing.  We therefore suggested tha t, in addition to 
providing assurance that non -microbiological hazards in LACF were adequately controlled, 
following the FSVP provisions would also be an appropriate verification approach for all 
hazards, including microbiological hazards.  
On our own initi ative, we are adopting corresponding FSVP requirements for the 
importation of raw materials and other ingredients of LACF by LACF manufacturers, for reasons 
similar to those we stated (in section III.B.1 of this document) for exempting from the FSVP 
regula tion importers of juice or seafood raw materials or other ingredients that are manufacturers 
or processors of juice or seafood products.  As we stated with respect to section 805(e)(1) and 
(e)(2) of the FD&C Act regarding juice and seafood, we conclude tha t in enacting section 
805(e)(3), Congress intended to exclude from the FSVP provisions food covered by and in 
compliance with the LACF regulation in part 113 (with respect to microbiological hazards 
addressed under those regulations), likely reflecting a c onclusion that the LACF regulation 
make s supplier verification under FSVP unnecessary for microbiological hazards because 
importers who are in compliance with the LACF regulation will be addressing the 
microbiological hazards in such food.  We therefore co nclude that a more reasonable 
interpretation of section 805(e)(3) than what we originally proposed to adopt is that Congress 
intended to exempt from the FSVP requirements the activities of a facility that a re subject to the 
LACF regulation in part 113 with  respect to microbiological hazards.   
Based on this interpretation, we are applying section 805( e)(3) not only to the importation 
of LACF produced by foreign suppliers subject to and in compliance with the  LACF regulation, 
but also to the importation of r aw materials and other ingredients by U.S. facilities for use in 150 
 
 
 manufacturing or processing LACF.  Therefore, §  1.502(b)(2) of the final rule states that with 
respect to microbiological hazards that are controlled by part 113, an importer is not required to 
comply with the FSVP requirements for raw materials or other ingredients that it imports for use 
in the manufacturing or processing of LACF provided that the importer is in compliance with 
part 113 with respect to the LACF that it manufactures or proces ses from the imported raw 
materials or other ingredients.  With respect to all hazards other than microbiological hazards 
that are controlled by part 113, the importer must have an FSVP for the raw materials and other 
ingredients that it uses in the manufa cture or processing of LACF.  
(Comment 108)  One comment requests that we advise importers of LACF to conduct 
finished product testing for typical pathogens and spoilage organisms because finished canned 
goods can be contaminated and might be used in produc ing other products.  
 (Response  108)  We do not agree that periodic sampling and testing of an imported 
LACF would be an appropriate means of verifying control of all hazards in such food.  The 
primary hazard of concern for LACF is C. botulinum  toxin, and strict controls as required under 
part 113 are needed  to address this hazard.  Sampling and testing cannot provide statistically 
valid assurance that potential pathogens in LACF products are adequately controlled.   
Section 805(e) of the FD& C Act states that the section does not apply to LACF facilities 
that are required to comply, and are in compliance, with the FDA standards and regulations on 
LACF, but only with respect to the microbiological hazards regulated under part 113.  In 
accordanc e with section 805(e), § 1.502(b) of the final rule provides that with respect to those 
microbiological hazards that are controlled under part 113, an importer of a n LACF  must verify 
and document that the food was produced in accordance with part 113.  An importer of a n LACF  151 
 
 
 would not know if it was importing the food from a foreign supplier whose facility was in 
compliance with part 113 (and thus eligible for the exemption from section 805 with respect to 
microbiological hazards) unless it conducted some a ppropriate form of verification.  Although 
the proposed rule suggested that an audit would be an appropriate form of verification, we 
conclude than an audit might not be necessary.  Although the importer may still choose to do an 
audit, an appropriate veri fication activity might also be review ing the scheduled processes  and 
processing and production records  required under part 113 that relate to the specific LACF being 
offered for import, as well as verifying that c ans are not swollen or leaking.  With resp ect to 
hazards other than microbiological hazards controlled under  part 113 that an importer m ight 
identify, an importer of a n LACF  must have an FSVP as specified in § 1.502(a).  For such an 
FSVP, sampling and testing might be appropriate verification acti vities in addition to an audit (or 
an audit might be used to verify control of non -microbial as well as  microbial hazards).    
 (Comment 109)  One comment, noting that proposed §  1.502(b) does not address 
acidified foods, states that if we intentionally om itted acidified foods from §  1.502(b), we should 
provide a rationale for treating acidified food differently than LACF.  
 (Response  109)  The provisions regarding LACF in §  1.502(b) reflect the statutory 
exemption (in section 805(e) of the FD&C Act) from th e FSVP requirements for microbiological 
hazards in LACF.  There is no analogous statutory exemption for acidified foods.  
An importer of acidified foods can consider the processor’s current scheduled processes, 
established in accordance with the regulation on acidified foods in part 114  (21 CFR part 114) , 
when conducting the hazard analysis required in § 1.504 and the evaluation required in § 1.505.  
An importer of acidified foods could, through its hazard analysis, determine that the 152 
 
 
 microbiological hazards associated with the imported food  are addressed  by controls in the 
supplier’s  scheduled processes established under part 114.  In turn, an importer of acidified foods 
can consider the processor’s current procedures  when determining what supplier verification 
activities are appropriate.  For example, an  importer might determine that reviewing its foreign 
supplier’s validated scheduled process and records and reports is an appropriate supplier 
verification activity.  As another example, it may be appropriate for an importer to review its 
foreign supplier’ s procedures for complying with the requirements of part 114, including 
frequent testing and recording of results, to verify that the finished equilibrium pH values for an 
acidified food are not higher than 4.6 ( see § 114.80(a)(2)) and to confirm the respo nse to any 
deviations from scheduled processes ( see § 114.89).   
3.  Importers in Compliance With Supply -Chain  Program Provisions in the Preventive Controls 
Regulations  
In the Supplemental Notice, we proposed to specify (in § 1.502(c)) that if an importer 
was required to establish and implement a risk -based supplier program under the preventive 
controls regulations (for either human or animal food), and the importer was in compliance with 
the supplier program requirements in those regulations, the importer would be deemed in 
compliance with the FSVP regulation (except for the requirement to identify the importer at 
entry of the fo od into the United States).  We proposed this change in response to several 
comments and consistent with our intent (as stated in the preambles of the proposed rules on 
FSVP and preventive controls for human food) to avoid imposing redundant supplier verification 
requirements on importers that also are food facilities that would be required to comply with any 
supplier verification pr ovisions in the preventive controls regulations.  153 
 
 
  (Comment 110)  Although the comments agree that there should not be redundant 
supplier verification requirements under the FSVP and preventive controls regulations, the 
comments differ in their views on ho w the regulations should achieve this.  Some comments 
state that, rather than deem importers in compliance with the preventive controls supplier 
program provisions to be in compliance with the FSVP requirements, the regulations should 
deem receiving facili ties that are in compliance with the FSVP requirements to be in compliance 
with the preventive controls supplier program provisions.  One comment suggests that the 
preventive controls supplier program requirements be applied only to verification of domesti c 
suppliers unless the imported food was exempt from the FSVP requirements.  However, some 
comments assert that entities subject to the preventive controls regulations are in a better position 
to determine the safety of imported ingredients in the context of the finished food product.  Some 
comments request that the FSVP and preventive controls final rules  allow for recognition of 
supplier verification performed under either rule, even if the verification was performed by a 
third party.  Some comments reque st that the preventive controls regulations include a provision 
exempting from  the supplier program requirements any food that had already been subject to 
verification under the FSVP regulation, even if the verification was conducted by a third party.  
Some comments suggest that a facility receiv ing such food for processing should be required to 
ensure that the importer met its FSVP obligations; one comment suggests that such a facility be 
required to annually obtain written assurance of FSVP compliance fro m the importer.  
 (Response  110)  We conclude that it is appropriate, under §  1.502(c) (3) of the final rule, 
to deem to be in compliance with most of the FSVP requirements those importers that are 
receiving facilities that have established and implemented a  risk-based  supply -chain  program in 154 
 
 
 compliance with  the regulations on preventive controls for human food or animal food  (subpart 
G of part 117 and subpart E of part 507, respectively) .  Given that we have aligned the supply -
chain  program provisions of the  preventive controls regulations and the  FSVP  requirements to 
the extent appropriate and feasible, the preventive controls regulations  allow  importers that are  
receiving facilit ies to take advantage of that fact so they do not have to conduct  duplicative 
verification activities.  Under the preventive control s regulations, receiving facilities that are 
importers in compliance with the FSVP requirements and have documentation of activities 
conducted under §  1.506(e) need not conduct verification activities fo r that raw material or other 
ingredient  (see § § 117.405(a)(2) and 507.105 (a)(2) ).  The issue of what, if any, additional effect 
the preventive controls regulations should give to an importer ’s FSVP is beyond the scope of this 
rulemaking.  However, w e note that importers that are receiving facilities might obtain  raw 
materials and  other  ingredients from both domestic and foreign suppliers.  Given that  receiving 
facilities should  already  be complying with other provisions in the preventive controls 
regulations , we believe that the preventive controls regulations  avoid  unnecessary duplication  
while ensuring that raw materials and other ingredients from both domestic and foreign suppliers 
are subject to appropriate verification activities . 
 In addition, w e have broadened §  1.502(c) to include not just those importers that have 
implemented a supply -chain program in accordance with the preventive controls regulations, but 
also two other circumstances in which the importer is also a food facility.  These circ umstances 
are: 155 
 
 
 •  When the  importer /facility  is not required to have a supply -chain program under th e 
preventive controls  regulations because  it implement s preventive controls for the hazards in the 
food in accordance with § 117.135 or § 507.3 4; and  
•  When the importer /facility  is not required to implement a preventive control under 
§ 117.136 or § 507.36 ( e.g., because the food is a type of food that cannot be consumed without 
application of an appropriate control, or because the facility’s customer or a subsequent entity in 
the distribution chain is controlling the hazards and certain other conditions are met) .   
In the Supplemental Notice, we proposed to specify, in § 1.504(g) of the proposed 
regulations, that if the preventive controls an importer and /or its customer implemented in 
accordance with the preventive controls regulations were adequate to significantly minimize or 
prevent all significant hazards in an imported food, the importer would not be required to  
determine appropriate foreign supplier  verification and related activities or to conduct any such 
activities.  We included §  1.504(g) in the revised proposed rule because proposed § 1.502(c) did 
not encompass certain circumstances in which a receiving facility is not required to have a 
supply -chain  program for a raw material or other ingredient . 
Rather than separately specify, in §  1.504(g), the requirements for importers that control 
all hazards requiring a control, we have broadened the scope of §  1.502(c) to incorporate these 
circumstances.  Thus, §  1.502(c) (1) specifies that if an importer is  a receiving facility that 
implements preventive controls for the hazards in a food in accordance with §  117.135 or 
§ 507.34 , then the importer is deemed to be in compliance with the FSVP regulation, exc ept for 
the requirement to identify the importer at entry in §  1.509.   156 
 
 
  In addition, §  1.502(c)(2) of the final rule deems in compliance with the FSVP regulation 
(except the requirements of §  1.509) importers that are food facilities who are not required to 
implement a prevent ive control for a hazard  in a food they import  in accordance with  § 117.136 
or § 507.35  (in the regulations on preventive controls for human food and animal food, 
respectively).  Under those provisions, a food manufacturer/processor i s not required to 
implement a preventive control when it identifies a hazard requiring a preventive control and one 
of the following applies:  
 •  The manufacturer/processor  determines and documents that the type of food (e.g., a 
RAC such coffee beans) coul d not be consumed without application of an appropriate control  
(see §§ 117.136(a)(1) and 507.36(a)(1)) ; 
 •  The manufacturer/processor relies on its customer who is subject to the preventive 
controls requirements to ensure that the identified hazard will be significantly minimized or 
prevented , and the manufacturer/processor  meets certain disclosure (i.e., that the food has not 
been processed to control identified hazards) and written assurance requirements (see 
§§ 117.136(a)(2) and 507.36(a)(2)) ;  
 •  The manufacturer/processor relies on its customer who is not subject to the preventive 
controls requirements to provide assurance it is manufacturing, processing, or preparing the food 
in accordance with the applicable food safety requirements , and the manufa cturer/processor  
meets certain disclosure and written assurance requirements  (see §§  117.136(a)(3) and 
507.36(a)(3)) ; 
 •  The manufacturer/processor relies on its customer to provide assurance that the food 
will be processed to control the identified hazar d by an entity in the distribution chain su bsequent 157 
 
 
 to the customer and the manufacturer/processor meets certain disclosure and written assurance 
requirements (see §§ 117.136(a)(4) and 507.36(a)(4)); or  
 •  The manufacturer/processor has established, docum ented, and implemented a system 
that ensures control, at a subsequent distribution step, of the hazards in the food it distribute s (see 
§§ 117.136(a)(5) and 507.36(a)(5)) . 
We conclude that it is appropriate to exempt from the FSVP requirements importers th at 
are facilities importing a food and acting in accordance with §  117.136 or § 507.36 with respect 
to that food, because compliance with those requirements will provide adequate assurance of the 
safety of this food.  The FSVP regulation contain s similar provisions  regarding foods that cannot 
be consumed without application of a control and foods whose haz ards will be controlled by the 
importer’s customer or a subsequent entity in the distribution chain .  These provisions, which 
appear in §  1.507 of the final rule, are discussed in section III.H of this document.   Because these 
FSVP provisions so closely align with the preventive controls regulations, we see no need for 
importers that are receiving facilities to have to comply with both § § 1.507 an d 117.136 or 
§ 507.3 6, as applicable.  Although the preventive controls regulations do not include a provision 
comparable to § 1.502(c)(2) that deems receiving facilities that are importers to be in compliance 
with § 117.136 or § 507.36 if they are in comp liance with § 1.507 in the FSVP regulation, we  do 
not believe that such receiving facilities need to comply with these provisions in both the FSVP 
and preventive controls regulations.  Therefore, we intend  to consider receiving facilities that are 
importer s to be in compliance with § 117.136 or § 507.36, as applicable, if they are in 
compliance with § 1.507.    158 
 
 
 (Comment 111)  One comment asks that we state how we will certify that an 
importer/facility is in compliance with the preventive controls supplier program requirements.  
 (Response  111)  Although we will inspect food facilities for compliance with the 
preventive controls regulations, including the  supply -chain program provisions, we will not 
“certify” or otherwise designate a facility as being in comp liance with the supply -chain program 
requirements.  Rather, an importer that expects to be deemed in compliance with most of the 
FSVP requirements under §  1.502(c) (3) will be responsible for ensuring that it is in compliance 
with the supply -chain program provisions of the preventive controls regulations and will need to 
be able to demonstrate its compliance during an inspection.  
 (Comment 112)  Some comments suggest that §  1.502(c) should specify §  507.37 rather 
than §  507.43 to refer to the suppli er program provisions in the regulations on preventive 
controls for animal food.  
 (Response  112)  Because the supply -chain  program provisions in the regulations on 
preventive controls for animal food are in subpart E of part 507, § 1.502(c) (3) of the FSVP final 
rule cites that subpart.  
4.  Importer Whose Customer Is in Compliance With the Preventive Controls Supply -Chain 
Program Requirements  
 We proposed, in §  1.502(d), that if an importer’s customer was required to establish and 
implement a risk -based supp ly-chain  program under the preventive controls regulations (for 
either human or animal food), and the importer annually obtained written assurance that its 
customer was in compliance with those requirements, the importer would be deemed in 
compliance with the FSVP regulation (except for the requirement to identify the importer at 159 
 
 
 entry of the food into the United States and the requirement to maintain records of the written 
assurances).  
We conclude that it is appropriate to address verification requirements  that apply when an 
importer’s customer controls the hazards in an imported food in the same provisions as those that 
apply to control of hazards by entities after the importer’s customer in the U.S. distribution 
chain.  As previously stated, t hese provisi ons are set forth in §  1.507 of the final rule.  In section 
III.H.2 of this document we discuss §  1.507 and respond to the comments we received regarding 
proposed §  1.502(d) concerning importers whose customers are in compliance with the supply -
chain  progr am provisions of the preventive controls  regulations.  
D.  Personnel Developing and Performing FSVP Activities (§ 1.503)  
We proposed to require , in §  1.503,  that importers use a qualified individual to conduct 
most FSVP activities, and provided several exceptions to this proposed requirement.  We then 
updated this proposal in the Supplemental Notice with a revised reference to one of the 
exceptions and delete d one of the exceptions because it was no longer applicable under the 
changes to the proposed rule provided by the Supplemental Notice.  As the proposal was updated 
in the Supplemental Notice, the exceptions to the requirement to use a qualified individual  were 
the activities required under proposed §§ 1.506(a) (procedures to ensure the importation of food 
from approved suppliers), 1.509 (identification of the importer at entry), 1.510 (recordkeeping), 
1.511(c)(2) (procedures to ensure the importation of di etary supplements from approved 
suppliers), and 1.512(b)(5) (recordkeeping by very small importers).   
In addition, as stated in sections III.A.1 8 and III.A.1 9 of this document, we have 
concluded that it is appropriate to specify the general qualifications  that qualified individuals and 160 
 
 
 qualified auditors must have in provisions outside of the definitions of those terms --specifically, 
in § 1.503 of the final rule.  Under §  1.503(a), a qualified individual must have education, 
training, or experience (or a c ombination thereof) necessary to perform their assigned activities 
and must be able to read and understand the language of any records that must be reviewed in 
performing an activity.  Under §  1.503(b), a qualified auditor must conduct any audit conducted 
in accordance with §  1.506(e)(1)(i) or §  1.511(c)( 5)(i)(A) and must have technical expertise 
obtained through education, training, or experience (or a combination thereof) necessary to 
perform the auditing function.  
In the final rule, for several reasons w e are eliminating the proposed exemption of the 
performance of certain FSVP activities from the requirement to use a qualified individual, as 
well as the proposed exemption for certain importers from having to use a qualified individual to 
meet FSVP requir ements.  First, requiring use of a qualified individual to meet all FSVP 
requirements is consistent with the goal of aligning the FSVP regulation with the preventive 
controls regulations.  Those preventive controls regulations (§§  117.4(a)(2) and 507.4(a)( 2)) 
require that every person engaged in the manufacturing, processing, packing, or holding of food 
subject to the preventive controls regulations, including the supply -chain program provisions, 
must be a qualified individual.  This requirement applies to all tasks related to these activities, 
including such tasks as ensuring the receipt of food from approved suppliers and recordkeeping.  
Second, we note that the FSVP final rule makes the definition and requirements for 
qualified individuals more flexible an d less burdensome than as originally proposed, thus making 
the requirement applicable to a wider variety of tasks.  Instead of a qualified individual having to 
possess necessary education, training,  and experience (as we initially proposed), the final rule  161 
 
 
 states that a qualified individual must have education, training, or experience --or a combination 
of these elements --necessary to perform an assigned FSVP activity.  This allows importers more 
flexibility in meeting the requirement to have qualified indiv iduals perform required tasks.  This 
also means that the final rule does not require any particular education, training, or experience 
beyond what is needed to successfully perform the FSVP task to which the qualified individual is 
assigned, whether the ta sk is a core component of the FSVP requirements (e.g., hazard analysis, 
supplier verification activities) or something requiring expertise not necessarily directly related 
to food safety, such as recordkeeping or ensuring that the importer is identified as  the FSVP 
importer for the food at entry.  In lig ht of the revised definition of a qualified individual , we 
conclude that a person who meets the definition should always perform an y activity required 
under the FSVP regulation.  Any other individua l might  not necessarily have the ability to 
effectively perform the activity.   
With respect to the proposed exemption from the use of a qualified individual 
requirement for the development of procedures to ensure the use of approved foreign suppliers, 
we note that  in the Supplemental Notice we had substituted t he requirement to establish and 
follow such procedures for a proposed requirement (set forth in the proposed rule) to maintain a 
written list of foreign suppliers.  That change effectively transformed this re quirement from an 
administrative one to a substantive one.  Requiring use of a qualified individual for developing 
and implementing procedures to ensure the use of approved suppliers is consistent with the 
principle stated in the preamble to the proposed r ule that education and training are important to 
ensure the development of FSVPs.  Similarly, although recordkeeping and ensuring that the 
importer is properly identified as the importer of the food at entry may require comparably less 162 
 
 
 food safety training  and experience, we conclude that persons responsible for meeting these 
FSVP requirements should have the education, training, and/or experience needed to effectively 
perform these tasks.  
In the proposed rule, we also proposed to exempt from the requiremen t to use a qualified 
individual the following types of importers:  
•  Importers of certain dietary supplements and dietary supplement components who are 
in compliance with proposed §  1.511(a) or (b); and  
•  Importers of food from foreign suppliers in countr ies whose food safety systems FDA 
has recognized as comparable or determine d to be equivalent to that of the United States in 
accordance with proposed §  1.513.  
Although the modified FSVP requirements applicable to these importers under 
§§ 1.511(a) and (b) and 1.513  of the final rule are limited ( in the case of §  1.511(a) and (b), to 
recordkeeping and/or identification of the importer at entry), we believe that it is nevertheless 
appropriate that persons with necessary education, training, and/or experience perform the tasks 
required under these provisions.   
(Comment 113)  One comment on proposed §  1.503 states that importers should not be 
required to have a qualified individual conduct the review of a foreign supplier’s food safety 
records.    
 (Response  113)  We do not agree.  We conclude that to adequately review and understand 
a foreign supplier’s food safety records, a person must have adequate education, training, and/or  
experience regarding the food safety operations addressed in the records, including, where 
applicable, training in the principles of hazard analysis and risk -based preventive controls and 163 
 
 
 measures to ensure produce safety.  Review of food safety records requires an understanding of 
the applicable food safety principles.  
 (Comment 114)  On e comment states that a foreign government employee who is 
designated as a qualified individual by the foreign government should have the authority to 
conduct any kind of verification activities under the FSVP regulation s without having to be 
accredited as  a third -party auditor.  
 (Response  114)  The importer of a food, not a foreign government or any other entity, is 
responsible for determining whether a person who is to conduct FSVP activities has the 
education, training, and/or experience necessary to con duct those activities in accordance  
§ 1.503(a) of the final rule.  The FSVP regulations do not require that a qualified auditor or 
qualified individual be accredited under any accreditation scheme or system, including FDA’s 
regulations on the accreditation  of third -party certification bodies  implementing section 808 of 
the FD&C Act, as long as the  person  otherwise satisf ies the requirements to be a qualified 
auditor or individual under  § 1.503. 
E.  Hazard Analysis (§ 1.504)  
 In the Supplemental Notice , we made several changes to the proposed requirements 
concerning importers’ analysis of the hazards in the foods they import in response to several 
comments and to align the FSVP requirements with the proposed supply -chain  program 
provisions in the prevent ive controls regulations.  These revisions primarily involved changing 
the requirement to analyze hazards that are reasonably likely to occur to a requirement to analyze 
known or reasonably foreseeable hazards (to determine if the se hazards are significant ), as well 164 
 
 
 as the addition of a proposed requirement that importers consider hazards intentionally 
introduced for purposes of economic gain.  
 As discussed in the following paragraphs, we are making several additional changes to 
the hazard analysis provisio ns in response to comments .  We also are adding flexibility by 
broadening the proposed provision  allowing an importer to rely on a hazard analysis conducted 
by its foreign supplier (rather than conducting an entirely separate evaluation of hazards using 
information that the importer itself has obtained).  As described further in the following 
paragraphs, the final rule  permit s reliance on a hazard analysis conducted by additional entities 
in importers’ supply chains.  
1.  General  
 (Comment 115)  Some comments suggest that the hazard analysis provisions in the FSVP 
regulations should cross -reference the hazard analysis provisions in the regulations on preventive 
controls for human food.  
 (Response  115)  We conclude that this is not necessary or appropri ate.  Although the 
hazard analysis provisions in the two regulations are very similar, there are some differences in 
the requirements that primarily reflect the difference in scope between the FSVP regulation and 
the preventive control for human food regul ation.  The former generally apply to importers who 
must analyze the hazards  in the foods produced by  their foreign suppliers , while t he latter  
primarily apply to food facilities that must determine the hazards for the food that they 
themselves manufacture , process, pack , or hold.   
 (Comment 116)  Some comments request that we not apply the FSVP  regulation to any 
food until we have conducted a risk assessment and made a risk management determination for 165 
 
 
 each food according to internationally agreed standar ds and after public comment.  The 
comments assert that requiring importers to identify hazards and conduct verification will cause 
small businesses to withdraw from the market or choose too carefully which products to import 
and from which geographic regio ns, stifling international trade.  The comments maintain that this 
will happen not because there are hazards in particular foods but because the importer or foreign  
supplier cannot scientifically identify it or because the verification requirements will be  
unnecessarily stringent or costly for most foods.  However, the comments assert that most foods 
do not present a food safety risk and that there is no scientific proof that specific foods covered 
by FSMA are unsafe or need to be made safer.  
The comments also assert that we must conduct the risk assessments to meet U.S.  
obligations under the SPS Agreement.  The comments object to what they regard as FDA’s 
shifting of its obligation to conduct risk assessments to the priva te sector by requiring importers 
to conduct hazard analyses .  
The comments also request that that the FSVP regulations be applied only to designated 
high-risk foods for at least 5 years after we have designated such foods.   
(Response 116)  We do not agree  with the suggested approach to the determination of 
risks in imported foods .  There are known hazards in many types of food, and many types of 
domestic and foreign foods have been identified as the source of foodborne illness outbreaks in 
the United State s.  As stated previously, we conclude that it is appropriate to require importers to 
analyze the hazards in the foods they import and conduct foreign supplier verification activities 
that take into account the risks posed by these hazards and provide assur ances that suppliers are 
following procedures to ensure food safety consistent with U.S. standards, including the 166 
 
 
 preventive controls and produce safety regulations.  Therefore, we do not believe that the 
comments provide a justification for requiring that  we conduct individual  risk assessment s of 
specific foods  before we require imp orters to conduct hazard analyse s and supplier verification  
activities .  However, we note that to the extent that the comment s express particular concern 
about the ability of sm aller entities to comply with the FSVP regulations, §  1.512 of the final rule 
(discussed in section III.M of this document) specifies modified requirements for very small 
importers and importers of food from certain small foreign suppliers. . 
We also deny t he request that  the FSVP regulation be applied only to foods that we have 
designated as high risk for at least 5 years after we make such designations.   Under the 
regulation, importers will be responsible for determining the hazards in the food they import , 
evaluating the risk posed by that food and the characteristics of the foreign supplier, and 
determining appropriate foreign supplier verification activities based on that evaluation.  Thus, 
the regulation allow s importers the flexibility to tailor the supplier verification they conduct to 
the nature of the risks posed by the foods they import.  In addition, as discussed in secti on IV.B 
of this document, we are providing considerable time for importers to adjust their procedures and 
practices (if necessary) to come into compliance with the regulation.  Consequently, we conclude 
that it is unnecessary and not in the interest of public health to delay implem entation of the FSVP 
regulation until we conduct risk assessments and designate high -risk foods, or to limit the scope 
of the regulation to high -risk foods for 5 years.  
2.  Requirement to Conduct a Hazard Analysis  
We proposed to require that an importer  identify and evaluate, based on experience, 
illness data, scientific reports, and other information, known or reasonably foreseeable hazards 167 
 
 
 for each food it imports to determine whether there are any significant hazards (proposed 
§ 1.504(a)).  We further pr oposed to define a “significant hazard” as a known or reasonably 
foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, 
packing, or holding of food would, based on the outcome of a hazard analysis, establish controls 
to significantly minimize or prevent the hazard in a food and components to manage those 
controls (such as monitoring, corrections and corrective actions, verification, and records), as 
appropriate to the food, the facility, and the control.   
 We also pro posed that the hazard analysis be written (proposed § 1.504(a)).  
As discussed in section III.A. 11 of this document, the final rule uses the term “hazard 
requiring a control” instead of “significant hazard.”  Following is a discussion of comments on 
other a spects of the proposed hazard analysis requirements in §  1.504(a).  
 (Comment 117)  One comment requests that we replace “illness data” with “FDA 
foodborne illness data” to ensure that a review of illness data is based on a well -known and 
relatively easy -to-access source of information.  
 (Response  117)  We decline to make the change because illness data from any reliable 
source, not just FDA, would be relevant in evaluating known or reasonably foreseeable hazards.   
For example,  importers might consider data  on foodborne illnesses published by the Centers for 
Disease Control in determining whether hazards that cause such illnesses are hazards that require 
a control.   
 (Comment 118)  Some comments ask that we change proposed §  1.504(a)  to refer to 
“experience,  illness data, scientific reports, or other information” instead of “ and other 168 
 
 
 information” because they believe that there might not be any such data or reports regarding 
animal food.  
 (Response  118)  We decline this request.  We agree that in some cases some of the 
specified types of information might not be available.  For example, there would be no illness 
data for a food that has never been associated with a foodborne illness.  However, changing the 
provision as requested would allow importers to choos e which information to evaluate , 
irrespective of whether the information is available.   We conclude that importers must consider 
each of these types of information --to the extent that each type exists for a food --in conducting a 
hazard analysis.  
 (Comment 119)  One comment suggests that importers should be required to evaluate 
known or reasonably foreseeable hazards for each “type of food” rather than each “food.”  The 
comment maintains that it would be unnecessarily burdensome to require a separate hazard 
analysis for each individual food imported; instead, the comment requests that importers be 
permitted to group foods appropriately by type for purposes of hazard analysis.  
 (Response  119)  We agree and have changed §  1.504(a) accordingly.  We conclude that  it 
might be appropriate to analyze the hazards for a particular type of food, rather than an 
individual food product, if the resulting determination of hazards requiring a control will apply 
for all foods of this type.  For example, it might be appropriat e to conduct a hazard analysis for 
multiple product sizes of a particular food, or to conduct one hazard analysis applicable to two or 
more related foods that are manufactured, processed, grown , or harvested  under very similar 
conditions if all such food i nvolves the same hazards.  However, if foods that might be said to be 169 
 
 
 of the same “type” have different hazards that require a control, it generally would not be 
appropriate to use the same hazard analysis for each of those foods.    
3.  Hazard Identificat ion 
 a.  General types of hazards . 
We proposed to require, in §  1.504(b)(1), that an importer’s analysis of the known or 
reasonably foreseeable hazards in each food include the following types of hazards:  
•  Biological hazards, including microbiological ha zards such as parasites, environmental 
pathogens, and other pathogens;  
•  Chemical hazards, including radiological hazards, pesticide and drug residues, natural 
toxins, decomposition, unapproved food or color additives, and food allergens; and  
•  Physical hazards.    
 (Comment 120)  Some comments ask that we delete “decomposition” from the listing of 
chemical hazards.  The comments assert that many products used in the animal food industry 
have begun decomposition but are processed in a controlled system to halt decomposition before 
harmful toxins are formed.  The comments maintain that the inclusion of “natural toxins” among 
chemical hazards addresses the Agency’s concerns about hazards associated with uncontrolled 
decomposition or spoiled foods resulting fr om chemical changes induced by the microbial 
breakdown that releases potentially hazardous toxins, and that including “decomposition” would 
be redundant and unnecessary because some levels of decomposition do not pose an animal food 
safety risk.  
 (Response  120)  We decline to make this change .  Decomposition of animal food  consists  
of microbial breakdown of normal food product tissues and the subsequent enzyme -induced 170 
 
 
 chemical changes.  These changes are manifested by abnormal odors, taste s, texture s, color s, 
etc., and can lead to reduced food intake or rejection of the food by the intended animal species, 
potentially resulting in illness or death .  Thus, decomposition can be a hazard requiring a control 
in animal food.  
 (Comment 121)  Some comments ask that  we add the term “nutrient deficiencies or 
toxicities” to the list of chemical hazards because animal safety is related to established nutrient 
deficiencies and toxicities.  
 (Response  121)  We agree that nutrient deficiencies or toxicities may be hazards i n 
animal food (for reasons discussed in the preventive controls for animal food rulemaking) and 
have revised the list of chemical hazards accordingly.  
b.  Reasons for presence of a hazard . 
We proposed to require, in §  1.504(b)(2), that an importer’s analysis of hazards include 
hazards that may be present in a food for any of the following reasons:  
•  The hazard occurs naturally;  
•  The hazard may be unintentionally introduced;  or 
•  The hazard may be intentionally introduced for purposes of economic g ain. 
 (Comment 122)  Several comments object to the proposed requirement to consider 
hazards that might be intentionally introduced for purposes of economic gain.  Some comments 
assert that because economically motivated adulteration (EMA) is nearly always  an issue of 
product quality and integrity rather than food safety, requiring importers to consider EMA 
hazards would provide little benefit to food safety.  Some comments suggest that it would not be 
appropriate to require consideration of EMA hazards bec ause such hazards  often  are addressed 171 
 
 
 by a corporate parent company rather than at the facility level.  Some comments maintain that 
addressing EMA requires a completely different approach than that used for unintentional 
adulteration and that it would be b etter to address EMA in an importer’s food defense plan.  
Some comments therefore request that we consider proposing regulations on EMA in a future 
rulemaking rather than in the FSVP  regulation.   
 (Response  122)  We decline to delete this requirement.  EM A can and has resulted in 
safety concerns, including, as in the case of melamine in infant formula and pet food, the deaths 
of humans and animals.  The fact that a plan for addressing EMA might be developed at the 
corporate level is irrelevant to whether a n importer can determine whether EMA in a particular 
food is known or reasonably foreseeable.  Further, we disagree that economically motivated 
adulteration requires a completely different approach than unintentional adulteration.  Although 
we acknowledge that many firms currently might not include EMA in their analyses of safety 
hazards in food, as we stated in the Supplemental Notice, some of the measures that industry 
uses in supplier verification programs, such as audits and sample testing, are used to guard 
against EMA.  Moreover, we believe that the burden posed by having to analyze potential EMA 
hazards is limited because, as with hazards that occur naturally or that may be unintentionally 
introduced, we define hazards to include only those agents tha t have the potential to cause illness 
or injury.  In the EMA context, we anticipate that importers will identify such hazards in rare 
circumstances, usually in cases where there has been a pattern of economically motivated 
adulteration of a food .  Therefor e, we conclude it is appropriate that importers consider EMA 
hazards under the FSVP regulation.  172 
 
 
  (Comment 123)  Some comments assert that it would be more appropriate to address 
EMA hazards separately from the hazard analysis because they are not considere d as part of the 
hazard analysis when designing a food safety plan; rather, the comments maintain that EMA 
should be considered as part of supplier verification.  
 (Response  123)  We do not agree.  Importers are required to conduct a hazard analysis 
under §  1.504 of the final rule precisely to understand what manner of supplier verification under 
§ 1.506 is needed and appropriate.  Therefore, importers need to evaluate EMA as part of the 
hazard analysis for a food so that, if EMA is determined to be a hazard  requiring a control for 
that food, importers can conduct appropriate suppler verification activities to obtain assurance 
that the food has not been intentionally adulterated for economic gain.  
 (Comment 124)  One comment asserts that looking retrospective ly at instances of 
economic adulteration might not be effective because it would be less likely that others would 
engage in such activity in the future.  
 (Response  124)  We are not aware of evidence supporting the comment’s assertion.   
However, given that it would not be feasible  or appropriate  to require importers to speculate 
about, and guard against, any conceivable form of EMA of a food, we conclude that it is 
reasonable to require importers to consider, among other things, whether  a food has been 
previously linked to EMA that might cause harm to consumers.  
 (Comment 125)  Some comments assert that the analysis of hazards intentionally 
introduced for economic gain should be limited to whether there is a history of any particular 
EMA .  Some comments request that we limit the requirement to consider hazards that might be 173 
 
 
 intentionally introduced for economic gain to such hazards that are “already known” or for which 
there is a “historical precedent.”  
 (Response  125)  As with other haz ards, importers need only consider EMA hazards that 
are known or reasonably foreseeable.  This means that importers are not required to consider 
purely speculative hazards.  We expect that EMA hazards will be identified in rare 
circumstances, usually in ca ses where there has been a pattern of EMA  in the past.  The revisions 
suggested by the comments are unnecessary and could be interpreted to narrow the requirement 
that importers consider hazards  that are known or reasonably foreseeable.  We continue to 
believe that this requirement  is appropriate, even for EMA , and we reiterate that we would not 
expect importers to consider  merely  hypothetical EMA  scenarios for their food products.  This is 
consistent with our position on EMA  in the preventive controls regulations . 
 (Comment 126)  One comment requests that if the requirement to consider EMA is 
included in the final rule, it should be limited to “food safety” hazards that might be intentionally 
introduced for economic gain.  
 (Response  126)  We conclude that t his change is unnecessary.  Because “hazards” are 
defined as certain agents that are reasonably likely to cause illness or injury, the requirement to 
consider hazard s that might be introduced for purposes of economic gain  is already limited to 
EMA  that rel ates to food safety.  EMA that relates to the quality  of food  (for example ) but not 
food safety is beyond the scope of this rulemaking.  
 (Comment 127)  Some comments request that importers be given flexibility to determine 
appropriate verification activities for EMA hazards.  Some comments assert that testing should 174 
 
 
 not be the only suitable control or verification measure for EMA because for many facilities it 
would be impractical to test every imported lot of ingredients.  
 (Response  127)  Section 1 .506 of the final rule provides importers flexibility in 
determining appropriate supplier verification activities for all hazards --including EMA --
consistent with the evaluation of the risk posed by a food and the foreign supplier’s performance, 
among other  factors, conducted in accordance with §  1.505.   
 (Comment 128)  Some comments suggest that we publish a list of previous instances of 
EMA that importers should use in considering possible EMA hazards.  
 (Response  128)  Although we agree that it would be u seful to have a centralized list 
involving all previous instances of EMA, creating such a list would likely be unduly resource -
intensive for FDA and therefore would not be consistent with the efficient enforcement of 
section 805 of the FD&C Act.  We theref ore decline this request.  We note, however, that 
information about incidents of EMA is widely available from public sources  (Refs. 10-12).   
 (Comment 129)  One comment asks that we require importers to identify harmless 
economically motivated adulterants  during the review process.  
 (Response  129)  Although we encourage  importers to identify --and verify control  of--all 
EMA, we think it is appropriate to treat EMA consistently with our general approach to hazard 
analysis and only require identification of those agents that have the potential to cause illness or 
injury .  We there fore decline this request.  
4.  Hazard Evaluation  
 a.  Probability and severity of hazards . 175 
 
 
 We proposed in §  1.504(c)(1) to require that the importer’s hazard analysis include an 
assessment of the probability that hazards will occur in the absence of controls and the severity 
of the illness or injury if the hazards were to occur.   
 (Comment 130)  Some comments suggest that the provision should require importers to 
consider any relevant geographic, temporal, agricultural, or other factors that might affect the 
severity or probability of a hazard.  
 (Response  130)  We do not believe it is appropriat e to address these factors within the 
basic requirement to assess the probability that hazards will occur in the absence of controls and 
the severity of illness or injury if the hazards were to occur.  Rather, we think that this 
requirement, stated  in § 1. 504(c)(1),  establishes  the general scope of the hazard analysis.  
However, we agree that such factors might be relevant in a hazard evaluation for a food, such as 
year-to-year fluctuation of aflatoxin levels in some RACs due to weather conditions.  We 
therefore believe it is appropriate to include these factors in the list of factors that must be 
considered in the hazard evaluation required under §  1.504(c)(3)  of the final rule .  Thus, we have 
revised the list of factors that a hazard evaluation must addres s under §  1.504(c)(3) to include, 
among “other relevant factors,” the temporal (e.g., weather -related) nature of some hazards, such 
as levels of natural toxins.  
b.  Environmental pathogens in certain ready -to-eat foods . 
We proposed that a hazard evaluatio n would have to include an evaluation of 
environmental pathogens whenever a ready -to-eat food is exposed to the environment before 
packaging and the packaged food does not receive a treatment that would significantly minimize 
the pathogen (proposed §  1.504 (c)(2)).  176 
 
 
 In the final rule, we have revised th is requirement to specify that instead of receiving a 
treatment to significantly minimize the pathogen, the ready -to-eat food might include a control 
measure (such as a formulation that is lethal to the pathoge n) that would significantly minimize 
the pathogen, because controls such as formulation can function as a “kill step ,” and the 
provision should make clear that such controls can be used in lieu of “treatment.”  This change is 
consistent with corresponding provisions in the preventive controls regulations.  
 (Comment 131)  Some comments ask that we expand the requirement to evaluate 
environmental pathogens to include all foods, not just certain ready -to-eat foods.  
 (Response  131)  We conclude that th is change  is not needed because importers will be 
required, under §  1.504(b)(1)(i), to consider whether there are any known or reasonably 
foreseeable environmental pathogens in a food.  The requirement in §  1.504(c)(2) is designed to 
address the specific safety con cern known to be associated with ready -to-eat foods that are 
exposed to the environment before packaging and would not undergo treatment (or otherwise 
include a control measure) to significantly minimize environmental pathogens.  
 (Comment 132)  One comment  requests that we limit the requirement concerning ready -
to-eat foods that are exposed to the environment to such foods that are “capable of supporting 
pathogen growth to, or survival at, infectious levels.”  
 (Response  132)  We decline to make this change because this suggestion  prejudges the 
outcome of the hazard analysis for a wide variety of food products .  An importer may consider 
factors such as whether the formulation of a food would not support the growth of a pathogen to 
increased numbers, or would cause pathogens to die off over time, in determining whether an 
environmental pathogen is a hazard requiring a control.  If an importer determines that any 177 
 
 
 environmental pathogens in a ready -to-eat food would not pose a hazard that requires a control, 
the importer would need to document the basis for that determination in its written hazard 
analysis.  
 (Comment 133)  Some comments request that we delete th is proposed requirement or 
define what is meant by a ready -to-eat food that is “exposed to the environme nt.”   
 (Response  133)  We decline this request .  The Appendix to the 2013 proposed rule on 
preventive controls for human food provides examples of food products that are, or are not, 
exposed to the environment (78 FR 3646 at 3819).    
(Comment 134)  One comment asks that the requirement specify that a qualified 
individual must determine that exposure of the ready -to-eat food to the environment before 
packaging would constitute a risk of introduction of a significant hazard.  The comment asserts 
that a qua lified individual is best suited to make a determination of whether the exposure poses 
an actual risk.  
 (Response  134)  We decline to make this change.  As with all activities required under 
the FSVP regulation, a qualified individual must conduct the haza rd analysis for each food that 
the importer imports.  Therefore, it is unnecessary to specify in §  1.504(c)(2) that a qualified 
individual must make the determination of whether exposure to the environment of a ready -to-
eat food might result in the develop ment of an environmental pathogen that requires a control.  
c.  Hazard evaluation factors . 
We proposed, under §  1.504(c)(3), that an importer’s hazard evaluation of a food would 
have to consider the effect of the following factors on the safety of the fini shed food for the 
intended consumer:  178 
 
 
 1.  The formulation of the food;  
2.  The condition, function, and design of the foreign supplier’s establishment and 
equipment;  
3.  Raw materials and ingredients;  
4.  Transportation practices;  
5.  Harvesting, raising, manufacturing, processing, and packing procedures;  
6.  Packaging and labeling activities;  
7.  Storage and distribution;  
8.  Intended or reasonably foreseeable use;  
9.  Sanitation, including employee hygiene; and  
10.  Any other relev ant factors.  
 (Comment 135)  Some comments request that importers be required to consider the 
hazard evaluation factors only “as appropriate” because not all factors will be relevant in every 
case.  The comments maintain that because an importer is not alw ays procuring a finished food, a 
hazard analysis of a foreign supplier conducted for FSVP purposes has a narrower scope than a 
hazard analysis conducted as part of a food safety plan.  The comments also assert that importers 
might not always know all fores eeable uses of an ingredient when initially sourcing it from a 
foreign supplier.  Therefore, the comments maintain that importers should have the flexibility to 
apply the listed factors as they deem appropriate.  
 (Response  135)  We decline to require that importers only consider the hazard evaluation 
factors “as appropriate.”  We understand that importers might import raw materials or other 
ingredients and that this might affect how some of the factors are evaluated, such as the intended 179 
 
 
 use of a raw materi al that is used in many foods.  But importers must at least consider the 
potential effect of each of the factors on the safety of the finished food.  If a factor is not relevant 
with respect to a particular food, the consideration might be brief.   With reg ard to the importation 
of raw materials or other ingredients, we note that t he final rule includes provisions applicable to 
when an imported raw material or other ingredient will be processed further in the United States .  
 (Comment 136)  Some comments express concern that the proposed requirement to 
consider the condition, function, and design of the foreign supplier’s establishment and 
equipment would necessitate an onsite audit of the foreign supplier.  Some comments request 
that if o nsite audits are required, we should provide guidance regarding such audits.  
 (Response  136)  Importers will not be required to conduct onsite audits of potential 
foreign suppliers as part of the hazard analysis of a food under §  1.504(c)(3)(ii) of the fi nal rule.  
We have revised this hazard evaluation factor from the “condition, function, and design of the 
foreign supplier’s establishment and equipment” to the “condition, function, and design of the 
establishment and equipment of a typical entity that manufacture s/process es, grow s, harvest s, or 
raises  this type of food.”  This change is designed to make clear that importers must consider 
how a typical establishment and equipment used to manufacture/process , grow , harvest , or raise  
a food affect the hazard s in the food, rather than the potential effect of a particular foreign 
supplier’s operations.  (The requirement to consider a particular foreign suppli er’s performance 
is located in § 1.505 of the final rule, which sets forth the requirements for evaluati on for foreign 
supplier approval and verification .)  Importers can obtain information about the nature of 
establishments that produce a particular food and the equipment they use by consulting a number 
of sources of information other than audits.  Th ese may include, for example, trade journals and 180 
 
 
 other publications, academic literature, and materials obtained directly from potential foreign 
suppliers.   
 (Comment 137)  Some comments suggest that we substitute “expected use” for “intended 
or reasonably fore seeable use” because they believe  that the former is too vague to provide clear 
direction to importers and the Agency regarding compliance obligations.  
 (Response  137)  We decline this request.  Although we agree that the term “expected 
use” has the potent ial to communicate both intended and reasonably foreseeable use, we are 
concerned that the term might not be universally interpreted that way.  For example, an importer 
might interpret  “expected use” to mean “probable use” and consequently  not consider reasonably 
foreseeable uses as part of the hazard evaluation.  Therefore, we are retaining the term “intended 
or reasonably foreseeable use” to make it clear that an importer must consider use that  is 
reasonably foreseeable in addition to int ended  use.   
5.  Review of Another Entity’s Hazard Analysis  
We proposed to provide that if the importer’s foreign supplier had analyzed the known or 
reasonably foreseeable hazards for the food to determine whether there were any significant 
hazards, the im porter could meet its requirement to determine whether there were any significant 
hazards by reviewing and assessing the hazard analysis conducted by the foreign supplier 
(proposed §  1.504(d)).  
As described in  section s III.E.5, III.F. 4, and III.G.4  of this  document, we conclude that it 
is appropriate to allow importers to obtain certain information needed to meet their FSVP 
responsibilities from other entities , in some cases  in their supply chains , for the foods they 
import.  Therefore, we have revised §  1.504(d) to provide that if another entity (including the 181 
 
 
 foreign supplier) has, using a qualified individual, analyzed the known or reasonably foreseeable 
hazards for a food to determine whether there are any hazards requiring a control, the importer 
may me et its requirement to determine whether there are any hazards requiring a control for the 
food by reviewing and assessing the hazard analysis conducted by that entity.  The importer is 
also required to document its review and assessment of the other entity ’s hazard analysis, 
including documenting that the hazard analysis was conducted by a qualified individual.  
 (Comment 138)  Some comments assert that importers’ opportunities to rely on a hazard 
analysis conducted by the foreign supplier might be limited b ecause many suppliers would not 
want to share their hazard analys es. 
 (Response  138)  We recognize that, due to commercial confidentiality concerns or other 
reasons, there might be circumstances in which some foreign supplier s might be reluctant to 
share their hazard analyses of foods that importers seek to obtain from them.  However, we also 
believe that some foreign suppliers will desire to share their hazard analyses as a means of 
attracting customers for their products.  In  those cases, we want to provide importers with the 
flexibility to eliminate redundancy that would have occurred by not requiring the importer to 
conduct an independent hazard analysis when the foreign supplier has already conducted one.   
 (Comment 139)  One comment suggests that we substitute “food safety hazard” for 
“hazard” so importers do not conclude that they must address all types of hazards.  
 (Response  139)  We conclude that this change is unnecessary because this provision 
refers to another entity ’s analysis of known or reasonably foreseeable hazards for a food, and a 
hazard is specifically defined in the FSVP regulation as an agent that is reasonably likely to 
cause illness or injury if not controlled, i.e., it affects the safety of the food.  182 
 
 
 6.  Biological Hazards in RACs That Are Fruits or Vegetables  
We proposed to provide that an importer of a RAC that is a fruit or vegetable would not 
be required to determine whether there were any significant microbiological hazards in such food 
(proposed §  1.504(e) in the Supplemental Notice).  We stated in the preamble to the proposed 
rule that the hazard analysis requirements were not needed for RACs that are fruits or vegetables 
and that are subject to the regulation on produce safety in part 112 because FD A has already 
identified the biological hazards associated with fruits and vegetables and has proposed 
requirements for measures intended to prevent the introduction of these hazards into produce.  
 (Comment 140)  Several comments ask that we clarify propos ed § 1.504(e).  Some 
comments ask that we specify  that imported food is subject to the produce safety regulation 
when applicable, which would directly address the microbial hazards in the food.  The comments 
assert that biological hazards are very signific ant in some fruits and vegetables and importers 
should consider them.  The comments ask whether the provision is intended to apply to RACs 
that are fruits or vegetables that are not covered under the produce safety regulation.  Some 
comments ask that we cl arify how the FSVP and produce safety regulations work together.  
Some comments assert that all fresh produce must be subject to supplier verification, including 
evaluation of hazards, whether covered under the FSVP regulation or the produce safety 
regulat ion.  
 (Response  140)  We proposed to “exempt” importers of RACs that are fruits or 
vegetables that are “covered produce” (as that term is defined in  the produce safety regulation ) 
from having to analyze the micro biological hazards in such food.  Although proposed § 1.504(e) 
did not specifically state that the “exemption” from hazard analysis only applies when the 183 
 
 
 imported RACs are  “covered produce” as defined in proposed  § 112.3, the preamble to the 
proposed rule essentially stated that the exemption only applies in these circumstances and 
explained the reason for the exemption.  Specifically, the preamble explained that the ex emption 
is appropriate because  FDA has designed the produce safety regulation so that compliance with 
the regulation would ensure th at microbiological  hazards are adequately addressed .  (Although 
proposed § 1.504(e) refers to “microbiological” hazards, it should have referred to “biological” 
hazards because “hazard” is defined in both the proposed and final rules on produce safety as any 
“biological agent” that is reasonably likely to cause illness or injury in the absence of its control.)  
Indeed, the produce safety regulation  is intended  to minimize the risk of serious adverse health 
consequences or death from the introduction of known or reasonably foreseeable biological 
hazards in produce, and to provide a ssurance that fruits and vegetables are not adulterated 
because of such hazards.  To make this clear, we have revised §  1.504(e) to state that an importer 
of a RAC that is a fruit or vegetable is not required to determine whether there are any biological 
hazards requiring a control in such food only if the RACs are “ covered produce” as defined in 
§ 112.3 (i.e., produce that is subject to the produce safety regulation in accordance with §§  112.1 
and 112.2).    
In addi tion, we are clarifying that this partial  exemption from the hazard analysis 
requirements is appropriate because the biological hazards in such fruits or vegetables require a 
control and compliance with the regulation in part 112 significantly minimizes or prevents the 
biological hazards.  Althou gh importers of such RACs need not conduct a hazard analysis with 
respect to the biological hazards in this food, they must conduct supplier verification for the food 184 
 
 
 in accordance with §  1.506 of the final rule to ensure that all hazards in the RACs, incl uding 
biological hazards, are significantly minimized or prevented . 
 (Comment 141)  Some comments request that importers of RACs that are fruits or 
vegetables not be required to analyze non -biological hazards in the food.  The comments assert 
that there ha ve been no outbreaks linked to chemical or physical hazards in imported produce, no 
examples of EMA in fresh produce, and no chemical contamination of fresh produce at levels 
reasonably likely to cause illness.  The comments maintain that analyzing non-biological  hazards 
would be very burdensome because it would likely require a visit to the location in which the  
food is grown, and would be complicated by the seasonal nature of fruit and vegetable 
production and harvesting.  
 (Response  141)  We decline to make this change.  In the preamble to the proposed rule on 
produce safety (78 FR 3504 at 3524), we acknowledged that there can be non -biological hazards 
in produce, and a reference memorandum to that proposed rule provided an overview of the 
chemical, phys ical, and radiological agents that are reasonably likely to occur in produce at the 
farm and are capable of causing adverse health effects  (Ref. 13).  Our analysis of those hazards 
led us to conclude that they rarely pose a risk of serious adverse health c onsequences or death for 
consumers of produce, making it unnecessary to establish a new regulatory regime for their 
control  under section  105 of FSMA .  We stated that existing programs, such as the registration of 
pesticides with the Environmental Protecti on Agency (EPA) and State and industry efforts to 
control the presence of pesticides and mycotoxins in produce, are sufficient to keep these hazards 
under control.  We also noted that FDA monitors natural toxins, pesticides, industrial chemicals, 
other che mical contaminants, and radionuclides in food.  For these reasons, we tentatively 185 
 
 
 concluded that it was appropriate to limit the scope of the produce safety regulations to 
biological hazards and science -based standards necessary to minimize the risk of ser ious adverse 
health consequences or death associated with biological hazards (78 FR 3504 at 3524).  We have 
reaffirmed this conclusion in the final rule on produce safety published elsewhere in this issue of 
the Federal Register . 
Thus , although the produce  safety regulation  does not address non -biological hazards in 
fruits or vegetables, such hazards are sometimes associated with this food .  We  conclude that it is 
appropriate to require importers to determine whether there are any such hazards requiring a 
control in a fruit or vegetable they are importing  because section 805 of the FD&C Act requires 
importers to verify that produce is produced not only in compliance with the produce safety 
regulation issued in accordance with section 419 of the FD&C Act but also in accordance with 
section 402 , i.e., that it is not adulterated .  As we stated in the preamble to the FSVP proposed 
rule, we do not believe that the analysis of non -biological hazards will create a significant burden 
for importers of fruits and veget ables; importers will need to be aware of how a crop is produced 
and whether there have been non -biological hazards, such as pesticide residues, associated with 
it.  We believe that in many cases importers can obtain the information they need to assess non -
biological hazards from public sources, such as any regulations applicable to the control of such 
hazards, scientific literature, and information on FDA’s Web site (including guidance 
documents, import alerts, recall notices, warning letters, and untitled  letters), as well as 
information from the foreign suppliers themselves.   The consideration of chemical and physical 
hazards for RACs that are  fruits and vegetables is consistent with the requirements for these 
products under the regulation on p reventive controls for human food. 186 
 
 
  (Comment 142)  One comment notes that importers of produce must include chemical 
and physical contamination hazards when they analyze hazards in imported produce while 
domestic purchasers of produce need only confirm that the produce was produced in compliance 
with the produce safety regulation, which require s the control of biological hazards but not 
chemical or physical hazards.  The comment asserts that this constitutes inconsistent treatment of 
domestic and imported product s and may invite a challenge before the WTO.  
 (Response 142)  We do not agree.  The FSVP regulation do es not result in different 
treatment of foreign and domestic produce producers with respect to chemical and physical 
hazards in produce.  Although the pr oduce safety regulation do es not address such hazards, the 
presence of such hazards may cause produce --whether produced domestically or overseas --to be 
adulterated under section 402 of the FD&C Act.  Therefore, both domestic and foreign producers 
of produc e are prohibited from distributing produce contaminated with certain chemical and 
physical hazards, and domestic and foreign -produced produce is held to the same standard.   
 (Comment 143)  One comment suggests that instead of “fruits or vegetables,” the 
provision should refer to RACs that are “fresh, intact fruits, nuts, culinary herbs, or vegetables.”  
The comment maintains that this change is needed because many importers will not be aware of 
FDA’s scheme to distinguish RACs from processed foods and may not understand that the 
Agency considers fruits and vegetables to include nuts and culinary herbs.  The comment 
suggests a corresponding change to proposed § 1.504(f).  
 (Response  143)  We decline to make this change because the produce safety regulation 
refers to fruit s, nuts, culinary herbs, and vegetables collectively as “fruits and vegetables.”  We 187 
 
 
 believe it would be confusing, and could imply a different meaning, if we were to adopt a 
different term to capture the same set of food in th e FSVP regulatio n. 
 (Comment 144)  Some comments suggest that this provision state whether importers of 
RACs that are fruits or vegetables must analyze hazards other than biological hazards.  
 (Response  144)  We agree and have revised §  1.504(e) to specify that importers o f RACs 
that are fruits or vegetables must analyze hazards other than biological hazards in such food.  
7.  No Hazards Requiring a Control  
We proposed to provide, in §  1.504(f), that if an importer evaluates the known and 
reasonably foreseeable hazards in a food and determines that there are no significant hazards, the 
importer would not be required to determine what foreign supplier verification and related 
activities to conduct under §  1.505 and would not be required to conduct such activities under 
§ 1.506 .  We proposed that this provision would not apply if the food is a RAC that is a fruit or 
vegetable and that is subject to the produce safety regulation.  
Consistent with the change to § 1.504(e)  discussed in Response 140, we have revised 
§ 1.504(f) to sta te that it does not apply if the food is a RAC that is a fruit or vegetable that is 
“covered produce” as defined in §  112.3 in the produce safety regulation.  
(Comment 145)  Some comments assert that we should declare certain foods, such as 
chocolates, conf ectionery, jams, preserves, baked goods, and non -alcoholic beverages, to be safe, 
as the Agency has done with several products under the proposed rule on produce safety.  
(Response 145)  We are finalizing proposed § 1.504(f) because w e agree  that there are 
many  foods that have no hazards requir ing a control.  In the preamble to the proposed rule, we 
suggested salt and certain food -grade chemicals as examples of food for which, depending on the 188 
 
 
 circumstances, there might not be any hazards that would be reaso nably likely to occur.  Other 
examples of food for which there might  be no hazards requiring a control  include , but are not 
limited to,  many crackers, most bread, dried pasta, many types of cookies, many types of candy 
(e.g., hard candy, fudg e, maple candy, taffy, toffee), honey, molasses, sugar, syrup, soft drinks , 
and jams, jellies, and preserves from acid fruits .   
However, because many of these foods can be made using a variety of ingredients under 
different processes by different manufact urers, we decline to completely exempt these foods 
from the FSVP regulation by declaring them to be “safe.”  Rather, we conclude that it is 
appropriate to require importers to determine whether there are any hazards requiring a control in 
a particular food .  However, as previously stated, importers will be able to rely on hazard 
analyses conducted by other entitie s, including analyse s that find no hazards requiring a control 
in foods.  
 (Comment 146)  Some comments request that importers be required to reeva luate food 
and foreign supplier risks annually even when an importer determines that there are no 
significant hazards in a food.  
 (Response  146)  We do not agree.  Under §  1.505(c) of the final rule, importers will be 
required to reevaluate the risk posed by a food as well as a foreign supplier’s performance when 
the importer  becomes aware of new information about these matters (including new information 
about potential hazards), or at least every 3 years (see section III. F.3 of this document).  We 
conclude  that it is unnecessary to require more frequent reevaluation of the risks in a food and a 
foreign supplier’s performance for those foods for which an importer determines that there are no 
hazards requiring a control.  189 
 
 
  (Comment 147)  Some comments maintain  that proposed §  1.504(f) conflicts with 
proposed §  1.504(e), which exempts importers of RACs that are fruits or vegetables from having 
to analyze the biological hazards in such produce.  Some comments suggest that §  1.504(f) 
creates an assumption that the re are always significant hazards in fruits and vegetables subject to 
the produce safety regulation s. 
 (Response  147)  We do not believe that §  1.504(f) conflicts with §  1.504(e).  As we stated 
in the preamble to the proposed rule, this exception is approp riate because for such food the 
importer is not conducting a hazard analysis to identify the biological hazards that need to be 
significantly minimized or prevented .  If we did not specify that §  1.504(f) did not apply to 
RACs that are fruits or vegetables  that are covered produce , an importer of such food might 
mistakenly conclude that because it had determined that there were no non -biological hazards 
requiring a control in the food, the importer need not conduct supplier verification.  However, 
because there are presumed to be biological hazards associated with all fruits and vegetables  that 
are covered produce under  the produce safety regulation , even if there are no non -biological 
hazards in a fruit or vegetable, the importer must conduct supplier veri fication to obtain 
assurances that the food was grown and harvested consistent with the produce safety regulation 
and is not adulterated.  
8.  Hazards Controlled by the Importer or Its Customer  
In the Supplemental Notice, we proposed to provide (in §  1.504( g)) that if the preventive 
controls that the importer and/or its customer implement in accordance with the proposed 
preventive controls requirements  in subpart C of part 117 are adequate to significantly minimize 
or prevent all significant hazards in a foo d, the importer would not be required to determine or 190 
 
 
 conduct appropriate foreign supplier verification.  Proposed §  1.504(g) further stated that if the 
importer’s customer controlled one or more such hazards, the importer would be required to 
annually obt ain from the customer written assurance that it had established and was following 
procedures (identified in the written assurance) that would significantly minimize or prevent the 
hazard.  
As set forth in §  1.507 of the final rule and discussed in section I II.H of this document, 
we have broadened the circumstances under which certain importers are not required to conduct 
an evaluation under §  1.505 or supplier verification activities under §  1.506 whe n the hazard 
requiring a control in a food will be adequat ely controlled by another entity and certain other 
requirements are met.  We discuss those provisions and respond to the comments on proposed 
§ 1.504(g) in section III. H. 
F.  Evaluation for Foreign Supplier Approval and Verification (§ 1.505)  
In the Supplemental Notice, we replaced a proposed requirement that importers conduct a 
compliance status review of the food and foreign supplier with a requirement to evaluate the 
risks associated with a food to be imported (as determined in the hazard analysis for the food) 
and the potential foreign supplier of that food.  Although the comments generally support this 
more  comprehensive, “holistic” approach to selecting suppliers, several comments suggest 
changes regarding the proposed risk factors or the proposa l to require reevaluation of risk.   As 
discussed in the following paragraphs, we have made some relatively minor changes with respect 
to the proposed food and foreign supplier factors, and the final rule permits importers to rely on 
evaluations of  these factors  conducted by other  entities (except for the foreign supplier) , 
provided that the importer reviews and assesses the evaluation  and documents the review and 191 
 
 
 assessment .  In addition,  we have revised the provisions concerning reevaluation of th ese factors  
so that they take the place of the proposed requirements on FSVP reassessment.  
1.  Evaluation for Approving Suppliers and Determining Verification Activities  
 We proposed (in § 1.505(a) (1)(i) through (vi)) to require importers, in  determining t he 
appropriate supplier verification and related activitie s to conduct, to consider the following:  
•  The hazard analysis for the food  conducted under proposed §  1.504 , including the 
nature of the hazard.  
•  Th e entity that will be applying controls for th e hazards , such as the foreign supplier or 
the foreign supplier’s raw material or ingredient supplier.  
•  The foreign supplier’s procedures, processes, and practices re lated to the safety of the 
food.  
•  Ap plicable FDA food safety regulations and informati on regarding the foreign 
supplier’s  compliance with those regulations, including whether the foreign supplier is the 
subject of an FDA warning letter or import alert.  
•  The foreign supplier’s food safety performance history, including results from testing  
foods for hazards, audit results relating to the safety of the food, and the supplier’s record of 
correc ting problems.  
•  Any other factors as appropriate and necessary, such as storage and transportation 
practices.    
 We also proposed to require importe rs to document their risk evaluations.  
a.  General . 192 
 
 
  (Comment 148)  Some comments request that we define “risk” because some people 
might not understand the difference between “risk” and “hazard” as the terms are frequently 
interchanged in common usage.  One comment suggests that the regulations define “risk” as “the 
chance or probability that harm will occur, taking into account both the likelihood that a hazard 
will occur in the absence of controls to prevent it and the severity of the illness or injury that the 
hazard might cause.”  
 (Response  148)  Although we conclude that it is not necessary to include a definition of 
risk in the codified provision s, we agree that, i n the context of food safety  science , a risk is 
different from a hazard.  Although the regulations on preventive controls for human food and for 
animal food do not include a definition of “risk,” in those regulations we regard risk in the way 
that it is described in  the Codex Alimentarius , which  defines “risk” as “a function of the 
probabili ty of an adverse health effect and the severity of that effect, consequential to a hazard(s) 
in a food.”   Therefore, a risk posed by a food is the potential effect on health related to the 
hazards in the food.   
Because Codex defines risk in relation to inh erent food hazards only, rather than also 
considering the effect of actions by a producer or supplier of a food, we conclude that, to apply 
the term “risk” consistently throughout the FSMA regulations, § 1.505 of the FSVP regulation 
should not refer to the  “risks” posed by a foreign supplier.  Therefore, we have revised § 1.505 (a) 
so that it refers , in §  1.505(a)(1)(iii)(A) through (C) of the final rule,  to factors related to  the 
foreign supplier’s “performance” rather the “ risks” associated with  the foreig n supplier.  These 
factors, which we have not substantially changed in the final rule, are the supplier’s food safety -193 
 
 
 related processes and procedures, its compliance wit h FDA food safety regulations, and its f ood 
safety history with the importer  and others . 
 (Comment 149)  Several comments ask that we revise §  1.505(a)(1) to state that 
importers must consider the food and foreign supplier factors in deciding whether to approve a 
supplier, rather than  in selecting appropriate  supplier verification  activities.  
 (Response  149)  We do not agree  that the use of the factors should be limited in this way .  
Many comments assert  that factors such as a foreign supplier’s compliance status and contractual 
performan ce history can play an important  role in det ermining appropriate verification activities, 
such as in concluding that onsi te auditing on an annual basis of a highly -compliant foreign 
supplier is not n ecessary even when the supplier is providing foods with SAHCODHA hazards .  
Therefore, we conclude tha t it is appropriate that importers evaluate certain safety factors related 
to a food and the foreign supplier in deciding what supplier verification activities (and the 
frequency of such activities ) are needed  to provide adequate ass urance of the safety of  the food . 
Although  proposed §  1.506(a) stated that importers must have procedures to ensure that 
they import food only from foreign suppliers approved based on the evaluation conducted under 
proposed §  1.505 , we have revised § 1.505(a)(1) to make clear that an importer must conduct an 
evaluation of the foreign supplier’s performance and the risks posed by a food to both approve 
foreign suppliers and determine appropriate foreign supplier verification ac tivities.  
 (Comment 150)  Some comments ask that we revise § 1.505(a)  to give  importers the 
flexibility to consider only those  factors tha t they conclude  are appropriate for a particular food 
and foreign supplier.  As an example, one comment states that an importer typically would not 194 
 
 
 review a supplier’s FD A compliance history to determine a verification activity but might 
consider it later as part of the actual verification and qualification of the supplier.   
 (Response  150)  We decline to make this change.  We conclude that generally each of the 
factors s et forth in § 1.505(a) will be relevant to approving a foreign supplier for a particular 
food and to determining appropriate verification activities for the supplier.  If a particular factor 
is of little or no relevance with respect to a particular food an d foreign supplier, the importer 
might only need to brief ly consider that factor.   For example, an importer that has never obtained 
food from a potential foreign supplier would not have any direct “history” with that supplier; for 
a foreign supplier that has just begun exporting food and, therefore , would not have been 
inspected by FDA , there might not be any associated warning letters or other compliance -related 
documents.  However, w ith respect to a foreign supplier’s compliance with FDA food safety 
regulations, we believe that there would be very few circumstances in which this factor would 
not be relevant to deciding whether to approve a foreign supplier as a source of a food and 
selecting appropriate supplier verification activities.  
b.  Hazard analysi s. 
On our own initiative, we have revised § 1.505(a)(1)( i) to include the hazard analysis “of 
the food conducted under § 1.504 ” because , as discussed in section III. E.5 of this document,  
under §  1.504(d)  of the final rule an importer may review and assess a hazard an alysis conducted 
by another entity . 
 (Comment 151)  One comment states that, when considering the hazard analysis, the 
requirement to include the nature of the hazard should refer to the nature of the “hazard requiring 195 
 
 
 control” because importers  should evaluate supplier risks primarily as they relate to those 
hazards.  
 (Response  151)  We agree that referring to the nature of the hazard requiring a control is 
appropriate and have revised  § 1.505(a)(1 )(i) accordingly . 
c.  Entity applying controls . 
 (Comment 152)  Several comments express concern regarding the proposed requirement 
to consider the entity that will be applying hazard controls because it refers not only to the 
foreign supplier but to the foreign supplier’s raw material or ingredient sup plier (proposed 
§ 1.505(a)(1)(ii)) .  Several comments state that the importer’s responsibility to conduct supplier 
verification should be limited to its direct supplier’s compliance with applicable regulations, 
maintaining that this would be consistent wit h the Bioterrorism Act  requirements , which provide 
for the identification of the immediate non -transporter previous source and subsequent recipient.   
Some comments state that requiring importers to document the actions of their suppliers’ 
suppliers would require a major  change to the produce supply chain because the identity of a 
broker’s or aggregator’s suppliers often is proprietary information.  
 (Response  152)  We do not agree  that it is inappropriate to require importers to consider 
which entities control hazards, regardless of whether the entity is the foreign supplier, the foreign 
supplier’s supplier, or some other entity in the supply chain .  The records requirements of the  
Bioterrorism Act serve a different function and are not directly applicable to the scope of 
evaluations conducted in accordance with the FSVP provisions of FSMA.  Moreo ver, knowing 
the entity or entities that will be significantly minimizing or preventing  the hazards in a food is 
directly relevant to the type of foreign supplier or other verification activity that the importer will 196 
 
 
 need to conduct under § 1.506 or § 1.507 of the final rule.  For example, when a forei gn 
supplier’s raw material supplier is c ontrolling a hazard in a food that the importer obtains from 
the fo reign supplier, the importer might conclude that reviewing the foreign supplier’s records of 
verification t hat its supplier produced the raw material  in accordance with  the preventive contr ols 
or produce safety regulations is more appropriate than auditing the foreign suppl ier with respect 
to this hazard.   
In the final rule, we are revising §  1.505(a)(1)(ii) to require consideration of the entity or 
entities that will be significantly minim izing or preventing the hazards requiring a  control or 
verifying that such  hazards have been significantly minimized or prevented , such as the foreign 
supplier, the foreign supplier’s raw material or other ingredient supplier, or another entity in the 
importer’s  supply chain.  (The provision refers to significant minimization or prevention of 
hazards in accordance  with the change we are making to proposed § 1.506(c), discussed in 
section III. G.3 of this document.)  We conclude that this clarification is  needed to address 
circumstances such as when a foreign supplier grows produce but another entity performs certain 
activities, such as harvest ing the produce .  Entities that fit the definition of “farm,” such as 
harvester s, might be required to significant ly minimize or prevent hazards under the produce 
safety regulation .  To ensure that the importer  will meet  its obligation under s ection 805(a)(1) of 
the FD&C to perform supplier verification activit ies to verify that the imported food is produced 
in compli ance wi th sections 418 and  419, as applicable, and not adulterated under section 402  or 
misbranded under  section 403(w) , the importer must  evaluate which entities in the supply chain 
have either significantly minimized or prevented  the hazards or verified that the hazards  were 
significantly minimized or prevented .  The results of th is evaluation  might be a factor  in 197 
 
 
 determining (1) whether to approve the foreign supplier (the grower of the produce) or (2) the 
type and frequency of  verification activities.   Consequently, we conclude that importers must 
consider the entities that will be significantly minimizing or preventing  the hazards or verifying 
significant minimization or prevention of the hazards in the foods they import  as part of the 
evaluation condu cted for supplier approval and determination of supplier verification activities . 
d.  Foreign s upplier’ s safety procedures, processes, and practices . 
 (Comment 153)  Some comments express  concern about how the confidentiality of a 
foreign supplier’s food safety procedures, processes, and practices will be ensured, considering 
that some information regarding these matters might  include data of a commercially sensitive 
nature.  The comment s suggest that we revise these provisions  to respect  the right of foreign 
companies not to disclose confidential information to third parties  (the comment s raise  this same 
concern with respect to information regarding a foreign supplier’s food safety performance 
history under proposed § 1.505(a)( 1)(v) ). 
 (Response  153)  We decline to make this change.  As discussed in section III. K.6 of this 
document, under §  1.510(f) of the final rule, records obtained by FDA  in accordance with  the 
FSVP regulation will be subject to the public disclosure provisions in part 20  (21 CFR part 20) , 
including the protections against disclosure of trade secrets and commercial or financial 
information that is privileged or confidential .  How foreign sup pliers and importers choose to 
handle the issues surrounding the sharing of any confidential information with each other  is 
between those parties.   While we recognize that there might be some suppliers who are reluctant 
to provide information relevant to t he kind of verification activities required by this rule, we 198 
 
 
 believe that many suppliers will agree to such activities in order to facilitate the exportation of 
their products to the United States and access new customers.    
e.  Supplier’s compliance with  applicable FDA food safety regulations . 
On our own initiative, we have modified the proposed requirement to consider applicable 
FDA food safety regulations and the foreign supplier’s compliance with those regulations to 
address circumstances in which a po tential  foreign supplier is in a country whose food safety 
system we have officially recognized as comparable or determined to be equivalent to the U.S. 
system.   Section 1.505(a)(1)(iii)(B) of the final rule r equire s importers, when applicable, to 
conside r the relevant laws and regulations of a country whose food safety system we have 
officially recognized as comparable or determined to be equivalent  to that of the United States, 
and information relevant to the supplier’s compliance with those laws and re gulations.  This 
means that if an importer’s potential foreign supplier is located in a country whose food safety 
system we have officially recognized as comparable or determined to be equivalent (as discussed 
in section III.N of this document), the import er would consider, as part of its evaluation of the 
supplier, the supplier’s compliance with the laws and regulations of that country rather than its 
compliance with U.S. food safety law.  As discussed in section III.N, this reflects the nature of 
FDA reco gnition of the comparability of a foreign food safety authority in a systems recognition 
arrangement.  
(Comment 154)  Some comments express concern about the availability to importer s of 
information about  foreign suppliers’ compliance with FDA food safety regulations.  Some 
comments state that i nformation about warning letters and import alerts often is not available on 
the FDA W eb site in a timely manner and it can be difficult to navigate the Web site .  Some 199 
 
 
 comment s assert  that any requirement to consider foreign supplier compliance information 
should be limited to  information that is available on our Web site or to information that is 
publicly available .  One comment states that we should not require a prescriptive review of 
regulatory information unless we develop a system that allows importers to efficiently monitor 
new regulatory enforcement actions.  One comment asks that we consider developing  online 
databases that importers could use to obtain info rmation on foreign suppliers . 
 (Response  154)  We agree with the comments that the requirement to consider 
information on a foreign supplier’s compliance with applicable FDA food safety regulations --as 
well as information on the other factors in § 1.505(a) (1)--should be limited to information that is 
publicly availabl e or that the importer has otherwise been able to obtain (e.g., from a foreign 
supplier) .  We currently have searchable online databases for warning letters and import alerts; 
both of these dat abases are available to the public from our Web homepage at 
http://www.fda.gov.  Other relevant compliance -related information available on FDA’s Web 
site include s recall notices and notices of  suspensions of facility registration s.  We are  
considering ways to make this information more accessible to importers who will now be 
required to check the compliance history of their suppliers.  To make clear that an importer must 
consider such publicly available information, §  1.505(a)(1)(iii)(B) of  the final rule specifies that 
the applicable information includes whether the foreign supplier is the subject of  any “other 
FDA compliance ac tion related to food safety.”  We also note that, although the requirement to 
consider information on supplier co mpliance with applicable FDA food safety regulations is 
limited to publicly available information or information that the importer has otherwise  obtained , 200 
 
 
 if we became aware that an importer did not consider information that it had obtained  relating to 
a supplier’s FDA compliance, that would be a violation of the requirement.   
 (Comment 155)  Some  comment s assert that this provision shoul d be delete d because an 
importer’s evaluation of the food and the foreign supplier should focus on information pertainin g 
to risks identified in the imported food  rather than  the supplier.  The comment s note  that if a 
foreign supplier were subject to an FDA warning letter or import alert for a food other than the 
food the i mporter was importing, that information would not be relevant to the importer’s risk 
evaluation.  
 (Response  155)  We do not agree.   We conclude that evidence that a foreign supplier h ad 
received a warning letter or been placed on i mport alert with respect to a particular food, even a 
food different than t he food an importer is considering obtaining  from the foreign supplier, could 
be relevant to deciding  whether to source a food from the supplier.  In particular, a pattern of 
non-compliance, even if it did not involve the particu lar food that the importer sought  to obtain, 
should affect an importer’s decision on whether to approve a foreign supplier and, if so, what 
supplier verification activities would be appropriate with respect to this supplier.  
 (Comment 156)  Some comments suggest that the scope of da ta sources reviewed be 
expanded to include Food Facility Registration Module (FFRM) status, Reportable Food 
Registry (RFR) entries , and outcomes from recent FDA CGMP inspections . 
(Response  156)  In accordance with section 415(a)(5) of the FD&C Act regardin g 
disclosure of certain food facility registration information, information regarding whether a 
particular food facility is registered is generally not publicly available; however, as stated 
previously, FDA may publicize actions to suspend a facility’s registration, which would be 201 
 
 
 relevant information under §  1.505(a)(1)(iii)(B).  In addition, importers may obtain information 
about a foreign facility’s registration status from the foreign facility.  Information f rom the RFR 
that we make available in our RFR annual report s is generally not provided on a company -
specific basis.   Under section 417(h) of the FD&C Act  (21 U.S.C. 350f(h)) , a record in the RFR  
is subject to a request under the Freedom of Information Act (FOIA) (5 U.S.C. 552), except that 
FDA registration numbers and information derived from such registrations are protected from 
disclosure to the extent that they would disclose the identity or location of a specific registered 
person in accordance with sec tion 415(a)(5) of the FD&C Act.   In addition, confidential 
commercial information in such records is also protected from disclosure, and in many cases the 
name of the original producer of the food may constitute confidential commercial 
information.   We also generally do not proactively make available information related to FDA 
inspections of foreign suppliers, including Form FDA 483s and Establishment Inspection 
Reports  (EIRs) , although it is possible that an importer could obtain such information from a 
foreign supplier or from FDA through a FOIA request.  Any confidential commercial 
information, trade secret information, or other protected information in Form FDA 483s and 
EIRs that we provide through a FOIA request would be redacted (i.e., deleted) in acco rdance 
with the disclosure exemptions set forth in the FOIA  and FDA’s public information provisions in 
part 20 .   
f.  Forei gn supplier’s food safety history . 
 (Comment 157)  One comment suggests that, t o be consistent with the preventive 
controls regulatio ns and to avoid an implied requirement to perform testing and auditing, we 
should  revise proposed § 1.505(a)(1)(v) to state that a foreign supplier’s f ood safety performance 202 
 
 
 history “includ[es]  available information ” about results from testing foods for hazards, audit 
results relating to the safety of the food, and the supplier’s record of correcting problems.   One 
comment states that § 1.505(a)(1)(v) should not obligate an importer (or a foreign supplier 
through its importer) to provide FDA with details of an audit because this would have a chilling 
effect on the number of audits to which a supplier submits.  The comment asks that we revise 
§ 1.505(a)(1)(v) to refer to supplier performance history that is “relevant to  the intended use” of 
raw materials or ingredients and to make the provision consistent with the corresponding 
provision in the proposed  regulation on  preventive controls for animal food.  
 (Response  157)  We have revise d this provision (§  1.505(a)(1)(iii)( C) in the final rule) to 
make it consistent with the corresponding provisions in the p reventive controls regulations by 
specifying that the foreign supplier’s food safety history includes available information about 
results from testing foods for hazards, audit results relating to the safety of the food, and 
responsiveness of the foreign supplier in correcting problems .  We agree that 
§ 1.505(a)(1)(iii )(C) does not require importers to conduct additional testing or auditing, but 
rather requires them to cons ider the results of any such activities that the importer has conducted 
in assessing the performance of its supplier in eva luating or reevaluating the concern s associated 
with use of a particular supplier, including when considering obtaining an additional  food from 
an approved supplier.  We have not limited the requirem ent to consider only the supplier’s 
history with the importer that is “relevant to the intended use” of a food because some actions of 
a supplier, such as how quickly it has acted to address  safety problems that have emerged in food 
it has provided to an importer, do not necessarily relate to the intended use of a food  but are 
nevertheless important in assessing a supplier.  203 
 
 
 g.  Other factors as appropriate and necessary . 
 (Comment 158)  One comment encourages us to make it clear to FDA investigators that 
additional considerations, including transportation and storage practices, are not required in all 
cases and might not be reflected in importers’ records.  As an example, the comment notes th at 
some food additive and GRAS substance s do not require refrigeration and are stored and 
transported in sealed containers ; the comment  asserts that changes in those storage and 
transportation conditions would not create a significant hazard.  
 (Response  158)  We agree that it is possible that an importer might consider the nature of 
a food a s well as  a potential foreign supplier and appropriately conclude that there are no “other” 
factors that wi ll have a significant effect on (1) whether the importer shoul d approve th e use of 
the supplier or (2) what supplier verification activities might be appropriate with respect to 
assessing the safety of the food obtained from that supplier.  Regarding  the example provided in 
the comment, we agree that storage and tran sportation may not be relevant factors for foods that 
do not require refrigeration and that are stored and transported in sealed containers.  To the 
extent the comment is requesting a change to the codified to that effect, we do not believe  that is 
necessa ry. 
h.  Guidance on evaluating  food risk  and foreign supplier performance . 
 (Comment 159)  Several comments request that we develop guidance on the specific 
information that importers should consider under each factor in § 1.505(a)(1).  
 (Response  159)  We anticipate that the FSVP guidance, once finalized, will provide 
recommendations on the information that importers should consider for each factor in 
§ 1.505(a)(1).  204 
 
 
 2.  Approval of Foreign Suppliers  
Under proposed §  1.506(a), importers would be required to establish and follow written 
procedures to ensure that they import foods only from foreign suppliers approved based on the 
risk evaluation they conducted under proposed §1.505  (or when necessary and  appropriate, on a 
temporary basis from unapproved foreign suppliers whose foods they subject to adequate 
verification activities before using or distributing) .  Thus, there was an implicit requirement that 
importers “approve” their foreign suppliers on th e basis of the risk evaluation they conducted.  
Section 1.505(b) of the final rule makes this requirement clear by specifying that an importer 
must approve its foreign suppliers (and document the approval) on the basis of the evaluation the 
importer conduc ts under § 1.505(a) or the importer’s review and assessment of an evaluation 
conducted by another entity under § 1.505(d) (discussed in section III. F.4 of this document).  
3.  Reevaluation of Food Risks and Foreign Supplier Performance  
We proposed (in § 1.505(b))  to require importers to promptly reevaluate the risk  posed by 
a food and other  factors associated with a food or foreign supplier when the importer becomes 
aware of new informati on about these factors.  We further proposed that if an importer 
determine d that it was  appropriate to continue to import the food  from the foreign supplier, the 
importer would have to  document the reevaluation and its determination.  
 (Comment 160)  Some comment s suggest  that we delete  the proposed requirement to 
reeval uate risks in § 1.505(b) because importers would  be required to reevaluate the factors 
affecting food and supplier risks when they become aware of new information about these risks 
under the FSVP reasse ssment requirements in § 1.508  of the proposed rule .     205 
 
 
  (Response  160)  We agree that we should  eliminate potentially redundant requirements to 
reevaluate food risks and foreign supplier performance .  However, we conclude that we should 
do so by deleting the FSVP reassessment requirements in proposed § 1.508 and essentially 
placing those requirements in § 1.505  of the final rule .  We are taking this approach  because 
changes in the risk  posed by a  food or the performance of the foreign supplier  are the principal 
reasons why it might be necessary to reasse ss the appropriateness of an importer’s FSVP for a 
food and supplier .  Consistent with this approach , the final rule specifies, in § 1.505( c)(1), that if 
an importer becomes aware of new information about the food and supplier -related factors in 
§ 1.505(a) (1), the importer must promptly reevaluate the concerns associated with those factors 
and document this reevaluation.  Section 1.505(c)(1) further requires that if the importer 
deter mines that any of the matters addressed in the evaluation have  changed  (such as the 
emergence of a new hazard or a significant supplier compliance problem ), the importer  must 
promptly determine (and document) whether to continue to import the food from the foreign 
supplier and whether the verification acti vities it conducts need  to be c hanged.  Under 
§ 1.505( c)(2), if in any 3 -year period an importer has not reevaluated the food and supplier 
concerns on the basis of new information, the importer must conduct a reevaluation and take 
other appropriate actions, if necessary, in acco rdance with §  1.505 (c)(1).  The importer is 
required to document such a reevaluation and any subsequent actions it takes under 
§ 1.505 (c)(1).  
 (Comment 161)  One comment suggests that, in addition, to being required to document a 
determination (following a reevaluation of risks) that it is appropriate to continue to import a 206 
 
 
 food from a foreign supplier, importers should be required to document a determination to 
discontinue importing a food from a foreign supplier.  
 (Response  161)  We agree.  Because § 1.505(c)(1) of the final rule  requires importers to 
document their determination as to whether  to continue to import food from a foreign supplier , 
this would include a decision to discontinue use of a supplier.  
 (Comment 162)  Some comments suggest that importers should be required to conduct a 
reevaluation of food and suppli er risks annually  regardless of whether the importer becomes 
aware of new information about risks .  The comments maintai n that an annual reevaluation 
would not be overly burdenso me, adding that if no changes were required, the importer could 
simply note that  determination .  Regarding the proposed FSVP reassessment provisions, several 
comments maintain that, when an importer finds that there are no hazards in a food, the importer 
should be required to reassess the FSVP annually  because importers sometimes incorrectly 
determine that no hazards are present .  On the other  hand, several comments assert  that importers  
should not be require d to reassess the ir FSVP at least every 3 years  because this is not required 
by FSMA (unlike the requirement to reanalyze a food safety plan under FSMA’s preventive 
controls provisions) and would  not be risk-based because importers do not need to respond to 
changed conditions within a manufacturing facility , as is the case with facilities’ management of 
food safety plans . 
(Response  162)  We conclude that it is not necessary to require importers to conduct a 
reevaluation of the factors in §  1.505(a)(1) annually even when importers do not acquire new 
information about these factors.  We see no reason to establish a different requirement for when 
an importer has determined that there are no hazards in a food.  Instead, § 1.505( c)(2) of the final 207 
 
 
 rule requires importers to reevaluate the factors at least every 3 years.  Because importers also 
are required to conduct a reevaluation when they become aware of new information about the 
factors, we believe that the 3 -year minimum requirement to reevaluate the factors strikes an 
appropriate balance by provid ing adequate assurance that importers’ FSVPs will remain 
effectively risk -based without imposing an unnecessary burden on importers.  We believe that a 
requirement to reevaluate within  a defined period is necessary because some importers might fail 
to actively  seek information about potential food risks or supplier performance or fail to actually 
reevaluate these concerns when they become aware of relevant new information.  Because 
changes to food risks and supplier performance are not uncommon, we believe that  the 3 -year 
minimum reevaluation requirement likely will have little effect on those importers who are in 
compliance with the requirement to reevaluate the food and supplier  when they become aware of 
new information.  
 (Comment 163)  Regarding the proposed FSVP reassessme nt provisions, one comment 
expresses  concern about the suggestion in the preamble to the proposed rule that new 
information about potential hazards might include changes to the source of raw materials (78 FR 
45730 at 45761).  The comment sta tes that produce packing operations routinely source R ACs 
from numerous farms and it would be impractical for importers to reassess their FSVPs every 
time a new farm is used as a source of a RAC.  The comment asserts that the importer should 
only be expected to ensure that the foreign supplier has controls to qualify suppliers provid ing 
ingredients to the foreign supplier.  
 (Response  163)  We do not agree.  Obtaining a RAC from a new farm would necessitate 
conducting an evaluation under §  1.505(a) to determine whether it would be appropriate to 208 
 
 
 source  the RAC from the farm and, if so, what the appropriate foreign supplier verification 
activities for the farm should be.  However, as discussed in the following subsection of this 
document, the importer co uld rely on another entity (such as a distributor or consolidator in the 
supply chain for the RAC ) to conduct the evaluation of the risk of the food, the entity controlling 
the hazard , and the foreign supplier’s perform ance.  
4.  Review of Evaluation or Ree valuation by Another Entity  
 Consistent with the discussion in sections III.A. 7 and III. E.5 of this document, we 
conclude that it is appropriate to give importers the flexibility to either conduct their own 
evaluation of the risk posed by a food, the entit y that significantly minimizes or prevents hazards 
in a food  or verifies that the hazards have been significantly minimized or prevented , and the 
foreign supplier’s performance under § 1.505(a), or to rely instead on an evaluation conducted by 
another entity (other than the foreign supplier).  For example, an importer of oranges might rely 
on such an evaluation conducted by a firm that obtains oranges from many farms and exports 
them to the United States.  In this c ase, the aggregator of the oranges would evaluate the risk 
posed by the food and the performance of the individual farms in deciding whether to accept 
oranges from particular farms and in determining what supplier verification activities should be 
conducte d for each farm.  Therefore, §  1.505( d) of the final rule provides that if an entity  other 
than the importer (and other than the foreign supplier)  has, using a qualified individual, 
performed the evaluation described in §  1.505(a) or the reevaluation descr ibed in §  1.505( c), the 
importer may meet its requirement under the applicable provision by reviewing and assessing the 
evaluation or reevaluation conducted by the other entity.  If the importer relies on another 
entity’s evaluation or reevaluation, the im porter must document its review and assessment of that 209 
 
 
 evaluation or reevaluation, including documenting that the evaluation or reevaluation was 
conducted by a qualified individual.   
G.  Foreign Supplier Verification Activities (§ 1.506)  
 We proposed to r equire importers to conduct certain activities to verify that their foreign 
suppliers are producing food in a manner consistent with FDA requirements.  In response to 
comments we received, in the Supplemental Notice we issued changes to the proposed 
requir ements, including requiring importers to establish procedures to ensure the use of approved 
suppliers (rather than requiring importers to maintain a list of their supplier s) and changes 
regarding the manner and documentation of verification activities that  importers must conduct.  
As discussed in the following paragraphs, the final rule incorporates additional changes to the 
proposed verification activity provisions in response to comments.  
 In the final rule, we have added significant flexibility in perfor ming  supplier verification 
to reflect modern supply chains.  As with other FSVP requirements, we are allowing entities 
other than the importer to conduct supplier verification activities.  In general, entities other than 
the importer  (and other than the foreign supplier)  may conduct verification activities as long as 
the importer reviews and assesses the results of those activities.  This additional flexibility is 
consistent with the flexibility we are allowing with respect to hazard analysis and determin ation 
of verification activities  and is consistent with the flexibility afforded to receiving facilities 
implementing supply -chain  programs under  the preventive controls regulations.  To incorporate 
this flexibility and specify the importer’s ultimate resp onsibility, w e have made small revisions, 
like changing some of the verbs to passive voice (e.g., chang ing “evaluation you conduct” to 
“evaluation conducted” in § 1.506(a)) and adding short, clarifying phrases (e.g., chang ing “you 210 
 
 
 must establish and follow  written procedures for conducting appropriate foreign supplier 
verification activities” to “you must establish and follow adequate written procedures for 
ensuring that appropriate foreign supplier verification activities are conducted” in § 1.506(b)).  
We also have made small changes to make clear that the verification activities to which the 
importer subjects unapproved suppliers must take place before “importing the food” rather than 
before “using or distributing the food.”  
We also have made more signifi cant changes , such as adding provisions that explicitly 
allow an importer to rely on the following:  
•  A determination of appropriate foreign supplier verification activities made by an entity 
other than the importer (and other than the foreign supplier ) if the importer reviews and assesses 
whether the determination is appropriate (§ 1.506(d)(3)); and  
•  The performance of activities by an entity other than the importer (and other than the 
foreign supplier ) provided that the importer review s and assess es the results of these activities 
(§ 1.506(e)(2)).   
The supply -chain program requirements of the preventive controls regulations include 
corresponding versions of these provisions.  
 In addition, we have made changes to the terminology used in this section to reflect the 
change in § 1.505 from “risk evaluation” to “evaluation for foreign supplier approval and 
verification” and from “evaluation of food and supplier risks” to “evaluation of the  foreign 
supplier’s performance and the  risk posed by a food.”  Fin ally, as in other sections  of the final 
rule, we have made additional changes to the codified for consistency with the supply -chain  
program provisions of the preventive controls regulations.   211 
 
 
  These and other changes are described more fully in the paragr aphs that follow . 
1.  Procedures to Ensure Use of Approved Suppliers  
In the original proposed rule, we proposed to require importers to maintain a written list 
of foreign suppliers from which the importers obtain food.  In response to comments that 
maintai ning such a list would pose logistical or administrative burdens, in the Supplemental 
Notice we deleted this proposed requirement.  Instead, in accordance with several comments, we 
proposed (in revised § 1.506(a)) that importers be required to establish an d follow written 
procedures to ensure they import foods only from foreign suppliers they have approved based on 
the risk evaluation they conduct.  In addition, we proposed to allow importers, when necessary 
and appropriate, to obtain food from unapproved s uppliers on a temporary basis if the importer 
subjects the food to adequate verification activities before using or distributing it.  We also 
proposed that importers be required to document their use of these procedures.  
In the final rule, we have revised § 1.506(a) to reflect that an  entity other than the 
importer might  conduct the evaluation described in § 1.505.  In addition, we have deleted the 
word “risk” in the phrase “risk evaluation” when describing the evaluation conducted under 
§ 1.505 to reflect the terminology change in that section.  Finally, we have added §  1.506(a)(2) to 
explicitly allow an importer to rely on another entity  (other than the foreign supplier) to establish 
the procedures and perform and document the activities required in propos ed § 1.506(a) 
(finalized as § 1.506(a)(1))  to ensure that importers import foods only from foreign suppliers 
they have approved (or, when necessary and appropriate, on a temporary basis from unapproved 
foreign suppliers whose foods the importer  subject s to adequate verification activities before 
importing the food ), provided that the importer reviews and assesses that entity’s documentation 212 
 
 
 of the procedures and activities .  Section 1.506(a)(1) also requires  importer s to document  their 
review and assessment.   
a.  Use of approved suppliers . 
 (Comment 164)  Several comments express support for replacing the proposed 
requirement to maintain a list of foreign suppliers with a requirement to use procedure s to ensure 
the use of approved supp liers.  One comment questions how an importer would know whether a 
food is from an approved supplier if it did not have a list of such suppliers, and states that there is 
a need to ensure that an importer is using a complete, accurate, and updated approval  process.   
 (Response  164)  We agree that, whether through use of a single list, multiple lists, or 
some other mechanism, importers will need to adopt and follow procedures t o enable  them to 
confirm that the food they import is from suppliers they have ap proved in accordance with the 
evaluation conduct ed under § 1.505 (or, when necessary and appropriate, on a temporary basis 
from unapproved foreign suppliers whose foods importers subject to adequate verification 
activities before using or distributing) .  The procedures importers use will need to ensure that the 
importer can accurately identify approved suppliers and to reflect changes in such suppliers (e.g., 
addition of new approved suppliers, deletion of suppliers no longer deemed approved).   
 b.  Tempor ary use of unapproved suppliers . 
 (Comment 165)  Two comments suggest that, instead of referring to “unapproved” 
suppliers, the regulation should refer to foreign suppliers that are used on a “contingency” or 
“provisional” basis.  
 (Response  165)  We declin e to make this change.  The key feature of these suppliers is 
that they are not approved, thereby necessitating that the importer conduct or review and  assess  213 
 
 
 documentation of adequate verification of the food obtained from th e supplier before importing  
the food.  
 (Comment 166)  Some comments request that importers be given considerable flexibility 
to import from unapproved suppliers on a temporary basis.  One comment states that use of an 
unapproved supplier should be deemed “necessary and appropriate” as  long as the importer can 
provide a necessary and adequate reason to use the unapproved supplier.  
Some comments recommend that use of unapproved suppliers be restricted to a 
designated time period during which the importer must approve the supplier.  One c omment 
requests that we provide guidance on what constitutes “temporary” use of an unapproved 
supplier and on the circumstances under which use of an unapproved supplier might be 
appropriate.  
 (Response  166)  We agree that importers should have  some flexibility to import food 
from unapproved suppliers, particularly whe n unexpected circumstances arise that make it 
impossible for an importer to obtain a food from an approved supplier.  We continue to believe 
that these circumstances will be limite d.  Examples of circumstances in which  the use of an 
unapproved supplier on a temporary basis would be “necessary and appropriate” include a 
problem with a long -standing supplier due to an equipment breakdown or an environmental or 
weather -related crisis ( e.g., severe drought or flooding).  Because the importer would be unable 
to immediately fully evaluate the potential supplier, the importer would need to take other steps 
to verify that the food obtained from the unapproved supplier is safe.  We also agree  that the use 
of unapproved suppliers is only appropriate on a temporary basis, though we decline to specify a 214 
 
 
 particular time limitation on such use, given that the appropriate time period might vary 
depending on the circumstances.  We intend to provide a dditional guidance on these issues.  
 (Comment 167)  Some comments state that the importer should be required to follow 
guidelines on their “conditional” approval procedures and conduct a reassessment of their hazard 
analysis for the food.  
 (Response  167)  It is unclear what the comments mean by “guidelines,” but we do intend 
to provide guidance on the temporary use of unapproved suppliers.  An importer does not  
necessarily  need to reanalyze hazard s when using an unapproved supplier unless the nature of the 
food or the hazards associated with the food have changed.  The hazard analysis relates to the 
type of food being imported and is not necessarily relate d to the particular supplier providing the 
food.  
 (Comment 168)  One comment states that it should not be necessary to require 
verification of food from an unapproved foreign supplier if other importers have imported the 
same food from that supplier.  
 (Response  168)  An importer must subject food from an unapproved foreign supplier to 
adequate verification  activities before importing  the food, but the importer does not need to 
perform the verification activities itself.  As previously described, while the importer is 
ultimately responsible for compliance with the requirements in § 1.506 , other entities may 
perform certain key activities as long as the importer reviews and assesses documentation of 
those activities.  Consistent with this approach, if one importer has already conducted 
appropriate verification activities (e.g., sampling and testing) for a foo d from a foreign supplier, 
another importer could, depending on the specific circumstances, review and assess that 215 
 
 
 documentation in lieu of conducting the activities itself .   In accordance with § 1.503, the 
individual performing the verification activitie s must be a qualified individual.   
(Comment 169)  Some comments suggest activities that importers should be permitted to 
conduct to verify food from unapproved foreign suppliers before using or distributing the food.  
These activities include the following :  Obtaining certification that a food is produced in 
accordance with good agricultural practices or good manufacturing practices; testing the 
imported food; obtaining a certificate of analysis; and obtaining an official verification “result” 
from the expo rting country, the foreign supplier, or FDA.  One comment maintains that it is 
likely that verification procedures for an unapproved supplier would be similar to the procedures 
used to verify an approved supplier and should be based on the importer’s hazar d analysis.  
 (Response  169)  We agree that food verification activities under §  1.506(a)(1) should be 
based, at least in part, on the hazard analysis conducted under § 1.504.  The adequacy of the 
verification activities will vary depending on the food, the  hazard, and the nature of the control, 
as well as information that the importer may have about the supplier.  Depending on the 
circumstances, it may be appropriate for an importer to review and assess a certificate , test the 
imported food, obtain a certif icate of analysis, obtain information from the exporting country or 
other relevant government authority, or conduct some other verification activity . 
 (Comment 170)  One comment asks that we issue guidelines to direct importers to first 
consider domestic s uppliers before seeking to obtain a food from an unapproved foreign supplier.   
 (Response  170)  We do not agree.  Such a directive would be beyond the scope of section 
805 of the FD&C Act, which requires importers to take appropriate steps to ensure that the food 
they import is safe . 216 
 
 
  c.  Documentation of use of procedures to ensure use of approved suppliers . 
 (Comment 171)  One comment suggests that, instead of having to document use of 
procedures to ensure importation of food from approved suppliers, an importer should be 
required to provide evidence to FDA upon request that the importer is using these procedures.  
 (Response  171)  We do not agree with this suggested change.  If an importer did not 
document its use of these receipt -from -approved -supplier p rocedures, it is unclear how it would 
be able to demonstrate to FDA investigators that it had actually followed such procedures.  
2.  Written Procedures for Foreign Supplier Verification  
We proposed to require importers to establish and follow adequate written procedures for 
conducting foreign supplier verification activities with respect to the foods imported.  The 
comments generally support this requirement, which we are finalizing  in § 1.506(b)  of the final 
rule.   
 (Comment 172)  One comment asks that we consider providing model verification 
activity procedures that importers could use.  
 (Response  172)  We intend to provide general guidance on complying with this 
requirement.  However, it is unlikely that we will be able to provide model verification activity 
procedures for all foods, hazards, and suppliers.  In addition to guidance, we will conduct 
outreach to assist importers in complying with the final rule.  
3.  Purpose of Supplier V erification  
We initially proposed to require that importers’ foreign supplier verification activities 
provide adequate assurance that identified hazards are adequately controlled (proposed 
§ 1.506(c)).  In response to comments that the proposal was inconsis tent with the statute and was 217 
 
 
 improperly limited to hazard control, in the Supplemental Notice we revised the proposed 
requirement to specify, consistent with section 805(a)(1) of the FD&C Act, that foreign supplier 
verification activities must provide ade quate assurances that the foreign supplier produces the 
food in compliance with processes and procedures that provide the same level of public health 
protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, 
and produc es the food in compliance with sections 402 and 403(w) of the FD&C Act.  
As discussed in response to the following comment, i n the final rule we are returning to 
an approach to supplier verification activities similar to what we had originally proposed, in part 
to align the FSVP regulation with the supply -chain provisions of the preventive controls 
regulations.  We also are chang ing the first word in § 1.506(c)  to refer to  “The ” foreign supplier 
verification activities rather than “Your” activities  to reflect the flexibility we are providing with 
respect to the entity who must conduct supplier verification activities.    
 (Comment 173)  Several comments express support for the revised proposed purpose of  
supplier verification activities.  However, o ne comment states that the purpose of verification 
activities should be as originally proposed, while one comment states that FSVPs should be 
designed to ensure that the foreign supplier is producing food in compliance with sections 402 
and 403(w), which t he comment contends would more closely align the FSVP requirements with 
domestic requirements.  
 (Response  173)  Upon consideration of the comments on this revised provision as well as 
the need to align the FSVP regulation with the supply -chain provisions o f the preventive controls 
regulations, the final rule requires that foreign supplier verification activities provide assurance 
that the hazards requiring a control in imported food have been significantly minimized or 218 
 
 
 prevented.  This requirement is consis tent with the corresponding requirement in the preventive 
controls regulations, i.e., that the “supply -chain program must provide adequate assurance that a 
hazard requiring a supply -chain applied control has been significantly minimized or prevented” 
(see §§ 117.410(c) and 507.110(c)).  As stated in the FSVP proposed rule and the Supplemental 
Notice, alignment with the preventive controls regulations is appropriate to avoid imposing 
redundant  requirements (because entities may be both registered food facilities subject to the 
preventive controls regulations and food importers subject to the FSVP  regulation ).  In addition, 
we conclude that this modification is consistent with the hazard identif ication framework of the 
final rule.  Under the final rule, importers are required to comprehensively analyze and evaluate 
hazards requiring a control (see §§ 1.504 and 1.505).   Requiring such analysis and evaluation 
makes the most sense if the supplier v erification activities performed in accordance with § 1.506 
are designed to specifically address the hazards that importers have identified and evaluated.    
However, we emphasize that t his change regarding the requirement  of supplier 
verification activiti es in § 1.506(c) does not alter the  fundamental purpose of importers’ FSVPs .  
Consistent with section 805(c)(2)(A)  of the FD&C Act , § 1.502(a) of the final rule directs  
importer s to develop, maintain, and follow FSVPs that  provide adequate assurances that their 
foreign supplier s produce the imported food in compliance with processes and procedures  that 
provide the same level of public health protection as those required under sections 418 and 419 
of the FD&C Act  (if applicable) and the implementing regulati ons, as well as assurances that 
their suppliers are producing food that is not adulterated or misbranded with respect to allergen 
labeling .  The requirement of supplier verification in § 1.506(c) does not change the requirement 
in § 1.502(a) but instead sp ecifies what we co nclude is an appropriate and functional  measure for 219 
 
 
 gauging whether foreign supplier verification activities can provide the statutory assurances of 
food safety.  In short, we conclude that conducting activities to verify that hazards requiring a 
control have been significantly minimized or prevented will serve as an effective mechanism  for 
providing assurance that a foreign supplier is producing food in compliance with the preventive 
controls or produce safety regulations (when applicable) and that the imported food is not 
adulterated or misbranded with respect to allergen labeling.  
The requirement of supplier verification in § 1.506(c) encompasses situations in whi ch 
hazards are significantly minimized or prevented directly by a foreign supplier as well as when  
hazards  are addressed  by entities in an importer’s supply chain other than the foreign supplier.  
When  an entity other than the foreign supplier is significa ntly minimizing or preventing  the 
hazards  in a food , an importer would need to  conduct supplier verification activities to ensure 
that its foreign supplier is verifying that the hazard is being significantly minimized or prevented  
or otherwise verify that the other entity is significantly minimizing or preventing  the hazard.   
As previously discussed, one situation in which an entity other tha n the foreign supplier 
significantly minimizes or prevents the hazards in a food is when produce growing  and 
harvest ing operations are performed by different business entities.  When the foreign supplier of 
produce is the grower and another entity that is subject to the produce safety regulation performs 
certain activities such as  harvesting , an importer might review applicable records maintained by 
the harvester, such as records of training for harvest workers and records related to  agricultural 
water quality used in harvest operations .  The importer would review such records for hazards 
not being significantly minimized or prevented by the grower  of the produce .  As discussed 
elsewhere, we are allowing various entities to determine, conduct, and document verification 220 
 
 
 activities that apply to foreign suppliers, provided that the importer reviews and assesses 
applicable documentation provided by that entity and documents the review and assessment.  To 
satisfy the requirements of § 1.506(c), an importer could obtain documentation of review by 
another entity of applicable records maintained by the harvester or packer  and also review and 
assess the entity’s documentation (and document that review and assessment).  
 (Comment 174)  One comment asks whether verification activities also should provide 
assurance of supplier compliance with sections 416 (concerning sanitary transportation) and 420 
(concerning intentional adulteration) of the FD&C Act  (21 U.S.C. 350e and 350i, respectively) . 
(Response 174)  We address specifics about the responsibilities of shipping facilities and 
receiving facilities under section 416 of the FD&C Act in the 2014 proposed rule on sanitary 
transportation (79 FR 7006 , February 5 , 2014 ).  We will address comments regarding the 
responsibilities of shippers and receivers in the final rule on sanitary transportation.  However, 
because the sanitary tr ansport procedures that we proposed in accordance with section 416 are 
focused on shipment by rail and motor vehicle within or into the United States, th at regulation, if 
finalized as proposed, would generally not be applicable to transport in foreign coun tries.  For 
the purpose of supplier verification under the FSVP regulation, whether evaluating transportation 
practices is necessary will depend on the particular supplier and the particular food being 
imported.  If certain transportation practices  could lead to hazards , an importer would need to 
verify that such hazards are significantly minimized or prevented .   
With respect to intentional adulteration, hazards that may be intentionally introduced by 
acts of terrorism are the subject of the 2013 proposed rule on intentional adulteration (78 FR 
78014, December 24, 2013) that we issued to implement section 420 of th e FD&C Act.  Under 221 
 
 
 the FSVP regulation, importers need only consider hazards that are known or reasonably 
foreseeable.  This means that importers are not required to consider purely speculative hazards.  
However, there may be circumstances in which intenti onal adulteration may present a known or 
reasonably foreseeable hazard, so part of providing assurance that the hazards in a food have 
been significantly minimized or prevented might , depending on the circumstances, include 
ensuring that the food is not in tentionally adulterated.  In those circumstances, importers may 
include intentional adulteration in their hazard evaluation and conduct appropriate verification 
activities for that hazard.   One way an importer could do that would be to review a foreign 
supplier’s vulnerability assessment and, if applicable, their plan under the intentional 
adulteration regulation (once finalized), documenting the measures the supplier would take to 
mitigate vulnerability to intentional adulteration.  
 (Comment 175)  Two comm ents contend that asking importers to conduct verification 
activities to provide assurances that the foreign supplier is producing food in compliance with 
processes and procedures that provide the same level of public health protection as those 
required un der the preventive controls or produce safety regulations is unrealistic because there 
are no established standards for determining “same level of public health protection.”  One 
comment requests more clarity on the meaning of “same level of public health protection.”  
 (Response  175)  As stated in Response 17 3, § 1.506(c) of t he final rule does not specify 
that importers must  conduct supplier verification activities to provide assurances that the foreign 
supplier is producing food in compliance with process es and procedures that provide the same 
level of public health protection as those required under the preventive controls or produce safety 
regulations.  In addition, w e responded to comments requesting clarity regarding the nature of 222 
 
 
 processes and procedu res that will provide the same level of public health protection in Response 
99.  As previously noted, our draft guidance on FSVP s will include recommendations on how 
importers should assess foreign suppliers’ processes and procedures to determine whether they 
provide the same level of public health protection as those required under the preventive controls 
or produce safety regulati ons. 
 (Comment 176)  One comment suggests that th e requirement to conduct activities to 
provide certain assurances be revised to refer only to food that will not be subject to further 
processing (including a pathogen mitigation  or kill step) because when a  food will be subject to 
further processing, the FSVP regulation should not apply.  
 (Response 176)  We do not believe that this change is necessary.  When a food will be 
subject to further processing by the importer under the preventive controls regulation s, the 
importer will be deemed to be in compliance with most, but not all, of the FSVP requirements if 
the importer is required to establish and implement a risk -based supply -chain  program under the 
preventive controls regulations for the imported food and  is in compliance with those 
requirements.  In other circumstances involving further processing of a food in the United States, 
the importer might import the food in accordance with § 1.507, as discussed in section III.H of 
this document.  
 (Comment 177)  Several comments maintain that the revised proposed rule continues to 
suggest that the primary purpose of supplier verification is control of hazards.  The comments 
maintain that FDA should recognize that importers’ records might not show  a listing of each  
hazard and corresponding verification activity.   223 
 
 
  (Response  177)  We agree that importers will not be required to separately document the 
verification of each individual hazard in an imported food .  The FSVP requirements generally do 
not require documentation of individual hazards and their controls, but rather require 
documentation with respect to the food and the foreign supplier of the food (e.g., a hazard 
analysis for a type of food, a food and supplier evaluation, verification activities appr opriate for a 
food and the supplier).  On the other hand, some circumstances might necessitate documentation 
related to a single particular hazard, such as when the importer determines that there is only one 
hazard in a food and the importer documents this  determination and its determination regarding 
appropriate supplier verification activities for the food .  In addition, when a SAHCODHA hazard 
in a food will be controlled by the foreign supplier, the importer must conduct or obtain 
documentation of an ons ite audit of the foreign supplier before initially importing the food and at 
least annually thereafter, unless the importer makes an adequate written determination that, 
instead of such initial and annual onsite auditing, other supplier verification activi ties conducted 
under §  1.506(e)(1) and/or less frequent onsite auditing are appropriate to provide adequate 
assurances that the foreign supplier is producing the food in accordance with § 1.506(c).  
4.  Foreign Supplier Verification A ctivities  
 In the Supplemental Notice, we revised our proposed approach to requirements for 
foreign supplier verification activities in several ways.  We discuss the c omments on these 
changes and other aspects of the proposed supplier verification activity requiremen ts in the 
following paragraphs.  
 For clarity, § 1.506(d)(1)( i) of the final rule states that an importer must determine and 
document which verification activities, as well as the frequency with which the activity or 224 
 
 
 activities must be conducted, to provide  adequate assurances that the food the importer obtains 
from the foreign supplier is produced in accordance with § 1.506(c).  To reflect changes we are 
making to § 1.506(c), we have revised § 1.506(d)(1)( i) to specify that verification activities must 
address the entity or entities that are significantly minimizing or preventing  the hazards or 
verifying that hazards  have been significantly minimized or prevented  (e.g., when an entity other 
than the grower of produce subject to part 112 harvests or packs the  produce, or when the foreign 
supplier’s raw material supplier prevents  a hazard).  The determination of appropriate supplier 
verification activities must be based on the evaluation of the food and foreign supplier conducted 
under § 1.505.  Section  1.506(d )(1)(ii) specifies  appropriate supplier verification activities:  
onsite audits, sampling and testing, review of the foreign supplier’s relevant food safety records, 
and other supplier verification activities determined to be appropriate.  The addition of this list of 
appropriate supplier verification activities is to aid understanding of the requirements and is not a 
substantive change from the proposed rule.   
 We also have added § 1.506(d)(3) to explicitly allow an importer to rely on a 
determination of appropriate foreign supplier verification activities (including the frequency with 
which such activities must be conducted) by another entity in an importer’s supply chain.  To 
take advantage of this provision, an importer must review and assess whether th e entity’s 
determination is appropriate based on the evaluation conducted in accordance with § 1.505.  In 
addition, the importer must document the review and assessment, including documenting that it 
was made by a qualified individual.  
 Section 1.506(e) of  the final rule, regarding the performance of foreign supplier 
verification activities, is generally the same as proposed § 1.506(d)(1) , with certain changes to  225 
 
 
 provide more flexibility  to importers .  Section  1.506(e)(1) requires the importer to conduct and 
document (or obtain documentation of) supplier verification activities in accordance with the 
determination made under §  1.506(d) and sets forth documentation requirements for these 
activities.  Section 1.5 06(e)(2) explicitly allows an importer to rely on the performance of 
verification activities by other entities as long as the importer reviews and assesses the results of 
the verification activities in accordance with § 1.50 6(e)(3), and documents the revie w and 
assessment.     
Section 1.506(e)(3) makes clear that importers must promptly review and assess the 
results of supplier  verification activities and document the review and assessment.  This 
provision also requires  that if the results of the verificati on activity do not provide adequate 
assurances that the hazards in the food from the foreign supplier have not been significantly 
minimized or prevented , the importer must take appropriate action in accordance with § 1.508(a) 
of the final rule (concerning corrective actions).  Finally, because we do not believe that it is 
necessary  for public health for the importer itself to retain documentation of supplier verification 
activities conducted by other entities, § 1.506(e)(3) does not require the importer to retain this 
documentation, provided that it can  obtain the underlying documentation and make it available to 
FDA upon request, in accordance with the recordkeeping provisions in §  1.510(b).    
We have reflected importers’  greater flexibility in meeting sup plier verification 
requirements by adding various phrases throughout § 1.506 .  For example, we are changing “you 
must conduct and document one or more . . . supplier verification activities” in § 1.506(e)(1) to 
“you must conduct (and document) or obtain do cumentation of one or more . . . supplier 
verification activities.”  Similarly, in § 1.506(e)(1)(ii), documentation of sampling and testing 226 
 
 
 must include documentation that the testing was conducted by a qualified individual.  We added 
this to ensure that e ven if the importer itself is not conducting sampling and testing, the sampling 
and testing must be performed by a qualified individual.   
In addition, as a general matter, the final rule does not allow foreign suppliers to perform 
verification activities of themselves because of the potential for a conflict of interest (codified in 
§ 1.506(e)(2)(ii)).  However, we recognize that many suppliers have onsite sampling and testing 
regimes that are reliable, and we see no need to require an importer to duplicate  those efforts.  
Therefore , § 1.506(e)(2)(ii) allows an importer to rely on sampling and testing of food conducted 
by a foreign supplier as long as the other criteria for the verification activity are met.  We 
emphasize that it is still the importer’s resp onsibility to ensure that the verification activities 
conducted for a particular food and foreign supplier are appropriate.   
We also have added flexibility to the verification activity of reviewing a foreign 
supplier’s relevant food safety records.  Secti on 1.506(e)(1)(iii) provides that when reviewing a 
foreign supplier’s relevant food safety records is the appropriate verification activity, 
documentation must include the conclusions of the review.  This change helps to ensure that an 
importer has all the  information it needs to review and assess the documentation if the importer 
is relying on another entity to conduct the records review , and  is consistent with the 
documentation requirements for other verification activities.  
We have made additional change s to the verification activity provisions  as described in 
the following paragraphs . 
 a.  Verification activity requirements . 227 
 
 
 In the proposed rule, we requested comment on two alternatives for supplier verification 
activity requirements.  “Option 1” would h ave established certain requirements for SAHCODHA 
hazards to be controlled by the foreign supplier, and different requirements for non -
SAHCODHA hazards and SAHCODHA hazards that the foreign supplier verified had been 
controlled by its raw material or ingre dient supplier.  “Option 2” would have required the 
importer to determine the supplier verification activity it would use for all hazards that the 
foreign supplier controlled or for which it verified control.   
Under Option 1, for a SAHCODHA hazard that wa s to be controlled at the foreign 
supplier’s establishment, the importer would have been required to conduct and document initial 
and subsequent periodic (at least annual) onsite audits of the foreign supplier.  For non -
SAHCODHA hazards to be controlled by  the foreign supplier and all hazards for which the 
supplier verified control by its raw material or ingredient supplier, Option 1 would have required 
that the importer conduct one or more of the following activities:  onsite auditing of the foreign 
suppli er, periodic or lot -by-lot sampling and testing of the food, review of the foreign supplier’s 
food safety records, or some other procedure established as being appropriate based on the risk 
associated with the hazard.  
On the other hand, Option 2 of the ori ginal proposal would have allowed the importer to 
determine, for all hazards either controlled by the foreign supplier or for which the foreign 
supplier verified control by its supplier, which of the previously listed verification activities 
would be appro priate to verify that the hazard was adequately controlled.   
We received many comments that supported Option 1 for supplier verification activities 
and many that supported Option 2.  In the Supplemental Notice, we proposed an approach to 228 
 
 
 supplier verifica tion activity requirements that is a hybrid of the original proposal’s Option 1 and 
Option 2.  We proposed to establish a general rule under which an importer would be required to 
conduct and document one or more of the previously listed supplier verificat ion activities for 
each foreign supplier before using or distributing the food and periodically thereafter.  Importers 
would be required to use the risk evaluation they conduct to determine which verification activity 
or activities are appropriate and the frequency with which those activities must be conducted.  
However, with respect to foods with a SAHCODHA hazard that would be controlled by the 
foreign supplier, the importer would be required to conduct or obtain documentation of an onsite 
audit of the fo reign supplier before initially importing the food and at least annually thereafter, 
unless the importer documented a determination, based on the risk evaluation, that instead of 
initial and annual onsite supplier auditing, some other supplier verification  activities and/or less 
frequent onsite auditing would be appropriate to provide adequate assurances of safety.  We are 
finalizing the requirement as proposed in the Supplemental Notice.  
 (Comment 178)  Several comments support the revised approach to supplier verification 
activity requirements because they believe that it will provide flexibility to importers to 
determine appropriate supplier verification steps based on the importer’s assessment of th e risks 
posed by the food and supplier.  However, several comments oppose the lack of a mandatory 
onsite auditing requirement for SAHCODHA hazards.  One comment states that granting 
flexibility to importers might lead to confusion and place additional resp onsibility on FDA staff 
for validating an importer’s verification methods.   
 (Response  178)  We believe that giving importers the flexibility to tailor their supplier 
verification activities to unique food risks and supplier characteristics more closely a ligns with 229 
 
 
 the statutory requirement  that importers perform risk -based verification activities.  We continue 
to believe that annual audits would be appropriate for many foods and suppliers, particularly 
when there is a SAHCODHA hazard in a food.  However, we think that even when there is a 
SAHCODHA hazard in a food, it is possible that an importer might reasonably conclude that 
because of its supplier’s excellent compliance and performance history, annual audits are not 
needed to ensure the safety of the fo od.  An importer who chose to conduct an alternative activity 
in these circumstances would need to maintain documentation that the activity provides adequate 
assurances of safety, and this documentation would be available for FDA review during any 
inspecti on of the importer or review of the importer’s records.  
 (Comment 179)  One comment suggests that the FSVP supplier verification provisions 
cross -reference the supplier program provisions in the preventive controls regulations as a way 
of aligning the rule s. 
 (Response  179)  We have strived to make the FSVP supplier verification requirements  as 
consistent with the preventive controls regulations’ supply -chain program provisions  as is 
feasible and appropriate .  For ease of reading and to facilitate a compreh ensive understanding of 
the FSVP requirements, we set forth those requirements  in one place --subpart L of part 1 --rather 
than require the reader to switch back and forth between subpart L of part 1 and part 117 or part 
507 (the preventive controls regulations) through the use of cross -references.   
However, a s previously stated, § 1.502(c) of the final rule applies to  importers that are 
receiving facilities who are in compliance with certain  provisions in part 117 or part 507.  Th us, 
this provision does refer to the supply -chain  program provisions in the preventive controls 
regulations.  230 
 
 
  (Comment 180)  Some comments as k that we provide guidance on how to determine 
whether a hazard is a SAHCODHA hazard and differentiate such hazards from significant 
hazards.  Some comments request that we provide guidance on circumstances under which 
verification activities other than an nual onsite auditing would provide adequate assurance of 
safety when there is a SAHCODHA hazard in a food.  
 (Response  180)  As discussed in section III.A. 11 of this document, we have replaced the 
term “significant hazard” with the term “hazard requiring a control.”  A hazard requiring a 
control is a known or reasonably foreseeable hazard for which a person knowledgeable about the 
safe manufacturing, processin g, packing, or holding of food would, based on the outcome of a 
hazard analysis, establish one or more controls or measures to significantly minimize or prevent 
the hazard and components to manage those controls or measures (see the definition of “hazard 
requiring a control” in §  1.500).  All SAHCODHA hazards require a control, but not every 
hazard requiring a control has the potential to result in serious adverse health consequences or 
death.  For additional information on how we interpret the SAHCODHA st andard, see our 
guidance  on the RFR  (Ref. 1 4), which addresses statutory requirements for “reportable foods.”  
As explained in that guidance, a “reportable food” is an article of food (other than dietary 
supplements or infant formula) for which there is a reasonable probability that the use of, or 
exposure to, such article of food will cause SAHCODHA.  The guidance includes examples of 
circumstances under which food might be reportable .   
 (Comment 181)  One comment asks that we provide guidance on how impo rters should 
verify that their foreign suppliers are verifying the safety practices of their raw material or other 
ingredient suppliers.  231 
 
 
  (Response  181)  As stated in the preamble to the proposed rule, an importer might rely on 
a review of its foreign supp lier’s food safety records to verify that the foreign supplier is 
verifying that its raw material or other ingredient supplier is controlling a hazard in the raw 
material or other ingredient.  For example, because a foreign supplier that is subject to the 
supply -chain program requirements under the preventive controls regulations would be required 
to have documentation (e.g., audit results) of its program for  verification of its raw material 
supplier as part of its compliance with those regulations , an impo rter obtaining food from that 
supplier might review this documentation in conducting verification of the supplier .  However, 
the FSVP regulation give s importers flexibility to choose the most appropriate verification 
activity for the circumstance.  
 (Commen t 182)  One comment maintains that importers should have discretion as to 
whether to include the results of supplier  verification activities as part of official activities.  
 (Response  182)  To the extent that the comment suggests that importers may disregard 
the results of supplier verification activities, we do not agree .  Importers have the flexibility to 
determine appropriate verification activities based on the food and supplier evaluations they 
conduct, but they may not disregard the results of those activities.  Instead, importers must 
review such results and document the review and assessment.  If the results do not provide 
adequate assurances that the imported food is produced in accordance with the standards in this 
rule, the importer must ta ke appropriate corrective action in accordance with §  1.508.   
 (Comment 183)  Some comments suggest that, i f there is no mandatory requirement for 
annual onsite auditing, importers should be required to affirmatively inform FDA if they 232 
 
 
 determine that veri fication activities other than annual auditing are appropriate, and the Agency 
should specify the documentation required to justify the use of such activities.  
 (Response  183)  We do not believe that an affirmative reporting requirement is 
warranted.  When  we inspect importers and review their records to determine compliance with 
the FSVP regulations , we will review the importer’s documentation o f the determination of 
appropriate verification activities.  We believe that our ability to conduct inspections a nd review 
records provides appropriate tools to ensure compliance.  The appropriateness of the justification 
for a given verification activity will depend on the particular food and supplier.  We intend to 
provide general guidance on the requirements in th is rule, but given the rule’s flexibility, we will 
be unable to specify particular documentation required for every circumstance.   
 (Comment 184)  Some comments ask that we make clear that an importer is allowed to 
rely on activities performed by others i nstead of activities that it has itself conducted.  
 (Response  184)  We agree and have changed the codified to specify that an importer may 
either conduct (and document) foreign supplier verification activities or obtain documentation of 
verification activities conducted by others (e.g., the results of a third -party audit o f a foreign 
supplier) (§ 1.506(e)(1)).  In addition, as discussed previously, §  1.506(e)(2) permits an importer 
to rely on the results of verification activities performed by other entities (other than the foreign 
supplier) .  The importer remains ultimatel y responsible for the performance of appropriate 
supplier verification activities.  
b.  Need for multiple supplier verification activities . 
We proposed to specify, in § 1.506(d)(3), that based on an importer’s risk evaluation  of a 
food and foreign supplier , it might be necessary for the importer to conduct more than one 233 
 
 
 supplier verification activity to address an individual hazard or risk factor or multiple hazards or 
risk factors.  
 (Comment 185)  One comment recommends that we  delete this provision because  it is 
confusing and contrary to other provisions.  
 (Response  185)  We have deleted this provision as redundant because §  1.506(d) and (e) 
of the final rule require the performance of multiple foreign supplier verification activities when 
it is determined,  based on an evaluation of the hazards in a food and foreign supplier 
performance in accordance with § 1.505, that conducting more than one activity is necessary to 
provide adequate assurances of safety . 
c.  Requirements for food from certain farms, facili ties, and egg producers . 
In the Supplemental Notice, we proposed to require that if a foreign supplier of a food is 
a farm that is not subject to the produce safety regulation in accordance with § 112.4 regarding a 
food being imported, the importer would not need to comply with the standard supplier 
verification activity requirements if the importer did the following:  
•  Documented, at the end of each calendar year, that the food provided by the foreign 
supplier was not subject to the produce safety regula tion; and  
•  Obtained written assurance, at least every 2 years, that the foreign supplier was 
producing the food in compliance with the FD&C Act.  
We stated that this modified supplier verification activity was appropriate because FDA had 
determined that this food did not pose a sufficient risk to public health that it needed to be 
subject to the standard produce safety requirements .   234 
 
 
  We are finalizing modified requirements applicable to the importation of food from a 
farm  that grows produce and is not a  covered farm under the produce safety regulation in 
accordance with certain provisions .  In addition, we are adding provisions that provide for 
modified requirements applicable to the importation of food from a qualified facility, as defined 
under the pre ventive controls regulations, or a shell egg producer with fewer  than 3,000 laying 
hens.  These requirements, which are included in the modified FSVP requirements in §  1.512  of 
the final rule, are discussed in section III. M of this document.  
d.  Substituti on of results of certain inspections for onsite auditing . 
We proposed to permit importers to rely  on, instead of an onsite audit of a foreign 
supplier, the results of an inspection of the foreign supplier by FDA or the food safety authority 
of a country wh ose food safety system FDA has officially recognized as comparable or has 
determined to be equivalent to that of the United States, provided that the inspection was 
conducted within 1 year of the date by which  the onsite audit would have been required to b e 
conducted (proposed §  1.506(d)(5)).  For inspections that were conducted by the food safety 
authority of a country whose food safety system FDA has officially recognized as comparable or 
determined to be equivalent, we proposed that the food that was the  subject of the onsite audit 
would have to be within the scope of the official recognition or equivalence determination, and 
the foreign supplier would have to be in, and under the regulatory oversight of, that country.  
 (Comment 186)  Some comments oppose  the proposed provisions allowing for the 
substitution of the results of certain inspections for onsite audits of foreign suppliers.  The 
comments assert that an FDA inspection might not assess the relevant lines or processes, there 
might not be timely acc ess to inspection results, and the proposed rule does not establish 235 
 
 
 parameters for the results of such inspections.  The comments are concerned that foreign 
suppliers might not allow their importers to audit their facilities for FSVP purposes if the 
suppli er had been subject to an FDA inspection in the last year.  
 (Response 186)  We decline to delete this provision.  We believe that  inspection results 
likely will  be available  to importers  on a timely basis, and a lack of timely access in some  cases  
would  not warrant  entirely eliminating the opportunity to rely on inspection results.  In addition, 
we believe it is unlikely that there would be many foreign suppliers willing to risk losing 
customers by refusing to be audited because they had recently been inspected by FDA.  
However, we have made certain change s that we believe address some of the concerns of the 
comments.  To clarify the scope of this provision (which we have moved to § 1.506(e)(1)(i)(E) 
so that it is part of the requirements for onsite audits), we have added language specifying the 
food safety  standards that an inspection must address, whe n the inspection is not conducted by a 
food safety authority in a country whose food safety system FDA has officially recognized as 
comparable or equivalent.  In those cases, an importer may rely only on the w ritten results of an 
appropriate inspection of the foreign supplier for compliance with applicable FDA food safety 
regulations.  If another authority’s inspection does not assess  compliance with FDA food safety 
regulations, the other authority’s inspection  would not, as a general matter, substitute for an 
onsite audit.   
We have also revised who can perform such inspections to include representatives of 
other Federal agencies (such as the USDA) and representatives of State, local, tribal, or territorial 
agencies.  These entities are all part of FDA’s Integrated Food Safety System, and their inclusion 
in § 1.506(e)(1)(i)( E)(1) adds flexibility to the rule.  Although representatives of foreign 236 
 
 
 governments are not included in this provision, they are still a ble to conduct onsite audits for 
FSVP purposes as long as they are qualified auditors and they consider applicable FDA food 
safety regulations.  Importers may rely on such audits to satisfy the requirements of this rule if 
the audits provide a basis for th e importer to determine that the foreign supplier used processes 
and procedures that provide the same level of public health protection provided by the preventive 
controls or  produce safety reg ulations, as applicable, and produces  the food in compliance wi th 
requirements concer ning adulteration and misbranding with respect to allergen labeling.   
However, f or inspections conducted by the food safety authority of a country whose food 
safety system FDA has officially recognized as comparable or determined to b e equivalent, the 
food safety authority need not inspect for compliance with relevant FDA standards.  Under 
§ 1.506(e)(1)(i)(E)(2) of the final rule, p rovided that the food that is the subject of the onsite 
inspection or audit is within the scope of the of ficial recognition or equivalence determination, 
and the foreign supplier is in, and under the regulatory oversight of , the country  with the 
comparable or equivalent food safety system , the inspection or audit may inspect for compliance 
with the standards that FDA has recognized as comparable or equivalent.      
 (Comment 187)  One comment asks that we  provide information on how we will make 
available to importers the results of inspections of foreign suppliers by FDA and comparable 
foreign authorities.  
(Response  187)  As a routine matter, we do not intend to proactively make available the 
results of all foreign inspections, either to importers or other members of the public.  However, 
under the FOIA  and FDA’s implementing regulations in part 20, members of the public 
(including importers) may submit requests for records in FDA’s files, including records of 237 
 
 
 foreign food establishment inspections.  In accordance with FOIA, FDA generally makes those 
records available, except to the extent those records are c overed by one or more of the nine 
exemptions enumerated in the statute (5  U.S.C. 552(b)).   
Importantly, exemption 4 of FOIA  protects from mandatory disclosure trade secrets and 
confidential  commercial  information  (5 U.S.C. 552(b)(4)).  In addition, sectio n 301(j) of the 
FD&C Act  requires withholding of trade secret information from the public, and the Trade 
Secrets Act also prohibits disclosure of trade secrets and confidential  commercial  information  
unless specifically authorized by law  (see 18 U.S.C. 190 5).  Accordingly, when we receive FOIA  
requests for foreign inspection reports that are intended for public disclosure (as opposed to 
requests submitted by the foreign establishment itself) , ordinarily we will redact  trade secret and 
confidential  commercial  information  before we release the materials to the public.  Given the 
restrictions on our ability to provide unredacted inspection reports for public disclosure, we 
recommend that an importer directly ask the foreign supplier for a copy of the r esults of any 
government inspection of that foreign supplier .   
 (Comment 188)  Some comments recommend that importers be permitted to rely on the 
results of an inspection of a supplier by FDA or a comparable/equivalent food safety authority 
for longer tha n 1 year after the date that the onsite audit would have been required to be 
conducted.  One comment states that under National Organic Program (NOP) regulations, an 
organics certificate is valid until withdrawn, usually up to 18 months after the issue dat e; 
therefore, the comment recommends that the FSVP regulations allow for reliance on an 
inspection for at least 15 months post -issue date.  The comment adds that if we cannot permit 
this, we should require auditing firms to change the way they conduct busi ness, such as by 238 
 
 
 issuing a document on the date of the audit acknowledging its completion and (if applicable) the 
absence of critical findings.  Other comments ask that we change the period in which the 
inspection needs to have been conducted to within 2 o r 3 years of the date by which  the importer 
determined that an onsite audit was appropriate.  
(Response  188)  We disagree with these comments.  We are allowing the specified 
inspection results to be substituted for an onsite audit because we believe that s uch inspections 
may provide an importer with information on the foreign supplier’s food safety practices that is 
sufficiently similar to information that can be obtained from an onsite audit.  In addition, use of 
such inspection results may lessen the burde n of conducting supplier verification activities by 
eliminating the need for an onsite audit.  At the same time, we believe that requiring the 
inspection to have been conducted within 1 year of the date that the onsite audit would have been 
required to be conducted is appropriate to ensure that any inspection provides relevant and 
meaningful information that is similar to the information that could be obtained from an audit.  
Allowing the inspection to be conducted more than 1 year from the date an audit wo uld have 
been required would make it more likely that the inspection would address different processes 
and procedures from what an audit would have addressed.   
As one comment notes, NOP organic certificates are valid until withdrawn (either 
suspended or r evoked for cause by the certifying agent or voluntarily surrendered by the certified 
operation), although it is incorrect to suggest that certificates are valid up to 18 months  after 
issuance.  Regardless , NOP inspections serve a different function from ons ite FSVP audits.  
Unlike onsite FSVP audits, NOP inspections do not address whether  the processes and 
procedures of foreign food producers provide the same level of public health protection as 239 
 
 
 sections 418 and 419 of the FD& C Act, and that foreign food is produced in accordance with 
sections 402 and 403(w) of the FD&C Act, as applicable.  Regarding the comment suggesting 
that if we do not allow for more than a 1 -year period, we should instead require auditing firms to 
change the way they conduct business, such as by issuing a document on the date of the audit 
acknowledging its completion and (if applicable) the absence of critical findings, such a request 
is beyond the scope of this rulemaking.  Th e FSVP regulation does not im pose any requirements 
on audit firms, and we do not believe it is necessary to do so in order to efficiently enforce 
Congress’ directive in section 805 of the FD&C Act to ensure that imported food is as safe as 
domestically -produced food.  However, nothing  in this rulemaking would preclude audit firms 
from changing the way they conduct business as the comment suggests, though it is unclear how 
such a change would be helpful to the importer in meeting the requirements of this rule.  
 (Comment 189)  One commen t asks that we explain what is regarded as a food safety 
authority of a country whose food safety system FDA has officially recognized as comparable or 
determined to be equivalent.  
 (Response  189)  In section III. N of this document we discuss our systems r ecognition 
initiative, under which are assessing food safety systems in other countries to determine whether 
they provide a similar system of protections as that provided under the U.S. food safety system 
and therefore can be officially recognized as compa rable to the U.S. system.  We also discuss 
food safety equivalence determinations.  In response to the specific comment, a systems 
recognition agreement would specify the relevant food safety authority for the country under a 
particular agreement.  240 
 
 
  (Commen t 190)  One comment requests that we accept a State inspection of a foreign 
supplier as an audit, suggesting that the Manufactured Food Regulatory Program Standards and 
other programs could be used to evaluate State programs as equivalent food safety autho rities.  
 (Response  190)  As stated previously, we have changed § 1.506(e)(1)(i)(E)( 1) to allow an 
importer to rely on the results of an inspection of a foreign supplier conducted by officials from 
State, local, tribal, or territorial food safety authoritie s.  As discussed in section III.N  of this 
document, systems recognition only applies to foreign countries.   
5.  Review of Results of Verification Activities  
We proposed to require importers to promptly review the results of their foreign supplier 
verification activities and, if the results of the review showed that the risks for the food or foreign 
supplier were not adequately controlled, to take appropriate corrective action (proposed 
§ 1.506(d)(6)).  This requirement is codified in §  1.506(e)(3) of the final rule , with the following 
changes to ensure consistency with other supplier verification activity provisions:  
•  Importers must promptly review and assess the results of verification activities that 
they conduct (or obtain documentation of) or that other entities conduct.  
•  Importers must document their review and assessment.  
•  Importers must take appropriate action under § 1.508(a) if the results of verification 
activities do not provide adequate assurances that hazards requiring a control ha ve been 
significantly minimized or prevented.  
•  Importers are not required to retain documentation of verification activities conducted 
by other entities provided that they can obtain such documentation and make it available to FDA 
in accordance with §  1.510(b) . 241 
 
 
  (Comment 191)  One comment requests that we delete the requirement to review results 
promptly.  The comment maintains that this requirement is too prescriptive and that importers 
should have the flexibility and discretion to review results in a ti mely manner.  
 (Response  191)  We do not agree.  We believe that it is reasonable and appropriate to 
require importers to promptly review the results of their verification activities so that they can 
determine whether the results suggest that there is a pro blem with a supplier and, if so, take steps 
to address th e problem on a timely basis.   In the absence of any such review, the verification 
activities would not serve their intended purpose of ensuring the safety of imported food, as 
contemplated by section  805 of the FD&C Act.  
6.  Documentation and Other Requirements for Supplier Verification Activities  
 In response to concerns primarily regarding the documentation of foreign supplier audits 
that importers would be required to retain and make available to FDA investigators, in the 
Supplemental Notice we added provisions specifying the content of documentation of importers’ 
supplier verification activities.  We also proposed other requirements regarding how these 
activities should be conducted.  
 (Comment 192)  One comment recommended that we not establish specific requirements 
regarding the format of required documentation.  
 (Response  192)  We agree.  The regulations we have adopted do not specify a particular 
format in which documentation of supplier verific ation activities must be recorded.   
 (Comment 193)  Some comments express concern that importers might have limited 
access to qualified auditors and appropriately certified laboratories ; the comments  recommend 242 
 
 
 that we provide training and certification opportunities.  One comment states that we should 
require auditors to be trained and certified to U.S. standards.     
 (Response  193)  We do not have plans  to provid e training and certification opportunities 
for qualifie d auditors .  (We note that, under §  1.500 of the final rule, examples of potential  
qualified auditor s include  (but are not limited to ) an audit agent of a certification body (also 
known as a third -party auditor) that has been accredited under subpart M of part 1 (FDA’s 
regulations implementing the third -party certification provisions of FSMA ).)  We believe there 
are many opportunities for auditing training available in the private sector, particularly for third -
party auditors.  We do not agree that auditors  must be trained and certified “to U.S. standards” if 
this refers to being trained by FDA .  What is important is that audits conducted for FSVP 
purposes be conducted by qualified auditors, who are qualified individuals who have the 
technical expertise obta ined through education, training, or experience (or a combination thereof) 
necessary  to perform onsite auditing to meet FSVP requirements , and that the audits be 
conducted in accordance with the requirements for such audits in §  1.506(e)(1)(i) of the final 
rule, discussed in section III.G.4 of this document.       
 (Comment 194)  Several comments state that FDA should specify which verifica tion 
activities and corrective actions must be recorded and the circumstances under which the records 
must be made available or submitted to the Agency.  
 (Response 194)  As specified in § 1.506(e)(1), except for when an importer relies on 
performance of ac tivities by other entities in accordance with § 1.506(e)(2), importers must 
document the supplier verification activities they conduct.  If an importer relies on verification 
activities conducted by another entity, the importer is not required to retain do cumentation of 243 
 
 
 those activities, provided that it can obtain the documentation and make it available to FDA in 
accordance with § 1.510(b).  In addition, any corrective action taken in accordance with § 1.508 
must be documented.  Under § 1.510(b) (1), import ers must make FSVP  records available 
promptly to an authorized FDA representative, upon request, for inspection and copying .  In 
addition,  under §  1.510(b)(3),  upon our written request, importers must send records to us  
electronically or through other prom pt means .  For more information about the circumstances 
under which records must be made available or submitted to FDA, see the discussion of §  1.510 
in section III.K.3 of this document.  
 a.  Onsite auditing . 
In the Supplemental Notice we acknowledged the concerns that having to make full 
reports of onsite audits of foreign suppliers available to FDA would make suppliers reluctant to 
be audited or result in less robust audits, and we agreed that importers should not be required to 
retain full audit reports.   Instead, we proposed  (in § 1.506(d)(1)(i)) that importers be required to 
retain documentation of audit procedures, the dates the audit was conducted, the conclusions of 
the audit, any corrective actions taken in response to significant deficiencies ident ified during the 
audit, and documentation that the audit was conducted by a qualified auditor.  We also proposed 
to retain the provision in the proposed rule requiring, for food subject to one or more FDA food 
safety regulations, that an onsite audit consi der those regulations and include a review of the 
supplier’s written food safety plan, if any, and its implementation.  In addition, we proposed to 
require that an onsite audit of a supplier be performed by a qualified auditor.  
Section 1.506(e)(1)(i)(B) of  the final rule  includes the requirement that an onsite audit of a 
foreign supplier of a food subject to one or more FDA food safety regulations consider those 244 
 
 
 regulations and include a review of any food safety plan and its implementation.  However, as  
previously discussed, we recognize that there might be circumstances in which a company 
imports a food from a supplier in a country whose food safety system FDA has officially 
recognized as comparable or determined to be equivalent to that of the United S tates, but the 
modified requirements for certain food from certain suppliers in such countries in § 1.513 of the 
final rule do not apply.  To account for these circumstances, § 1.506(e)(1)(i )(B) of the final rule  
specifies that, when applicable, an onsite audit may consider relevant laws and regulations of a 
country whose food safety system FDA has officially recognized as comparable or determined to 
be equivalent.   
 (Comment 195)  Some comments request that audits that are conducted to meet FSVP 
requiremen ts by auditors accredited under the third -party auditing regulations that FDA is 
developing under section 808 of the FD&C Act should not be required to meet the proposed 
requirements for audits conducted under that regulation, including the requirements to  submit the 
audit reports to FDA and to report serious findings to the Agency.  The comments assert that 
applying such requirements to audits conducted for FSVP by third -party auditors accredited 
under the FDA system would create a disincentive to use such  auditors to meet FSVP 
requirements.  
 (Response 195)  As we have stated in public meetings regarding the FSVP proposed rule, 
we will not require that audits conducted to meet FSVP requirements by third -party auditors 
accredited under FDA’s third -party cert ification  regulation  (in subpart M of part 1)  meet the 
requirements for audits conducted under that regulation, which is set forth in a final rule 
published elsewhere in this issue of the Federal Register .  The only audits that must meet the 245 
 
 
 requirements o f the third -party certification regulation are regulatory audits performed for the 
purposes of the issuance of (1) certifications required for participation in the Voluntary Qualified 
Importer Program (VQIP) under section 806 of the FD&C Act (21 U.S.C. 384 b) and (2) 
mandatory import certifications under section 801(q) of the FD&C Act , as well as consultative 
audits conducted in preparation for a regulatory audit .  To make clear that those auditing 
requirements do not apply to audits conducted solely for FSV P purposes, §  1.506(e)(1)(i)(C) of 
the FSVP final rule states that if an onsite audit is conducted solely to meet FSVP requirements 
by an audit agent of a certification body that has been accredited under the third -party 
certification regulation, the audit  is not subject to th at regulation.  
 (Comment 196)  Noting that facility certifications  issued by accredited third -party 
auditors are  required for participation in VQIP , one comment questions whether there is a 
difference  in the scope of audits conducted to meet FSVP requirements and audits conducted in 
accordance with FDA’s third -party certification  regulation.  The comment asserts  that while 
proposed §  1.506(d) would require that audits conducted to meet FSVP requirement s consider all 
FDA food safety regulations, audits conducted in accordance with the proposed third -party  
certification  regulation must determine a facility’s compliance with the FD&C Act.   The 
comment asks what accredited third -party audits will entail giv en that the FD&C Act addresses 
more than just food safety requirements.  
 (Response  196)  The scope of accredited third -party audits conducted in accordance with 
the third -party certification regulation is addressed in the final rule  on third -party certific ation 
published elsewhere in this issue of the Federal Register  (see Response 7 in the preamble to the 
final rule) .   246 
 
 
  (Comment 197)  Several comments address the standards that we will require onsite 
audits of foreign suppliers to meet.  Some comments rec ommend that when third -party audits are 
used, FDA should require that audits be conducted in accordance with nationally or globally 
accepted standards, such as schemes that are benchmarked in accordance with the Global Food 
Safety Initiative ( GFSI ).  One comment recommends that we take into consideration audits 
conducted by recognized auditing firms and certification  bodie s.  One comment suggests that for 
fruits and vegetables, good agricultural practice (GAP) and good manufacturing practice (GMP) 
certificates issued by independent third -party certification bodies accredited by competent 
authorities should be accepted.  One comment states that audits conducted to meet FSVP 
requirements should be held to the same standards as audits performed domestic ally.  One 
comment maintains that some private food safety auditing standards provide the same level of 
public health protection as the FSMA standards.  
(Response  197)  We agree that audits conducted to meet FSVP requirements should be 
held to the same stan dards as audits performed domestically for the purpose of supplier 
verification.   To the extent that the results of GFSI, GAP, or any other audit schemes 
appropriately verify that the foreign supplier produces the food consistent with FDA food safety 
stand ards, importers may use audits conducted under those s chemes  to meet the requirements of 
the FSVP regulation.   We understand that, as of the publication of this document, many of the 
widely used food safety audit ing schemes are considering whether and how to revise their 
practices in light of the requirements of FDA regulations, including our new FSMA 
regulations.   We further understand that the updating of schemes is a lengthy process that often 
involves engagement with experts and other stakeholders.   Therefore, we believe it is premature 247 
 
 
 to reach any definitive conclusions as to whether importers can rely on the results of audits 
conducted under any existing audit ing schemes to verify compliance with the safety 
requirements of this rule.   Over time, we ex pect that scheme owners and benchmarking 
organizations will develop tools to assess their schemes against FDA requirements to 
demonstrate the levels of health protection their schemes provide.   We believe there is value in 
such efforts and foresee possible  implications for the Agency’s work.   Until such time, if an 
importer chose s to use a GFSI, GAP, or other similar audit, the importer might  need to 
supplement that audit to meet the requirements of § 1.506  or otherwise determine that the audit 
meets the requirements of this section .  Even after scheme owners and benchmarking 
organizations update their tools to reflect the new FDA food safety requirements, it will remain 
the importer’s responsibility to dete rmine whether the results of any particular audit are adequate 
to conclude that a foreign supplier produces a food in accordance with the standards required by  
this rule.  
 (Comment 198)  One comment states that the WTO Agreement  on Technical Barriers to 
Trade (TBT Agreement) encourages WTO members to reduce multiple certification and testing 
requirements by entering into mutual recognition agreements  to facilitate trade.   The comment 
also suggests that we adopt a regulatory scheme similar to that in the jui ce and seafood HACCP 
regulations in parts 120 and 123, including allowing foreign government officials to conduct 
verification audits of suppliers.  
 (Response 198)  Because t he FSVP regulation  is a food safety measure and therefore are 
not subject to  the T BT Agreement,  the provisions in the TBT Agreement regarding mutual 
recognition agreements do not app ly.  We agree that reducing multiple testing and certification 248 
 
 
 requirements for food safety is an important guiding principle, and the FSVP regulation  does not 
impose multiple testing and certification requirements on suppliers.  The FSVP regulation 
provide s importers with flexibility to determin e appropriate supplier verification activities and 
allow s multiple importers to rely on the same results of auditing, testing, and other verification 
measures.  We believe that as importers and foreign suppliers become more familiar with the 
FSVP requirements, more suppliers are likely to arrange to be audited a nd share the audit results 
with multiple U.S. importers.  
We agree that it is appropriate to allow foreign government officials to 
conduct  audits.   Under the final rule, onsite audits must be performed by qualified auditors.   As 
we discussed in section III. A.18 of this document, foreign government employees may be 
qualified auditors, and the standard for being a qualified auditor does not differ when the audit is 
performed by a foreign government employee.  We see no reason why an importer could not rely 
on an audit of a foreign supplier conducted by a foreign government employee with appropriate 
technical expertise obtained through  education, training, and /or experience, as long as the foreign 
official  considers applicable FDA food safety standards.  The imp orter could rely on such an 
audit to meet the requirements of this rule if the audit allows the importer to determine whether 
the foreign supplier uses processes and procedures that provide the same level of health 
protection provided by the produce safety  or preventive controls regulations, as applicable, and 
produces the food in compliance with sections 402 and 403(w) of the FD&C Act, as applicable.   
At this time, we do not envision establishing a program to recognize individuals as meeting the 
definition  of qualified auditor for the purposes of FSVP.   However, we intend to conduct 
outreach, develop training modules, and provide technical assistance to facilitate compliance 249 
 
 
 with the FSVP regulation, including regarding importers’ reliance on the results  of onsite audits 
of foreign suppliers.  
As for other potential ways to design the FSVP regulation to be similar to the importer 
requirements in FDA’s juice and seafood HACCP regulations, we do not agree that doing so 
would be appropriate.   As stated in the pr eamble to the proposed rule, section 805 of the FD&C 
Act contemplates a more comprehensive approach to supplier verification than the juice and 
seafood HACCP regulations.   The juice and seafood importer provisions were adopted more than 
a decade ago,  and t he U.S. Government Accountability Office has expressed concerns with the 
effectiveness of the seafood importer provisions (see 78 FR 45730 at 45745).   In light of 
FSMA’s increased emphasis on the safety of imported food and importers’ role in ensuring food  
safety, as well as the adoption of the FSVP regulation, we will consider whether it would be 
appropriate in the future to initiate a rulemaking to revise the regulations applicable to importers 
of juice and seafood.  
 (Comment 199)  One comment suggests th at we consult the Good Manufacturing 
Practice and Quality Assurance Guides for Food Additives and GRAS Substances developed by 
the International Food Additives Council when evaluating audits of foreign suppliers of food 
additives and GRAS substances.  
 (Response 199)  When evaluating audits of foreign suppliers, we will consider whether 
the audits verify compliance with applicable food safety requirements contained in the FD&C 
Act and any FDA regulations to which the food is subject.  
 (Comment 200)  One comment maintains that the a dded value of an audit conducted by 
an importer is limited especially when the supplier is already certified or audited.  The comment 250 
 
 
 states that importers should be able to provide “data on paper --in the form of an up -to-date 
dossier” in place of conducting duplicative supplier verification activities.  Another comment 
recommends that importers rely on third -party audits to avoid unnecessary multiple audits of 
foreign suppliers and suggests that importers who rely on the report of a third -party audit of a 
supplier be deemed in compliance with the supplier verification requirements.  
 (Response 200)  As a general matter, we agree that if an importer can obtain 
documentation of an foreign supplier audit conducted in accordance with  the requirements of the 
FSVP regulation (e.g., performed by a qualified auditor and evaluating compliance with 
applicable FDA food safety standards), the importer can rely on it provided that the importer 
reviews and assesses the results of the audit.  We  have explicitly added this flexibility in 
§ 1.506(e)(2) of the final rule.  We anticipate that many importers will, in accordance with the 
FSVP regulation, rely on audits conducted by third -party auditors or by other entities rather than 
conducting their own separate audit of the supplier.  
 (Comment 201)  One comment states that the frequency of auditing conducted to meet 
FSVP requirements should take into consideration risks in the food and the quality control 
capability of suppliers.  
 (Response  201)  We agree.  Section 1.506(d)(1) of the final rule states that an importer 
must determine and document which verification activity or activities (including, potentially, 
onsite audits) are needed, as well as the frequency with which those activities must be con ducted, 
to provide adequate assurances that the hazards in the food obtained from the foreign supplier are 
significantly minimized or prevented .  This determination must be based on the evaluation of the 
food and the foreign supplier conducted under § 1.50 5. 251 
 
 
  (Comment 202)  One comment requests that the regulation specify that importers must 
accept verification results of other importers on the same food from the same foreign supplier to 
avoid multiple verifications.  
 (Response  202)  We decline to require i mporters to accept verification results of other 
importers.  However, § 1.506(e)(2) of the final rule does allow an importer to rely on verification 
activities performed  by other entities (other than the foreign supplier), and such other entities 
may inclu de other importers of the same food from the same foreign supplier.  In such cases, the 
importer must review and assess the results of those activities  and document the review and 
assessment .  The importer remains ultimately responsible for the safety of the food it imports and 
its own compliance with th is regulation.   In accordance with § 1.503, the individual performing 
the verification activities must be a qualified individual.  
 (Comment 203)  Some comments  object to limiting the Agency’s access to com plete 
audit report s.  On the other hand, some comments request that the regulation clearly specify that 
we will not require review of a full audit report.  One comment asks us to clarify that summary 
data and recognized auditor or foreign government certif ication are adequate.  The comment 
maintains that it is unrealistic to expect foreign suppliers to provide highly confidential data to 
importers.  
 (Response  203)  As stated in the Supplemental Notice, we conclude that we do not need 
to see full audit repor ts to effectively monitor importer compliance with the supplier verification 
requirements.  Section 1.506(e)(1)(i)(D) only requires that an importer retain documentation of 
each onsite audit, including the audit procedures, the dates the audit was conducte d, the 
conclusions of the audit, any corrective actions taken in response to significant deficiencies 252 
 
 
 identified during the audit, and documentation that the audit was conducted by a qualified 
auditor.  We conclude that it is unnecessary to state in the re gulatory text that importers need not 
retain full audit reports.  We believe that the information required under §  1.506(e)(1)(i)(D) is 
the information our investigators will need  to assess the adequacy of the audit and, thus, the 
importer’s compliance wit h the FSVP requirements.  In turn, if an importer is relying on another 
entity (such as a third -party auditor hired by a foreign supplier) to conduct the audit, the importer 
would need to obtain the relevant information regarding the audit to fulfill its o bligation to 
review the results of the audit.  As for the comment that it is unrealistic to expect foreign 
suppliers to provide highly confidential data to importers, w e recognize that, due to commercial 
confidentiality concerns or other reasons, there mig ht be circumstances in which some foreign 
supplier s might be reluctant to share food safety information with importers.  However, we also 
believe that some foreign suppliers will desire to share such information as a means of attracting 
customers for their  products.   
 (Comment 204)  One comment contends that making audit conclusions or corrective 
actions available to FDA could result in suppliers refusing to allow unannounced audits.  
Therefore, the comment suggests that FDA only review an importer’s proce dures for verifying 
suppliers, including procedures for audits, rather than the results of the procedures.  
Alternatively, the comment contends that importers should only be required to provide 
documentation of corrective actions taken to address significa nt deficiencies that create a risk to 
public health.   
 (Response 204)  We do not agree that we should only review an importer’s procedures 
for verifying suppliers.  We also need to be able to confirm that those procedures are followed by 253 
 
 
 reviewing the importer’s records, including documentation of review and assessment of audit 
results and any necessary corrective actions taken.  As to whether this will result in suppliers 
refusing to allow unannounced audits, we note that nothing in the final rule requires that audits 
be unannounced.  Nevertheless, there may be some advant ages to unannounced audits, as 
discussed in the preamble to  the proposed  rule on third -party certification (see 78 FR 45782 at 
45812, July 29, 2013) .      
With respect to whether importers should only be required to provide documentation of 
corrective acti ons taken to address significant deficiencies that create a risk to public health, we 
do not agree.  S ection 805(a)(1) of the FD&C Act requires each importer to perform risk -based 
foreign supplier verification activities for the purpose of verifying that t he food imported by the 
importer is not adulterated under section 402 of the FD&C Act or misbranded under section 
403(w) of the FD&C Act, among other requirements.  If imported food is adulterated or 
misbranded with respect to allergen labeling, corrective  action is required to satisfy the 
requirements of section 805(a)(1).  Because we can only efficiently enforce section 805(a)(1) if 
we are able verify such corrective action, and because we can only verify corrective actions if 
importers provide appropriat e documentation, the final rule requires documentation of all 
corrective actions.  However, the particular corrective action warranted could differ depending 
on the circumstances, including the level of risk to public health posed by the particular non -
compliance.  The importer’s documentation would reflect whatever corrective action might be 
warranted .   254 
 
 
  (Comment 205)  One comment states that the regulations should recognize that 
documentation of audits might be maintained by an importer’s corporate paren t rather than at an 
individual facility.  
 (Response  205)  We do not object to documentation of audits being maintained by an 
importer’s corporate parent.  In accordance with § 1.510(b)(2) of the final rule, offsite storage of 
records is permissible, as lon g as such records can be retrieved and provided onsite within 24 
hours of request for official review.  
b.  Sampling and testing . 
We proposed (in § 1.506(d)(1)(ii)) that sampling and testing of a food could be conducted 
by either the importer or the foreign  supplier.  We proposed that importers be required to retain 
documentation of each sampling and testing of a food, including identification of the food tested 
(including lot number, as appropriate), the number of samples tested, the test(s) conducted 
(including the analytical method(s) used), the date(s) on which the test(s) were conducted, the 
results of the testing, any corrective actions taken in response to detection of hazards, and 
information identifying the laboratory conducting the testing.  We are finalizing these 
requirements in § 1.506(e)(1)(ii).  In addition, we are adding the requirement that importers 
retain  documentation of  the date of the report of the testing because we believe that the date of 
the report can be important .  As previously sta ted, we are also adding language stat ing that 
importers must retain documentation that the testing was performed by a qualified individual (to 
clarify that testing must  be conducted by a qualified individual).  
 (Comment 206)  One comment requests that we clarify that testing could be conducted on 
behalf of an importer or foreign supplier.   255 
 
 
  (Response 206)  We agree.  An importer or a foreign supplier may hire another entity to 
conduct the testing on its behalf; the importer o r supplier need not conduct the actual testing 
itself.  In addition, under §  1.506(e)(2)(i) of the final rule, sampling and testing may be 
conducted by other entities provide d the importer reviews and assesses the results of the testing.  
 (Comment 207)  On e comment maintains that because testing documentation is routinely 
maintained by the testing entity, importers should be required to either retain “or have access to” 
such documentation.   
 (Response  207)  Importers must obtain the required testing inform ation so that, in 
accordance with §  1.506(e)(3), they can review the testing results and, if appropriate, take 
corrective action to address supplier non -compliance.  However, as previously noted, 
§ 1.510(b)(2) does allow offsite storage of records if they can be retrieved and provided onsite 
within 24 hours of request for official review.  
 (Comment 208)  One comment suggests that proposed §  1.506(d)(1)(ii) be revised to 
reflect that, when outside laboratories are used, the importer might not have access to 
information about the dates on which tests were conducted, but only information on the dates on 
which the tests were reported.    
(Response  208)  We do not agree.  Information on the dates on which testing was 
conducted is standard information in laborator y testing reports  and may be important 
information .  However, we agree that the date on which the test results were reported is also 
important information, so we are revising §  1.506(d)(1)(ii) by adding a reference to “ the date of 
the report of the testing .”  This change is consistent with the approach taken in the preventive 
controls regulations for documentation of sampling and testing.  256 
 
 
  (Comment 209)  Some comments suggest that because testing often is more efficient 
when it is conducted by the supplier, FDA should develop guidance on when “test and hold” 
procedures could be used.   
 (Response  209)  We recognize that it could be appropriate for testing to be performed by 
suppliers in certain circumstances.  Section 1.506(e)(2)(ii) of the final rule allows for suppliers to 
perform testing as a verification activity as long as the importer reviews and assesses the relevant 
documentation.  
  (Comment 210)  One comment suggests that testing should be the preferred activity when 
detecting or identifying the presence or absence of pathogenic bacteria, allergens, and spoilage 
organisms.    
 (Response  210)  To the extent that the comment suggests that testing is t he preferred 
supplier verification activity for pathogenic bacteria or allergens, we do not agree.  Although 
testing plays an important role in ensuring the safety of food, contamination with microbial 
pathogens and some allergens is likely to be non -homog eneous and the numbers of pathogens are 
likely to be low.  A negative result therefore does not guarantee the absence of contamination.  
An importer should take this into account when deciding which verification activity (or 
activities) is appropriate.  Because of the limitations of sampling and testing, the processes and 
procedures a supplier has in place to minimize contamination, and the management of those 
processes and procedures, are key in determining when sampling and testing is appropriate as a 
verification activity.  We discussed the role of testing in ensuring the safety of food in the 
proposed rule on preventive controls for human food (see the Appendix to the proposed rule (78 
FR 3646 at 3818 through 3820), with reference numbers corrected in th e Federal Register  of 257 
 
 
 March 20, 2013 (78 FR 17142 at 17149 through 17151)).  For more information about other food 
safety issues, many of which helped inform both this rulemaking and the preventive controls 
rulemakings, see generally the proposed, suppleme ntal, and final rule on preventive controls for 
human food (78 FR 3646 ; 79 FR 58524 , September 29, 2014 ; 80 FR 55908 ).   
In many cases, an onsite audit to verify control of hazards may be more appropriate than 
sampling and testing, or may be appropriate to use in conjunction with sampling and testing.     
Onsite audits provide the opportunity to review a supplier’s  food safe ty plan (if the supplier has 
one) and written procedures and to observe the implementation of those procedures, as well as to 
review records.  In addition, an auditor  can interview a supplier’s employees to assess their 
understanding of the food safety mea sures for which they are responsible.  Therefore, an audit 
can provide for a more comprehensive assessment of food safety implementation than testing.  
For these reasons, when a SAHCODHA hazard in a food will be controlled by the foreign 
supplier, importer s must conduct or obtain documentation of an onsite audit of the foreign 
supplier before initially importing the food and at least annually thereafter (unless they make an 
adequate written determination  (based on the evaluation conducted under §  1.505)  that, instead 
of such auditing, other supplier verification activities and/or less frequent onsite auditing are 
appropriate to provide adequate assurances that the hazards in the food from the foreign supplier 
are significantly minimized or prevented ).   
With  respect to spoilage organisms, if there is reason to believe spoilage may have 
occurred  (e.g., the product may have been temperature abused during shipment ), testing to 
enumerate certain types of organisms might be appropriate.  However, if the testing for spoilage 258 
 
 
 organisms is to verify production processes and  procedures, a supplier audit of such procedures 
and their implementation might be more informative .  
 (Comment 211)  Several comments request that we establish minimum laboratory 
standards to ensure that laboratories used to test imported foods follow performance standards 
that are equivalent to U.S. standards.  Several comments ask us to issue a propo sed rule 
regarding the accreditation of laboratories and model standards to be used by accredited 
laboratories in accordance with section 202 of FSMA  (section 422 of the FD&C Act (21 U.S.C. 
350k)) .  One comment asks us to require that the laboratory report s on which importers rely align 
with international standards.  
 (Response  211)  We stated in the preamble to the proposed rule our tentative conclusion 
that, although we would expect sampling and testing conducted to meet FSVP requirements to be 
performed i n accordance with any applicable regulations or widely accepted industry standards, 
it was not appropriate to specify testing standards in the FSVP regulation.  Although the final 
rule does not include specific requirements for laboratory testing, importer s may not rely on the 
results of testing that was not conducted in accordance with methodologies and procedures 
designed to ensure valid and accurate results.  We are currently developing  a proposed rule to 
implement section 202 of FSMA.  The proposed rule  might include proposed circumstances 
under which use of accredited laboratories and model testing standards w ould be required.  
 (Comment 212)  One comment suggests that laboratories should make certificates of 
current accreditation from recognized laborat ory accreditation bodies available to importers to 
provide assurance that the laboratory is in compliance with recognized standards.  259 
 
 
  (Response  212)  We agree that importers could benefit from using accredited laboratories 
and that it could be beneficial  for laboratories to make certificates of accreditation available.  
However, such requirements are beyond the scope of this rulemaking.  
 c.  Review of foreign supplier food safety records . 
 We proposed (in § 1.506(d)(1)(iii)) that importers be required to r etain documentation of 
each review of relevant supplier food safety records, including the date(s) of review, any 
corrective actions taken in response to significant deficiencies identified during the review, and 
documentation that the review was conducted  by a qualified individual.  We are finalizing this 
requirement in §  1.506(e)(1)(iii).  We are adding a requirement that an importer must retain 
documentation of the conclusions of the review because t hey are essential to determining 
whether and what corre ctive actions are necessary.   
 (Comment 213)  One comment suggests that this provision refer to “food safety 
compliance records” rather than “relevant food safety records.”  
 (Response  213)  We do not agree.  The  suggested revision might be interpreted as 
limiting the provision to only those records that relate to a compliance action with a relevant 
authority.  However , it might be appropriate for an importer to review a broader set of food 
safety records, includi ng records documenting that the food safety procedures that the supplier 
has established to control hazards are being followed and are adequately controlling the hazards.  
Such records might include records of a foreign supplier’s audit of its supplier’s h azard control 
activities or records of environmental monitoring or product testing .  
 (Comment 214)  One comment maintains that importers should not be required to have a 
qualified individual conduct a review of supplier food safety records; the comment st ates that a  260 
 
 
 qualified individual is not required for review of food safety records of a supplier of a raw 
material or other ingredient under the proposed regulations on preventive controls for animal 
food.   
 (Response  214)  We do not agree.  We believe th at an importer must a have a qualified 
individual conduct all foreign supplier verification activities to ensure that these activities are 
performed adequately.  The final rule on preventive controls for animal food requires use of a 
preventive controls qualified individual  to review supplier food safety records (see 
§§ 507.49(a)(4) and 507.175(b)).  
 d.  Other appropriate verification activities . 
We proposed to allow importers to conduct supplier verification activities other than 
those previously discusse d if such activities were appropriate to address the risks associated with 
the food and the foreign supplier  (proposed §  1.506(d)(1)(iv)) .  Although we did not specify how 
importers would be required to document the performance of such verification activit ies, we 
requested comment on whether the final rule should include such requirements and, if so, what 
they should be.  
We are finalizing this provision in § 1.506(e)(1)(iv) (A).  To allow flexibility as to who 
must conduct the verification activities, consis tent with other provisions of the final regulatory 
text, we have revised the phrase “You may conduct and document other supplier verification 
activities …” to “You may conduct (and document) or obtain documentation of other supplier 
verification activities  ….”  We are also adding § 1.506(e)(1)(iv)(B) in response to comments, as 
discussed  below.  261 
 
 
  (Comment 215)  One comment suggests that importers could use third -party remote 
video auditing systems as an alternative verification measure under proposed § 1.506(d)(1)(iv).  
 (Response  215)  Depending on the circumstances, including the hazard analysis, the 
evaluation for foreign supplier approval and verification, and the specific characteristics and 
capabilities of the third -party remote video auditing sys tem, an importer could determine that it 
is appropriate to use such a system as an appropriate alternative verification activity  under 
§ 1.506(e)(1)(iv) of the final rule . 
 (Comment 216)  Some comments suggest that the regulation should not specify 
require ments for the documentation of such alternative verification activities .  One comment 
states that although FDA might specify minimum parameters for documentation, it would be 
better to allow specific industry sectors to develop their own forms.   Some comme nts suggest 
that for  these alternative activities, importers should be required to document the date of the 
activity, the findings, any corrective actions taken, and justification that the activity provides at 
least the same level of assurance as the other  verification activities in the regulations, particularly 
when there is a SAHCODHA hazard in a food.  
 (Response  216)  As with the previously discussed verification activities, we conclude that 
it is appropriate to include certain requirements for documenta tion of alternative verification 
conducted under § 1.506(e)(1)(iv).  Requiring such documentation will allow us to review the 
appropriateness of any particular verification activity to determine an importer’s compliance 
with the FSVP regulation, thereby al lowing us to efficiently enforce the requirements in section 
805 of the FD&C Act.  Therefore, § 1.506(e)(1)(iv)(B) of the final rule requires importers  to  
document  their use of such alternative activities by retaining  a description of the activity, the date 262 
 
 
 on which it was conducted, the findings or results of the activity, any corrective actions taken in 
response to significant deficiencies identified, and documentation that the activity was conducted 
by qualified ind ividual.  We do not believe it is necessary to specifically require an importer to 
document a justification that the activity provides at least the same level of assurance as the other 
verification activities, because §  1.506( d)(1) already requires importe rs to document their 
determination of the nature and frequency of appropriate supplier verification activities for a 
particular food and foreign supplier.  
7.  Independence of Qualified Individuals  
We proposed to specify that a qualified individual who conducted any foreign supplier 
verification activities could not have a financial interest in the supplier and payment could not be 
related to the results of the activity (proposed § 1.506(d)(7)).  However, this provision would not 
prohibit an importer or one of its employees from conducting verification activities.  In the final 
rule, we have moved this provision to § 1.506(e)(4)  and modified it so that it no longer  prohibit s 
the existence of a financial interest, but rather prohibit s the existence of fina ncial conflicts of 
interest  that influence the results of verification activities in § 1.506(e)(1) .  The rule continues to 
specify  that payment must not be related to the results of the activity.   
(Comment 217)  One comment recommends that the conflict of  interest provisions in the 
FSVP regulation be consistent with those in the preventive controls regulations.  One comment 
suggests that the provision s be revised to specify that a qualified individual must not have a 
“direct personal” financial interest in  the foreign supplier.   
 (Response  217)  The conflict of interest provisions in th e final  rule are the same as those 
in the preventive controls regulations.  We do not believe it is appropriate to limit the type of 263 
 
 
 financial interest of concern here to a “direct personal” financial interest, particularly since it is 
unclear what would count as a “direct personal” financial interest as oppo sed to any other 
financial interest.  If the qualified individual has a financial conflict of interest that influence s the 
results of verification activities , the qualified individual would be preclude d from being able to 
independently conduct verification  activities under th e FSVP regulation .  We believe that this 
limitation appropriately ensures that qualified individuals act objectively and are free from any 
undue commercial pressures that could compromise the performance of verification activities.   
 (Comment 218)  One comment requests that we clarify that an importer or its employee 
may conduct a verification activity “even if the foreign supplier is an affiliate, subsidiary, or 
parent company of yours.”  
 (Response  218)  We decline to add this language .  We recognize the variety of business 
relationships that can exist between importers and foreign suppliers, including a parent -
subsidiary relationship or an affiliate relationship.  Regardless of how the two entities relate to 
each other, the conflict of  interest provisions in § 1.506(e)(4)  are designed to maintain the 
integrity of the verification activities performed as part of an importer’s FSVP .  Section  
1.506(e)(4) does not prohibit an importer o r its employee from conducting a verification activity 
even if the foreign supplier is an affiliate, subsidiary, or parent company of the importer, and the 
language requested by the comment is unnecessary.  Neverth eless, any financial conflict of 
interest that may exist cannot influence the results of the verification activity.  W e expect that if 
an importer or its employee conducts a verification activity for a foreign supplier that is an 
affiliate, subsidiary, or parent company of the importer, there will be protections in place to 
ensure the integrity of  the verification activity , including, for example, ensuring that the 264 
 
 
 individual conducting the verification activity is not penalized for identifying food safety 
concerns.  In addition, any payment for the verification activity cannot influence the result s of 
the activity.   
 (Comment 219)  One comment states that the independence provisions s hould only 
extend to employees related to a foreign supplier’s business, marketing, and distribution because 
it would be too burdensome to expect an importer to know about any stockholding relationship, 
deals, or other potentially unethical practices.  
 (Response  219)  We do not believe that the independence requirement is too burdensome.  
An importer could, for example, ask the qualified individual to attest to whether it has any 
financial interest in the foreign supplier and, if the qualified individual has one, take steps to 
ensure that any such interest does not influence the results of the verification activity.  The final 
rule does not per se prohibit the qualified individual from holding any stock or having ever had 
any dealings with the entity that is the subject of the verification activities.  
 (Comment 220)  One comment states that it is unreasonable to suggest any qualified 
auditor would not have an interest in the outcome or success of the activities of the supplier.  
Another comment states that because the activities of employees are influenced by their 
employers, there can be no assurance that the results of employee activities will be impartial.  
 (Response  220)  We disagree.  The relevant requirement in § 1.506(e)(4) is that payment 
of the qualified individual conducting a verification activit y must not be related to the results of 
the activity.  We believe this requirement is necessary to ensur e the integrity of the performance 
of verification activities under this rule.  265 
 
 
  (Comment 221)  Several comments ask that we make clear that the independence 
requirements would not exclude the use of first -party (internal) audits.  One comment states that 
the regulations s hould not preclude a manufacturer from using its own qualified auditors from 
conducting onsite audits or using its qualified employees to conduct other supplier verification 
activities.  
 (Response  221)  Under § 1.506(e)(4) ,  the independence  of qualified individual 
requirement does not prohibit an importer or its employees from conducting supplier verification 
activities.  It does, however, prohibit a qualified individual who conducts any verification 
activities from having a financial confli ct of interest that may influence the results of an audit or 
other verification activity .   In addition, due to the potential for a conflict of interest, the final 
rule (in § 1.506(e)( 2)(ii)) provides that importers may not rely on the foreign supplier its elf or 
employees of the foreign supplier to perform supplier verification activities (except with respect 
to sampling and testing of food).  A foreign supplier’s audit of itself would therefore not be an 
appropriate verification activity under the regulati on. 
 (Comment  222)  One comment suggests that we not impose limitations on use of second -
party audits (i.e., audits by  an employee of a company conducting the verification activities).  
 (Response  222)  To the extent that the comment is asking whether importers may use 
their own employees to conduct audits of foreign suppliers, this is permissible under the final 
rule.   
 (Comment 223)  One comment suggests that we consider the conflict of interest 
provis ions in the NOP regulations (7 CFR 205.501(a)).   266 
 
 
  (Response  223)  The conflict of interest provisions in the NOP regulations  are tailored to 
the concerns addressed in those regulations.  We regard s ome provisions, such as  7 CFR 
205.501(a)(11)(i), which ma ndate s that a certifying agent not certify an entity if the certifying 
agent has held a commercial interest in the provision of consulting services, as similar  to the 
requirement we are finalizing here.  Many other provisions would not translate at all, e. g., the 
requirement that a certifying agent must prevent conflicts of interest by not giving advice or 
providing consultancy services to certification applicants or certified operations for overcoming 
identified barriers to certification (7 CFR 205.501(a)( 11)(iv)).  Having reviewed the conflict of 
interest provisions in the NOP regulations as the comment suggests, we continue to believe that 
our conflict of interest provision s are well suited for the  FSVP  regulation.  
8.  Food Stored for an Extended Time Bef ore Export  
 In the preamble to the proposed rule, we requested comment on what foreign supplier 
verification activities might be appropriate for foods that are exported to the United States long 
after they are produced in a foreign country.  
 (Comment 224)  Some comments state that no additional foreign supplier verification 
activities are necessary for specific products such as gelatin, which has a shelf life of about 5 
years and as a result can be exported long after production.  These comments recommend t hat 
FDA rely on safety procedures of foreign countries.  Other comments see challenges with 
conducting certain verification activities, such as onsite audit s, in situations whe n there is an 
extended delay between the production and export of a food.  Some comments recommend that 
we understand different scenarios in which  this may occur, stating that it will be easier to 267 
 
 
 develop a procedure or recommend appropriate supplier verification activities once there is a 
better understanding of the specific circumst ances.  
 (Response 224)  As the compliance date for the FSVP regulation approaches , we expect 
that there will be discussion of scenarios in which  different supplier verification activities will be 
appropriate.  The final rule includes considerable flexibil ity for an importer to determine and 
conduct the supplier verification activities that are most appropriate given various factors related 
to the food and the supplier, in accordance with §§ 1.504, 1.505, and 1.506.   Consequently, we 
conclude that it is not necessary to establish provisions specifically applicable to the importation 
of food stored for an extended period before export.  
H.  Foods That Cannot Be Consumed Without Control of Hazards and Foods Whose Hazard s 
Are Controlled After Importation (§  1.507)  
 In response to comments, we have included , in §  1.507 of  the final rule , new provisions  
to address certain circumstances in which a hazard requiring a control is identified in a food but 
foreign supplier verifi cation is unnecessary .  These provisions in §  1.507 are consistent with 
similar provisions in the preventive controls r egulation s.   
 In response to the proposed rule, we received comments addressing a variety of 
circumstances under which the hazards in im ported food typically are not controlled until after 
the food arrives in the United States.  As discussed in section III. B.7 of this document, several 
comments request that we exempt from the FSVP regulation importers of certain RACs, in 
particular coffee beans and cocoa beans, which purportedly cannot be consumed without 
undergoing processing involving the application of controls that will address all hazards in the 
food.  268 
 
 
 Other comments relate to circumstances under which an importer’s customer or a 
subse quent entity controls the hazards in an imported food.  As stated in sections III. C.4 and 
III.E.8 of this document, we proposed to allow for certain alternatives to supplier verification 
when an importer’s customer controlled a hazard in a food.  Under pro posed §  1.502(d), if an 
importer’s customer was required to establish and implement a supply -chain  program under the 
preventive controls regulations for a food that the importer imported, the importer would be 
deemed to be in compliance with most of the FS VP requirements if it annually obtained from the 
customer written assurance that the customer was in compliance with the supply -chain  program 
provisions.   
The proposed rule also included proposed provisions in §  1.504(g) regarding  when an 
importer or its customer was controlling the hazards in a food in accordance with the preventive 
controls regulations but was not required to have a supply -chain  program under those regulations 
(because the importer’s preventive controls were adeq uate to significantly minimize or prevent 
each hazard, or because the importer relied on its customer to control a hazard and annually 
obtained written assurance of such control).  Under proposed §  1.504(g), the importer in such 
circumstances would not be subject to the FSVP requirements for evaluating the food and 
foreign supplier (proposed §  1.505) or conducting supplier verification activities (§  1.506).  
However, if the importer’s customer controlled one or more hazards, the importer would be 
required t o annually obtain from the customer written assurance that it was following procedures 
to significantly minimize or prevent the hazard.  
 We received several comments regarding the proposals to permit importers to obtain 
written assurance from a customer co ntrolling a hazard in an imported food.  Although there is 269 
 
 
 general support for not requiring the importer to conduct supplier verification under these 
circumstances, many comments object to the proposed requirement to obtain written assurance 
from customer s.  Other comments raise concerns about what FSVP requirements should apply 
when an entity in the distribution chain beyond the importer’s customer controls the hazards in 
the imported food.   
In the following paragraphs, we respond to these comments and d iscuss the requirements 
under §  1.507 of the final rule applicable to importers of food that cannot be consumed without 
the hazards being controlled or for which the hazards are controlled after importation.  
1.  Food That Cannot Be Consumed Without Applica tion of Controls  
 (Comment 225)  Some comments note that, in the case of the cocoa bean and coffee bean 
supply chains, the importer does not have a direct relationship with the thousands of farms (the 
foreign suppliers) involved in the production  of the be ans.  Some comments ask for an 
exemption from supplier verification activities for foods such as cocoa and coffee beans because 
current distribution systems do not rely on the farms to control the hazards ; instead, t he hazards 
are controlled at the U.S. pr ocessing facility  for the beans , which may or may not be the 
importer.  
 (Response 225)  We agree that an importer of a food should not need to conduct supplier 
verification when th e importer knows that a subsequent entity in its distribution chain is 
contr olling the hazard  in the food .  Moreover, the foods specifically mentioned by these 
comments, cocoa beans and coffee beans, are types of food that could not be eaten without 
processing that would control the typical hazards requiring a control.  We believe  there are few 
other foods in this category.  Examples of such foods might  include grains (for human 270 
 
 
 consumption) and some RACs that are rarely consumed raw (again, as long as they are imported 
for human consumption).  The FSVP regulatory text does not refer to  RACs rarely consumed 
raw because “rarely consumed raw” is not the same as “could not be consumed without 
application of an appropriate control.”  However, depending on the facility, the RAC, and the 
food produced by the manufacturer/processor, the re may be some circumstances where a 
manufacturer/processor could determine that a particular RAC that passes through its facility  
could not be consumed without the RAC being processed to  control  any hazards .  Because  some 
or all of  the important food safe ty risks will be controlled before these foods reach consumers, 
we do not believe it is necessary for importers to conduct the evaluation under § 1.505 or 
supplier verification under § 1.506  for hazards in these foods .  Therefore, § 1.507(a)(1) of the 
final rule provides that an importer is not required to conduct an evaluation under § 1.505 or 
supplier verification under § 1.506 if the importer determines and documents that the type of 
food (e.g., RAC s such as cocoa beans and coffee beans) could not be con sumed without 
application of an appropriate control for the hazard by an entity in the supply or distribution 
chain other than the importer.   
2.  Control of Hazards by an Importer’s Customer or Subsequent Entities in the Distribution 
Chain  
 (Comment 226)  We received many comments objecting to our proposal to require 
importers to obtain annual written assurance from a customer controlling a hazard under either 
proposed §  1.502(d) or §  1.504(g).  Some comments state that an importer may have so many 
custome rs that it would not be practical or reasonable to obtain written assurance annually from 
all customers.  Other comments express concern that a customer may be unwilling to disclose 271 
 
 
 confidential trade secrets in order to identify in writing the procedures the customer has 
established and is following to control the hazard.  Some comments state that an importer may 
not know the identity of all its individual customers, particularly if the importer sells its products 
to a distributor who then sells to other e ntities.  Some comments oppose the written assurance 
requirement because they maintain that it does not contribute to safety given that it does not 
guarantee that the customer is actually doing anything to effectively minimize or prevent the 
hazard.  Some comments ask that we delete the written assurance requirement because it raises 
the question of whether the importer must evaluate the adequacy of the customer’s procedures, 
and the importer might not have the capability to do this.   
Other  comments sugges t that, i f the final rule includes a written assurance requirement, 
one of the following time intervals that should be required to obtain the assurance:  
•  Every 2 years;  
•  Every 3 years or when new information warrants; or  
•  Only at the beginning of the  importer -customer relationship.  
 Some comments maintain that there should  be a mechanism for when an importer’s 
customer’s customer (or a subsequent entity in the distribution chain) controls all the hazards in a 
food.  Some comments suggest that this be addressed by requiring the importer to specify in 
contracts for sale that the ultimate purchaser must control all hazards before distributing the food 
to consumers.   Some comments suggest that importers could be required to notify their 
customers of actual  or potential hazards in the food that have not been controlled.  
 (Response  226)  In consideration of these comments, we are establishing , in §  1.507,  a 
series of provisions that relieve an importer from the requirements to conduct an evaluation of 272 
 
 
 the food and foreign supplier under § 1.505 and supplier verification activities under § 1.506 
when a  subsequent  entity in the importer’s distribution chain is controlling the hazard  in a food .  
We conclude that compliance with certain requirements will provide adequate assurance that 
hazards in such food are being controlled by an entity in the importer’s distribution chain and 
will adequately inform entities in that distribution chain that the food requires a control.  These 
requirements concern the following:  
•  Disclosure in documentation provided by the customer of an importer, to accompany 
the food, that the food is “not processed to control  [identified hazard] ”, identifying  a specific  
hazard or hazards (e.g., Salmonella , Listeria monocytogenes ) the importer has identified as 
requiring a control ;  
•  Written assurances from the importer’s customer regarding appropriate processing of 
the food for safety; and  
•  Provisions holding the  customer and subsequent entities in the distribution chain 
accountable for the written assurances .  
These requirements vary based on whether the importer’s customer controls the hazard in 
a food (and, if so, whether the customer is or is not subject to the preventi ve controls regulations) 
or whether an entity subsequent to the customer in the distribution chain controls the hazard  
(and, if so, whether the subsequent entity is subject to the preventive controls regulations) . 
The first of these provisions, § 1.507(a)( 2), addresses the situation in which an importer’s 
customer  who is subject to the preventive controls regulations (for human or animal food)  is 
controlling the hazard requiring control in a food.  Under §  1.507(a)(2), a n importer is not 
required to conduct  an evaluation under § 1.505 or supplier verification under § 1.506 if it relies 273 
 
 
 on its customer  who is subject to the preventive controls regulations  to ensure that the identified 
hazard will be significantly minimized or prevented  and the importer:  
•  Discloses in documents accompanying the food, in accordance with the practice of the 
trade, that the food is “not processed to control [identified hazard]” ; and  
•  Annually obtains from the customer written assurance, subject to the requirements of 
§ 1.507 (c), that the customer has established and is following procedures (identified in the 
written assurance) that will significantly mi nimize or prevent the identified hazard.  Under 
§ 1.507(c), an importer’s customer or a subsequent entity in a food’s distrib ution chain that 
provides a written assurance under §  1.507(a)(2), (3), or (4) must act consistently with the 
assurance and document the actions it takes to satisfy the assurance.  
The required disclosure regarding the lack of  processing to control hazards is consistent 
with the suggestions of some  comments.  The disclosure documents accompany ing the food 
could be the bills of lading or other papers, or disclosure might be made on  the label of the 
food’s container.  
Section 1.507(a)(3) of the final rule addresses the situation in which an importer’s 
customer  is not subject to the preventive controls regulations  (e.g., because it is a qualified 
facility or a retail food establishment) .  Under §  1.507(a)(3), an importer is not required to 
conduct an evaluat ion under §  1.505 or supp lier verification  under §  1.506  if it relies on its 
customer who is not subject to the preventive controls regulations  to provide assurance that it is 
manufacturing, processing, or preparing the food in accordance with applicable f ood safety 
requirements  and the importer:  274 
 
 
 •  Discloses in documents accompanying the food, in accordance with the practice of the 
trade, that the food is “not processed to control [identified hazard]”; and  
•  Annually obtains from the customer written assurance, subject to the requirements of 
§ 1.507(c) , that it is manufacturing, processing, or preparing the food in accordance with 
applicable food safety requirements .  Because the importer’s customer is not subject to the 
preventive controls regulations , rather than providing assurance that it is significantly 
minimizing or preventing a ha zard (as required under § 1.507(a)(2 )), it is appropriate for the 
importer’s customer to provide assurance that it is manufacturing, processing, or preparing the 
food i n accordance with applicable food safety requirements.  These food safety require ments 
might include FDA’s food CGMP regulations in subpart B of part 117 or subpart B of part 507 
(for qualified facilities) , or applicable  State or local food safety regulations (for retail 
establishments) .   
Section  1.507(a)( 4) of the final rule addresses the situation in which an  entity in the 
importer’s distribution chain beyond the importer’s  customer is controlling the hazard in a food.   
Under §  1.507(a)(4), a n importer is not required to conduct an evaluation under § 1.505 or 
supplier verification under § 1.506 if it relies on its customer to provide assurance that the 
identified hazard will be adequately controlled by an entity in the distribution chain subsequent 
to the customer and the importer:  
•  Discloses in documents accompanying the food, in accordance with the practice of the 
trade, that the food is “not process ed to control [identified  hazard ]”; and  
•  Annually obtains from i ts customer written assurance, subject to the requirements of 
§ 1.507(c), that the customer will disclose in documents accompanying the food, in accordance 275 
 
 
 with the practice of the trade, that the food is not processed to  control an identified  hazard.  The  
importer must also obtain written assurance that its customer will only sell the food to another 
entity that agrees, in writing, that it will either:  (1) Follow procedures (identified in a written 
assurance) that will significantly minimize or prevent th e identified hazard  (if the entity is 
subject to the preventive controls requirements) or manufacture, process, or prepare the food in 
accordance with applicable food safety requirements (if the entity is not subject to the preventive 
controls requirements ); or (2) obtain written assurance from its customer  similar to that which 
the importer’s customer must provide.  
The final provision in §  1.507 applicable to control of hazards by entities in an importer’s 
distribution chain, § 1.507(a)(5), allows for the possibility that another approach could ensure the 
control of an identified hazard in a food.  Under §  1.507(a)(5), an importer is not required to 
conduct an evaluation under § 1.505 or supplier verification under § 1.506 if it has established, 
documented,  and implemented a system that ensures adequate control, at a subsequent 
distribution step, of the hazards in a food it distributes, and the importer documents its 
implementation of that system.  We do not have any examples of such a system, but we do not 
want to preclude the development or use of such systems.  If an importer avails itself of this 
provision, we would evaluate its system during our inspection of the importer.  
The provisions allowing for hazards to be controlled by an importer’s customer or an 
entity in the distribution chain subsequent to the customer accommodate the realities of modern 
food production.  A food m ight pass through multiple entities in the distribution chain before a 
control is applied.  However, the control must eventually be  applied.  Under § 1.507(c), the 
customer or a subsequent entity in the distribution chain for a food that provides a written 276 
 
 
 assurance under §  1.507(a)(2) , (3), or (4)  must act consistently with the assurance and document 
the actions it takes to satisfy t he written assurance.  This requirement is supported by  section s 
701(a) and  805(c)(2)(B) of the FD&C Act, the latter of which provides that the FSVP regulations 
must  include other requirements the Secretary deems necessary and appropriate to verify that 
food imported into the United States is as safe as food produced and sold within the United 
States.   
In the preventive control s regulations for human and animal food, facilities may also rely 
on subsequent entities in their distribution chains to apply cont rols.  Those provisions also 
provide for the combination of (1) disclosure of documentation to a direct customer that the food 
is “not processed to control [identified hazard] ”; (2) written assurances from the customer 
regarding appropriate procedures to e nsure that the food will receive further processing for food 
safety; and (3) provisions holding the direct customer accountable for its written assurances.  
Under those regulations, a facility that provides the written assurance must act consistently with 
the assurance and document its actions taken to satisfy the written assurance.  Because the 
preventive controls regulations hold the customer accountable for its written assurance, the 
FSVP regulation would not be ensuring that imported food is as safe as domestically -produced 
food if the FSVP provisions  did not do the same.   
When a hazard will not be significantly minimized or prevented by an importer’s 
customer but by some subsequent entity in the distribution chain, the importer’s customer must 
still pa ss forward documentation to that subsequent entity disclosing the need to control the 
hazard.  The written disclosure must state that the food has not been processed to address the 
hazard identified as requiring a control.  This requirement is supported by  sections 701(a), 277 
 
 
 805(a)(1), and 805(c)(2)(B) of the FD&C Act.  O rdinarily it is not apparent from visual 
examination of a food whether a hazard has been addressed.  Consequently, without labeling, a 
subsequent entity in the distribution chain might not kn ow that an entity upstream in the supply 
chain has not significantly minimized or prevented a hazard and is relying on a downstream 
entity to do so.  Therefore, we conclude that information that food has not been processed to 
address an identified hazard i s necessary for an importer to fulfill its obligations under section 
805(a)(1) to perform risk -based verification activities to ensure that the imported food meets 
applicable food safety requirements .  We also conclude that the disclosure requirement is 
consistent with section 805(c)(2)(B) because the preventive controls regulations include a 
comparable provision, and including this requirement in the FSVP regulation  helps ensure that 
food imported into the United States is as safe as food produced and sold  within the United 
States.  In addition, the labeling is necessary for the efficient enforcement of the FD&C Act 
because labeling is critical for FDA to hold entities responsible for their obligations under this 
regulatory scheme.  Further, when a hazard c an cause a communicable disease, we conclude that 
the labeling requirement, in addition to the requirement that the importer’s customer or 
subsequent entity act in accordance with the assurance, is necessary to prevent the spread of 
communicable disease fr om one State into another State and is therefore authorized under 
sections 311, 361, and 368 of the PHS Act (42 U.S.C. 243, 264, and 271).  
The overarching goal of the  § 1.507  provisions is to reflect that in modern supply and 
distribution chains, steps to ensure food safety can occur before an importer receives a food or 
after it  distributes a food that it has imported.  When those steps are all performed by a  
subsequent  entity in the distribution chain, the requirements for an evaluation of the risk posed 278 
 
 
 by the food and the foreign supplier’s performance (under § 1.505), and for the conduct of 
supplier verification and related activities (under § 1.506), are unnecessary to ensure the safety of 
the food with respect to those hazards for the ultimate consumer.   
These provisions reflect a balance of flexibility and accountability for ensuring the safety 
of such food.  We continue to believe that annual written assurance from an importer’s customer 
is an appropriate mechanism to ensure that its customer is aware of the hazard requiring a control 
and is taking responsibility for ensuring that the hazard is controlled.  We believe that less 
frequent receipt of assurances would not provide an adequate level of monitoring or 
accountability.  We do not believe that importers’ customers or subsequent entities in the 
distribution chain will need to provide a ll detail s of their processes  to state in writing the 
procedures used to control the hazard.  For example, a customer could merely state tha t its 
processing includes a lethality step for microbial pathogens of concern.  The specific assurances 
that are required when an importer’s customer or a subsequent entity in the distribution chain is 
controlling a hazard are designed to be practical whil e helping ensure that an entity is held 
accountable for processing the food to make it safe for consumers.   Of course, for any assurance 
to be meaningful, the importer must understand the substance of the assurance, which must 
address control of the hazard s identified by the importer in accordance with § 1.504.  
In response to the comment regarding what importers might need to do with written 
assurances (such as evaluate a customer’s safety procedures), §  1.507 does not require importers 
to assess whether th eir customers are controlling hazards in accordance with the assurance they 
provide.  Instead, we may , if necessary,  rely on the requirement in §  1.507(c) that the customer  
act consistently with the written assurance it  provide s (and document its actions) to determine 279 
 
 
 whether an importer’s customer or a subsequent entity in the distribution chain is in compliance 
with the requirements in this rule . 
Section 1.507(b) of the final rule establishes certain requirements for the written 
assurances that are requir ed under this section.  A written assurance must include the following:  
•  The effective date of the assurance;  
•  The printed names and signatures of authorized officials  of the entity providing the 
assurance ; and  
•  The assurance required under the appl icable provision of §  1.507(a) .   
(Comment 227)  One comment expresses concern that proposed § 1.504(g) might create 
confusion regarding what entity is controlling a hazard in a food in circumstances in which 
imported food is repurposed (redirected to anot her use) as a result of quality rejection by the 
customer or f or other reasons.  To illustrate this , the comment  states that an importer might 
purchase spinach from a foreign supplier to be used in its customer’s canning process that 
includes a validated kill step  to control microbiological hazards , but the spinach does not meet 
the customer’s quality specifications .  The comment suggests that the customer might repurpose 
the spinach for use in individually quick frozen  (IQF)  spinach or spinach dip, each of which is 
made without a validated kill step .  The comment maintains that it is unclear how the importer 
can bea r the responsibility to ensure that appropriate verification activities have been performed 
because it is likely to be unaware of the customer’s repurposed use of the spinach.   Alternatively, 
the comment states that if the customer was subject to supplier verification requirements under 
the preventive controls  for human food  regulation, it would need to go back to the importer to 
ensure that appropriate supplier verification activities had been conducted, resulting in multiple 280 
 
 
 verification activities and pr ocessing delays leading to spoiled spinach.   The comment therefore 
asks that we consider mechanisms that could support a requirement for consistent standards on 
entry of imported foods into the United States , such as creating a repository of audit reports,  
accessible by multiple importers, to allow sharing of audit costs and reports so that only one 
annual onsite audit of a foreign supplier is conducted.  
(Response 227)  We appreciate the safety and economic concerns associated with 
imported food that is red irected for a purpose different from its original intended use.  As 
discussed in section III. G.4 of this document, § 1.506(e) of the final rule allows multiple 
importers to rely on the results of an onsite audit of a foreign supplier, which has the potenti al to 
reduce supplier verification costs for both import ers and suppliers.  We also believe that  the 
ability to import food in accordance with §  1.507 (a)(2) when  an importer’s customer will 
significantly minimize or prevent ing the hazards in food could result in reduced burdens on 
importers because food and supplier evaluation and supplier verification activities are not 
required in such circumstances.   
With respect to the comment’ s example of “ repurposed ” spinach, we note that if the 
importer’s customer provided written assurance that it would significantly minimize or prevent 
biological hazards in the spinach in a canning process in accordance with §  1.507(a)(2), but 
instead used the spinach to make IQF spinach or spinach dip with out significantly minimizing or 
preventing the hazard, the importer’s customer would be in violation of §  1.507(c).  However, 
the assurance requirement in §  1.507(a)(2) does not require that the customer provide assurance 
as to the specific food it will ma nufacture or process from the imported food.  Instead, it requires 
that the customer provide assurance that it will significantly minimize or prevent the identified 281 
 
 
 hazard in the food.  It is likely that there is more than one way that the customer could a ct 
consistently with that assurance.  If the customer determines not to manufacture/process spinach 
in the originally -contemplated canning process, there are likely other foods that the customer 
could manufacture/process using procedures that would signifi cantly minimize or prevent the 
identified hazard.  Assuming that occurs, there would be no violation of § 1.507(c).  
(Comment 228)  One comment asserts that the absence of a definition of “customer” 
could result in requiring an importer that sells food dire ctly to consumers who are expected to 
cook the food to obtain multiple letters from consumers to comply the requirement in proposed 
§ 1.504(g) to obtain written assurances that customers are controlling hazards.  The comment 
suggests that we define “custom er” as a business that purchases the imported food for further 
processing or distribution, as stated in the preamble to the proposed rule.  
(Response 228)  We do not believe that it is necessary to include a definition of 
“customer” in the FSVP regulation.  However, we agree that a “customer” under § 1.507 of the 
final rule is not an individual consumer of the food .  Instead, a “customer” under §  1.507 is an 
entity that is subject to the preventive controls regulations or is otherwise subject to applicable 
food safety requirements (e.g., a retail food establishment or restaurant subject to State or local 
food safety requirements).   
I.  Corrective Actions  and Investigations Into FSVP Adequacy  (§ 1.50 8) 
 In § 1.507 of the proposed rule, we proposed that importers be required to review 
complaints of any customer, consumer, or other complain t to determine the adequacy of their 
FSVPs, conduct investigations into potential adulteration of the food they import, take corrective 
actions to address foreign supplier non -compliance, and investigate the potential inadequacy of 282 
 
 
 their FSVP s and make modi fications when appropriate.  As discussed in the following 
paragraphs , we are making several changes to these proposed requirements.  We also are 
renumbering this section  to § 1.508 to accommodate other revisions to the codified  provisions . 
1.  General Comments  
 (Comment 229)  One comment agrees with the requirements in proposed §  1.507 but 
does not believe that the proposed rule would establish adequate regulatory oversight of 
importers.   
 (Response  229)  Under §  1.508 of the final rule, importers will be  required, under certain 
circumstances, to take corrective actions and investigate the adequacy of their FSVPs, which we 
believe will promote more robust and effective FSVPs.  However, it is FDA’s responsibility to 
ensure that importers are in compliance w ith the FSVP regulation, and we intend to meet this 
responsibility by conducting regulatory inspections of importers and by providing guidance, 
outreach, and training to assist importers in meeting the FSVP requirements.  
 (Comment 230)  One comment suggest s that we use complaint and investigation data 
obtained from State and local regulatory agencies.  The comment maintains that these agencies 
play an important role given the local intelligence they maintain and their work with consumer 
complaints and food product investigations.    
 (Response  230)  We appreciate the significant role that State and local regulatory 
agencies play in ensuring food safety in the United States.  We will continue to work and share 
data, including investigative and compliance data , with these agencies to help protect the public 
health.  The purpose of §  1.508, however, is to require importers to perform their own 283 
 
 
 investigations and take their own corrective actions, rather than establish new procedures for 
FDA compliance and enforc ement activities.  
 (Comment 231)  Several comments contend that the recordkeeping associated with 
proposed §  1.507 would be substantially burdensome.  
 (Response  231)  We do not agree that the recordkeeping requirements in §  1.508 will 
impose unreasonable b urdens on importers.  We believe that taking corrective actions is an 
important responsibility for importers and retaining records of these actions is  essential to our 
ability to oversee importers.  Nevertheless, because we are removing certain proposed 
requirements, as discussed in the following paragraphs, we have reduced the recordkeeping 
burden associated with §  1.508 of the final rule.  
2.  Review of Complaints  
We proposed to require importers to promptly review any customer, consumer, or other 
complain t that the importer receives to determine whether the complaint relates to the adequacy 
of the importer’s FSVP (proposed §  1.507(a)).  
 (Comment 232)  Although some comments support the proposed requirement to review 
complaints to determine whether they rel ate to the importer’s FSVP, several comments oppose 
the requirement or ask that it be modified.  Some comments oppose a requirement to review 
complaints because complaint review is already part of reasonable business practice.  Several 
comments maintain th at the proposed requirement would be overly burdensome and that the time 
and effort to correlate complaints to the adequacy of FSVP would not be justified.  Some 
comments maintain that a majority of complaints concern the quality, rather than safety, of fo od.  
Some comments claim that complaints are not always a strong indicator of problems and cannot 284 
 
 
 be used to draw conclusions about the adequacy of an FSVP.  Some comments suggest focusing 
on the importer’s program of review and corrective actions, rather than on individual complaints.  
One comment contends that the PRIA for the proposed rule does not reflect the complexity of a 
complaint review.   
Some comments state that complaint review is required under the proposed FSVP 
regulation but not the preventiv e controls regulations.  Some comments assert that the 
requirement to review complaints may be duplicative given the reporting requirements related to 
the R FR.   
Several comments suggest limiting the requirement to review complaints to those related 
to foo d safety.  One comment asserts that complaints unrelated to food safety are not under FDA 
authority.  One comment asks that importers be required to consider whether complaints relate to 
the adequacy of the FSVP only if specific facts suggest a potential r elationship to supplied 
ingredients.  One comment suggests limiting the sharing of complaints with FDA to emergency 
situations  because this exchange  could be counterproductive to importers’ proactive efforts to 
collect and react to complaint information.   
 (Response  232)  We have removed the proposed requirement in proposed § 1 .507(a) to 
review complaints.  In the preambles to the proposed rule s on preventive controls for human 
food and animal food, we requested comment on whether and how a facility’s revi ew of 
complaints, including complaints from consumers, customers, or other parties, should be 
required as a component of its activities to verify that its preventive controls are effectively 
minimizing the occurrence of hazards (78 FR 3646 at 3768; 78 FR 6 4736 at 64809 , October 29, 
2013 ).  In the preventive controls  final rules , we did not establish a requirement for a review of 285 
 
 
 complaints as a verification activity.  We determined that, although we agree  that reviews of 
complaints occasionally do uncover f ood safety issues such as undeclared allergens, complaint  
reviews  are more likely to be useful in providing information and feedback for continuous 
improvement of the food safety system rather than as a verification of preventive controls.  We 
think that t he same reasoning applies to th e FSVP r egulation .    
In addition, removing the complaint review requirement is consistent with our intent, as 
stated  in the FSVP proposed rule and Supplemental Notice , to coordinate the FSVP regulation 
with any supplier veri fication provisions that might be included in the regulations on preventive 
controls for human and animal food (78 FR 45730 at 45740; 79 FR 58574 at 58576  through 
5857 7).  As we said in the preambles to the final rules on preventive controls, we neverthele ss 
encourage f irms to review complaints  as part of standard business practice .  
3.  Investigation  
In proposed § 1.507(b), we proposed to require that, if an importer became aware that an 
article of food it imported was adulterated under section 402 or misbranded under section 403(w) 
of the FD&C Act, either through review of a complaint or by other mean s, the importer would 
have to promptly investigate the cause or causes of such adulteration or misbranding and 
document the investigation.    
 (Comment 233)  Some comments support requiring importers to investigate adulteration 
of food from foreign supplie rs.  However, some comments express concern that importers might 
not have the capacity to conduct an investigation.  Some comments suggest limiting the 
requirement to conduct investigations to those that are related to food safety or, more 286 
 
 
 specifically, to  those related to adulteration or misbranding that might pose a risk to public 
health; the comments assert that not all adulterants pose a food safety risk.   
 (Response  233)  We are deleting  the requirement to conduct investigations when 
importers become aware that food they import is adulterated under section 402 of the FD&C Act 
or misbranded under section 403(w) of the FD&C Act.  We believe that the obligation to respond 
to negative information about food safety is partly  addressed in § 1.505(c)(1)  of the final rule, 
which requires importers  to reevaluate the risk  posed by  a food or a foreign supplier ’s 
performance  when they become aware of new information about the se factors .  We believe that a 
requirement to conduct investigations as specified in propos ed § 1.507(b) would be 
unnecessarily duplicative and would not substantially contribute to the public health.  In 
addition, removing the investigations requirement in proposed § 1.507(b) is consistent with the 
goal of aligning  the FSVP regulation with the supply -chain  program  provisions in the  preventive 
controls regulations, which  do not require investigations in the circumstances identified in 
proposed § 1.507(b).  We note, however, that investigating potential adulteration to determine 
whether it poses a risk to food safety is prudent, and we encourage importers to undertake such 
investigations when appropriate.  
4.  Corrective Actions  
We proposed, in proposed §  1.507(c), that importers be required to promptly take 
appropriate corrective actions if they d etermined that a foreign supplier of food they import did 
not produce the food in compliance with processes and procedures that provide the same level of 
public health protection as those required under section 418 or 419 of the FD& C Act, if either is 
applicable, or produced a food that was adulterated under section 402 or misbranded under 287 
 
 
 section 403(w) of the FD&C Act (the standard for FSVPs set forth in FSMA and proposed 
§ 1.502(a) of the FSVP regulation).  We proposed that this d etermination could be based on an 
investigation into adulteration conducted under proposed §  1.507(b), the supplier verification 
activities the importer conducted under proposed §  1.506 or § 1.511(c), the FSVP reassessment 
conducted under proposed § 1.508,  or otherwise.  Proposed 1.507(c) further stated  that the 
appropriate corrective actions would depend on the circumstances but could include 
discontinuing use of the foreign supplier until the cause or causes of noncompliance, 
adulteration, or misbranding had been adequately addressed.  We further proposed to require that 
importers document any corrective actions taken in accordance with §  1.507(c).  
To reflect changes we are making to other provisions in this final rule, we have revised 
the requirement to t ake corrective actions (§  1.508(a) of the final rule).  With respect to the basis 
for a determination that a corrective action is needed, we are replacing the reference to §  1.508 
with a references to §  1.505(c) to reflect the  replacement of FSVP reassessm ent with reanalysis 
of the food and foreign supplier .  We also are removing the reference to investigations conducted 
under proposed § 1.507(b) because we are  deleting  that provision.  In addition, § 1.508(a) states  
that a determination that corrective act ion is needed could be based on a review of consumer, 
customer, or other complaints related to food safety.  Under the proposed rule, such a  
determination could also have been based on a complaint , but g iven our decision to remove the 
requirement to review  complaints, we conclude that it is appropriate to direct importers to the 
fact that complaints may serve as the basis of the determination.  With all of these revisions, 
§ 1.508(a) of the final rule states that a determination that a corrective action is needed could be 
based on a review of consumer, customer, or other complaints related to food safety, verification 288 
 
 
 activities conducted under §  1.506 or §  1.511(c), a reevaluation of the risk posed by the food and 
the foreign supplier’s performance conducte d under §  1.505(c), or any other relevant information 
the importer obtains.  
 (Comment 234)  One comment assets that, because not all adulterants cause an actual 
food safety risk, the requirement  to take corrective actions should be limited to situations in  
which the foreign supplier’s failure causes a risk to public health.  Similarly, one comment 
requests that the proposed requirement (in § 1.507(d)) to investigate to determine the adequacy 
of the importer’s FSVP be limited to situations in which the forei gn supplier’s failure causes a 
risk to public health.  
(Response  234)  We decline to make changes in response to these comments.  To the 
extent that the comments suggest that importers need not take corrective actions if they believe 
that the food they import does not cause a risk to public health, we note that section 805(a)(1) of 
the FD&C Act states that each importer must  perform risk-based foreign supplier verification 
activities for the purpose of verifying that the food imported by the importer is not adulterated 
under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act.  If a 
food that an importer imp orts is adulterated or misbranded with respect to allergen labeling, not 
taking  corrective action would be inconsistent with section 805(a)(1).  However, the particular 
corrective action warranted could differ depending on the circumstances, including the level of 
risk to public health posed by the particular non -compliance.  For example, if non -compliance 
could cause a serious risk to public health, we would expect an importer to stop importing food 
from that supplier until the non -compliance was corrected .  However, we might not expect this 
type of correct ive action when the non -compliance c ould be corrected through other measures.   289 
 
 
 All corrective actions are relevant to decisions that an importer may need to make with regard to 
a supplier.  If, f or example, a supplier’s facility has filthy conditions or the food it supplies is 
contaminated with filth, an importer may find it inappropriate to approve that supplier even 
though filth often does not pose a risk to public health.  
 (Comment 235)  One co mment maintains that RACs will already have been consumed 
before responsibility for non -compliance or adulteration can be assigned and corrective actions 
taken.  
 (Response  235)  We do not agree that RACs in all cases will necessarily have been 
consumed bef ore an importer has the opportunity to take corrective action.  Regardless, under 
§ 1.508(a) of the final rule, importers must promptly take whatever corrective actions are 
appropriate depending on the circumstances.  In some circumstances, the appropriate  corrective 
actions may prevent problems from recurring.  For instance, in some cases the appropriate 
corrective actions m ight include discontinuing use of the foreign supplier until the cause or 
causes of non -compliance, adulteration, or misbranding have been adequately addressed.  
 (Comment 236)  Some comments object to the proposed requirement’s reference to 
discontinuing use of a foreign supplier under certain circumstances, asserting that discontinuing 
use of a supplier is an extreme response that shou ld be reserved for only the most serious 
situations.  Some comments suggest that if the foreign supplier implements appropriate 
corrective actions following a nonconformance, the importer should be permitted to continue to 
source from that supplier.  
 (Resp onse 236)  We decline to delete the reference to possible discontinuation of use of a 
foreign supplier.  Section 1.508(a) of the final rule does not specify conditions under which 290 
 
 
 importers must cease using a foreign supplier; rather, it states that such a ction, even if only on a 
temporary basis, might be an appropriate corrective action under certain circumstances.  We 
believe that some supplier actions, such as a failure to promptly or effectively respond to serious 
safety concerns identified in the food they have supplied, might warrant temporary or even 
permanent discontinuation of use of that supplier.  However, we agree with the comments that 
responsive actions by a foreign supplier to address its nonconformance could make it 
unnecessary for the import er to discontinue importing food from the supplier.  
 (Comment 237)  Several comments suggest that an importer’s corrective actions need not 
necessarily require a physical visit to a foreign supplier.  
 (Response  237)  We agree, and the final rule does not r equire that an importer visit the 
foreign supplier’s establishment as part of any corrective action conducted under §  1.508(a).   
 (Comment 238)  One comment recommends that actions taken to be removed from 
import alert be considered corrective.  
 (Response  238)  We agree that actions taken to remove a foreign supplier from an import 
alert might be appropriate corrective actions under §  1.508(a), provided that those actions correct 
the underlying problem that precipitated the need for corrective actions unde r that provision .  
 (Comment 239)  Some comments suggest we keep any information and dialogue 
concerning potential corrective actions confidential.  
 (Response  239)  As discussed in section III. K.6 of this document, §  1.510(f) of the final 
rule states that records obtained by FDA in accordance with the FSVP regulation (which would 
include documentation of corrective actions taken under §  1.508(a)) are subject to the public 291 
 
 
 information regulations in part 20.  The provisions  in part 20 provide protections from public 
disclosure for trade secrets and confidential commercial information.  
5.  Investigations to Assess Adequacy of FSVP  
We proposed to require, in §  1.507(d), that if an importer determines, by means other 
than the ve rification activities conducted under proposed § 1.506 or § 1.511(c) or the FSVP 
reassessment conducted under proposed § 1.508, that a foreign supplier of food does not produce 
food in compliance with processes and procedures that provide the same level of  public health 
protection as those required under section 418 or 419 of the F D&C  Act, if either is applicable, or 
produces food that is adulterated under section 402 or misbranded under section 403(w) of the 
FD&C  Act, the importer must promptly investigate  to determine whether i ts FSVP is adequate 
and, when appropriate, modify the FSVP.  We also proposed to require that the importer 
document any investigations, corrective actions, and changes to the FSVP that it undertakes in 
accordance with this requiremen t. 
 To reflect changes we are making to other provisions in this final rule, we have revised 
the requirement to investigate to determine the adequacy of FSVPs (§  1.508(b) of the final rule).   
With respect to the  means by which an importer might  determin e that a foreign supplier does not 
produce food in accordance with applicable requirements , we are replacing the reference to 
§ 1.508 with a reference to §  1.505(c)  (reevaluation of foreign supplier performance and the risk 
posed by a food) .   
6.  No Limitati on of Obligations  292 
 
 
 In the proposed rule, we proposed to specify (in § 1.507(e)) that § 1.507 does not limit an 
importer’s obligations with respect to other laws enforced by FDA , such as those relating to 
product recalls.  T his provision is codified  in § 1.5 08(c)  of the final rule . 
J.  Identification of Importer at Entry (§ 1.509)  
 We proposed to require that FSVP importers be identified as the importer of the food that 
they bring into the United States when the food is imported or offered for import.  Specifically, 
we proposed to require that, for each line entry of food product offered for importation into the 
United States, the importer’s name and Dun & Bradstreet Data Universal Numbering System 
(DUNS ) number identifying the importer be provided elect ronically when filing entry with CBP.  
This proposed requirement was intended to ensure that food importers are accurately identified 
so that we can effectively implement and monitor compliance with the FSVP regulation in a risk -
based manner.  
In response to comments, we have replaced the proposed requirement that importers 
obtain a DUNS number and ensure that it is provided when filing entry with a requirement to 
provide the importer’s unique facility identifier recognized as acceptable by FDA.  However, as 
discussed in the following paragraphs, we anticipate that we will issue a guidance document that 
recognizes DUNS numbers as being acceptable to FDA .  The final rule also adds a requirement 
to provide an electronic mail address for the importer  as part of  the identification at entry . 
1.  Provision of Importer’s DUNS Number  
We proposed to require importers to obtain a DUNS number from Dun & Bradstreet and 
to ensure, for each line of entry of food product, that the importer’s name & DUNS number are 
provided electronically when filing entry with CBP.  We proposed to require the use of a DUNS 293 
 
 
 number because, as a numerical identifier assigned to a specific business location, use of the 
DUNS number would provide more accurate identification of importers than use  of the firm’s 
name and address.  We requested comment on the proposed use of DUNS numbers to identify 
importers under the FSVP regulation as well as comments on the use of alternative  identifiers.  
 (Commen t 240)  Some comments oppose this proposed require ment generally because 
they believe it is unnecessary or would not assist FDA in monitoring importers.  One comment 
questions the need for the proposed requirement given Agency statements that it cannot inspect 
its way to food safety.  Some comments oppose  the proposed requirement because they assert 
that we already receive adequate information to establish the identity of the importer in 
accordance with  the prior notice regulation . 
 (Response  240)  We do not agree with the comments.  Although the prior notice 
regulation require s the submission of the name and full address of the importer of a food  
(21 CFR 1.281 (a)(12)), the entity named as the importer for prior notice might not necessarily be 
the importer of the food for purposes of FSVP, as the term “i mporter” is defined in § 1.500 .  We 
agree that we cannot ensure the safety of food through our inspections alone, which is why 
Congress directed us to promulgate these this regulation to require importers to conduct foreign 
supplier verification to  ensur e that the food they import is as safe as food produced in the United 
States .  Although we cannot inspect each and every food product that is imported into the United 
States, we can use our authority under section 805 of the FD&C Act to  help ensure th at impo rters 
conduct appropriate foreign supplier verification activities.  
We conclude that requiring importers  (under §  1.509)  to ensure that they are accurately 
identified at entry  will help us  efficiently and effectively ensur e that importers are complying 294 
 
 
 with the FSVP requirements.  For example, we might  use this information to create a 
comprehensive and up -to-date database that will allow us to efficiently and effectively identify 
and locate importers for inspection.  At the same time, knowing the identity of importers will 
also help us carry out section 421(b) of the FD&C Act.  This provision, also added by FSMA, 
requires FDA to allocate its  resources for examining imported products based on certain risk 
factors, including the rigor and effectiveness of the importer’s FSVP.  To effectively implement 
this provision , we need to know, at the time of importation, who the importer is.  While we 
currently receive information identifying the importer through  prior notice submissions in 
accordance with section 801(m) of the FD&C Act, the entities identified in prior notice 
submissions are not necessarily the importers for the purposes of FSVP, as disc ussed previously.  
Without information identifying the FSVP importer, we would be less equipped to account for 
the rigor and effectiveness of importers’ FSVPs in allocating our resources for examining food in 
accordance with section 421(b).    
Finally, obt aining the identity of the importer at entry will likely help us meet the 
requirement, stated in section 805(g) of the FD&C Act, to “publish and maintain on [our] 
Internet Web site . . . a current list that includes the name  of, location of, and other info rmation 
deemed necessary by [FDA] about, importers participating under [section 805].”   For all these 
reasons, the requirements regarding the identification of importers are consistent with sections 
421(b), 805 , and 701(a) of the FD&C Act, the la st of whic h authorizes us to promulgate 
regulations for the efficient enforcement of the FD&C Act.    
(Comment 241)  Several comments oppose requiring importers to obtain a DUNS 
number to provide when filing entry of products.  Some comments maintain that requiring use of 295 
 
 
 the DUNS number would cause confusion and impose unnecessary costs and burdens on 
importers because other adequate or even superior means of importer identification exist, such as 
information required for CBP entry and prior notice.  One comment sta tes that the existing 
facility registration system is sufficient to meet FSMA’s directives, less burdensome, and more 
secure.  One comment maintains that requiring use of DUNS numbers would cause importers to 
incur costs to create or modify their internal systems and relationships with brokers to establish a 
new numbering system and index the new identifier to the appropriate documents.  Some  
comments express concern about FDA relying on a privately owned and operated system when 
government -issued numbers c ould serve the same purpose.  Some comments question whether 
FSMA gives FDA legal authority to require importers to obtain a DUNS number.  Some 
comments are concerned that requiring use of a DUNS number might raise security and fraud 
risks because a DUNS n umber would not have the same protections under the FOIA as an FDA 
registration number.  Some comments express concern that the requirement would give the 
Agency access to importers’ business information in the DUNS database or otherwise lead to 
disclosure  of confidential information (e.g., through erroneous designation of a company as the 
importer of a food). 
Instead of, or as an alternative to , use of a DUNS number, some comments suggest that 
importers be allowed to use other identifiers , such as the foll owing:  
•  The taxpayer identification number (TIN) used with CBP ; 
•  The FDA facility registration number (if the importer is a registered facility) ; 
•  The form used to meet the prior notice requirements (modified to allow identification, 
where appropriat e, of a U.S. agent or representative as the importer for FSVP purposes) ; or 296 
 
 
 •  The CBP importer of record number.   
Some comments suggest that instead of requiring identification at entry, we should require 
importers to register with FDA.  
(Response  241)  We conclude that it is necessary to establish , in §  1.509(a) of the final 
rule, an importer identification requirement specifically for the FSVP regulation to ensure that 
the identified importer at the time of entry  is, in fact,  the “importer” of the food as defined in 
§ 1.500 of the final rule.  In addition, we conclude that use of a unique facility identifier, such as 
a DUNS number , is an appropriate mechanism for accurately identifying importers responsible 
for complying with the FSVP regulation because such identifiers provide unique identification 
numbers, which  will allow us to efficiently and accurately identify importers.  The DUNS 
number system, for instance, is an internationally recognized system  that is updated on a re gular 
basis  and makes numbers  available at no cost .  DUNS numbers also  provide for site -specific 
identification of business entities.   
We conclude that use of FDA registration numbers would not be appropriate for FSVP 
importer identification purposes beca use not all “importers ” under § 1.500 will necessarily be 
facilities required to register under section 415 of the FD&C Act.   Likewise, not all importers 
under §  1.500 will necessarily be “importers of record” for purposes of CBP entry submissions 
and ther efore will not necessarily have CBP importer of record numbers.  Any other CBP -
required identifying information also would not necessarily identify the FSVP importer because 
CBP requirements do not incorporate the definition of “importer” under § 1.500.  We do not 
believe that revising the information required for prior notice would be appropriate because the 
prior notice regulation serve s a different purpose than the FSVP regulation.  For these reasons , 297 
 
 
 we do not agree that using the alternative identifier s suggested by the comments would allow 
FDA to accurately identify FSVP importers.  Consequently , they would not allow FDA to 
efficiently enforce section 805 of the FD&C Act in the ways described in response to the 
previous comments.   
With respect to conc erns about use of unique facility identifiers  leading to the disclosure 
of confidential information or posing security risks, any confidential information that we obtain 
regarding importers would be subject to the applicable protections from public disclos ure under 
part 20 of our regulations  (see section III.K.6 of this document) .  Those protections include, 
among other things, exemptions from public disclosure for trade secret information and 
confidential commercial information  (§ 20.61 ).  As for concerns regarding security risks, we 
intend to take appropriate measures to secure all electronic data provided to the Agency, 
including data about the identification of importers.    
For these reasons, we believe that requiring unique facility identifiers is the most 
appropriate way to accurately identify food importers for purposes of monitoring FSVP 
compliance.  To provide additional flexibility beyond what we had proposed, the final rule does 
not require the submission of DUNS numbers for importers of  foods offered for importation into 
the United States.  Instead, it requires the submission of a unique facility identifier recognized as 
acceptable by FDA .  We anticipate that we will issue guidance specifying which unique facility 
identifier or identifiers FDA rec ognizes as acceptable, and we expect to state  that we recognize 
DUNS number s as acceptable  identifiers .  Although we will allow importers to request the use of 
different identification number s, it is possible that our information technology systems will not 
be able to accommodate any numbers other than those that we may specifically recognize as 298 
 
 
 acceptable in guidance.  If that is the case, we would have to manually review entry submissions 
that include alternate unique facility identifiers .   
In addition to the importer’s name and DUNS number, the final rule also requires that the 
importer’s electronic mail address be provided  as part of the identification at entry.  This 
requirement follows f rom our request for comment on whether we should require the submission 
of any additional identifiers for importers.  We believe that an e lectronic mail address is an 
appropriate additional identifier to require for importers, especially because e lectronic  mail 
addresses allow for quick and efficient communications between FDA and importers .  We 
anticipate that we might use the e lectronic mail address es to notify at least some of the persons 
listed at those addresses that they have been identified as FSVP i mporters, including persons 
who have been designated as the U.S. agent or representative of a foreign owner or consignee for 
purposes of the definition of “importer .”  We also might use e lectronic mail addresses to 
communicate with importer s more generally , including  to help us resolve any questions 
regarding a food offered for importation to potentially facilitate review of that food.   Requiring 
electronic mail addresses is thus grounded in the statutory objective of efficiently enforcing the 
food safety a nd FSVP requirements of the FD&C Act.  By requiring e lectronic mail addresses 
for importers, we would be able to communicate efficiently and effectively with importers 
regarding their role under the FSVP regulation and with respect to the food they offer f or import.  
 (Comment  242)  Some comments maintain that if an importer has multiple U.S. 
locations, it will only have a single DUNS number that will not provide information about the 
food’s destination (i.e., a specific importer facility).  On the other ha nd, one comment maintains 
that having a different DUNS number for each corporate location would be confusing.  Some 299 
 
 
 comments suggest that, if we were to require importers to use DUNS numbers, importers should 
be allowed to use a single DUNS number (e.g., f or their corporate headquarters) even if they 
have multiple U.S. sites.  
 (Response  242)  As discussed in the previous paragraphs, the final rule does not require 
that an importer’s DUNS number be  provided  for each line of entry of food.  Instead, it requires 
that a unique facility identifier recognized as acceptable by FDA be provided.  However , we 
anticipate that we will issue guidance that will recognize DUNS numbers as acceptable .  We 
understand that DUNS number s are specific  to physical location s; therefore,  an importer with 
more than one physical location likely would have more than one DUNS number.  In that 
circumstance, the  importer should generally provide  the DUNS number that applies to the 
locatio n at which the importer retains its records of FSVP activities  for the food for which it 
provides  its DUNS number  at entry under §  1.509(a) , as that typically is the location that FDA 
investigators would need to visit to inspect the importer for compliance  with the FSVP 
regulation.  If an importer elects to retain its FSVP records for the food at its corporate 
headquarters, we would expect the importer to provide the DUNS number for its headquarters 
when it provides the information required under §  1.509(a) . 
 (Comment 243)  One comment, stating that FDA databases include multiple assigned 
numbers (e.g., Central File Number ( CFN ), Firm Establishment Identifier ( FEI)) for a firm due to 
slight changes in names and addresses and fraudulent or misguided submissio ns, recommends 
that we take steps to prevent the issuance of multiple DUNS numbers for the same importer.  
 (Response  243)  We are unable to restrict importers’ ability to seek DUNS numbers for 
multiple office or facility locations.  However, as stated prev iously, we will expect importers to 300 
 
 
 provide the unique facility identifier for the location at which the importer retains its FSVP 
records for the food for which it submits the unique facility identifier .  
(Comment 244)  Some comments express concern that the process of applying for and 
receiving a DUNS number can be lengthy and might delay imports.   
 (Response  244)  We do not agree  that the process of applying for whatever unique 
facility identifier that we recognize as acceptable will delay imports .  With respect to DUNS 
numbers, a lthough we understand that it might take up to 45 business days to receive a DUNS 
number (when obtained at no charge), importers will have more than a year (in some cases much 
longer) to come into compliance with the FSVP regula tion, which will provide importers who do 
not currently have a DUNS number with ample time in which to obtain one.  
 (Comment 245)  One comment states that there should be an affirmative requirement for 
the importer of record for a food to provide the name and DUNS number of the FSVP importer 
on its entry declaration, because the importer of record is responsible for the entry.  
 (Response  245)  The final rule requires that the FSVP importer be identified at the time 
of entry , so the unique facility identifier for importers will be a mandatory data element in the 
entry filing process with CBP.  However, because a  food’s importer of record might not 
necessarily be the food’s FSVP importer, we do not think that the requirement to p rovide the 
unique facility identifier should fall to the importer of record.  Instead, we believe that it is 
appropriate for the requirement to apply to a person who is subject to the requirements of the 
FSVP regulation.  Depending on who files entry with CBP, an importer of record  for a food may 
or may not be the FSVP importer .  Of course, the FSVP importer of a food might arrange to have 
the importer of record for the food  provide the FSVP importer’s identification information at 301 
 
 
 entry.  In any case , it is the importer’s responsibility to ensure that the information identifying 
the importer is provided at entry by some entity.   
 (Comment 246)  Some comments assert that we should only require information on a 
line-entry basis when there is more than one importer for a shipment or when the CBP importer 
differs from the FSVP importer.  
 (Response  246)  We do not agree.  We conclude that FSVP importer identification is 
needed on a line -entry basis because importers are  required to establish FSVPs for each food that 
they import from a particular foreign supplier, and obtaining importer identification information 
on a line -entry basis will help us assess compliance with the FSVP requirements  in order to 
efficiently enforc e section 805 of the FD&C Act .  
 (Comment  247)  Some comments request that we specify the data elements that will be 
required at entry, when they must be provided, and in what format.  However, the comments ask 
that we provide this information in guidance rather than the final rule because information 
systems can change over time.  
 (Response  247)  To the extent that the comment s request that we use guidance to provide 
information on the details of the exact manner and format in which importer identification  
information should be provided, w e agree.  Section 1.509(a) of the final rule establishes the 
require ment s that importers ensure that their name, electronic mail address, and unique facility 
identifier are provided electronically to CBP for each line entr y of food product they import.  We 
anticipate that we will provide more detailed formatting and other information through guidance.   
 (Comment 248)  One comment requests that we specify what information will be 
publicly available under CBP’s confidentiali ty provisions.  302 
 
 
  (Response  248)  For information about the disclosure of records created or obtained by 
CBP and under the control of CBP, we suggest contacting  CBP directly.   However, we note that 
CBP regards  confidential commercial information appearing on  entry documents as exempt from 
disclosure under Exemption 4 of the FOIA  (5 U.S.C. 552(b)(4)) .   
 (Comment 249)  Some comments express concern about the proposed requirement that 
the importer’s name and identification number be provided electronically when  filing entry.  One 
comment asserts that this information might be “hacked” or fall into the wrong hands through 
error, creating a risk of adulteration or potential terrorist acts.  One comment suggests that we 
permit importers to file FSVP information bef ore filing entry with CBP as part of the prior notice 
form.  The comment also urges us to provide timely admissibility determinations about imports 
shipped under FSVP; the comment maintains that importers often do not file the CBP entry 
summary until after  the arrival of imported products, and release of goods might be delayed if 
importers must wait to file FSVP -required information.  The comment suggests that early 
submission of FSVP information would give FDA and the importer more time to make 
admissibili ty determinations, resolve any perceived failures to comply with FSVP, and, if 
admission is refused, give the foreign supplier more time to react to the delivery disruption.  
 (Response  249)  We do not agree that there is any need to change the requirement that 
FSVP importers be identified electronically when filing entry with CBP.  With respect to the 
concerns about information being “hacked,” CBP’s electronic filing system is a secure system 
and CBP takes adequate steps to address security.  With respect t o the request to permit 
importers to file FSVP information before submitting entry, we decline this request.  We believe 
that the requirement to submit importer identification information at entry is consistent with the 303 
 
 
 definition of importer in section 80 5(a)(2)(A) -(B) of the FD&C Act (i.e., the U.S. owner or 
consignee of an article of food “at the time of entry of such article into the United States” or, if 
there is no U.S. owner or consignee at the time of entry, the “United States agent or 
representativ e . . . at the time of entry”).  To ensure that the identified importer is the person who 
meets this definition, we believe it is appropriate to require that importers file their FSVP 
information at entry.   
With respect to the request to permit importers to file FSVP information as part of the 
prior notice form, we similarly do not think that doing so would be appropriate.  Some entities 
who submit prior notice information for a food might lack information ab out the FSVP importer 
of the food .  As a result, we anticipate that there would be technical challenges to allowing the 
submission of FSVP information during prior notice that could lead to delayed entries .  
However, we note that because some entities may make a business decision to file prior notice 
with the entry, there may be some cases in which FSVP information is provided at entry at the 
same time that prior notice is submitted.     
We also do not agree that it is necessary to make any changes to § 1.5 09 to account for 
the fact that some importers delay the submission of CBP entry summary information .  Although 
it might be the case that importers often do not file the CBP entry summary until after the arrival 
of imported products, importers can file ent ry earlier if they desire.  There is no requirement that 
importers wait until after the arrival of imported products to file entry with CBP.  Further, we do 
not think  filing of importer identification information under § 1.509 will ordinarily trigger entry  
delays.  304 
 
 
  (Comment 250)  Some comments request that we provide guidance to clarify FDA’s and 
CBP’s regulatory requirements regarding importer responsibilities.   Some comments ask that we 
provide a technology platform for industry to use to comply with the importer identification 
requirements.  
 (Response  250)  The FSVP draft guidance will advise importers on how they can ensure 
that their name, electronic mail address, and unique facility identifier are provided to CBP when 
a food is offered for importation  in accordance with §  1.509(a).  
2.  Designation of U.S. Agent or Representative  
 We proposed to require (in proposed § 1.509(a)) that, before an article of food is 
imported or offered for import into the United States, the foreign owner or consignee of th e food 
(if there is no U.S. owner or consignee) must designate a U.S. agent or representative as the 
importer of the food for the purposes of the definition of “importer” in §  1.500.  As discussed in 
section III.A. 13 of this document, we are adding a clari fication to the definition of “importer” in 
§ 1.500 stating  that for the foreign owner or consignee of the article to validly designate a U.S. 
agent or representative for the purposes of the definition of “importer,” the U.S. agent or 
representative’s role must be confirmed in a signed statement of consent.  The s igned statement 
of consent must confirm that the U.S. agent or representative agrees to serve as the importer for 
the purposes of the FSVP regulation.  
 (Comment 251)  Some comments suggest that we should have a better database of 
designated U.S. agents (fo r FSVP purposes) than exists for U.S. agents named in foreign facility 
registrations.  305 
 
 
  (Response  251)  Section 415(a)(1)(B) of the FD&C Act provides in relevant part that the 
registration of a foreign food facility must include the name of the U.S. agent f or the facility.  As 
we have  discussed in connection with a proposed rule to amend the Agency’s regulation on food 
facility registration, we have  learned that in some cases persons identified as U.S. agents in 
foreign food facility  registrations  were unawa re that they had been so identified, and had not in 
fact agreed to serve as U.S. agents for foreign food facilities (80 FR 19160 at 19169 , April 9, 
2015 ).  To the extent that the comment is concerned about the accuracy of designations of U.S. 
agents who would serve as FSVP importe rs in accordance with §  1.500, we conclude that the 
clarification we are making to the definition of “importer” in § 1.500 adequately addresses this 
concern.  Specifically, w e conclude that the clarification that any designation of  a U.S. agent or 
representative as the FSVP importer must be confirmed in a signed statement of consent will 
help ensure that the U.S. agents or representatives who are so designated have in fact agreed to 
serve in that role.  As discussed in section III.A.13, we might request the foreign owner or 
consignee that is exporting the food to provide us with the signed statement when and if any 
questions arise about whether the person designated as the U.S. agent or representative agreed to 
serve in that role.  Although we do not plan to  establish a separate database for U.S. agents and 
representatives responsible for functioning as FSVP importers , we will include these entities in 
the list of all importers subject to the FSVP regulations that we will maintain on  our Web site  in 
accordance with section 805( g) of the FD&C Act , as discussed in section III. J.3 of this 
document.  306 
 
 
  (Comment 252)  One comment asks that U.S. agents and representatives of foreign 
owners be excluded from the requirement to identify the impo rter at entry because agents and 
representatives have limited information available to them.  
 (Response  252)  We do not agree.  Under section 805(a)(2)(B) of the FD&C Act, the 
importer of a food for purposes of meeting the FSVP requirements must be the U.S . agent or 
representative of the foreign owner or consignee of the food when there is no U.S. owner or  
consignee at the time of entry of the food into the United States.  Foreign owners or consignees 
will need to ensure that the persons who agree to serve  as their U.S. agent or representative for 
purposes of functioning as the FSVP importer have or can obtain the information and capability 
needed to meet their obligations as importers subject to the FSVP regulation.  
3.  FDA List of Importers “Participating  Under” the FSVP Regulation  
In the preamble to the proposed rule, we stated that obtaining the identity of the importer 
at entry could help us meet the requirement, in section 805(g) of FD&C Act, to maintain on our 
Web site a list of “importers participati ng under this section,” i.e., section 805 regarding FSVPs.  
We stated that the meaning of the phrase “importers participating under this section” was 
ambiguous (e.g., it might refer to all importers subject to section 805 or only those importers in 
complia nce with section 805), and we sought comment on the meaning of the phrase and the 
purpose of section 805(g).  
 (Comment 253)  Some comments suggest that we identify all importers that are subject to 
the FSVP regulation.  Some comments agree that the meaning  of the phrase “participating under 
this section” is ambiguous but suggest that we focus on only those importers that are in 
compliance with the FSVP regulation.  These comments assert that such a list would be helpful 307 
 
 
 to retailers and others who seek to s ource from or otherwise employ the services of such 
importers.  Some comments maintain that although section 805(g) was intended to produce  a 
comprehensive list of all importers, FDA’s intended use of the list and its plans for maintaining 
an accurate data base are ambiguous.  Some comments request clarity regarding what other 
information about  importers we will “deem necessary” under section 805(g).  Some comments 
encourage us to comply with the statute in a manner that does not conflict with CBP’s 
confiden tiality regulations, allowing companies to continue protecting sensitive shipping details 
such as those concerning product sourcing and distribution.   
Some comments oppose any listing of importers “participating under” the FSVP 
regulation.  Some comments q uestion the meaning of the phrase “importers participating under 
this section” and the purpose of the list.  Some comments contend that this provision does not 
belong in section 805 because that section creates requirements for all importers; these 
comment s argue that maintaining a list of importers would be a huge task that would serve no 
purpose.  One comment contends that publishing a list of names and locations of importers 
appears to be in direct conflict with section 415(a)(5) of the FD&C Act, which e xempts facility 
registration records from public disclosure.  Some comments suggest that, before publishing a 
list of “participating” importers, we should seek clarification from Congress regarding the 
meaning of section 805(g) , or ask Congress to either d elete the requirement or move it to the 
FSMA provisions concerning the VQIP for food importers (set forth in section 806 of the FD&C 
Act).  
 (Response  253)  In publishing the list of importers “participating” in FSVP, we intend  to 
develop a  list that include s importers who are subject to the FSVP regulation (and not exempt 308 
 
 
 from the requirements under § 1.501 of the final rule).  Although we agree that a list of importers 
deemed to be in compliance with the FSVP regulation might be of interest to the pu blic, even 
importers that are the subject s of enforcement action s for non -compliance with the FSVP 
regulation are “participating” under th e regulations, given that importer compliance with the 
FSVP regulation is not voluntary.  Moreover, maintaining a list  of importers deemed to be in 
compliance with the FSVP regulation would impose a substantial burden on the Agency.   
Maintaining a list of importers that are subject to the FSVP regulation, however, would be more 
administratively manageable, especially beca use we will be able to use the importer 
identification information provided under § 1.509(a) to establish and maintain the list.  
 Besides the name and location of importers, we are uncertain what other information, if 
any, we will include as part of our li st of importers subject to the FSVP regulation.  We plan to 
continue to consider whether we should include any additional information in the list.  We will 
maintain the list on our Web site in accordance with the applicable public disclosure 
requirements , including the requirements  in part 20.  
K.  Records ( § 1.510)  
 We proposed several requirements concerning the manner in which FSVP records would 
be maintained and made available to FDA (proposed §  1.510).  In response to comments 
received and to better ali gn the FSVP records requirements with records provisions in other 
FSMA regulations, we have revised certain requirements regarding record availability (including 
offsite storage) and retention, and we have added provisions regarding electronic records, use  of 
existing records, and public disclosure.  309 
 
 
 1.  Records Content and Format  
 We received some comments of a general nature regarding recordkeeping requirements.  
 (Comment 254)  Some comments suggest that FDA educate itself about the content and 
format of r ecords that importers and foreign suppliers maintain; the comments state that we 
should take into account the use of different systems in different countries and not impose a 
single, restrictive reporting rubric.  One comment asks that the records importer s are required to 
keep be based on an importer’s risk assessment and not be specified in the regulation.  
 (Response  254)  As discussed elsewhere in this document, we are requiring that importers 
document certain determinations they make and actions they ta ke to meet the FSVP 
requirements, including regarding hazard analysis, evaluation of the risk posed by a food and the 
foreign supplier’s performance, and supplier verification.  In several areas, such as onsite 
auditing of foreign suppliers, testing of imp orted food, and review of foreign supplier food safety 
records, we conclude that it is appropriate to require the documentation of specific information to 
ensure that importers can adequately assess whether their suppliers are producing food consistent 
with the applicable requirements.  In addition, importer maintenance  of certain records 
containing information required under the regulations will help us determine whether importers 
are taking adequate measures to ensure that they import safe food.  However, as stated in section 
III.G.6 of this document with respect to documentation of foreign supplier verification activities, 
the regulation generally do es not specify a particular form or format for required documentation.  
In addition, § 1.510(e) of the final rule allows importers to use existing records if they contain 
the information required by this part (see the response to the following c omment ). 310 
 
 
  (Comment 255)  Some comments suggest that FDA train its investigators to understand 
that there will be a wide range of documentation approaches importers take that should be 
viewed as acceptable.  The comments maintain that importers should be allowed to docu ment 
their program as a whole (e.g., using a tier ed or matrix approach to assessing supplier and 
ingredient risk and determining the corresponding verification activities) rather than maintaining 
a separate file for each individual supplier or food.  The c omment s assert  that importers should 
not be required to keep a narrative file explaining their reasoning as to which verification 
activities are appropriate  for each supplier and food.   
 (Response  255)  As previously stated, the FSVP regulation generally does not require the 
use of specific formats for the information that must be included in required records.  However, 
the regulation require s importers to conduct a hazard analysis for each type of food they import, 
evaluate the risk associated with each f ood and the foreign supplier’s performance, and use that 
evaluation to approve their foreign suppliers and determine appropriate supplier verification 
activities.  Although importers may use a risk matrix or risk tier system to help them approve 
foreign su ppliers and determine appropriate verification activities for particular food s and 
suppliers, importers must document, for each food and its foreign supplier, the evaluation of the 
food and the supplier and the determination of the appropriate type and fre quency of supplier 
verification activities based on that evaluation.  FDA investigators might  not be able to 
determine whether an importer had met these and other FSVP requirements for a particular food 
and foreign supplier simply by reviewing an importer’ s risk matrix or tier system , depending on 
the level of information and detail provided in the matrix or system .  The maintenance of records 
on a food -and-supplier basis is essential to providing adequate assurance of the safety of foods 311 
 
 
 obtained from each  foreign supplier.  This is especially important when an importer determines 
that a method other than annual onsite auditing can provide adequate assurance that 
SAHCODHA hazards in food are significantly minimized or prevented . 
 However, on our own initiat ive to align the FSVP regulation with other FSMA 
regulations, we have added to the final rule provisions allowing importers to use existing records 
under certain conditions to meet FSVP requirements.  Section 1.510(e)(1) of the final rule states 
that exist ing records (e.g., records kept to comply with other Federal, State, or local regulations) 
do not need to be duplicated if they contain all of the information required under the FSVP 
regulation for each food and satisfy the FSVP requirements , including, as  described above, that 
the records are specific to each food .  Section 1.510(e)(1) further states that importers may 
supplement existing records as necessary to include all of the required information and satisfy 
the FSVP requirements.  In addition, under §1.510(e)(2), importers are not required to keep 
required information in one set of records.  If existing records contain some of the required 
information, any new information required by the FSVP regulation may be kept separately or 
combined with existing  records.  
2.  General Requirements  
 We proposed, in §  1.510(a), that importers be required to sign and date records 
concerning their FSVPs upon initial completion and subsequent modification.  
 (Comment 256)  Some comments support not specifying which particular qualified 
individual must sign the FSVP records.   
 (Response  256)  We agree that it is not necessary to specify a particular qualified 
individual who must sign and date all FSVP records for the impor ter.  However, the qualified 312 
 
 
 individual signing a record on behalf of the importer must have  the authority to do so and be 
qualified to review and assess what he or she is signing.  
 (Comment 257)  One comment suggests that only certain records should have to be 
signed and dated; these records would primarily be those concerning the following:  compliance 
status review (a proposed requirement that w e deleted in the Supplemental Notice); hazard 
analysis; supplier verification activities; complaint review, inv estigations, and corrective actions; 
FSVP reassessment; dietary supplements; and very small importers and very small foreign 
suppliers .  
 (Response  257)  We do not agree .  The comment did not provide a reason as to why the 
other records do not need to be s igned and dated , and we conclude that to aid in accountability 
and the efficient enforcement of the requirements in section 805 of the FD&C Act, importers 
must sign and date all records required under the FSVP regulation.  
 (Comment 258)  One comment asks that we state in guidance that electronic signatures 
are acceptable.  
 (Response  258)  We agree that electronic signatures are acceptable provided the importer 
maintains a system for ensuring that the signatures are trustworthy.  We discuss electronic 
recor ds generally in section III. K.5 of this document.  
 On our own initiative, we have added to §  1.510(a), consistent with other FSMA 
regulations, a requirement that importers keep records as original records, true copies (such as 
photocopies, pictures, scanne d copies, microfilm, microfiche, or other accurate reproductions of 
the original records), or electronic records.  We have also moved the proposed requirement that 313 
 
 
 all records be legible and stored to prevent deterioration or loss from proposed §  1.510(b) to 
§ 1.510(a) of the final rule.  
3.  Record s Availability  
 a.  Records in English . 
 We proposed, in §  1.510(b), that importers retain records in English and make them 
available promptly to an authorized FDA representative, upon request, for inspection and 
copying.  
 (Comment 259)  Some comments support the proposed requirement to retain records in 
English; however, most comments object to the proposal.  Several comments state that foreign 
supplier records and supplier audit reports usually are created in the  native language of the 
foreign supplier, which often is not English, and some importers do not speak English as their 
first language.  The comments maintain that a requirement to translate all such records into 
English would be costly, burdensome, and cou ld lead to confusion and misunderstandings that 
could adversely affect food safety when records are created for the foreign supplier or others in a 
language other than English.  One comment states that the proposed requirement could mean that 
native -langua ge speaking foreign suppliers would need to recruit dual -language speaking 
personnel so they could provide English language records to their importers, or it might require 
importers to enlist specialized resources to engage in translations.  Some comments contend  that 
the proposed requirement is not authorized by FSMA or the FD&C Act.  One comment states 
that translation is not needed to allow FDA to use its resources wisely and conduct efficient 
investigations.  Some comments contend that a requirement to main tain records in English would 
be inconsistent with industry standards such as those in the British Retail Consortium and Safety 314 
 
 
 Quality Food schemes.  Two comments suggest that because the official languages of the WTO 
are French, Spanish, and English,  importers should be allowed to keep records in these 
languages.   
Some comments request that the regulations specify which records must be maintained in 
English; a few comments suggest that any English requirement should apply only to records 
created by the importer.   
Some comments maintain that the English requirement is unnecessary because some 
importers have personnel who understand the languages of their foreign suppliers.  Instead of 
requiring that FSVP records be main tained in English, several comments suggest that the 
regulation require that persons reviewing records for the importer be able to understand the 
language in which the records were written, including documents written by a foreign supplier or 
an auditor of a foreign supplier in a language other than English.  
Several comments suggest that, as an alte rnative to the proposed requirement that records 
be main tained in English, the regulation could require importers to translate records upon FDA 
request in a reasonable time.  
 (Response  259)  Although existing FDA regulations ( §§ 120.14(c) and 123.12(c)) re quire 
importers of juice and seafood to maintain records in English, we conclude that it is not 
necessary to include such a requirement in the FSVP regulation.  Although we believe that 
having records in English would facilitate efficient FDA inspection of  importer  records , we 
believe that we can address most of the concerns related to the language of records through other 
requirements.  First, because an importer would not be able to meet its FSVP requirements (e.g., 
hazard analysis, review of results of s upplier verification activities) if it could not understand the 315 
 
 
 documents that it was reviewing, we have added a requirement, in § 1.503(a) of the final rule,  
that a qualified individual must be able to read and understand the language of any records that 
the qualified individual must review in performing activities to meet FSVP requirements.  
 Second, the final rule requires, in §  1.510(b)(1), that, upon FDA request, importers must 
provide within a reasonable time an English translation of records main taine d in a language other 
than English.  We believe that a “reasonable” time in which to provide translated records would 
depend on the volume of the records requested but should not be so long as to impair the 
Agency’s ability to conduct record reviews  and fo llow-up enforcement activities.   Without the 
requirement to translate records in a reasonable time, we would not be able to efficiently enforce 
section 805 of the FD&C Act.    
 b.  Place of business or reasonably accessible location . 
 We proposed that impo rters be required to maintain records at their place of business or 
at a reasonably accessible location; records would be considered to be at a reasonably accessible 
location if they could be immediately retrieved from another location by computer or other  
electronic means (proposed §  1.510(b)).   
 (Comment 260)  Some comments suggest that importers should have the flexibility to 
store records at any reasonabl y accessible location, including where the records are created or at 
a corporate office, import tea m facility, or offsite facility.  Some comments suggest that we align 
the FSVP regulation with the proposed requirement in the preventive controls regulations 
permitting offsite storage of records provided that the records can be retrieved and made 
availab le onsite within 24 hours of FDA request .  These comments maintain that the proposed 
FSVP approach would be too limiting because it would require importers to store all paper 316 
 
 
 records onsite for the entire retention period because offsite paper documents wo uld not be 
immediately retrievable by computer or other electronic means.  On the other hand, some 
comments suggest that we apply the term “immediately retrieved” in a practical manner to allow 
for an employee at another location being in a meeting at the time of a request, and ask that we 
modify the preventive controls provisions for consistency to provide further flexibility for the 
storage location.  One comment states that, rather than requiring that records be immediately 
retrieved from another locatio n, there should be a specific, reasonable interval, such as within 5 
business days, but in no case less than 1 business day.  
 (Response  260)  We conclude that it is appropriate, under §  1.510(b)(2) of the final rule, 
to permit offsite storage of records (i ncluding records retained by other entities) if such records 
can be retrieved and provided by the importer onsite within 24 hours of request for official 
review.  Electronic records are considered to be onsite if they are accessible from an onsite 
location .  We believe that this approach, which is consistent with the approach under the 
preventive controls regulations, gives importers the flexibility to store records at whatever 
location they deem suitable provided that any records stored offsite can be made  available onsite 
within 24 hours.  
 (Comment  261)  Some comments object to the proposed requirement that retrieval from 
an offsite location could only be achieved “by computer or other electronic means” because 
some offsite locations might not have adequate resources and the provision might inadvertently 
require expensive computer system validation.  317 
 
 
  (Response  261)  We agree.  The final rule does not specify the manner in which offsite 
records must be retrieved and provided onsite, only that the reco rds must be provided onsite 
within 24 hours.  
 c.  Sending records to FDA electronically . 
 We proposed that importers be required, when requested in writing by FDA, to send 
records to the Agency electronically rather than making the records available for re view at the 
importer’s place of business.   On our own initiative, we have modified the requirement so that 
§ 1.510(b)(3) of the final rule states that if requested in writing by FDA, an importer  must send 
records to us electronically, or through another me ans that delivers the records promptly, rather 
than making the records available for review at the importer’s  place of business.  Allowing use 
of another means that delivers the records promptly provides  additional flexibility for all 
importers in the reco rds review process.   We also note that for records that will need to be 
translated in to English, we expect to receive such records promptly after the reasonable time 
needed for translation.  
 (Comment 262)  Several comments oppose the proposed requirement t o send records to 
FDA electronically upon request.  Some comments maintain that neither FSMA nor the FD&C 
Act (including FDA’s authority to issue  regulations for the efficient enforcement of the FD&C 
Act under section 701(a)) provides authority for the req uirement and that such a requirement 
would be inconsistent with sections 414 and 704 of the FD&C Act.  Some comments state that 
only one section of FSMA (section 808(c)(3)(B) of the FD&C Act) gives FDA remote records 
access; some comments contend that the proposed requirement would be inconsistent with 
FSMA’s legislative history (because a similar requirement was included in a House of 318 
 
 
 Representatives version of the FSMA legislation that Congress did not enact).  Some comments 
maintain  that the language of section 805(d) of the FD&C Act does not provide authority to 
require importers to send records to the Agency electronically because the provision only 
requires that records “be made available promptly” to an FDA representative.  Some comments 
state that a requirement to submit records electronically would not be consistent with the 
HACCP regulation for juice or the proposed regulations on preventive controls or produce 
safety.  
 (Response 262)  We disagree with the comments stat ing that FDA does not have the 
authority to require records to be sent to us electronically or through another means that delivers 
the records promptly upon request, as set forth in § 1.510(b)(3).  Section 805(d) provides that 
FSVP  records “be made available promptly to a duly authorized representative of the Secretary 
upon request.”  Section 805(c)(5)(B) states that the FSVP  regulations must  “include such other 
requirements as the Secretary deems necessary and appropriate to verify that food imported into 
the United States is as safe as food produced and sold within the United States. ”  Section 701(a) 
provides for the efficient enforcement of the FD&C Act.  We conclude that we have the 
authority under these sections to require that records be made available to  us electronically upon 
written request or through another means that delivers the records promptly.  We conclude that 
this requirement is necessary for the efficient and effective enforcement of section 805 to ensure 
that importers are adequately verifyin g the safety of the food they import into the United States.  
It is important to note that the provision s in § 1.510(b)(1) and (2) describe FDA  inspection of 
records at an importer’s place of business, as authorized by section 805 and 701(a).  Section 319 
 
 
 1.510(b)(3), however, provides an alternative means of efficiently reviewing records upon 
request --electronically or through another means that delivers the records to us promptly.   
Several comments refer to the legislative history of FSMA and the “remote acc ess” to 
records provisions that were included in a separate food safety bill, H.R. 2749, which was not 
incorporated into FSMA and was not ultimately enacted.  The comments maintain that this 
legislative history indicates that Congress did not intend sectio n 805(d) to mean that records 
could be reviewed electronically.  S. 510, a separate bill with numerous distinct provisions, was 
passed by the Senate, enacted by both houses of Congress, and became FSMA.  While H.R. 2749 
does include specific provisions reg arding “remote access” to records in certain circumstances, 
we conclude that the existence of the “remote access” provisions in that bill does not in any way 
indicate that Congress’ decision to enact S. 510 was attributable to its disapproval of requests f or 
records outside of the inspection context.   
The decision to enact S.  510 could be attributable to any number of factors.  Indeed, H.R. 
2749 was a separate bill from S. 510 and differed in many critical respects.  Although there is no 
mention of the ter m “remote access to records” in any section of S.  510, it is notable that H.R. 
2749’s section regarding imports d id not refer to  FSVP at all and consisted only of what became 
the VQIP program (section 806 of the FD&C Act).  It is therefore impossible to dr aw the 
conclusion that, in enacting S. 510, Congress rejected the notion of FDA issuing written requests 
for FSVP records.  Indeed, there is no evidence in the legislative record and no evidence 
provided by the comments that the “remote access” to records provision in H.R. 2749 was even a 
factor regarding which of the two bills would be enacted as FSMA.  What actually occurred  was 320 
 
 
 the adoption of an entirely separate bill with many provisions that differed from H.R. 2749, 
including the requirements for fore ign supplier verification.   
We agree with the comments stat ing that the recordkeeping provisions in this rule differ 
from the recordkeeping provisions in FDA’s HACCP regulations, the preventive controls 
regulations, and the produce safety regulation.  Ind eed, the difference is intentional.  Unlike the 
recordkeeping provisions in those other regulations, the FSVP records requirements are designed 
to be specific to the imports context.  As to the comments stating that the FSVP proposal is 
inconsistent with s ections 414 and 704 of the FD&C Act, we disagree.  We are not relying on 
those provisions as authority for the records requirements.  In enacting section 805, we believe 
that Congress intended to provide FDA with a type of records authority tha t is specifi c to the 
FSVP  context.  Consistent with that intent, we conclude that it is appropriate for the FSVP 
records provisions in this rule to differ from certain  other Agency record s provisions.  We 
believe this is appropriate in light of the nature and purpose of FDA record review for the FSVP  
regulation .  Our r eview of importers’ FSVP records serves a distinct purpose from review of a 
manufacturing/processing facility’s records in t he context of an onsite inspection of activities at 
the facility.  Importers do not necessarily manufactur e, process, pack, or hold food.  Instead, they 
must  conduct activities to verify the food safety practices of their suppliers.  The FSVP  
regulation re quire s that those verification activities be appropriately documented and that records 
be adequately maintained.  Our enforcement of FSVP therefore ordinarily will not hinge on the 
observation of manufacturing/processing, packing, and holding activities.  Rather, it ordinarily 
will be based  on whether importers have conducted adequate verification activities, documented 
those activities, and maintained appropriate records.  The nature of the FSVP requirements 321 
 
 
 therefore allows us to more easily determine com pliance by reviewing records.  Thus, while 
several comments refer to being able to put records into context at a manufacturing location, 
§ 1.510 refers only to the importer’s FSVP records , and there might not be a manufacturing 
location to inspect for purp oses of assessing FSVP compliance.   
The fact that Congress  did not intend to limit FSVP records requests to the context of 
onsite inspections is evidenced by comparing section 805(d) to other FD&C Act records 
provisions that clearly contemplate onsite ins pections.   For example, s ection 414(a)(2) , which 
applies in certain circumstances involving use of or exposure to food of concern,  specifies that 
each person to which the section applies “shall permit such officer or employee, upon 
presentation of appropri ate credentials and a written notice to such person, at reasonable times 
and within reasonable limits and in a reasonable manner, to have access to and copy all records 
relating to such article  . . . .”  This is in contrast to the language in s ection 805(d ), which  states 
that FSVP records “shall be made available promptly to a duly authorized representative of the 
Secretary upon request .”  Notably, section 805 (d) differs from section 414(a)(2) in that it does 
not refer to copy ing records , providing access at reasonable times , or the presentation of 
credentials --all of which suggest  that any records request be preceded by, or be part of,  an onsite 
inspection.  In contrast to the language in section 414(a)(2), the language in section 805(d) leaves 
flexibility regarding the conditions under which FSVP records requests are made .   
In addition , section 808(c)(3)(B) regarding accredited third -party audits has a records 
provision distinct from that for FSVP, requiring accredited third -party certif ication bodies to 
“submit to the Secretary” regulatory audit reports and associated documents required under the 
third -party program.  While one comment regards this as evidence that this is the only provision 322 
 
 
 under which FSMA granted “remote records ” access, we conclude that this language reflects the 
nature of audits conducted in accordance with the third -party certification rule and the fact that 
such audits are conducted by entities other than FDA, thus creating the practical necessity for 
regulatory audit reports to be submitted to FDA.  It does not in any way suggest that Congress 
did not intend to authorize FDA to review FSVP records electronically or through other prompt 
means.  
In addition, we believe that our records requirements are consistent with section 
805(c)(2)(B), which provides that the FSVP regulations must  include other requirements as we 
deem necessary and appropriate to verify that food imported into the United State s is as safe as 
food produced and sold in the United States.  Providing records to us electronically or otherwise 
promptly upon our written request will help ensure that imported food is as safe as domestically -
produced food because it will enable  us to mo re efficiently review importers’ FSVP records.  
More efficient review of FSVP records will allow us to review more FSVP records than would 
otherwise be possible, which will help us ensure that more importers are importing food that 
meets  U.S. food safety s tandards.  More efficient review of records also will allow us to identify 
importers that have adequate FSVP records, as well as those that do not.  Consequently, our 
review of FSVP records will help us  target our inspection resources towards those importe rs that 
present a greater  risk to food safety  because the ir records are in adequate and/or raise concerns 
about compliance with other FSVP requirements .  Conversely, our review of records will help us  
determine which importers present a lower risk because they have adequate records, therefore 
lessening the need for follow -up inspection.  Importers we identif y as lower risk will therefore be 
less likely to be burdened by an FDA inspection.  323 
 
 
  The comments ’ references to inconsistency with records requirements outside of FSMA, 
such as section 704 of the FD&C Act and the HACCP regulations , are similarly misplaced.  We 
are not relying on our authority under section 704 to require access to FSVP records.  That 
provision lays out the general parameters for an inspection of a “factory, warehouse, or 
establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, 
processed, packed, or held, for introduction into interstate commerce or  after such introduction.”   
Because FSVP importers do not necessarily manufacture, process, pack, or hold food, section 
704 is not necessarily applicable to an FSVP importer and, unlike section 805(d), was not 
specifically designed to apply to access to records maintained as part of the FSVP program.  
Further, unlike a facility inspection, where a critical component of the inspection may be viewing 
the physical plant and observing the conditions in person, we often can evaluat e an FSVP 
importer  entirely by  reviewing the records that the importer provides to us.  Further, the HACCP 
regulations, like the preventive controls regulations, concern  the control of hazards , and viewing 
records in the context of an onsite inspection of the  HACCP processing facility where the actions 
described in the records occur is similarly important.   
  (Comment 263)  Several comments contend that reviewing records remotely would 
constitute a significant change from current FDA  practice of reviewing records onsite during 
inspectio ns of regulated entities.  The comments maintain that the Agency  could not adequately 
understand importer records except in the course of an onsite inspection, when company experts 
can answer questions and records can be viewed in the context of the import er’s facility and 
operations.  Some comments express concern that we might make unreasonable and burdensome 
demands for records, and that the requirement would create the potential for inadvertent 324 
 
 
 disclosure of confidential commercial information and secur ity breaches (including the potential 
for terrorist acts).  One comment states that the proposed provision would essentially require 
importers to maintain all records electronically, which would be overly burdensome to small 
businesses.  Some comments stat e that maintaining records submitted electronically would 
impose a significant burden on FDA.  Some comments contend that the proposed requirement 
would create the potential for fraud because unscrupulous companies might submit fraudulent 
records to the Agency.  
 (Response  263)  We disagree with these comments.  As previously discussed, the context 
of record review for the purposes of determining an importer’s compliance with the FSVP 
regulation can be quite different from a facility inspection.  In many c ases, depending on the type 
of importer, we might  find that it is more appropriate to perform onsite record inspection, where 
an FDA official can have  in-person, back -and-forth discussions with the importer, and 
§ 1.510(b)(1) and (b)(2) contemplate this ty pe of record review.  But § 1.510(b)(3) allows the 
importer and FDA to avoid the burden of performing that onsite record inspection if it does not 
make sense given the context.  For example, a n importer who maintains all records electronically 
and travels between ports of entry without a traditional “facility” m ight benefit from the 
flexibility of being able to demonstrate compliance with FSVP by making records available to us 
electronically.  We also disagree that importers will not be able to provide suff icient and 
appropriate context for records submitted electronically.  Nothing prevent s importers from 
providing  explanatory information  to accompany requested records  or discussing the request by 
email or telephone .  Moreover, because FSVP records will not  necessarily  address 
manufacturing/processing, packing, or holding activities  that take place at the entity being 325 
 
 
 inspected , we believe that the potential benefits of reviewing FSVP records onsite would be 
reduced.  
 We understand concerns  that unreasonable  demands for records might adversely affect 
both importers and the Agency.  Our need to use our enforcement resources in a risk -based, 
efficient manner  provides incentive for us to limit our requests to those records that will provide 
sufficient informatio n about an importer’s level of compliance with the FSVP regulation .  
Targeting our record requests in this way should minimize the burden of these requests on 
individual importers and avoid unnecessary expenditure of Agency resources, enabling us to 
evaluate more importers for FSVP compliance . 
We do not agree  that it would be more likely for importers to maintain or submit 
fraudulent records if the records are submitted electronically.  There have been times when we 
have  encountered fraudulent records  located at physical facilities.  Although  we understand 
concerns about  the security of data submitted electronically to the Agency, as well as concerns 
about confidential commercial information and terrorism, we will take appropriate steps to 
secure commu nications with importers and to protect any data we receive , whether submitted 
electronically or otherwise.  
We agree with the comment stat ing that small businesses should not be forced to 
maintain electronic records, as this might be a disproportionate bu rden on these importers.  For 
that reason, and to provide more flexibility in the review of records under the FSVP  regulation , 
importers will not be required to provide records electronically to FDA.  The final rule allows all 
importers , regardless of size , to either provide requested records electronically to  us or use 
another means that delivers the records promptly.  Therefore, there is no burden on small 326 
 
 
 importers to maintain or make their records available electronically ; they will be in compliance 
as long as they are able to send their records promptly.  
4.  Record s Retention  
Under proposed §  1.510(d), we proposed a two -part approach to the requirements for the 
length of time that records must be retained.  For records that would be created and used for  an 
extended or indefinite period, such as the hazard analysis that an importer conducts for a food or 
the procedures that an importer uses to determine appropriate supplier verification activities, we 
proposed that records be retained until at least 2 yea rs after use of the records was discontinued 
(e.g., because the importer no longer imported a particular food, no longer used a particular 
foreign supplier, or changed its FSVP procedures).  For certain records that involved 
documentation of the implementa tion of procedures and determinations, such as the performance 
of supplier verification activities, corrective actions, and FSVP reassessments, we proposed that 
records be retained for a period of at least 2 years after the records were created or obtained  (with 
certain exceptions).   We stated that these proposed requirements were consistent with section 
805(d) of the FD&C Act, which requires that FSVP records be maintained for a period of not 
less than 2 years.  
 (Comment 264)  One comment maintains that so me sections of the proposed regulation 
were not mentioned as having a records retention requirement and asks that we clarify the 
requirements.  Some comments maintain that having two separate record retention specifications 
would be unnecessarily complicat ed and confusing.  Instead, the comments suggest having the 
regulation require that all records be maintained for 2 years after use of the records is 
discontinued.  One comment states that this approach would be consistent with FSMA.  One 327 
 
 
 comment suggests that the phrase “after their use is discontinued” be modified because “their” 
might be seen as referring to use of the foreign supplier or use of the records.  If the former, 
according to the comment this would mean that all records regarding use of the su pplier must be 
kept until 2 years after the supplier is no longer used.  However, the comment suggests that 
“their” should refer to the records, which would mean that importers would be required to keep 
records 2 years after use of those records was discon tinued.  
 (Response  264)  We agree that referencing records retained in accordance with specific 
sections of the FSVP regulations was unnecessarily confusing.  However, we conclude that it is 
appropriate to distinguish records that are created and remain in  use for an extended time (e.g., 
records of procedures) from records that are created to document the performance of activities 
under established procedures and are not used on a continuing basis.  Therefore, § 1.5 10(c)(1) of 
the final rule specifies that importers must retain FSVP records until at least 2 years after the 
importer creates or obtains the records.  This requirement would apply, for example, to results of 
foreign supplier verification activities that the importer conducts (or obtains documenta tion of) 
and documentation of corrective actions taken.  However, §  1.510(c)(2) states that importers 
must retain records that relate to their FSVP processes and procedures, including the results of 
evaluations and determinations the importer conducts, for  at least 2 years after their use is 
discontinued (e.g., because the importer no longer imports a particular food, no longer uses a 
particular foreign supplier, has reevaluated the risk  posed by  a food and the foreign supplier ’s 
performance , or has changed  its supplier verification activities  for a particular food and foreign 
supplier ).  In other words, if the importer continues to rely on certain records to meet an FSVP 328 
 
 
 requirement more than 2 years after the records were created or obtained , the importer must 
retain those records for at least 2 years after their use is ultimately discontinued.  
As stated previously, s ection 805(d) of the FD&C Act mandates that FSVP records be 
maintained for a period of not less than 2 years, and § 1.5 10(c) reflects this sta tutory timeframe.  
We note that some food products are stored for longer than 2 years before they are exported  (but 
after they leave the foreign supplier).  In such cases, relevant supplier verification activities (e.g., 
onsite auditing) might occur long b efore the food is imported into the United States.  Although  
not required  by the final rule , it is good business practice for importers of these foods to retain 
the FSVP records for these foods at least until the foods are distributed in the United States.     
As further  discussed in section III.M.2  of this document , we conclude that it is necessary 
to include a specific requirement for records on which an importer relies to document its status as 
a very small importer (as defined in § 1.500) in accordance w ith § 1.512(b)(1) of the final rule.  
Therefore, §  1.512(b)(5)(iii)( C) specifies that records that an importer relies on during the 3 -year 
period preceding the applicable calendar year to support its status as a very small importer must 
be retained for at least 3 years.  
5.  Electronic Records  
 We did not specify requirements for the retention of electronic records in the proposed 
rule.  However, we received several comments regarding the potential application of the 
requirements for electronic records in part 11 (21 CFR part 11) to FSVP records.  
 (Comment 265)  Several comments ask that we not apply the part 11 requirements to 
FSVP records.  Several comments maintain that requiring importers to comply with part 11 
would be costly, burdensome, and discourage the use of electronic records without s ignificantly 329 
 
 
 benefitting public health.  One comment states that most electronic systems currently used by 
importers do not meet the stringent requirements of part 11  and would need to be recreated or 
redesigned at considerable expense if importers were re quired to comply with part 11.  Some 
comments note that FDA exempted from part 11 electronic records established or maintained to 
satisfy the requirements of the Bioterrorism Act records regulation  (21 CFR 1.329(b)).  Some 
comments suggest that, rather tha n require compliance with part 11, the FSVP regulation should 
include more simplified, practical requirements to have appropriate systems to ensure the 
integrity and security of electronic records.   
 (Response  265)  We agree that it would be unnecessarily  burdensome to require that 
FSVP records  meet  the requirements in part 11.  Therefore, §  1.510(d) of the final rule states that 
records that are established or maintained to satisfy the FSVP requirements and that meet the 
definition of electronic records i n § 11.3(b)(6) are exempt from the requirements of part 11.  
Section 1.510(d) further specifies that records that satisfy the FSVP requirements, but that also 
are required under other applicable statutory provisions or regulations, remain subject to part 1 1.  
Consistent with these provisions, we are making a conforming change in part 11 to specify in 
§ 11.1(l) that part 11 does not apply to records required to be established or maintained under the 
FSVP regulation, and that records that satisfy the requirem ents of the FSVP regulation, but that 
also are required under other statutory provisions or regulations, remain subject to part 11.  
 Although FSVP records are not subject to part 11, we will expect importers to maintain a 
system for their electronic record s to ensure  that the records are trustworthy, reliable, and 
generally equivalent to paper records and handwritten signatures executed on paper.  330 
 
 
 6.  Public Disclosure  
 In the proposed rule, we did not specify requirements regarding the public disclosure of  
records created and retained to meet FSVP requirements.  
 (Comment 266)  Several comments request that the regulations include provisions to 
protect FSVP records from public disclosure.  The comments maintain that FSVP records will 
contain much commerciall y sensitive information and information that terrorists could use to 
overcome an importer’s or foreign supplier’s food defense measures.  Some comments assert that 
the regulation should regard all information about foreign suppliers as confidential commerc ial 
information by default.  Some comments assert that viewing and redacting FSVP records would 
overburden FDA FOIA staff and result in inadvertent disclosure of trade secrets and confidential 
information.  Several comments ask that the regulation specify that FSVP records have the same 
level of protection from public disclosure under FOIA as juice and seafood HACCP records 
(which, under §§ 120.12(f) and 123.9(d), are exempt from disclosure unless previously disclosed 
or the records relate to a product or i ngredient that has been abandoned and the records no longer 
represent a trade secret or confidential commercial or financial information).  One comment 
states that it prefers the HACCP disclosure language to the provision included in the proposed 
regulatio n on preventive controls for human food, which specifies that records are subject to the 
disclosure requirements in part 20.   
 (Response  266)  We agree that many FSVP records retained by importers will contain 
confidential commercial information and trade  secrets that will be exempt from public disclosure 
under current law.  Therefore, §  1.510(f) of the final rule specifies that records  obtain ed by FDA  
pursuant to  the FSVP regulation are subject to the disclosure requirements under part 20.  This 331 
 
 
 means, for example, that certain information in records such as evaluations of foreign supplier 
performance and the results of onsite audits of suppliers likely would be e xempt from disclosure 
under FOIA because, under §  20.61(b), such information is likely to be regarded as commercial 
or financial information that is privileged or confidential that is submitted or divulged to FDA 
and therefore not available for public disc losure under §  20.61(b) and (c).   
We conclude that it is not necessary to use the disclosure provision contained in the 
HACCP regulations .  The regulations in part 20 regarding public information apply to all 
Agency records, regardless of whether a partic ular recordkeeping requirement says so.  In the 
case of the recordkeeping requirements for our HACCP regulations for juice and seafood, we 
framed the public disclosure provisions by providing specific details about how particular 
provisions in part 20 (i.e ., § 20.61 (concerning trade secrets and commercial or financial 
information which is privileged or confidential) and § 20.81 (concerning data and information 
previously disclosed to the public)) would apply to the applicable records because we recognized 
that such details were of particular interest to the regulated industries.  In the case of the 
recordkeeping requirements for this rule, we framed the provisions regarding public disclosure 
by more broadly referring to all the requirements of part 20 , cons istent with our approach in the 
recently issued preventive controls regulations .  For example, provisions such as § 20.20 
(concerning the policy on disclosure of FDA records) apply to all records that we have in our 
system, including HACCP records, even th ough the HACCP regulations do not specify that this 
is the case.  332 
 
 
  (Comment 267)  Several comments request that we train our investigators and staff 
regarding FSVP information that is confidential commercial information or trade secrets and 
therefore should be protected from disclosure under the FOIA.  
 (Response  267)  We agree.  We intend to include disclosure issues in the FSV P training 
that we will provide to Agency investigators.  We will evaluate the training currently provided to 
our FOIA personnel  and, if necessary, make modifications to address FSVP records . 
7.  Relationship to Records Required Under Customs Regulations  
  (Comment 268)  One comment asks whether any FSVP documents are considered “A1A” 
documents that must be maintained under CBP regulations, specifically 19 CFR 163.5(b)(2).  
 (Response  268)  We encourage the comment er to contact CBP about whether and under 
what circumstances CBP regulations apply  to FSVP documents .   
 (Comment 269)  One comment asks whether FSVP documents will need to be accessible 
by entry number.  
 (Response  269)  Documents that importers create and main tain to meet FSVP 
requirements, such as  hazard analyses, evaluations of the risk posed by food and of foreign 
supplier performance, and documentation of supplier verification activities, will not have to be 
linked to a particular entry number for an imported food.  However,  FDA investigators mi ght 
refer to entry documents for particular food products when requesting records concerning such 
products during an inspection to assess an importer’s compliance with the FSVP requirements.  
 (Comment 270)  One comment recommends that FDA collaborate with  CBP on the 
portion of the FSVP guidance that addresses importer identification at entry.  333 
 
 
  (Response  270)  We intend to work with CBP on implement ing the importer 
identification at entry provisions.  We also intend to consult with CBP as appropriate in dra fting 
FSVP guidance  on compliance with these requirements . 
L.  Dietary Supplements and Dietary Supplement Components  (§ 1.511)  
 We proposed to adopt modified  FSVP requirements for dietary supplements and dietary 
supplement components in §  1.511 of the prop osed rule.  We noted that facilities mak ing these 
foods are exempt from the preventive controls requirements in section 418 of the FD&C Act 
when the facilities are in compliance with statutory provisions concerni ng dietary supplement 
CGMP requirements (sec tion 402(g)(2)  of the FD&C Act ) and adverse event reporting (section 
761 of the FD&C Act  (21 U.S.C. 379aa -1)).  We stated that the proposed FSVP requirements for 
dietary supplements and dietary supplement components reflected the food safety regulations 
applicable to those products (i.e., the dietary supplement CGMP regulation  in part 111  (21 CFR 
part 111 )), rather than focusing on verification of hazard control, as we had proposed under the 
“standard” FSVP requirements.   
1.  Dietary Supplements for Furt her Processing  
 We proposed certain limited FSVP requirements for dietary supplements and dietary 
supplement components that will undergo further processing  by the importer or its customer in 
accordance with certain dietary supplement CGMP regulations.  We did this because we believe 
that the dietary supplement CGMP regulation, through its specification requirements, contain s 
provisions that already require supplier “ verification ” tailored to dietary supplement s.  
Specifically, these provisions require a di etary supplement manufacturer to verify that the 
ingredients they are using are identified properly, have the appropriate purity, strength, and 334 
 
 
 composition, and do not contain contaminants that adulterate or can lead to adulteration of the 
dietary suppleme nt.  Therefore, imposing additional verification requirements under the FSVP 
regulation  would be redundant and unnecessary.   
Under proposed § 1.511(a), if an importer was required to establish specifications under 
§ 111.70(b), (d), or (f) of the dietary s upplement CGMP regulation with respect to a food and the 
importer was in compliance with the regulations for determining whether the specifications had 
been met, the only FSVP requirements that the importer would have  to meet would be those 
concerning iden tification of the importer at entry and recordkeeping.  Section 111.70(b), (d), and 
(f) concern specification requirements for (1) dietary supplement components, (2) dietary 
supplement labels and packaging that may come into contact with dietary supplement s, and (3) 
products received for packaging or labeling as a dietary supplement and subsequent distribution, 
respectively.  
We proposed (in § 1.511(b)) similar requirements for importers whose customer was 
required to es tablish such specifications and was in compliance with the regulations for 
determining whether the specifications were met, except that the importer also would be required 
to annually  obtain written assurance that the customer was  in compl iance with those 
requirements .  We tentatively co ncluded that these specification and verification provisions in 
the dietary supplement CGMP regulation would provide adequate assurances that the foreign 
supplier of the dietary supplement or dietary supplement component produced the food in 
compliance wit h the FD&C Act.  
We also proposed that importers of dietary supplements and dietary supplement 
components acting in accordance with §  1.511(a) or (b) would not be subject to the proposed 335 
 
 
 requirement to use a qualified individual to perform FSVP activities.  As discussed in section 
III.D of this document, we conclude that it is appropriate to require these importers to use a 
qualified individual to perform the tasks required under these provisions.  
Several comment express support for the proposed modified app roach for dietary 
supplements and dietary supplement components under proposed § 1.511(a) and (b).  However, 
as discussed in the following paragraphs, some comments suggest changes to the pro posed 
requirements and some request that the FSVP regulation not include these requirements.   In the 
final rule, we have removed the reference to § 111.70(f), as discussed in response to those 
comments in the following paragraphs.  
 (Comment 271)  One comment suggests that, instead of referring to a “food” that is 
import ed, § 1.511(a)  and (b)  should refer to a “ food that is  a dietary supplement or dietary 
supplement component … import [ed] for further manufacturing, processing, packaging, and/or 
labeling as a dietary supplement. ” 
 (Response  271)  We agree and have revised § 1.511(a) and (b) of the final rule  
accordingly , except that we have not included the suggested reference to labeling, consistent 
with our deletion of the reference to § 111.70(f) from those provisions . 
 (Comment 272)  One comment objects to exempting from most FSVP requirements 
importers of dietary supplement co mponents that are determined to  meet specifications 
established by the importer in accordance with §  111.70(b).  The comment maintains that 
conformance to specifications under § 111.70(b) would not provide adequate assurance that the 
component was in compliance with part 111  and not adulterated .  The comment requests that 336 
 
 
 importation of such dietary supplement components be subject to the standard FSVP 
requirements for conventional food.  
 (Respon se 272)  We do not agree.  Section 111.70(b)  of the dietary supplement CGMP 
regulation and the requirements in §§  111.73 and 111.75 applicable to determining whether those 
specifications are met are intended to ensure that : 
•  A component used in the manuf acture of a dietary supplemen t has the proper identity;  
•  A dietary supplement manufactured using the component has the appropriate puri ty, 
strength, and composition; and  
•  The limits on the types of contamination that may adulterate or lead to adulteration of a 
finished batch of a dietary supplement are not exceeded.  
To import a dietary supplement component in accordance with §  1.511(a) of the final 
rule, t he manufacturer of a dietary supplement using an imported component will be required to 
determine whether the specifications for the component that the manufacturer has established 
under § 111.70(b) are met in accordance with §§  111.73 and 111.75.  We conclude that 
compliance by the importer/manufacturer with the se CGMP specification provisions  would 
provide adequate verification that the imported dietary supplement component was produced in 
accordance with the relevant CGMP requirements .  We also note that , in addition to determining 
whether  specifications for the dietary supplement component a re met in accordance with 
§§ 111.73 and 111.75, the manufacturer of the dietary supplement using the imported component 
must comply with all other applicable CGMP requirements in producing the dietary supplement.    
 On our own initiative, to provide clari ty we have added to the regulation references to the 
specific CGMP provisions  (i.e., §§  111.73 and 111.75) concerning determination of whether 337 
 
 
 established specifications are met for an imported dietary supplement or dietary supplement 
component.  
 (Comment 273)  One comment objects to exempt ing from most FSVP requirements 
importers of dietary supplements  for whose  label s or packaging the importer has established 
specifications in accordance with § 111.70(d) and determines whether  the specifications are met .  
The comment finds the reference to § 111.70(d) confusing.  The comment maintains that the 
reference might suggest that FDA regards labels a nd packaging as food; if this is the case, the 
comment does not believe that confirming that those materials meet sp ecifications would provide 
adequate assurance of their safe manufacture.  On the other hand,  the comment asserts that if the 
Agency does not regard labels and packaging as food, the reference to § 111.70(d) is misplaced 
because confirming that labels or pa ckaging met specifications would not provide adequate 
assurance that the imported food was produced in compliance with U.S. l aw.  The comment 
states that we should not consider labels and packaging to be food and  asks that we delete the 
reference to §  111.70(d) from proposed §  1.511(a) and (b) . 
 (Response  273)  We  do not agree with the comment that the reference to § 111.70(d) in 
§ 1.511(a) and (b) is inappropriate .  Section 111.70(d) is relevant to the extent tha t it covers 
packaging that may come in contact with dietary supplements.  The definition of food under the 
FSVP  regulation  includes food contact substances and § 111.70(d) refers to establishing 
specifications for packaging that may come in contact with di etary supplements .  Section 
111.70(d)  specifies that p ackaging that may come into contact with dietary supplements must be 
safe and suitable for its intended use and must not be reactive or absorptive or otherwise affect 
the safety or quality of the dietar y supplement .  This requirement  makes the verification of 338 
 
 
 specifications for these materials relevant for a dietary supplement manufacturer under 
§ 1.511(a) and (b) .  The domestic manufacturer is responsible for appropriate labeling of the 
dietary suppleme nt made from the imported component in accordance with its own obligations 
under part 111.  
 (Comment 274)  Some comments oppose  the proposed exemption from the standard 
FSVP requirements for importers of dietary supplements who, in accordance with § 111.70 (f), 
establish specifications to provide assurance that the product they receive for packaging or 
labeling (such as bulk capsules or tablets) is adequately identified and is consistent with the  
purchase order, and who determine whether t hese specifications  are met.  The comments 
maintain that this provision would be inconsistent with FDA’s statement, in the pream ble to the 
final rule on dietary supplement CGMP  (see 72 FR 34752 at 34851 , June 25, 2007), that a firm 
that only packages and labels a product may  rely on information about the content of the product 
that it receives from  the manufacturer.  The comments assert that under proposed § 1.511(a) , an 
importer that  packages or labels an imported dietary supplement would have  no obligation to 
verify that th e imported dietary supplement was produced in compliance with part 111.  One of 
the comments contends that retaining the reference to §  111.70(f)  in proposed §  1.511(a) and (b) 
would incentivize dietary supplement manufacturers to use foreign manufacturing  followed by  
domestic labeling or packaging instead of having the complete manufacturing occur either inside 
or outside the United States . 
 (Response  274)  We do not agree with the assertion in the comment that an importer that 
receives a dietary supplemen t from a supplier for packaging and labeling would not be obligated 
to verify that the imported dietary supplement was produced in compliance with part 111.  We 339 
 
 
 believe that this statement mischaracterizes the obligations that apply to a firm that packages  
and/or labels a finished dietary supplement to which §  111.70(f) applies.  Section 111.70(f) 
applies when the product received by the packager or labeler has left the control of the person 
who manufactured the product.  Although the packager/labeler does not manufacture the product, 
it is responsible for ensuring that the product it places into interstate commerce is not adulterated 
(see sections 402(g) and 301(a) of the FD&C Act).  The specifications that a packager/labeler 
would establish under §  111.70( f) must provide sufficient assurance that the received finished 
dietary supplement product is adequately identified and is consistent with the purchase order (see 
72 FR 34752 at 34844 to 34845).  The level and nature of information a packager/labeler 
requi res as “sufficient assurance” under §  111.70(f) may vary based , for example,  on the finished 
dietary supplement and the supplier from which it is received.   
The verification activities that a packager/labeler might conduct in accordance with 
§ 111.70(f) m ay not need to include, for a given supplier, verification that the manufacturer of 
the dietary supplement complied with all applicable requirements related to the manufacture of a 
finished dietary supplement.   However, the verification requirements contem plated by section 
805 of the FD&C Act would require that level of verification of the manufacturer.   Specifically, 
section 805(a)(1) of the FD&C Act requires importers of dietary supplements, like importers of 
all foods, to perform risk -based foreign suppl ier verification activities for the purpose of 
verifying that the food they import is not adulterated under section 402.  For importers of dietary 
supplements, this means that they are required to perform supplier verification activities for the 
purpose of  verifying that the dietary supplements they import are in compliance with section 340 
 
 
 402(g), which deems dietary supplements adulterated if they fail to meet the CGMP 
requirements established in part 111.   
Given this potential difference in required verific ation activities, we conclude that it is 
not appropriate to apply the modified requirements in §  1.511(a) and (b) of the final rule to 
importers of dietary supplements who establish (or whose customers establish) specifications 
under §  111.70(f) and ensure  they are met.   Instead, firms who import dietary supplements for 
packaging and labeling in the United States (by themselves or their customers) will need to 
comply with §  1.511(c) and verify that the imported product was produced in compliance with 
the ap plicable requirements of part 111 for the manufacture of the dietary supplement.  These 
importers may be able to use documentation provided under  § 111.70(f) (as well as §§  111.73 
and 111.75 regarding determination that specifications are met) to fulfill s ome of the 
requirements under §  1.511(c) (e.g., regarding the performance of supplier verification 
activities).    
 (Comment 275)  Two comments request that we broaden proposed § 1.511(a) and (b) to  
include not just importers  that are subject to, and  in compliance with , the specified dietary 
supplement CGMP requirements , but also importers that are not required to comply with those 
requirements  in manufacturing certain products but voluntarily do so.   The comments maintain 
that some facilities that ar e not  subject to part 111 choose to comply with the requirements  in 
that part for various reasons (e.g., a facility  that manufactures only dietary ingredients but does 
so in c ompliance with part 111 at the request of their customer or at FDA’s recommendati on).  
Therefore, the comments ask that we revise  proposed  § 1.5 11(a) and (b) to include importer s 
who voluntarily comply with §  111.70(b), (d), or (f).  341 
 
 
  (Response  275)  We decline this request.  Attempting  to enforce compliance with the 
dietary supplement CGMP regulation by firms that are not legally required to comply with the 
regulation could present problems for the Agency if we sought to take an enforcement action 
against an importer for failure to comply with § 1.511(a) of the final rule because we determined 
that the importer was not in compliance  with §  111.70(b)  or (d).   
 (Comment 276)  One comment objects to th e requirement in proposed § 1.511(b) that a n 
importer of a dietary supplement or dietary supplement ingr edient  obtain written assurance  of 
compliance when the importer’s customer is required to establish specifications under 
§ 111.70(b), (d), or (f) and the customer is in compliance with the requirements for determining 
whether the specifications are met.   The comment maintains that the written assurance 
requirement would impose a significant burden on importers (because importers might have 
hundreds or even thousands of customers) without protecting public health  because importers 
would not be in a position to audit their customers  or otherwise confirm their compliance with 
part 111 .  The comment suggests  that the exemption from most of the FSVP requirements under 
proposed § 1.511(b) should apply if either of the following occurs:  
•  The importer annually obtains written assurance  of its customer’s compliance with 
§ 111.70(b), (d), or (f) (as applicable); or 
•  The importer verifies  (such as through publicly availa ble information) that its  customer  
manufacture rs, packages, and/or labels dietary supplements  and the importer provides a 
disclosure in labels or commercial docu mentation acco mpanying the dietary supplement  or 
dietary supplement component  stating that the  food was n ot imported under the standard FSVP 
requirements and  is intended only for use in the  manufacture, processing, packaging, or labeling 342 
 
 
 of dietary supplements in comp liance with part 111 (except as may be allowed under the 
customer’s food safety plan).  
 (Response  276)  We decline to make the suggested change.   We acknowledge that 
obtaining w ritten assurance from the customer of compliance with the applicable specification 
requirements would provide less definitive assurance of the customer’s comp liance than  some 
other measures (such on onsite auditing or review of records); however, annually obtaining the 
assurance would necessitate the importer’s ongoing consideration of its customer’s compli ance 
status.  On the other hand, t he disclosure to the customer suggested by the comment  likely  would 
not communicate any additional information to the c ustomer that the customer would not already 
have learned through providing the required assurance .   
2.  Other Importers of  Dietary Supplements  
 For finished dietary supplements (packaged and labeled dietary supplements that will not 
be subject to further processing) and other dietary supplements not subject to proposed 
§ 1.511(a) and (b), we proposed to establish FSVP requirements that were similar to the 
proposed “standard” FSVP  requirements applicable to most imported foods.   Under proposed 
§ 1.511(c), if a dietary supplement  was imported  other than in accordance with proposed 
§ 1.511(a) or (b), the importer would not be required to comply with the standard FSVP 
requirements con cerning hazard analysis but it would be required to comply with requirements 
concerning the following:  
 •  Use of a qualified individual (proposed § 1.503) ; 
 •  Evaluation of risks (except hazard analysis) (proposed § 1.505 (a)(2) through (6) and 
(b)); 343 
 
 
  •  Certain supplier verification activities, including use of approved foreign suppliers, 
establishment of written procedures, and determination and performance of appropriate 
verification activities to provide adequate assurances that the foreign supplier  produced the 
dietary supplement in compliance with part 111  (proposed § 1.511(c)(2) through (8)) ; 
 •  Complaint review, investigations, corrective actions (proposed § 1.507) ; 
 •  FSVP reassessment (proposed § 1.508) ; 
 •  Identification of importer at entr y (proposed § 1.509) ; and  
 •  Recordkeeping (proposed § 1.510) . 
The comments generally s upport the proposed FSVP requirements for finished dietary 
supplements and other dietary supplements not imported in accordance with proposed § 1.511(a) 
or (b).  We respond to comments on these requirements in the following  paragraphs.   We also 
discuss the changes that we have made to these requirements in accordance with several changes  
to the standard FSVP requirements  discus sed previously in this document  and the u pdated 
references to these other sections  (and, as previously discussed, this provision now includes 
dietary supplements imported for packaging and labeling in the United States) .  Section  
1.511(c)(1) of the final rule states that if the food imported is a  dietary supplement and neither 
§ 1.511(a) or (b) is applicable, the importer must comply with §  1.511(c) and the requirements in 
§§ 1.503, 1.505(a)(1)(ii) through (iv), (a)(2), and (b) through (d), and 1.508 through 1.510, but is 
not required to comply wi th the requirements in §§ 1.504, 1.505(a)(1)(i), 1.506, and 1.507.  In 
addition to the changes discussed in the following paragraphs , we have made minor wording 
changes to several subsections .  
a.  Evaluation for supplier approval and verification . 344 
 
 
 Propose d § 1.511(c)(1) specified that importers of finished dietary supplements would be 
required to comply with the requirements in proposed §  1.505 related to  consider ation of the 
entity that will control the hazards in a food and evaluation of the foreign supp lier’s performance 
(but not evaluation of the risk posed by a food, i.e., the hazard analysis).  The applicable 
provisions  of § 1.505 are now §  1.505(a)(1)(ii) through (iv), (a)(2), and (b) through (d) rather 
than §  1.505(a)(2) through (6) and (b).  The changes that we have made to §  1.505(a) concerning 
the factors for the entity controlling the hazards and foreign supplier performance, discussed in 
section III. F.1 of this document, are also applicable to importers of finished dietary supplements 
under §  1.511(c)(1) of the final rule.  
b.  Corrective actions . 
Proposed §  1.511(c)(1) specified that importers of finished dietary supplements would be 
required to comply with the requirements in proposed §  1.507 , including those concerning 
review of complaints, i nvestigations, corrective actions, and modification of the FSVP (when 
necessary).  As discussed in section III. I of this document, the section of the r egulation  regarding 
corrective actions,  § 1.508 of the final rule , does not require importers to review c omplaints or 
conduct investigations  into possible adulteration , and includes certain changes to the corrective 
action requirements.   Finished dietary supplement importers will need to comply with these final 
provisions of §  1.508.  
c.  Identification of imp orter at entry . 
 As discussed in section III. J of this document, we have revised the requirements related 
to importer identification at entry in §  1.509 of the final rule; these changes apply to the 
importation of finished dietary supplements under § 1.511 (c)(1).  345 
 
 
 d.  Recordkeeping . 
As discussed in section III. K of this document, we have revised several recordkeeping 
requirements in §  1.510 of the final rule; these changes apply to the importation of finished 
dietary supplements under §  1.511(c)(1) of the fi nal rule.  
e.  Use of approved foreign suppliers . 
Section 1.511(c)(2) of the final rule finalizes the proposed requirement to establish and 
follow written procedures to ensure the importation of dietary supplements from approved 
foreign suppliers (and in limited circumstances from unapproved suppliers)  and codifies the 
requirements taken from revised § 1.506 that allow an entity  other than the  finished dietary 
supplement importer’s foreign supplier to establish and  follow such procedures , provided the 
impo rter reviews and assesses the other entity’s procedures and activities (see the discussion of 
these matters with respect to foods other than dietary supplements in section III. G.1 of this 
document).  
f.  Determination of appropriate foreign supplier verific ation activities . 
Section 1.511(c)( 4) of the final rule finalizes the requirement (in proposed §  1.511(c)(5)) 
to determine appropriate foreign supplier verification activities before importing a dietary 
supplement from a foreign supplier,  as well as the fr equency with thes e activities must be 
conducted.  (We deleted the separate reference to the “purpose” of supplier verification activities 
stated in proposed §  1.511(c)(4) --i.e., to provide adequate assurances that the foreign supplier is 
producing the diet ary supplement in accordance with processes and procedures that provide the 
same level of public health protection as those required under part 111 --and added it to the 
provision requiring determination of appropriate supplier verification activities (§  1.511(c)(4) of 346 
 
 
 the final rule).)  Section 1.511(c)(4) specifies that this determination must be based on the 
evaluation conducted under §  1.505,  lists the possible appropriate verification activities, and 
permits the importer to rely on a determination of appropriate verification activities made by an 
entity ot her than the foreign supplier , provided the importer reviews and assesses the entity’ s 
determination (see the discussion of these matters with respect to foods other than dietary 
supplements in section III. G.4 of this document).  
g.  Performance of foreign supplier verification activities . 
Section 1.511(c)( 5) of the final rule finalizes the pr oposed requirem ent to conduct 
verification activities for foreign suppliers of finished dietary supplements.  Among the changes 
to the verification activity provisions that match changes to proposed §  1.506  are the following:  
•  Section  1.511(c)(5)(i)(A)( 2) specifies that when the foreign supplier of a dietary 
supplement is in a country whose food safety system FDA has officially recognized as 
comparable or determined to be equivalent to that of the United States, an onsite audit of the 
supplier may conside r the relevant laws and regulations of that country instead of the 
requirements of part 111.  
•  Section  1.511(c)( 5)(i)(A)( 3) specifies that if an onsite audit of a foreign supplier of a 
dietary supplement is conducted solely to meet the FSVP supplier verification requirements by 
an audit agent of a certification body accredited in accord ance with FDA’s regulations on the 
accreditation of third -party certification bodies, the audit itself is not subject to the requirements 
for audits conducted under tho se regulations.  
•  Section  1.511(c) (5)(i)(A)( 5) broadens the scope of inspections on which an importer of 
a dietary supplement may rely instead of an onsite audit  of the foreign supplier to include 347 
 
 
 appropriate inspections for compliance with applicable FDA food safety regulations conducted 
by FDA, representatives of other Federal agencies (such as the U SDA ), and representatives of 
State, local, tribal, or territorial agencies, in addition to inspections conducted by  the foo d safety 
authority of a country whose food safety system FDA has officially recognized as comparable or 
determined to be equivalent to that of the United States, provided that the inspection was 
conducted within 1 year of the date that the onsite audit wou ld have been required to be 
conducted ( see the discussion of these provisions with respect to foods other than dietary 
supplements in section III. N of this document).  
 (Comment 277)  One comment suggests that, instead of allowing an importer to rely on 
the results of an inspection of a foreign supplier conducted by FDA or the food safety authority 
of a country whose food safety system FDA has officially recognized as comparable or 
determined to be equivalent to that of the United States, provided that the i nspection was 
conducted within 1 year of the date that the onsite audit would have been required to be 
conducted, the importer should be allowed to rely on the results of such an inspection conducted 
within “approximately” 1 year of when the audit would ha ve been required.  The comment 
maintains that it is not always possible to obtain audit documentation within an annual timeframe 
(asserting that it might take several weeks or more to obtain an updated certificate of compliance 
following completion of an a udit).  
 (Response  277)  We decline to make this change.  We are concerned that extending  
beyond 1 year  the time period for which an importer could rely on inspection results would 
substantially weaken the likelihood that those results would accurately refl ect the foreign 348 
 
 
 supplier’s current state of compliance with applicable regulations and therefore diminish the 
assurance of food safety that such inspection results might provide.   
•  Section  1.511(c)( 5)(i) includes other relatively minor changes to the req uirements for 
documentation of foreign supplier verification activities.  
•  Under § 1.511(c)( 5)(ii) and (iii)  of the final rule, an importer of a dietary supplement  
may rely on supplier verification activities conducted  by an e ntity in its supply chain provided 
that it  review s and assesses the results of tho se activities.   However, the importer may not rely on 
the foreign supplier to conduct these activities except with respect to sampling and testing of a 
dietary supplement . 
h.  Verification of customers and other subsequent entities . 
Section  1.507 of the final rule contains provisions regarding verification when an 
importer imports a food that cannot be consumed without the hazards being controlled or for 
which the hazards are controlled after importation .  Section 1.511(c)(1) states that this section 
does not apply to dietary supplements.  This is b ecause § 1.507 is based on the hazard analysis 
performed by  importer s.  Specifically, importers can only avail themselves of the distribution 
chain provisions in § 1.507 if they identify the specific hazards that require  control, thus enabling  
them to ensure either that the food could not be consumed without the application of an 
appropriate control or that the hazard will be appropriately controlled after impor tation. Because 
the FSVP regulation does not require hazard analysis by importers of  dietary supplements, the 
provisions of  § 1.507 are not suitable for dietary supplements.    
 (Comment 278)  One comment suggests that if we do not delete the  proposed 
requirement to obtain written assurance from customers subject to certain dietary supplement 349 
 
 
 CGMP requirements under proposed § 1.511(b) , then proposed § 1.511(c) should specify that the 
requirements under that paragraph, rather than the standard FSVP requirements, will apply when 
an importer is “unable to obtain the required written assurance” from the customer . 
 (Response  278)  Although we agree with the comment that an importer of a dietary 
supplement or dietary supplement component that fails to obt ain written assurance from its 
customer in accordan ce with § 1.511(b) of the final rule would be subject to the requirements in 
§ 1.511(c ), we conclude that it is not necessary to change §  1.511(c)  as requested.  The FSVP  
draft guidance will reiterate that  when a dietary supplement  is imported and neither §  1.511 (a) 
nor (b) is applicable (including because the importer elects not to annually obtain the appropriate 
written assurance from its customer), the i mporter must comply with § 1.511 (c). 
3.  Mixed -Use Food/Drug Ingredients  
 (Comment 279)  One comment asks that we exempt from the preventive controls 
regulations certain ingredients that are used in the manufacture of both food and drugs , and also 
asks that we establish separate modified FSVP requirements  for these ingredients.   The comment 
states that t here are many ing redients that are used in the United States  as conventional foods, 
dietary supplements, and drugs, and many ingredients that can be used as drugs in foreign 
countries but only as foods i n the United State s.  The comment maintains that i f an ingredien t is 
made in compliance with the United States Pharmacopeia (USP) /National Formulary ( NF) or 
other official monographs and internationally recognized drug CGMP  standard s, it would be 
superfluous for the facility to be required to comply with proposed subparts B and C of the 
regulation on preventive controls  for human food  (proposed part 117) .  (The comment suggests  
that we include in the preventive controls regulation a definition of “monograph in gredient, ” 350 
 
 
 defined as  an ingredient that is allowed for food use in the United States , meets certain criteria 
related to compliance with certain official monographs , and is manufacture d in accordance with 
certain pharmaceutical CGMP standards  or guidelines .)  The comment  assert s that because the 
construction, equip ment, recordkeeping, training, and quality control operations  of an 
establishment making a “monograph ingredient” will already be conducted in a manner that 
meets or ex ceeds the standards for CGMP  in subpart B  of part 117 , it would  be unnecessary to 
require the establishment  to comply with that subpart .  The comment also asserts that hazard 
analysis and preventive controls requirements in subpart C of part 117 also should not apply to 
monograph  ingredients because  official monographs and pharmaceutical CGMPs already 
provide preventive con trols for harmful contaminants in these ingredients .   
The comment also requests that we establish separate modified FSVP requirements for 
monograph ingredients.  These modified requirements , which would be mandatory for 
monograph ingredients used as a conventional food and optional for monograph ingredients used 
as a dietary supplement  or dietary supplement component, would be  tailored toward providing 
adequate assu rances that the food is in compliance with the applicable monograph and/or that the 
monograph ingredient was  produced in accordance with the require ments of the applicable 
pharmaceutical CGMP  standard s. 
The comment asserts that requiring manufacturers of “ monograph  ingredients ” to comply 
with the preventive controls regulation and failing to adopt the comment’s suggested modified 
FSVP requirements for these ingredients would be inconsistent with U.S. obligations under 
WTO agre ement s.  The comment also maint ains that the suggested modified FSVP provisions 
would be consistent with the intent of Congress because they would help ensure that imported 351 
 
 
 food is as safe as food produced in the United States and they take into account differences 
among types of import ed food and their level of risk.  
 (Response  279)  We are not responding to the comments suggesting revision of the 
proposed regulation on preventive controls for human food as those comments are beyond the 
scope of this rulemaking.  W e decline to establish  separate FSVP requirements for “monograph 
ingredients” as defined by the comment.  We do not believe that the proposed definition of 
“monograph ingredient” is feasible given its references to multiple and in some cases unspecified 
official monographs and CGMP standards and guidelines .  In addition, because the FSVP 
regulation appl ies to importers of food, we conclude that it would not be appropriate to establish 
FSVP provisions  that would require importers of certain products to conduct activities to provi de 
assurances that the food is specifically in compliance with a pharmaceutical monograph and/or 
that the foreign supplier was in compliance with certain pharmaceutical CGMP requirements.   
Importers of ingredients that are dietary supplements will be requ ired to comply with 
§ 1.511 (c) of the final r ule; importers of such ingredients that are dietary ingredients will be 
required to comply with the “standard” F SVP requirements.  Howev er, in either case,  importers 
might  be able to rely on records regarding conformance to a foreign country’s drug standards or 
compliance with a foreign country’s drug regulations if such records also contain the in formation 
required under §  1.511 (c) or the standard FSVP provisions (as applicable) .  Those requirements 
are for veri fication of the same level of public health protection as required under part 111 , not 
strict compliance with the regulation.  In our records provision in §  1.510(e), we state that an 
importer does not need to duplicate existing records it has (e.g., records retained to comply with 
other Federal, State, or local regulations) if they contain all of the information required by the 352 
 
 
 FSVP regulation , and that an importer may supplement any such existing records as necessary to 
include all of the required in formation .  If, as the comment states, these products are produced at 
higher standards than the relevant FDA requirements, then it should not pose a significant  burden 
to demonstrate that the relevant FDA standards are met using existing records.  
With resp ect to the comment’s WTO -related assertion, we do not agree  that our WTO 
obligations compel us to establish special FSVP requirements for producers of “monograph 
ingredients.”   As we stated in the preceding paragraph, the FSVP requirements are to obtain 
assurances that the foreign supplier is producing food in compliance with processes and 
procedures that provide the same level of public health protection as required by the relevant 
FDA regulations.  T o the extent that the information regarding the producti on of foods in 
compliance with foreign pharmaceutical monograph specifications is relevant, importers may be 
able to use that information.  
4.  Dietary Supplements  Regulated in Foreign Countries as Drugs  
 (Comment 280)  One comment requests that we exempt from the dietary supplement 
CGMP regulation and subparts B and C of the preventive controls for human food regulation 
certain finished food products that are imported as dietary supplements but regulated as drug 
products in the count ries in which they are manufactured.  The comment also requests that we 
adopt separate modified FSVP requirements for these products.  The comment proposes to call 
such products “foreign registered products,” which it proposes to define as products  that ar e 
allowed for sale in the United States as dietary supplements and that meet the following criteria:  353 
 
 
 •  The product is manufactured in a foreign jurisdiction and is registered as a drug  
product, medicine, therapeutic good, or natural health product by the government of that 
jurisdiction.  
•  The product complies with a standard setting forth required physical, chemical, and/or 
biological characteristics, including limits on any harmful contaminants likely to occur , such as a 
product registration, market auth orization, or official monograph in a national pharmacopeia, 
codex , or formulary . 
•  The product is manufactured at a facility that is registered with FDA as a food facility 
and registered with the government of the jurisdiction in which it is located, and  the facility is 
regularly inspected for compliance with applicable CGMP  requirement s. 
•  The product is manufactured in accordance with one or more of several specified drug 
CGMP regulations or guidelines.  
The comment state s that m any finished products imported into t he United States as 
dietary supplements  are regulated as drugs in their country of manufacture and generally must 
comply with an official monograph, product registration, or market authorization that sets forth 
required attributes, and must  be manufactured under CGMP  requirement s.  The comment 
contends that a pplication of parts 111 and 117 (or equivale nt foreign regulations) to  suppliers of 
foreign registered products would pose a burden w ithout any benefit because the st andards and 
CGMPs app licable to these suppliers exceed the U.S. requirements for dietary supplements .  The 
comment therefore maintains that importers of such products should have the option to verify the 
product against any applicable monograph, product registration, or market  authorizati on and/or 
to verify the supplier ’s compliance with the applicable CGMP  requirement s, rather that its 354 
 
 
 compliance with part 111 or 117 (or eq uivalent foreign regulations).  The comment also asks that  
importers of foreign registered products be provided t he option of complying with the FSVP 
requirements in proposed § 1.511 or complying with separate modified FSVP requir ements  
tailored toward providing adequate assurances that the food is in compliance with the 
requirements of the applicable monog raph, product registration, or market authorization and/or 
that the supplier is producing the product in accordance with the applicable CGMP  requirement s 
of the foreign jurisdiction.   
The comment asserts that requiring manufacturers of “foreign registered  products” to 
comply with the dietary supplement CGMP or preventive controls regulations , and failing to 
adopt the comment’s suggested modified FSVP requirements for these product s, would be 
inconsistent with U.S. obligations under WTO  agreements.  The com ment also maintains that the 
suggested modified FSVP provisions for foreign registered products would be consistent with the  
intent of Congress because the provisions  would help ensure that imported food is as safe as food 
produced in the United States and  they take into account differences among types of imported 
food and their level of risk.  
 (Response  280)  We decline to establish separate FSVP requirements for “foreign 
registered products” as defined by the comment  for the reasons we stated in declining  to adopt 
separate FSVP requirements for monograph ingredients .  In particular, because the FSVP 
regulation appl ies to importers of food, we conclude that it would not be appropriate to establish 
FSVP provisions  requir ing importers of certain products to c onduct activities to provide 
assurances that the food is in compliance w ith the requirements of an applicable pharmaceutical 
monograph, product registration, or market authorization and/or that the supplier is producing the 355 
 
 
 product in accordance with the a pplicable drug CGMP requirements or guidelines.  Importers of 
finished dietary supplements that are used as drugs in foreign countries will be  required to 
comply with §  1.511 (c) of the final r ule.  Howev er, importers of such products might be able to 
rely on records of conformance to drug standards or compliance with other drug regulations if 
such records contain the in formation required under §  1.511 (c) or the standard FSVP provisions 
(as applicable).  In the FSVP draft guidance, we intend to address how impo rters of such 
products  might use information related to foreign supplier compliance with drug monographs, 
product registrations, market authorizations, and drug CGMP regulations and guidelines to meet 
their FSVP requirements.    
 For the reasons stated in our response to the comment regarding “monograph 
ingredients,” we do not agree that the failure to adopt the suggested modified FSVP requirements 
for so -called “foreign registered products” would be inconsistent with U.S. obligations under 
WTO agreement s.   
5.  Location of FSVP Regulations Applicable to Dietary Supplements  
 In the proposed rule, we sought comment on whether we should add the proposed foreign 
supplier verification requirements applicable to dietary supplements  to the regulation on dietary  
supplement CGMP in part 111, rather than include them in the FSVP regulation in subpart L of 
part 1.  
 (Comment 281)  Two comments support including the FSVP requirements for importers 
of dietary supplements in the FSVP regulation because they believe that  the FSVP regulation 
should be comprehensive, but they suggest that the dietary supplement CGMP regulation include 
a reference  to the FSVP requirements applicable to dietary supplement importers.  T wo 356 
 
 
 comments suggest that taking  the opposite approach  would facilitate clarity and compliance with 
the requirements for verification of foreign suppliers of dietary supplements . 
 (Response  281)  We conclude that it is appropriate to locate the FSVP requirements 
applicable to importers of dietary supplements and dietary supplement components in the FSVP  
regulation  in part 1, subpart L, in part because the requirements for the importation of finished 
dietary supplements in § 1.511(c) are very similar to the “standard” FSVP requirements and 
include cross -referen ces to some of those requirements.  However, we are adding , to § 111.5 in 
the dietary supplement CGMP regulation , a statement  that importers of dietary supplements and 
dietary supplement components can find  the FSVP  requirement s in part 1, subpart L.  
M.  V ery Small Importers and Importers of Food From Certain Small Foreign Suppliers 
(§ 1.512)  
In the proposed rule, we proposed modified FSVP requirements for importers that are 
very small importers and for import ers of food from very small foreign suppliers.  We proposed 
some changes to these modified requirements in the Supplemental Notice.  An importer 
following the proposed modified requirements would still be subject to the requirements in 
§§ 1.502 (concerning the scope of an FSVP), 1.503 (concerning the us e of qualified individuals), 
and 1.509 (concerning identification of the importer at entry), but it would not be required to 
comply with the proposed requirements in §§ 1.504 through 1.508 or § 1.510.  This means that 
very small importers and importers obt aining food from very small foreign suppliers would not 
have to meet many of the standard FSVP requirements, including those for hazard analysis and 
supplier verification.   357 
 
 
 Under the proposed modified requirements, an importer would need to obtain written  
assurance, before importing the food and at least every 2 years thereafter, that its foreign 
suppliers are producing food in compliance with the processes and procedures that provide the 
same level of public health protection as those required under secti on 418 or 419 of the FD&C 
Act, if either is applicable, and is producing the food in compliance with sections 402 and 
403(w) of the FD&C Act.  The written assurance would be required to include a brief description 
of the processes and procedures that the f oreign supplier is following to ensure the safety of the 
food.  An importer would be required to promptly take appropriate corrective actions, as 
necessary, maintain relevant records, and make those records available to FDA upon request.   
1.  Modified Req uirements for Very Small Importers and Importers of Food From Certain Small 
Foreign Suppliers  
 We received many comments both for and against the proposed modified FSVP 
requirements for very small importers and importers of food from very small foreign sup pliers.  
As discussed in the following paragraphs, we conclude that it is appropriate to include in the 
final rule modified requirements for very small importers as well as for importers of food from 
certain small foreign suppliers.  We are making changes to the proposed requirements in 
response to comments and to align with requirements applicable to the verification of certain 
suppliers of raw materials and other ingredients under the supply -chain program provisions of 
the preventive controls regulations.  
(Comment 282)  Some comments agree with the proposal to have modified requirements 
for very small importers and importers of food from very small foreign suppliers.  The comments 
assert that applying special and fewer requirements to these entities would assist small 358 
 
 
 businesses that create jobs and innovate without creating public health concerns.  These 
comments argue that application of the detailed and technical requirements of the FSVP 
regulation would be overly burdensome for very small businesses giv en the administrative and 
related costs.  Some comments state that FDA should recognize that the vast majority of recent 
foodborne illness -related public health incidents were caused by large U.S. companies, not small 
businesses or foreign suppliers of pro cessed food.  
Other comments object to the proposed modified requirements, asserting that food safety 
risks are not limited to any particular business size and that food produced by very small foreign 
suppliers or imported by very small importers could stil l be high risk.  Some comments argue 
that no producer of food, whether foreign or domestic, should be exempt from good food safety 
practices.  Some comments assert that inherent risk factors associated with smaller farms due to 
economic challenges increase  the likelihood of food safety compliance problems.  Some 
comments maintain that foods imported from very small operations have been the source of 
significant illness outbreaks in the past.  One comment points to spices in particular, arguing that 
a single  very small supplier can have a huge negative effect on the food supply.  Another 
comment argues that certain microbial contamination issues in imported food most likely would 
involve a very small importer or very small supplier.  Some comments contend  that the costs of 
outbreaks, including the costs associated with a loss of consumer confidence that are borne by 
firms not responsible for the outbreak, would be greater than the costs to very small foreign 
suppliers and very small importers of complying with  the full FSVP requirements.  Some 
comments assert that adopting FSVP requirements based on the size of the importer or foreign 359 
 
 
 supplier, rather than the hazards in the imported food, might be inconsistent with international 
trade agreements.  
Some comments  express concern that a significant percentage of imported food would be 
eligible for the modified requirements under our proposed definitions of very small importer and 
very small foreign supplier.  These comments cite the PRIA of the original proposal, w hich 
estimated that 59 percent of processed food suppliers and 93 percent of raw produce suppliers 
would fall under the very small foreign supplier category.   
Some comments maintain that the modified requirements should only be adopted if very 
small produ cers in the United States are treated in the same way.  Other comments state that the 
definitions of very small importer and very small foreign supplier should correspond with the 
definitions of similar terms in the preventive controls regulations to align  the requirements, 
comply with WTO obligations, and avoid confusion.  
 (Response 282)  We agree with three main concerns expressed by the comments  on very 
small importers and importers of food from very small suppliers .  First, we recognize that some 
very s mall entities might  have great financial difficulty complying with this rule.  Second, while 
we recognize that small entities are not immune from food safety problems, their operations 
typically involve a relatively low volume of food, which, in most cases , should reduce 
consumers’ exposure to, and thus potential risk from, such food.  We are not aware of data 
conclusively demonstrating that small or large firms are more likely to be responsible for 
foodborne illness outbreaks.  Third, we agree that the sco pe of any modified FSVP requirements 
for very small entities should align with the scope of modified requirements under the supply -360 
 
 
 chain program provisions of the preventive controls regulations, to the extent appropriate and 
feasible.   
With respect to the comments concerning the consistency of the modified requirements 
with U.S. international obligations, we believe that the requirements are proportionate to the risk 
posed by food imported by or from these smaller entities  but will still  provide adequate 
assurances of the safety of the food, and therefore are consistent with our international trade 
obligations .  We also conclude that aligning the FSVP and preventive controls regulations to the 
extent feasible and appropriate regarding foo d from small suppliers helps provide parity 
in supplier verification requirements for  domestic and foreign food producers and is therefore 
consistent with the national treatment provisions in international  trade agreements  to which the 
United States is a p arty.  
In response to comments, we are finalizing modified requirements for certain very small 
entities, but we are changing the scope of the entities to which the modified requirements will 
apply.  As discussed in section III.A.23  of this document , we have changed the definition of very 
small importer to better align with the definitions of very small business under the regulations on 
preventive controls for human food and for animal food.   
In addition, we are convinced by the comments to re consid er whether all food from “very 
small foreign suppliers” as we defined the term in the Supplemental Notice (i.e., suppliers with 
less than $1 million in annual food sales) should be eligible for modified requirements.  We 
agree that making a large percentag e of imported produce not subject to the full FSVP 
requirements by adopting such a definition would be concerning.  We also recognize that the 
produce safety regulation exclude s from coverage farms with $25,000 or less in annual produce 361 
 
 
 sales  (while also p roviding for qualified exemptions in certain other circumstances) , which is 
clearly a lower monetary ceiling than the proposed $1 million ceiling for very small foreign 
suppliers.   
In addition, we note that there is no analogous “very small supplier” cate gory in the 
supply -chain program provisions of the preventive controls regulations.  However, those 
regulations include modified supplier verification requirements (in §§ 117.430(c), (d), and (e) 
(for human food) and 507.130(c), (d), and (e) (for animal fo od)) applicable to raw materials or 
other ingredients from the following suppliers  (both domestic and foreign) : 
•  Qualified facilities;  
•  Farms that grow produce and are not covered farms under the produce safety regulation 
in accordance with § 112.4(a) (the farm has 3 -year average annual produce sales of $25,000 or 
less) or in accordance with §§ 112.4(b) and 112.5 (the farm satisfies the requirements for a 
qualified exemption under the produce safety regulation and associated modified requirements in 
§ 112.6) ; and  
•  Shell egg producers not subject to part 118 because the supplier has fewer than 3,000 
laying hens.   
 In each case, the underlying food safety regulation s (i.e., the regulations on preventive 
controls, produce safety, and the production, stor age, and transportation of shell eggs) exclude or 
provide modified requirements for entities based at least in part on their size.  To verify such 
suppliers, the receiving facility must obtain written assurance, at least every 2 years, of the 
supplier’s co mpliance  (or acknowledgement that it is subject to the adulteration provisions of the 362 
 
 
 FD&C Act) .  The verification requirement  varies depending on the type of small supplier  as 
follows : 
•  Written assurance from a qualified facility must attest to the faci lity’s compliance with 
applicable FDA food safety regulations (or, when applicable, relevant laws and regulations of a 
country whose food safety system FDA has officially recognized as comparable or determined to 
be equivalent to that of the United States) , and the assurance must include either a brief 
description of the supplier’s preventive controls for a hazard or a statement that the facility is in 
compliance with State, local, county, tribal, or other applicable non -Federal food safety law, 
including r elevant laws and regulations of foreign countries.  
•  Written assurance from a farm that grows produce and is not a covered farm in 
accordance with §  112.4(a) or in accordance with §§  112.4(b) and 112.5, or a shell egg producer 
with fewer  than 3,000 laying  hens, must attest that the farm or shell egg producer acknowledges 
that its food is subject to  section 402 of the FD&C Act  (or, when applicable, relevant laws and 
regulations of a country whose food safety system FDA has officially recognized as comparabl e 
or determined to be equivalent to that of the United States) .  
 In addition to these modified requirements for supplier verification activities, receiving 
facilities obtaining raw materials or other ingredients from these small suppliers are subject to 
other modified supply -chain program requirements.  Rather than having to conduct a full review 
of a supplier’s performance in accordance with §  117.410(d)(1)(iii) or §  507.110(d)(1)(iii), these 
receiving facilities need only consider the small supplier’s co mpliance history under 
§ 117.410(d)(1)(iii)(B) or §  507.110(d)(1)(iii)(B).  However, these receiving facilities still must 
approve these suppliers and include them in the procedures the receiving facilities establish and 363 
 
 
 follow to ensure that they obtain r aw materials and other ingredients from approved suppliers 
(see §§  117.420 and 507.120).  
We conclude that the FSVP regulation should include analogous modified requirements 
for food imported from these same types of small suppliers.  (In §  1.506(d)(4) of the proposed 
rule as revised by the Supplemental Notice, we had already proposed parallel provisions for food 
from certain small farms; we respond to comments on proposed §  1.506(d)(4) later in this section 
of the document.)  Therefore, under §  1.512(a)(2)  of the final rule, the FSVP regulation include s 
modified requirements for importers of food from the following small foreign suppliers:  
•  Qualified facilit ies under the regulations on preventive controls for human food or for 
animal food (§ 117.3 or § 50 7.3, respectively);  
•  Farms that grow produce and are not covered farm s under the produce safety regulation 
in accordance with §  112.4(a) (the farm has 3 -year average annual sales of $25,000 or less), or in 
accordance with §§ 112.4(b) and 112.5 (the farm satisfies the requirements for a qualified 
exemption under the produce safety regulation and associated modified requirements in § 112.6); 
and 
•  Shell egg producer s that are not subject to part 118 because they have  fewer than 3,000 
laying hens.     
For b oth human food (under § 117.3) and animal food (under § 507.3), a qualified facility 
is (when including the sales by any subsidiary; affiliate; or subsidiaries or affiliates, collectively, 
of any entity of which the facility is a subsidiary or affiliate) a  facility that is a “very small 
business,” or a facility to which both of the following apply:  
1.  During the 3 -year period preceding the applicable calendar year, the average annual 364 
 
 
 monetary value of the food manufactured, processed, packed , or held at such facility that is sold 
directly to qualified end -users during such period exceeded the average annual monetary value of 
the food sold by such facility to all other purchasers; and  
2.  The average annual monetary value of all food sold during the 3 -year period preceding 
the applicable calendar year was less than $500,000, adjusted for inflation.  
For human food, under § 117.3, a very small business is a business (including any 
subsidiar ies and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during 
the 3 -year period preceding the applicable calendar year in sales of human food plus the market 
value of human food manufactured, processed, packed, or held withou t sale (e.g., held for a fee).  
For animal food, under § 507.3, a very small business is a business (including any subsidiaries 
and affiliates) averaging less than $2,500,000, adjusted for inflation, per year, during the 3 -year 
period preceding the applica ble calendar year in sales of animal food plus the market value of 
animal food manufactured, processed, packed, or held without sale (e.g., held for a fee or 
supplied to a farm without sale).  More information about qualified facilities and very small 
businesses appears in the preventive controls final rules.   
For produce, produce farms that are not “covered farms” under § 112.4 of the 
forthcoming produce safety rule have less than $25,000 in annual sales averaged over the 
previous 3 -year period, or satisf y the requirements for a qualified exemption in § 112.5 and 
associated modified requirements in § 112.6 , based on average monetary value of all food sold 
(less than $500,000) and direct farm marketing (during the previous 3 -year period, the average 
annual monetary value of food sold directly to qualified end users exceeded the average annual 
monetary value of the food sold to all other buyers).  In the Supplemental Notice, we erroneously 365 
 
 
 referred to these farms as farms “not subject to the requirements in p art 112.”  While produce 
farms that make less than $25,000 annually are not subject to the requirements in part 112, 
produce farms that satisfy the requirements for a qualified exemption are not subject to the full 
requirements of part 112, but they do hav e certain modified requirements that they must meet, as 
described in § 112.6.  In the Supplemental Notice we further erroneously described the types of 
farms that are not subject to the requirements in part 112  under § 112.4 as including farms that 
do not grow and harvest “produce” and certain farms that grow and harvest produce that is not 
covered under the proposed produce safet y regulation  (i.e., produce that is rarely consumed raw 
and produce for personal consumption or consumption on the farm) .  Althou gh the produce rule 
does not apply to food from such farms, § 112.4 does not establish this.  Rather, § § 112.3 and 
112.2 of the produce safety final rule define what con stitutes produce and specify  what produce 
is not covered by part 112, respectively.  
For shell eggs, we considered the regulations on production, storage, and transportation 
of shell eggs in part 118.  Section 118.1(a) states that the regulations in part 118 apply only to 
shell egg producers with 3,000 or more laying hens at a particular farm  that do not sell all of their 
eggs directly to consumers and that produce shell eggs for the table market.  Therefore, any shell 
egg producer with fewer than 3,000 laying hens is not subject to the requirements in part 118.  
The reasoning behind this cuto ff, that producers with fewer than 3,000 layers do not contribute 
significantly to the table egg market ( see the final rule on the production, storage, and 
transportation of shell eggs, 74 FR 33030 at 33036, July 9, 2009), is consistent with our basis for 
establishing modified requirements when suppliers are farms that are not covered farms under 
the produce safety regulation or qualified facilities under the preventive controls regulations.  As 366 
 
 
 a result, we are including shell egg producers with fewer than  3,000 lay ing hen s among the small 
foreign suppliers from which an importer could import food subject to the modified requirements  
in § 1.512 .   
As with the importation of food by very small importers, we conclude that modified 
FSVP requirements are approp riate for the importation of food from these small foreign 
suppliers because they provide a relatively low volume of food imported into the United States, 
resulting in less consumer exposure and potential risk.  To align the FSVP regulation with the 
supply -chain program provisions of the preventive controls regulations, the modified 
requirements in §  1.512 include certain different requirements for importers of food from the 
specified small foreign suppliers compared to the requirements for very small impor ters.   
One such difference concerns the applicable standard of compliance for written assurance 
from the foreign supplier.  Under §  1.512(b)(3)(i) of the final rule, a very small importer must 
obtain written assurance , before importing a food and  at least  every 2 years thereafter, that its 
foreign supplier is producing the food in compliance with processes and procedures that provide 
the same level of public health protection as those required under section 418 or 419 of the 
FD&C Act, if either is applicab le, and implementing regulations, and is producing the food in 
compliance with sections 402 and 403(w) (if applicable) of the FD&C Act.  However, consistent 
with the analogous requirements in the supply -chain program provisions of the preventive 
controls r egulations, importers of food from small foreign suppliers must obtain written 
assurances as follows:  
•  If the foreign supplier is a qualified facility as defined by § 117.3 or § 503, the written 
assurance must attest that the foreign supplier is producin g the food in compliance with 367 
 
 
 applicable FDA food safety regulations (or, when applicable, relevant laws and regulations of a 
country whose food safety system FDA has officially recognized as comparable or determined to 
be equivalent to that of the United States) .  The written assurance must include either (1) a brief 
description of the preventive controls that the supplier is implementing to control the applicable 
hazard in the food or (2) a statement that the supplier is in compliance with State, local, c ounty, 
tribal or other applicable non -Federal food safety law, including relevant laws and regulations of 
foreign countries (§  1.512(b)(3)(ii)).   
•  If the foreign supplier is a farm that grows produce and is not a covered farm under part 
112 in accordanc e with § 112.4(a), or in accordance with §§ 112.4(b) and 112.5, the written 
assurance must attest that the farm acknowledges that its food  is subject to section 402 of the 
FD&C Act  (or, when applicable, that its food is subject to relevant laws and regulat ions of a 
country whose food safety system FDA has officially recognized as comparable or determined to 
be equivalent to that of the United States) (§ 1.512(b)(3)(iii)).  
•  If the foreign supplier is a shell egg producer that is not subject to the requirem ents of 
part 118 because it has fewer  than 3,000 laying hens, the written assurance must attest that the 
shell egg producer acknowledges that its food is subject to  section 402 of the FD&C Act  (or, 
when applicable, that its food is subject to relevant laws and regulations of a country whose food 
safety system FDA has officially recognized as comparable or determined to be equivalent to 
that of the United States)  (§ 1.512(b)(3)(iv)).  
We believe that these requirements for supplier verification appropriately reflect the laws 
and regulations applicable to the relevant type of foreign supplier in the different circumstances, 
such that the specified foreign suppliers need only provide assurances that  their food is in 368 
 
 
 compliance with , or is subject to,  applicable food safety requirements .  With respect to the 
written assurances from certain farms that are not covered farms (as specified in 
§ 1.512(b)(3(iii)) a nd shell egg producers with fewer  than 3,00 0 laying hens, we believe that the 
acknowledgement that the producer’s food is subject to the adulteration provisions of the FD&C 
Act (or, when applicable, that its food is subject to relevant laws and regulations of a country 
whose food safety system FDA has officially recognized as comparable or determined to be 
equivalent to that of the United States) provides adequate and proportional assurance of safety 
given the lower risk to U.S. consumers posed by the lesser volume of food from such suppliers.  
Any business that introduces food into interstate commerce, including these small suppliers, is 
subject to the prohibited acts provisions in section 301 of the FD&C Act and is accountable if it 
produces food that is adulterated under section 402.   We therefore  conclude that the written 
assurances required from such suppliers provide adequate assurance of safety while minimizing 
the burden that providing the assurances to importers may indirectly impose on these suppliers.  
Consistent with these requirements , we have correspondingly revised the requirement 
(§ 1.512(b)(4) of the final rule) for a very small importer or importer of food from one of the 
specified types of small foreign suppliers to take corrective actions if the foreign supplier does 
not produce the food in accordance with the applicable standards just discussed to make clear 
that corrective action is only required if an importer determines that the foreign supplier of the 
imported food does not produce the food consistent  with the assurance provided under  
§ 1.512(b)(3)(i) through (iv).  
Paragraph (c) of §  1.512 of the final rule sets forth certain requirements that apply to  
importers of food from the specified small foreign suppliers but not to very small importers.  We 369 
 
 
 believe that these provisions pr ovide an additional level of food safety assurance that should be 
part of the standard operations for most food importers , except for very small importers .  This 
approach to FSVP requirements for importers of food from certain small suppliers is consistent  
with the supply -chain requirements applicable to receiving facilities that obtain raw materials or 
other ingredients from these types of suppliers under the preventive controls regulations.  
 Section 1.512(c)(1)(i) requires that in approving foreign suppli ers, importers of food from 
the specified small foreign suppliers must conduct (and document) a limited evaluation of a 
potential foreign supplier by considering the applicable FDA food safety regulations and 
information relevant to the foreign supplier’s compliance with those regulations, including 
whether the foreign supplier is the subject of an FDA warning letter, import alert, or other FDA 
compliance action related to food safety.  Section 1.512(c)(1)(i) also states that the importer may 
also consider other factors relevant to a foreign supplier’s performance, including those specified 
in § 1.505(a)(1)(iii)(A) and (a)(1)(iii)(C) (i.e., a foreign supplier’s food safety processes, 
procedures, and practices and its food safety history).   
 Section 1.512(c) (1)(ii)(A) requires the importer to promptly reevaluate the concerns 
associated with the foreign supplier’s compliance history when the importer becomes aware of 
new information about the supplier’s compliance history and to document the reevaluation.  If 
the importer determines as a result of the reevaluation that the concerns associated with 
importing a food from a foreign supplier have changed, the importer must promptly determine 
(and document) whether it is appropriate to continue to import the food fr om the foreign 
supplier.  However, §  1.512(c)(1)(ii)(B ) requires that if, at the end of any 3 -year period, an 
importer has not reevaluated the concerns associated with the foreign supplier’s compliance 370 
 
 
 history, the importer must reevaluate those concerns a nd take other appropriate actions, if 
necessary, and document the reevaluation and any subsequent actions taken.  
The potential burden of reviewing a small foreign supplier’s compliance history may be 
reduced because the regulation permit s the importer to r eview another entity’s evaluation or 
reevaluation of a foreign supplier ’s compliance history.  Under §  1.512(c)(1)(iii) of the final rule, 
if another entity (other than the foreign supplier) has, using a qualified individual, performed the 
supplier complia nce evaluation or the reevaluation, the importer may meet its requirements by 
reviewing and assessing the evaluation or reevaluation conducted by that entity.  If an importer 
chooses to do this, it must document its review and assessment, including documenting that the 
evaluation or reevaluation was conducted by a qualified individual.  
Under §  1.512(c)(2) of the final rule, importers of food from certain small foreign 
suppliers must approve these suppliers on the basis of the compliance history evalu ation the 
importer either conducts or reviews and assesses, and the importer must document the approval.   
 Finally, §  1.512(c)(3) (i) requires these importers of food from certain small foreign 
suppliers to establish and follow written procedures to ensure  that they import foods only from 
foreign suppliers approved based on the compliance history evaluation (or, when necessary and 
appropriate, on a temporary basis from unapproved foreign suppliers whose foods the importer 
subjects to adequate verification a ctivities before importing the food ).  The importer must 
document its use of these procedures.  However, under §  1.512(c)(3)(ii), the importer may rely 
on another entity (other than its foreign supplier ) to establish these procedures and perform and 
docume nt the required activities, provided that the importer reviews and assesses that entity’s 371 
 
 
 documentation of the procedures and activities, and the importer documents its review and 
assessment.  
 Having discussed the principal changes the final rule makes to the proposed modified 
requirements for very small importers and importers of food from very small foreign suppliers, 
in the following paragraphs we respond to comments on various aspects of the proposed 
requirements and, in doing so, note other changes inc luded in the final rule.  
a.  Comments regarding the proposed modified verification requirements for certain 
farms . 
 (Comment 283)  Some comments state that the produce safety regulation exclude s farms 
with annual sales of $25,000 or less but the FSVP regul ation do es not include an analogous 
exclusion.  The comments ask that we delete the exclusion from the produce safety regulation 
because they believe that mandating importers to hold foreign operations to standards that 
domestic operations are not required  to meet would invite a WTO challenge.   
(Response 283)  As previously stated, importers obtaining produce from farms with 
annual sales of $25,000 or less are subject to modified requirements under the FSVP regulation.  
While these requirements do not const itute an exclusion from FSVP, they significantly decrease 
the burden of the regulation for these importers.  Because farms with $25,000 or less in annual 
sales are not subject to the produce safety regulation, the modified requirements do not mandate 
that an importer of produce from such a farm obtain assurance that the farm is in compliance 
with section 419 of the FD&C Act, as the produce safety regulation  would not apply.   
 In addition, we have aligned the supplier verification provisions in the FSVP reg ulation 
with the supply -chain program provisions of the preventive controls regulations, to the extent 372 
 
 
 appropriate and feasible, including the eligibility criteria for the modified requirements for 
produce imported from suppliers that are farms that are no t covered farms under the produce 
safety regulation in accordance with § 112.4(a) or in accordance with §§ 112.4(b) and 112.5.  
Therefore, receiving facilities subject to the preventive controls regulations that obtain produce 
from domestic farms are not s ubject to less burdensome supplier verification requirements for 
that produce than importers importing produce from foreign farms.  
 (Comment  284)  One comment suggests that we not provide modified requirements for 
certain farm suppliers and delete proposed  § 1.506(d)(4)  because modified requirements would 
not give importers the tools they need to assure that they are addressing safety issues with food 
from such farms.  On the other hand, o ne comment asks that we apply the proposed modified 
requirements to a ll farms that are not subject to the produce safety regulations.  
 (Response  284)  We stated in the preamble to the Supplemental Notice that proposed 
§ 1.506(d)(4) would have provided modified verification requirements with respect to food from 
the followin g:  
•  Farms that grow or harvest crops such as grains that are not “produce,” as defined in 
§ 112.3(c) of the proposed produce safety regulation.  
•  Farms that grow and harvest produce that is not covered by the proposed produce 
safety regulation in accordance with proposed § 112.1.  Such “non -covered produce” includes 
produce that is rarely consumed raw, produce that is produced for personal consumption or for 
consumption on the farm or another farm under the same ownership.  
•  Farms that are not “co vered farms” because they produce an average annual monetary 
value of produce of no more than $25,000.  373 
 
 
 • Farms that are not covered farms because they satisfy the requirements for a qualified 
exemption from the proposed produce safety regulation under prop osed § 112.5 and the 
exemption has not been withdrawn.    
Although § 1.512 of the final rule provides modified verification requirements for the 
latter two types of farms, it does not provide modified verification requirements for the former 
two types of fa rms.  That is, final § 1.512 does not provide modified verification requirements 
for farms that grow and harvest crops such as grains that are not “produce” as defined in 
proposed § 112.3(c), and does not provide modified requirements for farms that grow or harvest 
produce that is not covered by the proposed produce safety regulation in accordance with 
proposed § 112.1 (e.g., because such produce is rarely consumed raw  or is produced for personal 
or on -farm consumption).  We believe that th is approach is  appropriate.  
 With respect to crops such as grains that are not “produce” as defined in the produce 
safety regulation (and thus are not subject to the regulation), much of this  imported food likely 
will not be consumed without processing that provides for th e application of an appropriate kill  
step or control.  Rather than provide for modified verification requirements for such food under § 
1.512, we think it is more appropriate to allow importers to rely on the provisions of § 1.507 
discussed in section III. H of this document , as applicable .  Under those provisions, if the hazards 
have not been significantly minimized or prevented before importation, an importer may 
determine and document that the food could not be consumed without applicatio n of an 
appropria te control (e.g ., cooking or other treatment of the food  for grains for human 
consumption) or could obtain assurances from its customer that the customer or a subsequent 
entity in the distribution chain will process the food for food safety .  This approach  allows the 374 
 
 
 hazard control to be applied after importation while also providing the importer with flexibility 
as to which entity will apply the appropriate control.  In addition, importers of some grains may 
appropriately determine through their hazard ana lysis that there are no hazards requiring control.  
In such cases, the importer would document that determination in its written hazard analysis but 
would not be required to conduct an evaluation for foreign supplier approval and verification 
under §  1.505  and would not be required to conduct foreign supplier verification activities under 
§ 1.506.  Importers of other grains might determine that the only way to ensure that identified 
hazards are significantly minimized or prevented would be to conduct verifi cation activities in 
accordance with §  1.506.  
For similar reasons, the final rule requires  importers of produce rarely consumed raw to 
comply with  the provisions in §§ 1.505, 1.506, and 1.507 , as applicable,  instead of providing 
modified provisions for such produce.  For some produce rarely consumed raw , an importer 
might determine it is appropriate  to conduct supplier verification activities to ensure that hazards 
in the food have been significantly minimized or prevented before importation.  For other 
produce in this category, we believe that the requirements in § 1.507 are suitable to ensuring the 
safety of such produce because the food will be subject to the application of a control after 
importation, and § 1.507 provides flexibility as to which entit y will apply the control.  With 
respect to produce for personal or on -farm consumption, this produce would either never be 
exported to the United States (because it is consumed on the farm) or could be eligible for the 
personal consumption exemption from t he FSVP regulation  under  § 1.501 (d).  We therefore do 
not see any need to establish modified requirements applicable to this category.    375 
 
 
 We are not certain whether the comment requesting that the modified requirements apply 
to all farms not subject to the produce safety regulation contemplates any other food or farms 
being subject to the modified verification requirements in § 1.512.  To the extent that the 
comment requests that food produced by such operations as dairy farms be covered by the 
modified requ irements in § 1.512, we do not agree.  Safety problems may arise in food produced 
by such operations.  Providing modified requirements for such operations would increase the 
volume of imported food subject to modified requirements, and would therefore also  increase 
consumers’ risk of exposure to such food.  Consistent with Congress’ intent that we implement 
the FSVP requirements based on the level of risk posed by the imported food (see section 
805(c)(3) of the FD&C Act), we believe it is appropriate that importers of food from such farms  
be subject to the standard supplier verification requirements.  Indeed, w e have designed the 
modified verification requirements in §  1.512 so they apply only to operations that expose 
consumers to less risk because the oper ations export a relatively small volume of food to the 
United States.  We also believe that o ur treatment of produce and food from other farms not 
subject to the produce safety regulation is consistent with the coverage of the supply -chain 
program provisio ns in the preventive controls regulations.    
In the context of the nature of the imports for which we are providing modified 
verification requirements in § 1.512, we continue to believe that the modified requirements 
would be adequate to provide assurance s from these particular suppliers that the food is produced 
in compliance with the applicable standards in this rule.  In addition, the foods covered by the 
modified requirements in § 1.512 are and will continue to be covered under the adulteration 376 
 
 
 provisi ons of the FD&C Act and applicable implementing regulations, irrespective of the 
modified verification requirements under the FSVP regulation.  
(Comment 285)  Several comments request that importers not be required to obtain 
written assurance of compliance with the FD&C Act from the farms specified in proposed 
§ 1.506(d)(4).  The comments assert that obtaining written assurance would be unnecessary or 
inappropriate because FDA has already determined that these foods are of minimal or no risk.  
The comments a lso state that, with respect to a RAC that is not subject to the produce safety 
regulations, the importer might not know the identity of the farmer who grows the RAC (e.g., 
RACs that are consolidated before export to the United States).  
 (Response 285)  As stated previously, the fact that we are allowing importers to obtain 
written assurance, instead of requiring importers to determine and conduct what might be more 
burdensome supplier verification activities, reflects our view of the risk to public healt h 
attributable to produce from these farms.  To the extent that the comments believe  that requiring 
assurances is inconsistent with the risk to public health posed by these suppliers, we disagree.  
Obtaining assurances is an appropriate verification activi ty because it requires importers to 
obtain from suppliers information about the safety of the imported food.  For produce RACs 
consolidated before export to the United States from farms described in §  1.512(a)(2)(ii) of the 
final rule, the regulation do es not prohibit  an importer from enlisting the consolidator to help 
obtain the necessary written assurances.  
 (Comment 286)  One comment contends that obtaining written assurances from grain 
farmers is not feasible because FDA has not established safety stand ards for grain.  377 
 
 
  (Response 286)  As finalized and as previously discussed , § 1.512 does not establish any 
modified requirements specific  to the importation of grain.  However, we expect that the risk -
based framework of this rule will still generally result  in a relatively low verification burden for 
the importation of grain.  As described in the previous paragraphs, importers may be able to take 
advantage of the flexibility in § 1.507 for imported grains for which hazards will be controlled 
after importatio n. 
b.  Other comments related to the appropriateness or implementation of modified 
provisions for small entities . 
 (Comment 287)  Some comments assert that Congress did not provide an exemption for 
very small importers and food from very small foreign supp liers and FDA should not create one.  
 (Response 287)  As discussed in the proposed rule, section 805(c)(3) of the FD&C Act 
directed FDA to, as appropriate, take into account differences among importers and types of 
imported food, including based on the lev el of risk posed by the imported food.  We have not 
created an exemption from the FSVP regulation for very small importers or very small foreign 
suppliers.  Instead, as discussed previously, we are adopting modified requirements that 
generally apply to sit uations that involve a relatively low volume of imported food, which should 
reduce consumers’ exposure to, and thus potential risk from, the food (see 78 FR 45730 at 
45765).  We think this approach is commensurate with the risk to public health posed by th ese 
importers and suppliers, consistent with section 805(c)(3), because the food affected by these 
provisions constitutes a relatively low volume of imported food, which should reduce the risk to 
consumers  posed by this  food.   378 
 
 
  (Comment 288)  Some comments agree with the idea of having modified requirements 
for very small importers and very small foreign suppliers, but state that the modified 
requirements should be different from what we proposed.  Some comments maintain that we 
should require a thi rd-party audit by a qualified individual for very small importers and importers 
of food from very small foreign suppliers.  Some comments argue that these importers should be 
subject to the full requirements of the FSVP regulation, but that we should addre ss the challenges 
for these entities in complying by giving them additional time to comply.  
 (Response 288)  Although an importer may determine that a third -party audit is the most 
appropriate verification activity for a given food and foreign supplier, the FSVP regulation  does 
not mandate a third -party audit of a foreign supplier for any imported food.  We do not see the 
logic in creating more stringent requirements for very small importers and importers of food 
from small suppliers than for all other im porters subject to the FSVP regulations.  
(Comment 289)  Some comments support modified requirements for very small foreign 
suppliers but state that importers’ requirements should be the same regardless of the size of the 
importer or its supplier.   
 (Respo nse 289)  The FSVP regulations apply to importers; they do not impose direct 
requirements on foreign suppliers.  The size of the importer is relevant to its ability to comply 
with the FSVP requirements and to the volume of food imported by the importer (an d thus 
consumers’ exposure to the food).  We therefore believe it is appropriate to adopt  modified 
requirements for very small importers.  379 
 
 
  (Comment 290)  Some comments state that very small foreign suppliers may already be 
exempt from the preventive contro ls or produce safety regulations and do not need a duplicative 
exemption from importers’ verification requirements.  
 (Response 290)  We did not propose and are not finalizing an exemption for food from 
qualified facilities or certain small farms.  We are e stablishing modified, risk -based verification 
requirements for importers of such food.   
 (Comment 291)  Some comments express concern that these provisions will allow 
businesses to alter their structures to ensure that the imported food is exempt from the  regulation.  
Some comments assert that businesses would assign the FSVP importer responsibility to the 
entity most likely to be exempt.  Comments also maintain that large exporters of food to the 
United States might break shipments into smaller units to a void application of the full FSVP 
requirements.   
 (Response 291)  While this rule does not prevent various business arrangements from 
developing, we do not believe that it would be cost -effective for an importer to alter its entire 
supply chain to only im port food from many small facilities  or farms  to meet its needs instead of 
from its usual large supplier s.  We understand that many large importers that import food from 
large suppliers are already performing supplier verification activities of some kind.  We believe 
they are much more likely to simply modify their current practices, if such modification is 
needed, rather than adopt entirely new supply structures to evade  application of the full 
requirements of the rule.   
We do not agree that large exporte rs of food to the United States are likely to break 
shipments into smaller units to avoid the full FSVP requirements.  An importer of food from a 380 
 
 
 large exporter would not be eligible for modified requirements just because the particular 
shipment the import er received happened to be small.  To make its products eligible for 
application of the modified requirements, an exporter would have to divide itself into smaller, 
distinct businesses, which could create  significant costs for the underlying business.   
 (Comment 292)  Some comments assert that if FDA believes the modified requirements 
are sufficient, those requirements should apply to all importers regardless of size.  
 (Response 292)  As previously stated, FSMA directed FDA to, as appropriate, take into 
account differences among importers and types of imported food, including based on the level of 
risk posed by the imported food.  The modified requirements are designed to specify verification 
activities that take into account the risk to overall public heal th posed by the low volume of food 
from these entities imported into the United States.  The modified requirements would not be 
appropriate for all importers regardless of risk.  
 (Comment 293)  Some comments express concern that eligibility reporting and 
verification activities will create additional work for FDA.  They assert that verification of sales 
data might be possible for importers through interagency cooperation with the Internal Revenue 
Service but not for foreign suppliers.  The comments maintain  that without verification, 
importers might fraudulently document that an entity meets the very small foreign supplier 
definition as well as assurances of compliance.  
 (Response 293)  When we review records of  importers who are following modified 
requireme nts in accordance with § 1.512 , we will expect to review documentation supporting 
their determination that the food they import is eligible for the modified requirements.  Importers 
should expect that we will use information available to us to verify the t ruthfulness and accuracy 381 
 
 
 of this information.  Falsely reporting eligibility criteria to FDA could subject importers to 
penalties under  18 U.S.C. 1001.   
 (Comment 294)  Some comments ask what course of action FDA would have in the event 
of a foodborne ill ness outbreak if an outbreak is traced back to a very small foreign supplier or 
food imported by a very small importer.   
 (Response 294)  If a foodborne illness outbreak is traced back to food subject to modified 
requirements under the FSVP regulation, we  will be able to use our enforcement tools to address 
the issue  in the same manner as we would with importers subject to the “standard” FSVP 
requirements , including, if appropriate, placing the foreign supplier or importer on import alert.   
 (Comment 295)  Some comments state that the modified requirements do not solve the 
problems associated with having to verify thousands of farms, including maintaining a list of 
approved suppliers, conducting compliance status reviews, and documenting the entities’ 
eligibility for the modified requirements.  Some comments question whether compliance status 
review for thousands of small farms that do not directly sell food to the United States is a good 
use of resources.  
 (Response 295)  The final modified requirements do  not include maintaining a list of 
approved suppliers; they do include documenting eligibility for the modified requirements and, 
for importers of food from the specified small foreign suppliers, evaluating their potential 
suppliers’ compliance history.  I f an importer wants to follow the modified requirements, it must  
make a determination about its eligibility through reviewing its own annual sales information or 
obtaining written assurance from  a foreign supplier.  Maintaining the record of that 382 
 
 
 determination allows  the importer to show that it  meet s the eligibility criteria  and enables us  to 
verify the importer’s eligibility.   
Regarding the comments on compliance status review, §  1.512 of the final rule does not 
require very small importers to conduct a compliance status review of potential foreign suppliers, 
as we had originally proposed.  As previously discussed, §  1.512(c)(1) does require importers of 
food from certain small foreign supplier s to evaluate their foreign suppliers’ compliance history.  
With respect to produce imported from a farm that grows produce and is not a covered farm in 
accordance with §  112.4(a) or in accordance with §§  112.4(b) and 112.5, under §  1.512(c)(1)(iii), 
an im porter of such produce could rely on another entity (other than the foreign supplier)  to 
evaluate the  compliance history of a potential foreign supplier.   
2.  Provisions of the Modified Requirements for Very Small Importers  and Importers of Food 
From Cert ain Small Suppliers  
 Some comments address particular aspects of the proposed modified requirements for 
very small importers and importers of food from very small foreign suppliers.  We respond to 
these concerns in the following paragraphs.  
 a.  Calculatin g eligibility . 
 Under proposed §  1.512(b)(1), an importer seeking to import food under the modified 
requirements would have to document, at the end of each calendar year, that it meets the 
definition of “very small importer” in §  1.500  or that the foreign supplier meets the definition of 
“very small foreign supplier” in §  1.500 .  For the purpose of determining whether the definition s 
were satisfied , the baseline year for calculating the adjustment for inflation would be 2012.  
Proposed §  1.512(b)(1) further  states that if the importer or foreign supplier conducts food sales 383 
 
 
 in currency other than U.S. dollars, the importer would have to use the relevant currency 
exchange rate in effect on December 31 of the year in which sales occurred to calculate the value  
of these sales.  
The final rule includes changes to §  1.512(b)(1) t o clarify how importers must determine 
their eligibility for the modified provisions for very small importers and importers of food from 
certain small foreign suppliers .  To import food as a very small importer , an importer must 
document its eligibility as a “very small importer ” (as defined in §  1.500)  with respect t o human 
food and/or animal food  before initially importing food and thereafter on an annual basis by 
December 31 of each calen dar year  (§ 1.512(b)(1)(i)(A)).  F or the pu rpose of determining 
whether the importer satisfies  the definition of very small importer with respect to human food 
and/or animal food for a given calendar year, the relevant 3 -year period of sales (and U.S. mark et 
value of human or animal food, as appropriate) is the period ending 1 year before the calendar 
year for which the importer  intend s to import food as a very small importer  (§ 1.512(b)(1)(i)(B)) .  
To align the very small importer requirements with the requirements for qualified facilities in the 
preventive controls regulations, the baseline year for calculating the adjustment for inflation is 
2011 rather than 2012  as proposed.  If the importer conduct s any food sales in curren cy other 
than U.S. dollars,  it must use the relevant currency exchange rate in effect on December 31 of the 
year in which sales occurred to calculate the value of these sales.  
To import food under the modified provisions for food from small foreign suppliers, an 
importer must obtain  written assurance  that its foreign supplier  meets the criteria for one of the 
types of small suppliers in §  1.512 (a)(2)(i), (ii) , or (iii)  before first approving the supplier for an 384 
 
 
 applicable calendar year and thereafter on an annual basis by December 31  of each calendar year, 
for the following calendar year . 
 (Comment 296)  One comment seeks clarification as to who will determine the monetary 
value of an importer and how such criteria will be enforceable.    
 (Response 296)  Under §  1.512(b)(1) (i) of the final rule, the importer itself must 
determine the dollar amount of its sales of human or animal food and the market value of any 
human or animal food imported, manufactured, processed, packed, or held without 
sale.  Importers must retain documentation of eligibility for the modified requirements and make 
it available for FDA review.  
b.  Written assurance s. 
 We proposed (in §  1.512(b)(3)) that an importer seeking to import food under the 
modified requirements be required to obtain written assurance, before importing a food and at 
least every 2 years thereafter, that the foreign supplier is producing food in compliance with 
processes and procedures that provide the same level of public health protection as those 
required under section 418 or 419 of the FD&C A ct, if either is applicable, and is producing the 
food in compliance with sections 402 and 403(w) of the FD&C Act.  The written assurance 
would have to include a brief description of the processes and procedures that the foreign 
supplier is following to en sure the safety of the food.  
 As previously discussed, the final rule contains revised written assurance requirements 
for very small importers and importers of food from certain small foreign suppliers.  
 (Comment 297)  Some comments agree with the proposed  requirement to obtain  written 
assurances  from foreign suppliers .  Other comments argue that we should allow greater 385 
 
 
 flexibility by allowing a very small supplier to provide records, like a commercial invoice, a 
certification of safety by the supplier’s re gulatory authority, a HACCP plan/certification, or a 
private certification, to meet the verification requirements.  These comments also state that if a 
food is specifically named as high risk by FDA , or food from the foreign supplier was rejected 
twice at the border for its food safety performance, then additional proof of safety could be 
demanded according to FDA guidance developed in consultation with small food companies.  
 (Response 297)  We believe that the requirement to obtain written assurances from 
foreign suppliers will not be more burdensome tha n obtaining records from those suppliers.  
Recognizing the variety of business practices that currently produce safe food, the final rule 
provides a significant amount of flexibility concerning the form of w ritten assurances.  The 
modified requirements do not specify the particular form of documentation that must be used as 
written assurance for FSVP purposes.  Some records suggested by the comments, such as a  
certification of safety by a supplier’s regulator y authority or a private certification , might be 
sufficient  for written assurance purposes if they  satisfy  the applicable requirement s for written 
assurance in §  1.512(b)(3) .  However, for food from qualified facilities, the written assurance 
must include the information required by §  1.512(b)(3)(ii).   
We believe that basing supplier verification requirements for a particular food on whether 
it had been refused admission, as suggested by some comments, would be too administratively 
burdensome for both impor ters and the Agency.   As to the issue of basing the level of supplier 
verification on whether a food is high risk, we generally ag ree that supplier verification should 
be risk -based and this rule applies a risk -based  framework.   In general, the rule allows  importers 
to tailor the supplier verification activities they conduct based on the hazards applicable to the 386 
 
 
 food and the characteristics of the supplier.   For very small importers, however, we believe that 
the modif ied requirements, including the require ment to obtain supplier assurances, are 
appropriate given the reduced risk to consumers posed by the  relatively low volume  of food 
imported by these firms.   
c.  Corrective actions . 
We proposed (in §  1.512(b)(4)) that very small importers be required to pro mptly take 
corrective actions if they determine that a foreign supplier of food they import does not produce 
the food in compliance with processes and procedures that provide the same level of public 
health protection as those required under section 418 or  419 of the FD&C Act, if either is 
applicable, or produces food that is adulterated under section 402 or misbranded under section 
403(w) of the FD&C Act.  The appropriate corrective actions would depend on the 
circumstances but could include discontinuing use of the foreign supplier until the cause or 
causes of non -compliance, adulteration, or misbranding have been adequately addressed.  We 
further proposed that importers be required to document any corrective actions they take to meet 
this requirement.  
We have revised the corrective action requirements in §  1.512(b)(4) to reflect the revised 
requirements for written assurances for very small importers and importers of food from certain 
small foreign suppliers  by specifying that appropriate corrective action s would be required if the 
importer determines that its foreign supplier does not produce food consistent with the assurance 
provided  in accordance with  § 1.512(b)(3).  
 (Comment 298)  Some comments ask that the provision be revised to specify that 
correcti ve actions are only necessary when non -compliance causes a risk to public health.  The 387 
 
 
 comments assert that this would be consistent with FDA’s statement in the preamble to the 
proposed rule that regulations should focus on foreseeable food safety risks id entified through a 
hazard assessment process, rather than all risks covered by the adulteration provisions in section 
402 of the FD&C Act.  
 (Response 298)  For the reasons stated with respect to the corrective action provisions in 
§ 1.508 of the final rule  (see section I II.I.4 of this document), we disagree that corrective actions 
are only necessary when non -compliance causes a risk to public health.  
d.  Records . 
We proposed certain requirements (in §  1.512(b)(5)) related to the availability, quality, 
and retention of records of activities under the modified requirements for very small importers 
and importers of food from very small foreign suppliers.  We proposed to require importers to 
maintain records, in English, and to make them available promptly to a n authorized FDA 
representative, upon request, for inspection and copying.  We also proposed that importers be 
required to maintain records at their places of business or at a reasonably accessible location; 
records would be considered to be at a reasonabl y accessible location if they could be 
immediately retrieved from another location by computer or other electronic means.  
The final rule includes several changes to the proposed requirements to align the 
recordkeeping requirements in §  1.512(b)(5) of the final rule with the changed recordkeeping 
requirements in §  1.510 (discussed in section III.K of this document) as well as for consistency 
with the supply -chain program provisions in the preventive controls regulations.   Section 
1.512(b)(5)(ii)(A) of the final rule does not require that records be maintained in English.  388 
 
 
 Instead, u pon FDA request, importers must provide within a reasonable time an English 
translation of records maintained in a language other than English.   
The record retention provisions in § 1.512(b)(5)(iii) require importers to retain records 
for at least 2 years after records are created or obtained.  However, records of importers who 
obtain food from certain small foreign suppliers that relate to the importers’ processes and 
procedures  (e.g., evaluations of supplier compliance history under §  1.512(c)(1), approvals of 
suppliers under §  1.512(c)(2)) must be retained for at least 2 years after their use is discontinued.   
Also, records relied on to support an importer ’s status as a very s mall importer must be retained 
for at least 3 years.  
Section 1.512(b)(5)(iv) specifies that records of very small importers and importers of 
food from certain small foreign suppliers obtain ed by FDA  in accordance with  the FSVP 
regulations are subject to the disclosure requirements under part 20.  In addition, under 
§ 1.512(b)(5)(v)(A), these importers do not need to duplicate their existing records if they 
contain all of the information required under the FSVP regulation, and importers may 
supplement any existing records as necessary to include all required information.  Under 
§ 1.512(b)(5)(v)(B), importers are not required to keep required information in one set of 
records; if existing records contain some of the required information, any n ew information 
required by the FSVP regulation may be kept separately or combined with existing records.    
 (Comment 299)  Some comments suggest that records should be considered to be at a 
reasonably accessible location if they can be retrieved within 5 business days from another 
location, rather than immediately retrieved by computer or other means.  The comments state 
that “immediately” is subject to misinterpretation, and FDA should replace the term  with a 389 
 
 
 specific, reasonable time interval.  The comme nts suggest that 5 days is adequate, but in no case 
should FDA impose an interval of less than 1 business day.  Some comments object to the 
requirement that only computer or other electronic means are suitable for record retrieval 
because some locations of  offsite records might not have adequate resources, and a requirement 
to use electronic means might inadvertently require expensive computer system validation.  
 (Response 299)  Consistent with changes to proposed §  1.510 discussed in section 
III.K.3.b of t his document, we have changed §  1.512(b)(5)(ii)(B) to specify that offsite storage of 
records is permitted if such records can be retrieved and provided onsite within 24 hours of 
request for official review.  Under the final rule, electronic records are co nsidered to be onsite if 
they are accessible from an onsite location.  We believe that the 24 -hour deadline is important 
because records must be available to FDA investigators during inspections.  We do not believe it 
is reasonable for an inspection to be put on hold for 5 business days so that an importer can 
acquire the necessary records.  However, the provision no longer specifies retrieval by computer 
or other electronic means; an importer could use a non -electronic means (e.g., courier service) to 
retrieve and provide records onsite.  
(Comment 300)  Some comments request that the regulations specify that there is no 
requirement for compliance with any part of part 11.  
 (Response 300)  The final rule includes a provision (§  1.512(b)(5)(iv)) specifying that 
electronic records that are established or maintained to satisfy the requirements of §  1.512 are 
exempt from the requirements of part 11.  
3.  Other Concerns Regarding the Modified Requirements  
 a.  Withdrawal of eligibility . 390 
 
 
  (Comment 301)  One commen t expresses concern that the modified requirements for very 
small importers do not include a provision on withdrawal of eligibility for the exemption, as 
there is in the preventive controls regulations.  The comment asks that we consider adding the 
ability  to withdraw eligibility from an importer that imports food that causes an illness outbreak.  
 (Response 301)  We do not believe such a provision is necessary, given the risk -based 
nature of the eligibility criteria for these modified requirements and our e xisting enforcement 
tools in the imports arena.  For example, if an importer imports food that causes an illness 
outbreak, we can place the importer on import alert, as appropriate, among other options to 
ensure the safety of the food.   
b.  Identifying ve ry small importer eligibility at the time of entry . 
 (Comment 302)  Some comments say that exemptions and exceptions to the FSVP 
requirements, including the proposed modified requirements for very small importers and 
importers of food from very small forei gn suppliers, should be identified at the time of entry by 
using an exemption/exception code, similar to the structure in place under the prior notice 
regulations.  
 (Response 302)  We are planning to establish data elements that can be submitted at the 
time of entry to identify shipments that  are exempt  from the FSVP regulation  or, as with very 
small importers and importers of food from certain small foreign suppliers, subject to modified 
FSVP requirements . 
c.  Compliance period . 391 
 
 
  (Comment 303)  Some commen ts ask that we consider giving very small importers and 
importers of food from very small foreign suppliers  more time, beyond the 3 years proposed, to 
comply with the requirements.  Some comments suggest 5 years.   
 (Response 303)  We do not believe that t he modified requirements are sufficiently 
onerous to justify a longer compliance period for very small importers  or importers of food from 
small suppliers .  With respect to the compliance period for all importers , we are aligning the 
FSVP regulation with t he compliance dates of the supply -chain program provisions in the 
preventive controls regulations, to the extent feasible.  For more discussion about the applicable 
compliance dates, see section IV of this document.  
d.  Outreach . 
 (Comment 304)  Some comme nts ask that we commit to engaging in capacity building 
and education to help improve the knowledge and performance of very small entities, 
particularly for very small importers.  
 (Response 304)  We are committed to stakeholder engagement throughout the 
implementation of FSMA.  We plan to issue several guidance documents to assist entities in 
complying with the new FSMA regulations, including a general guidance document on FSVPs.  
We intend for this guidance to include  recommendations on compliance with the  modified 
requirements  for very small importers and importers of food from small foreign suppliers .  We 
will develop and issue these guidances in accordance with our good guidance practice regulation, 
which establish es criteria for when we issue a guidance document as an initial draft, invite public 
comment, and prepare a final version of the guidance document that incorporates suggested 392 
 
 
 changes, when appropriate (21 CFR 10.115(g)).  In addition, we plan to develop trai ning 
materials to assist importers in complying with the requirements of this rule.   
With respect to capacity building, we issued a comprehensive plan to expand the 
technical, scientific , and regulatory food safety capacity of foreign governments and thei r 
respective food industries in countries from which foods are exported to the United States in 
accordance with section 305 of FSMA in 2013  (Ref. 1 5).  We anticipate that this plan will 
provide a strategic framework for our capacity -building efforts  over t he next several years.  
N.  Importing a Food From a Foreign Supplier in a Country With an Officially Recognized or 
Equivalent Food Safety System (§ 1.513)  
 We proposed to establish alternative FSVP requirements for food from foreign suppliers 
in countries whose food safety systems  FDA has officially recognized as comparable or 
determined to be equivalent to that of the United States, when certain conditions a re met.  These 
provisions would allow the importation of such food without being subject to most of the 
standard FSVP requirements.   
Proposed § 1.513(a) specified that the importation of food from a foreign supplier in, and 
under the regulatory oversight of, a country whose food safety system FDA has officially 
recognized as comparable to that of the United States, or that FDA has determined to be 
equivalent to that of the United States, would be subject to modified FSVP requirements when 
certain condition s are met and documented.  The proposed conditions (stated in proposed 
§ 1.513(b)(1)) were the following:  393 
 
 
 •  The foreign supplier must be in, and under the regulatory oversight of, a country whose 
food safety system FDA has officially recognized as compara ble or determined to be equivalent  
to that of the United States ; and  
•  The food must be within the scope of the relevant official recognition or equivalency 
determination.  
Proposed § 1.513(b)(1) also specified that these conditions be documented before 
importing a food from the foreign supplier and annually thereafter.  
Under proposed § 1.513(b)(2), when those conditions were met, the importer would have  
the option of complying with modified FSVP requirements.  Under such modified requirements, 
the import er would be required to determine and document whether the foreign supplier of the 
food was in good compliance standing with the food safety authority of the country in which the 
foreign supplier is located.  Importers would be required to continue to moni tor whether the 
foreign supplier is in good compliance standing and promptly review any information obtained.  
If the information indicate d that food safety hazards associated with the food are not being 
adequate ly controlled, we proposed that the importer  would be required to take prompt corrective 
action , which  would depend on the circumstances but could include discontinuing use of the  
foreign supplier.  We also proposed to require that the se importer s document any corrective 
actions.  If an importer met those conditions and requirements for a food, the importer would not 
be required to comply with most of the proposed FSVP requirements (e.g., for hazard analysis, 
compliance status review, supplier verification activities).  (However, fo r the reasons stated in 
section III.D of this document, we conclude that it is appropriate to require these importers to use 
a qualified individual to perform the tasks required under §  1.513 of the final rule.)  But we 394 
 
 
 proposed that  these importer s would be required to comply with the requirements concerning 
identification of the importer at entry and recordkeeping.  
In the preamble to the proposed rule, we discussed how these proposed modified 
requirements were consistent with a risk -based approach to food  safety, which includes 
leveraging the regulatory efforts of food safety authorities in foreign countries.  We discussed 
our systems recognition initiative, under which we are conducting assessments of foreign food 
safety systems  to determine whether they provide similar protections to those offered under the 
U.S. system and a similar level of oversight and monitoring.  The systems recognition process, 
which is described on our Web site at 
http://www.fda.gov/food/internationalinteragencycoordination/ucm3674 00.htm  (Ref. 16) , 
involves a comprehensive review of a country’s food safety system by FDA scientists, auditors, 
and investigators, along with use of a food safety authority self -assessment tool (currently in 
draft form) called the International Comparabil ity Assessment Tool (ICAT), to determine 
whether a country has a food safety system that is comparable to that of the United States.  
As stated in the preamble to the proposed rule, the systems recognition review process 
consists of two principal stages.  A fter satisfactory completion of a review of a country’s ICAT 
submission, audit teams from FDA, including persons specializing in particular high -risk 
commodities, will perform an in -country assessment to verify the implementation of programs 
and measures a s outlined in the ICAT submission.  The assessment provide s an objective and 
comprehensive means of assessing the foreign food safety system.  FDA will only enter into a 
systems recognition arrangement with a foreign government if we are confident that the  395 
 
 
 oversight of the foreign food safety authority is sufficiently rigorous and reliable that it can 
ensure that food produced in that country is as safe as food produced in the United States.    
After FDA enters into a systems recognition arrangement with an other food safety 
authority, we will maintain an ongoing dialogue and hold annual consultations to determine 
whether any substantial changes in the country’s food safety system have developed  to ensure 
that the country’s food safety system continues to be comparable .  Although we are still 
developing the systems recognition  process, w e plan to reevaluate the operation and status of 
each arrangement every 5 years, including review ing changes in a country’s food safety system 
and conduct ing system audits as n eeded.   
We requested comment on the appropriateness of our proposed modified FSVP 
requirements for food imported from a country with a  comparable  or equivalent food safety 
system, including the proposed conditions and modified FSVP requirements that would  be 
applicable to such imported food.  In addition, in light of the possible inclusion of supplier 
verification provisions for raw materials and other ingredients in the preventive controls 
regulations, we requested comment on whether the modified requirem ents should apply to the 
importation of raw materials and other ingredients.  
1.  Appropriateness of the Modified Requirements  
 We received comments supporting and opposing  the proposed modified FSVP 
requirements for food from foreign suppliers in countries  with comparable or equivalent food 
safety systems.  As discussed in the following paragraphs, we conclude that the modified 
provisions are an appropriate component of risk -based foreign supplier verification requirements.  
However, for the reasons describ ed in the following paragraphs , we conclude that it is 396 
 
 
 appropriate to limit the scope of the modified provisions to imported food that will not be further 
manufactured/processed in the United States, including packaged food products and fresh 
produce inten ded for consumption without further commercial manufacturing/ processing.  This 
change will ensure  that food from foreign suppliers in countries whose food safety systems  we 
have  officially recognized as comparable or determined to be equivalent to that of the United 
States will be subject to supplier verification under the FSVP regulation  in the same 
circumstances that food from domestic suppliers will be subject to supplier verification under the 
preventive controls regulations . 
 (Com ment 305)  Several comments express support for the application of modified FSVP 
requirements for importing a food from a country with a  comparable  or equivalent food safety 
system.  These comments maintain that the requirements are consistent with a risk -based 
approach to food safety that avoids unnecessary expenditure of verification resources by 
incorporating the regulatory efforts of foreign food safety authorities.  With respect to the 
importation of raw materials and other ingredients, some comments s upport applying the 
modified requirements to these products.  
On the other hand, some comments oppose the modified provisions, asserting that 
supplier verification is needed to provide adequate assurance of safety regardless of the 
regulatory environment in  the country in which a food is produced.  The comments assert that 
just because a country’s food safety system has been deemed comparable does not mean that the 
system operates perfectly all the time.  The comments express concern that under the modified 
provisions not all foreign suppliers would be held to the same standards that apply to domestic 
producers.   397 
 
 
  (Response  305)  We conclude that the application of the modified FSVP requirements for 
imports of food from foreign suppliers in countries with a  food safety system  officially 
recognized as comparable or determined to be equivalent  is consistent with a modern, risk -based 
approach to food safety.  As previously stated, the systems recognition process provides for a 
thorough and rigorous assessment of  whether the food safety system in a foreign country 
provides similar protection to that provided to consumers under the U.S. system.  We believe that 
the production of food by a foreign supplier in good compliance standing with a food safety 
authority imp lementing a system that FDA has deemed comparable or equivalent to the U.S. 
system will provide adequate assurance of safety and make supplier verification by importers 
unnecessary.  Thus, importation of food under these modified provisions should reduce t he 
regulatory burden on importers while still providing assurance that the food will be produced 
consistent with U.S. standards.   
However, we conclude that the scope of the modified requirements for food from 
countries with comparable or equivalent food s afety systems must be revised with respect to raw 
materials and other ingredients.  Supplier verification for raw materials and other ingredients is 
an important part of a preventive approach to food safety.  Through supplier verification , the 
entity recei ving raw materials or other ingredients from a supplier can help ensure that the 
supplier (or a supplier to the supplier) has implemented controls to significantly minimize or 
prevent known or reasonably foreseeably hazards in the raw material or other ing redients.  As a 
result of these considerations, we have  finalized requirement s for supplier verification  in the 
preventive controls regulations --even for suppliers that operate under the U.S. food safety 
system .  Under th e preventive controls regulations , receiving facilities that obtain raw materials 398 
 
 
 or other ingredients from either domestic or foreign suppliers w ill, under certain circumstances , 
need to have a supply -chain  program that includes the performance of supplier verification 
activities.   
We bel ieve that verifying foreign suppliers of raw materials and other ingredients is as 
important to food safety as verifying domestic suppliers , and that where the supplier operates and 
the nature of government oversight does not change the need for supplier verification 
requirements.  In other words, supplier requirements are important when food is produced in the 
United States, when it is produced in foreign countries whose food safety systems FDA has not 
officially recognized as comparable  or determined to be equivalent , and when it is produced 
under  food safety systems that FDA has found to be comparable  or equivalent .  When a supplier 
has not controlled a hazard requiring a control , the entity receiving that food can help ensure that 
the hazard is controlled before there is a finished product  to be distributed to consumers --
regardless  of whether the supplier is located domestically or in a foreign country.    
The U.S. food safety system requires that hazards be significantly minimized or 
prevented  in finished food products, and the same will be the case for the food safety system in 
any country that FDA officially recognizes as comparable or determines to be equivalent.  When 
food that does not require further manufacturing/processing is im ported from foreign suppliers in 
good compliance standing in those countries, we do not believe that there will be significant 
public health benefit in an importer conducting verification that the supplier’s hazards have been 
significantly minimized or pre vented .  In those circumstances , we will have confidence that the 
food safety system of the foreign supplier’s country adequately requires the control of hazards  
for which controls  are needed .  Furthermore, we do not see a reason for the FSVP regulation to  399 
 
 
 permit imports of raw materials and other ingredients under the modified requirements for food 
from countries with comparable or equivalent food safety systems while  raw materials and other 
ingredients would be subject to supplier verification under the p reventive controls regulations.  
Therefore, §  1.513(a)(2) of the final rule specifies that the modified provisions apply only to 
food that is not intended for further manufacturing/processing, including packaged finished food 
products and RACs that will no t be commercially processed further before consumption.  
 (Comment 306)  Several comments maintain that we should exempt U.S. producers that 
are in good compliance standing with FDA from the supplier verification requirements in the 
preventive controls regu lations.  These comments assert that if domestic manufacturers are 
subject to supplier verification requirements under the preventive controls regulations while 
importers of food from countries with comparable or equivalent food safety systems are exempt 
from most FSVP requirements, this would result in imported food being subject to less oversight 
than domestic food.  
 (Response  306)  As discussed previously, § 1.513(a)(2) of the final rule provides that 
supplier verification of raw materials and other ing redients is treated the same under the FSVP 
and preventive controls regulations by limiting the applicability of the modified provisions on 
food from countries with comparable or equivalent food safety systems to food that will not be 
subject to further ma nufacturing/processing.  Further , we believe , as stated previously, that 
supplier verification of raw materials or other ingredients is important regardless  of whether the 
food is produced by domestic or foreign suppliers.  Such verification allows the fac ility receiving 
the raw material or other ingredient to take steps, when necessary,  to control hazards requiring a 
control that have not been controlled by the supplier.  400 
 
 
  (Comment 307)  Some comments suggest that there is an inconsistency with the 
provisions of proposed §§  1.513 and  1.506(d)(5).  As discussed in section III. G.4 of this 
document, proposed §  1.506(d)(5) would permit an importer to rely on an inspection of a foreign 
supplier that is conducted by the food safety authority of a country w hose food safety system we 
had officially recognized as comparable or determined to be equivalent, as a substitute for 
conducting a required onsite audit of the foreign supplier.  The comments assert that this 
provision is superfluous because proposed § 1. 513 would relieve the importer of the obligation to 
conduct an onsite audit of the foreign supplier.  
 (Response  307)  We do not agree.  As stated previously, the modified provisions in 
§ 1.513 of the final rule appl y only to food that will not be commerci ally processed further in the 
United States.  However, under §  1.506(e)(1)(i)(E)( 2) of the final rule, an importer of a raw 
material or other ingredient from a country with a comparable or equivalent food safety system 
may substitute an inspection by the f ood safety authority for an onsite audit of the foreign 
supplier of the raw material or other ingredient provided that certain conditions are met.  In 
addition, the provisions allowing substitution of an inspection for an onsite audit do not require 
docume ntation that the foreign supplier is in good compliance standing with the food safety 
authority in a country with a comparable or equivalent food safety system, which is required for 
importing food under the modified provisions in §  1.513.  Consequently, w e conclude that there 
are circumstances under which an importer of food from a country with a comparable or 
equivalent food safety system might wish to rely on the results of an inspection conducted by the 
food safety authority of that country in accordanc e with §  1.506(e)(1)(i)(E)( 2).   401 
 
 
 2.  Systems Recognition Process  
 Several comments request changes to, or clarification of, our systems recognition 
process, while some comments request a change to proposed § 1.513 to address a concern about 
the systems recognition process.  
 (Comment 308)  Some comments request that we c larify and simplify the process of 
making systems recognition determinations.  Some comments, noting their understanding that 
the systems recognition approach will allow FDA to prioritize its inspection and surveillance 
activities according to risk, ask th at we more clearly show the benefits for exporting countries 
under the approach to increase the incentive for participation in systems recognition.   
 (Response  308)  The systems recognition initiative is a food safety regulatory cooperation 
program and it is not intended to be a program for the promotion of trade or market access.  
Systems recognition is a regulator -to-regulator program that allows FDA to take into account the 
role of food safety systems of exporting countries in our risk -based decision making regarding 
inspections, monitoring, admissibility, and follow -up when food safety incidents occur.  As a 
regulatory coo rdination program, systems recognition em braces cooperation in many areas such 
as research, capacity building with third countries, and outbreak response.   
We are using systems recognition as a tool to determine when we can rely on the 
implementation of science -based food safety programs by fore ign regulatory authorities and take 
action based on information provided by such authorities.  However, we note that the systems 
recognition program is based on the principle that foreign food producers can meet U.S. food 
safety requirements by providing a ssurances that these foods are produced according to the food 
safety standards of a country whose food safety system we have found to be comparable or 402 
 
 
 equivalent.  Therefore, it is appropriate, under §  1.513 of the final rule, to exempt from the 
applicatio n of most FSVP requirements certain food from foreign suppliers that are in good 
compliance standing with the food safety authority of a country whose food safety system we 
have found  to be comparable to ours as a result of a systems recognition assessment .   
 (Comment 309)  One comment requests that we revise proposed § 1.513 (b) to replace 
“country” with “country or entity” in the phrase “country with an officially recognized or 
equivalent food safety system” to recognize that, in addition to individual co untries, entities such 
as the E U might also be the subject of a food safety system s recognition agreement.  This 
comment also asks that we establish a transition program or grace period for countries that are 
undergoing systems recognition evaluation so th at exports from those countries are not subject to 
the full range of FSVP requirements while FDA conducts its evaluation.  
 (Response  309)  We appreciate that the E U plays an important role in coordinating the 
food safety policy of its Member States.  Howev er, within the E U the food safety agencies of the 
national governments of the Member States are responsible for enforcing the feed and food 
safety laws and implementing official controls for food safety through all stages of production, 
processing, and dis tribution ( Ref. 1 7).  In that context, we are continuing to evaluate and 
consider how to best address the functions and processes of both the E U and its Member States.  
We do not believe that it is necessary to revise §  1.513(b)(1) as requested to address this aspect 
of our systems recognition review.   
We also decline to apply modified FSVP requirements to importers of food from 
countries that are undergoing , but have not completed,  a systems recognition assessment.  403 
 
 
 Applying such requirements to systems r ecognition candidates before we have completed the 
evaluation process would prejudge the outcome of the process.    
 (Comment 310)  Some comments request that we rapidly expand the list of countries 
participating in the systems recognition program so that it includes the major trading partners of 
the United States.  These comments assert that a systems recognition program covering the 
United States’ largest trading partners would significantly reduce burdens on food importers.  
 (Response  310)  We are trans itioning the systems recognition program from the pilot 
phase to the implementation phase.  During this transition we will be addressing modifications of 
our internal procedures and training of FDA personnel involved in systems recognition 
determinations.  As a result, we will be applying more resources to the program in response to 
requests for recognition from additional countries.  As we gain more experience with the systems 
recognition program, we expect to  improve the efficiency of the review process.  However, 
because there is variation in the level of maturity of food safety systems in countries around the 
world, not all countries are likely to qualify to participate in the systems recognition program.   
 (Comment 311)  One comment asserts that in sel ecting countries to review under the 
systems recognition process, FDA will be biased towards countries with legal systems and 
official languages that are similar to those of the United States, making it difficult for other 
countries to obtain systems recog nition status.  
 (Response  311)  We do not agree.  We are administering the systems recognition pilot 
program through a transparent and objective science -based evaluation of the food safety systems 
of the candidate countries.  We will continue to provide i nformation and opportunities for 
stakeholder input as the program transitions from the pilot stage to the full implementation stage.   404 
 
 
  (Comment 312)  Some comments assert that FDA should only make equivalency 
determinations and not systems recognition det erminations.  One of these comments maintains 
that equivalency determination is a more robust approach than systems recognition for 
determining whether the United States can rely on another country’s food safety system.  
 (Response  312)  We do not agree.  Both equivalence and systems recognition have 
unique aspects, but both can be considered robust enough to satisfy the objectives of the FSVP 
regulations, which include  several methods for an importer to achieve compliance.   Systems 
recognition, in particul ar, involves a sufficiently r igorous  analysis of the food safety system of 
the foreign country so that it is appropriate to include it as an alternative.    
3.  Commodity -Specific Arrangements with FDA  
In the proposed rule, we requested comment on what FSVP  requirements might be 
appropriate for food imported from countries whose food safety authorities have entered into 
commodity -specific arrangements or agreements with FDA.  
 (Comment 313)  Several comments support the idea of having commodity -specific 
syste ms recognition arrangements.  These comments assert that there are certain countries with 
excellent food safety systems for specific products.  The comments suggest that limiting 
compliance assurance to these specific products rather than requesting equiva lence for all food 
products should be sufficient and appropriate in certain cases.  The comments ask that we 
publish a listing of all commodity/country arrangements for specific food sectors within 
countries that can demonstrate equivalent public health pr otection with respect to the listed 
commodities.  Some comments ask that we consider products that are already covered under 405 
 
 
 bilateral memoranda of understanding (MOUs), such as FDA’s agreement with Mexico 
regarding cantaloupe, as subjects for future commo dity-specific systems recognition agreements.  
 (Response  313)  We are considering whether and how best to develop commodity -
specific recognition programs.  In considering the best path forward, we are aware  that, a lthough 
a country’s overall food safety sy stem may not be comparable to that of the United States for 
FDA -regulated products, the country might be able to successfully demonstrate that a specific 
production practice or set of practices for a particular food or foods provides the same level of 
public health protection for a specific measure or a set of measures as described in FDA 
regulations.  At the same time, we know  that an evaluation of an overall food control system 
allows for intensive and extensive review of many components of that safety sy stem.  We will 
provide opportunities for stakeholder input as we continue to consider whether and how  to 
recognize programs for specific commodities when a country demonstrates that their programs 
provide the same level of public health protection as those  being applied to food production in 
the United States.  If we establish commodity -specific arrangements in the future, we will 
provide information about such arrangements on our Web site.  
 (Comment 314)  One comment suggests that FDA base an equivalence d etermination on 
an evaluation of the official food safety control system of the exporting country by investigating 
the food safety control systems of a specific number of suppliers in the exporting country.  
 (Response  314)  We agree that consideration of the food safety control systems of 
exporting suppliers might be a relevant factor in an equivalence determination.  However, more 
important to this determination would be the quality and strength of the foreign authority’s food 
safety operations.  406 
 
 
 O.  Cons equences of Failure to Comply With FSVP Requirements  (§ 1.514)  
We proposed to codify in the FSVP regulation certain FSMA provisions related to the 
consequences of failing to comply with the FSVP requirements.  In accordance with section 
801(a) of the FD&C Act, we proposed to specify, in §  1.514 (a), that an article of food is subject 
to refusal of admission under section 801(a)(3) of the FD&C Act if it appears that the importer of 
the food fails to comply with the FSVP regulations with respect to that food.  Proposed 
§ 1.514(a) further states that if an article of food has not been sold or consigned to a person in the 
United States at the time the food is offered for entry into the Uni ted States, the article of food 
may not be imported into the United States unless the foreign owner or consignee has designated 
a U.S. agent or representative as the importer for the purposes of the definition of “importer” in 
§ 1.500.  In accordance with section 301(b) of FSMA , we proposed to specify, in §  1.514(b), that 
the importation or offering for importation into the United States of an article of food by an 
importer without having an FSVP that meets the requirements of section 805 of the FD&C Act, 
including the FSVP regulation, is prohibited under section 301(zz) of the FD&C Act.  
In the final rule, we are making  certain  change s to the regulatory text for these 
provisions.  Specifically, in §  1.514(a) we are changing the phrase “has not been sold…to” to “is 
not owned by” in accordance with the changes we made to the definition of “importer” in 
§ 1.500.  Another change we are making to §  1.500 also is relevant to these provisions.  As 
discussed in section III.A.11 of this document , we are  adding a clari fication to the definition of 
importer in §  1.500 stating  that a designation of a U.S. agent or representative  by a foreign owner 
or consignee of a food  (when there is no U.S. owner or consignee  at the time of entry ) must be 
confirmed in a signed statement  of consent that the U.S. agent or representative agrees to serve 407 
 
 
 as the importer under the FSVP regulation.  In cases where there is no such signed statement of 
consent, there would not be a  valid  designation of a  U.S. agent or representative  for purposes  of 
the definition of importer in § 1.500.  In those circumstances, food offered for entry into the 
United States may be refused admission under §  1.514(a).  We might  ask the foreign owner or 
consignee that is exporting the food to provide us with the sign ed statement if any questions arise 
about whether the person designated as the U.S. agent or representative in fact agreed to serve in 
that role.  
 (Comment 315)  One comment states that FDA should share with port officials from 
relevant agencies information on refusals of admission due to an importer’s failure to comply 
with the FSVP regulation.  The comment also suggests that we take steps to ensure that 
import ers do not “port shop” to gain entry after previously being denied.   
(Response  315)  We currently post information related to all admission refusals on our 
Web site.  In addition, we share information on refusals with CBP, relevant partner government 
agen cies (PGAs), and State officials as appropriate .  Once compliance with the FSVP regulation 
is required, this information might include refusals related to non -compliance  with the 
regulation .   
In addition, we believe that the FSVP regulation will provide us with tools to respond to 
any inappropriate “port shopping.”  Under § 1.509(a) of the final rule, the name, electronic mail 
address, and unique facility identifier identifying the importer must be provided electronically 
when filing entry with CBP for eac h line entry of food product offered for importation into the 
United States.  Because we will have information about individual importers, we will be able to 
identify shipments linked to those importers.  We plan to use this information to respond to any 408 
 
 
 inappropriate “port shopping” that importers might attempt.  In addition, in appropriate 
situations, when we identif y violations with respect to products, shippers, and/or importers, we 
may place the products , shippers, and/or importers on import alert.  Import alerts provide 
guidance to  FDA field staff that future shipments appear violative within the meaning of 
applicable FD&C Act provisions.  Based on information in an import alert, field staff might 
detain  products in shipments  without physical examination.  Detention without physical 
examination  places the burden on the importer to demonstrate that each shipment is in 
compliance.  When products, shippers, and/or importers are included on an import alert, t his 
prompts the FDA district office to flag relevant shipments  involving these products and entities .  
Flagging such shipments makes “port shopping” less likely to be successful.    
 (Comment 316)  One comment asks that we provide importers with a means to  pose 
questions or request secondary consideration of shipment refusal due to FSVP non -compliance.  
One comment suggests that we develop procedures for inform ing foreign suppliers (and 
presumably importers) how they can obtain entry for future shipments fo llowing an admission 
refusal.  
 (Response  316)  Importers will be able to use existing procedures  to resolve matters 
related to non -compliance with the FSVP regulation.  Under § 1.514(a), an article of food is 
subject to refusal of admission under section 8 01(a)(3) of the FD&C Act if it appears that the 
importer of that food fails to comply with the FSVP regulation  with respect to that food.  If there 
appears to be a violation, we might  issue a Notice of Detention and Hearing specifying a place 
and period of  time in which  testimony may be introduced either verbally or in writing concerning 409 
 
 
 the detention to prove compliance with the regulatory requirements.  Throughout this process, 
the importer may  contact the local District compliance office to ask questions .   
To the extent that the second comment is asking about procedures for  removal of food 
from detention without physical examination under an  import alert due to FSVP non -compliance, 
existing procedures are likely to be applicable.  An importer is placed o n detention without 
physical examination because information indicates the appearance of a violation of an 
applicable  provision of the  FD&C Act.  Our decisions to remove an importer from an import 
alert are based on evidence establishing that the conditions that gave rise to the appearance of a 
violation have been resolved and we have confidence that future entries will be in compliance 
with the releva nt FD&C Act requirements.  FDA import alerts often  provide guidance about 
removal from th e import alert , in particular  how to remove the appearance of a violation.  If we 
place any importers on import alert for FSVP violations, we plan to provide informati on in the 
import alert about achieving removal from the alert.  Depending on the nature of the violations at 
issue, that guidance may specify that we might  require reviewing the records  of the importer 
before granting removal.   However, this review  might not always be necessary.  
 (Comment 317)  One comment states that FDA might sample an imported food and 
determine that it is adulterated or misbranded even though the importer is meeting all FSVP 
requirements.  The comment states that although the food itsel f would be subject to detention or 
refusal, it is not clear what action the Agency would pursue regarding the importer’s FSVP.  The 
comment suggests that we explain what action we might take, such as conducting a follow -up 
inspection of the importer or dir ecting the importer to revise its FSVP as needed to address 
inadequacies.   410 
 
 
  (Response  317)  We agree that it is possible that we might find, based on an examination 
of samples or otherwise, that an importer’s food appears  to be adulterated , even in circum stances 
in which we ha d found the importer to be in compliance with the FSVP requirements during our 
most recent review  of the importer ’s records .  In such circumstances, we may take appropriate 
action in response to any such finding of an appearance of a violation, including, where 
appropriate, detention and subsequent refusal of admission of the food.  Any finding that 
imported food appears to be adulterated may require  the importer to take appropriate corrective 
action under § 1.508 to ensure that its foreign supplier produc es food consistent with the 
applicable requirements of the FD&C Act.  The importer also might need to modify its FSVP for 
the food to provide adequate assurance of the food’s safety.  Depending on the circumstances, 
we might determin e that we should inspect the importer to assess its compliance with the FSVP 
regulation and, potentially, place the importer, the food, and /or its foreign supplier on import 
alert.  However, we realize that there are circumstances in which the finding of a dulteration in 
any particular shipment might not necessarily mean that the importer is in violation of the FSVP 
regulation.   
To the extent that the comment is addressing circumstances in which the hazards in a 
food are controlled after importation, those circumstances are addressed, in part, in section 
III.H.2  of this document.  As explained in that section, under § 1.507 in the final rule , importers 
are not required to conduct an evaluation under §  1.505 or supplier verification activities under 
§ 1.506 u nder specified circumstances.  For instance, importers  are not required to conduct 
§ 1.505 evaluations or §  1.506 activities if they demonstrate and document that they rely on their 
customer to ensure that the identified hazard will be significantly minimi zed or prevented , or that 411 
 
 
 they rely on a customer to provide assurance that the food will be processed to control the 
identified hazard by an entity in the distribution chain subsequent to the customer, and that other 
specified requirements are satisfied  (§ 1.507(a)(2) through  (4)).  In addition, § 1.502(c)(1) deems 
in compliance with most of the FSVP requirements an importer that is a facility subject to the 
preventive controls regulations that is implementing preventive controls for the hazards in the 
food in accordance with those regulations . 
 (Comment 318)  One comment suggests that food from a foreign supplier for which FDA 
has refused admission under §  1.514(a) should be located and placed under embargo or “stop 
sale,” adding that FDA should work with State and local government authorities in this effort 
whenever possible.  
 (Response  318)  Under section 801(a)(3) of the FD&C Act, food that is refused 
admission under section 801(a) must be exported or destroyed within 90 days after its refusal .  If, 
after a reasonable time, FDA has not received notification of exportation or destruction of 
articles refused admission, FDA guidance for import operations recommends that FDA district 
offices investigate the status of the disposition.  Because of the requireme nt to either export or 
destroy  such food , we do not agree that there is any general need to embargo the food or place it 
on “stop sale. ”  However, if the need arises, we may work with State counterparts in connection 
with use of their  “embargo” authority under State and/or local law.  Our ability to work with 
States in this manner is one of the reasons we agree with the suggestion that we work with State 
and local government authorities  when  appropriate.   
 (Comment 319)  Some comments state that, although  it will be very easy for FDA to find 
technical infractions of the FSVP regulation, the Agency should focus more on infractions that 412 
 
 
 may be linked to food safety problems rather than violations related to paperwork or 
recordkeeping procedures.  
 (Response  319)  As with all of our FSMA -related enforcement efforts, we intend 
to apply our FSVP enforcement resources in a risk -based manner, placing greater emphasis on 
violations of the regulation that are more likely to result in harm to the public health.   In 
considering what enforcement actions, if any, are appropriate, we expect to consider factors 
including the severity of the violation, the risk to public health, and the willingness of the 
importer to cooperate and take corrective actions.  In addition, we pl an to provide guidance and 
technical assistance to  assist importers in achieving compliance .  
(Comment 320)  Some comments request that we establish an appeals process for 
disputes regarding compliance with the FSVP regulation.  
 (Response  320)  Importers w ill be able to use existing procedures to challenge FDA 
findings regarding non -compliance with the FSVP regulation .  If we cite violations of the FSVP 
regulation upon inspection of an importer , the importer will have the opportunity to respond to 
the inspe ctional observations, and any such inspectional observations will not represent a final 
Agency determination regarding compliance.   In addition, if we issue a warning letter to an 
importer, the importer will likewise have the opportunity to respond.  Gener ally, FDA warning 
letters request corrective actions and a written response within a specified period of time after the 
date of receipt of the letter, usually 15 working days.  At our discretion, the recipient of a 
warning letter may be offered an opportun ity to discuss the letter with FDA district officials or, 
when appropriate, with other FDA officials.   413 
 
 
  (Comment 321)  Some comments request that we provide information on the measures 
we will use to assess an importer’s compliance with the FSVP regulatio n. 
 (Response  321)  FDA investigators may conduct inspections of importers and review 
importers’ records.  In conducting such inspections and reviews, we might  consult any 
information and/or Agency guidance that is relevant and appropriate.  
P.  Other Issues  
 We received comments on several matters related to FDA implementation and 
enforcement of the FSVP regulation as well as Agency outreach and training.  We respond to the 
comments in the following paragraphs.  
1.  Implementation and Enforcement  
 As di scussed in the following paragraphs, we received comments concerning FDA 
inspections of importers, the role of States in enforcing the FSVP regulation, and other 
implementation and enforcement issues.  
 a.  How should FDA conduct FSVP inspections?  
 (Comment  322)  We received many comments addressing how we should conduct FSVP 
inspections.  Several comments ask that we  provide companies with flexibility to develop their 
supplier verification programs.  Some comments assert that FDA inspections of supplier 
verification programs should focus on ensuring that importers establish  strong, risk -based 
programs that are consistently implemented  and documented .   
Some  comments assert that FDA inspectors should focus on whether the qualified 
individual s responsible for developing the FSVPs have the necessary education and experience.   414 
 
 
 Some  comments recommend that  we assess the evaluation of hazards and suppliers, 
consider whether the importer properly used the evaluation to determine  the appropriate supplier 
verificatio n activities, and verify that  the importer conducted the appropriate  activities.  Some  
comments assert that unless there is cause, we should not routinely question an importer’s 
determinations about individual suppliers or review the food and supplier evaluations  and 
determination s of appropriate verification activities.  One comment suggests that we defer to 
importers in our inspection and enforcement relating to supplier verification activities.  
 (Response  322)  We understand the need for both flexibi lity and accountability when 
conducting records reviews  for compliance with the FSVP regulation .  The regulation  is written 
to provide importer s with flexibility in meeting the requirements, including by determining  
appropriate supplier verification activi ties based on the risk posed by a  food and the foreign 
supplier’s performance.  However, t he regulation  require s importers to document their 
procedures, determinations , and activities to allow us to assess importers’ compliance.  
 We disagree that we shoul d not review any particular aspect of an importer’s FSVP.   
Because the final rule allows importer s flexibility in meeting the requirements , we must assess 
the choices  the importer  makes  to ensure that its FSVP adequately protects U.S. consumers from 
unsaf e imported products.  It is not our practice to defer to regulated entities in our 
implementation and enforcement of regulations.   
However, we realize that no method of supplier verification can provide complete  
assurance against the emergence of foodborne illness,  and there might be circumstances in which 
the failure to detect or control a hazard might not necessarily mean that the importer has 
incorrectly analyzed the hazards, selected a  “wrong” method of verif ication, or has otherwise 415 
 
 
 violated the FSVP regulation.  In such circumstances, however, an importer might  be required to 
revise its  procedures  to be in compliance with  the requirements .    
 (Comment  323)  Some comments recommend that we conduct our inspec tions of FSVP 
activities at the central locations where such activities are carried out.  Some comments s uggest  
that we conduct targeted inspections at corporate headquarters that focus only on the importer’s 
FSVP , because most supplier verification  progra ms are managed at the corporate level.   
 (Response  323)  Because the FSVP regulation require s documentation of an importer’s 
implementation of its FSVP,  our inspection s will be  records -based.  Therefore, in the event of an 
in-person inspection, the inspec tion generally will  take place where the majority of FSVP  records 
are kept.  That m ight be at the importer’s corporate headquarters or another central location.  
Although  § 1.509 (b)(2)  permits  offsite storage of records, those records must be retrieved and 
provided onsite within 24 hours of FDA’s request for review.   
   b.  Role of States in enforc ement.  
 (Comment  324)  Some comments ask how we will coordinate our FSVP enforcement 
activities w ith State and local agencies.  Some comments assert that State and local authorities 
can play an important role in ensuring the effectiveness of this verification system through the 
inspection and surveillance of imported food products marketed to establis hments routinely 
inspected by State and local agencies.  Some comments ask that we  communicate early and often 
with States and local authorities regarding anticipated roles, options, and resources that will be 
available for the implementation of this rule.   Other comments suggest that we establish 
cooperative agreements with States explain ing what type of enforcement actions we will support, 
how States should respond to discovered food hazards, and how we will use information reported 416 
 
 
 by State s.  Some comme nts ask whether we will provide funding to State agencies to assist them 
in meeting inspection mandates.    
(Response 324)  We agree that State and local food safety regulatory authorities play an 
important role in helping to protect consumers from unsafe food.  As previously stated, w e are 
working through the Partnership for Food Protection to develop and implement the IFSS 
consistent with FSMA’s emphasis on establishing partnerships for achieving compliance (see 
section 209(b) of FSMA).  We are currently developing our compliance strategy for the FSVP 
regulation and are considering the role that State and local authorities can  play in helping to 
achieve compliance.   
 (Comment  325)  Many comments ask us to be more open and transparent with records of 
imported foods distributed within the States.  Some comments assert that State agencies must 
have access to all relevant import r ecords when a State agency discovers an adulterated product.  
Some comments ask  that we  develop a formal mechanism through which States can supply 
surveillance information to  us so that we can better target import inspections and review problem 
products, c ompanies, and countries.  Other comments ask us to develop a method to allow  States 
to efficiently access FDA records.  
 (Response  325)  In general, we work with our State partners in enforcement actions, 
including coordinating actions or deferring to each other when one department has authority to 
act swiftly to protect the consumer.  As previously stated , we are still determining the 
appropriate role of our State partners in FSVP  implementation and enforcement .   
 c.  Decreased border sampling for food sub ject to FSVP . 417 
 
 
  (Comment  326)  Some comments ask that we  consider decreasing the sampling 
frequency of regular border inspections for chemical, physical , and radiological contamination of 
imported foods if the importer is in compliance with the FSVP regulation.  These comments 
assert that chemical, physical, and radiological hazards are not increased during transport, unlike 
biological hazards.    
 (Respon se 326)  We agree that the results of FSVP inspections should factor into our 
operations at ports of entry.  We plan on incorporating data from the inspections into our 
PREDICT system to help better target food imports based on risk , which could include ri sks 
associated with different types of hazards .    
2.  Outreach and Training  
 (Comment 327)  Some comments support the efforts of the FSPCA  and encourage 
supplier verification -specific training as part of Alliance programs.  Some comments offer 
recommendat ions for the content, delivery, and timing of education and training for FDA and 
industry.  These comments suggest that materials be designed for simplicity of understanding but 
also completely address all requirements, that FDA take advantage of the wide range of methods 
available for distribution and dissemination of educational and instructional materials (e.g., 
workshops, webinars, publications/media, and onsite trainings/consultations), and that we begin 
training efforts as soon as the final rule is pu blished.   
 (Response 327)  We agree that the FSVP materials we develop for industry need to be 
comprehensive and understandable to importers and other stakeholders.  We also agree that our 
outreach methods for distribution and dissemination of educational  and instructional materials 
should vary and be easily accessible.  We have solicited input on how to best reach all affected 418 
 
 
 stakeholders and will continue to do so.  We intend to begin external outreach soon after we 
issue the final rule.  
 (Comment 328)  Some comments request that we provide “special and differential 
treatment” along with technical assistance to help exporters from developing countries meet the 
requirements of the FSVP regulation.  One comment also states that providing training will be 
particularly useful for addressing how implementation of FSMA will impact developing 
countries.   
 (Response 328)  The concept of special and differential treatment is incorporated in the 
WTO agreements.   Article 10.2 of the SPS Agreement states:  “Where the appropriate level of 
sanitary or phytosanitary protection allows scope for the phased introduction . . .  longer time -
frames for compliance should be accorded on products of interest to developing country 
Members so as to maintain opportunities for thei r exports”  (Ref.  4).  At the 2001 WTO 
Ministerial Conference in Doha, WTO Members issued a Ministerial Decision that interpreted 
the special and differential obligations of the SPS Agreement (Ref. 18).  The Ministerial 
Decision defined “longer time -frame f or compliance” with regulatory measures to normally 
mean a period of not less than 6 months.    
As discussed in section VI.B of this document, we proposed that importers generally 
would be required to come into compliance with the FSVP regulation 18 months after the 
publication date of the final rule.   For importation of foods subject to the preventive controls or 
produce safety regulations, importers would be required to comply with the FSVP regulation 6 
months after their foreign suppliers were required to  comply with the applicable regulations.  419 
 
 
 However, recognizing that smaller businesses may need more time to comply with the 
requirements, the preventive controls and produce  safety  regulations contain extended 
compliance deadlines for very small businesses and small businesses.   For example, in the final 
rule on preventive controls for human food, we are allowing 2 years for small businesses and 3 
years for very small businesses to comply with th at regulation.   We anticipate that these extended 
implementation periods for small businesses and very small businesses will apply to many firms 
that would be foreign suppliers for FSVP purposes, including suppliers in developing 
countries.   We believe these implementation periods are sufficient to address the needs of 
producers in developing countries, particularly for small and very small producers in such 
countries.  
In addition to the extended time periods for compliance for small and very  small 
businesses, we have also established modified supplier verification requirements for  importers of 
food from  three types of small foreign suppliers.   These foreign suppliers are:  (1) qualified 
facilities under the preventive controls regulations for  human food or animal food, (2) certain 
smaller farms that grow produce and are not covered farms under the produce safety regulation 
in accordance with § 112.4(a) or in accordance with §§ 112.4(b) and 112.5, and (3) shell egg 
producers not subject to the shell egg production regulation because they have fewer  than 3,000 
laying hens.   Each of these types of suppliers is either exempt from their underlying FDA food 
safety regulations or subject to modified requirements, mostly if not wholly because of the size 
of the entity . 
In addition to the 18 -month time periods for compliance for all firms, extended 
compliance dates for small and very small businesses subject to the preventive controls and 420 
 
 
 produce safety regulations, and modified requirements for very sma ll businesses, we intend to 
work with the food industry, education al organizations, the USDA, the United States Agency for 
International Development, and foreign governments to develop the tools and training programs 
needed to facilitate compliance with  these new food safety regulations by exporters, including 
those from developing countries.  In addition, as previously stated, w e have issued a 
comprehensive plan to expand the technical, scientific and regulatory food safety capacity of 
foreign governments and their respective food industries in countries from which foods are 
exported to the United States .  
 (Comment 329)  Some comments assert that effective implementation of the FSVP 
regulation will require comprehensive FDA inspector training , and they recommend that we 
begin  developing such a training program .  Some comments ask us to establish a dedicated cadre 
of supplier verification inspectors who are specially trained to efficiently and effectively ensure 
that importers’ FSVPs  are subject to careful a nd thoughtful inspections.  These comments assert 
that inspectors who are only familiar with food facility operations will lack the necessary insight 
and understanding to effectively inspect supplier verification programs unless they are given 
considerable  training.  Some comments maintain  that inspectors should be trained to understand 
what is required of the FSVP regulation, how inspections should be conducted, and what types of 
observations are appropriate to include on FDA -Form 483s  issued to importers .   
Some comments assert that inspector calibration will be essential to ensure that th e 
regulations are  enforced consistently from one region to another by both Federal and State 
officials.  These comments suggest that internal guidance and measures as we ll as extensive 421 
 
 
 training and education will help ensure that Federal and State inspection and enforcement 
programs are applied consistently.   
 (Response 329)  We agree that training is an important component of implementation of 
the FSVP regulation.  We a re currently developing a comprehensive training program for our 
inspectional and compliance staff with the goal of ensuring that our FSVP inspections are 
effective, efficient, and consistent.  Our goal is to provide real -time communication between our 
field investigators and our subject matter experts at Agency headquarters so that questions can be 
resolved quickly and consistently.  This will be important not only for the FSVP regulation  but 
also for the supplier verification components of the preventive controls regulations .   
While we agree that our FSVP inspections, which will be  records based, will be different 
from our food facility inspections, we believe that many of the skills needed to conduct these 
inspections will overlap.  For example, an inves tigator looking at an importer’s FSVP will have 
to understand the hazard analysis and food and supplier evaluation on which the importer relies 
to assess  the effectiveness of the importer’s FSVP.  We are currently exploring ways to leverage 
the work done b y the FSPCA  to aid FSVP  compliance efforts .   
 (Comment 330)  Some comments assert that border agents should be appropriately 
trained in applying FSVP requirements to avoid delays in entry of  imported food.  
 (Response 330)  We intend to provide education a nd training on the FSVP regulation  to 
all FDA staff.  We note, however, that FSVP inspections will not occur at entry.  These 
inspections will more likely occur at the offices of importers, their corporate headquarters, or 
other places where FSVP records a re kept.  Entry decisions will only be affected if we find 
problems with an importer’s FSVP that remain uncorrected or pose a risk to public health.   422 
 
 
  (Comment 331)  One comment express es concern that  we may not have adequate  
knowledge and appreciation of foreign food safety practices and asks that we train our inspectors 
to take these differences into account  and adopt a flexible approach to inspections .  The comment 
asserts that this  concern is heightened  by the FSMA mandate to increase inspections  of fo reign 
food facilities .    
 (Response 331)  Because the FSVP regulation appl ies to importers, we generally will not 
be inspecting foreign facilities as part of our implementation and enforcement of th is regulation.  
However, w e appreciate the differences in  food safety practices among different countries and 
will take them into account when implementing the FSVP  regulation .  FSMA mandates that 
importers provide adequate assurance s that their foreign suppliers produce food using  processes 
and procedures that provide  the same level of public health protection as those required under 
applicable regulations  in the United States.  We will need to train our investigators and 
compliance staff to  properly apply  this standard  when inspecting importers .  Ensuring real -time 
communication between our field staff and subject matter experts at FDA headquarters will help 
provid e consistency in interpretation and judgment.  
 (Comment 332)  Some comments assert that we should  design and develop a functional 
scheme to ensure  that States receive needed funds and training to assist in implement ing the 
FSVP regulation  if they decide to do so.  Some comments assert that we should pursue fund ing 
to invest in State agencies that can assist in meeting inspection mandates.    
 (Response 332)  As stated previously, we are currently developing our compliance 
strategy for FSVP and are considering the role that State and local authorities can play in helping 
to achieve compliance.   423 
 
 
 IV.  Effective and Compliance Dates  
A.  Effective Date  
We proposed that any final rule on FSVPs would become effective 60 days after the date 
on which it is published in the Federal Register .   
 (Comment 333)  Some comments support the proposed effective date while others assert 
that the effective date sh ould be a minimum of 6 months to 1 year after the publication of the 
final FSVP guidance.   
 (Response  333)  We decline the request to extend the effective date for this rule beyond 
60 days after publication.  Sixty days is a customary effective date perio d for significant rules.  
To the extent that the comments would like importers to have additional time to comply with the 
final rule, compliance dates are more relevant than the rule’s effective date.  As discussed in 
section IV.B of this document , we are providing  more time for importers to comply with the 
FSVP regulation .  We intend to issue guidance in a timely manner to facilitate compliance with 
the new requirements.  
B.  Compliance Dates  
We proposed that generally importers would be required to come into compliance with 
the FSVP regulation 18 months after the publication date of the final rule.  We believed that this 
would give importers enough time to make changes to their business practi ces that would be 
needed to come into compliance with the various requirements we proposed.  We proposed 
exceptions to this approach to take into account the different compliance dates suggested in the 
proposed rules on preventive controls for human food, preventive controls for animal food, and 
produce safety.   424 
 
 
 We proposed that with respect to foods subject to the preventive controls regulations, the 
importer would be required to comply with the FSVP regulation 6 months after the foreign 
supplier of the f ood is required to comply with the preventive controls regulations.   
With regard to foreign suppliers that are farms, we proposed to stagger the compliance 
dates for FSVP activities for RACs from farms as follows:  
•  The compliance date for an importer to  comply with the FSVP regulation with respect 
to a RAC from a farm would be 18 months after the publication date of the final rule or 6 months 
after the date on which the supplier must be in compliance with the produce safety regulation, 
whichever is later . 
•  If the foreign supplier is not subject to the produce safety regulation, the compliance 
date for the importer to comply with the FSVP regulation with respect to a RAC received from a 
farm would be 18 months after the publication date of the final rule  or 6 months after the 
effective date of the produce safety final rule, whichever is later.  This approach would ensure 
that the receiving facility would be able to know whether the farm supplier was subject to the 
produce safety regulation before choosing  any appropriate verification activities.  
 (Comment 334)  Some comments support the proposed general compliance date of 18 
months after publication of the final rule.  Some comments assert that the proposed compliance 
period is too short and ask that the c ompliance date be extended to 30 months, 3 years, or 5 years 
after the publication of the final rule.  Some comments ask us to coordinate uniform compliance 
dates for all the FSMA implementing rules to provide certainty and allow businesses to plan for 
the extensive changes that will be mandated.  425 
 
 
  (Response  334)  We agree that we should coordinate compliance dates for the FSMA 
implementing rules that are interrelated.  We continue to believe that 18 months is a reasonable 
timeframe for certain importers to begin complying with the requirements.  In addition, we 
continue to strive to minimize the likelihood that an importer will be required to comply with the 
FSVP regulation before its supplier is required to comply with other FSMA  food safety 
regulations.  F inally, we see value in having the compliance dates of this rulemaking align with 
the compliance dates of the supply -chain  program provisions in the preventive controls 
regulations, to the extent feasible.  Therefore, we conclude that the date that importe rs must 
comply with the FSVP regulation is the latest of the following dates:  
•  18 months after the publication of this final rule;  
•  For the importation of food from a supplier that is subject to the preventive controls 
regulations for human food or ani mal food or the produce safety regulation, 6 months after the 
foreign supplier of the food is required to comply with the relevant regulations; or  
•  For an importer that is also subject to the supply -chain  program provisions in the 
preventive controls reg ulations for human food or animal food, the date the importer, as a 
receiving facility, is required to comply with the  supply -chain program provisions of the relevant 
regulation.  
 (Comment 335)  Some comments assert that there should be an informed complia nce or 
transition period after the end of the pre -compliance period during which importers would be 
expected to comply gradually with the FSVP regulation without the threat of full enforcement 
and associated penalties.  Some comments specify 12 months as t he appropriate time for such an 426 
 
 
 informed compliance or transition period.  Some comments ask that we give developing 
countries longer transition periods.  
 (Response  335)  We decline these requests for an informed compliance period because 
we conclude that we are providing importers with adequate time in which to come into 
compliance with the FSVP regulation.  However, we intend to conduct outreach, training, and 
engagement activities to help importers understand the new requirements and enable them to 
compl y with the requirements by the applicable compliance dates.  
V.  Executive Order 13175  
 In accordance with Executive Order 13175, FDA has consulted with tribal governmental 
officials regarding this rulemaking.  We have prepared a Tribal Summary Impact State ment that 
includes a summary of tribal officials’ concerns and how we have addressed them (Ref. 19).  
Persons with access to the Internet may obtain the Tribal Summary Impact Statement at 
http://www.fda.gov/fsvprule or at http://www.regulations.gov.  Copie s of the Tribal Summary 
Impact Statement also may be obtained by contacting the person listed under FOR FURTHER 
INFORMATION CONTACT.  
VI.  Economic Analysis of Impacts  
FDA has examined the impacts of the final rule under Executive Order 12866, Executive 
Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601 -612), and the Unfunded Mandates 
Reform Act of 1995 (Pub . L. 104-4).  Executive Orders 12866 and 13563 direct agencies to 
assess all costs and benefits of available regulatory alternatives and, when regulation is 
necessary, to select regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other ad vantages; distributive impacts; 427 
 
 
 and equity).  We believe that this final rule is a significant regulatory action under Executive 
Order 12866.  
The Regulatory Flexibility Act requires agencies to analyze regulatory options that would 
minimize any significant  impact of a rule on small entities.  Because many small businesses will 
need to adopt FSVPs or conduct additional verification activities , we conclude that the final rule 
will have a significant economic impact on a substantial number of small entities.  
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies 
prepare a written statement, which includes an assessment of anticipated costs and benefits, 
before proposing “any rule that includes any Federal mandate that may result in th e expenditure 
by State, local, and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one year. ”  The current threshold 
after adjustment for inflation is $14 4 million, using the most current (201 4) Implicit Price 
Deflator for the Gross Domestic Product.  We expect this final rule to result in a 1 -year 
expenditure that would meet or exceed this amount.  
The final analyses conducted in accordance with these Executive Orders and statu tes will 
be made available in the docket for this rulemaking and at 
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/Economic Analyses/ (Ref. 20) . 
VII.  Analysis of Environmental Impact  
 We have determined under 21 CFR 25.30(j) that this action is o f a type that does not 
individually or cumulatively have a significant effect on the human environment.  Therefore, 
neither an environmental assessment nor an environmental impact statement is required.  
VIII.  Paperwork Reduction Act of 1995  428 
 
 
 This final rul e contains information collection provisions that are subject to review by the 
Office of Management  and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501 -3520).  The title, description, and respondent description of the information 
collection provisions are shown in the paragraphs that follow  with an estimate of the annual 
reporting and recordkeeping burden.  Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and maintaining the d ata needed, and 
completing and reviewing each collection of information.  
Title :  Foreign Supplier Verification Programs for Importers of Food for Humans and Animals.  
Description :  FDA is finalizing its regulation on FSVPs for food for humans and animals.  The 
regulation  is intended to help ensure that food imported into the United States is produced in 
compliance with processes and procedures, including reasonably appropriate risk -based 
preventive controls, that provide the same level of public health protection as the proc esses and 
procedures required for production of food in compliance with section 418 or 419 of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350g or 350h), if either is applicable, and 
in compliance with sections 402 and 403(w) (if applicab le) of the FD&C Act (21 U.S.C. 342 and 
343(w)).  
Description of Respondents :  We estimate that currently there are approximately 56,800 persons 
who meet the definition of importer set forth in this final rule (and are not exempt from the rule) 
and are there fore subject to its information collection requirements.  The rule exempts from these 
requirements the importation of certain foods, including  the following:  certain juice and seafood 
products  and ingredients ; food for research or evaluation ; food for per sonal consumption ; certain 
alcoholic beverages and ingredients imported for use in alcoholic beverages ; food that is 429 
 
 
 transshipped  through the United States;  food that is imported for processing and future export ; 
food that is produced in the United States,  exported, and returned to the United States without 
further manufacturing/processing in a foreign country; and meat, poultry, and egg products that 
at the time of importation are subject to the requirements of the U.S. Department of Agriculture 
under the Federal Meat Inspection Act (21 U.S.C. 601 et seq .), the Poultry Products Inspection 
Act (21 U.S.C. 451 et seq .), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq .).  The 
final rule also specifies that importers who are in compliance with the supp ly-chain  program 
provisions in the preventive controls regulations , who implement preventive controls for the 
hazards in the food they import, or who are not required to implement a preventive control under 
certain provisions of the preventive controls reg ulations, are deemed in compliance with most of 
the FSVP requirements.  Certain exceptions to the standard FSVP requirements would apply to 
importers of food for which the importer ’s customer  or a subsequent  entity in the distribution 
chain controls a hazard.  In addition, the final rule establishes modified FSVP requirements for 
importers of dietary supplements, very small importers, importers of food from certain small 
foreign manufacturers/processors and farms, and importers of certain food from supplier s in 
countries whose food safety systems FDA has officially recognized as comparable or determined 
to be equivalent to that of the United States.  
 In the Federal Register  of July 29, 2013 (78 FR 45729), we published a notice of 
proposed rulemaking includin g a Paperwork Reduction Act (PRA) analysis of the information 
collection provisions found in the proposed regulation.  In the Federal Register  of September 29, 
2014 (79 FR 58573), we published a supplemental notice of proposed rulemaking also including 
a PRA analysis.  While we received some comments regarding recordkeeping requirements 430 
 
 
 generally, which are discussed in section III.K  of this document , we did not receive specific 
comme nts addressing the four information collection topics solicited in both the original and 
supplemental proposed rules.  We are, therefore, retaining the estimates provided in our 
supplemental notice of proposed rulemaking, except to the extent that revision s are necessary to 
address changes to the proposed regulation included in the final rule, as discussed in the 
following paragraphs .  For more information on our original calculations of the information 
collection burden associated with this rulemaking, you  may refer to the PRA analyses found 
under Docket No. FDA -2011 -N-0143 at www.regulations.gov.  
We estimate the burden for this information collection as follows:  
Reporting Burden  
Table 4 shows the total estimated annual reporting burden associated with thi s final rule.  
This estimate is consistent with the reporting estimates found in the supplemental notice of 
proposed rulemaking published on September 29, 2014 (79 FR 58573 at 58590) , except where 
revisions are necessary to reflect new requirements include d in the final rule . 
 
Table  4.--Estimated A nnual Reporting Burden1 
 
21 CFR Section; 
Activity  No. of 
Respondents No. of 
Responses  per 
Respondent Total 
Annual 
Responses  Average 
Burden Per 
Response  Total 
Hours 
1.501(c); exe mption f or 
food for resear ch 36,360 40 1,454,400 0.083 
(5 minutes)  120,715 
1.509(a), 1.511(c), 1.512(b)(2); 
importer identification 
information for filing with  
CBP  
 56,800 157 8,917,600 0.02 
(1.2 minutes)  178,352 
Total 299,067 
 1 There are  no capital  costs  or operating  and mai ntenance costs ass ociated with  this collecti on of 
informati on. 
 
A.  Exemption for Food for Research or Evaluation  431 
 
 
 Section 1.501(c) of the FSVP regulation exempts food that is imported for research or 
evaluation purposes, provided that:  
• The food is not intended for retail sale and is not sold or distributed to the public.  
• The food is labeled with the statement ‘‘Food for research or evaluation use.’’  
•  The food is imported in a small quantity that is consistent with a research, analysis, or 
quality assurance purpo se, the food is used only for this purpose, and any unused quantity is 
properly disposed of.  
• When filing entry for the food with CBP, the customs broker or filer for the food 
provides an electronic declaration that the food will be used for research or e valuation purposes 
and will not be sold or distributed to the public.  
As shown in Table 4, we estimate that annually there will be 36,360 persons for whom a 
declaration that a food will be used for research or evaluation purposes will be submitted, and 
that about 40 declarations will be submitted for each such person annually.  We further estimate 
that submission of this declaration should take approximately 0.083 hours, resulting in a total 
annual burden of 120,715 hours.  
B.  Importer Identification at Ent ry 
Section 1.509(a) requires importers to ensure that, for each line entry of food product 
offered for importation into the United States, its name, electronic mail address, and unique 
facility identifier recognized as acceptable by FDA is provided electro nically when filing entry 
with CBP.  As shown in Table 4, we estimate that each of the estimated 56,800 importers would 
need to ensure that this information is provided for an average of 157 line entries each year.  We 
further estimate that each such submi ssion would require 0.02 hours, resulting in a total annual 432 
 
 
 burden of 178,352 hours.  
Recordkeeping Burden  
Table 5 shows the total estimated annual recordkeeping burden associated with this final 
rule.  While this estimate is consistent with many of the re cordkeeping estimates found in our 
previous analyses, we have revised certain estimates to reflect changes to the proposed 
requirements included in the final rule and adopted additional requirements under §1.507( a) and 
have revised our calculations accordi ngly. 
Table 5 .--Estimated Annual Recordkeeping Burden  
21 CFR Section  No. of 
Recordkeepers  No. of 
Records per 
Recordkeeper  Total 
Annual 
Records  Average Burden 
per 
Recordkeeping 
(hours)  Total Hours  
Controls for 
LACF  
1.502(b)  2,443  4 9,772  1 9,772  
Determine  and 
document hazards  
1.504(a)  11,701  1 11,701  3.5 40,954  
Review hazard 
analysis  
1.504(d)  11,701  7 81,907  0.33 27,029  
Evaluation of food 
and foreign 
supplier  
1.505(a)(2), 
1.511(c)(1)  11,701  1 11,701  4 46,804  
Approval of 
suppliers 1.505(b), 
1.512(c)(1)(iii)  8,191  1 8,191  12 98,292  
Reevaluation of 
food and foreign 
supplier  
1.505(c), 
1.512(c)(1)(ii)(A)  11,701  365 4,270,865  0.25 1,067,716  
Confirm or change 
requirements of 
foreign supplier 
verification 
activity  
1.505(c),  
1.512(c)(1)(ii)(A)  2,340  1 2,340  2 4,680  433 
 
 
 Review of other 
entities 
assessments 
1.505(d), 
1.512(c)(1)(iii)  3,510  1 3,510  1.2 4,212  
Written 
procedures for use 
of approved 
foreign suppliers  
1.506(a)(1), 
1.511(c)(2), 
1.512(c)(3)(i)  11,701  1 11,701  8 93,608  
Review of written 
procedures 
1.506(a)(2), 
1.511(c)(2)(ii), 
1.512(c)(3)(ii)  11,701  1 11,701  1 11,701  
Written 
procedures for 
conducting 
verification 
activities  
1.506(b), 
1.511(c)(3)  11,701  1 11,701  2 23,402  
Determination  
and 
documentation of 
appropriate 
supplier 
verification 
activities 
1.506(d)(1) -(2) 
1.511(c)( 4)(i) 11,701  4 46,804  3.25 152,113  
Review of 
appropriate 
supplier 
verification 
activities 
determin ation  by 
another entity 
1.506(d)(3)  
1.511(c)( 4)(iii) 11,701  2 23,402  0.33 7,723  
Conduct/review 
audits  
1.506(e)(1)(i), 
1.511(c)( 5)(i)(A)  11,701  2 23,402  3 70,206  
Conduct periodic 
sampling/testing  
1.506(e)(1)(ii), 
1.511(c)( 5)(i)(B)  11,701  2 23,402  1 23,402  434 
 
 
 Review records  
1.506(e)(1)(iii), 
1.511(c)( 5)(i)(C)  11,701  2 23,402  1.6 37,443  
Document your 
review of supplier 
verification 
activity records 
1.506(e)(3), 
1.511(c)( 5)(iii) 11,701  6 70,206  0.25 17,552  
1.507(a)(1)  11,701  3.17 37,082  1.25 46,353  
Written 
assurances 
1.507(a)(2),  
1.507(a)(3), and 
1.507(a)(4)  11,701  8.72 102,038  0.50 51,019  
Disclosures that  
accompany 
assurances 
1.507(a)(2), 
1.507(a)(3), and 
1.507(a)(4)  102,038  1 102,038  0.50 51,019  
Document 
assurances from 
customers  
1.507(c)  36,522  2.8 102,262  0.25 25,566  
Document 
corrective actions 
1.508(a) and 
1.512(b)(4)  2,340  1 2,340  2 4,680  
Investigate and 
determine FSVP 
adequacy  
1.508(b), 
1.511(c)(1)  2,340  1 2,340  5 11,700  
Written 
assurances for 
food produced 
under dietary 
supplement 
CGMPs  
1.511(b)  11,701  2.88 33,664  2.25 75,744  
Document very 
small 
importer/certain 
small foreign 
supplier status  
1.512(b)(1)  50,450  1 50,450  1 50,450  435 
 
 
 Written 
assurances 
associated with 
very small 
importer/certain 
small foreign 
supplier  
1.512(b)(3)  50,450  2.8 141,084  2.25 317,439  
Total   
1 There are  no capital  costs  or operating  and mai ntenance costs ass ociated with  this collecti on of informati on. 
 
A. Documentation of Production of LACF  in Accordance With Part 113  
 Section  1.502(b) (1) requires importers of LACF  to verify and document that, with respect 
to microbiological hazards that are controlled under p art 113, the food was produced in 
accordance with those regulations, and for all matters not controlled under part 113, to have an 
FSVP as specified in § 1.502(a).  As shown in Table 5, we estimate that there are 2,443 
importers of LACF importing an estima ted 4 LACF products annually.  We further estimate that 
it would take each LACF importer 1 hour to document that a food was produced in accordance 
with part 113.  This results in a total annual burden of 9,772 hours.  
B.  Hazard Analysis  
 Section 1.504(a) r equires importers, for each food they import or offer for import, to have 
a written hazard analysis.  We have updated our estimates.  We estimate that 11,701  importers 
would need to spend an average of 3.5 hours each determining and documenting hazard analyses 
for imported foods, resulting in an estimated burden of 40,954  hours ( 13,651  hours annualized).  
 Section 1.504(d) permits importers to identify the hazards that are reasonably likely to 
occur with a  food by reviewing and evaluating the hazard analysis conducted by another entity 
(including the foreign supplier).  If the importer selects this approach to hazard analysis it must 
document the determination it makes based on its review and evaluation of the foreign supplier’s 436 
 
 
 hazard analysis.  As shown in table 5, we estimate that 11,701  importers would take this 
approach to hazard analysis for about 7 products each, and that evaluating the supplier’s hazard 
analysis and documenting each evaluation would require about 1 hour on average.  This results 
in a total burden of 27,029  hours ( 9,010  hours annualized).  
C.  Evaluation for Supplier Approval and Verification  
 Section  1.505(a)(2) requires importers to document their evaluation of the risk posed by a 
food and the foreign supplier’s performance.  As shown in table 5, we estimate that it will take 
12 hours for each of an estimated 11,701  importers to conduct and document their evaluation  
under § § 1.505(a)  and 1.511(c) , resulting in a total burden of 46,804  hours ( 15,601  hours 
annualized).   
Section 1.505(b) requires importers to document the approval of their foreign suppliers 
on the basis of the food and supplier evaluation the importer conducts under §  1.505(a).  As 
shown in table 5, we estimate that it wi ll take 12 hours for each of an estimated 8,191 importers 
to approve their foreign suppliers and document their approval of the suppliers, resulting in a 
total burden of 98,292 hours (32,764 hours annualized).  
Section  1.505(c) requires that the importer re evaluate factors associated with the food and 
foreign suppliers when the importer becomes aware of new information.  Recognizing that some 
importers may choose to spend more time less often, we estimate it would take about 15 minutes 
per day to maintain an d follow these procedures by reviewing information regarding hazards and 
suppliers.  This results in a burden of 1,067,716  hours annually.  
Section 1.505(c) also requires that if an importer determines that the concerns associated 
with importing a food from  a foreign supplier have changed, the importer must promptly 437 
 
 
 determine (and document) whether it is appropriate to continue to import the food from the 
foreign supplier and whether the supplier verification activities conducted need to be changed.  
We esti mate that 2,340 importers will need to determine and document whether they need to 
change their supplier verification activities 1 time per year, resulting in a total burden of 4,680 
hours.  
Section 1.505(d) allows importers to review another entity’s evalu ation or reevaluation of 
the risk posed by a food and the foreign supplier’s performance and requires the importer 
document the review and assessment or reassessment.  As shown in table 5, we estimate that it 
will take 1.2 hours for each of an estimated 3, 510 importers to review and assess or reassess 
documentation provided by another entity, resulting in a total burden of 4,212 hours (1,404 hours 
annualized).  
D.  Foreign Supplier Verification and Related Activities  
 Under § 1.506(a) (1), importers must est ablish and follow adequate written procedures to 
ensure that they import foods only from foreign suppliers that they have approved based on the 
evaluation conducted under § 1.505 (or, when necessary and appropriate, on a temporary basis 
from unapproved for eign suppliers whose foods importers subject to adequate verification 
activities before using or distributing), and document the use of those procedures.  As shown in 
table 5, we estimate that it would take each of 11,701  importers 8 hours to establish pro cedures 
resulting in a burden of 107,112 hours (35,749 hours annualized) and 4 hours annually to 
document the use of such procedures resulting in an annual burden of 93,608  hours , for a grand 
total of 31,203  hours annual ized. 438 
 
 
 Under §  1.506(a)(2), an import er may rely on an entity other than the foreign supplier to 
establish the procedures and perform and document the activities required under §  1.506(a)(1) 
provided that the importer reviews and assesses that entity’s documentation of the procedures 
and acti vities, and the importer document its review and assessment.  As shown in table 5, we 
estimate that it would take each of 11,701 importers 1 hour to review and assess another entity’s 
procedures, resulting in a burden of 11,701hours (3,900 hours annualized ). 
 Under §§ 1.506(b)  and 1.511(c)(3) , importers must establish and follow adequate written 
procedures for ensuring that appropriate foreign supplier verification activities are conducted.  
As shown in table 5, we estimate that it would take each of 11,701  importers 2 hours to establish 
procedures resulting in a total burden of 23,402  hours ( 7,801  hours annualized).  
 Section 1.506(d) requires importers to determine and document which supplier 
verification activities are appropriate in order to provide adequ ate assurances that the hazards 
requiring a control in the food the importer bring into the United States have been significantly 
minimized or prevented .  Under §  1.506(d)(2), when a hazard in a food will be controlled by the 
foreign supplier and is one fo r which there is a reasonable probability that exposure to the hazard 
will result in serious adverse health consequences or death to humans or animals, the importer 
must conduct or obtain documentation of an onsite audit of the foreign supplier before init ially 
importing the food and at least annually thereafter, unless the importer makes an adequate 
written determination that, instead of such initial and annual onsite auditing, other supplier 
verification activities and/or less frequent onsite auditing are  appropriate to provide adequate 
assurances that the hazards requiring a control in the food are significantly minimized or 
prevented.  As shown in table 5, we estimate that it would take an estimated 11,701 importers 439 
 
 
 3.25 hours to determine and document a ppropriate supplier verification activities under either 
§ 1.506(d)(1) or (2) or § 1.511(c)( 4)(i) for 4 food and foreign supplier combinations per 
importer, resulting in a total burden of 152,113 hours (50,704 hours annualized).  
Under § § 1.506(d)(3) and 1 .511(c)( 4)(iii), instead of determining the verification 
activities themselves, importers can review and document that they have reviewed and assessed 
the supplier activities determinations made by another entity.  As shown in table 5, we estimate 
that it would take an estimated 11,701 importers 0.33 hours to review and document review of 
another entity’s determination of the appropriate supplier verification activities 2 food and 
foreign supplier combinations per importer, resulting in a total burden of 7, 723 hours (2,574 
hours annualized).  
 Under § 1.506(e)(1)(i)  or § 1.511(c)( 5)(i)(A) , an importer may conduct (and document) 
or obtain documentation of a n onsite audit of the foreign supplier.  As shown in table 5, we 
estimate that 32,402  such audits would be conducted (or documentation obtained for ) annually , 
with each audit requiring an average of 3 hours each, resulting in a total annual burden of 70,206  
hours.  
 Under § 1.506(e)(1)(ii)  or § 1.511(c)( 5)(i)(B) , an importer may conduct (and document) 
or obta in documentation of sampling and testing of a food for a hazard.  As shown in table 5, we 
estimate that 11,701  importers each year would determine that this approach to verification is 
appropriate for an average of two products they import .  We further est imate that each incidence 
of sampling and testing and corresponding documentation will require 1 hour.  This results in an 
estimated annual burden of 23,402  hours.  440 
 
 
  Under § 1.506(e)(1)(iii)  or § 1.511(c)( 5)(i)(C) , an importer may conduct (and document) 
or obtain documentation of a review of its foreign supplier’s food safety records to verify control 
of a hazard.  As shown in table 5, we estimate that 11,701  importers each year would determine 
that this approach to verification is appropriate  for an average  of two products they import .  We 
further estimate that documentation of food safety record review would require 1.6 hours, 
resulting in a total annual burden of 37,443  hours.  
 Under § 1.506(e)(1)(iv)  or § 1.511(c)(5)(i)(D) , an importer may use a different 
verification procedure that it has established as being appropriate based on an evaluation of the 
risk posed by a  food and the foreign supplier ’s performance ; the importer must document such 
use.  We have not identified an y alternative verification procedure nor included an estimated 
cost, nor have we estimated any associated burden for revised § 1.506(e)(1)(iv).  
 Section 1.506(e)(3) requires importers to promptly review and assess the results of the 
verification activities  that they conduct or obtain documentation of under §  1.506(e)(1), or that 
are conducted by other entities in accordance with § 1.506(e)(2), and to document the review and 
assessment of the results.  However, importers are not required to retain documentat ion of 
supplier verification activities conducted by other entities, provided that the importer can obtain 
the documentation and make it available to FDA in accordance with §  1.510(b).  As shown in 
table 5, we estimate that 11,701 importers will review and  assess the results of 70,206 supplier 
verification activities annually, and that each review and assessment will take 0.25 hours.  This 
results in a total annual burden of 17,552 hours.   
E.  Requirements for Food That Cannot Be Consumed Without Hazards Be ing Controlled 
or for Which Hazards Are Controlled After Importation  441 
 
 
 Section 1.507 of the final rule includes provisions for activities that were partially 
addressed under the proposed rule and the supplemental notice of pr oposed rulemaking.  Under 
§ 1.507 (a)(1) of the final rule, an importer is not required to conduct a food and foreign supplier 
evaluation under §  1.505 or conduct supplier verification activities under §  1.506 if it determines 
and documents that the type of food it is importing could not b e consumed without application of 
an appropriate control.  As shown in table 5, we estimate that each year 11,701 importers will 
determine that 37,082 foods cannot be consumed without application of a control and that it will 
take 1.25 hours, on average, t o make the determination, resulting in a total annual burden of 
46,353 hours.  
 Under §  1.507(a)(2), an importer is not required to conduct an evaluation under §  1.505 
or verification activities under §  1.506 if it relies on its customer who is subject to s ubpart C of 
part 117 or part 507 (the regulations on hazard analysis and risk -based preventive controls) to 
ensure that the identified hazard will be significantly minimized or prevented, and the importer:  
 •  Discloses in documents accompanying the food t hat the food is “not processed to 
control [identified hazard]”; and  
 •  Annually obtains from its customer written assurance that the customer has established 
and is following procedures (identified in the written assurance) that will significantly minimiz e 
or prevent the hazard.  
 Under §  1.507(a)(3), an importer is not required to conduct an evaluation under §  1.505 
or verification activities under §  1.506 if it relies on its customer who is not required to 
implement preventive controls under part 117 or p art 507 to provide assurance it is 442 
 
 
 manufacturing, processing, or preparing the food in accordance with applicable food safety 
requirements and the importer:  
 •  Discloses in documents accompanying the food that the food is “not processed to 
control [identi fied hazard]”; and  
 •  Annually obtains from its customer written assurance that the customer is 
manufacturing, processing, or preparing the food in accordance with applicable food safety 
requirements.  
 Under § 1.507(a)(4), an importer is not required to c onduct an evaluation under § 1.505 
or verification activities under § 1.506 if it relies on its customer to provide assurance that the 
food will be processed to control the identified hazard by an entity in the distribution chain 
subsequent to the customer  and the importer:  
 •  Discloses in documents accompanying the food that the food is “not processed to 
control [identified hazard]” and  
 •  Annually obtains from its customer written assurance that the customer w ill disclose in 
documents accompanying the food that the food is “not processed to control [identified hazard]” 
and will only sell to another entity that agrees, in writing, it will:   (1) Follow procedures 
(identified in a written assurance) that will significantly minimize or prevent the identifie d 
hazard (if the entity is subject to subpart C of part 117 or part 507) or manufacture, process, or 
prepare the food in accordance with applicable food safety requirements (if the entity is not 
required to implement preventive controls under part 117 or p art 507); or ( 2) obtain a similar 
written assurance from the entity’s customer as required under §  1.507(a)(4)(ii)(A) or (B).  443 
 
 
  As shown in table 5, we estimate that 11,701 importers will obtain such a written 
assurance from 102,038 customers annually in ac cordance with § 1.507(a)(2), (3), and (4), 
collectively, and that it will take 0.50 hours to document the written assurance.  This results in an 
estimated annual burden of 51,019 hours.  We estimate that the disclosure burdens under these 
provisions will a lso take 0.50 hours each and will be done for each of the 102,038 assurances 
identified resulting in an annual burden of 51,019 hours.   
 Under §  1.507(a)(5), an importer is not required to conduct an evaluation under §  1.505 
or verification activities und er § 1.506 if it establishes, documents, and implements a system that 
ensures control, at a subsequent distribution step, of the hazards in a food and the importer 
documents its implementation of that system.  We did not include an estimate for compliance 
with this provision because we do not know any examples of such a system for hazard control.   
 Under §  1.507(c), the customer of an importer or some other subsequent entity in the 
distribution chain for a food that provides a written assurance under §  1.507(a)(2) , or (3) , or (4) 
must document its actions taken to satisfy the written assurance.  As shown in table 5, we 
estimate that 36,522 customers of importers or other subsequent entities in the distribution chain 
will need to document its actions in accordance with §  1.507(c) 2.8 times annually and that this 
documentation will require 0.25 hours, resulting in a total annual burden of 25,566 hours.  
F.  Investigations , Corrective Actions , and Investigations Into FSVP Adequacy  
 Proposed § 1.507(b) would have required an importer, if it became aware that an article 
of food that it imported was adulterated or misbranded, to promptly investigate the cause or 
causes of such adulteration or misbranding and to document any such investigation.  As 
previously discussed, this requirement was not in cluded  in the final rule and we have therefore 444 
 
 
 removed the burden previously calculated for its implementation and revised our estimate 
accordingly.  
 Section 1.508(a) of the final rule requires an importer to take correct ive actions if it 
determines that one of its foreign suppliers of a food does not produce the food in compliance 
with processes and procedures that provide the same level of public health protection as those 
required under  section 418 or 419 of the FD&C Ac t, if either is applicable, and the implementing 
regulations, or produces food that is adulterated under section 402 or misbranded under section 
403(w) (if applicable) of the FD&C Act.  Such corrective actions will depend on the 
circumstances but could inc lude discontinuing use of the foreign supplier until the cause or 
causes of noncompliance, adulteration, or misbranding have been adequately addressed.  As 
shown in table 5, we estimate that 2,340 importers will need to take a corrective action 1 time 
annu ally, and that the corrective action will require 2 hours to complete, resulting in a total 
annual burden of 4,680 hours.  
 Section 1.508(b) requires an importer, if it determines by means other than its verification 
activities conducted under § 1.506 or § 1.511(c) or a reevaluation conducted under §  1.505(c) or 
(d), that one of its foreign suppliers does not produce food using processes and procedures that 
provide the same level of public health protection as those required under  section 418 or 419 of 
the F D&C Act, if either is applicable, and the implementing regulations, or produces food that is 
adulterated under section 402 or misbranded under section 403(w) (if applicable) of the FD&C 
Act, to promptly investigate to determine whether the importer’s FSVP is adequate and, when 
appropriate, to modify the FSVP.  This provision also requires importers to document any such 
investigations and FSVP changes.  As shown in table 5, we estimate that, on average, 2,340  445 
 
 
 importers will need to conduct an investigation o nce a year to determine the adequacy of their 
FSVP in accordance with § 1.50 8(b) and that conducting and documenting the investigation will 
require 5 hours.  This results in an estimated annual burden of 11,700  hours.  
G.  Food Subject to Certain Dietary Su pplement CGMP Re quirements  
 Section 1.511 sets forth modified FSVP requirements for food that is subject to certain 
dietary supplement CGMP requirements .  Under § 1.511(a), importers who are required to 
establish specifications under § 111.70(b)  or (d) wit h respect to a food  that is a dietary 
supplement or dietary supplement component it imports for further manufacturing or processing 
as a dietary supplement , and are in compliance with the requirements in §§  111.73 and 111.75  
applicable to determining wheth er those specifications are met, must comply with the 
requirements under §§ 1.503  and 1.509, but are not required to comply with the requirements in 
§§ 1.502 , §§ 1.504  through 1.508 , or §  1.510 .  These importers are included in the estimated 
reporting burden for § 1.509( a). 
 Under § 1.511(b), if an importer’s customer is required to establish specifications under 
§ 111.70(b)  or (d) with respect to a food that is a dietary supplement or dietary supplement 
component it imports for further manufacturing  or processing as a dietary supplement, the 
customer is in compliance with the requirements in §§  111.73 and 111.75  applicable to 
determining whether those specifications are met, and the importer annually obtains from its 
customer written assurance that the customer is in compliance with those requirements, then for 
that food the importer must comply with the requirements in §§  1.503, 1.509 , and 1.510, but is 
not required to comply with the requirements in §§ 1.502  and §§  1.504  through 1.508.  As shown 
in tab le 5, we estimate that 5,574 importers would need to obtain written assurance from an 446 
 
 
 average of 6 customers in accordance with § 1.511(b) and that documentation of each assurance 
would take 2.25 hours, resulting in a total annual burden of 75,249 hours.  In addition, these 
importers are included in the estimated annual reporting burden for § 1.509( a). 
 Under § 1.511(c), importers of other dietary supplements, including ‘‘finished’’ dietary 
supplements (i.e., packaged and labeled dietary supplements that ar e not subject to further 
processing) and dietary supplements imported only for packaging and labeling are subject to 
different FSVP requirements.  
 Section 1.511(c)(2) (i) requires importers of finished dietary supplements to establish and 
follow written pro cedures to ensure that food is imported only from foreign suppliers that have 
been approved for use based on the evaluation conducted under § 1.505  (or, when necessary and 
appropriate, on a temporary basis from unapproved foreign suppliers whose foods the  importer 
subjects to adequate verification activities) .  This burden to importers of ‘‘finished’’ dietary 
supplements  and dietary supplements imported only for packaging and labeling is captured in the 
burden calculated for § 1.506(a) (1). 
Under §  1.511(c)( 2)(ii), an importer of a dietary supplement may rely on an entity other 
than the foreign supplier to establish the procedures and perform and document the activities 
required under §  1.511(c)(2)(i) provided that the importer reviews and assesses that entit y’s 
documentation of the procedures and activities, and the importer document its review and 
assessment.  This burden is captured in the burden calculated for §  1.506(a)(2).  
 Section 1.511(c)(3) requires importers of finished dietary supplements to establi sh and 
follow procedures for conducting foreign supplier verification activities.  This burden is included 
in the burden calculated for § 1.506(b).  447 
 
 
  Section 1.511(c)( 4)(i) requires importers of finished dietary supplements to determine 
and document which a ppropriate verification activities should be conducted, and the frequency 
with which they should be conducted.  The estimated burden for this provision is included in the 
burden calculated for §  1.506(d)(1) and (2).   
Under §  1.511(c)( 4)(iii), a dietary su pplement importer may rely on a determination of 
appropriate foreign supplier verification activities made by an entity other than the foreign 
supplier if the importer reviews and assesses whether the entity’s determination regarding 
appropriate activities  is appropriate and documents the review and assessment.  This burden is 
included in the burden calculated for §  1.506(d)(3).  
For each dietary supplement imported  in accordance with §  1.511(c) , the importer would 
need to conduct one or more of the verifica tion activities listed in  § 1.511(c)( 5)(i)(A) through (D) 
before using or distributing the dietary supplement and periodically thereafter.  Estimates 
associated with these activities are included in the burdens presented in table 5 for 
§ 1.506(e)(1)(i) through (e)(1)(iv), respectively.  
Section 1.511(c)( 5)(iii) r equires importers to promptly review and assess the results of 
the verification activities that they conduct or obtain documentation of under §  1.511(c)( 5)(i), or 
that are conducted by other entities in accordance with § 1.511(c)( 5)(ii), and to document th e 
review and assessment of the results.  However, importers are not required to retain 
documentation of supplier verification activities conducted by other entities, provided that the 
importer can obtain the documentation and make it available to FDA in ac cordance with 
§ 1.510(b).  This burden is included in the burden calculated for §  1.506(e)(3).  448 
 
 
  Section 1.511(c) also requires importers of finished dietary supplements to conduct 
evaluation s of the foreign supplier , conduct investigations (in certain circ umstances) to 
determine the adequacy of their FSVPs , and ensure that information identifying them as the 
importer is provided at entry.  These importers have been included in the estimated record  
keeping and reporting burdens for these activities under §§ 1.505, 1.508, and 1.509( a), 
respectively.    
H.  Food Imported by Very Small Importers and From Certain Small Foreign Suppliers  
Section 1.512 sets forth modifie d proposed FSVP requirements for very small importers 
as defined in § 1.500; food from a foreign  supplier that is a qualified facility as defined by 
§ 117.3 or § 507.3; produce from a farm that is not a covered farm under the produce safety 
regulation in accordance with §  112.4(a), or in accordance with §§ 112.4(b) and 112.5; or shell 
eggs from an eg g producer with fewer than 3000 lay ing hens .  Under §  1.512(b)(1), if a very 
small importer or an importer of food from such a foreign supplier chooses to comply with the 
requirements in § 1.512, the importer would be required to document, at the end of ea ch calendar 
year, that it meets the definition of very small importer in § 1.500 or that the foreign supplier 
meets the criteria in § 1.512(a)(2)(i), (ii), or (iii) , as applicable.  As shown in table 5, we estimate 
that 37,206  very small importers and importers and importers involved with 13,244 certain small 
suppliers would need to document eligibility each year for themselves and their small suppliers 
and that such documentation would require 1 hour.  The resulting annual burden is 50,450 hours.  
 Under §  1.512(b)(3), each very small importer or importer of food from foreign suppliers 
that meet the criteria in § 1.512(a)(2)(i), (ii), or (iii) needs to obtain written assurance, before 
importing the food and at least every 2 years thereafter, that its  foreign supplier is producing the 449 
 
 
 food in  accordance with applicable statutory and regulatory standards .  Importers of food from 
the specified foreign suppliers must obtain written assurance that the supplier is producing food 
in compliance with applicabl e requirements  or acknowledges that it is subject to applicable 
standards (as specified in §  1.512(b)(3)(i i) through (iv)).   As shown in table 5, we estimate that 
50,450  very small importers and importers of food from certain small suppliers would need to 
obtain an average of 2 .8 such written assurances each year and that documentation of each 
assurance would require 2.25 hours, resulting in a total annual burden of 317,439  hours.  
 Section 1.512(b)(4) requires very small importers and importers of food from  certain 
small foreign suppliers to take corrective actions .  This burden is included in the burden 
calculated for §  1.508(a).   
Section 1.512(c) sets forth requirements that apply to importers of food from the 
specified types of small foreign suppliers, bu t not to very small importers.  Under 
§ 1.512(c)(1)(i), in approving their foreign suppliers, these importers must consider the 
applicable FDA food safety regulations and evaluate information relevant to the foreign 
supplier’s compliance with those regulat ions, including whether the foreign supplier is the 
subject of an FDA warning letter, import alert, or other FDA compliance action related to food 
safety, and document the evaluation.  We include this burden in our calculation of the burden 
associated with  § 1.505(a)(2) in table 5.  
 Under §  1.512(c)(1)(ii)( A), these importers must promptly reevaluate the concerns 
associated with the foreign supplier’s compliance history when the importer becomes aware of 
new information about supplier compliance history, an d the reevaluation must be documented. 
Section 1.512(c)(1)(ii)(A) further requires that if the importer determines that the concerns 450 
 
 
 associated with importing a food from a foreign supplier have changed, the importer must 
promptly determine (and document) whether it is appropriate to continue to import the food from 
the foreign supplier.  We include these burdens in our calculation of the burdens associated with 
§ 1.505(c) in table 5.  
Section 1.512(c)(1)(ii)(A) further requires that if the importer determin es that the 
concerns associated with importing a food from a foreign supplier have changed, the importer 
must promptly determine (and document) whether it is appropriate to continue to import the food 
from the foreign supplier.  This burden is included in the estimate for § 1.505(c) in table 5.     
Under §  1.512(c)(1)(iii), if an entity other than the foreign supplier has, using a qualified 
individual, performed the evaluation or reevaluation of foreign supplier compliance history, the 
importer may review a nd assess the evaluation or reevaluation conducted by that entity, and 
document its review and assessment.  We include this burden in our calculation of the burden 
associated with § 1.505(d) in table 5.  
Under §  1.512(c)(2), the importer of a food from cert ain small foreign suppliers must 
approve the foreign suppliers on the basis of the evaluation the importer conducts (or reviews 
and assesses) and document its approval.  We include this burden in our calculation of the 
burden associated with § 1.505(b).  
 Under §  1.512(c)(3)(i), importers of food from certain small foreign suppliers must 
establish and follow written procedures to ensure that they import foods only from approved 
foreign suppliers (or, when necessary and appropriate, on a temporary basis from unapproved 
foreign suppliers whose foods are subjected to adequate verification activities before using or 451 
 
 
 distributing).  Importers must document their use of these procedures.  We include this burden in 
our calculation of the burden associated with § 1.5 06(a)(1).   
Under §  1.512(c)(3)(ii), an importer may rely on an entity other than the foreign supplier 
to establish the procedures and perform and document the activities required under 
§ 1.512(c)(3)(i) provided that the importer reviews and assesses that entity’s documentation of 
the procedures and activities, and the importer documents its review and assessment.  We include 
this burden in our calculation of the burden associated with § 1.506(a)(2).  
I.  Food Imported From a Country With an Officially Recog nized or Equivalent Food Safety 
System  
 Section 1.513 establishes modified FSVP requirements for importers of certain food from 
foreign suppliers in countries whose food safety systems FDA has officially recognized as 
comparable or determined to be equival ent to that of the United States.  If such importers me et 
certain conditions or requirements, they w ill not be required to comply with the requirements in 
§§ 1.50 4 through 1.508, but they w ill be required to comply with §§ 1.503, 1.509 , and 1.510.  
 Section  1.513(b)(1) requires an importer, before importing a food from the foreign 
supplier and annually thereafter, to document that the foreign supplier is in, and under the 
regulatory oversight of, a country whose food safety system FDA has officially recogniz ed as 
comparable or determined to be equivalent and that the food is within the scope of FDA’s 
official recognition or equivalency determination regarding the food safety authority of the 
country in which the foreign supplier is located.  
 Section 1.513(b)( 2) requires an importer, before importing a food from the foreign 
supplier, to determine and document whether the foreign supplier of the food is in good 452 
 
 
 compliance standing, as defined in § 1.500, with the food safety authority of the country in 
which the  foreign supplier is located.  The importer must  continue to monitor whether the foreign 
supplier is in good compliance standing and promptly review any information obtained.  If the 
information indicate s that food safety hazards associated with the food are not being significantly 
minimized or prevented , the importer is then required to take prompt corrective action and to 
document any such action.  
 FDA has officially recognized New Zealand as having a food safety system that is 
comparable to that of the U nited States; however, we have not recognized  any other food safety 
systems as comparable or determined them to be equivalent.  Because we have only recently 
entered into a systems recognition arrangement with New Zealand  recognizing that country’s 
food sa fety system as being comparable to that of the United States , we are not able to assess the 
effect of the arrangement on the importation of food from that country.  Therefore, we are not 
including estimates for the recordkeeping burdens associated with § 1 .513.  
 The information collection provisions of this final rule have been submitted to OMB for 
review.  Prior to the effective date of this final rule, FDA will publish a notice in the Federal 
Register  announcing OMB ’s decision to approve, modify, or disap prove the information 
collection provisions in this final rule.  An agency may not conduct or sponsor, and a person is 
not required to respond to, a collection of information unless it displays a currently valid OMB 
control number.  
IX.  Federalism  
 We have  analyzed the final rule in accordance with the principles set forth in Executive 
Order 13132.  We have determined that the rule does not contain policies that have substantial 453 
 
 
 direct effects on the States, on the relationship between the National Governme nt and the States, 
or on the distribution of power and responsibilities among the various levels of government.  
Accordingly, we conclude that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, conse quently, a federalism summary impact 
statement is not required.  
X.  References  
 The following references have been placed on display in the Division of Dockets 
Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 
p.m., Mond ay through Friday, and are available electronically at http://www.regulations.gov. We 
have verified the Web site addresses  provided for certain documents , but we are  not responsible 
for any subsequent changes to the Web sites after this document publishes in the Federal 
Register . 
 1. FDA, “Transcript: FSMA Proposed Rules on Foreign Supplier Verification Programs 
and the Accreditation of Third -Party Auditors/Certification Bodies, Public Meeting, Day One, ” 
September 19, 2013 , available in Docket No. FDA -2011 -N-0143.  
 2. FDA, “Transcript: FSMA Proposed Rules on Foreign Supplier Verification Programs 
and the Accreditation of Third -Party Auditors/Certification Bodies, Public Meeting, Day Two, ” 
September 20, 2013 , available in Docket No. FDA -2011 -N-0143.   
 3. FDA, “Record of Outreach Sessions on FDA Proposed Rules ,” 2013 , available in 
Docket No. FDA -2011 -N-0143.  
 4. World Trade Organization, “ The WTO Agreement on the Application of Sanitary and 
Phytosanitary Measures ” (http://www.wto.org/english/tratop_e/s ps_e/spsagr_e.htm ), 1994.  454 
 
 
 5. Partnership for Food Protection National Workplan Workgroup, “Model for Local 
Federal/State Planning and Coordination of Field Operations and Training: A Partnership for 
Food Protection ‘Best Practice’” 
(http://www.fda.gov/down loads/ForFederalStateandLocalOfficials/FoodSafetySystem/UCM373
333.pdf), October 2013.  
 6. Codex Committee on Food Import and Export Inspection and Certification Systems: 
Guidelines for Food Import Control Systems (CAC/GL 47 -2003) (Rev. 1 —2006 ) 
(http://www .codexalimentarius.net/download/standards/10075/CXG_047e.pdf ), 2003 . 
7. Codex Alimentarius Commission, “Hazard Analysis and Critical Control Point 
(HACCP) System and Guidelines for Its Application ,” Annex to CAC/RCP 1 -1969 (Rev. 4 —
2003)  (http://www.codexal imentarius.org/download/standards/23/CXP_001e.pdf) , 2003.  
8. Codex Alimentarius Commission, “General Principles of Food Hygiene, ” CAC/RCP 
1-1969 (Rev.  4—2003)  
(http://www.codexalimentarius.org/download/standards/23/CXP_001e.pdf) , 2003.   
9.  Codex Alimenta rius Commission, “General Standard for the Labelling of Prepackaged 
Food,” CODEX STAN 1 -1985 (Rev. 7 —2010)  
(http://codexalimentarius.org/download/standards/32/CXS_001e.pdf) , 2010.  
 10. U.S. Pharmacopeial Convention, “U.S. Pharmacopeial Convention (USP) Food Fraud 
Database”  (http://www.usp.org/food -ingredients/food -fraud -database ), March 6, 2014 .   
 11. Congressional Research Service, “Food Fraud and ‘Economically Motivated 
Adulteration ’ of Food and Food Ingredients,” (http://www.fas.org.sgp/crs/misc/R433 58.pdf ), 
January 10, 2014 .    455 
 
 
  12. Everstine, K., J. Spink, and S. Kennedy, “Economically Motivated Adulteration 
(EMA) of Food: Common Characteristics of EMA Incidents,” Journal of Food Protection , 
76:723 -735, 2013.  
13. Beru, N. , and FDA  s.v., “ Memo on Che mical, Physical and Radiological Hazards 
Associated with Produce,” Memorandum to the Record  in Docket No. FDA -2011 -N-0921, May 
29, 2012.  
 14. FDA, “Guidance for Industry: Questions and Answers Regarding the Reportable 
Food Registry as Established by the Fo od and Drug Administration Amendments Act of 2007” 
(http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/RF
R/ucm180761.htm), September 2009 .  
 15. FDA, “FDA’s International Food Safety Capacity -Building Plan” 
(http://www.fda.go v/downloads/Food/GuidanceRegulation/UCM341440.pdf ), February 2013 .  
 16. FDA, “Information for Foreign Governments: Frequently Asked Questions on 
Systems Recognition” 
(http://fda.gov/food/internationalinteragencycoordination/ucm367400.htm), September 5, 20 13. 
 17. Regulation (EC) No 882/2004 of the European Parliament and of the Council, 
Official Journal of the European Union  (http://eur -
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:165:0001:0141:EN:PDF ), April 30, 
2004 .  
 18.  World Trade Organization, “WTO Ministerial Conference: Implementation -Related 
Issues and Concerns ,” WT/MIN(01)/17 456 
 
 
 (http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_implementation_e.htm), 
November 20, 2001.  
19. FDA, “Tribal Summary Impact Statement :  Final Rule on Foreign Supplier 
Verification Programs for Importers of Food for Humans and Animals,” Docket No. FDA -2011 -
N-0143.  
20. FDA, “ Regulatory Impact Analysis For Final Rule On Foreign Supplier Verification 
Programs (Docket No. FDA -2011 -N-0143) Under Execu tive Order 12866, Executive Order 
13563, the Regulatory Flexibility Act (5 U.S.C. 601 -612), the Unfunded Mandates Reform Act 
of 1995 (Public Law 104 -4), and the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 -3520),” 
Docket No. FDA -2011 -N-0143.  
List of Sub jects 
21 CFR Part 1  
 Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, Reporting and 
recordkeeping requirements.  
21 CFR Part 11  
 Administrative practice and procedure, Computer technology, Reporting and 
recordkeeping requirements.  
21 CFR Part 111 
 Dietary foods, Drugs, Foods, Packaging and containers.  
 Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority 
delegated to the Commissioner of Food and Drugs, 21 CFR parts 1, 11, and 111 are amended as 
follows:  457 
 
 
 PART 1 --GENERAL ENFORCEMENT REGULATIONS  
 1.  The authority citation for 21 CFR part 1 is revised to read as follows:  
 Authority :  15 U.S.C. 1333, 1453, 1 454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 
321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc -1, 360ccc -
2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264, 271.  
 2.  Add subpart L, consisting of §§ 1.500 through 1.514, to read as follows:  
Subpart L --Foreign Supplier Verification Programs for Foo d Importers  
Sec. 
1.500  What definitions apply to this subpart?  
1.501  To what foods do the regulations in this subpart apply?   
1.502  What foreign supplier verification program (FSVP) must I have?  
1.503  Who must develop my FSVP and perform FSVP activitie s? 
1.504  What hazard analysis must I conduct?  
1.505  What evaluation for foreign supplier approval and verification must I conduct?  
1.506  What foreign supplier verification and related activities must I conduct?  
1.507  What requirements apply when I impo rt a food that cannot be consumed without the 
hazards being controlled or for which the hazards are controlled after importation?  
1.508  What corrective actions must I take under my FSVP?  
1.509  How must the importer be identified at entry?  
1.510  How must  I maintain records of my FSVP?  
1.511  What FSVP must I have if I am importing a food subject to certain dietary supplement 
current good manufacturing practice regulations?  458 
 
 
 1.512  What FSVP may I have if I am a very small importer or if I am importing cert ain food 
from certain small foreign suppliers?  
1.513  What FSVP may I have if I am importing certain food from a country with an officially 
recognized or equivalent food safety system?  
1.514  What are some consequences of failing to comply with the requirements of this subpart?  
Subpart L --Foreign Supplier Verification Programs for Food Importers  
§ 1.500  What definitions apply to this subpart?  
The following definitions apply to words and phrases as they are used in this subpart.  
Other definitions of  these terms may apply when they are used in other subparts of this part.  
Adequate  means that which is needed to accomplish the intended purpose in keeping with 
good public health practice.  
Audit  means the systematic, independent, and documented examinatio n (through 
observation, investigation, discussions with employees of the audited entity, records review, and, 
as appropriate, sampling and laboratory analysis) to assess an audited entity’s food safety 
processes and procedures.   
Dietary supplement  has the  meaning given in section 201(ff) of the Federal Food, Drug, 
and Cosmetic Act.  
Dietary supplement component  means any substance intended for use in the manufacture 
of a dietary supplement, including those that may not appear in the finished batch of the di etary 
supplement.  Dietary supplement components include dietary ingredients (as described in section 
201(ff) of the Federal Food, Drug, and Cosmetic Act ) and other ingredients.  459 
 
 
 Environmental pathogen  means a pathogen that is capable of surviving and persi sting 
within the manufacturing, processing, packing, or holding environment such that food may be 
contaminated and may result in foodborne illness if that food is consumed without treatment to 
significantly minimize or prevent the environmental pathogen.  Examples of environmental 
pathogens for the purposes of this subpart include Listeria monocytogenes  and Salmonella  spp. 
but do not include the spores of pathogenic sporeformers.  
Facility  means a domestic facility or a foreign facility that is required to r egister under 
section 415 of the Federal Food, Drug, and Cosmetic Act, in accordance with the requirements of 
subpart H of this part.  
Farm  means farm as defined in § 1.227.  
Farm mixed -type facility  means an establishment that is a farm but that also conduc ts 
activities outside the farm definition that require the establishment to be registered under section 
415 of the Federal Food, Drug, and Cosmetic Act.  
Food  has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic 
Act, except that f ood does not include pesticides (as defined in 7 U.S.C. 136(u)).  
Food allergen  means a major food allergen as defined in section 201(qq) of the Federal 
Food, Drug, and Cosmetic Act.  
Foreign supplier  means, for an article of food, the establishment that 
manufactures/processes the food, raises the animal, or grows the food that is exported to the 
United States without further manufacturing/processing by another establishment, except for 
further manufacturing/processing that consists solely of the addition of labeling or any similar 
activity of a de minimis nature.  460 
 
 
 Good compliance standing with a foreign food safety authority  means that the foreign 
supplier -- 
(1)  Appears on the current version of a list, issued by the food safety authority of the 
country in wh ich the foreign supplier is located and which has regulatory oversight of the 
supplier, of food producers  that are in good compliance standing with the food safety authority ; 
or  
(2)  Has otherwise been designated by such food safety authority as being in good 
compliance standing.  
Harvesting  applies to farms and farm mixed -type facilities and means activities that are 
traditionally performed on farms for the purpose of removing raw agricultural commodities from 
the place they were grown or raised and prepar ing them for use as food.  Harvesting is limited to 
activities performed on raw agricultural commodities on a farm.  Harvesting does not include 
activities that transform a raw agricultural commodity into a processed food as defined in section 
201(gg) of t he Federal Food, Drug, and Cosmetic Act.  Examples of harvesting include 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., folia ge, husks, 
roots or stems).  Examples of harvesting also include cooling, field coring, filtering, gathering, 
hulling, removing stems and husks from, shelling, sifting, threshing, trimming of outer leaves of, 
and washing raw agricultural commodities grown on a farm.  
Hazard  means any biological, chemical (including radiological), or physical agent that is 
reasonably likely to cause illness or injury.  461 
 
 
 Hazard requiring a control  means a known or reasonably foreseeable hazard for which a 
person knowledgeable a bout the safe manufacturing, processing, packing, or holding of food 
would, based on the outcome of a hazard analysis (which includes an assessment of the 
probability that the hazard will occur in the absence of controls or measures and the severity of 
the illness or injury if the hazard were to occur), establish one or more controls or measures to 
significantly minimize or prevent the hazard in a food and components to manage those controls 
or measures (such as monitoring, corrections or corrective actions , verification, and records) as 
appropriate to the food, the facility, and the nature of the control or measure and its role in the 
facility’s food safety system.  
Holding  means storage of food and also includes activities performed incidental to 
storage of  a food (e.g., activities performed for the safe or effective storage of that food, such as 
fumigating food during storage, and drying/dehydrating raw agricultural commodities when the 
drying/dehydrating does not create a distinct commodity (such as drying /dehydrating hay or 
alfalfa) ).  Holding also includes activities performed as a practical necessity for the distribution 
of that food (such as blending of the same raw agricultural commodity and breaking down 
pallets), but does not include activities that transform a raw agricultural commodity into a 
processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act.  
Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, 
and liquid storag e tanks.  
Importer  means the U.S. owner or consignee of an article of food that is being offered for 
import into the United States.  If there is no U.S. owner or consignee of an article of food at the 
time of U.S. entry, the importer is the U.S. agent or re presentative of the foreign owner or 462 
 
 
 consignee at the time of entry, as confirmed in a signed statement of consent to serve as the 
importer under this subpart .   
Known or reasonably foreseeable hazard  means a biological, chemical (including 
radiological), or physical hazard that is known to be, or has the potential to be, associated with a 
food or the facility in which it is manufactured/processed.  
Lot means the food produced during a period of time an d identified by an establishment’s 
specific code.  
Manufacturing/processing  means making food from one or more ingredients, or 
synthesizing, preparing, treating, modifying, or manipulating food, including food crops or 
ingredients.  Examples of manufacturin g/processing activities include:  Baking, boiling, bottling, 
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to 
create a distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating,  
eviscerating, extracting juice, extruding  (of animal food) , formulating, freezing, grinding, 
homogenizing, labeling, milling, mixing, packaging, pasteurizing, peeling, pelleting (of animal 
food), rendering, treating to manipulate ripening, trimming, washi ng, or waxing.  For farms and 
farm mixed -type facilities, manufacturing/processing does not include activities that are part of 
harvesting, packing, or holding.  
Microorganisms  means yeasts, molds, bacteria, viruses, protozoa, and microscopic 
parasites and includes species that are pathogens.   
Packing  means placing food into a container other than packaging the food and also 
includes re-packing and activities performed incidental to packing  or re-packing  a food (e.g., 
activities performed for the safe or effective packing  or re-packing  of that food (such as sorting, 463 
 
 
 culling, grading, and weighing or conveying incidental to packing or re -packing) ), but does not 
include activities that transform a raw agric ultural commodity into a processed food as defined in 
section 201(gg) of the Federal Food, Drug, and Cosmetic Act.  
Pathogen  means a microorganism of public health significance.  
Qualified auditor  means a person who is a qualified individual as defined in th is section 
and has technical expertise obtained through education, training, or experience (or a combination 
thereof) necessary to perform the auditing function as required by §  1.506(e)(1)(i) or 
§ 1.511(c)( 5)(i)(A).  Examples of potential qualified audito rs include:  
(1)  A government employee, including a foreign government employee; and   
(2)  An audit agent of a certification body that is accredited in accordance with subpart M 
of this part.  
Qualified individual  means a person who has the education, trai ning, or experience (or a 
combination thereof) necessary to perform an activity required under this subpart, and can read 
and understand the language of any records that the person must review in performing this 
activity.  A qualified individual may be, bu t is not required to be, an employee of the importer.  
A government employee, including a foreign government employee, may be a qualified 
individual.  
Raw agricultural commodity  has the meaning given in section 201(r) of the Federal Food, 
Drug, and Cosmetic  Act. 
Ready -to-eat food (RTE food)  means any food that is normally eaten in its raw state or 
any food, including a processed food, for which it is reasonably foreseeable that the food will be 
eaten without further processing that would significantly minimi ze biological hazards.  464 
 
 
 Receiving facility  means a facility that is subject to subparts C and G of part 117 of this 
chapter, or subparts C and E of part 507 of this chapter, and that manufactures/processes a raw 
material or other ingredient that it receives  from a supplier.  
U.S. owner or consignee  means the person in the United States who, at the time of U.S. 
entry, either owns the food, has purchased the food, or has agreed in writing to purchase the 
food.  
Very small importer  means:  
(1)  With respect to th e importation of human food, an importer (including any 
subsidiaries and affiliates) averaging less than $1 million per year, adjusted for inflation, during 
the 3 -year period preceding the applicable calendar year, in sales of human food combined with 
the U.S. market value of human food imported, manufactured, processed, packed, or held 
without sale (e.g., imported for a fee); and  
(2)  With respect to the importation of animal food, an importer (including any 
subsidiaries and affiliates) averaging less than  $2.5 million per year, adjusted for inflation, 
during the 3 -year period preceding the applicable calendar year, in sales of animal food 
combined with the U.S. market value of animal food imported, manufactured, processed, packed, 
or held without sale (e.g ., imported for a fee).  
You means a person who is subject to some or all of the requirements in this subpart.  
§ 1.501  To what foods do the regulations in this subpart apply?  
(a)  General .  Except as specified otherwise in this section, the requirements in  this 
subpart appl y to all food imported or offered for import into the United States and to the 
importers of such food.   465 
 
 
 (b)  Exemptions for juice and seafood --(1)  Importers of certain juice and seafood 
products .  This subpart do es not apply with respec t to juice, fish, and fishery products that are 
imported from a foreign supplier that is required to comply with, and is in compliance with, the 
requirements in part 120 or part 123 of this chapter.  If you import juice or fish and fishery 
products that ar e subject to part 120 or part 123, respectively, you must comply with the 
requirements applicable to importers of those products under § 120.14 or § 123.12 of this 
chapter, respectively.  
(2)  Certain importers of juice or seafood raw materials or other in gredients subject to 
part 120 or part 123  of this chapter .  This subpart do es not apply with respect to any raw 
materials or other ingredients that you import and use in manufacturing or processing juice 
subject to part 120 or fish and fishery products sub ject to part 123, provided that you are in 
compliance with the requirements in part 120 or part 123 with respect to the juice or fish or 
fishery product that you manufacture or process from the imported raw materials or other 
ingredients.  
(c)  Exemption fo r food imported for research or evaluation .  This subpart do es not apply 
to food that is imported for research or evaluation use, provided that such food:  
(1)  Is not intended for retail sale and is not sold or distributed to the public;  
(2)  Is labeled with the statement “Food for research or evaluation use”;  
(3)  Is imported in a small quantity that is consistent with a research, analysis, or quality 
assurance purpose, the food is used only for this purpose, and any unused quantity is properly 
disposed of; and  466 
 
 
 (4)  Is accompanied, when filing entry with U.S. Customs and Border Protection, by an 
electronic declaration that the food will be used for research or evaluation purposes and will not 
be sold or distributed to the public.  
(d)  Exemption for food  imported for personal consumption .  This subpart do es not apply 
to food that is imported for personal consumption, provided that such food is not intended for 
retail sale and is not sold or distributed to the public.  Food is imported for personal consump tion 
only if it is purchased or otherwise acquired by a person in a small quantity that is consistent 
with a non -commercial purpose and is not sold or distributed to the public.   
(e)  Exemption for alcoholic beverages .  (1)  This subpart do es not apply wit h respect to 
alcoholic beverages that are imported from a foreign supplier that is a facility that meets the 
following two conditions:  
(i)  Under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq .) or chapter 51 
of subtitle E of the Internal Rev enue Code of 1986 (26 U.S.C. 5001 et seq .), the facility is a 
foreign facility of a type that, if it were a domestic facility, would require obtaining a permit 
from, registering with, or obtaining approval of a notice or application from the Secretary of t he 
Treasury as a condition of doing business in the United States; and  
(ii)  Under section 415 of the Federal Food, Drug, and Cosmetic Act, the facility is 
required to register as a facility because it is engaged in manufacturing/processing one or more 
alcoholic beverages.  
(2)  This subpart do es not apply with respect to food that is not an alcoholic beverage that 
is imported from a foreign supplier described in paragraph (e)(1) of this section, provided such 
food:  467 
 
 
 (i)  Is in prepackaged form that preven ts any direct human contact with such food; and  
(ii)  Constitutes not more than 5 percent of the overall sales of the facility, as determined 
by the Secretary of the Treasury.  
(3)  This subpart do es not apply with respect to raw materials and other ingredi ents that 
are imported for use in alcoholic beverages provided that:  
(i)  The imported raw materials and other ingredients are used in the 
manufacturing/processing, packing, or holding of alcoholic beverages;  
(ii)  Such manufacturing/processing, packing, o r holding is performed by the importer;  
(iii)  The importer is required to register under section 415 of the Federal Food, Drug, and 
Cosmetic Act; and  
(iv)  The importer is exempt from the regulations in part 117 of this chapter in accordance 
with § 117.5 (i) of this chapter .  
(f)  Inapplicability to food that is transshipped or imported for processing and export .  
This subpart do es not apply to food:  
(1)  That is transshipped through the United States to another country and is not sold or 
distributed to th e public in the United States; or 
(2)  That is imported for processing and future export and that is not sold or distributed to 
the public in the United States.  
(g)  Inapplicability to U.S. food returned .  This subpart do es not apply to food that is 
manufa ctured/processed, raised, or grown in the United States, exported, and returned to the 
United States without further manufacturing/processing in a foreign country.  468 
 
 
 (h)  Inapplicability to certain meat, poultry, and egg products .  This  subpart do es not 
apply with respect to:  
(1)  Meat food products that at the time of importation are subject to the requirements of 
the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act (21 U.S.C. 
601 et seq .);  
(2)  Poultry  products  that at the time of importation are subject to the requirements of the 
USDA under the Poultry  Products  Inspection Act (21 U.S.C. 451 et seq .); and  
(3)  Egg products that at the time of importation are subject to the requirements of the 
USDA under the Egg Products Inspecti on Act (21 U.S.C. 1031 et seq .). 
§ 1.502  What foreign supplier verification program (FSVP) must I have?  
(a)  General .  Except as specified in paragraph (b) of this section, for each food you 
import, you must develop, maintain, and follow an FSVP that prov ides adequate assurances that 
your foreign supplier is producing the food in compliance with processes and procedures that 
provide at least the same level of public health protection as those required under section 418 
(regarding hazard analysis and risk -based preventive controls for certain foods) or 419 (regarding 
standards for produce safety), if either is applicable, and the implementing regulations, and is 
producing the food in compliance with sections 402 (regarding adulteration) and 403(w) (if 
applic able) (regarding misbranding with respect to labeling for the presence of major food 
allergens) of the Federal Food, Drug, and Cosmetic Act.   
(b)  Low-acid canned foods --(1)  Importers of low -acid canned foods not subject to 
further manufacturing or proce ssing .  With respect to those microbiological hazards that are 
controlled by part 113 of this chapter, if you import a thermally processed low -acid food 469 
 
 
 packaged in a hermetically sealed container  (low-acid canned food) , you must verify and 
document that the food was produced in accordance with part 113.  With respect to all matters 
that are not controlled by part 113, you must have an FSVP as specified in paragraph (a) of this 
section.  
(2)  Certain importers of raw materials or other ingredients subject t o part 113  of this 
chapter .  With respect to microbiological hazards that are controlled by part 113, you are not 
required to comply with the requirements of this subpart for raw materials or other ingredients 
that you import and use in the manufacturing o r processing of low -acid canned food provided 
that you are in compliance with part 113 with respect to the low -acid canned food that you 
manufacture or process from the imported raw materials or other ingredients.  With respect to all 
hazards other than mi crobiological hazards that are controlled by part 113, you must have an 
FSVP as specified in paragraph (a) of this section for the imported raw materials and other 
ingredients that you use in the manufacture or processing of low -acid canned foods.  
(c)  Importers subject to section 418 of the Federal Food, Drug, and Cosmetic Act .  You 
are deemed to be in compliance with the requirements of this subpart for a food you import, 
except for the requirements in §  1.509, if you are a receiving facility as defined i n § 117.3 or 
§ 507.3 of this chapter and you are in compliance with the following requirements of part 117 or 
part 507  of this chapter , as applicable:  
(1)  You implement preventive controls for the hazards in the food in accordance with 
§ 117.135 or  § 507.34 of this chapter;  
(2)  You are not required to implement a preventive control under §  117.136 or §  507.36 
of this chapter with respect to the food; or  470 
 
 
 (3)  You have established and implemented a risk -based supply -chain program in 
compliance with subpart  G of part 117 or subpart E of part 507 of this chapter with respect to the 
food.  
§ 1.503  Who must develop my FSVP and perform FSVP activities?  
(a)  Qualified individual .  A qualified individual must develop your FSVP and perform 
each of the activities r equired under this subpart.  A qualified individual must have the 
education, training, or experience (or a combination thereof) necessary to perform their assigned 
activities and must be able to read and understand the language of any records that must be 
reviewed in performing an activity.  
(b)  Qualified auditor .  A qualified auditor must conduct any audit conducted in 
accordance with §  1.506(e)(1)(i) or §  1.511(c)( 5)(i)(A).  A qualified auditor must have technical 
expertise obtained through education, tra ining, or experience (or a combination thereof) 
necessary to perform the auditing function.  
§ 1.504  What hazard analysis must I conduct?  
(a)  Requirement for a hazard analysis .  Except as specified in paragraph (d) of this 
section, you must conduct a hazard analysis to identify and evaluate, based on experience, illness 
data, scientific reports, and other information, known or reasonably foreseeable hazards for each 
type of food you import to determine whether there are any hazards requiring a control.   Your 
hazard analysis must be written regardless of its outcome.  
(b)  Hazard identification .  (1)  Your analysis of the known or reasonably foreseeable 
hazards in each food must include the following types of hazards:   471 
 
 
 (i)  Biological hazards, including m icrobiological hazards such as parasites, 
environmental pathogens, and other pathogens;  
(ii)  Chemical hazards, including radiological hazards, pesticide and drug residues, 
natural toxins, decomposition, unapproved food or color additives, food allergens, and (in animal 
food) nutrient deficiencies or toxicities; and  
(iii)  Physical hazards (such as stones, glass, and metal fragments).    
(2)  Your analysis must include known or reasonably foreseeable hazards that may be 
present in a food for any of the follo wing reasons:  
(i)  The hazard occurs naturally;  
(ii)  The hazard may be unintentionally introduced; or 
(iii)  The hazard may be intentionally introduced for purposes of economic gain.  
(c)  Hazard evaluation .  (1)  Your hazard analysis must include an evalu ation of the 
hazards identified in paragraph (b) of this section to assess the probability that the hazard will 
occur in the absence of controls and the severity of the illness or injury if the hazard were to 
occur.   
(2)  The hazard evaluation required by  paragraph (c)(1) of this section must include an 
evaluation of environmental pathogens whenever a ready -to-eat food is exposed to the 
environment before packaging and the packaged food does not receive a treatment or otherwise 
include a control or measure  (such as a formulation lethal to the pathogen) that would 
significantly minimize the pathogen.  
(3)  Your hazard evaluation must consider the effect of the following on the safety of the 
finished food for the intended consumer:  472 
 
 
 (i)  The formulation of the food;  
(ii)  The condition, function, and design of the establishment and equipment of a typical 
entity that manufactures/processes, grows, harvests, or raises this type of food;  
(iii)  Raw materials and other ingredients;  
(iv)  Transportation practices;  
(v)  Harvesting, raising, manufacturing, processing, and packing procedures;  
(vi)  Packaging and labeling activities;  
(vii)  Storage and distribution;  
(viii)  Intended or reasonably foreseeable use;  
(ix)  Sanitation, including employee hygiene; and  
(x)  Any  other relevant factors, such as the temporal (e.g., weather -related) nature of 
some hazards (e.g., levels of natural toxins).  
(d)  Review of another entity’s hazard analysis .  If another entity (including your foreign 
supplier) has, using a qualified indi vidual, analyzed the known or reasonably foreseeable hazards 
for the food to determine whether there are any hazards requiring a control, you may meet your 
requirement to determine whether there are any hazards requiring a control in a food by 
reviewing an d assessing the hazard analysis conducted by that entity.  You must document your 
review and assessment of that hazard analysis, including documenting that the hazard analysis 
was conducted by a qualified individual.  
(e)  Hazards in raw agricultural commod ities that are fruits or vegetables .  If you are 
importing a raw agricultural commodity that is a fruit or vegetable that is “covered produce” as 
defined in §  112.3 of this chapter, you are not required to determine whether there are any 473 
 
 
 biological hazards  requiring a control in such food because the biological hazards in such fruits 
or vegetables require a control and compliance with the requirements in part 112  of this chapter  
significantly minimizes or prevents the biological hazards.  However, you must determine 
whether there are any other types of hazards requiring a control in such food.  
(f)  No hazards requiring a control .  If you evaluate the known and reasonably foreseeable 
hazards in a food and determine that there are no hazards requiring a contro l, you are not 
required to conduct an evaluation for foreign supplier approval and verification under §  1.505 
and you are not required to conduct foreign supplier verification activities under §  1.506.  This 
paragraph (f) does not apply if the food is a ra w agricultural commodity that is a fruit or 
vegetable that is “covered produce” as defined in §  112.3 of this chapter.  
§ 1.505  What evaluation for foreign supplier approval and verification must I conduct?  
 (a)  Evaluation of a foreign supplier’s performance and the risk posed by a food .  (1)  
Except as specified in paragraphs (d) and (e) of this section, in approving your foreign suppliers 
and determining the appropriate supplier verification activities that must be conducted fo r a 
foreign supplier of a type of food you import, you must consider the following:  
 (i)  The hazard analysis of the food conducted in accordance with §  1.504, including the 
nature of the hazard requiring a control.  
(ii)  The entity or entities that will b e significantly minimizing or preventing the hazards 
requiring a control or verifying that such hazards have been significantly minimized or 
prevented, such as the foreign supplier, the foreign supplier’s raw material or other ingredient 
supplier, or anoth er entity in your supply chain.  
(iii)  Foreign supplier performance, including:  474 
 
 
 (A)  The foreign supplier’s procedures, processes, and practices related to the safety of 
the food;  
(B)  Applicable FDA food safety regulations and information relevant to the foreign 
supplier’s compliance with those regulations, including whether the foreign supplier is the 
subject of an FDA warning letter, import alert, or other FDA compliance action related to food 
safety (or, when applicable, the relevant laws and regulation s of a country whose food safety 
system FDA has officially recognized as comparable or determined to be equivalent to that of the 
United States, and information relevant to the supplier’s compliance with those laws and 
regulations); and  
(C)  The foreign su pplier’s food safety history, including available information about 
results from testing foods for hazards, audit results relating to the safety of the food, and 
responsiveness of the foreign supplier in correcting problems.  
(iv)  Any other factors as appr opriate and necessary, such as storage and transportation 
practices.    
(2)  You must document the evaluation you conduct under paragraph (a)(1) of this 
section.  
 (b)  Approval of foreign suppliers.   You must approve your foreign suppliers on the basis 
of the evaluation that you conducted under paragraph (a) of this section or that you review and 
assess under paragraph (d) of this section, and document your approval.  
(c)  Reevaluation of a foreign supplier’s performance and the  risk posed by a food .  (1)  
Except as specified in paragraph (d) of this section, you must promptly reevaluate the concerns 
associated with the factors in paragraph (a)(1) of this section when you become aware of new 475 
 
 
 information about these factors, and the reevaluation must be documented.  If you determine that 
the concerns associated with importing a food from a foreign supplier have changed, you must 
promptly determine (and document) whether it is appropriate to continue to import the food from 
the foreign supplier and whet her the supplier verification activities conducted under §  1.506 or 
§ 1.511(c) need to be changed.   
(2)  If at the end of any 3 -year period you have not reevaluated the concerns associated 
with the factors in paragraph (a)(1) of this section in accordance  with paragraph (c)(1) of this 
section, you must reevaluate those concerns and take other appropriate actions, if necessary, in 
accordance with paragraph (c)(1).  You must document your reevaluation and any subsequent 
actions you take in accordance with pa ragraph (c)(1).  
(d)  Review of another entity’s evaluation or reevaluation of a foreign supplier’s 
performance and the risk posed by a food .  If an entity other than the foreign supplier has, using 
a qualified individual, performed the evaluation describe d in paragraph (a) of this section or the 
reevaluation described in paragraph (c)  of this section , you may meet the requirements of the 
applicable paragraph by reviewing and assessing the evaluation or reevaluation conducted by 
that entity.  You must docum ent your review and assessment, including documenting that the 
evaluation or reevaluation was conducted by a qualified individual.  
(e)  Inapplicability to certain circumstances .  You are not required to conduct an 
evaluation under this section or to conduc t foreign supplier verification activities under §  1.506 if 
one of the circumstances described in §  1.507 applies to your importation of a food and you are 
in compliance with that section.  
§ 1.506  What foreign supplier verification and related activities must I conduct?  476 
 
 
 (a)  Use of approved foreign suppliers .  (1)  You must establish and follow written 
procedures to ensure that you import foods only from foreign suppliers you have approved based 
on the evaluation conducted under § 1.505 (or, when necessary  and appropriate, on a temporary 
basis from unapproved foreign suppliers whose foods you subject to adequate verification 
activities before importing the food).  You must document your use of these procedures.  
(2)  You may rely on an entity other than your  foreign supplier to establish the procedures 
and perform and document the activities required under paragraph (a)(1) of this section provided 
that you review and assess that entity’s documentation of the procedures and activities, and you 
document your re view and assessment.  
(b)  Foreign supplier verification procedures .  You must establish and follow adequate 
written procedures for ensuring that appropriate foreign supplier verification activities are 
conducted with respect to the foods you import.  
(c)  Requirement of supplier verification .  The foreign supplier verification activities 
must provide assurance that the hazards requiring a control in the food you import have been 
significantly minimized or prevented.  
(d)  Determination of appropriate foreign supplier verification activities --(1)(i)  General .  
Except as provided in paragraphs (d)(2) and (3) of this section, before importing a food from a 
foreign supplier, you must determine and document which verification activity or activities listed 
in paragr aphs (d)(1)(ii)(A)  through ( D) of this section, as well as the frequency with which the 
activity or activities must be conducted, are needed to provide adequate assurances that the food 
you obtain from the foreign supplier is produced in accordance with pa ragraph (c) of this section.  
Verification activities must address the entity or entities that are significantly minimizing or 477 
 
 
 preventing the hazards or verifying that the hazards have been significantly minimized or 
prevented (e.g., when an entity other t han the grower of produce subject to part 112 of this 
chapter harvests or packs the produce and significantly minimizes or prevents the hazard or 
verifies that the hazard has been significantly minimized or prevented, or when the foreign 
supplier’s raw mat erial supplier significantly minimizes or prevents a hazard).  The 
determination of appropriate supplier verification activities must be based on the evaluation of 
the food and foreign supplier conducted under §  1.505.   
(ii)  Appropriate verification acti vities .  The following are appropriate supplier 
verification activities:  
(A)  Onsite audits as specified in paragraph (e)(1)(i) of this section;  
(B)  Sampling and testing of a food as specified in paragraph (e)(1)(ii) of this section;  
(C)  Review of the fo reign supplier’s relevant food safety records as specified in 
paragraph (e)(1)(iii) of this section; and  
(D)  Other appropriate supplier verification activities as specified in paragraph (e)(1)(iv) 
of this section.  
(2)  Verification activities for certain  serious hazards .  When a hazard in a food will be 
controlled by the foreign supplier and is one for which there is a reasonable probability that 
exposure to the hazard will result in serious adverse health consequences or death to humans or 
animals, you m ust conduct or obtain documentation of an onsite audit of the foreign supplier 
before initially importing the food and at least annually thereafter, unless you make an adequate 
written determination that, instead of such initial and annual onsite auditing,  other supplier 
verification activities listed in  paragraph ( d)(1)(ii) of this section and/or less frequent onsite 478 
 
 
 auditing are appropriate to provide adequate assurances that the foreign supplier is producing the 
food in accordance with paragraph (c) of t his section, based on the determination made under 
§ 1.505.  
(3)  Reliance on a determination by another entity .  You may rely on a determination of 
appropriate foreign supplier verification activities in accordance with paragraph (d)(1) or (2) of 
this sect ion made by an entity other than the foreign supplier if you review and assess whether 
the entity’s determination regarding appropriate activities (including the frequency with which 
such activities must be conducted) is appropriate.  You must document you r review and 
assessment, including documenting that the determination of appropriate verification activities 
was made by a qualified individual.    
(e)  Performance of foreign supplier verification activities --(1)  Verification activities .  
Except as provi ded in paragraph (e)(2) of this section, based on the determination made in 
accordance with paragraph (d) of this section, you must conduct (and document) or obtain 
documentation of one or more of the supplier verification activities listed in paragraphs ( e)(1)(i) 
through (iv) of this section for each foreign supplier before importing the food and periodically 
thereafter.   
(i)  Onsite audit of the foreign supplier .  (A)  An onsite audit of a foreign supplier must be 
performed by a qualified auditor.  
(B)  If the food is subject to one or more FDA food safety regulations, an onsite audit of 
the foreign supplier must consider such regulations and include a review of the supplier’s written 
food safety plan, if any, and its implementation, for the hazard b eing controlled (or, when 
applicable, an onsite audit may consider relevant laws and regulations of a country whose food 479 
 
 
 safety system FDA has officially recognized as comparable or determined to be equivalent to 
that of the United States).   
(C)  If the o nsite audit is conducted solely to meet the requirements of paragraph (e) of 
this section by an audit agent of a certification body that is accredited in accordance with subpart 
M of this part, the audit is not subject to the requirements in that subpart.   
(D)  You must retain documentation of each onsite audit, including the audit procedures, 
the dates the audit was conducted, the conclusions of the audit, any corrective actions taken in 
response to significant deficiencies identified during the audit, and  documentation that the audit 
was conducted by a qualified auditor.  
(E)  The following inspection results may be substituted for an onsite audit, provided that 
the inspection was conducted within 1 year of the date by which the onsite audit would have 
been required to be conducted:  
(1)  The written results of an appropriate inspection of the foreign supplier for 
compliance with applicable FDA food safety regulations conducted by FDA, representatives of 
other Federal Agencies (such as the USDA), or representatives of State, local, tribal, or territorial 
agencies; or  
(2)  The written results of an inspection of the foreign supplier by the food safety 
authority of a country whose food safety system FDA has officially recognized as comparable or 
determ ined to be equivalent to that of the United States, provided that the food that is the subject 
of the onsite audit is within the scope of the official recognition or equivalence determination, 
and the foreign supplier is in, and under the regulatory oversi ght of, such country.  480 
 
 
 (ii)  Sampling and testing of the food .  You must retain documentation of each sampling 
and testing of a food, including identification of the food tested (including lot number, as 
appropriate), the number of samples tested, the test( s) conducted (including the analytical 
method(s) used), the date(s) on which the test(s) were conducted and the date of the report of the 
testing, the results of the testing, any corrective actions taken in response to detection of hazards, 
information ide ntifying the laboratory conducting the testing, and documentation that the testing 
was conducted by a qualified individual.  
(iii)  Review of the foreign supplier’s relevant food safety records .  You must retain 
documentation of each record review, includin g the date(s) of review, the general nature of the 
records reviewed, the conclusions of the review, any corrective actions taken in response to 
significant deficiencies identified during the review, and documentation that the review was 
conducted by a qual ified individual.  
(iv)  Other appropriate activity .  (A)  You may conduct (and document) or obtain 
documentation of other supplier verification activities that are appropriate based on foreign 
supplier performance and the risk associated with the food.  
(B)  You must retain documentation of each activity conducted in accordance with 
paragraph (e)(1)(iv) of this section, including a description of the activity, the date on which it 
was conducted, the findings or results of the activity, any corrective actions  taken in response to 
significant deficiencies identified, and documentation that the activity was conducted by a 
qualified individual.  
(2)  Reliance upon performance of activities by other entities .  (i)  Except as specified in 
paragraph (e)(2)(ii) of thi s section, you may rely on supplier verification activities conducted in 481 
 
 
 accordance with paragraph (e)(1) of this section by another entity provided that you review and 
assess the results of these activities in accordance with paragraph (e)(3) of this sect ion. 
(ii)  You may not rely on the foreign supplier itself or employees of the foreign supplier 
to perform supplier verification activities, except with respect to sampling and testing of food in 
accordance with paragraph (e)(1)(ii) of this section.  
(3)  Review of results of verification activities .  You must promptly review and assess the 
results of the verification activities that you conduct or obtain documentation of under paragraph 
(e)(1) of this section, or that are conducted by other entities in acco rdance with paragraph (e)(2) 
of this section.  You must document your review and assessment of the results of verification 
activities.  If the results do not provide adequate assurances that the hazards requiring a control 
in the food you obtain from the f oreign supplier have been significantly minimized or prevented, 
you must take appropriate action in accordance with §  1.508(a).  You are not required to retain 
documentation of supplier verification activities conducted by other entities, provided that you  
can obtain the documentation and make it available to FDA in accordance with §  1.510(b).  
(4)  Independence of qualified individuals conducting verification activities .  There must 
not be any financial conflicts of interests that influence the results of  the verification activities set 
forth in paragraph  (e)(1) of this section , and payment must not be related to the results of the 
activity.  
§ 1.507  What requirements apply when I import a food that cannot be consumed without the 
hazards being controlled or for which the hazards are controlled after importation?  
 (a)  Circumstances .  You are not required to conduct an evaluation of a food and foreign 
supplier under §  1.505 or supplier verification activities under §  1.506 when you identify a 482 
 
 
 hazard requiring a control (identified hazard) in a food and any of the following circumstances 
apply:  
 (1)  You determine and document that the type of food (e.g., raw agricultural 
commodities such as cocoa beans and coffee beans) could not be consumed without application  
of an appropriate control;  
 (2)  You rely on your customer who is subject to the requirements for hazard analysis and 
risk-based preventive controls in subpart C of part 117 or subpart C of part 507 of this chapter to 
ensure that the identified hazard wil l be significantly minimized or prevented and you:  
 (i)  Disclose in documents accompanying the food, in accordance with the practice of the 
trade, that the food is “not processed to control [identified hazard]”; and  
 (ii)  Annually obtain from your custom er written assurance, subject to the requirements of 
paragraph (c) of this section, that the customer has established and is following procedures 
(identified in the written assurance) that will significantly minimize or prevent the identified 
hazard;  
 (3)  You rely on your customer who is not subject to the requirements for hazard analysis 
and risk -based preventive controls in subpart C of part 117 or subpart C of part 507 of this 
chapter to provide assurance it is manufacturing, processing, or preparing t he food in accordance 
with the applicable food safety requirements and you:  
 (i)  Disclose in documents accompanying the food, in accordance with the practice of the 
trade, that the food is “not processed to control [identified hazard]”; and  
 (ii)  Annual ly obtain from your customer written assurance that it is manufacturing, 
processing, or preparing the food in accordance with applicable food safety requirements;  483 
 
 
  (4)  You rely on your customer to provide assurance that the food will be processed to 
contr ol the identified hazard by an entity in the distribution chain subsequent to the customer and 
you: 
 (i)  Disclose in documents accompanying the food, in accordance with the practice of the 
trade, that the food is “not processed to control [identified haza rd]”; and  
 (ii)  Annually obtain from your customer written assurance, subject to the requirements of 
paragraph (c) of this section, that your customer:  
 (A)  Will disclose in documents accompanying the food, in accordance with the practice 
of the trade, t hat the food is “not processed to control [identified hazard]”; and  
 (B)  Will only sell the food to another entity that agrees, in writing, it will:  
 (1)  Follow procedures (identified in a written assurance) that will significantly minimize 
or prevent the identified hazard (if the entity is subject to the requirements for hazard analysis 
and risk -based preventive controls in subpart C of part 117 or subpart C of part 507 of this 
chapter) or manufacture, process, or prepare the food in accordance with ap plicable food safety 
requirements (if the entity is not subject to the requirements for hazard analysis and risk -based 
preventive controls in subpart C of part 117 or subpart C of part 507); or  
 (2)  Obtain a similar written assurance from the entity’s cus tomer, subject to the 
requirements of paragraph (c) of this section, as in paragraphs (a)(4)(ii)(A) and (B) of this 
section, as appropriate; or  
 (5)  You have established, documented, and implemented a system that ensures control, 
at a subsequent distribut ion step, of the hazards in the food you distribute and you document 
your implementation of that system.    484 
 
 
 (b)  Written assurances .  Any written assurances required under this section must contain 
the following:  
 (1)  Effective date;  
 (2)  Printed names a nd signatures of authorized officials; and  
 (3)  The assurance specified in the applicable paragraph.  
 (c)  Provision of assurances .  The customer or other subsequent entity in the distribution 
chain for a food that provides a written assurance under parag raph (a)(2), (3), or (4) of this 
section must act consistently with the assurance and document its actions taken to satisfy the 
written assurance.  
§ 1.508  What corrective actions must I take under my FSVP?  
 (a)  You must promptly take appropriate correcti ve actions if you determine that a 
foreign supplier of food you import does not produce the food in compliance with processes and 
procedures that provide at least the same level of public health protection as those required under 
section 418 or 419 of the Federal Food, Drug, and Cosmetic Act, if either is applicable, and the 
implementing regulations, or produces food that is adulterated under section 402 or misbranded 
under section 403(w) (if applicable) of the Federal Food, Drug, and Cosmetic Act.  This 
determination could be based on a review of consumer, customer, or other complaints related to 
food safety, the verification activities conducted under §  1.506 or §  1.511(c), a reevaluation of 
the risks posed by the food and the foreign supplier’s performanc e conducted under § 1.505(c) or 
(d), or any other relevant information you obtain.  The appropriate corrective actions will depend 
on the circumstances but could include discontinuing use of the foreign supplier until the cause 485 
 
 
 or causes of noncompliance, adulteration, or misbranding have been adequately addressed.  You 
must document any corrective actions you take in accordance with this paragraph.   
(b)  If you determine, by means other than the verification activities conducted under 
§ 1.506 or § 1.511(c ) or a reevaluation conducted under §  1.505(c) or (d), that a foreign supplier 
of food that you import does not produce food in compliance with processes and procedures that 
provide at least the same level of public health protection as those required unde r section 418 or 
419 of the Federal Food, Drug, and Cosmetic Act, if either is applicable, and the implementing 
regulations, or produces food that is adulterated under section 402 or misbranded under section 
403(w) (if applicable) of the Federal Food, Drug , and Cosmetic Act, you must promptly 
investigate to determine whether your FSVP is adequate and,  when appropriate, modify your 
FSVP.  You must document any investigations, corrective actions, and changes to your FSVP 
that you undertake in accordance with this paragraph.  
(c)  This section does not limit your obligations with respect to other laws enforced by 
FDA, such as those relating to product recalls.  
§ 1.509  How must the importer be identified at entry?  
(a)  You must ensure that, for each line entry o f food product offered for importation into 
the United States, your name, electronic mail address, and unique facility identifier recognized as 
acceptable by FDA, identifying you as the importer of the food, are provided electronically when 
filing entry wi th U.S. Customs and Border Protection.  
(b)  Before an article of food is imported or offered for import into the United States, the 
foreign owner or consignee of the food (if there is no U.S. owner or consignee) must designate a 486 
 
 
 U.S. agent or representativ e as the importer of the food for the purposes of the definition of 
“importer” in §  1.500.  
§ 1.510  How must I maintain records of my FSVP?  
(a)  General requirements for records .  (1)  You must keep records as original records, 
true copies (such as photoco pies, pictures, scanned copies, microfilm, microfiche, or other 
accurate reproductions of the original records), or electronic records.   
(2)  You must sign and date records concerning your FSVP upon initial completion and 
upon any modification of the FSVP . 
(3)  All records must be legible and stored to prevent deterioration or loss.  
(b)  Record availability .  (1)  You must make all records required under this subpart 
available promptly to an authorized FDA representative, upon request, for inspection and 
copying.  Upon FDA request, you must provide within a reasonable time an English translation 
of records maintained in a language other than English.  
(2)  Offsite storage of records, including records maintained by other entities in 
accordance with §  1.504,  § 1.505, or § 1.506, is permitted if such records can be retrieved and 
provided onsite within 24 hours of request for official review.  Electronic records are considered 
to be onsite if they are accessible from an onsite location.   
(3)  If requested in w riting by FDA, you must send records to the Agency electronically, 
or through another means that delivers the records promptly, rather than making the records 
available for review at your place of business.   487 
 
 
 (c)  Record retention .  (1)  Except as specified  in paragraph (c)(2) of this section, you 
must retain records referenced in this subpart until at least 2 years after you created or obtained 
the records.  
(2)  You must retain records that relate to your processes and procedures, including the 
results of e valuations and determinations you conduct, for at least 2 years after their use is 
discontinued (e.g., because you no longer import a particular food, you no longer use a particular 
foreign supplier, you have reevaluated the risks associated with a food an d the foreign supplier, 
or you have changed your supplier verification activities for a particular food and foreign 
supplier).     
(d)  Electronic records .  Records that are established or maintained to satisfy the 
requirements of this subpart and that mee t the definition of electronic records in § 11.3(b)(6) of 
this chapter are exempt from the requirements of part 11 of this chapter.  Records that satisfy the 
requirements of this subpart, but that also are required under other applicable statutory provisio ns 
or regulations, remain subject to part 11.  
(e)  Use of existing records .  (1)  You do not need to duplicate existing records you have 
(e.g., records that you maintain to comply with other Federal, State, or local regulations) if they 
contain all of the information required by this subpart.  You may supplement any such existing 
records as necessary to include all of the information required by this subpart.  
(2)  You do not need to maintain the information required by this subpart in one set of 
records.  If existing records you have contain some of the required information, you may 
maintain any new information required by this subpart either separately or combined with the 
existing records.  488 
 
 
 (f)  Public disclosure .  Records obtained by FDA in accordance wit h this subpart are 
subject to the disclosure requirements under part 20 of this chapter.   
§ 1.511  What FSVP must I have if I am importing a food subject to certain dietary supplement 
current good manufacturing practice regulations?  
 (a)  Importers subjec t to certain dietary supplement current good manufacturing 
regulations .  If you are required to establish specifications under § 111.70(b) or (d) of this 
chapter with respect to a food that is a dietary supplement or dietary supplement component you 
import  for further manufacturing, processing, or packaging as a dietary supplement, and you are 
in compliance with the requirements in §§  111.73 and 111.75 of this chapter applicable to 
determining whether the specifications you established are met for such food , then for that food 
you must comply with the requirements in §§ 1.503 and 1.509, but you are not required to 
comply with the requirements in §  1.502, §§  1.504  through 1.508, or §  1.510.  This requirement 
does not limit your obligations with respect to par t 111 of this chapter or any other laws enforced 
by FDA.   
 (b)  Importers whose customer is subject to certain dietary supplement current good 
manufacturing practice regulations .  If your customer is required to establish specifications under 
§ 111.70(b) or (d) of this chapter with respect to a food that is a dietary supplement or dietary 
supplement component you import for further manufacturing, processing, or packaging as a 
dietary supplement, your customer is in compliance with the requirements of §§  111.73 and 
111.75 of this chapter applicable to determining whether the specifications it established are met 
for such food, and you annually obtain from your customer written assurance that it is in 
compliance with those requirements, then for that food you  must comply with the requirements 489 
 
 
 in §§ 1.503, 1.509, and 1.510, but you are not required to comply with the requirements in § 
1.502 or §§  1.504 through 1.508.   
 (c)  Other importers of dietary supplements --(1)  General .  If the food you import is a 
dietary supplement and neither paragraph (a) or (b) of this section is applicable, you must 
comply with paragraph (c) of this section and the requirements in §§ 1.503, 1.505(a)(1)(ii) 
through (iv) , (a)(2), and (b) through (d), and 1.508 through 1.510, but you are not required to 
comply with the requirements in §§  1.504, 1.505(a)(1)(i), 1.506, and 1.507.  This requirement 
does not limit your obligations with respect to part 111 of this chapter or any other laws enforced 
by FDA.  
 (2)  Use of approved foreign supp liers.  (i)  You must establish and follow written 
procedures to ensure that you import foods only from foreign suppliers that you have approved 
based on the evaluation conducted under § 1.505 (or, when necessary and appropriate, on a 
temporary basis from unapproved foreign suppliers whose foods you subject to adequate 
verification activities before importing the food).  You must document your use of these 
procedures.  
 (ii)  You may rely on an entity other than the foreign supplier to establish the procedur es 
and perform and document the activities required under paragraph (c)(2)(i) of this section 
provided that you review and assess that entity’s documentation of the procedures and activities, 
and you document your review and assessment.  
(3)  Foreign suppli er verification procedures .  You must establish and follow adequate 
written procedures for ensuring that appropriate foreign supplier verification activities are 
conducted with respect to the foods you import.  490 
 
 
 (4)  Determination of appropriate foreign supp lier verification activities --(i)  General .  
Except as provided in paragraph (c)(4)(iii) of this section, before importing a dietary supplement 
from a foreign supplier, you must determine and document which verification activity or 
activities listed in paragraphs (c)(4)(ii)(A) through (D) of this section, as well as the frequency 
with which the activity or activities must be conducted, are needed to provide adequate 
assurances that the foreign supplier is producing the dietary supplement in accordance with 
processes and procedures that provide the same level of public health protection as those 
required under part 111 of this chapter.  This determination must be based on the evaluation 
conducted under §  1.505.   
(ii)  Appropriate verification activities .  The following are appropriate supplier 
verif ication activities:  
(A)  Onsite audits as specified in paragraph (c)(5)(i)(A) of this section;  
(B)  Sampling and testing of a food as specified in paragraph (c)(5)(i)(B) of this section;  
(C)  Review of the foreign supplier’s relevant food safety records as  specified in 
paragraph (c)(5)(i)(C) of this section; and  
(D)  Other appropriate supplier verification activities as specified in paragraph 
(c)(5)(i)(D) of this section.  
(iii)  Reliance upon determination by other entity .  You may rely on a determination of 
appropriate foreign supplier verification activities in accordance with paragraph (c)(4)(i) of this 
section made by an entity other than the foreign supplier if you review and assess whether the 
entity’s determination regarding appropriate activities (i ncluding the frequency with which such 
activities must be conducted) is appropriate based on the evaluation conducted in accordance 491 
 
 
 with §  1.505.  You must document your review and assessment, including documenting that the 
determination of appropriate ver ification activities was made by a qualified individual.  
(5)  Performance of foreign supplier verification activities .  (i)  Except as provided in 
paragraph (c)(5)(ii) of this section, for each dietary supplement you import under paragraph (c) 
of this sect ion, you must conduct (and document) or obtain documentation of one or more of the 
verification activities listed in paragraphs (c)(5)(i)(A) through (D) of this section before 
importing the dietary supplement and periodically thereafter.   
(A)  Onsite audi ting.  You conduct (and document) or obtain documentation of a periodic 
onsite audit of your foreign supplier.  
(1)  An onsite audit of a foreign supplier must be performed by a qualified auditor.  
(2)  The onsite audit must consider the applicable requirem ents of part 111 of this chapter 
and include a review of the foreign supplier’s written food safety plan, if any, and its 
implementation (or, when applicable, an onsite audit may consider relevant laws and regulations 
of a country whose food safety system FDA has officially recognized as comparable or 
determined to be equivalent to that of the United States).  
(3)  If the onsite audit is conducted solely to meet the requirements of paragraph (c)(5) of 
this section by an audit agent of a certification body t hat is accredited in accordance with subpart 
M of this part, the audit is not subject to the requirements in that subpart.  
(4)  You must retain documentation of each onsite audit, including the audit procedures, 
the dates the audit was conducted, the concl usions of the audit, any corrective actions taken in 
response to significant deficiencies identified during the audit, and documentation that the audit 
was conducted by a qualified auditor.  492 
 
 
 (5)  The following inspection results may be substituted for an on site audit, provided that 
the inspection was conducted within 1 year of the date by which the onsite audit would have 
been required to be conducted:  
(i)  The written results of appropriate inspection of the foreign supplier for compliance 
with the applicab le requirements  in part 111 of this chapter conducted by FDA, representatives 
of other Federal Agencies (such as the USDA), or representatives of State, local, tribal, or 
territorial agencies; or  
(ii)  The written results of an inspection by the food safet y authority of a country whose 
food safety system FDA has officially recognized as comparable or determined to be equivalent 
to that of the United States, provided that the food that is the subject of the onsite audit is within 
the scope of the official re cognition or equivalence determination, and the foreign supplier is in, 
and under the regulatory oversight of, such country.  
(B)  Sampling and testing of the food .  You must retain documentation of each sampling 
and testing of a dietary supplement, includi ng identification of the food tested (including lot 
number, as appropriate), the number of samples tested, the test(s) conducted (including the 
analytical method(s) used), the date(s) on which the test(s) were conducted and the date of the 
report of the te sting, the results of the testing, any corrective actions taken in response to 
detection of hazards, information identifying the laboratory conducting the testing, and 
documentation that the testing was conducted by a qualified individual.  
(C)  Review of t he foreign supplier’s food safety records .  You must retain 
documentation of each record review, including the date(s) of review, the general nature of the 
records reviewed, the conclusions of the review, any corrective actions taken in response to 493 
 
 
 signifi cant deficiencies identified during the review, and documentation that the review was 
conducted by a qualified individual.  
(D)  Other appropriate activity .  (1)  You may conduct (and document) or obtain 
documentation of other supplier verification activities that are appropriate based on foreign 
supplier performance and the risk associated with the food.  
(2)  You must retain documentation of each activity condu cted in accordance with 
paragraph (c)(5)(i)(D)( 1) of this section, including a description of the activity, the date on which 
it was conducted, the findings or results of the activity, any corrective actions taken in response 
to significant deficiencies id entified, and documentation that the activity was conducted by a 
qualified individual.  
(ii)  Reliance upon performance of activities by other entities .  (A)  Except as specified in 
paragraph (c)(5)(ii)(B) of this section, you may rely on supplier verification activities conducted 
in accordance with paragraph (c)(5)(i) by another entity provided that you review and assess the 
results of these activities in accordance with paragraph (c)(5)(iii) of this section.  
(B)  You may not rely on the foreign su pplier or employees of the foreign supplier to 
perform supplier verification activities, except with respect to sampling and testing of food in 
accordance with paragraph (c)(5)(i)(B) of this section.  
(iii)  Review of results of verification activities .  Yo u must promptly review and assess 
the results of the verification activities that you conduct or obtain documentation of under 
paragraph (c)(5)(i) of this section, or that are conducted by other entities in accordance with 
paragraph (c)(5)(ii) of this sect ion.  You must document your review and assessment of the 
results of verification activities.  If the results show that the foreign supplier is not producing the 494 
 
 
 dietary supplement in accordance with processes and procedures that provide the same level of 
public health protection as those required under part 111 of this chapter, you must take 
appropriate action in accordance with §  1.508(a).  You are not required to retain documentation 
of supplier verification activities conducted by other entities, provid ed that you can obtain the 
documentation and make it available to FDA in accordance with §  1.510(b).  
 (iv)  Independence of qualified individuals conducting verification activities .  There must 
not be any financial conflicts of interest that influence the results of  the verification activities set 
forth in paragraph  (c)(5)(i) of this section , and payment must not be related to the results of the 
activity.   
§ 1.512  What FSVP may I have if I am a very small importer or I am importing certain food 
from certa in small foreign suppliers?  
 (a)  Eligibility .  This section applies only if:  
(1)  You are a very small importer; or  
(2)  You are importing certain food from certain small foreign suppliers as follows:  
(i)  The foreign supplier is a qualified facility as defined by § 117.3 or § 507.3 of this 
chapter;  
(ii)  You are importing produce from a foreign supplier that is a farm that grows produce 
and is not a covered farm under part 112 of this chapter in accordance with § 112.4(a)  of this 
chapter , or in accordanc e with §§  112.4(b) and 112.5  of this chapter ; or 
(iii)  You are importing shell eggs from a foreign supplier that is not subject to the 
requirements of part 118 of this chapter because it has fewer than 3,000 laying hens.  495 
 
 
  (b)  Applicable requirements --(1)  Documentation of eligibility --(i)  Very small importer 
status .  (A)  If you are a very small importer and you choose to comply with the requirements in 
this section, you must document that you meet the definition of very small importer in § 1.500 
with r espect to human food and/or animal food before initially importing food as a very small 
importer and thereafter on an annual basis by December 31 of each calendar year.   
(B)  For the purpose of determining whether you satisfy the definition of very small 
importer with respect to human food and/or animal food for a given calendar year, the relevant 3 -
year period of sales (and U.S. market value of human or animal food, as appropriate) is the 
period ending 1 year before the calendar year for which you intend to import food as a very small 
importer.  The baseline year for calculating the adjustment for inflation is 2011.  If you conduct 
any food sales in currency other than U.S. dollars, you must use the relevant currency exchange 
rate in effect on December 31 of the year in which sales occurred to calculate the value of these 
sales.  
(ii)  Small foreign supplier status .  If you are a importing food from a small foreign 
supplier as specified in paragraph (a)(2) of this section and you choose to comply with the 
requirements in this section, you must obtain written assurance that your foreign supplier meets 
the criteria in paragraph (a)(2)(i), (ii), or (iii) of this section before first approving the supplier 
for an applicable calendar year and thereafter on an annu al basis by December 31 of each 
calendar year, for the following calendar year.  
 (2)  Additional requirements .  If this section applies and you choose to comply with the 
requirements in paragraph (b) of this section, you also are required to comply with th e 496 
 
 
 requirements in §§  1.502, 1.503, and 1.509, but you are not required to comply with the 
requirements in §§ 1.504 through 1.508 or § 1.510.  
 (3)  Foreign supplier verification activities .  (i)  If you are a very small importer, for each 
food you import, y ou must obtain written assurance, before importing the food and at least every 
2 years thereafter, that your foreign supplier is producing the food in compliance with processes 
and procedures that provide at least the same level of public health protection  as those required 
under section 418 or 419 of the Federal Food, Drug, and Cosmetic Act, if either is applicable, 
and the implementing regulations, and is producing the food in compliance with sections 402 and 
403(w) (if applicable) of the Federal Food, Dr ug, and Cosmetic Act.  
(ii)  If your foreign supplier is a qualified facility as defined by § 117.3 or § 507.3 of this 
chapter and you choose to comply with the requirements in this section, you must obtain written 
assurance before importing the food and a t least every 2 years thereafter that the foreign supplier 
is producing the food in compliance with applicable FDA food safety regulations (or, when 
applicable, the relevant laws and regulations of a country whose food safety system FDA has 
officially reco gnized as comparable or determined to be equivalent to that of the United States).  
The written assurance must include either:  
(A)  A brief description of the preventive controls that the supplier is implementing to 
control the applicable hazard in the foo d; or  
(B)  A statement that the supplier is in compliance with State, local, county, tribal, or 
other applicable non -Federal food safety law, including relevant laws and regulations of foreign 
countries.   497 
 
 
 (iii)  If your foreign supplier is a farm that gr ows produce and is not a covered farm under 
part 112 of this chapter in accordance with § 112.4(a)  of this chapter , or in accordance with §§ 
112.4(b) and 112.5  of this chapter , and you choose to comply with the requirements in this 
section, you must obtain  written assurance before importing the produce and at least every 2 
years thereafter that the farm acknowledges that its food is subject to section 402 of the Federal 
Food, Drug, and Cosmetic Act (or, when applicable, that its food is subject to relevant laws and 
regulations of a country whose food safety system FDA has officially recognized as comparable 
or determined to be equivalent to that of the United States).  
(iv)  If your foreign supplier is a shell egg producer that is not subject to the requireme nts 
of part 118 of this chapter because it has fewer than 3,000 laying hens and you choose to comply 
with the requirements in this section, you must obtain written assurance before importing the 
shell eggs and at least every 2 years thereafter that the she ll egg producer acknowledges that its 
food is subject to section 402 of the Federal Food, Drug, and Cosmetic Act (or, when applicable, 
that its food is subject to relevant laws and regulations of a country whose food safety system 
FDA has officially recogn ized as comparable or determined to be equivalent to that of the United 
States) .  
 (4)  Corrective actions .  You must promptly take appropriate corrective actions if you 
determine that a foreign supplier of food you import does not produce the food consis tent with 
the assurance provided in accordance with § 1.512(b)(3)(i) through (iv).  The appropriate 
corrective actions will depend on the circumstances but could include discontinuing use of the 
foreign supplier until the cause or causes of noncompliance, adulteration, or misbranding have 
been adequately addressed.  You must document any corrective actions you take in accordance 498 
 
 
 with this paragraph (b)(4).  This paragraph (b)(4) does not limit your obligations with respect to 
other laws enforced by FDA, suc h as those relating to product recalls.  
(5)  Records --(i)  General requirements for records .  (A)  You must keep records as 
original records, true copies (such as photocopies, pictures, scanned copies, microfilm, 
microfiche, or other accurate reproductions  of the original records), or electronic records.   
(B)  You must sign and date records concerning your FSVP upon initial completion and 
upon any modification of the FSVP.   
(C)  All records must be legible and stored to prevent deterioration or loss.  
(ii)  Availability .  (A)  You must make all records required under this subpart available 
promptly to an authorized FDA representative, upon request, for inspection and copying.  Upon 
FDA request, you must provide within a reasonable time an English transl ation of records 
maintained in a language other than English.   
(B)  Offsite storage of records, including records retained by other entities in accordance 
with paragraph (c) of this section, is permitted if such records can be retrieved and provided 
onsit e within 24 hours of request for official review.  Electronic records are considered to be 
onsite if they are accessible from an onsite location.  
(C)  If requested in writing by FDA, you must send records to the Agency electronically 
or through another mea ns that delivers the records promptly, rather than making the records 
available for review at your place of business.  
(iii)  Record retention .  (A)  Except as specified in paragraph (b)(5)(iii)(B) or (C) of this 
section, you must retain records required un der this subpart for a period of at least 2 years after 
you created or obtained the records.   499 
 
 
 (B)  If you are subject to paragraph (c) of this section, you must retain records that relate 
to your processes and procedures, including the results of evaluati ons of foreign suppliers and 
procedures to ensure the use of approved suppliers, for at least 2 years after their use is 
discontinued (e.g., because you have reevaluated a foreign supplier’s compliance history or 
changed your procedures to ensure the use o f approved suppliers).  
(C)  You must retain for at least 3 years records that you rely on during the 3 -year period 
preceding the applicable calendar year to support your status as a very small importer.  
(iv)  Electronic records .  Records that are establish ed or maintained to satisfy the 
requirements of this subpart and that meet the definition of electronic records in §  11.3(b)(6) of 
this chapter are exempt from the requirements of part 11 of this chapter.  Records that satisfy the 
requirements of this part , but that also are required under other applicable statutory provisions or 
regulations, remain subject to part 11.  
(v)  Use of existing records .  (A)  You do not need to duplicate existing records you have 
(e.g., records that you maintain to comply with other Federal, State, or local regulations) if they 
contain all of the information required by this subpart.  You may supplement any such existing 
records as necessary to include all of the information required by this subpart.  
(B)  You do not need to main tain the information required by this subpart in one set of 
records.  If existing records you have contain some of the required information, you may 
maintain any new information required by this subpart either separately or combined with the 
existing recor ds. 
(vi)  Public disclosure .  Records obtained by FDA in accordance with this subpart are 
subject to the disclosure requirements under part 20 of this chapter.  500 
 
 
  (c)  Requirements for importers of food from certain small foreign suppliers .  The 
following ad ditional requirements apply if you are importing food from certain small foreign 
suppliers as specified in paragraph (a)(2) of this section and you are not a very small importer:  
 (1)  Evaluation of foreign supplier compliance history --(i)  Initial evaluat ion.  In 
approving your foreign suppliers, you must evaluate the applicable FDA food safety regulations 
and information relevant to the foreign supplier’s compliance with those regulations, including 
whether the foreign supplier is the subject of an FDA wa rning letter, import alert, or other FDA 
compliance action related to food safety, and document the evaluation.  You may also consider 
other factors relevant to a foreign supplier’s performance, including those specified in 
§ 1.505(a)(1)(iii)(A) and (C).   
 (ii)  Reevaluation of foreign supplier compliance history .  (A)  Except as specified in 
paragraph (c)(1)(iii) of this section, you must promptly reevaluate the concerns associated with 
the foreign supplier’s compliance history when you become aware of ne w information about the 
matters in paragraph (c)(1)(i) of this section, and the reevaluation must be documented.  If you 
determine that the concerns associated with importing a food from a foreign supplier have 
changed, you must promptly determine (and doc ument) whether it is appropriate to continue to 
import the food from the foreign supplier.  
 (B)  If at the end of any 3 -year period you have not reevaluated the concerns associated 
with the foreign supplier’s compliance history in accordance with paragraph  (c)(1)(ii)(A) of this 
section, you must reevaluate those concerns and take other appropriate actions, if necessary, in 501 
 
 
 accordance with paragraph (c)(1)(ii)(A).  You must document your reevaluation and any 
subsequent actions you take in accordance with par agraph (c)(1)(ii)(A).  
(iii)  Review of another entity’s evaluation or reevaluation of foreign supplier compliance 
history .  If an entity other than the foreign supplier has, using a qualified individual, performed 
the evaluation described in paragraph (c)( 1)(i) of this section or the reevaluation described in 
paragraph (c)(1)(ii), you may meet the requirements of the applicable paragraph by reviewing 
and assessing the evaluation or reevaluation conducted by that entity.  You must document your 
review and as sessment, including documenting that the evaluation or reevaluation was conducted 
by a qualified individual.  
(2)  Approval of foreign supplier .  You must approve your foreign suppliers on the basis 
of the evaluation you conducted under paragraph (c)(1)(i) of this section or that you review and 
assess under paragraph (c)(1)(iii) of this section, and document your approval.   
 (3)  Use of approved foreign suppliers .  (i)  You must establish and follow written 
procedures to ensure that you import foods only fr om foreign suppliers you have approved based 
on the evaluation conducted under paragraph (c)(1)(i) of this section (or, when necessary and 
appropriate, on a temporary basis from unapproved foreign suppliers whose foods you subject to 
adequate verification activities before importing the food).  You must document your use of 
these procedures.  
(ii)  You may rely on an entity other than the foreign supplier to establish the procedures 
and perform and document the activities required under paragraph (c)(3)(i) o f this section 502 
 
 
 provided that you review and assess that entity’s documentation of the procedures and activities, 
and you document your review and assessment.  
§ 1.513  What FSVP may I have if I am importing certain food from a country with an officially 
recognized or equivalent food safety system?  
 (a)  General .  (1)  If you meet the conditions and requirements of paragraph (b) of this 
section for a food of the type specified in paragraph (a)(2) of this section that you are importing, 
then you are not requir ed to comply with the requirements in §§  1.504 through 1.508.  You 
would still be required to comply with the requirements in §§ 1.503, 1.509, and 1.510.  
 (2)  This section applies to food that is not intended for further manufacturing/processing, 
includin g packaged food products and raw agricultural commodities that will not be 
commercially processed further before consumption.  
 (b)  Conditions and requirements .  (1)  Before importing a food from the foreign supplier 
and annually thereafter, you must docum ent that the foreign supplier is in, and under the 
regulatory oversight of, a country whose food safety system FDA has officially recognized as 
comparable or determined to be equivalent to that of the United States, and that the food is 
within the scope of  that official recognition or equivalency determination.  
 (2)  Before importing a food from the foreign supplier, you must determine and document 
whether the foreign supplier of the food is in good compliance standing with the food safety 
authority of the country in which the foreign supplier is located.  You must continue to monitor 
whether the foreign supplier is in good compliance standing and promptly review any 
information obtained.  If the information indicates that food safety hazards associated with  the 
food are not being significantly minimized or prevented, you must take prompt corrective action.  503 
 
 
 The appropriate corrective action will depend on the circumstances but could include 
discontinuing use of the foreign supplier.  You must document any co rrective actions that you 
undertake in accordance with this paragraph  (b)(2) . 
§ 1.514  What are some consequences of failing to comply with the requirements of this subpart?  
(a)  Refusal of admission .  An article of food is subject to refusal of admission under 
section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act if it appears that the importer of 
that food fails to comply with this subpart with respect to that food.  If there is no U.S. owner or 
consignee of an article of food at the time the food  is offered for entry into the United States, the 
article of food may not be imported into the United States unless the foreign owner or consignee 
has appropriately designated a U.S. agent or representative as the importer in accordance with 
§ 1.500.  
(b)  Prohibited act .  The importation or offering for importation into the United States of 
an article of food without the importer having an FSVP that meets the requirements of section 
805 of the Federal Food, Drug, and Cosmetic Act, including the requirements  of this subpart, is 
prohibited under section 301(zz) of the Federal Food, Drug, and Cosmetic Act.  
PART 11 --ELECTRONIC RECORDS; ELECTRONIC SIGNATURES  
 3.  The authority citation for 21 CFR part 11 continues to read as follows:  
 Authority :  21 U.S.C. 321 -393; 42 U.S.C. 262.  
 4.  In §  11.1, add and reserve paragraph (h)  and (k)  and add paragraph ( l) to read as 
follows:  
§ 11.1  Scope.  
* * * * *  504 
 
 
  (l)  This part does not apply to records required to be established or maintained by 
subpart L of part 1 of this cha pter.  Records that satisfy the requirements of subpart L of part 1 of 
this chapter, but that also are required under other applicable statutory provisions or regulations, 
remain subject to this part.  
PART 111 --CURRENT GOOD MANUFACTURING PRACTICE IN MANUFA CTURING, 
PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS  
 5.  The authority citation for 21 CFR part 111 continues to read as follows:  
 Authority :  21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.  
 6.  In §  111.5, add a senten ce after the existing sentence to read as follows:  
§ 111.5  Do other statutory provisions and regulations apply?  
 * * * For importers of dietary supplements and dietary supplement components, the 
regulation on foreign supplier verification programs can be found in subpart L of part 1 of this 
chapter.  
Dated :  October 30, 2015.  
Leslie Kux,  
Associate Commissioner for Policy.
[FR Doc. 2015 -28158 Filed: 11/13/2015 8:45 am; Publication Date:  11/27/2015]