[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Rules and Regulations]
[Pages 74226-74352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28158]



[[Page 74225]]

Vol. 80

Friday,

No. 228

November 27, 2015

Part II





Department of Health and Human Services





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Food and Drug Administration





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21 CFR Parts 1, 11, and 111





Foreign Supplier Verification Programs for Importers of Food for Humans 
and Animals; Final Rule

  Federal Register / Vol. 80 , No. 228 / Friday, November 27, 2015 / 
Rules and Regulations  

[[Page 74226]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 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.

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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 requires 
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 this 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 January 26, 2016. 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 of this final rule into 
the ``Search'' box and follow the prompts, and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, 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 INFORMATION:

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 (Sec.  1.500)
    B. Applicability and Exemptions (Sec.  1.501)
    C. Purpose and Scope of FSVPs (Sec.  1.502)
    D. Personnel Developing and Performing FSVP Activities (Sec.  
1.503)
    E. Hazard Analysis (Sec.  1.504)
    F. Evaluation for Foreign Supplier Approval and Verification 
(Sec.  1.505)
    G. Foreign Supplier Verification Activities (Sec.  1.506)
    H. Foods That Cannot Be Consumed Without Control of Hazards and 
Foods Whose Hazards Are Controlled After Importation (Sec.  1.507)
    I. Corrective Actions and Investigations Into FSVP Adequacy 
(Sec.  1.508)
    J. Identification of Importer at Entry (Sec.  1.509)
    K. Records (Sec.  1.510)
    L. Dietary Supplements and Dietary Supplement Components (Sec.  
1.511)
    M. Very Small Importers and Importers of Food From Certain Small 
Foreign Suppliers (Sec.  1.512)
    N. Importing a Food From a Foreign Supplier in a Country With an 
Officially Recognized or Equivalent Food Safety System (Sec.  1.513)
    O. Consequences of Failure To Comply With FSVP Requirements 
(Sec.  1.514)
    P. Other Issues
IV. Effective and Compliance Dates
    A. Effective Date
    B. Compliance Dates
V. Executive Order 13175
VI. Economic Analysis of Impacts
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, produce, 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 same 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, 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 focuses on known or 
reasonably 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 proposed rule and 
the subsequently revised proposal along with other stakeholder input, 
we continue to believe that hazard analysis, which is well accepted and 
understood throughout the international food safety community, provides 
the most effective way to implement a risk-based framework in which 
importers can evaluate potential products and suppliers and ensure that 
appropriate verification activities occur.
    The FSVP regulation aligns with key components of the food safety 
plans that facilities that manufacture, 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 
regulations). In particular, the 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

[[Page 74227]]

requirements applicable to certain importers and foods, are intended to 
be 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 United States without 
manufacturing/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 requirements 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 verification activities as long as 
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 procedures to ensure they 
only import foods from foreign suppliers they have approved. However, 
importers 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 provide 
assurance that hazards requiring a control in food are significantly 
minimized or prevented. Importers must conduct supplier verification 
activities for each foreign supplier before importing a food into 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, including 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 auditing, 
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 reasonable probability that exposure to 
the hazard will result in serious adverse health 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 adequate 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 modern 
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 the 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 
disclose 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 throughout 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 importer must take appropriate 
corrective actions promptly if it determines that a foreign supplier of 
a food it imports does not produce the food in compliance with the 
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) (if applicable) of the 
FD&C Act. This determination could be based on a review of consumer, 
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 will 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

[[Page 74228]]

not have to conduct hazard analyses, and their supplier verification 
activities would focus on verifying that the supplier is in compliance 
with the dietary 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 animal 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 
preventive controls for animal food regulation.
    In addition, food 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 Sec.  112.4(a), or in accordance with 
Sec. Sec.  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 regulations or subject to 
modified requirements, mostly, and in some cases entirely, because of 
the size of these producers.
    The relatively small volume of food imported by and from these 
entities should reduce consumers' exposure to, and potential risk from, 
this imported food. Therefore, we are proposing that in these 
situations the importer would not be required to conduct a hazard 
analysis 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 
acknowledgement 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 regulations.
    Third, the rule excludes from most of the standard FSVP 
requirements (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 determined 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 standing 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 food safety authorities in 
countries the Agency has officially determined 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 use 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 per year under 3 percent and 7 percent discount rates over 
10 years. In the proposed rule's Preliminary Regulatory Impact Analysis 
(PRIA), we calculated costs under three different scenarios reflecting 
different percentages of importers who, under proposed Option 2 for 
supplier verification requirements, might choose to conduct onsite 
audits of their foreign suppliers rather than perform different 
permitted verification activities. We present 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 facilitate comparison with the summary tables 
in the PRIA and the Supplemental PRIA; however, the summary table 
provides totals costs under all three scenarios.

        Total Annual Cost Summary for All Elements of Final Rule
                      [Rounded to nearest million]
------------------------------------------------------------------------
                                                               Total
------------------------------------------------------------------------
                                 Year 1
------------------------------------------------------------------------
Hiring Qualified Individuals:
    Scenario 1..........................................             $34
    Scenario 2..........................................              33
    Scenario 3..........................................              32
    Conducting Information Collection and Food and                    89
     Supplier Evaluations...............................
    Writing and Maintaining Procedures Relating to                    51
     Verification Requirements..........................
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,              31
     Customers, and Other Entities in U.S. Distribution.
    Documenting Very Small Importer or Small Supplier                  6
     Status.............................................
    Conducting Corrective Actions.......................               1

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    Importer Identification.............................               7
Grand Total Year 1:
    Scenario 1..........................................             464
    Scenario 2..........................................             459
    Scenario 3..........................................             456
------------------------------------------------------------------------
                         Every Year After Year 1
------------------------------------------------------------------------
Hiring Qualified Individuals:
    Scenario 1..........................................              34
    Scenario 2..........................................              33
    Scenario 3..........................................              32
    Conducting Information Collection and Food and                    74
     Supplier Evaluations...............................
    Writing and Maintaining Procedures Relating to                    42
     Verification Requirements..........................
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,              23
     Customers, and Other Entities in U.S. Distribution.
    Documenting Very Small Importer or Small Supplier                  6
     Status.............................................
    Conducting Corrective Actions.......................               1
    Importer Identification.............................               7
Grand Total Every Year After Year 1:
    Scenario 1..........................................             431
    Scenario 2..........................................             426
    Scenario 3..........................................             422
------------------------------------------------------------------------

    Although the FSVP regulation does not establish safety requirements 
for food manufacturing and processing, it benefits 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 with 
them. The FSVP regulation will be an important mechanism for improving 
and helping to ensure 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 determine 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 safety, 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 safety problems rather 
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 regulations 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        2013 preventive     78 FR 3646,
 Practice and Hazard Analysis      controls for        January 16, 2013.
 and Risk-Based Preventive         human food
 Controls for Human Food.          proposed rule.
Standards for the Growing,        2013 produce        78 FR 3504,
 Harvesting, Packing, and          safety proposed     January 16, 2013.
 Holding of Produce for Human      rule.
 Consumption.
Current Good Manufacturing        2013 preventive     78 FR 64736,
 Practice and Hazard Analysis      controls for        October 29, 2013.
 and Risk-Based Preventive         animal food
 Controls for Food for Animals.    proposed rule.
Foreign Supplier Verification     2013 FSVP proposed  78 FR 45730, July
 Programs for Importers of Food    rule.               29, 2013.
 for Humans and Animals.
Accreditation of Third-Party      2013 third-party    78 FR 45782, July
 Auditors/Certification Bodies     certification       29, 2013.
 to Conduct Food Safety Audits     proposed rule.
 and to Issue Certifications.

[[Page 74230]]

 
Focused Mitigation Strategies to  2013 intentional    78 FR 78014,
 Protect Food Against              adulteration        December 24,
 Intentional Adulteration.         proposed rule.      2013.
Sanitary Transportation of Human  2014 sanitary       79 FR 7006,
 and Animal Food.                  transportation      February 5, 2014.
                                   proposed rule.
------------------------------------------------------------------------

    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.

 Table 2--Published Supplemental Notices of Proposed Rulemaking for the
              Foundational Rules for Implementation of FSMA
------------------------------------------------------------------------
              Title                  Abbreviation         Publication
------------------------------------------------------------------------
Current Good Manufacturing        2014 preventive     79 FR 58524,
 Practice and Hazard Analysis      controls for        September 29,
 and Risk-Based Preventive         human food          2014.
 Controls for Human Food.          supplemental
                                   notice.
Standards for the Growing,        2014 produce        79 FR 58434,
 Harvesting, Packing, and          safety              September 29,
 Holding of Produce for Human      supplemental        2014.
 Consumption.                      notice.
Current Good Manufacturing        2014 preventive     79 FR 58476,
 Practice and Hazard Analysis      controls for        September 29,
 and Risk-Based Preventive         animal food         2014.
 Controls for Food for Animals.    supplemental
                                   notice.
Foreign Supplier Verification     2014 FSVP           79 FR 58574,
 Programs for Importers of Food    supplemental        September 29,
 for Humans and Animals.           notice.             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        Preventive          80 FR 55908,
 Practice and Hazard Analysis      controls for        September 17,
 and Risk-Based Preventive         human food final    2015.
 Controls for Human Food.          rule.
Current Good Manufacturing        Preventive          80 FR 56170,
 Practice and Hazard Analysis      controls for        September 17,
 and Risk-Based Preventive         animal food final   2015.
 Controls for Food for Animals.    rule.
------------------------------------------------------------------------

    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 efforts 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 notices of proposed rulemaking to announce 
several changes to our proposals, share our current thinking on key 
issues, and get additional stakeholder input on those issues. As we 
move forward into the next phase of FSMA implementation, we intend to 
continue this dialogue and collaboration 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 toward 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, July 
29, 2013). We published new and revised 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 revised 
provisions we included in the regulatory text were based on a 
preliminary review of the comments.
    In this document, we use the terms ``FSVP proposed regulations'' 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 revised provisions we published in the 
2014 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

[[Page 74231]]

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 regulation was 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 preventive 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 responsibilities under the FD&C Act to produce safe food.
    While FSMA grants 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 imported food. Thus, FSMA creates new obligations for food 
importers. 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 
producers 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 recognize 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 businesses. 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, the 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;
     Analyze known or reasonably foreseeable hazards in foods 
they import to determine if the hazards are significant;
     Determine and perform verification 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 appropriate, 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 effectiveness 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.

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: Importers; 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 organizations. The comments 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 that are outside the scope of this 
rulemaking. 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 Registry. We do not discuss such comments in this 
document.

II. Legal Authority

    On January 4, 2011, 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 production 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 403(w) of the FD&C Act (concerning food 
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 appropriate, and in

[[Page 74232]]

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 imported 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 plans 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 and 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.
    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 defined 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 this 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 PHS 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 authority 
from the Surgeon General to the Secretary).

III. Comments on the Proposed Rule and Supplemental Notice of Proposed 
Rulemaking

A. Definitions (Sec.  1.500)

    We proposed to codify definitions of several terms that we use in 
the FSVP regulation. As discussed 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 Sec.  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 aligned the definitions used in the 
different regulations as much as possible. However, in some cases the 
definitions of terms differ because 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 
review, 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 supplier'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.
    (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 audit relied upon by an importer would need to meet the requirements 
for independence set forth in Sec.  1.506(e)(4), discussed in section 
III.G.7 of this document. Note, however, that under Sec.  
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 Sec.  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 be 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 agree 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 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. 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 examples of environmental pathogens include 
Listeria monocytogenes and Salmonella spp.
    (Comment 4) Some comments suggest that instead of a ``pathogen,'' 
the definition of environmental pathogen

[[Page 74233]]

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 Sec.  1.227 (21 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 facility'' is an establishment that is 
a farm but that also conducts 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).
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. 321(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 requirements 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 Sec.  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 substances 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 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 
regulation.
    (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 
sometimes 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 not be based solely on whether 
a substance is declared 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 Supplier
    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 supplier 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 food, 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 particular 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 minimis 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)).
    (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 comments 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 
producer 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 or 
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

[[Page 74234]]

same farm or manufacturer. Therefore, some comments request that we 
define the 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 
manufacturers) 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 
consolidators 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 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 step, such as 
distributors and some consolidators of RACs.
    However, we understand that the requirement to perform supplier 
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 verification, and supplier verification 
activities 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 
activities 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 reduce the need for importers to directly verify the 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 the FSVP requirements are consistent with 
FSMA while limiting the burden that 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 might be the 
establishment that owns (or owns and packs) a harvested food.
    (Response 9) We decline to change the definition 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 the 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 specifically 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 
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 at 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 change 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 aggregator 
is merely packing and/or holding RACs, and not performing 
manufacturing/processing (and no other 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 to 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.

[[Page 74235]]

    (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 
only 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) after 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 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 same 
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 separate operations grow and harvest a 
crop (80 FR 55908 at 55926 to 55927, September 17, 2015). Therefore, 
the definition of farm in Sec.  1.227 (which is included in the 
definitions applicable to the FSVP regulation under Sec.  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 in 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 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, for purposes 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 
hygiene, 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 relationships, 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 food 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 harvesting and packing of 
food are being significantly minimized or prevented. Without such 
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 with sections 418 and 419, as applicable, 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 ``grower'' 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 
Sec.  1.276(b)(9) as the last facility (as defined in Sec.  1.227) that 
manufactured/processed the food. Under Sec.  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 rule 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 Sec.  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.
    (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 these 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 does not require that the importer be the entity to gather

[[Page 74236]]

information about the farms. Rather, the regulation allows 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 establishment that 
manufactures/processes the food, raises the animal, or grows the food 
that is exported to the United States without further 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/processing, 
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 generally 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 would 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 reference to re-packing, re-packing is a 
packing activity (i.e., the definition of packing includes re-packing), 
not a manufacturing/processing activity. We regard waxing and cooling 
RACs, when done by a packing operation for purposes of storage or 
transport, to be packing activities rather than manufacturing/
processing activities.
    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 finalized, 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 accordance 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 
conducted additional manufacturing/processing that is not of a de 
minimis nature before export to the United States). We note, however, 
that under Sec.  1.507(a)(1) of the final rule, importers of foods that 
cannot be consumed without the application of an appropriate control, 
including RACs like coffee beans, are not subject to the full 
requirements of the FSVP regulation (see the discussion in section 
III.H.1 of this document).
    (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 establishment'' 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 processes 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 authority'' 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 
processors 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 Sec.  1.513 of 
the final rule (discussed in section III.N of this document), 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 equivalent to the U.S. 
system. One of the requirements for eligibility for the modified 
requirements is that 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 foreign supplier's inclusion on a 
list maintained by a foreign food safety authority will

[[Page 74237]]

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 develop 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 Sec.  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 good 
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 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 records 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 country 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 good compliance standing within the meaning in Sec.  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. 
Therefore, 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 list 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 regulations. Our new definition states that 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 use 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 FD&C Act. Examples 
of harvesting include cutting (or otherwise 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 RACs 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 illness 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 under 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 Sec.  1.504(c)(3) 
of the final rule, in determining whether a hazard is a ``hazard 
requiring a control,'' an importer must consider, among other factors, 
the intended or reasonably foreseeable use of the food, including 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 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.
    (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 comments recommend using the term ``food safety hazard'' 
because it has no association 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 appropriate 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 
``controls or measures'' to significantly minimize or prevent the 
hazard. 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 refers 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.

[[Page 74238]]

    (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 which 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 controls 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.
    (Response 22) We agree with the comments 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 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.
    (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 Sec.  1.504(c)(3) of the 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 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 RACs 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 RAC and breaking down pallets), but does 
not include activities that transform a RAC into a processed food as 
defined in section 201(gg) of the FD&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 or 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.
    On our own initiative, 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. agent 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 statutory definition 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 food, 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 firm 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 importer as the 
person who purchased an article of food. The comment asserts that 
because 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 definition 
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

[[Page 74239]]

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 or 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 importer, 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 designated by the owner, purchaser, or consignee of the 
merchandise, a person holding a valid customs broker license. The 
comments maintain that this definition of importer of record is 
substantially similar to the statutory definition of importer under 
FSMA. (The comments 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 comments 
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 is 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 importer 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 purposes 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 consignee, 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. 
Although the CBP definition of importer may be 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 requirements, 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 previously 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 Sec.  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 
Sec.  1.509(b) of the final rule) to serve 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.
    (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 clarify 
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 food 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 
purchase the product when it is offered for import into 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. importers of foreign products due to their unwillingness 
to assume responsibility 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 Sec.  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

[[Page 74240]]

meet 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 the 
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. territory. Given it might not 
always be clear when an imported item physically enters U.S. territory, 
we conclude that Congress intended that the importer be the U.S. owner 
or consignee at the time of submission of entry documents. Therefore, 
``time of U.S. entry,'' as used in Sec.  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 these 
regulations.
    (Comment 30) One comment expresses concern 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 might 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 procedures 
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 otherwise 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 result in duplicative supplier verification. Regardless, the 
definition of ``importer'' is consistent with the definition 
established by Congress in section 805(a)(2) of the FD&C Act.
    (Comment 31) Some comments request that we define the term 
``consignee'' because 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.
    (Response 31) We agree with the comments to the extent they 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 confirmed 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 be 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 when 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 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 possible 
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 United 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 the United States at the time of entry 
who owns the food, purchased 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 ``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 persons other than owners. Requiring a U.S. 
owner or consignee to have direct ownership 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 that time. Requiring a U.S. owner or consignee to have 
direct ownership in the product at the time of entry would

[[Page 74241]]

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 (Sec.  1.227) and section 415(a) of 
the FD&C Act. The comments note that while 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 
comments 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 when there is no U.S. owner or consignee 
with respect to an article of food, the term ``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 United 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. agent for the facility (21 CFR 
1.232(d)). The facility registration regulation also defines 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 facility designates as its agent for purposes of food 
facility registration (Sec.  1.227). The regulation further specifies 
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 ``United 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 ``United 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 FSVP regulation. These 
activities involve ensuring the safety of imported food, which 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 facilities 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 Sec.  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 which 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 
importer 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 
consigned 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 representative 
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. 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'' explaining 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 definition 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 importer 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 effectively 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 
serve 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 affirmative 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 owner or 
consignee unless the person has agreed to serve in this capacity. As

[[Page 74242]]

explained in Response 33, we therefore are adding a clarification to 
the definition of ``importer'' stating that when the foreign owner 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 confirm 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 Sec.  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 Sec.  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 could be considered a technical barrier 
to trade according to the World Trade Organization (WTO).
    (Response 35) We do not agree that the regulation requires that 
foreign producers obtain U.S. agents or otherwise imposes a barrier to 
trade. To the extent that the comment's reference to U.S. agents 
relates to who may be an FSVP ``importer,'' the definition of importer 
in Sec.  1.500 is flexible and does not require that the importer be a 
U.S. agent. Instead, the FSVP importer is the U.S. owner or consignee 
of the imported 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 Sec.  1.500 is inconsistent with U.S. obligations under 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.
    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 
maintaining 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 believe 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 ``hazard 
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 known to be, or 
has the potential to be, associated with a food or the facility in 
which it is manufactured/processed.
    (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 radiological), or physical 
hazard'' because we agree the use of that word is redundant. The 
remaining portion of the definition of ``known or reasonably 
foreseeable 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 requests 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 the agricultural methods used on the farm that produced the 
food.
    (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 will be 
addressed as part of the hazard evaluation conducted under Sec.  
1.504(c) of the final rule, which considers factors such as those 
related to the harvesting and raising of the food.

[[Page 74243]]

15. Lot
    We proposed to define ``lot'' as the food produced during a period 
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 multiple 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. One 
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 block 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 comment requests that importers be permitted to independently 
define lot and make the definition available to FDA during an 
inspection.
    One comment suggests that lot be defined as a batch, or a specified 
identified portion of a batch or, in the case of food produced 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. For 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 clarify 
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 food, including food 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, mixing, formulating, bottling, milling, grinding, 
extracting juice, distilling, labeling, or packaging. The proposed 
definition stated that for farms and farm mixed-type facilities, 
manufacturing/processing would not include activities that are part of 
harvesting, 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 classify 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 making these changes so that the definition of 
manufacturing/processing in this regulation aligns with the definitions 
in the regulations on preventive controls for human food and animal 
food. For a discussion of the classification of these and other 
activities, 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 substantial 
transformation of the produce item into a different product in 
commerce: cutting, trimming, washing, waxing, cooling, mixing, 
labeling, and packaging of fresh produce RACs. One comment requests 
that coring, artificial ripening, waxing, cutting, labeling, 
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 Sec.  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 regarding 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 because 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 the definition refer to 
``human or animal'' public health significance.
    (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 might affect 
humans or animals. The definition's reference to microorganisms ``of 
public health significance'' takes into account factors such as the 
severity of illness and the route of exposure. In addition, the term 
``microorganism of public health significance'' is broad enough to 
address both humans and animals.

[[Page 74244]]

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 revise the definition of 
qualified 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 auditor; 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 through 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.
    (Response 44) We agree a qualified auditor might obtain the 
necessary auditing expertise through education, training, or 
experience, or some combination 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 
separately set forth in Sec.  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 to 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 comment maintains that a qualified auditor 
should not be required to have knowledge, skills, and abilities beyond 
those of a qualified individual; instead, the definition should give a 
qualified individual the discretion to conduct an audit himself/herself 
or identify someone to perform this function.
    (Response 45) We do not agree with the comments. For purposes of 
FSVP, the final rule defines 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 experience needed to perform all 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, whatever 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 
onsite 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 
only 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 processes 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 does 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.
    (Comment 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 
preventive controls for animal food regulations are essentially the 
same. Therefore, no changes are needed.
    (Comment 47) Some comments ask that we define or provide guidance 
on the criteria for the technical expertise required under the 
definition of qualified 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 expertise 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 
guidance 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 requirements. 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 suggests 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 not 
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, training, and/or experience 
could not audit against 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 individuals 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 that we include in the definition of

[[Page 74245]]

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 of 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 limited 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 accredited 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 elsewhere in this issue of the Federal 
Register, refers to third-party auditors 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 is not limited to, a third-party 
auditor (certification body) 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 
accredited 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 
``accreditation''), and/or experience. For example, a government 
employee 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.
    (Comment 52) One comment, stating that it uses its internal 
auditors to conduct onsite audits of its foreign suppliers, suggests 
that the definition of qualified 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 suggested. 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 individual 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 section 418 of the FD&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 accordance with section 
808 of the FD&C Act; and
     A foreign government employee could be a qualified 
individual.
    (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 
activity. (We have separately set forth the requirement that a 
qualified individual have such education, training, and/or experience 
in Sec.  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 with 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 
defined 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 individual.''
    (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 ``qualified individual'' in the 
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 ``qualified individual'' across the different 
regulations, we disagree. Fundamentally, the definition of ``qualified 
individual'' in the FSVP regulation is aligned with the definition of 
qualified individual in the preventive

[[Page 74246]]

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 
regulations. However, the definitions vary as a result of the different 
activities a qualified 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 restricted 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 
be able to obtain the necessary education, training, and/or experience 
through a variety of methods and experiences. The principal concern is 
that the education, training, and experience equip them to conduct the 
FSVP activity or activities they are performing.
    (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 adequately 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 performance-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, 
training, 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 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 kept 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 Sec.  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 Sec.  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 controls 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 
providers 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 training 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.
    (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 option 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. Training providers will not need to obtain express 
approval from the Agency to use any particular curriculum. In addition, 
the qualified individuals used by importers to perform FSVP activities 
related to preventive controls will not be required to obtain 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 suppliers' preventive controls, training in the 
development 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.
    (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 we agree that this change would be 
appropriate, we have deleted 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

[[Page 74247]]

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'' 
already 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 inadequate 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 qualified individuals for an 
importer--whether located in the United States or another country, 
whether a government official or privately 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 does 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 states 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 minimize 
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 definition 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 any entity 
of which the foreign supplier 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.
    (Comment 64) We received many comments on the proposed definition 
of very small foreign supplier. Some comments support the definition 
while others question the 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. 
dollar 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 supplier'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 comment 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 biofuels). Some comments suggest that the reference to food 
``sales'' include returns received by members of cooperatives for the 
crops the members provide.
    One comment states that if a very small foreign supplier is defined 
on the basis of dollar revenues, we should clarify whether the 
adjustment for inflation is to be based on the U.S. inflation rate or 
the rate in the supplier's country. The comment also suggests that a 
neutral outside source 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 suppliers, 
we have deleted the proposed provisions applicable to food imported 
from ``very small foreign suppliers.'' Instead, in alignment with the 
supply-chain program provisions of the preventive controls regulations, 
Sec.  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 obtaining written assurance from the importer's 
foreign supplier that the supplier meets the specified criteria as a 
certain type of small facility or farm under FDA regulations on 
preventive controls, produce safety, 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 history 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 appropriate to align the FSVP and preventive controls 
provisions to help provide parity in supplier verification requirements 
for 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 food 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

[[Page 74248]]

foreign suppliers are based on the underlying food safety regulations, 
a foreign supplier's qualification for these modified requirements or 
exemptions depends on the eligibility criteria specified in those 
regulations. Concerns regarding the appropriateness 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 affiliates, 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 stated 
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 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 preventive 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 asserting 
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 support 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 regulations. 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 situation 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 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 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--as discussed in 
the following paragraphs). For importers that import both 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 this 
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 circumstances in 
which an importer charges fees for importing food. 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 are 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 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 importer 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 confusing.
    (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 that 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.
    (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 conclusion from the proposed rule 
that, given the risk to overall public health,

[[Page 74249]]

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 (Sec.  1.501)

    We proposed to specify (in Sec.  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 Sec.  1.501. In 
response to comments, we have made some changes to the exemptions and 
added certain exemptions.
1. Exemption for Certain Juice and Seafood Products
    In accordance with section 805(e) of the FD&C Act, we 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 part 
120) or the regulation on fish and fishery products in part 123 (21 CFR 
part 123) (proposed Sec.  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 
Sec.  120.14 or Sec.  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 does 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 
products in Sec.  1.501(b)(1) of the final rule provides that the FSVP 
regulation does 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. Among other 
things, part 123 requires importers to comply with requirements for 
imported fish and fishery products, which may include implementing 
written procedures for ensuring that imported products were processed 
in accordance with the HACCP regulation, including 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 Sec.  123.12). Thus, Sec.  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 inconsistent with congressional intent, we do not agree. 
Section 805(e) of the FD&C Act states that the 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 with,'' the HACCP regulation for 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 conclude 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 is 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 subject 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 foreign suppliers in 
compliance with FDA requirements for juice or seafood HACCP.
    However, as the comment notes, applying 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 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, in 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 to 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 
would fulfill the apparent goal of 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, Sec.  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 products subject to part 123, 
provided the importer complies with the relevant regulation when 
manufacturing or processing the juice or seafood product.
    (Comment 70) Some comments express concern regarding the statement 
in the preamble to the proposed rule that 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

[[Page 74250]]

emphasis on importers' role in ensuring the safety of imported food. 
The comments 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 additional 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 Sec. Sec.  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 verification 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 the regulations applicable to importers of juice 
and seafood. We believe that the comment on the juice HACCP processing 
requirements is misplaced because the FSVP regulation concerns 
verification that the food safety requirements applicable to the 
manufacturing/processing, growing, or raising of food are met, not the 
establishment of the food safety requirements themselves.
2. Exemption for Food Imported for Research or Evaluation
    In proposed Sec.  1.501(c), we proposed to exempt from the FSVP 
regulation food that 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 entry 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 imported 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 requirements 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 or 
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.
    (Comment 72) One comment maintains that the regulation should not 
require the importer to declare electronically that 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 declaration 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 exempt under Sec.  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 this 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 the 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 
quantity; 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 should 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 Sec.  1.501(c). In drafting section 805(f) 
of the FD&C Act, Congress specified that the 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 
specification 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 regarding ``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 provide an important marketing 
opportunity for small and medium companies at the early stage of 
expanding 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

[[Page 74251]]

imported 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 be inconsistent with the limitation in 
section 805(f). We also believe such an exemption would be 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 
requirements of Sec.  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 market research 
activities like home-use tests, consumer panels, and sales samples, the 
facility will be subject to the FSVP regulation.
    (Response 77) Imported food that is sold or distributed to the 
public is not eligible for the exemption for food for research and 
evaluation purposes in Sec.  1.501(c). Therefore, if the comment is 
referring to a foreign supplier that is a research and development 
facility but is producing food to 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 section 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 imported 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 Sec.  1.509 
(see Sec.  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 food 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 Sec.  1.501(c) of the final rule. 
Importation of other food from a foreign 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 into the United States be exempt from the FSVP requirements. 
According 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 the 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, we 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 Sec.  1.501(d)). We 
proposed to specify that food is imported for personal 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 
1.277(b)(1) and 1.327(m)) that refer to food for ``personal 
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' worth 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 Sec.  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 comment 
recommends that FDA and State and local agencies share information 
about such food to better control such violations.
    (Response 81) We agree it is important that agencies involved in 
ensuring the safety of food imported into the United States share 
relevant 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 activities. To the 
extent we become aware of any abuses of the personal consumption 
exemption in Sec.  1.501(d), we intend to take appropriate action in 
response.

[[Page 74252]]

4. Exemption for Alcoholic Beverages
    Under proposed Sec.  1.501(e), we proposed to exempt from the FSVP 
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 (FAAA) (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/processing 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 Sec.  1.501(e)(1) provided that such food:
    (1) Is in prepackaged form that prevents any direct human contact 
with such food; and
    (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 
the 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 materials 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 controls 
regulation under Sec.  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 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 regulation on preventive controls for human food includes 
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 exempts 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 approval 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 facility 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 not necessarily be 
one. Given section 116's emphasis on status as a facility that is 
required to register under 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 the second approach.
    In reaching this tentative conclusion we noted that, under the 
first approach, firms might import the same 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 eligible 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 
need 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 proposed 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 ``foreign 
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 or any similar activity of a de 
minimis nature (see Sec.  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 interpretation 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

[[Page 74253]]

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 FSVP regulation, a facility that meets the 
requirements for the alcoholic beverage exemption under Sec.  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 materials to be used in the manufacture/processing of 
alcoholic beverages. Because the importer/facility would be exempt from 
the preventive controls regulation under Sec.  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 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 facilities that meet the requirements for the alcoholic 
beverage exemption under Sec.  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 
such facilities from the supplier verification requirements of the 
preventive controls regulation by operation of Sec.  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 section 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 potential 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 Sec.  117.5(i). As discussed in the 
previous paragraphs, we included supplier verification requirements in 
the preventive control regulation. As a result, requiring alcohol-
related facilities that are exempt from the supplier verification 
requirements in the preventive controls regulation under Sec.  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 established by Sec.  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, when such facilities are 
exempt from the preventive controls regulation under Sec.  117.5(i). 
This exemption applies to food, such as grapes, hops, 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 clarifying the exemption for food 
that is not an alcoholic beverage imported from foreign suppliers 
described in Sec.  1.501(e)(1) that is in prepackaged form preventing 
any direct human contact with the food, when such food constitutes not 
more than 5 percent of the overall sales of the facility. Instead of 
using the term ``food other than 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.''
5. Inapplicability to Food That Is Transshipped or Imported for Further 
Processing and Export
    We proposed 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 comment 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 domestic manufacturer.
    (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 section 
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 change 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 clarifying 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, followed 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.'')
    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.
    (Comment 84) One comment asks whether the exemption for 
transshipped food applies to all imported food or only

[[Page 74254]]

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 whether 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 transshipment 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 able to manage any risks with such food 
through other mechanisms, including the Predictive Risk-based 
Evaluation for Dynamic Import 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 conducting verification of its own operations.
    (Response 85) We agree in part and disagree in part. Considering 
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. Therefore, we are finalizing Sec.  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 
returned to the United States. Although section 805 of the FD&C Act 
applies to ``each importer'' and ``the food imported by the importer 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 that 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 protection as those required under sections 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 necessary 
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 food 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, Sec.  1.501(g), specifying 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 supplier 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 between the importer and the U.S. facility that 
manufactures/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 regulation, the requirements for FSVP are 
separate from the requirements for produce safety. We do not believe 
that an exemption for all RACs other than fruits and vegetables--
whether commingled, 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 subject 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 Sec.  1.504(f) of the final rule that there 
are no hazards requiring a control in a particular RAC, the importer 
would not be required to determine what foreign supplier verification 
and related activities would need to be conducted, 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

[[Page 74255]]

document, under Sec.  1.507 of the final rule, an importer will not be 
required 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 accompanying 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 in 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 an 
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 from the produce safety regulation and asks 
that these products not be exempt from the 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 public health significance. 
Regarding produce rarely consumed raw, we are allowing importers to 
rely on the provisions in Sec. Sec.  1.505, 1.506, and 1.507 instead of 
providing an exemption. For some produce in this category, an importer 
might determine it is appropriate 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 Sec.  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 Sec.  1.502(c) of the final rule, when the importer itself is a 
receiving facility as defined in the preventive controls regulations 
and either (1) implements preventive controls for the hazards in the 
food, (2) is not required to implement a preventive control under Sec.  
117.135 or Sec.  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 Sec.  1.509). When such 
processing is performed by the importer's customer or a subsequent 
entity, the flexibility provided in Sec.  1.507 would allow the 
importer to forego supplier verification activities provided it meets 
certain other requirements to help ensure that the processing is 
adequately 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 Bioterrorism 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 notice if it is 
reasonably 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 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 foreign 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 chain 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 
regulations food that is imported from a foreign supplier who is part 
of the same corporate structure as the importer. The comments assert 
that when the importer and the foreign supplier follow the same food 
safety standards and practices, supplier verification 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 under 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 appear as if the importer and the foreign supplier are integrated 
companies.
    (Response 89) We decline to exempt from the FSVP regulation food an

[[Page 74256]]

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 when the foreign supplier and 
importer may otherwise be affiliated, and when the foreign supplier and 
importer are part of the same company-wide ``approach'' to food safety. 
We conclude that the fact 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 the 
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 controls 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 supplier'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 
subject to the same integrated, corporate approach to food safety may 
take this into account in evaluating the foreign supplier's performance 
under Sec.  1.505 of the final rule and determining appropriate 
supplier verification activities for the supplier under Sec.  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 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 supplier 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 intra-
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 appropriate 
verification activities. Therefore, we do not believe the FSVP 
regulation increases 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 
105). Inspections of domestic food facilities (including farms, 
manufacturing facilities, 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 
detail 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 California 
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 the 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 
in countries whose food safety systems 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 forth in Sec.  1.513 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.
    (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 previously, 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 foods 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 Sec.  1.512 of the final rule and section III.M of this document). 
In addition, the FSVP regulation takes 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 businesses 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 asks whether the FSVP regulation applies to live 
animals intended for consumption, specifically cattle. The comment 
asserts that for live cattle imported from Canada, the Canadian 
government and USDA's

[[Page 74257]]

Animal and Plant Health Inspection Service (APHIS) and FSIS share 
responsibility for verifying safety (with respect to 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 exemption is appropriate with 
respect to cattle, poultry, and egg products, but not live animals. The 
final rule adds Sec.  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 subject 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 
that 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 consistent 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 regulations 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, PPIA, and EPIA, respectively. We 
therefore conclude that Sec.  1.501(h) is consistent with Congress' 
intent in promulgating section 403 of FSMA and section 805 of the FD&C 
Act.
    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 
importation. Indeed, FDA has exercised authority and responsibility 
over the importation of live food animals. For example, FDA's final 
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 are excluded from the 
scope of the FSVP regulation under Sec.  1.501(h).
    However, with 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 expect that importers 
likely will determine, in accordance with Sec.  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 required to conduct an evaluation under Sec.  
1.505 or supplier verification activities under Sec.  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 requirements 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, 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 FSIS 
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 
residues or other hazards requiring control. Importers of such live 
animals might therefore be required to conduct supplier verification 
for the foreign supplier that raised the animals.

C. Purpose and Scope of FSVPs (Sec.  1.502)

    In Sec.  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 processed low-acid foods packaged in hermetically sealed 
containers (low-acid canned foods or LACF). In the Supplemental Notice, 
we revised proposed Sec.  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 compliance with 
most of the FSVP requirements. As discussed in the following 
paragraphs, the final rule includes several changes to proposed Sec.  
1.502 in response to comments and on our own initiative.
1. Requirement To Develop and Follow an FSVP
    We proposed to require importers to develop, maintain, and follow 
an FSVP for each food imported that provides adequate assurances that 
the 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 (regarding hazard analysis and 
risk-based preventive controls for certain foods) or 419 (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) of the FD&C Act.
    On our own initiative, to clarify the relevant requirements, we 
have revised Sec.  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 Sec.  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

[[Page 74258]]

provisions in the FSVP regulation citing this FSMA standard for FSVPs.
a. Meaning of ``For Each Food''
    (Comment 94) Several comments ask that we clarify the meaning of 
proposed Sec.  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 for 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 squash 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 the suggested changes. 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 the 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 need 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 draft 
guidance.
    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 food, 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 analysis 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 foreign suppliers, the importer must have 
a separate FSVP for each supplier. This is appropriate because the FSVP 
regulation requires importers to consider not just hazards inherent in 
the foods they import, but also the performance history and 
characteristics 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 evaluations 
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 does not establish requirements 
for the safe production of food; those requirements are set forth in 
other FDA regulations, including those on 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 state that Sec.  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 importers accordingly.
    (Response 96) The requirements to develop FSVPs and keep records 
apply to importers as defined in Sec.  1.500 of the final rule, and 
Sec.  1.502(a) accordingly does not refer to a particular ``facility'' 
but to the importer. For purposes of FDA inspection 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. Therefore, if a contract 
manufacturer for a U.S. food facility is the importer of a food under 
Sec.  1.500, the contract manufacturer would be required to maintain 
and administer the FSVP for the food.
c. Entity Controlling the Hazards
    (Comment 97) One comment 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 
supplier, 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 
comply with the majority of the provisions of this rule. As discussed 
in section III.C.3 of this document, under Sec.  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 with Sec.  117.135 or 
Sec.  507.34 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 Sec.  1.509. For these reasons, it is not 
necessary to change Sec.  1.502(a) as suggested.
d. Adequate Assurances of Foreign Supplier's Adherence to Food Safety 
Standards
    (Comment 98) Some comments suggest that we explain what constitutes 
``adequate assurances'' that foreign suppliers are producing food in 
accordance with the standard specified in Sec.  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. One comment asks

[[Page 74259]]

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 should be the same for both 
domestic and foreign establishments. 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 adequate assurances of foreign 
supplier compliance with the applicable standards stated in Sec.  
1.502(a) primarily through foreign supplier verification activities 
conducted under Sec.  1.506 of the final rule, which must reflect the 
evaluation of the food and foreign supplier conducted under Sec.  
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 
or prevented (because such control of hazards provides assurance that 
the standard specified in Sec.  1.502(a) is met). Section 1.506 
specifies the foreign supplier verification activities that are 
appropriate under different circumstances for providing adequate 
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 manner 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 
the 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 III.G.4 of this document addresses the specific 
information that importers must review under Sec.  1.506 of the final 
rule when conducting supplier verification activities to assess whether 
the supplier is producing food in accordance with U.S. standards.
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 permitting 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 the 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 comment 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 for 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 the same level of public health 
protection standard because of 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 
comment 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 public 
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 preventive 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 includes provisions (Sec.  112.12) 
permitting the use of alternatives to certain requirements in the 
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 includes 
provisions (subpart P of part 112) under which 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, the 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 Sec.  1.502 
include a requirement that importers document each procedure used by a 
foreign supplier that 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 Sec.  
1.505 or

[[Page 74260]]

the results of foreign supplier verification activities under Sec.  
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 regulations 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 following procedures, processes, or 
practices specified in an approved variance from the produce safety 
regulation conducted for the 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 requirements 
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 procedures 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 regulations in particular 
countries or regions 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 being 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 conducting 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 detail 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 providing 
assurances that these foods are produced according to the food safety 
standards of a country whose food safety system we have found to be 
comparable. Under Sec.  1.513 of the final rule, once 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 modified FSVP requirements (provided that certain conditions are 
met). These provisions will allow the importation of such food without 
being subject to most of the 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 issue 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 controlled 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 
framework for foreign supplier verification. We have confidence that 
importers 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 assessments 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 and foreign and domestic 
producers in complying with the new regulations that we are adopting 
under FSMA, including guidance on the analysis of hazards in food. With 
respect to variances under the produce safety regulation, we note that 
the final rule adopting that regulation published elsewhere in this 
issue of the Federal Register addresses how FDA will evaluate requests 
for variances submitted 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 
obligations.
    (Response 102) The purpose and scope of importers' FSVPs, as set 
forth in Sec.  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 and is not misbranded with respect to 
allergen labeling, if applicable. The FSVP regulation does not impose 
on foreign suppliers any requirements that they are not already subject 
to under the FD&C Act and implementing regulations, including the 
regulations on preventive controls and produce safety. In addition, the 
FSVP regulation is drafted to be consistent with U.S. obligations under 
international agreements.
    (Comment 103) One comment suggests that the phrase ``if either is 
applicable'' when referring to 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 compliance with section 419, rather than meaning that any imported 
``produce'' 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 that 
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 regulation 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

[[Page 74261]]

many forms of adulteration are not 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 food 
in accordance with Sec.  1.504 of the final rule. However, under Sec.  
1.504(f), if an importer determines there are no hazards requiring a 
control in a food, the importer would not be required to conduct an 
evaluation of the risk posed by the food and the foreign 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 contain 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 Agreement) (Ref. 4).
    (Response 105) The FSVP regulation aligns 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 under 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 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 the 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 section 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 
produce 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 addition, 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 strategy to 
implement the new food safety standards. We intend there to be an FDA 
or State inspection of every domestic high-risk human food facility 
annually to verify compliance with the new regulations.
    Our implementation of the final rule on produce safety (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 will 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 intend 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 domestic 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 authority 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 
farms, 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 conducted by 
USDA and others with a goal of annual verification of 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 physically 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 countries 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 same 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 face diplomatic and logistical challenges

[[Page 74262]]

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 qualified translators, procuring foreign 
travel authorizations, difficulties in coordinating with foreign 
authorities, and extradition.
    Because of these challenges, we largely rely on the cooperation of 
foreign governments when conducting inspections in foreign 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 imported 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 requires importers to share 
responsibility for verifying the safety of imported food. The FSVP 
regulation requires that U.S. importers, who are domestic entities 
under direct legal jurisdiction, take action to ensure the safety of 
the food they import by performing 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 applies 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 verification 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 which the United States 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 foreign 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.
    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 and 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 under 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 the Codex 
Committee on Food Import and Export Inspection and 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 recognize 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 standards should be based on risk and, as far as 
possible, applied equally to imported and domestic food.
    The FSVP regulation contains requirements to ensure that imported 
foods are produced in compliance with processes and procedures that 
provide the same level 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 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 
regulations, 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, evaluation, 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 prepackaged foods (Refs. 7, 9).
    Many countries have adopted similar food safety regulations 
mandating that certain principles and conditions be applied to food 
manufacturing and food

[[Page 74263]]

importation. These include mandatory HACCP programs for seafood and 
other foods.
    In addition to aligning with Codex standards and guidance, the FSVP 
regulation incorporates a risk-based approach to food safety that 
allows importers the flexibility to tailor the supplier verification 
activities they conduct so that they provide adequate 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.
    Regarding the comments' assertion that the FSVP regulation will 
result in more onsite auditing of foreign suppliers, we note 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 verification 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 significantly 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 different 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 suppliers 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 supplier 
might choose to rely on the same supplier audit 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 food 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, we 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 accordance 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 Sec.  1.502(a). In the preamble 
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 appropriate form of 
verification, such as auditing. We therefore suggested that, 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 initiative, 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 
regulation 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 that 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 conclusion that the LACF 
regulation makes 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 conclude 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 are 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 raw materials and other ingredients by U.S. facilities 
for use in manufacturing or processing LACF. Therefore, Sec.  
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 processes 
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 manufacture or processing of 
LACF.
    (Comment 108) One comment requests that we advise importers of

[[Page 74264]]

LACF to conduct finished product testing for typical pathogens and 
spoilage organisms because finished canned goods can be contaminated 
and might be used in producing 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 accordance with section 805(e), Sec.  1.502(b) of the final rule 
provides that with respect to those microbiological hazards that are 
controlled under part 113, an importer of an LACF must verify and 
document that the food was produced in accordance with part 113. An 
importer of an LACF 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 appropriate 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 verification activity might also be reviewing 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 cans are not swollen or leaking. With 
respect to hazards other than microbiological hazards controlled under 
part 113 that an importer might identify, an importer of an LACF must 
have an FSVP as specified in Sec.  1.502(a). For such an FSVP, sampling 
and testing might be appropriate verification activities 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 Sec.  1.502(b) does 
not address acidified foods, states that if we intentionally omitted 
acidified foods from Sec.  1.502(b), we should provide a rationale for 
treating acidified food differently than LACF.
    (Response 109) The provisions regarding LACF in Sec.  1.502(b) 
reflect the statutory exemption (in section 805(e) of the FD&C Act) 
from the 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 Sec.  1.504 and the evaluation required in 
Sec.  1.505. An importer of acidified foods could, through its hazard 
analysis, determine that the 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 Sec.  114.80(a)(2)) and to confirm the response to any deviations 
from scheduled processes (see Sec.  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 Sec.  
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 food 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 provisions in the preventive 
controls regulations.
    (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 
how 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 facilities 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 domestic 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 request 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 
receiving 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 from the importer.
    (Response 110) We conclude that it is appropriate, under Sec.  
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 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

[[Page 74265]]

allow importers that are receiving facilities to take advantage of that 
fact so they do not have to conduct duplicative verification 
activities. Under the preventive controls regulations, receiving 
facilities that are importers in compliance with the FSVP requirements 
and have documentation of activities conducted under Sec.  1.506(e) 
need not conduct verification activities for that raw material or other 
ingredient (see Sec. Sec.  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, we 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, we have broadened Sec.  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 
circumstances are:
     When the importer/facility is not required to have a 
supply-chain program under the preventive controls regulations because 
it implements preventive controls for the hazards in the food in 
accordance with Sec.  117.135 or Sec.  507.34; and
     When the importer/facility is not required to implement a 
preventive control under Sec.  117.136 or Sec.  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 Sec.  
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 Sec.  1.504(g) in the revised proposed rule because 
proposed Sec.  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 Sec.  1.504(g), the requirements 
for importers that control all hazards requiring a control, we have 
broadened the scope of Sec.  1.502(c) to incorporate these 
circumstances. Thus, Sec.  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 Sec.  117.135 or Sec.  507.34, 
then the importer is deemed to be in compliance with the FSVP 
regulation, except for the requirement to identify the importer at 
entry in Sec.  1.509.
    In addition, Sec.  1.502(c)(2) of the final rule deems in 
compliance with the FSVP regulation (except the requirements of Sec.  
1.509) importers that are food facilities who are not required to 
implement a preventive control for a hazard in a food they import in 
accordance with Sec.  117.136 or Sec.  507.35 (in the regulations on 
preventive controls for human food and animal food, respectively). 
Under those provisions, a food manufacturer/processor is 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) could not be consumed 
without application of an appropriate control (see Sec. Sec.  
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 Sec. Sec.  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 
manufacturer/processor meets certain disclosure and written assurance 
requirements (see Sec. Sec.  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 hazard by an entity in the distribution chain subsequent to 
the customer and the manufacturer/processor meets certain disclosure 
and written assurance requirements (see Sec. Sec.  117.136(a)(4) and 
507.36(a)(4)); or
     The manufacturer/processor has established, documented, 
and implemented a system that ensures control, at a subsequent 
distribution step, of the hazards in the food it distributes (see 
Sec. Sec.  117.136(a)(5) and 507.36(a)(5)).
    We conclude that it is appropriate to exempt from the FSVP 
requirements importers that are facilities importing a food and acting 
in accordance with Sec.  117.136 or Sec.  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 contains 
similar provisions regarding foods that cannot be consumed without 
application of a control and foods whose hazards will be controlled by 
the importer's customer or a subsequent entity in the distribution 
chain. These provisions, which appear in Sec.  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 Sec. Sec.  1.507 and 117.136 or Sec.  507.36, as 
applicable. Although the preventive controls regulations do not include 
a provision comparable to Sec.  1.502(c)(2) that deems receiving 
facilities that are importers to be in compliance with Sec.  117.136 or 
Sec.  507.36 if they are in compliance with Sec.  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 importers to be in compliance with Sec.  117.136 or Sec.  507.36, 
as applicable, if they are in compliance with Sec.  1.507.
    (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 compliance with the supply-chain 
program requirements. Rather, an importer that expects to be deemed in 
compliance with most of the FSVP requirements under Sec.  1.502(c)(3) 
will be responsible for ensuring that it is in compliance with the 
supply-chain program provisions of the preventive

[[Page 74266]]

controls regulations and will need to be able to demonstrate its 
compliance during an inspection.
    (Comment 112) Some comments suggest that Sec.  1.502(c) should 
specify Sec.  507.37 rather than Sec.  507.43 to refer to the supplier 
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, Sec.  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 Sec.  1.502(d), that if an importer's customer was 
required to establish and implement a risk-based supply-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 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, these provisions are set 
forth in Sec.  1.507 of the final rule. In section III.H.2 of this 
document we discuss Sec.  1.507 and respond to the comments we received 
regarding proposed Sec.  1.502(d) concerning importers whose customers 
are in compliance with the supply-chain program provisions of the 
preventive controls regulations.

D. Personnel Developing and Performing FSVP Activities (Sec.  1.503)

    We proposed to require, in Sec.  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 deleted 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 
Sec. Sec.  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 dietary supplements from approved suppliers), and 
1.512(b)(5) (recordkeeping by very small importers).
    In addition, as stated in sections III.A.18 and III.A.19 of this 
document, we have concluded that it is appropriate to specify the 
general qualifications that qualified individuals and qualified 
auditors must have in provisions outside of the definitions of those 
terms--specifically, in Sec.  1.503 of the final rule. Under Sec.  
1.503(a), a qualified individual must have 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. Under Sec.  1.503(b), a qualified auditor must conduct any 
audit conducted in accordance with Sec.  1.506(e)(1)(i) or Sec.  
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 we 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 requirements. 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 (Sec. Sec.  
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 and 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 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 individuals 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 task 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 light of the revised 
definition of a qualified individual, we conclude that a person who 
meets the definition should always perform any activity required under 
the FSVP regulation. Any other individual 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 the 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 requirement 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 rule 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 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 
requirement to use a qualified individual the following types of 
importers:

[[Page 74267]]

     Importers of certain dietary supplements and dietary 
supplement components who are in compliance with proposed Sec.  
1.511(a) or (b); and
     Importers of food from foreign suppliers in countries 
whose food safety systems FDA has recognized as comparable or 
determined to be equivalent to that of the United States in accordance 
with proposed Sec.  1.513.
    Although the modified FSVP requirements applicable to these 
importers under Sec. Sec.  1.511(a) and (b) and 1.513 of the final rule 
are limited (in the case of Sec.  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 Sec.  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 measures to ensure 
produce safety. Review of food safety records requires an understanding 
of the applicable food safety principles.
    (Comment 114) One 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 regulations 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 conduct those activities in accordance Sec.  
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 satisfies the 
requirements to be a qualified auditor or individual under Sec.  1.503.

E. Hazard Analysis (Sec.  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 
preventive 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 these hazards are significant), as well 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 provisions 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 permits 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 
appropriate. 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 regulation. 
The former generally apply to importers who must analyze the hazards in 
the foods produced by their foreign suppliers, while the 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 each food according to 
internationally agreed standards 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 
regions, 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 private 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 States. 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 assurances that 
suppliers are following procedures to ensure food safety consistent 
with U.S. standards, including the preventive controls and produce 
safety regulations. Therefore, we do not believe that the comments 
provide a justification for requiring that we conduct individual risk 
assessments of specific foods before we require importers to conduct 
hazard analyses and supplier verification activities. However, we note 
that to the extent that the comments express particular concern about 
the ability of smaller entities to comply with the FSVP regulations, 
Sec.  1.512 of the final rule (discussed in section III.M of this 
document) specifies modified requirements for very small importers

[[Page 74268]]

and importers of food from certain small foreign suppliers.
    We also deny the 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 
allows 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 section 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 implementation 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 for each food it 
imports to determine whether there are any significant hazards 
(proposed Sec.  1.504(a)). We further proposed 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 proposed that the hazard analysis be written (proposed 
Sec.  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 aspects of the 
proposed hazard analysis requirements in Sec.  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 Sec.  
1.504(a) to refer to ``experience, illness data, scientific reports, or 
other information'' instead of ``and other 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 choose 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 Sec.  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 
appropriate 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 involves the 
same hazards. However, if foods that might be said to be 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 Identification
a. General Types of Hazards
    We proposed to require, in Sec.  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 hazards 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 from 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 chemical changes. These 
changes are manifested by abnormal odors, tastes, textures, colors, 
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 in animal food (for reasons discussed in the preventive 
controls for animal food rulemaking) and have revised the list of 
chemical hazards accordingly.

[[Page 74269]]

b. Reasons for Presence of a Hazard
    We proposed to require, in Sec.  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 gain.
    (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 because such hazards often are addressed 
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 better 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. EMA 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 an 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 that 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. Therefore, we conclude it is appropriate that 
importers consider EMA hazards under the FSVP regulation.
    (Comment 123) Some comments assert that it would be more 
appropriate to address EMA hazards separately from the hazard analysis 
because they are not considered 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 Sec.  1.504 of the final rule precisely to 
understand what manner of supplier verification under Sec.  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 retrospectively 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 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 hazards, 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 cases 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 this change is unnecessary. Because 
``hazards'' are defined as certain agents that are reasonably likely to 
cause illness or injury, the requirement to consider hazards that might 
be introduced for purposes of economic gain is already limited to EMA 
that relates 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 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 Sec.  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 useful 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 therefore decline this request. We note, however, 
that information about incidents of EMA is widely

[[Page 74270]]

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 therefore decline this request.
4. Hazard Evaluation
a. Probability and Severity of Hazards
    We proposed in Sec.  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 appropriate 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 Sec.  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 Sec.  1.504(c)(3) of the final rule. Thus, we have 
revised the list of factors that a hazard evaluation must address under 
Sec.  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 evaluation 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 Sec.  1.504(c)(2)).
    In the final rule, we have revised this 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 pathogen) 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 this change is not needed because 
importers will be required, under Sec.  1.504(b)(1)(i), to consider 
whether there are any known or reasonably foreseeable environmental 
pathogens in a food. The requirement in Sec.  1.504(c)(2) is designed 
to address the specific safety concern 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 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 this proposed 
requirement or define what is meant by a ready-to-eat food that is 
``exposed to the environment.''
    (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 
qualified 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 hazard analysis for each food that the importer 
imports. Therefore, it is unnecessary to specify in Sec.  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 
development of an environmental pathogen that requires a control.
c. Hazard Evaluation Factors
    We proposed, under Sec.  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 finished food for the intended consumer:
    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 relevant 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 always 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 foreseeable uses of an ingredient when initially sourcing it 
from a foreign supplier. Therefore, the

[[Page 74271]]

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 use of a raw material 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 regard to the importation of raw materials or other ingredients, 
we note that the 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 
onsite 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 Sec.  1.504(c)(3)(ii) of the final 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 manufactures/processes, grows, harvests, 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 
hazards in the food, rather than the potential effect of a particular 
foreign supplier's operations. (The requirement to consider a 
particular foreign supplier's performance is located in Sec.  1.505 of 
the final rule, which sets forth the requirements for evaluation 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. These may include, for 
example, trade journals and 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 foreseeable 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 potential 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 intended 
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 importer 
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 Sec.  1.504(d)).
    As described in sections 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 Sec.  1.504(d) to provide 
that if another entity (including the 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 meet 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 because many suppliers would not want to share their hazard 
analyses.
    (Response 138) We recognize that, due to commercial confidentiality 
concerns or other reasons, there might be circumstances in which some 
foreign suppliers 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.
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 Sec.  
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 FDA 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 proposed Sec.  
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 significant in some fruits and 
vegetables and importers should consider them. The comments ask whether 
the provision is intended to

[[Page 74272]]

apply to RACs that are fruits or vegetables that are not covered under 
the produce safety regulation. Some comments ask that we clarify 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 regulation.
    (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 
microbiological hazards in such food. Although proposed Sec.  1.504(e) 
did not specifically state that the ``exemption'' from hazard analysis 
only applies when the imported RACs are ``covered produce'' as defined 
in proposed Sec.  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 exemption is appropriate because FDA has designed 
the produce safety regulation so that compliance with the regulation 
would ensure that microbiological hazards are adequately addressed. 
(Although proposed Sec.  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 
assurance that fruits and vegetables are not adulterated because of 
such hazards. To make this clear, we have revised Sec.  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 Sec.  112.3 (i.e., produce that is subject to 
the produce safety regulation in accordance with Sec. Sec.  112.1 and 
112.2).
    In addition, 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. Although 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 in accordance with 
Sec.  1.506 of the final rule to ensure that all hazards in the RACs, 
including 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 have 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, physical, 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 
consequences 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 Protection 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 chemical contaminants, and radionuclides in 
food. For these reasons, we tentatively 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 serious 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 vegetables; 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 preventive controls for human food.
    (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 requires the control of biological 
hazards but not chemical or physical hazards. The comment asserts that 
this constitutes inconsistent treatment of domestic and imported 
products and may invite a challenge before the WTO.
    (Response 142) We do not agree. The FSVP regulation does not result 
in different treatment of foreign and domestic produce producers with 
respect to chemical and physical hazards in produce. Although the 
produce safety regulation does 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,

[[Page 74273]]

both domestic and foreign producers of produce 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 Sec.  1.504(f).
    (Response 143) We decline to make this change because the produce 
safety regulation refers to fruits, nuts, culinary herbs, and 
vegetables collectively as ``fruits and vegetables.'' We 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 the FSVP 
regulation.
    (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 Sec.  1.504(e) to specify 
that importers of 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 Sec.  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 Sec.  1.505 and would not be 
required to conduct such activities under Sec.  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 Sec.  1.504(e) discussed in Response 
140, we have revised Sec.  1.504(f) to state that it does not apply if 
the food is a RAC that is a fruit or vegetable that is ``covered 
produce'' as defined in Sec.  112.3 in the produce safety regulation.
    (Comment 145) Some comments assert that we should declare certain 
foods, such as chocolates, confectionery, 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 Sec.  1.504(f) because we 
agree that there are many foods that have no hazards requiring 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 circumstances, there might not be any hazards that would be 
reasonably 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, fudge, 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 manufacturers, 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 entities, including analyses that find no hazards 
requiring a control in foods.
    (Comment 146) Some comments request that importers be required to 
reevaluate 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 Sec.  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.
    (Comment 147) Some comments maintain that proposed Sec.  1.504(f) 
conflicts with proposed Sec.  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 Sec.  1.504(f) 
creates an assumption that there are always significant hazards in 
fruits and vegetables subject to the produce safety regulations.
    (Response 147) We do not believe that Sec.  1.504(f) conflicts with 
Sec.  1.504(e). As we stated in the preamble to the proposed rule, this 
exception is appropriate 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 Sec.  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 verification 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 Sec.  
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 food, the importer 
would not be required to determine or conduct appropriate foreign 
supplier verification. Proposed Sec.  1.504(g) further stated that if 
the importer's customer controlled one or more such hazards, the 
importer would be required to annually obtain 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 Sec.  1.507 of the final rule and discussed in 
section III.H of this document, we have broadened the circumstances 
under which certain importers are not required to conduct an evaluation 
under Sec.  1.505 or supplier verification activities under Sec.  1.506 
when the hazard requiring a control in a food will be adequately 
controlled by another entity and certain other requirements are met. We 
discuss those provisions and respond to the comments on proposed Sec.  
1.504(g) in section III.H.

[[Page 74274]]

F. Evaluation for Foreign Supplier Approval and Verification (Sec.  
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 proposal 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 assessment. In addition, we 
have revised the provisions concerning reevaluation of these 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 Sec.  1.505(a)(1)(i) through (vi)) to require 
importers, in determining the appropriate supplier verification and 
related activities to conduct, to consider the following:
     The hazard analysis for the food conducted under proposed 
Sec.  1.504, including the nature of the hazard.
     The entity that will be applying controls for the hazards, 
such as the foreign supplier or the foreign supplier's raw material or 
ingredient supplier.
     The foreign supplier's procedures, processes, and 
practices related to the safety of the food.
     Applicable FDA food safety regulations and information 
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 
correcting problems.
     Any other factors as appropriate and necessary, such as 
storage and transportation practices.
    We also proposed to require importers to document their risk 
evaluations.
a. General
    (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 provisions, we agree that, 
in 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 probability 
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 inherent 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, Sec.  1.505 of the FSVP 
regulation should not refer to the ``risks'' posed by a foreign 
supplier. Therefore, we have revised Sec.  1.505(a) so that it refers, 
in Sec.  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 foreign supplier. These factors, which we have not 
substantially changed in the final rule, are the supplier's food 
safety-related processes and procedures, its compliance with FDA food 
safety regulations, and its food safety history with the importer and 
others.
    (Comment 149) Several comments ask that we revise Sec.  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 performance 
history can play an important role in determining appropriate 
verification activities, such as in concluding that onsite auditing on 
an annual basis of a highly-compliant foreign supplier is not necessary 
even when the supplier is providing foods with SAHCODHA hazards. 
Therefore, we conclude that 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 assurance of the safety 
of the food.
    Although proposed Sec.  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 Sec.  1.505, 
we have revised Sec.  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 activities.
    (Comment 150) Some comments ask that we revise Sec.  1.505(a) to 
give importers the flexibility to consider only those factors that they 
conclude are appropriate for a particular food and foreign supplier. As 
an example, one comment states that an importer typically would not 
review a supplier's FDA 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 set forth in Sec.  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 and foreign supplier, the importer might only need to 
briefly 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, with 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.

[[Page 74275]]

b. Hazard Analysis
    On our own initiative, we have revised Sec.  1.505(a)(1)(i) to 
include the hazard analysis ``of the food conducted under Sec.  1.504'' 
because, as discussed in section III.E.5 of this document, under Sec.  
1.504(d) of the final rule an importer may review and assess a hazard 
analysis 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 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 Sec.  
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 supplier (proposed 
Sec.  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 with 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. Moreover, 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 need to 
conduct under Sec.  1.506 or Sec.  1.507 of the final rule. For 
example, when a foreign supplier's raw material supplier is controlling 
a hazard in a food that the importer obtains from the foreign supplier, 
the importer might conclude that reviewing the foreign supplier's 
records of verification that its supplier produced the raw material in 
accordance with the preventive controls or produce safety regulations 
is more appropriate than auditing the foreign supplier with respect to 
this hazard.
    In the final rule, we are revising Sec.  1.505(a)(1)(ii) to require 
consideration of the entity or entities that will be 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 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 Sec.  
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 harvesting the produce. Entities that fit the 
definition of ``farm,'' such as harvesters, might be required to 
significantly minimize or prevent hazards under the produce safety 
regulation. To ensure that the importer will meet its obligation under 
section 805(a)(1) of the FD&C to perform supplier verification 
activities to verify that the imported food is produced in compliance 
with 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 this evaluation 
might be a factor in 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 conducted for supplier approval and determination of 
supplier verification activities.
d. Foreign Supplier'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 comments suggest that we revise 
these provisions to respect the right of foreign companies not to 
disclose confidential information to third parties (the comments raise 
this same concern with respect to information regarding a foreign 
supplier's food safety performance history under proposed Sec.  
1.505(a)(1)(v)).
    (Response 153) We decline to make this change. As discussed in 
section III.K.6 of this document, under Sec.  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 suppliers 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 the kind of verification activities required by this rule, 
we 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 potential 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 requires importers, when applicable, to consider 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 regulations. This means that if an

[[Page 74276]]

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 importer 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 
recognition of the comparability of a foreign food safety authority in 
a systems recognition arrangement.
    (Comment 154) Some comments express concern about the availability 
to importers of information about foreign suppliers' compliance with 
FDA food safety regulations. Some comments state that information about 
warning letters and import alerts often is not available on the FDA Web 
site in a timely manner and it can be difficult to navigate the Web 
site. Some comments 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 information 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 Sec.  1.505(a)(1)--should be limited to information that is 
publicly available 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 
databases 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 includes recall notices and notices of suspensions of 
facility registrations. 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, Sec.  
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 action related to food safety.'' We also note 
that, although the requirement to consider information on supplier 
compliance with applicable FDA food safety regulations is limited to 
publicly available information or information that the importer has 
otherwise obtained, 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 comments assert that this provision should be 
deleted because an importer's evaluation of the food and the foreign 
supplier should focus on information pertaining to risks identified in 
the imported food rather than the supplier. The comments note that if a 
foreign supplier were subject to an FDA warning letter or import alert 
for a food other than the food the importer 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 had received a warning letter or been placed on import 
alert with respect to a particular food, even a food different than the 
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 particular 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 data 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 
regarding 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 relevant information under Sec.  1.505(a)(1)(iii)(B). In addition, 
importers may obtain information about a foreign facility's 
registration status from the foreign facility. Information from the RFR 
that we make available in our RFR annual reports 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 section 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 accordance with the disclosure 
exemptions set forth in the FOIA and FDA's public information 
provisions in part 20.
f. Foreign Supplier's Food Safety History
    (Comment 157) One comment suggests that, to be consistent with the 
preventive controls regulations and to avoid an implied requirement to 
perform testing and auditing, we should revise proposed Sec.  
1.505(a)(1)(v) to state that a foreign supplier's food safety 
performance 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 Sec.  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 
Sec.  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 revised this provision (Sec.  
1.505(a)(1)(iii)(C) in the final rule) to make it consistent with the 
corresponding provisions in the

[[Page 74277]]

preventive 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 Sec.  1.505(a)(1)(iii)(C) does not 
require importers to conduct additional testing or auditing, but rather 
requires them to consider the results of any such activities that the 
importer has conducted in assessing the performance of its supplier in 
evaluating or reevaluating the concerns associated with use of a 
particular supplier, including when considering obtaining an additional 
food from an approved supplier. We have not limited the requirement 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.
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 that 
some food additive and GRAS substances 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 as well as a potential foreign supplier 
and appropriately conclude that there are no ``other'' factors that 
will have a significant effect on (1) whether the importer should 
approve the 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 transportation 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 necessary.
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 Sec.  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 Sec.  1.505(a)(1).
2. Approval of Foreign Suppliers
    Under proposed Sec.  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 Sec.  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 the 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 conducts under Sec.  1.505(a) or the importer's 
review and assessment of an evaluation conducted by another entity 
under Sec.  1.505(d) (discussed in section III.F.4 of this document).
3. Reevaluation of Food Risks and Foreign Supplier Performance
    We proposed (in Sec.  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 
information about these factors. We further proposed that if an 
importer determined 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 comments suggest that we delete the proposed 
requirement to reevaluate risks in Sec.  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 reassessment requirements in Sec.  1.508 of the proposed rule.
    (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 Sec.  1.508 and essentially 
placing those requirements in Sec.  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 reassess the appropriateness of an importer's 
FSVP for a food and supplier. Consistent with this approach, the final 
rule specifies, in Sec.  1.505(c)(1), that if an importer becomes aware 
of new information about the food and supplier-related factors in Sec.  
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 determines 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 activities it conducts need to be changed. Under Sec.  
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 accordance with Sec.  1.505(c)(1). The 
importer is required to document such a reevaluation and any subsequent 
actions it takes under Sec.  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 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 Sec.  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 supplier risks annually 
regardless of whether the importer becomes aware of new information 
about risks. The comments maintain that an annual reevaluation would 
not be overly burdensome, adding that if no changes were required, the 
importer could simply note that determination. Regarding the proposed 
FSVP

[[Page 74278]]

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 required to 
reassess their 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 Sec.  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, Sec.  1.505(c)(2) of the final 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 
providing 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 reassessment 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 states that produce packing operations routinely source 
RACs 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 
providing ingredients to the foreign supplier.
    (Response 163) We do not agree. Obtaining a RAC from a new farm 
would necessitate conducting an evaluation under Sec.  1.505(a) to 
determine whether it would be appropriate to 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 could 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 
performance.
4. Review of Evaluation or Reevaluation 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 entity 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 Sec.  
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 case, 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 conducted 
for each farm. Therefore, Sec.  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 Sec.  1.505(a) or the reevaluation described in Sec.  
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 importer must document its 
review and assessment of that evaluation or reevaluation, including 
documenting that the evaluation or reevaluation was conducted by a 
qualified individual.

G. Foreign Supplier Verification Activities (Sec.  1.506)

    We proposed to require 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 
requirements, including requiring importers to establish procedures to 
ensure the use of approved suppliers (rather than requiring importers 
to maintain a list of their suppliers) 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 
performing 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 determination 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 responsibility, we have made small revisions, like changing 
some of the verbs to passive voice (e.g., changing ``evaluation you 
conduct'' to ``evaluation conducted'' in Sec.  1.506(a)) and adding 
short, clarifying phrases (e.g., changing ``you 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 Sec.  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.''

[[Page 74279]]

    We also have made more significant 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 (Sec.  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 reviews and assesses the results of these activities (Sec.  
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 Sec.  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.'' Finally, 
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.
    These and other changes are described more fully in the paragraphs 
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 maintaining 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 Sec.  1.506(a)) that 
importers be required to establish and 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 suppliers 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 Sec.  1.506(a) to reflect that 
an entity other than the importer might conduct the evaluation 
described in Sec.  1.505. In addition, we have deleted the word 
``risk'' in the phrase ``risk evaluation'' when describing the 
evaluation conducted under Sec.  1.505 to reflect the terminology 
change in that section. Finally, we have added Sec.  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 proposed Sec.  1.506(a) (finalized as Sec.  
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 subjects to adequate verification activities before importing 
the food), provided that the importer reviews and assesses that 
entity's documentation of the procedures and activities. Section 
1.506(a)(1) also requires importers 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 procedures to ensure the use of approved suppliers. 
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 to enable them to confirm that the food they 
import is from suppliers they have approved in accordance with the 
evaluation conducted under Sec.  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. Temporary 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 decline 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 documentation of 
adequate verification of the food obtained from the 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 comment 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 when 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 limited. 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 particular time limitation on such use, 
given that the appropriate time period might vary depending on the 
circumstances. We intend to provide additional 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

[[Page 74280]]

we do intend to provide guidance on the temporary use of unapproved 
suppliers. An importer does not necessarily need to reanalyze hazards 
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 
related 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 Sec.  
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 
food from a foreign supplier, another importer could, depending on the 
specific circumstances, review and assess that documentation in lieu of 
conducting the activities itself. In accordance with Sec.  1.503, the 
individual performing the verification activities 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 
exporting 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 hazard analysis.
    (Response 169) We agree that food verification activities under 
Sec.  1.506(a)(1) should be based, at least in part, on the hazard 
analysis conducted under Sec.  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 certificate 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 suppliers 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.
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 procedures, 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 Sec.  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 Verification
    We initially proposed to require that importers' foreign supplier 
verification activities provide adequate assurance that identified 
hazards are adequately controlled (proposed Sec.  1.506(c)). In 
response to comments that the proposal was inconsistent with the 
statute and was 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 adequate 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 produces the food in compliance with sections 402 and 
403(w) of the FD&C Act.
    As discussed in response to the following comment, in 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 changing the first word in Sec.  
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, one 
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 the 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 of 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 prevented. This requirement is 
consistent 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 
Sec. Sec.  117.410(c) and 507.110(c)). As stated in the FSVP proposed 
rule and the Supplemental Notice, alignment

[[Page 74281]]

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 identification framework of the final rule. Under the final 
rule, importers are required to comprehensively analyze and evaluate 
hazards requiring a control (see Sec. Sec.  1.504 and 1.505). Requiring 
such analysis and evaluation makes the most sense if the supplier 
verification activities performed in accordance with Sec.  1.506 are 
designed to specifically address the hazards that importers have 
identified and evaluated.
    However, we emphasize that this change regarding the requirement of 
supplier verification activities in Sec.  1.506(c) does not alter the 
fundamental purpose of importers' FSVPs. Consistent with section 
805(c)(2)(A) of the FD&C Act, Sec.  1.502(a) of the final rule directs 
importers to develop, maintain, and follow FSVPs that provide adequate 
assurances that their foreign suppliers 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 regulations, 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 Sec.  1.506(c) does not change 
the requirement in Sec.  1.502(a) but instead specifies what we 
conclude is an appropriate and functional measure for 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 Sec.  1.506(c) 
encompasses situations in which 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 
significantly 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 
than the foreign supplier significantly minimizes or prevents the 
hazards in a food is when produce growing and harvesting 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 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 Sec.  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 transport 
procedures that we proposed in accordance with section 416 are focused 
on shipment by rail and motor vehicle within or into the United States, 
that regulation, if finalized as proposed, would generally not be 
applicable to transport in foreign countries. 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 the FD&C Act. 
Under 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 intentional 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 
intentionally 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 comments 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 
under 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 173, Sec.  1.506(c) of the 
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 processes and

[[Page 74282]]

procedures that provide the same level of public health protection as 
those required under the preventive controls or produce safety 
regulations. In addition, we responded to comments requesting clarity 
regarding the nature of processes and procedures that will provide the 
same level of public health protection in Response 99. As previously 
noted, our draft guidance on FSVPs 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 regulations.
    (Comment 176) One comment suggests that the 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 regulations, 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 Sec.  
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.
    (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 appropriate 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 
onsite 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 activities conducted under 
Sec.  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 Sec.  1.506(c).
4. Foreign Supplier Verification Activities
    In the Supplemental Notice, we revised our proposed approach to 
requirements for foreign supplier verification activities in several 
ways. We discuss the comments on these changes and other aspects of the 
proposed supplier verification activity requirements in the following 
paragraphs.
    For clarity, Sec.  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 activities must be 
conducted, to provide adequate assurances that the food the importer 
obtains from the foreign supplier is produced in accordance with Sec.  
1.506(c). To reflect changes we are making to Sec.  1.506(c), we have 
revised Sec.  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 Sec.  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 Sec.  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 the entity's determination is appropriate based on the 
evaluation conducted in accordance with Sec.  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 Sec.  1.506(d)(1), with certain changes to 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 Sec.  
1.506(d) and sets forth documentation requirements for these 
activities. Section 1.506(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 Sec.  1.506(e)(3), and documents the 
review 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 verification 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 Sec.  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, Sec.  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 Sec.  1.510(b).
    We have reflected importers' greater flexibility in meeting 
supplier

[[Page 74283]]

verification requirements by adding various phrases throughout Sec.  
1.506. For example, we are changing ``you must conduct and document one 
or more . . . supplier verification activities'' in Sec.  1.506(e)(1) 
to ``you must conduct (and document) or obtain documentation of one or 
more . . . supplier verification activities.'' Similarly, in Sec.  
1.506(e)(1)(ii), documentation of sampling and testing must include 
documentation that the testing was conducted by a qualified individual. 
We added this to ensure that even 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 Sec.  
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, Sec.  
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 responsibility 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. Section 
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 changes to the verification activity 
provisions as described in the following paragraphs.
a. Verification Activity Requirements
    In the proposed rule, we requested comment on two alternatives for 
supplier verification activity requirements. ``Option 1'' would have 
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 ingredient 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 was 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 
supplier, 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 original 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 appropriate 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 supplier verification 
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 verification 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 
foreign 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 the 
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 responsibility 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 aligns with 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 food. 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 inspection 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 rules.
    (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 comprehensive 
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

[[Page 74284]]

L of part 1 and part 117 or part 507 (the preventive controls 
regulations) through the use of cross-references.
    However, as previously stated, Sec.  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. Thus, this 
provision does refer to the supply-chain program provisions in the 
preventive controls regulations.
    (Comment 180) Some comments ask 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 annual 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, processing, 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 Sec.  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 standard, 
see our guidance on the RFR (Ref. 14), 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 
importers should verify that their foreign suppliers are verifying the 
safety practices of their raw material or other ingredient suppliers.
    (Response 181) As stated in the preamble to the proposed rule, an 
importer might rely on a review of its foreign supplier'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 importer obtaining food from that supplier might review 
this documentation in conducting verification of the supplier. However, 
the FSVP regulation gives importers flexibility to choose the most 
appropriate verification activity for the circumstance.
    (Comment 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 take 
appropriate corrective action in accordance with Sec.  1.508.
    (Comment 183) Some comments suggest that, if there is no mandatory 
requirement for annual onsite auditing, importers should be required to 
affirmatively inform FDA if they determine that verification 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 of the determination of appropriate 
verification activities. We believe that our ability to conduct 
inspections and 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 this 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 instead 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 of a foreign supplier) (Sec.  1.506(e)(1)). In addition, as 
discussed previously, Sec.  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 ultimately 
responsible for the performance of appropriate supplier verification 
activities.
b. Need for Multiple Supplier Verification Activities
    We proposed to specify, in Sec.  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 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 
Sec.  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 Sec.  1.505, that conducting 
more than one activity is necessary to provide adequate assurances of 
safety.
c. Requirements for Food From Certain Farms, Facilities, 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 Sec.  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 regulation; and

[[Page 74285]]

     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.
    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 preventive 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 Sec.  1.512 of the final rule, are discussed in section 
III.M of this document.
d. Substitution 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 whose 
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 be conducted (proposed Sec.  
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 access to inspection results, and the proposed rule does not 
establish 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 supplier 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 changes that we believe address some of the concerns of the 
comments. To clarify the scope of this provision (which we have moved 
to Sec.  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, when 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 written 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 Sec.  1.506(e)(1)(i)(E)(1) adds flexibility to the rule. 
Although representatives of foreign governments are not included in 
this provision, they are still able 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 the 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 
regulations, as applicable, and produces the food in compliance with 
requirements concerning adulteration and misbranding with respect to 
allergen labeling.
    However, for inspections conducted by the food safety authority of 
a country whose food safety system FDA has officially recognized as 
comparable or determined to be equivalent, the food safety authority 
need not inspect for compliance with relevant FDA standards. Under 
Sec.  1.506(e)(1)(i)(E)(2) of the final rule, provided that the food 
that is the subject of the onsite inspection or audit is within the 
scope of the official 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 foreign food establishment inspections. In 
accordance with FOIA, FDA generally makes those records available, 
except to the extent those records are covered 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, section 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. 1905). 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 results of any government inspection of that 
foreign supplier.

[[Page 74286]]

    (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 than 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 date; 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 business, such as by 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 or 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 such 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 
burden 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 would 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 revoked for cause by the certifying 
agent or voluntarily surrendered by the certified operation), although 
it is incorrect to suggest that certificates are valid up to18 months 
after issuance. Regardless, NOP inspections serve a different function 
from onsite 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 
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. The FSVP regulation does not impose 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 comment 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 recognition 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 comparable 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.
    (Comment 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 
authorities.
    (Response 190) As stated previously, we have changed Sec.  
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 authorities. 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 Sec.  1.506(d)(6)). This requirement is codified in Sec.  
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 Sec.  
1.508(a) if the results of verification activities do not provide 
adequate assurances that hazards requiring a control have 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 Sec.  1.510(b).
    (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 timely 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 problem with a supplier and, if so, 
take steps to address the 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

[[Page 74287]]

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 
verification 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 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 provide training and 
certification opportunities for qualified auditors. (We note that, 
under Sec.  1.500 of the final rule, examples of potential qualified 
auditors 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 obtained 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 Sec.  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 
verification 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 Sec.  1.506(e)(1), except for when 
an importer relies on performance of activities by other entities in 
accordance with Sec.  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 documentation of those activities, provided that 
it can obtain the documentation and make it available to FDA in 
accordance with Sec.  1.510(b). In addition, any corrective action 
taken in accordance with Sec.  1.508 must be documented. Under Sec.  
1.510(b)(1), importers must make FSVP records available promptly to an 
authorized FDA representative, upon request, for inspection and 
copying. In addition, under Sec.  1.510(b)(3), upon our written 
request, importers must send records to us electronically or through 
other prompt means. For more information about the circumstances under 
which records must be made available or submitted to FDA, see the 
discussion of Sec.  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 Sec.  
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 identified 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 consider 
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 
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 States, but the modified requirements for certain food from 
certain suppliers in such countries in Sec.  1.513 of the final rule do 
not apply. To account for these circumstances, Sec.  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 requirements 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 certification 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 requirements of 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. 384b) 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 FSVP purposes, Sec.  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 that 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

[[Page 74288]]

FSVP requirements and audits conducted in accordance with FDA's third-
party certification regulation. The comment asserts that while proposed 
Sec.  1.506(d) would require that audits conducted to meet FSVP 
requirements 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 given 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 certification published 
elsewhere in this issue of the Federal Register (see Response 7 in the 
preamble to the final rule).
    (Comment 197) Several comments address the standards that we will 
require onsite audits of foreign suppliers to meet. Some comments 
recommend 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 bodies. 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 
domestically. 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 standards 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 standards, importers may use audits conducted under those 
schemes 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 auditing 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 to reach any definitive conclusions as to whether importers 
can rely on the results of audits conducted under any existing auditing 
schemes to verify compliance with the safety requirements of this rule. 
Over time, we expect 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 
choses to use a GFSI, GAP, or other similar audit, the importer might 
need to supplement that audit to meet the requirements of Sec.  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 determine 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 juice 
and seafood HACCP regulations in parts 120 and 123, including allowing 
foreign government officials to conduct verification audits of 
suppliers.
    (Response 198) Because the FSVP regulation is a food safety measure 
and therefore are not subject to the TBT Agreement, the provisions in 
the TBT Agreement regarding mutual recognition agreements do not apply. 
We agree that reducing multiple testing and certification 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 provides importers with 
flexibility to determine appropriate supplier verification activities 
and allows 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 and 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 importer 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 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 preamble 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 the 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

[[Page 74289]]

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 that 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 added value of an 
audit conducted by an importer is limited especially when the supplier 
is already certified or audited. The comment 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 Sec.  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 
conducted, 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 Sec.  1.505.
    (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 importers to accept 
verification results of other importers. However, Sec.  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 include 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 this 
regulation. In accordance with Sec.  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 complete audit reports. 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 certification 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 reports 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 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. We conclude that it is unnecessary to 
state in the regulatory text that importers need not retain full audit 
reports. We believe that the information required under Sec.  
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 
with 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 obligation 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, we recognize that, due to commercial confidentiality 
concerns or other reasons, there might be circumstances in which some 
foreign suppliers 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 procedures 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 significant 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 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 advantages 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 actions taken to address 
significant deficiencies that create a risk to public health, we do not 
agree. Section 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 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, among other requirements. If imported 
food is

[[Page 74290]]

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 appropriate 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.
    (Comment 205) One comment states that the regulations should 
recognize that documentation of audits might be maintained by an 
importer's corporate parent 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 Sec.  
1.510(b)(2) of the final rule, offsite storage of records is 
permissible, as long as such records can be retrieved and provided 
onsite within 24 hours of request for official review.
b. Sampling and Testing
    We proposed (in Sec.  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 Sec.  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 stated, we are also adding language 
stating 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.
    (Response 206) We agree. An importer or a foreign supplier may hire 
another entity to conduct the testing on its behalf; the importer or 
supplier need not conduct the actual testing itself. In addition, under 
Sec.  1.506(e)(2)(i) of the final rule, sampling and testing may be 
conducted by other entities provided the importer reviews and assesses 
the results of the testing.
    (Comment 207) One 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 
information so that, in accordance with Sec.  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, Sec.  
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 Sec.  
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 laboratory 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 Sec.  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.
    (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 the 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-homogeneous 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 the Federal Register of 
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, supplemental, 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 safety 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 measures 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, importers 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 Sec.  1.505) that, instead of such 
auditing, other supplier verification activities

[[Page 74291]]

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 
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 proposed 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 reports 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 in 
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, importers 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 would be required.
    (Comment 212) One comment suggests that laboratories should make 
certificates of current accreditation from recognized laboratory 
accreditation bodies available to importers to provide assurance that 
the laboratory is in compliance with recognized standards.
    (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 Sec.  1.506(d)(1)(iii)) that importers be required 
to retain 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 Sec.  
1.506(e)(1)(iii). We are adding a requirement that an importer must 
retain documentation of the conclusions of the review because they are 
essential to determining whether and what corrective 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, including 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 hazard 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 states that a 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 that 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 Sec. Sec.  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 discussed if such activities 
were appropriate to address the risks associated with the food and the 
foreign supplier (proposed Sec.  1.506(d)(1)(iv)). Although we did not 
specify how importers would be required to document the performance of 
such verification activities, 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 Sec.  1.506(e)(1)(iv)(A). To 
allow flexibility as to who must conduct the verification activities, 
consistent 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 Sec.  1.506(e)(1)(iv)(B) in response to 
comments, as discussed below.
    (Comment 215) One comment suggests that importers could use third-
party remote video auditing systems as an alternative verification 
measure under proposed Sec.  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 system, an importer could determine 
that it is appropriate to use such a system as an appropriate 
alternative verification activity under Sec.  1.506(e)(1)(iv) of the 
final rule.
    (Comment 216) Some comments suggest that the regulation should not 
specify requirements 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 
comments 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

[[Page 74292]]

appropriate to include certain requirements for documentation of 
alternative verification conducted under Sec.  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 allowing us to 
efficiently enforce the requirements in section 805 of the FD&C Act. 
Therefore, Sec.  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 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 individual. 
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 
Sec.  1.506(d)(1) already requires importers 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 Sec.  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 Sec.  1.506(e)(4) and modified it so that it no 
longer prohibits the existence of a financial interest, but rather 
prohibits the existence of financial conflicts of interest that 
influence the results of verification activities in Sec.  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 
provisions 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 the final 
rule are the same as those in the preventive controls regulations. We 
do not believe it is appropriate to limit the type of 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 opposed to any other financial 
interest. If the qualified individual has a financial conflict of 
interest that influences the results of verification activities, the 
qualified individual would be precluded from being able to 
independently conduct verification activities under the 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 Sec.  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 or 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. Nevertheless, any financial conflict of 
interest that may exist cannot influence the results of the 
verification activity. We 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 individual 
conducting the verification activity is not penalized for identifying 
food safety concerns. In addition, any payment for the verification 
activity cannot influence the results of the activity.
    (Comment 219) One comment states that the independence provisions 
should 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 Sec.  
1.506(e)(4) is that payment of the qualified individual conducting a 
verification activity must not be related to the results of the 
activity. We believe this requirement is necessary to ensure the 
integrity of the performance of verification activities under this 
rule.
    (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 should 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 Sec.  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 conflict 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 Sec.  1.506(e)(2)(ii)) provides that importers 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). A foreign supplier's audit of itself 
would therefore not be an appropriate verification activity under the 
regulation.
    (Comment 222) One comment suggests that we not impose limitations

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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 provisions in the NOP regulations (7 CFR 205.501(a)).
    (Response 223) The conflict of interest provisions in the NOP 
regulations are tailored to the concerns addressed in those 
regulations. We regard some provisions, such as 7 CFR 
205.501(a)(11)(i), which mandates 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 provisions are well suited for the FSVP regulation.
8. Food Stored for an Extended Time Before 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 
that FDA rely on safety procedures of foreign countries. Other comments 
see challenges with conducting certain verification activities, such as 
onsite audits, in situations when 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 develop a procedure or recommend appropriate supplier 
verification activities once there is a better understanding of the 
specific circumstances.
    (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 flexibility 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 Sec. Sec.  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 Hazards Are Controlled After Importation (Sec.  1.507)

    In response to comments, we have included, in Sec.  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 
verification is unnecessary. These provisions in Sec.  1.507 are 
consistent with similar provisions in the preventive controls 
regulations.
    In response to the proposed rule, we received comments addressing a 
variety of circumstances under which the hazards in imported 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.
    Other comments relate to circumstances under which an importer's 
customer or a subsequent 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 
proposed Sec.  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 FSVP 
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 Sec.  
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 
adequate 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 Sec.  
1.504(g), the importer in such circumstances would not be subject to 
the FSVP requirements for evaluating the food and foreign supplier 
(proposed Sec.  1.505) or conducting supplier verification activities 
(Sec.  1.506). However, if the importer's customer controlled one or 
more hazards, the importer would be required to 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 controlling a 
hazard in an imported food. Although there is 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 customers. 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 
discuss the requirements under Sec.  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 Application 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 beans. 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, the hazards are controlled 
at the U.S.

[[Page 74294]]

processing 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 the importer knows that a 
subsequent entity in its distribution chain is controlling 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 
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, there 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 safety risks will be controlled before these 
foods reach consumers, we do not believe it is necessary for importers 
to conduct the evaluation under Sec.  1.505 or supplier verification 
under Sec.  1.506 for hazards in these foods. Therefore, Sec.  
1.507(a)(1) of the final rule provides that an importer is not required 
to conduct an evaluation under Sec.  1.505 or supplier verification 
under Sec.  1.506 if the importer determines and documents that the 
type of food (e.g., RACs such as cocoa beans and coffee beans) could 
not be consumed 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 Sec.  1.502(d) or Sec.  
1.504(g). Some comments state that an importer may have so many 
customers 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 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 entities. 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 suggest that, if 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 Sec.  1.507, a series of provisions that relieve an 
importer from the requirements to conduct an evaluation of the food and 
foreign supplier under Sec.  1.505 and supplier verification activities 
under Sec.  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 preventive 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, Sec.  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 Sec.  
1.507(a)(2), an importer is not required to conduct an evaluation under 
Sec.  1.505 or supplier verification under Sec.  1.506 if it relies 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 Sec.  1.507(c), that the customer has 
established and is following procedures (identified in the written 
assurance) that will significantly minimize or prevent the identified 
hazard. Under Sec.  1.507(c), an importer's customer or a subsequent 
entity in a food's distribution chain that provides a written assurance 
under Sec.  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 accompanying 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.,

[[Page 74295]]

because it is a qualified facility or a retail food establishment). 
Under Sec.  1.507(a)(3), an importer is not required to conduct an 
evaluation under Sec.  1.505 or supplier verification under Sec.  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 food 
safety requirements 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 Sec.  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 
hazard (as required under Sec.  1.507(a)(2)), it is appropriate for the 
importer's customer to provide assurance that it is manufacturing, 
processing, or preparing the food in accordance with applicable food 
safety requirements. These food safety requirements 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 Sec.  
1.507(a)(4), an importer is not required to conduct an evaluation under 
Sec.  1.505 or supplier verification under Sec.  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 
processed to control [identified hazard]''; and
     Annually obtains from its customer written assurance, 
subject to the requirements of Sec.  1.507(c), that the customer will 
disclose in documents accompanying the food, in accordance 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 the 
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 Sec.  1.507 applicable to control of hazards 
by entities in an importer's distribution chain, Sec.  1.507(a)(5), 
allows for the possibility that another approach could ensure the 
control of an identified hazard in a food. Under Sec.  1.507(a)(5), an 
importer is not required to conduct an evaluation under Sec.  1.505 or 
supplier verification under Sec.  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 might pass through multiple entities in the distribution chain 
before a control is applied. However, the control must eventually be 
applied. Under Sec.  1.507(c), the customer or a subsequent entity in 
the distribution chain for a food that provides a written assurance 
under Sec.  1.507(a)(2), (3), or (4) must act consistently with the 
assurance and document the actions it takes to satisfy the written 
assurance. This requirement is supported by sections 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 controls regulations for human and animal food, 
facilities may also rely on subsequent entities in their distribution 
chains to apply controls. 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 ensure 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 pass 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), 805(a)(1), and 
805(c)(2)(B) of the FD&C Act. Ordinarily 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 know 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 is 
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 
can cause a communicable disease, we conclude that the labeling 
requirement, in addition to the requirement that the importer's

[[Page 74296]]

customer or subsequent entity act in accordance with the assurance, is 
necessary to prevent the spread of communicable disease from 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 Sec.  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 by the food and the 
foreign supplier's performance (under Sec.  1.505), and for the conduct 
of supplier verification and related activities (under Sec.  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 all 
details of their processes to state in writing the procedures used to 
control the hazard. For example, a customer could merely state that 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 while 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 hazards identified by the importer in accordance 
with Sec.  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), Sec.  1.507 does not require importers to assess whether 
their customers are controlling hazards in accordance with the 
assurance they provide. Instead, we may, if necessary, rely on the 
requirement in Sec.  1.507(c) that the customer act consistently with 
the written assurance it provides (and document its actions) to 
determine 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 required 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 applicable provision of 
Sec.  1.507(a).
    (Comment 227) One comment expresses concern that proposed Sec.  
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 another use) as a result of quality rejection by the 
customer or for 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 bear 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 verification activities and processing 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 redirected for a purpose 
different from its original intended use. As discussed in section 
III.G.4 of this document, Sec.  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 potential to reduce supplier 
verification costs for both importers and suppliers. We also believe 
that the ability to import food in accordance with Sec.  1.507(a)(2) 
when an importer's customer will significantly minimize or preventing 
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 Sec.  1.507(a)(2), but 
instead used the spinach to make IQF spinach or spinach dip without 
significantly minimizing or preventing the hazard, the importer's 
customer would be in violation of Sec.  1.507(c). However, the 
assurance requirement in Sec.  1.507(a)(2) does not require that the 
customer provide assurance as to the specific food it will manufacture 
or process from the imported food. Instead, it requires that the 
customer provide assurance that it will significantly minimize or 
prevent the identified hazard in the food. It is likely that there is 
more than one way that the customer could act 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 significantly minimize or prevent the identified 
hazard. Assuming that occurs, there would be no violation of Sec.  
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 
directly to consumers who are expected to cook the food to obtain 
multiple letters from consumers to comply the requirement in proposed 
Sec.  1.504(g) to obtain written assurances that customers are 
controlling hazards. The comment suggests that we define ``customer'' 
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.

[[Page 74297]]

However, we agree that a ``customer'' under Sec.  1.507 of the final 
rule is not an individual consumer of the food. Instead, a ``customer'' 
under Sec.  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 (Sec.  
1.508)

    In Sec.  1.507 of the proposed rule, we proposed that importers be 
required to review complaints of any customer, consumer, or other 
complaint 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 their FSVPs and make 
modifications when appropriate. As discussed in the following 
paragraphs, we are making several changes to these proposed 
requirements. We also are renumbering this section to Sec.  1.508 to 
accommodate other revisions to the codified provisions.
1. General Comments
    (Comment 229) One comment agrees with the requirements in proposed 
Sec.  1.507 but does not believe that the proposed rule would establish 
adequate regulatory oversight of importers.
    (Response 229) Under Sec.  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 with 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 suggests 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 Sec.  1.508, however, is to require 
importers to perform their own investigations and take their own 
corrective actions, rather than establish new procedures for FDA 
compliance and enforcement activities.
    (Comment 231) Several comments contend that the recordkeeping 
associated with proposed Sec.  1.507 would be substantially burdensome.
    (Response 231) We do not agree that the recordkeeping requirements 
in Sec.  1.508 will impose unreasonable burdens 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 
Sec.  1.508 of the final rule.
2. Review of Complaints
    We proposed to require importers to promptly review any customer, 
consumer, or other complaint that the importer receives to determine 
whether the complaint relates to the adequacy of the importer's FSVP 
(proposed Sec.  1.507(a)).
    (Comment 232) Although some comments support the proposed 
requirement to review complaints to determine whether they relate 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 that 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 food. Some comments claim that 
complaints are not always a strong indicator of problems and cannot 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 preventive controls regulations. 
Some comments assert that the requirement to review complaints may be 
duplicative given the reporting requirements related to the RFR.
    Several comments suggest limiting the requirement to review 
complaints to those related to food 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 relationship 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 
Sec.  1.507(a) to review complaints. In the preambles to the proposed 
rules on preventive controls for human food and animal food, we 
requested comment on whether and how a facility's review 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 64736 at 64809, October 29, 2013). 
In the preventive controls final rules, we did not establish a 
requirement for a review of complaints as a verification activity. We 
determined that, although we agree that reviews of complaints 
occasionally do uncover food 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 the same reasoning applies to the FSVP regulation.
    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 verification 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 58577). As we said in the 
preambles to the final rules on preventive controls, we nevertheless 
encourage firms to review complaints as part of standard business 
practice.
3. Investigation
    In proposed Sec.  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

[[Page 74298]]

misbranded under section 403(w) of the FD&C Act, either through review 
of a complaint or by other means, 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 suppliers. 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 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 Sec.  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 these factors. We 
believe that a requirement to conduct investigations as specified in 
proposed Sec.  1.507(b) would be unnecessarily duplicative and would 
not substantially contribute to the public health. In addition, 
removing the investigations requirement in proposed Sec.  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 Sec.  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 Sec.  1.507(c), that importers be required 
to promptly take appropriate corrective actions if they determined 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 section 403(w) of the 
FD&C Act (the standard for FSVPs set forth in FSMA and proposed Sec.  
1.502(a) of the FSVP regulation). We proposed that this determination 
could be based on an investigation into adulteration conducted under 
proposed Sec.  1.507(b), the supplier verification activities the 
importer conducted under proposed Sec.  1.506 or Sec.  1.511(c), the 
FSVP reassessment conducted under proposed Sec.  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 Sec.  1.507(c).
    To reflect changes we are making to other provisions in this final 
rule, we have revised the requirement to take corrective actions (Sec.  
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 Sec.  1.508 with a references to Sec.  1.505(c) to reflect 
the replacement of FSVP reassessment with reanalysis of the food and 
foreign supplier. We also are removing the reference to investigations 
conducted under proposed Sec.  1.507(b) because we are deleting that 
provision. In addition, Sec.  1.508(a) states that a determination that 
corrective action 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 given 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, Sec.  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 activities conducted under Sec.  1.506 or Sec.  
1.511(c), a reevaluation of the risk posed by the food and the foreign 
supplier's performance conducted under Sec.  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 Sec.  1.507(d)) to investigate to 
determine the adequacy of the importer's FSVP be limited to situations 
in which the foreign 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 imports 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 corrective action when the non-compliance 
could be corrected through other measures. All corrective actions are 
relevant to decisions that an importer may need to make with regard to 
a supplier. If, for 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 comment 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 before an importer has the opportunity 
to take corrective action. Regardless, under Sec.  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 might 
include discontinuing use of the foreign supplier until the cause or 
causes of non-compliance, adulteration, or

[[Page 74299]]

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 should 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.
    (Response 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 importers must cease 
using a foreign supplier; rather, it states that such action, 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 importer 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 require that 
an importer visit the foreign supplier's establishment as part of any 
corrective action conducted under Sec.  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 Sec.  1.508(a), provided that those actions correct the 
underlying problem that precipitated the need for corrective actions 
under 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, 
Sec.  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 Sec.  1.508(a)) are subject to the 
public 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 Sec.  1.507(d), that if an importer 
determines, by means other than the verification activities conducted 
under proposed Sec.  1.506 or Sec.  1.511(c) or the FSVP reassessment 
conducted under proposed Sec.  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 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 importer must promptly investigate 
to determine whether its 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 requirement.
    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 (Sec.  1.508(b) of the final rule). With respect to 
the means by which an importer might determine that a foreign supplier 
does not produce food in accordance with applicable requirements, we 
are replacing the reference to Sec.  1.508 with a reference to Sec.  
1.505(c) (reevaluation of foreign supplier performance and the risk 
posed by a food).
6. No Limitation of Obligations
    In the proposed rule, we proposed to specify (in Sec.  1.507(e)) 
that Sec.  1.507 does not limit an importer's obligations with respect 
to other laws enforced by FDA, such as those relating to product 
recalls. This provision is codified in Sec.  1.508(c) of the final 
rule.

J. Identification of Importer at Entry (Sec.  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 electronically 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 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.
    (Comment 240) Some comments oppose this proposed requirement 
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 requires 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

[[Page 74300]]

``importer'' is defined in Sec.  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 ensure 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 that importers conduct appropriate foreign supplier 
verification activities.
    We conclude that requiring importers (under Sec.  1.509) to ensure 
that they are accurately identified at entry will help us efficiently 
and effectively ensure that importers are complying 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 discussed 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, obtaining 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 
information 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 last of which 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 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 
states 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 could 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 number 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 following:
     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 appropriate, of a U.S. agent 
or representative as the importer for FSVP purposes); or
     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 
Sec.  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 Sec.  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 regular 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 because not all 
``importers'' under Sec.  1.500 will necessarily be facilities required 
to register under section 415 of the FD&C Act. Likewise, not all 
importers under Sec.  1.500 will necessarily be ``importers of record'' 
for purposes of CBP entry submissions and therefore 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 Sec.  1.500. We do not believe that revising the 
information required for prior notice would be appropriate because the 
prior notice regulation serves a different purpose than the FSVP 
regulation. For these reasons, we do not agree that using the 
alternative identifiers 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 concerns 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 
disclosure 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 (Sec.  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.

[[Page 74301]]

    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 recognizes as acceptable, 
and we expect to state that we recognize DUNS numbers as acceptable 
identifiers. Although we will allow importers to request the use of 
different identification numbers, 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 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 from 
our request for comment on whether we should require the submission of 
any additional identifiers for importers. We believe that an electronic 
mail address is an appropriate additional identifier to require for 
importers, especially because electronic mail addresses allow for quick 
and efficient communications between FDA and importers. We anticipate 
that we might use the electronic mail addresses to notify at least some 
of the persons listed at those addresses that they have been identified 
as FSVP importers, 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 
electronic mail addresses to communicate with importers 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 and FSVP requirements of the 
FD&C Act. By requiring electronic 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 for 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 hand, one comment maintains 
that having a different DUNS number for each corporate location would 
be confusing. Some 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., for 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 numbers are specific to physical 
locations; 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 
location at which the importer retains its records of FSVP activities 
for the food for which it provides its DUNS number at entry under Sec.  
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 Sec.  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 submissions, 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 previously, we will expect importers to 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, although 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 
regulation, 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 provide 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 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-

[[Page 74302]]

entry basis will help us assess compliance with the FSVP requirements 
in order to efficiently enforce 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 comments 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, 
we agree. Section 1.509(a) of the final rule establishes the 
requirements that importers ensure that their name, electronic mail 
address, and unique facility identifier are provided electronically to 
CBP for each line entry 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 confidentiality provisions.
    (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 before 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 admissibility 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 to 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 definition of importer in section 805(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 representative . . . 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 about 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 
Sec.  1.509 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 entry 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 Sec.  
1.509 will ordinarily trigger entry delays.
    (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 Sec.  1.509(a).
2. Designation of U.S. Agent or Representative
    We proposed to require (in proposed Sec.  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 the 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 Sec.  1.500. As discussed in section III.A.13 of this 
document, we are adding a clarification to the definition of 
``importer'' in Sec.  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 signed 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 (for FSVP purposes) than exists for 
U.S. agents named in foreign facility registrations.
    (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 for 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 unaware 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 importers in accordance with Sec.  1.500, we 
conclude that the clarification we are making to the definition of 
``importer'' in Sec.  1.500 adequately addresses this concern. 
Specifically, we conclude that the clarification that any designation 
of a

[[Page 74303]]

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.
    (Comment 252) One comment asks that U.S. agents and representatives 
of foreign owners be excluded from the requirement to identify the 
importer 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 participating 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 
compliance 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 to retailers and others who seek to source 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 database 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 confidentiality 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 question 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 comments 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 
exempts 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 delete 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 includes 
importers who are subject to the FSVP regulation (and not exempt from 
the requirements under Sec.  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 public, even importers that are 
the subjects of enforcement actions for non-compliance with the FSVP 
regulation are ``participating'' under the 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 because we will be able to use the importer identification 
information provided under Sec.  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 list 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 (Sec.  1.510)

    We proposed several requirements concerning the manner in which 
FSVP records would be maintained and made available to FDA (proposed 
Sec.  1.510). In response to comments received and to better align 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.
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 records 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 
importers 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 take 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

[[Page 74304]]

onsite auditing of foreign suppliers, testing of imported 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 does not specify a particular form 
or format for required documentation. In addition, Sec.  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 comment).
    (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 
document their program as a whole (e.g., using a tiered 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 comments 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 requires 
importers to conduct a hazard analysis for each type of food they 
import, evaluate the risk associated with each food 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 suppliers and determine appropriate 
verification activities for particular foods 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 frequency 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 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 initiative 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 existing 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 Sec.  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 Sec.  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 importer. However, the qualified 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 we deleted in the Supplemental Notice); hazard 
analysis; supplier verification activities; complaint review, 
investigations, 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 signed 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 records generally in 
section III.K.5 of this document.
    On our own initiative, we have added to Sec.  1.510(a), consistent 
with other FSMA regulations, a requirement that importers 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. We have also moved the 
proposed requirement that all records be legible and stored to prevent 
deterioration or loss from proposed Sec.  1.510(b) to Sec.  1.510(a) of 
the final rule.
3. Records Availability
a. Records in English
    We proposed, in Sec.  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 could 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

[[Page 74305]]

than English. One comment states that the proposed requirement could 
mean that native-language 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 maintain records in English 
would be inconsistent with industry standards such as those in the 
British Retail Consortium and Safety 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 
maintained 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 alternative to the proposed 
requirement that records be maintained in English, the regulation could 
require importers to translate records upon FDA request in a reasonable 
time.
    (Response 259) Although existing FDA regulations (Sec. Sec.  
120.14(c) and 123.12(c)) require 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 supplier 
verification activities) if it could not understand the documents that 
it was reviewing, we have added a requirement, in Sec.  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 Sec.  1.510(b)(1), that, upon 
FDA request, importers must provide within a reasonable time an English 
translation of records maintained 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 follow-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 importers 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 Sec.  1.510(b)).
    (Comment 260) Some comments suggest that importers should have the 
flexibility to store records at any reasonably accessible location, 
including where the records are created or at a corporate office, 
import team 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 available 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 records onsite for the entire retention 
period because offsite paper documents would 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 
location, 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 Sec.  
1.510(b)(2) of the final rule, to permit offsite storage of records 
(including 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.
    (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 records 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 review at the importer's place of business. 
On our own initiative, we have modified the requirement so that Sec.  
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 means 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 records review 
process. We also note that for records that will need to be translated 
into English, we expect to receive such records promptly after the 
reasonable time needed for translation.
    (Comment 262) Several comments oppose the proposed requirement to 
send records to FDA electronically upon request. Some comments maintain 
that neither FSMA nor the FD&C Act (including FDA's authority to issue

[[Page 74306]]

regulations for the efficient enforcement of the FD&C Act under section 
701(a)) provides authority for the requirement 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 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 stating 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 Sec.  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 verifying the 
safety of the food they import into the United States. It is important 
to note that the provisions in Sec.  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 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 access'' 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 section 
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 regarding ``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 for 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 term 
``remote access to records'' in any section of S. 510, it is notable 
that H.R. 2749's section regarding imports did 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 draw 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 the adoption of an entirely separate bill with 
many provisions that differed from H.R. 2749, including the 
requirements for foreign supplier verification.
    We agree with the comments stating 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. Indeed, 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 sections 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 that is 
specific 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 records provisions. We believe this is 
appropriate in light of the nature and purpose of FDA record review for 
the FSVP regulation. Our review of importers' FSVP records serves a 
distinct purpose from review of a manufacturing/processing facility's 
records in the context of an onsite inspection of activities at the 
facility. Importers do not necessarily manufacture, process, pack, or 
hold food. Instead, they must conduct activities to verify the food 
safety practices of their suppliers. The FSVP regulation requires 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 therefore allows us to 
more easily determine compliance by reviewing records. Thus, while 
several comments refer to being able to put records into context at a 
manufacturing location, Sec.  1.510 refers only to the importer's FSVP 
records, and there might not be a manufacturing location to inspect for 
purposes 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 inspections. For example, section 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 
appropriate 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 section 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 copying records, providing

[[Page 74307]]

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 certification 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 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 States 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 more 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 standards. 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 importers that present 
a greater risk to food safety because their records are inadequate 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 
identify as lower risk will therefore be less likely to be burdened by 
an FDA inspection.
    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 evaluate 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 inspections 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 importer'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 disclosure of confidential commercial 
information and security 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 
state 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 cases, 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 Sec.  1.510(b)(1) and 
(b)(2) contemplate this type of record review. But Sec.  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, an importer who maintains all records electronically and 
travels between ports of entry without a traditional ``facility'' might 
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 sufficient and 
appropriate context for records submitted electronically. Nothing 
prevents 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 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 information 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,

[[Page 74308]]

as well as concerns about confidential commercial information and 
terrorism, we will take appropriate steps to secure communications with 
importers and to protect any data we receive, whether submitted 
electronically or otherwise.
    We agree with the comment stating that small businesses should not 
be forced to maintain electronic records, as this might be a 
disproportionate burden 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 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. Records Retention
    Under proposed Sec.  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 years 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 implementation 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 some 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 complicated 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 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 supplier 
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 discontinued.
    (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, Sec.  1.510(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 
documentation of) and documentation of corrective actions taken. 
However, Sec.  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 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, section 805(d) of the FD&C Act mandates that 
FSVP records be maintained for a period of not less than 2 years, and 
Sec.  1.510(c) reflects this statutory 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 before 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 Sec.  1.500) in accordance with Sec.  
1.512(b)(1) of the final rule. Therefore, Sec.  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 significantly 
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 required 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 than 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, Sec.  1.510(d) of the final rule states that records that 
are established or maintained to satisfy the FSVP

[[Page 74309]]

requirements and that meet the definition of electronic records in 
Sec.  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 11. 
Consistent with these provisions, we are making a conforming change in 
part 11 to specify in Sec.  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 requirements 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 records to ensure 
that the records are trustworthy, reliable, and generally equivalent to 
paper records and handwritten signatures executed on paper.
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 commercially 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 commercial 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 Sec. Sec.  120.12(f) and 123.9(d), are exempt from 
disclosure unless previously disclosed or the records relate to a 
product or ingredient 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 regulation 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, Sec.  1.510(f) of the final rule specifies that records 
obtained by FDA pursuant to the FSVP regulation are subject to the 
disclosure requirements under part 20. This 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 exempt from disclosure under FOIA because, under Sec.  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 disclosure under 
Sec.  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 particular 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., 
Sec.  20.61 (concerning trade secrets and commercial or financial 
information which is privileged or confidential) and Sec.  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, consistent with our approach in the 
recently issued preventive controls regulations. For example, 
provisions such as Sec.  20.20 (concerning the policy on disclosure of 
FDA records) apply to all records that we have in our system, including 
HACCP records, even though the HACCP regulations do not specify that 
this is the case.
    (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 FSVP 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 commenter 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 maintain 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 might 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.
    (Response 270) We intend to work with CBP on implementing the 
importer identification at entry provisions. We also intend to consult 
with CBP as appropriate in drafting FSVP guidance on compliance with 
these requirements.

L. Dietary Supplements and Dietary Supplement Components (Sec.  1.511)

    We proposed to adopt modified FSVP requirements for dietary 
supplements and dietary supplement components in Sec.  1.511 of the 
proposed rule. We noted that facilities making 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 
concerning dietary supplement CGMP requirements (section 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

[[Page 74310]]

verification of hazard control, as we had proposed under the 
``standard'' FSVP requirements.
1. Dietary Supplements for Further 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, contains provisions that already require supplier 
``verification'' tailored to dietary supplements. Specifically, these 
provisions require a dietary supplement manufacturer to verify that the 
ingredients they are using are identified properly, have the 
appropriate purity, strength, and composition, and do not contain 
contaminants that adulterate or can lead to adulteration of the dietary 
supplement. Therefore, imposing additional verification requirements 
under the FSVP regulation would be redundant and unnecessary.
    Under proposed Sec.  1.511(a), if an importer was required to 
establish specifications under Sec.  111.70(b), (d), or (f) of the 
dietary supplement 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 identification 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 supplements, and (3) products received for 
packaging or labeling as a dietary supplement and subsequent 
distribution, respectively.
    We proposed (in Sec.  1.511(b)) similar requirements for importers 
whose customer was required to establish 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 
compliance with those requirements. We tentatively concluded 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 with the FD&C Act.
    We also proposed that importers of dietary supplements and dietary 
supplement components acting in accordance with Sec.  1.511(a) or (b) 
would not be subject to the proposed 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 approach 
for dietary supplements and dietary supplement components under 
proposed Sec.  1.511(a) and (b). However, as discussed in the following 
paragraphs, some comments suggest changes to the proposed requirements 
and some request that the FSVP regulation not include these 
requirements. In the final rule, we have removed the reference to Sec.  
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 imported, Sec.  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 Sec.  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 Sec.  111.70(f) from those provisions.
    (Comment 272) One comment objects to exempting from most FSVP 
requirements importers of dietary supplement components that are 
determined to meet specifications established by the importer in 
accordance with Sec.  111.70(b). The comment maintains that conformance 
to specifications under Sec.  111.70(b) would not provide adequate 
assurance that the component was in compliance with part 111 and not 
adulterated. The comment requests that importation of such dietary 
supplement components be subject to the standard FSVP requirements for 
conventional food.
    (Response 272) We do not agree. Section 111.70(b) of the dietary 
supplement CGMP regulation and the requirements in Sec. Sec.  111.73 
and 111.75 applicable to determining whether those specifications are 
met are intended to ensure that:
     A component used in the manufacture of a dietary 
supplement has the proper identity;
     A dietary supplement manufactured using the component has 
the appropriate purity, 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 Sec.  
1.511(a) of the final rule, the 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 Sec.  111.70(b) are met in accordance with Sec. Sec.  111.73 and 
111.75. We conclude that compliance by the importer/manufacturer with 
these 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 are met in accordance with Sec. Sec.  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 clarity we have added to the 
regulation references to the specific CGMP provisions (i.e., Sec. Sec.  
111.73 and 111.75) concerning determination of whether established 
specifications are met for an imported dietary supplement or dietary 
supplement component.
    (Comment 273) One comment objects to exempting from most FSVP 
requirements importers of dietary supplements for whose labels or 
packaging the importer has established specifications in accordance 
with Sec.  111.70(d) and determines whether the specifications are met. 
The comment finds the reference to Sec.  111.70(d) confusing. The 
comment maintains that the reference might suggest that FDA regards 
labels and packaging as food; if this is the case, the comment does not 
believe that confirming that those materials meet specifications 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 Sec.  111.70(d) is misplaced 
because confirming that labels or packaging met specifications would 
not provide adequate assurance that the imported food was produced in 
compliance with U.S. law. The comment states that we should not

[[Page 74311]]

consider labels and packaging to be food and asks that we delete the 
reference to Sec.  111.70(d) from proposed Sec.  1.511(a) and (b).
    (Response 273) We do not agree with the comment that the reference 
to Sec.  111.70(d) in Sec.  1.511(a) and (b) is inappropriate. Section 
111.70(d) is relevant to the extent that it covers packaging that may 
come in contact with dietary supplements. The definition of food under 
the FSVP regulation includes food contact substances and Sec.  
111.70(d) refers to establishing specifications for packaging that may 
come in contact with dietary supplements. Section 111.70(d) specifies 
that packaging 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 dietary 
supplement. This requirement makes the verification of specifications 
for these materials relevant for a dietary supplement manufacturer 
under Sec.  1.511(a) and (b). The domestic manufacturer is responsible 
for appropriate labeling of the dietary supplement 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 Sec.  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 these specifications 
are met. The comments maintain that this provision would be 
inconsistent with FDA's statement, in the preamble 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 Sec.  1.511(a), 
an importer that packages or labels an imported dietary supplement 
would have no obligation to verify that the imported dietary supplement 
was produced in compliance with part 111. One of the comments contends 
that retaining the reference to Sec.  111.70(f) in proposed Sec.  
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 supplement 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 believe that this statement mischaracterizes the obligations that 
apply to a firm that packages and/or labels a finished dietary 
supplement to which Sec.  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 Sec.  
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 requires as ``sufficient 
assurance'' under Sec.  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 Sec.  111.70(f) may 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 
contemplated 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 supplier 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 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 verification 
activities, we conclude that it is not appropriate to apply the 
modified requirements in Sec.  1.511(a) and (b) of the final rule to 
importers of dietary supplements who establish (or whose customers 
establish) specifications under Sec.  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 Sec.  1.511(c) and verify that the imported product 
was produced in compliance with the applicable requirements of part 111 
for the manufacture of the dietary supplement. These importers may be 
able to use documentation provided under Sec.  111.70(f) (as well as 
Sec. Sec.  111.73 and 111.75 regarding determination that 
specifications are met) to fulfill some of the requirements under Sec.  
1.511(c) (e.g., regarding the performance of supplier verification 
activities).
    (Comment 275) Two comments request that we broaden proposed Sec.  
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 are 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 compliance with part 111 at the request of their 
customer or at FDA's recommendation). Therefore, the comments ask that 
we revise proposed Sec.  1.511(a) and (b) to include importers who 
voluntarily comply with Sec.  111.70(b), (d), or (f).
    (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 Sec.  1.511(a) of the 
final rule because we determined that the importer was not in 
compliance with Sec.  111.70(b) or (d).
    (Comment 276) One comment objects to the requirement in proposed 
Sec.  1.511(b) that an importer of a dietary supplement or dietary 
supplement ingredient obtain written assurance of compliance when the 
importer's customer is required to establish specifications under Sec.  
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

[[Page 74312]]

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 Sec.  1.511(b) should 
apply if either of the following occurs:
     The importer annually obtains written assurance of its 
customer's compliance with Sec.  111.70(b), (d), or (f) (as 
applicable); or
     The importer verifies (such as through publicly available 
information) that its customer manufacturers, packages, and/or labels 
dietary supplements and the importer provides a disclosure in labels or 
commercial documentation accompanying the dietary supplement or dietary 
supplement component stating that the food was not imported under the 
standard FSVP requirements and is intended only for use in the 
manufacture, processing, packaging, or labeling of dietary supplements 
in compliance 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 written assurance from the customer of 
compliance with the applicable specification requirements would provide 
less definitive assurance of the customer's compliance 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 compliance status. On the other 
hand, the disclosure to the customer suggested by the comment likely 
would not communicate any additional information to the customer 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 Sec.  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 Sec.  1.511(c), if a dietary supplement was 
imported other than in accordance with proposed Sec.  1.511(a) or (b), 
the importer would not be required to comply with the standard FSVP 
requirements concerning hazard analysis but it would be required to 
comply with requirements concerning the following:
     Use of a qualified individual (proposed Sec.  1.503);
     Evaluation of risks (except hazard analysis) (proposed 
Sec.  1.505(a)(2) through (6) and (b));
     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 Sec.  
1.511(c)(2) through (8));
     Complaint review, investigations, corrective actions 
(proposed Sec.  1.507);
     FSVP reassessment (proposed Sec.  1.508);
     Identification of importer at entry (proposed Sec.  
1.509); and
     Recordkeeping (proposed Sec.  1.510).
    The comments generally support the proposed FSVP requirements for 
finished dietary supplements and other dietary supplements not imported 
in accordance with proposed Sec.  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 
discussed previously in this document and the updated 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 Sec.  1.511(a) or 
(b) is applicable, the importer must comply with Sec.  1.511(c) and the 
requirements in Sec. Sec.  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 with the requirements in Sec. Sec.  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
    Proposed Sec.  1.511(c)(1) specified that importers of finished 
dietary supplements would be required to comply with the requirements 
in proposed Sec.  1.505 related to consideration of the entity that 
will control the hazards in a food and evaluation of the foreign 
supplier's performance (but not evaluation of the risk posed by a food, 
i.e., the hazard analysis). The applicable provisions of Sec.  1.505 
are now Sec.  1.505(a)(1)(ii) through (iv), (a)(2), and (b) through (d) 
rather than Sec.  1.505(a)(2) through (6) and (b). The changes that we 
have made to Sec.  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 Sec.  1.511(c)(1) of the final rule.
b. Corrective Actions
    Proposed Sec.  1.511(c)(1) specified that importers of finished 
dietary supplements would be required to comply with the requirements 
in proposed Sec.  1.507, including those concerning review of 
complaints, investigations, corrective actions, and modification of the 
FSVP (when necessary). As discussed in section III.I of this document, 
the section of the regulation regarding corrective actions, Sec.  1.508 
of the final rule, does not require importers to review complaints 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 
Sec.  1.508.
c. Identification of Importer at Entry
    As discussed in section III.J of this document, we have revised the 
requirements related to importer identification at entry in Sec.  1.509 
of the final rule; these changes apply to the importation of finished 
dietary supplements under Sec.  1.511(c)(1).
d. Recordkeeping
    As discussed in section III.K of this document, we have revised 
several recordkeeping requirements in Sec.  1.510 of the final rule; 
these changes apply to the importation of finished dietary supplements 
under Sec.  1.511(c)(1) of the final 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 Sec.  1.506 that allow an entity other 
than the finished dietary supplement importer's foreign supplier to 
establish and follow such procedures, provided the importer reviews and 
assesses the other entity's procedures and activities (see the 
discussion of

[[Page 74313]]

these matters with respect to foods other than dietary supplements in 
section III.G.1 of this document).
f. Determination of Appropriate Foreign Supplier Verification 
Activities
    Section 1.511(c)(4) of the final rule finalizes the requirement (in 
proposed Sec.  1.511(c)(5)) to determine appropriate foreign supplier 
verification activities before importing a dietary supplement from a 
foreign supplier, as well as the frequency with these activities must 
be conducted. (We deleted the separate reference to the ``purpose'' of 
supplier verification activities stated in proposed Sec.  1.511(c)(4)--
i.e., 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--and added it to the provision requiring 
determination of appropriate supplier verification activities (Sec.  
1.511(c)(4) of the final rule).) Section 1.511(c)(4) specifies that 
this determination must be based on the evaluation conducted under 
Sec.  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 other 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 proposed 
requirement to conduct verification activities for foreign suppliers of 
finished dietary supplements. Among the changes to the verification 
activity provisions that match changes to proposed Sec.  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 consider 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 accordance 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 
those 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 
appropriate inspections for compliance with applicable FDA food safety 
regulations conducted by FDA, representatives of other Federal agencies 
(such as the USDA), and representatives of State, local, tribal, or 
territorial agencies, in addition to inspections conducted by 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 inspection was conducted 
within 1 year of the date that the onsite audit would 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 
inspection 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 have 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 audit).
    (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 reflect the foreign 
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 requirements for documentation of foreign supplier 
verification activities.
     Under Sec.  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 entity in its supply chain provided that it 
reviews and assesses the results of those 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 because Sec.  
1.507 is based on the hazard analysis performed by importers. 
Specifically, importers can only avail themselves of the distribution 
chain provisions in Sec.  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 importation. 
Because the FSVP regulation does not require hazard analysis by 
importers of dietary supplements, the provisions of Sec.  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 CGMP requirements under proposed Sec.  
1.511(b), then proposed Sec.  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 
obtain written assurance from its customer in accordance with Sec.  
1.511(b) of the final rule would be subject to the requirements in 
Sec.  1.511(c), we conclude that it is not necessary to change Sec.  
1.511(c) as requested. The FSVP draft guidance will reiterate that when 
a dietary supplement is imported and neither Sec.  1.511(a) nor (b) is 
applicable (including because the importer elects not to annually 
obtain the appropriate written assurance from its customer), the 
importer must comply with Sec.  1.511(c).

[[Page 74314]]

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 there are many ingredients 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 in the United States. The comment maintains that if an ingredient 
is made in compliance with the United States Pharmacopeia (USP)/
National Formulary (NF) or other official monographs and 
internationally recognized drug CGMP standards, 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 ingredient,'' 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 manufactured in accordance with certain 
pharmaceutical CGMP standards or guidelines.) The comment asserts that 
because the construction, equipment, recordkeeping, training, and 
quality control operations of an establishment making a ``monograph 
ingredient'' will already be conducted in a manner that meets or 
exceeds 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 controls 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 assurances that the food is in compliance 
with the applicable monograph and/or that the monograph ingredient was 
produced in accordance with the requirements of the applicable 
pharmaceutical CGMP standards.
    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 
agreements. The comment also maintains that the suggested modified FSVP 
provisions would be consistent with the intent of Congress because they 
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 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. We 
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 applies 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 provide 
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 
required to comply with Sec.  1.511(c) of the final rule; importers of 
such ingredients that are dietary ingredients will be required to 
comply with the ``standard'' FSVP requirements. However, 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 information 
required under Sec.  1.511(c) or the standard FSVP provisions (as 
applicable). Those requirements are for verification of the same level 
of public health protection as required under part 111, not strict 
compliance with the regulation. In our records provision in Sec.  
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 FSVP regulation, and that an importer may supplement 
any such existing records as necessary to include all of the required 
information. 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 respect 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. To the 
extent that the information regarding the production 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 countries 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 are allowed 
for sale in the United States as dietary supplements and that meet the 
following criteria:
     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 authorization, 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

[[Page 74315]]

government of the jurisdiction in which it is located, and the facility 
is regularly inspected for compliance with applicable CGMP 
requirements.
     The product is manufactured in accordance with one or more 
of several specified drug CGMP regulations or guidelines.
    The comment states that many finished products imported into the 
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 
requirements. The comment contends that application of parts 111 and 
117 (or equivalent foreign regulations) to suppliers of foreign 
registered products would pose a burden without any benefit because the 
standards and CGMPs applicable 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 authorization and/or to verify the supplier's compliance with 
the applicable CGMP requirements, rather that its compliance with part 
111 or 117 (or equivalent foreign regulations). The comment also asks 
that importers of foreign registered products be provided the option of 
complying with the FSVP requirements in proposed Sec.  1.511 or 
complying with separate modified FSVP requirements tailored toward 
providing adequate assurances that the food is in compliance with the 
requirements of the applicable monograph, product registration, or 
market authorization and/or that the supplier is producing the product 
in accordance with the applicable CGMP requirements 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 products, would be 
inconsistent with U.S. obligations under WTO agreements. The comment 
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 
applies to importers of food, we conclude that it would not be 
appropriate to establish FSVP provisions requiring importers of certain 
products to conduct activities to provide assurances that the food is 
in compliance with the requirements of an applicable pharmaceutical 
monograph, product registration, or market authorization and/or that 
the supplier is producing the product in accordance with the applicable 
drug CGMP requirements or guidelines. Importers of finished dietary 
supplements that are used as drugs in foreign countries will be 
required to comply with Sec.  1.511(c) of the final rule. However, 
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 information required under Sec.  1.511(c) 
or the standard FSVP provisions (as applicable). In the FSVP draft 
guidance, we intend to address how importers 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 agreements.
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. 
Two 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 Sec.  1.511(c) are very similar to the 
``standard'' FSVP requirements and include cross-references to some of 
those requirements. However, we are adding, to Sec.  111.5 in the 
dietary supplement CGMP regulation, a statement that importers of 
dietary supplements and dietary supplement components can find the FSVP 
requirements in part 1, subpart L.

M. Very Small Importers and Importers of Food From Certain Small 
Foreign Suppliers (Sec.  1.512)

    In the proposed rule, we proposed modified FSVP requirements for 
importers that are very small importers and for importers 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 Sec. Sec.  1.502 (concerning the scope of an FSVP), 
1.503 (concerning the use 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 Sec. Sec.  
1.504 through 1.508 or Sec.  1.510. This means that very small 
importers and importers obtaining 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.
    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 section 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 foreign supplier is following to 
ensure

[[Page 74316]]

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 Requirements 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 suppliers. 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 
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 given 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 processed 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 still 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 
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, which 
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 producers 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 small 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 
scope of any modified FSVP requirements for very small entities should 
align with the scope of modified requirements under the supply-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 food 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 party.
    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 reconsider 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 percentage 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 
excludes from coverage farms with $25,000 or less in annual produce 
sales (while also providing 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'' category in the supply-chain program provisions of the 
preventive controls regulations. However, those regulations include 
modified supplier verification requirements (in Sec. Sec.  117.430(c), 
(d), and (e) (for human food) and 507.130(c), (d), and (e) (for animal 
food)) applicable to raw materials or other ingredients from the 
following suppliers (both domestic and foreign):

[[Page 74317]]

     Qualified facilities;
     Farms that grow produce and are not covered farms under 
the produce safety regulation in accordance with Sec.  112.4(a) (the 
farm has 3-year average annual produce sales of $25,000 or less) or in 
accordance with Sec. Sec.  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 Sec.  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 regulations (i.e., the 
regulations on preventive controls, produce safety, and the production, 
storage, 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 compliance (or 
acknowledgement that it is subject to the adulteration provisions of 
the 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 facility'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 relevant laws and regulations of 
foreign countries.
     Written assurance from a farm that grows produce and is 
not a covered farm in accordance with Sec.  112.4(a) or in accordance 
with Sec. Sec.  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 comparable 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 
Sec.  117.410(d)(1)(iii) or Sec.  507.110(d)(1)(iii), these receiving 
facilities need only consider the small supplier's compliance history 
under Sec.  117.410(d)(1)(iii)(B) or Sec.  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 follow to ensure that they obtain raw materials and other 
ingredients from approved suppliers (see Sec. Sec.  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 Sec.  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 Sec.  
1.506(d)(4) later in this section of the document.) Therefore, under 
Sec.  1.512(a)(2) of the final rule, the FSVP regulation includes 
modified requirements for importers of food from the following small 
foreign suppliers:
     Qualified facilities under the regulations on preventive 
controls for human food or for animal food (Sec.  117.3 or Sec.  507.3, 
respectively);
     Farms that grow produce and are not covered farms under 
the produce safety regulation in accordance with Sec.  112.4(a) (the 
farm has 3-year average annual sales of $25,000 or less), or in 
accordance with Sec. Sec.  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 Sec.  112.6); and
     Shell egg producers that are not subject to part 118 
because they have fewer than 3,000 laying hens.
    For both human food (under Sec.  117.3) and animal food (under 
Sec.  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 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 Sec.  117.3, a very small business is a 
business (including any subsidiaries 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 without sale (e.g., held for a fee). For animal food, under Sec.  
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 applicable 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 
Sec.  112.4 of the forthcoming produce safety rule have less than 
$25,000 in annual sales averaged over the previous 3-year period, or 
satisfy the requirements for a qualified exemption in Sec.  112.5 and 
associated modified requirements in Sec.  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 referred to these 
farms as farms ``not subject to the requirements in part 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 have certain modified 
requirements that they must meet, as described in Sec.  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 Sec.  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 safety regulation (i.e., produce that is rarely 
consumed raw and produce for personal consumption or consumption on the 
farm). Although the produce rule does not apply to food from such 
farms, Sec.  112.4 does not establish this. Rather, Sec. Sec.  112.3 
and 112.2 of the produce safety

[[Page 74318]]

final rule define what constitutes 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 cutoff, 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 a result, we 
are including shell egg producers with fewer than 3,000 laying hens 
among the small foreign suppliers from which an importer could import 
food subject to the modified requirements in Sec.  1.512.
    As with the importation of food by very small importers, we 
conclude that modified FSVP requirements are appropriate 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 Sec.  
1.512 include certain different requirements for importers of food from 
the specified small foreign suppliers compared to the requirements for 
very small importers.
    One such difference concerns the applicable standard of compliance 
for written assurance from the foreign supplier. Under Sec.  
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 applicable, 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 regulations, importers of food from small foreign suppliers 
must obtain written assurances as follows:
     If the foreign supplier is a qualified facility as defined 
by Sec.  117.3 or Sec.  503, the written assurance must attest that the 
foreign supplier is producing the food in 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). 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, county, 
tribal or other applicable non-Federal food safety law, including 
relevant laws and regulations of foreign countries (Sec.  
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 accordance with Sec.  112.4(a), 
or in accordance with Sec. Sec.  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 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) (Sec.  
1.512(b)(3)(iii)).
     If the foreign supplier is a shell egg producer that is 
not subject to the requirements 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) (Sec.  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 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 Sec.  
1.512(b)(3(iii)) and shell egg producers with fewer than 3,000 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 (Sec.  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 
Sec.  1.512(b)(3)(i) through (iv).
    Paragraph (c) of Sec.  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 believe that 
these provisions provide 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 
suppliers, 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

[[Page 74319]]

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 Sec.  
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 
from the foreign supplier. However, Sec.  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 history, the importer must reevaluate those concerns and 
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 permits the 
importer to review another entity's evaluation or reevaluation of a 
foreign supplier's compliance history. Under Sec.  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 compliance 
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 Sec.  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 evaluation the importer either conducts 
or reviews and assesses, and the importer must document the approval.
    Finally, Sec.  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 activities 
before importing the food). The importer must document its use of these 
procedures. However, under Sec.  1.512(c)(3)(ii), the importer may rely 
on another entity (other than its foreign supplier) to establish these 
procedures and perform and document the required activities, provided 
that the importer reviews and assesses that entity's 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 included 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 excludes farms with annual sales of $25,000 or less but the 
FSVP regulation does 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 
constitute 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 regulation with the supply-chain program provisions of the 
preventive controls regulations, to the extent appropriate and 
feasible, including the eligibility criteria for the modified 
requirements for produce imported from suppliers that are farms that 
are not covered farms under the produce safety regulation in accordance 
with Sec.  112.4(a) or in accordance with Sec. Sec.  112.4(b) and 
112.5. Therefore, receiving facilities subject to the preventive 
controls regulations that obtain produce from domestic farms are not 
subject 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 Sec.  
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, one comment asks that we apply 
the proposed modified requirements to all farms that are not subject to 
the produce safety regulations.
    (Response 284) We stated in the preamble to the Supplemental Notice 
that proposed Sec.  1.506(d)(4) would have provided modified 
verification requirements with respect to food from the following:
     Farms that grow or harvest crops such as grains that are 
not ``produce,'' as defined in Sec.  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 
Sec.  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 ``covered farms'' because they produce 
an average annual monetary value of produce of no more than $25,000.
     Farms that are not covered farms because they satisfy the 
requirements for a qualified exemption from the proposed produce safety 
regulation under proposed Sec.  112.5 and the exemption has not been 
withdrawn.
    Although Sec.  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 farms. That is, final Sec.  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 Sec.  112.3(c), 
and does not provide

[[Page 74320]]

modified requirements for farms that grow or harvest produce that is 
not covered by the proposed produce safety regulation in accordance 
with proposed Sec.  112.1 (e.g., because such produce is rarely 
consumed raw or is produced for personal or on-farm consumption). We 
believe that this 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 the application of an appropriate 
kill step or control. Rather than provide for modified verification 
requirements for such food under Sec.  1.512, we think it is more 
appropriate to allow importers to rely on the provisions of Sec.  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 application of an 
appropriate 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 
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 analysis 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 Sec.  1.505 and would not be required to conduct foreign supplier 
verification activities under Sec.  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 verification 
activities in accordance with Sec.  1.506.
    For similar reasons, the final rule requires importers of produce 
rarely consumed raw to comply with the provisions in Sec. Sec.  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 Sec.  
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 Sec.  1.507 provides flexibility as to which entity 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 the FSVP regulation under Sec.  
1.501(d). We therefore do not see any need to establish modified 
requirements applicable to this category.
    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 Sec.  1.512. To the extent that 
the comment requests that food produced by such operations as dairy 
farms be covered by the modified requirements in Sec.  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, we have designed the modified 
verification requirements in Sec.  1.512 so they apply only to 
operations that expose consumers to less risk because the operations 
export a relatively small volume of food to the United States. We also 
believe that our 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 provisions in the preventive 
controls regulations.
    In the context of the nature of the imports for which we are 
providing modified verification requirements in Sec.  1.512, we 
continue to believe that the modified requirements would be adequate to 
provide assurances 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 Sec.  1.512 
are and will continue to be covered under the adulteration provisions 
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 Sec.  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 also 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 health 
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 activity 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 Sec.  1.512(a)(2)(ii) of the 
final rule, the regulation does 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 standards for grain.
    (Response 286) As finalized and as previously discussed, Sec.  
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 Sec.  1.507 for imported grains for which hazards will 
be controlled after importation.

[[Page 74321]]

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 
suppliers 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 level 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 situations 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 these 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.
    (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 third-
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 address 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 importers 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.
    (Response 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 (and 
thus consumers' exposure to the food). We therefore believe it is 
appropriate to adopt modified requirements for very small importers.
    (Comment 290) Some comments state that very small foreign suppliers 
may already be exempt from the preventive controls 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 establishing 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 avoid 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 
import food from many small facilities or farms to meet its needs 
instead of from its usual large suppliers. 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 exporters 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 large exporter would not be 
eligible for modified requirements just because the particular shipment 
the importer 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 health 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 requirements in accordance with Sec.  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 truthfulness and accuracy 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 illness 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.

[[Page 74322]]

    (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. If 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 determination allows the importer to show that it meets 
the eligibility criteria and enables us to verify the importer's 
eligibility.
    Regarding the comments on compliance status review, Sec.  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, Sec.  1.512(c)(1) does 
require importers of food from certain small foreign suppliers 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 Sec.  112.4(a) or in accordance with Sec. Sec.  
112.4(b) and 112.5, under Sec.  1.512(c)(1)(iii), an importer 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 Certain 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. Calculating Eligibility
    Under proposed Sec.  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 Sec.  1.500 or that the foreign supplier meets the 
definition of ``very small foreign supplier'' in Sec.  1.500. For the 
purpose of determining whether the definitions were satisfied, the 
baseline year for calculating the adjustment for inflation would be 
2012. Proposed Sec.  1.512(b)(1) further states that if the importer or 
foreign supplier conducts food sales 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 Sec.  1.512(b)(1) to 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 Sec.  1.500) with respect to human food and/or animal food before 
initially importing food and thereafter on an annual basis by December 
31 of each calendar year (Sec.  1.512(b)(1)(i)(A)). For the purpose 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. market 
value of human or animal food, as appropriate) is the period ending 1 
year before the calendar year for which the importer intends to import 
food as a very small importer (Sec.  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 conducts any food sales in currency 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 Sec.  1.512(a)(2)(i), (ii), or (iii) before first 
approving the supplier for an 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 Sec.  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 Assurances
    We proposed (in Sec.  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 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 have to include a brief description of the processes 
and procedures that the foreign supplier is following to ensure 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 flexibility by allowing a very small 
supplier to provide records, like a commercial invoice, a certification 
of safety by the supplier's regulatory 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 than 
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 
written assurances. The modified requirements do not specify the 
particular form of

[[Page 74323]]

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 regulatory authority or a private certification, 
might be sufficient for written assurance purposes if they satisfy the 
applicable requirements for written assurance in Sec.  1.512(b)(3). 
However, for food from qualified facilities, the written assurance must 
include the information required by Sec.  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 
importers and the Agency. As to the issue of basing the level of 
supplier verification on whether a food is high risk, we generally 
agree 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 food and the characteristics of the 
supplier. For very small importers, however, we believe that the 
modified requirements, including the requirement 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 Sec.  1.512(b)(4)) that very small importers be 
required to promptly 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 Sec.  
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 actions 
would be required if the importer determines that its foreign supplier 
does not produce food consistent with the assurance provided in 
accordance with Sec.  1.512(b)(3).
    (Comment 298) Some comments ask that the provision be revised to 
specify that corrective actions are only necessary when non-compliance 
causes a risk to public health. The 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 
identified 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 Sec.  1.508 of the final rule (see 
section III.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 Sec.  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 an 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 reasonably 
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 Sec.  
1.512(b)(5) of the final rule with the changed recordkeeping 
requirements in Sec.  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. Instead, upon 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 Sec.  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 
Sec.  1.512(c)(1), approvals of suppliers under Sec.  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 small 
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 
obtained by FDA in accordance with the FSVP regulations are subject to 
the disclosure requirements under part 20. In addition, under Sec.  
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 Sec.  
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 new 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 specific, reasonable time interval. The 
comments 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 Sec.  1.510 
discussed in section III.K.3.b of this document, we have changed Sec.  
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 considered to be onsite if they are accessible 
from an onsite location. We believe that the 24-hour deadline is 
important because records must be

[[Page 74324]]

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 (Sec.  
1.512(b)(5)(iv)) specifying that electronic records that are 
established or maintained to satisfy the requirements of Sec.  1.512 
are exempt from the requirements of part 11.
3. Other Concerns Regarding the Modified Requirements
a. Withdrawal of Eligibility
    (Comment 301) One comment 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 existing 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 Very 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 foreign 
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
    (Comment 303) Some comments 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 the 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 the 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 comments 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 
establishes 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 changes, when 
appropriate (21 CFR 10.115(g)). In addition, we plan to develop 
training 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 their respective food industries in 
countries from which foods are exported to the United States in 
accordance with section 305 of FSMA in 2013 (Ref. 15). We anticipate 
that this plan will provide a strategic framework for our capacity-
building efforts over the next several years.

N. Importing a Food From a Foreign Supplier in a Country With an 
Officially Recognized or Equivalent Food Safety System (Sec.  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 are met. These 
provisions would allow the importation of such food without being 
subject to most of the standard FSVP requirements.
    Proposed Sec.  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 conditions are met and documented. The 
proposed conditions (stated in proposed Sec.  1.513(b)(1)) were the 
following:
     The foreign supplier must be 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
     The food must be within the scope of the relevant official 
recognition or equivalency determination.
    Proposed Sec.  1.513(b)(1) also specified that these conditions be 
documented before importing a food from the foreign supplier and 
annually thereafter.
    Under proposed Sec.  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 importer 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 monitor whether the foreign supplier is in 
good compliance standing and promptly review any information obtained. 
If the information indicated that food safety hazards associated with 
the food are not being adequately 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 these 
importers document any corrective actions. If an importer met

[[Page 74325]]

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, for 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 Sec.  
1.513 of the final rule.) But we proposed that these importers 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/ucm367400.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 Comparability 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. After 
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 as outlined in the ICAT 
submission. The assessment provides 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 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 
another 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, we plan to 
reevaluate the operation and status of each arrangement every 5 years, 
including reviewing changes in a country's food safety system and 
conducting system audits as needed.
    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 requirements 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 described in the following 
paragraphs, we conclude that it is 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 intended 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.
    (Comment 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 support 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.
    (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 implementing 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 the 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 safety 
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 receiving raw 
materials or other

[[Page 74326]]

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 ingredients. As a result of these considerations, we 
have finalized requirements for supplier verification in the preventive 
controls regulations--even for suppliers that operate under the U.S. 
food safety system. Under the preventive controls regulations, 
receiving facilities that obtain raw materials or other ingredients 
from either domestic or foreign suppliers will, under certain 
circumstances, need to have a supply-chain program that includes the 
performance of supplier verification activities.
    We believe 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 imported 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 prevented. 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 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 
preventive controls regulations. Therefore, Sec.  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 not 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 
regulations. 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, Sec.  1.513(a)(2) of the 
final rule provides that supplier verification of raw materials and 
other ingredients 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 
manufacturing/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 facility 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.
    (Comment 307) Some comments suggest that there is an inconsistency 
with the provisions of proposed Sec. Sec.  1.513 and 1.506(d)(5). As 
discussed in section III.G.4 of this document, proposed Sec.  
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 whose 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 
Sec.  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 Sec.  1.513 of the final rule apply only to food that 
will not be commercially processed further in the United States. 
However, under Sec.  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 food 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 
documentation 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 Sec.  1.513. Consequently, we 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 accordance with Sec.  
1.506(e)(1)(i)(E)(2).
2. Systems Recognition Process
    Several comments request changes to, or clarification of, our 
systems recognition process, while some comments request a change to 
proposed Sec.  1.513 to address a concern about the systems recognition 
process.
    (Comment 308) Some comments request that we clarify 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 that 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 
coordination program, systems recognition embraces cooperation in

[[Page 74327]]

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 
foreign 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 
assurances 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 equivalent. Therefore, it is appropriate, under Sec.  
1.513 of the final rule, to exempt from the application 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 Sec.  
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 countries, 
entities such as the EU might also be the subject of a food safety 
systems recognition agreement. This comment also asks that we establish 
a transition program or grace period for countries that are undergoing 
systems recognition evaluation so that 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 EU plays an important role in 
coordinating the food safety policy of its Member States. However, 
within the EU 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 distribution (Ref. 17). In 
that context, we are continuing to evaluate and consider how to best 
address the functions and processes of both the EU and its Member 
States. We do not believe that it is necessary to revise Sec.  
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. Applying such requirements to systems 
recognition 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 transitioning 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 selecting 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 recognition 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 information and opportunities for 
stakeholder input as the program transitions from the pilot stage to 
the full implementation stage.
    (Comment 312) Some comments assert that FDA should only make 
equivalency determinations and not systems recognition determinations. 
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 particular, involves a sufficiently rigorous 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 systems 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 
equivalence 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 protection with 
respect to the listed commodities. Some comments ask that we consider 
products that are already covered under bilateral memoranda of 
understanding (MOUs), such as FDA's agreement with Mexico regarding 
cantaloupe, as subjects for future commodity-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, although a country's overall food safety 
system 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 system. 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

[[Page 74328]]

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 
determination 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.

O. Consequences of Failure To Comply With FSVP Requirements (Sec.  
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 Sec.  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 Sec.  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 United 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 Sec.  1.500. In 
accordance with section 301(b) of FSMA, we proposed to specify, in 
Sec.  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 changes to the regulatory 
text for these provisions. Specifically, in Sec.  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 Sec.  1.500. Another change we are making to Sec.  
1.500 also is relevant to these provisions. As discussed in section 
III.A.11 of this document, we are adding a clarification to the 
definition of importer in Sec.  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 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 Sec.  
1.500. In those circumstances, food offered for entry into the United 
States may be refused admission under Sec.  1.514(a). We might ask the 
foreign owner or consignee that is exporting the food to provide us 
with the signed 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 importers 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 agencies (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 
Sec.  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 each 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 inappropriate ``port shopping'' that 
importers might attempt. In addition, in appropriate situations, when 
we identify 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, 
this 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 informing foreign suppliers (and presumably 
importers) how they can obtain entry for future shipments following 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 Sec.  1.514(a), 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 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 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 on 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 relevant FD&C Act requirements. FDA 
import alerts often provide guidance about removal from the 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 information in the import alert about achieving removal from 
the alert.

[[Page 74329]]

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 itself 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 directing the importer to revise its FSVP as needed to address 
inadequacies.
    (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 circumstances in which we had 
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 Sec.  1.508 to ensure that 
its foreign supplier produces 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 determine 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 adulteration 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 Sec.  1.507 in the final 
rule, importers are not required to conduct an evaluation under Sec.  
1.505 or supplier verification activities under Sec.  1.506 under 
specified circumstances. For instance, importers are not required to 
conduct Sec.  1.505 evaluations or Sec.  1.506 activities if they 
demonstrate and document that they rely on their customer to ensure 
that the identified hazard will be significantly minimized or 
prevented, or that 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 (Sec.  1.507(a)(2) through 
(4)). In addition, Sec.  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 Sec.  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 requirement 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 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 plan 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 will 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 inspectional 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. Generally, 
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 opportunity to discuss the letter with 
FDA district officials or, when appropriate, with other FDA officials.
    (Comment 321) Some comments request that we provide information on 
the measures we will use to assess an importer's compliance with the 
FSVP regulation.
    (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 discussed 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.

[[Page 74330]]

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 individuals responsible for developing the FSVPs have the 
necessary education and experience.
    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 verification 
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 
determinations 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 flexibility and 
accountability when conducting records reviews for compliance with the 
FSVP regulation. The regulation is written to provide importers with 
flexibility in meeting the requirements, including by determining 
appropriate supplier verification activities based on the risk posed by 
a food and the foreign supplier's performance. However, the regulation 
requires importers to document their procedures, determinations, and 
activities to allow us to assess importers' compliance.
    We disagree that we should not review any particular aspect of an 
importer's FSVP. Because the final rule allows importers flexibility in 
meeting the requirements, we must assess the choices the importer makes 
to ensure that its FSVP adequately protects U.S. consumers from unsafe 
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 
verification, or has otherwise 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 
inspections of FSVP activities at the central locations where such 
activities are carried out. Some comments suggest that we conduct 
targeted inspections at corporate headquarters that focus only on the 
importer's FSVP, because most supplier verification programs are 
managed at the corporate level.
    (Response 323) Because the FSVP regulation requires documentation 
of an importer's implementation of its FSVP, our inspections will be 
records-based. Therefore, in the event of an in-person inspection, the 
inspection generally will take place where the majority of FSVP records 
are kept. That might be at the importer's corporate headquarters or 
another central location. Although Sec.  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 Enforcement
    (Comment 324) Some comments ask how we will coordinate our FSVP 
enforcement activities with 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 
establishments 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 explaining 
what type of enforcement actions we will support, how States should 
respond to discovered food hazards, and how we will use information 
reported by States. Some comments 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, we 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 records 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, companies, 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 Subject to FSVP
    (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.
    (Response 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 risks 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 recommendations for the content, 
delivery, and timing of education and training for FDA and

[[Page 74331]]

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 published.
    (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 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 their 
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 for 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.
    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 that 
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 
Sec.  112.4(a) or in accordance with Sec. Sec.  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 produce safety regulations, and 
modified requirements for very small businesses, we intend to work with 
the food industry, educational 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, we 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 and 
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 the regulations are enforced consistently from one 
region to another by both Federal and State officials. These comments 
suggest that internal guidance and measures as well as extensive 
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 are 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 investigator 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

[[Page 74332]]

the work done by 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 and 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 are 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.
    (Comment 331) One comment expresses 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 foreign food facilities.
    (Response 331) Because the FSVP regulation applies to importers, we 
generally will not be inspecting foreign facilities as part of our 
implementation and enforcement of this regulation. However, we 
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 assurances 
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 provide 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 implementing the FSVP regulation if they 
decide to do so. Some comments assert that we should pursue funding 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.

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 should 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 period 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 practices 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.
    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 food 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 compliance 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.
    (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. Finally, 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 importers 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 animal 
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 regulations for human 
food or animal food, the date the importer, as a receiving facility, is

[[Page 74333]]

required to comply with the supply-chain program provisions of the 
relevant regulation.
    (Comment 335) Some comments assert that there should be an informed 
compliance 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 the 
appropriate time for such an 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 comply 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 Statement 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. Copies 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 advantages; distributive impacts; 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 the 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 $144 million, using the most current (2014) 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 statutes will be made available in the docket for this 
rulemaking and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ (Ref. 20).

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(j) that this action is of 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

    This final rule 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 data 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 processes 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 
applicable) 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 
therefore 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 personal 
consumption; certain alcoholic beverages and ingredients imported for 
use in alcoholic beverages; food that is 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 
supply-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 regulations, 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

[[Page 74334]]

certain food from suppliers 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 including 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 generally, which are 
discussed in section III.K of this document, we did not receive 
specific comments 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 revisions 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 this 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 
included in the final rule.

                                                     Table 4--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
          21 CFR section; activity               Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.501(c); exemption for food for research...          36,360              40       1,454,400  0.083 (5 minutes).........................         120,715
1.509(a), 1.511(c), 1.512(b)(2); importer             56,800             157       8,917,600  0.02 (1.2 minutes)........................         178,352
 identification information for filing with
 CBP.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................         299,067
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

A. Exemption for Food for Research or Evaluation

    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 purpose, 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 evaluation 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 Entry

    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 electronically 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 submission would require 0.02 hours, resulting 
in a total annual 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 recordkeeping 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 Sec.  1.507(a) and have revised our calculations 
accordingly.

                                 Table 5--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
         21 CFR section            recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                       (hours)
----------------------------------------------------------------------------------------------------------------
Controls for LACF--1.502(b).....           2,443               4           9,772               1           9,772
Determine and document hazards--          11,701               1          11,701             3.5          40,954
 1.504(a).......................
Review hazard analysis--1.504(d)          11,701               7          81,907            0.33          27,029
Evaluation of food and foreign            11,701               1          11,701               4          46,804
 supplier--1.505(a)(2),
 1.511(c)(1)....................
Approval of suppliers--1.505(b),           8,191               1           8,191              12          98,292
 1.512(c)(1)(iii)...............
Reevaluation of food and foreign          11,701             365       4,270,865            0.25       1,067,716
 supplier--1.505(c),
 1.512(c)(1)(ii)(A).............

[[Page 74335]]

 
Confirm or change requirements             2,340               1           2,340               2           4,680
 of foreign supplier
 verification activity--
 1.505(c), 1.512(c)(1)(ii)(A)...
Review of other entities                   3,510               1           3,510             1.2           4,212
 assessments--1.505(d),
 1.512(c)(1)(iii)...............
Written procedures for use of             11,701               1          11,701               8          93,608
 approved foreign suppliers--
 1.506(a)(1), 1.511(c)(2),
 1.512(c)(3)(i).................
Review of written procedures--            11,701               1          11,701               1          11,701
 1.506(a)(2), 1.511(c)(2)(ii),
 1.512(c)(3)(ii)................
Written procedures for                    11,701               1          11,701               2          23,402
 conducting verification
 activities--1.506(b),
 1.511(c)(3)....................
Determination and documentation           11,701               4          46,804            3.25         152,113
 of appropriate supplier
 verification activities--
 1.506(d)(1)-(2) 1.511(c)(4)(i).
Review of appropriate supplier            11,701               2          23,402            0.33           7,723
 verification activities
 determination by another
 entity--1.506(d)(3)
 1.511(c)(4)(iii)...............
Conduct/review audits--                   11,701               2          23,402               3          70,206
 1.506(e)(1)(i),
 1.511(c)(5)(i)(A)..............
Conduct periodic sampling/                11,701               2          23,402               1          23,402
 testing--1.506(e)(1)(ii),
 1.511(c)(5)(i)(B)..............
Review records--                          11,701               2          23,402             1.6          37,443
 1.506(e)(1)(iii),
 1.511(c)(5)(i)(C)..............
Document your review of supplier          11,701               6          70,206            0.25          17,552
 verification activity records--
 1.506(e)(3), 1.511(c)(5)(iii)..
1.507(a)(1).....................          11,701            3.17          37,082            1.25          46,353
Written assurances--1.507(a)(2),          11,701            8.72         102,038            0.50          51,019
 1.507(a)(3), and 1.507(a)(4)...
Disclosures that accompany               102,038               1         102,038            0.50          51,019
 assurances--1.507(a)(2),
 1.507(a)(3), and 1.507(a)(4)...
Document assurances from                  36,522             2.8         102,262            0.25          25,566
 customers--1.507(c)............
Document corrective actions--              2,340               1           2,340               2           4,680
 1.508(a) and 1.512(b)(4).......
Investigate and determine FSVP             2,340               1           2,340               5          11,700
 adequacy--1.508(b), 1.511(c)(1)
Written assurances for food               11,701            2.88          33,664            2.25          75,744
 produced under dietary
 supplement CGMPs--1.511(b).....
Document very small importer/             50,450               1          50,450               1          50,450
 certain small foreign supplier
 status--1.512(b)(1)............
Written assurances associated             50,450             2.8         141,084            2.25         317,439
 with very small importer/
 certain small foreign supplier--
 1.512(b)(3)....................
                                 -------------------------------------------------------------------------------
    Total
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

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 part 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 Sec.  1.502(a). As shown in Table 5, we 
estimate that there are 2,443 importers of LACF importing an estimated 
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) requires 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 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 Sec. Sec.  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 Sec.  1.505(a). As shown in 
table 5, we estimate that it will 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

[[Page 74336]]

burden of 98,292 hours (32,764 hours annualized).
    Section 1.505(c) requires that the importer reevaluate 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 and 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 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 estimate 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 
evaluation 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 Sec.  1.506(a)(1), importers must establish 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 Sec.  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), 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 procedures 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 annualized.
    Under Sec.  1.506(a)(2), an importer may rely on an entity other 
than the foreign supplier to establish the procedures and perform and 
document the activities required under Sec.  1.506(a)(1) provided that 
the importer reviews and assesses that entity's documentation of the 
procedures and activities, 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 11,701 hours (3,900 hours 
annualized).
    Under Sec. Sec.  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 
adequate assurances that the hazards requiring a control in the food 
the importer bring into the United States have been significantly 
minimized or prevented. Under Sec.  1.506(d)(2), 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, the importer must conduct or obtain documentation of an onsite 
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 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 3.25 hours to determine and document 
appropriate supplier verification activities under either Sec.  
1.506(d)(1) or (2) or Sec.  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 Sec. Sec.  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 Sec.  1.506(e)(1)(i) or Sec.  1.511(c)(5)(i)(A), an importer 
may conduct (and document) or obtain documentation of an 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 Sec.  1.506(e)(1)(ii) or Sec.  1.511(c)(5)(i)(B), an importer 
may conduct (and document) or obtain 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 estimate 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.
    Under Sec.  1.506(e)(1)(iii) or Sec.  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 Sec.  1.506(e)(1)(iv) or Sec.  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 any alternative verification procedure nor 
included an estimated cost, nor have we estimated any associated burden 
for revised Sec.  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 Sec.  1.506(e)(1), or that are

[[Page 74337]]

conducted by other entities in accordance with Sec.  1.506(e)(2), and 
to document the 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 
accordance with Sec.  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 Being 
Controlled or for Which Hazards Are Controlled After Importation

    Section 1.507 of the final rule includes provisions for activities 
that were partially addressed under the proposed rule and the 
supplemental notice of proposed rulemaking. Under Sec.  1.507(a)(1) of 
the final rule, an importer is not required to conduct a food and 
foreign supplier evaluation under Sec.  1.505 or conduct supplier 
verification activities under Sec.  1.506 if it determines and 
documents that the type of food it is importing could not be 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, to make the determination, resulting 
in a total annual burden of 46,353 hours.
    Under Sec.  1.507(a)(2), an importer is not required to conduct an 
evaluation under Sec.  1.505 or verification activities under Sec.  
1.506 if it relies on its customer who is subject to subpart 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 that 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 minimize or prevent the 
hazard.
    Under Sec.  1.507(a)(3), an importer is not required to conduct an 
evaluation under Sec.  1.505 or verification activities under Sec.  
1.506 if it relies on its customer who is not required to implement 
preventive controls under part 117 or part 507 to provide assurance it 
is 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 [identified 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 Sec.  1.507(a)(4), an importer is not required to conduct an 
evaluation under Sec.  1.505 or verification activities under Sec.  
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 will 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 identified 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 part 507); or (2) obtain a similar written assurance from the 
entity's customer as required under Sec.  1.507(a)(4)(ii)(A) or (B).
    As shown in table 5, we estimate that 11,701 importers will obtain 
such a written assurance from 102,038 customers annually in accordance 
with Sec.  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 also 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 Sec.  1.507(a)(5), an importer is not required to conduct an 
evaluation under Sec.  1.505 or verification activities under Sec.  
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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 included in the final 
rule and we have therefore 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 
corrective 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 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. Such 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. As shown in table 5, we 
estimate that 2,340 importers will need to take a corrective action 1 
time annually, 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 Sec.  1.506 or 
Sec.  1.511(c) or a reevaluation conducted under Sec.  1.505(c) or (d), 
that one of its foreign suppliers does not produce food using processes 
and procedures that provide the same level

[[Page 74338]]

of public health protection as those required under section 418 or 419 
of the FD&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 
importers will need to conduct an investigation once a year to 
determine the adequacy of their FSVP in accordance with Sec.  1.508(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 Supplement CGMP Requirements

    Section 1.511 sets forth modified FSVP requirements for food that 
is subject to certain dietary supplement CGMP requirements. Under Sec.  
1.511(a), importers who are required to establish specifications under 
Sec.  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, and are in 
compliance with the requirements in Sec. Sec.  111.73 and 111.75 
applicable to determining whether those specifications are met, must 
comply with the requirements under Sec. Sec.  1.503 and 1.509, but are 
not required to comply with the requirements in Sec. Sec.  1.502, 
Sec. Sec.  1.504 through 1.508, or Sec.  1.510. These importers are 
included in the estimated reporting burden for Sec.  1.509(a).
    Under Sec.  1.511(b), if an importer's customer is required to 
establish specifications under Sec.  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 
Sec. Sec.  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 Sec. Sec.  1.503, 1.509, and 1.510, but is not 
required to comply with the requirements in Sec. Sec.  1.502 and 
Sec. Sec.  1.504 through 1.508. As shown in table 5, we estimate that 
5,574 importers would need to obtain written assurance from an average 
of 6 customers in accordance with Sec.  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 Sec.  1.509(a).
    Under Sec.  1.511(c), importers of other dietary supplements, 
including ``finished'' dietary supplements (i.e., packaged and labeled 
dietary supplements that are 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 procedures to ensure that 
food is imported only from foreign suppliers that have been approved 
for use based on the evaluation conducted under Sec.  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 Sec.  1.506(a)(1).
    Under Sec.  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 Sec.  
1.511(c)(2)(i) provided that the importer reviews and assesses that 
entity's documentation of the procedures and activities, and the 
importer document its review and assessment. This burden is captured in 
the burden calculated for Sec.  1.506(a)(2).
    Section 1.511(c)(3) requires importers of finished dietary 
supplements to establish and follow procedures for conducting foreign 
supplier verification activities. This burden is included in the burden 
calculated for Sec.  1.506(b).
    Section 1.511(c)(4)(i) requires importers of finished dietary 
supplements to determine and document which appropriate 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 Sec.  1.506(d)(1) and (2).
    Under Sec.  1.511(c)(4)(iii), a dietary supplement 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 Sec.  1.506(d)(3).
    For each dietary supplement imported in accordance with Sec.  
1.511(c), the importer would need to conduct one or more of the 
verification activities listed in Sec.  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 Sec.  1.506(e)(1)(i) through 
(e)(1)(iv), respectively.
    Section 1.511(c)(5)(iii) requires importers to promptly review and 
assess the results of the verification activities that they conduct or 
obtain documentation of under Sec.  1.511(c)(5)(i), or that are 
conducted by other entities in accordance with Sec.  1.511(c)(5)(ii), 
and to document the 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 
accordance with Sec.  1.510(b). This burden is included in the burden 
calculated for Sec.  1.506(e)(3).
    Section 1.511(c) also requires importers of finished dietary 
supplements to conduct evaluations of the foreign supplier, conduct 
investigations (in certain circumstances) 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 Sec. Sec.  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 modified proposed FSVP requirements for 
very small importers as defined in Sec.  1.500; food from a foreign 
supplier that is a qualified facility as defined by Sec.  117.3 or 
Sec.  507.3; produce from a farm that is not a covered farm under the 
produce safety regulation in accordance with Sec.  112.4(a), or in 
accordance with Sec. Sec.  112.4(b) and 112.5; or shell eggs from an 
egg producer with fewer than 3000 laying hens. Under Sec.  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 Sec.  1.512, the 
importer would be required to document, at the end of each calendar 
year, that it meets the definition of very small importer in Sec.  
1.500 or that the foreign supplier

[[Page 74339]]

meets the criteria in Sec.  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 Sec.  1.512(b)(3), each very small importer or importer of 
food from foreign suppliers that meet the criteria in Sec.  
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 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 applicable requirements 
or acknowledges that it is subject to applicable standards (as 
specified in Sec.  1.512(b)(3)(ii) 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 Sec.  1.508(a).
    Section 1.512(c) sets forth requirements that apply to importers of 
food from the specified types of small foreign suppliers, but not to 
very small importers. Under Sec.  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 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, and 
document the evaluation. We include this burden in our calculation of 
the burden associated with Sec.  1.505(a)(2) in table 5.
    Under Sec.  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, and the reevaluation must be 
documented. Section 1.512(c)(1)(ii)(A) further requires that if the 
importer determines 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. We include these burdens in 
our calculation of the burdens associated with Sec.  1.505(c) in table 
5.
    Section 1.512(c)(1)(ii)(A) further requires that if the importer 
determines 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 
Sec.  1.505(c) in table 5.
    Under Sec.  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 and 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 Sec.  1.505(d) in 
table 5.
    Under Sec.  1.512(c)(2), the importer of a food from certain 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 Sec.  1.505(b).
    Under Sec.  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 distributing). Importers must document their 
use of these procedures. We include this burden in our calculation of 
the burden associated with Sec.  1.506(a)(1).
    Under Sec.  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 Sec.  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 Sec.  1.506(a)(2).

I. Food Imported From a Country With an Officially Recognized 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 
equivalent to that of the United States. If such importers meet certain 
conditions or requirements, they will not be required to comply with 
the requirements in Sec. Sec.  1.504 through 1.508, but they will be 
required to comply with Sec. Sec.  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 recognized 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 compliance standing, as defined 
in Sec.  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 indicates 
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 United 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 safety 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 Sec.  
1.513.
    The information collection provisions of this final rule have been 
submitted to OMB for review. Prior to the effective

[[Page 74340]]

date of this final rule, FDA will publish a notice in the Federal 
Register announcing OMB's decision to approve, modify, or disapprove 
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 direct effects on the 
States, on the relationship between the National Government 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, consequently, 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., Monday 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/sps_e/spsagr_e.htm), 1994.
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/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/UCM373333.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.codexalimentarius.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 Alimentarius 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/R43358.pdf), January 10, 2014.
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 Chemical, 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 Food and Drug 
Administration Amendments Act of 2007'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/RFR/ucm180761.htm), September 2009.
15. FDA, ``FDA's International Food Safety Capacity-Building Plan'' 
(http://www.fda.gov/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, 
2013.
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 (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 
Executive Order 12866, Executive Order 13563, the Regulatory 
Flexibility Act (5 U.S.C. 601-612), the Unfunded Mandates Reform Act 
of 1995 (Pub. L. 104-4), and the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3520),'' Docket No. FDA-2011-N-0143.

List of Subjects

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:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 is revised to read as 
follows:

    Authority:  15 U.S.C. 1333, 1453, 1454, 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.


0
2. Add subpart L, consisting of Sec. Sec.  1.500 through 1.514, to read 
as follows:
Subpart L--Foreign Supplier Verification Programs for Food 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 activities?
1.504 What hazard analysis must I conduct?

[[Page 74341]]

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 import 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?
1.512 What FSVP may I have if I am a very small importer or if I am 
importing certain 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


Sec.  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 examination 
(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 dietary supplement. Dietary 
supplement components include dietary ingredients (as described in 
section 201(ff) of the Federal Food, Drug, and Cosmetic Act) and other 
ingredients.
    Environmental pathogen means a pathogen that is capable of 
surviving and persisting 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 register 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 Sec.  1.227.
    Farm mixed-type facility means an establishment that is a farm but 
that also conducts 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 food 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.
    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 which 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 preparing 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 the 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., 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 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.
    Hazard requiring a control 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 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 storage tanks.

[[Page 74342]]

    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 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 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 and 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 
manufacturing/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, washing, 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, culling, grading, and weighing or conveying incidental to 
packing or re-packing)), 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.
    Pathogen means a microorganism of public health significance.
    Qualified auditor means a person who is a qualified individual as 
defined in this section and has technical expertise obtained through 
education, training, or experience (or a combination thereof) necessary 
to perform the auditing function as required by Sec.  1.506(e)(1)(i) or 
Sec.  1.511(c)(5)(i)(A). Examples of potential qualified auditors 
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, 
training, 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, but 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 minimize biological hazards.
    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 the 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.


Sec.  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 apply to all food imported or offered for 
import into the United States and to the importers of such food.
    (b) Exemptions for juice and seafood--(1) Importers of certain 
juice and seafood products. This subpart does not apply with respect 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 are subject to part 120 or part 
123, respectively, you must comply with the requirements applicable to 
importers of those products under Sec.  120.14 or Sec.  123.12 of this 
chapter, respectively.
    (2) Certain importers of juice or seafood raw materials or other 
ingredients subject to part 120 or part 123 of this chapter. This 
subpart does 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 subject 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 for food imported for research or evaluation. This 
subpart does 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
    (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 does not apply to food that is imported

[[Page 74343]]

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 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.
    (e) Exemption for alcoholic beverages. (1) This subpart does not 
apply with 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 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
    (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 does 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:
    (i) Is in prepackaged form that prevents 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 does not apply with respect to raw materials and 
other ingredients 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, or 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 Sec.  117.5(i) of this chapter.
    (f) Inapplicability to food that is transshipped or imported for 
processing and export. This subpart does not apply to food:
    (1) That is transshipped through the United States to another 
country and is not sold or distributed to the 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 does not 
apply to food that is manufactured/processed, raised, or grown in the 
United States, exported, and returned to the United States without 
further manufacturing/processing in a foreign country.
    (h) Inapplicability to certain meat, poultry, and egg products. 
This subpart does 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 Inspection Act (21 
U.S.C. 1031 et seq.).


Sec.  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 provides 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 applicable) (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 processing. With respect to 
those microbiological hazards that are controlled by part 113 of this 
chapter, if you import a thermally processed low-acid food 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 
to 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 or 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 microbiological 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 
Sec.  1.509, if you are a receiving facility as defined in Sec.  117.3 
or Sec.  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 Sec.  117.135 or Sec.  507.34 of this chapter;
    (2) You are not required to implement a preventive control under 
Sec.  117.136 or Sec.  507.36 of this chapter with respect to the food; 
or
    (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.


Sec.  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 required 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 Sec.  1.506(e)(1)(i) or Sec.  
1.511(c)(5)(i)(A). A qualified auditor must have technical

[[Page 74344]]

expertise obtained through education, training, or experience (or a 
combination thereof) necessary to perform the auditing function.


Sec.  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:
    (i) Biological hazards, including microbiological 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 following 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 
evaluation 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:
    (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 individual, 
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 and 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 commodities 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 Sec.  
112.3 of this chapter, you are not required to determine whether there 
are any 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 control, you are not required to conduct an 
evaluation for foreign supplier approval and verification under Sec.  
1.505 and you are not required to conduct foreign supplier verification 
activities under Sec.  1.506. This paragraph (f) does not apply if the 
food is a raw agricultural commodity that is a fruit or vegetable that 
is ``covered produce'' as defined in Sec.  112.3 of this chapter.


Sec.  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 for 
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 
Sec.  1.504, including the nature of the hazard requiring a control.
    (ii) The entity or entities that will be 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 another entity in your supply chain.
    (iii) Foreign supplier performance, including:
    (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 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 
information relevant to the supplier's compliance with those laws and 
regulations); and
    (C) The foreign supplier'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 appropriate 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

[[Page 74345]]

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 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 whether the supplier verification activities conducted under Sec.  
1.506 or Sec.  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 
paragraph (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 described 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 document 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 conduct foreign 
supplier verification activities under Sec.  1.506 if one of the 
circumstances described in Sec.  1.507 applies to your importation of a 
food and you are in compliance with that section.


Sec.  1.506  What foreign supplier verification and related activities 
must I conduct?

    (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 Sec.  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 review 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 paragraphs (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 paragraph (c) of this section. Verification activities must 
address the entity or entities that are significantly minimizing or 
preventing the hazards or verifying that the hazards have been 
significantly minimized or prevented (e.g., when an entity other than 
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 material 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 Sec.  1.505.
    (ii) Appropriate verification activities. 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 foreign 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 must 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 auditing are appropriate to 
provide adequate assurances that the foreign supplier is producing the 
food in accordance with paragraph (c) of this section, based on the 
determination made under Sec.  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 section 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 your 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 provided 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 being controlled 
(or, when applicable, an onsite audit may consider relevant laws

[[Page 74346]]

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).
    (C) If the onsite 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 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 recognition or 
equivalence determination, and the foreign supplier is in, and under 
the regulatory oversight of, such country.
    (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 identifying 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, 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 
significant deficiencies identified during the review, and 
documentation that the review was conducted by a qualified 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 this section, you may 
rely on supplier verification activities conducted in 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 section.
    (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 accordance 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 foreign supplier have been significantly 
minimized or prevented, you must take appropriate action in accordance 
with Sec.  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 Sec.  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.


Sec.  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 Sec.  1.505 or supplier verification 
activities under Sec.  1.506 when you identify a 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 will 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 customer 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 the 
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) Annually obtain from your customer written assurance that it 
is manufacturing, processing, or preparing the food in accordance with 
applicable food safety requirements;
    (4) You rely on your 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 you:

[[Page 74347]]

    (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 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, that 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 applicable 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 customer, 
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 distribution step, of the hazards in 
the food you distribute and you document your implementation of that 
system.
    (b) Written assurances. Any written assurances required under this 
section must contain the following:
    (1) Effective date;
    (2) Printed names and 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 paragraph (a)(2), (3), or (4) of this section must act 
consistently with the assurance and document its actions taken to 
satisfy the written assurance.


Sec.  1.508  What corrective actions must I take under my FSVP?

    (a) You must promptly take appropriate corrective 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 Sec.  1.506 or Sec.  1.511(c), a reevaluation of the 
risks posed by the food and the foreign supplier's performance 
conducted under Sec.  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 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 Sec.  1.506 or Sec.  1.511(c) or a 
reevaluation conducted under Sec.  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 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, 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.


Sec.  1.509  How must the importer be identified at entry?

    (a) You must ensure that, for each line entry of 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 with 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 U.S. agent or 
representative as the importer of the food for the purposes of the 
definition of ``importer'' in Sec.  1.500.


Sec.  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 photocopies, 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 Sec.  1.504, Sec.  1.505, or Sec.  
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 writing 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.
    (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 evaluations 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 and 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 meet the 
definition of electronic

[[Page 74348]]

records in Sec.  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 provisions 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.
    (f) Public disclosure. Records obtained by FDA in accordance with 
this subpart are subject to the disclosure requirements under part 20 
of this chapter.


Sec.  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 subject to certain dietary supplement current good 
manufacturing regulations. If you are required to establish 
specifications under Sec.  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 Sec. Sec.  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 
Sec. Sec.  1.503 and 1.509, but you are not required to comply with the 
requirements in Sec.  1.502, Sec. Sec.  1.504 through 1.508, or Sec.  
1.510. This requirement does not limit your obligations with respect to 
part 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 Sec.  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 Sec. Sec.  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 in Sec. Sec.  1.503, 1.509, and 1.510, but you are not 
required to comply with the requirements in Sec.  1.502 or Sec. Sec.  
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 Sec. Sec.  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 Sec. Sec.  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 suppliers. (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 Sec.  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 procedures 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 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.
    (4) Determination of appropriate foreign supplier 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 Sec.  
1.505.
    (ii) Appropriate verification activities. The following are 
appropriate supplier verification 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 (including 
the frequency with which such activities must be conducted) is 
appropriate based on the evaluation conducted in accordance with Sec.  
1.505. You must document your review and assessment, including 
documenting that the determination of appropriate verification 
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 section, 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 auditing. 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 requirements 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

[[Page 74349]]

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 that 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 
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.
    (5) 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:
    (i) The written results of appropriate inspection of the foreign 
supplier for compliance with the applicable 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 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 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 
oversight of, such country.
    (B) Sampling and testing of the food. You must retain documentation 
of each sampling and testing of a dietary supplement, 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 identifying the laboratory conducting 
the testing, and documentation that the testing was conducted by a 
qualified individual.
    (C) Review of the 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 significant 
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 conducted 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 identified, 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 supplier 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. You 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 section. 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 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 
Sec.  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 Sec.  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.


Sec.  1.512  What FSVP may I have if I am a very small importer or I am 
importing certain food from certain 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 
Sec.  117.3 or Sec.  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 Sec.  112.4(a) of this chapter, or in 
accordance with Sec. Sec.  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.
    (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 Sec.  
1.500 with respect 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

[[Page 74350]]

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 annual 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 the requirements in Sec. Sec.  1.502, 
1.503, and 1.509, but you are not required to comply with the 
requirements in Sec. Sec.  1.504 through 1.508 or Sec.  1.510.
    (3) Foreign supplier verification activities. (i) If you are a very 
small importer, for each food you import, you 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, Drug, and Cosmetic Act.
    (ii) If your foreign supplier is a qualified facility as defined by 
Sec.  117.3 or Sec.  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 at 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 recognized 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 food; 
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.
    (iii) If your foreign supplier is a farm that grows produce and is 
not a covered farm under part 112 of this chapter in accordance with 
Sec.  112.4(a) of this chapter, or in accordance with Sec. Sec.  
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 requirements 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 
shell 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 recognized 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 consistent with the assurance provided 
in accordance with Sec.  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 with this paragraph (b)(4). This paragraph (b)(4) does not 
limit your obligations with respect to other laws enforced by FDA, such 
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 translation 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 onsite 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 means 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 
under this subpart for a period of at least 2 years after you created 
or obtained the records.
    (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 evaluations 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 of 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 established or maintained 
to satisfy the requirements of this subpart and that meet the 
definition of electronic records in Sec.  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 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.

[[Page 74351]]

    (vi) Public disclosure. Records obtained by FDA in accordance with 
this subpart are subject to the disclosure requirements under part 20 
of this chapter.
    (c) Requirements for importers of food from certain small foreign 
suppliers. The following additional 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 
evaluation. 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 warning 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 Sec.  
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 new 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 document) 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 accordance with paragraph (c)(1)(ii)(A). You must 
document your reevaluation and any subsequent actions you take in 
accordance with paragraph (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 assessment, 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 from 
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) 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.


Sec.  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 required to comply with the requirements in Sec. Sec.  1.504 
through 1.508. You would still be required to comply with the 
requirements in Sec. Sec.  1.503, 1.509, and 1.510.
    (2) This section applies to food that is not intended for further 
manufacturing/processing, including 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 document 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. The appropriate corrective action will depend on the 
circumstances but could include discontinuing use of the foreign 
supplier. You must document any corrective actions that you undertake 
in accordance with this paragraph (b)(2).


Sec.  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 Sec.  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

0
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.

[[Page 74352]]


0
4. In Sec.  11.1, add and reserve paragraph (h) and (k) and add 
paragraph (l) to read as follows:


Sec.  11.1  Scope.

* * * * *
    (l) This part does not apply to records required to be established 
or maintained by subpart L of part 1 of this chapter. 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 MANUFACTURING, 
PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

0
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.

0
6. In Sec.  111.5, add a sentence after the existing sentence to read 
as follows:


Sec.  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 11-13-15; 8:45 am]
 BILLING CODE 4164-01-P