[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Rules and Regulations]
[Pages 74225-74352]
[FR Doc No: 2015-28158]

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

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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,<PHONE_NUMBER>; 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,<PHONE_NUMBER>.

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

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

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

    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.

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

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

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

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

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.

    (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

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

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.

    (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

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

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

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

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.

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