[Federal Register Volume 78, Number 145 (Monday, July 29, 2013)]
[Proposed Rules]
[Pages 45729-45779]
[FR Doc No: 2013-17993]

Vol. 78

Monday,

No. 145

July 29, 2013

Part III

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Part 1

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

Federal Register / Vol. 78 , No. 145 / Monday, July 29, 2013 /
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to adopt
regulations on foreign supplier verification programs (FSVPs) for
importers of food for humans and animals. The proposed regulations
would require importers to help ensure that food imported into the
United States is produced in compliance with processes and procedures,
including reasonably appropriate risk-based preventive controls, that
provide the same level of public health protection as those required
under the hazard analysis and risk-based preventive controls and
standards for produce safety sections 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 proposing these
regulations in accordance with the FDA Food Safety Modernization Act
(FSMA). The proposed regulations would help ensure that imported food
is produced in a manner consistent with U.S. standards.

DATES: Submit either electronic or written comments on the proposed
rule by November 26, 2013.

ADDRESSES: You may submit comments on this proposed rule, identified by
Docket No. FDA-2011-N-0143 and/or Regulatory Information Number (RIN)
0910-AG64, by any of the following methods, except that comments on
information collection issues under the Paperwork Reduction Act of 1995
must be submitted to the Office of Regulatory Affairs, Office of
Management and Budget (OMB) (see the ``Paperwork Reduction Act of
1995'' section of this document).

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency
name, Docket No. FDA-2011-N-0143, and RIN 0910-AG64 for this
rulemaking. All comments received may be posted without change to
http://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
    Docket: 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 document 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 of the Proposed Rule
    Summary of Major Provisions
    Modified Provisions for Certain Types of Importers
    Costs and Benefits
I. Background
    A. Background and Legal Authority
    B. Considerations Regarding Verification of Compliance of
Imported Food With U.S. Requirements
    C. Principal Features of the Proposed Rule
II. Description of the Proposed Rule
    A. Definitions (Proposed Sec.  1.500)
    B. Applicability and Exemptions (Proposed Sec.  1.501)
    C. Scope of FSVP (Proposed Sec.  1.502)
    D. Personnel (Proposed Sec.  1.503)
    E. Review of Food and Foreign Supplier Compliance Status
(Proposed Sec.  1.504)
    F. Hazard Analysis (Proposed Sec.  1.505)
    G. Foreign Supplier Verification and Related Activities
(Proposed Sec.  1.506)
    H. Complaints, Investigations, and Corrective Actions (Proposed
Sec.  1.507)
    I. Reassessment of FSVP (Proposed Sec.  1.508)
    J. Identification of Importer at Entry (Proposed Sec.  1.509)
    K. Records (Proposed Sec.  1.510)
    L. Dietary Supplements and Dietary Supplement Components
(Proposed Sec.  1.511)
    M. Very Small Importers and Very Small Foreign Suppliers
(Proposed Sec.  1.512)
    N. Food From Countries With Officially Recognized or Equivalent
Food Safety Systems (Proposed Sec.  1.513)
    O. Consequences of Failure To Comply (Proposed Sec.  1.514)
III. Preliminary Regulatory Impact Analysis
    A. Overview
    B. Regulatory Flexibility Act
    C. Small Business Regulatory Enforcement Fairness Act of 1996
    D. Unfunded Mandates Reform Act of 1995
    E. Paperwork Reduction Act of 1995
    F. Public Access to the Analyses
IV. Analysis of Environmental Impact
V. Federalism
VI. Proposed Effective and Compliance Dates
VII. Comments
VIII. References

Executive Summary

Purpose of the Proposed Rule

    The proposed rule would adopt regulations on FSVPs that importers
must create and follow to help ensure the safety of imported food. The
proposed regulations 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 proposed regulations would require importers to
implement FSVPs that 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.

Summary of Major Provisions

    We are proposing a flexible, risk-based approach to foreign
supplier verification. The regulations focus on foreseeable food safety
risks identified through a hazard assessment process, rather than all
risks covered by the adulteration provisions in section 402 of the FD&C
Act. Because the principle of

hazard assessment is well accepted and understood throughout the
international food safety community (e.g., as a key component of hazard
analysis and critical control point (HACCP) and preventive controls
programs), we believe that it provides the most effective way to
implement a risk-based framework in which importers can evaluate
potential products and suppliers and conduct appropriate verification
efforts.
    The proposed FSVP regulations also align with key components of the
preventive controls programs that food manufacturers and processors
should follow to ensure food safety, as discussed in FDA's recently
issued proposed rule on current good manufacturing practice (CGMP) and
hazard analysis and risk-based preventive controls for human food. The
general FSVP framework, together with the modified provisions discussed
in the next section, are intended to be sufficiently general and
flexible to apply to a variety of circumstances without being unduly
burdensome or restrictive of trade.
    Although the FSVP requirements would apply to most imported food
under FDA's regulatory jurisdiction, certain categories of imported
food would not be covered under the FSVP regulations, as shown in
Diagram 1 below. (The diagrams set forth below are intended to
illustrate the FSVP requirements and do not include all aspects of the
proposed regulations.) These exemptions include certain juice, fish,
and fishery products (which are already subject to verification under
FDA's HACCP regulations), food for personal consumption, alcoholic
beverages, food that is transshipped, food that is imported for re-
export, and food for research or evaluation.
BILLING CODE 4160-01-P

[GRAPHIC] [TIFF OMITTED] TP29JY13.002

    The proposed FSVP regulations would require importers to:
    (1) Review the compliance status of foods and potential foreign
suppliers. Before importing a food from a foreign supplier, importers
would be required to review the compliance status of the food and the
foreign supplier, including whether either is the subject of an FDA
warning letter, import alert, or certification requirement relating to
the safety of the food. These documents are or would be available at
FDA's Web site.
    (2) Determine the hazards reasonably likely to occur with each
food. Importers could conduct their own analysis of the potential
hazards with a food or review and evaluate the hazard analysis
conducted by the food's foreign supplier.
    (3) Conduct supplier verification activities. Importers would need
to maintain a written list of foreign suppliers and establish written
verification procedures. Importers would need to verify that hazards
identified as reasonably likely to occur in a food they import are
being adequately controlled. If the importer or its customer is
controlling a hazard, the proposed rule would require the importer to
document such control. For other hazards, the proposed rule

presents two alternative proposals for requirements regarding
verification activities. Under Option 1 of this co-proposal, onsite
auditing of the foreign supplier would be required for hazards to be
controlled by the foreign supplier when there is a reasonable
probability that exposure to the hazard will result in serious adverse
health consequences or death. Onsite auditing also would be required
under Option 1 for microbiological hazards in certain raw agricultural
commodities (RACs) that are fruits or vegetables. Audits could be
conducted by auditors that are accredited in accordance with the
accreditation system that FDA is developing to implement section 307 of
FSMA, but the proposal would not require the use of accredited
auditors. Also, instead of an onsite audit, an importer could rely on
the results of an inspection of the foreign supplier conducted by FDA
or the food safety authority of a country whose food safety system FDA
has officially recognized as comparable or determined to be equivalent
to that of the United States.
    For other hazards, including less serious hazards and hazards that
the foreign supplier verifies have been controlled by its supplier,
importers would have the flexibility under Option 1 to choose the
verification activity or activities that will provide sufficient
assurance that the hazards are adequately controlled. These activities
could include onsite auditing of the foreign supplier, periodic or lot-
by-lot sampling and testing, periodic review of the supplier's food
safety records, and any other procedure that an importer has
established as being appropriate to verify adequate control of a
hazard.
    Option 2 of the co-proposal would allow importers to choose from
among these verification activities for all types of hazards not
controlled by the importer or its customer. In determining the
appropriate verification activities and how frequently they should be
conducted, the importer would need to consider the risk presented by
the hazard, the probability that exposure to the hazard will result in
serious harm, and the food and foreign supplier's compliance with U.S.
food safety regulations.
    (4) Review complaints, investigate adulteration or misbranding
(with respect to allergen labeling), and take corrective actions in the
case of supplier noncompliance.
    (5) Reassess the effectiveness of its FSVP when the importer
becomes aware of new information about potential hazards associated
with a food, or otherwise every 3 years.
    (6) Ensure that the importer's name and Dun and Bradstreet Data
Universal Numbering System (DUNS) number is provided for each line of
entry of food.
    (7) Maintain records of their FSVP activities.
    These ``standard'' FSVP requirements are summarized in Diagram 2
(under Options 1 and 2) below:

[GRAPHIC] [TIFF OMITTED] TP29JY13.003

[GRAPHIC] [TIFF OMITTED] TP29JY13.004

Modified Provisions for Certain Types of Importers

    We are proposing several exceptions to the standard FSVP
requirements for certain types of foods and importers. First, as shown
in Diagram 3 below, for dietary supplements and dietary supplement
components, importers who establish and verify compliance with certain
specifications (concerning dietary supplement components, labels,
packaging, and labeling) under the dietary supplement CGMP regulations
would not be required to comply with most of the standard FSVP
requirements, including hazard analysis and standard supplier
verification activities. The same 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. On
the other hand, importers of finished dietary supplements would be
required to comply with most of the standard FSVP requirements, but
they 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 regulations, rather than verifying that hazards identified as
reasonably likely to occur are being adequately controlled.
[GRAPHIC] [TIFF OMITTED] TP29JY13.005

    Second, as shown in Diagram 4 below, the proposed rule would
establish modified FSVP requirements for very small food importers and
importers of food from very small foreign suppliers (i.e., entities
with annual food sales of no more than $500,000). Because of the
relatively small volume of food imported by and from these entities,
which should reduce consumers' exposure to, and therefore potential
risk from, the imported food, we are proposing that in these situations
the importer would not be required to conduct hazard analyses and would
be able to verify their foreign suppliers by obtaining written
assurance that describes the processes and procedures the suppliers use
to ensure the safety of the food.

[GRAPHIC] [TIFF OMITTED] TP29JY13.006

    Third, as shown in Diagram 5 below, the proposed rule would exclude
from most of the standard FSVP requirements (including hazard analysis
and verification that identified hazards are adequately controlled)
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 FDA's official recognition
or equivalency determination regarding the food safety authority of the
country in which the foreign supplier is located; and
     The importer determines that the foreign supplier of the
food is in good compliance standing with the food safety authority of
the country in which the foreign supplier is located.

[GRAPHIC] [TIFF OMITTED] TP29JY13.007

BILLING CODE 4160-01-C

Costs and Benefits

    We summarize the annualized costs (over a 10-year time period
discounted at both 3 percent and 7 percent) of the two options for the
proposed rule in the table immediately below.

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                                                3 percent     7 percent
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Co-Proposal Option 1........................  $472,971,342  $473,380,038
Co-Proposal Option 2........................   461,407,455   461,821,706
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    Although the FSVP proposed rule would not itself establish safety
requirements for food manufacturing and processing, it would benefit
the public health by helping to ensure that imported food is produced
in compliance with other applicable food safety regulations. The
Preliminary Regulatory Impact Analyses for the proposed rules on hazard
analysis and preventive controls for human food and standards for
produce safety consider and analyze the number of illnesses and deaths
that the proposed 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
proposed rule on FSVPs is an important mechanism for improving and
ensuring compliance with the above-noted food safety regulations as
they apply to imported food. For this reason, we account for the public
health benefits of the FSVP proposed rule in the preventive controls,
produce safety, and other applicable food safety regulations instead of
in this rule.

I. Background

A. Background and Legal Authority

    In fiscal year 2011, nearly 10.5 million product lines of food
(representing unique food products) were imported into the United
States (Ref. 1). Human and animal food constitutes nearly 40 percent of
all imported product lines regulated by FDA. About 15 percent of all
food consumed in the United States is imported, including approximately
50 percent of fresh fruit and 20 percent of fresh vegetables (Ref. 2).
    Each year, about 48 million Americans (1 in 6) get sick, 128,000
are hospitalized, and 3,000 die from foodborne diseases, according to
estimates from the Centers for Disease Control and Prevention (CDC).
Several foodborne disease outbreaks have been traced to imported food,
including

outbreaks resulting from consumption of imported fruits, vegetables,
and nuts (Ref. 3).
    FSMA (Pub. L. 111-353), signed into law by President Obama on
January 4, 2011, enables FDA to better protect public health by helping
to ensure the safety and security of the U.S. food supply, including
both domestic and imported food. FSMA enables us to focus more on
preventing food safety problems rather than primarily reacting to
problems after they occur. The law also provides us with new
enforcement authorities to help us achieve higher rates of compliance
for both domestic and imported food with prevention- and risk-based
safety standards and to better respond to and contain problems when
they do occur.
    Section 301 of FSMA adds 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 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 (21 U.S.C. 350g and 350h), as appropriate; (2)
the food is not adulterated under section 402 of the FD&C Act (21
U.S.C. 342); and (3) the food is not misbranded under section 403(w) of
the FD&C Act (21 U.S.C. 343(w)) (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
shall require that the FSVP of each importer be adequate to provide
assurances that each of the importer's foreign suppliers produces food
in compliance with processes and procedures, including risk-based
preventive controls, that provide the same level of public health
protection as those required under sections 418 or 419 of the FD&C Act,
as appropriate, and in compliance with sections 402 and 403(w) of the
FD&C Act. Section 805(c)(2)(B) states that these regulations shall
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(g) directs FDA to publish and maintain a list of importers
participating under this section 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 shall 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
(adding section 805 of the FD&C Act) to issue these proposed
regulations, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) gives us
the authority to promulgate regulations for the efficient enforcement
of the FD&C Act. Also, some aspects of the proposed FSVP regulations
are being issued under section 421(b) of the FD&C Act (21 U.S.C.
350j(b)).
    Section 805(b) of the FD&C Act (in section 301(a) of FSMA) directs
FDA to issue guidance to assist importers in developing FSVPs. We
intend to issue guidance that will provide importers with
recommendations on how to comply with the various aspects of the FSVP
requirements. We intend to issue a draft FSVP guidance that addresses
the final, rather than proposed, regulations. We plan to issue the
draft guidance concurrently with the final rule because we believe that
this would facilitate more meaningful review and comment on the draft
guidance. We anticipate that we will publish the finalized FSVP
guidance before importers would be required to come into compliance
with the FSVP regulations. We invite comment on our proposed approach
to issuance of the draft and final FSVP guidances.

B. Considerations Regarding Verification of Compliance of Imported Food
With U.S. Requirements

    The proposed FSVP regulations 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 FSVP regulations are intended to work in
tandem with other 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 proactive and risk-based
approach that assigns to the food industry the primary responsibility
for food safety. The use of preventive controls, which is one of the
significant elements of this approach, is not new to FDA or the
industry. FDA's regulations on the processing of juice and seafood
products under HACCP systems, as well as our regulations on thermally
processed low-acid foods packaged in hermetically sealed containers
(low-acid canned foods or LACF), are examples of preventive controls
regulations that we have issued to help ensure that those sectors of
the food industry meet their obligation to produce safe food.
    FSMA specifies additional explicit responsibilities for the rest of
the food industry by emphasizing the use of prevention-oriented
standards. In particular, FSMA requires food facilities that
manufacture, process, pack, and hold food to implement hazard analysis
and risk-based preventive controls (in section 103 of FSMA, codified in
section 418 of the FD&C Act), with certain exceptions. FSMA also
requires FDA to establish science-based, minimum standards for those
that grow, harvest, pack, and hold produce (i.e., RACs that are fruits
or vegetables) on a farm (also with certain exceptions) (in section 105
of FSMA, codified in section 419 of the FD&C Act). The intent of these
requirements is to ensure that all segments of the food industry meet
their responsibility under the FD&C Act to produce safe food.
1. Regulatory Approaches to Domestic and Imported Food
    Although FDA applies the same safety standards to domestic and
imported food marketed in the United States, we have long taken
different regulatory compliance approaches to products produced
domestically and abroad.
    The logistics associated with conducting foreign inspections in
most countries make the kind of unannounced routine inspections of
establishments that FDA conducts domestically almost impossible. The
same is true of ``for cause'' inspections when we have evidence of a
compliance problem. FDA also has to overcome very

significant hurdles to conduct foreign civil and criminal
investigations and prosecutions when violations occur.
    These difficulties associated with foreign inspection and
enforcement are compounded by the number of foreign firms. There are
more foreign firms registered with FDA than domestic firms (even though
fewer kinds of foreign firms are required to register).\1\ In addition,
FDA is able to physically examine only a small fraction of the food
that is offered for import into this country. The number of food import
lines has grown significantly over the past decade, reaching nearly
10.5 million lines in fiscal year 2011, and we expect this trend to
continue in the coming years (Ref. 1; Ref. 2). Finally, foreign firms
can be located in places with limited infrastructure where food safety
regulatory mandates may lack requirements for risk-based preventive
controls or other measures, such as export programs, that provide food
safety assurances.
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    \1\ Unlike domestic facilities, a foreign facility is not
required to register with FDA if the food undergoes further
manufacturing/processing (other than de minimis) outside the United
States (21 CFR 1.226).
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    FSMA seeks to create a strong preventive system that places primary
responsibility for food safety on industry, but also continues the
practice, accepted by the Codex Alimentarius Commission (Codex) (see
section I.B.3 of this document), of using a different compliance
approach for imported food. For inspections, section 201 of FSMA
requires that FDA increase the frequency of inspections at all
facilities, but prescribes different rates for domestic and foreign
facilities. More specifically, FDA is to inspect domestic high-risk
facilities at least every 3 years, after an initial inspection within
the first 5 years of FSMA's enactment. For domestic non-high-risk
facilities, we must inspect at least every 5 years, after an initial
inspection within the first 7 years of enactment. In contrast, FSMA
only requires that we conduct at least 600 foreign inspections in the
first year after enactment, and then doubles that inspection
requirement each year for the next 5 years. In 2016, FDA would be
required to do 19,200 foreign inspections.\2\ Because there are
currently more than 250,000 foreign food facilities registered to
export food to the United States (in contrast to approximately 167,000
domestic food facilities) (Ref. 1), even completing 19,200 foreign
inspections in 2016 would translate to a statutory inspection rate of
less than once every 10 years.
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    \2\ The Agency's ability to fully meet the foreign facility
inspection requirements is contingent upon having adequate
resources.
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    The preventive controls and produce safety regulations discussed in
section I.B.2 of this document, which are cornerstones of FSMA's strong
preventive system and place primary responsibility for food safety on
industry, will also apply somewhat differently to domestic and foreign
producers. Under FSMA, with limited exceptions, preventive controls
must be adopted by firms that are required to register with FDA. For
U.S. firms, that means that most domestic facilities that manufacture,
process, pack, or hold food must implement preventive controls. In
contrast, under section 418 of the FD&C Act, far fewer foreign firms
will be subject to preventive controls requirements. The only foreign
firms that will be subject to those requirements are those facilities
that export to the United States without further manufacturing/
processing by another facility, except for the addition of labeling or
any similar activity of a de minimis nature (section 418; 21 CFR 1.225
and 1.226).
    Because of the different challenges to U.S. government oversight of
foreign food establishments exporting to the United States, FSMA
includes several provisions that focus on imported food, including the
requirement that importers establish FSVPs. FSMA also states (in
section 404) that the provisions of the act and any amendments to the
FD&C Act may not be construed in a way that is inconsistent with the
agreement establishing the World Trade Organization (WTO) or any other
treaty or international agreement to which the United States is a
party. The FSVP provisions in FSMA ensure that U.S. importers, who are
domestic entities, share responsibility for food safety with the
foreign suppliers of those foods by requiring that importers perform
risk-based supplier verification activities. This requirement, in
conjunction with FDA oversight of importers, is vital to ensuring a
consistent level of protection for domestic and imported foods.
    FSMA's FSVP provisions build on existing approaches to importer
regulation. Importers of juice and certain seafood products have for
more than a decade been required to comply with FDA regulations
designed to help ensure that these imported products are processed in
accordance with regulations on HACCP systems for juice and seafood
products in parts 120 and 123 of FDA's regulations (Title 21 of the
Code of Federal Regulations) (21 CFR parts 120 and 123), respectively.
The regulations applicable to seafood importers in Sec.  123.12 became
effective on December 18, 1997 (see 60 FR 65096, December 18, 1995),
and the regulations applicable to juice importers in Sec.  120.14
became effective on January 22, 2002 (see 66 FR 6138, January 19,
2001). The principal components of both the juice and seafood importer
requirements are as follows:
     Establish product specifications designed to ensure that
each product is not adulterated.
     Implement affirmative steps to ensure that products being
offered for entry into the United States were processed under controls
that meet the requirements of the relevant HACCP regulations.
     Have evidence that products offered for U.S. entry have
been processed under conditions that comply with the applicable HACCP
regulations.
2. Proposed Rules on Preventive Controls and Produce Safety
    The understanding that the principal responsibility for food safety
resides with industry forms the basis of our proposed regulations
implementing not only the FSVP provisions but also the preventive
controls and produce safety provisions of FSMA. On January 16, 2013,
FDA published, in accordance with section 418 of the FD&C Act, a
proposed rule on CGMP and hazard analysis and risk-based preventive
controls for human food (the ``Preventive Controls Proposed Rule'') (78
FR 3646). On the same date that we published the Preventive Controls
Proposed Rule, we also published, in accordance with section 419 of the
FD&C Act, a proposed rule on standards for the growing, harvesting,
packing, and holding of produce for human consumption (the ``Produce
Safety Proposed Rule'') (78 FR 3503). Although Congress did not
specifically direct us to include provisions on supplier verification
in the preventive controls regulations (in contrast to its directive to
establish FSVP regulations), section 103(a) of FSMA (section 418(o)(3)
of the FD&C Act) states that supplier verification activities that
relate to the safety of food are included among the appropriate
preventive controls procedures, practices, and processes that might be
used by food manufacturers and processors. Approval and verification of
suppliers of raw materials and ingredients is widely accepted in the
domestic and international food safety community, and, as stated in the
Preventive Controls Proposed Rule, we believe that such programs are an
important part of an effective preventive controls approach.

    Therefore, although we did not propose specific regulations on
supplier verification in the Preventive Controls Proposed Rule, we
requested comment on when and how approval and verification of
suppliers of raw materials and ingredients are an appropriate part of
preventive controls (78 FR 3646 at 3665 to 3667). We sought comment on
several different aspects of supplier approval and verification
programs, including whether to require that a facility consider
regulatory information about the supplier, whether to specify that the
type of verification conducted be linked to the seriousness of the
hazard in a food, and whether to specify the frequency with which
verification activities should be conducted. In addition, we stated
that ``FDA intends to align regulations implementing supplier
verification under section 418 and regulations implementing FSVP under
section 805 to the fullest extent'' to avoid imposing duplicative
requirements on entities under those regulations (because they are both
a registered food facility and a food importer). We also emphasized the
importance of ensuring that any supplier verification provisions that
are included in the preventive controls and FSVP regulations comport
with U.S. international obligations, including those under the WTO's
Agreement on the Application of Sanitary and Phytosanitary Measures
(SPS Agreement) (78 FR 3646 at 3767). Elsewhere in this document, we
discuss particular areas where we believe it is important to coordinate
the FSVP and preventive controls regulations.
3. Consistency With Relevant International Standards and Agreements
    As noted previously, section 404 of FSMA states that the provisions
of FSMA are not to be construed in a manner inconsistent with U.S.
international obligations. As a WTO Member, the United States must act
consistently with all WTO obligations, including those contained in the
SPS Agreement (Ref. 4). FSMA was notified to the WTO on February 14,
2011 (G/SPS/N/USA/2156) (Ref. 5), to provide information on the act to
WTO Members. The notification included an electronic mailbox link to
receive comments from Members. Several comments have been received via
the mailbox. The comments note a high degree of interest in FSMA
implementation, particularly with respect to how implementation will
impact developing countries.
    The proposed FSVP regulations recognize the relevance of the work
of Codex in establishing international food safety standards,
guidelines, and recommendations. Codex was formed in 1963 by the Food
and Agriculture Organization and the World Health Organization of the
United Nations to develop food standards, guidelines, and related texts
such as codes of practice, and is recognized by the WTO as the
international standards organization for food safety. In describing the
general characteristics of food import control systems, the Guidelines
for Food Import Control Systems (CAC/GL 47-2003) (Ref. 6) developed by
the Codex Committee on Food Import and Export Inspection and
Certification Systems recognize a number of related concepts,
including: that countries can set their own appropriate levels of
protection (para. 1); that standards should be based on risk and, as
far as possible, applied equally to imported and domestic food (paras.
2, 4, 5); that there is a potential need for different approaches to
compliance monitoring of domestic and imported food to ensure
consistent levels of protection (e.g., para. 15); and that there is
utility in conducting audits, along with using other tools, in addition
to assessing importer controls to ensure that imported foods are safe,
including importers' use of supplier verification systems (e.g., paras.
11, 36).
4. Public Comments on FSVPs
    Our development of the proposed FSVP regulations also has been
informed by the comments on FSVPs provided at the public meeting on the
import safety provisions of FSMA on March 29, 2011, and the public
hearing on comparability of food safety systems and import practices of
foreign countries on March 30-31, 2011, as well as the comments
submitted to the public dockets for these matters (i.e., the docket for
this rulemaking, FDA-2011-N-0143, and docket FDA-2011-N-0135).

C. Principal Features of the Proposed Rule

    Consistent with section 805 of the FD&C Act, we are proposing a
flexible approach to foreign supplier verification that addresses risk-
based differences among certain types of food and their importers. We
have tentatively concluded that we should focus the regulations on
foreseeable food safety risks rather than all risks covered by the
various adulteration provisions in section 402 of the FD&C Act. We
therefore are proposing that importers develop and implement FSVPs to
adequately verify the control of all hazards that are reasonably likely
to occur with the food being imported. We believe that this approach,
which is well accepted and understood throughout the food industry as a
key component of HACCP and preventive controls, also provides the most
comprehensive risk-based framework in which importers can evaluate
potential products and suppliers and conduct appropriate verification
efforts.
    We emphasize that by using this approach to determining which
hazards importers should focus on, we do not intend to indirectly
impose preventive controls requirements on importers or their suppliers
when they are not subject to the proposed preventive controls
regulations. For example, as discussed in the Produce Safety Proposed
Rule, we have already identified the reasonably foreseeable
microbiological hazards associated with produce and are proposing
requirements designed to ensure that those hazards are adequately
controlled. Therefore, the proposed rule would not require importers of
RACs that are fruits or vegetables and that are subject to the
regulations on produce safety in proposed part 112 (21 CFR part 112) to
reanalyze these microbiological hazards. In addition, in part because
section 418 of the FD&C Act contains an exemption relating to
facilities that manufacture, process, pack, or hold dietary
supplements, we are proposing a modified verification approach for such
products. We also are proposing modified FSVP requirements for food
from very small foreign suppliers (as determined by annual food sales),
and many such suppliers would be exempt from preventive controls as
``qualified facilities'' under section 418. The proposed rule also
would establish modified requirements for food imported by very small
importers (matching the requirements for food from very small foreign
suppliers). Modified requirements also would apply to food from a
foreign supplier in, and under the regulatory oversight of, a country
whose food safety system FDA has officially recognized as
``comparable'' to that of the United States (e.g., through a signed
systems recognition arrangement or other agreement between FDA and the
country establishing official recognition of the foreign food safety
system) or determined to be equivalent to that of the United States,
provided the importer documents that certain conditions are met.
    Another principal feature of the proposed rule is that we are
presenting two different alternative proposals regarding the
requirements for foreign supplier verification activities. Under Option
1, for the importation of food with hazards that are reasonably likely

to cause serious adverse health consequences or death to humans or
animals (SAHCODHA) (e.g., many microbiological hazards), the importer
would be required, at a minimum, to conduct or obtain the results of an
annual onsite audit to ensure that the foreign supplier is adequately
addressing the hazards. In other situations involving less serious
hazards (e.g., illegal residues of pesticides or animal drugs),
importers would have more flexibility to choose an appropriate supplier
verification method. Under Option 2 of the co-proposal, importers would
have to select a verification activity from among onsite auditing,
sampling and testing, review of the supplier's food safety records, or
some other appropriate procedure, taking into account the risk
presented by the hazard in the food, the probability that exposure to
the hazard will result in serious harm, and the food and supplier's
status of compliance with U.S. food safety requirements.
    Importers have always had the responsibility to offer for entry
into the United States products that are not adulterated (60 FR 65096
at 65153). Section 301(a) of the FD&C Act makes it a prohibited act to
introduce an adulterated food into interstate commerce, which means
that an importer would commit a prohibited act if it offered for import
a food that is adulterated under section 402 of the FD&C Act. While
many food importers already conduct activities to verify the safety of
the foods they import, establishing and following FSVPs will
necessitate changes to the operations of many importers, especially
those that have not previously conducted significant verification
activities. Although many importers will need to change at least some
of their business practices and incur costs to comply with the FSVP
requirements, conducting foreign supplier verification activities will
help these companies ensure that the products they import meet U.S.
requirements and are safe for consumption.

II. Description of the Proposed Rule

    We are proposing a new subpart L to part 1 of the FDA regulations
(21 CFR part 1), entitled ``Foreign Supplier Verification Programs for
Food Importers,'' to specify the content of FSVPs for importers of food
for humans and animals.

A. Definitions (Proposed Sec.  1.500)

    Proposed Sec.  1.500 sets forth the meaning of several terms that
we propose to use in the FSVP regulations. Some of the definitions are
self-explanatory or are being used for consistency with the Preventive
Controls Proposed Rule; we discuss the definitions for which additional
explanation is appropriate.
1. Audit
    As set forth in proposed Sec.  1.506(g) and (h) and discussed in
section II.G of this document, the proposed rule would require onsite
auditing of foreign suppliers in certain circumstances (under one
proposed option) and permit onsite auditing as a mechanism for supplier
verification under other circumstances. Proposed Sec.  1.500 would
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.
2. Food
    Proposed Sec.  1.500 would define food as having the meaning given
in section 201(f) of the FD&C Act (21 U.S.C. 321(f)), except that it
would not include pesticides as defined in 7 U.S.C. 136(u). As
discussed in the preamble to the interim final rule entitled ``Prior
Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002,'' pesticides,
including those used in or on food for human or animal use, are
comprehensively regulated by the Environmental Protection Agency (69 FR
58974 at 58986, October 10, 2003). For the same reason, we tentatively
conclude that pesticides were not intended to be considered ``food''
for purposes of section 805 of the FD&C Act and the FSVP regulations.
We request comment on this exclusion and on whether there should be
additional exclusions from the definition of food. Comments seeking
additional exclusions should provide specific justifications.
3. Foreign Supplier
    Proposed Sec.  1.500 would define foreign supplier as 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.
    We tentatively conclude that the proposed definition of foreign
supplier makes the term generally consistent with the definition of
foreign facility under the preventive controls section of the FD&C Act.
Section 418(o) defines ``facility'' as a domestic or foreign facility
that is required to register with FDA under section 415 of the FD&C Act
(21 U.S.C. 350d). Section 415(b)(3)(A) defines ``foreign facility'' as
a facility that manufactures, processes, packs, or holds food, but only
if food from such facility is exported to the United States without
further processing or packaging outside the United States. Because (as
discussed in section II.B of this document) importers generally must
verify that, among other things, their foreign suppliers produce food
in compliance with processes and procedures that provide the same level
of public health protection as those required under section 418 of the
FD&C Act, we believe that it is appropriate to define foreign suppliers
in a manner that is generally consistent with the scope of section 418.
    However, our proposed definition of foreign supplier does not
include firms that only pack or hold food even if they are required to
register with FDA under section 415 of the FD&C Act. We tentatively
conclude 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 that
food, excluding a subsequent (and registered) packer or holder would be
consistent with this intent. As stated previously in this document, the
proposed rule would state that the addition of labeling or any similar
activity of a de minimis nature does not constitute further processing
or packaging. This proposed limitation to the definition of foreign
supplier is consistent with FDA's regulations on the registration of
foreign food facilities in Sec.  1.226(a). Because section 805 of the
FD&C Act is not limited to suppliers that are subject to section 418 of
the FD&C Act, the proposed definition of foreign supplier is not
limited to registered facilities. In addition to establishments that
manufacture/process food, the definition also encompasses
establishments that raise animals or harvest food (unless the animal or
harvested food is further manufactured or processed by another
establishment).
4. Hazard and Hazard Reasonably Likely To Occur
    Proposed Sec.  1.500 would define hazard as any biological,
chemical, physical, or radiological agent that is reasonably likely to
cause illness or injury in the absence of its control. Proposed Sec.
1.500 would define hazard reasonably likely to occur as a hazard for
which a prudent

importer would establish controls or verify that the supplier controls
because experience, illness data, scientific reports, or other
information provides a basis to conclude that there is a reasonable
possibility that the hazard will occur in the type of food being
imported in the absence of those controls. These definitions match
those that appear in the Preventive Controls Proposed Rule.
5. Importer
    The term ``importer'' is defined in section 801(a)(2) of the FD&C
Act as follows: ``(A) the United States owner or consignee of the
article of food at the time of entry of such article into the United
States; or (B) in the case when there is no United States owner or
consignee as described in subparagraph (A), 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.''
    Under proposed Sec.  1.500, the importer of a food would be the
U.S. owner of the food if there is one or the consignee if there is not
a U.S. owner at the time of entry. Thus, importer would be defined as
the person in the United States who has purchased an article of food
that is being offered for entry into the United States; if the article
of food has not been sold at the time of U.S. entry, the importer would
be the person in the United States to whom the article has been
consigned at the time of entry; if the article of food has not been
sold or consigned at the time of U.S. entry, the importer would be the
U.S. agent or representative of the foreign owner or consignee at the
time of entry.
    Under the proposed definition, the importer of an article of food
might be, but would not necessarily be, the importer of record of the
article, i.e., the individual or firm responsible for making entry and
payment of import duties. We agree with the majority of comments we
received on how to define ``importer,'' which stated that the person
who caused a food to be imported is the person who should be
responsible for verifying that the food was produced in accordance with
applicable U.S. safety requirements. This person has a direct financial
interest in the food and is most likely to have knowledge and control
over the product's supply chain. This person is more likely to be the
food's U.S. owner (or consignee) than the importer of record for the
food, which might be an express consignment operator with little to no
knowledge of the safety regulations applicable to the products for
which they obtain clearance from U.S. Customs and Border Protection
(CBP).
    In cases in which a food has not been sold or consigned to a person
in the United States at the time of entry, the foreign owner or
consignee would need to have a U.S. agent or representative who would
be responsible for meeting the FSVP requirements. To make this clear,
proposed Sec.  1.509(a) states (as discussed in section II.J.1 of this
document) that before an article of food is imported or offered for
import into the United States, the foreign owner or consignee of the
article (if there is no U.S. owner or consignee) must designate a U.S.
agent or representative as the importer of the food for the purposes of
the definition of ``importer'' in Sec.  1.500. This would ensure that
there is an entity in the United States who is responsible for meeting
the various FSVP requirements, which would improve importer
accountability and Agency oversight and enforcement.
    Some importers obtain food from foreign suppliers who are part of
the same corporate structure as the importer and who may, along with
the importer, be subject to a single integrated, company-wide approach
to food safety in which hazards are controlled and verified by a common
supply chain management system. We request comment on whether importers
should not be required to conduct foreign supplier verification, or
should be subject to different FSVP requirements, when importing food
from entities under the same corporate ownership and, if so, the
specific justifications and conditions under which foreign supplier
verification should not be required or should be modified.
6. Qualified Individual
    Proposed Sec.  1.500 would define qualified individual as a person
who has the necessary education, training, and experience to perform
the activities needed to meet the requirements of this subpart; this
person may be, but is not required to be, an employee of the importer.
Depending on the applicable requirements, a qualified individual would
need to be capable of performing, for example, food hazard analysis and
verification of foreign supplier processes and procedures to ensure
that hazards are adequately controlled. Proposed Sec.  1.500 further
states that, regarding the performance of verification activities
related to preventive controls implemented by the foreign supplier in
accordance with section 418 of the FD&C Act, a qualified individual
must have successfully completed training in the development and
application of risk-based preventive controls at least equivalent to
that received under a standardized curriculum recognized as adequate by
FDA or be otherwise qualified through job experience to develop and
implement a food safety system. We are proposing to define the term
qualified individual in a slightly different way in the FSVP
regulations than in the Preventive Controls Proposed Rule because not
all of the foreign suppliers from which importers obtain their food
products will be subject to the preventive controls regulations.
Therefore, when an importer obtains food from a foreign supplier that
is not subject to section 418 of the FD&C Act, such as a manufacturer
of dietary supplements, a qualified individual performing FSVP
activities for the importer would need to have appropriate education,
training, and experience to conduct those activities, but would not
necessarily have to be trained or have experience in the development
and implementation of the particular risk-based preventive controls
required under section 418. We request comment on whether the
definition of qualified individual should include additional
requirements regarding education, training, and experience.
    As noted, the qualified individual may be, but is not required to
be, an employee of the importer. The entity best suited to handling
supplier verification may not fall within the definition of
``importer'' as proposed in this rule. The flexibility in the
definition of qualified individual means that another entity may be
able to conduct many of the supplier verification activities on the
importer's behalf.
    Proposed Sec.  1.500 further states that the term qualified
individual includes, but is not limited to, a third-party auditor that
has been accredited in accordance with section 808 of the FD&C Act. As
discussed more fully in section II.G.7.a.i of this document, section
307 of FSMA (codified in section 808 of the FD&C Act (21 U.S.C. 384d))
directs us to establish a system for the recognition of accreditation
bodies that can accredit third-party auditors as being qualified to
conduct food safety audits of foreign suppliers, as well as to develop
model accreditation standards. Elsewhere in this issue of the Federal
Register (78 FR XXXXX), we are publishing a proposed rule to establish
a third-party accreditation system in accordance with section 808. We
anticipate that in the future many importers will rely on onsite audits
conducted at the request of foreign suppliers by third-party auditors
accredited in accordance with section

808 to verify that the importers' foreign suppliers are producing food
in accordance with U.S. requirements. We expect that this will reduce
the costs of complying with the FSVP regulations for both importers and
foreign suppliers by reducing the number of onsite audits that
importers conduct themselves. However, even after FDA has implemented
section 808 and importers begin using accredited third-party auditors
to provide verification of their foreign suppliers in accordance with
the FSVP regulations, we believe that it would be acceptable for an
importer to rely on an audit conducted by a third-party auditor who is
a qualified individual but is not accredited in accordance with section
808. We invite comment on whether, at some future date and/or under
particular circumstances, importers should no longer be permitted to
rely on third-party auditors who are not accredited in accordance with
section 808 to conduct onsite audits or other FSVP activities.
    In addition, proposed Sec.  1.500 states that an employee of a
foreign government may be a qualified individual. We believe that this
provision is appropriate because foreign food safety authorities might
conduct certain activities on which an importer might rely in complying
with its FSVP requirements. For example, as part of an importer's
supplier verification activities, the importer might rely on the
results of an onsite audit of a foreign supplier conducted by an
employee of the food safety authority in that country. Although a
foreign food safety authority could be an accredited third-party
auditor under section 808 of the FD&C Act, an importer's use of foreign
government employees as qualified individuals would not be limited to
such accredited auditors. We request comment on ways in which importers
might rely on the actions of foreign government employees in complying
with FSVP requirements.
7. Raw Agricultural Commodity
    As previously stated, this proposed rule includes provisions on
foreign supplier verification with respect to RACs that are fruits or
vegetables. Proposed Sec.  1.500 states that raw agricultural commodity
means ``raw agricultural commodity'' as defined in section 201(r) of
the FD&C Act (21 U.S.C. 321(r)).
8. Very Small Importer and Very Small Foreign Supplier
    As stated in section I.C of this document, we propose to apply
modified FSVP requirements (set forth in proposed Sec.  1.512,
discussed in section II.M of this document) to very small importers of
food and to food from very small foreign suppliers. Proposed Sec.
1.500 would define very small importer as an importer, including any
subsidiary, affiliate, or subsidiaries or affiliates, collectively, of
any entity of which the importer is a subsidiary or affiliate, whose
average annual monetary value of sales of food during the previous 3-
year period (on a rolling basis) is no more than $500,000, adjusted for
inflation. Likewise, very small foreign supplier would be defined as a
foreign supplier, including any subsidiary, affiliate, or subsidiaries
or affiliates, collectively, of any entity of which the foreign
supplier is a subsidiary or affiliate, whose average annual monetary
value of sales of food during the previous 3-year period (on a rolling
basis) is no more than $500,000, adjusted for inflation. The limitation
of $500,000 in annual food sales is consistent with the sales
limitation in the definitions of ``qualified facility'' in the
Preventive Controls Proposed Rule and ``small business'' in the Produce
Safety Proposed Rule. As discussed more fully in section II.M of this
document, we believe that it is appropriate to establish certain
modified FSVP requirements for very small importers and food from very
small foreign suppliers under proposed Sec.  1.512.
    We tentatively conclude that it is appropriate to limit the scope
of the definition of ``very small importer'' to those importers that
have no more than $500,000 in annual food sales. Because the sales
value of food is related to the volume of food being brought into the
United States by the importer or shipped to this country by the
supplier, use of this dollar-value ceiling would help limit the total
volume of food imported under these modified provisions.
    Our proposed approach to the definitions of very small importer and
very small foreign supplier and the FSVP requirements for these
entities is discussed further in section II.M of this document. We
believe that our proposed approach to defining very small importers and
foreign suppliers is an appropriate as well as workable way to
determine which importers and foreign suppliers would be subject to
modified FSVP requirements. We request comment on this approach,
including whether the limit of $500,000 in annual food sales is
appropriate. We also request comment on whether the definitions should
apply only to U.S. sales of food by the importer or the foreign
supplier, rather than worldwide sales by these entities.
    We note that the Preventive Controls Proposed Rule includes three
options for a proposed definition of ``very small business,'' a term
that is relevant to three provisions of that proposed rule (78 FR 3646
at 3701). The proposal specifies three options for the limit on total
annual food sales under the definition of very small business:
$250,000, $500,000, or $1,000,000. We request comment on whether the
definitions of very small importer and very small foreign supplier
under the FSVP regulations should take into account the definition of
very small business under the preventive controls regulations and, if
so, what limit on total annual food sales would be appropriate for use
in these definitions.

B. Applicability and Exemptions (Proposed Sec.  1.501)

    Proposed Sec.  1.501 answers the question, ``To what foods do the
regulations in this subpart apply?'' Proposed Sec.  1.501(a) states
that, except as specified otherwise in Sec.  1.501, the regulations in
subpart L apply to all food imported into the United States and to the
importers of such food. Proposed Sec.  1.501(b) through (e) set forth
exemptions and exceptions from subpart L for several types of foods:
food from juice and seafood HACCP facilities that are in compliance
with the HACCP regulations; food imported for research or evaluation
purposes; food for personal consumption; alcoholic beverages; and food
that is transshipped or imported for further processing and export.
1. Exemption for Food From Juice and Seafood HACCP Facilities
    In accordance with section 805(e)(1) and (e)(2) of the FD&C Act,
proposed Sec.  1.501(b) would exempt products from certain juice and
seafood facilities from subpart L. Section 805(e) states that the
foreign supplier verification requirements ``shall not apply to a
facility if the owner, operator, or agent in charge of such facility is
required to comply with, and is in compliance with,'' the HACCP
regulations for seafood or juice. Section 805(e) further states that
the exemption applies to ``a facility'' that is required to comply with
and is in compliance with the juice or seafood HACCP regulations. This
raises the question of whether the word ``facility'' in this context
relates to the foreign supplier or the importer.
    The language of section 805(e) of the FD&C Act mirrors the language
of the juice and seafood HACCP exemption in section 418 of the FD&C
Act, which exempts facilities that are required to comply with and are
in compliance

with HACCP for juice or seafood from the hazard analysis and risk-based
preventive controls required by that section. Given that many foreign
suppliers are facilities subject to section 418, and given the role
that importers play under section 805 in verifying foreign supplier
compliance with applicable U.S. food safety regulations, we tentatively
conclude that it was Congress's intent that section 805(e) apply to
food being imported from foreign suppliers that are facilities subject
to and in compliance with FDA requirements for juice or seafood HACCP.
The importer would still be required to verify a foreign supplier's
compliance with the juice or seafood HACCP provisions, but would do so
under the regulations that are specific to those foods.
    There are at least two other potential readings of section 805(e)'s
language. One is that section 805(e) would apply to importers that are
facilities subject to and in compliance with the juice or seafood HACCP
regulations. This interpretation does not account for the fact that not
all importers are facilities (e.g., a commodity broker that does not
manufacture/process, pack, or hold food), so it would not exempt such
an importer even if the juice or seafood products have been produced in
compliance with the applicable HACCP requirements. The other reading is
that section 805(e) would apply to importers, whether or not they are
facilities, that are subject to the importer verification provisions of
the juice or seafood HACCP regulations. However, this interpretation is
not consistent with the language of section 805(e), which states that
it applies to facilities. Thus, we tentatively conclude that the
proposed reading that section 805(e) applies to food being imported
from foreign suppliers that are facilities subject to and in compliance
with FDA requirements for juice or seafood HACCP effectuates the
purpose of the FSVP provisions more clearly than either of these other
possible interpretations.
    Therefore, proposed Sec.  1.501(b) states that the regulations in
subpart L do not apply with respect to juice, fish, and fishery
products that are imported from a foreign supplier that is required to
comply with, and is in compliance with, the regulations on juice in
part 120 or the regulations on fish and fishery products in part 123.
Proposed Sec.  1.501(b) further states that importers of juice and
seafood products that are subject to the regulations in part 120 or
part 123, respectively, must comply with the requirements applicable to
importers of those products under Sec.  120.14 or Sec.  123.12,
respectively. Among other things, those provisions require importers to
implement written procedures for ensuring that imported products were
processed in accordance with the HACCP regulations, including the use
of ``affirmative steps'' such as obtaining continuing or lot-specific
certificates from an appropriate foreign government inspection
authority or competent third party, or regularly inspecting foreign
processor facilities. Thus, Sec.  1.501(b) makes clear that, in
accordance with section 805(e) of the FD&C Act, importers of juice or
seafood HACCP products from foreign suppliers that are facilities
required to comply with and in compliance with the juice or seafood
HACCP regulations are not subject to the verification requirements in
the FSVP regulations.
    We recognize that section 805 of the FD&C Act and the implementing
regulations we are proposing set forth a more comprehensive approach to
verification than the existing juice and seafood HACCP regulations. As
noted in section I.B of this document, the juice and seafood importer
provisions were adopted more than a decade ago. The U.S. Government
Accountability Office (GAO), in its April 2011 report entitled
``Seafood Safety: FDA Needs to Improve Oversight of Imported Seafood
and Better Leverage Limited Resources'' (Ref. 7), noted that the
seafood importer regulations allow importers to obtain a copy of the
foreign processor's HACCP plan and an attestation that the foreign firm
processes its seafood products in compliance with the HACCP regulations
without also requiring an onsite audit. The GAO report noted some
concerns that the purposes of this provision and the HACCP regulations
can be defeated if a foreign processor claims to have a HACCP plan that
it is not actually following and the importer does not visit the
processor to determine whether the processor is implementing the plan
it has provided to the importer. In light of FSMA's increased emphasis
on the safety of imported food and importers' role in ensuring food
safety, as well as the proposed FSVP regulations discussed in this
document, we are considering whether it would be appropriate in the
future to initiate a rulemaking to revise the regulations applicable to
importers of juice and seafood.
2. Food Imported for Research or Evaluation or for Personal Consumption
    Section 805(f) of the FD&C Act states that FDA, by notice published
in the Federal Register, shall establish an exemption from the
requirements of section 805 for articles of food imported in small
quantities for research and evaluation purposes or for personal
consumption, provided that such foods are not intended for retail sale
and are not sold or distributed to the public. We tentatively conclude
that it is appropriate to include these section 805 exemptions in the
proposed regulations implementing that section to allow interested
persons to comment on how we propose to implement these exemptions.
    Regarding food for research or evaluation, proposed Sec.  1.501(c)
states that the regulations in subpart L do not apply to food that is
imported for research or evaluation purposes, provided that:
     Such food is not intended for retail sale and is not sold
or distributed to the public.
     The food is labeled with the statement ``Food for research
or evaluation use.''
     When filing entry for the food with CBP, the importer of
record provides an electronic declaration that the food will be used
for research or evaluation purposes and will not be sold or distributed
to the public.
    The latter two provisions are intended to help ensure that the food
is, in fact, not intended for retail sale and is not sold or
distributed to the public. We tentatively conclude that they would
provide an efficient and effective means of determining whether a food
is exempt.
    Proposed Sec.  1.501(c) further states that food is considered to
be imported for research or evaluation purposes only if it is imported
in a small quantity that is consistent with a research, analysis, or
quality assurance purpose and the entire quantity is used for this
purpose.
    Under proposed Sec.  1.501(d), the regulations in subpart L would
not apply to food that is imported for personal consumption, provided
that such food is not intended for retail sale and is not sold or
distributed to the public. Proposed Sec.  1.501(d) further states that
food is considered to be imported for personal consumption when it is
purchased or otherwise acquired by a person in a small quantity for a
non-commercial purpose and is not sold or distributed to the public.
    We request comment on the proposed exemptions from the FSVP
requirements for food imported for research use or for personal
consumption, in particular regarding whether and how to define the
amount of food that constitutes a ``small quantity.''
3. Exemption for Alcoholic Beverages
    Section 116(a) of FSMA (21 U.S.C. 2206(a)) provides that, except as

provided by certain listed sections in FSMA, nothing in FSMA, or the
amendments made by FSMA, shall be construed to apply to a facility that
(1) under the Federal Alcohol Administration Act (27 U.S.C. 201 et
seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986
(26 U.S.C. 5001 et seq.) is required to obtain a permit or to register
with the Secretary of the Treasury as a condition of doing business in
the United States; and (2) under section 415 of the FD&C Act is
required to register as a facility because such facility is engaged in
manufacturing, processing, packing, or holding one or more alcoholic
beverages (with respect to the activities of such facility that relate
to the manufacturing, processing, packing, or holding of alcoholic
beverages).
    Section 116(b) of FSMA provides that section 116(a) shall not apply
to a facility engaged in the receipt and distribution of any non-
alcohol food, except that section 116(a) shall apply to a facility
described in section 116(a) that receives and distributes non-alcohol
food, provided such food is received and distributed (1) in a
prepackaged form that prevents any direct human contact with such food
and (2) in amounts that constitute not more than 5 percent of the
overall sales of such facility, as determined by the Secretary of the
Treasury.
    Section 116(c) of FSMA provides that, except as provided in section
116(a) and (b), section 116 shall not be construed to exempt any food,
other than alcoholic beverages, as defined in section 214 of the
Federal Alcohol Administration Act (27 U.S.C. 214), from the
requirements of FSMA (including amendments made by FSMA).
    The Preventive Controls Proposed Rule includes provisions
implementing the exemptions provided in section 116 of FSMA to
establish by regulation the reach of the exemptions. As discussed in
the Preventive Controls Proposed Rule, FDA tentatively concludes the
following regarding the reach of the exemptions for the purposes of
that rule:
     The phrase ``obtain a permit or register'' should be
interpreted broadly, to include not only facilities that must obtain
what is technically named a ``permit'' or must ``register'' with
Treasury, but also those facilities that must adhere to functionally
similar requirements as a condition of doing business in the United
States, namely, by submitting a notice or application to Treasury and
obtaining Treasury approval of that notice or application.
     The exemption would apply not only to domestic facilities
that are required to secure a permit, registration, or approval from
Treasury under the relevant statutes, but also to foreign facilities of
a type that would require such a permit, registration, or approval if
they were domestic facilities.
     Activities related to alcoholic beverages (including the
manufacturing, processing, packing, or holding of alcoholic beverages)
at facilities within the scope of section 116(a) of FSMA would not be
subject to section 418 of the FD&C Act. Activities related to foods
other than alcoholic beverages (including the receiving, manufacturing,
processing, packing, holding, and distributing of such foods) would be
subject to section 418 even if those activities occur at facilities
that are otherwise within the scope of section 116(a) (unless they
qualify for another exemption or are in prepackaged form and constitute
5 percent or less of the facility's overall sales). (For clarity, we
use the term ``food other than alcoholic beverages'' rather than ``non-
alcohol food'' in the Preventive Controls Proposed Rule and in this
document.)
     Section 418 of the FD&C Act does not apply to the
manufacturing, processing, packing, or holding of food other than
alcoholic beverages to the extent that it is physically inseparable
from the manufacturing, processing, packing, or holding of alcoholic
beverages.
    Section 116 of FSMA is premised in part upon status as a facility
required to register under section 415 of the FD&C Act (section
116(a)(2) of FSMA). Under the definition in this proposed rule, an
``importer'' might be a registered facility but would not necessarily
be one. If the alcoholic beverages exemption from the FSVP regulations
was based on whether the importer of an alcoholic beverage was a
registered facility, two firms might import the same product (e.g., a
bottled alcoholic beverage) and one would be eligible for the alcoholic
beverage exemption from the FSVP regulations because it is required to
register (e.g., it packs or holds the alcoholic beverage), while the
other would not be eligible for this exemption because it is not
required to register (e.g., it is a commodity broker that does not
manufacture, process, pack, or hold food for consumption in the United
States, or it is a restaurant or retailer). The latter importer would
need to conduct supplier verification under section 805 of the FD&C Act
while the former would not. Under this interpretation, an importer
would be exempt from the section 805 requirements if the importer is a
facility required to register under section 415 of the FD&C Act and the
importer and the food in question (i.e., the alcoholic beverage or food
other than alcoholic beverages) otherwise meet the requirements for
exemption under section 116 of FSMA.
    An alternative approach to the alcoholic beverages exemption from
the FSVP regulations would focus on the foreign supplier. If an
alcoholic beverage is being imported, under our proposal the foreign
supplier would, by definition, be a facility that is required to
register. Our proposed definition of ``foreign supplier'' means that
the supplier would be engaged in manufacturing/processing the alcoholic
beverage and that this beverage would not undergo further
manufacturing/processing before being exported to the United States,
except for labeling or any similar activity of a de minimis nature (see
21 CFR 1.226 regarding foreign facility registration). Under this
interpretation, whether an imported food is exempt from section 805 of
the FD&C Act would not depend on who the importer happens to be, but
the nature of the product being imported--whether the foreign supplier
and the food in question (i.e., the alcoholic beverage or food other
than alcoholic beverages) meet the requirements for exemption under
section 116 of FSMA. This interpretation is consistent with our
approach to the alcoholic beverages exemption in the Preventive
Controls Proposed Rule. In considering the two proposals together, if a
foreign supplier is exempt from section 418 of the FD&C Act by
operation of section 116 of FSMA for a particular food, then the
importer would not be required to conduct verification of the supplier
for the food under section 805. For these reasons, we tentatively
conclude that the second approach better effectuates the intent of
section 805 and it is appropriate to exempt certain alcoholic
beverages, under the conditions stated in proposed Sec.  1.501(e), from
the scope of the FSVP regulations.
    Therefore, under proposed Sec.  1.501(e)(1)(i) and (e)(1)(ii), the
FSVP regulations would not apply with respect to alcoholic beverages
that are imported from a foreign supplier that is a facility that meets
the following two conditions:
     Under the Federal Alcohol Administration Act (27 U.S.C.
201 et seq.) or chapter 51 of subtitle E of the Internal Revenue Code
of 1986 (26 U.S.C. 5001 et seq.), the facility is a foreign facility of
a type that, if it were a domestic facility, would require obtaining a
permit from, registering with, or obtaining approval of a notice or
application from the Secretary of the Treasury as a condition of doing
business in the United States; and

     Under section 415 of the FD&C Act, the facility is
required to register as a facility because it is engaged in
manufacturing/processing one or more alcoholic beverages.
    Proposed Sec.  1.501(e)(2)(i) and (e)(2)(ii) would specify that the
FSVP regulations would not apply with respect to food other than
alcoholic beverages that is imported from a foreign supplier described
in Sec.  1.501(e)(1), provided such food:
     Is in prepackaged form that prevents any direct human
contact with such food; and
     Constitutes not more than 5 percent of the overall sales
of the facility, as determined by the Secretary of the Treasury.
    We request comment on our proposed exemption of alcoholic beverages
and food other than alcoholic beverages under the conditions specified
in proposed Sec.  1.501(e).
4. Inapplicability to Food for Transshipment and Export
    Some food is imported into the United States but is not distributed
into the U.S. market. For example, some food is transshipped from a
foreign country through the United States to a different country. In
addition, food may be imported into the United States, subjected to
manufacturing or processing, and exported to another country without
being consumed or distributed in U.S. commerce. Section 805 of the FD&C
Act applies to ``each importer'' and ``the food imported by the
importer or agent of an importer.'' This could mean that the FSVP
requirements apply to all food that is brought across the U.S. border
except where there is a specific exemption, such as the exemption for
food imported for personal consumption. However, taking into
consideration the context of section 805 of the FD&C Act, under which
the importer must take affirmative steps to verify the compliance of
the food with U.S. safety requirements, we tentatively conclude that
section 805 is not intended to apply to food that is neither consumed
nor distributed in the United States. Therefore, under proposed Sec.
1.501(f), the regulations in subpart L would not apply to food that is:
     Transshipped through the United States to another country;
or
     Imported for future export and that is neither consumed
nor distributed in the United States.

C. Scope of FSVP (Proposed Sec.  1.502)

    Proposed Sec.  1.502 answers the question, ``What foreign supplier
verification program (FSVP) must I have?'' This section addresses the
scope of FSVPs.
    As noted above, section 805(c)(2) of the FD&C Act sets forth the
scope of an importer's FSVP, i.e., the program must be adequate to
provide assurances that each of the importer's foreign suppliers
produces food in compliance with processes and procedures that provide
the same level of public health protection as those required under
section 418 or 419, as appropriate, and with sections 402 and 403(w).
We tentatively conclude that the scope of an appropriate FSVP should be
as set forth below.
1. General Standard and Verification Approach
    Proposed Sec.  1.502(a) states that, except as specified in
proposed Sec.  1.502(b), for each food imported, the importer must
develop, maintain, and follow an FSVP that provides adequate assurances
that its foreign supplier is producing the food in compliance with
processes and procedures that provide at least the same level of public
health protection as those required under section 418 or 419 of the
FD&C Act, if either is applicable, and is producing the food in
compliance with sections 402 and 403(w). Under this provision,
importers would be required to develop procedures for the operation of
their FSVPs, such as procedures for the following:
     Review of the compliance status of foods and foreign
suppliers
     Analysis of hazards reasonably likely to occur with foods
     Determination and performance of appropriate foreign
supplier verification activities for foods
     Review of complaints, investigation of adulteration or
misbranding, and taking of corrective actions
     Reassessment of the FSVP
     Ensuring that required information is submitted at entry
     Maintenance of records
    We tentatively conclude that by developing, maintaining, and
following an FSVP that meets the requirements set forth in this
proposed rule, an importer would be able to provide assurances that its
foreign suppliers were producing food in a manner consistent with the
preventive controls or produce safety regulations (if either were
applicable) as well as provide assurances that the food is not
adulterated or misbranded regarding allergen labeling.
2. Low-Acid Canned Food
    In accordance with section 805(e) of the FD&C Act, proposed Sec.
1.502(b) sets forth a standard for FSVPs regarding the importation of
thermally processed low-acid canned foods packaged in hermetically
sealed containers (low-acid canned foods) that differs slightly from
the standard in proposed Sec.  1.502(a). Section 805(e) states that
section 805 does not apply to LACF facilities that are required to
comply, and are in compliance, with the FDA standards and regulations
on LACF, but only with respect to the microbiological hazards regulated
under part 113 (21 CFR part 113). With respect to all other types of
hazards for LACF, section 805 would apply. Therefore, under proposed
Sec.  1.502(b), with respect to those microbiological hazards that are
controlled by part 113, an importer of a low-acid canned food must
verify and document that the food was produced in accordance with part
113. An importer of a low-acid canned food would not know if it was
importing the food from a foreign supplier whose facility was in
compliance with part 113 (and thus eligible for the exemption from
section 805 with respect to microbiological hazards) unless it
conducted some appropriate form of verification, such as auditing. We
tentatively conclude that following the FSVP provisions would be an
appropriate verification approach if the importer chose to follow this
for all LACF hazards, including microbiological hazards. Proposed Sec.
1.502(b) further states that, with respect to all matters that are not
controlled by part 113, an importer of a low-acid canned food must have
an FSVP as specified in proposed Sec.  1.502(a).
3. Food Imported by Facilities Subject to the Preventive Controls
Requirements
    Many domestic food manufacturers, both large and small companies,
import food ingredients for use in the food products they manufacture
or process. These facilities are (with certain exceptions) subject to
section 418, and they will be subject to the preventive controls
regulations once those regulations become effective.
    As stated in section I.B of this document, the Preventive Controls
Proposed Rule seeks comment on when supplier approval and verification
programs would be appropriate food safety requirements under the
preventive controls regulations, as well as comment on what specific
supplier approval and verification requirements are appropriate. As
stated in that proposed rule and in section I.B of this document, we
recognize the importance of coordinating the final preventive controls
and FSVP regulations to avoid duplicative requirements, as well as the
importance of ensuring that the food safety measures we adopt are
consistent

with U.S. international trade obligations, including those contained in
the SPS Agreement.
    We request comment on how to address foreign supplier verification
by importers who could be subject to both the FSVP and preventive
controls regulations to prevent the imposition of any duplicative
supplier verification requirements. For example, should the FSVP
regulations state that an importer that is also required to establish a
supplier approval and verification program under the preventive
controls regulations for a food, and is in compliance with those
regulations, is deemed to be in compliance with the FSVP regulations
that address the same matters?
    We intend to publish in the near future a proposed rule on
preventive controls for animal food that will be similar to the
Preventive Controls Proposed Rule applicable to human food. We expect
to issue the final rule on FSVPs concurrently with the final rules on
preventive controls for human food and animal food, and we expect to
adopt the same approach for animal food as we do for human food
regarding importers that are in compliance with any supplier
verification provisions in those respective preventive controls
regulations. We request comment on this proposed approach.
4. Food for Which Importers' Customers Are Subject to the Preventive
Controls Requirements
    In some cases, an importer's customer is a domestic food facility
that would be subject to any supplier verification requirements that we
might ultimately adopt as part of the preventive controls regulations.
As with the above-described circumstances involving importers who
themselves would be subject to any supplier verification requirements
under the preventive controls regulations, we believe that requiring
importers to conduct verification activities that their customers would
have to conduct would not provide additional assurance of the safety of
the imported food. Therefore, we request comment on how to coordinate
the FSVP and preventive controls regulations to avoid imposing
duplicative requirements on importers whose customers could be subject
to any supplier verification requirements that are ultimately included
in the preventive controls regulations. For example, would it be
appropriate for the FSVP regulations to state that an importer whose
customer is required to establish a supplier approval and verification
program under the preventive controls regulations for a food is deemed
to be in compliance with the FSVP regulations? We also request comment
on what assurance, if any, importers should be required to obtain from
their customer that the customer is in compliance with any preventive
controls supplier verification requirements and the frequency with
which they should obtain any such assurance.

D. Personnel (Proposed Sec.  1.503)

    Proposed Sec.  1.503 answers the question, ``Who must develop my
FSVP and perform FSVP activities?'' Proposed Sec.  1.503 states that,
except with respect to the requirements in proposed Sec. Sec.  1.506(a)
(concerning listing of foreign suppliers), 1.509 (concerning steps that
an importer must take to ensure that it is identified as the importer
of a food when the food is offered for entry into the United States),
1.510 (concerning record keeping), 1.511(c)(2) (concerning listing of
foreign suppliers of finished dietary supplements), and 1.512(b)(3) and
(b)(6) (concerning listing of foreign suppliers and record keeping by
very small importers and importers of food from very small foreign
suppliers), a qualified individual must develop an importer's FSVP and
perform each of the activities required under subpart L. These
activities include: reviewing a food and supplier's compliance status;
conducting hazard analysis and foreign supplier verification; reviewing
complaints, conducting investigations, and taking corrective actions;
and reassessing the FSVP and making any appropriate changes.
    Education and training are important to the effective development
and implementation of an FSVP, including activities such as:
identifying hazards that are reasonably likely to occur in foods;
evaluating controls that are intended to address those hazards;
assessing the appropriateness of the use of different verification
activities for different types of hazards; and determining whether
investigatory and corrective actions are appropriate. In addition, the
products produced by the food industry are diverse, and the hazards
that are reasonably likely to occur with a particular food and in a
particular facility depend on a range of factors.
    Proposed Sec.  1.503 is consistent with regulations and guidelines
requiring the use of trained individuals to conduct food safety
operations. The HACCP guidelines issued by the National Advisory
Committee on Microbiological Criteria for Foods (NACMCF) recommend that
experts who are knowledgeable in the food process either participate in
or verify the completeness of the HACCP plan (Ref. 8). Our HACCP
regulations for juice and seafood require that a trained individual be
responsible for developing the hazard analysis (juice only), developing
the HACCP plan, verifying and modifying the HACCP plan, and performing
the record review (Sec. Sec.  120.13 and 123.10, respectively). These
regulations also state that job experience will qualify an individual
to perform these functions if the experience has provided knowledge at
least equivalent to that provided through a standardized HACCP
curriculum recognized as adequate by FDA. The U.S. Department of
Agriculture's (USDA's) HACCP regulations for meat and poultry state
that only an individual who has completed a training course may conduct
certain activities, such as development and modification of the HACCP
plan (9 CFR 417.7).
    In accordance with the proposed definition of ``qualified
individual,'' proposed Sec.  1.503 would mean that an importer would
need to employ or obtain or otherwise rely on the services of a person
with the necessary education, training, and experience to perform all
FSVP activities except those specifically exempted from Sec.  1.503.
When these activities involve the review of food safety plans
established in accordance with section 418 of the FD&C Act, the
qualified individual would need to have training in the principles of
hazard analysis and risk-based preventive controls as set forth in
section 418.

E. Review of Food and Foreign Supplier Compliance Status (Proposed
Sec.  1.504)

    Proposed Sec.  1.504 answers the question, ``What review of a food
and foreign supplier's compliance status must I conduct?'' We
tentatively conclude that a prudent and responsible importer should
review readily-available information regarding whether the Agency has
identified any compliance problems with the food or the foreign
supplier. Therefore, proposed Sec.  1.504 would require an importer,
before importing a food from a foreign supplier, to assess the
compliance status of the food and the foreign supplier, including
whether either is the subject of an FDA warning letter, import alert,
or requirement for certification issued under section 801(q) of the
FD&C Act (21 U.S.C. 381(q)) relating to the safety of the food, to
determine whether it would be appropriate to import the food from the
foreign supplier. (As discussed in section II.G.7 of this document,
under proposed Sec.  1.506(g), an importer also would be required to
consider the food

and supplier's compliance status as assessed under Sec.  1.504 in
determining appropriate verification activities.)
    FDA warning letters and import alerts are available on the Agency's
Web site. Section 801(q) gives FDA the authority to require, as a
condition for granting admission into the United States to an article
of food, that a certification (or other assurance) that the article
complies with applicable requirements of the FD&C Act be provided by
either (1) an Agency or a representative of the government of the
country from which the article of food originated (as designated by
FDA) or (2) a person or entity accredited under section 808 of the FD&C
Act to provide such certification or assurance. Other information
relevant to the compliance status of a food or foreign supplier, which
an importer might obtain from FDA or the foreign supplier, could
include FDA Form 483s, Establishment Inspection Reports, recall
notices, and documents relating to injunctions or seizures. Proposed
Sec.  1.504 also would require an importer to document this review and
to continue to monitor and document the compliance status as long as
the importer obtains the food from the foreign supplier.
    We request comment on what compliance information about a food or
foreign supplier an importer should be required to obtain and consider
as part of its food/supplier compliance status review. We also request
comment on whether this information should include information about a
foreign supplier's compliance standing with the food safety authority
of the country in which it is located.

F. Hazard Analysis (Proposed Sec.  1.505)

    Proposed Sec.  1.505 answers the question, ``What hazard analysis
must I conduct?'' As discussed in section I.C of this document, we
believe that identification of the hazards that commonly occur with a
food is a widely accepted principle of food safety. Incorporating this
principle into the proposed FSVP regulations, we tentatively conclude
that it is appropriate for importers to identify the hazards that are
reasonably likely to occur with the foods they import so that they can
conduct verification activities to provide assurance that these hazards
are being controlled. We also believe that identification of hazards
that are likely to occur will be an effective, risk-based way of
focusing importers' verification efforts on ensuring that the
appropriate food safety risks have been addressed.
1. Hazard Analysis
    Proposed Sec.  1.505(a) would require each importer, except as
permitted under proposed Sec.  1.505(d) (discussed in section II.F.4 of
this document) and (e) (discussed in section II.F.5 of this document),
to determine, for each food imported, the hazards, if any, that are
reasonably likely to occur with the food and, for each, the severity of
the illness or injury if such a hazard were to occur. Proposed Sec.
1.505(a) further states that the importer must document this
determination and use it to determine appropriate verification
activities in accordance with proposed Sec.  1.506.
    In accordance with Congress's directive to use a risk-based
approach to foreign supplier verification, the proposed rule would
require that the importer identify only the hazards that are reasonably
likely to occur with the foods they import. Careful assessment of known
or reasonably foreseeable hazards will ensure that an importer has
determined whether they are reasonably likely to occur and, if they
are, whether the foreign supplier of the food has the capability to
produce the food in a manner that will adequately control such hazards.
In turn, the importer's verification activities will focus on ensuring
that its foreign supplier has adequately controlled such hazards during
the food's production (or, in some cases, that an entity such as the
importer, the importer's customer, or the supplier of a raw material to
the foreign supplier is controlling the hazard). Because hazard
analysis is widely accepted in the industry as a fundamental principle
of food safety, we tentatively conclude that it is appropriate to
require that importers use this basic approach for FSVPs, unless there
are applicable FDA food safety regulations intended to comprehensively
address all hazards, or a specific subset of the hazards, relevant to a
food (e.g., RACs that are fruits or vegetables). We also are proposing
this approach to focus importers' verification efforts on those hazards
that are reasonably likely to occur and thus can be addressed through
routine verification. We request comment on this proposed approach.
    We also tentatively conclude that it is appropriate to require
importers to consider the severity of the illness or injury if a hazard
determined to be reasonably likely to occur were to in fact occur. As
discussed in the Preventive Controls Proposed Rule, the HACCP
regulations issued by FDA and the USDA, the NACMCF HACCP guidelines
(Ref. 8), and the HACCP annex to the Codex General Principles of Food
Hygiene (Codex HACCP Annex) (Ref. 9) all recognize the importance of
considering the severity of the effects of a hazard when conducting a
hazard analysis for a food.
2. Potential Hazards
    Proposed Sec.  1.505(b) states that an importer's evaluation of the
hazards that are reasonably likely to occur with each food that is
imported must consider the following potential hazards that may occur
naturally or may be unintentionally introduced:
     Biological hazards, including microbiological hazards such
as parasites and environmental pathogens, and other microorganisms of
public health significance;
     Chemical hazards, including substances such as pesticide
and drug residues, natural toxins, decomposition, unapproved food or
color additives, and food allergens;
     Physical hazards; and
     Radiological hazards.
    These hazards are the kinds of contaminants and materials that can
lead to adulteration under section 402 of the FD&C Act. The Preventive
Controls Proposed Rule includes a discussion of each of these types of
hazards and the circumstances under which each can pose a risk to
public health (78 FR 3646 at 3734 to 3735). We tentatively conclude
that it is also appropriate for food importers to examine these
potential hazards as part of their FSVPs (with exceptions discussed
elsewhere in this document).
    We also tentatively conclude that it is appropriate to require
importers to consider only those hazards that occur naturally or may be
unintentionally introduced. Intentional hazards raise different issues
and concerns. We plan to address the issue of certain intentionally
introduced hazards as part of our rulemaking to implement section 106
of FSMA (codified in section 420 of the FD&C Act (21 U.S.C. 350i)),
which directs FDA to issue regulations to protect against the
intentional adulteration of food, including the establishment of
science-based mitigation strategies to prepare and protect the food
supply chain at specific vulnerable points. However, we also recognize
that some kinds of intentional adulterants could be viewed as
reasonably likely to occur, e.g., in foods for which there is a widely
recognized risk of economically motivated adulteration in certain
circumstances. An example of this kind of hazard is the addition of
melamine to certain food products apparently to enhance perceived
quality and/or protein content. We request comment on

whether to include potential hazards that may be intentionally
introduced for economic reasons. We also request comment on when an
economically motivated adulterant can be considered reasonably likely
to occur.
3. Hazard Evaluation
    Proposed Sec.  1.505(c) states that, in evaluating the hazards in
Sec.  1.505(b), the importer must consider the effect of several
factors on the safety of the finished food for the intended consumer.
These factors, listed in proposed Sec.  1.505(c)(1) through (c)(9), are
as follows:
     The ingredients of the food;
     The condition, function, and design of the foreign
supplier's establishment and equipment;
     Transportation practices;
     Harvesting, raising, manufacturing, processing, and
packing procedures;
     Packaging and labeling activities;
     Storage and distribution;
     Intended or reasonably foreseeable use;
     Sanitation, including employee hygiene; and
     Any other relevant factors.
We tentatively conclude that these are factors that a prudent person
who imports food would consider when evaluating hazards to determine
those that are reasonably likely to occur with a food. Further
information regarding such factors is provided in the Preventive
Controls Proposed Rule (78 FR 3646 at 3736 to 3738). We expect that
importers (or the qualified individuals assisting them) will obtain
information on these factors from FDA guidance, scientific and
technical experts, published scientific literature, trade publications,
and foreign suppliers of these foods.
    Proposed Sec.  1.505(c)(1) would require that the hazard evaluation
consider the ingredients of the imported food. Examples of problems
that might occur with a product's ingredients include the presence of
an undeclared allergen and inadequate roasting of nuts used in a food
product.
    Proposed Sec.  1.505(c)(2) would require that the hazard evaluation
consider the condition, function, and design of the establishment and
equipment of the foreign supplier. The condition, function, or design
of an establishment or its equipment could potentially result in the
introduction of hazards into foods. For example, older equipment (e.g.,
older slicing, rolling, and conveying equipment) may be more difficult
to clean (e.g., with close-fitting components or hollow parts) and,
therefore, provide more opportunities for pathogens to become
established in a niche environment than modern equipment designed to
address the problem of pathogen harborage in such environments.
Equipment designed so that there is metal-to-metal contact may generate
metal fragments. An establishment that manufactures soft, fresh cheese
(such as queso fresco, which is a ready-to-eat product) may have cold,
moist conditions that are conducive to the development of a niche where
the pathogen Listeria monocytogenes can become established and
contaminate food-contact surfaces and, eventually, foods. An
establishment design that has closely spaced equipment would provide
more opportunities for cross-contact of allergens (such as powdered
milk or soy) from one line to another (e.g., through dust) than a
facility that has more spacing between equipment.
    Proposed Sec.  1.505(c)(3) would require that the hazard evaluation
consider transportation practices. A food may become unsafe as a result
of poor transportation practices. For example, for certain types of
food, a supplier may need to take into account the method of
transporting the food in developing its preventive controls, such as
for food that is temperature sensitive or susceptible to cross-
contamination.
    Proposed Sec.  1.505(c)(4) would require that the hazard evaluation
consider harvesting, raising, manufacturing, processing, and packing
procedures. Examples of hazards that could arise during harvesting
include contamination with aflatoxin or a pesticide, and the
introduction of a physical hazard such as glass during mechanical
harvesting. Hazards may arise from manufacturing processes such as
cooling or holding of certain foods due to the potential for
germination of pathogenic spore-forming bacteria such as Clostridium
perfringens and Bacillus cereus (which may be present in food
ingredients) as a cooked product is cooled and reaches a temperature
that will allow germination of the spores and outgrowth. Hazards also
may arise from manufacturing processes such as acidification due to the
potential for germination of spores of C. botulinum, with subsequent
production of botulinum toxin, if the acidification is not done
correctly and the packaging environment otherwise supports C. botulinum
growth and toxin formation. Toxins can be produced by the bacteria
Staphylococcus aureus or B. cereus in a product that has been heated
and held at room temperature during the manufacturing process if the
product formulation supports growth of the bacteria and S. aureus or B.
cereus is present in the ingredients of the product. Physical hazards
may occur from metal fragments generated during the manufacture of food
on equipment in which metal (e.g., wires, saw blades, knives) is used
to cut products during manufacturing.
    Proposed Sec.  1.505(c)(5) would require that the hazard evaluation
consider packaging activities and labeling activities. For example,
whether a product is packaged in glass bottles or in plastic bottles
could affect what hazards are reasonably likely to occur with the
product.
    Proposed Sec.  1.505(c)(6) would require that the hazard evaluation
consider storage and distribution of a food. For example, biological
hazards are more likely to be reasonably likely to occur during storage
and distribution in foods that require refrigerated storage to maintain
safety than in shelf-stable foods, which are designed for control of
biological hazards.
    Proposed Sec.  1.505(c)(7) would require that the hazard evaluation
consider the intended or reasonably foreseeable use of a food. For
example, if the product may either be cooked by the consumer or used in
a manner that does not involve cooking, e.g., a soup mix used as a
component of a dip, hazards such as Salmonella would need to be
considered to determine if they are reasonably likely to occur.
    Proposed Sec.  1.505(c)(8) would require that the hazard evaluation
consider sanitation, including employee hygiene. Sanitation practices
can impact the likelihood of a hazard being introduced into a food. For
example, inadequate worker health and hygiene can present the potential
for transfer of pathogens such as Salmonella, hepatitis A, and
norovirus.
    Proposed Sec.  1.505(c)(9) would require that the hazard evaluation
consider any other relevant factors that might potentially affect the
safety of the food for the intended consumer. For example, an
unexpected natural disaster could flood some or all of a facility,
creating insanitary conditions and potentially contaminating the
facility with harmful micro-organisms or chemical residues. Following a
natural disaster, environmental contaminants that could enter a
facility could be hazards that are reasonably likely to occur.
    Although proper evaluation of potential hazards under proposed
Sec.  1.505(c) requires the consideration of factors that may occur at
various points throughout a food's production and distribution chain,
an importer's responsibility to conduct verification activities in
accordance with proposed

Sec.  1.506 applies only to the ability of its foreign supplier (as
defined in proposed Sec.  1.500) to control (or verify control of)
these hazards (unless they are controlled by the importer or the
importer's customer). This means that an importer's verification
activities would need to provide assurances regarding the actions of
its foreign supplier, but the importer would not be required to conduct
verification with respect to any other entities either before or after
the foreign supplier in the food's production and distribution chain.
4. Review by Qualified Individual of Foreign Supplier's Hazard Analysis
    Proposed Sec.  1.505(d) would permit an importer to identify the
hazards that are reasonably likely to occur for a particular food by
reviewing and evaluating the hazard analysis conducted by the foreign
supplier (rather than conducting an entirely separate evaluation of
hazards using information that the importer itself has obtained). We
tentatively conclude that this approach to hazard analysis would reduce
the burden on an importer while still ensuring that the importer has an
adequate understanding of the hazards that are reasonably likely to
occur with a particular food.
5. Microbiological Hazards in RACs That Are Fruits or Vegetables
    As stated in section I.C of this document, the proposed produce
safety regulations would not require produce farms to determine the
microbiological hazards that are associated with each fruit or
vegetable they grow. Instead, FDA has identified the reasonably
foreseeable microbiological hazards associated with fruits and
vegetables and has proposed requirements for measures intended to
prevent the introduction of these hazards into this food and to provide
reasonable assurances that the produce is not adulterated due to these
hazards. For this reason, we tentatively conclude that it would not be
appropriate to require importers of RACs that are fruits or vegetables
to determine whether there are any microbiological hazards that are
reasonably likely to occur with this food. Therefore, proposed Sec.
1.505(e) states that for a RAC that is a fruit or vegetable, an
importer is not required to conduct a hazard analysis regarding the
microbiological hazards that might be reasonably likely to occur with
this food. Instead, the importer will need to verify that this kind of
food is produced in compliance with FDA's produce safety standards or
equivalent standards.
    However, importers of RACs that are fruits or vegetables would
still be required to conduct a hazard analysis regarding all non-
microbiological hazards that might be associated with the food (i.e.,
chemical, physical, and radiological hazards). In the case of these
kinds of hazards, we anticipate that hazard analysis will not be
complicated; it should consist of being aware of how the crop is
produced and whether there have been non-microbiological problems
associated with the crop or the producer in the past. For example, if
an importer is purchasing cucumbers from a country, region, or grower
with a history of pesticide residue violations for that food, we would
expect the importer to address this potential adulteration. Conversely,
if the cucumbers come from a country or region with no history of
pesticide residue violations, we would not expect an importer to
identify unsafe pesticide residues as a hazard that is reasonably
likely to occur, unless new information came to light or questions
about the use of pesticides or control of pesticide residues indicated
an issue. We anticipate that, in addition to requesting information
from foreign suppliers, importers would use public information, such as
that available on FDA's Web site from FDA guidance, import alerts,
warning letters, and untitled letters, to decide if a hazard was
reasonably likely to occur. As we have explained, this assessment is
intended to allow importers to focus on those hazards that are likely
and thus can be addressed through routine verification.

G. Foreign Supplier Verification and Related Activities (Proposed Sec.
1.506)

    Proposed Sec.  1.506 answers the question, ``What foreign supplier
verification and related activities must I conduct?'' Requiring
importers to conduct foreign supplier verification activities is the
core component of the import safety responsibilities assigned to
importers under section 301 of FSMA. Verification of foreign suppliers
also is consistent with the principles of verification of suppliers of
raw materials and ingredients discussed in the Preventive Controls
Proposed Rule (78 FR 3646 at 3765 to 3767), as well as consistent with
the intent of the requirements applicable to importers of juice and
seafood products under parts 120 and 123.
1. List of Foreign Suppliers
    To help ensure that importers are obtaining food only from
appropriate foreign suppliers, proposed Sec.  1.506(a) would require
each importer to maintain a written list of the foreign suppliers from
which they are importing food. The list would also help importers to
quickly and accurately identify their foreign suppliers for purposes of
conducting FSVP activities such as supplier verification,
investigations, and corrective actions, and help ensure consistent
performance of these activities by importers' employees or other
qualified individuals. The list also would assist us in monitoring
importers' compliance with the FSVP requirements. We request comment on
how the foreign suppliers should be identified in this list to ensure
that the information is accurate and not ambiguous to the importer or
FDA (e.g., identified by the foreign supplier's name and address, by
their name and DUNS number, or by some other means). We would have
access to this information upon request under proposed Sec.  1.510(b).
Nonetheless, we also request comment on whether the identity of the
foreign supplier of the food should also be provided when the food is
offered for import, along with the importer information that must be
provided under proposed Sec.  1.509(c), and, if so, how the foreign
supplier should be identified to ensure that the information is
accurate and not ambiguous. Under the prior notice requirements, for
each line entry of imported food, we receive the identity of the
foreign manufacturer/processor and, if known, the grower (see 21 CFR
1.281). Therefore, any such comments should address how the identity of
the foreign supplier could be used in conjunction with the prior notice
and other relevant information we currently receive about foreign
suppliers.
2. Foreign Supplier Verification Procedures
    Proposed Sec.  1.506(b) would require that importers establish and
follow adequate written procedures for conducting foreign supplier
verification activities with respect to the foods they import. These
procedures will state how the importer will comply with Sec.  1.506,
including documenting when the importer itself controls hazards under
Sec.  1.506(e), documenting customer control of hazards under Sec.
1.506(f), and conducting appropriate foreign supplier verification
activities in accordance with Sec.  1.506(g) and (h). We tentatively
conclude that establishing and following written procedures on how
these activities will be conducted will help ensure that importers
properly and consistently verify that the hazards associated with the
foods they import are adequately controlled, and will allow us to more
effectively monitor

compliance with section 805 of the FD&C Act.
3. Purpose of Supplier Verification
    As stated in section II.F.1 of this document, the proposed rule
would require importers (with some exceptions) to conduct hazard
analyses as part of their FSVPs. To provide assurances of adequate
control of hazards reasonably likely to occur, proposed Sec.  1.506(c)
would require the importer to conduct activities to verify that such
hazards are adequately controlled. The approach of identifying hazards
that are reasonably likely to occur and verifying that they are being
adequately controlled is sufficiently general and flexible to apply to
a variety of circumstances. We tentatively conclude, however, that it
would not be appropriate to apply the supplier verification requirement
in proposed Sec.  1.506(c)--i.e., that verification activities provide
adequate assurances that the hazards identified by the importer have
been adequately controlled--to microbiological hazards in RACs that are
fruits or vegetables and that would be subject to the produce safety
regulations in proposed part 112. This is because, under proposed Sec.
1.505(e), importers of these fruits or vegetables would not be required
to conduct a hazard analysis regarding the microbiological hazards for
this food. Instead, as discussed below in section II.G.8 of this
document, verification for these hazards should address whether foreign
suppliers are producing these fruits and vegetables in accordance with
the produce safety regulations. Consequently, proposed Sec.  1.506(c)
states that supplier verification activities must provide assurances
that hazards identified as reasonably likely to occur are adequately
controlled ``[e]xcept with respect to verification activities specified
in [proposed Sec.  1.506(h)] regarding raw agricultural commodities
that are fruits or vegetables that are subject to [part 112].'' This
exception regarding the purpose of supplier assurances would apply only
to microbiological hazards for RACs that are fruits or vegetables and
that are subject to the proposed produce safety regulations; such RACs
that are not subject to those regulations (e.g., fruits and vegetables
that are rarely consumed raw or that receive commercial processing that
adequately reduces the presence of microorganisms of public health
significance) are regarded as having no microbiological hazards with
respect to which supplier verification would be warranted.
4. No Hazards Identified
    With some foods, an importer might conduct a hazard analysis and
conclude that there are no hazards that are reasonably likely to occur.
Examples of foods with respect to which it is possible that, depending
on the circumstances, no hazards would be reasonably likely to occur
are salt and food-grade chemicals such as citric acid. In the
forthcoming draft guidance on FSVPs, we intend to provide other
examples of foods for which it is possible that no hazard would be
reasonably likely to occur. We tentatively conclude that when an
importer has determined that no hazards are reasonably likely to occur
with a particular food, there would be no public health reason to
require the importer to conduct most of the activities under Sec.
1.506. Therefore, proposed Sec.  1.506(d) states that if an importer
conducts a hazard analysis in accordance with Sec.  1.505 and
determines that there are no hazards that are reasonably likely to
occur with a food, the only requirement in Sec.  1.506 with which the
importer must comply with respect to that food is to maintain a list of
its suppliers of this food in accordance with Sec.  1.506(a). However,
if an importer determined that there were no hazards in a food, the
importer would need to reassess this determination at least every 3
years in accordance with proposed Sec.  1.508.
    Proposed Sec.  1.506(d) also states that this provision regarding
an absence of hazards would not apply if the food is a RAC that is a
fruit or vegetable and that would be subject to the produce safety
regulations. This exception is appropriate because for such food the
importer is not conducting a hazard analysis to identify the
microbiological hazards that are reasonably likely to occur in the
food. The importer would still need to conduct verification activities
with respect to microbiological hazards in accordance with proposed
Sec.  1.506(h), discussed in section II.G.8 of this document.
5. Hazards Controlled by the Importer
    Certain hazards associated with an imported food might be
controlled through actions that the importer takes after the food is
brought into the United States. Proposed Sec.  1.506(e) states that for
a hazard that the importer has identified as reasonably likely to occur
with a food that the importer itself will control, the importer must
document, at least annually, that it has established and is following
procedures that adequately control the hazard. If the importer of a
food has established validated preventive controls to ensure that a
hazard is adequately controlled, there would be no need for the
importer to conduct a foreign supplier verification activity with
respect to that hazard. For example, a domestic food facility might
import raw peanuts for use as an ingredient in its products. If this
importer identifies Salmonella as a hazard reasonably likely to occur
in the peanuts, the importer would not need to conduct a verification
activity with respect to the Salmonella hazard in the peanuts if the
importer itself treats the peanuts using a process validated to
adequately reduce Salmonella. Because, in the context of hazards
controlled by an importer, process controls such as these generally are
designed for the control of microbiological hazards, proposed Sec.
1.506(e) likely would not apply to chemical hazards (such as
pesticides, mycotoxins, and drug residues) or radiological hazards
(such as iodine-131), although this would not necessarily always be the
case.
    We request comment on this proposal to require importers that
control the hazards in food they import to document their control of
these hazards, including on the frequency with which importers should
be required to document this control.
    As discussed in section II.C of this document, we are requesting
comment on whether it would be appropriate to deem importers who are in
compliance with any applicable supplier verification provisions that
are included in the preventive controls regulations to be in compliance
with the FSVP requirements, to avoid duplicative regulation of
importers who are also food facilities that are required to register.
We tentatively conclude that, if a provision to this effect were
included in the FSVP regulations in accordance with the inclusion of
any supplier verification provisions in the preventive controls
regulations, proposed Sec.  1.506(e) would be unnecessary, as importers
that control hazards in foods they import would be subject to the
supplier verification provisions in the preventive controls
regulations. We request comment on this proposed approach to provisions
on importers who control the hazards in the food they import.
    Imported food that is, or appears to be, adulterated, misbranded,
or manufactured, processed, or packed under insanitary conditions is
subject to refusal of admission under section 801(a) of the FD&C Act.
If the importer is importing food that has a hazard that is reasonably
likely to occur and that has not yet been controlled (because the
hazard is intended to be controlled by the importer or, as discussed in
section

II.G.6 of this document, by its customer), such food may be subject to
refusal of admission. We request comment regarding the importation of
such products and what process should be required to help ensure that
food that is subject to refusal of admission is not distributed without
the hazard being adequately controlled.
6. Hazards Controlled by the Importer's Customer
    Some hazards associated with imported foods are controlled through
procedures implemented by the importer's U.S. customer, i.e., a
business that purchases the imported food for further processing or
distribution. For example, imported macadamia nuts might be used as an
ingredient in cookies made by a bakery operation, or imported mushrooms
might be an ingredient of domestically produced canned soup. Proposed
Sec.  1.506(f) states that for a hazard that an importer has identified
as reasonably likely to occur with a food that the importer's customer
adequately controls, the importer must verify that its customer
controls the hazard by obtaining written assurance, at least annually,
from the customer that it has established and is following procedures
(identified in the written assurance) that adequately control the
hazard. The written assurance would need to briefly state the
procedures that the customer has put in place to control the hazard and
affirm that these procedures are in fact controlling the hazard.
    We invite comment on how frequently an importer should be required
to obtain written assurance from its customer that the customer is
following procedures to adequately control the hazard. For example, we
request comment on whether the importer should be required to obtain
this assurance the sooner of every 3 years or whenever there is a
change in the customer's control procedures (consistent with the
standard for reassessment of the importer's FSVP under proposed Sec.
1.507(a)), or whether the importer should be required to obtain the
assurance more frequently. As noted above, this food may be subject to
refusal of admission when it is imported. Therefore, we request comment
regarding the importation of such products and what process should be
required to help ensure that food that is subject to refusal of
admission is not distributed without the hazard being adequately
controlled.
    As with hazards to be controlled by an importer, we tentatively
conclude that proposed Sec.  1.506(f) would be unnecessary if the FSVP
regulations were to include a provision stating that an importer whose
customer was in compliance with any adopted preventive controls
supplier verification provisions is deemed to be in compliance with the
FSVP requirements. We request comment on this proposed approach to
provisions on importers whose customers control hazards in the food
they import.
7. Hazards Controlled or Verified by the Foreign Supplier
    Proposed Sec.  1.506(g) addresses foods with hazards that are