Document ID: FDA-2011-N-0143-0023
Agency: fda
Document Type: Proposed Rule
Title: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
Posted Date: 2013-07-29T04:00Z

[Federal Register Volume 78, Number 145 (Monday, July 29, 2013)]
[Proposed Rules]
[Pages 45729-45779]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17993]

[[Page 45729]]

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  

[[Page 45730]]

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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: 301-827-6870.
     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, 301-796-4614; or
Domenic Veneziano, Office of Enforcement and Import Operations (ELEM-
3108), Office of Regulatory Affairs, Food and Drug Administration, 
12420 Parklawn Dr., Element Bldg., Rockville, MD 20857, 301-796-6673.

SUPPLEMENTARY INFORMATION: 

Table of Contents

Executive Summary
    Purpose 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

[[Page 45731]]

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

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[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

[[Page 45733]]

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:

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[GRAPHIC] [TIFF OMITTED] TP29JY13.003

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[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

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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.

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[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.

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[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

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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

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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.

[[Page 45741]]

    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

[[Page 45742]]

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

[[Page 45743]]

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

[[Page 45744]]

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

[[Page 45745]]

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

[[Page 45746]]

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

[[Page 45747]]

     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

[[Page 45748]]

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

[[Page 45749]]

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

[[Page 45750]]

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

[[Page 45751]]

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

[[Page 45752]]

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

[[Page 45753]]

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 
controlled by, or for which control is verified by, the importer's 
foreign supplier. Requiring importers to conduct supplier verification 
with respect to these hazards will help to ensure, consistent with 
section 805(c)(2)(A) of the FD&C Act, that the foreign supplier is 
following processes and procedures that will provide the same level of 
public health protection as those required under section 418 or 419 of 
the FD&C Act (if either is applicable) and is otherwise producing food 
that is not adulterated under section 402 or misbranded under section 
403(w) of the FD&C Act. We tentatively conclude that requiring such 
verification is consistent with the principles of food safety 
underlying current industry practice with respect to the verification 
of the safety of imported food and food ingredients obtained from 
suppliers, as well as the principles behind the importer requirements 
in the juice and seafood HACCP regulations.
    We are co-proposing two options for the requirements regarding 
supplier verification activities for hazards that are controlled, or 
for which control is verified, by the importer's foreign supplier. 
Option 1 of the co-proposal would establish certain requirements for 
SAHCODHA hazards to be controlled by the foreign supplier and different 
requirements for non-SAHCODHA hazards and SAHCODHA hazards that the 
foreign supplier verifies have been controlled by its raw material or 
ingredient supplier. Option 2 of the co-proposal would require the 
importer to determine the supplier verification activity it would use 
for all hazards that the foreign supplier controls or for which it 
verifies control. We are proposing alternative codified provisions to 
facilitate consideration of, and comment on, these two different 
approaches to supplier verification.
    a. Option 1: Different approaches for SAHCODHA hazards controlled 
by the foreign supplier and other hazards.
    Option 1 of the co-proposal would establish mandatory onsite 
auditing requirements for SAHCODHA hazards to be controlled by the 
foreign supplier, while for non-SAHCODHA hazards and all hazards that a 
foreign supplier verifies have been controlled by its raw material or 
ingredient supplier, the importer would choose from among certain 
specified verification activities, as discussed below.
    i. SAHCODHA hazards to be controlled by the foreign supplier.
    Under Option 1, proposed Sec.  1.506(g)(1) sets forth the required 
verification activities for hazards that are to be controlled by the 
foreign supplier at its establishment when the hazard is one for which 
there is a reasonable probability that exposure to the hazard will 
result in serious adverse health consequences or death to humans or 
animals. These SAHCODHA hazards are those for which a recall of a 
violative product posing such a hazard is designated as ``Class 1'' 
under 21 CFR 7.3(m)(1). Proposed Sec.  1.506(g)(1) states that for a 
SAHCODHA hazard that is to be controlled at the foreign supplier's 
establishment, the importer must conduct and document certain onsite 
audits specified in Sec.  1.506(g)(1)(i) and (ii) for the hazard.
    Examples of hazards that, in some circumstances, historically have 
resulted in serious adverse health consequences or death to humans or 
animals include pathogens or their toxins in ready-to-eat food. Under 
Option 1's Sec.  1.506(g)(1), if such hazards are identified by the 
importer as hazards reasonably likely to occur in foods they receive 
from a foreign supplier, and the foreign supplier is to apply 
preventive controls to address those hazards, then onsite auditing of 
the foreign supplier must be conducted to verify that those controls 
have been properly applied. For example, if Salmonella, exposure to 
which creates a reasonable probability of serious adverse health 
consequences or death to humans or animals, is identified as a hazard 
reasonably likely to occur with peanuts and the foreign supplier 
applies a process control, e.g., oil roasting, onsite auditing must be 
conducted to verify that the supplier's roasting process is adequately 
controlling the Salmonella.
    Onsite verification is widely acknowledged in the food industry as 
an important component of an effective food safety management system. 
For example, the Grocery Manufacturers Association's (GMA's) Food 
Supply Chain Handbook (GMA Handbook) (Ref. 10) states that many food 
importers elect to audit a foreign supplier using an employee of the 
company (``second-party auditing'') or a qualified third-party auditing 
firm (independent auditor). In addition, onsite auditing is

[[Page 45754]]

a major component of effective food safety schemes described in the 
Global Food Safety Initiative (GFSI) Guidance Document (Ref. 11).
    We also believe that onsite auditing of a foreign supplier is a 
very effective way of verifying that the supplier understands the 
SAHCODHA hazard that must be addressed and has implemented appropriate 
controls. Through an audit conducted onsite, the auditor can observe 
physical conditions, interview employees, and review records to verify 
that preventive controls are being implemented and, if there is a 
written plan for controlling the hazard, that the controls are being 
implemented according to that plan.
    We believe that, for some SAHCODHA hazards in certain situations, 
conducting onsite auditing alone may not be sufficient to ensure that 
the hazard is adequately controlled. For example, an importer who was 
required by Option 1's Sec.  1.506(g)(1) to perform an onsite audit of 
its foreign supplier of semi-soft cheese might become aware that such 
cheese from that supplier's country frequently does not meet FDA's 
standard for the presence of L. monocytogenes. Under these 
circumstances, performance of annual onsite audits would not, by 
itself, provide sufficient assurance that the L. monocytogenes hazard 
has been adequately controlled; periodic sampling and testing of the 
cheese for the pathogen also would be needed. Similarly, an importer of 
acidified peppers receiving product from a foreign supplier that had 
experienced compliance problems because of inadequate pH controls, but 
that had instituted corrections to address the problem, should conclude 
that an annual audit to verify the adequacy of the pH controls would 
not provide sufficient assurances that the compliance problems did not 
reoccur, and that periodic pH testing of the peppers would be 
appropriate until confidence in the supplier has been restored. 
Therefore, proposed Sec.  1.506(g)(1) under Option 1 would require 
that, when onsite auditing alone cannot provide adequate assurances 
that such a hazard is adequately controlled, the importer must conduct 
one or more additional verification activities to provide such 
assurances.
     Initial onsite audit. For SAHCODHA hazards under Option 
1's Sec.  1.506(g)(1), foreign supplier verification would require an 
initial onsite audit and subsequent periodic onsite audits. Proposed 
Sec.  1.506(g)(1)(i) would require the importer to conduct (and 
document) or obtain documentation of an onsite audit before importing 
the food from the foreign supplier. The importer would use the results 
from the initial audit in determining whether any changes were 
warranted before obtaining food from this foreign supplier.
    The importer could either conduct the onsite audit itself (if it 
has a qualified individual on staff), engage the services of a 
qualified individual who would conduct the audit, or obtain a 
certification or other documentation of an audit of the foreign 
supplier conducted by a qualified individual, including an audit 
conducted by a third-party auditor at the request of the foreign 
supplier or by an auditor working for a foreign government. We note 
that others have adopted a similar approach. As previously stated, the 
GMA Handbook (Ref. 10) acknowledges that many customers audit a 
supplier themselves or use a qualified third-party auditor. The NACMCF 
HACCP guidelines (Ref. 8) recommend that a periodic comprehensive 
verification of the HACCP system be conducted by an unbiased, 
independent authority.
    It is widely recommended that persons conducting onsite audits have 
technical expertise in auditing. The NACMCF HACCP guidelines (Ref. 8) 
acknowledge that it is important that individuals performing 
verification have appropriate technical expertise to perform this 
function. GMA recommends that an auditor's competency include 
education/experience, advanced HACCP training, and a minimum amount of 
auditing expertise (Ref. 10). The GFSI Guidance Document states that an 
auditor's qualifications should include the following: Minimum full-
time work experience in food or an associated industry; formal training 
in auditing techniques; initial training for each product category with 
which the auditor will be working; audit experience; and continuous 
professional development (Ref. 11).
    We recognize that Option 1's proposed requirement to conduct or 
obtain documentation of onsite audits of foreign suppliers with respect 
to SAHCODHA hazards would be one of the most significant of the FSVP 
requirements. Many in the food industry already rely on third-party 
auditors to accomplish verification of food safety controls and we 
expect that they will continue to do so. However, we also recognize 
that currently there is considerable variance in the quality of 
auditing services and the nature of audit criteria.
    Along with industry's ongoing efforts to incorporate onsite 
auditing into food safety operations, we anticipate that our adoption 
of final preventive controls and produce safety regulations will 
improve auditing consistency by providing clear, uniform criteria 
against which suppliers' processes and controls can be assessed and 
audited. This greater consistency in auditing should make it easier for 
suppliers to demonstrate their products' safety to multiple customers 
through a single audit, resulting in a more efficient auditing system.
    We believe that this movement toward a more effective and efficient 
food safety auditing system will be further enhanced by FDA's adoption 
of regulations on the accreditation of third-party auditors. As 
previously stated, section 307 of FSMA (adding section 808 of the FD&C 
Act) requires FDA to establish a third-party accreditation system and 
develop model accreditation standards that will help ensure that these 
third parties provide high-quality auditing services. While neither the 
proposed FSVP regulations nor the proposed preventive controls 
regulations would require use of accredited third-party auditors, we 
expect that adoption of these regulations will increase the demand for 
such services. Proposed Sec.  1.500 states that a third-party auditor 
accredited in accordance with section 808 of the FD&C Act would be a 
``qualified individual'' for purposes of the FSVP regulations. Thus, 
although use of accredited auditors would not be required, once FDA's 
third-party accreditation system is in place, we expect that many 
importers will request that their suppliers obtain an accredited third-
party audit that meets the requirements under section 808. Rather than 
have each importer and processor request individual audits of their 
suppliers, we anticipate that the system ultimately will evolve into 
one in which the foreign supplier obtains an audit by an accredited 
third party that will be acceptable to, and used by, most of its 
customers. By minimizing the number of onsite audits conducted at each 
foreign supplier facility, this system will more efficiently leverage 
the resources of importers, processors, and suppliers. The proposed 
FSVP regulations are designed to permit this systematic use of 
accredited third parties.
    Regarding an importer's obligation under Option 1's section Sec.  
1.506(g)(1) to conduct or obtain documentation of an onsite audit of 
its foreign supplier, we request comment on whether it would be 
appropriate to allow an importer to rely on an audit conducted in 
accordance with section 801(q) of the FD&C Act as fulfillment of this 
obligation. Section 303(b) of FSMA

[[Page 45755]]

gives FDA the authority, in section 801(q) of the FD&C Act, to require, 
as a condition of granting admission to an article of food imported or 
offered for import into the United States, that a certification or 
other assurance (e.g., shipment-specific certificate, listing of 
certified facilities) be obtained stating that a food that FDA has 
identified as high risk, in accordance with that provision, complies 
with the requirements of the FD&C Act. Such certificates or other 
assurances would have to be obtained from an Agency or representative 
of the government of the country from which the food originated, as 
designated by FDA, or from a third-party auditor accredited under 
section 808 of the FD&C Act. In deciding whether to require such 
certification or other assurance, FDA would consider, among other 
factors, known safety risks associated with the food and with the 
country, territory, or region of origin of the food. We request comment 
on whether, if FDA required certification of a food under section 
801(q), an importer should be permitted to rely on the results of the 
audit that led to issuance of the section 801(q) certification to meet 
the requirement to conduct or obtain the results of an onsite audit 
under proposed Sec.  1.506(g)(1). If you believe that an importer 
should be permitted to rely on the results of the audit that led to 
issuance of the section 801(q) certification, we request comment on the 
circumstances and conditions under which this would be appropriate.
    We also request comment on whether an importer should be permitted 
to meet its onsite auditing requirements under the FSVP regulations by 
relying on the results of an audit conducted to obtain facility 
certification required for participation in the voluntary qualified 
importer program (VQIP), which Congress directed FDA to establish in 
section 302 of FSMA (codified in section 806 of the FD&C Act (21 U.S.C. 
384b)). As with audits for section 801(q) certification, we request 
comment on the particular circumstances and conditions under which 
reliance on audits conducted for facility certification under VQIP 
would be appropriate for meeting FSVP requirements.
     Subsequent periodic onsite audits. For ongoing 
verification with respect to SAHCODHA hazards controlled by a foreign 
supplier of a food, Option 1's proposed Sec.  1.506(g)(1)(ii) would 
require the importer to conduct (and document) or obtain documentation 
of an onsite audit of the foreign supplier at least annually, unless 
more frequent onsite audits were necessary to adequately verify 
adequate control of the hazard. We tentatively conclude that conducting 
audits annually for SAHCODHA hazards is often adequate for verifying 
that these hazards are appropriately controlled. The requirement for 
annual onsite audits is consistent with the recommendations on the 
frequency of third-party auditing issued by the GFSI (Ref. 11), 
although GFSI recommends annual auditing regardless of the potential 
severity of the hazard. However, if more frequent onsite audits were 
necessary to verify adequate control of the hazard, the importer would 
be required to conduct or obtain documentation of audits more 
frequently. GFSI states that the frequency of audits may be influenced 
by a number of factors, such as previous audit history, concerns about 
compliance with an audit scheme's standard, and changes in product 
technology (Ref. 11). We request comment on the proposed annual onsite 
audit frequency as well as comment on what criteria, if any, should be 
specified for determining whether more frequent audits are appropriate. 
We are aware that there are circumstances in which suppliers are 
audited multiple times each year due to multiple customer requests (in 
addition to, in some cases, the company's internal audit). It is not 
our intent to increase the number of audits of each foreign supplier; 
rather, we anticipate there will be consolidation of audits. We request 
comment on this approach.
    ii. Supplier verification activities for other hazards under Option 
1.
    Option 1's proposed Sec.  1.506(g)(2) sets forth the foreign 
supplier verification requirements for hazards not specified in 
proposed Sec.  1.506(g)(1), i.e., non-SAHCODHA hazards to be controlled 
by the foreign supplier of a food and any hazard which the foreign 
supplier verifies has been controlled by its supplier.
    We tentatively conclude that onsite auditing is not necessarily 
warranted to verify adequate control of a non-SAHCODHA hazard. Examples 
of hazards that historically have not resulted in serious adverse 
health consequences or death to humans or animals include drug residues 
and some foreign objects. We tentatively conclude that a verification 
activity other than onsite auditing may be adequate for such hazards.
    Also included in the hazards subject to Option 1's proposed Sec.  
1.506(g)(2) are hazards for which a foreign supplier, upon receipt of 
an ingredient from another entity, takes steps to verify that the 
hazards have been adequately controlled before the foreign supplier 
processes the received ingredient. For example, an importer might 
identify Salmonella as a hazard reasonably likely to occur in a 
seasoning mix made by blending milk powder and spices. The foreign 
supplier of the seasoning mix does not apply a control for Salmonella 
in its blending operation but instead conducts verification to ensure 
that the suppliers of milk powder and spice have used proper controls. 
Another example is when a foreign supplier conducts testing to verify 
that its raw material supplier has applied a procedure that removes a 
hazard posed by the potential presence of a pesticide in the raw 
material. For such hazards, a foreign supplier is not applying a 
process control during the manufacturing/processing of a raw material 
or ingredient to adequately reduce the hazard but is instead relying on 
testing the incoming raw material or ingredient or conducting some 
other activity to verify that the hazard is appropriately controlled by 
its supplier, thereby making in-plant audits of conditions and 
practices less important.
    To address these types of hazards and any others not subject to 
Option 1's proposed Sec.  1.506(g)(1), Option 1's proposed Sec.  
1.506(g)(2) would require that the importer conduct one or more of the 
verification activities specified in proposed Sec.  1.506(g)(2)(i) 
through (g)(2)(iv) before using or distributing the food and 
periodically thereafter as specified for the relevant activity. 
Proposed Sec.  1.506(g)(2) also would require that the importer 
determine and document the frequency with which the activity or 
activities must be conducted. Finally, proposed Sec.  1.506(g)(2) 
states that, in determining the appropriate verification activities and 
how frequently they should be conducted, the importer must consider the 
risk presented by the hazard and the food and foreign supplier's 
compliance status as reviewed under Sec.  1.504.
    As set forth in Option 1's proposed Sec.  1.506(g)(2)(i) through 
(g)(2)(iv), the foreign supplier verification activities that importers 
may choose to conduct, if they are appropriate for the hazard, are as 
follows:
     Periodic onsite auditing.
     Periodic or lot-by-lot sampling and testing of the food.
     Periodic review of the foreign supplier's food safety 
records.
     Any other procedure established to be appropriate.

These verification procedures, and examples of types of foods/hazards 
for which they may be appropriate, are discussed below.
     Periodic onsite auditing. Under Option 1's proposed Sec.  
1.506(g)(2)(i), an

[[Page 45756]]

importer could choose to conduct or obtain documentation of an onsite 
audit of its foreign supplier to verify control of a hazard subject to 
Sec.  1.506(g)(2). Using the example provided above involving imported 
seasoning mix, the importer might choose to conduct an audit or use a 
third-party auditor to conduct an audit of the foreign supplier's 
receiving and blending operations to verify that the foreign supplier 
tests incoming lots of powdered milk and spices to verify that they 
have been controlled for Salmonella.
    Because the frequency of onsite auditing must be risk-based under 
Sec.  1.506(g)(2), the frequency of audits may be affected by factors 
such as previous audit history, compliance history, seasonality of the 
product, significant capacity increases, structural changes, and 
changes in product technology. For example, audits might be conducted 
annually until a positive compliance history is developed with the 
foreign supplier.
     Periodic or lot-by-lot sampling and testing of the food. 
Under Option 1's proposed Sec.  1.506(g)(2)(ii), an importer could 
determine that it is appropriate to conduct and document periodic or 
lot-by-lot sampling and testing of an imported food before the importer 
uses or distributes the food. For example, an importer of the above-
described seasoning mix might conduct its own periodic Salmonella 
testing or use a contracted laboratory to test samples of seasoning mix 
on a monthly basis. This monthly testing could be conducted until a 
good history is established for the seasoning mix supplier, after which 
time the importer might determine it would be appropriate to test less 
frequently, such as quarterly.
    Alternatively, an importer could choose to obtain documentation 
(such as a certificate of analysis (COA)) of lot-by-lot or periodic 
testing of the food that is conducted before the food is distributed by 
the foreign supplier. This supplier verification method is consistent 
with the recommendation in the GMA Handbook that customers ask 
suppliers to provide COAs documenting that major analytical parameters 
for the specific foods, or lots, contained in a specific shipment have 
been met (Ref. 10). GMA also recommends the use of recognized 
analytical methods and statistically valid sampling plans, as well as, 
in some cases, approval of the use of outside laboratories.
    Although requirements for a COA or other documentation of testing 
will depend on factors such as the food involved, information included 
in a COA might include the following: A full description of the food; 
the name of the supplier; lot number(s) for products in the shipment; 
the date of production; whether the testing was done in-house or by an 
outside laboratory; the date the food was shipped; the quantity of 
product covered by the COA (e.g., 40 cases at 70 pounds each); results 
of chemical, physical, microbiological, or other analyses; methods of 
analysis; descriptions of sampling plans used to generate results 
contained in the COA; and the signature of the person issuing the 
certificate (Ref. 9). To ensure the accuracy and validity of testing, 
importers should verify that the testing has been performed using 
proper techniques.
    As with the other verification activities, Option 1's proposed 
Sec.  1.506(g)(2) would require that the frequency of supplier testing 
be based on the risk presented by the hazard in the food. For example, 
an importer might initially ask its new foreign supplier of roasted 
peanuts and tree nuts to provide lot-by-lot COAs for aflatoxin in 
accordance with a designated sample size and method. The importer might 
base its decision on the need for lot-by-lot certification on the 
following factors: The lack of a performance history for the new 
foreign supplier; the fact that the country in which the supplier is 
located has a history of aflatoxin occurrence; and the fact that the 
foreign supplier does not apply a preventive control for aflatoxin in 
its roasting facility. Until a performance baseline is established with 
the foreign supplier, the importer might even conduct its own periodic 
sampling and testing in addition to reviewing the COAs from the foreign 
supplier. Once the foreign supplier has established a history of no 
aflatoxin in the roasted peanuts and tree nuts, the importer might be 
assured that it is appropriate to have the foreign supplier provide 
COAs at some lesser frequency, such as every tenth delivery.
    Although we would expect that sampling and testing of food under 
Option 1's Sec.  1.506(g)(2)(ii) would be conducted in accordance with 
any applicable regulations or widely accepted industry standards, 
because of the diversity of hazards and foods that could potentially be 
tested, we tentatively conclude that it is not appropriate to specify 
standards of testing in the regulation. However, we request comment on 
whether the regulation should specify testing standards and, if so, 
what those standards should be.
     Periodic review of the foreign supplier's food safety 
records. Under Option 1's proposed Sec.  1.506(g)(2)(iii), an importer 
could choose to periodically review (and document) or obtain 
documentation of a review of a foreign supplier's food safety records. 
Food safety records are records documenting that the food safety 
procedures that the supplier has established to control hazards 
reasonably likely to occur are being followed and are adequately 
controlling the hazards. Such records might include records of a 
foreign supplier's audit of its supplier's hazard control activities or 
records of environmental monitoring or product testing. Record review 
might be an appropriate verification activity when, for example, a 
foreign supplier of venison performs onsite audits of the deer farms 
that supply the venison to verify that the farms are not using 
unapproved drugs. The foreign supplier of venison could provide the 
importer with copies of the reports of these audits.
     Other appropriate verification procedure. Under Option 1's 
proposed Sec.  1.506(g)(2)(iv), an importer could choose to follow any 
other procedure that it has established and documented as being 
appropriate, based on the risk associated with the hazard, for 
verifying that a foreign supplier is adequately controlling (or 
verifying control of) the hazard. We tentatively conclude that it is 
appropriate to allow an importer to use any other procedure that it can 
develop, as long as the importer can document that the procedure can 
effectively verify whether a foreign supplier is adequately controlling 
a hazard. We are aware that importers currently use onsite audits, 
product testing, and record review to verify the safety of the food 
they import; we request comment on other foreign supplier verification 
methods that may be appropriate.
    As stated in section I.A of this document, section 805(c)(4) of the 
FD&C Act states that verification activities under an FSVP may include 
monitoring records for shipment, 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. The 
potential methods for foreign supplier verification specified in Option 
1's proposed Sec.  1.506(g)(2) include each of the verification 
activities stated in section 805(c)(4) (we tentatively conclude that, 
by ``monitoring records for shipment,'' Congress meant review of the 
foreign supplier's food safety records).
    b. Option 2: Same approach for all hazards.

[[Page 45757]]

    Although we are aware that it is an industry best practice to 
conduct onsite audits to verify supplier control of SAHCODHA hazards 
and that audits are an effective and efficient means of verification, 
we are co-proposing an alternative approach to verification that is 
similar to the approach described above for non-SAHCODHA hazards. 
Option 2 of the co-proposal for supplier verification activities would 
require the importer to choose whatever verification activity would 
enable the importer to adequately verify that a hazard has been 
adequately controlled, whether it is a SAHCODHA hazard or a non-
SAHCODHA hazard.
    Under Option 2 for supplier verification activities, proposed Sec.  
1.506(g)(1) would require, for any hazard that the importer has 
identified as reasonably likely to occur with a food that is to be 
controlled by the foreign supplier or for which the foreign supplier 
verifies control by its supplier, that the importer conduct one or more 
of the verification activities listed in Sec.  1.506(g)(1)(i) through 
(g)(1)(iv) before using or distributing the food and periodically 
thereafter. Proposed Sec.  1.506(g)(1) also would require the importer 
to determine and document which verification activity or activities are 
appropriate to adequately verify that the hazard is adequately 
controlled, as well as to determine and document how frequently the 
verification activities must be conducted. In addition, Option 2's 
proposed Sec.  1.506(g)(1) would require the importer, in determining 
the appropriate verification activities and how frequently they should 
be conducted, to consider the risk presented by the hazard, the 
probability that exposure to the hazard will result in serious adverse 
health consequences or death to humans or animals, and the food and 
foreign supplier's compliance status as reviewed under Sec.  1.504.
    As set forth in Option 2's proposed Sec.  1.506(g)(2)(i) through 
(g)(2)(iv), the foreign supplier verification activities that importers 
may choose to conduct, if they are appropriate for the hazard, are as 
follows:
     Periodic onsite auditing: The importer would conduct (and 
document) or obtain documentation of a periodic onsite audit of its 
foreign supplier.
     Periodic or lot-by-lot sampling and testing of the food: 
The importer would conduct (and document) or obtain documentation (such 
as a COA containing the results of the testing) from its foreign 
supplier of lot-by-lot or periodic sampling and testing of the food for 
the hazard.
     Periodic review of the foreign supplier's food safety 
records: The importer would periodically review (and document) or 
obtain documentation of a review of its foreign supplier's food safety 
records (such as records of the foreign supplier's audit of its 
supplier's hazard control activities).
     Other appropriate procedure: The importer would use any 
other procedure that it had established as being appropriate based on 
the risk associated with the hazard, and the importer would document 
its use of any such procedure.
    As stated, Option 2 would require importers to consider certain 
factors in determining which verification activity or activities are 
appropriate and how frequently they must be conducted. First, the 
importer would need to consider the risk presented by the hazard and 
what activity could provide adequate verification of hazard control 
given the nature of this risk. In making this assessment, an importer 
would need to consider which verification activities might be needed to 
adequately assess the foreign supplier's operations to determine if the 
supplier is adequately and consistently applying its hazard controls 
(or verifying the controls applied by its raw material or ingredient 
suppliers). For example, product testing may not, by itself, provide 
adequate verification when a hazard is not likely to be uniformly 
distributed or present in a food, e.g., pathogens in untreated spices.
    Second, the importer would need to consider the probability that 
exposure to the hazard will result in serious adverse health 
consequences or death to humans or animals. Generally, we believe that 
conducting onsite auditing would provide adequate assurance of SAHCODHA 
hazard control. We request comment on whether there are circumstances 
under which other mechanisms might be effective and, if so, what these 
circumstances might be.
    Third, the importer would need to consider the food and foreign 
supplier's compliance status as reviewed under Sec.  1.504. For 
example, review of the supplier's food safety records might not provide 
adequate assurance of supplier compliance with applicable food safety 
regulations if the supplier had recently been found to be non-compliant 
with significant requirements.
    Section II.G.7.a of this document, which addresses the use of 
different verification activities for non-SAHCODHA hazards (and hazards 
to be controlled by the supplier to the foreign supplier) under Option 
1 of the co-proposal, offers further examples of circumstances in which 
particular verification activities might be appropriate under Option 2 
of the co-proposal.
    We request comment on Options 1 and 2 of the co-proposal regarding 
supplier verification activities. One advantage of Option 1 is that it 
would establish a clear verification requirement, i.e., onsite 
auditing, for the most serious hazards that are controlled during 
supplier processing, circumstances in which other verification methods 
(such as records review) might not provide adequate assurance that the 
foreign supplier has implemented appropriate controls. On the other 
hand, if verification mechanisms other than onsite auditing could 
provide adequate assurance of control of serious hazards, Option 2 
would give importers somewhat greater flexibility in selecting 
effective verification activities without adversely affecting food 
safety. If you recommend either Option 1 or Option 2 concerning 
verification requirements, provide your rationale and examples of the 
use of particular supplier verification activities for particular types 
of hazards that support your preferred approach.
    Regardless of the particular requirements for supplier verification 
activity that we adopt in the final rule, as stated in section I.B.2 of 
this document, we intend to align these provisions with any supplier 
verification provisions in the final rule on preventive controls.
    c. Requirements of onsite auditing. Proposed Sec.  1.506(g)(3) 
(under Option 1; this is Sec.  1.506(g)(2) under Option 2) sets forth 
the basic requirements for an onsite audit conducted under Sec.  
1.506(g) or (h) (the latter of which concerns auditing related to 
microbiological hazards in certain RACs). We tentatively conclude that, 
to provide adequate assurance that the hazard reasonably likely to 
occur with the food is adequately controlled, the onsite audit must:
     Consider any relevant FDA food safety regulations, such as 
those on preventive controls, produce safety, acidified foods (part 114 
(21 CFR part 114)), shell eggs (part 118 (21 CFR part 118)), and 
bottled drinking water (part 129 (21 CFR part 129)), and
     Include a review of the foreign supplier's written food 
safety plan, if any, for the hazard being audited and the supplier's 
implementation of such plan.
    Because different foods are subject to different food safety 
regulations, we believe it is appropriate that an onsite audit of the 
foreign supplier of a food should include consideration of the 
standards and requirements of the

[[Page 45758]]

applicable FDA food safety regulations to which the supplier is subject 
in assessing whether the supplier is adequately controlling the hazard. 
Because these regulations vary in scope and detail, the parameters and 
key components of an onsite audit conducted under Sec.  1.506(g) or (h) 
would necessarily vary depending on what regulations applied to the 
foreign supplier.
    We also tentatively conclude that review of the foreign supplier's 
written food safety plan, if any, and the supplier's implementation of 
such plan should be a required part of an effective onsite audit. If 
the supplier is required by section 418 of the FD&C Act to have a food 
safety plan, the onsite audit would focus on that plan and assess the 
implementation of the preventive controls applied by the supplier to 
address the hazards that the importer has identified as reasonably 
likely to occur. Preventive controls might include process controls, 
food allergen controls, sanitation controls, and other controls for 
biological, chemical, physical, or radiological hazards identified as 
reasonably likely to occur.
    For example, before an importer obtained roasted peanuts for which 
the importer had identified Salmonella as a hazard from a foreign 
supplier that was subject to the preventive controls regulations, the 
importer would audit the supplier (or obtain documentation of an audit 
performed by a third party) to determine whether the supplier's 
roasting process adequately controlled the Salmonella. Because the 
supplier was subject to the preventive controls regulations, the audit 
would include a review of the supplier's food safety plan. For example, 
the auditor would review whether the roasting process had been 
validated to significantly minimize Salmonella in peanuts and would 
examine whether the supplier had implemented the roasting procedures in 
accordance with the food safety plan (e.g., through observing the 
establishment's procedures and reviewing records).
    Reviewing the food safety plan during the audit is consistent with 
GMA's recommendation that all supplier food safety and quality programs 
be substantiated and documented (Ref. 10). For foreign suppliers that 
are not required to have a food safety plan under section 418 of the 
FD&C Act but are required to have one under another FDA food safety 
regulation, or that have opted to have a plan even though not required 
to do so, the onsite audit would also be required to include a review 
of the foreign supplier's written plan, and its implementation of the 
plan, to assure that hazards identified by the importer are being 
adequately controlled.
    For these reasons, proposed Sec.  1.506(g)(3) (or Sec.  1.506(g)(2) 
if Option 2 were adopted) states that an onsite audit conducted under 
Sec.  1.506 must consider the relevant FDA food safety regulations and 
must include a review of the foreign supplier's written plan, if any, 
including its implementation, for the hazard being audited. We believe 
that an onsite audit concerning such a food should, at a minimum, 
include these actions. We request comment on these proposed 
requirements as well as on whether any other requirements regarding the 
scope and content of onsite audits are appropriate.
    d. Substitution of inspection by FDA or an officially recognized or 
equivalent food safety authority. We tentatively conclude that, instead 
of an onsite audit conducted under Sec.  1.506(g), (concerning hazards 
controlled or verified by a foreign supplier) or (h) (concerning 
microbiological hazards associated with certain RACs that are fruits or 
vegetables), an importer may 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 to that of the United States (e.g., through a signed systems 
recognition arrangement 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. Proposed Sec.  
1.506(g)(4) (under Option 1; this is Sec.  1.506(g)(3) under Option 2) 
states that, to be valid for this purpose, the inspection would have to 
have been conducted within 1 year of the date that the onsite audit 
would have been required to be conducted. For inspections conducted by 
an officially recognized or equivalent food safety authority, proposed 
Sec.  1.506(g)(4) states that the food that is the subject of the 
onsite audit must be within the scope of the official recognition or 
equivalence determination, and the foreign supplier must be in such 
country and under the regulatory oversight of the country's food safety 
authority.
    As already noted, FSMA directs FDA to increase the number of 
inspections of foreign food manufacturing/processing facilities. We 
believe that it would be appropriate to allow an importer to use an FDA 
inspection in lieu of an audit by a qualified person to fulfill a 
supplier verification requirement under proposed Sec.  1.506(g) or (h). 
Similarly, we also believe that it would be appropriate to allow an 
importer to use the results of an inspection of its foreign supplier 
that was conducted by the food safety authority of a country whose food 
safety system FDA has officially recognized or determined to be 
equivalent to that of the United States. Such inspections would provide 
an importer with information on the foreign supplier's control of 
hazards that is sufficiently similar to information that can be 
obtained from an onsite audit to be relied upon instead of such an 
audit. In addition, use of such inspection results could lessen the 
burden of conducting supplier verification activities by eliminating 
the need for an onsite audit.
    We request comment on whether importers should be permitted to rely 
on an inspection of a foreign supplier by FDA or an officially 
recognized or equivalent food safety authority in substitution of an 
onsite audit. We request comment on whether the use of an FDA or 
foreign food safety authority inspection should be limited to the 
specific products/activities covered in the inspection, products/
activities that concern the same hazard(s) as the food for which the 
onsite audit would have been required, or any other limitation in 
scope. We also request comment on the likelihood that importers would 
choose to rely on such inspections to meet the requirements for 
supplier verification under proposed Sec.  1.506, rather than seek to 
import a food under the modified requirements in proposed Sec.  1.513 
(discussed in section II.N of this document) applicable to food 
imported from a foreign supplier in a country with an officially 
recognized or equivalent food safety system as described above. In 
addition, we request comment on whether there are other kinds of 
intergovernmental arrangements that might assist importers in meeting 
their foreign supplier verification requirements.
    We propose to require that inspections of foreign suppliers by FDA 
or foreign food safety authorities be conducted within 1 year of the 
date that the onsite audit would have been required to be conducted to 
help ensure that such an inspection can provide information about the 
supplier's control of a food's hazards that is similar to the 
information that could be obtained from an onsite audit. If commenters 
believe that importers should be permitted to use such inspections as 
an alternative to onsite audits, we request comment on the 
appropriateness of the proposed 1-year time limitation for use of such 
inspection.
    e. Review of results of verification activities. Importers' foreign 
supplier verification activities would not provide adequate assurance 
that suppliers are

[[Page 45759]]

controlling hazards if importers did not review the results of their 
verification activities and take corrective action if the results 
indicated that hazards were not adequately controlled. Therefore, 
proposed Sec.  1.506(g)(5) (under Option 1; this is Sec.  1.506(g)(4) 
under Option 2) would require that an importer promptly review the 
results of the verification activities that it conducts or for which it 
obtains documentation.
    Proposed Sec.  1.506(g)(5) further states that if the results of 
verification activities show that hazards identified as reasonably 
likely to occur with a food are not adequately controlled, the importer 
must take appropriate corrective action in accordance with proposed 
Sec.  1.507(c). As discussed in section II.H.3 of this document, Sec.  
1.507(c) would require that an importer promptly take appropriate 
corrective actions if it determines that its foreign supplier does not 
produce a 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, or 
produces food that is adulterated under section 402 or misbranded under 
section 403(w) of the FD&C Act. The appropriate corrective actions 
would depend on the circumstances but could include discontinuing use 
of the foreign supplier until the cause or causes have been adequately 
addressed. Thus, under proposed Sec.  1.506(g)(5), if, for example, the 
sampling and testing conducted by an importer in accordance with Sec.  
1.506(g)(2)(ii) (under Option 1) showed that a supplier was not 
adequately controlling a hazard reasonably likely to occur with a food, 
the importer likely would need to notify the supplier of the failing 
results so that the supplier could take appropriate corrective action, 
which could include changes to its processes and procedures or sources 
of ingredients. If the foreign supplier did not make changes necessary 
to ensure that it adequately controlled the hazard, the importer would 
need to cease obtaining the food from the supplier.
    f. Independence of qualified individuals. Proposed Sec.  
1.506(g)(6) (under Option 1; this is Sec.  1.506(g)(5) under Option 2) 
addresses the issue of financial conflicts of interests that might 
arise in the performance of verification activities by qualified 
individuals (as defined in proposed Sec.  1.500). We recognize the 
possibility that a conflict of interest might arise when there is a 
financial relationship between a qualified individual who is conducting 
a verification activity (such as an onsite audit or lot-by-lot testing) 
and the foreign supplier whose procedures the qualified individual is 
reviewing. For example, the owner of an auditing firm might own 
substantial shares of stock in a foreign supplier that has requested an 
audit by the firm. On the other hand, Sec.  1.506(g) and (h) permits 
the importer itself to conduct onsite audits of foreign suppliers and 
other verification activities under these regulations. In such cases, 
there would obviously be a financial relationship between the qualified 
individual, as an employee of the importer, and the importer itself, 
but this relationship should not pose a conflict of interest concern.
    To address concerns about conflict of interest in the performance 
of FSVP activities, proposed Sec.  1.506(g)(6) (Sec.  1.506(g)(5) under 
Option 2) specifies that a qualified individual who conducts any of the 
verification activities in Sec.  1.505(g)(1), (g)(2), and (h) (Sec.  
1.506(g)(1) and (h) under Option 2) must not have a financial interest 
in the foreign supplier and payment must not be related to the results 
of the activity conducted. Proposed Sec.  1.506(g)(6) further states 
that this provision would not prohibit the importer or one of its 
employees from conducting the verification activity.
    We invite comment on whether this prohibition reflects the 
appropriate approach to concerns about conflicts of interest in the 
performance of foreign supplier verification activities and, if not, 
what changes would be appropriate. We also request comment on whether 
and, if so, how, the regulations should specify what constitutes a 
financial interest.
8. Microbiological Hazards in RACs That Are Fruits or Vegetables and 
That Would Be Subject to the Produce Safety Regulations
    As discussed in section II.G.3 of this document, because importers 
of produce RACs that are subject to the proposed regulations on produce 
safety would not be required to conduct a hazard analysis regarding 
microbiological hazards in these products, we are not proposing that 
importers of such produce conduct verification activities on a hazard-
by-hazard basis in the manner described in section II.H.7 of this 
document. Instead, for such microbiological hazards we tentatively 
conclude that supplier verification with respect to these products 
should provide adequate assurances that the foreign supplier is 
producing the fruit or vegetable in accordance with processes and 
procedures that provide the same level of public health protection as 
those required under part 112, the produce safety regulations.
    Because we have presented two options in our co-proposal concerning 
supplier verification activities, we are presenting a co-proposal 
regarding supplier verification activities for RACs that are fruits or 
vegetables. Under Option 1 of the co-proposal, we tentatively conclude 
that, because all microbiological hazards associated with produce RACs 
that are subject to the proposed produce safety regulations have the 
potential to result in serious adverse health consequences or death to 
humans or animals, it would be appropriate to require importers of this 
food to conduct onsite auditing to verify that the food is being 
produced in a manner that is consistent with part 112. We also believe 
that such audits should be subject to the requirements concerning the 
scope of auditing, substitution of certain inspection results, review 
of results of verification activities, and independence of qualified 
individuals conducting verification activities discussed in sections 
II.G.7.c through II.G.7.f of this document (proposed Sec.  1.506(g)(3) 
through (g)(6)). Finally, because onsite auditing might also be 
required to verify control of any non-microbiological hazards 
associated with produce RACs that are subject to the proposed produce 
safety regulations, we propose to specify that an audit conducted to 
address microbiological hazards associated with such a food may be 
conducted in conjunction with an audit that is required under proposed 
Sec.  1.506(g). For these reasons, under Option 1, proposed Sec.  
1.506(h) states that, for a RAC that is a fruit or vegetable and that 
is subject to part 112, in addition to the other requirements of Sec.  
1.506, before importing the fruit or vegetable from the foreign 
supplier and at least annually thereafter, the importer must conduct or 
obtain documentation of an onsite audit to provide adequate assurances 
that the foreign supplier is producing the fruit or vegetable in 
accordance with processes and procedures that provide the same level of 
public health protection as those required under part 112; that such 
audits are subject to Sec.  1.506(g)(3) through (g)(6); and that an 
audit conducted under Sec.  1.506(h) may be conducted in conjunction 
with an audit, if any, that is required under Sec.  1.506(g).
    Under Option 2 of the co-proposal on supplier verification 
activities, importers would choose, from among several possible 
verification activities, an activity that would enable the importer to 
adequately verify that a hazard has been adequately controlled. 
Consistent with this approach, under

[[Page 45760]]

Option 2, for a RAC that is a fruit or vegetable and that is subject to 
part 112, proposed Sec.  1.506(h) would require the importer, in 
addition to meeting the other requirements of Sec.  1.506, to conduct 
one or more of the verification activities listed in Sec.  
1.506(g)(1)(i) through (g)(1)(iv), before importing the fruit or 
vegetable from the foreign supplier and at least annually thereafter, 
to provide adequate assurances that the foreign supplier was producing 
the fruit or vegetable in accordance with processes and procedures that 
provide the same level of public health protection as those required 
under part 112. Option 2's proposed Sec.  1.506(h) further states that 
any audits conducted under this paragraph would be subject to Sec.  
1.506(g)(2) through (g)(5) (as numbered in Option 2 of the co-proposal) 
and that an importer may conduct an activity under Sec.  1.506(h) in 
conjunction with an activity conducted in accordance with Sec.  
1.506(g)(1)(i) through (g)(1)(iv).
    We request comment on Options 1 and 2 of our co-proposal with 
respect to supplier verification of microbiological hazards in RACs 
that are fruits or vegetables that are subject to the produce safety 
regulations.
9. Hazards That Emerge Long After Foreign Supplier Processing But 
Before U.S. Entry
    Some foods are manufactured by a foreign supplier and then stored 
for a relatively long time before being exported to the United States. 
For example, some dried, packaged foods are stored before being 
exported. It is even conceivable that the entity that produced the food 
might no longer be in existence at the time the food is imported into 
the United States. When there is an extended delay between the 
production and export of a food, a verification activity such as onsite 
auditing might not be possible or might provide little assurance that 
the food was produced under procedures that controlled the hazards. We 
request comment on what foreign supplier verification activities are 
appropriate for foods that are exported to the United States long after 
they are produced.

H. Complaints, Investigations, and Corrective Actions (Proposed Sec.  
1.507)

    Proposed Sec.  1.507 answers the question, ``What investigations 
and corrective actions must I conduct under my FSVP?'' We tentatively 
conclude that, as part of the FSVP, it is appropriate to require 
importers to review complaints concerning the foods they import, 
investigate possible adulteration or misbranding, take certain 
corrective actions when the foods they import do not meet applicable 
U.S. requirements, and revise their FSVPs when appropriate. These 
requirements would be generally consistent with the requirements 
applicable to juice and seafood processors under the HACCP regulations 
as well as those that would apply to food facilities under the 
Preventive Controls Proposed Rule. The proposal would direct the 
importer to use available information to determine whether its FSVP is 
inadequate and, if so, to appropriately revise its program so it meets 
the statutory requirement to provide adequate assurances that the food 
is compliant with applicable standards. Similarly, we believe that the 
proposed corrective action requirements are among those that, 
consistent with section 805(c)(2)(B) of the FD&C Act, are necessary and 
appropriate to verify that food imported into the United States is as 
safe as food produced and sold within the United States.
    Proposed Sec.  1.507(a) states that an importer must promptly 
conduct a review of any customer, consumer, or other complaint that the 
importer receives to determine whether the complaint relates to the 
adequacy of the importer's FSVP. Examples of such complaints might 
include a consumer complaint of illness following consumption of food 
imported by the importer and a customer complaint regarding a positive 
test for a pathogen in food received from the importer. Not all 
complaints that an importer might receive will concern its FSVP. 
However, complaints that might raise questions about how well an 
importer's FSVP is functioning could have a significant impact on food 
safety. For example, review of consumer complaints of illness linked to 
consumption of a product could result in an investigation revealing 
that a particular supplier is not adequately controlling a hazard, 
which could prompt the importer to reconsider whether the verification 
approach it uses with this product and supplier is appropriate. 
Therefore, we propose that importers be required to review all 
complaints to determine whether they relate to the FSVP.
    Proposed Sec.  1.507(b) states that if an importer becomes aware 
that an article of imported food is adulterated under section 402 or 
misbranded under section 403(w) of the FD&C Act, either through review 
of a complaint or by other means, the importer must promptly 
investigate the cause or causes of such adulteration or misbranding and 
document any such investigation. An importer might learn that a food it 
imported is adulterated or misbranded as a result of investigating a 
complaint (such as a consumer reporting becoming ill after eating an 
imported food), being notified by FDA (such as during an Agency 
investigation of possible contamination), through media reports, or by 
other means. Regardless of how the importer becomes aware of 
adulteration or misbranding, the importer would be required to promptly 
investigate what might have caused the problem with the food. The 
investigation would seek to determine the source of the adulteration or 
misbranding, such as contamination of a food with Salmonella due to the 
use of improperly cleaned machinery or the introduction of metal 
fragments generated during the manufacture of a food. In many cases, 
the investigation might require the importer to coordinate with the 
foreign supplier to evaluate the information on adulteration or 
misbranding and review relevant factors and processes (e.g., source of 
raw materials, procedures for harvesting, manufacturing, processing, 
packing, labeling, and transportation) to identify the source of the 
problem and take steps to correct it.
    Proposed Sec.  1.507(c) would require an importer to take 
appropriate corrective actions if it determines that one of its foreign 
suppliers did not produce the food in compliance with processes and 
procedures that provide the same level of public health protection as 
those required under section 418 or 419 of the FD&C Act, if either is 
applicable, or produced food that is adulterated under section 402 or 
misbranded under section 403(w) of the FD&C Act. Proposed Sec.  
1.507(c) states that this determination regarding the need for 
corrective action could be based on an investigation conducted under 
Sec.  1.507(b), the verification activities the importer conducts under 
Sec.  1.506 or Sec.  1.511(c) (the latter of which concerns 
verification requirements for importers of finished dietary 
supplements, discussed in section II.L.2 of this document), the FSVP 
reassessment that the importer conducts under proposed Sec.  1.508 
(discussed in section II.I of this document), or otherwise. Regardless 
of how an importer obtains the information that forms the basis of the 
importer's determination that its foreign supplier did not produce the 
imported food in accordance with the applicable requirements, the 
importer must take action in response to this noncompliance.
    Proposed Sec.  1.507(c) further states that the appropriate 
corrective actions by the importer will depend on the circumstances but 
could include discontinuing use of the foreign

[[Page 45761]]

supplier until the cause or causes of noncompliance, adulteration, or 
misbranding have been adequately addressed. Finally, proposed Sec.  
1.507(c) would require the importer to document any corrective actions 
it takes in accordance with this provision.
    Under proposed Sec.  1.507(d), if an importer determines, by means 
other than its verification activities conducted under Sec.  1.506 or 
Sec.  1.511(c) or its FSVP reassessment conducted under Sec.  1.508, 
that one of its foreign suppliers does not produce an imported food in 
compliance with processes and procedures that provide the same level of 
public health protection as those required under section 418 or 419 of 
the FD&C Act, if either is applicable, or produces food that is 
adulterated under section 402 or misbranded under section 403(w), the 
importer must promptly investigate to determine whether its FSVP is 
adequate and, when appropriate, modify the program. For example, FDA 
might inform an importer that the Agency has determined that one of the 
importer's foreign suppliers does not have an adequate food safety plan 
as required under section 418. Upon investigating, the importer might 
conclude that it should modify its supplier verification procedures to 
increase the likelihood that the importer will be able to detect future 
supplier noncompliance. Proposed Sec.  1.507(d) further states that an 
importer must document any investigation, corrective actions, and FSVP 
changes it makes under this provision.
    Proposed Sec.  1.507(e) states that Sec.  1.507 would not limit an 
importer's obligations with respect to other laws enforced by the 
Agency, such as those relating to product recalls. In addition to 
recall provisions, these laws might include, for example, the 
provisions on the Reportable Food Registry in section 417 of the FD&C 
Act (21 U.S.C. 350f).

I. Reassessment of FSVP (Proposed Sec.  1.508)

    Proposed Sec.  1.508 answers the question, ``How must I reassess 
the effectiveness of my FSVP?'' Unless an importer periodically 
assesses how its FSVP is functioning, a once-effective program could 
become ineffective over time, due to changes to the foods that are 
imported, the processing methods of foreign suppliers, or other factors 
affecting safety. As with corrective actions, we believe that requiring 
importers to periodically reassess their FSVPs will help ensure that 
the FSVP is adequate to provide assurances that the food is compliant 
with applicable standards, within the meaning of section 805(c)(2)(A) 
of the FD&C Act. We also tentatively conclude that it is necessary and 
appropriate in accordance with section 805(c)(2)(B).
    Proposed Sec.  1.508(a) sets forth requirements concerning the 
timing of reassessments. Proposed Sec.  1.508(a)(1) states that, except 
as specified in proposed Sec.  1.508(a)(2), for each food imported, the 
importer must conduct a reassessment of its FSVP for the food, as 
described in proposed Sec.  1.508(b), within 3 years of establishing 
the FSVP and within 3 years of the last reassessment. This requirement 
parallels the required frequency for periodic reanalysis of food safety 
plans in the Preventive Controls Proposed Rule. For the reasons stated 
in that proposed rule, we tentatively conclude that reevaluation is 
also necessary to ensure the continued validity of an FSVP.
    Under proposed Sec.  1.508(a)(2), however, an importer might be 
required to reassess its FSVP sooner than every 3 years. Proposed Sec.  
1.508(a)(2) would require an importer to reassess the effectiveness of 
its FSVP for a food it imports when the importer becomes aware of new 
information about potential hazards associated with the food. Examples 
of such information might include information on changes to raw 
materials or the source of raw materials, product formulation (e.g., a 
change that results in higher moisture in a processed cheese could lead 
to C. botulinum), processing methods or systems (e.g., the foreign 
supplier switches from dedicated production lines for chocolate with 
nuts and chocolate without nuts to using combined production lines), 
finished product distribution systems, or the intended use or consumers 
of the food.
    We tentatively conclude that effective reassessment of an 
importer's FSVP should begin with a reanalysis of the hazards that 
might be reasonably likely to occur with a food. Therefore, proposed 
Sec.  1.508(b) would require an importer, in conducting a reassessment 
of its FSVP, to update its hazard analysis for the food in accordance 
with Sec.  1.505. For example, if, subsequent to an importer's hazard 
analysis for a food, the food became linked to the outbreak of a 
disease with which the food was not previously associated, this could 
result in identification of a new hazard reasonably likely to occur 
with the food. Proposed Sec.  1.508(b) further states that if the 
hazards the importer had previously identified as reasonably likely to 
occur change as a result of the reassessment, the importer must 
promptly determine whether the verification activities the importer 
conducts under Sec.  1.506 need to be changed to comply with that 
section and, if so, promptly implement any such changes. For example, 
identification of a new hazard associated with a food could, depending 
on the type of hazard, necessitate a change in supplier verification 
activity in accordance with Sec.  1.506.

J. Identification of Importer at Entry (Proposed Sec.  1.509)

    Proposed Sec.  1.509 answers the question, ``How must the importer 
be identified at entry?'' Section 1.509 is intended to ensure that the 
importer of each food imported or offered for import into the United 
States is accurately identified so that the Agency can effectively 
implement and monitor compliance with the FSVP regulations.
1. Designation of U.S. Agent or Representative
    Proposed Sec.  1.509(a) would require, before an article of food is 
imported or offered for import into the United States, that the foreign 
owner or consignee of the food (if there is no U.S. owner or consignee) 
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, when there is no U.S. owner or consignee of the food 
at the time of U.S. entry, there will be an entity in the United 
States--the U.S. agent or representative of the foreign owner or 
consignee of the food--who will be responsible for meeting the FSVP 
requirements with respect to that food. We also note that, under the 
proposed regulations, the U.S. agent or representative may rely on 
qualified individuals to perform FSVP activities on its behalf.
2. Identification of the Importer
    Proposed Sec.  1.509(b) would require importers to obtain a DUNS 
number (if the importer does not already have one). Proposed Sec.  
1.509(c) would require an importer to ensure that, for each line entry 
of food product offered for importation into the United States, the 
importer's name and DUNS number are provided electronically when filing 
entry with CBP to identify the importer of the product. Our reasons for 
proposing these requirements are twofold, although they both concern 
our ability to accurately identify importers who are subject to the 
FSVP regulations.
    First, knowing the identity of the importer for a particular food 
being imported would help us carry out section 421(b) of the FD&C Act. 
This provision, also added by FSMA, requires FDA to allocate its 
resources for examining imported products based on certain risk 
factors, including the rigor and effectiveness of the importer's

[[Page 45762]]

FSVP. To effectively implement this, we need to know, at the time of 
importation, who the importer is. While we currently receive 
information identifying the ``importer'' as part of entry and as part 
of prior notice under section 801(m) of the FD&C Act, the entities 
identified under those procedures are not necessarily the ``importer'' 
for the purposes of FSVP.
    In addition, accurate information identifying importers will enable 
us to effectively implement, monitor compliance with, and enforce the 
FSVP requirements. This information would help the Agency create a 
comprehensive and up-to-date database that will enable us to 
efficiently and effectively monitor compliance with and enforce the 
FSVP regulations.
    Obtaining the identity of the importer at entry could also help us 
meet the requirement, stated in section 805(g) of the FD&C Act, to 
``publish and maintain on [our] Internet Web site . . . a current list 
that includes the name and location of, and other important information 
deemed necessary by [FDA] about, importers participating under this 
section [i.e., section 805].'' The meaning of the phrase ``importers 
participating under this section'' is ambiguous. Among other things, it 
could mean that the list must include all importers subject to section 
805 or only those subject to section 805 and in compliance with that 
provision. If so, FDA must have a means of identifying these importers. 
One way to do this would be to obtain information about importers at 
the time they are shipping products for entry into the United States. 
We request comment on the meaning of the phrase and the purpose of 
section 805(g).
    We considered requiring food importers to register with FDA to 
develop a database of importers. Some, but not all, importers currently 
register with FDA as food facilities and are assigned registration 
numbers under 21 CFR part 1, subpart H (Sec. Sec.  1.225 through 
1.243). Because not all importers are required to register, the current 
food facility registration system would not be sufficient for FSVP 
purposes. Moreover, obtaining the identity of the importer at the time 
of entry would enable us to both carry out section 421(b) of the FD&C 
Act and develop a database of importers without creating a new or 
revised registration system. By collecting this information with each 
entry, we would know the firm's last importation date and would receive 
``fresh'' information with each importation (as opposed to, with a 
registration system, when the firm updates its registration or 
periodically re-registers). With the information gathered at the time 
of entry, our database would be able to include the types of food the 
firm is importing, which would better enable the Agency to assess and 
allocate its compliance and enforcement resources. For example, this 
information would help us target for inspection firms that import high-
risk products more often than other firms and enable us to identify 
importers who should participate in the recall of an adulterated food 
product.
    To identify the importer, proposed Sec.  1.509(b) would require 
each importer to obtain a DUNS number and proposed Sec.  1.509(c) would 
require each importer to ensure that, for each line of entry of food 
product offered for importation, the importer's name and DUNS number 
are provided. DUNS is an international business entity listing system 
under which a company can obtain, at no charge, a unique identification 
number for a business entity. Dun and Bradstreet continuously updates 
the business entity information (e.g., name, address, contact numbers) 
based on automated searches of publicly available information and 
regular follow-up with each business entity. We believe that, using the 
DUNS numbers that would be submitted at entry for each importer of 
food, we could develop a database of information about importers 
(including their location and the foods they import) that would be 
comparable to the information that we could obtain through an importer 
registration system and also enable us to effectively monitor 
importers' compliance with the FSVP requirements. The importer's name 
and DUNS number would enable FDA to accurately identify the importer. 
The use of DUNS, as a unique numerical ID, is less prone to mistake or 
ambiguity than the use of the firm's name and address. Obtaining both 
the importer's name and DUNS number would guard against inadvertent 
mistakes in providing just the latter. With respect to section 805(g) 
of the FD&C Act, depending on how we interpret this provision, the use 
of the unique DUNS number would help ensure that we have an accurate 
list of ``importers participating under this section.''
    We are currently conducting the study, required under section 
110(i) of FSMA, regarding the need for, and challenges associated with, 
development and implementation of a program that requires the use of a 
unique identification number for each registered food facility and, as 
appropriate, ``each broker that imports food into the United States.'' 
We intend to take the results of this study into consideration in 
finalizing the requirements in proposed Sec.  1.509 concerning 
identification of the importer at entry. We request comment on the 
proposed use of DUNS numbers to identify importers under the FSVP 
regulations and, if you recommend use of a different identifier, what 
that identifier should be.
3. Electronic Submission of Information
    Proposed Sec.  1.509(c) would require that the information 
identifying the importer of each line of entry of food product be 
provided electronically when filing entry with CBP. We tentatively 
conclude that this information must be submitted electronically to 
enable the Agency to effectively monitor and enforce compliance with 
the FSVP regulations. With several million product lines of food being 
imported into the United States each year, monitoring the safety of 
imported food imposes huge demands on FDA resources. In addition, the 
Agency has begun implementing the Predictive Risk-based Evaluation for 
Dynamic Import Compliance Targeting (PREDICT) electronic import 
screening system to target higher-risk products for examination and 
sampling and minimize delays for shipments of lower-risk products. 
Requiring the electronic submission of importer information would 
improve the accuracy and therefore the efficiency of PREDICT for the 
purposes of section 421(b) of the FD&C Act by allowing fast and 
accurate identification of importers not in compliance with the FSVP 
regulations. The CBP generally receives information about imports at 
entry in electronic form, so requiring electronic submission of 
importer information should require little change to import entry 
procedures. In addition, if section 805(g) of the FD&C Act is 
interpreted to mean that the list of participating importers must 
include all importers subject to section 805, or all importers subject 
to section 805 and in compliance with that provision, then it will be 
much more efficient to build such a database using information 
submitted electronically. For these reasons, we tentatively conclude 
that requiring the electronic submission of importer identifying 
information for a food when filing entry with CBP will help us 
effectively monitor and enforce compliance with the FSVP regulations 
and carry out section 421(b), and is therefore authorized under 
sections 805 (including section 805(c)(2)(B)), 421(b), and 701(a) of 
the FD&C Act.

[[Page 45763]]

K. Records (Proposed Sec.  1.510)

    Proposed Sec.  1.510 answers the question, ``How must I maintain 
records of my FSVP?''
    Proposed Sec.  1.510(a) would require importers to sign and date 
records concerning their FSVPs upon initial completion and upon any 
modification of the FSVP.
    Proposed Sec.  1.510(b) would require importers to maintain records 
required under the FSVP regulations in English and make these records 
available promptly to an authorized FDA representative, upon request, 
for inspection and copying. Section 805(d) of the FD&C Act states that 
records related to a foreign supplier verification program ``shall be 
made available promptly to a duly authorized representative [of FDA] 
upon request.'' Proposed Sec.  1.510(b) therefore states that an 
importer must maintain records at its place of business or at a 
reasonably accessible location; records would be considered to be at a 
reasonably accessible location if they could be immediately retrieved 
from another location by computer or other electronic means. Proposed 
Sec.  1.510(b) further states that if requested in writing by FDA, an 
importer must send records to the Agency electronically rather than 
making the records available for Agency review at the importer's place 
of business. We tentatively conclude that requiring prompt delivery to 
FDA will better enable us to efficiently and effectively monitor 
importers' compliance with the FSVP regulations and is therefore also 
authorized by sections 805 and 701(a) of the FD&C Act. We also believe 
that such access would reduce the burden on importers posed by a visit 
by Agency representatives to an importer's place of business.
    Proposed Sec.  1.510(c) would require that all records be legible 
and stored to prevent deterioration or loss.
    Proposed Sec.  1.510(d) sets forth requirements for the retention 
of FSVP records. Consistent with section 805(d) of the FD&C Act, 
proposed Sec.  1.510(d) would require importers to maintain all records 
for a period of at least 2 years, but the start of the 2-year period 
would differ depending on the type of record. We tentatively conclude 
that it is appropriate that importers maintain certain records, such as 
hazard analysis determinations, documentation of hazard control by an 
importer or its customer, and determinations that use of a particular 
foreign supplier verification activity is appropriate under Sec.  
1.506(g), for as long as the records remain in use and are not revised 
or replaced. Therefore, under proposed Sec.  1.510(d)(1), except as 
specified in Sec.  1.510(c)(2), importers must maintain records 
referenced in subpart L until at least 2 years after their use is 
discontinued (e.g., because the importer no longer imports a particular 
food, no longer uses a particular foreign supplier, or has changed its 
FSVP procedures).
    Records that concern the actual performance of supplier 
verification activities, relate to complaints, investigations, and 
corrective actions associated with particular foods, or involve the 
documentation of FSVP reassessments are not records that remain in use 
until revised; consequently, we tentatively conclude that the retention 
period for these records should begin at the time that the records are 
created or obtained. Therefore, proposed Sec.  1.510(d)(2) would 
require importers to maintain records required under Sec. Sec.  
1.506(g)(1), (g)(2), and (h) (certain verification activities) (these 
would be the applicable provisions under Option 1 of the co-proposal 
regarding supplier verification activities; under Option 2, the 
relevant provisions would be Sec.  1.506(g)(1) and (h)), 1.507 
(investigations and corrective actions), 1.508 (FSVP reassessments), 
1.511 (requirements for food subject to certain dietary supplement CGMP 
regulations), and 1.513(b) (conditions and requirements for food 
imported from a country whose food safety system FDA had officially 
recognized as comparable or determined to be equivalent) for a period 
of at least 2 years after the records were created or obtained, except 
that the importer must maintain records of any changes to its FSVP in 
accordance with Sec.  1.507(d) or Sec.  1.508(b) until at least 2 years 
after their use is discontinued.

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

    Proposed Sec.  1.511 answers the question, ``What FSVP must I have 
if I am importing a food subject to certain dietary supplement good 
manufacturing practice regulations?'' Under section 103(g) of FSMA, 
facilities that manufacture, process, pack, or hold dietary 
supplements, and that are in compliance with section 402(g)(2) 
(concerning CGMP regulations for dietary supplements) and 761 
(concerning adverse event reporting for dietary supplements) of the 
FD&C Act (21 U.S.C. 342(g)(2) and 379aa-1, respectively), are exempt 
from the preventive controls requirements set forth in section 418 of 
the FD&C Act. We are proposing FSVP requirements for dietary 
supplements and dietary supplement components that reflect the food 
safety regulations applicable to those products (i.e., the dietary 
supplement CGMP regulations) rather than the general approach of 
verifying that hazards identified as reasonably likely to occur are 
being adequately controlled.
    The modified requirements would vary depending on whether the 
importer is bringing in the following:
     Dietary supplement components or dietary supplements that 
will be subjected to further processing (including packaging or 
labeling); or
     ``Finished'' dietary supplements.
    The FSVP requirements applicable to the importation of these 
products are set forth below.
1. Dietary Supplements for Further Processing
    The dietary supplement CGMP regulations in Sec.  111.70 (21 CFR 
111.70) include provisions requiring firms that manufacture, package, 
or label dietary supplements to establish specifications for, among 
other things, components and packaging, as follows:
     Specifications for each component used in manufacturing a 
dietary supplement (Sec.  111.70(b)).
     Specifications for dietary supplement packaging that may 
come in contact with dietary supplements (Sec.  111.70(d)).
     Specifications to provide assurance that products from a 
supplier for packaging and labeling as a dietary supplement (for 
distribution rather than return to the supplier) are adequately 
identified and consistent with the purchase order (Sec.  111.70(f)).
    Part 111 (e.g., Sec. Sec.  111.73 and 111.75) requires these firms 
to verify that the specifications established under Sec.  111.70 are 
met. This applies regardless of whether the components are imported or 
sourced domestically.
    We believe that these specification and verification provisions in 
the dietary supplement CGMP regulations provide adequate assurances, in 
light of the nature of the product being imported, that the supplier 
produces the food in compliance with sections 402 and 403(w) of the 
FD&C Act. For this reason, we are proposing, in Sec.  1.511(a), that 
importers who are required to establish specifications under Sec.  
111.70(b), (d), or (f) with respect to a food they import, and who are 
in compliance with the requirements of part 111 applicable to 
determining whether those specifications are met, would not be required 
to comply with the requirements of Sec. Sec.  1.503 through 1.508 
(except Sec.  1.506(a)). This would mean that such importers of dietary

[[Page 45764]]

supplements and dietary supplement components complying with part 111 
would not be required to comply with most of the generally applicable 
FSVP requirements, including those on review of food and supplier 
compliance status, hazard analysis, supplier verification (except for 
listing of suppliers), investigative and corrective actions, and FSVP 
reassessment. Instead, proposed Sec.  1.511(a) would require such 
importers to comply with the requirements in part 111 applicable to 
determining whether the specifications they established are met for 
such food and with the requirements in Sec. Sec.  1.506(a) (listing of 
foreign suppliers), 1.509 (identification of the importer at entry), 
and 1.510 (records). Proposed Sec.  1.511(a) further states that this 
requirement would not limit these importers' obligations with respect 
to part 111 or any other laws enforced by FDA.
    We note that if an importer who was required to establish 
specifications under Sec.  111.70(b), (d), or (f) with respect to a 
food they imported was not in compliance with the requirements for 
determining whether those specifications were met, we could refuse 
admission of the food on the ground that it was adulterated because it 
was not in compliance with CGMP (under section 801(a)(1) of the FD&C 
Act) and, provided that an alternative FSVP was not in place, on the 
ground that the importer was in violation of section 805 of the FD&C 
Act (concerning FSVPs) (under section 801(a)(3)). We anticipate that 
such an importer typically would seek to come into compliance with the 
relevant specification provisions of part 111, and thereby bring itself 
into compliance with proposed Sec.  1.511(a), rather than elect to 
revise its approach to foreign supplier verification by complying with 
the ``standard'' FSVP requirements (e.g., regarding compliance status 
review, hazard analysis, and supplier verification).
    We are proposing, in Sec.  1.511(b), to establish similar 
requirements for importers who are not subject to these specification 
and verification requirements under part 111, but whose customers are 
subject to those requirements. The only difference from the 
requirements we are proposing for importers who are themselves subject 
to those specification provisions is that the importer also would have 
to obtain written assurance that its customer was in compliance with 
those provisions. Thus, proposed Sec.  1.511(b) would provide that if 
an importer's customer is required to establish specifications under 
Sec.  111.70(b), (d), or (f) with respect to an imported food, the 
customer is in compliance with the requirements of part 111 applicable 
to determining whether those specifications are met, and the importer 
annually obtains from its customer written assurance that it is in 
compliance with those requirements, then for that food the importer 
must comply with the requirements in Sec. Sec.  1.506(a), 1.509, and 
1.510, but is not required to comply with the requirements of 
Sec. Sec.  1.503 through 1.508 (except Sec.  1.506(a)).
    We request comment on whether it is appropriate to establish 
modified FSVP requirements for importers of dietary supplements and 
dietary supplement components when the importer or its customer will be 
subject to the above-noted specification provisions in the dietary 
supplement CGMP regulations. If you believe that modified requirements 
are appropriate, we request comment on the appropriateness of the 
specific requirements that we have proposed.
2. Finished Dietary Supplements
    We also are proposing modified FSVP requirements for importers of 
``finished'' dietary supplements, by which we mean, for purposes of 
this proposal, packaged and labeled dietary supplements that are not 
subject to further processing. Foreign suppliers of these products are 
subject to the very detailed and comprehensive dietary supplement CGMP 
regulations. Suppliers that are in compliance with these regulations, 
and with section 761 of the FD&C Act (relating to serious adverse event 
reporting), are exempt from section 418 of the FD&C Act (preventive 
controls) with regard to the manufacturing, processing, packing, and 
holding of a dietary supplement. Therefore, we tentatively conclude 
that the verification conducted by importers of these products should 
be specific to these CGMP regulations.
    One key difference in the FSVP requirements for importers of 
finished dietary supplements is that the importer would not have to 
evaluate the hazards reasonably likely to occur. This is appropriate 
because the dietary supplement CGMP regulations effectively address the 
control of relevant hazards by including provisions encompassing all 
aspects of dietary supplement production. Therefore, we tentatively 
conclude that the importer should verify its supplier's compliance with 
part 111 and not conduct a separate hazard evaluation to use as a means 
to determine what to verify. Another potential key difference is that 
we are not proposing that importers of finished dietary supplements 
always be required to conduct onsite auditing for SAHCODHA hazards, as 
would be required under Option 1 of proposed Sec.  1.506(g)(1), because 
we are not requiring these importers to conduct hazard analyses for the 
dietary supplements they import under Sec.  1.511(c) and the relevant 
hazards are not necessarily SAHCODHA hazards. However, this potential 
difference would not exist under Option 2 of proposed Sec.  
1.506(g)(1).
    For these reasons, we are proposing, under Sec.  1.511(c)(1), that 
if a dietary supplement is being imported and neither Sec.  1.511(a) 
nor (b) is applicable, the importer must comply with Sec.  1.511(c) and 
the requirements in Sec. Sec.  1.502 through 1.504 and Sec. Sec.  1.507 
through 1.510, but it is not required to comply with the requirements 
of Sec. Sec.  1.505 and 1.506. Proposed Sec.  1.511(c)(1) further 
states that this requirement does not limit the importer's obligations 
with respect to part 111 or any other laws enforced by FDA.
    As part of their verification requirements, importers of finished 
dietary supplements also would be subject to the following supplier 
verification requirements (some of which mirror the standard 
requirements in proposed Sec.  1.506), as follows:
     List of foreign suppliers: The importer must maintain a 
written list of foreign suppliers (proposed Sec.  1.511(c)(2)).
     Foreign supplier verification procedures: The importer 
must establish and follow adequate written procedures for conducting 
foreign supplier verification activities (proposed Sec.  1.511(c)(3)).
     Purpose of supplier verification: The importer's foreign 
supplier verification activities must provide adequate assurances that 
the supplier is producing the dietary supplement in accordance with the 
requirements of part 111 (i.e., the dietary supplement CGMP 
regulations) (proposed Sec.  1.511(c)(4)).
     Supplier verification activities: For each dietary 
supplement imported, the importer must conduct one or more of the 
verification activities listed in proposed Sec.  1.511(c)(5)(i) through 
(c)(5)(iv) before using or distributing the dietary supplement and 
periodically thereafter (proposed Sec.  1.511(c)(5)). These are the 
same verification activities in proposed Sec.  1.506(g)(2)(i) through 
(g)(2)(iv) under Option 1 and proposed Sec.  1.506(g)(1)(i) through 
(g)(1)(iv) under Option 2 for supplier verification, i.e., periodic 
onsite auditing, periodic or lot-by-lot sampling and testing, periodic 
review of the foreign supplier's food safety records, and any other 
procedure that the

[[Page 45765]]

importer has established as being appropriate. The importer of the 
dietary supplement must determine and document which verification 
activity or activities are appropriate to adequately verify that the 
foreign supplier is in compliance with the requirements of part 111, 
and determine and document how frequently the verification activities 
must be conducted. As under proposed Sec.  1.506(g)(2)(i) through 
(g)(2)(iv) (under Option 1), the importer would have to document, or 
obtain documentation of, any performance of these activities.
     Requirements of onsite auditing: Any onsite audit 
conducted under Sec.  1.511(c)(5)(i) must consider the requirements of 
part 111 (proposed Sec.  1.511(c)(6)). The audit also must include a 
review of the foreign supplier's written food safety plan, if any, and 
the supplier's implementation of such plan.
     Substitution of inspection for onsite audit: Instead of an 
onsite audit conducted under Sec.  1.511(c)(5)(i), an importer may rely 
on the results of an inspection of the foreign supplier by FDA or the 
food safety authority of a country whose food safety system FDA has 
officially recognized as comparable or determined to be equivalent to 
that of the United States, provided that the inspection was conducted 
within 1 year of the date that the onsite audit would have been 
required to be conducted (proposed Sec.  1.511(c)(7)). For inspections 
conducted by an officially recognized or equivalent food safety 
authority, the food that is the subject of the onsite audit must be 
within the scope of the official recognition or equivalence 
determination, and the foreign supplier must be in such country and 
under the regulatory oversight of the country's food safety authority.
     Review of results of verification activities: The importer 
must promptly review the results of the verification activities that it 
conducts or obtains documentation of under Sec.  1.511(c)(5) (proposed 
Sec.  1.511(c)(8)). If the results show that the foreign supplier does 
not meet the standard in Sec.  1.511(c)(4), the importer must take 
appropriate action in accordance with Sec.  1.507(c).
     Independence of qualified individuals conducting 
verification activities: A qualified individual who conducts any of the 
verification activities set forth in Sec.  1.511(c)(5) must not have a 
financial interest in the foreign supplier and payment must not be 
related to the results of the activity (proposed Sec.  1.511(c)(9)). 
This would not prohibit the importer or one of its employees from 
conducting the verification activity.
    We request comment on whether establishing modified FSVP 
requirements for importers of finished dietary supplement is 
appropriate and, if so, whether the requirements we have proposed are 
appropriate.
    We also request comment on whether it would be more appropriate to 
add the proposed FSVP requirements applicable to dietary supplements to 
the regulations on dietary supplement CGMP in part 111, instead of to 
the FSVP regulations in proposed subpart L of part 1. Such an approach 
would parallel the inclusion of importer requirements in the HACCP 
regulations on juice and seafood in parts 120 and 123 and might 
facilitate compliance by dietary supplement importers and suppliers 
with the applicable regulations.
3. Other Foods
    We request comment on whether there are any other types of food, in 
addition to dietary supplements, for which we should establish modified 
foreign supplier verification requirements and, if so, what these 
requirements should be. For example, should they include an evaluation 
of the hazards reasonably likely to occur with the type of food or, as 
with finished dietary supplements, should there be no requirement to 
conduct a hazard analysis? Similarly, what verification activities 
would be appropriate for the type of food? Your comments should include 
the rationale for any modified requirements, including whether, such as 
with dietary supplements, they are based on the nature of any existing 
regulations governing the manufacturing/processing, raising, or 
harvesting of the type of food. With respect to any such foods for 
which there are existing regulations establishing safety-related 
requirements (e.g., part 114 regarding acidified foods, part 118 
regarding shell eggs), we also request comment on whether modified 
supplier verification requirements for importers of these foods should 
be added to the regulations concerning the production of these foods or 
to the FSVP regulations being proposed under this proposed rule (i.e., 
proposed subpart L of part 1).

M. Very Small Importers and Very Small Foreign Suppliers (Proposed 
Sec.  1.512)

    Proposed Sec.  1.512 answers the question, ``What FSVP may I have 
if I am a very small importer or I am importing from a very small 
foreign supplier?'' As stated in sections I.C and II.A.8 of this 
document, we are proposing to adopt modified FSVP requirements for very 
small importers and food from very small foreign suppliers. 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. The 
modified requirements we are proposing are for situations that involve 
a relatively low volume of imported food, which should reduce 
consumers' exposure to, and thus potential risk from, the food.
    As stated in proposed Sec.  1.500, the proposed definitions of very 
small importer and very small foreign supplier would include a maximum 
annual sales volume of $500,000 in annual food sales. This is a 
conservative measure of the volume of food imported into the United 
States because a supplier may ship food to other countries and an 
importer may sell both domestically sourced and imported food. Using 
annual sales of food, we believe, would be a workable approach for 
importers, suppliers, and FDA to determine who is subject to the 
modified requirements applicable to very small importers and food from 
very small foreign suppliers. Other measures for the volume of imported 
food, while perhaps more precise, would be more complex. We request 
comment on our proposed measure.
    In sections 418(l) and 419(f) of the FD&C Act, ``qualified 
facilities'' and certain farms are subject to qualified exemptions with 
modified requirements. Eligible establishments are defined, in part, 
based on the relatively limited value of their annual food sales, which 
for those provisions is also capped at $500,000. The proposed modified 
FSVP requirements for very small importers and food from very small 
foreign suppliers are designed to specify verification activities that 
take into account the risk to overall public health posed by such food. 
In the context of the nature of their imports, we tentatively conclude 
that the modified requirements described below would be adequate to 
provide assurances that the foreign suppliers to these importers 
produce food in compliance with processes and procedures that provide 
the same level of public health protection as those required under 
section 418 or 419 of the FD&C Act, as applicable, and sections 402 and 
403(w) of the FD&C Act.
1. Eligibility
    Proposed Sec.  1.512(a) states that Sec.  1.512 applies only when 
the importer is a very small importer or when the food it is importing 
is from a very small foreign supplier.

[[Page 45766]]

2. Applicable Requirements
    Importers who meet the definition of very small importer may follow 
proposed Sec.  1.512, but they could instead choose to follow the 
standard FSVP requirements (or the FSVP requirements under proposed 
Sec.  1.513 for food from countries with officially recognized or 
equivalent food safety systems). Similarly, importers of food from very 
small foreign suppliers may follow proposed Sec.  1.512, but they are 
not required to do so. Therefore, proposed Sec.  1.512(b)(1) states 
that if Sec.  1.512 applies and the importer chooses to comply with the 
requirements in this section, the importer must document, at the end of 
each calendar year, that it meets the definition of very small importer 
in Sec.  1.500 or that the foreign supplier meets the definition of 
very small foreign supplier in Sec.  1.500, whichever is applicable. 
Proposed Sec.  1.512(b)(1) further states that, for the purpose of 
determining whether the definition of very small importer or very small 
foreign supplier is satisfied, the baseline year for calculating the 
adjustment for inflation is 2012. Proposed Sec.  1.512(b)(1) adds that 
if the importer or the foreign supplier conducts any food sales in 
currency other than U.S. dollars, the importer must use the relevant 
currency exchange rate in effect on December 31 of the year in which 
sales occurred to calculate the value of these sales.
    Proposed Sec.  1.512(b)(2) would require that if an importer is 
eligible to import a food under this section and chooses to comply with 
the requirements in Sec.  1.512(b), it also must comply with the 
requirements in Sec. Sec.  1.502 through 1.504 (concerning the 
``scope'' of an FSVP, the use of qualified individuals, and review of 
food and foreign supplier compliance status, respectively) and Sec.  
1.509 (concerning identification of the importer at entry), but it is 
not required to comply with the requirements in Sec. Sec.  1.505 
through 1.508 or Sec.  1.510. This means that very small importers and 
importers bringing in food from very small foreign suppliers would not 
have to meet many of the standard FSVP requirements, including those 
for hazard analysis and supplier verification.
3. List of Foreign Suppliers
    Proposed Sec.  1.512(b)(3) would require a very small importer and 
an importer who obtains food from very small foreign suppliers to 
maintain a written list of foreign suppliers from which it is importing 
food.
4. Supplier Verification
    Under proposed Sec.  1.512, very small importers and importers of 
food from very small foreign suppliers would not be required to conduct 
hazard analyses for each food they import. The other most significant 
modification of FSVP requirements for these entities involves supplier 
verification. Very small importers and importers of food from very 
small foreign suppliers would be required to obtain from their foreign 
suppliers, before importing a food and at least every 2 years 
thereafter, a written assurance that the 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 in compliance 
with sections 402 and 403(w) of the FD&C Act. We believe that it would 
be appropriate for importers to obtain this written assurance at least 
every 2 years so that the assurance that the importer obtains will more 
accurately reflect the current operations of the foreign supplier than 
would relying on assurance that was not updated.
    To provide adequate assurance of the safety of the food obtained by 
very small importers and from very small foreign suppliers, we 
tentatively conclude that the written assurance from the foreign 
supplier must include a brief description of the processes and 
procedures that the supplier is following to ensure the safety of the 
food. Thus, the supplier would need to provide the importer with enough 
information about its processes and procedures to enable the importer 
to understand what the supplier is doing to ensure the safety of the 
imported food.
    For these reasons, proposed Sec.  1.512(b)(4) would require, for 
each food imported, that the very small importer or importer of food 
from a very small foreign supplier obtain written assurance, before 
importing the food and at least every 2 years thereafter, 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 that required under section 418 or 419 of the FD&C Act, 
if either is applicable, and is producing the food in compliance with 
sections 402 and 403(w) of the FD&C Act. Proposed Sec.  1.512(b)(4) 
further states that the written assurance must include a brief 
description of the processes and procedures that the foreign supplier 
is following to ensure the safety of the food.
    Although we do not believe that merely checking the food safety 
plan of a supplier is an appropriate stand-alone verification activity 
under the standard supplier verification requirements in proposed Sec.  
1.506, we believe that obtaining written assurance of supplier 
compliance, including a description of the processes and procedures 
used to ensure safety, is an appropriate verification activity for 
importers of such food under proposed Sec.  1.512. We request comment 
on whether these proposed verification activities are appropriate for 
very small importers and importers of food from very small foreign 
suppliers and, if not, what verification activities these importers 
should instead be required to conduct.
5. Corrective Actions
    We tentatively conclude that it is appropriate that very small 
importers and importers of food from very small foreign suppliers not 
be required to comply with the provisions on complaint review and 
investigation of adulteration or misbranding in proposed Sec.  1.507(a) 
and (b). Similarly, because these importers would be subject to the 
modified FSVP requirements set forth in Sec.  1.512, we conclude that 
it is not appropriate to require these importers to comply with the 
requirements to investigate to determine the adequacy of, and make 
appropriate changes to, their FSVPs under proposed Sec.  1.507(d).
    However, we tentatively conclude that, as part of adequately 
verifying and ensuring the safety of imported food, very small 
importers and importers of food from very small foreign suppliers 
should be required to take corrective actions if they determine that a 
foreign supplier is not producing a food in compliance with applicable 
requirements. Therefore, proposed Sec.  1.512(b)(5) would require these 
importers to promptly take appropriate corrective actions if they 
determine that a foreign supplier does not produce the food in 
compliance with processes and procedures that provide at least the same 
level of public health protection as those required under section 418 
or 419 of the FD&C Act, or produces food that is adulterated under 
section 402 or misbranded under section 403(w) of the FD&C Act, and to 
document any such corrective actions. A need for corrective action 
could be based, for example, on the foreign supplier compliance status 
review conducted by the importer. Proposed Sec.  1.512(b)(5) further 
states that the appropriate corrective actions will depend on the 
circumstances but could include discontinuing use of the foreign 
supplier until the cause or causes of noncompliance, adulteration, or

[[Page 45767]]

misbranding have been adequately addressed. Proposed Sec.  1.512(b)(5) 
also notes that this provision does not limit the importer's 
obligations with respect to other laws enforced by FDA, such as those 
relating to product recalls.
6. Records
    Because of the modified nature of the FSVP requirements for very 
small importers and importers of food from very small foreign 
suppliers, we are proposing to tailor the recordkeeping requirements in 
proposed Sec.  1.510 for these importers as discussed below.
    Proposed Sec.  1.512(b)(6)(i) would require that a very small 
importer or importer of food from a very small foreign supplier 
maintain required FSVP records, in English, and make them available 
promptly to an authorized FDA representative, upon request, for 
inspection and copying. Further, proposed Sec.  1.512(b)(6)(i) would 
require such an importer to maintain records at its place of business 
or at a reasonably accessible location; records would be considered to 
be at a reasonably accessible location if they could be immediately 
retrieved from another location by computer or other electronic means. 
Finally, proposed Sec.  1.512(b)(6)(i) would require a very small 
importer or importer of food from a very small foreign supplier, when 
requested in writing by FDA, to send records to the Agency 
electronically or by mail rather than making the records available for 
review at its place of business. We propose to allow these importers to 
provide records by mail instead of electronically in the event that 
providing records electronically might be significantly burdensome to 
some of these entities (e.g., due to increased computer-related 
expenses).
    Proposed Sec.  1.512(b)(6)(ii) would require that all records 
maintained by very small importers and importers of food from very 
small foreign suppliers be legible and stored to prevent deterioration 
or loss.
    Because they are subject to different FSVP requirements, very small 
importers and importers of food from very small foreign suppliers, 
unlike other importers, will not be creating records that need to be 
maintained for as long as the records remain in use, such as records of 
hazard analysis determinations and determinations as to appropriate 
verification activities. Consequently, proposed Sec.  1.512(b)(6)(iii) 
would require these importers to maintain required FSVP records for a 
period of at least 2 years after the records were created or obtained. 
Such records would include documentation of eligibility as a very small 
importer or importer of food from a very small foreign supplier, food 
and foreign supplier compliance status reviews, written assurances from 
foreign suppliers, and documentation of corrective actions.

N. Food From Countries With Officially Recognized or Equivalent Food 
Safety Systems (Proposed Sec.  1.513)

    Proposed Sec.  1.513 answers the question, ``What FSVP may I have 
if I am importing a food from a country with an officially recognized 
or equivalent food safety system?'' Proposed Sec.  1.513 addresses the 
circumstances under which importers would be subject to modified FSVP 
requirements for food from a country whose food safety system we have 
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 officially recognizing the foreign food 
safety system) or that we have determined to be equivalent to that of 
the United States, for foods under FDA's jurisdiction. We are 
developing an approach for systems recognition involving assessing the 
food safety system of a foreign country and determining whether the 
system may be deemed comparable to that of the United States.
1. Bilateral and International Efforts To Enhance FDA's Food Safety 
Capability
    FDA is developing several complementary tools to assess countries' 
food safety systems (or parts of these systems) that are specific to 
countries' particular interests and the maturity of their regulatory 
systems. Food safety authorities in other countries may wish to have 
FDA assess their food safety systems in their entirety through systems 
recognition (discussed in section II.N.2 of this document), or they may 
pursue assessments of their food safety controls and oversight for 
particular export products through FDA's future third-party 
accreditation program (see the proposed rule published elsewhere in 
this issue of the Federal Register). Additionally, we will continue our 
longstanding practice of entering into commodity-specific arrangements 
and agreements with regulatory authorities in other countries to help 
ensure that specific commodities imported to the United States are 
safe.
    An example of FDA's ongoing efforts involving commodity-specific 
arrangements is the establishment of memoranda of understanding (MOUs) 
covering molluscan shellfish. Countries with which FDA has signed 
molluscan shellfish MOUs include Canada, Mexico, South Korea, and New 
Zealand. Shellfish processors certified by competent authorities in 
these countries are listed on the Interstate Certified Shellfish 
Shippers List (ICSSL). U.S. importers may use the ICSSL to meet their 
requirements under FDA's seafood HACCP regulations.2. FDA's Systems 
Recognition Assessment Program
    FDA is developing a program for conducting food safety systems 
recognition assessments to, among other things, assist us with setting 
our food safety regulatory priorities. Systems recognition is one tool 
that FDA can use to incorporate the efforts of foreign food safety 
systems into our risk-based decision making regarding inspections, 
monitoring, admissibility, and outbreak response. Another tool is 
accreditation of foreign governments to audit and certify foreign food 
facilities and foods offered for import into the United States. Because 
the national food safety control systems in place in different 
countries are unique, have varying outcomes, and differ in their 
approaches to providing assurances of the safety of exported food, we 
plan to work with competent authorities in different countries to 
determine which tools might be most appropriate for different systems 
and/or commodities. Our use of systems recognition will not preclude 
the use of other tools to help ensure the safety of imported food; 
rather, to the extent possible, we will use a variety of tools to 
leverage the work done by foreign food safety authorities to facilitate 
this effort.
    We envision a systems recognition assessment as a process for 
determining that (1) a country's food safety system provides a similar, 
though not identical, system of protections as the U.S. food safety 
system, and (2) the country's food safety authority provides similar 
oversight and monitoring activities for food produced under its 
jurisdiction. Systems recognition is based on the conclusion that food 
safety systems with similar elements and similar levels of oversight 
lead to similar food safety outcomes.
    A public hearing on systems recognition, which at the time was 
termed ``comparability,'' was held in March 2011, and a transcript of 
the hearing is posted on FDA's Web site at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/ucm243781.htm. We conducted a 
systems recognition assessment pilot project with New Zealand and 
signed a systems recognition arrangement with that country in December 
2012. Information regarding this pilot project

[[Page 45768]]

and outcomes can be found on FDA's Web site at http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm331276.htm. Neither the FD&C Act nor 
FSMA explicitly mentions systems recognition. While the concept of 
systems recognition, the development of assessment tools, and the 
launching of the systems recognition pilot were initiated before the 
enactment of FSMA, systems recognition is consistent with several of 
the principles of FSMA, including a preventive approach to food safety, 
leveraging of resources to help ensure the safety of domestic and 
imported foods, and the development of enhanced regulatory 
partnerships.
    The systems recognition initiative supports FDA strategies to 
accomplish Agency goals in our global approach to food safety 
regulation, as outlined in the Commissioner's June 2011 report on the 
``Pathway to Global Product Safety and Quality'' (Ref. 2). The systems 
recognition initiative focuses on creating global coalitions of 
regulators, building global data-information systems and networks, 
expanding capabilities in intelligence gathering and use (through the 
use of risk analytics and modernized information technology), and 
leveraging efforts of government authorities. In an era when the amount 
of food traded internationally increases annually, systems recognition 
will serve as a key tool for FDA to build partnerships, leverage 
resources, and strengthen international food safety.
    As currently structured, FDA's systems recognition assessment 
process involves a review of a country's food safety system by a team 
of FDA scientists, auditors, and investigators. The process includes a 
review of the elements of the country's food safety programs, including 
any export-specific programs. We are developing processes and 
procedures for conducting systems recognition assessments. The draft 
International Comparability Assessment Tool (ICAT) is a self-assessment 
tool that, along with analyses of compliance information, in-country 
assessments, and other information, will help us determine whether a 
country has a food safety system that is comparable to that of the 
United States. The ICAT provides an objective framework in which to 
assess certain factors affecting the effectiveness of a country's food 
safety system. These factors are a country's regulatory foundation, 
training program, inspection program, program assessment and audit 
program, control of food-related illness and outbreaks (including 
trace-back and emergency preparedness systems), compliance and 
enforcement, industry and community relations, program resources, 
international communication and harmonization, and laboratory support. 
Using lessons learned in the New Zealand pilot, we have revised and 
updated the ICAT (including by adding a reference guide for countries 
to use as they complete the self-assessment), and we have initiated a 
second pilot assessment project with Canada.
    A systems recognition assessment consists of two principal stages. 
After satisfactory completion of a documentation review of a country's 
ICAT submission, audit teams from FDA, including persons specializing 
in particular high-risk commodities, will perform an in-country 
assessment to verify the implementation of programs and measures as 
outlined in the ICAT submission. The assessments provide an objective 
and comprehensive means of assessing the level of assurance that the 
foreign food safety authority can provide that food produced in that 
country is as safe as food produced in the United States. An assessment 
also will incorporate data from the country's food safety system (e.g., 
review of the regulatory performance of the food safety authority and 
hazard monitoring databases) as well as data collected by FDA (e.g., 
through border examinations, notifications/recalls, and foreign audits 
and inspections). After successful completion of documentation and in-
country reviews, FDA may determine that a country's food safety system 
is ``comparable.'' If so, we intend to officially recognize the 
country's food safety system through a formal mechanism, such as 
establishing a systems recognition arrangement with the relevant food 
safety authority of the country. We expect to determine whether a 
country's food safety system continues to be comparable through open 
bilateral communications and periodic review. The specific process for 
periodic review is still in development as we establish the operational 
details of this new program.
    We intend to leverage the work being done by food safety 
authorities in countries whose food safety systems we have officially 
recognized to enhance our capabilities in ensuring the safety of 
imported foods. Systems recognition arrangements and other agreements 
establishing official recognition will not be static, but rather will 
serve as the basis for ongoing exchange and partnership, and will be 
reviewed and updated as appropriate. These arrangements are likely to 
also involve provisions for enhanced information exchange (e.g., 
inspection findings) and emergency response partnerships.
3. Equivalency
    In addition to food imported from foreign suppliers in countries 
with officially recognized food safety systems, proposed Sec.  1.513 
addresses food imported from suppliers in countries whose food safety 
systems are determined to be ``equivalent.'' In 1998, the United States 
and the European Union (EU) signed the Agreement between the European 
Community and the United States of America on Sanitary Measures to 
Protect Public and Animal Health in Trade in Live Animals and Animal 
Products, known as the Veterinary Equivalency Agreement (VEA) (Ref. 
12). Due to the complexity of determining equivalence, FDA and its EU 
counterpart thus far have been unable to conclude that there is full 
equivalence with respect to the FDA-regulated products that fall within 
the scope of the VEA.
    FDA has found equivalence determinations, under the VEA and 
otherwise, to be technically difficult and resource intensive. 
Equivalence determinations have involved a review of each measure 
(e.g., laws, regulations, requirements, procedures, processes, 
production methods) in place in each country to determine whether the 
exporting country meets the importing country's level of protection 
associated with each measure. In an effort to achieve efficiencies in 
the review of food safety systems, we are considering how to achieve 
similar objectives using the systems recognition approach.
4. Proposed Provisions on Importation of Food From Countries With 
Officially Recognized or Equivalent Food Safety Systems
    Under proposed Sec.  1.513, the importation of food from a foreign 
supplier in, and under the regulatory oversight of, a country whose 
food safety system FDA has officially recognized as comparable to that 
of the United States (e.g., when FDA and the other country have signed 
a systems recognition arrangement or other agreement establishing 
official recognition of the foreign food safety system) or that FDA has 
determined to be equivalent to that of the United States would be 
subject to modified FSVP requirements when certain conditions are met 
and documented. These conditions are that (1) the foreign supplier must 
be in, and under the regulatory oversight of, a country whose food 
safety system FDA has officially recognized as comparable or determined 
to be equivalent, and (2) the food must be within the scope of the 
relevant

[[Page 45769]]

official recognition or equivalency determination.
    When these conditions are met, the importer would be required to 
determine and document whether the foreign supplier of the food is in 
good compliance standing with the food safety authority of the country 
in which the foreign supplier is located.
    Proposed Sec.  1.513(a) states that if an importer meets the 
conditions and requirements of Sec.  1.513(b) for a food that it is 
importing, the importer is not required to comply with the requirements 
in Sec. Sec.  1.503 through 1.508 (except Sec.  1.506(a) (concerning 
listing of foreign suppliers)). As such, the importer would not be 
required to, for example, conduct a hazard analysis (Sec.  1.505) or 
the standard supplier verification (Sec.  1.506). Proposed Sec.  
1.513(a) further states that the importer would still be required to 
comply with the requirements in Sec. Sec.  1.506(a), 1.509 (concerning 
identification of the importer at entry), and 1.510 (concerning 
records).
    Proposed Sec.  1.513(b)(1) would require an importer, before 
importing a food from the foreign supplier and annually thereafter, to 
document that the foreign supplier is in, and under the regulatory 
oversight of, a country whose food safety system FDA has officially 
recognized as comparable or determined to be equivalent to that of the 
United States and that the food is within the scope of FDA's official 
recognition or equivalency determination regarding the food safety 
authority of the country in which the foreign supplier is located. For 
example, if we completed an equivalence determination for grade A dairy 
products with country ``X'', proposed Sec.  1.513 would not apply to 
the importation of other products from that country.
    Proposed Sec.  1.513(b)(2) would require an importer, before 
importing a food from the foreign supplier, to determine and document 
whether the foreign supplier is in good compliance standing, as defined 
in proposed Sec.  1.500, with the food safety authority of the country 
in which the foreign supplier is located. The importer would be 
required to continue to monitor whether the foreign supplier is in good 
compliance standing and promptly review any information obtained. If 
the information indicated that food safety hazards associated with the 
food were not being adequately controlled, the importer would be 
required to take prompt corrective action. The appropriate corrective 
action would depend on the circumstances but could include 
discontinuing use of the foreign supplier. Proposed Sec.  1.513(b)(2) 
also would require the importer to document any corrective actions that 
it undertakes.
    As defined in proposed Sec.  1.500, good compliance standing with a 
foreign food safety authority would mean that the foreign supplier (1) 
appears on the current version of a list, issued by the food safety 
authority of the country in which the foreign supplier is located and 
which has regulatory oversight of the supplier, of establishments that 
are in good compliance standing with the food safety authority, or (2) 
has otherwise been designated by such food safety authority as being in 
good compliance standing. Because it is possible that not all countries 
whose food safety systems we have officially recognized as comparable 
or determined to be equivalent may choose to maintain a list of food 
manufacturers that are in good compliance standing, we believe it is 
appropriate to provide for the possibility that countries may use other 
methods to designate food manufacturers as being in good compliance 
standing. We request comment on what should constitute good compliance 
standing under proposed Sec.  1.513, as well as what documents or other 
information issued by a food safety authority should be acceptable to 
demonstrate that a foreign supplier of a food is in good compliance 
standing with that food safety authority.
    We request comment on the appropriateness of our proposed modified 
FSVP requirements for food imported from a foreign supplier in, and 
under the regulatory oversight of, a country whose food safety system 
we have officially recognized as comparable or determined to be 
equivalent to that of the United States, including the proposed 
conditions and modified FSVP requirements that would be applicable to 
such imported food.
    As described in section II.N.1 of this document, the establishment 
of commodity-specific arrangements and agreements provides FDA and 
foreign governments with an important tool, in addition to systems 
recognition and the use of accredited third-party auditors, for 
leveraging work done by food safety authorities in those countries. The 
selection of the most appropriate tool for a particular country and/or 
a particular commodity will be made by FDA in consultation with the 
food safety authority of the particular country. Important factors 
affecting this decision include the volume of food and types of 
commodities that a country exports to the United States and the 
regulatory structure of the foreign country. We request comment on what 
FSVP requirements might be appropriate for food imported from countries 
whose food safety authorities have entered into commodity-specific 
arrangements or agreements with FDA.
    As discussed elsewhere in this document, the Preventive Controls 
Proposed Rule seeks comment on what requirements might be appropriate 
with respect to supplier approval and verification programs for raw 
materials and ingredients. Any such requirements would likely apply 
regardless of whether the supplier is located in the United States or 
in another country and, therefore, would apply regardless of the level 
of government oversight. In light of this, we request comment on 
whether it would be appropriate for the modified requirements in 
proposed Sec.  1.513 of the FSVP regulations to be applicable to the 
importation of raw materials and ingredients.

 O. Consequences of Failure To Comply (Proposed Sec.  1.514)

    Proposed Sec.  1.514 answers the question, ``What are some 
consequences of failing to comply with the requirements of this 
subpart?'' This section addresses certain circumstances related to 
noncompliance with the FSVP regulations under which we may refuse 
admission of certain foods. In addition, this section codifies the 
provision in FSMA designating as a prohibited act the importation of a 
food without an appropriate FSVP.
    Proposed Sec.  1.514(a) states that an article of food is subject 
to refusal of admission under section 801(a)(3) of the FD&C Act if it 
appears that the importer of that food fails to comply with subpart L 
with respect to that food. This provision incorporates into the 
regulations section 301(c) of FSMA, which amended section 801(a) of the 
FD&C Act.
    Proposed Sec.  1.514(a) further states that if an article of food 
has not been sold or consigned to a person in the United States at the 
time the food is offered for entry into the United States, the article 
of food may not be imported into the United States unless the foreign 
owner or consignee has designated a U.S. agent or representative as the 
importer for the purposes of the definition of ``importer'' in Sec.  
1.500. We tentatively conclude that when no designation has been made 
under section 805(a)(2)(B) of the FD&C Act, the ``importer'' for the 
purposes of refusal of admission in accordance with section 301(c) of 
FSMA is the foreign owner or consignee.
    Proposed Sec.  1.514(b) states that the importation or offering for 
importation into the United States of an article of food by an importer 
without having an FSVP that meets the requirements of section 805 of 
the FD&C Act, including

[[Page 45770]]

the requirements of subpart L, is prohibited under section 301(zz) of 
the FD&C Act. This provision incorporates into the regulations section 
301(b) of FSMA, which amended section 301 of the FD&C Act.
    Regardless of whether an importer is in compliance with the FSVP 
requirements, the food or the importer might still be in violation of 
other applicable requirements. For example, if the food was nonetheless 
adulterated or misbranded, it could not be introduced or delivered for 
introduction into interstate commerce under section 301(a) of the FD&C 
Act and it would be subject to refusal of admission under section 
801(a) of the FD&C Act. The FSVP regulations would not limit FDA's 
ability to take action to ensure that noncompliant food does not reach 
consumers.

III. Preliminary Regulatory Impact Analysis

A. Overview

    We have examined the impacts of this proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). We 
have developed a preliminary regulatory impact analysis (PRIA) that 
presents the benefits and costs of this proposed rule (along with the 
benefits and costs of the proposed rule on ``Accreditation of Third-
Party Auditors/Certification Bodies to Conduct Food Safety Audits and 
to Issue Certifications,'' Docket No. FDA-2011-N-0146) (Ref. 13). We 
believe that the proposed rule is a significant regulatory action as 
defined by Executive Order 12866. We request comment on the PRIA.
    The summary analysis of benefits and costs included in the 
Executive Summary of this document is drawn from the detailed PRIA, 
which is available at http://www.regulations.gov (enter Docket No. FDA-
2011-N-0143), and is also available on FDA's Web site at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because many small businesses will need to adopt 
FSVPs or conduct additional verification activities, we acknowledge 
that the final rule resulting from this proposed rule will have a 
significant economic impact on a substantial number of small entities.

C. Small Business Regulatory Enforcement Fairness Act of 1996

    The Small Business Regulatory Enforcement Fairness Act of 1996 
(Pub. L. 104-121) defines a major rule for the purpose of congressional 
review as having caused or being likely to cause one or more of the 
following: An annual effect on the economy of $100 million or more; a 
major increase in costs or prices; significant adverse effects on 
competition, employment, productivity, or innovation; or significant 
adverse effects on the ability of U.S.-based enterprises to compete 
with foreign-based enterprises in domestic or export markets. In 
accordance with the Small Business Regulatory Enforcement Fairness Act, 
the Office of Management and Budget (OMB) has determined that this 
proposed rule is a major rule for the purpose of congressional review.

D. Unfunded Mandates Reform Act of 1995

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $136 million, using the most current (2010) Implicit 
Price Deflator for the Gross Domestic Product. We expect that the 
proposed rule will result in a 1-year expenditure that would exceed 
this amount.

E. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by OMB under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). The collections of information in the proposed 
rule have been submitted to OMB for review under section 3507(d) of the 
Paperwork Reduction Act. We invite comments on: (1) Whether the 
proposed collection of information is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) ways to enhance 
the quality, utility, and clarity of the information to be collected; 
and (4) ways to minimize the burden of the collection of information on 
respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 
technology.
    To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, 
or emailed to oira_submission@omb.eop.gov. All comments should be 
identified with the title ``Foreign Supplier Verification Programs for 
Importers of Food for Humans and Animals.''
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3407(d)), the Agency has submitted the information collection 
provisions of this proposed rule to OMB for review. These requirements 
will not be effective until FDA obtains OMB approval. We will publish a 
notice concerning OMB approval of these requirements in the Federal 
Register.

F. Public Access to the Analyses

    The analyses that FDA has performed to examine the impacts of this 
proposed rule under Executive Order 12866, Executive Order 13563, the 
Regulatory Flexibility Act, the Unfunded Mandates Reform Act of 1995, 
and the Paperwork Reduction Act of 1995 are available to the public in 
the docket for this proposed rule (Ref. 13).

IV. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.30(j) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

V. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
the proposed rule, if finalized, would not contain policies that would 
have substantial direct effects on the States, on the relationship 
between the National Government and

[[Page 45771]]

the States, or on the distribution of power and responsibilities among 
the various levels of government. Accordingly, we tentatively conclude 
that the proposed rule does not contain policies that have federalism 
implications as defined in the order and, consequently, a federalism 
summary impact statement is not required.

VI. Proposed Effective and Compliance Dates

    We propose that any final rule on FSVPs become effective 60 days 
after the date on which it is published in the Federal Register. 
Section 301(d) of FSMA states that the amendments to the FD&C Act made 
by section 301--i.e., section 805 of the FD&C Act concerning FSVPs--
shall take effect 2 years after the date of the enactment of FSMA, 
i.e., on January 4, 2013. Although section 805 took effect on January 
4, 2013, we intend to require importers to comply with section 805 in 
accordance with the effective and compliance dates that will be 
established when we finalize the rule implementing section 805.
    Although we are proposing that the FSVP final rule become effective 
60 days after the date of publication in the Federal Register, we are 
proposing to provide additional time before importers would be required 
to come into compliance. In general, the compliance date would be 18 
months after the publication date of the final FSVP regulations. We 
believe this would give importers enough time to make changes to their 
business practices that would be needed to come into compliance with 
the various requirements we are proposing.
    We are proposing exceptions to this approach that would provide 
different compliance dates applicable to the importation of food that 
is the subject of certain regulations that are currently in 
development--specifically, the proposed regulations on preventive 
controls for human food (as well as the future proposed regulations on 
preventive controls for animal food) and the proposed regulations on 
produce safety. In the Preventive Controls Proposed Rule, we proposed a 
compliance date for the preventive controls regulations of 1 year after 
the date of publication of the final rule, with an additional 1 year 
for small businesses and an additional 2 years for very small 
businesses (78 FR 3646 at 3674). (We anticipate that we will issue the 
final rules on preventive controls for human food and preventive 
controls for animal food on the same date, and that these regulations 
will share the same effective and compliance dates.) Regarding the FSVP 
provisions, we are proposing that, with respect to a particular food, 
the importer be required to comply with the FSVP regulations 6 months 
after the foreign supplier of the food is required to comply with the 
preventive controls regulations (i.e., 6 months after the applicable 
compliance date for the supplier under those regulations). Our goal is 
to avoid a situation in which an importer would be required to develop 
an FSVP for a food from a particular supplier and then be required to 
revise this FSVP shortly thereafter once the supplier is subject to the 
preventive controls regulations. Because different foreign suppliers 
will be required to comply with those regulations at different times 
(e.g., based on the size of the firm), our proposed compliance dates 
for FSVP would be staggered depending on who the importer's supplier or 
suppliers are.
    Some foreign suppliers that are farms would be subject to the new 
standards for produce safety that we have proposed to establish in part 
112. Importers will not be certain which farm suppliers are covered by 
the produce safety standards or when a foreign supplier will be 
required to comply with the standards until a final produce safety rule 
is issued. If importers are required to conduct verification activities 
before a farm is subject to the produce rule, some importers could be 
required to change their verification activities for the supplier after 
the produce rule is in effect because, for example, the produce rule 
will establish food safety regulations that must be considered in any 
audit. RACs that are not fruits or vegetables would not be covered by 
the produce rule. Nonetheless, waiting to implement the FSVP 
requirements for all RACs from farms until after the produce safety 
rule is effective will facilitate implementation.
    In light of these circumstances, we believe that it is reasonable 
to stagger the compliance dates for FSVP activities for RACs from farms 
as follows:
     The compliance date for an importer to comply with the 
FSVP regulations with respect to a RAC from a farm would be 18 months 
after the publication date of the final rule or 6 months after the date 
on which the supplier must be in compliance with the produce safety 
regulations, whichever is later.
     If the foreign supplier is not subject to the produce 
safety regulations, the compliance date for an importer to comply with 
the FSVP regulations with respect to a RAC received from a farm would 
be 18 months after the publication date of the final rule or 6 months 
after the effective date of the produce final rule, whichever is later. 
This approach would ensure that the receiving facility would be able to 
know whether the farm supplier is subject to the produce safety 
regulations before choosing any appropriate verification activities.
    We request comment on our proposed approach to compliance dates.

VII. Comments

    We invite public comment on the matters specified in this document 
as well as any other matters concerning the proposed FSVP regulations 
that are of interest. As previously stated, we issued the Preventive 
Controls Proposed Rule and the Produce Safety Proposed Rule on January 
14, 2013. We understand that many persons who are directly affected by, 
or otherwise interested in, those proposed regulations also are 
affected by, or interested in, the proposed FSVP regulations, and that 
aspects of the FSVP proposed rule might affect views regarding the 
previously issued rules. To address these concerns, on April 26, 2013, 
we issued documents in the Federal Register (78 FR 24691 and 24692) 
extending the comment periods on the preventive controls and produce 
safety proposed rules to September 16, 2013, to allow additional time 
for interested persons to consider the potential impact of the proposed 
FSVP regulations on those rules.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

VIII. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(We have verified the Web site addresses, but we are not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)

1. U.S. Food and Drug Administration, ``Annual Report to Congress on 
Food Facilities, Food Imports, and FDA Foreign Offices Provisions of 
the FDA Food Safety and Modernization Act,''

[[Page 45772]]

August 2012 (http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm315486.htm
2. U.S. Food and Drug Administration, ``Pathway to Global Product 
Safety and Quality,'' July 2011 (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htm).
3. Centers for Disease Control and Prevention, Multistate Foodborne 
Outbreaks (http://www.cdc.gov/outbreaknet/outbreaks.html).
4. The WTO Agreement on the Application of Sanitary and 
Phytosanitary Measures (http://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm).
5. Notification to World Trade Organization, Committee on Sanitary 
and Phytosanitary Measures, G/SPS/N/USA/2156, February 14, 2011 
(https://docs.wto.org/imrd/directdoc.asp?DDFDocuments/t/G/SPS/NUSA2156.DOC).
6. Codex Committee on Food Import and Export Inspection and 
Certification Systems; Guidelines for Food Import Control Systems 
(CAC/GL 47-2003) (http://www.codexalimentarius.net/download/standards/10075/CXG_047e.pdf)
7. U.S. Government Accountability Office (GAO), ``Seafood Safety: 
FDA Needs to Improve Oversight of Imported Seafood and Better 
Leverage Limited Resources'' (GAO-11-286), April 2011 (http://www.gao.gov/new.items/d11286.pdf).
8. National Advisory Committee on Microbiological Criteria for Foods 
(NACMCF), 1998, Hazard Analysis and Critical Control Point 
Principles and Application Guidelines, Journal of Food Protection, 
61:1246-1259 (http://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006801.htm).
9. Codex Alimentarius Committee (CAC), 2003, General Principles of 
Food Hygiene (CAC/RCP 1-1969) (rev. 4-2003) (http://www.codexalimentarius.net/download/standards/23/CXP_001e.pdf).
10. Grocery Manufacturers Association (GMA), Food Supply Chain 
Handbook, April 18, 2008 (http://gmaonline.org/downloads/technical-guidance-and-tools/GMA_SupplyChain2.pdf).
11. The Global Food Safety Initiative (GFSI), GFSI Guidance 
Document, Version 6.2 (http://www.mygfsi.com/gfsifiles/Overview_GFSI_Guidance_Document_Sixth_Edition_Version_6.2.pdf).
12. Agreement between the European Community and the United States 
of America on Sanitary Measures to Protect Public and Animal Health 
in Trade in Live Animals and Animal Products (http://ec.europa.eu/world/agreements/downloadFile.do?fullText=yes&treatyTransId=751).
13. U.S. Food and Drug Administration, 2013, ``Preliminary 
Regulatory Impact Analysis,'' Docket Nos. FDA-2011-N-0143, Foreign 
Supplier Verification Programs for Importers of Food for Humans and 
Animals, and FDA-2011-N-0146, Accreditation of Third-Party Auditors/
Certification Bodies to Conduct Food Safety Audits and to Issue 
Certifications. (http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm).

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 1 be amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

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

    Authority:  15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21 
U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355, 
360b, 362, 371, 374, 381, 382, 384a, 393; 42 U.S.C. 216, 241, 243, 
262, 264.

0
2. Add subpart L, consisting of Sec. Sec.  1.500 through 1.514 to read 
as follows:
Subpart L--Foreign Supplier Verification Programs for Food Importers
Sec.
1.500 What definitions apply to this subpart?
1.501 To what foods do the regulations in this subpart apply?
1.502 What foreign supplier verification program (FSVP) must I have?
1.503 Who must develop my FSVP and perform FSVP activities?
1.504 What review of a food and foreign supplier's compliance status 
must I conduct?
1.505 What hazard analysis must I conduct?
1.506 What foreign supplier verification and related activities must 
I conduct?
1.507 What investigations and corrective actions must I conduct 
under my FSVP?
1.508 How must I reassess the effectiveness of my FSVP?
1.509 How must the importer be identified at entry?
1.510 How must I maintain records of my FSVP?
1.511 What FSVP must I have if I am importing a food subject to 
certain dietary supplement current good manufacturing practice 
regulations?
1.512 What FSVP may I have if I am a very small importer or I am 
importing from a very small foreign supplier?
1.513 What FSVP may I have if I am importing a food from a country 
with an officially recognized or equivalent food safety system?
1.514 What are some consequences of failing to comply with the 
requirements of this subpart?

Subpart L--Foreign Supplier Verification Programs for Food 
Importers

Sec.  1.500  What definitions apply to this subpart?

    The following definitions apply to words and phrases as they are 
used in this subpart. Other definitions of these terms may apply when 
they are used in other subparts of this part.
    Adequate means that which is needed to accomplish the intended 
purpose in keeping with good public health practice.
    Audit means the systematic, independent, and documented examination 
(through observation, investigation, records review, and, as 
appropriate, sampling and laboratory analysis) to assess a foreign 
supplier's food safety processes and procedures.
    Dietary supplement has the meaning given in section 201(ff) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)).
    Dietary supplement component means any substance intended for use 
in the manufacture of a dietary supplement, including those that may 
not appear in the finished batch of the dietary supplement. Dietary 
supplement components include dietary ingredients (as described in 
section 201(ff) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321(ff)) and other ingredients.
    Food has the meaning given in section 201(f) of the Federal Food, 
Drug, and Cosmetic Act, except that food does not include pesticides as 
defined in 7 U.S.C. 136(u).
    Food allergen means a major food allergen as defined in section 
201(qq) of the Federal Food, Drug, and Cosmetic Act.
    Foreign supplier means, for an article of food, the establishment 
that manufactures/processes the food, raises the animal, or 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.
    Good compliance standing with a foreign food safety authority means 
that the foreign supplier--
    (1) Appears on the current version of a list, issued by the food 
safety authority of the country in which the foreign supplier is 
located and which has regulatory oversight of the supplier, of food 
manufacturers and processors that are in good compliance standing with 
the food safety authority, or

[[Page 45773]]

    (2) Has otherwise been designated by such food safety authority as 
being in good compliance standing.
    Hazard means any biological, chemical, physical, or radiological 
agent that is reasonably likely to cause illness or injury in the 
absence of its control.
    Hazard reasonably likely to occur means 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.
    Importer means the person in the United States who has purchased an 
article of food that is being offered for import into the United 
States. If the article of food has not been sold to a person in the 
United States at the time of U.S. entry, the importer is the person in 
the United States to whom the article has been consigned at the time of 
entry. If the article of food has not been sold or consigned to a 
person in the United States at the time of U.S. entry, the importer is 
the U.S. agent or representative of the foreign owner or consignee at 
the time of entry.
    Lot means the food produced during a period of time indicated by a 
specific code.
    Manufacturing/processing means making food from one or more 
ingredients, or synthesizing, preparing, treating, modifying, or 
manipulating food, including food crops or ingredients. Examples of 
manufacturing/processing activities are cutting, peeling, trimming, 
washing, waxing, eviscerating, rendering, cooking, baking, freezing, 
cooling, pasteurizing, homogenizing, mixing, formulating, bottling, 
milling, grinding, extracting juice, distilling, labeling, or 
packaging. For farms and farm mixed-type facilities, manufacturing/
processing does not include activities that are part of harvesting, 
packing, or holding.
    Packaging (when used as a verb) means placing food into a container 
that directly contacts the food and that the consumer receives.
    Qualified individual means 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. Regarding the performance 
of verification activities related to preventive controls implemented 
by the foreign supplier in accordance with section 418 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 350g), 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. A qualified individual includes, but is 
not limited to, a third-party auditor that has been accredited in 
accordance with section 808 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 384d). A foreign government employee could be a qualified 
individual.
    Raw agricultural commodity means ``raw agricultural commodity'' as 
defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321(r)).
    Very small foreign supplier means 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.
    Very small importer means 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.
    You means a person who is subject to some or all of the 
requirements in this subpart.

Sec.  1.501  To what foods do the regulations in this subpart apply?

    (a) General. Except as specified otherwise in this section, the 
regulations in this subpart apply to all food imported or offered for 
import into the United States and to the importers of such food.
    (b) Exemption for certain juice and seafood products. The 
regulations in this subpart 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 of this chapter or the regulations on fish and 
fishery products in part 123 of this chapter. If you import juice or 
fish and fishery products that are subject to the regulations in part 
120 or part 123 of this chapter, respectively, you must comply with the 
requirements applicable to importers of those products under Sec.  
120.14 or Sec.  123.12 of this chapter, respectively.
    (c) Exemption for food imported for research or evaluation. The 
regulations in this subpart do not apply to food that is imported for 
research or evaluation use, provided that such food is not intended for 
retail sale and is not sold or distributed to the public, that it is 
labeled with the statement ``Food for research or evaluation use,'' and 
that, when filing entry with U.S. Customs and Border Protection, the 
customs broker or filer for the food provides an electronic declaration 
that the food will be used for research or evaluation purposes and will 
not be sold or distributed to the public. Food is imported for research 
or evaluation purposes only if it is imported in a small quantity that 
is consistent with a research, analysis, or quality assurance purpose 
and the entire quantity is used for this purpose.
    (d) Exemption for food imported for personal consumption. The 
regulations in this subpart do not apply to food that is imported for 
personal consumption, provided that such food is not intended for 
retail sale and is not sold or distributed to the public. Food is 
imported for personal consumption only if it is purchased or otherwise 
acquired by a person in a small quantity that is consistent with a non-
commercial purpose and is not sold or distributed to the public.
    (e) Exemption for alcoholic beverages. (1) The regulations in this 
subpart do not apply with respect to alcoholic beverages that are 
imported from a foreign supplier that is a facility that meets the 
following two conditions:
    (i) Under the Federal Alcohol Administration Act (27 U.S.C. 201 et 
seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 
(26 U.S.C. 5001 et seq.), the facility is a foreign facility of a type 
that, if it were a domestic facility, would require obtaining a permit 
from, registering with, or obtaining approval of a notice or 
application from the Secretary of the Treasury as a condition of doing 
business in the United States; and
    (ii) Under section 415 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 350d), the facility is required to register as a facility 
because it is engaged in manufacturing/processing one or more alcoholic 
beverages.
    (2) The regulations in this subpart do not apply with respect to 
food other than alcoholic beverages that is imported from a foreign 
supplier described in paragraph (e)(1) of this section, provided such 
food:

[[Page 45774]]

    (i) Is in prepackaged form that prevents any direct human contact 
with such food; and
    (ii) Constitutes not more than 5 percent of the overall sales of 
the facility, as determined by the Secretary of the Treasury.
    (f) Inapplicability to food that is transshipped or imported for 
further processing and export. The regulations in this subpart do not 
apply to food:
    (1) That is transshipped through the United States to another 
country; or
    (2) That is imported for future export and that is neither consumed 
nor distributed in the United States.

Sec.  1.502  What foreign supplier verification program (FSVP) must I 
have?

    (a) General. Except as specified in paragraph (b) of this section, 
for each food you import, you must develop, maintain, and follow an 
FSVP that provides adequate assurances that your foreign supplier is 
producing the food in compliance with processes and procedures that 
provide at least the same level of public health protection as those 
required under section 418 (regarding hazard analysis and risk-based 
preventive controls for certain foods) or 419 (regarding standards for 
produce safety), if either is applicable, and is producing the food in 
compliance with sections 402 (regarding adulteration) and 403(w) 
(regarding misbranding with respect to labeling for the presence of 
major food allergens) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 350g, 350h, 342, and 343(w)).
    (b) Low-acid canned foods. With respect to those microbiological 
hazards that are controlled by part 113 of this chapter, if you import 
a thermally processed low-acid canned food packaged in a hermetically 
sealed container, you must verify and document that the food was 
produced in accordance with part 113 of this chapter. With respect to 
all matters that are not controlled by part 113 of this chapter, you 
must have an FSVP as specified in paragraph (a) of this section.

Sec.  1.503  Who must develop my FSVP and perform FSVP activities?

    Except with respect to the requirements in Sec. Sec.  1.506(a), 
1.509, 1.510, 1.511(c)(2), and 1.512(b)(3) and (6), a qualified 
individual must develop your FSVP and perform each of the activities 
required under this subpart.

Sec.  1.504  What review of a food and foreign supplier's compliance 
status must I conduct?

    Before importing a food from a foreign supplier, you must review 
the compliance status of the food and the foreign supplier, including 
whether they are the subject of an FDA warning letter, import alert, or 
requirement for certification issued under section 801(q) of the 
Federal Food, Drug, and Cosmetic 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. You must document this 
review. You must continue to monitor and document the compliance status 
as long as you import the food from the foreign supplier.

Sec.  1.505  What hazard analysis must I conduct?

    (a) Requirement of a hazard analysis. Except as permitted under 
paragraphs (d) and (e) of this section, for each food you import, you 
must determine 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. You must document this determination and 
use it to determine appropriate verification activities in accordance 
with Sec.  1.506.
    (b) Potential hazards. Your evaluation of the hazards that are 
reasonably likely to occur with each food you import must consider 
hazards that may occur naturally or may be unintentionally introduced, 
including the following:
    (1) Biological hazards, including microbiological hazards such as 
parasites and environmental pathogens, and other microorganisms of 
public health significance;
    (2) Chemical hazards, including substances such as pesticide and 
drug residues, natural toxins, decomposition, unapproved food or color 
additives, and food allergens;
    (3) Physical hazards; and
    (4) Radiological hazards.
    (c) Hazard evaluation. In evaluating the hazards set forth in 
paragraph (b) of this section, you must consider the effect of the 
following on the safety of the finished food for the intended consumer:
    (1) The ingredients of the food;
    (2) The condition, function, and design of the foreign supplier's 
establishment and equipment;
    (3) Transportation practices;
    (4) Harvesting, raising, manufacturing, processing, and packing 
procedures;
    (5) Packaging and labeling activities;
    (6) Storage and distribution;
    (7) Intended or reasonably foreseeable use;
    (8) Sanitation, including employee hygiene; and
    (9) Any other relevant factors.
    (d) Review of hazard analysis developed by foreign supplier. If 
your foreign supplier has conducted a hazard analysis for the food, you 
may 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. You must document the determination 
you make based on this review and evaluation.
    (e) Microbiological hazards in raw agricultural commodities that 
are fruits or vegetables. If you are importing a raw agricultural 
commodity that is a fruit or vegetable, you are not required to conduct 
a hazard analysis regarding microbiological hazards that might be 
reasonably likely to occur with such food.

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

    (a) List of foreign suppliers. You must maintain a written list of 
foreign suppliers from which you are importing food.
    (b) Foreign supplier verification procedures. You must establish 
and follow adequate written procedures for conducting foreign supplier 
verification activities with respect to the foods you import.
    (c) Purpose of supplier verification. Except with respect to 
verification activities specified in paragraph (h) of this section 
concerning raw agricultural commodities that are fruits or vegetables 
and that are subject to part 112 of this chapter, your foreign supplier 
verification activities must provide adequate assurances that the 
hazards you have identified as reasonably likely to occur are 
adequately controlled.
    (d) No hazards identified. If you conduct your hazard analysis in 
accordance with Sec.  1.505 and determine that there are no hazards 
that are reasonably likely to occur with a food you import, you are 
only required to comply with paragraph (a) of this section with respect 
to this food. This paragraph does not apply if the food is a raw 
agricultural commodity that is a fruit or vegetable and that is subject 
to part 112 of this chapter.
    (e) Hazards controlled by you. For a hazard that you have 
identified as reasonably likely to occur with a food you import that 
you adequately control, you must document, at least annually, that you 
have established and are following procedures that adequately control 
the hazard.
    (f) Hazards controlled by your customer. For a hazard that you have 
identified as reasonably likely to occur with a food you import that 
your customer adequately controls, you must document that your customer 
controls the hazard by obtaining written

[[Page 45775]]

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.

Option 1 for Requirements for Hazards Not Controlled by You or Your 
Customer

    (g) Hazards controlled or verified by your foreign supplier. For a 
hazard that you have identified as reasonably likely to occur with a 
food that is not controlled by you or your customer, you must conduct 
the verification activities in paragraph (g)(1) or (2) of this section, 
depending on the type of hazard.
    (1) Hazards controlled by your foreign supplier for which there is 
a reasonable probability that exposure to the hazard will result in 
serious adverse health consequences or death to humans or animals. For 
a hazard to be controlled by your foreign supplier at its establishment 
for which there is a reasonable probability that exposure to the hazard 
will result in serious adverse health consequences or death to humans 
or animals, you must conduct and document the onsite auditing 
activities specified in paragraphs (g)(1)(i) and (ii) of this section 
for the hazard. When onsite auditing alone cannot provide adequate 
assurances that the hazard is adequately controlled, you must conduct 
one or more additional verification activities to provide such 
assurances.
    (i) Initial onsite audit. You must conduct (and document) or obtain 
documentation of an onsite audit before importing the food from the 
foreign supplier.
    (ii) Subsequent periodic onsite audits. You must conduct (and 
document) or obtain documentation of an onsite audit of the foreign 
supplier at least annually, unless more frequent onsite audits are 
necessary to adequately verify that the hazard is adequately 
controlled.
    (2) Other hazards. For a hazard that you have identified as 
reasonably likely to occur with a food from a foreign supplier that is 
not specified in paragraph (g)(1) of this section, you must conduct one 
or more of the verification activities listed in paragraphs (g)(2)(i) 
through (iv) of this section before using or distributing the food and 
periodically thereafter. You must determine and document which 
verification activity or activities are appropriate to adequately 
verify that the hazard is adequately controlled. You must determine and 
document how frequently the verification activities must be conducted. 
In determining the appropriate verification activities and how 
frequently they should be conducted, you must consider the risk 
presented by the hazard and the food and foreign supplier's compliance 
status as reviewed under Sec.  1.504.
    (i) Periodic onsite auditing. You conduct (and document) or obtain 
documentation of a periodic onsite audit of your foreign supplier.
    (ii) Periodic or lot-by-lot sampling and testing of the food. You 
conduct (and document) or obtain documentation (such as a certificate 
of analysis containing the results of the testing) from your foreign 
supplier of lot-by-lot or periodic sampling and testing of the food for 
the hazard.
    (iii) Periodic review of the foreign supplier's food safety 
records. You periodically review (and document) or obtain documentation 
of a review of your foreign supplier's food safety records (such as 
records of your foreign supplier's audit of its supplier's hazard 
control activities).
    (iv) Other appropriate procedure. You use any other procedure that 
you have established as being appropriate based on the risk associated 
with the hazard. You must document your use of any such procedure.
    (3) Requirements of onsite auditing. An onsite audit conducted 
under this section must consider the FDA food safety regulations, if 
any, that apply to the food and foreign supplier and must include a 
review of the foreign supplier's written food safety plan, if any, for 
the hazard being audited and the supplier's implementation of such 
plan.
    (4) Substitution of inspection by FDA or an officially recognized 
or equivalent food safety authority. Instead of an onsite audit 
conducted under paragraph (g) or (h) of this section, an importer may 
rely on the results of an inspection of the foreign supplier by FDA or 
the food safety authority of a country whose food safety system FDA has 
officially recognized as comparable or has determined to be equivalent 
to that of the United States, provided that the inspection was 
conducted within 1 year of the date that the onsite audit would have 
been required to be conducted. For inspections conducted by the food 
safety authority of a country whose food safety system FDA has 
officially recognized as comparable or determined to be equivalent, the 
food that is the subject of the onsite audit must be within the scope 
of the official recognition or equivalence determination, and the 
foreign supplier must be in, and under the regulatory oversight of, 
such country.
    (5) Review of results of verification activities. You must promptly 
review the results of the verification activities that you conduct or 
obtain documentation of under paragraph (g) or (h) of this section. If 
the results show that the hazards identified as reasonably likely to 
occur with a food are not adequately controlled, you must take 
appropriate action in accordance with Sec.  1.507(c).
    (6) Independence of qualified individuals conducting verification 
activities. A qualified individual who conducts any of the verification 
activities set forth in paragraphs (g)(1), (g)(2), and (h) of this 
section must not have a financial interest in the foreign supplier and 
payment must not be related to the results of the activity. This does 
not prohibit you or one of your employees from conducting the 
verification activity.

Option 2 for Requirements for Hazards Not Controlled by You or Your 
Customer

    (g) Other hazards. (1) For a hazard that you have identified as 
reasonably likely to occur with a food from a foreign supplier and that 
is not controlled by you or your customer, you must conduct one or more 
of the verification activities listed in paragraphs (g)(1)(i) through 
(iv) of this section before using or distributing the food and 
periodically thereafter. You must determine and document which 
verification activity or activities are appropriate to adequately 
verify that the hazard is adequately controlled. You must determine and 
document how frequently the verification activities must be conducted. 
In determining the appropriate verification activities and how 
frequently they should be conducted, you must consider the risk 
presented by the hazard, the probability that exposure to the hazard 
will result in serious adverse health consequences or death to humans 
or animals, and the food and foreign supplier's compliance status as 
reviewed under Sec.  1.504.
    (i) Periodic onsite auditing. You conduct (and document) or obtain 
documentation of a periodic onsite audit of your foreign supplier.
    (ii) Periodic or lot-by-lot sampling and testing of the food. You 
conduct (and document) or obtain documentation (such as a certificate 
of analysis containing the results of the testing) from your foreign 
supplier of lot-by-lot or periodic sampling and testing of the food for 
the hazard.
    (iii) Periodic review of the foreign supplier's food safety 
records. You periodically review (and document) or obtain documentation 
of a review of your foreign supplier's food safety records (such as 
records of your foreign

[[Page 45776]]

supplier's audit of its supplier's hazard control activities).
    (iv) Other appropriate procedure. You use any other procedure that 
you have established as being appropriate based on the risk associated 
with the hazard. You must document your use of any such procedure.
    (2) Requirements of onsite auditing. An onsite audit conducted 
under this section must consider the FDA food safety regulations, if 
any, that apply to the food and foreign supplier and must include a 
review of the foreign supplier's written food safety plan, if any, for 
the hazard being audited and the supplier's implementation of such 
plan.
    (3) Substitution of inspection by FDA or an officially recognized 
or equivalent food safety authority. Instead of an onsite audit 
conducted under paragraph (g) or (h) of this section, an importer may 
rely on the results of an inspection of the foreign supplier by FDA or 
the food safety authority of a country whose food safety system FDA has 
officially recognized as comparable or has determined to be equivalent 
to that of the United States, provided that the inspection was 
conducted within 1 year of the date that the onsite audit would have 
been required to be conducted. For inspections conducted by the food 
safety authority of a country whose food safety system FDA has 
officially recognized as comparable or determined to be equivalent, the 
food that is the subject of the onsite audit must be within the scope 
of the official recognition or equivalence determination, and the 
foreign supplier must be in, and under the regulatory oversight of, 
such country.
    (4) Review of results of verification activities. You must promptly 
review the results of the verification activities that you conduct or 
obtain documentation of under paragraph (g) or (h) of this section. If 
the results show that the hazards identified as reasonably likely to 
occur with a food are not adequately controlled, you must take 
appropriate action in accordance with Sec.  1.507(c).
    (5) Independence of qualified individuals conducting verification 
activities. A qualified individual who conducts any of the verification 
activities set forth in paragraphs (g)(1) and (h) of this section must 
not have a financial interest in the foreign supplier and payment must 
not be related to the results of the activity. This does not prohibit 
you or one of your employees from conducting the verification activity.

Option 1 for Importers of Certain Produce

    (h) Importers of certain produce. For a raw agricultural commodity 
that is a fruit or vegetable and that is subject to part 112 of this 
chapter, in addition to the other requirements of this section, before 
importing the fruit or vegetable from the foreign supplier and at least 
annually thereafter, you must conduct or obtain documentation of an 
onsite audit that examines the control of microbiological hazards 
associated with the fruit or vegetable. Such audit must provide 
adequate assurances that your foreign supplier is producing the fruit 
or vegetable in accordance with processes and procedures that provide 
the same level of public health protection as those required under part 
112 of this chapter. Such audits are subject to paragraphs (g)(3) 
through (6) of this section. An audit conducted under this paragraph 
may be conducted in conjunction with an audit, if any, that is required 
under paragraph (g) of this section.

Option 2 for Importers of Certain Produce

    (h) Importers of certain produce. For a raw agricultural commodity 
that is a fruit or vegetable and that is subject to part 112 of this 
chapter, in addition to the other requirements of this section, before 
importing the fruit or vegetable from the foreign supplier and at least 
annually thereafter, you must conduct one or more of the verification 
activities listed in paragraphs (g)(1)(i) through (iv) of this section 
to provide adequate assurances that your foreign supplier is producing 
the fruit or vegetable in accordance with processes and procedures that 
provide the same level of public health protection as those required 
under part 112 of this chapter. An audit conducted under this paragraph 
is subject to paragraphs (g)(2) through (5) of this section. You may 
conduct an activity under this paragraph in conjunction with an 
activity that you conduct in accordance with paragraph (g)(1)(i) 
through (iv) of this section.

Sec.  1.507  What investigations and corrective actions must I conduct 
under my FSVP?

    (a) You must promptly conduct a review of any customer, consumer, 
or other complaint that you receive to determine whether the complaint 
relates to the adequacy of your FSVP.
    (b) If you become aware that an article of food you import is 
adulterated under section 402 or misbranded under section 403(w) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342 and 343(w)), either 
through review of a complaint or by other means, you must promptly 
investigate the cause or causes of such adulteration or misbranding. 
You must document any such investigation.
    (c) You must promptly take appropriate corrective actions if you 
determine that a foreign supplier of food you import does not produce 
the food in compliance with processes and procedures that provide at 
least the same level of public health protection as those required 
under section 418 or 419 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 350g or 350h), if either is applicable, or produces food 
that is adulterated under section 402 or misbranded under section 
403(w) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342 and 
343(w)). This determination could be based on an investigation 
conducted under paragraph (b) of this section, the verification 
activities you conduct under Sec.  1.506 or Sec.  1.511(c), the FSVP 
reassessment you conduct under Sec.  1.508, or otherwise. The 
appropriate corrective actions will depend on the circumstances but 
could include discontinuing use of the foreign supplier until the cause 
or causes of noncompliance, adulteration, or misbranding have been 
adequately addressed. You must document any corrective actions you take 
in accordance with this paragraph.
    (d) If you determine, by means other than your verification 
activities conducted under Sec.  1.506 or Sec.  1.511(c) or your FSVP 
reassessment conducted under Sec.  1.508, that a foreign supplier of 
food that you import does not produce food in compliance with processes 
and procedures that provide at least the same level of public health 
protection as those required under section 418 or 419 of the Federal 
Food, Drug, and Cosmetic Act, if either is applicable, or produces food 
that is adulterated under section 402 or misbranded under section 
403(w) of the Federal Food, Drug, and Cosmetic Act, you must promptly 
investigate to determine whether your FSVP is adequate and, when 
appropriate, modify your FSVP. You must document any investigations, 
corrective actions, and changes to your FSVP that you undertake in 
accordance with this paragraph.
    (e) This section does not limit your obligations with respect to 
other laws enforced by FDA, such as those relating to product recalls.

Sec.  1.508  How must I reassess the effectiveness of my FSVP?

    (a) Timing. (1) Except as specified in paragraph (a)(2) of this 
section, for each food you import, you must conduct a

[[Page 45777]]

reassessment of your FSVP for the food, as described in paragraph (b) 
of this section, within 3 years of establishing the FSVP and within 3 
years of the last reassessment.
    (2) You must promptly reassess the effectiveness of your FSVP for a 
food you import when you become aware of new information about 
potential hazards associated with the food.
    (b) Reassessment and implementation of changes. In conducting a 
reassessment of your FSVP as required by paragraph (a) of this section, 
you must update your hazard analysis for the food in accordance with 
Sec.  1.505. If the hazards you previously identified as reasonably 
likely to occur change as a result of the reassessment, you must 
promptly determine whether the verification activities you conduct 
under Sec.  1.506 or Sec.  1.511(c) need to be changed to comply with 
that section, and you must promptly implement any such changes. You 
must document each reassessment you conduct and any resulting changes 
to your FSVP.

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

    (a) Before an article of food is imported or offered for import 
into the United States, the foreign owner or consignee of the food (if 
there is no U.S. owner or consignee) must designate a U.S. agent or 
representative as the importer of the food for the purposes of the 
definition of ``importer'' in Sec.  1.500.
    (b) You must obtain a Dun & Bradstreet Data Universal Numbering 
System (DUNS) number.
    (c) You must ensure that, for each line entry of food product 
offered for importation into the United States, your name and DUNS 
number identifying you as the importer of the food is provided 
electronically when filing entry with U.S. Customs and Border 
Protection.

Sec.  1.510  How must I maintain records of my FSVP?

    (a) Records of FSVP. You must sign and date records concerning your 
FSVP upon initial completion and upon any modification of the FSVP.
    (b) Record availability. You must maintain records required under 
this subpart, in English, and make them available promptly to an 
authorized FDA representative, upon request, for inspection and 
copying. You must maintain records at your place of business or at a 
reasonably accessible location; records are considered to be at a 
reasonably accessible location if they can be immediately retrieved 
from another location by computer or other electronic means. If 
requested in writing by FDA, you must send records to the Agency 
electronically rather than making the records available for review at 
your place of business.
    (c) Record quality. All records must be legible and stored to 
prevent deterioration or loss.
    (d) Record retention. (1) Except as specified in paragraph (d)(2) 
of this section, you must maintain records referenced in this subpart 
until at least 2 years after their use is discontinued (e.g., because 
you no longer import a particular food, you no longer use a particular 
foreign supplier, or you have changed your FSVP procedures).

Option 1

    (2) You must maintain records required under Sec.  1.506(g)(1), 
(g)(2), and (h) (certain verification activities), Sec.  1.507 
(investigations and corrective actions), Sec.  1.508 (FSVP 
reassessments), Sec.  1.511 (food subject to certain dietary supplement 
current good manufacturing practice regulations), and Sec.  1.513(b) 
(food imported from a country with an officially recognized or 
equivalent food safety system) for a period of at least 2 years after 
the records were created or obtained, except that you must maintain 
records of any changes to your FSVP in accordance with Sec.  1.507(d) 
or Sec.  1.508(b) until at least 2 years after their use is 
discontinued.

Option 2

    (2) You must maintain records required under Sec.  1.506(g)(1) and 
(h) (certain verification activities), Sec.  1.507 (investigations and 
corrective actions), Sec.  1.508 (FSVP reassessments), Sec.  1.511 
(food subject to certain dietary supplement current good manufacturing 
practice regulations), and Sec.  1.513(b) (food imported from a country 
with an officially recognized or equivalent food safety system) for a 
period of at least 2 years after the records were created or obtained, 
except that you must maintain records of any changes to your FSVP in 
accordance with Sec.  1.507(d) or Sec.  1.508(b) until at least 2 years 
after their use is discontinued.

Sec.  1.511  What FSVP must I have if I am importing a food subject to 
certain dietary supplement current good manufacturing practice 
regulations?

    (a) Importers subject to certain dietary supplement current good 
manufacturing regulations. If you are required to establish 
specifications under Sec.  111.70(b), (d), or (f) of this chapter with 
respect to a food you import and you are in compliance with the 
requirements of part 111 of this chapter applicable to determining 
whether the specifications you established are met for such food, then 
for that food you must comply with the requirements in Sec. Sec.  
1.506(a), 1.509, and 1.510, but you are not required to comply with the 
requirements in Sec. Sec.  1.502 through 1.508 (except Sec.  1.506(a)). 
This requirement does not limit your obligations with respect to part 
111 of this chapter or any other laws enforced by FDA.
    (b) Importers whose customer is subject to certain dietary 
supplement CGMP regulations. If your customer is required to establish 
specifications under Sec.  111.70(b), (d), or (f) of this chapter with 
respect to a food you import, your customer is in compliance with the 
requirements of part 111 of this chapter applicable for determining 
whether the specifications it established are met for such food, and 
you annually obtain from your customer written assurance that it is in 
compliance with those requirements, then for that food you must comply 
with the requirements in Sec. Sec.  1.506(a), 1.509, and 1.510, but you 
are not required to comply with the requirements in Sec. Sec.  1.502 
through 1.508 (except Sec.  1.506(a)).
    (c) Other importers of dietary supplements--(1) General. If the 
food you import is a dietary supplement and neither paragraph (a) or 
(b) of this section is applicable, you must comply with paragraph (c) 
of this section and the requirements in Sec. Sec.  1.503, 1.504, and 
1.507 through 1.510, but you are not required to comply with the 
requirements in Sec. Sec.  1.505 and 1.506. This requirement does not 
limit your obligations with respect to part 111 of this chapter or any 
other laws enforced by FDA.
    (2) List of foreign suppliers. You must maintain a written list of 
foreign suppliers from which you are importing food.
    (3) Foreign supplier verification procedures. You must establish 
and follow adequate written procedures for conducting foreign supplier 
verification activities with respect to the foods you import.
    (4) Purpose of supplier verification. Your foreign supplier 
verification activities must provide adequate assurances that your 
supplier is producing the dietary supplement in accordance with the 
requirements of part 111 of this chapter.
    (5) Supplier verification activities. For each dietary supplement 
you import under paragraph (c) of this section, you must conduct one or 
more of the verification activities listed in paragraphs (c)(5)(i) 
through (iv) of this section before using or distributing the dietary 
supplement and periodically thereafter. You must determine and document 
which verification activity or

[[Page 45778]]

activities are appropriate to adequately verify that the foreign 
supplier is in compliance with the requirements of part 111 of this 
chapter. You must determine and document how frequently the 
verification activities must be conducted.
    (i) Periodic onsite auditing. You conduct (and document) or obtain 
documentation of a periodic onsite audit of your foreign supplier.
    (ii) Periodic or lot-by-lot sampling and testing of the food. You 
conduct (and document) or obtain documentation (such as a certificate 
of analysis containing the results of the testing) from your foreign 
supplier of lot-by-lot or periodic sampling and testing of the dietary 
supplement.
    (iii) Periodic review of the foreign supplier's food safety 
records. You periodically review (and document) or obtain documentation 
of a review of your foreign supplier's food safety records.
    (iv) Other appropriate procedure. You use any other procedure that 
you have established as being appropriate. You must document your use 
of any such procedure.
    (6) Requirements of onsite auditing. An onsite audit conducted 
under paragraph (c)(5)(i) of this section must consider the 
requirements of part 111 of this chapter and must include a review of 
the foreign supplier's written food safety plan, if any, and the 
supplier's implementation of such plan.
    (7) Substitution of inspection by FDA or an officially recognized 
or equivalent food safety authority. Instead of an onsite audit 
conducted under paragraph (c)(5)(i) of this section, an importer may 
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, provided that the inspection 
was conducted within 1 year of the date that the onsite audit would 
have been required to be conducted. For inspections conducted by the 
food safety authority of a country whose food safety system FDA has 
officially recognized as comparable or determined to be equivalent, the 
food that is the subject of the onsite audit must be within the scope 
of the official recognition or equivalence determination, and the 
foreign supplier must be in, and under the regulatory oversight of, 
such country.
    (8) Review of results of verification activities. You must promptly 
review the results of the verification activities that you conduct or 
obtain documentation of under paragraph (c)(5) of this section. If the 
results show that the foreign supplier does not meet the standard in 
paragraph (c)(4) of this section, you must take appropriate action in 
accordance with Sec.  1.507(c).
    (9) Independence of qualified individuals conducting verification 
activities. A qualified individual who conducts any of the verification 
activities set forth in paragraph (c)(5) of this section must not have 
a financial interest in the foreign supplier and payment must not be 
related to the results of the activity. This does not prohibit you or 
one of your employees from conducting the verification activity.

Sec.  1.512  What FSVP may I have if I am a very small importer or I am 
importing food from a very small supplier?

    (a) Eligibility. This section applies only if you a very small 
importer or the food you are importing is from a very small foreign 
supplier.
    (b) Applicable requirements--(1) Documentation. If this section 
applies and you choose to comply with the requirements in this section, 
you must document, at the end of each calendar year, that you meet the 
definition of very small importer in Sec.  1.500 or that the foreign 
supplier meets the definition of very small foreign supplier in Sec.  
1.500, whichever is applicable. For the purpose of determining whether 
you satisfy the definition of very small importer or the foreign 
supplier satisfies the definition of very small foreign supplier, the 
baseline year for calculating the adjustment for inflation is 2012. If 
you or the foreign supplier conduct any food sales in currency other 
than U.S. dollars, you must use the relevant currency exchange rate in 
effect on December 31 of the year in which sales occurred to calculate 
the value of these sales.
    (2) Additional requirements. If this section applies and you choose 
to comply with the requirements in paragraph (b) of this section, you 
also are required to comply with the requirements in Sec. Sec.  1.502 
through 1.504 and Sec.  1.509, but you are not required to comply with 
the requirements in Sec. Sec.  1.505 through 1.508 or Sec.  1.510.
    (3) List of foreign suppliers. You must maintain a written list of 
foreign suppliers from which you are importing food.
    (4) Foreign supplier verification activities. For each food you 
import, you must obtain written assurance, before importing the food 
and at least every 2 years thereafter, that your foreign supplier is 
producing the food in compliance with processes and procedures that 
provide at least the same level of public health protection as those 
required under section 418 or 419 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 350g or 350h), if either is applicable, and is 
producing the food in compliance with sections 402 and 403(w) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342, 343(w)). The 
written assurance must include a brief description of the processes and 
procedures that the foreign supplier is following to ensure the safety 
of the food.
    (5) Corrective actions. You must promptly take appropriate 
corrective actions if you determine that a foreign supplier of food you 
import does not produce the food in compliance with processes and 
procedures that provide at least the same level of public health 
protection as those required under section 418 or 419 of the Federal 
Food, Drug, and Cosmetic Act, if either is applicable, or produces food 
that is adulterated under section 402 or misbranded under section 
403(w) of the Federal Food, Drug, and Cosmetic Act. The appropriate 
corrective actions will depend on the circumstances but could include 
discontinuing use of the foreign supplier until the cause or causes of 
noncompliance, adulteration, or misbranding have been adequately 
addressed. You must document any corrective actions you take in 
accordance with this paragraph. This paragraph does not limit your 
obligations with respect to other laws enforced by FDA, such as those 
relating to product recalls.
    (6) Records--(i) Availability. You must maintain records required 
under this subpart, in English, and make them available promptly to an 
authorized FDA representative, upon request, for inspection and 
copying. You must maintain records at your place of business or at a 
reasonably accessible location; records are considered to be at a 
reasonably accessible location if they can be immediately retrieved 
from another location by computer or other electronic means. If 
requested in writing by FDA, you must send records to the Agency 
electronically or by mail rather than making the records available for 
review at your place of business.
    (ii) Record quality. All records must be legible and stored to 
prevent deterioration or loss.
    (iii) Record retention. You must maintain records required under 
this subpart for a period of at least 2 years after the records were 
created or obtained.

[[Page 45779]]

Sec.  1.513  What FSVP may I have if I am importing a food from a 
country with an officially recognized or equivalent food safety system?

    (a) General. If you meet the conditions and requirements of 
paragraph (b) of this section for a food you are importing, then you 
are not required to comply with the requirements in Sec. Sec.  1.503 
through 1.508 (except Sec.  1.506(a)). You would still be required to 
comply with the requirements in Sec. Sec.  1.506(a), 1.509, and 1.510.
    (b) Conditions and requirements. (1) Before importing a food from 
the foreign supplier and annually thereafter, you must document that 
the foreign supplier is in, and under the regulatory oversight of, a 
country whose food safety system FDA has officially recognized as 
comparable or determined to be equivalent to that of the United States, 
and that the food is within the scope of FDA's official recognition or 
equivalency determination regarding the food safety authority of the 
country in which the foreign supplier is located.
    (2) Before importing a food from the foreign supplier, you must 
determine and document whether the foreign supplier of the food is in 
good compliance standing with the food safety authority of the country 
in which the foreign supplier is located. You must continue to monitor 
whether the foreign supplier is in good compliance standing and 
promptly review any information obtained. If the information indicates 
that food safety hazards associated with the food are not being 
adequately controlled, you must take prompt corrective action. The 
appropriate corrective action will depend on the circumstances but 
could include discontinuing use of the foreign supplier. You must 
document any corrective actions that you undertake in accordance with 
this paragraph.

Sec.  1.514  What are some consequences of failing to comply with the 
requirements of this subpart?

    (a) Refusal of admission. An article of food is subject to refusal 
of admission under section 801(a)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(a)(3)) if it appears that the importer of 
that food fails to comply with this subpart with respect to that food. 
If an article of food has not been sold or consigned to a person in the 
United States at the time the food is offered for entry into the United 
States, the article of food may not be imported into the United States 
unless the foreign owner or consignee has designated a U.S. agent or 
representative as the importer for the purposes of the definition of 
``importer'' in Sec.  1.500.
    (b) Prohibited act. The importation or offering for importation 
into the United States of an article of food by an importer without 
having an FSVP that meets the requirements of section 805 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384a), including the 
requirements of this subpart, is prohibited under section 301(zz) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(zz)).

    Dated: July 23, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17993 Filed 7-26-13; 8:45 am]
BILLING CODE 4160-01-P