To import a dietary supplement component in accordance with Sec.
1.511(a) of the final rule, the manufacturer of a dietary supplement
using an imported component will be required to determine whether the
specifications for the component that the manufacturer has established
under Sec.  111.70(b) are met in accordance with Sec. Sec.  111.73 and
111.75. We conclude that compliance by the importer/manufacturer with
these CGMP specification provisions would provide adequate verification
that the imported dietary supplement component was produced in
accordance with the relevant CGMP requirements. We also note that, in
addition to determining whether specifications for the dietary
supplement component are met in accordance with Sec. Sec.  111.73 and
111.75, the manufacturer of the dietary supplement using the imported
component must comply with all other applicable CGMP requirements in
producing the dietary supplement.
    On our own initiative, to provide clarity we have added to the
regulation references to the specific CGMP provisions (i.e., Sec. Sec.
111.73 and 111.75) concerning determination of whether established
specifications are met for an imported dietary supplement or dietary
supplement component.
    (Comment 273) One comment objects to exempting from most FSVP
requirements importers of dietary supplements for whose labels or
packaging the importer has established specifications in accordance
with Sec.  111.70(d) and determines whether the specifications are met.
The comment finds the reference to Sec.  111.70(d) confusing. The
comment maintains that the reference might suggest that FDA regards
labels and packaging as food; if this is the case, the comment does not
believe that confirming that those materials meet specifications would
provide adequate assurance of their safe manufacture. On the other
hand, the comment asserts that if the Agency does not regard labels and
packaging as food, the reference to Sec.  111.70(d) is misplaced
because confirming that labels or packaging met specifications would
not provide adequate assurance that the imported food was produced in
compliance with U.S. law. The comment states that we should not

consider labels and packaging to be food and asks that we delete the
reference to Sec.  111.70(d) from proposed Sec.  1.511(a) and (b).
    (Response 273) We do not agree with the comment that the reference
to Sec.  111.70(d) in Sec.  1.511(a) and (b) is inappropriate. Section
111.70(d) is relevant to the extent that it covers packaging that may
come in contact with dietary supplements. The definition of food under
the FSVP regulation includes food contact substances and Sec.
111.70(d) refers to establishing specifications for packaging that may
come in contact with dietary supplements. Section 111.70(d) specifies
that packaging that may come into contact with dietary supplements must
be safe and suitable for its intended use and must not be reactive or
absorptive or otherwise affect the safety or quality of the dietary
supplement. This requirement makes the verification of specifications
for these materials relevant for a dietary supplement manufacturer
under Sec.  1.511(a) and (b). The domestic manufacturer is responsible
for appropriate labeling of the dietary supplement made from the
imported component in accordance with its own obligations under part
111.
    (Comment 274) Some comments oppose the proposed exemption from the
standard FSVP requirements for importers of dietary supplements who, in
accordance with Sec.  111.70(f), establish specifications to provide
assurance that the product they receive for packaging or labeling (such
as bulk capsules or tablets) is adequately identified and is consistent
with the purchase order, and who determine whether these specifications
are met. The comments maintain that this provision would be
inconsistent with FDA's statement, in the preamble to the final rule on
dietary supplement CGMP (see 72 FR 34752 at 34851, June 25, 2007), that
a firm that only packages and labels a product may rely on information
about the content of the product that it receives from the
manufacturer. The comments assert that under proposed Sec.  1.511(a),
an importer that packages or labels an imported dietary supplement
would have no obligation to verify that the imported dietary supplement
was produced in compliance with part 111. One of the comments contends
that retaining the reference to Sec.  111.70(f) in proposed Sec.
1.511(a) and (b) would incentivize dietary supplement manufacturers to
use foreign manufacturing followed by domestic labeling or packaging
instead of having the complete manufacturing occur either inside or
outside the United States.
    (Response 274) We do not agree with the assertion in the comment
that an importer that receives a dietary supplement from a supplier for
packaging and labeling would not be obligated to verify that the
imported dietary supplement was produced in compliance with part 111.
We believe that this statement mischaracterizes the obligations that
apply to a firm that packages and/or labels a finished dietary
supplement to which Sec.  111.70(f) applies. Section 111.70(f) applies
when the product received by the packager or labeler has left the
control of the person who manufactured the product. Although the
packager/labeler does not manufacture the product, it is responsible
for ensuring that the product it places into interstate commerce is not
adulterated (see sections 402(g) and 301(a) of the FD&C Act). The
specifications that a packager/labeler would establish under Sec.
111.70(f) must provide sufficient assurance that the received finished
dietary supplement product is adequately identified and is consistent
with the purchase order (see 72 FR 34752 at 34844 to 34845). The level
and nature of information a packager/labeler requires as ``sufficient
assurance'' under Sec.  111.70(f) may vary based, for example, on the
finished dietary supplement and the supplier from which it is received.
    The verification activities that a packager/labeler might conduct
in accordance with Sec.  111.70(f) may not need to include, for a given
supplier, verification that the manufacturer of the dietary supplement
complied with all applicable requirements related to the manufacture of
a finished dietary supplement. However, the verification requirements
contemplated by section 805 of the FD&C Act would require that level of
verification of the manufacturer. Specifically, section 805(a)(1) of
the FD&C Act requires importers of dietary supplements, like importers
of all foods, to perform risk-based foreign supplier verification
activities for the purpose of verifying that the food they import is
not adulterated under section 402. For importers of dietary
supplements, this means that they are required to perform supplier
verification activities for the purpose of verifying that the dietary
supplements they import are in compliance with section 402(g), which
deems dietary supplements adulterated if they fail to meet the CGMP
requirements established in part 111.
    Given this potential difference in required verification
activities, we conclude that it is not appropriate to apply the
modified requirements in Sec.  1.511(a) and (b) of the final rule to
importers of dietary supplements who establish (or whose customers
establish) specifications under Sec.  111.70(f) and ensure they are
met. Instead, firms who import dietary supplements for packaging and
labeling in the United States (by themselves or their customers) will
need to comply with Sec.  1.511(c) and verify that the imported product
was produced in compliance with the applicable requirements of part 111
for the manufacture of the dietary supplement. These importers may be
able to use documentation provided under Sec.  111.70(f) (as well as
Sec. Sec.  111.73 and 111.75 regarding determination that
specifications are met) to fulfill some of the requirements under Sec.
1.511(c) (e.g., regarding the performance of supplier verification
activities).
    (Comment 275) Two comments request that we broaden proposed Sec.
1.511(a) and (b) to include not just importers that are subject to, and
in compliance with, the specified dietary supplement CGMP requirements,
but also importers that are not required to comply with those
requirements in manufacturing certain products but voluntarily do so.
The comments maintain that some facilities that are not subject to part
111 choose to comply with the requirements in that part for various
reasons (e.g., a facility that manufactures only dietary ingredients
but does so in compliance with part 111 at the request of their
customer or at FDA's recommendation). Therefore, the comments ask that
we revise proposed Sec.  1.511(a) and (b) to include importers who
voluntarily comply with Sec.  111.70(b), (d), or (f).
    (Response 275) We decline this request. Attempting to enforce
compliance with the dietary supplement CGMP regulation by firms that
are not legally required to comply with the regulation could present
problems for the Agency if we sought to take an enforcement action
against an importer for failure to comply with Sec.  1.511(a) of the
final rule because we determined that the importer was not in
compliance with Sec.  111.70(b) or (d).
    (Comment 276) One comment objects to the requirement in proposed
Sec.  1.511(b) that an importer of a dietary supplement or dietary
supplement ingredient obtain written assurance of compliance when the
importer's customer is required to establish specifications under Sec.
111.70(b), (d), or (f) and the customer is in compliance with the
requirements for determining whether the specifications are met. The
comment maintains that the written assurance requirement would impose a
significant burden on importers (because importers might have hundreds
or even thousands of

customers) without protecting public health because importers would not
be in a position to audit their customers or otherwise confirm their
compliance with part 111. The comment suggests that the exemption from
most of the FSVP requirements under proposed Sec.  1.511(b) should
apply if either of the following occurs:
     The importer annually obtains written assurance of its
customer's compliance with Sec.  111.70(b), (d), or (f) (as
applicable); or
     The importer verifies (such as through publicly available
information) that its customer manufacturers, packages, and/or labels
dietary supplements and the importer provides a disclosure in labels or
commercial documentation accompanying the dietary supplement or dietary
supplement component stating that the food was not imported under the
standard FSVP requirements and is intended only for use in the
manufacture, processing, packaging, or labeling of dietary supplements
in compliance with part 111 (except as may be allowed under the
customer's food safety plan).
    (Response 276) We decline to make the suggested change. We
acknowledge that obtaining written assurance from the customer of
compliance with the applicable specification requirements would provide
less definitive assurance of the customer's compliance than some other
measures (such on onsite auditing or review of records); however,
annually obtaining the assurance would necessitate the importer's
ongoing consideration of its customer's compliance status. On the other
hand, the disclosure to the customer suggested by the comment likely
would not communicate any additional information to the customer that
the customer would not already have learned through providing the
required assurance.
2. Other Importers of Dietary Supplements
    For finished dietary supplements (packaged and labeled dietary
supplements that will not be subject to further processing) and other
dietary supplements not subject to proposed Sec.  1.511(a) and (b), we
proposed to establish FSVP requirements that were similar to the
proposed ``standard'' FSVP requirements applicable to most imported
foods. Under proposed Sec.  1.511(c), if a dietary supplement was
imported other than in accordance with proposed Sec.  1.511(a) or (b),
the importer would not be required to comply with the standard FSVP
requirements concerning hazard analysis but it would be required to
comply with requirements concerning the following:
     Use of a qualified individual (proposed Sec.  1.503);
     Evaluation of risks (except hazard analysis) (proposed
Sec.  1.505(a)(2) through (6) and (b));
     Certain supplier verification activities, including use of
approved foreign suppliers, establishment of written procedures, and
determination and performance of appropriate verification activities to
provide adequate assurances that the foreign supplier produced the
dietary supplement in compliance with part 111 (proposed Sec.
1.511(c)(2) through (8));
     Complaint review, investigations, corrective actions
(proposed Sec.  1.507);
     FSVP reassessment (proposed Sec.  1.508);
     Identification of importer at entry (proposed Sec.
1.509); and
     Recordkeeping (proposed Sec.  1.510).
    The comments generally support the proposed FSVP requirements for
finished dietary supplements and other dietary supplements not imported
in accordance with proposed Sec.  1.511(a) or (b). We respond to
comments on these requirements in the following paragraphs. We also
discuss the changes that we have made to these requirements in
accordance with several changes to the standard FSVP requirements
discussed previously in this document and the updated references to
these other sections (and, as previously discussed, this provision now
includes dietary supplements imported for packaging and labeling in the
United States). Section 1.511(c)(1) of the final rule states that if
the food imported is a dietary supplement and neither Sec.  1.511(a) or
(b) is applicable, the importer must comply with Sec.  1.511(c) and the
requirements in Sec. Sec.  1.503, 1.505(a)(1)(ii) through (iv), (a)(2),
and (b) through (d), and 1.508 through 1.510, but is not required to
comply with the requirements in Sec. Sec.  1.504, 1.505(a)(1)(i),
1.506, and 1.507. In addition to the changes discussed in the following
paragraphs, we have made minor wording changes to several subsections.
a. Evaluation for Supplier Approval and Verification
    Proposed Sec.  1.511(c)(1) specified that importers of finished
dietary supplements would be required to comply with the requirements
in proposed Sec.  1.505 related to consideration of the entity that
will control the hazards in a food and evaluation of the foreign
supplier's performance (but not evaluation of the risk posed by a food,
i.e., the hazard analysis). The applicable provisions of Sec.  1.505
are now Sec.  1.505(a)(1)(ii) through (iv), (a)(2), and (b) through (d)
rather than Sec.  1.505(a)(2) through (6) and (b). The changes that we
have made to Sec.  1.505(a) concerning the factors for the entity
controlling the hazards and foreign supplier performance, discussed in
section III.F.1 of this document, are also applicable to importers of
finished dietary supplements under Sec.  1.511(c)(1) of the final rule.
b. Corrective Actions
    Proposed Sec.  1.511(c)(1) specified that importers of finished
dietary supplements would be required to comply with the requirements
in proposed Sec.  1.507, including those concerning review of
complaints, investigations, corrective actions, and modification of the
FSVP (when necessary). As discussed in section III.I of this document,
the section of the regulation regarding corrective actions, Sec.  1.508
of the final rule, does not require importers to review complaints or
conduct investigations into possible adulteration, and includes certain
changes to the corrective action requirements. Finished dietary
supplement importers will need to comply with these final provisions of
Sec.  1.508.
c. Identification of Importer at Entry
    As discussed in section III.J of this document, we have revised the
requirements related to importer identification at entry in Sec.  1.509
of the final rule; these changes apply to the importation of finished
dietary supplements under Sec.  1.511(c)(1).
d. Recordkeeping
    As discussed in section III.K of this document, we have revised
several recordkeeping requirements in Sec.  1.510 of the final rule;
these changes apply to the importation of finished dietary supplements
under Sec.  1.511(c)(1) of the final rule.
e. Use of Approved Foreign Suppliers
    Section 1.511(c)(2) of the final rule finalizes the proposed
requirement to establish and follow written procedures to ensure the
importation of dietary supplements from approved foreign suppliers (and
in limited circumstances from unapproved suppliers) and codifies the
requirements taken from revised Sec.  1.506 that allow an entity other
than the finished dietary supplement importer's foreign supplier to
establish and follow such procedures, provided the importer reviews and
assesses the other entity's procedures and activities (see the
discussion of

these matters with respect to foods other than dietary supplements in
section III.G.1 of this document).
f. Determination of Appropriate Foreign Supplier Verification
Activities
    Section 1.511(c)(4) of the final rule finalizes the requirement (in
proposed Sec.  1.511(c)(5)) to determine appropriate foreign supplier
verification activities before importing a dietary supplement from a
foreign supplier, as well as the frequency with these activities must
be conducted. (We deleted the separate reference to the ``purpose'' of
supplier verification activities stated in proposed Sec.  1.511(c)(4)--
i.e., to provide adequate assurances that the foreign supplier is
producing the dietary supplement in accordance with processes and
procedures that provide the same level of public health protection as
those required under part 111--and added it to the provision requiring
determination of appropriate supplier verification activities (Sec.
1.511(c)(4) of the final rule).) Section 1.511(c)(4) specifies that
this determination must be based on the evaluation conducted under
Sec.  1.505, lists the possible appropriate verification activities,
and permits the importer to rely on a determination of appropriate
verification activities made by an entity other than the foreign
supplier, provided the importer reviews and assesses the entity's
determination (see the discussion of these matters with respect to
foods other than dietary supplements in section III.G.4 of this
document).
g. Performance of Foreign Supplier Verification Activities
    Section 1.511(c)(5) of the final rule finalizes the proposed
requirement to conduct verification activities for foreign suppliers of
finished dietary supplements. Among the changes to the verification
activity provisions that match changes to proposed Sec.  1.506 are the
following:
     Section 1.511(c)(5)(i)(A)(2) specifies that when the
foreign supplier of a dietary supplement is in a country whose food
safety system FDA has officially recognized as comparable or determined
to be equivalent to that of the United States, an onsite audit of the
supplier may consider the relevant laws and regulations of that country
instead of the requirements of part 111.
     Section 1.511(c)(5)(i)(A)(3) specifies that if an onsite
audit of a foreign supplier of a dietary supplement is conducted solely
to meet the FSVP supplier verification requirements by an audit agent
of a certification body accredited in accordance with FDA's regulations
on the accreditation of third-party certification bodies, the audit
itself is not subject to the requirements for audits conducted under
those regulations.
     Section 1.511(c)(5)(i)(A)(5) broadens the scope of
inspections on which an importer of a dietary supplement may rely
instead of an onsite audit of the foreign supplier to include
appropriate inspections for compliance with applicable FDA food safety
regulations conducted by FDA, representatives of other Federal agencies
(such as the USDA), and representatives of State, local, tribal, or
territorial agencies, in addition to inspections conducted by the food
safety authority of a country whose food safety system FDA has
officially recognized as comparable or determined to be equivalent to
that of the United States, provided that the inspection was conducted
within 1 year of the date that the onsite audit would have been
required to be conducted (see the discussion of these provisions with
respect to foods other than dietary supplements in section III.N of
this document).
    (Comment 277) One comment suggests that, instead of allowing an
importer to rely on the results of an inspection of a foreign supplier
conducted by FDA or the food safety authority of a country whose food
safety system FDA has officially recognized as comparable or determined
to be equivalent to that of the United States, provided that the
inspection was conducted within 1 year of the date that the onsite
audit would have been required to be conducted, the importer should be
allowed to rely on the results of such an inspection conducted within
``approximately'' 1 year of when the audit would have been required.
The comment maintains that it is not always possible to obtain audit
documentation within an annual timeframe (asserting that it might take
several weeks or more to obtain an updated certificate of compliance
following completion of an audit).
    (Response 277) We decline to make this change. We are concerned
that extending beyond 1 year the time period for which an importer
could rely on inspection results would substantially weaken the
likelihood that those results would accurately reflect the foreign
supplier's current state of compliance with applicable regulations and
therefore diminish the assurance of food safety that such inspection
results might provide.
     Section 1.511(c)(5)(i) includes other relatively minor
changes to the requirements for documentation of foreign supplier
verification activities.
     Under Sec.  1.511(c)(5)(ii) and (iii) of the final rule,
an importer of a dietary supplement may rely on supplier verification
activities conducted by an entity in its supply chain provided that it
reviews and assesses the results of those activities. However, the
importer may not rely on the foreign supplier to conduct these
activities except with respect to sampling and testing of a dietary
supplement.
h. Verification of Customers and Other Subsequent Entities
    Section 1.507 of the final rule contains provisions regarding
verification when an importer imports a food that cannot be consumed
without the hazards being controlled or for which the hazards are
controlled after importation. Section 1.511(c)(1) states that this
section does not apply to dietary supplements. This is because Sec.
1.507 is based on the hazard analysis performed by importers.
Specifically, importers can only avail themselves of the distribution
chain provisions in Sec.  1.507 if they identify the specific hazards
that require control, thus enabling them to ensure either that the food
could not be consumed without the application of an appropriate control
or that the hazard will be appropriately controlled after importation.
Because the FSVP regulation does not require hazard analysis by
importers of dietary supplements, the provisions of Sec.  1.507 are not
suitable for dietary supplements.
    (Comment 278) One comment suggests that if we do not delete the
proposed requirement to obtain written assurance from customers subject
to certain dietary supplement CGMP requirements under proposed Sec.
1.511(b), then proposed Sec.  1.511(c) should specify that the
requirements under that paragraph, rather than the standard FSVP
requirements, will apply when an importer is ``unable to obtain the
required written assurance'' from the customer.
    (Response 278) Although we agree with the comment that an importer
of a dietary supplement or dietary supplement component that fails to
obtain written assurance from its customer in accordance with Sec.
1.511(b) of the final rule would be subject to the requirements in
Sec.  1.511(c), we conclude that it is not necessary to change Sec.
1.511(c) as requested. The FSVP draft guidance will reiterate that when
a dietary supplement is imported and neither Sec.  1.511(a) nor (b) is
applicable (including because the importer elects not to annually
obtain the appropriate written assurance from its customer), the
importer must comply with Sec.  1.511(c).

3. Mixed-Use Food/Drug Ingredients
    (Comment 279) One comment asks that we exempt from the preventive
controls regulations certain ingredients that are used in the
manufacture of both food and drugs, and also asks that we establish
separate modified FSVP requirements for these ingredients. The comment
states that there are many ingredients that are used in the United
States as conventional foods, dietary supplements, and drugs, and many
ingredients that can be used as drugs in foreign countries but only as
foods in the United States. The comment maintains that if an ingredient
is made in compliance with the United States Pharmacopeia (USP)/
National Formulary (NF) or other official monographs and
internationally recognized drug CGMP standards, it would be superfluous
for the facility to be required to comply with proposed subparts B and
C of the regulation on preventive controls for human food (proposed
part 117). (The comment suggests that we include in the preventive
controls regulation a definition of ``monograph ingredient,'' defined
as an ingredient that is allowed for food use in the United States,
meets certain criteria related to compliance with certain official
monographs, and is manufactured in accordance with certain
pharmaceutical CGMP standards or guidelines.) The comment asserts that
because the construction, equipment, recordkeeping, training, and
quality control operations of an establishment making a ``monograph
ingredient'' will already be conducted in a manner that meets or
exceeds the standards for CGMP in subpart B of part 117, it would be
unnecessary to require the establishment to comply with that subpart.
The comment also asserts that hazard analysis and preventive controls
requirements in subpart C of part 117 also should not apply to
monograph ingredients because official monographs and pharmaceutical
CGMPs already provide preventive controls for harmful contaminants in
these ingredients.
    The comment also requests that we establish separate modified FSVP
requirements for monograph ingredients. These modified requirements,
which would be mandatory for monograph ingredients used as a
conventional food and optional for monograph ingredients used as a
dietary supplement or dietary supplement component, would be tailored
toward providing adequate assurances that the food is in compliance
with the applicable monograph and/or that the monograph ingredient was
produced in accordance with the requirements of the applicable
pharmaceutical CGMP standards.
    The comment asserts that requiring manufacturers of ``monograph
ingredients'' to comply with the preventive controls regulation and
failing to adopt the comment's suggested modified FSVP requirements for
these ingredients would be inconsistent with U.S. obligations under WTO
agreements. The comment also maintains that the suggested modified FSVP
provisions would be consistent with the intent of Congress because they
would help ensure that imported food is as safe as food produced in the
United States and they take into account differences among types of
imported food and their level of risk.
    (Response 279) We are not responding to the comments suggesting
revision of the proposed regulation on preventive controls for human
food as those comments are beyond the scope of this rulemaking. We
decline to establish separate FSVP requirements for ``monograph
ingredients'' as defined by the comment. We do not believe that the
proposed definition of ``monograph ingredient'' is feasible given its
references to multiple and in some cases unspecified official
monographs and CGMP standards and guidelines. In addition, because the
FSVP regulation applies to importers of food, we conclude that it would
not be appropriate to establish FSVP provisions that would require
importers of certain products to conduct activities to provide
assurances that the food is specifically in compliance with a
pharmaceutical monograph and/or that the foreign supplier was in
compliance with certain pharmaceutical CGMP requirements.
    Importers of ingredients that are dietary supplements will be
required to comply with Sec.  1.511(c) of the final rule; importers of
such ingredients that are dietary ingredients will be required to
comply with the ``standard'' FSVP requirements. However, in either
case, importers might be able to rely on records regarding conformance
to a foreign country's drug standards or compliance with a foreign
country's drug regulations if such records also contain the information
required under Sec.  1.511(c) or the standard FSVP provisions (as
applicable). Those requirements are for verification of the same level
of public health protection as required under part 111, not strict
compliance with the regulation. In our records provision in Sec.
1.510(e), we state that an importer does not need to duplicate existing
records it has (e.g., records retained to comply with other Federal,
State, or local regulations) if they contain all of the information
required by the FSVP regulation, and that an importer may supplement
any such existing records as necessary to include all of the required
information. If, as the comment states, these products are produced at
higher standards than the relevant FDA requirements, then it should not
pose a significant burden to demonstrate that the relevant FDA
standards are met using existing records.
    With respect to the comment's WTO-related assertion, we do not
agree that our WTO obligations compel us to establish special FSVP
requirements for producers of ``monograph ingredients.'' As we stated
in the preceding paragraph, the FSVP requirements are to obtain
assurances that the foreign supplier is producing food in compliance
with processes and procedures that provide the same level of public
health protection as required by the relevant FDA regulations. To the
extent that the information regarding the production of foods in
compliance with foreign pharmaceutical monograph specifications is
relevant, importers may be able to use that information.
4. Dietary Supplements Regulated in Foreign Countries as Drugs
    (Comment 280) One comment requests that we exempt from the dietary
supplement CGMP regulation and subparts B and C of the preventive
controls for human food regulation certain finished food products that
are imported as dietary supplements but regulated as drug products in
the countries in which they are manufactured. The comment also requests
that we adopt separate modified FSVP requirements for these products.
The comment proposes to call such products ``foreign registered
products,'' which it proposes to define as products that are allowed
for sale in the United States as dietary supplements and that meet the
following criteria:
     The product is manufactured in a foreign jurisdiction and
is registered as a drug product, medicine, therapeutic good, or natural
health product by the government of that jurisdiction.
     The product complies with a standard setting forth
required physical, chemical, and/or biological characteristics,
including limits on any harmful contaminants likely to occur, such as a
product registration, market authorization, or official monograph in a
national pharmacopeia, codex, or formulary.
     The product is manufactured at a facility that is
registered with FDA as a food facility and registered with the

government of the jurisdiction in which it is located, and the facility
is regularly inspected for compliance with applicable CGMP
requirements.
     The product is manufactured in accordance with one or more
of several specified drug CGMP regulations or guidelines.
    The comment states that many finished products imported into the
United States as dietary supplements are regulated as drugs in their
country of manufacture and generally must comply with an official
monograph, product registration, or market authorization that sets
forth required attributes, and must be manufactured under CGMP
requirements. The comment contends that application of parts 111 and
117 (or equivalent foreign regulations) to suppliers of foreign
registered products would pose a burden without any benefit because the
standards and CGMPs applicable to these suppliers exceed the U.S.
requirements for dietary supplements. The comment therefore maintains
that importers of such products should have the option to verify the
product against any applicable monograph, product registration, or
market authorization and/or to verify the supplier's compliance with
the applicable CGMP requirements, rather that its compliance with part
111 or 117 (or equivalent foreign regulations). The comment also asks
that importers of foreign registered products be provided the option of
complying with the FSVP requirements in proposed Sec.  1.511 or
complying with separate modified FSVP requirements tailored toward
providing adequate assurances that the food is in compliance with the
requirements of the applicable monograph, product registration, or
market authorization and/or that the supplier is producing the product
in accordance with the applicable CGMP requirements of the foreign
jurisdiction.
    The comment asserts that requiring manufacturers of ``foreign
registered products'' to comply with the dietary supplement CGMP or
preventive controls regulations, and failing to adopt the comment's
suggested modified FSVP requirements for these products, would be
inconsistent with U.S. obligations under WTO agreements. The comment
also maintains that the suggested modified FSVP provisions for foreign
registered products would be consistent with the intent of Congress
because the provisions would help ensure that imported food is as safe
as food produced in the United States and they take into account
differences among types of imported food and their level of risk.
    (Response 280) We decline to establish separate FSVP requirements
for ``foreign registered products'' as defined by the comment for the
reasons we stated in declining to adopt separate FSVP requirements for
monograph ingredients. In particular, because the FSVP regulation
applies to importers of food, we conclude that it would not be
appropriate to establish FSVP provisions requiring importers of certain
products to conduct activities to provide assurances that the food is
in compliance with the requirements of an applicable pharmaceutical
monograph, product registration, or market authorization and/or that
the supplier is producing the product in accordance with the applicable
drug CGMP requirements or guidelines. Importers of finished dietary
supplements that are used as drugs in foreign countries will be
required to comply with Sec.  1.511(c) of the final rule. However,
importers of such products might be able to rely on records of
conformance to drug standards or compliance with other drug regulations
if such records contain the information required under Sec.  1.511(c)
or the standard FSVP provisions (as applicable). In the FSVP draft
guidance, we intend to address how importers of such products might use
information related to foreign supplier compliance with drug
monographs, product registrations, market authorizations, and drug CGMP
regulations and guidelines to meet their FSVP requirements.
    For the reasons stated in our response to the comment regarding
``monograph ingredients,'' we do not agree that the failure to adopt
the suggested modified FSVP requirements for so-called ``foreign
registered products'' would be inconsistent with U.S. obligations under
WTO agreements.
5. Location of FSVP Regulations Applicable to Dietary Supplements
    In the proposed rule, we sought comment on whether we should add
the proposed foreign supplier verification requirements applicable to
dietary supplements to the regulation on dietary supplement CGMP in
part 111, rather than include them in the FSVP regulation in subpart L
of part 1.
    (Comment 281) Two comments support including the FSVP requirements
for importers of dietary supplements in the FSVP regulation because
they believe that the FSVP regulation should be comprehensive, but they
suggest that the dietary supplement CGMP regulation include a reference
to the FSVP requirements applicable to dietary supplement importers.
Two comments suggest that taking the opposite approach would facilitate
clarity and compliance with the requirements for verification of
foreign suppliers of dietary supplements.
    (Response 281) We conclude that it is appropriate to locate the
FSVP requirements applicable to importers of dietary supplements and
dietary supplement components in the FSVP regulation in part 1, subpart
L, in part because the requirements for the importation of finished
dietary supplements in Sec.  1.511(c) are very similar to the
``standard'' FSVP requirements and include cross-references to some of
those requirements. However, we are adding, to Sec.  111.5 in the
dietary supplement CGMP regulation, a statement that importers of
dietary supplements and dietary supplement components can find the FSVP
requirements in part 1, subpart L.

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

    In the proposed rule, we proposed modified FSVP requirements for
importers that are very small importers and for importers of food from
very small foreign suppliers. We proposed some changes to these
modified requirements in the Supplemental Notice. An importer following
the proposed modified requirements would still be subject to the
requirements in Sec. Sec.  1.502 (concerning the scope of an FSVP),
1.503 (concerning the use of qualified individuals), and 1.509
(concerning identification of the importer at entry), but it would not
be required to comply with the proposed requirements in Sec. Sec.
1.504 through 1.508 or Sec.  1.510. This means that very small
importers and importers obtaining food from very small foreign
suppliers would not have to meet many of the standard FSVP
requirements, including those for hazard analysis and supplier
verification.
    Under the proposed modified requirements, an importer would need to
obtain written assurance, before importing the food and at least every
2 years thereafter, that its foreign suppliers are producing food in
compliance with the processes and procedures that provide the same
level of public health protection as those required under section 418
or 419 of the FD&C Act, if either is applicable, and is producing the
food in compliance with sections 402 and 403(w) of the FD&C Act. The
written assurance would be required to include a brief description of
the processes and procedures that the foreign supplier is following to
ensure

the safety of the food. An importer would be required to promptly take
appropriate corrective actions, as necessary, maintain relevant
records, and make those records available to FDA upon request.
1. Modified Requirements for Very Small Importers and Importers of Food
From Certain Small Foreign Suppliers
    We received many comments both for and against the proposed
modified FSVP requirements for very small importers and importers of
food from very small foreign suppliers. As discussed in the following
paragraphs, we conclude that it is appropriate to include in the final
rule modified requirements for very small importers as well as for
importers of food from certain small foreign suppliers. We are making
changes to the proposed requirements in response to comments and to
align with requirements applicable to the verification of certain
suppliers of raw materials and other ingredients under the supply-chain
program provisions of the preventive controls regulations.
    (Comment 282) Some comments agree with the proposal to have
modified requirements for very small importers and importers of food
from very small foreign suppliers. The comments assert that applying
special and fewer requirements to these entities would assist small
businesses that create jobs and innovate without creating public health
concerns. These comments argue that application of the detailed and
technical requirements of the FSVP regulation would be overly
burdensome for very small businesses given the administrative and
related costs. Some comments state that FDA should recognize that the
vast majority of recent foodborne illness-related public health
incidents were caused by large U.S. companies, not small businesses or
foreign suppliers of processed food.
    Other comments object to the proposed modified requirements,
asserting that food safety risks are not limited to any particular
business size and that food produced by very small foreign suppliers or
imported by very small importers could still be high risk. Some
comments argue that no producer of food, whether foreign or domestic,
should be exempt from good food safety practices. Some comments assert
that inherent risk factors associated with smaller farms due to
economic challenges increase the likelihood of food safety compliance
problems. Some comments maintain that foods imported from very small
operations have been the source of significant illness outbreaks in the
past. One comment points to spices in particular, arguing that a single
very small supplier can have a huge negative effect on the food supply.
Another comment argues that certain microbial contamination issues in
imported food most likely would involve a very small importer or very
small supplier. Some comments contend that the costs of outbreaks,
including the costs associated with a loss of consumer confidence that
are borne by firms not responsible for the outbreak, would be greater
than the costs to very small foreign suppliers and very small importers
of complying with the full FSVP requirements. Some comments assert that
adopting FSVP requirements based on the size of the importer or foreign
supplier, rather than the hazards in the imported food, might be
inconsistent with international trade agreements.
    Some comments express concern that a significant percentage of
imported food would be eligible for the modified requirements under our
proposed definitions of very small importer and very small foreign
supplier. These comments cite the PRIA of the original proposal, which
estimated that 59 percent of processed food suppliers and 93 percent of
raw produce suppliers would fall under the very small foreign supplier
category.
    Some comments maintain that the modified requirements should only
be adopted if very small producers in the United States are treated in
the same way. Other comments state that the definitions of very small
importer and very small foreign supplier should correspond with the
definitions of similar terms in the preventive controls regulations to
align the requirements, comply with WTO obligations, and avoid
confusion.
    (Response 282) We agree with three main concerns expressed by the
comments on very small importers and importers of food from very small
suppliers. First, we recognize that some very small entities might have
great financial difficulty complying with this rule. Second, while we
recognize that small entities are not immune from food safety problems,
their operations typically involve a relatively low volume of food,
which, in most cases, should reduce consumers' exposure to, and thus
potential risk from, such food. We are not aware of data conclusively
demonstrating that small or large firms are more likely to be
responsible for foodborne illness outbreaks. Third, we agree that the
scope of any modified FSVP requirements for very small entities should
align with the scope of modified requirements under the supply-chain
program provisions of the preventive controls regulations, to the
extent appropriate and feasible.
    With respect to the comments concerning the consistency of the
modified requirements with U.S. international obligations, we believe
that the requirements are proportionate to the risk posed by food
imported by or from these smaller entities but will still provide
adequate assurances of the safety of the food, and therefore are
consistent with our international trade obligations. We also conclude
that aligning the FSVP and preventive controls regulations to the
extent feasible and appropriate regarding food from small suppliers
helps provide parity in supplier verification requirements for domestic
and foreign food producers and is therefore consistent with the
national treatment provisions in international trade agreements to
which the United States is a party.
    In response to comments, we are finalizing modified requirements
for certain very small entities, but we are changing the scope of the
entities to which the modified requirements will apply. As discussed in
section III.A.23 of this document, we have changed the definition of
very small importer to better align with the definitions of very small
business under the regulations on preventive controls for human food
and for animal food.
    In addition, we are convinced by the comments to reconsider whether
all food from ``very small foreign suppliers'' as we defined the term
in the Supplemental Notice (i.e., suppliers with less than $1 million
in annual food sales) should be eligible for modified requirements. We
agree that making a large percentage of imported produce not subject to
the full FSVP requirements by adopting such a definition would be
concerning. We also recognize that the produce safety regulation
excludes from coverage farms with $25,000 or less in annual produce
sales (while also providing for qualified exemptions in certain other
circumstances), which is clearly a lower monetary ceiling than the
proposed $1 million ceiling for very small foreign suppliers.
    In addition, we note that there is no analogous ``very small
supplier'' category in the supply-chain program provisions of the
preventive controls regulations. However, those regulations include
modified supplier verification requirements (in Sec. Sec.  117.430(c),
(d), and (e) (for human food) and 507.130(c), (d), and (e) (for animal
food)) applicable to raw materials or other ingredients from the
following suppliers (both domestic and foreign):

     Qualified facilities;
     Farms that grow produce and are not covered farms under
the produce safety regulation in accordance with Sec.  112.4(a) (the
farm has 3-year average annual produce sales of $25,000 or less) or in
accordance with Sec. Sec.  112.4(b) and 112.5 (the farm satisfies the
requirements for a qualified exemption under the produce safety
regulation and associated modified requirements in Sec.  112.6); and
     Shell egg producers not subject to part 118 because the
supplier has fewer than 3,000 laying hens.
    In each case, the underlying food safety regulations (i.e., the
regulations on preventive controls, produce safety, and the production,
storage, and transportation of shell eggs) exclude or provide modified
requirements for entities based at least in part on their size. To
verify such suppliers, the receiving facility must obtain written
assurance, at least every 2 years, of the supplier's compliance (or
acknowledgement that it is subject to the adulteration provisions of
the FD&C Act). The verification requirement varies depending on the
type of small supplier as follows:
     Written assurance from a qualified facility must attest to
the facility's compliance with applicable FDA food safety regulations
(or, when applicable, relevant laws and regulations of a country whose
food safety system FDA has officially recognized as comparable or
determined to be equivalent to that of the United States), and the
assurance must include either a brief description of the supplier's
preventive controls for a hazard or a statement that the facility is in
compliance with State, local, county, tribal, or other applicable non-
Federal food safety law, including relevant laws and regulations of
foreign countries.
     Written assurance from a farm that grows produce and is
not a covered farm in accordance with Sec.  112.4(a) or in accordance
with Sec. Sec.  112.4(b) and 112.5, or a shell egg producer with fewer
than 3,000 laying hens, must attest that the farm or shell egg producer
acknowledges that its food is subject to section 402 of the FD&C Act
(or, when applicable, relevant laws and regulations of a country whose
food safety system FDA has officially recognized as comparable or
determined to be equivalent to that of the United States).
    In addition to these modified requirements for supplier
verification activities, receiving facilities obtaining raw materials
or other ingredients from these small suppliers are subject to other
modified supply-chain program requirements. Rather than having to
conduct a full review of a supplier's performance in accordance with
Sec.  117.410(d)(1)(iii) or Sec.  507.110(d)(1)(iii), these receiving
facilities need only consider the small supplier's compliance history
under Sec.  117.410(d)(1)(iii)(B) or Sec.  507.110(d)(1)(iii)(B).
However, these receiving facilities still must approve these suppliers
and include them in the procedures the receiving facilities establish
and follow to ensure that they obtain raw materials and other
ingredients from approved suppliers (see Sec. Sec.  117.420 and
507.120).
    We conclude that the FSVP regulation should include analogous
modified requirements for food imported from these same types of small
suppliers. (In Sec.  1.506(d)(4) of the proposed rule as revised by the
Supplemental Notice, we had already proposed parallel provisions for
food from certain small farms; we respond to comments on proposed Sec.
1.506(d)(4) later in this section of the document.) Therefore, under
Sec.  1.512(a)(2) of the final rule, the FSVP regulation includes
modified requirements for importers of food from the following small
foreign suppliers:
     Qualified facilities under the regulations on preventive
controls for human food or for animal food (Sec.  117.3 or Sec.  507.3,
respectively);
     Farms that grow produce and are not covered farms under
the produce safety regulation in accordance with Sec.  112.4(a) (the
farm has 3-year average annual sales of $25,000 or less), or in
accordance with Sec. Sec.  112.4(b) and 112.5 (the farm satisfies the
requirements for a qualified exemption under the produce safety
regulation and associated modified requirements in Sec.  112.6); and
     Shell egg producers that are not subject to part 118
because they have fewer than 3,000 laying hens.
    For both human food (under Sec.  117.3) and animal food (under
Sec.  507.3), a qualified facility is (when including the sales by any
subsidiary; affiliate; or subsidiaries or affiliates, collectively, of
any entity of which the facility is a subsidiary or affiliate) a
facility that is a ``very small business,'' or a facility to which both
of the following apply:
    1. During the 3-year period preceding the applicable calendar year,
the average annual monetary value of the food manufactured, processed,
packed, or held at such facility that is sold directly to qualified
end-users during such period exceeded the average annual monetary value
of the food sold by such facility to all other purchasers; and
    2. The average annual monetary value of all food sold during the 3-
year period preceding the applicable calendar year was less than
$500,000, adjusted for inflation.
    For human food, under Sec.  117.3, a very small business is a
business (including any subsidiaries and affiliates) averaging less
than $1,000,000, adjusted for inflation, per year, during the 3-year
period preceding the applicable calendar year in sales of human food
plus the market value of human food manufactured, processed, packed, or
held without sale (e.g., held for a fee). For animal food, under Sec.
507.3, a very small business is a business (including any subsidiaries
and affiliates) averaging less than $2,500,000, adjusted for inflation,
per year, during the 3-year period preceding the applicable calendar
year in sales of animal food plus the market value of animal food
manufactured, processed, packed, or held without sale (e.g., held for a
fee or supplied to a farm without sale). More information about
qualified facilities and very small businesses appears in the
preventive controls final rules.
    For produce, produce farms that are not ``covered farms'' under
Sec.  112.4 of the forthcoming produce safety rule have less than
$25,000 in annual sales averaged over the previous 3-year period, or
satisfy the requirements for a qualified exemption in Sec.  112.5 and
associated modified requirements in Sec.  112.6, based on average
monetary value of all food sold (less than $500,000) and direct farm
marketing (during the previous 3-year period, the average annual
monetary value of food sold directly to qualified end users exceeded
the average annual monetary value of the food sold to all other
buyers). In the Supplemental Notice, we erroneously referred to these
farms as farms ``not subject to the requirements in part 112.'' While
produce farms that make less than $25,000 annually are not subject to
the requirements in part 112, produce farms that satisfy the
requirements for a qualified exemption are not subject to the full
requirements of part 112, but they do have certain modified
requirements that they must meet, as described in Sec.  112.6. In the
Supplemental Notice we further erroneously described the types of farms
that are not subject to the requirements in part 112 under Sec.  112.4
as including farms that do not grow and harvest ``produce'' and certain
farms that grow and harvest produce that is not covered under the
proposed produce safety regulation (i.e., produce that is rarely
consumed raw and produce for personal consumption or consumption on the
farm). Although the produce rule does not apply to food from such
farms, Sec.  112.4 does not establish this. Rather, Sec. Sec.  112.3
and 112.2 of the produce safety

final rule define what constitutes produce and specify what produce is
not covered by part 112, respectively.
    For shell eggs, we considered the regulations on production,
storage, and transportation of shell eggs in part 118. Section 118.1(a)
states that the regulations in part 118 apply only to shell egg
producers with 3,000 or more laying hens at a particular farm that do
not sell all of their eggs directly to consumers and that produce shell
eggs for the table market. Therefore, any shell egg producer with fewer
than 3,000 laying hens is not subject to the requirements in part 118.
The reasoning behind this cutoff, that producers with fewer than 3,000
layers do not contribute significantly to the table egg market (see the
final rule on the production, storage, and transportation of shell
eggs, 74 FR 33030 at 33036, July 9, 2009), is consistent with our basis
for establishing modified requirements when suppliers are farms that
are not covered farms under the produce safety regulation or qualified
facilities under the preventive controls regulations. As a result, we
are including shell egg producers with fewer than 3,000 laying hens
among the small foreign suppliers from which an importer could import
food subject to the modified requirements in Sec.  1.512.
    As with the importation of food by very small importers, we
conclude that modified FSVP requirements are appropriate for the
importation of food from these small foreign suppliers because they
provide a relatively low volume of food imported into the United
States, resulting in less consumer exposure and potential risk. To
align the FSVP regulation with the supply-chain program provisions of
the preventive controls regulations, the modified requirements in Sec.
1.512 include certain different requirements for importers of food from
the specified small foreign suppliers compared to the requirements for
very small importers.
    One such difference concerns the applicable standard of compliance
for written assurance from the foreign supplier. Under Sec.
1.512(b)(3)(i) of the final rule, a very small importer must obtain
written assurance, before importing a food and at least every 2 years
thereafter, that its foreign supplier is producing the food in
compliance with processes and procedures that provide the same level of
public health protection as those required under section 418 or 419 of
the FD&C Act, if either is applicable, and implementing regulations,
and is producing the food in compliance with sections 402 and 403(w)
(if applicable) of the FD&C Act. However, consistent with the analogous
requirements in the supply-chain program provisions of the preventive
controls regulations, importers of food from small foreign suppliers
must obtain written assurances as follows:
     If the foreign supplier is a qualified facility as defined
by Sec.  117.3 or Sec.  503, the written assurance must attest that the
foreign supplier is producing the food in compliance with applicable
FDA food safety regulations (or, when applicable, relevant laws and
regulations of a country whose food safety system FDA has officially
recognized as comparable or determined to be equivalent to that of the
United States). The written assurance must include either (1) a brief
description of the preventive controls that the supplier is
implementing to control the applicable hazard in the food or (2) a
statement that the supplier is in compliance with State, local, county,
tribal or other applicable non-Federal food safety law, including
relevant laws and regulations of foreign countries (Sec.
1.512(b)(3)(ii)).
     If the foreign supplier is a farm that grows produce and
is not a covered farm under part 112 in accordance with Sec.  112.4(a),
or in accordance with Sec. Sec.  112.4(b) and 112.5, the written
assurance must attest that the farm acknowledges that its food is
subject to section 402 of the FD&C Act (or, when applicable, that its
food is subject to relevant laws and regulations of a country whose
food safety system FDA has officially recognized as comparable or
determined to be equivalent to that of the United States) (Sec.
1.512(b)(3)(iii)).
     If the foreign supplier is a shell egg producer that is
not subject to the requirements of part 118 because it has fewer than
3,000 laying hens, the written assurance must attest that the shell egg
producer acknowledges that its food is subject to section 402 of the
FD&C Act (or, when applicable, that its food is subject to relevant
laws and regulations of a country whose food safety system FDA has
officially recognized as comparable or determined to be equivalent to
that of the United States) (Sec.  1.512(b)(3)(iv)).
    We believe that these requirements for supplier verification
appropriately reflect the laws and regulations applicable to the
relevant type of foreign supplier in the different circumstances, such
that the specified foreign suppliers need only provide assurances that
their food is in compliance with, or is subject to, applicable food
safety requirements. With respect to the written assurances from
certain farms that are not covered farms (as specified in Sec.
1.512(b)(3(iii)) and shell egg producers with fewer than 3,000 laying
hens, we believe that the acknowledgement that the producer's food is
subject to the adulteration provisions of the FD&C Act (or, when
applicable, that its food is subject to relevant laws and regulations
of a country whose food safety system FDA has officially recognized as
comparable or determined to be equivalent to that of the United States)
provides adequate and proportional assurance of safety given the lower
risk to U.S. consumers posed by the lesser volume of food from such
suppliers. Any business that introduces food into interstate commerce,
including these small suppliers, is subject to the prohibited acts
provisions in section 301 of the FD&C Act and is accountable if it
produces food that is adulterated under section 402. We therefore
conclude that the written assurances required from such suppliers
provide adequate assurance of safety while minimizing the burden that
providing the assurances to importers may indirectly impose on these
suppliers.
    Consistent with these requirements, we have correspondingly revised
the requirement (Sec.  1.512(b)(4) of the final rule) for a very small
importer or importer of food from one of the specified types of small
foreign suppliers to take corrective actions if the foreign supplier
does not produce the food in accordance with the applicable standards
just discussed to make clear that corrective action is only required if
an importer determines that the foreign supplier of the imported food
does not produce the food consistent with the assurance provided under
Sec.  1.512(b)(3)(i) through (iv).
    Paragraph (c) of Sec.  1.512 of the final rule sets forth certain
requirements that apply to importers of food from the specified small
foreign suppliers but not to very small importers. We believe that
these provisions provide an additional level of food safety assurance
that should be part of the standard operations for most food importers,
except for very small importers. This approach to FSVP requirements for
importers of food from certain small suppliers is consistent with the
supply-chain requirements applicable to receiving facilities that
obtain raw materials or other ingredients from these types of suppliers
under the preventive controls regulations.
    Section 1.512(c)(1)(i) requires that in approving foreign
suppliers, importers of food from the specified small foreign suppliers
must conduct (and document) a limited evaluation of a potential foreign
supplier by considering the applicable FDA food safety regulations and
information relevant to the foreign supplier's compliance with those

regulations, including whether the foreign supplier is the subject of
an FDA warning letter, import alert, or other FDA compliance action
related to food safety. Section 1.512(c)(1)(i) also states that the
importer may also consider other factors relevant to a foreign
supplier's performance, including those specified in Sec.
1.505(a)(1)(iii)(A) and (a)(1)(iii)(C) (i.e., a foreign supplier's food
safety processes, procedures, and practices and its food safety
history).
    Section 1.512(c)(1)(ii)(A) requires the importer to promptly
reevaluate the concerns associated with the foreign supplier's
compliance history when the importer becomes aware of new information
about the supplier's compliance history and to document the
reevaluation. If the importer determines as a result of the
reevaluation that the concerns associated with importing a food from a
foreign supplier have changed, the importer must promptly determine
(and document) whether it is appropriate to continue to import the food
from the foreign supplier. However, Sec.  1.512(c)(1)(ii)(B) requires
that if, at the end of any 3-year period, an importer has not
reevaluated the concerns associated with the foreign supplier's
compliance history, the importer must reevaluate those concerns and
take other appropriate actions, if necessary, and document the
reevaluation and any subsequent actions taken.
    The potential burden of reviewing a small foreign supplier's
compliance history may be reduced because the regulation permits the
importer to review another entity's evaluation or reevaluation of a
foreign supplier's compliance history. Under Sec.  1.512(c)(1)(iii) of
the final rule, if another entity (other than the foreign supplier)
has, using a qualified individual, performed the supplier compliance
evaluation or the reevaluation, the importer may meet its requirements
by reviewing and assessing the evaluation or reevaluation conducted by
that entity. If an importer chooses to do this, it must document its
review and assessment, including documenting that the evaluation or
reevaluation was conducted by a qualified individual.
    Under Sec.  1.512(c)(2) of the final rule, importers of food from
certain small foreign suppliers must approve these suppliers on the
basis of the compliance history evaluation the importer either conducts
or reviews and assesses, and the importer must document the approval.
    Finally, Sec.  1.512(c)(3)(i) requires these importers of food from
certain small foreign suppliers to establish and follow written
procedures to ensure that they import foods only from foreign suppliers
approved based on the compliance history evaluation (or, when necessary
and appropriate, on a temporary basis from unapproved foreign suppliers
whose foods the importer subjects to adequate verification activities
before importing the food). The importer must document its use of these
procedures. However, under Sec.  1.512(c)(3)(ii), the importer may rely
on another entity (other than its foreign supplier) to establish these
procedures and perform and document the required activities, provided
that the importer reviews and assesses that entity's documentation of
the procedures and activities, and the importer documents its review
and assessment.
    Having discussed the principal changes the final rule makes to the
proposed modified requirements for very small importers and importers
of food from very small foreign suppliers, in the following paragraphs
we respond to comments on various aspects of the proposed requirements
and, in doing so, note other changes included in the final rule.
a. Comments Regarding the Proposed Modified Verification Requirements
for Certain Farms
    (Comment 283) Some comments state that the produce safety
regulation excludes farms with annual sales of $25,000 or less but the
FSVP regulation does not include an analogous exclusion. The comments
ask that we delete the exclusion from the produce safety regulation
because they believe that mandating importers to hold foreign
operations to standards that domestic operations are not required to
meet would invite a WTO challenge.
    (Response 283) As previously stated, importers obtaining produce
from farms with annual sales of $25,000 or less are subject to modified
requirements under the FSVP regulation. While these requirements do not
constitute an exclusion from FSVP, they significantly decrease the
burden of the regulation for these importers. Because farms with
$25,000 or less in annual sales are not subject to the produce safety
regulation, the modified requirements do not mandate that an importer
of produce from such a farm obtain assurance that the farm is in
compliance with section 419 of the FD&C Act, as the produce safety
regulation would not apply.
    In addition, we have aligned the supplier verification provisions
in the FSVP regulation with the supply-chain program provisions of the
preventive controls regulations, to the extent appropriate and
feasible, including the eligibility criteria for the modified
requirements for produce imported from suppliers that are farms that
are not covered farms under the produce safety regulation in accordance
with Sec.  112.4(a) or in accordance with Sec. Sec.  112.4(b) and
112.5. Therefore, receiving facilities subject to the preventive
controls regulations that obtain produce from domestic farms are not
subject to less burdensome supplier verification requirements for that
produce than importers importing produce from foreign farms.
    (Comment 284) One comment suggests that we not provide modified
requirements for certain farm suppliers and delete proposed Sec.
1.506(d)(4) because modified requirements would not give importers the
tools they need to assure that they are addressing safety issues with
food from such farms. On the other hand, one comment asks that we apply
the proposed modified requirements to all farms that are not subject to
the produce safety regulations.
    (Response 284) We stated in the preamble to the Supplemental Notice
that proposed Sec.  1.506(d)(4) would have provided modified
verification requirements with respect to food from the following:
     Farms that grow or harvest crops such as grains that are
not ``produce,'' as defined in Sec.  112.3(c) of the proposed produce
safety regulation.
     Farms that grow and harvest produce that is not covered by
the proposed produce safety regulation in accordance with proposed
Sec.  112.1. Such ``non-covered produce'' includes produce that is
rarely consumed raw, produce that is produced for personal consumption
or for consumption on the farm or another farm under the same
ownership.
     Farms that are not ``covered farms'' because they produce
an average annual monetary value of produce of no more than $25,000.
     Farms that are not covered farms because they satisfy the
requirements for a qualified exemption from the proposed produce safety
regulation under proposed Sec.  112.5 and the exemption has not been
withdrawn.
    Although Sec.  1.512 of the final rule provides modified
verification requirements for the latter two types of farms, it does
not provide modified verification requirements for the former two types
of farms. That is, final Sec.  1.512 does not provide modified
verification requirements for farms that grow and harvest crops such as
grains that are not ``produce'' as defined in proposed Sec.  112.3(c),
and does not provide

modified requirements for farms that grow or harvest produce that is
not covered by the proposed produce safety regulation in accordance
with proposed Sec.  112.1 (e.g., because such produce is rarely
consumed raw or is produced for personal or on-farm consumption). We
believe that this approach is appropriate.
    With respect to crops such as grains that are not ``produce'' as
defined in the produce safety regulation (and thus are not subject to
the regulation), much of this imported food likely will not be consumed
without processing that provides for the application of an appropriate
kill step or control. Rather than provide for modified verification
requirements for such food under Sec.  1.512, we think it is more
appropriate to allow importers to rely on the provisions of Sec.  1.507
discussed in section III.H of this document, as applicable. Under those
provisions, if the hazards have not been significantly minimized or
prevented before importation, an importer may determine and document
that the food could not be consumed without application of an
appropriate control (e.g., cooking or other treatment of the food for
grains for human consumption) or could obtain assurances from its
customer that the customer or a subsequent entity in the distribution
chain will process the food for food safety. This approach allows the
hazard control to be applied after importation while also providing the
importer with flexibility as to which entity will apply the appropriate
control. In addition, importers of some grains may appropriately
determine through their hazard analysis that there are no hazards
requiring control. In such cases, the importer would document that
determination in its written hazard analysis but would not be required
to conduct an evaluation for foreign supplier approval and verification
under Sec.  1.505 and would not be required to conduct foreign supplier
verification activities under Sec.  1.506. Importers of other grains
might determine that the only way to ensure that identified hazards are
significantly minimized or prevented would be to conduct verification
activities in accordance with Sec.  1.506.
    For similar reasons, the final rule requires importers of produce
rarely consumed raw to comply with the provisions in Sec. Sec.  1.505,
1.506, and 1.507, as applicable, instead of providing modified
provisions for such produce. For some produce rarely consumed raw, an
importer might determine it is appropriate to conduct supplier
verification activities to ensure that hazards in the food have been
significantly minimized or prevented before importation. For other
produce in this category, we believe that the requirements in Sec.
1.507 are suitable to ensuring the safety of such produce because the
food will be subject to the application of a control after importation,
and Sec.  1.507 provides flexibility as to which entity will apply the
control. With respect to produce for personal or on-farm consumption,
this produce would either never be exported to the United States
(because it is consumed on the farm) or could be eligible for the
personal consumption exemption from the FSVP regulation under Sec.
1.501(d). We therefore do not see any need to establish modified
requirements applicable to this category.
    We are not certain whether the comment requesting that the modified
requirements apply to all farms not subject to the produce safety
regulation contemplates any other food or farms being subject to the
modified verification requirements in Sec.  1.512. To the extent that
the comment requests that food produced by such operations as dairy
farms be covered by the modified requirements in Sec.  1.512, we do not
agree. Safety problems may arise in food produced by such operations.
Providing modified requirements for such operations would increase the
volume of imported food subject to modified requirements, and would
therefore also increase consumers' risk of exposure to such food.
Consistent with Congress' intent that we implement the FSVP
requirements based on the level of risk posed by the imported food (see
section 805(c)(3) of the FD&C Act), we believe it is appropriate that
importers of food from such farms be subject to the standard supplier
verification requirements. Indeed, we have designed the modified
verification requirements in Sec.  1.512 so they apply only to
operations that expose consumers to less risk because the operations
export a relatively small volume of food to the United States. We also
believe that our treatment of produce and food from other farms not
subject to the produce safety regulation is consistent with the
coverage of the supply-chain program provisions in the preventive
controls regulations.
    In the context of the nature of the imports for which we are
providing modified verification requirements in Sec.  1.512, we
continue to believe that the modified requirements would be adequate to
provide assurances from these particular suppliers that the food is
produced in compliance with the applicable standards in this rule. In
addition, the foods covered by the modified requirements in Sec.  1.512
are and will continue to be covered under the adulteration provisions
of the FD&C Act and applicable implementing regulations, irrespective
of the modified verification requirements under the FSVP regulation.
    (Comment 285) Several comments request that importers not be
required to obtain written assurance of compliance with the FD&C Act
from the farms specified in proposed Sec.  1.506(d)(4). The comments
assert that obtaining written assurance would be unnecessary or
inappropriate because FDA has already determined that these foods are
of minimal or no risk. The comments also state that, with respect to a
RAC that is not subject to the produce safety regulations, the importer
might not know the identity of the farmer who grows the RAC (e.g., RACs
that are consolidated before export to the United States).
    (Response 285) As stated previously, the fact that we are allowing
importers to obtain written assurance, instead of requiring importers
to determine and conduct what might be more burdensome supplier
verification activities, reflects our view of the risk to public health
attributable to produce from these farms. To the extent that the
comments believe that requiring assurances is inconsistent with the
risk to public health posed by these suppliers, we disagree. Obtaining
assurances is an appropriate verification activity because it requires
importers to obtain from suppliers information about the safety of the
imported food. For produce RACs consolidated before export to the
United States from farms described in Sec.  1.512(a)(2)(ii) of the
final rule, the regulation does not prohibit an importer from enlisting
the consolidator to help obtain the necessary written assurances.
    (Comment 286) One comment contends that obtaining written
assurances from grain farmers is not feasible because FDA has not
established safety standards for grain.
    (Response 286) As finalized and as previously discussed, Sec.
1.512 does not establish any modified requirements specific to the
importation of grain. However, we expect that the risk-based framework
of this rule will still generally result in a relatively low
verification burden for the importation of grain. As described in the
previous paragraphs, importers may be able to take advantage of the
flexibility in Sec.  1.507 for imported grains for which hazards will
be controlled after importation.

b. Other Comments Related to the Appropriateness or Implementation of
Modified Provisions for Small Entities
    (Comment 287) Some comments assert that Congress did not provide an
exemption for very small importers and food from very small foreign
suppliers and FDA should not create one.
    (Response 287) As discussed in the proposed rule, section 805(c)(3)
of the FD&C Act directed FDA to, as appropriate, take into account
differences among importers and types of imported food, including based
on the level of risk posed by the imported food. We have not created an
exemption from the FSVP regulation for very small importers or very
small foreign suppliers. Instead, as discussed previously, we are
adopting modified requirements that generally apply to situations that
involve a relatively low volume of imported food, which should reduce
consumers' exposure to, and thus potential risk from, the food (see 78
FR 45730 at 45765). We think this approach is commensurate with the
risk to public health posed by these importers and suppliers,
consistent with section 805(c)(3), because the food affected by these
provisions constitutes a relatively low volume of imported food, which
should reduce the risk to consumers posed by this food.
    (Comment 288) Some comments agree with the idea of having modified
requirements for very small importers and very small foreign suppliers,
but state that the modified requirements should be different from what
we proposed. Some comments maintain that we should require a third-
party audit by a qualified individual for very small importers and
importers of food from very small foreign suppliers. Some comments
argue that these importers should be subject to the full requirements
of the FSVP regulation, but that we should address the challenges for
these entities in complying by giving them additional time to comply.
    (Response 288) Although an importer may determine that a third-
party audit is the most appropriate verification activity for a given
food and foreign supplier, the FSVP regulation does not mandate a
third-party audit of a foreign supplier for any imported food. We do
not see the logic in creating more stringent requirements for very
small importers and importers of food from small suppliers than for all
other importers subject to the FSVP regulations.
    (Comment 289) Some comments support modified requirements for very
small foreign suppliers but state that importers' requirements should
be the same regardless of the size of the importer or its supplier.
    (Response 289) The FSVP regulations apply to importers; they do not
impose direct requirements on foreign suppliers. The size of the
importer is relevant to its ability to comply with the FSVP
requirements and to the volume of food imported by the importer (and
thus consumers' exposure to the food). We therefore believe it is
appropriate to adopt modified requirements for very small importers.
    (Comment 290) Some comments state that very small foreign suppliers
may already be exempt from the preventive controls or produce safety
regulations and do not need a duplicative exemption from importers'
verification requirements.
    (Response 290) We did not propose and are not finalizing an
exemption for food from qualified facilities or certain small farms. We
are establishing modified, risk-based verification requirements for
importers of such food.
    (Comment 291) Some comments express concern that these provisions
will allow businesses to alter their structures to ensure that the
imported food is exempt from the regulation. Some comments assert that
businesses would assign the FSVP importer responsibility to the entity
most likely to be exempt. Comments also maintain that large exporters
of food to the United States might break shipments into smaller units
to avoid application of the full FSVP requirements.
    (Response 291) While this rule does not prevent various business
arrangements from developing, we do not believe that it would be cost-
effective for an importer to alter its entire supply chain to only
import food from many small facilities or farms to meet its needs
instead of from its usual large suppliers. We understand that many
large importers that import food from large suppliers are already
performing supplier verification activities of some kind. We believe
they are much more likely to simply modify their current practices, if
such modification is needed, rather than adopt entirely new supply
structures to evade application of the full requirements of the rule.
    We do not agree that large exporters of food to the United States
are likely to break shipments into smaller units to avoid the full FSVP
requirements. An importer of food from a large exporter would not be
eligible for modified requirements just because the particular shipment
the importer received happened to be small. To make its products
eligible for application of the modified requirements, an exporter
would have to divide itself into smaller, distinct businesses, which
could create significant costs for the underlying business.
    (Comment 292) Some comments assert that if FDA believes the
modified requirements are sufficient, those requirements should apply
to all importers regardless of size.
    (Response 292) As previously stated, FSMA directed FDA to, as
appropriate, take into account differences among importers and types of
imported food, including based on the level of risk posed by the
imported food. The modified requirements are designed to specify
verification activities that take into account the risk to overall
public health posed by the low volume of food from these entities
imported into the United States. The modified requirements would not be
appropriate for all importers regardless of risk.
    (Comment 293) Some comments express concern that eligibility
reporting and verification activities will create additional work for
FDA. They assert that verification of sales data might be possible for
importers through interagency cooperation with the Internal Revenue
Service but not for foreign suppliers. The comments maintain that
without verification, importers might fraudulently document that an
entity meets the very small foreign supplier definition as well as
assurances of compliance.
    (Response 293) When we review records of importers who are
following modified requirements in accordance with Sec.  1.512, we will
expect to review documentation supporting their determination that the
food they import is eligible for the modified requirements. Importers
should expect that we will use information available to us to verify
the truthfulness and accuracy of this information. Falsely reporting
eligibility criteria to FDA could subject importers to penalties under
18 U.S.C. 1001.
    (Comment 294) Some comments ask what course of action FDA would
have in the event of a foodborne illness outbreak if an outbreak is
traced back to a very small foreign supplier or food imported by a very
small importer.
    (Response 294) If a foodborne illness outbreak is traced back to
food subject to modified requirements under the FSVP regulation, we
will be able to use our enforcement tools to address the issue in the
same manner as we would with importers subject to the ``standard'' FSVP
requirements, including, if appropriate, placing the foreign supplier
or importer on import alert.

    (Comment 295) Some comments state that the modified requirements do
not solve the problems associated with having to verify thousands of
farms, including maintaining a list of approved suppliers, conducting
compliance status reviews, and documenting the entities' eligibility
for the modified requirements. Some comments question whether
compliance status review for thousands of small farms that do not
directly sell food to the United States is a good use of resources.
    (Response 295) The final modified requirements do not include
maintaining a list of approved suppliers; they do include documenting
eligibility for the modified requirements and, for importers of food
from the specified small foreign suppliers, evaluating their potential
suppliers' compliance history. If an importer wants to follow the
modified requirements, it must make a determination about its
eligibility through reviewing its own annual sales information or
obtaining written assurance from a foreign supplier. Maintaining the
record of that determination allows the importer to show that it meets
the eligibility criteria and enables us to verify the importer's
eligibility.
    Regarding the comments on compliance status review, Sec.  1.512 of
the final rule does not require very small importers to conduct a
compliance status review of potential foreign suppliers, as we had
originally proposed. As previously discussed, Sec.  1.512(c)(1) does
require importers of food from certain small foreign suppliers to
evaluate their foreign suppliers' compliance history. With respect to
produce imported from a farm that grows produce and is not a covered
farm in accordance with Sec.  112.4(a) or in accordance with Sec. Sec.
112.4(b) and 112.5, under Sec.  1.512(c)(1)(iii), an importer of such
produce could rely on another entity (other than the foreign supplier)
to evaluate the compliance history of a potential foreign supplier.
2. Provisions of the Modified Requirements for Very Small Importers and
Importers of Food From Certain Small Suppliers
    Some comments address particular aspects of the proposed modified
requirements for very small importers and importers of food from very
small foreign suppliers. We respond to these concerns in the following
paragraphs.
a. Calculating Eligibility
    Under proposed Sec.  1.512(b)(1), an importer seeking to import
food under the modified requirements would have to document, at the end
of each calendar year, that it meets the definition of ``very small
importer'' in Sec.  1.500 or that the foreign supplier meets the
definition of ``very small foreign supplier'' in Sec.  1.500. For the
purpose of determining whether the definitions were satisfied, the
baseline year for calculating the adjustment for inflation would be
2012. Proposed Sec.  1.512(b)(1) further states that if the importer or
foreign supplier conducts food sales in currency other than U.S.
dollars, the importer would have to use the relevant currency exchange
rate in effect on December 31 of the year in which sales occurred to
calculate the value of these sales.
    The final rule includes changes to Sec.  1.512(b)(1) to clarify how
importers must determine their eligibility for the modified provisions
for very small importers and importers of food from certain small
foreign suppliers. To import food as a very small importer, an importer
must document its eligibility as a ``very small importer'' (as defined
in Sec.  1.500) with respect to human food and/or animal food before
initially importing food and thereafter on an annual basis by December
31 of each calendar year (Sec.  1.512(b)(1)(i)(A)). For the purpose of
determining whether the importer satisfies the definition of very small
importer with respect to human food and/or animal food for a given
calendar year, the relevant 3-year period of sales (and U.S. market
value of human or animal food, as appropriate) is the period ending 1
year before the calendar year for which the importer intends to import
food as a very small importer (Sec.  1.512(b)(1)(i)(B)). To align the
very small importer requirements with the requirements for qualified
facilities in the preventive controls regulations, the baseline year
for calculating the adjustment for inflation is 2011 rather than 2012
as proposed. If the importer conducts any food sales in currency other
than U.S. dollars, it must use the relevant currency exchange rate in
effect on December 31 of the year in which sales occurred to calculate
the value of these sales.
    To import food under the modified provisions for food from small
foreign suppliers, an importer must obtain written assurance that its
foreign supplier meets the criteria for one of the types of small
suppliers in Sec.  1.512(a)(2)(i), (ii), or (iii) before first
approving the supplier for an applicable calendar year and thereafter
on an annual basis by December 31 of each calendar year, for the
following calendar year.
    (Comment 296) One comment seeks clarification as to who will
determine the monetary value of an importer and how such criteria will
be enforceable.
    (Response 296) Under Sec.  1.512(b)(1)(i) of the final rule, the
importer itself must determine the dollar amount of its sales of human
or animal food and the market value of any human or animal food
imported, manufactured, processed, packed, or held without sale.
Importers must retain documentation of eligibility for the modified
requirements and make it available for FDA review.
b. Written Assurances
    We proposed (in Sec.  1.512(b)(3)) that an importer seeking to
import food under the modified requirements be required to obtain
written assurance, before importing a food and at least every 2 years
thereafter, that the foreign supplier is producing food in compliance
with processes and procedures that provide the same level of public
health protection as those required under section 418 or 419 of the
FD&C Act, if either is applicable, and is producing the food in
compliance with sections 402 and 403(w) of the FD&C Act. The written
assurance would have to include a brief description of the processes
and procedures that the foreign supplier is following to ensure the
safety of the food.
    As previously discussed, the final rule contains revised written
assurance requirements for very small importers and importers of food
from certain small foreign suppliers.
    (Comment 297) Some comments agree with the proposed requirement to
obtain written assurances from foreign suppliers. Other comments argue
that we should allow greater flexibility by allowing a very small
supplier to provide records, like a commercial invoice, a certification
of safety by the supplier's regulatory authority, a HACCP plan/
certification, or a private certification, to meet the verification
requirements. These comments also state that if a food is specifically
named as high risk by FDA, or food from the foreign supplier was
rejected twice at the border for its food safety performance, then
additional proof of safety could be demanded according to FDA guidance
developed in consultation with small food companies.
    (Response 297) We believe that the requirement to obtain written
assurances from foreign suppliers will not be more burdensome than
obtaining records from those suppliers. Recognizing the variety of
business practices that currently produce safe food, the final rule
provides a significant amount of flexibility concerning the form of
written assurances. The modified requirements do not specify the
particular form of

documentation that must be used as written assurance for FSVP purposes.
Some records suggested by the comments, such as a certification of
safety by a supplier's regulatory authority or a private certification,
might be sufficient for written assurance purposes if they satisfy the
applicable requirements for written assurance in Sec.  1.512(b)(3).
However, for food from qualified facilities, the written assurance must
include the information required by Sec.  1.512(b)(3)(ii).
    We believe that basing supplier verification requirements for a
particular food on whether it had been refused admission, as suggested
by some comments, would be too administratively burdensome for both
importers and the Agency. As to the issue of basing the level of
supplier verification on whether a food is high risk, we generally
agree that supplier verification should be risk-based and this rule
applies a risk-based framework. In general, the rule allows importers
to tailor the supplier verification activities they conduct based on
the hazards applicable to the food and the characteristics of the
supplier. For very small importers, however, we believe that the
modified requirements, including the requirement to obtain supplier
assurances, are appropriate given the reduced risk to consumers posed
by the relatively low volume of food imported by these firms.
c. Corrective Actions
    We proposed (in Sec.  1.512(b)(4)) that very small importers be
required to promptly take corrective actions if they determine that a
foreign supplier of food they import does not produce the food in
compliance with processes and procedures that provide the same level of
public health protection as those required under section 418 or 419 of
the FD&C Act, if either is applicable, or produces food that is
adulterated under section 402 or misbranded under section 403(w) of the
FD&C Act. The appropriate corrective actions would depend on the
circumstances but could include discontinuing use of the foreign
supplier until the cause or causes of non-compliance, adulteration, or
misbranding have been adequately addressed. We further proposed that
importers be required to document any corrective actions they take to
meet this requirement.
    We have revised the corrective action requirements in Sec.
1.512(b)(4) to reflect the revised requirements for written assurances
for very small importers and importers of food from certain small
foreign suppliers by specifying that appropriate corrective actions
would be required if the importer determines that its foreign supplier
does not produce food consistent with the assurance provided in
accordance with Sec.  1.512(b)(3).
    (Comment 298) Some comments ask that the provision be revised to
specify that corrective actions are only necessary when non-compliance
causes a risk to public health. The comments assert that this would be
consistent with FDA's statement in the preamble to the proposed rule
that regulations should focus on foreseeable food safety risks
identified through a hazard assessment process, rather than all risks
covered by the adulteration provisions in section 402 of the FD&C Act.
    (Response 298) For the reasons stated with respect to the
corrective action provisions in Sec.  1.508 of the final rule (see
section III.I.4 of this document), we disagree that corrective actions
are only necessary when non-compliance causes a risk to public health.
d. Records
    We proposed certain requirements (in Sec.  1.512(b)(5)) related to
the availability, quality, and retention of records of activities under
the modified requirements for very small importers and importers of
food from very small foreign suppliers. We proposed to require
importers to maintain records, in English, and to make them available
promptly to an authorized FDA representative, upon request, for
inspection and copying. We also proposed that importers be required to
maintain records at their places of business or at a reasonably
accessible location; records would be considered to be at a reasonably
accessible location if they could be immediately retrieved from another
location by computer or other electronic means.
    The final rule includes several changes to the proposed
requirements to align the recordkeeping requirements in Sec.
1.512(b)(5) of the final rule with the changed recordkeeping
requirements in Sec.  1.510 (discussed in section III.K of this
document) as well as for consistency with the supply-chain program
provisions in the preventive controls regulations. Section
1.512(b)(5)(ii)(A) of the final rule does not require that records be
maintained in English. Instead, upon FDA request, importers must
provide within a reasonable time an English translation of records
maintained in a language other than English.
    The record retention provisions in Sec.  1.512(b)(5)(iii) require
importers to retain records for at least 2 years after records are
created or obtained. However, records of importers who obtain food from
certain small foreign suppliers that relate to the importers' processes
and procedures (e.g., evaluations of supplier compliance history under
Sec.  1.512(c)(1), approvals of suppliers under Sec.  1.512(c)(2)) must
be retained for at least 2 years after their use is discontinued. Also,
records relied on to support an importer's status as a very small
importer must be retained for at least 3 years.
    Section 1.512(b)(5)(iv) specifies that records of very small
importers and importers of food from certain small foreign suppliers
obtained by FDA in accordance with the FSVP regulations are subject to
the disclosure requirements under part 20. In addition, under Sec.
1.512(b)(5)(v)(A), these importers do not need to duplicate their
existing records if they contain all of the information required under
the FSVP regulation, and importers may supplement any existing records
as necessary to include all required information. Under Sec.
1.512(b)(5)(v)(B), importers are not required to keep required
information in one set of records; if existing records contain some of
the required information, any new information required by the FSVP
regulation may be kept separately or combined with existing records.
    (Comment 299) Some comments suggest that records should be
considered to be at a reasonably accessible location if they can be
retrieved within 5 business days from another location, rather than
immediately retrieved by computer or other means. The comments state
that ``immediately'' is subject to misinterpretation, and FDA should
replace the term with a specific, reasonable time interval. The
comments suggest that 5 days is adequate, but in no case should FDA
impose an interval of less than 1 business day. Some comments object to
the requirement that only computer or other electronic means are
suitable for record retrieval because some locations of offsite records
might not have adequate resources, and a requirement to use electronic
means might inadvertently require expensive computer system validation.
    (Response 299) Consistent with changes to proposed Sec.  1.510
discussed in section III.K.3.b of this document, we have changed Sec.
1.512(b)(5)(ii)(B) to specify that offsite storage of records is
permitted if such records can be retrieved and provided onsite within
24 hours of request for official review. Under the final rule,
electronic records are considered to be onsite if they are accessible
from an onsite location. We believe that the 24-hour deadline is
important because records must be

available to FDA investigators during inspections. We do not believe it
is reasonable for an inspection to be put on hold for 5 business days
so that an importer can acquire the necessary records. However, the
provision no longer specifies retrieval by computer or other electronic
means; an importer could use a non-electronic means (e.g., courier
service) to retrieve and provide records onsite.
    (Comment 300) Some comments request that the regulations specify
that there is no requirement for compliance with any part of part 11.
    (Response 300) The final rule includes a provision (Sec.
1.512(b)(5)(iv)) specifying that electronic records that are
established or maintained to satisfy the requirements of Sec.  1.512
are exempt from the requirements of part 11.
3. Other Concerns Regarding the Modified Requirements
a. Withdrawal of Eligibility
    (Comment 301) One comment expresses concern that the modified
requirements for very small importers do not include a provision on
withdrawal of eligibility for the exemption, as there is in the
preventive controls regulations. The comment asks that we consider
adding the ability to withdraw eligibility from an importer that
imports food that causes an illness outbreak.
    (Response 301) We do not believe such a provision is necessary,
given the risk-based nature of the eligibility criteria for these
modified requirements and our existing enforcement tools in the imports
arena. For example, if an importer imports food that causes an illness
outbreak, we can place the importer on import alert, as appropriate,
among other options to ensure the safety of the food.
b. Identifying Very Small Importer Eligibility at the Time of Entry
    (Comment 302) Some comments say that exemptions and exceptions to
the FSVP requirements, including the proposed modified requirements for
very small importers and importers of food from very small foreign
suppliers, should be identified at the time of entry by using an
exemption/exception code, similar to the structure in place under the
prior notice regulations.
    (Response 302) We are planning to establish data elements that can
be submitted at the time of entry to identify shipments that are exempt
from the FSVP regulation or, as with very small importers and importers
of food from certain small foreign suppliers, subject to modified FSVP
requirements.
c. Compliance Period
    (Comment 303) Some comments ask that we consider giving very small
importers and importers of food from very small foreign suppliers more
time, beyond the 3 years proposed, to comply with the requirements.
Some comments suggest 5 years.
    (Response 303) We do not believe that the modified requirements are
sufficiently onerous to justify a longer compliance period for very
small importers or importers of food from small suppliers. With respect
to the compliance period for all importers, we are aligning the FSVP
regulation with the compliance dates of the supply-chain program
provisions in the preventive controls regulations, to the extent
feasible. For more discussion about the applicable compliance dates,
see section IV of this document.
d. Outreach
    (Comment 304) Some comments ask that we commit to engaging in
capacity building and education to help improve the knowledge and
performance of very small entities, particularly for very small
importers.
    (Response 304) We are committed to stakeholder engagement
throughout the implementation of FSMA. We plan to issue several
guidance documents to assist entities in complying with the new FSMA
regulations, including a general guidance document on FSVPs. We intend
for this guidance to include recommendations on compliance with the
modified requirements for very small importers and importers of food
from small foreign suppliers. We will develop and issue these guidances
in accordance with our good guidance practice regulation, which
establishes criteria for when we issue a guidance document as an
initial draft, invite public comment, and prepare a final version of
the guidance document that incorporates suggested changes, when
appropriate (21 CFR 10.115(g)). In addition, we plan to develop
training materials to assist importers in complying with the
requirements of this rule.
    With respect to capacity building, we issued a comprehensive plan
to expand the technical, scientific, and regulatory food safety
capacity of foreign governments and their respective food industries in
countries from which foods are exported to the United States in
accordance with section 305 of FSMA in 2013 (Ref. 15). We anticipate
that this plan will provide a strategic framework for our capacity-
building efforts over the next several years.

N. Importing a Food From a Foreign Supplier in a Country With an
Officially Recognized or Equivalent Food Safety System (Sec.  1.513)

    We proposed to establish alternative FSVP requirements for food
from foreign suppliers in countries whose food safety systems FDA has
officially recognized as comparable or determined to be equivalent to
that of the United States, when certain conditions are met. These
provisions would allow the importation of such food without being
subject to most of the standard FSVP requirements.
    Proposed Sec.  1.513(a) specified that the importation of food from
a foreign supplier in, and under the regulatory oversight of, a country
whose food safety system FDA has officially recognized as comparable to
that of the United States, or that FDA has determined to be equivalent
to that of the United States, would be subject to modified FSVP
requirements when certain conditions are met and documented. The
proposed conditions (stated in proposed Sec.  1.513(b)(1)) were the
following:
     The foreign supplier must be in, and under the regulatory
oversight of, a country whose food safety system FDA has officially
recognized as comparable or determined to be equivalent to that of the
United States; and
     The food must be within the scope of the relevant official
recognition or equivalency determination.
    Proposed Sec.  1.513(b)(1) also specified that these conditions be
documented before importing a food from the foreign supplier and
annually thereafter.
    Under proposed Sec.  1.513(b)(2), when those conditions were met,
the importer would have the option of complying with modified FSVP
requirements. Under such modified requirements, the importer would be
required to determine and document whether the foreign supplier of the
food was in good compliance standing with the food safety authority of
the country in which the foreign supplier is located. Importers would
be required to continue to monitor whether the foreign supplier is in
good compliance standing and promptly review any information obtained.
If the information indicated that food safety hazards associated with
the food are not being adequately controlled, we proposed that the
importer would be required to take prompt corrective action, which
would depend on the circumstances but could include discontinuing use
of the foreign supplier. We also proposed to require that these
importers document any corrective actions. If an importer met

those conditions and requirements for a food, the importer would not be
required to comply with most of the proposed FSVP requirements (e.g.,
for hazard analysis, compliance status review, supplier verification
activities). (However, for the reasons stated in section III.D of this
document, we conclude that it is appropriate to require these importers
to use a qualified individual to perform the tasks required under Sec.
1.513 of the final rule.) But we proposed that these importers would be
required to comply with the requirements concerning identification of
the importer at entry and recordkeeping.
    In the preamble to the proposed rule, we discussed how these
proposed modified requirements were consistent with a risk-based
approach to food safety, which includes leveraging the regulatory
efforts of food safety authorities in foreign countries. We discussed
our systems recognition initiative, under which we are conducting
assessments of foreign food safety systems to determine whether they
provide similar protections to those offered under the U.S. system and
a similar level of oversight and monitoring. The systems recognition
process, which is described on our Web site at http://www.fda.gov/food/internationalinteragencycoordination/ucm367400.htm (Ref. 16), involves
a comprehensive review of a country's food safety system by FDA
scientists, auditors, and investigators, along with use of a food
safety authority self-assessment tool (currently in draft form) called
the International Comparability Assessment Tool (ICAT), to determine
whether a country has a food safety system that is comparable to that
of the United States.
    As stated in the preamble to the proposed rule, the systems
recognition review process consists of two principal stages. After
satisfactory completion of a review of a country's ICAT submission,
audit teams from FDA, including persons specializing in particular
high-risk commodities, will perform an in-country assessment to verify
the implementation of programs and measures as outlined in the ICAT
submission. The assessment provides an objective and comprehensive
means of assessing the foreign food safety system. FDA will only enter
into a systems recognition arrangement with a foreign government if we
are confident that the oversight of the foreign food safety authority
is sufficiently rigorous and reliable that it can ensure that food
produced in that country is as safe as food produced in the United
States.
    After FDA enters into a systems recognition arrangement with
another food safety authority, we will maintain an ongoing dialogue and
hold annual consultations to determine whether any substantial changes
in the country's food safety system have developed to ensure that the
country's food safety system continues to be comparable. Although we
are still developing the systems recognition process, we plan to
reevaluate the operation and status of each arrangement every 5 years,
including reviewing changes in a country's food safety system and
conducting system audits as needed.
    We requested comment on the appropriateness of our proposed
modified FSVP requirements for food imported from a country with a
comparable or equivalent food safety system, including the proposed
conditions and modified FSVP requirements that would be applicable to
such imported food. In addition, in light of the possible inclusion of
supplier verification provisions for raw materials and other
ingredients in the preventive controls regulations, we requested
comment on whether the modified requirements should apply to the
importation of raw materials and other ingredients.
1. Appropriateness of the Modified Requirements
    We received comments supporting and opposing the proposed modified
FSVP requirements for food from foreign suppliers in countries with
comparable or equivalent food safety systems. As discussed in the
following paragraphs, we conclude that the modified provisions are an
appropriate component of risk-based foreign supplier verification
requirements. However, for the reasons described in the following
paragraphs, we conclude that it is appropriate to limit the scope of
the modified provisions to imported food that will not be further
manufactured/processed in the United States, including packaged food
products and fresh produce intended for consumption without further
commercial manufacturing/processing. This change will ensure that food
from foreign suppliers in countries whose food safety systems we have
officially recognized as comparable or determined to be equivalent to
that of the United States will be subject to supplier verification
under the FSVP regulation in the same circumstances that food from
domestic suppliers will be subject to supplier verification under the
preventive controls regulations.
    (Comment 305) Several comments express support for the application
of modified FSVP requirements for importing a food from a country with
a comparable or equivalent food safety system. These comments maintain
that the requirements are consistent with a risk-based approach to food
safety that avoids unnecessary expenditure of verification resources by
incorporating the regulatory efforts of foreign food safety
authorities. With respect to the importation of raw materials and other
ingredients, some comments support applying the modified requirements
to these products.
    On the other hand, some comments oppose the modified provisions,
asserting that supplier verification is needed to provide adequate
assurance of safety regardless of the regulatory environment in the
country in which a food is produced. The comments assert that just
because a country's food safety system has been deemed comparable does
not mean that the system operates perfectly all the time. The comments
express concern that under the modified provisions not all foreign
suppliers would be held to the same standards that apply to domestic
producers.
    (Response 305) We conclude that the application of the modified
FSVP requirements for imports of food from foreign suppliers in
countries with a food safety system officially recognized as comparable
or determined to be equivalent is consistent with a modern, risk-based
approach to food safety. As previously stated, the systems recognition
process provides for a thorough and rigorous assessment of whether the
food safety system in a foreign country provides similar protection to
that provided to consumers under the U.S. system. We believe that the
production of food by a foreign supplier in good compliance standing
with a food safety authority implementing a system that FDA has deemed
comparable or equivalent to the U.S. system will provide adequate
assurance of safety and make supplier verification by importers
unnecessary. Thus, importation of food under these modified provisions
should reduce the regulatory burden on importers while still providing
assurance that the food will be produced consistent with U.S.
standards.
    However, we conclude that the scope of the modified requirements
for food from countries with comparable or equivalent food safety
systems must be revised with respect to raw materials and other
ingredients. Supplier verification for raw materials and other
ingredients is an important part of a preventive approach to food
safety. Through supplier verification, the entity receiving raw
materials or other

ingredients from a supplier can help ensure that the supplier (or a
supplier to the supplier) has implemented controls to significantly
minimize or prevent known or reasonably foreseeably hazards in the raw
material or other ingredients. As a result of these considerations, we
have finalized requirements for supplier verification in the preventive
controls regulations--even for suppliers that operate under the U.S.
food safety system. Under the preventive controls regulations,
receiving facilities that obtain raw materials or other ingredients
from either domestic or foreign suppliers will, under certain
circumstances, need to have a supply-chain program that includes the
performance of supplier verification activities.
    We believe that verifying foreign suppliers of raw materials and
other ingredients is as important to food safety as verifying domestic
suppliers, and that where the supplier operates and the nature of
government oversight does not change the need for supplier verification
requirements. In other words, supplier requirements are important when
food is produced in the United States, when it is produced in foreign
countries whose food safety systems FDA has not officially recognized
as comparable or determined to be equivalent, and when it is produced
under food safety systems that FDA has found to be comparable or
equivalent. When a supplier has not controlled a hazard requiring a
control, the entity receiving that food can help ensure that the hazard
is controlled before there is a finished product to be distributed to
consumers--regardless of whether the supplier is located domestically
or in a foreign country.
    The U.S. food safety system requires that hazards be significantly
minimized or prevented in finished food products, and the same will be
the case for the food safety system in any country that FDA officially
recognizes as comparable or determines to be equivalent. When food that
does not require further manufacturing/processing is imported from
foreign suppliers in good compliance standing in those countries, we do
not believe that there will be significant public health benefit in an
importer conducting verification that the supplier's hazards have been
significantly minimized or prevented. In those circumstances, we will
have confidence that the food safety system of the foreign supplier's
country adequately requires the control of hazards for which controls
are needed. Furthermore, we do not see a reason for the FSVP regulation
to permit imports of raw materials and other ingredients under the
modified requirements for food from countries with comparable or
equivalent food safety systems while raw materials and other
ingredients would be subject to supplier verification under the
preventive controls regulations. Therefore, Sec.  1.513(a)(2) of the
final rule specifies that the modified provisions apply only to food
that is not intended for further manufacturing/processing, including
packaged finished food products and RACs that will not be commercially
processed further before consumption.
    (Comment 306) Several comments maintain that we should exempt U.S.
producers that are in good compliance standing with FDA from the
supplier verification requirements in the preventive controls
regulations. These comments assert that if domestic manufacturers are
subject to supplier verification requirements under the preventive
controls regulations while importers of food from countries with
comparable or equivalent food safety systems are exempt from most FSVP
requirements, this would result in imported food being subject to less
oversight than domestic food.
    (Response 306) As discussed previously, Sec.  1.513(a)(2) of the
final rule provides that supplier verification of raw materials and
other ingredients is treated the same under the FSVP and preventive
controls regulations by limiting the applicability of the modified
provisions on food from countries with comparable or equivalent food
safety systems to food that will not be subject to further
manufacturing/processing. Further, we believe, as stated previously,
that supplier verification of raw materials or other ingredients is
important regardless of whether the food is produced by domestic or
foreign suppliers. Such verification allows the facility receiving the
raw material or other ingredient to take steps, when necessary, to
control hazards requiring a control that have not been controlled by
the supplier.
    (Comment 307) Some comments suggest that there is an inconsistency
with the provisions of proposed Sec. Sec.  1.513 and 1.506(d)(5). As
discussed in section III.G.4 of this document, proposed Sec.
1.506(d)(5) would permit an importer to rely on an inspection of a
foreign supplier that is conducted by the food safety authority of a
country whose food safety system we had officially recognized as
comparable or determined to be equivalent, as a substitute for
conducting a required onsite audit of the foreign supplier. The
comments assert that this provision is superfluous because proposed
Sec.  1.513 would relieve the importer of the obligation to conduct an
onsite audit of the foreign supplier.
    (Response 307) We do not agree. As stated previously, the modified
provisions in Sec.  1.513 of the final rule apply only to food that
will not be commercially processed further in the United States.
However, under Sec.  1.506(e)(1)(i)(E)(2) of the final rule, an
importer of a raw material or other ingredient from a country with a
comparable or equivalent food safety system may substitute an
inspection by the food safety authority for an onsite audit of the
foreign supplier of the raw material or other ingredient provided that
certain conditions are met. In addition, the provisions allowing
substitution of an inspection for an onsite audit do not require
documentation that the foreign supplier is in good compliance standing
with the food safety authority in a country with a comparable or
equivalent food safety system, which is required for importing food
under the modified provisions in Sec.  1.513. Consequently, we conclude
that there are circumstances under which an importer of food from a
country with a comparable or equivalent food safety system might wish
to rely on the results of an inspection conducted by the food safety
authority of that country in accordance with Sec.
1.506(e)(1)(i)(E)(2).
2. Systems Recognition Process
    Several comments request changes to, or clarification of, our
systems recognition process, while some comments request a change to
proposed Sec.  1.513 to address a concern about the systems recognition
process.
    (Comment 308) Some comments request that we clarify and simplify
the process of making systems recognition determinations. Some
comments, noting their understanding that the systems recognition
approach will allow FDA to prioritize its inspection and surveillance
activities according to risk, ask that we more clearly show the
benefits for exporting countries under the approach to increase the
incentive for participation in systems recognition.
    (Response 308) The systems recognition initiative is a food safety
regulatory cooperation program and it is not intended to be a program
for the promotion of trade or market access. Systems recognition is a
regulator-to-regulator program that allows FDA to take into account the
role of food safety systems of exporting countries in our risk-based
decision making regarding inspections, monitoring, admissibility, and
follow-up when food safety incidents occur. As a regulatory
coordination program, systems recognition embraces cooperation in

many areas such as research, capacity building with third countries,
and outbreak response.
    We are using systems recognition as a tool to determine when we can
rely on the implementation of science-based food safety programs by
foreign regulatory authorities and take action based on information
provided by such authorities. However, we note that the systems
recognition program is based on the principle that foreign food
producers can meet U.S. food safety requirements by providing
assurances that these foods are produced according to the food safety
standards of a country whose food safety system we have found to be
comparable or equivalent. Therefore, it is appropriate, under Sec.
1.513 of the final rule, to exempt from the application of most FSVP
requirements certain food from foreign suppliers that are in good
compliance standing with the food safety authority of a country whose
food safety system we have found to be comparable to ours as a result
of a systems recognition assessment.
    (Comment 309) One comment requests that we revise proposed Sec.
1.513(b) to replace ``country'' with ``country or entity'' in the
phrase ``country with an officially recognized or equivalent food
safety system'' to recognize that, in addition to individual countries,
entities such as the EU might also be the subject of a food safety
systems recognition agreement. This comment also asks that we establish
a transition program or grace period for countries that are undergoing
systems recognition evaluation so that exports from those countries are
not subject to the full range of FSVP requirements while FDA conducts
its evaluation.
    (Response 309) We appreciate that the EU plays an important role in
coordinating the food safety policy of its Member States. However,
within the EU the food safety agencies of the national governments of
the Member States are responsible for enforcing the feed and food
safety laws and implementing official controls for food safety through
all stages of production, processing, and distribution (Ref. 17). In
that context, we are continuing to evaluate and consider how to best
address the functions and processes of both the EU and its Member
States. We do not believe that it is necessary to revise Sec.
1.513(b)(1) as requested to address this aspect of our systems
recognition review.
    We also decline to apply modified FSVP requirements to importers of
food from countries that are undergoing, but have not completed, a
systems recognition assessment. Applying such requirements to systems
recognition candidates before we have completed the evaluation process
would prejudge the outcome of the process.
    (Comment 310) Some comments request that we rapidly expand the list
of countries participating in the systems recognition program so that
it includes the major trading partners of the United States. These
comments assert that a systems recognition program covering the United
States' largest trading partners would significantly reduce burdens on
food importers.
    (Response 310) We are transitioning the systems recognition program
from the pilot phase to the implementation phase. During this
transition we will be addressing modifications of our internal
procedures and training of FDA personnel involved in systems
recognition determinations. As a result, we will be applying more
resources to the program in response to requests for recognition from
additional countries. As we gain more experience with the systems
recognition program, we expect to improve the efficiency of the review
process. However, because there is variation in the level of maturity
of food safety systems in countries around the world, not all countries
are likely to qualify to participate in the systems recognition
program.
    (Comment 311) One comment asserts that in selecting countries to
review under the systems recognition process, FDA will be biased
towards countries with legal systems and official languages that are
similar to those of the United States, making it difficult for other
countries to obtain systems recognition status.
    (Response 311) We do not agree. We are administering the systems