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

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

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

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

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

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

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

controlling hazards if importers did not review the results of their
verification activities and take corrective action if the results
indicated that hazards were not adequately controlled. Therefore,
proposed Sec.  1.506(g)(5) (under Option 1; this is Sec.  1.506(g)(4)
under Option 2) would require that an importer promptly review the
results of the verification activities that it conducts or for which it
obtains documentation.
    Proposed Sec.  1.506(g)(5) further states that if the results of
verification activities show that hazards identified as reasonably
likely to occur with a food are not adequately controlled, the importer
must take appropriate corrective action in accordance with proposed
Sec.  1.507(c). As discussed in section II.H.3 of this document, Sec.
1.507(c) would require that an importer promptly take appropriate
corrective actions if it determines that its foreign supplier does not
produce a food in compliance with processes and procedures that provide
at least the same level of public health protection as those required
under section 418 or 419 of the FD&C Act, if either is applicable, or
produces food that is adulterated under section 402 or misbranded under
section 403(w) of the FD&C Act. The appropriate corrective actions
would depend on the circumstances but could include discontinuing use
of the foreign supplier until the cause or causes have been adequately
addressed. Thus, under proposed Sec.  1.506(g)(5), if, for example, the
sampling and testing conducted by an importer in accordance with Sec.
1.506(g)(2)(ii) (under Option 1) showed that a supplier was not
adequately controlling a hazard reasonably likely to occur with a food,
the importer likely would need to notify the supplier of the failing
results so that the supplier could take appropriate corrective action,
which could include changes to its processes and procedures or sources
of ingredients. If the foreign supplier did not make changes necessary
to ensure that it adequately controlled the hazard, the importer would
need to cease obtaining the food from the supplier.
    f. Independence of qualified individuals. Proposed Sec.
1.506(g)(6) (under Option 1; this is Sec.  1.506(g)(5) under Option 2)
addresses the issue of financial conflicts of interests that might
arise in the performance of verification activities by qualified
individuals (as defined in proposed Sec.  1.500). We recognize the
possibility that a conflict of interest might arise when there is a
financial relationship between a qualified individual who is conducting
a verification activity (such as an onsite audit or lot-by-lot testing)
and the foreign supplier whose procedures the qualified individual is
reviewing. For example, the owner of an auditing firm might own
substantial shares of stock in a foreign supplier that has requested an
audit by the firm. On the other hand, Sec.  1.506(g) and (h) permits
the importer itself to conduct onsite audits of foreign suppliers and
other verification activities under these regulations. In such cases,
there would obviously be a financial relationship between the qualified
individual, as an employee of the importer, and the importer itself,
but this relationship should not pose a conflict of interest concern.
    To address concerns about conflict of interest in the performance
of FSVP activities, proposed Sec.  1.506(g)(6) (Sec.  1.506(g)(5) under
Option 2) specifies that a qualified individual who conducts any of the
verification activities in Sec.  1.505(g)(1), (g)(2), and (h) (Sec.
1.506(g)(1) and (h) under Option 2) must not have a financial interest
in the foreign supplier and payment must not be related to the results
of the activity conducted. Proposed Sec.  1.506(g)(6) further states
that this provision would not prohibit the importer or one of its
employees from conducting the verification activity.
    We invite comment on whether this prohibition reflects the
appropriate approach to concerns about conflicts of interest in the
performance of foreign supplier verification activities and, if not,
what changes would be appropriate. We also request comment on whether
and, if so, how, the regulations should specify what constitutes a
financial interest.
8. Microbiological Hazards in RACs That Are Fruits or Vegetables and
That Would Be Subject to the Produce Safety Regulations
    As discussed in section II.G.3 of this document, because importers
of produce RACs that are subject to the proposed regulations on produce
safety would not be required to conduct a hazard analysis regarding
microbiological hazards in these products, we are not proposing that
importers of such produce conduct verification activities on a hazard-
by-hazard basis in the manner described in section II.H.7 of this
document. Instead, for such microbiological hazards we tentatively
conclude that supplier verification with respect to these products
should provide adequate assurances that the foreign supplier is
producing the fruit or vegetable in accordance with processes and
procedures that provide the same level of public health protection as
those required under part 112, the produce safety regulations.
    Because we have presented two options in our co-proposal concerning
supplier verification activities, we are presenting a co-proposal
regarding supplier verification activities for RACs that are fruits or
vegetables. Under Option 1 of the co-proposal, we tentatively conclude
that, because all microbiological hazards associated with produce RACs
that are subject to the proposed produce safety regulations have the
potential to result in serious adverse health consequences or death to
humans or animals, it would be appropriate to require importers of this
food to conduct onsite auditing to verify that the food is being
produced in a manner that is consistent with part 112. We also believe
that such audits should be subject to the requirements concerning the
scope of auditing, substitution of certain inspection results, review
of results of verification activities, and independence of qualified
individuals conducting verification activities discussed in sections
II.G.7.c through II.G.7.f of this document (proposed Sec.  1.506(g)(3)
through (g)(6)). Finally, because onsite auditing might also be
required to verify control of any non-microbiological hazards
associated with produce RACs that are subject to the proposed produce
safety regulations, we propose to specify that an audit conducted to
address microbiological hazards associated with such a food may be
conducted in conjunction with an audit that is required under proposed
Sec.  1.506(g). For these reasons, under Option 1, proposed Sec.
1.506(h) states that, for a RAC that is a fruit or vegetable and that
is subject to part 112, in addition to the other requirements of Sec.
1.506, before importing the fruit or vegetable from the foreign
supplier and at least annually thereafter, the importer must conduct or
obtain documentation of an onsite audit to provide adequate assurances
that the foreign supplier is producing the fruit or vegetable in
accordance with processes and procedures that provide the same level of
public health protection as those required under part 112; that such
audits are subject to Sec.  1.506(g)(3) through (g)(6); and that an
audit conducted under Sec.  1.506(h) may be conducted in conjunction
with an audit, if any, that is required under Sec.  1.506(g).
    Under Option 2 of the co-proposal on supplier verification
activities, importers would choose, from among several possible
verification activities, an activity that would enable the importer to
adequately verify that a hazard has been adequately controlled.
Consistent with this approach, under

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

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

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

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

I. Reassessment of FSVP (Proposed Sec.  1.508)

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

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

    Proposed Sec.  1.509 answers the question, ``How must the importer
be identified at entry?'' Section 1.509 is intended to ensure that the
importer of each food imported or offered for import into the United
States is accurately identified so that the Agency can effectively
implement and monitor compliance with the FSVP regulations.
1. Designation of U.S. Agent or Representative
    Proposed Sec.  1.509(a) would require, before an article of food is
imported or offered for import into the United States, that the foreign
owner or consignee of the food (if there is no U.S. owner or consignee)
designate a U.S. agent or representative as the importer of the food
for the purposes of the definition of ``importer'' in Sec.  1.500. This
would ensure that, when there is no U.S. owner or consignee of the food
at the time of U.S. entry, there will be an entity in the United
States--the U.S. agent or representative of the foreign owner or
consignee of the food--who will be responsible for meeting the FSVP
requirements with respect to that food. We also note that, under the
proposed regulations, the U.S. agent or representative may rely on
qualified individuals to perform FSVP activities on its behalf.
2. Identification of the Importer
    Proposed Sec.  1.509(b) would require importers to obtain a DUNS
number (if the importer does not already have one). Proposed Sec.
1.509(c) would require an importer to ensure that, for each line entry
of food product offered for importation into the United States, the
importer's name and DUNS number are provided electronically when filing
entry with CBP to identify the importer of the product. Our reasons for
proposing these requirements are twofold, although they both concern
our ability to accurately identify importers who are subject to the
FSVP regulations.
    First, knowing the identity of the importer for a particular food
being imported would help us carry out section 421(b) of the FD&C Act.
This provision, also added by FSMA, requires FDA to allocate its
resources for examining imported products based on certain risk
factors, including the rigor and effectiveness of the importer's

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

K. Records (Proposed Sec.  1.510)

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

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

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

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

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

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

    Proposed Sec.  1.512 answers the question, ``What FSVP may I have
if I am a very small importer or I am importing from a very small
foreign supplier?'' As stated in sections I.C and II.A.8 of this
document, we are proposing to adopt modified FSVP requirements for very
small importers and food from very small foreign suppliers. Section
805(c)(3) of the FD&C Act directs FDA to, as appropriate, take into
account differences among importers and types of imported food,
including based on the level of risk posed by the imported food. The
modified requirements we are proposing are for situations that involve
a relatively low volume of imported food, which should reduce
consumers' exposure to, and thus potential risk from, the food.
    As stated in proposed Sec.  1.500, the proposed definitions of very
small importer and very small foreign supplier would include a maximum
annual sales volume of $500,000 in annual food sales. This is a
conservative measure of the volume of food imported into the United
States because a supplier may ship food to other countries and an
importer may sell both domestically sourced and imported food. Using
annual sales of food, we believe, would be a workable approach for
importers, suppliers, and FDA to determine who is subject to the
modified requirements applicable to very small importers and food from
very small foreign suppliers. Other measures for the volume of imported
food, while perhaps more precise, would be more complex. We request
comment on our proposed measure.
    In sections 418(l) and 419(f) of the FD&C Act, ``qualified
facilities'' and certain farms are subject to qualified exemptions with
modified requirements. Eligible establishments are defined, in part,
based on the relatively limited value of their annual food sales, which
for those provisions is also capped at $500,000. The proposed modified
FSVP requirements for very small importers and food from very small
foreign suppliers are designed to specify verification activities that
take into account the risk to overall public health posed by such food.
In the context of the nature of their imports, we tentatively conclude
that the modified requirements described below would be adequate to
provide assurances that the foreign suppliers to these importers
produce food in compliance with processes and procedures that provide
the same level of public health protection as those required under
section 418 or 419 of the FD&C Act, as applicable, and sections 402 and
403(w) of the FD&C Act.
1. Eligibility
    Proposed Sec.  1.512(a) states that Sec.  1.512 applies only when
the importer is a very small importer or when the food it is importing
is from a very small foreign supplier.

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

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

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

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

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

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

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

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

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

III. Preliminary Regulatory Impact Analysis

A. Overview

    We have examined the impacts of this proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.