provide the same level of public health protection as the requirements
under section 419.
    We conclude it is not necessary to state in the regulation specific
actions that importers must take in evaluating whether alternative
procedures used by foreign suppliers provide the same level of public
health protection as procedures required in the regulations
implementing sections 418 and 419 of the FD&C Act.
    (Comment 100) One comment maintains that food safety regulations in
the EU, and particularly in France, provide the same level of public
health protection as the FSMA standards and urges that we recognize
these standards.
    (Response 100) We do not have sufficient information at this time
to determine whether the food safety regulations in particular
countries or regions provide the same level of public health protection
as U.S. standards. However, importers may find that compliance with the
laws of France and other EU countries is relevant to determining
whether foods are being produced using processes and procedures that
provide the same level of public health protection as those required
under FDA's regulations. In addition, as discussed in section III.N of
this document, FDA has established a systems recognition initiative,
under which we are conducting comprehensive assessments of foreign food
safety systems to determine whether they provide similar protections to
those offered under the U.S. system and a similar level of oversight
and monitoring. As discussed in more detail in section III.N, the
systems recognition program is based on the principle that foreign food
producers can meet U.S. food safety requirements by providing
assurances that these foods are produced according to the food safety
standards of a country whose food safety system we have found to be
comparable. Under Sec.  1.513 of the final rule, once we have made a
determination that a foreign food safety system is comparable to ours,
certain foods within the scope of such a determination may be imported
under modified FSVP requirements (provided that certain conditions are
met). These provisions will allow the importation of such food without
being subject to most of the standard FSVP requirements.
    (Comment 101) Some comments state that, to ensure that the concept
of ``same level of public health protection'' is applied consistently,
FDA must conduct risk assessments of foods to formulate an appropriate
risk matrix that can be applied domestically and internationally. The
comments request that, before we issue the final rules on produce
safety and FSVPs, we issue for public comment the risk model that we
intend to use for evaluating requests for variances under the produce
safety proposed regulation.
    (Response 101) We do not agree. This rule establishes a flexible,
risk-based approach to foreign supplier verification based in
significant part on a requirement that importers understand the hazards
in the foods they import so they can take appropriate steps to verify
that their suppliers have adequately controlled these hazards. We
believe that a system of hazard analysis, control, and verification is
well accepted and understood throughout the international food safety
community and provides the most effective way to implement a risk-based
framework for foreign supplier verification. We have confidence that
importers will be able to implement FSVPs based on their own hazard
analyses or their review of analyses conducted by others, without our
having to conduct risk assessments for all foods to generate a risk
matrix that all food producers would use. As stated previously, we
intend to issue guidance to assist importers and foreign and domestic
producers in complying with the new regulations that we are adopting
under FSMA, including guidance on the analysis of hazards in food. With
respect to variances under the produce safety regulation, we note that
the final rule adopting that regulation published elsewhere in this
issue of the Federal Register addresses how FDA will evaluate requests
for variances submitted in accordance with subpart P of part 112.
f. Relevant Statutory Requirements
    (Comment 102) One comment states that FSVPs should be limited to
verifying foreign supplier compliance with the preventive controls or
produce safety regulations. One comment states that the FSVP regulation
should not impose any additional obligations on foreign suppliers
beyond those required under other FDA regulations, and should be based
on relevant international standards and conform to U.S. international
obligations.
    (Response 102) The purpose and scope of importers' FSVPs, as set
forth in Sec.  1.502(a) of the final rule, implements the standard
mandated in FSMA for FSVPs. Consequently, it requires importers to take
steps to ensure that their foreign suppliers are producing food in a
manner consistent with the preventive controls or produce safety
regulations, to the extent that those regulations apply to the foreign
supplier's production of a food, and to ensure that the food from the
supplier is not adulterated and is not misbranded with respect to
allergen labeling, if applicable. The FSVP regulation does not impose
on foreign suppliers any requirements that they are not already subject
to under the FD&C Act and implementing regulations, including the
regulations on preventive controls and produce safety. In addition, the
FSVP regulation is drafted to be consistent with U.S. obligations under
international agreements.
    (Comment 103) One comment suggests that the phrase ``if either is
applicable'' when referring to the preventive controls and produce
safety provisions be interpreted to mean that if a type of produce is
covered by section 419 (and the produce safety regulation), it must be
in compliance with section 419, rather than meaning that any imported
``produce'' would be subject to section 419.
    (Response 103) We agree. If an imported item of produce is not
subject to the produce safety regulation, the importer would not be
required to verify that the produce was grown in accordance with that
regulation.
    (Comment 104) One comment suggests that the requirement to have an
FSVP be limited to problems that ``cause a risk to the public health,''
which the comment maintains would be consistent with the statement in
the preamble to the proposed rule that the regulation should focus on
foreseeable food safety risks identified through hazard assessment
rather than all risks covered by the adulteration provisions. The
comment contends that not all adulterants cause a food safety risk and

many forms of adulteration are not amenable to discovery by the
importer.
    (Response 104) We do not believe that the proposed change is
necessary. The importance of the existence of a risk to public health
is incorporated in the definition of ``hazard,'' meaning any
biological, chemical, or physical agent that is reasonably likely to
cause illness or injury. Except as specified otherwise, each importer
would need to have an FSVP for each food that it imports from each
foreign supplier and to conduct a hazard analysis for each type of food
in accordance with Sec.  1.504 of the final rule. However, under Sec.
1.504(f), if an importer determines there are no hazards requiring a
control in a food, the importer would not be required to conduct an
evaluation of the risk posed by the food and the foreign supplier's
performance and would not be required to conduct supplier verification
activities.
g. U.S. International Obligations
    (Comment 105) One comment notes that domestic farms supplying foods
directly to retailers are not subject to supplier verification
requirements because the supplying entity (i.e., the farm) and
receiving entity (i.e., the retailer) are not subject to the
regulations on preventive controls, which contain supplier program
provisions. The comment asks that we revise the FSVP provisions
regarding produce to ensure that there are no differences in treatment
between domestic and foreign suppliers with respect to the obligations
of the WTO Agreement on the Application of Sanitary and Phytosanitary
Measures (SPS Agreement) (Ref. 4).
    (Response 105) The FSVP regulation aligns with the supply-chain
program provisions of the preventive controls regulations by requiring
importers to verify that their suppliers have systems in place to
significantly minimize or prevent the hazards associated with the foods
they are supplying and that their suppliers meet or provide the same
level of public health protection as required under applicable FDA
safety standards. In addition, an importer conducting supplier
verification under the preventive controls regulations for imported raw
materials or other ingredients would be deemed in compliance with most
of the FSVP requirements.
    Nevertheless, the supply-chain program provisions of the preventive
controls regulations do not apply to certain domestic entities,
including restaurants or retail food establishments. However, this does
not mean that farms that supply produce to such entities are subject to
different or lesser safety standards than foreign farms that supply
produce to U.S. importers subject to the FSVP regulation. To the
contrary, the requirements in the produce safety regulation apply with
equal force to domestic and foreign farms.
    Under the food safety system envisioned by FSMA, supplier
verification of imported produce to be sold by U.S. retailers is needed
to ensure a consistent level of oversight and protection for domestic
and imported food. Consistent with other provisions of FSMA, FDA is
taking several steps to establish a more comprehensive, effective,
risk-based approach to domestic food safety oversight and enforcement.
We are working through the Partnership for Food Protection (PFP), a
group of dedicated professionals from Federal, State, local, tribal,
and territorial governments with roles in protecting the food supply
and public health, to develop and implement a national Integrated Food
Safety System (IFSS) for domestic compliance oversight (Ref. 5). We are
also adopting a new domestic inspection paradigm, stemming from our
authority to inspect under section 704 of the FD&C Act (21 U.S.C. 374),
focused on whether firms are implementing systems that effectively
prevent or significantly minimize food contamination in compliance with
the new FSMA regulations, including those on preventive controls and
produce safety. This new paradigm involves a major reorientation and
retraining of more than 2,000 FDA inspectors, compliance officers, and
other staff involved in food safety activities, as well as thousands of
State, local, and tribal inspectors.
    In addition, section 201 of FSMA (section 421 of the FD&C Act (21
U.S.C. 350j)) mandates that we inspect domestic high-risk facilities
not less than once every 3 years. We are currently meeting this mandate
and we intend to significantly exceed it as part of our strategy to
implement the new food safety standards. We intend there to be an FDA
or State inspection of every domestic high-risk human food facility
annually to verify compliance with the new regulations.
    Our implementation of the final rule on produce safety (published
elsewhere in this issue of the Federal Register) will entail a broad,
collaborative effort to foster awareness and compliance domestically.
Our strategy includes guidance, education, technical assistance, and
verification. Verification will be achieved through the actions of
multiple public and private entities, including inspections by FDA and
partner agencies, USDA audits, marketing agreements, and private audits
required by commercial purchasers. In keeping with this broad vision,
we intend to focus our domestic efforts on several important
activities, including the following:
     Supporting and collaborating with public and private
parties involved in audits and other accountability and verification
activities;
     Conducting targeted domestic on-farm surveys and risk-
based inspections to understand current practices and identify gaps in
compliance; and
     Taking administrative compliance and enforcement action
when needed to correct problems that put consumers at risk.
    We have the authority to inspect farms subject to the produce
safety regulation under section 704 of the FD&C Act. We will target our
inspections on the basis of risk. We intend to rely heavily on the
States to conduct a large proportion of the routine inspections of
farms, and we are committed to working closely with the States to
verify compliance with the new FSMA requirements. In addition to FDA
and State inspections, we will leverage third-party audits conducted by
USDA and others with a goal of annual verification of all domestic
farms subject to the produce safety rule.
    In contrast, we expect to have a far less robust system of direct
public oversight of foreign food facilities and farms that are subject
to the new FSMA regulations. We have less ability to physically inspect
and take enforcement actions against those who produce food abroad for
export to the United States due to legal and practical limitations. For
example, diplomatic and practical logistics associated with conducting
foreign inspections in most countries complicate, and in some cases
make impossible, the kind of routine unannounced inspections of
establishments that we conduct in the United States. As a result,
neither we nor our IFSS partners can rely on unannounced inspections
abroad in the same way as we can domestically.
    We also face challenges in conducting ``for cause'' inspections of
foreign facilities when we have evidence of a compliance problem.
Domestically, we can respond to a refusal to permit inspection or a
refusal to permit access to or copying of records by obtaining
inspection warrants in the federal courts. For foreign inspections,
however, we do not have the same access to the courts, and it can be
challenging to compel inspections and access to records when needed. We
also face diplomatic and logistical challenges

in conducting foreign civil and criminal investigations and
prosecutions when violations occur that do not hinder our domestic
enforcement efforts. In addition to legal issues related to
extraterritoriality, practical and operational challenges to our
foreign enforcement activities include obtaining visas and official
travel documents, finding qualified translators, procuring foreign
travel authorizations, difficulties in coordinating with foreign
authorities, and extradition.
    Because of these challenges, we largely rely on the cooperation of
foreign governments when conducting inspections in foreign countries
and bringing enforcement actions against foreign businesses and
individuals. Today, our main approach to oversight of imported food is
reactive, involving sampling and testing food at ports of entry.
However, with the increased volume of imported foods coming across U.S.
borders and limited resources, we are able to physically examine less
than 2 percent of food offered for import each year.
    Given the difficulties in conducting direct FDA regulatory
oversight of foreign producers, FSMA requires importers to share
responsibility for verifying the safety of imported food. The FSVP
regulation requires that U.S. importers, who are domestic entities
under direct legal jurisdiction, take action to ensure the safety of
the food they import by performing risk-based supplier verification
activities. Combined with FDA's foreign inspections and enforcement
efforts, the FSVP requirements will help ensure that imported food is
subject to the same level of risk-based oversight and accountability
that applies to domestic food under our comprehensive, integrated
domestic food safety system.
    In establishing these requirements for supplier verification by
importers, we are integrating practices that industry has adopted in
the last two decades to ensure that imported food is produced under
modern food safety standards. Global industry best practices include
not only risk-based, prevention-oriented standards for producing safe
food but also verification measures to ensure that those standards are
being met, including supplier verification and other supply-chain
management activities. These oversight and verification approaches also
are recognized by the Codex Alimentarius Commission (Codex) and are
consistent with the approach of export oversight agencies in
governments of countries with which the United States trades (see the
discussion of Codex and relevant Codex standards and guidelines in
Response 106). Therefore, in relying on the FSVP regulation to help
ensure that oversight of imported food matches the level of domestic
oversight made possible under FSMA, we are relying on mechanisms that
are consistent with internationally recognized standards.
    Our goal is for our domestic implementation strategy, including
outreach, inspection frequencies, and other mechanisms to achieve
compliance, to be operational on a schedule that corresponds with the
dates by which domestic food producers are required to comply with the
new FSMA standards. We have designed the compliance dates for importers
under this final rule in a parallel fashion. As described in section
IV.B of this guidance, an FSVP importer whose foreign supplier is
subject to new FSMA requirements will not have to comply with the FSVP
regulation until after its supplier is required to comply with its new
requirements.
    (Comment 106) Some comments assert that assigning responsibility
for ensuring food safety to importers could result in events that might
breach WTO agreements, such as importer-specific supplier verification
lists, different importers imposing different verification criteria on
the same foreign supplier, and additional and more frequent onsite
auditing. Some comments maintain that oversight of foreign suppliers is
best left to the private sector, and imposing requirements on importers
might be inconsistent with WTO obligations.
    (Response 106) We do not agree. Supplier verification of imported
food is needed to ensure a consistent level of oversight and protection
for domestic and imported food. Requiring importers to share
responsibility for ensuring that imported food is safe is consistent
with industry practice, principles of Codex, and the approaches of
export oversight agencies of many U.S. trading partners.
    As a member of the WTO trade agreements, the United States has
assumed international obligations including those set out in the SPS
Agreement. The SPS Agreement requires that measures adopted by WTO
members to protect human or animal health be risk-based and that such
measures are not more trade-restrictive than required to achieve their
appropriate level of sanitary or phytosanitary protection, taking into
account technical and economic feasibility.
    Codex was formed in 1963 by the Food and Agriculture Organization
and the World Health Organization of the United Nations to develop food
standards, guidelines, and related texts such as codes of practice, and
is recognized under the SPS Agreement as the international standards
organization for food safety. In describing the general characteristics
of food import control systems, the Guidelines for Food Import Control
Systems (CAC/GL 47-2003) (Food Import Guidelines) issued by the Codex
Committee on Food Import and Export Inspection and Certification
Systems (Ref. 6) note the importance of clearly defined legislation on
import control systems and recognize the value of importer verification
systems. The Food Import Guidelines recognize the need for importing
countries to perform inspections and audits where appropriate in
exporting countries, and also acknowledge the utility of additional
activities in ensuring that imported foods are safe. The Guidelines
recommend that standards should be based on risk and, as far as
possible, applied equally to imported and domestic food.
    The FSVP regulation contains requirements to ensure that imported
foods are produced in compliance with processes and procedures that
provide the same level of public health protection as those required
under the preventive controls and produce safety regulations, and in
compliance with sections 402 (regarding adulteration) and 403(w)
(regarding misbranding with respect to labeling for the presence of
major food allergens) of the FD&C Act. These underlying preventive
controls regulations are based on and conform to scientific evidence
and international food safety standards, including the HACCP Annex to
the Codex General Principles of Food Hygiene (Annex to CAC/RCP 1-1969
(Rev. 4--2003)) (HACCP Annex) (Ref. 7). In developing these
regulations, we also considered the recommendations of the Codex Code
of Hygienic Practice for Fresh Fruits and Vegetables (CAC/RCP 53-2003)
(the Codex Code) (Ref. 8). Similarly, components of the FSVP
regulation, including the hazard analysis requirements, are consistent
with principles in the HACCP Annex that require private sector food
producers to play a role in implementing HACCP by conducting hazard
identification, evaluation, and subsequent control operations. In
addition, certain FSVP requirements correlate with Codex codes and
principles on food safety relating to the basic definition of food
safety standards and to the Codex standards for labeling of allergens
in prepackaged foods (Refs. 7, 9).
    Many countries have adopted similar food safety regulations
mandating that certain principles and conditions be applied to food
manufacturing and food

importation. These include mandatory HACCP programs for seafood and
other foods.
    In addition to aligning with Codex standards and guidance, the FSVP
regulation incorporates a risk-based approach to food safety that
allows importers the flexibility to tailor the supplier verification
activities they conduct so that they provide adequate assurance that
hazards in the food they import have been significantly minimized or
prevented. The regulations are also designed to require verification
that imported food meets the same standards that apply to domestic food
(including the preventive controls and produce safety regulations) and
align with the supplier verification provisions that apply to food from
domestic suppliers under the preventive controls regulations.
    Regarding the comments' assertion that the FSVP regulation will
result in more onsite auditing of foreign suppliers, we note that the
FSVP regulation does not require importers to conduct onsite audits of
foreign suppliers. Instead, applying risk-based principles, importers
are required to determine appropriate supplier verification activities
based on the risks associated with the food being imported and the
capabilities of the foreign supplier of the food. Because the FSVP
requirements are flexible and not prescriptive, we do not agree that
the FSVP regulations will significantly increase costs or impede trade.
    With respect to the possibility that different importers might
subject the same foreign supplier to different verification activities,
we believe it is unlikely that different importers would identify
significantly different hazards requiring control for the same food
from the same foreign supplier. We do not expect that to happen because
all importers likely will be considering similar information on hazards
associated with particular foods that is available from food producers,
consultants, trade associations, industry-related publications, and
regulatory agencies. Therefore, we anticipate that different importers
are likely to conduct (or obtain documentation of) similar supplier
verification activities for particular types of food. In addition, the
final rule allows importers to rely on verification activities
conducted by other importers for the same food imported from the same
foreign supplier. This flexibility reduces the potential extent to
which foreign suppliers might be subject to different verification
activities by different importers. We also note that, to the extent
private food safety audit scheme owners and benchmarking organizations
continue to develop tools to verify that foreign suppliers produce food
consistent with FDA food safety standards, importers could rely on such
audit schemes to help meet FSVP requirements. If this were to occur,
multiple importers of the same food from the same foreign supplier
might choose to rely on the same supplier audit conducted in accordance
with such a scheme.
    (Comment 107) One comment maintains that, to satisfy WTO
obligations, we need to ensure that domestic and foreign supplier
verification requirements are aligned, and therefore need to require
that domestic food facilities conduct supplier verification with
respect to RACs (if RACs are subject to the FSVP regulation as
proposed).
    (Response 107) The regulations on preventive controls for human and
animal foods include supply-chain program requirements that are closely
aligned with the FSVP supplier verification requirements, which we
believe, for the reasons previously stated, are consistent with our WTO
obligations. Raw materials and other ingredients such as RACs that are
manufactured/processed at domestic U.S. receiving facilities (as well
as at foreign receiving facilities) are within the scope of the supply-
chain program requirements in the FSVP and preventive controls
regulations.
2. Low-Acid Canned Foods
    In accordance with section 805(e)(3) of the FD&C Act, we proposed
that, with respect to those microbiological hazards that are controlled
by the LACF regulation set forth in part 113 (21 CFR part 113), the
importer of an LACF would be required to verify and document that the
food was produced in accordance with part 113. For all matters not
controlled by part 113 (e.g., hazards other than microbiological
hazards addressed under part 113), the importer would be required to
have an FSVP as specified in proposed Sec.  1.502(a). In the preamble
to the proposed rule, we noted that an LACF importer would not know if
it was importing the food from a foreign supplier whose facility was in
compliance with part 113 unless it conducted some appropriate form of
verification, such as auditing. We therefore suggested that, in
addition to providing assurance that non-microbiological hazards in
LACF were adequately controlled, following the FSVP provisions would
also be an appropriate verification approach for all hazards, including
microbiological hazards.
    On our own initiative, we are adopting corresponding FSVP
requirements for the importation of raw materials and other ingredients
of LACF by LACF manufacturers, for reasons similar to those we stated
(in section III.B.1 of this document) for exempting from the FSVP
regulation importers of juice or seafood raw materials or other
ingredients that are manufacturers or processors of juice or seafood
products. As we stated with respect to section 805(e)(1) and (e)(2) of
the FD&C Act regarding juice and seafood, we conclude that in enacting
section 805(e)(3), Congress intended to exclude from the FSVP
provisions food covered by and in compliance with the LACF regulation
in part 113 (with respect to microbiological hazards addressed under
those regulations), likely reflecting a conclusion that the LACF
regulation makes supplier verification under FSVP unnecessary for
microbiological hazards because importers who are in compliance with
the LACF regulation will be addressing the microbiological hazards in
such food. We therefore conclude that a more reasonable interpretation
of section 805(e)(3) than what we originally proposed to adopt is that
Congress intended to exempt from the FSVP requirements the activities
of a facility that are subject to the LACF regulation in part 113 with
respect to microbiological hazards.
    Based on this interpretation, we are applying section 805(e)(3) not
only to the importation of LACF produced by foreign suppliers subject
to and in compliance with the LACF regulation, but also to the
importation of raw materials and other ingredients by U.S. facilities
for use in manufacturing or processing LACF. Therefore, Sec.
1.502(b)(2) of the final rule states that with respect to
microbiological hazards that are controlled by part 113, an importer is
not required to comply with the FSVP requirements for raw materials or
other ingredients that it imports for use in the manufacturing or
processing of LACF provided that the importer is in compliance with
part 113 with respect to the LACF that it manufactures or processes
from the imported raw materials or other ingredients. With respect to
all hazards other than microbiological hazards that are controlled by
part 113, the importer must have an FSVP for the raw materials and
other ingredients that it uses in the manufacture or processing of
LACF.
    (Comment 108) One comment requests that we advise importers of

LACF to conduct finished product testing for typical pathogens and
spoilage organisms because finished canned goods can be contaminated
and might be used in producing other products.
    (Response 108) We do not agree that periodic sampling and testing
of an imported LACF would be an appropriate means of verifying control
of all hazards in such food. The primary hazard of concern for LACF is
C. botulinum toxin, and strict controls as required under part 113 are
needed to address this hazard. Sampling and testing cannot provide
statistically valid assurance that potential pathogens in LACF products
are adequately controlled.
    Section 805(e) of the FD&C Act states that the section does not
apply to LACF facilities that are required to comply, and are in
compliance, with the FDA standards and regulations on LACF, but only
with respect to the microbiological hazards regulated under part 113.
In accordance with section 805(e), Sec.  1.502(b) of the final rule
provides that with respect to those microbiological hazards that are
controlled under part 113, an importer of an LACF must verify and
document that the food was produced in accordance with part 113. An
importer of an LACF would not know if it was importing the food from a
foreign supplier whose facility was in compliance with part 113 (and
thus eligible for the exemption from section 805 with respect to
microbiological hazards) unless it conducted some appropriate form of
verification. Although the proposed rule suggested that an audit would
be an appropriate form of verification, we conclude than an audit might
not be necessary. Although the importer may still choose to do an
audit, an appropriate verification activity might also be reviewing the
scheduled processes and processing and production records required
under part 113 that relate to the specific LACF being offered for
import, as well as verifying that cans are not swollen or leaking. With
respect to hazards other than microbiological hazards controlled under
part 113 that an importer might identify, an importer of an LACF must
have an FSVP as specified in Sec.  1.502(a). For such an FSVP, sampling
and testing might be appropriate verification activities in addition to
an audit (or an audit might be used to verify control of non-microbial
as well as microbial hazards).
    (Comment 109) One comment, noting that proposed Sec.  1.502(b) does
not address acidified foods, states that if we intentionally omitted
acidified foods from Sec.  1.502(b), we should provide a rationale for
treating acidified food differently than LACF.
    (Response 109) The provisions regarding LACF in Sec.  1.502(b)
reflect the statutory exemption (in section 805(e) of the FD&C Act)
from the FSVP requirements for microbiological hazards in LACF. There
is no analogous statutory exemption for acidified foods.
    An importer of acidified foods can consider the processor's current
scheduled processes, established in accordance with the regulation on
acidified foods in part 114 (21 CFR part 114), when conducting the
hazard analysis required in Sec.  1.504 and the evaluation required in
Sec.  1.505. An importer of acidified foods could, through its hazard
analysis, determine that the microbiological hazards associated with
the imported food are addressed by controls in the supplier's scheduled
processes established under part 114. In turn, an importer of acidified
foods can consider the processor's current procedures when determining
what supplier verification activities are appropriate. For example, an
importer might determine that reviewing its foreign supplier's
validated scheduled process and records and reports is an appropriate
supplier verification activity. As another example, it may be
appropriate for an importer to review its foreign supplier's procedures
for complying with the requirements of part 114, including frequent
testing and recording of results, to verify that the finished
equilibrium pH values for an acidified food are not higher than 4.6
(see Sec.  114.80(a)(2)) and to confirm the response to any deviations
from scheduled processes (see Sec.  114.89).
3. Importers in Compliance With Supply-Chain Program Provisions in the
Preventive Controls Regulations
    In the Supplemental Notice, we proposed to specify (in Sec.
1.502(c)) that if an importer was required to establish and implement a
risk-based supplier program under the preventive controls regulations
(for either human or animal food), and the importer was in compliance
with the supplier program requirements in those regulations, the
importer would be deemed in compliance with the FSVP regulation (except
for the requirement to identify the importer at entry of the food into
the United States). We proposed this change in response to several
comments and consistent with our intent (as stated in the preambles of
the proposed rules on FSVP and preventive controls for human food) to
avoid imposing redundant supplier verification requirements on
importers that also are food facilities that would be required to
comply with any supplier verification provisions in the preventive
controls regulations.
    (Comment 110) Although the comments agree that there should not be
redundant supplier verification requirements under the FSVP and
preventive controls regulations, the comments differ in their views on
how the regulations should achieve this. Some comments state that,
rather than deem importers in compliance with the preventive controls
supplier program provisions to be in compliance with the FSVP
requirements, the regulations should deem receiving facilities that are
in compliance with the FSVP requirements to be in compliance with the
preventive controls supplier program provisions. One comment suggests
that the preventive controls supplier program requirements be applied
only to verification of domestic suppliers unless the imported food was
exempt from the FSVP requirements. However, some comments assert that
entities subject to the preventive controls regulations are in a better
position to determine the safety of imported ingredients in the context
of the finished food product. Some comments request that the FSVP and
preventive controls final rules allow for recognition of supplier
verification performed under either rule, even if the verification was
performed by a third party. Some comments request that the preventive
controls regulations include a provision exempting from the supplier
program requirements any food that had already been subject to
verification under the FSVP regulation, even if the verification was
conducted by a third party. Some comments suggest that a facility
receiving such food for processing should be required to ensure that
the importer met its FSVP obligations; one comment suggests that such a
facility be required to annually obtain written assurance of FSVP
compliance from the importer.
    (Response 110) We conclude that it is appropriate, under Sec.
1.502(c)(3) of the final rule, to deem to be in compliance with most of
the FSVP requirements those importers that are receiving facilities
that have established and implemented a risk-based supply-chain program
in compliance with the regulations on preventive controls for human
food or animal food (subpart G of part 117 and subpart E of part 507,
respectively). Given that we have aligned the supply-chain program
provisions of the preventive controls regulations and the FSVP
requirements to the extent appropriate and feasible, the preventive
controls regulations

allow importers that are receiving facilities to take advantage of that
fact so they do not have to conduct duplicative verification
activities. Under the preventive controls regulations, receiving
facilities that are importers in compliance with the FSVP requirements
and have documentation of activities conducted under Sec.  1.506(e)
need not conduct verification activities for that raw material or other
ingredient (see Sec. Sec.  117.405(a)(2) and 507.105(a)(2)). The issue
of what, if any, additional effect the preventive controls regulations
should give to an importer's FSVP is beyond the scope of this
rulemaking. However, we note that importers that are receiving
facilities might obtain raw materials and other ingredients from both
domestic and foreign suppliers. Given that receiving facilities should
already be complying with other provisions in the preventive controls
regulations, we believe that the preventive controls regulations avoid
unnecessary duplication while ensuring that raw materials and other
ingredients from both domestic and foreign suppliers are subject to
appropriate verification activities.
    In addition, we have broadened Sec.  1.502(c) to include not just
those importers that have implemented a supply-chain program in
accordance with the preventive controls regulations, but also two other
circumstances in which the importer is also a food facility. These
circumstances are:
     When the importer/facility is not required to have a
supply-chain program under the preventive controls regulations because
it implements preventive controls for the hazards in the food in
accordance with Sec.  117.135 or Sec.  507.34; and
     When the importer/facility is not required to implement a
preventive control under Sec.  117.136 or Sec.  507.36 (e.g., because
the food is a type of food that cannot be consumed without application
of an appropriate control, or because the facility's customer or a
subsequent entity in the distribution chain is controlling the hazards
and certain other conditions are met).
    In the Supplemental Notice, we proposed to specify, in Sec.
1.504(g) of the proposed regulations, that if the preventive controls
an importer and/or its customer implemented in accordance with the
preventive controls regulations were adequate to significantly minimize
or prevent all significant hazards in an imported food, the importer
would not be required to determine appropriate foreign supplier
verification and related activities or to conduct any such activities.
We included Sec.  1.504(g) in the revised proposed rule because
proposed Sec.  1.502(c) did not encompass certain circumstances in
which a receiving facility is not required to have a supply-chain
program for a raw material or other ingredient.
    Rather than separately specify, in Sec.  1.504(g), the requirements
for importers that control all hazards requiring a control, we have
broadened the scope of Sec.  1.502(c) to incorporate these
circumstances. Thus, Sec.  1.502(c)(1) specifies that if an importer is
a receiving facility that implements preventive controls for the
hazards in a food in accordance with Sec.  117.135 or Sec.  507.34,
then the importer is deemed to be in compliance with the FSVP
regulation, except for the requirement to identify the importer at
entry in Sec.  1.509.
    In addition, Sec.  1.502(c)(2) of the final rule deems in
compliance with the FSVP regulation (except the requirements of Sec.
1.509) importers that are food facilities who are not required to
implement a preventive control for a hazard in a food they import in
accordance with Sec.  117.136 or Sec.  507.35 (in the regulations on
preventive controls for human food and animal food, respectively).
Under those provisions, a food manufacturer/processor is not required
to implement a preventive control when it identifies a hazard requiring
a preventive control and one of the following applies:
     The manufacturer/processor determines and documents that
the type of food (e.g., a RAC such coffee beans) could not be consumed
without application of an appropriate control (see Sec. Sec.
117.136(a)(1) and 507.36(a)(1));
     The manufacturer/processor relies on its customer who is
subject to the preventive controls requirements to ensure that the
identified hazard will be significantly minimized or prevented, and the
manufacturer/processor meets certain disclosure (i.e., that the food
has not been processed to control identified hazards) and written
assurance requirements (see Sec. Sec.  117.136(a)(2) and 507.36(a)(2));
     The manufacturer/processor relies on its customer who is
not subject to the preventive controls requirements to provide
assurance it is manufacturing, processing, or preparing the food in
accordance with the applicable food safety requirements, and the
manufacturer/processor meets certain disclosure and written assurance
requirements (see Sec. Sec.  117.136(a)(3) and 507.36(a)(3));
     The manufacturer/processor relies on its customer to
provide assurance that the food will be processed to control the
identified hazard by an entity in the distribution chain subsequent to
the customer and the manufacturer/processor meets certain disclosure
and written assurance requirements (see Sec. Sec.  117.136(a)(4) and
507.36(a)(4)); or
     The manufacturer/processor has established, documented,
and implemented a system that ensures control, at a subsequent
distribution step, of the hazards in the food it distributes (see
Sec. Sec.  117.136(a)(5) and 507.36(a)(5)).
    We conclude that it is appropriate to exempt from the FSVP
requirements importers that are facilities importing a food and acting
in accordance with Sec.  117.136 or Sec.  507.36 with respect to that
food, because compliance with those requirements will provide adequate
assurance of the safety of this food. The FSVP regulation contains
similar provisions regarding foods that cannot be consumed without
application of a control and foods whose hazards will be controlled by
the importer's customer or a subsequent entity in the distribution
chain. These provisions, which appear in Sec.  1.507 of the final rule,
are discussed in section III.H of this document. Because these FSVP
provisions so closely align with the preventive controls regulations,
we see no need for importers that are receiving facilities to have to
comply with both Sec. Sec.  1.507 and 117.136 or Sec.  507.36, as
applicable. Although the preventive controls regulations do not include
a provision comparable to Sec.  1.502(c)(2) that deems receiving
facilities that are importers to be in compliance with Sec.  117.136 or
Sec.  507.36 if they are in compliance with Sec.  1.507 in the FSVP
regulation, we do not believe that such receiving facilities need to
comply with these provisions in both the FSVP and preventive controls
regulations. Therefore, we intend to consider receiving facilities that
are importers to be in compliance with Sec.  117.136 or Sec.  507.36,
as applicable, if they are in compliance with Sec.  1.507.
    (Comment 111) One comment asks that we state how we will certify
that an importer/facility is in compliance with the preventive controls
supplier program requirements.
    (Response 111) Although we will inspect food facilities for
compliance with the preventive controls regulations, including the
supply-chain program provisions, we will not ``certify'' or otherwise
designate a facility as being in compliance with the supply-chain
program requirements. Rather, an importer that expects to be deemed in
compliance with most of the FSVP requirements under Sec.  1.502(c)(3)
will be responsible for ensuring that it is in compliance with the
supply-chain program provisions of the preventive

controls regulations and will need to be able to demonstrate its
compliance during an inspection.
    (Comment 112) Some comments suggest that Sec.  1.502(c) should
specify Sec.  507.37 rather than Sec.  507.43 to refer to the supplier
program provisions in the regulations on preventive controls for animal
food.
    (Response 112) Because the supply-chain program provisions in the
regulations on preventive controls for animal food are in subpart E of
part 507, Sec.  1.502(c)(3) of the FSVP final rule cites that subpart.
4. Importer Whose Customer Is in Compliance With the Preventive
Controls Supply-Chain Program Requirements
    We proposed, in Sec.  1.502(d), that if an importer's customer was
required to establish and implement a risk-based supply-chain program
under the preventive controls regulations (for either human or animal
food), and the importer annually obtained written assurance that its
customer was in compliance with those requirements, the importer would
be deemed in compliance with the FSVP regulation (except for the
requirement to identify the importer at entry of the food into the
United States and the requirement to maintain records of the written
assurances).
    We conclude that it is appropriate to address verification
requirements that apply when an importer's customer controls the
hazards in an imported food in the same provisions as those that apply
to control of hazards by entities after the importer's customer in the
U.S. distribution chain. As previously stated, these provisions are set
forth in Sec.  1.507 of the final rule. In section III.H.2 of this
document we discuss Sec.  1.507 and respond to the comments we received
regarding proposed Sec.  1.502(d) concerning importers whose customers
are in compliance with the supply-chain program provisions of the
preventive controls regulations.

D. Personnel Developing and Performing FSVP Activities (Sec.  1.503)

    We proposed to require, in Sec.  1.503, that importers use a
qualified individual to conduct most FSVP activities, and provided
several exceptions to this proposed requirement. We then updated this
proposal in the Supplemental Notice with a revised reference to one of
the exceptions and deleted one of the exceptions because it was no
longer applicable under the changes to the proposed rule provided by
the Supplemental Notice. As the proposal was updated in the
Supplemental Notice, the exceptions to the requirement to use a
qualified individual were the activities required under proposed
Sec. Sec.  1.506(a) (procedures to ensure the importation of food from
approved suppliers), 1.509 (identification of the importer at entry),
1.510 (recordkeeping), 1.511(c)(2) (procedures to ensure the
importation of dietary supplements from approved suppliers), and
1.512(b)(5) (recordkeeping by very small importers).
    In addition, as stated in sections III.A.18 and III.A.19 of this
document, we have concluded that it is appropriate to specify the
general qualifications that qualified individuals and qualified
auditors must have in provisions outside of the definitions of those
terms--specifically, in Sec.  1.503 of the final rule. Under Sec.
1.503(a), a qualified individual must have education, training, or
experience (or a combination thereof) necessary to perform their
assigned activities and must be able to read and understand the
language of any records that must be reviewed in performing an
activity. Under Sec.  1.503(b), a qualified auditor must conduct any
audit conducted in accordance with Sec.  1.506(e)(1)(i) or Sec.
1.511(c)(5)(i)(A) and must have technical expertise obtained through
education, training, or experience (or a combination thereof) necessary
to perform the auditing function.
    In the final rule, for several reasons we are eliminating the
proposed exemption of the performance of certain FSVP activities from
the requirement to use a qualified individual, as well as the proposed
exemption for certain importers from having to use a qualified
individual to meet FSVP requirements. First, requiring use of a
qualified individual to meet all FSVP requirements is consistent with
the goal of aligning the FSVP regulation with the preventive controls
regulations. Those preventive controls regulations (Sec. Sec.
117.4(a)(2) and 507.4(a)(2)) require that every person engaged in the
manufacturing, processing, packing, or holding of food subject to the
preventive controls regulations, including the supply-chain program
provisions, must be a qualified individual. This requirement applies to
all tasks related to these activities, including such tasks as ensuring
the receipt of food from approved suppliers and recordkeeping.
    Second, we note that the FSVP final rule makes the definition and
requirements for qualified individuals more flexible and less
burdensome than as originally proposed, thus making the requirement
applicable to a wider variety of tasks. Instead of a qualified
individual having to possess necessary education, training, and
experience (as we initially proposed), the final rule states that a
qualified individual must have education, training, or experience--or a
combination of these elements--necessary to perform an assigned FSVP
activity. This allows importers more flexibility in meeting the
requirement to have qualified individuals perform required tasks. This
also means that the final rule does not require any particular
education, training, or experience beyond what is needed to
successfully perform the FSVP task to which the qualified individual is
assigned, whether the task is a core component of the FSVP requirements
(e.g., hazard analysis, supplier verification activities) or something
requiring expertise not necessarily directly related to food safety,
such as recordkeeping or ensuring that the importer is identified as
the FSVP importer for the food at entry. In light of the revised
definition of a qualified individual, we conclude that a person who
meets the definition should always perform any activity required under
the FSVP regulation. Any other individual might not necessarily have
the ability to effectively perform the activity.
    With respect to the proposed exemption from the use of a qualified
individual requirement for the development of procedures to ensure the
use of approved foreign suppliers, we note that in the Supplemental
Notice we had substituted the requirement to establish and follow such
procedures for a proposed requirement (set forth in the proposed rule)
to maintain a written list of foreign suppliers. That change
effectively transformed this requirement from an administrative one to
a substantive one. Requiring use of a qualified individual for
developing and implementing procedures to ensure the use of approved
suppliers is consistent with the principle stated in the preamble to
the proposed rule that education and training are important to ensure
the development of FSVPs. Similarly, although recordkeeping and
ensuring that the importer is properly identified as the importer of
the food at entry may require comparably less food safety training and
experience, we conclude that persons responsible for meeting these FSVP
requirements should have the education, training, and/or experience
needed to effectively perform these tasks.
    In the proposed rule, we also proposed to exempt from the
requirement to use a qualified individual the following types of
importers:

     Importers of certain dietary supplements and dietary
supplement components who are in compliance with proposed Sec.
1.511(a) or (b); and
     Importers of food from foreign suppliers in countries
whose food safety systems FDA has recognized as comparable or
determined to be equivalent to that of the United States in accordance
with proposed Sec.  1.513.
    Although the modified FSVP requirements applicable to these
importers under Sec. Sec.  1.511(a) and (b) and 1.513 of the final rule
are limited (in the case of Sec.  1.511(a) and (b), to recordkeeping
and/or identification of the importer at entry), we believe that it is
nevertheless appropriate that persons with necessary education,
training, and/or experience perform the tasks required under these
provisions.
    (Comment 113) One comment on proposed Sec.  1.503 states that
importers should not be required to have a qualified individual conduct
the review of a foreign supplier's food safety records.
    (Response 113) We do not agree. We conclude that to adequately
review and understand a foreign supplier's food safety records, a
person must have adequate education, training, and/or experience
regarding the food safety operations addressed in the records,
including, where applicable, training in the principles of hazard
analysis and risk-based preventive controls and measures to ensure
produce safety. Review of food safety records requires an understanding
of the applicable food safety principles.
    (Comment 114) One comment states that a foreign government employee
who is designated as a qualified individual by the foreign government
should have the authority to conduct any kind of verification
activities under the FSVP regulations without having to be accredited
as a third-party auditor.
    (Response 114) The importer of a food, not a foreign government or
any other entity, is responsible for determining whether a person who
is to conduct FSVP activities has the education, training, and/or
experience necessary to conduct those activities in accordance Sec.
1.503(a) of the final rule. The FSVP regulations do not require that a
qualified auditor or qualified individual be accredited under any
accreditation scheme or system, including FDA's regulations on the
accreditation of third-party certification bodies implementing section
808 of the FD&C Act, as long as the person otherwise satisfies the
requirements to be a qualified auditor or individual under Sec.  1.503.

E. Hazard Analysis (Sec.  1.504)

    In the Supplemental Notice, we made several changes to the proposed
requirements concerning importers' analysis of the hazards in the foods
they import in response to several comments and to align the FSVP
requirements with the proposed supply-chain program provisions in the
preventive controls regulations. These revisions primarily involved
changing the requirement to analyze hazards that are reasonably likely
to occur to a requirement to analyze known or reasonably foreseeable
hazards (to determine if these hazards are significant), as well as the
addition of a proposed requirement that importers consider hazards
intentionally introduced for purposes of economic gain.
    As discussed in the following paragraphs, we are making several
additional changes to the hazard analysis provisions in response to
comments. We also are adding flexibility by broadening the proposed
provision allowing an importer to rely on a hazard analysis conducted
by its foreign supplier (rather than conducting an entirely separate
evaluation of hazards using information that the importer itself has
obtained). As described further in the following paragraphs, the final
rule permits reliance on a hazard analysis conducted by additional
entities in importers' supply chains.
1. General
    (Comment 115) Some comments suggest that the hazard analysis
provisions in the FSVP regulations should cross-reference the hazard
analysis provisions in the regulations on preventive controls for human
food.
    (Response 115) We conclude that this is not necessary or
appropriate. Although the hazard analysis provisions in the two
regulations are very similar, there are some differences in the
requirements that primarily reflect the difference in scope between the
FSVP regulation and the preventive control for human food regulation.
The former generally apply to importers who must analyze the hazards in
the foods produced by their foreign suppliers, while the latter
primarily apply to food facilities that must determine the hazards for
the food that they themselves manufacture, process, pack, or hold.
    (Comment 116) Some comments request that we not apply the FSVP
regulation to any food until we have conducted a risk assessment and
made a risk management determination for each food according to
internationally agreed standards and after public comment. The comments
assert that requiring importers to identify hazards and conduct
verification will cause small businesses to withdraw from the market or
choose too carefully which products to import and from which geographic
regions, stifling international trade. The comments maintain that this
will happen not because there are hazards in particular foods but
because the importer or foreign supplier cannot scientifically identify
it or because the verification requirements will be unnecessarily
stringent or costly for most foods. However, the comments assert that
most foods do not present a food safety risk and that there is no
scientific proof that specific foods covered by FSMA are unsafe or need
to be made safer.
    The comments also assert that we must conduct the risk assessments
to meet U.S. obligations under the SPS Agreement. The comments object
to what they regard as FDA's shifting of its obligation to conduct risk
assessments to the private sector by requiring importers to conduct
hazard analyses.
    The comments also request that that the FSVP regulations be applied
only to designated high-risk foods for at least 5 years after we have
designated such foods.
    (Response 116) We do not agree with the suggested approach to the
determination of risks in imported foods. There are known hazards in
many types of food, and many types of domestic and foreign foods have
been identified as the source of foodborne illness outbreaks in the
United States. As stated previously, we conclude that it is appropriate
to require importers to analyze the hazards in the foods they import
and conduct foreign supplier verification activities that take into
account the risks posed by these hazards and provide assurances that
suppliers are following procedures to ensure food safety consistent
with U.S. standards, including the preventive controls and produce
safety regulations. Therefore, we do not believe that the comments
provide a justification for requiring that we conduct individual risk
assessments of specific foods before we require importers to conduct
hazard analyses and supplier verification activities. However, we note
that to the extent that the comments express particular concern about
the ability of smaller entities to comply with the FSVP regulations,
Sec.  1.512 of the final rule (discussed in section III.M of this
document) specifies modified requirements for very small importers

and importers of food from certain small foreign suppliers.
    We also deny the request that the FSVP regulation be applied only
to foods that we have designated as high risk for at least 5 years
after we make such designations. Under the regulation, importers will
be responsible for determining the hazards in the food they import,
evaluating the risk posed by that food and the characteristics of the
foreign supplier, and determining appropriate foreign supplier
verification activities based on that evaluation. Thus, the regulation
allows importers the flexibility to tailor the supplier verification
they conduct to the nature of the risks posed by the foods they import.
In addition, as discussed in section IV.B of this document, we are
providing considerable time for importers to adjust their procedures
and practices (if necessary) to come into compliance with the
regulation. Consequently, we conclude that it is unnecessary and not in
the interest of public health to delay implementation of the FSVP
regulation until we conduct risk assessments and designate high-risk
foods, or to limit the scope of the regulation to high-risk foods for 5
years.
2. Requirement To Conduct a Hazard Analysis
    We proposed to require that an importer identify and evaluate,
based on experience, illness data, scientific reports, and other
information, known or reasonably foreseeable hazards for each food it
imports to determine whether there are any significant hazards
(proposed Sec.  1.504(a)). We further proposed to define a
``significant hazard'' as a known or reasonably foreseeable hazard for
which a person knowledgeable about the safe manufacturing, processing,
packing, or holding of food would, based on the outcome of a hazard
analysis, establish controls to significantly minimize or prevent the
hazard in a food and components to manage those controls (such as
monitoring, corrections and corrective actions, verification, and
records), as appropriate to the food, the facility, and the control.
    We also proposed that the hazard analysis be written (proposed
Sec.  1.504(a)).
    As discussed in section III.A.11 of this document, the final rule
uses the term ``hazard requiring a control'' instead of ``significant
hazard.'' Following is a discussion of comments on other aspects of the
proposed hazard analysis requirements in Sec.  1.504(a).
    (Comment 117) One comment requests that we replace ``illness data''
with ``FDA foodborne illness data'' to ensure that a review of illness
data is based on a well-known and relatively easy-to-access source of
information.
    (Response 117) We decline to make the change because illness data
from any reliable source, not just FDA, would be relevant in evaluating
known or reasonably foreseeable hazards. For example, importers might
consider data on foodborne illnesses published by the Centers for
Disease Control in determining whether hazards that cause such
illnesses are hazards that require a control.
    (Comment 118) Some comments ask that we change proposed Sec.
1.504(a) to refer to ``experience, illness data, scientific reports, or
other information'' instead of ``and other information'' because they
believe that there might not be any such data or reports regarding
animal food.
    (Response 118) We decline this request. We agree that in some cases
some of the specified types of information might not be available. For
example, there would be no illness data for a food that has never been
associated with a foodborne illness. However, changing the provision as
requested would allow importers to choose which information to
evaluate, irrespective of whether the information is available. We
conclude that importers must consider each of these types of
information--to the extent that each type exists for a food--in
conducting a hazard analysis.
    (Comment 119) One comment suggests that importers should be
required to evaluate known or reasonably foreseeable hazards for each
``type of food'' rather than each ``food.'' The comment maintains that
it would be unnecessarily burdensome to require a separate hazard
analysis for each individual food imported; instead, the comment
requests that importers be permitted to group foods appropriately by
type for purposes of hazard analysis.
    (Response 119) We agree and have changed Sec.  1.504(a)
accordingly. We conclude that it might be appropriate to analyze the
hazards for a particular type of food, rather than an individual food
product, if the resulting determination of hazards requiring a control
will apply for all foods of this type. For example, it might be
appropriate to conduct a hazard analysis for multiple product sizes of
a particular food, or to conduct one hazard analysis applicable to two
or more related foods that are manufactured, processed, grown, or
harvested under very similar conditions if all such food involves the
same hazards. However, if foods that might be said to be of the same
``type'' have different hazards that require a control, it generally
would not be appropriate to use the same hazard analysis for each of
those foods.
3. Hazard Identification
a. General Types of Hazards
    We proposed to require, in Sec.  1.504(b)(1), that an importer's
analysis of the known or reasonably foreseeable hazards in each food
include the following types of hazards:
     Biological hazards, including microbiological hazards such
as parasites, environmental pathogens, and other pathogens;
     Chemical hazards, including radiological hazards,
pesticide and drug residues, natural toxins, decomposition, unapproved
food or color additives, and food allergens; and
     Physical hazards.
    (Comment 120) Some comments ask that we delete ``decomposition''
from the listing of chemical hazards. The comments assert that many
products used in the animal food industry have begun decomposition but
are processed in a controlled system to halt decomposition before
harmful toxins are formed. The comments maintain that the inclusion of
``natural toxins'' among chemical hazards addresses the Agency's
concerns about hazards associated with uncontrolled decomposition or
spoiled foods resulting from chemical changes induced by the microbial
breakdown that releases potentially hazardous toxins, and that
including ``decomposition'' would be redundant and unnecessary because
some levels of decomposition do not pose an animal food safety risk.
    (Response 120) We decline to make this change. Decomposition of
animal food consists of microbial breakdown of normal food product
tissues and the subsequent enzyme-induced chemical changes. These
changes are manifested by abnormal odors, tastes, textures, colors,
etc., and can lead to reduced food intake or rejection of the food by
the intended animal species, potentially resulting in illness or death.
Thus, decomposition can be a hazard requiring a control in animal food.
    (Comment 121) Some comments ask that we add the term ``nutrient
deficiencies or toxicities'' to the list of chemical hazards because
animal safety is related to established nutrient deficiencies and
toxicities.
    (Response 121) We agree that nutrient deficiencies or toxicities
may be hazards in animal food (for reasons discussed in the preventive
controls for animal food rulemaking) and have revised the list of
chemical hazards accordingly.

b. Reasons for Presence of a Hazard
    We proposed to require, in Sec.  1.504(b)(2), that an importer's
analysis of hazards include hazards that may be present in a food for
any of the following reasons:
     The hazard occurs naturally;
     The hazard may be unintentionally introduced; or
     The hazard may be intentionally introduced for purposes of
economic gain.
    (Comment 122) Several comments object to the proposed requirement
to consider hazards that might be intentionally introduced for purposes
of economic gain. Some comments assert that because economically
motivated adulteration (EMA) is nearly always an issue of product
quality and integrity rather than food safety, requiring importers to
consider EMA hazards would provide little benefit to food safety. Some
comments suggest that it would not be appropriate to require
consideration of EMA hazards because such hazards often are addressed
by a corporate parent company rather than at the facility level. Some
comments maintain that addressing EMA requires a completely different
approach than that used for unintentional adulteration and that it
would be better to address EMA in an importer's food defense plan. Some
comments therefore request that we consider proposing regulations on
EMA in a future rulemaking rather than in the FSVP regulation.
    (Response 122) We decline to delete this requirement. EMA can and
has resulted in safety concerns, including, as in the case of melamine
in infant formula and pet food, the deaths of humans and animals. The
fact that a plan for addressing EMA might be developed at the corporate
level is irrelevant to whether an importer can determine whether EMA in
a particular food is known or reasonably foreseeable. Further, we
disagree that economically motivated adulteration requires a completely
different approach than unintentional adulteration. Although we
acknowledge that many firms currently might not include EMA in their
analyses of safety hazards in food, as we stated in the Supplemental
Notice, some of the measures that industry uses in supplier
verification programs, such as audits and sample testing, are used to
guard against EMA. Moreover, we believe that the burden posed by having
to analyze potential EMA hazards is limited because, as with hazards
that occur naturally or that may be unintentionally introduced, we
define hazards to include only those agents that have the potential to
cause illness or injury. In the EMA context, we anticipate that
importers will identify such hazards in rare circumstances, usually in
cases where there has been a pattern of economically motivated
adulteration of a food. Therefore, we conclude it is appropriate that
importers consider EMA hazards under the FSVP regulation.
    (Comment 123) Some comments assert that it would be more
appropriate to address EMA hazards separately from the hazard analysis
because they are not considered as part of the hazard analysis when
designing a food safety plan; rather, the comments maintain that EMA
should be considered as part of supplier verification.
    (Response 123) We do not agree. Importers are required to conduct a
hazard analysis under Sec.  1.504 of the final rule precisely to
understand what manner of supplier verification under Sec.  1.506 is
needed and appropriate. Therefore, importers need to evaluate EMA as
part of the hazard analysis for a food so that, if EMA is determined to
be a hazard requiring a control for that food, importers can conduct
appropriate suppler verification activities to obtain assurance that
the food has not been intentionally adulterated for economic gain.
    (Comment 124) One comment asserts that looking retrospectively at
instances of economic adulteration might not be effective because it
would be less likely that others would engage in such activity in the
future.
    (Response 124) We are not aware of evidence supporting the
comment's assertion. However, given that it would not be feasible or
appropriate to require importers to speculate about, and guard against,
any conceivable form of EMA of a food, we conclude that it is
reasonable to require importers to consider, among other things,
whether a food has been previously linked to EMA that might cause harm
to consumers.
    (Comment 125) Some comments assert that the analysis of hazards
intentionally introduced for economic gain should be limited to whether
there is a history of any particular EMA. Some comments request that we
limit the requirement to consider hazards that might be intentionally
introduced for economic gain to such hazards that are ``already known''
or for which there is a ``historical precedent.''
    (Response 125) As with other hazards, importers need only consider
EMA hazards that are known or reasonably foreseeable. This means that
importers are not required to consider purely speculative hazards. We
expect that EMA hazards will be identified in rare circumstances,
usually in cases where there has been a pattern of EMA in the past. The
revisions suggested by the comments are unnecessary and could be
interpreted to narrow the requirement that importers consider hazards
that are known or reasonably foreseeable. We continue to believe that
this requirement is appropriate, even for EMA, and we reiterate that we
would not expect importers to consider merely hypothetical EMA
scenarios for their food products. This is consistent with our position
on EMA in the preventive controls regulations.
    (Comment 126) One comment requests that if the requirement to
consider EMA is included in the final rule, it should be limited to
``food safety'' hazards that might be intentionally introduced for
economic gain.
    (Response 126) We conclude that this change is unnecessary. Because
``hazards'' are defined as certain agents that are reasonably likely to
cause illness or injury, the requirement to consider hazards that might
be introduced for purposes of economic gain is already limited to EMA
that relates to food safety. EMA that relates to the quality of food
(for example) but not food safety is beyond the scope of this
rulemaking.
    (Comment 127) Some comments request that importers be given
flexibility to determine appropriate verification activities for EMA
hazards. Some comments assert that testing should not be the only
suitable control or verification measure for EMA because for many
facilities it would be impractical to test every imported lot of
ingredients.
    (Response 127) Section 1.506 of the final rule provides importers
flexibility in determining appropriate supplier verification activities
for all hazards--including EMA--consistent with the evaluation of the
risk posed by a food and the foreign supplier's performance, among
other factors, conducted in accordance with Sec.  1.505.
    (Comment 128) Some comments suggest that we publish a list of
previous instances of EMA that importers should use in considering
possible EMA hazards.
    (Response 128) Although we agree that it would be useful to have a
centralized list involving all previous instances of EMA, creating such
a list would likely be unduly resource-intensive for FDA and therefore
would not be consistent with the efficient enforcement of section 805
of the FD&C Act. We therefore decline this request. We note, however,
that information about incidents of EMA is widely

available from public sources (Refs. 10-12).
    (Comment 129) One comment asks that we require importers to
identify harmless economically motivated adulterants during the review
process.
    (Response 129) Although we encourage importers to identify--and
verify control of--all EMA, we think it is appropriate to treat EMA
consistently with our general approach to hazard analysis and only
require identification of those agents that have the potential to cause
illness or injury. We therefore decline this request.
4. Hazard Evaluation
a. Probability and Severity of Hazards
    We proposed in Sec.  1.504(c)(1) to require that the importer's
hazard analysis include an assessment of the probability that hazards
will occur in the absence of controls and the severity of the illness
or injury if the hazards were to occur.
    (Comment 130) Some comments suggest that the provision should
require importers to consider any relevant geographic, temporal,
agricultural, or other factors that might affect the severity or
probability of a hazard.
    (Response 130) We do not believe it is appropriate to address these
factors within the basic requirement to assess the probability that
hazards will occur in the absence of controls and the severity of
illness or injury if the hazards were to occur. Rather, we think that
this requirement, stated in Sec.  1.504(c)(1), establishes the general
scope of the hazard analysis. However, we agree that such factors might
be relevant in a hazard evaluation for a food, such as year-to-year
fluctuation of aflatoxin levels in some RACs due to weather conditions.
We therefore believe it is appropriate to include these factors in the
list of factors that must be considered in the hazard evaluation
required under Sec.  1.504(c)(3) of the final rule. Thus, we have
revised the list of factors that a hazard evaluation must address under
Sec.  1.504(c)(3) to include, among ``other relevant factors,'' the
temporal (e.g., weather-related) nature of some hazards, such as levels
of natural toxins.
b. Environmental Pathogens in Certain Ready-To-Eat Foods
    We proposed that a hazard evaluation would have to include an
evaluation of environmental pathogens whenever a ready-to-eat food is
exposed to the environment before packaging and the packaged food does
not receive a treatment that would significantly minimize the pathogen
(proposed Sec.  1.504(c)(2)).
    In the final rule, we have revised this requirement to specify that
instead of receiving a treatment to significantly minimize the
pathogen, the ready-to-eat food might include a control measure (such
as a formulation that is lethal to the pathogen) that would
significantly minimize the pathogen, because controls such as
formulation can function as a ``kill step,'' and the provision should
make clear that such controls can be used in lieu of ``treatment.''
This change is consistent with corresponding provisions in the
preventive controls regulations.
    (Comment 131) Some comments ask that we expand the requirement to
evaluate environmental pathogens to include all foods, not just certain
ready-to-eat foods.
    (Response 131) We conclude that this change is not needed because
importers will be required, under Sec.  1.504(b)(1)(i), to consider
whether there are any known or reasonably foreseeable environmental
pathogens in a food. The requirement in Sec.  1.504(c)(2) is designed
to address the specific safety concern known to be associated with
ready-to-eat foods that are exposed to the environment before packaging
and would not undergo treatment (or otherwise include a control
measure) to significantly minimize environmental pathogens.
    (Comment 132) One comment requests that we limit the requirement
concerning ready-to-eat foods that are exposed to the environment to
such foods that are ``capable of supporting pathogen growth to, or
survival at, infectious levels.''
    (Response 132) We decline to make this change because this
suggestion prejudges the outcome of the hazard analysis for a wide
variety of food products. An importer may consider factors such as
whether the formulation of a food would not support the growth of a
pathogen to increased numbers, or would cause pathogens to die off over
time, in determining whether an environmental pathogen is a hazard
requiring a control. If an importer determines that any environmental
pathogens in a ready-to-eat food would not pose a hazard that requires
a control, the importer would need to document the basis for that
determination in its written hazard analysis.
    (Comment 133) Some comments request that we delete this proposed
requirement or define what is meant by a ready-to-eat food that is
``exposed to the environment.''
    (Response 133) We decline this request. The Appendix to the 2013
proposed rule on preventive controls for human food provides examples
of food products that are, or are not, exposed to the environment (78
FR 3646 at 3819).
    (Comment 134) One comment asks that the requirement specify that a
qualified individual must determine that exposure of the ready-to-eat
food to the environment before packaging would constitute a risk of
introduction of a significant hazard. The comment asserts that a
qualified individual is best suited to make a determination of whether
the exposure poses an actual risk.
    (Response 134) We decline to make this change. As with all
activities required under the FSVP regulation, a qualified individual
must conduct the hazard analysis for each food that the importer
imports. Therefore, it is unnecessary to specify in Sec.  1.504(c)(2)
that a qualified individual must make the determination of whether
exposure to the environment of a ready-to-eat food might result in the
development of an environmental pathogen that requires a control.
c. Hazard Evaluation Factors
    We proposed, under Sec.  1.504(c)(3), that an importer's hazard
evaluation of a food would have to consider the effect of the following
factors on the safety of the finished food for the intended consumer:
    1. The formulation of the food;
    2. The condition, function, and design of the foreign supplier's
establishment and equipment;
    3. Raw materials and ingredients;
    4. Transportation practices;
    5. Harvesting, raising, manufacturing, processing, and packing
procedures;
    6. Packaging and labeling activities;
    7. Storage and distribution;
    8. Intended or reasonably foreseeable use;
    9. Sanitation, including employee hygiene; and
    10. Any other relevant factors.
    (Comment 135) Some comments request that importers be required to
consider the hazard evaluation factors only ``as appropriate'' because
not all factors will be relevant in every case. The comments maintain
that because an importer is not always procuring a finished food, a
hazard analysis of a foreign supplier conducted for FSVP purposes has a
narrower scope than a hazard analysis conducted as part of a food
safety plan. The comments also assert that importers might not always
know all foreseeable uses of an ingredient when initially sourcing it
from a foreign supplier. Therefore, the

comments maintain that importers should have the flexibility to apply
the listed factors as they deem appropriate.
    (Response 135) We decline to require that importers only consider
the hazard evaluation factors ``as appropriate.'' We understand that
importers might import raw materials or other ingredients and that this
might affect how some of the factors are evaluated, such as the
intended use of a raw material that is used in many foods. But
importers must at least consider the potential effect of each of the
factors on the safety of the finished food. If a factor is not relevant
with respect to a particular food, the consideration might be brief.
With regard to the importation of raw materials or other ingredients,
we note that the final rule includes provisions applicable to when an
imported raw material or other ingredient will be processed further in
the United States.
    (Comment 136) Some comments express concern that the proposed
requirement to consider the condition, function, and design of the
foreign supplier's establishment and equipment would necessitate an
onsite audit of the foreign supplier. Some comments request that if
onsite audits are required, we should provide guidance regarding such
audits.
    (Response 136) Importers will not be required to conduct onsite
audits of potential foreign suppliers as part of the hazard analysis of
a food under Sec.  1.504(c)(3)(ii) of the final rule. We have revised
this hazard evaluation factor from the ``condition, function, and
design of the foreign supplier's establishment and equipment'' to the
``condition, function, and design of the establishment and equipment of
a typical entity that manufactures/processes, grows, harvests, or
raises this type of food.'' This change is designed to make clear that
importers must consider how a typical establishment and equipment used
to manufacture/process, grow, harvest, or raise a food affect the
hazards in the food, rather than the potential effect of a particular
foreign supplier's operations. (The requirement to consider a
particular foreign supplier's performance is located in Sec.  1.505 of
the final rule, which sets forth the requirements for evaluation for
foreign supplier approval and verification.) Importers can obtain
information about the nature of establishments that produce a
particular food and the equipment they use by consulting a number of
sources of information other than audits. These may include, for
example, trade journals and other publications, academic literature,
and materials obtained directly from potential foreign suppliers.
    (Comment 137) Some comments suggest that we substitute ``expected
use'' for ``intended or reasonably foreseeable use'' because they
believe that the former is too vague to provide clear direction to
importers and the Agency regarding compliance obligations.
    (Response 137) We decline this request. Although we agree that the
term ``expected use'' has the potential to communicate both intended
and reasonably foreseeable use, we are concerned that the term might
not be universally interpreted that way. For example, an importer might
interpret ``expected use'' to mean ``probable use'' and consequently
not consider reasonably foreseeable uses as part of the hazard
evaluation. Therefore, we are retaining the term ``intended or
reasonably foreseeable use'' to make it clear that an importer must
consider use that is reasonably foreseeable in addition to intended
use.
5. Review of Another Entity's Hazard Analysis
    We proposed to provide that if the importer's foreign supplier had
analyzed the known or reasonably foreseeable hazards for the food to
determine whether there were any significant hazards, the importer
could meet its requirement to determine whether there were any
significant hazards by reviewing and assessing the hazard analysis
conducted by the foreign supplier (proposed Sec.  1.504(d)).
    As described in sections III.E.5, III.F.4, and III.G.4 of this
document, we conclude that it is appropriate to allow importers to
obtain certain information needed to meet their FSVP responsibilities
from other entities, in some cases in their supply chains, for the
foods they import. Therefore, we have revised Sec.  1.504(d) to provide
that if another entity (including the foreign supplier) has, using a
qualified individual, analyzed the known or reasonably foreseeable
hazards for a food to determine whether there are any hazards requiring
a control, the importer may meet its requirement to determine whether
there are any hazards requiring a control for the food by reviewing and
assessing the hazard analysis conducted by that entity. The importer is
also required to document its review and assessment of the other
entity's hazard analysis, including documenting that the hazard
analysis was conducted by a qualified individual.
    (Comment 138) Some comments assert that importers' opportunities to
rely on a hazard analysis conducted by the foreign supplier might be
limited because many suppliers would not want to share their hazard
analyses.
    (Response 138) We recognize that, due to commercial confidentiality
concerns or other reasons, there might be circumstances in which some
foreign suppliers might be reluctant to share their hazard analyses of
foods that importers seek to obtain from them. However, we also believe
that some foreign suppliers will desire to share their hazard analyses
as a means of attracting customers for their products. In those cases,
we want to provide importers with the flexibility to eliminate
redundancy that would have occurred by not requiring the importer to
conduct an independent hazard analysis when the foreign supplier has
already conducted one.
    (Comment 139) One comment suggests that we substitute ``food safety
hazard'' for ``hazard'' so importers do not conclude that they must
address all types of hazards.
    (Response 139) We conclude that this change is unnecessary because
this provision refers to another entity's analysis of known or
reasonably foreseeable hazards for a food, and a hazard is specifically
defined in the FSVP regulation as an agent that is reasonably likely to
cause illness or injury if not controlled, i.e., it affects the safety
of the food.
6. Biological Hazards in RACs That Are Fruits or Vegetables
    We proposed to provide that an importer of a RAC that is a fruit or
vegetable would not be required to determine whether there were any
significant microbiological hazards in such food (proposed Sec.
1.504(e) in the Supplemental Notice). We stated in the preamble to the
proposed rule that the hazard analysis requirements were not needed for
RACs that are fruits or vegetables and that are subject to the
regulation on produce safety in part 112 because FDA has already
identified the biological hazards associated with fruits and vegetables
and has proposed requirements for measures intended to prevent the
introduction of these hazards into produce.
    (Comment 140) Several comments ask that we clarify proposed Sec.
1.504(e). Some comments ask that we specify that imported food is
subject to the produce safety regulation when applicable, which would
directly address the microbial hazards in the food. The comments assert
that biological hazards are very significant in some fruits and
vegetables and importers should consider them. The comments ask whether
the provision is intended to

apply to RACs that are fruits or vegetables that are not covered under
the produce safety regulation. Some comments ask that we clarify how
the FSVP and produce safety regulations work together. Some comments
assert that all fresh produce must be subject to supplier verification,
including evaluation of hazards, whether covered under the FSVP
regulation or the produce safety regulation.
    (Response 140) We proposed to ``exempt'' importers of RACs that are
fruits or vegetables that are ``covered produce'' (as that term is
defined in the produce safety regulation) from having to analyze the
microbiological hazards in such food. Although proposed Sec.  1.504(e)
did not specifically state that the ``exemption'' from hazard analysis
only applies when the imported RACs are ``covered produce'' as defined
in proposed Sec.  112.3, the preamble to the proposed rule essentially
stated that the exemption only applies in these circumstances and
explained the reason for the exemption. Specifically, the preamble
explained that the exemption is appropriate because FDA has designed
the produce safety regulation so that compliance with the regulation
would ensure that microbiological hazards are adequately addressed.
(Although proposed Sec.  1.504(e) refers to ``microbiological''
hazards, it should have referred to ``biological'' hazards because
``hazard'' is defined in both the proposed and final rules on produce
safety as any ``biological agent'' that is reasonably likely to cause
illness or injury in the absence of its control.) Indeed, the produce
safety regulation is intended to minimize the risk of serious adverse
health consequences or death from the introduction of known or
reasonably foreseeable biological hazards in produce, and to provide
assurance that fruits and vegetables are not adulterated because of
such hazards. To make this clear, we have revised Sec.  1.504(e) to
state that an importer of a RAC that is a fruit or vegetable is not
required to determine whether there are any biological hazards
requiring a control in such food only if the RACs are ``covered
produce'' as defined in Sec.  112.3 (i.e., produce that is subject to
the produce safety regulation in accordance with Sec. Sec.  112.1 and
112.2).
    In addition, we are clarifying that this partial exemption from the
hazard analysis requirements is appropriate because the biological
hazards in such fruits or vegetables require a control and compliance
with the regulation in part 112 significantly minimizes or prevents the
biological hazards. Although importers of such RACs need not conduct a
hazard analysis with respect to the biological hazards in this food,
they must conduct supplier verification for the food in accordance with
Sec.  1.506 of the final rule to ensure that all hazards in the RACs,
including biological hazards, are significantly minimized or prevented.
    (Comment 141) Some comments request that importers of RACs that are
fruits or vegetables not be required to analyze non-biological hazards
in the food. The comments assert that there have been no outbreaks
linked to chemical or physical hazards in imported produce, no examples
of EMA in fresh produce, and no chemical contamination of fresh produce
at levels reasonably likely to cause illness. The comments maintain
that analyzing non-biological hazards would be very burdensome because
it would likely require a visit to the location in which the food is
grown, and would be complicated by the seasonal nature of fruit and
vegetable production and harvesting.
    (Response 141) We decline to make this change. In the preamble to
the proposed rule on produce safety (78 FR 3504 at 3524), we
acknowledged that there can be non-biological hazards in produce, and a
reference memorandum to that proposed rule provided an overview of the
chemical, physical, and radiological agents that are reasonably likely
to occur in produce at the farm and are capable of causing adverse
health effects (Ref. 13). Our analysis of those hazards led us to
conclude that they rarely pose a risk of serious adverse health
consequences or death for consumers of produce, making it unnecessary
to establish a new regulatory regime for their control under section
105 of FSMA. We stated that existing programs, such as the registration
of pesticides with the Environmental Protection Agency (EPA) and State
and industry efforts to control the presence of pesticides and
mycotoxins in produce, are sufficient to keep these hazards under
control. We also noted that FDA monitors natural toxins, pesticides,
industrial chemicals, other chemical contaminants, and radionuclides in
food. For these reasons, we tentatively concluded that it was
appropriate to limit the scope of the produce safety regulations to
biological hazards and science-based standards necessary to minimize
the risk of serious adverse health consequences or death associated
with biological hazards (78 FR 3504 at 3524). We have reaffirmed this
conclusion in the final rule on produce safety published elsewhere in
this issue of the Federal Register.
    Thus, although the produce safety regulation does not address non-
biological hazards in fruits or vegetables, such hazards are sometimes
associated with this food. We conclude that it is appropriate to
require importers to determine whether there are any such hazards
requiring a control in a fruit or vegetable they are importing because
section 805 of the FD&C Act requires importers to verify that produce
is produced not only in compliance with the produce safety regulation
issued in accordance with section 419 of the FD&C Act but also in
accordance with section 402, i.e., that it is not adulterated. As we
stated in the preamble to the FSVP proposed rule, we do not believe
that the analysis of non-biological hazards will create a significant
burden for importers of fruits and vegetables; importers will need to
be aware of how a crop is produced and whether there have been non-
biological hazards, such as pesticide residues, associated with it. We
believe that in many cases importers can obtain the information they
need to assess non-biological hazards from public sources, such as any
regulations applicable to the control of such hazards, scientific
literature, and information on FDA's Web site (including guidance
documents, import alerts, recall notices, warning letters, and untitled
letters), as well as information from the foreign suppliers themselves.
The consideration of chemical and physical hazards for RACs that are
fruits and vegetables is consistent with the requirements for these
products under the regulation on preventive controls for human food.
    (Comment 142) One comment notes that importers of produce must
include chemical and physical contamination hazards when they analyze
hazards in imported produce while domestic purchasers of produce need
only confirm that the produce was produced in compliance with the
produce safety regulation, which requires the control of biological
hazards but not chemical or physical hazards. The comment asserts that
this constitutes inconsistent treatment of domestic and imported
products and may invite a challenge before the WTO.
    (Response 142) We do not agree. The FSVP regulation does not result
in different treatment of foreign and domestic produce producers with
respect to chemical and physical hazards in produce. Although the
produce safety regulation does not address such hazards, the presence
of such hazards may cause produce--whether produced domestically or
overseas--to be adulterated under section 402 of the FD&C Act.
Therefore,

both domestic and foreign producers of produce are prohibited from
distributing produce contaminated with certain chemical and physical
hazards, and domestic and foreign-produced produce is held to the same
standard.
    (Comment 143) One comment suggests that instead of ``fruits or
vegetables,'' the provision should refer to RACs that are ``fresh,
intact fruits, nuts, culinary herbs, or vegetables.'' The comment
maintains that this change is needed because many importers will not be
aware of FDA's scheme to distinguish RACs from processed foods and may
not understand that the Agency considers fruits and vegetables to
include nuts and culinary herbs. The comment suggests a corresponding
change to proposed Sec.  1.504(f).
    (Response 143) We decline to make this change because the produce
safety regulation refers to fruits, nuts, culinary herbs, and
vegetables collectively as ``fruits and vegetables.'' We believe it
would be confusing, and could imply a different meaning, if we were to
adopt a different term to capture the same set of food in the FSVP
regulation.
    (Comment 144) Some comments suggest that this provision state
whether importers of RACs that are fruits or vegetables must analyze
hazards other than biological hazards.
    (Response 144) We agree and have revised Sec.  1.504(e) to specify
that importers of RACs that are fruits or vegetables must analyze
hazards other than biological hazards in such food.
7. No Hazards Requiring a Control
    We proposed to provide, in Sec.  1.504(f), that if an importer
evaluates the known and reasonably foreseeable hazards in a food and
determines that there are no significant hazards, the importer would
not be required to determine what foreign supplier verification and
related activities to conduct under Sec.  1.505 and would not be
required to conduct such activities under Sec.  1.506. We proposed that
this provision would not apply if the food is a RAC that is a fruit or
vegetable and that is subject to the produce safety regulation.
    Consistent with the change to Sec.  1.504(e) discussed in Response
140, we have revised Sec.  1.504(f) to state that it does not apply if
the food is a RAC that is a fruit or vegetable that is ``covered
produce'' as defined in Sec.  112.3 in the produce safety regulation.
    (Comment 145) Some comments assert that we should declare certain
foods, such as chocolates, confectionery, jams, preserves, baked goods,
and non-alcoholic beverages, to be safe, as the Agency has done with
several products under the proposed rule on produce safety.
    (Response 145) We are finalizing proposed Sec.  1.504(f) because we
agree that there are many foods that have no hazards requiring a
control. In the preamble to the proposed rule, we suggested salt and
certain food-grade chemicals as examples of food for which, depending
on the circumstances, there might not be any hazards that would be
reasonably likely to occur. Other examples of food for which there
might be no hazards requiring a control include, but are not limited
to, many crackers, most bread, dried pasta, many types of cookies, many
types of candy (e.g., hard candy, fudge, maple candy, taffy, toffee),
honey, molasses, sugar, syrup, soft drinks, and jams, jellies, and
preserves from acid fruits.
    However, because many of these foods can be made using a variety of
ingredients under different processes by different manufacturers, we
decline to completely exempt these foods from the FSVP regulation by
declaring them to be ``safe.'' Rather, we conclude that it is
appropriate to require importers to determine whether there are any
hazards requiring a control in a particular food. However, as
previously stated, importers will be able to rely on hazard analyses
conducted by other entities, including analyses that find no hazards
requiring a control in foods.
    (Comment 146) Some comments request that importers be required to
reevaluate food and foreign supplier risks annually even when an
importer determines that there are no significant hazards in a food.
    (Response 146) We do not agree. Under Sec.  1.505(c) of the final
rule, importers will be required to reevaluate the risk posed by a food
as well as a foreign supplier's performance when the importer becomes
aware of new information about these matters (including new information
about potential hazards), or at least every 3 years (see section
III.F.3 of this document). We conclude that it is unnecessary to
require more frequent reevaluation of the risks in a food and a foreign
supplier's performance for those foods for which an importer determines
that there are no hazards requiring a control.
    (Comment 147) Some comments maintain that proposed Sec.  1.504(f)
conflicts with proposed Sec.  1.504(e), which exempts importers of RACs
that are fruits or vegetables from having to analyze the biological
hazards in such produce. Some comments suggest that Sec.  1.504(f)
creates an assumption that there are always significant hazards in
fruits and vegetables subject to the produce safety regulations.
    (Response 147) We do not believe that Sec.  1.504(f) conflicts with
Sec.  1.504(e). As we stated in the preamble to the proposed rule, this
exception is appropriate because for such food the importer is not
conducting a hazard analysis to identify the biological hazards that
need to be significantly minimized or prevented. If we did not specify
that Sec.  1.504(f) did not apply to RACs that are fruits or vegetables
that are covered produce, an importer of such food might mistakenly
conclude that because it had determined that there were no non-
biological hazards requiring a control in the food, the importer need
not conduct supplier verification. However, because there are presumed
to be biological hazards associated with all fruits and vegetables that
are covered produce under the produce safety regulation, even if there
are no non-biological hazards in a fruit or vegetable, the importer
must conduct supplier verification to obtain assurances that the food
was grown and harvested consistent with the produce safety regulation
and is not adulterated.
8. Hazards Controlled by the Importer or Its Customer
    In the Supplemental Notice, we proposed to provide (in Sec.
1.504(g)) that if the preventive controls that the importer and/or its
customer implement in accordance with the proposed preventive controls
requirements in subpart C of part 117 are adequate to significantly
minimize or prevent all significant hazards in a food, the importer
would not be required to determine or conduct appropriate foreign
supplier verification. Proposed Sec.  1.504(g) further stated that if
the importer's customer controlled one or more such hazards, the
importer would be required to annually obtain from the customer written
assurance that it had established and was following procedures
(identified in the written assurance) that would significantly minimize
or prevent the hazard.
    As set forth in Sec.  1.507 of the final rule and discussed in
section III.H of this document, we have broadened the circumstances
under which certain importers are not required to conduct an evaluation
under Sec.  1.505 or supplier verification activities under Sec.  1.506
when the hazard requiring a control in a food will be adequately
controlled by another entity and certain other requirements are met. We
discuss those provisions and respond to the comments on proposed Sec.
1.504(g) in section III.H.

F. Evaluation for Foreign Supplier Approval and Verification (Sec.
1.505)

    In the Supplemental Notice, we replaced a proposed requirement that
importers conduct a compliance status review of the food and foreign
supplier with a requirement to evaluate the risks associated with a
food to be imported (as determined in the hazard analysis for the food)
and the potential foreign supplier of that food. Although the comments
generally support this more comprehensive, ``holistic'' approach to
selecting suppliers, several comments suggest changes regarding the
proposed risk factors or the proposal to require reevaluation of risk.
As discussed in the following paragraphs, we have made some relatively
minor changes with respect to the proposed food and foreign supplier
factors, and the final rule permits importers to rely on evaluations of
these factors conducted by other entities (except for the foreign
supplier), provided that the importer reviews and assesses the
evaluation and documents the review and assessment. In addition, we
have revised the provisions concerning reevaluation of these factors so
that they take the place of the proposed requirements on FSVP
reassessment.
1. Evaluation for Approving Suppliers and Determining Verification
Activities
    We proposed (in Sec.  1.505(a)(1)(i) through (vi)) to require
importers, in determining the appropriate supplier verification and
related activities to conduct, to consider the following:
     The hazard analysis for the food conducted under proposed
Sec.  1.504, including the nature of the hazard.
     The entity that will be applying controls for the hazards,
such as the foreign supplier or the foreign supplier's raw material or
ingredient supplier.
     The foreign supplier's procedures, processes, and
practices related to the safety of the food.
     Applicable FDA food safety regulations and information
regarding the foreign supplier's compliance with those regulations,
including whether the foreign supplier is the subject of an FDA warning
letter or import alert.
     The foreign supplier's food safety performance history,
including results from testing foods for hazards, audit results
relating to the safety of the food, and the supplier's record of
correcting problems.
     Any other factors as appropriate and necessary, such as
storage and transportation practices.
    We also proposed to require importers to document their risk
evaluations.
a. General
    (Comment 148) Some comments request that we define ``risk'' because
some people might not understand the difference between ``risk'' and
``hazard'' as the terms are frequently interchanged in common usage.
One comment suggests that the regulations define ``risk'' as ``the
chance or probability that harm will occur, taking into account both
the likelihood that a hazard will occur in the absence of controls to
prevent it and the severity of the illness or injury that the hazard
might cause.''
    (Response 148) Although we conclude that it is not necessary to
include a definition of risk in the codified provisions, we agree that,
in the context of food safety science, a risk is different from a
hazard. Although the regulations on preventive controls for human food
and for animal food do not include a definition of ``risk,'' in those
regulations we regard risk in the way that it is described in the Codex
Alimentarius, which defines ``risk'' as ``a function of the probability
of an adverse health effect and the severity of that effect,
consequential to a hazard(s) in a food.'' Therefore, a risk posed by a
food is the potential effect on health related to the hazards in the
food.
    Because Codex defines risk in relation to inherent food hazards
only, rather than also considering the effect of actions by a producer
or supplier of a food, we conclude that, to apply the term ``risk''
consistently throughout the FSMA regulations, Sec.  1.505 of the FSVP
regulation should not refer to the ``risks'' posed by a foreign
supplier. Therefore, we have revised Sec.  1.505(a) so that it refers,
in Sec.  1.505(a)(1)(iii)(A) through (C) of the final rule, to factors
related to the foreign supplier's ``performance'' rather the ``risks''
associated with the foreign supplier. These factors, which we have not
substantially changed in the final rule, are the supplier's food
safety-related processes and procedures, its compliance with FDA food
safety regulations, and its food safety history with the importer and
others.
    (Comment 149) Several comments ask that we revise Sec.  1.505(a)(1)
to state that importers must consider the food and foreign supplier
factors in deciding whether to approve a supplier, rather than in
selecting appropriate supplier verification activities.
    (Response 149) We do not agree that the use of the factors should
be limited in this way. Many comments assert that factors such as a
foreign supplier's compliance status and contractual performance
history can play an important role in determining appropriate
verification activities, such as in concluding that onsite auditing on
an annual basis of a highly-compliant foreign supplier is not necessary
even when the supplier is providing foods with SAHCODHA hazards.
Therefore, we conclude that it is appropriate that importers evaluate
certain safety factors related to a food and the foreign supplier in
deciding what supplier verification activities (and the frequency of
such activities) are needed to provide adequate assurance of the safety
of the food.
    Although proposed Sec.  1.506(a) stated that importers must have
procedures to ensure that they import food only from foreign suppliers
approved based on the evaluation conducted under proposed Sec.  1.505,
we have revised Sec.  1.505(a)(1) to make clear that an importer must
conduct an evaluation of the foreign supplier's performance and the
risks posed by a food to both approve foreign suppliers and determine
appropriate foreign supplier verification activities.
    (Comment 150) Some comments ask that we revise Sec.  1.505(a) to
give importers the flexibility to consider only those factors that they
conclude are appropriate for a particular food and foreign supplier. As
an example, one comment states that an importer typically would not
review a supplier's FDA compliance history to determine a verification
activity but might consider it later as part of the actual verification
and qualification of the supplier.
    (Response 150) We decline to make this change. We conclude that
generally each of the factors set forth in Sec.  1.505(a) will be
relevant to approving a foreign supplier for a particular food and to
determining appropriate verification activities for the supplier. If a
particular factor is of little or no relevance with respect to a
particular food and foreign supplier, the importer might only need to
briefly consider that factor. For example, an importer that has never
obtained food from a potential foreign supplier would not have any
direct ``history'' with that supplier; for a foreign supplier that has
just begun exporting food and, therefore, would not have been inspected
by FDA, there might not be any associated warning letters or other
compliance-related documents. However, with respect to a foreign
supplier's compliance with FDA food safety regulations, we believe that
there would be very few circumstances in which this factor would not be
relevant to deciding whether to approve a foreign supplier as a source
of a food and selecting appropriate supplier verification activities.

b. Hazard Analysis
    On our own initiative, we have revised Sec.  1.505(a)(1)(i) to
include the hazard analysis ``of the food conducted under Sec.  1.504''
because, as discussed in section III.E.5 of this document, under Sec.
1.504(d) of the final rule an importer may review and assess a hazard
analysis conducted by another entity.
    (Comment 151) One comment states that, when considering the hazard
analysis, the requirement to include the nature of the hazard should
refer to the nature of the ``hazard requiring control'' because
importers should evaluate supplier risks primarily as they relate to
those hazards.
    (Response 151) We agree that referring to the nature of the hazard
requiring a control is appropriate and have revised Sec.
1.505(a)(1)(i) accordingly.
c. Entity Applying Controls
    (Comment 152) Several comments express concern regarding the
proposed requirement to consider the entity that will be applying
hazard controls because it refers not only to the foreign supplier but
to the foreign supplier's raw material or ingredient supplier (proposed
Sec.  1.505(a)(1)(ii)). Several comments state that the importer's
responsibility to conduct supplier verification should be limited to
its direct supplier's compliance with applicable regulations,
maintaining that this would be consistent with the Bioterrorism Act
requirements, which provide for the identification of the immediate
non-transporter previous source and subsequent recipient. Some comments
state that requiring importers to document the actions of their
suppliers' suppliers would require a major change to the produce supply
chain because the identity of a broker's or aggregator's suppliers
often is proprietary information.
    (Response 152) We do not agree that it is inappropriate to require
importers to consider which entities control hazards, regardless of
whether the entity is the foreign supplier, the foreign supplier's
supplier, or some other entity in the supply chain. The records
requirements of the Bioterrorism Act serve a different function and are
not directly applicable to the scope of evaluations conducted in
accordance with the FSVP provisions of FSMA. Moreover, knowing the
entity or entities that will be significantly minimizing or preventing
the hazards in a food is directly relevant to the type of foreign
supplier or other verification activity that the importer will need to
conduct under Sec.  1.506 or Sec.  1.507 of the final rule. For
example, when a foreign supplier's raw material supplier is controlling
a hazard in a food that the importer obtains from the foreign supplier,
the importer might conclude that reviewing the foreign supplier's
records of verification that its supplier produced the raw material in
accordance with the preventive controls or produce safety regulations
is more appropriate than auditing the foreign supplier with respect to
this hazard.
    In the final rule, we are revising Sec.  1.505(a)(1)(ii) to require
consideration of the entity or entities that will be significantly
minimizing or preventing the hazards requiring a control or verifying
that such hazards have been significantly minimized or prevented, such
as the foreign supplier, the foreign supplier's raw material or other
ingredient supplier, or another entity in the importer's supply chain.
(The provision refers to significant minimization or prevention of
hazards in accordance with the change we are making to proposed Sec.
1.506(c), discussed in section III.G.3 of this document.) We conclude
that this clarification is needed to address circumstances such as when
a foreign supplier grows produce but another entity performs certain
activities, such as harvesting the produce. Entities that fit the
definition of ``farm,'' such as harvesters, might be required to
significantly minimize or prevent hazards under the produce safety
regulation. To ensure that the importer will meet its obligation under
section 805(a)(1) of the FD&C to perform supplier verification
activities to verify that the imported food is produced in compliance
with sections 418 and 419, as applicable, and not adulterated under
section 402 or misbranded under section 403(w), the importer must
evaluate which entities in the supply chain have either significantly
minimized or prevented the hazards or verified that the hazards were
significantly minimized or prevented. The results of this evaluation
might be a factor in determining (1) whether to approve the foreign
supplier (the grower of the produce) or (2) the type and frequency of
verification activities. Consequently, we conclude that importers must
consider the entities that will be significantly minimizing or
preventing the hazards or verifying significant minimization or
prevention of the hazards in the foods they import as part of the
evaluation conducted for supplier approval and determination of
supplier verification activities.
d. Foreign Supplier's Safety Procedures, Processes, and Practices
    (Comment 153) Some comments express concern about how the
confidentiality of a foreign supplier's food safety procedures,
processes, and practices will be ensured, considering that some
information regarding these matters might include data of a
commercially sensitive nature. The comments suggest that we revise
these provisions to respect the right of foreign companies not to
disclose confidential information to third parties (the comments raise
this same concern with respect to information regarding a foreign
supplier's food safety performance history under proposed Sec.
1.505(a)(1)(v)).
    (Response 153) We decline to make this change. As discussed in
section III.K.6 of this document, under Sec.  1.510(f) of the final
rule, records obtained by FDA in accordance with the FSVP regulation
will be subject to the public disclosure provisions in part 20 (21 CFR
part 20), including the protections against disclosure of trade secrets
and commercial or financial information that is privileged or
confidential. How foreign suppliers and importers choose to handle the
issues surrounding the sharing of any confidential information with
each other is between those parties. While we recognize that there
might be some suppliers who are reluctant to provide information
relevant to the kind of verification activities required by this rule,
we believe that many suppliers will agree to such activities in order
to facilitate the exportation of their products to the United States
and access new customers.
e. Supplier's Compliance With Applicable FDA Food Safety Regulations
    On our own initiative, we have modified the proposed requirement to
consider applicable FDA food safety regulations and the foreign
supplier's compliance with those regulations to address circumstances
in which a potential foreign supplier is in a country whose food safety
system we have officially recognized as comparable or determined to be
equivalent to the U.S. system. Section 1.505(a)(1)(iii)(B) of the final
rule requires importers, when applicable, to consider the relevant laws
and regulations of a country whose food safety system we have
officially recognized as comparable or determined to be equivalent to
that of the United States, and information relevant to the supplier's
compliance with those laws and regulations. This means that if an

importer's potential foreign supplier is located in a country whose
food safety system we have officially recognized as comparable or
determined to be equivalent (as discussed in section III.N of this
document), the importer would consider, as part of its evaluation of
the supplier, the supplier's compliance with the laws and regulations
of that country rather than its compliance with U.S. food safety law.
As discussed in section III.N, this reflects the nature of FDA
recognition of the comparability of a foreign food safety authority in
a systems recognition arrangement.
    (Comment 154) Some comments express concern about the availability
to importers of information about foreign suppliers' compliance with
FDA food safety regulations. Some comments state that information about
warning letters and import alerts often is not available on the FDA Web
site in a timely manner and it can be difficult to navigate the Web
site. Some comments assert that any requirement to consider foreign
supplier compliance information should be limited to information that
is available on our Web site or to information that is publicly
available. One comment states that we should not require a prescriptive
review of regulatory information unless we develop a system that allows
importers to efficiently monitor new regulatory enforcement actions.
One comment asks that we consider developing online databases that
importers could use to obtain information on foreign suppliers.
    (Response 154) We agree with the comments that the requirement to
consider information on a foreign supplier's compliance with applicable
FDA food safety regulations--as well as information on the other
factors in Sec.  1.505(a)(1)--should be limited to information that is
publicly available or that the importer has otherwise been able to
obtain (e.g., from a foreign supplier). We currently have searchable
online databases for warning letters and import alerts; both of these
databases are available to the public from our Web homepage at http://www.fda.gov. Other relevant compliance-related information available on
FDA's Web site includes recall notices and notices of suspensions of
facility registrations. We are considering ways to make this
information more accessible to importers who will now be required to
check the compliance history of their suppliers. To make clear that an
importer must consider such publicly available information, Sec.
1.505(a)(1)(iii)(B) of the final rule specifies that the applicable
information includes whether the foreign supplier is the subject of any
``other FDA compliance action related to food safety.'' We also note
that, although the requirement to consider information on supplier
compliance with applicable FDA food safety regulations is limited to
publicly available information or information that the importer has
otherwise obtained, if we became aware that an importer did not
consider information that it had obtained relating to a supplier's FDA
compliance, that would be a violation of the requirement.
    (Comment 155) Some comments assert that this provision should be
deleted because an importer's evaluation of the food and the foreign
supplier should focus on information pertaining to risks identified in
the imported food rather than the supplier. The comments note that if a
foreign supplier were subject to an FDA warning letter or import alert
for a food other than the food the importer was importing, that
information would not be relevant to the importer's risk evaluation.
    (Response 155) We do not agree. We conclude that evidence that a
foreign supplier had received a warning letter or been placed on import
alert with respect to a particular food, even a food different than the
food an importer is considering obtaining from the foreign supplier,
could be relevant to deciding whether to source a food from the
supplier. In particular, a pattern of non-compliance, even if it did
not involve the particular food that the importer sought to obtain,
should affect an importer's decision on whether to approve a foreign
supplier and, if so, what supplier verification activities would be
appropriate with respect to this supplier.
    (Comment 156) Some comments suggest that the scope of data sources
reviewed be expanded to include Food Facility Registration Module
(FFRM) status, Reportable Food Registry (RFR) entries, and outcomes
from recent FDA CGMP inspections.
    (Response 156) In accordance with section 415(a)(5) of the FD&C Act
regarding disclosure of certain food facility registration information,
information regarding whether a particular food facility is registered
is generally not publicly available; however, as stated previously, FDA
may publicize actions to suspend a facility's registration, which would
be relevant information under Sec.  1.505(a)(1)(iii)(B). In addition,
importers may obtain information about a foreign facility's
registration status from the foreign facility. Information from the RFR
that we make available in our RFR annual reports is generally not
provided on a company-specific basis. Under section 417(h) of the FD&C
Act (21 U.S.C. 350f(h)), a record in the RFR is subject to a request
under the Freedom of Information Act (FOIA) (5 U.S.C. 552), except that
FDA registration numbers and information derived from such
registrations are protected from disclosure to the extent that they
would disclose the identity or location of a specific registered person
in accordance with section 415(a)(5) of the FD&C Act. In addition,
confidential commercial information in such records is also protected
from disclosure, and in many cases the name of the original producer of
the food may constitute confidential commercial information. We also
generally do not proactively make available information related to FDA
inspections of foreign suppliers, including Form FDA 483s and
Establishment Inspection Reports (EIRs), although it is possible that
an importer could obtain such information from a foreign supplier or
from FDA through a FOIA request. Any confidential commercial
information, trade secret information, or other protected information
in Form FDA 483s and EIRs that we provide through a FOIA request would
be redacted (i.e., deleted) in accordance with the disclosure
exemptions set forth in the FOIA and FDA's public information
provisions in part 20.
f. Foreign Supplier's Food Safety History
    (Comment 157) One comment suggests that, to be consistent with the
preventive controls regulations and to avoid an implied requirement to
perform testing and auditing, we should revise proposed Sec.
1.505(a)(1)(v) to state that a foreign supplier's food safety
performance history ``includ[es] available information'' about results
from testing foods for hazards, audit results relating to the safety of
the food, and the supplier's record of correcting problems. One comment
states that Sec.  1.505(a)(1)(v) should not obligate an importer (or a
foreign supplier through its importer) to provide FDA with details of
an audit because this would have a chilling effect on the number of
audits to which a supplier submits. The comment asks that we revise
Sec.  1.505(a)(1)(v) to refer to supplier performance history that is
``relevant to the intended use'' of raw materials or ingredients and to
make the provision consistent with the corresponding provision in the
proposed regulation on preventive controls for animal food.
    (Response 157) We have revised this provision (Sec.
1.505(a)(1)(iii)(C) in the final rule) to make it consistent with the
corresponding provisions in the

preventive controls regulations by specifying that the foreign
supplier's food safety history includes available information about
results from testing foods for hazards, audit results relating to the
safety of the food, and responsiveness of the foreign supplier in
correcting problems. We agree that Sec.  1.505(a)(1)(iii)(C) does not