1.Short title; references;
table of contents
(a)This Act may be cited as the Safe Food Enforcement, Assessment, Standards, and
Targeting Act of 2009
or as the Safe FEAST Act of 2009
.
(b)Except
as otherwise specified, whenever in this Act an amendment is expressed in terms
of an amendment to a section or other provision, the reference shall be
construed to be made to a section or other provision of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.).
(c)The table of contents of this Act is as follows:
Sec. 1. Short title; references; table of contents.
Title I—General Food Provisions
Sec. 101. Inspection of records during food-related
emergencies.
Sec. 102. Registration of food facilities.
Sec. 103. Mandatory recall authority.
Sec. 104. Hazard analysis and risk-based preventive
controls.
Sec. 105. Performance standards.
Sec. 106. Standards for the safety of fruits and
vegetables.
Sec. 107. Targeting of inspection resources for domestic
facilities, foreign facilities, and ports of entry; annual report.
Sec. 108. Administrative detention of food.
Sec. 109. National agriculture and food defense
strategy.
Sec. 110. Food and Agriculture Coordinating
Councils.
Sec. 111. Authority to collect fees.
Title II—Detection and surveillance
Sec. 201. Recognition of laboratory accreditation for analyses
of foods.
Sec. 202. Integrated consortium of laboratory
networks.
Sec. 203. Building domestic capacity.
Sec. 204. Enhancing traceback and recordkeeping.
Sec. 205. Surveillance.
Title III—Specific provisions for imported food
Sec. 301. Foreign supplier verification program.
Sec. 302. Voluntary qualified importer program.
Sec. 303. Authority to require import certifications for
food.
Sec. 304. Prior notice of imported food shipments.
Sec. 305. Review of a regulatory authority of a foreign
country.
Sec. 306. Building capacity of foreign governments with respect
to food.
Sec. 307. Inspection of foreign food facilities.
Sec. 308. Third-party accreditation of qualified auditors and
audit agents.
Sec. 309. Jurisdiction; authorities.
<enum>I</enum><header>General Food
Provisions</header>
<section display-inline="no-display-inline" id="H145095B8604242E4A36D84590218A85D" section-type="subsequent-section"><enum>101.</enum><header>Inspection of
records during food-related emergencies</header>
<subsection id="H494F9413C8D140F1874D0DA540527DF4"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 414 (21
U.S.C. 350c) is amended—</text>
<paragraph id="H13A7762C03F442459068D55145D85ED5"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating subsections (b), (c), and
(d) as subsections (c), (d), and (e), respectively; and</text>
</paragraph><paragraph id="HC1E1A4610C2247949D26DC36AE916122"><enum>(2)</enum><text>by inserting after
subsection (a) the following:</text>
<quoted-block display-inline="no-display-inline" id="HD15E5F5BDE9F40CF9143DE9F88FC40B3" style="OLC">
<subsection id="HE44F93BD7119450E8EE3DFCCB6BE6409"><enum>(b)</enum><header>Records
inspections during food-related emergencies</header><text display-inline="yes-display-inline">If the Secretary has a reasonable belief
that an article of food presents a threat of serious adverse health
consequences or death to humans or animals, during a food-related emergency,
the Secretary—</text>
<paragraph id="H70B8FD2E16004BFDB9FE1CBB33074109"><enum>(1)</enum><text>may have access to
and copy all records relating to such article of food in the same manner and
for the same purpose as described in subsection (a); and</text>
</paragraph><paragraph id="H1A99E0308B5F44669DE2DE53897213D3"><enum>(2)</enum><text display-inline="yes-display-inline">shall, from each person (excluding farms
and restaurants) who manufactures, processes, packs, distributes, receives,
holds, or imports an article of food related to the article of food referred to
under paragraph (1) (such as an article of food produced on the same
manufacturing line or any other article of food that the Secretary reasonably
believes is likely to be affected in a similar manner) at the request of an
officer or employee duly designated by the Secretary, have permission for such
officer or employee, upon presentation of appropriate credentials and a written
notice to such person, at reasonable times and within reasonable limits and in
a reasonable manner, to have access to and copy all records relating to such
article that are needed to assist the Secretary in determining whether the food
presents a threat of serious adverse health consequences or death to humans or
animals.</text>
</paragraph></subsection><after-quoted-block>.
</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="H38861A913C374386BA447BCE556A1CE1"><enum>(b)</enum><header>Conforming
amendments</header>
<paragraph id="H0800809BC16C4918902288A8BA266567"><enum>(1)</enum><text>Section 301(e) (21
U.S.C. 331(e)) is amended by striking <quote>414(b)</quote> and inserting
<quote>414(c)</quote>.</text>
</paragraph><paragraph id="HD5D6F4FE7412416A83FDBE8F86781468"><enum>(2)</enum><text>Section 704(a)(1)
(21 U.S.C. 374(a)(1)) is amended by striking <quote>414(d)</quote> and
inserting <quote>414(e)</quote>.</text>
</paragraph></subsection></section><section id="H6F85FC2FA0664C80A93EE51E257FD167"><enum>102.</enum><header>Registration of
food facilities</header>
<subsection id="HE680A2CCD6BF4970B468DCF7302E6392"><enum>(a)</enum><header>Updating of food
category regulations; biennial registration renewal</header><text display-inline="yes-display-inline">Section 415(a) (21 U.S.C. 350d(a)) is
amended—</text>
<paragraph id="H18CB2D6F08534366B30E6D03C30F5185"><enum>(1)</enum><text>in paragraph (2),
by—</text>
<subparagraph id="HE2FF28493D6F4DA6B2FDDF28F3849DF0"><enum>(A)</enum><text>striking
<quote>conducts business and</quote> and inserting <quote>conducts business,
the e-mail address for the contact person of the facility, and</quote>;
and</text>
</subparagraph><subparagraph id="HB0A2C8A440BE480993FD14F3E65FA42E"><enum>(B)</enum><text>inserting <quote>,
or any other food categories as determined appropriate by the Secretary,
including by guidance)</quote> after <quote>Code of Federal
Regulations</quote>;</text>
</subparagraph></paragraph><paragraph id="H3358BB3C6ECE473089DBD232DDE5AAB7"><enum>(2)</enum><text>by redesignating
paragraphs (3) and (4) as paragraphs (4) and (5), respectively; and</text>
</paragraph><paragraph id="HC61FA3B073F647628F193A800584BF2F"><enum>(3)</enum><text>by inserting after
paragraph (2) the following:</text>
<quoted-block display-inline="no-display-inline" id="HCCD15F129CBC419DB9B0291CD9D5B138" style="OLC">
<paragraph id="H642C5321ADAB4D53926F6A696C14B862"><enum>(3)</enum><header>Biennial
registration renewal</header><text>During the period beginning on October 1 and
ending on December 31 of each even-numbered year, a registrant that has
submitted a registration under paragraph (1) shall submit to the Secretary a
renewal registration containing the information described in paragraph (2). The
Secretary shall provide for an abbreviated registration renewal process for any
registrant that has not had any changes to such information since the
registrant submitted the preceding registration or registration renewal for the
facility
involved.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="H0B33CE5EF0354560812F6DE145B01D3F"><enum>(b)</enum><header>Suspension of
registration</header>
<paragraph id="H83D70DFCC0214328A113AB42BA1B17AA"><enum>(1)</enum><header>In
general</header><text>Section 415 (21 U.S.C. 350d) is amended—</text>
<subparagraph id="HDD13A2A1CDC547E484924E3A70EC4C39"><enum>(A)</enum><text>in subsection
(a)(2), by inserting after the first sentence the following: <quote>The
registration shall contain a consent to permit the Secretary to inspect such
facility.</quote>;</text>
</subparagraph><subparagraph id="HEF458BEBC1D4471F992A719E4A4CCFF9"><enum>(B)</enum><text>by redesignating
subsections (b) and (c) as subsections (c) and (d), respectively; and</text>
</subparagraph><subparagraph id="HB10C874A8D4343BB9DB138773401BCA3"><enum>(C)</enum><text>by inserting after
subsection (a) the following:</text>
<quoted-block display-inline="no-display-inline" id="H4D85A77243934AD19057B2A802D96A33" style="OLC">
<subsection id="H07BA9425A32B4551967F86677C6DAFE8"><enum>(b)</enum><header>Suspension of
registration</header>
<paragraph id="H9B168AC91B57460C86A277BD8D1B75B5"><enum>(1)</enum><header>In
general</header><text>If the Secretary determines that food manufactured,
processed, packed, or held by a facility registered under this section has a
reasonable probability of causing serious adverse health consequences or death
to humans or animals, the Secretary may by order suspend the registration of
the facility under this section in accordance with this subsection.</text>
</paragraph><paragraph id="H3AFFCBAF269F42D7B7E21D9400B099A3"><enum>(2)</enum><header>Hearing on
suspension</header><text>The Secretary shall provide the registrant subject to
an order under paragraph (1) with an opportunity for an informal hearing, to be
held as soon as possible but not later than 2 days after the issuance of the
order, on the actions required for reinstatement of registration and why the
registration that is subject to suspension should be reinstated. The Secretary
shall reinstate a registration if the Secretary determines, based on evidence
presented, that adequate grounds do not exist to continue the suspension of the
registration.</text>
</paragraph><paragraph id="H34FC5F5706B642F78DB649A3DFE87DD5"><enum>(3)</enum><header>Post-hearing
corrective action plan; vacating of order</header>
<subparagraph id="HD110E1FDF7E840609E5097B9DF457C9B"><enum>(A)</enum><header>Corrective
action plan</header><text>If, after providing opportunity for an informal
hearing under paragraph (2), the Secretary determines that the suspension of
registration remains necessary, the Secretary shall require the registrant to
submit a corrective action plan to demonstrate how the registrant plans to
correct the conditions found by the Secretary. The Secretary shall review such
plan in a timely manner.</text>
</subparagraph><subparagraph id="H8A9F156DF77145B680D755FE183C1561"><enum>(B)</enum><header>Vacating of
order</header><text>Upon a determination by the Secretary that adequate grounds
do not exist to continue the suspension actions required by the order, or that
such actions should be modified, the Secretary shall vacate the order or modify
the order.</text>
</subparagraph></paragraph><paragraph id="H4DEF1FA629F949BE8E9E2062304AB9EA"><enum>(4)</enum><header>Effect of
suspension</header><text>If the registration of a facility is suspended under
this subsection, such facility shall not import food or offer to import food
into the United States, or otherwise introduce food into interstate commerce in
the United States.</text>
</paragraph><paragraph id="H28B08F8F4A564FD896FC39107E8B8DE4"><enum>(5)</enum><header>Regulations</header><text>The
Secretary shall promulgate regulations that describe the standards officials
will use in making a determination to suspend a registration, and the format
such officials will use to explain to the registrant the conditions found at
the facility.</text>
</paragraph><paragraph commented="no" id="H40DACB591ADB4860B9B8E3739D4721E0"><enum>(6)</enum><header>No
delegation</header><text>The authority conferred by this subsection to issue an
order to suspend a registration or vacate an order of suspension shall not be
delegated to any officer or employee other than the
Commissioner.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" id="HF57D58E41C5A4BD193EC57EBC022575E"><enum>(2)</enum><header>Imported
food</header><text>Section 801(l) (21 U.S.C. 381(l)) is amended by inserting
<quote>(or for which a registration has been suspended under such
section)</quote> after <quote>section 415</quote>.</text>
</paragraph></subsection><subsection commented="no" id="H7EA80781A66445BE900546EC9C027D47"><enum>(c)</enum><header>Conforming
amendments</header>
<paragraph commented="no" id="HAA6BE68E0CDF41E58D17095E06437563"><enum>(1)</enum><text>Section 301(d) (21
U.S.C. 331(d)) is amended by inserting <quote>415,</quote> after
<quote>404,</quote>.</text>
</paragraph><paragraph commented="no" id="HE19FD5E956984A9BAD8857BF0926F5CE"><enum>(2)</enum><text>Section 415(d), as
redesignated by subsection (b), is amended by adding at the end before the
period <quote>for a facility to be registered, except with respect to the
reinstatement of a registration that is suspended under subsection
(b)</quote>.</text>
</paragraph></subsection></section><section id="H6A8C480AB1B6456BAFD5EAF8AC7F96D2"><enum>103.</enum><header>Mandatory
recall authority</header>
<subsection id="H0F9092E52D4A4022B8A15D4E40F7BDFE"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Chapter IV (21 U.S.C.
341 et seq.) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H47B6304CC5BD4A3BB7BA231C8ED08EB7" style="OLC">
<section id="H923327905DE948A1A4E7FA7195AF0F81"><enum>418.</enum><header>Mandatory
recall authority</header>
<subsection id="HDFB9782CA561490F9276694955A309E2"><enum>(a)</enum><header>Voluntary
procedures</header><text>If the Secretary determines, based on information
gathered through the reportable food registry under section 417 or through any
other means, that there is a reasonable probability that an article of food
(other than infant formula) is adulterated under section 402 or misbranded
under section 403(w) and the use of or exposure to such article will cause
serious adverse health consequences or death to humans or animals, the
Secretary shall provide the responsible party (as defined in section 417) with
an opportunity to cease distribution and recall such article.</text>
</subsection><subsection id="HF84E23F43C9F43E880C2C9D70A14BEC2"><enum>(b)</enum><header>Prehearing order
To cease distribution and give notice</header><text>If the responsible party
refuses to or does not voluntarily cease distribution or recall such article
within the time and in the manner prescribed by the Secretary (if so
prescribed), the Secretary may, by order require, as the Secretary deems
necessary, such person to—</text>
<paragraph id="H63A090E3CCFA4204A558B09CF52B5018"><enum>(1)</enum><text>immediately cease
distribution of such article; or</text>
</paragraph><paragraph id="H31B3613B663640BDA7BFC20040914A46"><enum>(2)</enum><text>immediately notify
all persons—</text>
<subparagraph id="HB7221FD564A04466A6EE8D16F010C832"><enum>(A)</enum><text>manufacturing,
processing, packing, transporting, distributing, receiving, holding, or
importing and selling such article; and</text>
</subparagraph><subparagraph id="H7B97A12026914A4DB1884A4AAAF2970F"><enum>(B)</enum><text>to which such
article has been distributed, transported, or sold, to immediately cease
distribution of such article.</text>
</subparagraph></paragraph></subsection><subsection id="H94857F726F3D4D36884BE7C8FBA02D32"><enum>(c)</enum><header>Hearing on
order</header><text>The Secretary shall provide the responsible party subject
to an order under subsection (b) with an opportunity for an informal hearing,
to be held as soon as possible but not later than 2 days after the issuance of
the order, on the actions required by the order and on why the article that is
the subject of the order should not be recalled.</text>
</subsection><subsection id="H8C7CA0E59DBD49B687BDF3F7D91B91E2"><enum>(d)</enum><header>Post-hearing
recall order and modification of order</header>
<paragraph id="H8C5FF35EF7FA4F509191DC086371C82C"><enum>(1)</enum><header>Amendment of
order</header><text>If, after providing opportunity for an informal hearing
under subsection (c), the Secretary determines that removal of the article from
commerce is necessary, the Secretary shall, as appropriate—</text>
<subparagraph id="HAD8ED1A0B6E94A10B9F865844F3F2072"><enum>(A)</enum><text>amend the order to
require recall of such article or other appropriate action;</text>
</subparagraph><subparagraph id="H2E16E3CCA8AE4902B56A786AFF976FE9"><enum>(B)</enum><text>specify a
timetable in which the recall shall occur;</text>
</subparagraph><subparagraph id="H243903D8A9664840ACAF2CAB56F8363C"><enum>(C)</enum><text>require periodic
reports to the Secretary describing the progress of the recall; and</text>
</subparagraph><subparagraph id="H8B4B866E189E4A29B88125E01888722B"><enum>(D)</enum><text>provide notice to
consumers to whom such article was, or may have been, distributed.</text>
</subparagraph></paragraph><paragraph id="H4C4E19ED2B0A46E3ABA86F48F4AC2B31"><enum>(2)</enum><header>Vacating of
order</header><text>If, after such hearing, the Secretary determines that
adequate grounds do not exist to continue the actions required by the order, or
that such actions should be modified, the Secretary shall vacate the order or
modify the order.</text>
</paragraph></subsection><subsection id="HF9EC5E0B5838414E9A2A22EA3C3CE196"><enum>(e)</enum><header>Cooperation and
consultation</header><text display-inline="yes-display-inline">The Secretary
shall work with State and local public health officials in carrying out this
section, as appropriate.</text>
</subsection><subsection commented="no" id="H2A2D472FB6A44A22935D505F79F9763A"><enum>(f)</enum><header>Public
notification</header><text display-inline="yes-display-inline">In conducting a
recall under this section, the Secretary shall ensure that a press release is
published regarding the recall, as well as alerts and public notices, as
appropriate, in order to provide notification of the recall to consumers and
retailers to whom such article was, or may have been, distributed. The
notification shall include, at a minimum—</text>
<paragraph commented="no" id="H87D130711AAB4CA09F31F2838768D4DD"><enum>(1)</enum><text display-inline="yes-display-inline">the name of the article of food subject to
the recall; and</text>
</paragraph><paragraph commented="no" id="H5A1C65C394A14D85A831A34E5EC0F286"><enum>(2)</enum><text>a description of
the risk associated with such article.</text>
</paragraph></subsection><subsection commented="no" id="H0AD604AF56B047A0A7D5115EA3533D84"><enum>(g)</enum><header>No
delegation</header><text>The authority conferred by this section to order a
recall or vacate a recall order shall not be delegated to any officer or
employee other than the Commissioner.</text>
</subsection><subsection commented="no" id="H4E4233CFD2244B9D8BD7DF6EC4DCCE11"><enum>(h)</enum><header>Effect</header><text display-inline="yes-display-inline">Nothing in this section shall affect the
authority of the Secretary to request or participate in a voluntary
recall.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HB346A957DC1E4800BB7997E63509E79C"><enum>(b)</enum><header>Prohibited
acts</header><text>Section 301 (21 U.S.C. 331 et seq.) is amended by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H0A49160303CC4AD6A0BFA34AF6C66D0D" style="OLC">
<subsection id="H814D792B25284F3089B1D6E0B3682CF1"><enum>(oo)</enum><text>The refusal or
failure to follow an order under section
418.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" id="H45B4AA2E05CF4B7EA37E9A939DE7B68E"><enum>104.</enum><header>Hazard analysis
and risk-based preventive controls</header>
<subsection id="H9847783AAED54B8A937779F6339C7CE6"><enum>(a)</enum><header>In
general</header><text>Chapter IV (21 U.S.C. 341 et seq.), as amended by section
103, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H7A503669BD234071B4BAB0D7922A7F98" style="OLC">
<section id="HF292BF6320394EC0963B58D5A77CEA30"><enum>419.</enum><header>Hazard analysis
and risk-based preventive controls</header>
<subsection id="H8E0FDA5C69A449C2B012C3154C2B53BF"><enum>(a)</enum><header>In
general</header><text>Each owner, operator, or agent in charge of a facility
shall, in accordance with this section, evaluate the hazards that could affect
food manufactured, processed, packed, or held by such facility, identify and
implement preventive controls to significantly minimize or prevent their
occurrence and provide assurances that such food is not adulterated under
section 402 or misbranded under section 403(w), monitor the performance of
those controls, and maintain records of this monitoring as a matter of routine
practice.</text>
</subsection><subsection id="H0EAFDB0B77184CC7A77FE7F0177D0BEF"><enum>(b)</enum><header>Hazard
analysis</header><text>The owner, operator, or agent in charge of a facility
shall—</text>
<paragraph id="H4BADDA50FE7E4D45BD00A98541FD829B"><enum>(1)</enum><text>identify and
evaluate known or reasonably foreseeable hazards that may be associated with
the facility, including—</text>
<subparagraph id="H815C88FD1711465F8459522DFA011507"><enum>(A)</enum><text>biological,
chemical, physical, and radiological hazards, natural toxins, pesticides, drug
residues, decomposition, parasites, allergens, and unapproved food and color
additives; and</text>
</subparagraph><subparagraph id="HF62697C482D14D06A949345046E9F6F0"><enum>(B)</enum><text>hazards that occur
naturally, may be unintentionally introduced, or may be intentionally
introduced, including by acts of terrorism; and</text>
</subparagraph></paragraph><paragraph id="HF0B3C937BA1D4CE0921D6E43B3A5F68E"><enum>(2)</enum><text>develop a written
analysis of the hazards.</text>
</paragraph></subsection><subsection id="HF61ED7B71BB74D79A79A27DC265B3DE1"><enum>(c)</enum><header>Preventive
controls</header><text>The owner, operator, or agent in charge of a facility
shall identify and implement preventive controls, including at critical control
points, if any, to provide assurances that—</text>
<paragraph id="HA43F547A6A2F4105ADC77717F4A0D66D"><enum>(1)</enum><text>hazards identified
in the hazard analysis conducted under subsection (b) will be significantly
minimized or prevented; and</text>
</paragraph><paragraph id="HC7AA22C99B08483BAD790EE07430E0E5"><enum>(2)</enum><text>the food
manufactured, processed, packed, or held by such facility will not be
adulterated under section 402 or misbranded under section 403(w).</text>
</paragraph></subsection><subsection id="HAF2A7264F39143628468913EAC491048"><enum>(d)</enum><header>Monitoring of
effectiveness</header><text>The owner, operator, or agent in charge of a
facility shall monitor the effectiveness of the preventive controls implemented
under subsection (c) to provide assurances that the outcomes described in
subsection (c) shall be achieved.</text>
</subsection><subsection id="HC82E7194733644D09D34A6352BC95767"><enum>(e)</enum><header>Corrective
actions</header><text>The owner, operator, or agent in charge of a facility
shall establish procedures that a facility will implement if the preventive
controls implemented under subsection (c) are found to be ineffective through
monitoring under subsection (d).</text>
</subsection><subsection id="H1AF55571405946D1A1011EEEBA189FCD"><enum>(f)</enum><header>Verification</header><text>The
owner, operator, or agent in charge of a facility shall verify that—</text>
<paragraph id="H57997F9B48E644888EB9114FA5AEC68E"><enum>(1)</enum><text>the preventive
controls implemented under subsection (c) are adequate to control the hazards
identified under subsection (b);</text>
</paragraph><paragraph id="HAA0032284A6B4A30896BEF736C5738A6"><enum>(2)</enum><text>the owner,
operator, or agent is conducting monitoring in accordance with subsection
(d);</text>
</paragraph><paragraph id="H15859FBFFBF14E46AFBC819F835BCDDE"><enum>(3)</enum><text>the owner,
operator, or agent is making appropriate decisions about corrective actions
taken under subsection (e); and</text>
</paragraph><paragraph id="H9ED36F4F06AE47758611E2C9650A041E"><enum>(4)</enum><text>there is
documented, periodic reanalysis of the plan under subsection (i) to ensure that
the plan is still relevant to the raw materials, as well as to conditions and
processes in the facility, and to new and emerging threats.</text>
</paragraph></subsection><subsection id="H51A8DB567B084C3196F25BFDCACEE1E6"><enum>(g)</enum><header>Recordkeeping</header><text>The
owner, operator, or agent in charge of a facility shall maintain, for not less
than 2 years, records documenting the monitoring of the preventive controls
implemented under subsection (c), instances of nonconformance material to food
safety, instances when corrective actions were implemented, and the efficacy of
preventive controls and corrective actions.</text>
</subsection><subsection id="HB8F9A7CFFB304393B689C95B0CE001CB"><enum>(h)</enum><header>Written plan and
documentation</header><text display-inline="yes-display-inline">Each owner,
operator, or agent in charge of a facility shall prepare a written plan that
documents and describes the procedures used by the facility to comply with the
requirements of this section, including analyzing the hazards under subsection
(b) and identifying the preventive controls adopted to address those hazards
under subsection (c). High-risk facilities, as determined by the Secretary,
shall submit such written plan to the Food and Drug Administration’s Center for
Food Safety and Applied Nutrition. The Secretary or a duly authorized
representative of the Secretary may review the plan and may make
recommendations regarding the effectiveness of the plan in preventing or
minimizing the threat of serious adverse health consequences or death to humans
or animals. All facilities shall promptly make available such written plan,
together with documentation that the plan is being implemented, to a duly
authorized representative of the Secretary upon oral or written request.</text>
</subsection><subsection id="H2BE6FADB51B44BC595AA4340D7E05D57"><enum>(i)</enum><header>Requirement To
reanalyze</header><text>Each owner, operator, or agent in charge of a facility
shall conduct a reanalysis under subsection (b) whenever a significant change
is made in the activities conducted at a facility operated by such owner,
operator, or agent if the change creates a reasonable potential for a new
hazard or a significant increase in a previously identified hazard or not less
frequently than once every 3 years, whichever is earlier. Such reanalysis shall
be completed and additional preventive controls needed to address the hazard
identified, if any, shall be implemented before the change in activities at the
facility is commenced. Such owner, operator, or agent shall revise the written
plan required under subsection (h) if such a significant change is made or
document the basis for the conclusion that no additional or revised preventive
controls are needed. The Secretary may require a reanalysis under this section
to respond to new hazards and developments in scientific understanding.</text>
</subsection><subsection id="HA358B5A4F91F4E04B4C4FB67A701E12F"><enum>(j)</enum><header>Deemed
compliance of seafood, juice, and low-acid canned food facilities in compliance
with HACCP</header><text>An owner, operator, or agent in charge of a facility
required to comply with 1 of the following standards and regulations with
respect to such facility shall be deemed to be in compliance with this section,
with respect to such facility:</text>
<paragraph id="H2CAF531EC46E4D6A96A54573A5A00DD4"><enum>(1)</enum><text>The Seafood Hazard
Analysis Critical Control Points Program of the Food and Drug
Administration.</text>
</paragraph><paragraph id="HC47CAEAC63484BD5B8712DD607922724"><enum>(2)</enum><text>The Juice Hazard
Analysis Critical Control Points Program of the Food and Drug
Administration.</text>
</paragraph><paragraph id="HDB9A95241307459483FFE0A5056B92F9"><enum>(3)</enum><text>The Thermally
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards
of the Food and Drug Administration (or any successor standards).</text>
</paragraph></subsection><subsection id="H75FB6A16C70B4561B9CA230E5F58B0A0"><enum>(k)</enum><header>Exception for
facilities in compliance with section 420</header><text>This section shall not
apply to a facility that is subject to section 420.</text>
</subsection><subsection id="H49D3FD1BFB3D4220A71195D9DBFC384C"><enum>(l)</enum><header>Authority with
respect to certain facilities</header><text>The Secretary may, by regulation,
exempt or modify the requirements for compliance under this section with
respect to facilities that are solely engaged in the storage of packaged foods
that are not exposed to the environment.</text>
</subsection><subsection id="H1F714466CF87402F891E6DB571B43D47"><enum>(m)</enum><header>Definitions</header><text>For
purposes of this section:</text>
<paragraph id="HEE97BFF613D64A85A634A36681CEBD11"><enum>(1)</enum><header>Critical control
point</header><text>The term <term>critical control point</term> means a point,
step, or procedure in a food process at which control can be applied and is
essential to prevent or eliminate a food safety hazard or reduce it to an
acceptable level.</text>
</paragraph><paragraph id="H5F1FBEBCB3854DAE816C0FC48DDC1758"><enum>(2)</enum><header>Facility</header><text>The
term <term>facility</term> means a domestic facility or a foreign facility that
is required to register under section 415.</text>
</paragraph><paragraph id="H79614E7E3F9F401AB241EF62F4FD048D"><enum>(3)</enum><header>Preventive
controls</header><text>The term <term>preventive controls</term> means those
risk-based, reasonably appropriate procedures, practices, and processes that a
person knowledgeable about the safe manufacturing, processing, packing, or
holding of food would have employed to significantly minimize or prevent the
hazards identified under the hazard analysis conducted under subsection (a) and
that are consistent with the current scientific understanding of safe food
manufacturing, processing, packing, or holding at the time of the analysis.
Those procedures, practices, and processes shall include the following:</text>
<subparagraph id="HC431A3646177468C975AAAC674A8BFBC"><enum>(A)</enum><text>Sanitation
procedures for food contact surfaces and utensils and food-contact surfaces of
equipment.</text>
</subparagraph><subparagraph id="HBB83AE8B56F7474A98EF5C9CFA7C3154"><enum>(B)</enum><text>Supervisor,
manager, and employee hygiene training.</text>
</subparagraph><subparagraph id="HCBA83A4D0ADE420AA58123537332983A"><enum>(C)</enum><text>An environmental
monitoring program to verify the effectiveness of pathogen controls.</text>
</subparagraph><subparagraph id="H3D2F791FE36648E9B59ED661819763EF"><enum>(D)</enum><text>An allergen
control program.</text>
</subparagraph><subparagraph id="H9B1ADE8ED2824F3AA2E270B1F05ED51E"><enum>(E)</enum><text>A recall
contingency plan.</text>
</subparagraph><subparagraph id="HA1BF6F9299F242D0BF65570323A0E9DE"><enum>(F)</enum><text>Good Manufacturing
Practices (GMPs).</text>
</subparagraph><subparagraph id="HE275423992EC41538F5B5B095275A60E"><enum>(G)</enum><text>Supplier
verification
activities.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H932FBC4324764FCDBF9036D50F0CD778"><enum>(b)</enum><header>Regulations</header>
<paragraph id="H86AA774BE5DC4CC2A3256CE2130A9DF2"><enum>(1)</enum><header>In
general</header><text>The Secretary of Health and Human Services (referred to
in this Act as the <quote>Secretary</quote>) shall promulgate regulations to
establish science-based minimum standards for conducting a hazard analysis,
documenting hazards, implementing preventive controls, and documenting the
implementation of the preventive controls under section 419 of the Federal
Food, Drug, and Cosmetic Act (as added by subsection (a)).</text>
</paragraph><paragraph id="HAA183F3912604F3F973D6F6090CD8188"><enum>(2)</enum><header>Content</header><text>The
regulations promulgated under paragraph (1) shall provide sufficient
flexibility to be applicable in all situations, including in the operations of
small businesses.</text>
</paragraph><paragraph id="H71E0A57BFD144C04B274D84D2F924798"><enum>(3)</enum><header>Rule of
construction</header><text>Nothing in this subsection shall be construed to
provide the Secretary with the authority to apply specific technologies,
practices, or critical controls to an individual facility.</text>
</paragraph><paragraph id="HC7CD51CF50204A3FAAC0E21CE7FC3FE6"><enum>(4)</enum><header>Review</header><text>In
promulgating the regulations under paragraph (1), the Secretary shall review
regulatory hazard analysis and preventive control programs in existence on the
date of enactment of this Act to ensure that the program under such section 419
is consistent, to the extent practicable, with applicable internationally
recognized standards in existence on such date.</text>
</paragraph></subsection><subsection id="H6BEE2EB9147944A5B6F61D71AED3A0EC"><enum>(c)</enum><header>Guidance
document</header><text>The Secretary shall issue a guidance document related to
hazard analysis and preventive controls required under section 419 of the
Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).</text>
</subsection><subsection id="H0297518F8C894653AF2D8A774A1C05BF"><enum>(d)</enum><header>Prohibited
acts</header><text>Section 301 (21 U.S.C. 331), as amended by section 103, is
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HF785F0493C094572840A30EA83176973" style="OLC">
<subsection id="H6BE0D38ACF004B6595ACFED503DC13F2"><enum>(pp)</enum><text>The operation of
a facility that manufacturers, processes, packs, or holds food for sale in the
United States if the owner, operator, or agent in charge of such facility is
not in compliance with section
419.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H2320CF16B521480EBBC71C7F70EBA46D"><enum>(e)</enum><header>No effect on
HACCP authorities</header><text>Nothing in the amendments made by this section
limits the authority of the Secretary under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42
U.S.C. 201 et seq.) to revise, issue, or enforce product and category-specific
regulations, such as the Seafood Hazard Analysis Critical Controls Points
Program, the Juice Hazard Analysis Critical Control Program, and the Thermally
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
standards.</text>
</subsection><subsection id="HBB06CC8187E647E78219587CCF53DA17"><enum>(f)</enum><header>Effective
date</header>
<paragraph commented="no" id="H7FDC367C83874248AA4F2EBD02AEFA63"><enum>(1)</enum><header>General
rule</header><text>The amendments made by this section shall take effect 18
months after the date of enactment of this Act.</text>
</paragraph><paragraph id="HDD3A265812E640C999DDE0B142D8BEED"><enum>(2)</enum><header>Exceptions</header><text>Notwithstanding
paragraph (1)—</text>
<subparagraph id="H4F62E27BDC5446F0BCFDC708B66D1094"><enum>(A)</enum><text>the amendments
made by this section shall apply to a small business (as defined by the
Secretary) after the date that is 2 years after the date of enactment of this
Act; and</text>
</subparagraph><subparagraph id="H2045FBD130D140CDB5F83086C4CA73FF"><enum>(B)</enum><text>the amendments
made by this section shall apply to a very small business (as defined by the
Secretary) after the date that is 3 years after the date of enactment of this
Act.</text>
</subparagraph></paragraph></subsection></section><section id="H4DB2CB16E4984D83B962C9DFD7C31B59"><enum>105.</enum><header>Performance
standards</header><text display-inline="no-display-inline">The Secretary shall,
not less frequently than every 2 years, review and evaluate relevant health
data and other relevant information, including from toxicological and
epidemiological studies and analyses, to determine the most significant
food-borne contaminants and, when appropriate to reduce the risk of serious
illness or death to humans or animals, to prevent the adulteration of the food
under section 402 of the Federal Food, Drug, or Cosmetic Act (21 U.S.C. 342),
or to prevent the spread of communicable disease under the Public Health
Service Act (42 U.S.C. 201 et seq.), shall issue contaminant-specific,
science-based guidance documents, actions levels, or regulations. Such guidance
documents, action levels, or regulations shall apply to products or product
classes, take into account naturally occurring substances in the case of raw
agricultural products, and shall not be written to be facility-specific.</text>
</section><section display-inline="no-display-inline" id="H15575B28C2A14AF1B883E5AB6956D604"><enum>106.</enum><header>Standards for
the safety of fruits and vegetables</header>
<subsection id="HFC69F2C18ECD4C3BA9CB179F29BCA28B"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Chapter IV (21 U.S.C.
341 et seq.), as amended by section 104, is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HB6DBACF218454488A1BF44F091FBD3D9" style="OLC">
<section id="H7E827B80C4E04827AD8D2DEC61DAF043"><enum>420.</enum><header>Standards for
the safety of fruits and vegetables</header>
<subsection id="HBA4B4DDA682A4B86860DB3F12D3B4C6A"><enum>(a)</enum><header>Definition</header><text display-inline="yes-display-inline">For purposes of this section, the term
<term>fruits and vegetables</term> means raw agricultural products as defined
in section 201(r).</text>
</subsection><subsection id="HA2C5032AD3B946559A5C85C2F72CBE33"><enum>(b)</enum><header>In
general</header><text display-inline="yes-display-inline">Not later than 1 year
after enactment of this section, the Secretary, in consultation with the
Secretary of Agriculture and representatives of State departments of
agriculture, shall publish a notice of proposed rulemaking to establish
regulations for the safe production, harvesting, handling, and packing of those
types of fruits and vegetables for which the Secretary has determined that such
regulations are necessary to minimize the risk of serious adverse health
consequences.</text>
</subsection><subsection id="HDA07BB368B944F24B95654057D25719E"><enum>(c)</enum><header>Final
regulation</header><text>Not later than 1 year after the close of the comment
period on the notice of proposed rulemaking under subsection (a), the Secretary
shall adopt a final regulation covering those types of fruits and vegetables
for which the Secretary has determined that such regulations are necessary to
minimize the risk of serious adverse health consequences. The final regulation
shall provide a reasonable period of time for implementation, taking into
account the needs of small businesses for additional time to comply. The final
regulation shall provide for coordination of education and enforcement
activities by the Secretary of Agriculture, appropriate State and local
agencies, and appropriate agencies of foreign governments.</text>
</subsection><subsection display-inline="no-display-inline" id="H553CDF97057A47489E9C8CE5BCAD0C7B"><enum>(d)</enum><header>Cooperation</header><text display-inline="yes-display-inline">The Secretary shall work with State and
local public health officials in carrying out this section. The Secretary shall
coordinate activities with the Secretary of Agriculture related to on-farm
requirements for growers including the development of food safety standards and
enforcement mechanisms that will address regulations adopted under subsection
(c).</text>
</subsection><subsection id="H357ECA0782724506B6AB8B3BE221FF8F"><enum>(e)</enum><header>Criteria</header><text>The
regulations adopted under subsection (b) shall—</text>
<paragraph id="H2F790F4F8CAF4048871A6D0954AC51F4"><enum>(1)</enum><text>set forth such
procedures, processes, and practices as the Secretary determines to be
reasonably necessary to minimize the introduction of known or reasonably
foreseeable biological, chemical, and physical hazards into fruits and
vegetables and to provide reasonable assurance that the fruits and vegetables
are not adulterated under section 402;</text>
</paragraph><paragraph id="H5EBC98A552D44529B50FED6B6CF1413A"><enum>(2)</enum><text>permit States and
foreign governments to seek variances from the requirements of the regulations,
where the State or foreign government determines that the variance is necessary
in light of local growing conditions and that the procedures, processes, and
practices to be followed under the variance are reasonably likely to ensure
that the fruits or vegetables are not adulterated within the meaning of section
402 to the same extent as the requirements of the regulation adopted under
subsection (b);</text>
</paragraph><paragraph id="H604E3A2422E24DA094599FD167AE7FC5"><enum>(3)</enum><text>require that any
State or foreign government seeking a variance under paragraph (2) shall first
notify the Secretary of the intended variance and the basis for it, and the
Secretary may grant the variance after 90 days of such notification if
Secretary does not communicate objections or modifications to the intended
variance to the respective State or foreign government prior to the conclusion
of the 90-day period; and</text>
</paragraph><paragraph id="H7A45E613CC684423881D06CCC31E3C60"><enum>(4)</enum><text>provide for
publication of notices of requests for variances under paragraph (2) at the
time they are received.</text>
</paragraph></subsection><subsection id="HEB92C63C42564AFC8BA4529D5DD458B5"><enum>(f)</enum><header>Enforcement</header><text display-inline="yes-display-inline">The Secretary shall coordinate enforcement
under this section with appropriate State and local agencies and with
appropriate agencies of foreign governments. In enforcing any standards for the
safety of fruits and vegetables, the Secretary shall, to the maximum extent
practicable, use the Department of Agriculture and state agricultural agencies.
Such enforcement may be in the form of audit-based verification systems or
other methods of inspection.</text>
</subsection><subsection id="HAC648EEA48B547B1BD80EA4840687587"><enum>(g)</enum><header>Guidance for
good agricultural practices</header><text>Not later than 1 year after the date
of the enactment of this section, the Secretary shall publish updated guidance,
in coordination with the Secretary of Agriculture and representatives of State
departments of agriculture, based on the most currently available scientific
evidence, for the safe production, harvesting, handling, packing, and
traceability of fruits and vegetables. The Secretary shall publish subsequently
updated guidance, as necessary.</text>
</subsection><subsection id="HC6712C44743B4521A312B0AB169728FA"><enum>(h)</enum><header>Scope</header><text>This
section shall apply to the production, harvesting, packaging, and traceability
of fruits and vegetables intended for human consumption, but not to—</text>
<paragraph id="HF423C765F0E7498FA20AAAED95B1D7D3"><enum>(1)</enum><text>activities
involving the further processing of fruits and vegetables which shall be
subject to section 419; or</text>
</paragraph><paragraph id="HEE337E60344941F0A728DC64C7920862"><enum>(2)</enum><text display-inline="yes-display-inline">those activities that occur in a retail
food establishment (as such term is defined in regulations to carry out section
415(b)(1)).</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H9E6723272AC947DCA6AE61D069959CAF"><enum>(b)</enum><header>Prohibited</header><text>Section
301 (21 U.S.C. 331), as amended by section 104, is further amended by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H92A753F93730401A870ABBE9B1EB7534" style="OLC">
<subsection id="idE372CC45B1774E6F8729DD2C4AE9B7AE"><enum>(qq)</enum><text display-inline="yes-display-inline">Production, harvesting, handling, and
packing of fruits or vegetables not in accordance with the regulations under
section 419 or a variance issued under section
419(e)(2).</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section id="HEE7356DD3DD546719465724D0AC77FE8"><enum>107.</enum><header>Targeting of
inspection resources for domestic facilities, foreign facilities, and ports of
entry; annual report</header>
<subsection id="H350C895B58EE4E7EA01E1E0053AEC8B5"><enum>(a)</enum><header>Targeting of
inspection resources for domestic facilities, foreign facilities, and ports of
entry</header><text display-inline="yes-display-inline">Chapter IV (21 U.S.C.
341 et seq.), as amended by section 106, is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HDA5338D9A66449EA840648B599222E8F" style="OLC">
<section id="H5DEF300C6F5A49CA8DE4F5DEC1A5C8D1"><enum>421.</enum><header>Targeting of
inspection resources for domestic facilities, foreign facilities, and ports of
entry; annual report</header>
<subsection id="H23ED59D40737496EBC7E2FCDB7FA2043"><enum>(a)</enum><header>Identification
and inspection of facilities</header>
<paragraph id="H002A8925B60F408CA82B0B654CF0600A"><enum>(1)</enum><header>Identification</header><text display-inline="yes-display-inline">The Secretary shall allocate resources to
inspect facilities according to the risk profile of the facilities, which shall
be based on the following factors:</text>
<subparagraph id="HA7C1EC75A42249369C2C45CB2CE98F55"><enum>(A)</enum><text>The risk profile
of the food manufactured, processed, packed, or held at the facility.</text>
</subparagraph><subparagraph id="H189D9A8ADC53458DB94D7487A0A9F48E"><enum>(B)</enum><text>The facility's
history of food recalls, outbreaks, and violations of food safety
standards.</text>
</subparagraph><subparagraph id="HB80EB95F4F594A509270D2A20EDB0C2A"><enum>(C)</enum><text>The rigor of the
facility's hazard analysis and risk-based preventive controls.</text>
</subparagraph><subparagraph id="H9C40F79B6A4A49BC88094773B0C5EA61"><enum>(D)</enum><text>Whether the food
manufactured, processed, packed, handled, prepared, treated, distributed, or
stored at the facility meets the criteria for priority under section
801(h)(1).</text>
</subparagraph><subparagraph id="H9B4D8ADBC4CC44889A4C0770D5567151"><enum>(E)</enum><text>Whether the
facility has received a certificate as described in section 809(b).</text>
</subparagraph><subparagraph id="H01BE5D388F0743CCAC032A3DE8AE87DF"><enum>(F)</enum><text>Any other criteria
deemed necessary and appropriate by the Secretary for purposes of allocating
inspection resources.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H10CAA6A57587445DA2E71D1CD543C281"><enum>(2)</enum><header>Inspections</header><text>The
Secretary shall increase the frequency of inspections of all facilities such
that—</text>
<subparagraph id="H8225807C1B7746C4924D2D1F053F5BF6"><enum>(A)</enum><text>all facilities
registered under section 415 are inspected not less than once every 4 years;
and</text>
</subparagraph><subparagraph id="H838489BD28254944AF5E1050FCEA3D88"><enum>(B)</enum><text>all facilities
identified under paragraph (1) as a high-risk facility are inspected—</text>
<clause id="HF1D3FBE7ADD94ED0A38BF87989477031"><enum>(i)</enum><text>not less than once
within a 2-year period after the date of enactment of this section; and</text>
</clause><clause id="H3CB01A5361544F3999088BF1655E0C83"><enum>(ii)</enum><text>for each
succeeding year, each high-risk facility is inspected not less than once each
year.</text>
</clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HB28214031AF34838A407DB5E1D265289"><enum>(b)</enum><header>Identification
and inspection at ports of entry</header><text>The Secretary, in consultation
with the Secretary of Homeland Security, shall allocate resources to inspect
articles of food imported into the United States according to the risk profile
of the article of food, which shall be based on the following factors:</text>
<paragraph id="H5C7435216191429398D2C025BC4F6D2C"><enum>(1)</enum><text>The risk profile
of the food imported.</text>
</paragraph><paragraph id="H5574B26103C84A0291E9C0F624231138"><enum>(2)</enum><text>The risk profile
of the countries of origin and countries of transport of the food
imported.</text>
</paragraph><paragraph id="H0C12209C307E4F5FBD4330130EFB1087"><enum>(3)</enum><text>The history of
food recalls, outbreaks, and violations of food safety standards of the food
importer.</text>
</paragraph><paragraph id="HB9AB6D7D64BA4FA48E164FC0D90AC802"><enum>(4)</enum><text>The rigor of the
foreign supplier verification program under section 805.</text>
</paragraph><paragraph id="HD567EAA102D64F549626BBBAFFAEC1D0"><enum>(5)</enum><text>Whether the food
importer participates in the Voluntary Qualified Importer Program under section
806.</text>
</paragraph><paragraph id="HEBCFFD1C4DE741AEBDC73F08C65767F0"><enum>(6)</enum><text>Whether the food
meets the criteria for priority under section 801(h)(1).</text>
</paragraph><paragraph id="H4CCD22F4E433438B9CC3B82AA9CF651E"><enum>(7)</enum><text>Whether the food
is from a facility that has received a certificate as described in section
809(b).</text>
</paragraph><paragraph id="H7797B0F0765749CE81B97E4A5C69DDFC"><enum>(8)</enum><text>Any other criteria
deemed appropriate by the Secretary for purposes of allocating inspection
resources.</text>
</paragraph></subsection><subsection id="H74EB0945DED74B6898275C2EA6E439F8"><enum>(c)</enum><header>Coordination</header><text>The
Secretary shall improve coordination and cooperation with the Secretary of
Agriculture to target food inspection resources.</text>
</subsection><subsection id="H4C21FCAA5613404E91C515FC44F6ECFD"><enum>(d)</enum><header>Facility</header><text>For
purposes of this section, the term <term>facility</term> means a domestic
facility or a foreign facility that is required to register under section
415.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H7A0802B76EA24E679DA2F6709E2FFE7E"><enum>(b)</enum><header>Annual
report</header><text>Section 903 (21 U.S.C. 393) is amended by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="H9E10FE65889D4A26A7725E15A0869BC5" style="OLC">
<subsection id="HB97B281EE99D40CF9605009E64DCA6A5"><enum>(h)</enum><header>Annual report
regarding food</header><text>Not later than February 1 of each year, the
Secretary shall submit to Congress a report regarding—</text>
<paragraph id="HDB7BCB047FA84B2D8FC99FEDF2AD46CE"><enum>(1)</enum><text>information about
food facilities including—</text>
<subparagraph id="HFB485DAB119245DCB170BF5A996F119A"><enum>(A)</enum><text>the appropriations
used to inspect facilities registered pursuant to section 415 in the previous
fiscal year;</text>
</subparagraph><subparagraph id="H7C3D544D45D34C2084D25DD4BA79CA9B"><enum>(B)</enum><text>the average cost
of both a non-high-risk food facility inspection and a high-risk food facility
inspection, if such a difference exists, in the previous fiscal year;</text>
</subparagraph><subparagraph id="HE41BFC26E81A483ABCAD5271735FAE46"><enum>(C)</enum><text>the number of
domestic facilities and the number of foreign facilities registered pursuant to
section 415 that the Secretary inspected in the previous fiscal year;</text>
</subparagraph><subparagraph id="HA322EC1B4D1044E381F9D81B712BE705"><enum>(D)</enum><text>the number of
domestic facilities and the number of foreign facilities registered pursuant to
section 415 that the Secretary did not inspect in the previous fiscal
year;</text>
</subparagraph><subparagraph id="HF39BCF558D874E8DB52E977EE234FCB4"><enum>(E)</enum><text>the number of
high-risk facilities identified pursuant to section 421 that the Secretary
inspected in the previous fiscal year; and</text>
</subparagraph><subparagraph id="HAC75FD71A2F1472D9002E456E3F6F003"><enum>(F)</enum><text>the number of
high-risk facilities identified pursuant to section 421 that the Secretary did
not inspect in the previous fiscal year; and</text>
</subparagraph></paragraph><paragraph id="H17394614D96046DBB5A5096C220B1DF2"><enum>(2)</enum><text>information about
food imports including—</text>
<subparagraph id="HBB08B0D6D7ED4D83A7A09DDD4604AED6"><enum>(A)</enum><text>the number of
lines of food imported into the United States that the Secretary physically
inspected or sampled in the previous fiscal year;</text>
</subparagraph><subparagraph id="HE0671FDD638749B5B3ACF74F1EF4AB95"><enum>(B)</enum><text>the number of
lines of food imported into the United States that the Secretary did not
physically inspect or sample in the previous fiscal year; and</text>
</subparagraph><subparagraph id="HE060F79BB87E49D094B7147EEDB4EEF3"><enum>(C)</enum><text>the average cost
of physically inspecting or sampling a food line subject to this Act that is
imported or offered for import into the United States.</text>
</subparagraph></paragraph></subsection><subsection id="HD46BF08E7E92436583775A98AE585FE9"><enum>(i)</enum><header>Public
availability of annual food reports</header><text>The Secretary shall make the
reports required under subsection (h) available to the public on the Internet
Web site of the Food and Drug
Administration.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section id="H1E0FADAC3C4346378A03663290568898"><enum>108.</enum><header>Administrative
detention of food</header>
<subsection id="H28AB8F17E28B4E76A476FB5B81B08E1B"><enum>(a)</enum><header>In
general</header><text>Section 304(h)(1)(A) (21 U.S.C. 334(h)(1)(A)) is amended
by—</text>
<paragraph id="HFE8D5938D8CF4DC3B4D35619860F5293"><enum>(1)</enum><text>striking
<quote>credible evidence or information indicating</quote> and inserting
<quote>reason to believe</quote>; and</text>
</paragraph><paragraph id="HB336D629DD45406F9B00F9A9F093CFFD"><enum>(2)</enum><text>striking
<quote>presents a threat of serious adverse health consequences or death to
humans or animals</quote> and inserting <quote>is adulterated or misbranded
under section 403(w)</quote>.</text>
</paragraph></subsection><subsection id="HFC0DD53306BB426387280F9F7C8C86EC"><enum>(b)</enum><header>Regulations</header><text>Not
later than 120 days after the date of enactment of this Act, the Secretary
shall issue an interim final rule amending subpart K of part 1 of title 21,
Code of Federal Regulations, to implement the amendment made by this
section.</text>
</subsection><subsection id="H35FBA376A1E843678D6D12F75ED10BD6"><enum>(c)</enum><header>Effective
date</header><text>The amendment made by this section shall take effect 180
days after the date of enactment of this Act.</text>
</subsection></section><section commented="no" id="HF6412EF5A9FA4554937D64698497BF15"><enum>109.</enum><header>National
agriculture and food defense strategy</header>
<subsection commented="no" id="H97A7104272AF4DB7AD4986DD49C3636C"><enum>(a)</enum><header>Development and
submission of strategy</header>
<paragraph commented="no" id="H00771AFD0CC545FCA2582A9D817501F3"><enum>(1)</enum><header>In
general</header><text>Not later than 1 year after the date of enactment of this
Act, the Secretary of Health and Human Services and the Secretary of
Agriculture, in coordination with the Secretary of Homeland Security, shall
prepare and submit to the relevant committees of Congress, and make publicly
available on the Internet Web site of the Department of Health and Human
Services and the Department of Agriculture, the National Agriculture and Food
Defense Strategy.</text>
</paragraph><paragraph commented="no" id="HF6DAC9EDEEC54973AF3A946D9ED49378"><enum>(2)</enum><header>Implementation
plan</header><text>The strategy shall include an implementation plan for use by
the Secretaries described under paragraph (1) in carrying out the
strategy.</text>
</paragraph><paragraph commented="no" id="HCD4F69C963BA44FE8D13E73FCB53DCF2"><enum>(3)</enum><header>Research</header><text>The
strategy shall include a coordinated research agenda for use by the Secretaries
described under paragraph (1) in conducting research to support the goals and
activities described in paragraphs (1) and (2) of subsection (b).</text>
</paragraph><paragraph commented="no" id="H7F5FC691E250479DAF3716CED81AF9EA"><enum>(4)</enum><header>Revisions</header><text>Not
later than 4 years after the date on which the strategy is submitted to the
relevant committees of Congress under paragraph (1), and not less frequently
than every 4 years thereafter, the Secretary of Health and Human Services and
the Secretary of Agriculture, in coordination with the Secretary of Homeland
Security, shall revise and submit to the relevant committees of Congress the
strategy.</text>
</paragraph><paragraph commented="no" id="HBAEDE0E1020D437B8A1953D778F8CE7B"><enum>(5)</enum><header>Consistency with
existing plans</header><text>The strategy described in paragraph (1) shall be
consistent with—</text>
<subparagraph commented="no" id="HE6B07FACE83C4A9FB3084F709B827107"><enum>(A)</enum><text>the National
Incident Management System;</text>
</subparagraph><subparagraph commented="no" id="HA302231AE8DD45E8A9C329A3332DB193"><enum>(B)</enum><text>the National
Response Framework;</text>
</subparagraph><subparagraph commented="no" id="H25C9F99F23A14DC083340B4B9070E28C"><enum>(C)</enum><text>the National
Infrastructure Protection Plan;</text>
</subparagraph><subparagraph commented="no" id="H7DB655DA922B4129A96101036FBEA751"><enum>(D)</enum><text>the National
Preparedness Goals; and</text>
</subparagraph><subparagraph commented="no" id="H8BD283BCF5234B5EB7B0636200339B2D"><enum>(E)</enum><text>other relevant
national strategies.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="H9574353262EF4A5BAE9AC59CF4C25604"><enum>(b)</enum><header>Components</header>
<paragraph commented="no" id="H5217D849093F4DEE8E702EC90FA0F9BF"><enum>(1)</enum><header>In
general</header><text>The strategy shall include a description of the process
to be used by the Department of Health and Human Services, the Department of
Agriculture, and the Department of Homeland Security—</text>
<subparagraph commented="no" id="H2C4B5989A7A84391A0E4D815E4B04BA8"><enum>(A)</enum><text>to achieve each
goal described in paragraph (2); and</text>
</subparagraph><subparagraph commented="no" id="H74C7FD919B5B432BBC95326E04B60BCC"><enum>(B)</enum><text>to evaluate the
progress made by Federal, State, local, and tribal governments towards the
achievement of each goal described in paragraph (2).</text>
</subparagraph></paragraph><paragraph commented="no" id="H20035DEB88274E23AC23457C5B8FB0BE"><enum>(2)</enum><header>Goals</header><text>The
strategy shall include a description of the process to be used by the
Department of Health and Human Services, the Department of Agriculture, and the
Department of Homeland Security to achieve the following goals:</text>
<subparagraph commented="no" id="HCFB4591D64004999AFCD056DA5CE96E7"><enum>(A)</enum><header>Preparedness
goal</header><text>Enhance the preparedness of the agriculture and food system
by—</text>
<clause commented="no" id="HD4EC1787C0194023A150B78AB372451D"><enum>(i)</enum><text>conducting
vulnerability assessments of the agriculture and food system;</text>
</clause><clause commented="no" id="H0E9A95EF3F3147068FD4A6F0A836913D"><enum>(ii)</enum><text>mitigating
vulnerabilities of the system;</text>
</clause><clause commented="no" id="H3E35FE9B7F704786ABF0045E6159AC5D"><enum>(iii)</enum><text>improving
communication and training relating to the system;</text>
</clause><clause commented="no" id="H5B83F8FA6AAA4F078C821E47D1BA69BC"><enum>(iv)</enum><text>developing and
conducting exercises to test decontamination and disposal plans;</text>
</clause><clause commented="no" id="HE3B9F27B31074E5EA87AEEA853BD3908"><enum>(v)</enum><text>developing
modeling tools to improve event consequence assessment and decision support;
and</text>
</clause><clause commented="no" id="H8B7569DB2FFC48E9953FCF185AFE4BE0"><enum>(vi)</enum><text>preparing risk
communication tools and enhancing public awareness through outreach.</text>
</clause></subparagraph><subparagraph commented="no" id="H0BC3F1CA938B4C7989786FB11B4D03F2"><enum>(B)</enum><header>Detection
goal</header><text>Improve agriculture and food system detection capabilities
by—</text>
<clause commented="no" id="H04977D4C25804599B19413EE7B48D9A7"><enum>(i)</enum><text>identifying
contamination in food products at the earliest possible time; and</text>
</clause><clause commented="no" id="HFD52BEBF3DD649EBBAD1E03D782C0820"><enum>(ii)</enum><text>conducting
surveillance to prevent the spread of diseases.</text>
</clause></subparagraph><subparagraph commented="no" id="H6180FB060DE84CA3B794C437879D80F8"><enum>(C)</enum><header>Emergency
response goal</header><text>Ensure an efficient response to agriculture and
food emergencies by—</text>
<clause commented="no" id="H14A316A3119F4CB99DDE7996B6815167"><enum>(i)</enum><text>immediately
investigating animal disease outbreaks and suspected food contamination;</text>
</clause><clause commented="no" id="H5886B9EBAA1E49969C682FD779E7C22B"><enum>(ii)</enum><text>preventing
additional human illnesses;</text>
</clause><clause commented="no" id="H2A813986216543698F5A4C6930916CDC"><enum>(iii)</enum><text>organizing,
training, and equipping animal, plant, and food emergency response teams
of—</text>
<subclause commented="no" id="H4B0461C587994B1FBF19503FF1423F62"><enum>(I)</enum><text>the Federal
Government; and</text>
</subclause><subclause commented="no" id="H2A30886C5F1E498A912D4A9D6AE287B8"><enum>(II)</enum><text>State, local, and
tribal governments;</text>
</subclause></clause><clause commented="no" id="H11D3B4ACD17840BC8B886EF890BD6B56"><enum>(iv)</enum><text>designing,
developing, and evaluating training and exercises carried out under agriculture
and food defense plans; and</text>
</clause><clause commented="no" id="H28F7CF3CA2794C25846C597DB64B778F"><enum>(v)</enum><text>ensuring
consistent and organized risk communication to the public by—</text>
<subclause commented="no" id="HE2A6694328684BD58EC4797AED87568F"><enum>(I)</enum><text>the Federal
Government;</text>
</subclause><subclause commented="no" id="H900C73677859436CB83A0E208EA4DB18"><enum>(II)</enum><text>State, local, and
tribal governments; and</text>
</subclause><subclause commented="no" id="HD008EDDE0BEB4980BCE7590580A6A93A"><enum>(III)</enum><text>the private
sector.</text>
</subclause></clause></subparagraph><subparagraph commented="no" id="H9FC9F29292F5463CA42BCB7F46DCACA2"><enum>(D)</enum><header>Recovery
goal</header><text>Secure agriculture and food production after an agriculture
or food emergency by—</text>
<clause commented="no" id="H4725394D055146EC952B07F9F9D06FEB"><enum>(i)</enum><text>working with the
private sector to develop business recovery plans to rapidly resume agriculture
and food production;</text>
</clause><clause commented="no" id="HBA525BC549BD4C3B9A82FE7548E18542"><enum>(ii)</enum><text>conducting
exercises of the plans described in subparagraph (C) with the goal of long-term
recovery results;</text>
</clause><clause commented="no" id="H02F01AAAA74648E4BF3FB24D25DD7B19"><enum>(iii)</enum><text>rapidly
removing, and effectively disposing of—</text>
<subclause commented="no" id="H3FC4A8C852F04AC3B8421F96BFCB4B69"><enum>(I)</enum><text>contaminated
agriculture and food products; and</text>
</subclause><subclause commented="no" id="HA6C8BAD47DDD40C784579BD65972F55D"><enum>(II)</enum><text>infected plants
and animals; and</text>
</subclause></clause><clause commented="no" id="H3E6E4868C45F481AB9954A8465286D42"><enum>(iv)</enum><text>decontaminating
and restoring areas affected by an agriculture or food emergency.</text>
</clause></subparagraph></paragraph></subsection></section><section commented="no" id="HACE5595AAF134EEFABE9D034E98DE5E0"><enum>110.</enum><header>Food and
Agriculture Coordinating Councils</header><text display-inline="no-display-inline">The Secretary of Homeland Security, in
consultation with the Secretary of Health and Human Services and the Secretary
of Agriculture, shall within 180 days of enactment of this Act, and annually
thereafter, submit to the relevant committees of Congress, and make publicly
available on the Internet Web site of the Department of Homeland Security, a
report on the activities of the Food and Agriculture Government Coordinating
Council and the Food and Agriculture Sector Coordinating Council, including the
progress of such Councils on—</text>
<paragraph commented="no" id="HE9546376EA4A47D6A715F42F28449732"><enum>(1)</enum><text>facilitating
partnerships between public and private entities to help unify and enhance the
protection of the agriculture and food system of the United States;</text>
</paragraph><paragraph commented="no" id="H6C3214A2559549FB95481FA94900C3E0"><enum>(2)</enum><text>providing for the
regular and timely interchange of information between each council relating to
the security of the agriculture and food system (including intelligence
information);</text>
</paragraph><paragraph commented="no" id="H7D1D0364291F49B598057DC60D1A4090"><enum>(3)</enum><text>identifying best
practices and methods for improving the coordination among Federal, State,
local, and private sector preparedness and response plans for agriculture and
food defense; and</text>
</paragraph><paragraph commented="no" id="HC5E67971BA0D467A972390AA9978D412"><enum>(4)</enum><text>recommending
methods by which to protect the economy and the public health of the United
States from the effects of—</text>
<subparagraph commented="no" id="H685861FBA7994F308F6E24F3ACE471B2"><enum>(A)</enum><text>animal or plant
disease outbreaks;</text>
</subparagraph><subparagraph commented="no" id="H9659BD284A7D4D929E4A0464B8E333A2"><enum>(B)</enum><text>food
contamination; and</text>
</subparagraph><subparagraph commented="no" id="H134DEB9479934CAFBCB9A815ED74C1AE"><enum>(C)</enum><text>natural disasters
affecting agriculture and food.</text>
</subparagraph></paragraph></section><section display-inline="no-display-inline" id="HF579A3D3F6564F16A659155DE769AA83" section-type="subsequent-section"><enum>111.</enum><header>Authority to collect
fees</header>
<subsection id="H67196F0C6CBE4F2192ADB02FAE4E8881"><enum>(a)</enum><header>Fees for
reinspection, recall, and importation activities</header><text>Subchapter C of
chapter VII (21 U.S.C. 379f et seq.) is amended by inserting after section 742
the following:</text>
<quoted-block display-inline="no-display-inline" id="HEE2457A97F51446AA0AA0B1C007700" style="OLC">
<part commented="no" id="HBAC2139243F44BA3A0832C565FDE7812"><enum>6</enum><header>Fees related to
food</header>
<section commented="no" id="HD78B6CDFF37B49C89098D1B4B5769685"><enum>743.</enum><header>Authority to
collect and use fees</header>
<subsection commented="no" id="H7B91DE09384B485A93FFED009994F925"><enum>(a)</enum><header>In
general</header>
<paragraph commented="no" id="H9BCA1D3BF518418086A4AA3C188673F8"><enum>(1)</enum><header>Purpose and
authority</header><text>For fiscal year 2010 and each subsequent fiscal year,
the Secretary shall, in accordance with this section, assess and collect fees
from—</text>
<subparagraph commented="no" id="H56EBD19AB74A4E19A0D5E700E956ED9F"><enum>(A)</enum><text>each domestic
facility (as defined in section 415(b)) subject to a reinspection in such
fiscal year, to cover reinspection-related costs for such year;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB041DB317D28471283488B76B90652D3"><enum>(B)</enum><text>each domestic
facility (as defined in section 415(b)) and importer subject to a food recall
in such fiscal year, to cover food recall activities performed by the
Secretary, including technical assistance, follow-up effectiveness checks, and
public notifications, for such year;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA6CE388E072B4052B2DD1B5EE2EF1D77"><enum>(C)</enum><text>each importer
participating in the voluntary qualified importer program under section 806 in
such year, to cover the administrative costs such program for such year;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H899CAF54177647FBBA2240172914762C"><enum>(D)</enum><text>each importer
subject to a reinspection in such fiscal year at a port of entry, to cover
reinspection-related costs at ports of entry for such year.</text>
</subparagraph></paragraph><paragraph commented="no" id="HCB97F6D692A643C10006000432A548A2"><enum>(2)</enum><header>Definitions</header><text>For
purposes of this section—</text>
<subparagraph commented="no" id="HCE3B6A084A80416591171DC385E20942"><enum>(A)</enum><text>the term
<term>reinspection</term> means—</text>
<clause commented="no" id="HF8DA0E07DA114BE9BE47F89280407EC6"><enum>(i)</enum><text>with respect to
domestic facilities (as defined in section 415(b)), 1 or more inspections
conducted under section 704 subsequent to an inspection conducted under such
provision which identified noncompliance materially related to a food safety
requirement of this Act, specifically to determine whether compliance has been
achieved to the Secretary's satisfaction; and</text>
</clause><clause commented="no" id="H2C63655B966747CCBD639B9E526CB840"><enum>(ii)</enum><text>with respect to
importers, 1 or more examinations conducted under section 801 subsequent to an
examination conducted under such provision which identified noncompliance
materially related to a food safety requirement of this Act, specifically to
determine whether compliance has been achieved to the Secretary’s satisfaction;
and</text>
</clause></subparagraph><subparagraph commented="no" id="HE62B67C702374434858373DCF7FE2ED7"><enum>(B)</enum><text>the term
<term>reinspection-related costs</term> means all expenses, including
administrative expenses, incurred in connection with—</text>
<clause commented="no" id="H006F03803F964E10B104D22332FEC6D7"><enum>(i)</enum><text>arranging,
conducting, and evaluating the results of reinspections; and</text>
</clause><clause commented="no" id="HD020E6259887442498FBC7C7D3488769"><enum>(ii)</enum><text>assessing and
collecting reinspection fees under this section.</text>
</clause></subparagraph></paragraph></subsection><subsection commented="no" id="H69ED6729F2264D5798FCD745575DE053"><enum>(b)</enum><header>Establishment of
fees</header>
<paragraph commented="no" id="H334D9DA45E5F47AF96ACE0DA03B33D4B"><enum>(1)</enum><header>In
general</header><text>Subject to subsections (c) and (d), the Secretary shall
establish the fees to be collected under this section for each fiscal year
specified in subsection (a)(1), based on the methodology described under
paragraph (2), and shall publish such fees in a Federal Register notice not
later than 60 days before the start of each such year.</text>
</paragraph><paragraph commented="no" id="HD4A715B615B448F799FED95CC2017840"><enum>(2)</enum><header>Fee
methodology</header>
<subparagraph commented="no" id="H28B94ADC5DF4423A83AE56B2A43DE387"><enum>(A)</enum><header>Fees</header><text>Fees
amounts established for collection—</text>
<clause commented="no" id="HDB53BDF3B24F42D0842BC757D0DE4C94"><enum>(i)</enum><text>under subparagraph
(A) of subsection (a)(1) for a fiscal year shall be based on the Secretary's
estimate of 100 percent of the costs of the reinspection-related activities
(including by type or level of reinspection activity, as the Secretary
determines applicable) described in such subparagraph (A) for such year;</text>
</clause><clause commented="no" id="H256629E17AF74F21AFEC02BB4BD210ED"><enum>(ii)</enum><text>under
subparagraph (B) of subsection (a)(1) for a fiscal year shall be based on the
Secretary's estimate of 100 percent of the costs of the activities described in
such subparagraph (B) for such year;</text>
</clause><clause commented="no" id="H90E5DFFC0F5141499D44C7AA3D159845"><enum>(iii)</enum><text>under
subparagraph (C) of subsection (a)(1) for a fiscal year shall be based on the
Secretary's estimate of 100 percent of the costs of the activities described in
such subparagraph (C) for such year; and</text>
</clause><clause commented="no" id="HDDD1E2B2334F4D27BAA6021964C3DDAF"><enum>(iv)</enum><text>under
subparagraph (D) of subsection (a)(1) for a fiscal year shall be based on the
Secretary's estimate of 100 percent of the costs of the activities described in
such subparagraph (D) for such year.</text>
</clause></subparagraph><subparagraph commented="no" id="H9F9FF91517DA470F994788AAC1B48E82"><enum>(B)</enum><header>Other
considerations</header>
<clause commented="no" id="H2C5AB3DE8F294A990068A050425F8CD9"><enum>(i)</enum><header>Voluntary
qualified importer program</header>
<subclause commented="no" id="H8DAD4D0D15AD4B5AAAA33711F1FCAE24"><enum>(I)</enum><header>Participation</header><text>In
establishing the fee amounts under subparagraph (A)(iii) for a fiscal year, the
Secretary shall provide for the number of importers who have submitted to the
Secretary a notice under section 806 informing the Secretary of the intent of
such importer to participate in the program under section 806 in such fiscal
year.</text>
</subclause><subclause commented="no" id="HB4A9536593164B2C93CCF770673C5232"><enum>(II)</enum><header>Recoupment</header><text>In
establishing the fee amounts under subparagraph (A)(iii) for the first 5 fiscal
years after the date of enactment of this section, the Secretary shall include
in such fee a reasonable surcharge that provides a recoupment of the costs
expended by the Secretary to establish and implement the first year of the
program under section 806.</text>
</subclause></clause><clause commented="no" id="H8B0FB8B7309E4DCD92CF52590098F96C"><enum>(ii)</enum><header>Crediting of
fees</header><text>In establishing the fee amounts under subparagraph (A) for a
fiscal year, the Secretary shall provide for the crediting of fees from the
previous year to the next year if the Secretary overestimated the amount of
fees needed to carry out such activities, and consider the need to account for
any adjustment of fees and such other factors as the Secretary determines
appropriate.</text>
</clause></subparagraph></paragraph><paragraph commented="no" id="H1ACD72E9F2C14898BBD078E7CA73259"><enum>(3)</enum><header>Use of
fees</header><text>The Secretary shall make all of the fees collected pursuant
to clause (i), (ii), (iii), and (iv) of paragraph (2)(A) available solely to
pay for the costs referred to in such clause (i), (ii), (iii), and (iv) of
paragraph (2)(A), respectively.</text>
</paragraph><paragraph commented="no" id="HB52F4C0F5B43406389CC13E413A0C07D"><enum>(4)</enum><header>Compliance with
international agreements</header><text>Nothing in this section shall be
construed to authorize the assessment of any fee inconsistent with the
agreement establishing the World Trade Organization or any other treaty or
international agreement to which the United States is a party.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H2F6398556D944FF69DF315F6E1D4ED65"><enum>(c)</enum><header display-inline="yes-display-inline">Limitations</header>
<paragraph commented="no" display-inline="no-display-inline" id="H1BF36300EDA9438E966248116E4968D"><enum>(1)</enum><header>In
general</header><text>Fees under subsection (a) shall be refunded for a fiscal
year beginning after fiscal year 2010 unless appropriations for the Center for
Food Safety and Applied Nutrition and the Center for Veterinary Medicine and
related activities of the Office of Regulatory Affairs at the Food and Drug
Administration for such fiscal year (excluding the amount of fees appropriated
for such fiscal year) are equal to or greater than the amount of appropriations
for the Center for Food Safety and Applied Nutrition and the Center for
Veterinary Medicine and related activities of the Office of Regulatory Affairs
at the Food and Drug Administration for the preceding fiscal year (excluding
the amount of fees appropriated for such fiscal year) multiplied by 1 plus 4.5
percent.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H24945E59DA0A4FEC85EB3E3F77A65D37"><enum>(2)</enum><header>Authority</header><text>If
the Secretary does not assess fees under subsection (a) during any portion of a
fiscal year because of paragraph (1) and if at a later date in such fiscal year
the Secretary may assess such fees, the Secretary may assess and collect such
fees, without any modification in the rate, under subsection (a),
notwithstanding the provisions of subsection (a) relating to the date fees are
to be paid.</text>
</paragraph><paragraph commented="no" id="H5B4D3C5677934962AED2FBABF02DFCA2"><enum>(3)</enum><header>Limitation on
amount of certain fees</header>
<subparagraph commented="no" id="H8EFEE356F1564D2291C29E48BC5F6F00"><enum>(A)</enum><header>In
general</header><text>Notwithstanding any other provision of this section and
subject to subparagraph (B), the Secretary may not collect fees in a fiscal
year such that the amount collected—</text>
<clause commented="no" id="H09A40CF1F6E64383A778BEB311E8FB1"><enum>(i)</enum><text>under subparagraph
(B) of subsection (a)(1) exceeds $20,000,000; and</text>
</clause><clause commented="no" id="HB5D34B82132741BB84A9CFF3B174E43D"><enum>(ii)</enum><text>under
subparagraphs (A) and (D) of subsection (a)(1) exceeds $25,000,000
combined.</text>
</clause></subparagraph><subparagraph commented="no" id="HADC5613C32A04EED9D71FD63987DBAA5"><enum>(B)</enum><header>Exception</header><text>If
a domestic facility (as defined in section 415(b)) or an importer becomes
subject to a fee described in subparagraph (A), (B), or (D) of subsection
(a)(1) after the maximum amount of fees has been collected by the Secretary
under subparagraph (A), the Secretary may collect a fee from such facility or
importer.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="HBF5BD40B7F3A434394EB271EE6DE2776"><enum>(d)</enum><header>Crediting and
availability of fees</header><text>Fees authorized under subsection (a) shall
be collected and available for obligation only to the extent and in the amount
provided in appropriations Acts. Such fees are authorized to remain available
until expended. Such sums as may be necessary may be transferred from the Food
and Drug Administration salaries and expenses account without fiscal year
limitation to such appropriation account for salaries and expenses with such
fiscal year limitation. The sums transferred shall be available solely for the
purpose of paying the operating expenses of the Food and Drug Administration
employees and contractors performing activities associated with these food
safety fees.</text>
</subsection><subsection commented="no" id="H5C2CA248FEC94AB400B1203450AC96A9"><enum>(e)</enum><header>Collection of
fees</header>
<paragraph commented="no" id="HE4148A27A8704B0EB886D478D5513CAD"><enum>(1)</enum><header>In
general</header><text>The Secretary shall specify in the Federal Register
notice described in subsection (b)(1) the time and manner in which fees
assessed under this section shall be collected.</text>
</paragraph><paragraph commented="no" id="HFAD3FEA06A6B48AE005B5111255EABDA"><enum>(2)</enum><header>Collection of
unpaid fees</header><text>In any case where the Secretary does not receive
payment of a fee assessed under this section within 30 days after it is due,
such fee shall be treated as a claim of the United States Government subject to
provisions of subchapter II of chapter 37 of title 31, United States
Code.</text>
</paragraph></subsection><subsection commented="no" id="H740F0EBF59EC4598809C187118E5ECEE"><enum>(f)</enum><header>Annual report to
congress</header><text>Not later than 120 days after each fiscal year for which
fees are assessed under this section, the Secretary shall submit a report to
the Committee on Health, Education, Labor, and Pensions of the United States
Senate and the Committee on Energy and Commerce of the United States House of
Representatives, to include a description of fees assessed and collected for
each such year and a summary description of the entities paying such fees and
the types of business in which such entities engage.</text>
</subsection><subsection commented="no" id="H69E1A6025CE74BB7A01C6D8BBBF18E50"><enum>(g)</enum><header>Authorization of
appropriations</header><text>For fiscal year 2010 and each fiscal year
thereafter, there is authorized to be appropriated for fees under this section
an amount equal to the total revenue amount determined under subsection (b) for
the fiscal year, as adjusted or otherwise affected under the other provisions
of this
section.</text>
</subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H7A8BBDCB558A43F0981578B89ED1D14E"><enum>(b)</enum><header>Export
certification fees for foods and animal feed</header>
<paragraph id="H406038784FE14BDBA8B93EB0ED84AF46"><enum>(1)</enum><header>Authority for
export certifications for food, including animal feed</header><text>Section
801(e)(4)(A) (21 U.S.C. 381(e)(4)(A)) is amended—</text>
<subparagraph id="H1321098EDA7C4409AA29479E007857CB"><enum>(A)</enum><text>in the matter
preceding clause (i), by striking <quote>a drug</quote> and inserting <quote>a
food, drug</quote>;</text>
</subparagraph><subparagraph id="H5D4B25C785EB4D5EBFA700198600EB14"><enum>(B)</enum><text>in clause (i), by
striking <quote>exported drug</quote> and inserting <quote>exported food,
drug</quote>; and</text>
</subparagraph><subparagraph id="H923097F92B89494C83D8921D96C21011"><enum>(C)</enum><text>in clause (ii), by
striking <quote>the drug</quote> each place it appears and inserting <quote>the
food, drug</quote>.</text>
</subparagraph></paragraph><paragraph id="HA7A9E72DF5E54537954BE10624F1018C"><enum>(2)</enum><header>Clarification of
certification</header><text>Section 801(e)(4) (21 U.S.C. 381(e)(4)) is amended
by inserting after subparagraph (B) the following new subparagraph:</text>
<quoted-block display-inline="no-display-inline" id="HAF73C4DBD29341FAAE249C416BD7F3E2" style="OLC">
<subparagraph id="H177082CC96694435001DB2984D5486C1"><enum>(C)</enum><text>For purposes of
this paragraph, a certification by the Secretary shall be made on such basis,
and in such form (including a publicly available listing) as the Secretary
determines
appropriate.</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection></section><enum>II</enum><header>Detection and
surveillance</header>
<section id="H0F556256BE6F47FC8709B985A614C49A"><enum>201.</enum><header>Recognition of
laboratory accreditation for analyses of foods</header>
<subsection id="H3D6DC163046A4EE6BC0601F5BF9CA3FF"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Chapter IV (21 U.S.C.
341 et seq.), as amended by section 107, is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HF9E8649883AA4EDB9D861B1987AF404D" style="OLC">
<section commented="no" id="H4A38162148BC43B3A4B72C06851C1C56"><enum>422.</enum><header>Recognition of
laboratory accreditation for analyses of foods</header>
<subsection id="HCB84F5E901714A75A2F94EF12C73CAAE"><enum>(a)</enum><header>Recognition of
laboratory accreditation</header>
<paragraph id="HFA793ACA0F7042599EFDB07638198441"><enum>(1)</enum><header>In
general</header><text>Not later than 2 years after the date of enactment of
this section, the Secretary shall—</text>
<subparagraph id="HE51C88F4C3B14C85B8B7014CAEC3CEDD"><enum>(A)</enum><text>provide for the
recognition of accreditation bodies that accredit laboratories, including
laboratories run and operated by a State or locality, with a demonstrated
capability to conduct analytical testing of food products; and</text>
</subparagraph><subparagraph id="H2BBDDA6DFCCB4FA097AC79A7393CD54D"><enum>(B)</enum><text>establish a
publicly available registry of accreditation bodies, including the name of,
contact information for, and other information deemed necessary by the
Secretary about such bodies.</text>
</subparagraph></paragraph><paragraph id="HC5C39EE0A98043F8B8C98CD14CA04F0E"><enum>(2)</enum><header>Model
accreditation standards</header><text>The Secretary shall develop model
standards that an accreditation body shall require laboratories to meet in
order to be included in the registry provided for under paragraph (1). In
developing the model standards, the Secretary shall look to existing standards
for guidance. The model standards shall include methods to ensure that—</text>
<subparagraph id="H169AE1278A8540B2A93E20DDC52A9061"><enum>(A)</enum><text>appropriate
sampling and analytical procedures are followed and reports of analyses are
certified as true and accurate;</text>
</subparagraph><subparagraph id="H85A0B0DCFFA044E79598D81545BBD842"><enum>(B)</enum><text>internal quality
systems are established and maintained;</text>
</subparagraph><subparagraph id="H9874D1F9D1C048048078D1E56D599362"><enum>(C)</enum><text>procedures exist
to evaluate and respond promptly to complaints regarding analyses and other
activities for which the laboratory is recognized;</text>
</subparagraph><subparagraph id="HABBAC0946CC8475BA0FC3F24D7590CD2"><enum>(D)</enum><text>individuals who
conduct the analyses are qualified by training and experience to do so;
and</text>
</subparagraph><subparagraph id="H056A56B30A4447D1BAF93692D9F31E78"><enum>(E)</enum><text>any other criteria
determined appropriate by the Secretary.</text>
</subparagraph></paragraph><paragraph commented="no" id="H4A6B9913D3D448DA8B239282FC0FEE97"><enum>(3)</enum><header>Review of
accreditation</header><text>To assure compliance with the requirements of this
section, the Secretary shall—</text>
<subparagraph id="H082ECF00D23643259426D80EA94C2CDF"><enum>(A)</enum><text>periodically, or
at least every 5 years, reevaluate accreditation bodies recognized under
paragraph (1); and</text>
</subparagraph><subparagraph id="HD83583C672E44571B7AD00B83CF16C8F"><enum>(B)</enum><text>promptly revoke
the recognition of any accreditation body found not to be in compliance with
the requirements of this section.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="H7419D38DFF5E4585A2E1A31CE424C77B"><enum>(b)</enum><header>Testing
procedures</header><text>Food testing shall be conducted by either Federal
laboratories or non-Federal laboratories that have been accredited by an
accreditation body on the registry established by the Secretary under
subsection (a) whenever such testing—</text>
<paragraph commented="no" id="H1F340047751540FB846309971E153B4B"><enum>(1)</enum><text display-inline="yes-display-inline">is either conducted by or on behalf of an
owner or consignee—</text>
<subparagraph id="H6113E9ABAC774D728A7561CA3AE45E72"><enum>(A)</enum><text>in support of
admission of an article of food under section 801(a); or</text>
</subparagraph><subparagraph commented="no" id="H7A948F0F43A1406FB5ED4990682728F1"><enum>(B)</enum><text>under an Import
Alert that requires successful consecutive tests; or</text>
</subparagraph></paragraph><paragraph commented="no" id="HB6239AAE0945421C9EDDC0B837D6A81E"><enum>(2)</enum><text display-inline="yes-display-inline">is required by the Secretary as the
Secretary deems appropriate to identify or address a threat of serious adverse
health consequences or death to humans or animals.</text>
</paragraph><continuation-text continuation-text-level="subsection">The
results of any such testing shall be sent directly to the Food and Drug
Administration.</continuation-text></subsection><subsection commented="no" display-inline="no-display-inline" id="H4EA1A1E810B1412389C262D1FD537854"><enum>(c)</enum><header>Review by
Secretary</header><text>If food testing performed by a laboratory run and
operated by a State or locality that is accredited by an accreditation body on
the registry established by the Secretary under subsection (a) result in a
State recalling a food, the Secretary shall review the testing results for the
purpose of determining the need for a national recall or other compliance and
enforcement
activities.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HC20D182971F4449FAE5CAB3137E54654"><enum>(b)</enum><header>Food emergency
response network</header><text>The Secretary, in coordination with the
Secretary of Agriculture, the Secretary of Homeland Security, and State, local,
and tribal governments shall, not later than 180 days after the date of
enactment of this Act, and biennially thereafter, submit to the relevant
committees of Congress, and make publicly available on the Internet Web site of
the Department of Health and Human Services, a report on the progress in
implementing a national food emergency response laboratory network that—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HDFA5505410FE45C684553D3F6FADCD95"><enum>(1)</enum><text>provides ongoing
surveillance, rapid detection, and surge capacity for large-scale food-related
emergencies, including intentional adulteration of the food supply;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H092DF0F150524C33B05CF3FDD190A786"><enum>(2)</enum><text>coordinates the
food laboratory capacities of State food laboratories, including the sharing of
data between State laboratories to develop national situational
awareness;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF98D98EDE53F415FB68D34B1E8A29D65"><enum>(3)</enum><text>provides
accessible, timely, accurate, and consistent food laboratory services
throughout the United States;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H18A898A738A14998B143E0902BB59A88"><enum>(4)</enum><text>develops and
implements a methods repository for use by Federal, State, and local
officials;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD1C4CB7FC82446FCB6846A26BCA25F8F"><enum>(5)</enum><text>responds to
food-related emergencies; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBB3C46BBCD2B41DD83412839EA2DB4D4"><enum>(6)</enum><text>is integrated with
relevant laboratory networks administered by other Federal agencies.</text>
</paragraph></subsection></section><section id="H5342AAD641844EFCB42BD13AA1D48A68"><enum>202.</enum><header>Integrated
consortium of laboratory networks</header>
<subsection id="H138A443713A443A8AB07C167C875CD8D"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">The Secretary of
Homeland Security, in consultation with the Secretary of Health and Human
Services, the Secretary of Agriculture, and the Administrator of the
Environmental Protection Agency, shall maintain an agreement through which
relevant laboratory network members, as determined by the Secretary of Homeland
Security, shall—</text>
<paragraph id="H24BC24E82EA948C5BD9CA5C426A59DDE"><enum>(1)</enum><text>agree on common
laboratory methods in order to facilitate the sharing of knowledge and
information relating to animal health, agriculture, and human health;</text>
</paragraph><paragraph id="H9E52AB21018B443DBED542FF934F92EA"><enum>(2)</enum><text>identify the means
by which each laboratory network member could work cooperatively—</text>
<subparagraph id="H194B43C15C934BC5AD92B663A50B505A"><enum>(A)</enum><text>to optimize
national laboratory preparedness; and</text>
</subparagraph><subparagraph id="HC9D9A81330B44BB3A5D6DB196F6B5CDC"><enum>(B)</enum><text>to provide surge
capacity during emergencies; and</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9D838C902D244277AC34EE44E34BB642"><enum>(3)</enum><text>engage in ongoing
dialogue and build relationships that will support a more effective and
integrated response during emergencies.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HC7A73C5A2E1746A083FEDF7F04FE1AEC"><enum>(b)</enum><header>Reporting
requirement</header><text>The Secretary of Homeland Security shall, on a
biennial basis, submit to the relevant committees of Congress, and make
publicly available on the Internet Web site of the Department of Homeland
Security, a report on the progress of the integrated consortium of laboratory
networks, as established under subsection (a), in carrying out this
section.</text>
</subsection></section><section id="H62C836AF6F214CF5B68CDFB42438C6F2"><enum>203.</enum><header>Building
domestic capacity</header>
<subsection id="HD8C15D72E4E2418ABBAA0E415E306D28"><enum>(a)</enum><header>In
general</header>
<paragraph id="H72ED2BF602E4449FA895DDC881E440D7"><enum>(1)</enum><header>Initial
report</header><text>The Secretary shall, not later than 2 years after the date
of enactment of this Act, submit to Congress a comprehensive report that
identifies programs and practices that are intended to promote the safety and
security of food and to prevent outbreaks of food-borne illness and other
food-related hazards that can be addressed through preventive activities. Such
report shall include a description of the following:</text>
<subparagraph id="H44D812A6284C46D088D3B21361E35D2E"><enum>(A)</enum><text>Analysis of the
need for regulations or guidance to industry.</text>
</subparagraph><subparagraph id="HED43969971D949B6BCB011FF26C1A4A6"><enum>(B)</enum><text>Outreach to food
industry sectors, including through the Food and Agriculture Coordinating
Councils referred to in section 111, to identify potential sources of emerging
threats to the safety and security of the food supply and preventive strategies
to address those threats.</text>
</subparagraph><subparagraph id="HFA0C44EBD4E44931A98C81637E5DD7F1"><enum>(C)</enum><text>Systems to ensure
the prompt distribution to the food industry of information and technical
assistance concerning preventive strategies.</text>
</subparagraph><subparagraph id="H70F775F4B36247ED830E1584ADC025E9"><enum>(D)</enum><text>Communication
systems to ensure that information about specific threats to the safety and
security of the food supply are rapidly and effectively disseminated.</text>
</subparagraph><subparagraph commented="no" id="H4C22B3449F9A40EBBF177448DF750355"><enum>(E)</enum><text>Surveillance
systems and laboratory networks to rapidly detect and respond to food-borne
illness outbreaks and other food-related hazards, including how such systems
and networks are integrated.</text>
</subparagraph><subparagraph commented="no" id="H16CEDCEFE10B4C66BF0F3C44A9CFC735"><enum>(F)</enum><text>Outreach,
education, and training provided to States to build State food safety and food
defense capabilities, including progress implementing strategies developed
under sections 109 and 205.</text>
</subparagraph><subparagraph id="HB3B6C10DE2DA47C987F6BDA87159428A"><enum>(G)</enum><text>The estimated
resources needed to effectively implement the programs and practices identified
in the report developed in this section over a 5-year period.</text>
</subparagraph></paragraph><paragraph id="HD1EA9DAC9B854E74AC99ADE2AFA80019"><enum>(2)</enum><header>Biennial
reports</header><text>On a biennial basis following the submission of the
report under paragraph (1), the Secretary shall submit to Congress a report
that—</text>
<subparagraph id="H42BD4316EE41413DA2E8F7BEEF1C2812"><enum>(A)</enum><text>reviews previous
food safety programs and practices;</text>
</subparagraph><subparagraph id="HCA5521FD7E24471692E381DCEA4C5437"><enum>(B)</enum><text>outlines the
success of those programs and practices;</text>
</subparagraph><subparagraph id="H6D91EC8FA7E243D1A93A1BECF77651F6"><enum>(C)</enum><text>identifies future
programs and practices; and</text>
</subparagraph><subparagraph id="H988C435107C24FF2AA9BD1BBC931F81C"><enum>(D)</enum><text>includes
information related to any matter described in subparagraphs (A) through (G) of
paragraph (1), as necessary.</text>
</subparagraph></paragraph></subsection><subsection id="HB9058265DAF84C48A3CE29ECDFE6676E"><enum>(b)</enum><header>Risk-based
activities</header><text>The report developed under subsection (a)(1) shall
describe methods that seek to ensure that resources available to the Secretary
for food safety-related activities are directed at those actions most likely to
reduce risks from food, including the use of preventive strategies and
allocation of inspection resources. The Secretary shall promptly undertake
those risk-based actions that are identified during the development of the
report as likely to contribute to the safety and security of the food
supply.</text>
</subsection><subsection id="HDA2827EAEB66418B8A5E6226CCF80C87"><enum>(c)</enum><header>Capability for
laboratory analyses; research</header><text>The report developed under
subsection (a)(1) shall provide a description of methods to increase capacity
to undertake analyses of food samples promptly after collection, to identify
new and rapid analytical techniques, including techniques that can be employed
at ports of entry and through Food Emergency Response Network laboratories, and
to provide for well-equipped and staffed laboratory facilities.</text>
</subsection><subsection id="H69BE7FAA166548A3814AE4476ADE3213"><enum>(d)</enum><header>Information
technology</header><text>The report developed under subsection (a)(1) shall
include a description of such information technology systems as may be needed
to identify risks and receive data from multiple sources, including foreign
governments, State, local, and tribal governments, other Federal agencies, the
food industry, laboratories, laboratory networks, and consumers. The
information technology systems that the Secretary describes shall also provide
for the integration of the facility registration system under section 415 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), and the prior notice
system under section 801(m) of such Act (21 U.S.C. 381(m)) with other
information technology systems that are used by the Federal Government for the
processing of food offered for import into the United States.</text>
</subsection><subsection id="H402443C74773466194D14BDD99EE0595"><enum>(e)</enum><header>Automated risk
assessment</header><text>The report developed under subsection (a)(1) shall
include a description of progress toward developing and improving an automated
risk assessment system for food safety surveillance and allocation of
resources.</text>
</subsection><subsection id="HD19BD65626DF48C6BC1AAB508144D295"><enum>(f)</enum><header>Traceback and
surveillance report</header><text>The Secretary shall include in the report
developed under subsection (a)(1) an analysis of the Food and Drug
Administration’s performance in food-borne illness outbreaks during the 5-year
period preceding the date of enactment of this Act involving fruits and
vegetables that are raw agricultural commodities (as defined in section 201(r)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(r))) and
recommendations for enhanced surveillance, outbreak response, and traceability.
Such findings and recommendations shall address communication and coordination
with the public and industry, outbreak identification, and traceback.</text>
</subsection><subsection id="H07332781FCD8406095C2D30FD7A6D477"><enum>(g)</enum><header>Biennial food
safety and food defense research plan</header><text>The Secretary and the
Secretary of Agriculture shall, on a biennial basis, submit to Congress a joint
food safety and food defense research plan which may include studying the
long-term health effects of food-borne illness. Such biennial plan shall
include a list and description of projects conducted during the previous 2-year
period and the plan for projects to be conducted during the following 2-year
period.</text>
</subsection></section><section id="H7816B79E3BD94B07940693C2A7256258"><enum>204.</enum><header>Enhancing
traceback and recordkeeping</header>
<subsection id="H9D782CBCCC3847D4A8A6065D7FE9799D"><enum>(a)</enum><header>In
general</header><text>The Secretary, in consultation with the Secretary of
Agriculture and representatives of State departments of health and agriculture,
shall improve the capacity of the Secretary to effectively and rapidly track
and trace, in the event of an outbreak, fruits and vegetables that are raw
agricultural commodities.</text>
</subsection><subsection id="H4CFE786E38E9410FB93DEF0642215617"><enum>(b)</enum><header>Pilot
project</header>
<paragraph id="H42D70F13995C4C0F9903587C00E33CB9"><enum>(1)</enum><header>In
general</header><text>Not later than 12 months after the date of enactment of
this Act, the Secretary shall establish a pilot project in coordination with
the produce industry to explore and evaluate new methods for rapidly and
effectively tracking and tracing fruits and vegetables that are raw
agricultural commodities so that, if an outbreak occurs involving such a fruit
or vegetable, the Secretary may quickly identify the source of the outbreak and
the recipients of the contaminated food.</text>
</paragraph><paragraph id="H1EB2046CF9EA4C6BBCD2B0DFA296AC9E"><enum>(2)</enum><header>Content</header><text>The
Secretary shall select participants from the produce industry to run projects
which overall shall include at least 3 different types of fruits or vegetables
that have been the subject of outbreaks during the 10-year period preceding the
date of enactment of this Act, and shall be selected in order to develop and
demonstrate—</text>
<subparagraph id="HD33DB8F3B4C74D19B75EB421A8ACA682"><enum>(A)</enum><text>methods that are
applicable and appropriate for small businesses; and</text>
</subparagraph><subparagraph id="H4FB89B2CC6924941A4ED1D4E79CE10D6"><enum>(B)</enum><text>technologies,
including existing technologies, that enhance traceback and trace
forward.</text>
</subparagraph></paragraph></subsection><subsection id="H81B578B5EBD24FBC83EAA08279E8CD5A"><enum>(c)</enum><header>Report</header><text>Not
later than 18 months after the date of enactment of this Act, the Secretary
shall report to Congress on the findings of the pilot project under subsection
(b) together with recommendations for establishing more effective traceback and
trace forward procedures for fruits and vegetables that are raw agricultural
commodities.</text>
</subsection><subsection id="HC81EF1CC64034FE49D531F4589DBFED0"><enum>(d)</enum><header>Traceback
performance requirements</header><text>Not later than 24 months after the date
of enactment of this Act, the Secretary shall publish a notice of proposed
rulemaking to establish standards for the type of information, format, and
timeframe for persons to submit records to aid the Secretary in effectively and
rapidly tracking and tracing, in the event of an outbreak, fruits and
vegetables that are raw agricultural commodities. Nothing in this section shall
be construed as giving the Secretary the authority to prescribe specific
technologies for the maintenance of records.</text>
</subsection><subsection id="HAE6BA5DDC73D436CA2985DA3DB530166"><enum>(e)</enum><header>Public
input</header><text>During the comment period in the notice of proposed
rulemaking under subsection (d), the Secretary shall conduct not less than 3
public meetings in diverse geographical areas of the United States to provide
persons in different regions an opportunity to comment.</text>
</subsection><subsection id="HDE76895D1703441AABC8CAB3D7D576DF"><enum>(f)</enum><header>Raw agricultural
commodity</header><text>In this section, the term <term>raw agricultural
commodity</term> has the meaning given that term in section 201(r) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(r)).</text>
</subsection></section><section id="H70CFC2B1265745BCB639C634513D342E"><enum>205.</enum><header>Surveillance</header>
<subsection id="HDC35B1B2B3184F78A72D4A01F6FF2031"><enum>(a)</enum><header>Definition of
food-borne illness outbreak</header><text>In this section, the term
<term>food-borne illness outbreak</term> means the occurrence of 2 or more
cases of a similar illness resulting from the ingestion of a food.</text>
</subsection><subsection id="H30D3A82202BC4923B0F02172CEE5714E"><enum>(b)</enum><header>Food-borne
illness surveillance systems</header>
<paragraph id="H1FC778689636458698E40B993AB6ACF6"><enum>(1)</enum><header>In
general</header><text>The Secretary, acting through the Director of the Centers
for Disease Control and Prevention, shall enhance food-borne illness
surveillance systems to improve the collection, analysis, reporting, and
usefulness of data on food-borne illnesses by—</text>
<subparagraph id="H3A513BA4323943A3990BF239F0D80DA2"><enum>(A)</enum><text>coordinating
Federal, State and local food-borne illness surveillance systems, including
complaint systems, and increasing participation in national networks of public
health and food regulatory agencies and laboratories;</text>
</subparagraph><subparagraph id="H0DFFE1BAB14E4FD8817573F63C66D444"><enum>(B)</enum><text>facilitating
sharing of findings on a more timely basis among governmental agencies,
including the Food and Drug Administration, the Department of Agriculture, and
State and local agencies, and with the public;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3FAE4079A8E2454783089996F2D1D640"><enum>(C)</enum><text>ensuring early
notification to the affected food industry when a particular food may be
suspected in the outbreak and sharing of all relevant data with the affected
food industry during the course of the investigation;</text>
</subparagraph><subparagraph id="H2E0B65AC120A448081A01E9EBD7463F8"><enum>(D)</enum><text>developing
improved epidemiological tools for obtaining quality exposure data, and
microbiological methods for classifying cases;</text>
</subparagraph><subparagraph id="H5F753F4829DE434FB65AE248868A5FCF"><enum>(E)</enum><text>augmenting such
systems to improve attribution of a food-borne illness outbreak to a specific
food;</text>
</subparagraph><subparagraph id="H8D309574BD8F45CBBEBF5C0FF72352B0"><enum>(F)</enum><text>expanding capacity
of such systems, including working toward automatic electronic searches, for
implementation of fingerprinting strategies for food-borne infectious agents,
in order to identify new or rarely documented causes of food-borne illness and
submit standardized information to a centralized database;</text>
</subparagraph><subparagraph id="H91A61FB4A93E4D9AB682DBDE52B39F56"><enum>(G)</enum><text>allowing timely
public access to aggregated, de-identified surveillance data;</text>
</subparagraph><subparagraph id="H9DDAA4198EB84C1B9A652F868023DC44"><enum>(H)</enum><text>at least annually,
publishing current reports on findings from such systems;</text>
</subparagraph><subparagraph id="H07AD6607AB09444D9E118A24AC229A4D"><enum>(I)</enum><text>establishing a
flexible mechanism for rapidly initiating scientific research by academic
institutions;</text>
</subparagraph><subparagraph id="H2A05EA4918194226A895177A5C39EB0D"><enum>(J)</enum><text>integrating
food-borne illness surveillance systems and data with other biosurveillance and
public health situational awareness capabilities at the state and federal
levels; and</text>
</subparagraph><subparagraph id="HC35B34EB76994452872F2ED5DA9772AA"><enum>(K)</enum><text>other activities
as determined appropriate by the Secretary.</text>
</subparagraph></paragraph><paragraph id="H47871FDBA0E040B7B9812F4B6723D8A1"><enum>(2)</enum><header>Advisory group
on improving foodborne illness surveillance and outbreak
investigations</header>
<subparagraph id="HB8B39C72ACBF42F3B2C026F14C732CCD"><enum>(A)</enum><header>In
general</header><text>The Secretary shall support and maintain a diverse
working group of experts and stakeholders from Federal, State, and local food
safety and health agencies, the food industry, consumer organizations, and
academia. Such working group shall provide the Secretary, through at least
annual meetings of the working group and an annual public report, advice and
recommendations on an ongoing and regular basis regarding the improvement of
food-borne illness surveillance, outbreak investigation, and implementation of
this section, including advice and recommendations on—</text>
<clause id="HC3D8D3AA7D984B7CA470584BD9768116"><enum>(i)</enum><text>the
priority needs of regulatory agencies, the food industry, and consumers for
information and analysis on food-borne illness and its causes;</text>
</clause><clause id="HD3485E4011E3465E8EEF05AE115FCA44"><enum>(ii)</enum><text>the
priority needs of regulatory agencies, the food industry, and consumers for
information and analysis on outbreak investigations that can be used to improve
the line of authority and accountability;</text>
</clause><clause id="H8798BECC749643E59B2CC4374565F17B"><enum>(iii)</enum><text>opportunities to
improve the effectiveness of initiatives at the Federal, State, and local
levels, including coordination and integration of activities among Federal
agencies, and between the Federal, State, and local levels of
government;</text>
</clause><clause id="HDA9D168439D74729B93F9083B4FC4A84"><enum>(iv)</enum><text>improvement in
the timeliness and depth of access by regulatory and health agencies, the food
industry, academic researchers, and consumers to food-borne illness
surveillance data and food recall survey data collected by government agencies
at all levels, including data compiled by the Centers for Disease Control and
Prevention;</text>
</clause><clause id="H95E521C84CAE47838C634314C2936F67"><enum>(v)</enum><text>key
barriers to improvement in food-borne illness surveillance and its utility for
preventing food-borne illness at Federal, State, and local levels;</text>
</clause><clause id="H78403B3360EF43A18450A5E52F863754"><enum>(vi)</enum><text>the
capabilities needed for establishing automatic electronic searches of
surveillance data; and</text>
</clause><clause id="HE7C76EE5E071494D9B16CD2BDFC70C20"><enum>(vii)</enum><text>specific actions
to reduce barriers to improvement, implement the working group’s
recommendations, and achieve the purposes of this section, with measurable
objectives and timelines, and identification of resource and staffing
needs.</text>
</clause></subparagraph></paragraph><paragraph id="HE23FF6C4E0454700B9BB596FDC54DFA9"><enum>(3)</enum><header>Additional
duties</header><text>The Secretary shall also utilize the working group under
paragraph (1) to assist in outbreak investigations as deemed
appropriate.</text>
</paragraph></subsection><subsection id="HED247F401EF14CF18A9831FE5057E183"><enum>(c)</enum><header>Improving food
safety and defense capacity at the State and local level</header>
<paragraph id="H60795008D135431BBFCAB8128347596E"><enum>(1)</enum><header>In
general</header><text>The Secretary shall develop and implement strategies to
leverage and enhance the food safety and defense capacities of State and local
agencies in order to achieve the following goals:</text>
<subparagraph id="H57DA13A0592D48E7B2CE64952DDB56A4"><enum>(A)</enum><text>Improve food-borne
illness outbreak response and containment.</text>
</subparagraph><subparagraph id="HB0EC0C7CE62648BC8022A538BA1D1FF7"><enum>(B)</enum><text>Accelerate
food-borne illness surveillance and outbreak investigation, including rapid
shipment of clinical isolates from clinical laboratories to appropriate State
laboratories, and conducting more standardized illness outbreak
interviews.</text>
</subparagraph><subparagraph id="HB2EBD7105ABF4C0A8A58D080691F300A"><enum>(C)</enum><text>Strengthen the
capacity of State and local agencies to carry out inspections and enforce
safety standards.</text>
</subparagraph><subparagraph id="H89AEB43B00CA44A7A1E9B2D2F9DFF74D"><enum>(D)</enum><text>Improve the
effectiveness of Federal-State partnerships to coordinate food safety and
defense resources and reduce the incidence of food-borne illness.</text>
</subparagraph><subparagraph id="H2B361699B6F644CDA2D93D61ACF8EF5C"><enum>(E)</enum><text>Share information
on a timely basis among public health and food regulatory agencies, with the
food industry, with health care providers, and with the public.</text>
</subparagraph><subparagraph id="HB9578A6A0374400299F4C2ABE0C7A866"><enum>(F)</enum><text>Strengthen the
capacity of State and local agencies to achieve the goals described in section
109.</text>
</subparagraph></paragraph><paragraph id="H3AB0537152814A878D0A0740D09EDC1C"><enum>(2)</enum><header>Review</header><text>In
developing of the strategies required by paragraph (1), the Secretary shall,
not later than 1 year after the date of enactment of this Act, complete a
review of State and local capacities, and needs for enhancement, which may
include a survey with respect to—</text>
<subparagraph id="HCEB63A6770F749A5916F7F4D4D83C7A8"><enum>(A)</enum><text>staffing levels
and expertise available to perform food safety and defense functions;</text>
</subparagraph><subparagraph id="H5E2C3DFB593A427B8408C8EC4E5D6F9B"><enum>(B)</enum><text>laboratory
capacity to support surveillance, outbreak response, inspection, and
enforcement activities;</text>
</subparagraph><subparagraph id="H1BDA622C07B543DAA21A8D0AB2CE199A"><enum>(C)</enum><text>information
systems to support data management and sharing of food safety and defense
information among State and local agencies and with counterparts at the Federal
level; and</text>
</subparagraph><subparagraph id="HBAE41D90843746C18CD9D4C86E4CE5ED"><enum>(D)</enum><text>other State and
local activities and needs as determined appropriate by the Secretary.</text>
</subparagraph></paragraph></subsection><subsection id="HE2EC6AC2CEB34C44A152699F0C209D69"><enum>(d)</enum><header>Food safety
capacity building grants</header><text>Section 317R(b) of the Public Health
Service Act (42 U.S.C. 247b–20(b)) is amended—</text>
<paragraph id="H5B81101E74684FD4B769748D6C729463"><enum>(1)</enum><text>by striking
<quote>2002</quote> and inserting <quote>2010</quote>; and</text>
</paragraph><paragraph commented="no" id="H19D68FD1C3B345D2A216FC2BB05FD614"><enum>(2)</enum><text>by striking
<quote>2003 through 2006</quote> and inserting <quote>2011 through
2014</quote>.</text>
</paragraph></subsection></section><enum>III</enum><header>Specific
provisions for imported food</header>
<section id="HD7FDAAC3D77A41249DFF500FEA908E6D"><enum>301.</enum><header>Foreign
supplier verification program</header>
<subsection id="HD90608BF0F174B3F9ABBD0A366A6CC7F"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Chapter VIII (21
U.S.C. 381 et seq.) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H6A5868AD169C4C0BA12B4061379950EF" style="OLC">
<section id="HACA50C222EE4425FA6F6105AECC39716"><enum>805.</enum><header>Foreign
supplier verification program</header>
<subsection id="HC2DAF5417243430BB2832124D2DFBDF0"><enum>(a)</enum><header>In
general</header>
<paragraph id="H5B397346486C49C7B9F4B412FBDBE6FE"><enum>(1)</enum><header>Verification
requirement</header><text>Each United States importer of record shall perform
risk-based foreign supplier verification activities in accordance with
regulations promulgated under subsection (c) for the purpose of verifying that
the food imported by the importer of record or its agent is—</text>
<subparagraph id="H715B6A97AB784F9296C5B40F31275BDC"><enum>(A)</enum><text>produced in
compliance with the requirements of section 419 or 420, as appropriate;
and</text>
</subparagraph><subparagraph id="H0F978538976C43838AF4FCBE8EF11C13"><enum>(B)</enum><text>is not adulterated
under section 402 or misbranded under section 403(w).</text>
</subparagraph></paragraph><paragraph commented="no" id="H9E25DABEF10B44A5A9647EC94E16D037"><enum>(2)</enum><header>Importer
exclusion</header><text>For purposes of this section, an <term>importer of
record</term> shall not include a person holding a valid license under section
641 of the Tariff Act of 1930 (19 U.S.C. 1641) (referred to as a <term>customs
broker</term>) if the customs broker has executed a written agreement with
another person who has agreed to comply with the requirements of this section
with regard to food imported or offered for import by the customs
broker.</text>
</paragraph></subsection><subsection id="H475283604A4E451C80AF3A0DE4DB722A"><enum>(b)</enum><header>Guidance</header><text>Not
later than 270 days after the date of the enactment of this section, the
Secretary shall issue guidance to assist United States importers of record in
developing foreign supplier verification programs.</text>
</subsection><subsection id="H6C2BF58B014E46F9890BAC6C6AE69C88"><enum>(c)</enum><header>Regulations</header>
<paragraph id="H9E9288E334FA4F4594044FA0D44D51BB"><enum>(1)</enum><header>In
general</header><text>Not later than 1 year after issuing guidance under
subsection (b), the Secretary shall promulgate regulations to provide for the
content of the foreign supplier verification program established under
subsection (a). Such regulations shall, as appropriate, include a process for
verification by a United States importer of record, with respect to each
foreign supplier from which it obtains food, that the imported food is produced
in compliance with the requirements of section 419 or 420, as appropriate, and
is not adulterated under section 402 or misbranded under section 403(w).</text>
</paragraph><paragraph id="H496491A1D1C04FD19EFC85D46D926338"><enum>(2)</enum><header>Verification</header><text>The
regulations under paragraph (1) shall require that the foreign supplier
verification program of each importer of record be adequate to provide
assurances that each foreign supplier to the importer of record produces the
imported food employing processes and procedures, including risk-based
reasonably appropriate preventive controls, that are documented in a written
plan under subsection (d) and equivalent in preventing adulteration and
reducing hazards as those required by section 419 or section 420, as
appropriate.</text>
</paragraph><paragraph id="HAF58462E0AB8440FB75F9B0C5E43F2ED"><enum>(3)</enum><header>Activities</header><text>Verification
activities under a foreign supplier verification program under this section may
include monitoring records for shipments, lot-by-lot certification of
compliance, annual on-site inspections, checking the hazard analysis and
risk-based preventive control plan of the foreign supplier, and periodically
testing and sampling shipments.</text>
</paragraph></subsection><subsection id="H97F2DE219CF44CA080F830AE3B2D4432"><enum>(d)</enum><header>Record
maintenance and access</header><text display-inline="yes-display-inline">Each
facility required to be registered under section 415 that is, as determined by
the Secretary, a high-risk facility shall submit to the Secretary a written
plan that documents and describes its hazard analysis and preventative control
procedures. The Secretary or a duly authorized representative of the Secretary
may review the plan and may make recommendations to improve the effectiveness
of the plan in preventing or minimizing the threat of serious adverse health
consequences or death to humans or animals. Records of all United States
importers related to a foreign supplier verification program shall be
maintained for a period of not less than 2 years and shall be made available
promptly to a duly authorized representative of the Secretary upon
request.</text>
</subsection><subsection commented="no" id="H3DBA67EED029443D90673CFD530751E1"><enum>(e)</enum><header>Deemed
compliance of seafood, juice, and low-acid canned food facilities in compliance
with HACCP</header><text>An owner, operator, or agent in charge of a facility
required to comply with 1 of the following standards and regulations with
respect to such facility shall be deemed to be in compliance with this section
with respect to such facility:</text>
<paragraph commented="no" id="H2247DB08F4244745A303B86A9E0183AC"><enum>(1)</enum><text>The Seafood Hazard
Analysis Critical Control Points Program of the Food and Drug
Administration.</text>
</paragraph><paragraph commented="no" id="H275E3D6A1B924688A9C559F8FE27CEBF"><enum>(2)</enum><text>The Juice Hazard
Analysis Critical Control Points Program of the Food and Drug
Administration.</text>
</paragraph><paragraph commented="no" id="H1BDB601B2B044C1D81731B4019033651"><enum>(3)</enum><text>The Thermally
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards
of the Food and Drug Administration (or any successor standards).</text>
</paragraph></subsection><subsection commented="no" id="H0878C5F0B01E42E5BE5D762142F57C24"><enum>(f)</enum><header>Publication of
list of participants</header><text>The Secretary shall publish and maintain on
the Internet Web site of the Food and Drug Administration a current list that
includes the name of, location of, and other information deemed necessary by
the Secretary about, importers participating under this
section.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HD4C4AF465CFA4A07B9C540918181FF2D"><enum>(b)</enum><header>Prohibited
act</header><text>Section 301 (21 U.S.C. 331), as amended by section 106, is
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H9844EFACB7FF4E0BB15A8162A6E7CC70" style="OLC">
<subsection id="H487006B31FCF447B934129AB946FD501"><enum>(rr)</enum><text>The importation
or offering for importation of a food if the importer of record does not have
in place a foreign supplier verification program in compliance with section
805.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HCB1DDDDA1D6A48618AB30ED88CF446E0"><enum>(c)</enum><header>Imports</header><text>Section
801(a) (21 U.S.C. 381(a)) is amended by adding <quote>or the importer of record
is in violation of section 805</quote> after <quote>or in violation of section
505</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HDC952A01E1BA4AB8939BF6C3E599CE20"><enum>(d)</enum><header>Effective
date</header><text>The amendments made by this section shall take effect 2
years after the date of enactment of this Act.</text>
</subsection></section><section id="HC840AADDC2F64FA9937A4FD2B46B9B7A"><enum>302.</enum><header>Voluntary
qualified importer program</header><text display-inline="no-display-inline">Chapter VIII (21 U.S.C. 381 et seq.), as
amended by section 301, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HE58F18C0D3E84568B5A99336DA6D61C9" style="OLC">
<section id="H7B8B86747F6C480689C3618A1D3E98AF"><enum>806.</enum><header>Voluntary
qualified importer program</header>
<subsection id="HCCE8B97368604F7F97861C5DD27B8637"><enum>(a)</enum><header>In
general</header><text>Beginning not later than 1 year after the date of
enactment of this section, the Secretary shall—</text>
<paragraph id="H003C7D9A29814B47B9D55D56137CF2A0"><enum>(1)</enum><text>establish a
program, in consultation with the Department of Homeland Security, to provide
for the expedited review and importation of food offered for importation by
United States importers who have voluntarily agreed to participate in such
program; and</text>
</paragraph><paragraph id="HF2A121831C47481089FE6DD12D39D528"><enum>(2)</enum><text>issue a guidance
document related to participation and compliance with such program.</text>
</paragraph></subsection><subsection id="H1BAC173C27384DC39B73F48DD97531A5"><enum>(b)</enum><header>Voluntary
participation</header><text>An importer may request the Secretary to provide
for the expedited review and importation of designated foods in accordance with
the program procedures established by the Secretary.</text>
</subsection><subsection id="HCEBB1AEBDB6E471CA1236D0128970828"><enum>(c)</enum><header>Eligibility</header><text>In
order to be eligible, an importer shall be offering food for importation from a
facility that has a certification described in section 809(b). In reviewing the
applications and making determinations on such requests, the Secretary shall
consider the risk of the food to be imported based on factors, such as the
following:</text>
<paragraph id="HE9247FFA53BD4EF58B185B0B48415B4A"><enum>(1)</enum><text>The nature of the
food to be imported.</text>
</paragraph><paragraph id="H83BF5D45F7F940319B25F3E0960D6B7B"><enum>(2)</enum><text>The compliance
history of the foreign supplier.</text>
</paragraph><paragraph id="H040C4FFA83F444A980E84FA8312CD21A"><enum>(3)</enum><text>The capability of
the regulatory system of the country of export to ensure compliance with United
States food safety standards.</text>
</paragraph><paragraph id="H05522C9446AD414684838564314C4BAC"><enum>(4)</enum><text>The compliance of
the importer with the requirements of section 805.</text>
</paragraph><paragraph id="H9BF3E916ACAB4CB0A21EB0318B2E34DC"><enum>(5)</enum><text>The recordkeeping,
testing, inspections and audits of facilities, traceability of articles of
food, temperature controls, and sourcing practices of the importer.</text>
</paragraph><paragraph id="HB8A3826E0DE14522A5D86CFBD5C0651D"><enum>(6)</enum><text>The potential risk
for intentional adulteration of the food.</text>
</paragraph><paragraph id="H7E8CCA9732A84D73B49DF665909F2219"><enum>(7)</enum><text>Any other factor
that the Secretary determines appropriate.</text>
</paragraph></subsection><subsection id="H53D84E7059104FD5BF67971B15B8A80C"><enum>(d)</enum><header>Review and
revocation</header><text>Any importer qualified by the Secretary in accordance
with the eligibility criteria set forth in this section shall be reevaluated
not less often than once every 3 years and the Secretary shall promptly revoke
the qualified importer status of any importer found not to be in compliance
with such criteria.</text>
</subsection><subsection id="H752E359FC10B48A285817DF5592A9701"><enum>(e)</enum><header>Definition</header><text>For
purposes of this section, the term <term>importer</term> means the person that
brings food, or causes food to be brought, from a foreign country into the
customs territory of the United
States.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H0E206BD4BBD74D93B942B862B67AE4F9"><enum>303.</enum><header>Authority to
require import certifications for food</header>
<subsection id="HBCDD37B4744248A0908841473CF14F60"><enum>(a)</enum><header>In
general</header><text>Section 801(a) (21 U.S.C. 381(a)) is amended by inserting
after the third sentence the following: <quote>With respect to an article of
food, if importation of such food is subject to, but not compliant with, the
requirement under subsection (p) that such food be accompanied by a
certification or other assurance that the food meets some or all applicable
requirements of this Act, then such article shall be refused
admission.</quote>.</text>
</subsection><subsection id="H975578DC489B4D2781BCD0C6A8FF12D9"><enum>(b)</enum><header>Addition of
certification requirement</header><text>Section 801 (21 U.S.C. 381) is amended
by adding at the end the following new subsection:</text>
<quoted-block display-inline="no-display-inline" id="HAEA45C52CC184DA884DB075D633F4831" style="OLC">
<subsection id="H9BCE566308854ED18759CCE72A2AED4F"><enum>(p)</enum><header>Certifications
concerning imported foods</header>
<paragraph id="HD4CEFA65A2864316B373A51A5C295D34"><enum>(1)</enum><header>In
general</header><text>The Secretary, based on public health considerations,
including risks associated with the food or its place of origin, may require as
a condition of granting admission to an article of food imported or offered for
import into the United States, that an entity specified in paragraph (2)
provide a certification or such other assurances as the Secretary determines
appropriate that the article of food complies with some or all applicable
requirements of this Act, as specified by the Secretary. Such certification or
assurances may be provided in the form of shipment-specific certificates, a
listing of certified entities, or in such other form as the Secretary may
specify. Such certification shall be used for designated food imported from
countries with which the Food and Drug Administration has an agreement to
establish a certification program.</text>
</paragraph><paragraph id="H4A39D928FB1240ADA1B031AADB25983C"><enum>(2)</enum><header>Certifying
entities</header><text>For purposes of paragraph (1), entities that shall
provide the certification or assurances described in such paragraph are—</text>
<subparagraph id="HE2AE91D9F8724E619201BC3E6A3D5E83"><enum>(A)</enum><text>an agency or a
representative of the government of the country from which the article of food
at issue originated, as designated by such government or the Secretary;
or</text>
</subparagraph><subparagraph commented="no" id="H44461F781E3942BB8D22B7464273BFE7"><enum>(B)</enum><text>such other persons
or entities accredited pursuant to section 809 to provide such certification or
assurance.</text>
</subparagraph></paragraph><paragraph id="H530E91FE48604999ABDBE60479EC075A"><enum>(3)</enum><header>Renewal and
refusal of certifications</header><text>The Secretary may—</text>
<subparagraph id="H272638B1EC404299AA02136C727DDD42"><enum>(A)</enum><text>require that any
certification or other assurance provided by an entity specified in paragraph
(2) be renewed by such entity at such times as the Secretary determines
appropriate; and</text>
</subparagraph><subparagraph id="H1B2FCE34BE784553BCDD109C28C7A279"><enum>(B)</enum><text>refuse to accept
any certification or assurance if the Secretary determines that such
certification or assurance is no longer valid or reliable.</text>
</subparagraph></paragraph><paragraph id="H0CFF8260608049B2BAD09BBFEF1CAEFF"><enum>(4)</enum><header>Electronic
submission</header><text>The Secretary shall provide for the electronic
submission of certifications under this
subsection.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H3BDAFA42C6AF40B9B20CC77F2630797E"><enum>(c)</enum><header>Conforming
technical amendment</header><text>Section 801(b) (21 U.S.C. 381(b)) is amended
in the second sentence by striking <quote>with respect to an article included
within the provision of the fourth sentence of subsection (a)</quote> and
inserting <quote>with respect to an article described in subsection (a)
relating to the requirements of sections 760 or 761,</quote>.</text>
</subsection><subsection id="H4D05303C1E1B4AEFA42734A919BC9E1C"><enum>(d)</enum><header>No limit on
authority</header><text>Nothing in the amendments made by this section shall
limit the authority of the Secretary to conduct random inspections of imported
food or to take such other steps as the Secretary deems appropriate to
determine the admissibility of imported food.</text>
</subsection></section><section id="HB38B0EA3A27A4C1EB2622059FC527B2D"><enum>304.</enum><header>Prior notice of
imported food shipments</header>
<subsection id="H980887B98F074DF7B0C3F13AC0978740"><enum>(a)</enum><header>In
general</header><text>Section 801(m)(1) (21 U.S.C. 381(m)(1)) is amended by
inserting <quote>any country to which the article has been refused
entry;</quote> after <quote>the country from which the article is
shipped;</quote>.</text>
</subsection><subsection id="HD995EBBCAD3B49E6A5DADEC8C2A24B88"><enum>(b)</enum><header>Regulations</header><text>Not
later than 120 days after the date of enactment of this Act, the Secretary
shall issue an interim final rule amending subpart I of part 1 of title 21,
Code of Federal Regulations, to implement the amendment made by this
section.</text>
</subsection><subsection id="HD8E01F75E9CE46169D3BD43E2B741CC5"><enum>(c)</enum><header>Effective
date</header><text>The amendment made by this section shall take effect 180
days after the date of enactment of this Act.</text>
</subsection></section><section id="H869478CFC22B4F3B8C3EA53899895148"><enum>305.</enum><header>Review of a
regulatory authority of a foreign country</header><text display-inline="no-display-inline">Chapter VIII (21 U.S.C. 381 et seq.), as
amended by section 302, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H1EE73E5557C84927813F166D80BDADD4" style="OLC">
<section id="H0654390E23D44DD091120919C45974FC"><enum>807.</enum><header>Review of a
regulatory authority of a foreign country</header><text display-inline="no-display-inline">The Secretary may review information from a
country outlining the statutes, regulations, standards, and controls of such
country, and conduct on-site audits in such country to verify the
implementation of those statutes, regulations, standards, and controls. Based
on such review, the Secretary shall determine whether such country can provide
reasonable assurances that the food supply of the country is equivalent in
safety to food manufactured, processed, packed, or held in the United
States.</text>
</section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" id="H8C126D65D39E4EE8AC49763E4CC7CC4F"><enum>306.</enum><header>Building
capacity of foreign governments with respect to food</header>
<subsection id="HFAA29E9F6A89447EB061547222658BE8"><enum>(a)</enum><header>In
general</header><text>The Secretary shall, not later than 2 years of the date
of enactment of this Act, develop a comprehensive plan to expand the technical,
scientific, and regulatory capacity of foreign governments, and their
respective food industries, from which foods are exported to the United
States.</text>
</subsection><subsection id="H43C7AB69A372498398B9F944D7522827"><enum>(b)</enum><header>Consultation</header><text>In
developing the plan under subsection (a), the Secretary shall consult with the
Secretary of Agriculture, Secretary of State, Secretary of the Treasury, and
the Secretary of Commerce, representatives of the food industry, appropriate
foreign government officials, and nongovernmental organizations that represent
the interests of consumers, and other stakeholders.</text>
</subsection><subsection id="H39741B593BBA44C5B4C821733C96DB3F"><enum>(c)</enum><header>Plan</header><text>The
plan developed under subsection (a) shall include, as appropriate, the
following:</text>
<paragraph id="H518A455EC9F34FB483107CF80B1F5A6B"><enum>(1)</enum><text>Recommendations
for bilateral and multilateral arrangements and agreements, including
provisions to provide for responsibility of exporting countries to ensure the
safety of food.</text>
</paragraph><paragraph id="H478B78615446411DA71CC7C23D25AFA0"><enum>(2)</enum><text>Provisions for
electronic data sharing.</text>
</paragraph><paragraph id="H04BDB2C4EA2540D8B5B825E781D7A381"><enum>(3)</enum><text>Provisions for
mutual recognition of inspection reports.</text>
</paragraph><paragraph id="H30F42D58A341483697565A9BD5AB00D3"><enum>(4)</enum><text>Training of
foreign governments and food producers on United States requirements for safe
food.</text>
</paragraph><paragraph id="H7EC6762FB22E4CA08158C3234925AC1F"><enum>(5)</enum><text>Recommendations to
harmonize requirements under the Codex Alimentarius.</text>
</paragraph><paragraph id="H23E1017EB16D4FB48DD626E113848982"><enum>(6)</enum><text>Provisions for the
multilateral acceptance of laboratory methods and detection techniques.</text>
</paragraph></subsection></section><section id="H4AA16D7DF830490095ADF60D22C103B4"><enum>307.</enum><header>Inspection of
foreign food facilities</header><text display-inline="no-display-inline">Chapter VIII (21 U.S.C. 381 et seq.), as
amended by section 305, is amended by inserting at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H919AB1D0D0344561AB6F77EDBC8976F5" style="OLC">
<section id="H409123ED3B784F29B9C18BDCAECC3105"><enum>808.</enum><header>Inspection of
foreign food facilities</header>
<subsection id="H1CA6C163C28D45378D10F61EBA867F19"><enum>(a)</enum><header>Inspection</header><text>The
Secretary—</text>
<paragraph id="H64338F7D804F4D699290792E26F08D6D"><enum>(1)</enum><text>may enter into
arrangements and agreements with foreign governments to facilitate the
inspection of foreign facilities registered under section 415; and</text>
</paragraph><paragraph id="H02EC29F6E27747E893B1319B3E3B7F99"><enum>(2)</enum><text>shall direct
resources to inspections of foreign facilities, suppliers, and food types,
especially such facilities, suppliers, and food types that present a high risk
(as identified by the Secretary), to help ensure the safety and security of the
food supply of the United States.</text>
</paragraph></subsection><subsection id="HDB7D60314C974C2A95AE5A6C0E357D39"><enum>(b)</enum><header>Effect of
inability To inspect</header><text>Notwithstanding any other provision of law,
food shall be refused admission into the United States if it is from a foreign
facility registered under section 415 of which the owner, operator, or agent in
charge of the facility, or the government of the foreign country, refuses to
permit entry of United States inspectors, upon request, to inspect such
facility. For purposes of this subsection, such an owner, operator, or agent in
charge shall be considered to have refused an inspection if such owner,
operator, or agent in charge refuses such a request to inspect a facility more
than 48 hours after such request is
submitted.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="HA4BC298F17A34B94BB6343354B77C1A7"><enum>308.</enum><header>Third-party
accreditation of qualified auditors and audit agents</header><text display-inline="no-display-inline">Chapter VIII (21 U.S.C. 381 et seq.), as
amended by section 307, is further amended by adding at the end the
following:</text>
<quoted-block id="HEDB522B4D290453F8C38BFFCE912619B" style="OLC">
<section id="H0E841829E41A4755B66C4A7784E89733"><enum>809.</enum><header>Third-party
auditors and audit agents accreditation</header>
<subsection id="H73F6DF07A03C41D699DC29344CA4FDF7"><enum>(a)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this section:</text>
<paragraph id="HE20CF4182C9B4A4E8D0F4806E1317A29"><enum>(1)</enum><header>Accreditation
body</header><text>The term <term>accreditation body</term> means a recognized
authority that performs accreditation of third-party auditors and audit
agents.</text>
</paragraph><paragraph id="HB59A0656AC2748C09AD919EB1D3B3E9B"><enum>(2)</enum><header>Audit
agent</header><text>The term <term>audit agent</term> means an individual who
is qualified to conduct food safety audits, and who may be an employee or an
agent of a third-party auditor.</text>
</paragraph><paragraph id="H7C83926C906A4344BF5CEDA61729874A"><enum>(3)</enum><header>Accredited audit
agent</header><text>The term <term>accredited audit agent</term> means an audit
agent accredited by an accreditation body under this section.</text>
</paragraph><paragraph id="HEA628E8EABF24CE6B44A7F89F0D34795"><enum>(4)</enum><header>Accredited
third-party auditor</header><text>The term <term>accredited third-party
auditor</term> means a third-party auditor accredited by an accreditation body
under this section.</text>
</paragraph><paragraph id="HF4598F1F80CA4CA094008490F92BB0A5"><enum>(5)</enum><header>Consultative
audit</header><text>The term <term>consultative audit</term> means an audit of
an eligible entity—</text>
<subparagraph id="H1D965168F49048B4B5C7B0BDB3FF5516"><enum>(A)</enum><text>to determine
whether such entity is in compliance with the provisions of this Act and with
applicable industry standards and practices; and</text>
</subparagraph><subparagraph id="HA29017DD34D34FB99CF388109348A353"><enum>(B)</enum><text>the results of
which are for internal facility purposes only.</text>
</subparagraph></paragraph><paragraph id="HB68EDA8EA3B84C88B9E9DE4414696A5C"><enum>(6)</enum><header>Eligible
entity</header><text>The term <term>eligible entity</term> means a foreign
entity, including foreign facilities registered under section 415, in the food
import supply chain that chooses to be audited by an accredited third-party
auditor or audit agent.</text>
</paragraph><paragraph id="H4B448FF73766471294B75216EDCF591D"><enum>(7)</enum><header>Regulatory
audit</header><text>The term <term>regulatory audit</term> means an audit of an
eligible entity—</text>
<subparagraph id="HFC1556C83BEF4434BB6AC4C99ECAA723"><enum>(A)</enum><text>to determine
whether such entity is in compliance with the provisions of this Act;
and</text>
</subparagraph><subparagraph id="H4C2E68B0A2D04D0A8B09C5BC4F284B9C"><enum>(B)</enum><text>the results of
which determine—</text>
<clause id="H21148E9F6AB74F168123514CC57E9BFD"><enum>(i)</enum><text>whether an entity
is eligible to receive a certification under section 801(p); and</text>
</clause><clause id="HF2286B6AA33B4F0FB595C8E231E9A093"><enum>(ii)</enum><text>whether the
entity is eligible to participate in the voluntary qualified importer program
under section 806.</text>
</clause></subparagraph></paragraph><paragraph id="H1DDE8458A4004F6A9483031AF44977DE"><enum>(8)</enum><header>Third-party
auditor</header><text>The term <term>third-party auditor</term> means a foreign
government, foreign cooperative, or any other qualified third party, as the
Secretary determines appropriate, that conducts audits of eligible entities to
certify that such eligible entities meet the applicable requirements of this
section.</text>
</paragraph></subsection><subsection id="H52EE155A6248415EA08EC39D08639D92"><enum>(b)</enum><header>System of
accreditation</header>
<paragraph id="H866DBFEB7C41428ABC225E1731C1F10E"><enum>(1)</enum><header>Accreditation
bodies</header>
<subparagraph id="HB9EF407134104936B4BFB842619CA635"><enum>(A)</enum><header>Accreditation
bodies recognition</header><text>No later than 2 years after the date of
enactment of the Safe Food Enforcement, Assessment, Standards and Targeting Act
of 2009, the Secretary shall establish a system for the recognition of
accreditation bodies that accredit third-party auditors and audit agents to
certify that eligible entities meet the applicable requirements of this
Act.</text>
</subparagraph><subparagraph id="HA993F84DD2274F7FADD96E18E0B53DBE"><enum>(B)</enum><header>Notification</header><text>Each
accreditation body recognized by the Secretary under this section shall submit
to the Secretary a list of all accredited third-party auditors and audit agents
accredited by such body.</text>
</subparagraph><subparagraph id="HF28DB5A0442E4644BE2BA232E0DDCF0F"><enum>(C)</enum><header>Revocation of
accreditation body recognition</header><text>The Secretary shall promptly
revoke the recognition of any accreditation body found not to be in compliance
with the requirements of this section.</text>
</subparagraph></paragraph><paragraph id="H29879E51EFFD4E8DABA905AC77E555EB"><enum>(2)</enum><header>Model
accreditation standards</header><text>The Secretary shall develop model
standards, including audit report requirements, and each recognized
accreditation body shall ensure that third-party auditors and audit agents meet
such standards in order to qualify as an accredited third-party auditor or
audit agent under this section. In developing the model standards, the
Secretary shall look to standards in place on the date of the enactment of this
section for guidance, to avoid unnecessary duplication of efforts and
costs.</text>
</paragraph></subsection><subsection id="H1707F20BFA0B4B9DB4FAC5D0AAEB0095"><enum>(c)</enum><header>Third-party
auditors and audit agencies</header>
<paragraph id="H89DBB883B95F470FB384F6B5C8728520"><enum>(1)</enum><header>Third-party
auditor or audit agent accreditation requirements</header>
<subparagraph id="H91A5391F845249BD976C51EFD71B5EFA"><enum>(A)</enum><header>Foreign
governments</header><text>Prior to accrediting a foreign government as an
accredited third-party auditor, the accreditation body shall perform such
reviews and audits of food safety programs, systems, and standards of the
government as the Secretary deems necessary to determine that the foreign
government is capable of adequately ensuring that eligible entities certified
by such government meet the requirements of this Act with respect to food
manufactured, processed, packed, or held for import to the United
States.</text>
</subparagraph><subparagraph id="H0317F796A5C54A06A7C9963D10CE9A6D"><enum>(B)</enum><header>Foreign
cooperatives and other third parties</header><text>Prior to accrediting a
foreign cooperative that aggregates the products of growers or processors, or
any other third party that the Secretary determines appropriate to be an
accredited third-party auditor or audit agent, the accreditation body shall
perform such reviews and audits of the training and qualifications of auditors
used by that cooperative or party and conduct such reviews of internal systems
and such other investigation of the cooperative or party as the Secretary deems
necessary to determine that each eligible entity certified by the cooperative
or party has systems and standards in use to ensure that such entity meets the
requirements of this Act.</text>
</subparagraph></paragraph><paragraph id="H3959A25B4B224602917F1CC992CB8EBC"><enum>(2)</enum><header>Requirement to
issue certification of eligible entities</header>
<subparagraph id="HB1217459662D46CB9180E6DDB3EF539D"><enum>(A)</enum><header>In
general</header><text>An accreditation body may not accredit a third-party
auditor or audit agent unless such third-party auditor or audit agent agrees to
issue a written and electronic certification to accompany each food shipment
for import into the United States from an eligible entity certified by the
third-party auditor or audit agent, subject to requirements set forth by the
Secretary. The Secretary shall consider such certificates when targeting
inspection resources under section 421.</text>
</subparagraph><subparagraph id="H0A40355FB62F495CA9BFD77898A7C36E"><enum>(B)</enum><header>Purpose of
certification</header><text>The Secretary shall use evidence of certification
provided by accredited third-party auditors and audit agents—</text>
<clause id="H436E52A9A1BE4640B01B8B9FEF1F8D15"><enum>(i)</enum><text>to
determine the eligibility of an importer to receive a certification under
section 801(p); and</text>
</clause><clause id="H0D7246A0CD6B429FA6726FBCED656962"><enum>(ii)</enum><text>to determine the
eligibility of an importer to participate in the voluntary qualified importer
program under section 806.</text>
</clause></subparagraph></paragraph><paragraph id="HBAD83DA34A7747E9B40FE0474FD0851C"><enum>(3)</enum><header>Audit report
requirements</header>
<subparagraph id="H61E1592F150A4E6480CB221ED0DB635C"><enum>(A)</enum><header>Requirements in
general</header><text>As a condition of accreditation, an accredited
third-party auditor or audit agent shall prepare the audit report for an audit,
in a form and manner designated by the Secretary, which shall include—</text>
<clause id="H18EF8ADA40704E5AB990EBB985A14FF6"><enum>(i)</enum><text>the identity of
the persons at the audited eligible entity responsible for compliance with food
safety requirements;</text>
</clause><clause id="H26516C483D964153B0337F894C047FE2"><enum>(ii)</enum><text>the dates of the
audit;</text>
</clause><clause id="HE563AE3ABA6046ABA4353499F276120B"><enum>(iii)</enum><text>the scope of the
audit; and</text>
</clause><clause id="HC28FD076798D494182E8DEBB9EDBC2BB"><enum>(iv)</enum><text>any other
information required by the Secretary that relates to or may influence an
assessment of compliance with this Act.</text>
</clause></subparagraph><subparagraph id="HE38A430684FF49608509E14FF3CDE82D"><enum>(B)</enum><header>Submission of
reports to the secretary</header>
<clause id="H414959A8251044268FE3DFB22BDAD899"><enum>(i)</enum><header>In
general</header><text>Following any accreditation of a third-party auditor or
audit agent, the Secretary may, at any time, require the accredited third-party
auditor or audit agent to submit to the Secretary an onsite audit report and
such other reports or documents required as part of the audit process, for any
eligible entity certified by the third-party auditor or audit agent. Such
report may include documentation that the eligible entity is in compliance with
any applicable registration requirements.</text>
</clause><clause id="H25E0FE2E3A0D45C5BD45262C5B5DAA95"><enum>(ii)</enum><header>Limitation</header><text>The
requirement under clause (i) shall not include any report or other documents
resulting from a consultative audit by the accredited third-party auditor or
audit agent, except that the Secretary may access the results of a consultative
audit in accordance with section 414.</text>
</clause></subparagraph></paragraph><paragraph id="H4CC973060C474795B829C7AF5E90CEA1"><enum>(4)</enum><header>Audit agent
requirements</header>
<subparagraph id="H365C950CA0CC4C5D924D8A5AAE93F56F"><enum>(A)</enum><header>Public health
risks</header><text>If, at any time during an audit, an accredited audit agent
discovers a condition that could cause or contribute to a serious risk to the
public health, the audit agent shall immediately notify the Secretary
of—</text>
<clause id="H052FEE57FFC740B29385EBAD93444ECD"><enum>(i)</enum><text>the identification
of the eligible entity subject to the audit; and</text>
</clause><clause id="HD7698D7767BB41B7AFDC3AF480F98883"><enum>(ii)</enum><text>such
condition.</text>
</clause></subparagraph><subparagraph id="HC799326AEDD94B3F80429AB6E20F4E2C"><enum>(B)</enum><header>Audit
types</header><text>An accredited audit agent may perform consultative and
regulatory audits of eligible entities.</text>
</subparagraph><subparagraph id="H66B5854C8BBF49C5BEEA5CCDF438040B"><enum>(C)</enum><header>Limitations</header><text>An
accredited audit agent may not perform a regulatory audit of an eligible entity
if such agent has performed a consultative audit or a regulatory audit of such
eligible entity during the previous 24-month period.</text>
</subparagraph></paragraph><paragraph id="HAA5AC2655A5F4229894CFE9C357FC283"><enum>(5)</enum><header>Conflicts of
interest</header>
<subparagraph id="HDE0120A447A7417495E1D692DCF379D7"><enum>(A)</enum><header>Third-party
auditors</header><text>An accredited third-party auditor shall—</text>
<clause id="HBBFA871C6DD94375BFBC2B3F554D6B5B"><enum>(i)</enum><text>not be owned,
managed, or controlled by any person that owns or operates an eligible entity
to be certified by such auditor;</text>
</clause><clause id="H08992CF185C4472686F0143C96B7EDA1"><enum>(ii)</enum><text>in carrying out
audits of eligible entities under this section, have procedures to ensure
against the use of any officer or employee of such auditor that has a financial
conflict of interest regarding an eligible entity to be certified by such
auditor; and</text>
</clause><clause id="H244457053E2F441DB338250BB990760A"><enum>(iii)</enum><text>annually make
available to the Secretary disclosures of the extent to which such auditor and
the officers and employees of such auditor have maintained compliance with
clauses (i) and (ii) relating to financial conflicts of interest.</text>
</clause></subparagraph><subparagraph id="H34D3A4C20D894BE48C6811634755368D"><enum>(B)</enum><header>Audit
agents</header><text>An accredited audit agent shall—</text>
<clause id="H8B383DF8DCA649EF80EACF508E45D7D6"><enum>(i)</enum><text>not own or operate
an eligible entity to be certified by such agent;</text>
</clause><clause id="H01755BF04DC24DD587719F598DE27D80"><enum>(ii)</enum><text>in carrying out
audits of eligible entities under this section, have procedures to ensure that
such agent does not have a financial conflict of interest regarding an eligible
entity to be certified by such agent; and</text>
</clause><clause id="HBD09208211BA4B5E933644F80E648C40"><enum>(iii)</enum><text>annually make
available to the Secretary disclosures of the extent to which such agent has
maintained compliance with clauses (i) and (ii) relating to financial conflicts
of interest.</text>
</clause></subparagraph><subparagraph id="H6CFA1E57324C4C4986D92DF35DA9A734"><enum>(C)</enum><header>Regulations</header><text>The
Secretary shall promulgate regulations not later than 18 months after the date
of enactment of the <short-title>Safe Food Enforcement,
Assessment, Standards, and Targeting Act of 2009</short-title> to ensure that
there are protections against conflicts of interest between an accredited
third-party auditor or audit agent and the eligible entity to be certified by
such auditor or audit agent. Such regulations shall include—</text>
<clause id="H330E6A8C76C043F0B0A889B7619CCF8C"><enum>(i)</enum><text>requiring that
audits performed under this section be unannounced;</text>
</clause><clause id="H2FA161C135234FD28CE09472FA316EB2"><enum>(ii)</enum><text>a
structure, including timing and public disclosure, for fees paid by eligible
entities to accredited third-party auditors or audit agents to decrease the
potential for conflicts of interest; and</text>
</clause><clause id="H1241647E2930471A92317006F738414C"><enum>(iii)</enum><text>appropriate
limits on financial affiliations between an accredited third-party auditor or
audit agent and any person that owns or operates an eligible entity to be
certified by such auditor or audit agent.</text>
</clause></subparagraph></paragraph><paragraph id="H0792ED6314614E78AAEAAD4EA19AF45C"><enum>(6)</enum><header>Withdrawal of
accreditation</header><text>The Secretary shall withdraw accreditation from an
accredited third-party auditor or audit agent—</text>
<subparagraph id="H642F6003141D4972983C4F2ACB1EF859"><enum>(A)</enum><text>if food from an
eligible entity certified by such third-party auditor or audit agent is linked
to an outbreak of human or animal illness;</text>
</subparagraph><subparagraph id="H3E639E45ECAD453EBDBCAA4366F78026"><enum>(B)</enum><text>following a
performance audit and finding by the Secretary that the third-party auditor or
audit agent no longer meets the requirements for accreditation; or</text>
</subparagraph><subparagraph id="H3296C9DBCEE24ABE871754B869A94349"><enum>(C)</enum><text>following a
refusal to allow United States officials to conduct such audits and
investigations as may be necessary to ensure continued compliance with the
requirements set forth in this section.</text>
</subparagraph></paragraph><paragraph id="H10B955F67E1F45F7958290679E98FDF5"><enum>(7)</enum><header>Neutralizing
costs</header><text>The Secretary shall establish a method, similar to the
method used by the Department of Agriculture, by which accredited third-party
auditors and audit agents reimburse the Food and Drug Administration for the
work performed to establish and administer the accreditation system under this
section. The Secretary shall make operating this program revenue-neutral and
shall not generate surplus revenue from such a reimbursement mechanism.</text>
</paragraph></subsection><subsection id="HA24256279A77401DBD6E0B5D7ED40E45"><enum>(d)</enum><header>Eligible
entities recertification</header><text>An eligible entity shall apply for
annual recertification by an accredited third-party auditor or audit agent if
such entity—</text>
<paragraph id="H7F3F47B5A0094B7E8B31655F23715ABE"><enum>(1)</enum><text>intends to
participate in voluntary qualified importer program under section 806;
or</text>
</paragraph><paragraph id="H949D7B52F72A44FB8BDABA7C665CA749"><enum>(2)</enum><text>must provide to
the Secretary a certification under section 801(p) for any food from such
entity.</text>
</paragraph></subsection><subsection id="H42075FA6B1D347B9B75F34A4536A798D"><enum>(e)</enum><header>False
statements</header><text>Any statement or representation made—</text>
<paragraph id="HE6F1D1AE841A4F6E90E5B654AAD6776D"><enum>(1)</enum><text>by an employee or
agent of an eligible entity to an accredited third-party auditor or audit
agent; or</text>
</paragraph><paragraph id="H29C482A7D82949EA80C69F829DE58553"><enum>(2)</enum><text>by an accredited
third-party auditor or an audit agent to the Secretary,</text>
</paragraph><continuation-text continuation-text-level="subsection">shall be
subject to section 1001 of title 18, United States
Code.</continuation-text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H06325557256447F1A0F309B1D2E7BD49"><enum>309.</enum><header>Jurisdiction;
authorities</header><text display-inline="no-display-inline">Nothing in this
Act, or an amendment made by this Act, shall be construed to—</text>
<paragraph id="H7FE2804205204780B53C1B6684BBB47F"><enum>(1)</enum><text>alter the
jurisdiction between the Secretary of Agriculture and the Secretary of Health
and Human Services, under applicable statutes and regulations;</text>
</paragraph><paragraph id="H943A4530680141CF8719CF37959243C8"><enum>(2)</enum><text>limit the
authority of the Secretary of Health and Human Services to issue regulations
related to the safety of food under—</text>
<subparagraph id="HC3DA806EBFC841D0B682F83B92CEE63F"><enum>(A)</enum><text>the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) as in effect on the day before
the date of enactment of this Act; or</text>
</subparagraph><subparagraph id="H3A89A267ECA242FFB8CFB04855DAB2DE"><enum>(B)</enum><text>the Public Health
Service Act (42 U.S.C. 301 et seq.) as in effect on the day before the date of
enactment of this Act; or</text>
</subparagraph></paragraph><paragraph id="HF54E2CA879AE49559C5BF46E61FB1662"><enum>(3)</enum><text>impede, minimize,
or affect the authority of the Secretary of Agriculture to prevent, control, or
mitigate a plant or animal health emergency, or a food emergency involving
products regulated under the Federal Meat Inspection Act, the Poultry Products
Inspection Act, or the Egg Products Inspection Act.</text>
</paragraph></section>