1.Short
title; references; table of contents
(a)This Act may be cited
as the FDA Food Safety Modernization
Act
.
(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
considered 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 for this Act is as follows:
Sec. 1. Short title;
references; table of contents.
TITLE I—General Food Provisions
Sec. 101. Inspections of records.
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 produce safety.
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. Protection against intentional
adulteration.
Sec. 110. National agriculture and food defense
strategy.
Sec. 111. Food and Agriculture Coordinating
Councils.
Sec. 112. Decontamination and disposal standards and
plans.
Sec. 113. Authority to collect fees.
Sec. 114. Final rule for prevention of Salmonella Enteritidis
in shell eggs during production.
Sec. 115. Sanitary transportation of food.
Sec. 116. Food allergy and anaphylaxis management.
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. Accreditation of qualified third-party
auditors.
Sec. 309. Foreign offices of the Food and Drug
Administration.
Sec. 310. Funding for food safety.
Sec. 311. Jurisdiction; authorities.
<enum>I</enum><header>General Food
Provisions</header>
<section id="idC40328712F8B494BBFA7F6BD01DB05B6"><enum>101.</enum><header>Inspections of
records</header><text display-inline="no-display-inline">Section 414(a) (21
U.S.C. 350c(a)) is amended—</text>
<paragraph id="idAAA98E4E3D7C46248F55502926E676F5"><enum>(1)</enum><text>by striking the
heading and all follows through <quote>of food is</quote> and inserting the
following: <header-in-text level="subsection" style="OLC">“Records
inspection</header-in-text>.—</text>
<quoted-block display-inline="no-display-inline" id="id2BC528CDE74E49979339B6497477C050" style="OLC">
<paragraph id="idAEC462FE04554718AA584CB5F8DF775F"><enum>(1)</enum><header>Adulterated
food</header><text>If the Secretary has a reasonable belief that an article of
food, and any other article of food that the Secretary reasonably believes is
likely to be affected in a similar manner,
is</text>
</paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph id="idC7E0A333DDCD42F78A9C622A4DF2CC02"><enum>(2)</enum><text>by inserting
<quote>, and to any other article of food that the Secretary reasonably
believes is likely to be affected in a similar manner,</quote> after
<quote>relating to such article</quote>;</text>
</paragraph><paragraph id="id8B21FB1C1F664A79817AE154E057E43F"><enum>(3)</enum><text>by striking the
last sentence; and</text>
</paragraph><paragraph id="id85EBCAEE034A418991F5903C16B168C7"><enum>(4)</enum><text>by inserting at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idFD3EAE16D85045EBB9110AB07404C753" style="OLC">
<paragraph id="idAAC78EB45B684AD996EB12D38510CE00"><enum>(2)</enum><header>Serious adverse
health consequences</header><text>If the Secretary believes that there is a
reasonable probability that the use of or exposure to an article of food, and
any other article of food that the Secretary reasonably believes is likely to
be affected in a similar manner, will cause serious adverse health consequences
or death to humans or animals, each person (excluding farms and restaurants)
who manufactures, processes, packs, distributes, receives, holds, or imports
such article shall, at the request of an officer or employee duly designated by
the Secretary, permit 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 and to any other article of
food that the Secretary reasonably believes is likely to be affected in a
similar manner, that are needed to assist the Secretary in determining whether
there is a reasonable probability that the use of or exposure to the food will
cause serious adverse health consequences or death to humans or animals.</text>
</paragraph><paragraph id="id2C8860163C6D4B3B8B6DA96E05017C71"><enum>(3)</enum><header>Application</header><text>The
requirement under paragraphs (1) and (2) applies to all records relating to the
manufacture, processing, packing, distribution, receipt, holding, or
importation of such article maintained by or on behalf of such person in any
format (including paper and electronic formats) and at any
location.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section id="id16194DF807E34D1D914A788BA285667F"><enum>102.</enum><header>Registration
of food facilities</header>
<subsection id="idA9B62ABE57C2464FA2C43F1FEA93DB36"><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="id8C0368C809714749B6F10AF932C9E097"><enum>(1)</enum><text>in paragraph (2),
by—</text>
<subparagraph id="idF5E803390CDC4446879A36C8EBD226A3"><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="id54C89058190240C0901D2754B4C3A0E6"><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="id9679A324E56A4CE189E6409B5F80019D"><enum>(2)</enum><text>by redesignating
paragraphs (3) and (4) as paragraphs (4) and (5), respectively; and</text>
</paragraph><paragraph id="id19464363A7EB451BB9FEF90C5BF7AFDD"><enum>(3)</enum><text>by inserting
after paragraph (2) the following:</text>
<quoted-block display-inline="no-display-inline" id="id91F171BFE4184AAA931B38BF9DB842CD" style="OLC">
<paragraph id="id26D77CAB49874627AD42CBDE0B7B9B9E"><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="idE305D3D46DF340F0BA5A696609570FDC"><enum>(b)</enum><header>Suspension of
registration</header>
<paragraph id="id4B34FF6FB1344AD5AE41D80830C640F2"><enum>(1)</enum><header>In
general</header><text>Section 415 (21 U.S.C. 350d) is amended—</text>
<subparagraph id="id819478CAFE234E34A59C2E0BFDF973FA"><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="idB96A4DA940814FDBBFB54A6CDD364232"><enum>(B)</enum><text>by redesignating
subsections (b) and (c) as subsections (c) and (d), respectively; and</text>
</subparagraph><subparagraph id="idF9AD41800ED344B8A39BF21258B68892"><enum>(C)</enum><text>by inserting
after subsection (a) the following:</text>
<quoted-block display-inline="no-display-inline" id="id63E94B94503640879843B20AFE92F876" style="OLC">
<subsection id="id75022CA0B2694DFCAC487791D44E7051"><enum>(b)</enum><header>Suspension of
registration</header>
<paragraph id="idC6F3ABE0C54D44C5A03860E19B704761"><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="id9E62D2F452634FFA95D0A88988FD4DC0"><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
may 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="id6D1C8DD93B4F44479DFD8A86FFEFF141"><enum>(3)</enum><header>Post-hearing
corrective action plan; vacating of order</header>
<subparagraph id="idA35B357D5DE24ED19FE403F1B365AF95"><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="idA5800828B82C40D7885D0FA49CE76E7A"><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="id010F36D7442E4644A72A83965DBCCFE1"><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="IDaba78d1f16a045f4ab326029035eece5"><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="id19CD3F8FD9534FF5A3BAB698A8841B10"><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="idDD7285E59C934F6DA497FD544C434639"><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="id136C9AA70B474BF4B673A26317EB8530"><enum>(c)</enum><header>Conforming
amendments</header>
<paragraph commented="no" id="id0F309C998F4448C78BC1BBDE4FF28D3D"><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="id1A02CA27417A4B4EBFEDF6FAEA87C235"><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="idD7E1B29B11F940A988ADEE9B18241508"><enum>103.</enum><header>Mandatory
recall authority</header>
<subsection id="idE7068A9E299D4D4D9706B97EA2E91F48"><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="id45ADA24E01494A8ABC3996A8FCB242EA" style="OLC">
<section id="id5E8458818782404EB27A9BDF42BD15C1"><enum>418.</enum><header>Mandatory
recall authority</header>
<subsection id="ID13baea3e74084fbd80b1cd84af39cc83"><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="ID20a33b12433948b0bbd34a4b23b24e48"><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="IDd9790193623f4bb5b4629ba2296bbb17"><enum>(1)</enum><text>immediately cease
distribution of such article; or</text>
</paragraph><paragraph id="ID7c88319108cb4fcd8db8541af68657c5"><enum>(2)</enum><text>immediately
notify all persons—</text>
<subparagraph id="ID97ba6f8dc3064363bc49c1582d6f9407"><enum>(A)</enum><text>manufacturing,
processing, packing, transporting, distributing, receiving, holding, or
importing and selling such article; and</text>
</subparagraph><subparagraph id="ID25963b0bbe274aa88f106411dd7c1c3d"><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="ID5ad942fa1c57494cadba472f86e2fe35"><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="IDedb477b7f8ca49a0a69342d0fdd68cd8"><enum>(d)</enum><header>Post-hearing
recall order and modification of order</header>
<paragraph id="IDe9182f88f2bd49d59129c995a9725ce0"><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="ID1534d5ac68d14ec8a15b50eb53c67d45"><enum>(A)</enum><text>amend the order
to require recall of such article or other appropriate action;</text>
</subparagraph><subparagraph id="IDd314f2ba139e44e788192bc3be241f3c"><enum>(B)</enum><text>specify a
timetable in which the recall shall occur;</text>
</subparagraph><subparagraph id="ID35e20306b16b49578a6c0509fac07624"><enum>(C)</enum><text>require periodic
reports to the Secretary describing the progress of the recall; and</text>
</subparagraph><subparagraph id="ID3db5d0a8273546cd8fb526e72934680d"><enum>(D)</enum><text>provide notice to
consumers to whom such article was, or may have been, distributed.</text>
</subparagraph></paragraph><paragraph id="ID627d85dc241f4b23827663e62c8e5525"><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="id134C07C75A014A0CB0436053A720831C"><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="idF797EE02B70A4940ACC6A82D0DA8D2FB"><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="idD7CC8CF77FE24C8599F3AB866E8A4193"><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="id403AB7B733FB48C3A1750AAB1D5F3B0E"><enum>(2)</enum><text>a description of
the risk associated with such article.</text>
</paragraph></subsection><subsection commented="no" id="id3C710EEC276546C0BF417AD49C283370"><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="id20479ABD811545468A503C4CDE3CC9E9"><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="ID43d32cfc0c164d81a35155bc478f28a7"><enum>(b)</enum><header>Civil
penalty</header><text>Section 303(f)(2)(A) (21 U.S.C. 333(f)(2)(A)) is amended
by inserting <quote>or any person who does not comply with a recall order under
section 418</quote> after <quote>section 402(a)(2)(B)</quote>.</text>
</subsection><subsection id="ID42fdb50b3ab34a3fa71167941c840cb7"><enum>(c)</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="id40593F898920447C88C7BACADEF7878B" style="OLC">
<subsection id="ID9ee2af4e3a4444b5b5e3b51eac875620"><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="ID7887d3f8190c42249b5870905490b880"><enum>104.</enum><header>Hazard
analysis and risk-based preventive controls</header>
<subsection id="IDdc602a7b64b14eb78436dd553b7e3ac5"><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="id0AE53CC452F849E082830DFC91DF1071" style="OLC">
<section id="ID10f83818e1a54d47a338ceb82f5fb739"><enum>419.</enum><header>Hazard
analysis and risk-based preventive controls</header>
<subsection id="IDf4bc6fa9cf4942d4907eac8fe7f7b26a"><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="ID1654fe2d257542aebd4fd5db9ebc2327"><enum>(b)</enum><header>Hazard
analysis</header><text>The owner, operator, or agent in charge of a facility
shall—</text>
<paragraph id="IDff0537bbf09245189787c0363c93b9bd"><enum>(1)</enum><text>identify and
evaluate known or reasonably foreseeable hazards that may be associated with
the facility, including—</text>
<subparagraph id="id7B122B6B990B45BBAEA6FF35AB419530"><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="id8F68918BBF39498DB71D3C801019CF97"><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="ID6a036b4cf0a54cababd63aff7ad1c2a3"><enum>(2)</enum><text>develop a written
analysis of the hazards.</text>
</paragraph></subsection><subsection id="IDb720244c110a4f2fa1b93d01818dfea9"><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="IDcc385b83cb064db688040c535831966c"><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="ID1caabd8d0b834b479403b28c54a17b8f"><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="ID7e1bb254b2c34b8ca844e65afdceb275"><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="IDa312122d42d542aabed2e860286dffce"><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="IDdc24e07dfd7d44d69235f2b9edc07f72"><enum>(f)</enum><header>Verification</header><text>The
owner, operator, or agent in charge of a facility shall verify that—</text>
<paragraph id="IDc214c5c229004bd0a9c0d77784c9e03a"><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="ID9bbed22131334737b10cdbc2a98074c8"><enum>(2)</enum><text>the owner,
operator, or agent is conducting monitoring in accordance with subsection
(d);</text>
</paragraph><paragraph id="ID208171edb8c642ae948ef11480159fa7"><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="IDfda5c585bcba4220b471642dbdaf60db"><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="IDbb24f3cdc342449aa417b0636f1ad02b"><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="IDa949313b539942b0a8d8813f69414795"><enum>(h)</enum><header>Written plan
and documentation</header><text>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).
Such written plan, together with documentation that the plan is being
implemented, shall be made promptly available to a duly authorized
representative of the Secretary upon oral or written request.</text>
</subsection><subsection id="ID3490a963636b4b8c94d60981cd25bc56"><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="ID4e8ee5d5e4f24f0681d5277eadff7e10"><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="ID8545c416fe2e463d9211dc24d1465e27"><enum>(1)</enum><text>The Seafood
Hazard Analysis Critical Control Points Program of the Food and Drug
Administration.</text>
</paragraph><paragraph id="IDc44e5fc2ba7a44a2a0ef8a1b08803828"><enum>(2)</enum><text>The Juice Hazard
Analysis Critical Control Points Program of the Food and Drug
Administration.</text>
</paragraph><paragraph id="IDbb064611e6624564b428c0f242a40710"><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="ID1fa54abfc2b946fdb74cbe862b077ee6"><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="id5E390506DC55409AA0F80BDB386CCE9F"><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="ID8f46a515994f494a846d62ef5fd24c22"><enum>(m)</enum><header>Definitions</header><text>For
purposes of this section:</text>
<paragraph id="ID79d04db3e94144578a3a683a31a5944b"><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="ID48859bc194a14c2ab392a20a5f63cee5"><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="ID25737397c1bb4bb38df832659da1e145"><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 may include the following:</text>
<subparagraph id="IDa92e83befbfb4a37bcf7d9fb5b365ad7"><enum>(A)</enum><text>Sanitation
procedures for food contact surfaces and utensils and food-contact surfaces of
equipment.</text>
</subparagraph><subparagraph id="ID5dee94f397134a58828d379993bbacdf"><enum>(B)</enum><text>Supervisor,
manager, and employee hygiene training.</text>
</subparagraph><subparagraph id="ID174b26945b39450681b7dabb90dd8f29"><enum>(C)</enum><text>An environmental
monitoring program to verify the effectiveness of pathogen controls.</text>
</subparagraph><subparagraph id="ID03bd60884cc24569b7daf85fcef8e056"><enum>(D)</enum><text>An allergen
control program.</text>
</subparagraph><subparagraph id="IDb484842d1b604c8c9df2c018b06f2e2d"><enum>(E)</enum><text>A recall
contingency plan.</text>
</subparagraph><subparagraph id="ID8f40ff7ff3d2467e8a12a84c958686aa"><enum>(F)</enum><text>Good
Manufacturing Practices (GMPs).</text>
</subparagraph><subparagraph id="IDadf49d82e14e4bc4a3fb80722fa6b073"><enum>(G)</enum><text>Supplier
verification
activities.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="ID8b61e094c9cb43e4805c9754dd92558c"><enum>(b)</enum><header>Regulations</header>
<paragraph id="ID613479f2ffd840c59c5a84955ecf4131"><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="IDad734a69d692474392ea2d8f9d23401b"><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="id45F0E581119E437DB34DDEF7A27896EA"><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="ID4bcaeb89f0ee413b8a7ad02e2a9b210e"><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="ID4c5ad4a455e54de7891308682fbe8fb8"><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="ID1538b86edb604372964fb590dd59df70"><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="id8A894FD2547D49EA83508F21D307CD79" style="OLC">
<subsection id="IDec6265ade9cd4e55b502440b2cbc8279"><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="ID61be0a03247748a4840d15a9d459c7b5"><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="IDc4293dec455f4013a2de64586d5603b9"><enum>(f)</enum><header>Effective
date</header>
<paragraph commented="no" id="ID3c898b7855814e5fbb3d005d6aebad03"><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="IDbf702774d6784794ba93a82539ae10b8"><enum>(2)</enum><header>Exceptions</header><text>Notwithstanding
paragraph (1)—</text>
<subparagraph id="ID5811a83e710249a49f2f0bd66b53957e"><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="IDaef3c34491524ce48ee77e6719811c91"><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="id31692B49ECD840838E4D40CB84DEA824"><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 epidemiological
data and other appropriate sources of information to determine the most
significant food-borne contaminants and the most significant resulting hazards,
and may issue science-based guidance documents, action levels, and regulations
to help prevent adulteration under section 402 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 342). Such standards shall be applicable to products
and product classes and shall not be written to be facility-specific.</text>
</section><section id="id6CE0A472590B4CEABAA9E17E4AC0955A"><enum>106.</enum><header>Standards for
produce safety</header>
<subsection id="idBD6EF334448A4B39963E7656D2555B0C"><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="idD19EFD40881441C2B17AB51AE1BC16AC" style="OLC">
<section id="ID21cc25b12fa441c282fbd48d5c61c4ad"><enum>420.</enum><header>Standards for
produce safety</header>
<subsection id="IDbbba75a8d119438c9f7b141381613bee"><enum>(a)</enum><header>Proposed
rulemaking</header>
<paragraph id="id55CB513184164326AC61C1E633E94604"><enum>(1)</enum><header>In
general</header><text>Not later than 1 year after the date of enactment of the
<short-title>FDA Food Safety Modernization
Act</short-title>, 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 science-based minimum
standards for the safe production and harvesting of those types of fruits and
vegetables that are raw agricultural commodities for which the Secretary has
determined that such standards minimize the risk of serious adverse health
consequences or death.</text>
</paragraph><paragraph id="idB4091592CA6447F080EE121775F6164E"><enum>(2)</enum><header>Public
input</header><text display-inline="yes-display-inline">During the comment
period on the notice of proposed rulemaking under paragraph (1), 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>
</paragraph><paragraph id="idCFC2995579AD4678A1FED6DD7ACB9A9F"><enum>(3)</enum><header>Content</header><text>The
proposed rulemaking under paragraph (1) shall—</text>
<subparagraph id="id27900EA5C583426AAB73814BA2E692ED"><enum>(A)</enum><text>include, with
respect to growing, harvesting, sorting, and storage operations, minimum
standards related to fertilizer use, nutrients, hygiene, packaging, temperature
controls, animal encroachment, and water; and</text>
</subparagraph><subparagraph id="id14AB290EF1214001B7971F0C3515E963"><enum>(B)</enum><text>consider hazards
that occur naturally, may be unintentionally introduced, or may be
intentionally introduced, including by acts of terrorism.</text>
</subparagraph></paragraph><paragraph commented="no" id="id6610C9AFF9F1419D8DC198D4C1256E60"><enum>(4)</enum><header>Prioritization</header><text>The
Secretary shall prioritize the implementation of the regulations for specific
fruits and vegetables that are raw agricultural commodities that have been
associated with food-borne illness outbreaks.</text>
</paragraph></subsection><subsection id="ID7bd0873aac54487487f877a3d080a237"><enum>(b)</enum><header>Final
regulation</header>
<paragraph id="id252EFAEB35B74ACDA64E8DA4B2764A1D"><enum>(1)</enum><header>In
general</header><text>Not later than 1 year after the close of the comment
period for the proposed rulemaking under subsection (a), the Secretary shall
adopt a final regulation to provide for minimum standards for those types of
fruits and vegetables that are raw agricultural commodities for which the
Secretary has determined that such standards minimize the risk of serious
adverse health consequences or death.</text>
</paragraph><paragraph id="idD4C36E9BF16C4074A2DDC4C4787D8B51"><enum>(2)</enum><header>Final
regulation</header><text>The final regulation shall—</text>
<subparagraph id="id3C99AB6D038E4208B651F935CEA835D6"><enum>(A)</enum><text>provide a
reasonable period of time for compliance, taking into account the needs of
small businesses for additional time to comply;</text>
</subparagraph><subparagraph id="id054ADC4B5096445DA016FF6B2B02BD8F"><enum>(B)</enum><text>provide for
coordination of education and enforcement activities by State and local
officials, as designated by the Governors of the respective States; and</text>
</subparagraph><subparagraph id="idD705C6AFCD10452B82D28FE8B1F810FE"><enum>(C)</enum><text>include a
description of the variance process under subsection (c) and the types of
permissible variances the Secretary may grant.</text>
</subparagraph></paragraph></subsection><subsection id="ID512dcf7d86e843e592c6d283952d2d92"><enum>(c)</enum><header>Criteria</header>
<paragraph id="idD677CBA939404A18A2FBAB2995DB1370"><enum>(1)</enum><header>In
general</header><text>The regulations adopted under subsection (b)
shall—</text>
<subparagraph id="ID3661f7c0bcce4dba822b93cd24521169"><enum>(A)</enum><text>set forth those
procedures, processes, and practices as the Secretary determines to be
reasonably necessary to prevent the introduction of known or reasonably
foreseeable biological, chemical, and physical hazards, including hazards that
occur naturally, may be unintentionally introduced, or may be intentionally
introduced, including by acts of terrorism, into fruits and vegetables that are
raw agricultural commodities and to provide reasonable assurances that the
produce is not adulterated under section 402; and</text>
</subparagraph><subparagraph id="ID7d495898e36747f894f7954e5132f345"><enum>(B)</enum><text>permit States and
foreign countries from which food is imported into the United States, subject
to paragraph (2), to request from the Secretary variances from the requirements
of the regulations, where upon approval of the Secretary, the variance is
considered permissible under the requirements of the regulations adopted under
subsection (b)(1)(C) and where the State or foreign country 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 produce is not adulterated under section
402 to the same extent as the requirements of the regulation adopted under
subsection (b).</text>
</subparagraph></paragraph><paragraph id="id2BBD771FCDD6499480D34F622E638A0D"><enum>(2)</enum><header>Approval of
variances</header><text>A State or foreign country from which food is imported
into the United States shall request a variance from the Secretary in writing.
The Secretary may deny such a request as not reasonably likely to ensure that
the produce is not adulterated under section 402 to the same extent as the
requirements of the regulation adopted under subsection (b).</text>
</paragraph></subsection><subsection id="ID6a8e886e0dcd40fc8b518d9fc2b3ef27"><enum>(d)</enum><header>Enforcement</header><text>The
Secretary may coordinate with the Secretary of Agriculture and shall contract
and coordinate with the agency or department designated by the Governor of each
State to perform activities to ensure compliance with this section.</text>
</subsection><subsection id="ID2b15deadb0004258949c4b3058fe4e3c"><enum>(e)</enum><header>Guidance</header><text>Not
later than 1 year after the date of enactment of the
<short-title>FDA Food Safety Modernization
Act</short-title>, the Secretary shall publish, after consultation with the
Secretary of Agriculture and representatives of State departments of
agriculture, updated good agricultural practices and guidance for the safe
production and harvesting of specific types of fresh produce.</text>
</subsection><subsection id="id02D60A96435F494C8EE9A513C84E63F5"><enum>(f)</enum><header>Exception for
facilities in compliance with section 419</header><text>This section shall not
apply to a facility that is subject to section
419.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="id2837483FBDE34DFFA3ACEE44F2F03248"><enum>(b)</enum><header>Prohibited
acts</header><text>Section 301 (21 U.S.C. 331), as amended by section 104, is
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id5B5ED05DD86C4BE89848F30BB6B676F3" style="OLC">
<subsection id="id970EFF7E976B4528BDC95402265099D5"><enum>(qq)</enum><text>The production
or harvesting of produce not in accordance with minimum standards as provided
by regulation under section 420(b) or a variance issued under section
420(c).</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="ID4064e6fb6c6d4f6a9d86538aa8483385"><enum>(c)</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></section><section id="id45B9435345E64AFD85D0A89F6001A8DD"><enum>107.</enum><header>Targeting of
inspection resources for domestic facilities, foreign facilities, and ports of
entry; annual report</header>
<subsection id="idD7E330B45236489DB33424A7A990676D"><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="id077A6AF774B449FF9A44ADE7927A0E3F" style="OLC">
<section id="id055A15F48D2145D589057858BE9CC248"><enum>421.</enum><header>Targeting of
inspection resources for domestic facilities, foreign facilities, and ports of
entry; annual report</header>
<subsection id="idD15E7F109F8B43418D068697B104EEFD"><enum>(a)</enum><header>Identification
and inspection of facilities</header>
<paragraph id="id7F4DE00E39DB4A6D81D21F7E968214B6"><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="IDdb5c834f6fac4122888a4a456511ab3d"><enum>(A)</enum><text>The risk profile
of the food manufactured, processed, packed, or held at the facility.</text>
</subparagraph><subparagraph id="id147D6FB311D94DF8896004B7708474D1"><enum>(B)</enum><text>The facility's
history of food recalls, outbreaks, and violations of food safety
standards.</text>
</subparagraph><subparagraph id="idA379DAF76EA54E5E8A2CBEF9604E758C"><enum>(C)</enum><text>The rigor of the
facility's hazard analysis and risk-based preventive controls.</text>
</subparagraph><subparagraph id="idFC60BFEDFFF54C8997071BFCBCAB5EC4"><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="id6549DEA3D8AC4AF08D14CF872941C656"><enum>(E)</enum><text>Whether the
facility has received a certificate as described in section 809(b).</text>
</subparagraph><subparagraph id="id03AA2096EC00488D908BF1D14B2D97E2"><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="idA3BC3580A8174CE19816A30B0BE47A0E"><enum>(2)</enum><header>Inspections</header><text>The
Secretary shall increase the frequency of inspection of all facilities, and
shall increase the frequency of inspection of facilities identified under
paragraph (1) as high-risk facilities such that—</text>
<subparagraph id="IDde36e12026a24c97a26cd4ca2f447c13"><enum>(A)</enum><text>for the first 2
years after the date of enactment of the <short-title>FDA
Food Safety Modernization Act</short-title>, each high-risk facility is
inspected not less often than once every 2 years; and</text>
</subparagraph><subparagraph id="IDecba64dc86594510861906a35be084c1"><enum>(B)</enum><text>for each
succeeding year, each high-risk facility is inspected not less often than once
each year.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id96914F64670F41FA851F130FB9852220"><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="IDe369ccb96bda4c06a61700b1e66adb94"><enum>(1)</enum><text>The risk profile
of the food imported.</text>
</paragraph><paragraph id="idA27D9602595144CAB27CBABC08F0A172"><enum>(2)</enum><text>The risk profile
of the countries of origin and countries of transport of the food
imported.</text>
</paragraph><paragraph id="id80ACD3AE2C7146B489755152DACDEC70"><enum>(3)</enum><text>The history of
food recalls, outbreaks, and violations of food safety standards of the food
importer.</text>
</paragraph><paragraph id="id1A48749E46014441925D48FC2FACE09E"><enum>(4)</enum><text>The rigor of the
foreign supplier verification program under section 805.</text>
</paragraph><paragraph id="id8E942A2AE7DB48B496913D3834798525"><enum>(5)</enum><text>Whether the food
importer participates in the Voluntary Qualified Importer Program under section
806.</text>
</paragraph><paragraph id="idEB7B56D8EF7F49C2B717874103695399"><enum>(6)</enum><text>Whether the food
meets the criteria for priority under section 801(h)(1).</text>
</paragraph><paragraph id="ID47e4cfb8dce649a9b78a9cd121f62653"><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="idE5C1C968C86643DE86EED6D1D92FF329"><enum>(8)</enum><text>Any other
criteria deemed appropriate by the Secretary for purposes of allocating
inspection resources.</text>
</paragraph></subsection><subsection id="idB953447078B14760BE2F26853FD659A1"><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="idE29B68DA7DF842E0A7BDC919937A02F8"><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="id94FA680F44AE4CB5AD94A7BDECDF8969"><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="id5A1F302E18C049AE92AAFF745EEAC401" style="OLC">
<subsection id="ID9224b7bd885943b38cb400a28f517d90"><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="ID581933ebf7d640cbbc4aeb70160d2997"><enum>(1)</enum><text>information about
food facilities including—</text>
<subparagraph id="IDdfce8f0fc4294dfe9a6968d88ede7aed"><enum>(A)</enum><text>the
appropriations used to inspect facilities registered pursuant to section 415 in
the previous fiscal year;</text>
</subparagraph><subparagraph id="ID9bf3025893ba4f75a3d27f2100fa312a"><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="ID4e7d55bb0d10447fa7338c064f55835d"><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="ID07a583868c7b4c459bf1c4afeca6aceb"><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="IDeb85711257e54f95b580727f798d6b21"><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="ID43b9292b8aba4dd2b714f01a22eaea9e"><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;</text>
</subparagraph></paragraph><paragraph id="ID497657bf71554528927da849e88b209a"><enum>(2)</enum><text>information about
food imports including—</text>
<subparagraph id="ID1ab82983ebc645429c98d787ae20cdac"><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="IDc4825e1bb5a44f2b9ac15182fcb8cdc2"><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="IDb59c2068915041cca9e092302e567042"><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; and</text>
</subparagraph></paragraph><paragraph id="IDe95f7503d1074fb08c56404bf5a615f8"><enum>(3)</enum><text>information on
the foreign offices established under section 309 of the
<short-title>FDA Food Safety Modernization
Act</short-title> including—</text>
<subparagraph id="ID965209d1324f4ea58b9698fdc1d34b8b"><enum>(A)</enum><text>the number of
foreign offices established; and</text>
</subparagraph><subparagraph id="ID902fa278da634b13b82e5fdede8d1c38"><enum>(B)</enum><text>the number of
personnel permanently stationed in each foreign office.</text>
</subparagraph></paragraph></subsection><subsection id="ID4864a69cc1bf44ea9c7379cda43e74f1"><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="id27A2350148944A55BD794AA763ACF49A"><enum>108.</enum><header>Administrative
detention of food</header>
<subsection id="ID0ebfa95a8b16499dbb510f0f55afbb71"><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="ID3ff5da7d662343159a5c69e18d091aa5"><enum>(1)</enum><text>striking
<quote>credible evidence or information indicating</quote> and inserting
<quote>reason to believe</quote>; and</text>
</paragraph><paragraph id="ID049062411eb8400fad23d84a4f618eaf"><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</quote>.</text>
</paragraph></subsection><subsection id="IDcd42421659f7411da757991e4b71dc4b"><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="ID79c43ee77e77400bbbd5c729b4e3a70d"><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="id02093FAC405B4E0BA33B96168B49CBE0"><enum>109.</enum><header>Protection
against intentional adulteration</header>
<subsection id="id1BD23141A46C4FB2842C8CC21F6814A8"><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="id5CDAFEA05C39449C94C64F050849C19D" style="OLC">
<section id="idBA4C2E587D684A839E20D004A79FBA7C"><enum>422.</enum><header>Protection
against intentional adulteration</header>
<subsection id="id2D1660B4594C4FF7AB1C90442AE212B0"><enum>(a)</enum><header>In
general</header><text>Not later than 24 months after the date of enactment of
the <short-title>FDA Food Safety Modernization
Act</short-title>, the Secretary, in consultation with the Secretary of
Homeland Security and the Secretary of Agriculture, shall promulgate
regulations to protect against the intentional adulteration of food subject to
this Act.</text>
</subsection><subsection id="IDf7c1c2d798734ee8a788861c299a93d2"><enum>(b)</enum><header>Content of
regulations</header><text>Regulations under subsection (a) shall only apply to
food—</text>
<paragraph id="IDd3b2d0d754e64ddeafbd39e88d1c59f2"><enum>(1)</enum><text>for which the
Secretary has identified clear vulnerabilities (such as short shelf-life or
susceptibility to intentional contamination at critical control points);</text>
</paragraph><paragraph id="ID6432016f48a3496badc5d1cce0cc56d8"><enum>(2)</enum><text>in bulk or batch
form, prior to being packaged for the final consumer; and</text>
</paragraph><paragraph id="ID0970c008ed2c4f6191f2b2a728f1d5f1"><enum>(3)</enum><text>for which there
is a high risk of intentional contamination, as determined by the Secretary,
that could cause serious adverse health consequences or death to humans or
animals.</text>
</paragraph></subsection><subsection id="ID4f5d2e7bf9e1492ba154e3f9e6c4ef0c"><enum>(c)</enum><header>Determinations</header><text>In
making the determination under subsection (b)(3), the Secretary shall—</text>
<paragraph id="IDb4a22bd6e190426eb719e1852f713ea2"><enum>(1)</enum><text>conduct
vulnerability assessments of the food system;</text>
</paragraph><paragraph id="ID8bca81d8a08847bab058e22d53f05396"><enum>(2)</enum><text>consider the best
available understanding of uncertainties, risks, costs, and benefits associated
with guarding against intentional adulteration at vulnerable points; and</text>
</paragraph><paragraph id="ID462b8b533ed54a2890243e662427c47c"><enum>(3)</enum><text>determine the
types of science-based mitigation strategies or measures that are necessary to
protect against the intentional adulteration of food.</text>
</paragraph></subsection><subsection id="IDadca2721485f4db8b3d5eead2e2e275a"><enum>(d)</enum><header>Exception</header><text>This
section shall not apply to food produced on farms, except for milk.</text>
</subsection><subsection id="IDb61ba9b29a3045348e0b169701b6e54e"><enum>(e)</enum><header>Definition</header><text>For
purposes of this section, the term <quote>farm</quote> has the meaning given
that term in section 1.227 of title 21, Code of Federal Regulations (or any
successor
regulation).</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="id2423D25265424ED4A21174742EE370F6"><enum>(b)</enum><header>Guidance
documents</header>
<paragraph id="id9E1D13648F0C4EAD92509881937DFBB5"><enum>(1)</enum><header>In
general</header><text>Not later than 1 year after the date of enactment of this
Act, the Secretary, in consultation with the Secretary of Homeland Security and
the Secretary of Agriculture, shall issue guidance documents related to
protection against the intentional adulteration of food, including mitigation
strategies or measures to guard against such adulteration as required under
section 422 of the Federal Food, Drug, and Cosmetic Act, as added by subsection
(a).</text>
</paragraph><paragraph id="id172A583BFFD146B6B497F06CDF9F6091"><enum>(2)</enum><header>Content</header><text>The
guidance document issued under paragraph (1) shall—</text>
<subparagraph id="IDdb8f9b6a8c5240ddbf1a1d1f1db99594"><enum>(A)</enum><text>specify how a
person shall assess whether the person is required to implement mitigation
strategies or measures intended to protect against the intentional adulteration
of food;</text>
</subparagraph><subparagraph id="idDC5AFDAB1EB749E0AF6635842E6FE9E8"><enum>(B)</enum><text>specify
appropriate science-based mitigation strategies or measures to prepare and
protect the food supply chain at specific vulnerable points, as
appropriate;</text>
</subparagraph><subparagraph id="id4CC1917250004ADE96791C3B169C5F76"><enum>(C)</enum><text>include a model
assessment for a person to use under subparagraph (A);</text>
</subparagraph><subparagraph id="id15E54DC90EEC4F9FBD24E96A7966120A"><enum>(D)</enum><text>include examples
of mitigation strategies or measures described in subparagraph (B); and</text>
</subparagraph><subparagraph id="idF76D02E337F54C38964244F5F4FC2159"><enum>(E)</enum><text>specify
situations in which the examples of mitigation strategies or measures described
in subparagraph (D) are appropriate.</text>
</subparagraph></paragraph><paragraph commented="no" id="id3DDD837E2E134D9BB99764B5C0E161C2"><enum>(3)</enum><header>Limited
distribution</header><text>In the interest of national security, the Secretary,
in consultation with the Secretary of Homeland Security, may determine the time
and manner in which the guidance documents issued under paragraph (1) are made
public, including by releasing such documents to targeted audiences.</text>
</paragraph></subsection><subsection commented="no" id="idE7048758C0F0406598C0A7EFB758870F"><enum>(c)</enum><header>Periodic
review</header><text>The Secretary shall periodically review and, as
appropriate, update the regulation under subsection (a) and the guidance
documents under subsection (b).</text>
</subsection><subsection id="idEAEEF5C0142141FABBB9F98A4DBFF1A2"><enum>(d)</enum><header>Prohibited
acts</header><text>Section 301 (21 U.S.C. 331 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="idFB2805248A8447E9A3C85C3FFBEB43D3" style="OLC">
<subsection id="idBB66258B137249BE9FEB1214B8B1AC6E"><enum>(rr)</enum><text>The failure to
comply with section
422.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" id="ID740786eb5e794560b9ee5b18a3ee78d6"><enum>110.</enum><header>National
agriculture and food defense strategy</header>
<subsection commented="no" id="ID3fdad0c0747f492cbb40497d2b80d52e"><enum>(a)</enum><header>Development and
submission of strategy</header>
<paragraph commented="no" id="IDf1a6175bdd1840e59b68b4d845069d83"><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="ID46e5d6aede124781a88e357922526c65"><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="ID54ddca1ff33f4096b3e707333fa185be"><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="IDa40d23fc7f794da289d0dbbe494e876c"><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="ID8d8eed3b4d2b4815b7779162fbadd90d"><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="ID7ae4748973aa475b9c9e48b875606d52"><enum>(A)</enum><text>the National
Incident Management System;</text>
</subparagraph><subparagraph commented="no" id="ID25a7a3a2cbc749a7b6d91769bd46abff"><enum>(B)</enum><text>the National
Response Framework;</text>
</subparagraph><subparagraph commented="no" id="IDcae2f0969de24c6296735c17d149325f"><enum>(C)</enum><text>the National
Infrastructure Protection Plan;</text>
</subparagraph><subparagraph commented="no" id="ID9df330752c2f47919f0c21892c5af863"><enum>(D)</enum><text>the National
Preparedness Goals; and</text>
</subparagraph><subparagraph commented="no" id="ID4333ef27e2a343539660b9d2dc48927e"><enum>(E)</enum><text>other relevant
national strategies.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="IDa012864dbc99478cb1e4a67ccef3b9a6"><enum>(b)</enum><header>Components</header>
<paragraph commented="no" id="IDa486181265c9468db2f8028e817ea8eb"><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="ID748c57318c8144cc94c875df170d6bbb"><enum>(A)</enum><text>to achieve each
goal described in paragraph (2); and</text>
</subparagraph><subparagraph commented="no" id="ID38e84341bdb7424ba711d5c07330e96f"><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="idEF851418CCB145DEB84CE78A02BE4FC7"><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="ID7d7579ea9f564a1ea24acd5cd2711004"><enum>(A)</enum><header>Preparedness
goal</header><text>Enhance the preparedness of the agriculture and food system
by—</text>
<clause commented="no" id="ID77158c63f04642ebb904ec5fa5faa9b5"><enum>(i)</enum><text>conducting
vulnerability assessments of the agriculture and food system;</text>
</clause><clause commented="no" id="ID141170afb83244ab8c54f0b6b2afc649"><enum>(ii)</enum><text>mitigating
vulnerabilities of the system;</text>
</clause><clause commented="no" id="IDcb18c750506a4fbfa26ac6109885f934"><enum>(iii)</enum><text>improving
communication and training relating to the system;</text>
</clause><clause commented="no" id="ID6fbbe4aa8c7e458bb4c051c2e99b14c3"><enum>(iv)</enum><text>developing and
conducting exercises to test decontamination and disposal plans;</text>
</clause><clause commented="no" id="IDbec59a42ab8447cea659acef755206ce"><enum>(v)</enum><text>developing
modeling tools to improve event consequence assessment and decision support;
and</text>
</clause><clause commented="no" id="ID0f5fb116125647a6b52f3a5f3390ca29"><enum>(vi)</enum><text>preparing risk
communication tools and enhancing public awareness through outreach.</text>
</clause></subparagraph><subparagraph commented="no" id="ID1dd0b2c6510d4a8e82643b1a75a2ada4"><enum>(B)</enum><header>Detection
goal</header><text>Improve agriculture and food system detection capabilities
by—</text>
<clause commented="no" id="IDfcc0e29aa03e49aa82496b18ae1fa6e0"><enum>(i)</enum><text>identifying
contamination in food products at the earliest possible time; and</text>
</clause><clause commented="no" id="ID20aea91a196b493685886b101fb4b7d9"><enum>(ii)</enum><text>conducting
surveillance to prevent the spread of diseases.</text>
</clause></subparagraph><subparagraph commented="no" id="ID977ec6addbb04ca4be2221e5471242e9"><enum>(C)</enum><header>Emergency
response goal</header><text>Ensure an efficient response to agriculture and
food emergencies by—</text>
<clause commented="no" id="ID401db45154ed4719922a4dd35c5da1c8"><enum>(i)</enum><text>immediately
investigating animal disease outbreaks and suspected food contamination;</text>
</clause><clause commented="no" id="ID65aaf8b0aa0340b5874c0fcc9b6fca53"><enum>(ii)</enum><text>preventing
additional human illnesses;</text>
</clause><clause commented="no" id="IDd2d1973d41ae4f1c8dc294191462ddba"><enum>(iii)</enum><text>organizing,
training, and equipping animal, plant, and food emergency response teams
of—</text>
<subclause commented="no" id="ID71a2b075d74847db9bc1e7a7ef3059a3"><enum>(I)</enum><text>the Federal
Government; and</text>
</subclause><subclause commented="no" id="ID583b8450da184834a953c2de08f7577d"><enum>(II)</enum><text>State, local,
and tribal governments;</text>
</subclause></clause><clause commented="no" id="IDcb00921b321646b985c5fc815bbbbe04"><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="ID1e1e3394ae9345ecbc099cbcc0ea990e"><enum>(v)</enum><text>ensuring
consistent and organized risk communication to the public by—</text>
<subclause commented="no" id="ID24be60a9aefb498a8379a0a29ddc1cc4"><enum>(I)</enum><text>the Federal
Government;</text>
</subclause><subclause commented="no" id="IDab1befd860964cb7b0ae4c03af97a65b"><enum>(II)</enum><text>State, local,
and tribal governments; and</text>
</subclause><subclause commented="no" id="IDbd2cfcced43042768b8064e8ac6ed96f"><enum>(III)</enum><text>the private
sector.</text>
</subclause></clause></subparagraph><subparagraph commented="no" id="IDa73317ca123342fc9f6c2b9fbeee4ec9"><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="ID21d890b3a2104144bbfb0bbbb13e5b11"><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="ID4c4a9542b10f4e8ca0311fbd264ecc34"><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="ID2696274949634dfb9a8816473b466e63"><enum>(iii)</enum><text>rapidly
removing, and effectively disposing of—</text>
<subclause commented="no" id="IDf087592b05ee4938bea8fb74893ee324"><enum>(I)</enum><text>contaminated
agriculture and food products; and</text>
</subclause><subclause commented="no" id="ID4af1242719064effba22c9345c1b4e2e"><enum>(II)</enum><text>infected plants
and animals; and</text>
</subclause></clause><clause commented="no" id="ID553b4624bf3044ae88102f21cae26a3b"><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="IDaac34e62c7d94c60ade597b765c9450a"><enum>111.</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="IDe7b263255e964a2f88d66197782fe067"><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="IDe577b48cf4d542a2b8590ab896b10e0f"><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="ID8d269133f9bb4e7582362e81e33abe56"><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="IDedbdd89d61a54815851ced4169e530d7"><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="IDe3d4a3b93dc14626b181d1d429b717f4"><enum>(A)</enum><text>animal or plant
disease outbreaks;</text>
</subparagraph><subparagraph commented="no" id="ID62057b9f953047b7bb65c31e8bdc086b"><enum>(B)</enum><text>food
contamination; and</text>
</subparagraph><subparagraph commented="no" id="IDe53635a393064898816ca11b133815c5"><enum>(C)</enum><text>natural disasters
affecting agriculture and food.</text>
</subparagraph></paragraph></section><section commented="no" id="IDfc21a396983c4986aeff336a81a16758"><enum>112.</enum><header>Decontamination
and disposal standards and plans</header>
<subsection commented="no" id="ID94d6715074a04c978fab19a9b4653000"><enum>(a)</enum><header>In
general</header><text>The Administrator of the Environmental Protection Agency
(referred to in this section as the <quote>Administrator</quote>), in
coordination with the Secretary of Health and Human Services, Secretary of
Homeland Security, and Secretary of Agriculture, shall provide support for, and
technical assistance to, State, local, and tribal governments in preparing for,
assessing, decontaminating, and recovering from an agriculture or food
emergency.</text>
</subsection><subsection commented="no" id="ID95f6ad3af7c643a59ee3b99f42e9d9fc"><enum>(b)</enum><header>Development of
standards</header><text>In carrying out subsection (a), the Administrator, in
coordination with the Secretary of Health and Human Services, Secretary of
Homeland Security, Secretary of Agriculture, and State, local, and tribal
governments, shall develop and disseminate specific standards and protocols to
undertake clean-up, clearance, and recovery activities following the
decontamination and disposal of specific threat agents and foreign animal
diseases.</text>
</subsection><subsection commented="no" id="ID61eead938608433eb7b0ed5db60168e2"><enum>(c)</enum><header>Development of
model plans</header><text>In carrying out subsection (a), the Administrator,
the Secretary of Health and Human Services, and the Secretary of Agriculture
shall jointly develop and disseminate model plans for—</text>
<paragraph commented="no" id="ID316da024367a41739353d035c57ecb41"><enum>(1)</enum><text>the
decontamination of individuals, equipment, and facilities following an
intentional contamination of agriculture or food; and</text>
</paragraph><paragraph commented="no" id="ID46e58d9e2f124b4ebf8d148e26b2cd15"><enum>(2)</enum><text>the disposal of
large quantities of animals, plants, or food products that have been infected
or contaminated by specific threat agents and foreign animal diseases.</text>
</paragraph></subsection><subsection commented="no" id="IDbe30bdeb76784cca8b5947900998ea76"><enum>(d)</enum><header>Exercises</header><text>In
carrying out subsection (a), the Administrator, in coordination with the
entities described under subsection (b), shall conduct exercises at least
annually to evaluate and identify weaknesses in the decontamination and
disposal model plans described in subsection (c). Such exercises shall be
carried out, to the maximum extent practicable, as part of the national
exercise program under section 648(b)(1) of the Post-Katrina Emergency
Management Reform Act of 2006 (6 U.S.C. 748(b)(1)).</text>
</subsection><subsection commented="no" id="ID1d7a765df99b4507bf872e082a72d761"><enum>(e)</enum><header>Modifications</header><text>Based
on the exercises described in subsection (d), the Administrator, in
coordination with the entities described in subsection (b), shall review and
modify as necessary the plans described in subsection (c) not less frequently
than biennially.</text>
</subsection><subsection commented="no" id="IDb8938c6db4bd426c8f893929a924aaa1"><enum>(f)</enum><header>Prioritization</header><text>The
Administrator, in coordination with the entities described in subsection (b),
shall develop standards and plans under subsections (b) and (c) in an
identified order of priority that takes into account—</text>
<paragraph commented="no" id="ID55a24d18d523467c9768218136e76a4a"><enum>(1)</enum><text>highest-risk
biological, chemical, and radiological threat agents;</text>
</paragraph><paragraph commented="no" id="ID2727b511f8e849db9cdb303ddb211b0d"><enum>(2)</enum><text>agents that could
cause the greatest economic devastation to the agriculture and food system;
and</text>
</paragraph><paragraph commented="no" id="ID40942f2277e74770948edd0b6f4754b3"><enum>(3)</enum><text>agents that are
most difficult to clean or remediate.</text>
</paragraph></subsection></section><section id="idF3EF014D09DB40998905EE805DF3D972"><enum>113.</enum><header>Authority to
collect fees</header>
<subsection id="idF627B305F2EA4A03B79604B27CC078F8"><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 740
the following:</text>
<quoted-block display-inline="no-display-inline" id="idF6BD4BF644F24D20A00873A9F8DC29DB" style="OLC">
<part id="id0329FB28692B407B93932EF9896BFE43"><enum>5</enum><header>Fees related to
food</header>
<section id="id1CBD82174EF4404B9A20B7E87638958F"><enum>740A.</enum><header>Authority to
collect and use fees</header>
<subsection id="ID2ade0bbfded44970b8fff239179aeec1"><enum>(a)</enum><header>In
general</header>
<paragraph id="ID74dcb9428c5b4e6bbf93757b3df5859b"><enum>(1)</enum><header>Purpose and
authority</header><text>For fiscal year 2009 and each subsequent fiscal year,
the Secretary shall, in accordance with this section, assess and collect fees
from—</text>
<subparagraph id="idE9D7DC66554F4CA7AE61DD24EC327F7F"><enum>(A)</enum><text>domestic
facilities required to register under section 415, to cover
reinspection-related costs for each such year;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9493E374869044BB8B255EB3E0D8B4FE"><enum>(B)</enum><text>domestic
facilities required to register under section 415, to cover food recall
activities performed by the Secretary, including technical assistance,
follow-up effectiveness checks, and public notifications, for each such
year;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id880D7A584AD4439DA25B5EFFE794AC68"><enum>(C)</enum><text>importers
required to register under section 415, to cover the administrative costs of
participating in the voluntary qualified importer program under section 806 for
each such year; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idDAE0F3A8660E484CB07C3FCA105F08A1"><enum>(D)</enum><text>importers, to
cover reinspection-related costs at ports of entry for each such year.</text>
</subparagraph></paragraph><paragraph id="ID6dea67e192af46d095f60e413a5ff999"><enum>(2)</enum><header>Definitions</header><text>For
purposes of this section—</text>
<subparagraph id="ID70106ecddd0a4ca6b4c12ca59fb6bfb3"><enum>(A)</enum><text>the term
<term>reinspection</term> means 1 or more inspections conducted under section
704 of this Act 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>
</subparagraph><subparagraph id="ID5c310aac55324bc7a6859301129e75fc"><enum>(B)</enum><text>the term
<term>reinspection-related costs</term> means all expenses, including
administrative expenses, incurred in connection with—</text>
<clause id="ID3852992ef1af46348d5342a482b01297"><enum>(i)</enum><text>arranging,
conducting, and evaluating the results of reinspections; and</text>
</clause><clause id="ID5cb1aace293a41e8bbe2e31e922b5e2e"><enum>(ii)</enum><text>assessing and
collecting reinspection fees under this section.</text>
</clause></subparagraph></paragraph></subsection><subsection id="ID941ce491c3124072928f94b3d960632c"><enum>(b)</enum><header>Establishment
of fees</header>
<paragraph id="IDd0b6b2a719014e5794c75067e70cd945"><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 id="ID0dca42947edf4324b739c0dbb141f98d"><enum>(2)</enum><header>Fee
methodology</header>
<subparagraph id="idB9DC205860B443E9B5F988F7C879DA95"><enum>(A)</enum><header>Fees</header><text>Fees
amounts established for collection—</text>
<clause id="id132388C1A2FB41CD9EAEFF24D818DD53"><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 id="idB71F0E4C236B4283A8EA106B69939480"><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 id="id9B230CDBF5894B6FBA5919444EFFE079"><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 id="id903395FE487840CA8881C6B7E716F181"><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 id="idA92DFBA415C649C99EC8324E42C94B59"><enum>(B)</enum><header>Other
considerations</header><text>In establishing the fee amounts 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>
</subparagraph></paragraph><paragraph id="IDe1fabb2de25048b69786b6d650e5c075"><enum>(3)</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="IDE708F3EB3EFE4AE9B3CE70EF966D84A7"><enum>(c)</enum><header display-inline="yes-display-inline">Limitations</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID3CE38ABCC7934073A28F717547501EB5"><enum>(1)</enum><header>In
general</header><text>Fees under subsection (a) shall be refunded for a fiscal
year beginning after fiscal year 2009 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="IDD48B38247D32408982CF15E546F0E8DE"><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 id="id12C8F410A13542978A169E8E4CF93A92"><enum>(3)</enum><header>Limitation on
amount of certain fees</header><text>Notwithstanding any other provision of
this section, in no case may the amount of the fees collected for a fiscal
year—</text>
<subparagraph id="id66F20AAA2BD941CF8EAE6AFA55F2D673"><enum>(A)</enum><text>under
subparagraph (B) of subsection (a)(1) exceed $20,000,000; and</text>
</subparagraph><subparagraph id="id032ADE8ABD9F405FA6A27B379812A1EA"><enum>(B)</enum><text>under
subparagraphs (A) and (D) of subsection (a)(1) exceed $25,000,000
combined.</text>
</subparagraph></paragraph></subsection><subsection id="ID0ddff08b95e74f38bfbf717110c67c58"><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 id="ID87d95c9137304bc2975a51b3679bb8bb"><enum>(e)</enum><header>Collection of
fees</header>
<paragraph id="ID5ee23c83aff446a0b54a80c799d8d0ee"><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 id="ID2326200b4c8a43b8aab506f695f08386"><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 id="ID48105578fb92485b8cfed7597042ceb9"><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="id46B75624977043E6BEBEA75E609BE448"><enum>(g)</enum><header>Authorization
of appropriations</header><text>For fiscal year 2009 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="IDe657f472126b40e489a10e48ff5a72c2"><enum>(b)</enum><header>Export
certification fees for foods and animal feed</header>
<paragraph id="ID2d09284882bc4de0898a30c12a416c9e"><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="ID44a46b2e0bdb45b49e3c982f7f6b2c00"><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="ID5627f85eba6b4353acc773c98bb46a87"><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="ID51546575dd3846319b4a45e542fffebf"><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="ID0a368bd888944a348bf051c965193ad9"><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="id67F7FF641DC0496CA974E87F0A066AAE" style="OLC">
<subparagraph id="ID5b59284f66354b789da43ce8e1447fd3"><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><section commented="no" display-inline="no-display-inline" id="idEF1EB108301D4B6AB4BE2A5ACB5D3CFA"><enum>114.</enum><header display-inline="yes-display-inline">Final rule for prevention of Salmonella
Enteritidis in shell eggs during production</header><text display-inline="no-display-inline">Not later than 1 year after the date of
enactment of this Act, the Secretary shall issue a final rule based on the
proposed rule issued by the Commissioner of Food and Drugs entitled
<quote>Prevention of Salmonella Enteritidis in Shell Eggs During
Production</quote>, 69 Fed. Reg. 56824, (September 22, 2004).</text>
</section><section commented="no" display-inline="no-display-inline" id="idEE913B2AB3C745D9A21F4B11102E76A9"><enum>115.</enum><header>Sanitary
transportation of food</header><text display-inline="no-display-inline">Not
later than 1 year after the date of enactment of this Act, the Secretary shall
promulgate regulations described in section 416(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 350e(b)).</text>
</section><section id="HBCD0CC7CE8524376B7FFBAF573B29D7C"><enum>116.</enum><header>Food allergy
and anaphylaxis management</header>
<subsection id="id6EAE1E8052E4401A8B6A8715EF3C4420"><enum>(a)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this section:</text>
<paragraph id="IDa13a9b2673eb47a2a8ebcbe0d0d42eb5"><enum>(1)</enum><header>Early childhood
education program</header><text>The term <term>early childhood education
program</term> means—</text>
<subparagraph id="ID616dbcb3da6c42bdb2feb4bfacb24906"><enum>(A)</enum><text>a Head Start
program or an Early Head Start program carried out under the Head Start Act (42
U.S.C. 9831 et seq.);</text>
</subparagraph><subparagraph id="ID6af4fac63b96448093b887f546d1edbe"><enum>(B)</enum><text>a State licensed
or regulated child care program or school; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID6fcbde1162d74b8aa58e984ef9c4cc1f"><enum>(C)</enum><text>a State
prekindergarten program that serves children from birth through
kindergarten.</text>
</subparagraph></paragraph><paragraph id="H9F2E7EF74403471697C8BAE99B73E4B"><enum>(2)</enum><header>ESEA
definitions</header><text>The terms <term>local educational agency</term>,
<term>secondary school</term>, <term>elementary school</term>, and
<term>parent</term> have the meanings given the terms in section 9101 of the
Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801).</text>
</paragraph><paragraph id="HFE16834FC5AF4771BBE68F6EF8A25524"><enum>(3)</enum><header>School</header><text>The
term <term>school</term> includes public—</text>
<subparagraph id="HBAFEE70501504542B6DA65FAD8370021"><enum>(A)</enum><text>kindergartens;</text>
</subparagraph><subparagraph id="H056DD6009613419CBA07CFFE99441073"><enum>(B)</enum><text>elementary
schools; and</text>
</subparagraph><subparagraph id="H02AC4016B32D4F18A317D5CD3BDBCA2E"><enum>(C)</enum><text>secondary
schools.</text>
</subparagraph></paragraph></subsection><subsection id="HF6AFA1FCE3F04E558E5BCD3860EC3D3"><enum>(b)</enum><header>Establishment of
voluntary food allergy and anaphylaxis management guidelines</header>
<paragraph id="H1C05C59B22394E0CA94F85FF52868C3"><enum>(1)</enum><header>Establishment</header>
<subparagraph id="idEC9CB6C771624AC0A79DBB96B752061C"><enum>(A)</enum><header>In
general</header><text>Not later than 1 year after the date of enactment of this
Act, the Secretary, in consultation with the Secretary of Education,
shall—</text>
<clause id="H276ABA49E2A3483DA400BF00BD01C996"><enum>(i)</enum><text>develop guidelines
to be used on a voluntary basis to develop plans for individuals to manage the
risk of food allergy and anaphylaxis in schools and early childhood education
programs; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H9A3F070ECAAE4C04BF2C0140A155A163"><enum>(ii)</enum><text>make such
guidelines available to local educational agencies, schools, early childhood
education programs, and other interested entities and individuals to be
implemented on a voluntary basis only.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id183079478DAF4B4E937553E20BC5E44C"><enum>(B)</enum><header>Applicability
of FERPA</header><text>Each plan described in subparagraph (A) that is
developed for an individual shall be considered an education record for the
purpose of the Family Educational Rights and Privacy Act of 1974 (20 U.S.C.
1232g).</text>
</subparagraph></paragraph><paragraph id="H745AD51F22164423A70841D61E9FF659"><enum>(2)</enum><header>Contents</header><text>The
voluntary guidelines developed by the Secretary under paragraph (1) shall
address each of the following, and may be updated as the Secretary deems
necessary:</text>
<subparagraph id="H68A52DE196FE4150A2C2DF3F4E48D0BB"><enum>(A)</enum><text>Parental
obligation to provide the school or early childhood education program, prior to
the start of every school year, with—</text>
<clause id="H470145EDBF554280B9C7D00DF5633FB"><enum>(i)</enum><text>documentation from
their child’s physician or nurse—</text>
<subclause id="HA15D956DA6654DA99EA798D59CCDF3DE"><enum>(I)</enum><text>supporting a
diagnosis of food allergy and the risk of anaphylaxis;</text>
</subclause><subclause id="HFF26FA6200FE4AAAA6C83F4653575563"><enum>(II)</enum><text>identifying any
food to which the child is allergic;</text>
</subclause><subclause id="HEFD95410FDE545F2A9004367733594CB"><enum>(III)</enum><text>describing, if
appropriate, any prior history of anaphylaxis;</text>
</subclause><subclause id="H7A506CD694A5449A83287F26D7FB05F6"><enum>(IV)</enum><text>listing any
medication prescribed for the child for the treatment of anaphylaxis;</text>
</subclause><subclause id="H7FE1C7B1B2A54B4EA9C69723003DB15C"><enum>(V)</enum><text>detailing
emergency treatment procedures in the event of a reaction;</text>
</subclause><subclause id="HDB39EEF5325E489781ADB5821072BD9B"><enum>(VI)</enum><text>listing the signs
and symptoms of a reaction; and</text>
</subclause><subclause id="HF9B4CAC011D44CE6B5B3C369A15F7B91"><enum>(VII)</enum><text>assessing the
child’s readiness for self-administration of prescription medication;
and</text>
</subclause></clause><clause id="HBFE68CB6F0C6441387301E17491E637E"><enum>(ii)</enum><text>a
list of substitute meals that may be offered to the child by school or early
childhood education program food service personnel.</text>
</clause></subparagraph><subparagraph id="HDAB257540C7F4157AFC017DEC36DB77F"><enum>(B)</enum><text>The creation and
maintenance of an individual health care plan for food allergy management, in
consultation with the parent, tailored to the needs of each child with a
documented risk for anaphylaxis, including any procedures for the
self-administration of medication by such children in instances where—</text>
<clause id="HA0CCA1DD98D843AABB3D072FB2D65B84"><enum>(i)</enum><text>the
children are capable of self-administering medication; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H87DFD2E009B340A394FE2F9BDCD9C200"><enum>(ii)</enum><text>such
administration is not prohibited by State law.</text>
</clause></subparagraph><subparagraph id="H595F5C6BE31A4C31AA5B10CD1218A5D"><enum>(C)</enum><text>Communication
strategies between individual schools or early childhood education programs and
local providers of emergency medical services, including appropriate
instructions for emergency medical response.</text>
</subparagraph><subparagraph id="HE5E8B9D5C9F145B6BB8B03554D25C6A2"><enum>(D)</enum><text>Strategies to
reduce the risk of exposure to anaphylactic causative agents in classrooms and
common school or early childhood education program areas such as
cafeterias.</text>
</subparagraph><subparagraph id="HE3BDFBC304044B999FECE17A82DF25"><enum>(E)</enum><text>The dissemination of
general information on life-threatening food allergies to school or early
childhood education program staff, parents, and children.</text>
</subparagraph><subparagraph id="H657C08A1CF64491282B618660F17DF1"><enum>(F)</enum><text>Food allergy
management training of school or early childhood education program personnel
who regularly come into contact with children with life-threatening food
allergies.</text>
</subparagraph><subparagraph id="H7C72502D8CA7410F96F6FEA27CC93E"><enum>(G)</enum><text>The authorization
and training of school or early childhood education program personnel to
administer epinephrine when the nurse is not immediately available.</text>
</subparagraph><subparagraph id="H3DD289E66DC6484F87009D9538DCF0F5"><enum>(H)</enum><text>The timely
accessibility of epinephrine by school or early childhood education program
personnel when the nurse is not immediately available.</text>
</subparagraph><subparagraph id="H2E9D0FC986044EE8B412A20615EF8D76"><enum>(I)</enum><text>The creation of a
plan contained in each individual health care plan for food allergy management
that addresses the appropriate response to an incident of anaphylaxis of a
child while such child is engaged in extracurricular programs of a school or
early childhood education program, such as non-academic outings and field
trips, before- and after-school programs or before- and after-early child
education program programs, and school-sponsored or early childhood education
program-sponsored programs held on weekends.</text>
</subparagraph><subparagraph id="H3168CC3E63CE47B5B2A5DBDF348003B"><enum>(J)</enum><text>Maintenance of
information for each administration of epinephrine to a child at risk for
anaphylaxis and prompt notification to parents.</text>
</subparagraph><subparagraph id="ID2495f4d503964ff3acb890384fe733d0"><enum>(K)</enum><text>Other elements
the Secretary deems necessary for the management of food allergies and
anaphylaxis in schools and early childhood education programs.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2B40A49AA9914CC082F2D51DE2779959"><enum>(3)</enum><header>Relation to
State law</header><text display-inline="yes-display-inline">Nothing in this
section or the guidelines developed by the Secretary under paragraph (1) shall
be construed to preempt State law, including any State law regarding whether
students at risk for anaphylaxis may self-administer medication.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H8C0910E06542492786957609F4005B16"><enum>(c)</enum><header>School-based
food allergy management grants</header>
<paragraph commented="no" display-inline="no-display-inline" id="HDC0A89C1F7E34445B20090947E00B0D4"><enum>(1)</enum><header>In
general</header><text>The Secretary may award grants to local educational
agencies to assist such agencies with implementing voluntary food allergy and
anaphylaxis management guidelines described in subsection (b).</text>
</paragraph><paragraph id="H9AAF1D077742491B00F46786E43DF372"><enum>(2)</enum><header>Application</header>
<subparagraph id="H8F4F7C590CB2434ABFE010A06B7F63B4"><enum>(A)</enum><header>In
general</header><text>To be eligible to receive a grant under this subsection,
a local educational agency shall submit an application to the Secretary at such
time, in such manner, and including such information as the Secretary may
reasonably require.</text>
</subparagraph><subparagraph id="HE857886A65AD45D500C7E60147001C86"><enum>(B)</enum><header>Contents</header><text>Each
application submitted under subparagraph (A) shall include—</text>
<clause id="HC955455A0F07489393598DAAB4D383D6"><enum>(i)</enum><text>an
assurance that the local educational agency has developed plans in accordance
with the food allergy and anaphylaxis management guidelines described in
subsection (b);</text>
</clause><clause id="H3AF7C0D54E9F478CB763BAA0C11E0F"><enum>(ii)</enum><text>a
description of the activities to be funded by the grant in carrying out the
food allergy and anaphylaxis management guidelines, including—</text>
<subclause id="H7FFDE5B4D1FE42C19C3575E4E3517C56"><enum>(I)</enum><text>how the guidelines
will be carried out at individual schools served by the local educational
agency;</text>
</subclause><subclause id="H1EA0283975F8499DBE42247351F3A0BF"><enum>(II)</enum><text>how the local
educational agency will inform parents and students of the guidelines in
place;</text>
</subclause><subclause id="H00F85E045A6342BE881B3B11002CE705"><enum>(III)</enum><text>how school
nurses, teachers, administrators, and other school-based staff will be made
aware of, and given training on, when applicable, the guidelines in place;
and</text>
</subclause><subclause id="HB7A44FD251BE41C8B034389C53260036"><enum>(IV)</enum><text>any other
activities that the Secretary determines appropriate;</text>
</subclause></clause><clause id="HEFA4F6CA2C9447AFB6ABC5D53F7D9DA8"><enum>(iii)</enum><text>an
itemization of how grant funds received under this subsection will be
expended;</text>
</clause><clause id="H0707506868AA4A0C96EEF14D016D1F6"><enum>(iv)</enum><text>a
description of how adoption of the guidelines and implementation of grant
activities will be monitored; and</text>
</clause><clause id="H3E764B93C26C4EBC9F3D86F20AB003D"><enum>(v)</enum><text>an
agreement by the local educational agency to report information required by the
Secretary to conduct evaluations under this subsection.</text>
</clause></subparagraph></paragraph><paragraph id="H6053B73ABCC54C259FD6AED5027C008E"><enum>(3)</enum><header>Use of
funds</header><text>Each local educational agency that receives a grant under
this subsection may use the grant funds for the following:</text>
<subparagraph id="H7FEC8A424BE543AC88296529EB4F57DF"><enum>(A)</enum><text>Purchase of
materials and supplies, including limited medical supplies such as epinephrine
and disposable wet wipes, to support carrying out the food allergy and
anaphylaxis management guidelines described in subsection (b).</text>
</subparagraph><subparagraph id="H049AF04B2A2F44DFA375E1001FCF4862"><enum>(B)</enum><text>In partnership
with local health departments, school nurse, teacher, and personnel training
for food allergy management.</text>
</subparagraph><subparagraph id="H33517E7379A344E994A21BA9C23279B"><enum>(C)</enum><text>Programs that
educate students as to the presence of, and policies and procedures in place
related to, food allergies and anaphylactic shock.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3095F6861B544AED81E12D67E7F773C0"><enum>(D)</enum><text>Outreach to
parents.</text>
</subparagraph><subparagraph id="H9DCC1332213B410400A27248CC98D48F"><enum>(E)</enum><text>Any other
activities consistent with the guidelines described in subsection (b).</text>
</subparagraph></paragraph><paragraph id="HC49E6DD4527D4B8F83B72DE80555DCC6"><enum>(4)</enum><header>Duration of
awards</header><text>The Secretary may award grants under this subsection for a
period of not more than 2 years. In the event the Secretary conducts a program
evaluation under this subsection, funding in the second year of the grant,
where applicable, shall be contingent on a successful program evaluation by the
Secretary after the first year.</text>
</paragraph><paragraph id="id3AC01A17E2A245AB81C52F541684458F"><enum>(5)</enum><header>Limitation on
grant funding</header><text>The Secretary may not provide grant funding to a
local educational agency under this subsection after such local educational
agency has received 2 years of grant funding under this subsection.</text>
</paragraph><paragraph id="H3A638AA3D0EB4B8CBC068F10A3B45719"><enum>(6)</enum><header>Maximum amount
of annual awards</header><text>A grant awarded under this subsection may not be
made in an amount that is more than $50,000 annually.</text>
</paragraph><paragraph id="H638B57EDF0CA4A4ABCF4904480CCE9AA"><enum>(7)</enum><header>Priority</header><text>In
awarding grants under this subsection, the Secretary shall give priority to
local educational agencies with the highest percentages of children who are
counted under section 1124(c) of the Elementary and Secondary Education Act of
1965 (20 U.S.C. 6333(c)).</text>
</paragraph><paragraph id="id731702E227BD4E0BBC65D270581A619D"><enum>(8)</enum><header>Matching
funds</header>
<subparagraph id="id2A6B6F32FA45403A973FD30A2F7A2A1D"><enum>(A)</enum><header>In
general</header><text>The Secretary may not award a grant under this subsection
unless the local educational agency agrees that, with respect to the costs to
be incurred by such local educational agency in carrying out the grant
activities, the local educational agency shall make available (directly or
through donations from public or private entities) non-Federal funds toward
such costs in an amount equal to not less than 25 percent of the amount of the
grant.</text>
</subparagraph><subparagraph id="ID9cf4825f654b4809a99b4113f0a177dd"><enum>(B)</enum><header>Determination
of amount of non-Federal contribution</header><text>Non-Federal funds required
under subparagraph (A) may be cash or in kind, including plant, equipment, or
services. Amounts provided by the Federal Government, and any portion of any
service subsidized by the Federal Government, may not be included in
determining the amount of such non-Federal funds.</text>
</subparagraph></paragraph><paragraph id="HE1C27FD7F5DC4A3A85579BC481162F48"><enum>(9)</enum><header>Administrative
funds</header><text>A local educational agency that receives a grant under this
subsection may use not more than 2 percent of the grant amount for
administrative costs related to carrying out this subsection.</text>
</paragraph><paragraph id="HA649111AECC241BB95AB704D01BAA36E"><enum>(10)</enum><header>Progress and
evaluations</header><text>At the completion of the grant period referred to in
paragraph (4), a local educational agency shall provide the Secretary with
information on how grant funds were spent and the status of implementation of
the food allergy and anaphylaxis management guidelines described in subsection
(b).</text>
</paragraph><paragraph id="H5FBBE601915345298B0059F6ED412204"><enum>(11)</enum><header>Supplement, not
supplant</header><text>Grant funds received under this subsection shall be used
to supplement, and not supplant, non-Federal funds and any other Federal funds
available to carry out the activities described in this subsection.</text>
</paragraph><paragraph id="H98598EBD2A7F4BFF8FD0F49B5ED93357"><enum>(12)</enum><header>Authorization
of appropriations</header><text>There is authorized to be appropriated to carry
out this subsection $30,000,000 for fiscal year 2009 and such sums as may be
necessary for each of the 4 succeeding fiscal years.</text>
</paragraph></subsection><subsection id="HD7C9AB722B5C477382E94DC2C00AC64"><enum>(d)</enum><header>Voluntary nature
of guidelines</header>
<paragraph id="HCC4F41078F5F4E4F8E5DF2D4E5D6EF8D"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">The food allergy and
anaphylaxis management guidelines developed by the Secretary under subsection
(b) are voluntary. Nothing in this section or the guidelines developed by the
Secretary under subsection (b) shall be construed to require a local
educational agency to implement such guidelines.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFAC3B588BF5747A9BC151164A818966E"><enum>(2)</enum><header>Exception</header><text>Notwithstanding
paragraph (1), the Secretary may enforce an agreement by a local educational
agency to implement food allergy and anaphylaxis management guidelines as a
condition of the receipt of a grant under subsection (c).</text>
</paragraph></subsection></section><enum>II</enum><header>Detection and
surveillance</header>
<section id="id8E396828E7384143987A74BCDEC5DF19"><enum>201.</enum><header>Recognition of
laboratory accreditation for analyses of foods</header>
<subsection id="id9323CCB809B5457587D1405AED569F24"><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 109, is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="id9B07FB262C174C7BBDD1F01CAE13764D" style="OLC">
<section commented="no" id="idD92F7DED9A0944E4947B0DC4153F3FA9"><enum>423.</enum><header>Recognition of
laboratory accreditation for analyses of foods</header>
<subsection id="ID7afb6bcd59d04a6586d55afb31f0d22f"><enum>(a)</enum><header>Recognition of
laboratory accreditation</header>
<paragraph id="id5042CE8AD18E4941B47E8E2F9F6C9AA7"><enum>(1)</enum><header>In
general</header><text>Not later than 2 years after the date of enactment of the
<short-title>FDA Food Safety Modernization
Act</short-title>, the Secretary shall—</text>
<subparagraph id="id8998EEF14B2D412493625AB725ACF2BF"><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="id581B5A76251A49CC86DBBAE12BB59FEC"><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="ID5b4d5685cf94400bb87bcac5f80de9f2"><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="IDbba78bf178ee4c95974ef7f7554858f5"><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="IDe026264b9b134f49819f7c5e15d2cbcb"><enum>(B)</enum><text>internal quality
systems are established and maintained;</text>
</subparagraph><subparagraph id="ID60077894c6bb40ab8f39823f8732ae0c"><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="IDa61ad020471f4754ae66e1e12ccce177"><enum>(D)</enum><text>individuals who
conduct the analyses are qualified by training and experience to do so;
and</text>
</subparagraph><subparagraph id="id599018FE1070497493DAF6B9C3A76E06"><enum>(E)</enum><text>any other
criteria determined appropriate by the Secretary.</text>
</subparagraph></paragraph><paragraph commented="no" id="IDc4500f829219481c94cc647a9b29b11a"><enum>(3)</enum><header>Review of
accreditation</header><text>To assure compliance with the requirements of this
section, the Secretary shall—</text>
<subparagraph id="ID38c74607823d42c9bf34402f74e7b9b0"><enum>(A)</enum><text>periodically, or
at least every 5 years, reevaluate accreditation bodies recognized under
paragraph (1); and</text>
</subparagraph><subparagraph id="IDb8be62ee4ac640fb9fd28dcad0eb3b25"><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="idB1F34B07C43347BC9603F044E9549E6D"><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 is either conducted by or on behalf of an
owner or consignee—</text>
<paragraph commented="no" id="id44709E7A7E2041D4B8F70F8E1B2A8FC3"><enum>(1)</enum><text>in support of
admission of an article of food under section 801(a);</text>
</paragraph><paragraph commented="no" id="idCEE189B230FA4E63B2DAF6E404FB4221"><enum>(2)</enum><text>due to a specific
testing requirement in this Act or implementing regulations;</text>
</paragraph><paragraph commented="no" id="idD818806B5CDD4E499DED878FEBCB524D"><enum>(3)</enum><text>under an Import
Alert that requires successful consecutive tests; or</text>
</paragraph><paragraph commented="no" id="id714F1A3A235C435D838688ECA79BA90E"><enum>(4)</enum><text>is so required by
the Secretary as the Secretary deems appropriate.</text>
</paragraph><continuation-text continuation-text-level="subsection">The
results of any such sampling or testing shall be sent directly to the Food and
Drug Administration.</continuation-text></subsection><subsection commented="no" display-inline="no-display-inline" id="idEE9DB0D2E3374FAD984B3809CA17F89D"><enum>(c)</enum><header>Review by
Secretary</header><text>If food sampling and 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 sampling and
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="id258493C7C04947F4BD50FA6E466CAF0F"><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="id5C4E22051957416D863070F95C4D3CA1"><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="id185C2BD4851A42B6A997AC6F07B9E4DF"><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="idBA10C89F09B14DDE85ECFBCC0A14CFA8"><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="idFD1B3F0B0BE048A29EA033DFF225B9AF"><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="idA40695EB918E47AEBF08BCF1A5C206F9"><enum>(5)</enum><text>responds to
food-related emergencies; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB82981BBEC864A54BAA41559FFA305CC"><enum>(6)</enum><text>is integrated
with relevant laboratory networks administered by other Federal
agencies.</text>
</paragraph></subsection></section><section id="ID433aff7c1b3a43438c684f5fe96ae267"><enum>202.</enum><header>Integrated
consortium of laboratory networks</header>
<subsection id="id8C99E613B5F14C9DA30CBA923119FD67"><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="ID537e762c6b8a4d5e9186dd00aee03832"><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="ID676db943b7294d79a19057f31b47ae16"><enum>(2)</enum><text>identify the
means by which each laboratory network member could work cooperatively—</text>
<subparagraph id="ID2dc047ea485e4e3590d83d789c3dedc0"><enum>(A)</enum><text>to optimize
national laboratory preparedness; and</text>
</subparagraph><subparagraph id="ID162f754e358c442c8b0de5169bc46b1a"><enum>(B)</enum><text>to provide surge
capacity during emergencies; and</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID2e7c5296ef7445da8a5c4429ab64b8df"><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="idBE54C996583B461D8BFF4F9A9F899DBA"><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="ID82100521b1e642e2a6022c0e0ef05612"><enum>203.</enum><header>Building
domestic capacity</header>
<subsection id="IDa58fa3ba05274b88a6f2e445460ccb3f"><enum>(a)</enum><header>In
general</header>
<paragraph id="id91C81911D466401C8E4BABE29E4FDF54"><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="ID0c1e7a9fc9c04144839f8ff0900e4a99"><enum>(A)</enum><text>Analysis of the
need for regulations or guidance to industry.</text>
</subparagraph><subparagraph id="ID9f387737034647a2ba07f2e76bc64725"><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="IDaebdb91b172847ff9d45133a4a52e344"><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="IDc744cc31276f4bf88e32dcbe5831db4e"><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="id45C8DF0A5C484D9A9F3CEB6978087F54"><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="idB4C6877AF77D4C608FCD417F1A4E0DD0"><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 110 and 205.</text>
</subparagraph><subparagraph id="IDb49a28918baa4686bb3a3d0e6f424aac"><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="id87631C0DDC254E44ABF1AF4D59003AE5"><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="id032E6D42720D46F8B55D25A2BF942161"><enum>(A)</enum><text>reviews previous
food safety programs and practices;</text>
</subparagraph><subparagraph id="idCB8249B673F1422881A8B1D4DC31F054"><enum>(B)</enum><text>outlines the
success of those programs and practices;</text>
</subparagraph><subparagraph id="id552729E286C94FEB8DC9979061957529"><enum>(C)</enum><text>identifies future
programs and practices; and</text>
</subparagraph><subparagraph id="id52224B2CB72A48849C039116AA277375"><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="ID008d5ad791c24d2db407c5738d18502b"><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="ID4a0156cc49fa427298bb01bc5ce96605"><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="IDdd6bbd316cef45ac954981b87cc42406"><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="ID08037932e9fc45b28b8f4377463e7ed8"><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="IDdfe8fbe0546f439584d0e20470f0f754"><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="idE71955CC215A4242B3FA2EAC474F1669"><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="ID229dfe1ad1fb4094aa1c369c9ac569a3"><enum>204.</enum><header>Enhancing
traceback and recordkeeping</header>
<subsection id="ID3dfedae8f54b4956ba50202ab9821b77"><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="IDe53bfe173cc248f38b5dc332de9d40e0"><enum>(b)</enum><header>Pilot
project</header>
<paragraph id="id246C8F60264041FF87C4BB15E8AF5E6E"><enum>(1)</enum><header>In
general</header><text>Not later than 9 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="idEC3346CC6FBE421092C58E1AE0136995"><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 5-year period preceding the
date of enactment of this Act, and shall be selected in order to develop and
demonstrate—</text>
<subparagraph id="IDde35a8e9fed344b09bd77fcd86f93916"><enum>(A)</enum><text>methods that are
applicable and appropriate for small businesses; and</text>
</subparagraph><subparagraph id="IDa361c05198a143f3a669db22a3928a29"><enum>(B)</enum><text>technologies,
including existing technologies, that enhance traceback and trace
forward.</text>
</subparagraph></paragraph></subsection><subsection id="ID50c84a6906444ee499a7fb2be696b172"><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="ID27c27fbb069d4655a79c563f888b28ae"><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="IDc86d3e53ea58443eb2c2db37fdb870c6"><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="id13F9A4144BF847F98E7F83FAF53B8B43"><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="IDc663c2f680d6450ca21c934c9ef74446"><enum>205.</enum><header>Surveillance</header>
<subsection id="ID06b87a7390f7458697ec7fbe76af4bb7"><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="ID4ad397fba5be431a9ce7207b5441d09e"><enum>(b)</enum><header>Food-borne
illness surveillance systems</header>
<paragraph id="ID772a1ad7ac1342efae1096a116221b53"><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="ID523816eb81ff45da8a19ecefbd365aa6"><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="IDc9a3b32f68454d25a6fcc05458f13f2a"><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 id="id73E27FC7297F42DBBD72866248D75ABC"><enum>(C)</enum><text>developing
improved epidemiological tools for obtaining quality exposure data, and
microbiological methods for classifying cases;</text>
</subparagraph><subparagraph id="ID36bfe76b1eca4fd080f2884ce5d3d7e9"><enum>(D)</enum><text>augmenting such
systems to improve attribution of a food-borne illness outbreak to a specific
food;</text>
</subparagraph><subparagraph id="ID59b7ab4029f14a858929672f37617be3"><enum>(E)</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="ID099d3ea142934b4bb73605d1688a9cb1"><enum>(F)</enum><text>allowing timely
public access to aggregated, de-identified surveillance data;</text>
</subparagraph><subparagraph id="ID9d3379efa4b740b7af54881cbf2ef1d6"><enum>(G)</enum><text>at least
annually, publishing current reports on findings from such systems;</text>
</subparagraph><subparagraph id="ID199bba0ab03343ebac9e100df724cd8e"><enum>(H)</enum><text>establishing a
flexible mechanism for rapidly initiating scientific research by academic
institutions;</text>
</subparagraph><subparagraph id="ID5a55acf6f30c4a72ac5a57cef2bc2017"><enum>(I)</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="id6A588A88A40D4575AA995312B88854C7"><enum>(J)</enum><text>other activities
as determined appropriate by the Secretary.</text>
</subparagraph></paragraph><paragraph id="ID5c6019f4036349b79beaa0e4cd9c9467"><enum>(2)</enum><header>Partnerships</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 and
implementation of this section, including advice and recommendations on—</text>
<subparagraph id="ID83d4b14554fc47b1a52d2d387c444ae8"><enum>(A)</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>
</subparagraph><subparagraph id="ID6b6d1f3837c348a683874da2924bc3cc"><enum>(B)</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>
</subparagraph><subparagraph id="IDf05d40009e0e48a9b3cabff6b83b0768"><enum>(C)</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 collected by government agencies at all levels, including
data compiled by the Centers for Disease Control and Prevention;</text>
</subparagraph><subparagraph id="ID074826a7deb14ce8818be18bbbaaa0a7"><enum>(D)</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>
</subparagraph><subparagraph id="ID1e43a327d80c409fbfb87b28fdf8caaa"><enum>(E)</enum><text>the capabilities
needed for establishing automatic electronic searches of surveillance data;
and</text>
</subparagraph><subparagraph id="ID3d1e9266055c4503a3d798adc0067865"><enum>(F)</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>
</subparagraph></paragraph></subsection><subsection id="ID0108ed1912a743b2ab5d180e49cdd0a3"><enum>(c)</enum><header>Improving food
safety and defense capacity at the State and local level</header>
<paragraph id="IDd2cdeacc0baf4e75b1243b6b945234d8"><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="ID35f84c2cf31e45b1acb6c2396fe786b3"><enum>(A)</enum><text>Improve
food-borne illness outbreak response and containment.</text>
</subparagraph><subparagraph id="IDa65e99e673a5483eafcbe78d1dadad3b"><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="ID74ac85aba31344629e08492d6edfa18d"><enum>(C)</enum><text>Strengthen the
capacity of State and local agencies to carry out inspections and enforce
safety standards.</text>
</subparagraph><subparagraph id="ID8778b365f65e4d6dab2e713446ee4485"><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="ID29f0633475044eae8bff5bfda06c7201"><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="ID0ef1cf4b832d43ee9f01cf88df398d63"><enum>(F)</enum><text>Strengthen the
capacity of State and local agencies to achieve the goals described in section
110.</text>
</subparagraph></paragraph><paragraph id="IDb9c1967e444440a4af790c1a40ceb13a"><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 the
<short-title>FDA Food Safety Modernization
Act</short-title>, complete a review of State and local capacities, and needs
for enhancement, which may include a survey with respect to—</text>
<subparagraph id="ID636c99ead1c0443991b6e04b04931c8e"><enum>(A)</enum><text>staffing levels
and expertise available to perform food safety and defense functions;</text>
</subparagraph><subparagraph id="ID07a323b67f634ee991508bae876796fc"><enum>(B)</enum><text>laboratory
capacity to support surveillance, outbreak response, inspection, and
enforcement activities;</text>
</subparagraph><subparagraph id="IDb297a8d2d9e04b31a0a7ae603a541986"><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="ID928f74cdb2c440998cab5fe91e2e644d"><enum>(D)</enum><text>other State and
local activities and needs as determined appropriate by the Secretary.</text>
</subparagraph></paragraph></subsection><subsection id="ID7be0f1acc7ae4d41881a1af07ebaaf45"><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="id03A884040BD847E39E648648B3C593E7"><enum>(1)</enum><text>by striking
<quote>2002</quote> and inserting <quote>2009</quote>; and</text>
</paragraph><paragraph commented="no" id="id9F07268A20E641CFA94D22A2B42671F6"><enum>(2)</enum><text>by striking
<quote>2003 through 2006</quote> and inserting <quote>2010 through
2013</quote>.</text>
</paragraph></subsection></section><enum>III</enum><header>Specific
provisions for imported food</header>
<section id="id345AADD1314F4C8D80B36547BC9A8853"><enum>301.</enum><header>Foreign
supplier verification program</header>
<subsection id="id830B67D844FE4677AA67694F0E4C3E0F"><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="idF5AA1C6790E84B22931B790674BAE0BD" style="OLC">
<section id="ID53c3d99cbb4b4539a3d4425b27e3122f"><enum>805.</enum><header>Foreign
supplier verification program</header>
<subsection id="ID13f1b1dfc55046ff980b89efed7c5101"><enum>(a)</enum><header>In
general</header>
<paragraph id="idD3F1EC37316B4B9C83F0C687A27EEFA7"><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="idF24B7C78B992417D8107333AB8C8A6C2"><enum>(A)</enum><text>produced in
compliance with the requirements of section 419 or 420, as appropriate;
and</text>
</subparagraph><subparagraph id="id1CC6B112703246E2BE1137F277F7E588"><enum>(B)</enum><text>is not
adulterated under section 402 or misbranded under section 403(w).</text>
</subparagraph></paragraph><paragraph commented="no" id="id636E8E0CB05647F9B7770E2581FB033F"><enum>(2)</enum><header>Importer
exclusion</header><text>For purposes of this section, an <quote>importer of
record</quote> 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 <quote>customs
broker</quote>) 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="ID7c1d9ab8aba9460e953515705a77a484"><enum>(b)</enum><header>Guidance</header><text>Not
later than 1 year after the date of enactment of the
<short-title>FDA Food Safety Modernization
Act</short-title>, the Secretary shall issue guidance to assist United States
importers of record in developing foreign supplier verification
programs.</text>
</subsection><subsection id="idD0D1289CBB1540A6A5F9ADA6AA503F77"><enum>(c)</enum><header>Regulations</header>
<paragraph id="id3F4EAE3A93ED4C24AD613F5A9441CC8A"><enum>(1)</enum><header>In
general</header><text>Not later than 1 year after the date of enactment of the
<short-title>FDA Food Safety Modernization
Act</short-title>, 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="idF83517B1187F46E48F9F4416B7C5BBDB"><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, equivalent in preventing
adulteration and reducing hazards as those required by section 419 or section
420, as appropriate.</text>
</paragraph><paragraph id="idA8CE480909484CFFB70A72F2AE176678"><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="ID8e53abe3593b4174bdbff768954dc999"><enum>(d)</enum><header>Record
maintenance and access</header><text>Records of a United States importer of
record 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="idF9897B9028764762BBF97144E4DA1C63"><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="id9C8CD6B60B234B8EBF93B7F21EADAF26"><enum>(1)</enum><text>The Seafood
Hazard Analysis Critical Control Points Program of the Food and Drug
Administration.</text>
</paragraph><paragraph commented="no" id="id5226B48949BB426B854CEB9D455D4618"><enum>(2)</enum><text>The Juice Hazard
Analysis Critical Control Points Program of the Food and Drug
Administration.</text>
</paragraph><paragraph commented="no" id="id9067BC47089E46068236DF3DEAD9B087"><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="id6431D3AF179A440C95107E337D40CF20"><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="idCE67551B6C6743AA932C7F19F9671349"><enum>(b)</enum><header>Prohibited
act</header><text>Section 301 (21 U.S.C. 331), as amended by section 109, is
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id7B455B0B1231405F86373ECFDA7155B8" style="OLC">
<subsection id="id76DC5CEBD8A042129C5BC3BF4F01BD84"><enum>(ss)</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="id292D3424331B478BA31FF85CD4E50C36"><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="id4B45EF85D60B469E888690D437801175"><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="id709ED756C66C486A976AE13F6D0C70BE"><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="id493C456CE89D4E17B31AC8B4C67EB88A" style="OLC">
<section id="ID2960ecc473c04710be868886b2ddad2a"><enum>806.</enum><header>Voluntary
qualified importer program</header>
<subsection id="IDb25a7432d9154b6087def95860edf731"><enum>(a)</enum><header>In
general</header><text>Beginning not later than 1 year after the date of
enactment of the <short-title>FDA Food Safety
Modernization Act</short-title>, the Secretary shall—</text>
<paragraph id="id9E2EBDD6E517462FBB47BB5D03020E7D"><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="id961D6DA9504A42D39B57FB852B0E02F8"><enum>(2)</enum><text>issue a guidance
document related to participation and compliance with such program.</text>
</paragraph></subsection><subsection id="id29C24B9CC25E4DB9957594345B87AE64"><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="idF48FE60D24C6401FAEBC7D0CBDB012E7"><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="idA4A866A6E719408A86DB101DF6CB5FED"><enum>(1)</enum><text>The nature of the
food to be imported.</text>
</paragraph><paragraph id="idA3DF049AD0CB4F0F8F09BDEE45D73C61"><enum>(2)</enum><text>The compliance
history of the foreign supplier.</text>
</paragraph><paragraph id="idCD2C202732CA408BA129F4D93B9B14C5"><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="idB62259AF5E98445C9C22C99667807F54"><enum>(4)</enum><text>The compliance of
the importer with the requirements of section 805.</text>
</paragraph><paragraph id="idBD6FF3A3ADB84CF286BC1E3C3F0A0672"><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="id07F0B961AAD64CF891A223EF3AEAD75D"><enum>(6)</enum><text>The potential
risk for intentional adulteration of the food.</text>
</paragraph><paragraph id="idF7A5389E5A9941B2AF5F15002D9F4D53"><enum>(7)</enum><text>Any other factor
that the Secretary determines appropriate.</text>
</paragraph></subsection><subsection id="ID46ff31fc455049db8ac84d7a99da246d"><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="id14B437C81C2249ADA2AF200AA305117B"><enum>(e)</enum><header>Definition</header><text>For
purposes of this section, the term <quote>importer</quote> 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="id9FA63E119BCF490D8519429A1B1D0B9F"><enum>303.</enum><header>Authority to
require import certifications for food</header>
<subsection id="id38B900AC76E84120A69763C364494F28"><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="idCDCEF06D1D844D3CB1449A312A417ED4"><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="id7D657F49603D4BF9A76BEB0EED22868B" style="OLC">
<subsection id="id1035BC2C7DF5426F980EBE09D062C461"><enum>(p)</enum><header>Certifications
concerning imported foods</header>
<paragraph id="idDF84E596F0A94F6DAB1F7E45D7761577"><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="id104FAA86137F489B9E3C1F880256340E"><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="idA2415B5AA38F484893109EC4E5937BF6"><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="id0BD198FD5B0B42CBA91FF596AF4DC8B0"><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="id00B803292A084FCF8E0DF0574DDDB185"><enum>(3)</enum><header>Renewal and
refusal of certifications</header><text>The Secretary may—</text>
<subparagraph id="idAF32A5964AEC4753806D50EF30D503A1"><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="idBE6D3DC25FC64899B77D09E4D18EE9A0"><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="id2E582F22E61A4B108662E04ADA649E08"><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="id16954B0E4D4A4DC6AF2A2F239A99A763"><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="id4BB060F01AFA41BA9476A870ECD16A4C"><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="ID98e7f60a8d5d4025a4d845d8e490efd3"><enum>304.</enum><header>Prior notice
of imported food shipments</header>
<subsection id="IDcd89d6defcaa41a7b82a599a3f91c8b4"><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="IDd1bf8f3785134cbc827c9aa6b34458b3"><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="IDbd234267e800417db2499475986815d3"><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="id0A45FA6BC38C45C6AE4E0F8CC5C6E3D4"><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="idBFA231FE84E94384AC17CF6E89E9CD3A" style="OLC">
<section id="id0375B42C2A9844E883F4F93A02270B6D"><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="id7CAC05AABEE54B92B758D12A1E2B88F0"><enum>306.</enum><header>Building
capacity of foreign governments with respect to food</header>
<subsection id="id27BC5766C6EA40559423D3E3C8F94577"><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="ID0c28b42106cb440187326827c9e3915c"><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="ID376fc2189e2b43beb12140db0b3e67b3"><enum>(c)</enum><header>Plan</header><text>The
plan developed under subsection (a) shall include, as appropriate, the
following:</text>
<paragraph id="IDa23e94a681144f49a5242edef632327e"><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="ID35e3c761fe8f4777831d5fb3e6904f7b"><enum>(2)</enum><text>Provisions for
electronic data sharing.</text>
</paragraph><paragraph id="ID090abadb315d4ef984c54c9a5593bf7c"><enum>(3)</enum><text>Provisions for
mutual recognition of inspection reports.</text>
</paragraph><paragraph id="ID28ea804f17644aa2bb58a6b18df108b5"><enum>(4)</enum><text>Training of
foreign governments and food producers on United States requirements for safe
food.</text>
</paragraph><paragraph id="ID2b69a55807044d4696d5201c2debf420"><enum>(5)</enum><text>Recommendations
to harmonize requirements under the Codex Alimentarius.</text>
</paragraph><paragraph id="IDaf3fd9ecb7e145c3ae88ff236817f562"><enum>(6)</enum><text>Provisions for
the multilateral acceptance of laboratory methods and detection
techniques.</text>
</paragraph></subsection></section><section id="idEB0FEB8C1FD84839A51C7AB66FE6CF69"><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="id6A6A6D898AA24748BFF32B56EA9372C3" style="OLC">
<section id="id12D57064E42A4B3FB56B33AF68CC60DF"><enum>808.</enum><header>Inspection of
foreign food facilities</header>
<subsection id="id2F9BE66E12C14A61883EA3CB3C1EC772"><enum>(a)</enum><header>Inspection</header><text>The
Secretary—</text>
<paragraph id="id4493C9B66BC843AA894A3E90CFFA92DA"><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="idA1DFDB789E844FE9B442D7558BFE0675"><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="id7FA8A8F86E41490BBF8C7137702C373B"><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="ID7c717e06556c42d891cf5351a8429bbd"><enum>308.</enum><header>Accreditation
of qualified third-party auditors</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 display-inline="no-display-inline" id="idF132B41587C142549B58C6D3D270655A" style="OLC">
<section id="ID608c4e1625a744a3a223608af6c683a7"><enum>809.</enum><header>Accreditation
of qualified third-party auditors</header>
<subsection id="ID394938bd07814e01822c10afeba81e30"><enum>(a)</enum><header>Accreditation
of certifying agents</header>
<paragraph id="id9B10F5BF9DCA44CD9123A7B1E5C3C665"><enum>(1)</enum><header>In
general</header><text>Beginning not later than 2 years after the date of
enactment of the <short-title>FDA Food Safety
Modernization Act</short-title>, the Secretary shall establish and implement an
accreditation system under which a foreign government, a State or regional food
authority, a foreign or domestic cooperative that aggregates the products of
growers or processors, or any other third party that the Secretary determines
appropriate, may request to be accredited as a certifying agent to certify that
eligible entities meet the applicable requirements of this Act.</text>
</paragraph><paragraph id="ID5cd7a84bff5f44ae87701c4eba0a3ddd"><enum>(2)</enum><header>Review by
Secretary</header><text>When establishing the accreditation system under
paragraph (1), the Secretary shall review third-party accreditation systems in
existence on the date of enactment of the <short-title>FDA
Food Safety Modernization Act</short-title>, to avoid unnecessary duplication
of efforts and costs.</text>
</paragraph><paragraph id="ID6839848834a844c68982026afaa1733d"><enum>(3)</enum><header>Request by
foreign government</header><text>Prior to accrediting a foreign government as a
certifying agent, the Secretary shall perform such reviews and audits of food
safety programs, systems, and standards of the government as the Secretary
deems necessary to determine that they are adequate to ensure 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>
</paragraph><paragraph id="IDc4b477cf2efd4b4ba414b2bfb319cf96"><enum>(4)</enum><header>Request by
State or regional food authority</header><text>Prior to accrediting a State or
regional food authority as a certifying agent, the Secretary shall perform such
reviews and audits of the training and qualifications of auditors used by the
authority and conduct such reviews of internal systems and such other
investigation of the authority as the Secretary deems necessary to determine
that each eligible entity certified by the authority has systems and standards
in use to ensure that such entity meets the requirements of this Act.</text>
</paragraph><paragraph id="ID1d21bae27a8142d6bb53d514366cdc1b"><enum>(5)</enum><header>Cooperatives
and other third parties</header><text>Prior to accrediting a foreign or
domestic cooperative that aggregates the products of growers or processors or
any other third party that the Secretary determines appropriate as a certifying
agent, the Secretary shall perform such reviews and audits of the training and
qualifications of auditors used by the 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>
</paragraph><paragraph id="id2B2CEBCD31A540B7AEAED29397A73BDC"><enum>(6)</enum><header>Limitation on
third parties</header><text>The Secretary may not accredit a third party that
the Secretary determines appropriate as a certifying agent unless each auditor
used by such party prepares the audit report for an audit under this section in
a form and manner designated by the Secretary. An audit report shall
include—</text>
<subparagraph id="IDa09995c6bd644f3ba58a0d2bf99507a6"><enum>(A)</enum><text>the identity of
the persons at the audited eligible entity responsible for compliance with food
safety requirements;</text>
</subparagraph><subparagraph id="ID4e050cbd51eb4c73bf7d1ada22c9eff1"><enum>(B)</enum><text>the dates of the
audit;</text>
</subparagraph><subparagraph id="ID117ed8381f99407eaf55ac12b10d824c"><enum>(C)</enum><text>the scope of the
audit; and</text>
</subparagraph><subparagraph id="IDd23e6e1a472c4b63bb523512147a3666"><enum>(D)</enum><text>any other
information required by the Secretary that relate to or may influence an
assessment of compliance with this Act.</text>
</subparagraph></paragraph></subsection><subsection id="ID9f83471c175245789d2108cdc9ced401"><enum>(b)</enum><header>Importation</header><text>As
a condition of accrediting a foreign government, a State or regional food
authority, a foreign or domestic cooperative that aggregates the products of
growers or processors, or any other third party that the Secretary determines
appropriate as a certifying agent, such government, authority, cooperative, or
party shall agree to issue a written and electronic certification to accompany
each food shipment made for import from an eligible entity certified by the
certifying agent, subject to requirements set forth by the Secretary. The
Secretary shall consider such certificates when targeting inspection resources
under section 421.</text>
</subsection><subsection id="ID4801a2cf99a244999fa0af2807cdbba0"><enum>(c)</enum><header>Monitoring</header><text>Following
any accreditation of a certifying agent, the Secretary may at any time—</text>
<paragraph id="IDc905f80f94d345ff8fce15314ea5928c"><enum>(1)</enum><text>conduct an
on-site audit of any eligible entity certified by the agent, with or without
the certifying agent present; or</text>
</paragraph><paragraph id="IDd932dd3a5c4d4103a9be9731187a15f7"><enum>(2)</enum><text>require the agent
to submit to the Secretary, for any eligible entity certified by the agent, an
onsite inspection report and such other reports or documents the agent requires
as part of the audit process, including, for an eligible entity located outside
the United States, documentation that the eligible is in compliance with any
applicable registration requirements.</text>
</paragraph></subsection><subsection id="IDb6159107c4694be18ef416b2ec347cc4"><enum>(d)</enum><header>Definitions</header><text>For
purposes of this section:</text>
<paragraph id="IDec44ad56f1fb4a6796ae8edfb85acc5f"><enum>(1)</enum><header>Auditor</header><text>The
term <term>auditor</term> means an individual who—</text>
<subparagraph id="ID7a5dd3d87b5349f1820f5e797eeb2fd8"><enum>(A)</enum><text>is qualified to
conduct food safety audits; and</text>
</subparagraph><subparagraph id="ID8885160a9f7d4a44b479e02f1abd9df2"><enum>(B)</enum><text>has successfully
completed any training requirements established by the Secretary for the
conduct of food safety audits.</text>
</subparagraph></paragraph><paragraph id="ID737ff0c69a574541970f60f2de90bdd7"><enum>(2)</enum><header>Certifying
agent</header><text>The term <term>certifying agent</term> means a foreign
government, a State or regional food authority, a foreign or domestic
cooperative that aggregates the products of growers or processors, or any other
third party that conducts audits of eligible entities and that is accredited by
the Secretary under this section.</text>
</paragraph><paragraph commented="no" id="ID6a454ccf018343c1b3fbb644d3c68476"><enum>(3)</enum><header>Eligible
entity</header><text>The term <quote>eligible entity</quote> means any entity
in the food supply chain that chooses to be audited by a certifying
agent.</text>
</paragraph></subsection><subsection id="ID982fe753cdf848318383e8d0e6aa7f7e"><enum>(e)</enum><header>Avoiding
conflicts of interest with certifying agents</header>
<paragraph id="ID323230fe9b614f9b9818f1e6e6686a4c"><enum>(1)</enum><header>In
general</header><text>A certifying agent shall—</text>
<subparagraph id="ID330815c18b904702b131ed7fa116ea06"><enum>(A)</enum><text>not be owned,
managed, or controlled by any person that owns or operates an eligible entity
to be certified by such agent;</text>
</subparagraph><subparagraph id="ID7d3949de1da14a8d8cf82e3f796fd30d"><enum>(B)</enum><text>have procedures
to ensure against the use, in carrying out audits of eligible entities under
this section, of any officer or employee of such agent that has a financial
conflict of interest regarding an eligible entity to be certified by such
agent; and</text>
</subparagraph><subparagraph id="IDf95ed43b5f1d4938a11827fab39d6dff"><enum>(C)</enum><text>annually make
available to the Secretary, disclosures of the extent to which such agent, and
the officers and employees of such agent, have maintained compliance with
subparagraphs (A) and (B) relating to financial conflicts of interest.</text>
</subparagraph></paragraph><paragraph id="IDff2c391f725e482c90f720764ad562d2"><enum>(2)</enum><header>Regulations</header><text>The
Secretary shall promulgate regulations not later than 18 months after the date
of enactment of the <short-title>FDA Food Safety
Modernization Act</short-title> to ensure that there are protections against
conflicts of interest between a certifying agent and the eligible entity to be
certified by such agent. Such regulations shall include—</text>
<subparagraph id="ID448503c846eb40aa8118944d1f1e8e6c"><enum>(A)</enum><text>requiring that
domestic audits performed under this section be unannounced;</text>
</subparagraph><subparagraph id="IDcaafa48ba5974205bc8fd6d0a7da25d7"><enum>(B)</enum><text>a structure,
including timing and public disclosure, for fees paid by eligible entities to
certifying agents to decrease the potential for conflicts of interest;
and</text>
</subparagraph><subparagraph id="idCE14D93EDE1341C580B86499B04822DF"><enum>(C)</enum><text>appropriate
limits on financial affiliations between a certifying agent and any person that
owns or operates an eligible entity to be certified by such agent.</text>
</subparagraph></paragraph></subsection><subsection id="ID56efaa3e85634ba9851bfa1879d979d1"><enum>(f)</enum><header>False
statements</header><text>Any statement of representation made by an employee or
agent of an eligible entity to an auditor of a certifying agent or a certifying
agent shall be subject to section 1001 of title 18, United States Code.</text>
</subsection><subsection id="ID7db3518c186f4e85a70a2f2fed40a7b7"><enum>(g)</enum><header>Risks to public
health</header><text>If, at any time during an audit, an auditor of a
certifying agent discovers a condition that could cause or contribute to a
serious risk to the public health, the auditor shall immediately notify the
Secretary of—</text>
<paragraph id="ID0c1a3459b7cd40fc854261a1ec184682"><enum>(1)</enum><text>the
identification of the eligible entity subject to the audit; and</text>
</paragraph><paragraph id="IDf927303e5f324bca957d02b09984df0c"><enum>(2)</enum><text>such
condition.</text>
</paragraph></subsection><subsection id="ID04c19cf961304db2a3f03e8a2f375530"><enum>(h)</enum><header>Withdrawal of
accreditation</header><text>The Secretary may withdraw accreditation from a
certifying agent—</text>
<paragraph id="ID32e2a798f7f6413caad29f75f0f06af7"><enum>(1)</enum><text>if food from
eligible entities certified by such agent is linked to an outbreak of human or
animal illness;</text>
</paragraph><paragraph id="ID1f2d88e3d09049c4b15d972474853604"><enum>(2)</enum><text>following a
performance audit and finding by the Secretary that the agent no longer meets
the requirements for accreditation; or</text>
</paragraph><paragraph id="IDe3d2305ac75d42df8ff1c49c64906521"><enum>(3)</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>
</paragraph></subsection><subsection id="ID502783082c9a499dbf4e26b95be095d7"><enum>(i)</enum><header>Performance
audits and renewal</header><text>To ensure that accreditation of a certifying
agent continues to meet the standards of this section and this Act and to allow
for the renewal of accreditation of such certifying agent, the Secretary
shall—</text>
<paragraph id="ID72418ace4dc44e6b9c80038ae2855568"><enum>(1)</enum><text>audit the
performance of such certifying agent on a periodic basis, not less than every 4
years, through the review of audit reports by such certifying agent and the
compliance history, as available, of eligible entities certified by such
certifying agent; and</text>
</paragraph><paragraph id="IDc5ad4a304fea483d9795f42f54730972"><enum>(2)</enum><text>any other
measures deemed necessary by the Secretary.</text>
</paragraph></subsection><subsection id="ID3786ce7bb2254562a140fce7eb97c404"><enum>(j)</enum><header>Publication of
list of certifying agents</header><text>The Secretary shall publish and
maintain on the Internet Web site of the Food and Drug Administration a current
list, including, the name, location and other information deemed necessary by
the Secretary, of certifying agents under this section.</text>
</subsection><subsection id="ID394efc072d334e39974df67542e55902"><enum>(k)</enum><header>Neutralizing
costs</header><text>The Secretary shall establish a method, similar to the
method used by the Department of Agriculture, by which certifying agents
reimburse the Food and Drug Administration for the work performed to accredit
such certifying agents. The Secretary shall make operating this program
revenue-neutral and shall not generate surplus revenue from such a
reimbursement mechanism.</text>
</subsection><subsection id="ID2cde297c596b4d4bba79a83c82832e3b"><enum>(l)</enum><header>No effect on
section 704 inspections</header><text>The audits performed under this section
shall not be considered inspections under section 704.</text>
</subsection><subsection id="ID3746cd2f0e824a2db4c2ba0ba32c0ff5"><enum>(m)</enum><header>No effect on
inspection authority</header><text>Nothing in this section affects the
authority of the Secretary to inspect any eligible entity pursuant to this
Act.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="id7BDBCBAE823E496D8863C71C8741905D"><enum>309.</enum><header>Foreign
offices of the Food and Drug Administration</header>
<subsection id="idEF31CE931F20428C92A4D0A6924D1429"><enum>(a)</enum><header>In
general</header><text>The Secretary shall by October 1, 2010, establish an
office of the Food and Drug Administration in not less than 5 foreign countries
selected by the Secretary, to provide assistance to the appropriate
governmental entities of such countries with respect to measures to provide for
the safety of articles of food and other products regulated by the Food and
Drug Administration exported by such country to the United States, including by
directly conducting risk-based inspections of such articles and supporting such
inspections by such governmental entity.</text>
</subsection><subsection id="id693DA8C6F2F14C91A9F69EF69E5DCFDB"><enum>(b)</enum><header>Consultation</header><text>In
establishing the foreign offices described in subsection (a), the Secretary
shall consult with the Secretary of State and the United States Trade
Representative.</text>
</subsection><subsection id="id16B9FEB13D60407A8A77B473E9CABABA"><enum>(c)</enum><header>Report</header><text>Not
later than October 1, 2011, the Secretary shall submit to Congress a report on
the basis for the selection by the Secretary of the foreign countries in which
the Secretary established offices under subsection (a), the progress which such
offices have made with respect to assisting the governments of such countries
in providing for the safety of articles of food and other products regulated by
the Food and Drug Administration exported to the United States, and the plans
of the Secretary for establishing additional foreign offices of the Food and
Drug Administration, as appropriate.</text>
</subsection></section><section id="idE8A2EEEB85054BD8ABB825647B82D499"><enum>310.</enum><header>Funding for
food safety</header>
<subsection id="idC18BD05A6BD240409CE5EE8DBB45817E"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">There are authorized
to be appropriated to carry out the activities of the Center for Food Safety
and Applied Nutrition, the Center for Veterinary Medicine, and related field
activities in the Office of Regulatory Affairs of the Food and Drug
Administration—</text>
<paragraph commented="no" id="id68235B274A2842C0AA708DAC983C215A"><enum>(1)</enum><text display-inline="yes-display-inline">$775,000,000 for fiscal year 2009;
and</text>
</paragraph><paragraph commented="no" id="idFEE9FF9F25FF4A188748A8C9B6C563C9"><enum>(2)</enum><text>such sums as may
be necessary for fiscal years 2010 through 2013.</text>
</paragraph></subsection><subsection id="id957FCAED7BAC47EAA30D3DE34385F009"><enum>(b)</enum><header>Increased
number of field staff</header><text>To carry out the activities of the Center
for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and
related field activities of the Office of Regulatory Affairs of the Food and
Drug Administration, the Secretary of Health and Human Services shall increase
the field staff of such Centers and Office with a goal of not fewer
than—</text>
<paragraph id="id1E7FB382DB404FEE9FAD9F9CC3B269AE"><enum>(1)</enum><text>3,600 staff
members in fiscal year 2009;</text>
</paragraph><paragraph id="idE5B13BE5C6EA450D881E64E07FAD12C8"><enum>(2)</enum><text>3,800 staff
members in fiscal year 2010;</text>
</paragraph><paragraph id="id3B278DBD162740EDA8EF94090664FD80"><enum>(3)</enum><text>4,000 staff
members in fiscal year 2011;</text>
</paragraph><paragraph id="idA489B928B0E14DF7AB7D076EBA2286ED"><enum>(4)</enum><text>4,200 staff
members in fiscal year 2012; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idDD7FB919AFCD41C8833B0ECB873F2E3E"><enum>(5)</enum><text>4,600 staff
members in fiscal year 2013.</text>
</paragraph></subsection></section><section id="ID4d54afcc3b314c87b9aa1767e8046a9e"><enum>311.</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="ID2072e8f3b204498eb552e726a943071f"><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="IDd21b2b8aa2454109b3d452b554986947"><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="ID9eb1290dedfd4648b7e4c99ccbcdd2e1"><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="ID3978d29051d24bfa963dfc4a5fdc3f27"><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="ID45201d59b83d4684873e8567c53e36ad"><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>