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—Improving capacity to prevent food safety
problems
Sec. 101. Inspections of records.
Sec. 102. Registration of food facilities.
Sec. 103. Hazard analysis and risk-based preventive
controls.
Sec. 104. Performance standards.
Sec. 105. Standards for produce safety.
Sec. 106. Protection against intentional
adulteration.
Sec. 107. Authority to collect fees.
Sec. 108. National agriculture and food defense
strategy.
Sec. 109. Food and Agriculture Coordinating
Councils.
Sec. 110. Building domestic capacity.
Sec. 111. Sanitary transportation of food.
Sec. 112. Food allergy and anaphylaxis management.
Sec. 113. New dietary ingredients.
Sec. 114. Requirement for guidance relating to post harvest
processing of raw oysters.
Sec. 115. Port shopping.
Sec. 116. Alcohol-related facilities.
TITLE II—Improving capacity to detect and respond to food safety
problems
Sec. 201. Targeting of inspection resources for domestic
facilities, foreign facilities, and ports of entry; annual report.
Sec. 202. Laboratory accreditation for analyses of
foods.
Sec. 203. Integrated consortium of laboratory
networks.
Sec. 204. Enhancing tracking and tracing of food and
recordkeeping.
Sec. 205. Surveillance.
Sec. 206. Mandatory recall authority.
Sec. 207. Administrative detention of food.
Sec. 208. Decontamination and disposal standards and
plans.
Sec. 209. Improving the training of State, local, territorial,
and tribal food safety officials.
Sec. 210. Enhancing food safety.
Sec. 211. Improving the reportable food registry.
TITLE III—Improving the safety of 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. Building capacity of foreign governments with respect
to food safety.
Sec. 306. Inspection of foreign food facilities.
Sec. 307. Accreditation of third-party auditors.
Sec. 308. Foreign offices of the Food and Drug
Administration.
Sec. 309. Smuggled food.
TITLE IV—Miscellaneous provisions
Sec. 401. Funding for food safety.
Sec. 402. Employee protections.
Sec. 403. Jurisdiction; authorities.
Sec. 404. Compliance with international agreements.
Sec. 405. Determination of budgetary effects.
<enum>I</enum><header display-inline="yes-display-inline">Improving capacity to prevent food safety
problems</header>
<section commented="no" display-inline="no-display-inline" id="idC40328712F8B494BBFA7F6BD01DB05B6" section-type="subsequent-section"><enum>101.</enum><header display-inline="yes-display-inline">Inspections of records</header>
<subsection commented="no" display-inline="no-display-inline" id="idD4F3E1AEC6CD44BF8933855F1159D3DD"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 414(a) (21 U.S.C. 350c(a)) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idAAA98E4E3D7C46248F55502926E676F5"><enum>(1)</enum><text display-inline="yes-display-inline">by striking the heading and all that
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 commented="no" display-inline="no-display-inline" id="idAEC462FE04554718AA584CB5F8DF775F"><enum>(1)</enum><header display-inline="yes-display-inline">Adulterated food</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idC7E0A333DDCD42F78A9C622A4DF2CC02"><enum>(2)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id8B21FB1C1F664A79817AE154E057E43F"><enum>(3)</enum><text display-inline="yes-display-inline">by striking the last sentence; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id85EBCAEE034A418991F5903C16B168C7"><enum>(4)</enum><text display-inline="yes-display-inline">by inserting at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="idFD3EAE16D85045EBB9110AB07404C753" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idAAC78EB45B684AD996EB12D38510CE00"><enum>(2)</enum><header display-inline="yes-display-inline">Use of or exposure to food of
concern</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id2C8860163C6D4B3B8B6DA96E05017C71"><enum>(3)</enum><header display-inline="yes-display-inline">Application</header><text display-inline="yes-display-inline">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></subsection><subsection commented="no" display-inline="no-display-inline" id="id9D33D3473D3843A692750002135E41F1"><enum>(b)</enum><header display-inline="yes-display-inline">Conforming amendment</header><text display-inline="yes-display-inline">Section 704(a)(1)(B) (21 U.S.C.
374(a)(1)(B)) is amended by striking <quote>section 414 when</quote> and all
that follows through <quote>subject to</quote> and inserting <quote>section
414, when the standard for records inspection under paragraph (1) or (2) of
section 414(a) applies, subject to</quote>.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id16194DF807E34D1D914A788BA285667F" section-type="subsequent-section"><enum>102.</enum><header display-inline="yes-display-inline">Registration of food facilities</header>
<subsection commented="no" display-inline="no-display-inline" id="idA9B62ABE57C2464FA2C43F1FEA93DB36"><enum>(a)</enum><header display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id8C0368C809714749B6F10AF932C9E097"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (2), by—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idF5E803390CDC4446879A36C8EBD226A3"><enum>(A)</enum><text display-inline="yes-display-inline">striking <quote>conducts business
and</quote> and inserting <quote>conducts business, the e-mail address for the
contact person of the facility or, in the case of a foreign facility, the
United States agent for the facility, and</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id54C89058190240C0901D2754B4C3A0E6"><enum>(B)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id9679A324E56A4CE189E6409B5F80019D"><enum>(2)</enum><text display-inline="yes-display-inline">by redesignating paragraphs (3) and (4) as
paragraphs (4) and (5), respectively; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id19464363A7EB451BB9FEF90C5BF7AFDD"><enum>(3)</enum><text display-inline="yes-display-inline">by inserting after paragraph (2) the
following:</text>
<quoted-block display-inline="no-display-inline" id="id91F171BFE4184AAA931B38BF9DB842CD" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="id26D77CAB49874627AD42CBDE0B7B9B9E"><enum>(3)</enum><header display-inline="yes-display-inline">Biennial registration renewal</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idE305D3D46DF340F0BA5A696609570FDC"><enum>(b)</enum><header display-inline="yes-display-inline">Suspension of registration</header>
<paragraph commented="no" display-inline="no-display-inline" id="id4B34FF6FB1344AD5AE41D80830C640F2"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 415 (21 U.S.C. 350d) is
amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id819478CAFE234E34A59C2E0BFDF973FA"><enum>(A)</enum><text display-inline="yes-display-inline">in subsection (a)(2), by inserting after
the first sentence the following: <quote>The registration shall contain an
assurance that the Secretary will be permitted to inspect such facility at the
times and in the manner permitted by this Act.</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idB96A4DA940814FDBBFB54A6CDD364232"><enum>(B)</enum><text display-inline="yes-display-inline">by redesignating subsections (b) and (c) as
subsections (c) and (d), respectively; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF9AD41800ED344B8A39BF21258B68892"><enum>(C)</enum><text display-inline="yes-display-inline">by inserting after subsection (a) the
following:</text>
<quoted-block display-inline="no-display-inline" id="id63E94B94503640879843B20AFE92F876" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id75022CA0B2694DFCAC487791D44E7051"><enum>(b)</enum><header display-inline="yes-display-inline">Suspension of registration</header>
<paragraph commented="no" display-inline="no-display-inline" id="idC6F3ABE0C54D44C5A03860E19B704761"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">If the Secretary determines that food
manufactured, processed, packed, received, 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 a facility—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idD548218885714F62AA9E0AF5D318AF36"><enum>(A)</enum><text display-inline="yes-display-inline">that created, caused, or was otherwise
responsible for such reasonable probability; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD48FF36F21324A53AC10E583581B352F"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="idA13E158090034457AAB6CBDA3BCDE1D0"><enum>(i)</enum><text display-inline="yes-display-inline">that knew of, or had reason to know of,
such reasonable probability; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idEAA721E6A7184F03981CF0688A4174F2" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">packed, received, or held such food.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9E62D2F452634FFA95D0A88988FD4DC0"><enum>(2)</enum><header display-inline="yes-display-inline">Hearing on suspension</header><text display-inline="yes-display-inline">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 business days
after the issuance of the order or such other time period, as agreed upon by
the Secretary and the registrant, on the actions required for reinstatement of
registration and why the registration that is subject to suspension should be
reinstated. The Secretary shall reinstate a registration if the Secretary
determines, based on evidence presented, that adequate grounds do not exist to
continue the suspension of the registration.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6D1C8DD93B4F44479DFD8A86FFEFF141"><enum>(3)</enum><header display-inline="yes-display-inline">Post-hearing corrective action plan;
vacating of order</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idA35B357D5DE24ED19FE403F1B365AF95"><enum>(A)</enum><header display-inline="yes-display-inline">Corrective action plan</header><text display-inline="yes-display-inline">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 not later than 14 days after the submission of the corrective
action plan or such other time period as determined by the Secretary.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA5800828B82C40D7885D0FA49CE76E7A"><enum>(B)</enum><header display-inline="yes-display-inline">Vacating of order</header><text display-inline="yes-display-inline">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
promptly vacate the order and reinstate the registration of the facility
subject to the order or modify the order, as appropriate.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id010F36D7442E4644A72A83965DBCCFE1"><enum>(4)</enum><header display-inline="yes-display-inline">Effect of suspension</header><text display-inline="yes-display-inline">If the registration of a facility is
suspended under this subsection, no person shall import or export food into the
United States from such facility, offer to import or export food into the
United States from such facility, or otherwise introduce food from such
facility into interstate or intrastate commerce in the United States.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDaba78d1f16a045f4ab326029035eece5"><enum>(5)</enum><header display-inline="yes-display-inline">Regulations</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id0A44176E18FC491DAD2083F7E189D795"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall promulgate regulations
to implement this subsection. The Secretary may promulgate such regulations on
an interim final basis.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8B0DB40D22484DE5BC0042C14C0C1B9E"><enum>(B)</enum><header display-inline="yes-display-inline">Registration requirement</header><text display-inline="yes-display-inline">The Secretary may require that registration
under this section be submitted in an electronic format. Such requirement may
not take effect before the date that is 5 years after the date of enactment of
the <short-title>FDA Food Safety Modernization
Act</short-title>.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id19CD3F8FD9534FF5A3BAB698A8841B10"><enum>(6)</enum><header display-inline="yes-display-inline">Application date</header><text display-inline="yes-display-inline">Facilities shall be subject to the
requirements of this subsection beginning on the earlier of—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idE32F5FFEF2AC42D1B093F0D25041189E"><enum>(A)</enum><text display-inline="yes-display-inline">the date on which the Secretary issues
regulations under paragraph (5); or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8D7ED095BFEE4E0FBAF9EFDFCFE51EFC"><enum>(B)</enum><text display-inline="yes-display-inline">180 days after the date of enactment of the
FDA Food Safety Modernization Act.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0CD11DA4D21D4581A14F5C25121ED349"><enum>(7)</enum><header display-inline="yes-display-inline">No delegation</header><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="idD413A9F1888B4A6C8FC12040081A2DE7"><enum>(2)</enum><header display-inline="yes-display-inline">Small entity compliance policy
guide</header><text display-inline="yes-display-inline">Not later than 180 days
after the issuance of the regulations promulgated under section 415(b)(5) of
the Federal Food, Drug, and Cosmetic Act (as added by this section), the
Secretary shall issue a small entity compliance policy guide setting forth in
plain language the requirements of such regulations to assist small entities in
complying with registration requirements and other activities required under
such section.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idDD7285E59C934F6DA497FD544C434639"><enum>(3)</enum><header display-inline="yes-display-inline">Imported food</header><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="IDdfdf5b390e414249ae35d3b03901e761"><enum>(c)</enum><header display-inline="yes-display-inline">Clarification of intent</header>
<paragraph commented="no" display-inline="no-display-inline" id="id83CFA4D3AE07434BA07FAEEFE6F9B759"><enum>(1)</enum><header display-inline="yes-display-inline">Retail food establishment</header><text display-inline="yes-display-inline">The Secretary shall amend the definition of
the term <quote>retail food establishment</quote> in section in 1.227(b)(11) of
title 21, Code of Federal Regulations to clarify that, in determining the
primary function of an establishment or a retail food establishment under such
section, the sale of food products directly to consumers by such establishment
and the sale of food directly to consumers by such retail food establishment
include—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idFC18117692A54E8CA3757A10F6DA6254"><enum>(A)</enum><text display-inline="yes-display-inline">the sale of such food products or food
directly to consumers by such establishment at a roadside stand or farmers’
market where such stand or market is located other than where the food was
manufactured or processed;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4C0B55FE4CE24E3CAF7FC688737F8218"><enum>(B)</enum><text display-inline="yes-display-inline">the sale and distribution of such food
through a community supported agriculture program; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idB5E56B946E2949A28152682BB88841FE"><enum>(C)</enum><text display-inline="yes-display-inline">the sale and distribution of such food at
any other such direct sales platform as determined by the Secretary.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id364B2A16FADC41B096ED080D495A3B8C"><enum>(2)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">For purposes of paragraph (1)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id7AEE04DA32B64EEEB8EBB04416E35C6D"><enum>(A)</enum><text display-inline="yes-display-inline">the term <term>community supported
agriculture program</term> has the same meaning given the term <quote>community
supported agriculture (CSA) program</quote> in section 249.2 of title 7, Code
of Federal Regulations (or any successor regulation); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8343457010494D47AA62130045990826"><enum>(B)</enum><text display-inline="yes-display-inline">the term <term>consumer</term> does not
include a business.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id136C9AA70B474BF4B673A26317EB8530"><enum>(d)</enum><header display-inline="yes-display-inline">Conforming amendments</header>
<paragraph commented="no" display-inline="no-display-inline" id="id0F309C998F4448C78BC1BBDE4FF28D3D"><enum>(1)</enum><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="id1A02CA27417A4B4EBFEDF6FAEA87C235"><enum>(2)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID7887d3f8190c42249b5870905490b880" section-type="subsequent-section"><enum>103.</enum><header display-inline="yes-display-inline">Hazard analysis and risk-based preventive
controls</header>
<subsection commented="no" display-inline="no-display-inline" id="IDdc602a7b64b14eb78436dd553b7e3ac5"><enum>(a)</enum><header display-inline="yes-display-inline">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="id0AE53CC452F849E082830DFC91DF1071" style="OLC">
<section commented="no" display-inline="no-display-inline" id="ID10f83818e1a54d47a338ceb82f5fb739" section-type="subsequent-section"><enum>418.</enum><header display-inline="yes-display-inline">Hazard analysis and risk-based preventive
controls</header>
<subsection commented="no" display-inline="no-display-inline" id="IDf4bc6fa9cf4942d4907eac8fe7f7b26a"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The 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
the occurrence of such hazards 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 commented="no" display-inline="no-display-inline" id="ID1654fe2d257542aebd4fd5db9ebc2327"><enum>(b)</enum><header display-inline="yes-display-inline">Hazard analysis</header><text display-inline="yes-display-inline">The owner, operator, or agent in charge of
a facility shall—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDff0537bbf09245189787c0363c93b9bd"><enum>(1)</enum><text display-inline="yes-display-inline">identify and evaluate known or reasonably
foreseeable hazards that may be associated with the facility, including—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id7B122B6B990B45BBAEA6FF35AB419530"><enum>(A)</enum><text display-inline="yes-display-inline">biological, chemical, physical, and
radiological hazards, natural toxins, pesticides, drug residues, decomposition,
parasites, allergens, and unapproved food and color additives; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8F68918BBF39498DB71D3C801019CF97"><enum>(B)</enum><text display-inline="yes-display-inline">hazards that occur naturally, or may be
unintentionally introduced; and</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idF3E1FBD977DE4838BC9837827D3F6516"><enum>(2)</enum><text display-inline="yes-display-inline">identify and evaluate hazards that may be
intentionally introduced, including by acts of terrorism; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID6a036b4cf0a54cababd63aff7ad1c2a3"><enum>(3)</enum><text display-inline="yes-display-inline">develop a written analysis of the
hazards.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDb720244c110a4f2fa1b93d01818dfea9"><enum>(c)</enum><header display-inline="yes-display-inline">Preventive controls</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="IDcc385b83cb064db688040c535831966c"><enum>(1)</enum><text display-inline="yes-display-inline">hazards identified in the hazard analysis
conducted under subsection (b)(1) will be significantly minimized or
prevented;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6C0C125CB22D4FF692DE9052997F8ED6"><enum>(2)</enum><text display-inline="yes-display-inline">any hazards identified in the hazard
analysis conducted under subsection (b)(2) will be significantly minimized or
prevented and addressed, consistent with section 420, as applicable; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID1caabd8d0b834b479403b28c54a17b8f"><enum>(3)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID7e1bb254b2c34b8ca844e65afdceb275"><enum>(d)</enum><header display-inline="yes-display-inline">Monitoring of effectiveness</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="IDa312122d42d542aabed2e860286dffce"><enum>(e)</enum><header display-inline="yes-display-inline">Corrective actions</header><text display-inline="yes-display-inline">The owner, operator, or agent in charge of
a facility shall establish procedures to ensure that, if the preventive
controls implemented under subsection (c) are not properly implemented or are
found to be ineffective—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id9497F19C6D1D4E248E790925749DC2FE"><enum>(1)</enum><text display-inline="yes-display-inline">appropriate action is taken to reduce the
likelihood of recurrence of the implementation failure;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id29100EEACC8345CCB8FF1506A9A1A37A"><enum>(2)</enum><text display-inline="yes-display-inline">all affected food is evaluated for safety;
and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6ADA39643A88423594E0EB02B325FAB8"><enum>(3)</enum><text display-inline="yes-display-inline">all affected food is prevented from
entering into commerce if the owner, operator or agent in charge of such
facility cannot ensure that the affected food is not adulterated under section
402 or misbranded under section 403(w).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDdc24e07dfd7d44d69235f2b9edc07f72"><enum>(f)</enum><header display-inline="yes-display-inline">Verification</header><text display-inline="yes-display-inline">The owner, operator, or agent in charge of
a facility shall verify that—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDc214c5c229004bd0a9c0d77784c9e03a"><enum>(1)</enum><text display-inline="yes-display-inline">the preventive controls implemented under
subsection (c) are adequate to control the hazards identified under subsection
(b);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID9bbed22131334737b10cdbc2a98074c8"><enum>(2)</enum><text display-inline="yes-display-inline">the owner, operator, or agent is conducting
monitoring in accordance with subsection (d);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID208171edb8c642ae948ef11480159fa7"><enum>(3)</enum><text display-inline="yes-display-inline">the owner, operator, or agent is making
appropriate decisions about corrective actions taken under subsection
(e);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id02C79E923FC54ED09636BFA056504A24"><enum>(4)</enum><text display-inline="yes-display-inline">the preventive controls implemented under
subsection (c) are effectively and significantly minimizing or preventing the
occurrence of identified hazards, including through the use of environmental
and product testing programs and other appropriate means; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDfda5c585bcba4220b471642dbdaf60db"><enum>(5)</enum><text display-inline="yes-display-inline">there is documented, periodic reanalysis of
the plan under subsection (i) to ensure that the plan is still relevant to the
raw materials, conditions and processes in the facility, and new and emerging
threats.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idDA97D5A5B3114CBFAE87C720EEB2C8AB"><enum>(g)</enum><header display-inline="yes-display-inline">Recordkeeping</header><text display-inline="yes-display-inline">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, the results of testing and
other appropriate means of verification under subsection (f)(4), instances when
corrective actions were implemented, and the efficacy of preventive controls
and corrective actions.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="IDa949313b539942b0a8d8813f69414795"><enum>(h)</enum><header display-inline="yes-display-inline">Written plan and
documentation</header><text display-inline="yes-display-inline">The 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 under subsection (c) to
address those hazards. Such written plan, together with the documentation
described in subsection (g), shall be made promptly available to a duly
authorized representative of the Secretary upon oral or written request.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID3490a963636b4b8c94d60981cd25bc56"><enum>(i)</enum><header display-inline="yes-display-inline">Requirement To reanalyze</header><text display-inline="yes-display-inline">The 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 operative. 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, including, as appropriate, results from the
Department of Homeland Security biological, chemical, radiological, or other
terrorism risk assessment.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID4e8ee5d5e4f24f0681d5277eadff7e10"><enum>(j)</enum><header display-inline="yes-display-inline">Exemption for seafood, juice, and low-acid
canned food facilities subject to HACCP</header>
<paragraph commented="no" display-inline="no-display-inline" id="idD1683A8188B849ED81C13D1C61577ED0"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">This section shall not apply to a facility
if the owner, operator, or agent in charge of such facility is required to
comply with, and is in compliance with, 1 of the following standards and
regulations with respect to such facility:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID8545c416fe2e463d9211dc24d1465e27"><enum>(A)</enum><text display-inline="yes-display-inline">The Seafood Hazard Analysis Critical
Control Points Program of the Food and Drug Administration.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDc44e5fc2ba7a44a2a0ef8a1b08803828"><enum>(B)</enum><text display-inline="yes-display-inline">The Juice Hazard Analysis Critical Control
Points Program of the Food and Drug Administration.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDbb064611e6624564b428c0f242a40710"><enum>(C)</enum><text display-inline="yes-display-inline">The Thermally Processed Low-Acid Foods
Packaged in Hermetically Sealed Containers standards of the Food and Drug
Administration (or any successor standards).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idEB7983CFF41A49D78C1BCF7F85EB069D"><enum>(2)</enum><header display-inline="yes-display-inline">Applicability</header><text display-inline="yes-display-inline">The exemption under paragraph (1)(C) shall
apply only with respect to microbiological hazards that are regulated under the
standards for Thermally Processed Low-Acid Foods Packaged in Hermetically
Sealed Containers under part 113 of chapter 21, Code of Federal Regulations (or
any successor regulations).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID1fa54abfc2b946fdb74cbe862b077ee6"><enum>(k)</enum><header display-inline="yes-display-inline">Exception for activities of facilities
subject to section 419</header><text display-inline="yes-display-inline">This
section shall not apply to activities of a facility that are subject to section
419.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id3DE36A2ECCB64F8DB3475E5A296B12CE"><enum>(l)</enum><header display-inline="yes-display-inline">Modified requirements for qualified
facilities</header>
<paragraph commented="no" display-inline="no-display-inline" id="id59001698E2F84D0493ECC3C9F466E498"><enum>(1)</enum><header display-inline="yes-display-inline">Qualified facilities</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id927AA9B48B684CE08A91B77A238B911C"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A facility is a qualified facility for
purposes of this subsection if the facility meets the conditions under
subparagraph (B) or (C).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idAE211ACFD6BE42DEB2EAE759D8F3EFD8"><enum>(B)</enum><header display-inline="yes-display-inline">Very small business</header><text display-inline="yes-display-inline">A facility is a qualified facility under
this subparagraph—</text>
<clause commented="no" display-inline="no-display-inline" id="idEF1A1DD5EF9A487B92E036B87739ABD6"><enum>(i)</enum><text display-inline="yes-display-inline">if the facility, including any subsidiary
or affiliate of the facility, is, collectively, a very small business (as
defined in the regulations promulgated under subsection (n)); and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id190E6A7C80444F96906182074ED31336"><enum>(ii)</enum><text display-inline="yes-display-inline">in the case where the facility is a
subsidiary or affiliate of an entity, if such subsidiaries or affiliates, are,
collectively, a very small business (as so defined).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idAC7F64D55DF44ADAB991A278053D7650"><enum>(C)</enum><header display-inline="yes-display-inline">Limited annual monetary value of
sales</header>
<clause commented="no" display-inline="no-display-inline" id="id35BAB54D8786402F8ED99E1A3D2E5A25"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A facility is a qualified facility under
this subparagraph if clause (ii) applies—</text>
<subclause commented="no" display-inline="no-display-inline" id="id2DAE720062F848F8BCE7925DBF48DDB0"><enum>(I)</enum><text display-inline="yes-display-inline">to the facility, including any subsidiary
or affiliate of the facility, collectively; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id34490F8058074E6F950018BDE3EB5EB0"><enum>(II)</enum><text display-inline="yes-display-inline">to the subsidiaries or affiliates,
collectively, of any entity of which the facility is a subsidiary or
affiliate.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="id8DE81C0847D043C38FA3C614B6A507CE"><enum>(ii)</enum><header display-inline="yes-display-inline">Average annual monetary value</header><text display-inline="yes-display-inline">This clause applies if—</text>
<subclause commented="no" display-inline="no-display-inline" id="idE4A1F88D08B54D34AC047F7F26397B35"><enum>(I)</enum><text display-inline="yes-display-inline">during the 3-year period preceding the
applicable calendar year, the average annual monetary value of the food
manufactured, processed, packed, or held at such facility (or the collective
average annual monetary value of such food at any subsidiary or affiliate, as
described in clause (i)) that is sold directly to qualified end-users during
such period exceeded the average annual monetary value of the food
manufactured, processed, packed, or held at such facility (or the collective
average annual monetary value of such food at any subsidiary or affiliate, as
so described) sold by such facility (or collectively by any such subsidiary or
affiliate) to all other purchasers during such period; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idEF16382B8D45410C82E8B953A9AA50BB"><enum>(II)</enum><text display-inline="yes-display-inline">the average annual monetary value of all
food sold by such facility (or the collective average annual monetary value of
such food sold by any subsidiary or affiliate, as described in clause (i))
during such period was less than $500,000, adjusted for inflation.</text>
</subclause></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5E74F490454D4653858F71626E63E7D9"><enum>(2)</enum><header display-inline="yes-display-inline">Exemption</header><text display-inline="yes-display-inline">A qualified facility—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id917AF57DFD304569B611539BA3DACAF1"><enum>(A)</enum><text display-inline="yes-display-inline">shall not be subject to the requirements
under subsections (a) through (i) and subsection (n) in an applicable calendar
year; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD3FEC2C290454935B40523DFC894480D"><enum>(B)</enum><text display-inline="yes-display-inline">shall submit to the Secretary—</text>
<clause commented="no" display-inline="no-display-inline" id="idF6920A3E545F43A99D4D1E67CA56FECD"><enum>(i)</enum><subclause commented="no" display-inline="yes-display-inline" id="id4C93C96C46D04C3BB277F5EAE4F870C3"><enum>(I)</enum><text display-inline="yes-display-inline">documentation that demonstrates that the
owner, operator, or agent in charge of the facility has identified potential
hazards associated with the food being produced, is implementing preventive
controls to address the hazards, and is monitoring the preventive controls to
ensure that such controls are effective; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id50AEFE2538D5494381427AEABB4D0F79" indent="up1"><enum>(II)</enum><text display-inline="yes-display-inline">documentation (which may include licenses,
inspection reports, certificates, permits, credentials, certification by an
appropriate agency (such as a State department of agriculture), or other
evidence of oversight), as specified by the Secretary, that the facility is in
compliance with State, local, county, or other applicable non-Federal food
safety law; and</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="id1F3D3F6A64374C2D9624BDE49DCCCB98"><enum>(ii)</enum><text display-inline="yes-display-inline">documentation, as specified by the
Secretary in a guidance document issued not later than 1 year after the date of
enactment of this section, that the facility is a qualified facility under
paragraph (1)(B) or (1)(C).</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC25DB6B26B114997940356BA28A5746F"><enum>(3)</enum><header display-inline="yes-display-inline">Withdrawal; rule of construction</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idA44D3972A93A447493787833ABD2F36B"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">In the event of an active investigation of
a foodborne illness outbreak that is directly linked to a qualified facility
subject to an exemption under this subsection, or if the Secretary determines
that it is necessary to protect the public health and prevent or mitigate a
foodborne illness outbreak based on conduct or conditions associated with a
qualified facility that are material to the safety of the food manufactured,
processed, packed, or held at such facility, the Secretary may withdraw the
exemption provided to such facility under this subsection.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idE565C3AD50A0420B8D225B6A18E028B9"><enum>(B)</enum><header display-inline="yes-display-inline">Rule of construction</header><text display-inline="yes-display-inline">Nothing in this subsection shall be
construed to expand or limit the inspection authority of the Secretary.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id657A8463E75F425AB7E2C8571258BA09"><enum>(4)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this subsection:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idC99E7AA595C64012B0836637B6527288"><enum>(A)</enum><header display-inline="yes-display-inline">Affiliate</header><text display-inline="yes-display-inline">The term <term>affiliate</term> means any
facility that controls, is controlled by, or is under common control with
another facility.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id22BBBE03A0714647A91F3EF9EB7E3309"><enum>(B)</enum><header display-inline="yes-display-inline">Qualified end-user</header><text display-inline="yes-display-inline">The term <term>qualified end-user</term>,
with respect to a food, means—</text>
<clause commented="no" display-inline="no-display-inline" id="id00BC8609CF6B46988A39794622BBC6FD"><enum>(i)</enum><text display-inline="yes-display-inline">the consumer of the food; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id3E9A32D1B1C2422BA724327CACAB64E4"><enum>(ii)</enum><text display-inline="yes-display-inline">a restaurant or retail food establishment
(as those terms are defined by the Secretary for purposes of section 415)
that—</text>
<subclause commented="no" display-inline="no-display-inline" id="idA75C6DBC374E4675812B3B961623C8FB"><enum>(I)</enum><text display-inline="yes-display-inline">is located—</text>
<item commented="no" display-inline="no-display-inline" id="id6DEFF989FB7341049376080B63E72717"><enum>(aa)</enum><text display-inline="yes-display-inline">in the same State as the qualified facility
that sold the food to such restaurant or establishment; or</text>
</item><item commented="no" display-inline="no-display-inline" id="idF96E7A335965414DA297246D4CE41E99"><enum>(bb)</enum><text display-inline="yes-display-inline">not more than 275 miles from such facility;
and</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="idE2C4E56D4EB64A13800FB1D9676E9315"><enum>(II)</enum><text display-inline="yes-display-inline">is purchasing the food for sale directly to
consumers at such restaurant or retail food establishment.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6C8F164A56504E1D87631633A75463FF"><enum>(C)</enum><header display-inline="yes-display-inline">Consumer</header><text display-inline="yes-display-inline">For purposes of subparagraph (B), the term
<term>consumer</term> does not include a business.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idC75C9DBF75584AEC98275692002829C8"><enum>(D)</enum><header display-inline="yes-display-inline">Subsidiary</header><text display-inline="yes-display-inline">The term <term>subsidiary</term> means any
company which is owned or controlled directly or indirectly by another
company.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idF723E8E50ADC4A60BA2CC1FC8468F55A"><enum>(5)</enum><header display-inline="yes-display-inline">Study</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id8AA4775B86154EA8AF5B10BF37813FA9"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary, in consultation with the
Secretary of Agriculture, shall conduct a study of the food processing sector
regulated by the Secretary to determine—</text>
<clause commented="no" display-inline="no-display-inline" id="ID4a194596fbbf4e38b2b54d21e6973690"><enum>(i)</enum><text display-inline="yes-display-inline">the distribution of food production by type
and size of operation, including monetary value of food sold;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDe6615d875df74c41a821424dd0870094"><enum>(ii)</enum><text display-inline="yes-display-inline">the proportion of food produced by each
type and size of operation;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id86FC038587D84F3DBAB78C56CE2283A3"><enum>(iii)</enum><text display-inline="yes-display-inline">the number and types of food facilities
co-located on farms, including the number and proportion by commodity and by
manufacturing or processing activity;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDd05e696ad0784f56a056e04b8d8a4004"><enum>(iv)</enum><text display-inline="yes-display-inline">the incidence of foodborne illness
originating from each size and type of operation and the type of food
facilities for which no reported or known hazard exists; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id279E919D95B842918A1F9D49BCF62B97"><enum>(v)</enum><text display-inline="yes-display-inline">the effect on foodborne illness risk
associated with commingling, processing, transporting, and storing food and raw
agricultural commodities, including differences in risk based on the scale and
duration of such activities.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id504A254A93AD43FE93A3DDD0204F81D0"><enum>(B)</enum><header display-inline="yes-display-inline">Size</header><text display-inline="yes-display-inline">The results of the study conducted under
subparagraph (A) shall include the information necessary to enable the
Secretary to define the terms <term>small business</term> and <term>very small
business</term>, for purposes of promulgating the regulation under subsection
(n). In defining such terms, the Secretary shall include consideration of
harvestable acres, income, the number of employees, and the volume of food
harvested.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idB5A9CFE676BF4BB1A27E2EB32DFD679A"><enum>(C)</enum><header display-inline="yes-display-inline">Submission of report</header><text display-inline="yes-display-inline">Not later than 18 months after the date of
enactment the FDA Food Safety Modernization Act, the Secretary shall submit to
Congress a report that describes the results of the study conducted under
subparagraph (A).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id84B46017865E4BE89D3B0B7C0A09045B"><enum>(6)</enum><header display-inline="yes-display-inline">No preemption</header><text display-inline="yes-display-inline">Nothing in this subsection preempts State,
local, county, or other non-Federal law regarding the safe production of food.
Compliance with this subsection shall not relieve any person from liability at
common law or under State statutory law.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC6B88F9031EF443EBCA72931A0597CB9"><enum>(7)</enum><header display-inline="yes-display-inline">Notification to consumers</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idF7F91953332C44E2A94F7605CDB24CC4"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A qualified facility that is exempt from
the requirements under subsections (a) through (i) and subsection (n) and does
not prepare documentation under paragraph (2)(B)(i)(I) shall—</text>
<clause commented="no" display-inline="no-display-inline" id="IDf0b02b6ca22e4d5f96140430ce60a136"><enum>(i)</enum><text display-inline="yes-display-inline">with respect to a food for which a food
packaging label is required by the Secretary under any other provision of this
Act, include prominently and conspicuously on such label the name and business
address of the facility where the food was manufactured or processed; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDdc9656b161aa4ce4bd4c56327878e0b3"><enum>(ii)</enum><text display-inline="yes-display-inline">with respect to a food for which a food
packaging label is not required by the Secretary under any other provisions of
this Act, prominently and conspicuously display, at the point of purchase, the
name and business address of the facility where the food was manufactured or
processed, on a label, poster, sign, placard, or documents delivered
contemporaneously with the food in the normal course of business, or, in the
case of Internet sales, in an electronic notice.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9178C4652BAB468E8B68867F3DD3B6B8"><enum>(B)</enum><header display-inline="yes-display-inline">No additional label</header><text display-inline="yes-display-inline">Subparagraph (A) does not provide authority
to the Secretary to require a label that is in addition to any label required
under any other provision of this Act.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id5E390506DC55409AA0F80BDB386CCE9F"><enum>(m)</enum><header display-inline="yes-display-inline">Authority with respect to certain
facilities</header><text display-inline="yes-display-inline">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 production of
food for animals other than man, the storage of raw agricultural commodities
(other than fruits and vegetables) intended for further distribution or
processing, or the storage of packaged foods that are not exposed to the
environment.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID8b61e094c9cb43e4805c9754dd92558c"><enum>(n)</enum><header display-inline="yes-display-inline">Regulations</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID613479f2ffd840c59c5a84955ecf4131"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 18 months after the date of
enactment of the <short-title>FDA Food Safety
Modernization Act</short-title>, the Secretary shall promulgate
regulations—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id3C4595C1DD5E4647B2D1ED3477024D5D"><enum>(A)</enum><text display-inline="yes-display-inline">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 this section; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id973D15747953414BBDCA4D06931BC202"><enum>(B)</enum><text display-inline="yes-display-inline">to define, for purposes of this section,
the terms <quote>small business</quote> and <quote>very small business</quote>,
taking into consideration the study described in subsection (l)(5).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2FAEF90C0D6B49F7B3D638F5D55E2148"><enum>(2)</enum><header display-inline="yes-display-inline">Coordination</header><text display-inline="yes-display-inline">In promulgating the regulations under
paragraph (1)(A), with regard to hazards that may be intentionally introduced,
including by acts of terrorism, the Secretary shall coordinate with the
Secretary of Homeland Security, as appropriate.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDad734a69d692474392ea2d8f9d23401b"><enum>(3)</enum><header display-inline="yes-display-inline">Content</header><text display-inline="yes-display-inline">The regulations promulgated under paragraph
(1)(A) shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDd358f4e07297491d9ed6699b458c014e"><enum>(A)</enum><text display-inline="yes-display-inline">provide sufficient flexibility to be
practicable for all sizes and types of facilities, including small businesses
such as a small food processing facility co-located on a farm;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDd1c515a56faa410380d97c50024a9daa"><enum>(B)</enum><text display-inline="yes-display-inline">comply with chapter 35 of title 44, United
States Code (commonly known as the <quote>Paperwork Reduction Act</quote>),
with special attention to minimizing the burden (as defined in section 3502(2)
of such Act) on the facility, and collection of information (as defined in
section 3502(3) of such Act), associated with such regulations;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDd2ef09ca92654824a9b84c3f4a6ce854"><enum>(C)</enum><text display-inline="yes-display-inline">acknowledge differences in risk and
minimize, as appropriate, the number of separate standards that apply to
separate foods; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID5b8110961daa4ce18891e2e56b15f935"><enum>(D)</enum><text display-inline="yes-display-inline">not require a facility to hire a consultant
or other third party to identify, implement, certify, or audit preventative
controls, except in the case of negotiated enforcement resolutions that may
require such a consultant or third party.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id45F0E581119E437DB34DDEF7A27896EA"><enum>(4)</enum><header display-inline="yes-display-inline">Rule of construction</header><text display-inline="yes-display-inline">Nothing in this subsection shall be
construed to provide the Secretary with the authority to prescribe specific
technologies, practices, or critical controls for an individual
facility.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID4bcaeb89f0ee413b8a7ad02e2a9b210e"><enum>(5)</enum><header display-inline="yes-display-inline">Review</header><text display-inline="yes-display-inline">In promulgating the regulations under
paragraph (1)(A), the Secretary shall review regulatory hazard analysis and
preventive control programs in existence on the date of enactment of the
<short-title>FDA Food Safety Modernization
Act</short-title>, including the Grade <quote>A</quote> Pasteurized Milk
Ordinance to ensure that such regulations are consistent, to the extent
practicable, with applicable domestic and internationally-recognized standards
in existence on such date.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID8f46a515994f494a846d62ef5fd24c22"><enum>(o)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">For purposes of this section:</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID79d04db3e94144578a3a683a31a5944b"><enum>(1)</enum><header display-inline="yes-display-inline">Critical control point</header><text display-inline="yes-display-inline">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 such hazard to an acceptable level.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID48859bc194a14c2ab392a20a5f63cee5"><enum>(2)</enum><header display-inline="yes-display-inline">Facility</header><text display-inline="yes-display-inline">The term <term>facility</term> means a
domestic facility or a foreign facility that is required to register under
section 415.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID25737397c1bb4bb38df832659da1e145"><enum>(3)</enum><header display-inline="yes-display-inline">Preventive controls</header><text display-inline="yes-display-inline">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 employ to significantly minimize or prevent
the hazards identified under the hazard analysis conducted under subsection (b)
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 commented="no" display-inline="no-display-inline" id="IDa92e83befbfb4a37bcf7d9fb5b365ad7"><enum>(A)</enum><text display-inline="yes-display-inline">Sanitation procedures for food contact
surfaces and utensils and food-contact surfaces of equipment.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID5dee94f397134a58828d379993bbacdf"><enum>(B)</enum><text display-inline="yes-display-inline">Supervisor, manager, and employee hygiene
training.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID174b26945b39450681b7dabb90dd8f29"><enum>(C)</enum><text display-inline="yes-display-inline">An environmental monitoring program to
verify the effectiveness of pathogen controls in processes where a food is
exposed to a potential contaminant in the environment.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID03bd60884cc24569b7daf85fcef8e056"><enum>(D)</enum><text display-inline="yes-display-inline">A food allergen control program.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDb484842d1b604c8c9df2c018b06f2e2d"><enum>(E)</enum><text display-inline="yes-display-inline">A recall plan.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID8f40ff7ff3d2467e8a12a84c958686aa"><enum>(F)</enum><text display-inline="yes-display-inline">Current Good Manufacturing Practices
(cGMPs) under part 110 of title 21, Code of Federal Regulations (or any
successor regulations).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDadf49d82e14e4bc4a3fb80722fa6b073"><enum>(G)</enum><text display-inline="yes-display-inline">Supplier verification activities that
relate to the safety of
food.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID4c5ad4a455e54de7891308682fbe8fb8"><enum>(b)</enum><header display-inline="yes-display-inline">Guidance document</header><text display-inline="yes-display-inline">The Secretary shall issue a guidance
document related to the regulations promulgated under subsection (b)(1) with
respect to the hazard analysis and preventive controls under section 418 of the
Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idD9360DA2D90D488DA01A01B123CB357B"><enum>(c)</enum><header display-inline="yes-display-inline">Rulemaking</header>
<paragraph commented="no" display-inline="no-display-inline" id="id4087470C4B5E4E96A185A58918E4708F"><enum>(1)</enum><header display-inline="yes-display-inline">Proposed rulemaking</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id7793DFA68EC342E588262BA74CF7C29C"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 9 months after the date of
enactment of this Act, the Secretary of Health and Human Services (referred to
in this subsection as the <quote>Secretary</quote>) shall publish a notice of
proposed rulemaking in the Federal Register to promulgate regulations with
respect to—</text>
<clause commented="no" display-inline="no-display-inline" id="ID7594c58f7876459ca0f7569b642ed2f9"><enum>(i)</enum><text display-inline="yes-display-inline">activities that constitute on-farm packing
or holding of food that is not grown, raised, or consumed on such farm or
another farm under the same ownership for purposes of section 415 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by this Act;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID4f0ffff8f5344686bd01e5310dcd5a66"><enum>(ii)</enum><text display-inline="yes-display-inline">activities that constitute on-farm
manufacturing or processing of food that is not consumed on that farm or on
another farm under common ownership for purposes of such section 415.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA430C207CF0F423FB507A74DFC81D068"><enum>(B)</enum><header display-inline="yes-display-inline">Clarification</header><text display-inline="yes-display-inline">The rulemaking described under subparagraph
(A) shall enhance the implementation of such section 415 and clarify the
activities that are included as part of the definition of the term
<quote>facility</quote> under such section 415. Nothing in this Act authorizes
the Secretary to modify the definition of the term <quote>facility</quote>
under such section.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7471F143015643B39FBA7389D8905E1F"><enum>(C)</enum><header display-inline="yes-display-inline">Science-based risk analysis</header><text display-inline="yes-display-inline">In promulgating regulations under
subparagraph (A), the Secretary shall conduct a science-based risk analysis
of—</text>
<clause commented="no" display-inline="no-display-inline" id="ID834256d0a1f14b79a0cdac4484bc1cbf"><enum>(i)</enum><text display-inline="yes-display-inline">specific types of on-farm packing or
holding of food that is not grown, raised, or consumed on such farm or another
farm under the same ownership, as such packing and holding relates to specific
foods; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID2183df21ff4847d2a9b9fdef0133cf23"><enum>(ii)</enum><text display-inline="yes-display-inline">specific on-farm manufacturing and
processing activities as such activities relate to specific foods that are not
consumed on that farm or on another farm under common ownership.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id58A55CF8CD73471A88D683CDCDE4F1D2"><enum>(D)</enum><header display-inline="yes-display-inline">Authority with respect to certain
facilities</header>
<clause commented="no" display-inline="no-display-inline" id="id9E1250BA05BE47F6AA720DE9A157EA0B"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">In promulgating the regulations under
subparagraph (A), the Secretary shall consider the results of the science-based
risk analysis conducted under subparagraph (C), and shall exempt certain
facilities from the requirements in section 418 of the Federal Food, Drug, and
Cosmetic Act (as added by this section), including hazard analysis and
preventive controls, and the mandatory inspection frequency in section 421 of
such Act (as added by section 201), or modify the requirements in such sections
418 or 421, as the Secretary determines appropriate, if such facilities are
engaged only in specific types of on-farm manufacturing, processing, packing,
or holding activities that the Secretary determines to be low risk involving
specific foods the Secretary determines to be low risk.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idF7993896BEF048B9BC7681F5447DC55D"><enum>(ii)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">The exemptions or modifications under
clause (i) shall not include an exemption from the requirement to register
under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d),
as amended by this Act, if applicable, and shall apply only to small businesses
and very small businesses, as defined in the regulation promulgated under
section 418(n) of the Federal Food, Drug, and Cosmetic Act (as added under
subsection (a)).</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id982E2322EE324AFA910B7F52FD4898DD"><enum>(2)</enum><header display-inline="yes-display-inline">Final regulations</header><text display-inline="yes-display-inline">Not later than 9 months after the close of
the comment period for the proposed rulemaking under paragraph (1), the
Secretary shall adopt final rules with respect to—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id61AC3F5F2FCA4BB8BD12F4E8F8828FEF"><enum>(A)</enum><text display-inline="yes-display-inline">activities that constitute on-farm packing
or holding of food that is not grown, raised, or consumed on such farm or
another farm under the same ownership for purposes of section 415 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by this
Act;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID564dc51a143a465880dd55ea4f921ec2"><enum>(B)</enum><text display-inline="yes-display-inline">activities that constitute on-farm
manufacturing or processing of food that is not consumed on that farm or on
another farm under common ownership for purposes of such section 415;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID86ee89ce12bb4933ad56efb3359888f0"><enum>(C)</enum><text display-inline="yes-display-inline">the requirements under sections 418 and 421
of the Federal Food, Drug, and Cosmetic Act, as added by this Act, from which
the Secretary may issue exemptions or modifications of the requirements for
certain types of facilities.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id9C45051C132346BFA65901FA80E5F317"><enum>(d)</enum><header display-inline="yes-display-inline">Small entity compliance policy
guide</header><text display-inline="yes-display-inline">Not later than 180 days
after the issuance of the regulations promulgated under subsection (n) of
section 418 of the Federal Food, Drug, and Cosmetic Act (as added by subsection
(a)), the Secretary shall issue a small entity compliance policy guide setting
forth in plain language the requirements of such section 418 and this section
to assist small entities in complying with the hazard analysis and other
activities required under such section 418 and this section.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID1538b86edb604372964fb590dd59df70"><enum>(e)</enum><header display-inline="yes-display-inline">Prohibited acts</header><text display-inline="yes-display-inline">Section 301 (21 U.S.C. 331) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id8A894FD2547D49EA83508F21D307CD79" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="IDec6265ade9cd4e55b502440b2cbc8279"><enum>(uu)</enum><text display-inline="yes-display-inline">The operation of a facility that
manufactures, 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
418.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID61be0a03247748a4840d15a9d459c7b5"><enum>(f)</enum><header display-inline="yes-display-inline">No effect on HACCP
authorities</header><text display-inline="yes-display-inline">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 Hazard
Analysis Critical Control programs and the Thermally Processed Low-Acid Foods
Packaged in Hermetically Sealed Containers standards.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="IDc4293dec455f4013a2de64586d5603b9"><enum>(g)</enum><header display-inline="yes-display-inline">Dietary supplements</header><text display-inline="yes-display-inline">Nothing in the amendments made by this
section shall apply to any facility with regard to the manufacturing,
processing, packing, or holding of a dietary supplement that is in compliance
with the requirements of sections 402(g)(2) and 761 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 342(g)(2), 379aa–1).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id20AD2BB5DA7C4B72BD7A77419BC7C587"><enum>(h)</enum><header display-inline="yes-display-inline">Updating guidance relating to fish and
fisheries products hazards and controls</header><text display-inline="yes-display-inline">The Secretary shall, not later than 180
days after the date of enactment of this Act, update the Fish and Fisheries
Products Hazards and Control Guidance to take into account advances in
technology that have occurred since the previous publication of such Guidance
by the Secretary.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idCA3ABBFE17E146288D4E6FFB6DCD9BCC"><enum>(i)</enum><header display-inline="yes-display-inline">Effective dates</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID0b73a29f0e764028847bcf66b29469c5"><enum>(1)</enum><header display-inline="yes-display-inline">General rule</header><text display-inline="yes-display-inline">The amendments made by this section shall
take effect 18 months after the date of enactment of this Act.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID83776905f79b4a6c9fca345909eb6d92"><enum>(2)</enum><header display-inline="yes-display-inline">Flexibility for small
businesses</header><text display-inline="yes-display-inline">Notwithstanding
paragraph (1)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID19b37c14a9dd4c68aef8adc4f009b87c"><enum>(A)</enum><text display-inline="yes-display-inline">the amendments made by this section shall
apply to a small business (as defined in the regulations promulgated under
section 418(n) of the Federal Food, Drug, and Cosmetic Act (as added by this
section)) beginning on the date that is 6 months after the effective date of
such regulations; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID44ee6ed9d4cb424c9ba44a0174c569d1"><enum>(B)</enum><text display-inline="yes-display-inline">the amendments made by this section shall
apply to a very small business (as defined in such regulations) beginning on
the date that is 18 months after the effective date of such regulations.</text>
</subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id31692B49ECD840838E4D40CB84DEA824" section-type="subsequent-section"><enum>104.</enum><header display-inline="yes-display-inline">Performance standards</header>
<subsection commented="no" display-inline="no-display-inline" id="id4BD3088105FA4D50BA515E401512510B"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall, in coordination with
the Secretary of Agriculture, not less frequently than every 2 years, review
and evaluate relevant health data and other relevant information, including
from toxicological and epidemiological studies and analyses, current Good
Manufacturing Practices issued by the Secretary relating to food, and relevant
recommendations of relevant advisory committees, including the Food Advisory
Committee, to determine the most significant foodborne contaminants.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idFF983FA7ACCD4801BF7E6196474BD66F"><enum>(b)</enum><header display-inline="yes-display-inline">Guidance documents and
regulations</header><text display-inline="yes-display-inline">Based on the
review and evaluation conducted under subsection (a), and when appropriate to
reduce the risk of serious illness or death to humans or animals or to prevent
adulteration of the food under section 402 of the Federal Food, Drug, or
Cosmetic Act (21 U.S.C. 342) or to prevent the spread by food of communicable
disease under section 361 of the Public Health Service Act (42 U.S.C. 264), the
Secretary shall issue contaminant-specific and science-based guidance
documents, including guidance documents regarding action levels, or
regulations. Such guidance, including guidance regarding action levels, or
regulations—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idF5A683EB3E2A40CEBF3E0FFFC0D755F2"><enum>(1)</enum><text display-inline="yes-display-inline">shall apply to products or product
classes;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id880272355BF24A86B5E64680FAC6FD48"><enum>(2)</enum><text display-inline="yes-display-inline">shall, where appropriate, differentiate
between food for human consumption and food intended for consumption by animals
other than humans; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8A12602279F7486696597220CECCC079"><enum>(3)</enum><text display-inline="yes-display-inline">shall not be written to be
facility-specific.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id1267695A2FB14B0899B5F77D5AD1DED8"><enum>(c)</enum><header display-inline="yes-display-inline">No duplication of efforts</header><text display-inline="yes-display-inline">The Secretary shall coordinate with the
Secretary of Agriculture to avoid issuing duplicative guidance on the same
contaminants.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idE9FD27CF210F4EB889EE545D6C49BB49"><enum>(d)</enum><header display-inline="yes-display-inline">Review</header><text display-inline="yes-display-inline">The Secretary shall periodically review and
revise, as appropriate, the guidance documents, including guidance documents
regarding action levels, or regulations promulgated under this section.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id6CE0A472590B4CEABAA9E17E4AC0955A" section-type="subsequent-section"><enum>105.</enum><header display-inline="yes-display-inline">Standards for produce safety</header>
<subsection commented="no" display-inline="no-display-inline" id="idBD6EF334448A4B39963E7656D2555B0C"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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="idD19EFD40881441C2B17AB51AE1BC16AC" style="OLC">
<section commented="no" display-inline="no-display-inline" id="ID21cc25b12fa441c282fbd48d5c61c4ad" section-type="subsequent-section"><enum>419.</enum><header display-inline="yes-display-inline">Standards for produce safety</header>
<subsection commented="no" display-inline="no-display-inline" id="IDbbba75a8d119438c9f7b141381613bee"><enum>(a)</enum><header display-inline="yes-display-inline">Proposed rulemaking</header>
<paragraph commented="no" display-inline="no-display-inline" id="id55CB513184164326AC61C1E633E94604"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id32A01F9DDF744967AE728B7D63C7A2EB"><enum>(A)</enum><header display-inline="yes-display-inline">Rulemaking</header><text display-inline="yes-display-inline">Not later than 1 year after the date of
enactment of the <short-title>FDA Food Safety
Modernization Act</short-title>, the Secretary, in coordination with the
Secretary of Agriculture and representatives of State departments of
agriculture (including with regard to the national organic program established
under the Organic Foods Production Act of 1990), and in consultation with the
Secretary of Homeland Security, 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, including specific mixes or
categories 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>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id20D6C5DC11E7428DA8618E9EA2B4ABB7"><enum>(B)</enum><header display-inline="yes-display-inline">Determination by Secretary</header><text display-inline="yes-display-inline">With respect to small businesses and very
small businesses (as such terms are defined in the regulation promulgated under
subparagraph (A)) that produce and harvest those types of fruits and vegetables
that are raw agricultural commodities that the Secretary has determined are low
risk and do not present a risk of serious adverse health consequences or death,
the Secretary may determine not to include production and harvesting of such
fruits and vegetables in such rulemaking, or may modify the applicable
requirements of regulations promulgated pursuant to this section.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB4091592CA6447F080EE121775F6164E"><enum>(2)</enum><header display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idCFC2995579AD4678A1FED6DD7ACB9A9F"><enum>(3)</enum><header display-inline="yes-display-inline">Content</header><text display-inline="yes-display-inline">The proposed rulemaking under paragraph (1)
shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id27900EA5C583426AAB73814BA2E692ED"><enum>(A)</enum><text display-inline="yes-display-inline">provide sufficient flexibility to be
applicable to various types of entities engaged in the production and
harvesting of fruits and vegetables that are raw agricultural commodities,
including small businesses and entities that sell directly to consumers, and be
appropriate to the scale and diversity of the production and harvesting of such
commodities;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id50C906108A324149AC3718E344D78CE6"><enum>(B)</enum><text display-inline="yes-display-inline">include, with respect to growing,
harvesting, sorting, packing, and storage operations, science-based minimum
standards related to soil amendments, hygiene, packaging, temperature controls,
animals in the growing area, and water;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id14AB290EF1214001B7971F0C3515E963"><enum>(C)</enum><text display-inline="yes-display-inline">consider hazards that occur naturally, may
be unintentionally introduced, or may be intentionally introduced, including by
acts of terrorism;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA1056FFC0F384F79BE9C80425A4F9FFF"><enum>(D)</enum><text display-inline="yes-display-inline">take into consideration, consistent with
ensuring enforceable public health protection, conservation and environmental
practice standards and policies established by Federal natural resource
conservation, wildlife conservation, and environmental agencies;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID889f0f21e8d54192ada3a057e56826d7"><enum>(E)</enum><text display-inline="yes-display-inline">in the case of production that is certified
organic, not include any requirements that conflict with or duplicate the
requirements of the national organic program established under the Organic
Foods Production Act of 1990, while providing the same level of public health
protection as the requirements under guidance documents, including guidance
documents regarding action levels, and regulations under the
<short-title>FDA Food Safety Modernization
Act</short-title>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0DD01F4D546440D9A68723C205BAAE1A"><enum>(F)</enum><text display-inline="yes-display-inline">define, for purposes of this section, the
terms <term>small business</term> and <term>very small business</term></text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6610C9AFF9F1419D8DC198D4C1256E60"><enum>(4)</enum><header display-inline="yes-display-inline">Prioritization</header><text display-inline="yes-display-inline">The Secretary shall prioritize the
implementation of the regulations under this section for specific fruits and
vegetables that are raw agricultural commodities based on known risks which may
include a history and severity of foodborne illness outbreaks.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID7bd0873aac54487487f877a3d080a237"><enum>(b)</enum><header display-inline="yes-display-inline">Final regulation</header>
<paragraph commented="no" display-inline="no-display-inline" id="id252EFAEB35B74ACDA64E8DA4B2764A1D"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 science-based
standards for those types of fruits and vegetables, including specific mixes or
categories of fruits or vegetables, that are raw agricultural commodities,
based on known safety risks, which may include a history of foodborne illness
outbreaks.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD4C36E9BF16C4074A2DDC4C4787D8B51"><enum>(2)</enum><header display-inline="yes-display-inline">Final regulation</header><text display-inline="yes-display-inline">The final regulation shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id054ADC4B5096445DA016FF6B2B02BD8F"><enum>(A)</enum><text display-inline="yes-display-inline">provide for coordination of education and
enforcement activities by State and local officials, as designated by the
Governors of the respective States or the appropriate elected State official as
recognized by State statute; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD705C6AFCD10452B82D28FE8B1F810FE"><enum>(B)</enum><text display-inline="yes-display-inline">include a description of the variance
process under subsection (c) and the types of permissible variances the
Secretary may grant.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idFC85D017C3F84151B7EBBE06C228060C"><enum>(3)</enum><header display-inline="yes-display-inline">Flexibility for small
businesses</header><text display-inline="yes-display-inline">Notwithstanding
paragraph (1)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDeeebc7df263444ef8dd3e3f652bc3471"><enum>(A)</enum><text display-inline="yes-display-inline">the regulations promulgated under this
section shall apply to a small business (as defined in the regulation
promulgated under subsection (a)(1)) after the date that is 1 year after the
effective date of the final regulation under paragraph (1); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDf5c4190ad0444fa0a101dada4f88c49a"><enum>(B)</enum><text display-inline="yes-display-inline">the regulations promulgated under this
section shall apply to a very small business (as defined in the regulation
promulgated under subsection (a)(1)) after the date that is 2 years after the
effective date of the final regulation under paragraph (1).</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID512dcf7d86e843e592c6d283952d2d92"><enum>(c)</enum><header display-inline="yes-display-inline">Criteria</header>
<paragraph commented="no" display-inline="no-display-inline" id="idD677CBA939404A18A2FBAB2995DB1370"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The regulations adopted under subsection
(b) shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID3661f7c0bcce4dba822b93cd24521169"><enum>(A)</enum><text display-inline="yes-display-inline">set forth those procedures, processes, and
practices that the Secretary determines to minimize the risk of serious adverse
health consequences or death, including procedures, processes, and practices
that 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, including specific mixes or
categories of fruits and vegetables, that are raw agricultural commodities and
to provide reasonable assurances that the produce is not adulterated under
section 402;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID883bac54708243b48f5fea3deace2d1d"><enum>(B)</enum><text display-inline="yes-display-inline">provide sufficient flexibility to be
practicable for all sizes and types of businesses, including small businesses
such as a small food processing facility co-located on a farm;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idB3B8780EF192428F9CFC0A2663D599A4"><enum>(C)</enum><text display-inline="yes-display-inline">comply with chapter 35 of title 44, United
States Code (commonly known as the <quote>Paperwork Reduction Act</quote>),
with special attention to minimizing the burden (as defined in section 3502(2)
of such Act) on the business, and collection of information (as defined in
section 3502(3) of such Act), associated with such regulations;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID511948d974674374bb36363d9569c12e"><enum>(D)</enum><text display-inline="yes-display-inline">acknowledge differences in risk and
minimize, as appropriate, the number of separate standards that apply to
separate foods; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDfe8ca22665e64a97be697ec0053fcc59"><enum>(E)</enum><text display-inline="yes-display-inline">not require a business to hire a consultant
or other third party to identify, implement, certify, compliance with these
procedures, processes, and practices, except in the case of negotiated
enforcement resolutions that may require such a consultant or third party;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID7d495898e36747f894f7954e5132f345"><enum>(F)</enum><text display-inline="yes-display-inline">permit States and foreign countries from
which food is imported into the United States to request from the Secretary
variances from the requirements of the regulations, subject to paragraph (2),
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 and to provide the same
level of public health protection as the requirements of the regulations
adopted under subsection (b).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2BBD771FCDD6499480D34F622E638A0D"><enum>(2)</enum><header display-inline="yes-display-inline">Variances</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idAC966B188FED4EDAA7CCFB798F40B150"><enum>(A)</enum><header display-inline="yes-display-inline">Requests for variances</header><text display-inline="yes-display-inline">A State or foreign country from which food
is imported into the United States may in writing request a variance from the
Secretary. Such request shall describe the variance requested and present
information demonstrating that the variance does not increase the likelihood
that the food for which the variance is requested will be adulterated under
section 402, and that the variance provides the same level of public health
protection as the requirements of the regulations adopted under subsection (b).
The Secretary shall review such requests in a reasonable timeframe.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF6C15A420A584A2B8AF780499AE92713"><enum>(B)</enum><header display-inline="yes-display-inline">Approval of variances</header><text display-inline="yes-display-inline">The Secretary may approve a variance in
whole or in part, as appropriate, and may specify the scope of applicability of
a variance to other similarly situated persons.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6E81B9B3AC3F4E9F91C868009707C802"><enum>(C)</enum><header display-inline="yes-display-inline">Denial of variances</header><text display-inline="yes-display-inline">The Secretary may deny a variance request
if the Secretary determines that such variance is not reasonably likely to
ensure that the food is not adulterated under section 402 and is not reasonably
likely to provide the same level of public health protection as the
requirements of the regulation adopted under subsection (b). The Secretary
shall notify the person requesting such variance of the reasons for the
denial.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id340BCE20471D44048C38C63052A189F5"><enum>(D)</enum><header display-inline="yes-display-inline">Modification or revocation of a
variance</header><text display-inline="yes-display-inline">The Secretary, after
notice and an opportunity for a hearing, may modify or revoke a variance if the
Secretary determines that such variance is not reasonably likely to ensure that
the food is not adulterated under section 402 and is not reasonably likely to
provide the same level of public health protection as the requirements of the
regulations adopted under subsection (b).</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID6a8e886e0dcd40fc8b518d9fc2b3ef27"><enum>(d)</enum><header display-inline="yes-display-inline">Enforcement</header><text display-inline="yes-display-inline">The Secretary may coordinate with the
Secretary of Agriculture and, as appropriate, 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 commented="no" display-inline="no-display-inline" id="ID2b15deadb0004258949c4b3058fe4e3c"><enum>(e)</enum><header display-inline="yes-display-inline">Guidance</header>
<paragraph commented="no" display-inline="no-display-inline" id="id1CFB8231844F4BDA9621103992E977B9"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 1 year after the date of
enactment of the FDA Food Safety Modernization Act, the Secretary shall
publish, after consultation with the Secretary of Agriculture, representatives
of State departments of agriculture, farmer representatives, and various types
of entities engaged in the production and harvesting or importing of fruits and
vegetables that are raw agricultural commodities, including small businesses,
updated good agricultural practices and guidance for the safe production and
harvesting of specific types of fresh produce under this section.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC76023B4B25542229E13CAF134949E87"><enum>(2)</enum><header display-inline="yes-display-inline">Public meetings</header><text display-inline="yes-display-inline">The Secretary shall conduct not fewer than
3 public meetings in diverse geographical areas of the United States as part of
an effort to conduct education and outreach regarding the guidance described in
paragraph (1) for persons in different regions who are involved in the
production and harvesting of fruits and vegetables that are raw agricultural
commodities, including persons that sell directly to consumers and farmer
representatives, and for importers of fruits and vegetables that are raw
agricultural commodities.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0792AE10F71E4E76939C7C8CDACB6B79"><enum>(3)</enum><header display-inline="yes-display-inline">Paperwork reduction</header><text display-inline="yes-display-inline">The Secretary shall ensure that any updated
guidance under this section will—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID25af02991ada4328a408a9fdba865ff2"><enum>(A)</enum><text display-inline="yes-display-inline">provide sufficient flexibility to be
practicable for all sizes and types of facilities, including small businesses
such as a small food processing facility co-located on a farm; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID8ee7118c1cff4a6a8a6c58b169d55f05"><enum>(B)</enum><text display-inline="yes-display-inline">acknowledge differences in risk and
minimize, as appropriate, the number of separate standards that apply to
separate foods.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id931321F0A20C46848C3CCCFBF422C789"><enum>(f)</enum><header display-inline="yes-display-inline">Exemption for direct farm
marketing</header>
<paragraph commented="no" display-inline="no-display-inline" id="id5E73CDEE03D5406B928EB9F535D6C5B2"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A farm shall be exempt from the
requirements under this section in a calendar year if—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idDE4051338AD04E9DA04C1F40281F9294"><enum>(A)</enum><text display-inline="yes-display-inline">during the previous 3-year period, the
average annual monetary value of the food sold by such farm directly to
qualified end-users during such period exceeded the average annual monetary
value of the food sold by such farm to all other buyers during such period;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id093FFE0757964332B2D3D12BA667AB86"><enum>(B)</enum><text display-inline="yes-display-inline">the average annual monetary value of all
food sold during such period was less than $500,000, adjusted for
inflation.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idDA3E8C5746FC4E85A6D73AE911A5D88A"><enum>(2)</enum><header display-inline="yes-display-inline">Notification to consumers</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idBDBA2765FB4F43D79DA35870F1C75AF2"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A farm that is exempt from the requirements
under this section shall—</text>
<clause commented="no" display-inline="no-display-inline" id="id9897D1E3B6C442B587D2836EB36C9B61"><enum>(i)</enum><text display-inline="yes-display-inline">with respect to a food for which a food
packaging label is required by the Secretary under any other provision of this
Act, include prominently and conspicuously on such label the name and business
address of the farm where the produce was grown; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id97C0FCF40DBE40D8973E1C7054336B11"><enum>(ii)</enum><text display-inline="yes-display-inline">with respect to a food for which a food
packaging label is not required by the Secretary under any other provision of
this Act, prominently and conspicuously display, at the point of purchase, the
name and business address of the farm where the produce was grown, on a label,
poster, sign, placard, or documents delivered contemporaneously with the food
in the normal course of business, or, in the case of Internet sales, in an
electronic notice.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id449369BACD8E4E49950800A3A86ED865"><enum>(B)</enum><header display-inline="yes-display-inline">No additional label</header><text display-inline="yes-display-inline">Subparagraph (A) does not provide authority
to the Secretary to require a label that is in addition to any label required
under any other provision of this Act.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idDB9482B44A5E4ED4B1095D5772E971DD"><enum>(3)</enum><header display-inline="yes-display-inline">Withdrawal; rule of construction</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idFFE9A82668B846A29B9A771C4E694CC8"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">In the event of an active investigation of
a foodborne illness outbreak that is directly linked to a farm subject to an
exemption under this subsection, or if the Secretary determines that it is
necessary to protect the public health and prevent or mitigate a foodborne
illness outbreak based on conduct or conditions associated with a farm that are
material to the safety of the food produced or harvested at such farm, the
Secretary may withdraw the exemption provided to such farm under this
subsection.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id367C93DAC37C49169DA52C9C41993D52"><enum>(B)</enum><header display-inline="yes-display-inline">Rule of construction</header><text display-inline="yes-display-inline">Nothing in this subsection shall be
construed to expand or limit the inspection authority of the Secretary.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idBD6DA75DF1CD425AA28FAD47AE1C7A96"><enum>(4)</enum><header display-inline="yes-display-inline">Definitions</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id3EAF5E6AA1B7466AB8676CC392555DA1"><enum>(A)</enum><header display-inline="yes-display-inline">Qualified end-user</header><text display-inline="yes-display-inline">In this subsection, the term
<term>qualified end-user</term>, with respect to a food means—</text>
<clause commented="no" display-inline="no-display-inline" id="id4CD548E86E964D45A04C7177F1167B16"><enum>(i)</enum><text display-inline="yes-display-inline">the consumer of the food; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idAD38A9D4FE3E42E9AEF2CCDB91DC3FFF"><enum>(ii)</enum><text display-inline="yes-display-inline">a restaurant or retail food establishment
(as those terms are defined by the Secretary for purposes of section 415) that
is located—</text>
<subclause commented="no" display-inline="no-display-inline" id="id6808D0FC915F4398851969E5FD3576BA"><enum>(I)</enum><text display-inline="yes-display-inline">in the same State as the farm that produced
the food; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id244B0757BB9E437FB8667290D584AFE0"><enum>(II)</enum><text display-inline="yes-display-inline">not more than 275 miles from such
farm.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idDA1DC30C807C4828A429C5CDEF17163E"><enum>(B)</enum><header display-inline="yes-display-inline">Consumer</header><text display-inline="yes-display-inline">For purposes of subparagraph (A), the term
<term>consumer</term> does not include a business.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0DF9B20FFAF64E918E534A6F24D646BE"><enum>(5)</enum><header display-inline="yes-display-inline">No preemption</header><text display-inline="yes-display-inline">Nothing in this subsection preempts State,
local, county, or other non-Federal law regarding the safe production,
harvesting, holding, transportation, and sale of fresh fruits and vegetables.
Compliance with this subsection shall not relieve any person from liability at
common law or under State statutory law.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID67bbe18030a34cb5a5404b225bf92a2f"><enum>(6)</enum><header display-inline="yes-display-inline">Limitation of effect</header><text display-inline="yes-display-inline">Nothing in this subsection shall prevent
the Secretary from exercising any authority granted in the other sections of
this Act.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id3B4DED1C5F5844189B57B3AD1870CFFD"><enum>(g)</enum><header display-inline="yes-display-inline">Clarification</header><text display-inline="yes-display-inline">This section shall not apply to produce
that is produced by an individual for personal consumption.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id02D60A96435F494C8EE9A513C84E63F5"><enum>(h)</enum><header display-inline="yes-display-inline">Exception for activities of facilities
subject to section 418</header><text display-inline="yes-display-inline">This
section shall not apply to activities of a facility that are subject to section
418.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id2837483FBDE34DFFA3ACEE44F2F03248"><enum>(b)</enum><header display-inline="yes-display-inline">Small entity compliance policy
guide</header><text display-inline="yes-display-inline">Not later than 180 days
after the issuance of regulations under section 419 of the Federal Food, Drug,
and Cosmetic Act (as added by subsection (a)), the Secretary of Health and
Human Services shall issue a small entity compliance policy guide setting forth
in plain language the requirements of such section 419 and to assist small
entities in complying with standards for safe production and harvesting and
other activities required under such section.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id25FDDA2971AA4024A6A55BF9A1758A03"><enum>(c)</enum><header display-inline="yes-display-inline">Prohibited acts</header><text display-inline="yes-display-inline">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="id5B5ED05DD86C4BE89848F30BB6B676F3" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id970EFF7E976B4528BDC95402265099D5"><enum>(vv)</enum><text display-inline="yes-display-inline">The failure to comply with the requirements
under section
419.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID4064e6fb6c6d4f6a9d86538aa8483385"><enum>(d)</enum><header display-inline="yes-display-inline">No effect on HACCP
authorities</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id9C587584196D43289EE50FD9C7F010AC" section-type="subsequent-section"><enum>106.</enum><header display-inline="yes-display-inline">Protection against intentional
adulteration</header>
<subsection commented="no" display-inline="no-display-inline" id="id25EDECF658584AC6B62092E9616B0967"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Chapter IV (21 U.S.C. 341 et seq.), as
amended by section 105, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idF610D25EC4C345B0B171C5BC81C00931" style="OLC">
<section commented="no" display-inline="no-display-inline" id="idB745EA98383444E788A721BCEDDD6069" section-type="subsequent-section"><enum>420.</enum><header display-inline="yes-display-inline">Protection against intentional
adulteration</header>
<subsection commented="no" display-inline="no-display-inline" id="id2A69AE54F2534DA0B1357EEA3568B533"><enum>(a)</enum><header display-inline="yes-display-inline">Determinations</header>
<paragraph commented="no" display-inline="no-display-inline" id="idACE15135EBD94BE48F49C84F4FB6A64A"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDf440002616694e398b77fa8e70236bc0"><enum>(A)</enum><text display-inline="yes-display-inline">conduct a vulnerability assessment of the
food system, including by consideration of the Department of Homeland Security
biological, chemical, radiological, or other terrorism risk assessments;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID389af1040d20466abc1beec3a546233a"><enum>(B)</enum><text display-inline="yes-display-inline">consider the best available understanding
of uncertainties, risks, costs, and benefits associated with guarding against
intentional adulteration of food at vulnerable points; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDdef6f39564554efaad53538a28d0af3c"><enum>(C)</enum><text display-inline="yes-display-inline">determine the types of science-based
mitigation strategies or measures that are necessary to protect against the
intentional adulteration of food.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA9DCE2455B60455AB475022A9194424E"><enum>(2)</enum><header display-inline="yes-display-inline">Limited distribution</header><text display-inline="yes-display-inline">In the interest of national security, the
Secretary, in consultation with the Secretary of Homeland Security, may
determine the time, manner, and form in which determinations made under
paragraph (1) are made publicly available.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDf299d5dc4a584fb78b9820ba275c68b4"><enum>(b)</enum><header display-inline="yes-display-inline">Regulations</header><text display-inline="yes-display-inline">Not later than 18 months after the date of
enactment of the FDA Food Safety Modernization Act, the Secretary, in
coordination with the Secretary of Homeland Security and in consultation with
the Secretary of Agriculture, shall promulgate regulations to protect against
the intentional adulteration of food subject to this Act. Such regulations
shall—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID9d1dfa9bb48a49e8a8f1a9405165adc1"><enum>(1)</enum><text display-inline="yes-display-inline">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; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID7bb2d5a39307438ab61a7bb3f2758da8"><enum>(2)</enum><text display-inline="yes-display-inline">specify appropriate science-based
mitigation strategies or measures to prepare and protect the food supply chain
at specific vulnerable points, as appropriate.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id7F966F58892A49738A95A0E742DCD4E1"><enum>(c)</enum><header display-inline="yes-display-inline">Applicability</header><text display-inline="yes-display-inline">Regulations promulgated under subsection
(b) shall apply only to food for which there is a high risk of intentional
contamination, as determined by the Secretary, in consultation with the
Secretary of Homeland Security, under subsection (a), that could cause serious
adverse health consequences or death to humans or animals and shall include
those foods—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDd5e926d7d4b148abbc57045ddbfe8b7d"><enum>(1)</enum><text display-inline="yes-display-inline">for which the Secretary has identified
clear vulnerabilities (including short shelf-life or susceptibility to
intentional contamination at critical control points); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDcf48a1b9fb0549c1a31790dc1bc6738b"><enum>(2)</enum><text display-inline="yes-display-inline">in bulk or batch form, prior to being
packaged for the final consumer.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id9C7A1632CD3749B5815A769EB22D38F0"><enum>(d)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">This section shall not apply to farms,
except for those that produce milk.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idC73476F547E34FE68FD2B0D9D9499342"><enum>(e)</enum><header display-inline="yes-display-inline">Definition</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idEA42F0BF8CE749E09FE830556BB5C476"><enum>(b)</enum><header display-inline="yes-display-inline">Guidance documents</header>
<paragraph commented="no" display-inline="no-display-inline" id="idDE3129A9071D41E2A3D6CD5F88D486C0"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human Services, 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 420 of the Federal
Food, Drug, and Cosmetic Act, as added by subsection (a).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id140D176803B740979FE8A0089482E81D"><enum>(2)</enum><header display-inline="yes-display-inline">Content</header><text display-inline="yes-display-inline">The guidance documents issued under
paragraph (1) shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDd5c33d1fedda4c0ba9a33f72d45098dd"><enum>(A)</enum><text display-inline="yes-display-inline">include a model assessment for a person to
use under subsection (b)(1) of section 420 of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDceac25ba1ecb415facccc3d0899e7453"><enum>(B)</enum><text display-inline="yes-display-inline">include examples of mitigation strategies
or measures described in subsection (b)(2) of such section; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID2a245421d91d48b1b18780f3b08ef389"><enum>(C)</enum><text display-inline="yes-display-inline">specify situations in which the examples of
mitigation strategies or measures described in subsection (b)(2) of such
section are appropriate.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idCD8392606A7743C9958B87846D452FB4"><enum>(3)</enum><header display-inline="yes-display-inline">Limited distribution</header><text display-inline="yes-display-inline">In the interest of national security, the
Secretary of Health and Human Services, in consultation with the Secretary of
Homeland Security, may determine the time, manner, and form 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" display-inline="no-display-inline" id="idE3B95BE35E624806A84FC86508C271F8"><enum>(c)</enum><header display-inline="yes-display-inline">Periodic review</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services
shall periodically review and, as appropriate, update the regulations under
section 420(b) of the Federal Food, Drug, and Cosmetic Act, as added by
subsection (a), and the guidance documents under subsection (b).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id9A37587506904B7C8F5EEE0E55E549A9"><enum>(d)</enum><header display-inline="yes-display-inline">Prohibited acts</header><text display-inline="yes-display-inline">Section 301 (21 U.S.C. 331 et seq.), as
amended by section 105, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id082BA90BFB494008B2C3E916193D4791" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="idDA6509CB6F4B4427B9E0652AD72955F5"><enum>(ww)</enum><text display-inline="yes-display-inline">The failure to comply with section
420.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" display-inline="no-display-inline" id="idF3EF014D09DB40998905EE805DF3D972" section-type="subsequent-section"><enum>107.</enum><header display-inline="yes-display-inline">Authority to collect fees</header>
<subsection commented="no" display-inline="no-display-inline" id="idF627B305F2EA4A03B79604B27CC078F8"><enum>(a)</enum><header display-inline="yes-display-inline">Fees for reinspection, recall, and
importation activities</header><text display-inline="yes-display-inline">Subchapter C of chapter VII (21 U.S.C. 379f
et seq.) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idF6BD4BF644F24D20A00873A9F8DC29DB" style="OLC">
<part commented="no" id="id0329FB28692B407B93932EF9896BFE43" level-type="subsequent"><enum>6</enum><header display-inline="yes-display-inline">Fees related to food</header>
<section commented="no" display-inline="no-display-inline" id="id1CBD82174EF4404B9A20B7E87638958F" section-type="subsequent-section"><enum>743.</enum><header display-inline="yes-display-inline">Authority to collect and use fees</header>
<subsection commented="no" display-inline="no-display-inline" id="ID2ade0bbfded44970b8fff239179aeec1"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID74dcb9428c5b4e6bbf93757b3df5859b"><enum>(1)</enum><header display-inline="yes-display-inline">Purpose and authority</header><text display-inline="yes-display-inline">For fiscal year 2010 and each subsequent
fiscal year, the Secretary shall, in accordance with this section, assess and
collect fees from—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idE9D7DC66554F4CA7AE61DD24EC327F7F"><enum>(A)</enum><text display-inline="yes-display-inline">the responsible party for each domestic
facility (as defined in section 415(b)) and the United States agent for each
foreign facility subject to a reinspection in such fiscal year, to cover
reinspection-related costs for such year;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9493E374869044BB8B255EB3E0D8B4FE"><enum>(B)</enum><text display-inline="yes-display-inline">the responsible party for a domestic
facility (as defined in section 415(b)) and an importer who does not comply
with a recall order under section 423 or under section 412(f) in such fiscal
year, to cover food recall activities associated with such order performed by
the Secretary, including technical assistance, follow-up effectiveness checks,
and public notifications, for such year;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id880D7A584AD4439DA25B5EFFE794AC68"><enum>(C)</enum><text display-inline="yes-display-inline">each importer participating in the
voluntary qualified importer program under section 806 in such year, to cover
the administrative costs of such program for such year; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idDAE0F3A8660E484CB07C3FCA105F08A1"><enum>(D)</enum><text display-inline="yes-display-inline">each importer subject to a reinspection in
such fiscal year, to cover reinspection-related costs for such year.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID6dea67e192af46d095f60e413a5ff999"><enum>(2)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">For purposes of this section—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID70106ecddd0a4ca6b4c12ca59fb6bfb3"><enum>(A)</enum><text display-inline="yes-display-inline">the term <term>reinspection</term>
means—</text>
<clause commented="no" display-inline="no-display-inline" id="idCAFA293665B6486D82A07E0C63D5378A"><enum>(i)</enum><text display-inline="yes-display-inline">with respect to domestic facilities (as
defined in section 415(b)), 1 or more inspections conducted under section 704
subsequent to an inspection conducted under such provision which identified
noncompliance materially related to a food safety requirement of this Act,
specifically to determine whether compliance has been achieved to the
Secretary's satisfaction; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idEEE3C1E157AE4FFAA3BD77B63A15BCC3"><enum>(ii)</enum><text display-inline="yes-display-inline">with respect to importers, 1 or more
examinations conducted under section 801 subsequent to an examination conducted
under such provision which identified noncompliance materially related to a
food safety requirement of this Act, specifically to determine whether
compliance has been achieved to the Secretary’s satisfaction;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID5c310aac55324bc7a6859301129e75fc"><enum>(B)</enum><text display-inline="yes-display-inline">the term <term>reinspection-related
costs</term> means all expenses, including administrative expenses, incurred in
connection with—</text>
<clause commented="no" display-inline="no-display-inline" id="ID3852992ef1af46348d5342a482b01297"><enum>(i)</enum><text display-inline="yes-display-inline">arranging, conducting, and evaluating the
results of reinspections; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID5cb1aace293a41e8bbe2e31e922b5e2e"><enum>(ii)</enum><text display-inline="yes-display-inline">assessing and collecting reinspection fees
under this section; and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idDFA56D006D0340DE8749A66BB69E9313"><enum>(C)</enum><text display-inline="yes-display-inline">the term <term>responsible party</term> has
the meaning given such term in section 417(a)(1).</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID941ce491c3124072928f94b3d960632c"><enum>(b)</enum><header display-inline="yes-display-inline">Establishment of fees</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDd0b6b2a719014e5794c75067e70cd945"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Subject to subsections (c) and (d), the
Secretary shall establish the fees to be collected under this section for each
fiscal year specified in subsection (a)(1), based on the methodology described
under paragraph (2), and shall publish such fees in a Federal Register notice
not later than 60 days before the start of each such year.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID0dca42947edf4324b739c0dbb141f98d"><enum>(2)</enum><header display-inline="yes-display-inline">Fee methodology</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idB9DC205860B443E9B5F988F7C879DA95"><enum>(A)</enum><header display-inline="yes-display-inline">Fees</header><text display-inline="yes-display-inline">Fees amounts established for
collection—</text>
<clause commented="no" display-inline="no-display-inline" id="id132388C1A2FB41CD9EAEFF24D818DD53"><enum>(i)</enum><text display-inline="yes-display-inline">under subparagraph (A) of subsection (a)(1)
for a fiscal year shall be based on the Secretary's estimate of 100 percent of
the costs of the reinspection-related activities (including by type or level of
reinspection activity, as the Secretary determines applicable) described in
such subparagraph (A) for such year;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idB71F0E4C236B4283A8EA106B69939480"><enum>(ii)</enum><text display-inline="yes-display-inline">under subparagraph (B) of subsection (a)(1)
for a fiscal year shall be based on the Secretary's estimate of 100 percent of
the costs of the activities described in such subparagraph (B) for such
year;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id9B230CDBF5894B6FBA5919444EFFE079"><enum>(iii)</enum><text display-inline="yes-display-inline">under subparagraph (C) of subsection (a)(1)
for a fiscal year shall be based on the Secretary's estimate of 100 percent of
the costs of the activities described in such subparagraph (C) for such year;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id903395FE487840CA8881C6B7E716F181"><enum>(iv)</enum><text display-inline="yes-display-inline">under subparagraph (D) of subsection (a)(1)
for a fiscal year shall be based on the Secretary's estimate of 100 percent of
the costs of the activities described in such subparagraph (D) for such
year.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA92DFBA415C649C99EC8324E42C94B59"><enum>(B)</enum><header display-inline="yes-display-inline">Other considerations</header>
<clause commented="no" display-inline="no-display-inline" id="idFB66FAA86C3A4B9D83E9044F7BBFC7DE"><enum>(i)</enum><header display-inline="yes-display-inline">Voluntary qualified importer
program</header>
<subclause commented="no" display-inline="no-display-inline" id="idB88A7E48B9A84911AB99C05583B6613C"><enum>(I)</enum><header display-inline="yes-display-inline">Participation</header><text display-inline="yes-display-inline">In establishing the fee amounts under
subparagraph (A)(iii) for a fiscal year, the Secretary shall provide for the
number of importers who have submitted to the Secretary a notice under section
806(c) informing the Secretary of the intent of such importer to participate in
the program under section 806 in such fiscal year.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id23637F55121E4117B09935C772BFCDDB"><enum>(II)</enum><header display-inline="yes-display-inline">Recoupment</header><text display-inline="yes-display-inline">In establishing the fee amounts under
subparagraph (A)(iii) for the first 5 fiscal years after the date of enactment
of this section, the Secretary shall include in such fee a reasonable surcharge
that provides a recoupment of the costs expended by the Secretary to establish
and implement the first year of the program under section 806.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="id2A805C6939AC45089EC8B46E6B28D1A9"><enum>(ii)</enum><header display-inline="yes-display-inline">Crediting of fees</header><text display-inline="yes-display-inline">In establishing the fee amounts under
subparagraph (A) for a fiscal year, the Secretary shall provide for the
crediting of fees from the previous year to the next year if the Secretary
overestimated the amount of fees needed to carry out such activities, and
consider the need to account for any adjustment of fees and such other factors
as the Secretary determines appropriate.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDec79bbe671244289b769a6403a6a147e"><enum>(iii)</enum><header display-inline="yes-display-inline">Published guidelines</header><text display-inline="yes-display-inline">Not later than 180 days after the date of
enactment of the <short-title>FDA Food Safety
Modernization Act</short-title>, the Secretary shall publish in the Federal
Register a proposed set of guidelines in consideration of the burden of fee
amounts on small business. Such consideration may include reduced fee amounts
for small businesses. The Secretary shall provide for a period of public
comment on such guidelines. The Secretary shall adjust the fee schedule for
small businesses subject to such fees only through notice and comment
rulemaking.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4A3F8D19AB0745C189099B3C2EB174ED"><enum>(3)</enum><header display-inline="yes-display-inline">Use of fees</header><text display-inline="yes-display-inline">The Secretary shall make all of the fees
collected pursuant to clause (i), (ii), (iii), and (iv) of paragraph (2)(A)
available solely to pay for the costs referred to in such clause (i), (ii),
(iii), and (iv) of paragraph (2)(A), respectively.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idD0E180ECCD88445EB74C0D4515372869"><enum>(c)</enum><header display-inline="yes-display-inline">Limitations</header>
<paragraph commented="no" display-inline="no-display-inline" id="id8242B714915C4CAD988E8F8496D85DF7"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Fees under subsection (a) shall be refunded
for a fiscal year beginning after fiscal year 2010 unless the amount of the
total appropriations for food safety activities at the Food and Drug
Administration for such fiscal year (excluding the amount of fees appropriated
for such fiscal year) is equal to or greater than the amount of appropriations
for food safety activities at the Food and Drug Administration for fiscal year
2009 (excluding the amount of fees appropriated for such fiscal year),
multiplied by the adjustment factor under paragraph (3).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID8e9129dc1fd84177b101cd6bd8ea3251"><enum>(2)</enum><header display-inline="yes-display-inline">Authority</header><text display-inline="yes-display-inline">If—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id0CD321417CE448C2A1877729DA33EC6F"><enum>(A)</enum><text display-inline="yes-display-inline">the Secretary does not assess fees under
subsection (a) for a portion of a fiscal year because paragraph (1) applies;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idB37F18DA1B014713AD59EB9EA97B4792"><enum>(B)</enum><text display-inline="yes-display-inline">at a later date in such fiscal year, such
paragraph (1) ceases to apply,</text>
</subparagraph><continuation-text commented="no" continuation-text-level="paragraph">the Secretary may assess and collect
such fees under subsection (a), without any modification to the rate of such
fees, notwithstanding the provisions of subsection (a) relating to the date
fees are to be paid.</continuation-text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDec9448a91f484f5383857253da9ffbc3"><enum>(3)</enum><header display-inline="yes-display-inline">Adjustment factor</header>
<subparagraph commented="no" display-inline="no-display-inline" id="IDa29d7cf2a36b4e3f9b0d84637a19e65c"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The adjustment factor described in
paragraph (1) shall be the total percentage change that occurred in the
Consumer Price Index for all urban consumers (all items; United States city
average) for the 12-month period ending June 30 preceding the fiscal year, but
in no case shall such adjustment factor be negative.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID9ddc5733033a44cab303599f22597978"><enum>(B)</enum><header display-inline="yes-display-inline">Compounded basis</header><text display-inline="yes-display-inline">The adjustment under subparagraph (A) made
each fiscal year shall be added on a compounded basis to the sum of all
adjustments made each fiscal year after fiscal year 2009.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id12C8F410A13542978A169E8E4CF93A92"><enum>(4)</enum><header display-inline="yes-display-inline">Limitation on amount of certain
fees</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idE18A5C4241AA4369A75F8EBF6EFCB409"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Notwithstanding any other provision of this
section and subject to subparagraph (B), the Secretary may not collect fees in
a fiscal year such that the amount collected—</text>
<clause commented="no" display-inline="no-display-inline" id="id66F20AAA2BD941CF8EAE6AFA55F2D673"><enum>(i)</enum><text display-inline="yes-display-inline">under subparagraph (B) of subsection (a)(1)
exceeds $20,000,000; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id032ADE8ABD9F405FA6A27B379812A1EA"><enum>(ii)</enum><text display-inline="yes-display-inline">under subparagraphs (A) and (D) of
subsection (a)(1) exceeds $25,000,000 combined.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id5CF5E8310FBC44B18CB171909777F50A"><enum>(B)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">If a domestic facility (as defined in
section 415(b)) or an importer becomes subject to a fee described in
subparagraph (A), (B), or (D) of subsection (a)(1) after the maximum amount of
fees has been collected by the Secretary under subparagraph (A), the Secretary
may collect a fee from such facility or importer.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID0ddff08b95e74f38bfbf717110c67c58"><enum>(d)</enum><header display-inline="yes-display-inline">Crediting and availability of
fees</header><text display-inline="yes-display-inline">Fees authorized under
subsection (a) shall be collected and available for obligation only to the
extent and in the amount provided in appropriations Acts. Such fees are
authorized to remain available until expended. Such sums as may be necessary
may be transferred from the Food and Drug Administration salaries and expenses
account without fiscal year limitation to such appropriation account for
salaries and expenses with such fiscal year limitation. The sums transferred
shall be available solely for the purpose of paying the operating expenses of
the Food and Drug Administration employees and contractors performing
activities associated with these food safety fees.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID87d95c9137304bc2975a51b3679bb8bb"><enum>(e)</enum><header display-inline="yes-display-inline">Collection of fees</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID5ee23c83aff446a0b54a80c799d8d0ee"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall specify in the Federal
Register notice described in subsection (b)(1) the time and manner in which
fees assessed under this section shall be collected.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID2326200b4c8a43b8aab506f695f08386"><enum>(2)</enum><header display-inline="yes-display-inline">Collection of unpaid fees</header><text display-inline="yes-display-inline">In any case where the Secretary does not
receive payment of a fee assessed under this section within 30 days after it is
due, such fee shall be treated as a claim of the United States Government
subject to provisions of subchapter II of chapter 37 of title 31, United States
Code.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID48105578fb92485b8cfed7597042ceb9"><enum>(f)</enum><header display-inline="yes-display-inline">Annual report to congress</header><text display-inline="yes-display-inline">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
Senate and the Committee on Energy and Commerce of the 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" display-inline="no-display-inline" id="id46B75624977043E6BEBEA75E609BE448"><enum>(g)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">For fiscal
year 2010 and each fiscal year thereafter, there is authorized to be
appropriated for fees under this section an amount equal to the total revenue
amount determined under subsection (b) for the fiscal year, as adjusted or
otherwise affected under the other provisions of this
section.</text>
</subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="IDe657f472126b40e489a10e48ff5a72c2"><enum>(b)</enum><header display-inline="yes-display-inline">Export certification fees for foods and
animal feed</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID2d09284882bc4de0898a30c12a416c9e"><enum>(1)</enum><header display-inline="yes-display-inline">Authority for export certifications for
food, including animal feed</header><text display-inline="yes-display-inline">Section 801(e)(4)(A) (21 U.S.C.
381(e)(4)(A)) is amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID44a46b2e0bdb45b49e3c982f7f6b2c00"><enum>(A)</enum><text display-inline="yes-display-inline">in the matter preceding clause (i), by
striking <quote>a drug</quote> and inserting <quote>a food,
drug</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID5627f85eba6b4353acc773c98bb46a87"><enum>(B)</enum><text display-inline="yes-display-inline">in clause (i) by striking <quote>exported
drug</quote> and inserting <quote>exported food, drug</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID51546575dd3846319b4a45e542fffebf"><enum>(C)</enum><text display-inline="yes-display-inline">in clause (ii) by striking <quote>the
drug</quote> each place it appears and inserting <quote>the food,
drug</quote>.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID0a368bd888944a348bf051c965193ad9"><enum>(2)</enum><header display-inline="yes-display-inline">Clarification of
certification</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID5b59284f66354b789da43ce8e1447fd3"><enum>(C)</enum><text display-inline="yes-display-inline">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="ID740786eb5e794560b9ee5b18a3ee78d6" section-type="subsequent-section"><enum>108.</enum><header display-inline="yes-display-inline">National agriculture and food defense
strategy</header>
<subsection commented="no" display-inline="no-display-inline" id="ID3fdad0c0747f492cbb40497d2b80d52e"><enum>(a)</enum><header display-inline="yes-display-inline">Development and submission of
strategy</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDf1a6175bdd1840e59b68b4d845069d83"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 transmit to the relevant committees of Congress,
and make publicly available on the Internet Web sites 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" display-inline="no-display-inline" id="ID46e5d6aede124781a88e357922526c65"><enum>(2)</enum><header display-inline="yes-display-inline">Implementation plan</header><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="ID54ddca1ff33f4096b3e707333fa185be"><enum>(3)</enum><header display-inline="yes-display-inline">Research</header><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="IDa40d23fc7f794da289d0dbbe494e876c"><enum>(4)</enum><header display-inline="yes-display-inline">Revisions</header><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="ID8d8eed3b4d2b4815b7779162fbadd90d"><enum>(5)</enum><header display-inline="yes-display-inline">Consistency with existing
plans</header><text display-inline="yes-display-inline">The strategy described
in paragraph (1) shall be consistent with—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID7ae4748973aa475b9c9e48b875606d52"><enum>(A)</enum><text display-inline="yes-display-inline">the National Incident Management
System;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID25a7a3a2cbc749a7b6d91769bd46abff"><enum>(B)</enum><text display-inline="yes-display-inline">the National Response Framework;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDcae2f0969de24c6296735c17d149325f"><enum>(C)</enum><text display-inline="yes-display-inline">the National Infrastructure Protection
Plan;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID9df330752c2f47919f0c21892c5af863"><enum>(D)</enum><text display-inline="yes-display-inline">the National Preparedness Goals; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID4333ef27e2a343539660b9d2dc48927e"><enum>(E)</enum><text display-inline="yes-display-inline">other relevant national strategies.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDa012864dbc99478cb1e4a67ccef3b9a6"><enum>(b)</enum><header display-inline="yes-display-inline">Components</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDa486181265c9468db2f8028e817ea8eb"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="ID748c57318c8144cc94c875df170d6bbb"><enum>(A)</enum><text display-inline="yes-display-inline">to achieve each goal described in paragraph
(2); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID38e84341bdb7424ba711d5c07330e96f"><enum>(B)</enum><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="idEF851418CCB145DEB84CE78A02BE4FC7"><enum>(2)</enum><header display-inline="yes-display-inline">Goals</header><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="ID7d7579ea9f564a1ea24acd5cd2711004"><enum>(A)</enum><header display-inline="yes-display-inline">Preparedness goal</header><text display-inline="yes-display-inline">Enhance the preparedness of the agriculture
and food system by—</text>
<clause commented="no" display-inline="no-display-inline" id="ID77158c63f04642ebb904ec5fa5faa9b5"><enum>(i)</enum><text display-inline="yes-display-inline">conducting vulnerability assessments of the
agriculture and food system;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID141170afb83244ab8c54f0b6b2afc649"><enum>(ii)</enum><text display-inline="yes-display-inline">mitigating vulnerabilities of the
system;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDcb18c750506a4fbfa26ac6109885f934"><enum>(iii)</enum><text display-inline="yes-display-inline">improving communication and training
relating to the system;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID6fbbe4aa8c7e458bb4c051c2e99b14c3"><enum>(iv)</enum><text display-inline="yes-display-inline">developing and conducting exercises to test
decontamination and disposal plans;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDbec59a42ab8447cea659acef755206ce"><enum>(v)</enum><text display-inline="yes-display-inline">developing modeling tools to improve event
consequence assessment and decision support; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID0f5fb116125647a6b52f3a5f3390ca29"><enum>(vi)</enum><text display-inline="yes-display-inline">preparing risk communication tools and
enhancing public awareness through outreach.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID1dd0b2c6510d4a8e82643b1a75a2ada4"><enum>(B)</enum><header display-inline="yes-display-inline">Detection
goal</header><text display-inline="yes-display-inline">Improve agriculture and
food system detection capabilities by—</text>
<clause commented="no" display-inline="no-display-inline" id="IDfcc0e29aa03e49aa82496b18ae1fa6e0"><enum>(i)</enum><text display-inline="yes-display-inline">identifying contamination in food products
at the earliest possible time; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID20aea91a196b493685886b101fb4b7d9"><enum>(ii)</enum><text display-inline="yes-display-inline">conducting surveillance to prevent the
spread of diseases.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID977ec6addbb04ca4be2221e5471242e9"><enum>(C)</enum><header display-inline="yes-display-inline">Emergency response goal</header><text display-inline="yes-display-inline">Ensure an efficient response to agriculture
and food emergencies by—</text>
<clause commented="no" display-inline="no-display-inline" id="ID401db45154ed4719922a4dd35c5da1c8"><enum>(i)</enum><text display-inline="yes-display-inline">immediately investigating animal disease
outbreaks and suspected food contamination;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID65aaf8b0aa0340b5874c0fcc9b6fca53"><enum>(ii)</enum><text display-inline="yes-display-inline">preventing additional human
illnesses;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDd2d1973d41ae4f1c8dc294191462ddba"><enum>(iii)</enum><text display-inline="yes-display-inline">organizing, training, and equipping animal,
plant, and food emergency response teams of—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID71a2b075d74847db9bc1e7a7ef3059a3"><enum>(I)</enum><text display-inline="yes-display-inline">the Federal Government; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID583b8450da184834a953c2de08f7577d"><enum>(II)</enum><text display-inline="yes-display-inline">State, local, and tribal
governments;</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDcb00921b321646b985c5fc815bbbbe04"><enum>(iv)</enum><text display-inline="yes-display-inline">designing, developing, and evaluating
training and exercises carried out under agriculture and food defense plans;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID1e1e3394ae9345ecbc099cbcc0ea990e"><enum>(v)</enum><text display-inline="yes-display-inline">ensuring consistent and organized risk
communication to the public by—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID24be60a9aefb498a8379a0a29ddc1cc4"><enum>(I)</enum><text display-inline="yes-display-inline">the Federal Government;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDab1befd860964cb7b0ae4c03af97a65b"><enum>(II)</enum><text display-inline="yes-display-inline">State, local, and tribal governments;
and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDbd2cfcced43042768b8064e8ac6ed96f"><enum>(III)</enum><text display-inline="yes-display-inline">the private sector.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDa73317ca123342fc9f6c2b9fbeee4ec9"><enum>(D)</enum><header display-inline="yes-display-inline">Recovery goal</header><text display-inline="yes-display-inline">Secure agriculture and food production
after an agriculture or food emergency by—</text>
<clause commented="no" display-inline="no-display-inline" id="ID21d890b3a2104144bbfb0bbbb13e5b11"><enum>(i)</enum><text display-inline="yes-display-inline">working with the private sector to develop
business recovery plans to rapidly resume agriculture, food production, and
international trade;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID4c4a9542b10f4e8ca0311fbd264ecc34"><enum>(ii)</enum><text display-inline="yes-display-inline">conducting exercises of the plans described
in subparagraph (C) with the goal of long-term recovery results;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID2696274949634dfb9a8816473b466e63"><enum>(iii)</enum><text display-inline="yes-display-inline">rapidly removing, and effectively disposing
of—</text>
<subclause commented="no" display-inline="no-display-inline" id="IDf087592b05ee4938bea8fb74893ee324"><enum>(I)</enum><text display-inline="yes-display-inline">contaminated agriculture and food products;
and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID4af1242719064effba22c9345c1b4e2e"><enum>(II)</enum><text display-inline="yes-display-inline">infected plants and animals; and</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID553b4624bf3044ae88102f21cae26a3b"><enum>(iv)</enum><text display-inline="yes-display-inline">decontaminating and restoring areas
affected by an agriculture or food emergency.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idEA267207857E4D0B874EFCCC6A6D9C47"><enum>(3)</enum><header display-inline="yes-display-inline">Evaluation</header><text display-inline="yes-display-inline">The Secretary, in coordination with the
Secretary of Agriculture and the Secretary of Homeland Security, shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDd73991613f5248a887487cdff03b1576"><enum>(A)</enum><text display-inline="yes-display-inline">develop metrics to measure progress for the
evaluation process described in paragraph (1)(B); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID14782779409d4879b7840982f371a218"><enum>(B)</enum><text display-inline="yes-display-inline">report on the progress measured in
subparagraph (A) as part of the National Agriculture and Food Defense strategy
described in subsection (a)(1).</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idC3001F4134A149E9B2B6A49A7DE70952"><enum>(c)</enum><header display-inline="yes-display-inline">Limited distribution</header><text display-inline="yes-display-inline">In the interest of national security, the
Secretary of Health and Human Services and the Secretary of Agriculture, in
coordination with the Secretary of Homeland Security, may determine the manner
and format in which the National Agriculture and Food Defense strategy
established under this section is made publicly available on the Internet Web
sites of the Department of Health and Human Services, the Department of
Homeland Security, and the Department of Agriculture, as described in
subsection (a)(1).</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="IDaac34e62c7d94c60ade597b765c9450a" section-type="subsequent-section"><enum>109.</enum><header display-inline="yes-display-inline">Food and Agriculture Coordinating
Councils</header><text display-inline="no-display-inline">The Secretary of
Homeland Security, in coordination 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" display-inline="no-display-inline" id="IDe7b263255e964a2f88d66197782fe067"><enum>(1)</enum><text display-inline="yes-display-inline">facilitating partnerships between public
and private entities to help coordinate and enhance the protection of the
agriculture and food system of the United States;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDe577b48cf4d542a2b8590ab896b10e0f"><enum>(2)</enum><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="ID8d269133f9bb4e7582362e81e33abe56"><enum>(3)</enum><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="IDedbdd89d61a54815851ced4169e530d7"><enum>(4)</enum><text display-inline="yes-display-inline">recommending methods by which to protect
the economy and the public health of the United States from the effects
of—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDe3d4a3b93dc14626b181d1d429b717f4"><enum>(A)</enum><text display-inline="yes-display-inline">animal or plant disease outbreaks;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID62057b9f953047b7bb65c31e8bdc086b"><enum>(B)</enum><text display-inline="yes-display-inline">food contamination; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDe53635a393064898816ca11b133815c5"><enum>(C)</enum><text display-inline="yes-display-inline">natural disasters affecting agriculture and
food.</text>
</subparagraph></paragraph></section><section commented="no" display-inline="no-display-inline" id="ID82100521b1e642e2a6022c0e0ef05612" section-type="subsequent-section"><enum>110.</enum><header display-inline="yes-display-inline">Building domestic capacity</header>
<subsection commented="no" display-inline="no-display-inline" id="IDa58fa3ba05274b88a6f2e445460ccb3f"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header>
<paragraph commented="no" display-inline="no-display-inline" id="id91C81911D466401C8E4BABE29E4FDF54"><enum>(1)</enum><header display-inline="yes-display-inline">Initial
report</header><text display-inline="yes-display-inline">The Secretary, in
coordination with the Secretary of Agriculture and the Secretary of Homeland
Security, 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 supply chain security of
food and to prevent outbreaks of foodborne illness and other food-related
hazards that can be addressed through preventive activities. Such report shall
include a description of the following:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID0c1e7a9fc9c04144839f8ff0900e4a99"><enum>(A)</enum><text display-inline="yes-display-inline">Analysis of the need for further
regulations or guidance to industry.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID9f387737034647a2ba07f2e76bc64725"><enum>(B)</enum><text display-inline="yes-display-inline">Outreach to food industry sectors,
including through the Food and Agriculture Coordinating Councils referred to in
section 109, 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 commented="no" display-inline="no-display-inline" id="IDaebdb91b172847ff9d45133a4a52e344"><enum>(C)</enum><text display-inline="yes-display-inline">Systems to ensure the prompt distribution
to the food industry of information and technical assistance concerning
preventive strategies.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDc744cc31276f4bf88e32dcbe5831db4e"><enum>(D)</enum><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="id45C8DF0A5C484D9A9F3CEB6978087F54"><enum>(E)</enum><text display-inline="yes-display-inline">Surveillance systems and laboratory
networks to rapidly detect and respond to foodborne illness outbreaks and other
food-related hazards, including how such systems and networks are
integrated.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idB4C6877AF77D4C608FCD417F1A4E0DD0"><enum>(F)</enum><text display-inline="yes-display-inline">Outreach, education, and training provided
to States and local governments to build State and local food safety and food
defense capabilities, including progress implementing strategies developed
under sections 108 and 205.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDb49a28918baa4686bb3a3d0e6f424aac"><enum>(G)</enum><text display-inline="yes-display-inline">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><subparagraph commented="no" display-inline="no-display-inline" id="id8EB2265C7A354FC885546FA1F284FAE3"><enum>(H)</enum><text display-inline="yes-display-inline">The impact of requirements under this Act
(including amendments made by this Act) on certified organic farms and
facilities (as defined in section 415 (21 U.S.C. 350d).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id79B3955E94E04554BB6511A32780FD08"><enum>(I)</enum><text display-inline="yes-display-inline">Specific efforts taken pursuant to the
agreements authorized under section 421(c) of the Federal Food, Drug, and
Cosmetic Act (as added by section 201), together with, as necessary, a
description of any additional authorities necessary to improve seafood
safety.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id87631C0DDC254E44ABF1AF4D59003AE5"><enum>(2)</enum><header display-inline="yes-display-inline">Biennial reports</header><text display-inline="yes-display-inline">On a biennial basis following the
submission of the report under paragraph (1), the Secretary shall submit to
Congress a report that—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id032E6D42720D46F8B55D25A2BF942161"><enum>(A)</enum><text display-inline="yes-display-inline">reviews previous food safety programs and
practices;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idCB8249B673F1422881A8B1D4DC31F054"><enum>(B)</enum><text display-inline="yes-display-inline">outlines the success of those programs and
practices;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id552729E286C94FEB8DC9979061957529"><enum>(C)</enum><text display-inline="yes-display-inline">identifies future programs and practices;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id52224B2CB72A48849C039116AA277375"><enum>(D)</enum><text display-inline="yes-display-inline">includes information related to any matter
described in subparagraphs (A) through (H) of paragraph (1), as
necessary.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID008d5ad791c24d2db407c5738d18502b"><enum>(b)</enum><header display-inline="yes-display-inline">Risk-based activities</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID4a0156cc49fa427298bb01bc5ce96605"><enum>(c)</enum><header display-inline="yes-display-inline">Capability for laboratory analyses;
research</header><text display-inline="yes-display-inline">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 commercially-available
techniques that can be employed at ports of entry and by Food Emergency
Response Network laboratories, and to provide for well-equipped and staffed
laboratory facilities and progress toward laboratory accreditation under
section 422 of the Federal Food, Drug, and Cosmetic Act (as added by section
202).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="IDdd6bbd316cef45ac954981b87cc42406"><enum>(d)</enum><header display-inline="yes-display-inline">Information technology</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID08037932e9fc45b28b8f4377463e7ed8"><enum>(e)</enum><header display-inline="yes-display-inline">Automated risk assessment</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="IDdfe8fbe0546f439584d0e20470f0f754"><enum>(f)</enum><header display-inline="yes-display-inline">Traceback and surveillance
report</header><text display-inline="yes-display-inline">The Secretary shall
include in the report developed under subsection (a)(1) an analysis of the Food
and Drug Administration’s performance in foodborne 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)
(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, industry, and State and local
governments, as such communication and coordination relates to outbreak
identification and traceback.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idE71955CC215A4242B3FA2EAC474F1669"><enum>(g)</enum><header display-inline="yes-display-inline">Biennial food safety and food defense
research plan</header><text display-inline="yes-display-inline">The Secretary,
the Secretary of Agriculture, and the Secretary of Homeland Security 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
foodborne 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 subsequent 2-year period.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id033D60FAE1D3422682B5D02873996359"><enum>(h)</enum><header display-inline="yes-display-inline">Effectiveness of programs administered by
the Department of Health and Human Services</header>
<paragraph commented="no" display-inline="no-display-inline" id="id5D4CF092D5394DEDB2D0999F73539ABD"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">To determine whether existing Federal
programs administered by the Department of Health and Human Services are
effective in achieving the stated goals of such programs, the Secretary shall,
beginning not later than 1 year after the date of enactment of this Act—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID8838430003054d60b569f370959d6188"><enum>(A)</enum><text display-inline="yes-display-inline">conduct an annual evaluation of each
program of such Department to determine the effectiveness of each such program
in achieving legislated intent, purposes, and objectives; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID154ea708f5784f3fb5324c5ad1914f4d"><enum>(B)</enum><text display-inline="yes-display-inline">submit to Congress a report concerning such
evaluation.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1B7D868FC7474D23AA2026571EF184C3"><enum>(2)</enum><header display-inline="yes-display-inline">Content</header><text display-inline="yes-display-inline">The report described under paragraph (1)(B)
shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDa3532e6a642342a790808d6f70f2b611"><enum>(A)</enum><text display-inline="yes-display-inline">include conclusions concerning the reasons
that such existing programs have proven successful or not successful and what
factors contributed to such conclusions;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDbc8e0d1bdc64414d8705143b9629e74b"><enum>(B)</enum><text display-inline="yes-display-inline">include recommendations for consolidation
and elimination to reduce duplication and inefficiencies in such programs at
such Department as identified during the evaluation conduct under this
subsection; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID1771f51731fe4644aff46214b44e20b2"><enum>(C)</enum><text display-inline="yes-display-inline">be made publicly available in a publication
entitled <quote>Guide to the U.S. Department of Health and Human Services
Programs</quote>.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idF9F18FBC69FA40C2A345AD9F062C8AB6"><enum>(i)</enum><header display-inline="yes-display-inline">Unique identification numbers</header>
<paragraph commented="no" display-inline="no-display-inline" id="id091C7B34FF694051B4BE6245898D58B6"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 1 year after the date of
enactment of this Act, the Secretary, acting through the Commissioner of Food
and Drugs, shall conduct a study regarding the need for, and challenges
associated with, development and implementation of a program that requires a
unique identification number for each food facility registered with the
Secretary and, as appropriate, each broker that imports food into the United
States. Such study shall include an evaluation of the costs associated with
development and implementation of such a system, and make recommendations about
what new authorities, if any, would be necessary to develop and implement such
a system.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0E98BB6F9CA44CC09998EF01387B50E8"><enum>(2)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">Not later than 15 months after the date of
enactment of this Act, the Secretary shall submit to Congress a report that
describes the findings of the study conducted under paragraph (1) and that
includes any recommendations determined appropriate by the Secretary.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="idEE913B2AB3C745D9A21F4B11102E76A9" section-type="subsequent-section"><enum>111.</enum><header display-inline="yes-display-inline">Sanitary transportation of food</header>
<subsection commented="no" display-inline="no-display-inline" id="idAFF5116A98AA455FB0D03750FE7124FF"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 18 months 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>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idCA25495C09BF43D281F2ED1F9B1DA345"><enum>(b)</enum><header display-inline="yes-display-inline">Food transportation study</header><text display-inline="yes-display-inline">The Secretary, acting through the
Commissioner of Food and Drugs, shall conduct a study of the transportation of
food for consumption in the United States, including transportation by air,
that includes an examination of the unique needs of rural and frontier areas
with regard to the delivery of safe food.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id38246E92A0AB489490260956203DD9F3" section-type="subsequent-section"><enum>112.</enum><header display-inline="yes-display-inline">Food allergy and anaphylaxis
management</header>
<subsection commented="no" display-inline="no-display-inline" id="id671DA7259738449CAD3C1ABCE6E4D81B"><enum>(a)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this section:</text>
<paragraph commented="no" display-inline="no-display-inline" id="id7078493C57AC42099EB736635C13FC9B"><enum>(1)</enum><header display-inline="yes-display-inline">Early childhood education
program</header><text display-inline="yes-display-inline">The term <term>early
childhood education program</term> means—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id9CBDB39A32D74076A477CE643A030E3E"><enum>(A)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id4217D3F5AD79402CB04F65374FC2AD9D"><enum>(B)</enum><text display-inline="yes-display-inline">a State licensed or regulated child care
program or school; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3E0C0B7EB2844239B887494C75C111E5"><enum>(C)</enum><text display-inline="yes-display-inline">a State prekindergarten program that serves
children from birth through kindergarten.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id06BEC680F3AF4348AE7959A1A63AEF9F"><enum>(2)</enum><header display-inline="yes-display-inline">ESEA definitions</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id836933F0B87447EBB1FAA4B7B75526E2"><enum>(3)</enum><header display-inline="yes-display-inline">School</header><text display-inline="yes-display-inline">The term <term>school</term> includes
public—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id9D644BEB46A9456586BEB8E400406742"><enum>(A)</enum><text display-inline="yes-display-inline">kindergartens;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF58F9EB5879F4C9B8DCA8665BF7A95F2"><enum>(B)</enum><text display-inline="yes-display-inline">elementary schools; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6F03C4F2A85346959DA95A14B041D801"><enum>(C)</enum><text display-inline="yes-display-inline">secondary schools.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idF60306D73C81415CB2C6BA6990E5913C"><enum>(4)</enum><header display-inline="yes-display-inline">Secretary</header><text display-inline="yes-display-inline">The term <term>Secretary</term> means the
Secretary of Health and Human Services.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id8E051F5CFA824912A6DBD3D5CFF89BD7"><enum>(b)</enum><header display-inline="yes-display-inline">Establishment of voluntary food allergy and
anaphylaxis management guidelines</header>
<paragraph commented="no" display-inline="no-display-inline" id="idC1E93957A90642FBBC5984BC5902A5B8"><enum>(1)</enum><header display-inline="yes-display-inline">Establishment</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id66214E43D1A542AC95894418F98B2D78"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id452B4C04D17247E18326FE3A7DF2782F"><enum>(i)</enum><text display-inline="yes-display-inline">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="id120F719A8E0F4FDEBE25BEEF7D6CE4CD"><enum>(ii)</enum><text display-inline="yes-display-inline">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="id7EF321EFBC5F45B99879175B81ECD23D"><enum>(B)</enum><header display-inline="yes-display-inline">Applicability of FERPA</header><text display-inline="yes-display-inline">Each plan described in subparagraph (A)
that is developed for an individual shall be considered an education record for
the purpose of section 444 of the General Education Provisions Act (commonly
referred to as the <quote>Family Educational Rights and Privacy Act of
1974</quote>) (20 U.S.C. 1232g).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idFFF9BA4489E1463E8A774696990D7593"><enum>(2)</enum><header display-inline="yes-display-inline">Contents</header><text display-inline="yes-display-inline">The voluntary guidelines developed by the
Secretary under paragraph (1) shall address each of the following and may be
updated as the Secretary determines necessary:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id90E7E20ABC524E35A6B891D32E812ABD"><enum>(A)</enum><text display-inline="yes-display-inline">Parental obligation to provide the school
or early childhood education program, prior to the start of every school year,
with—</text>
<clause commented="no" display-inline="no-display-inline" id="id2F5FA109CB6C4DE0A886332F4C81E818"><enum>(i)</enum><text display-inline="yes-display-inline">documentation from their child’s physician
or nurse—</text>
<subclause commented="no" display-inline="no-display-inline" id="idD212A079BCDE4EE8AE84E9FC3B0237F1"><enum>(I)</enum><text display-inline="yes-display-inline">supporting a diagnosis of food allergy, and
any risk of anaphylaxis, if applicable;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idE556CB03DFE24C199AE489D071402D96"><enum>(II)</enum><text display-inline="yes-display-inline">identifying any food to which the child is
allergic;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id54A6657474BD46F889C50932E60CF359"><enum>(III)</enum><text display-inline="yes-display-inline">describing, if appropriate, any prior
history of anaphylaxis;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id546D667971194C00A8DBE75E9FCD06F8"><enum>(IV)</enum><text display-inline="yes-display-inline">listing any medication prescribed for the
child for the treatment of anaphylaxis;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id9DFBD2B13F614BC498E55C8013EB0A8C"><enum>(V)</enum><text display-inline="yes-display-inline">detailing emergency treatment procedures in
the event of a reaction;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id9FD0D3962EBA488C946936E6651EE9CB"><enum>(VI)</enum><text display-inline="yes-display-inline">listing the signs and symptoms of a
reaction; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id359AB73C31B14DFAA55D25D240F46038"><enum>(VII)</enum><text display-inline="yes-display-inline">assessing the child’s readiness for
self-administration of prescription medication; and</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="id125E620E07B44ED3886850575F50378D"><enum>(ii)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idEF3474DCBF794DA290363717229C51EC"><enum>(B)</enum><text display-inline="yes-display-inline">The creation and maintenance of an
individual 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 commented="no" display-inline="no-display-inline" id="id0DAF29E28D70482C93F68150BD0CEA27"><enum>(i)</enum><text display-inline="yes-display-inline">the children are capable of
self-administering medication; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id5351EB23B6954221AC5F2C5E52842149"><enum>(ii)</enum><text display-inline="yes-display-inline">such administration is not prohibited by
State law.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idAB300633C7784379A34B4D9F9BD0FA36"><enum>(C)</enum><text display-inline="yes-display-inline">Communication strategies between individual
schools or early childhood education programs and providers of emergency
medical services, including appropriate instructions for emergency medical
response.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id02239EE4211542A1930D64E8C5D471F0"><enum>(D)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id62D5FE4C28FD48B79B17DD71516406FF"><enum>(E)</enum><text display-inline="yes-display-inline">The dissemination of general information on
life-threatening food allergies to school or early childhood education program
staff, parents, and children.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2C1C6A6349AC44A3B25E30EF37A93DC3"><enum>(F)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id06AB3394680D40F7B55A1F3A0183D9A4"><enum>(G)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idFC6B40BF9F194599BE98E828717C1338"><enum>(H)</enum><text display-inline="yes-display-inline">The timely accessibility of epinephrine by
school or early childhood education program personnel when the nurse is not
immediately available.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id73B8A2E527F942109C1B0B7DE8DD3320"><enum>(I)</enum><text display-inline="yes-display-inline">The creation of a plan contained in each
individual 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 commented="no" display-inline="no-display-inline" id="id4C34392CA059406CB71115E26C262C7A"><enum>(J)</enum><text display-inline="yes-display-inline">Maintenance of information for each
administration of epinephrine to a child at risk for anaphylaxis and prompt
notification to parents.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7EE00323CAA340D9990E170AE911AC2E"><enum>(K)</enum><text display-inline="yes-display-inline">Other elements the Secretary determines
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="idCB4F0DB7FB4C4C10A10BAA86817F85EB"><enum>(3)</enum><header display-inline="yes-display-inline">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="id63AB5601FEF849189CC2E54508F0F9A2"><enum>(c)</enum><header display-inline="yes-display-inline">School-based food allergy management
grants</header>
<paragraph commented="no" display-inline="no-display-inline" id="idDC538C5FD49E4EEEA8026D433C7E62F2"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id3CEE4FD526D443A59F6E6F6B024D1A66"><enum>(2)</enum><header display-inline="yes-display-inline">Application</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id453C2AEED74D44FEA138C61479C97E63"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idD4219CC2728E4DE89712A73D88782E3F"><enum>(B)</enum><header display-inline="yes-display-inline">Contents</header><text display-inline="yes-display-inline">Each application submitted under
subparagraph (A) shall include—</text>
<clause commented="no" display-inline="no-display-inline" id="idBA67BDD4E88544A69D498F158D534070"><enum>(i)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id189E4AC38615441B99FE2B35F6ECAAAB"><enum>(ii)</enum><text display-inline="yes-display-inline">a description of the activities to be
funded by the grant in carrying out the food allergy and anaphylaxis management
guidelines, including—</text>
<subclause commented="no" display-inline="no-display-inline" id="idE5481B3FE84E4FA0A46BFC64EC153187"><enum>(I)</enum><text display-inline="yes-display-inline">how the guidelines will be carried out at
individual schools served by the local educational agency;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id52E97072D77147108F11FD571BCC9126"><enum>(II)</enum><text display-inline="yes-display-inline">how the local educational agency will
inform parents and students of the guidelines in place;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idA7ADFB8778BF483EADC8A12827C1AB15"><enum>(III)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id1B634A01C31640C68B23C683F9000F47"><enum>(IV)</enum><text display-inline="yes-display-inline">any other activities that the Secretary
determines appropriate;</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="id43FD2914CD974EF2A0DC40C52D64E5A7"><enum>(iii)</enum><text display-inline="yes-display-inline">an itemization of how grant funds received
under this subsection will be expended;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id55F7DCC5554E4012B9A3FF4188E33ECC"><enum>(iv)</enum><text display-inline="yes-display-inline">a description of how adoption of the
guidelines and implementation of grant activities will be monitored; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id17DA3E960EBF400E8A94C01AAD459235"><enum>(v)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id52F47746DE8D43D98B2092CCEC0B6C9A"><enum>(3)</enum><header display-inline="yes-display-inline">Use of funds</header><text display-inline="yes-display-inline">Each local educational agency that receives
a grant under this subsection may use the grant funds for the following:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id1B06258BCEA1481A87E75F002E479CF3"><enum>(A)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idFA36A1BBB949436A890D806AF90F318B"><enum>(B)</enum><text display-inline="yes-display-inline">In partnership with local health
departments, school nurse, teacher, and personnel training for food allergy
management.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA09527AE8649415FAF41682E0C830B7B"><enum>(C)</enum><text display-inline="yes-display-inline">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="idA6011CC3F1B24AB8AD96482820F8DED0"><enum>(D)</enum><text display-inline="yes-display-inline">Outreach to parents.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id45B609F522A84A59B997A26530FA190C"><enum>(E)</enum><text display-inline="yes-display-inline">Any other activities consistent with the
guidelines described in subsection (b).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB301E4CD2C8847BC878CFF36FC564CBC"><enum>(4)</enum><header display-inline="yes-display-inline">Duration of awards</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idAC99D355077A4570B81A2BC9BCC4315D"><enum>(5)</enum><header display-inline="yes-display-inline">Limitation on grant funding</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id34895CFFAE99466BAC2B93B9DBEEB454"><enum>(6)</enum><header display-inline="yes-display-inline">Maximum amount of annual
awards</header><text display-inline="yes-display-inline">A grant awarded under
this subsection may not be made in an amount that is more than $50,000
annually.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id00DCDDD5987E47F1951F4CD6A82BCCB2"><enum>(7)</enum><header display-inline="yes-display-inline">Priority</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idB43EF39EF56542E99EE1435846843A16"><enum>(8)</enum><header display-inline="yes-display-inline">Matching funds</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id9EDE37EEEAB4409D9B312D2F1ABD481A"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idB998CAF6359A4A6E819837128B76432E"><enum>(B)</enum><header display-inline="yes-display-inline">Determination of amount of non-Federal
contribution</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id956A4800B11D4944899A9F069CA5FC81"><enum>(9)</enum><header display-inline="yes-display-inline">Administrative funds</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idA7AC222AEA2B479E8B70D96A7E933A11"><enum>(10)</enum><header display-inline="yes-display-inline">Progress and evaluations</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id3ABF7EE78DF244858DD7CC714C8F43A6"><enum>(11)</enum><header display-inline="yes-display-inline">Supplement, not supplant</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idDD62727411D94EBC8C315CD0BB8F20AD"><enum>(12)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">There is
authorized to be appropriated to carry out this subsection $30,000,000 for
fiscal year 2011 and such sums as may be necessary for each of the 4 succeeding
fiscal years.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id7D0B6C42854044B0BE41A6C1DFEF82E8"><enum>(d)</enum><header display-inline="yes-display-inline">Voluntary nature of guidelines</header>
<paragraph commented="no" display-inline="no-display-inline" id="idCB56E1D1EAE645A0B5A5BF3026510B95"><enum>(1)</enum><header display-inline="yes-display-inline">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="id87C1D995AF91455E9BDE1F64DBB07A84"><enum>(2)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">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><section commented="no" display-inline="no-display-inline" id="id5D46E7F70C8544498841E7D1C0D8C6A5" section-type="subsequent-section"><enum>113.</enum><header display-inline="yes-display-inline">New dietary ingredients</header>
<subsection commented="no" display-inline="no-display-inline" id="idD9739AA1143747A4B680BFF0C06A6E04"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 413 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 350b) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id0B444436657F4A67989CC0878C0C75E1"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating subsection (c) as
subsection (d); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID4468c4660d4846819426e42a7a0f5b7a"><enum>(2)</enum><text display-inline="yes-display-inline">by inserting after subsection (b) the
following:</text>
<quoted-block display-inline="no-display-inline" id="idE8868A5176BA46D0B21C1E2CF60910CE" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id7197E25876E44C08AE2C7AC4D22FCF95"><enum>(c)</enum><header display-inline="yes-display-inline">Notification</header>
<paragraph commented="no" display-inline="no-display-inline" id="id7074055633614C2D9AB2BE8F3A81E0D2"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">If the Secretary determines that the
information in a new dietary ingredient notification submitted under this
section for an article purported to be a new dietary ingredient is inadequate
to establish that a dietary supplement containing such article will reasonably
be expected to be safe because the article may be, or may contain, an anabolic
steroid or an analogue of an anabolic steroid, the Secretary shall notify the
Drug Enforcement Administration of such determination. Such notification by the
Secretary shall include, at a minimum, the name of the dietary supplement or
article, the name of the person or persons who marketed the product or made the
submission of information regarding the article to the Secretary under this
section, and any contact information for such person or persons that the
Secretary has.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9475906CDA684139A6BAA3C25AB3B080"><enum>(2)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">For purposes of this subsection—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idA1FE849EDCD2404FA5531239FAE70F05"><enum>(A)</enum><text display-inline="yes-display-inline">the term <term>anabolic steroid</term> has
the meaning given such term in section 102(41) of the Controlled Substances
Act; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id449A90377A0747539B7B54CC94BDAF3F"><enum>(B)</enum><text display-inline="yes-display-inline">the term <term>analogue of an anabolic
steroid</term> means a substance whose chemical structure is substantially
similar to the chemical structure of an anabolic
steroid.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idE7604EB46ABB427CACA634419DFD69C7"><enum>(b)</enum><header display-inline="yes-display-inline">Guidance</header><text display-inline="yes-display-inline">Not later than 180 days after the date of
enactment of this Act, the Secretary shall publish guidance that clarifies when
a dietary supplement ingredient is a new dietary ingredient, when the
manufacturer or distributor of a dietary ingredient or dietary supplement
should provide the Secretary with information as described in section 413(a)(2)
of the Federal Food, Drug, and Cosmetic Act, the evidence needed to document
the safety of new dietary ingredients, and appropriate methods for establishing
the identify of a new dietary ingredient.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id35E9810B54EA4DFB9F6C4AA7E2482C07" section-type="subsequent-section"><enum>114.</enum><header display-inline="yes-display-inline">Requirement for guidance relating to post
harvest processing of raw oysters</header>
<subsection commented="no" display-inline="no-display-inline" id="idF4EA464479384EA389663E0E5B615393"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 90 days prior to the
issuance of any guidance, regulation, or suggested amendment by the Food and
Drug Administration to the National Shellfish Sanitation Program’s Model
Ordinance, or the issuance of any guidance or regulation by the Food and Drug
Administration relating to the Seafood Hazard Analysis Critical Control Points
Program of the Food and Drug Administration (parts 123 and 1240 of title 21,
Code of Federal Regulations (or any successor regulations), where such
guidance, regulation or suggested amendment relates to post harvest processing
for raw oysters, the Secretary shall prepare and submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives a report which shall
include—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID0ff86a0754ea45839b637b67f6283086"><enum>(1)</enum><text display-inline="yes-display-inline">an assessment of how post harvest
processing or other equivalent controls feasibly may be implemented in the
fastest, safest, and most economical manner;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDaacfe7de58ba478ca0af7f23a336af35"><enum>(2)</enum><text display-inline="yes-display-inline">the projected public health benefits of any
proposed post harvest processing;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID88352553f49942128ab0d5a6496ace4f"><enum>(3)</enum><text display-inline="yes-display-inline">the projected costs of compliance with such
post harvest processing measures;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID32d1e2aac4174e58934b2e69e70ba80e"><enum>(4)</enum><text display-inline="yes-display-inline">the impact post harvest processing is
expected to have on the sales, cost, and availability of raw oysters;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID9a4f02ccbc4c45feb602f65c3b4d84eb"><enum>(5)</enum><text display-inline="yes-display-inline">criteria for ensuring post harvest
processing standards will be applied equally to shellfish imported from all
nations of origin;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDc2168963720c4cd29b99ebfe7a22daf0"><enum>(6)</enum><text display-inline="yes-display-inline">an evaluation of alternative measures to
prevent, eliminate, or reduce to an acceptable level the occurrence of
foodborne illness; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID2c5974bc7dcd4169bd9f11927c310614"><enum>(7)</enum><text display-inline="yes-display-inline">the extent to which the Food and Drug
Administration has consulted with the States and other regulatory agencies, as
appropriate, with regard to post harvest processing measures.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id72E65047403D4DCCA1FD9556300D6687"><enum>(b)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">Subsection (a) shall not apply to the
guidance described in section 103(h).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id7D50EAC6646645CCB331E5EA79721861"><enum>(c)</enum><header display-inline="yes-display-inline">Review and evaluation</header><text display-inline="yes-display-inline">Not later than 30 days after the Secretary
issues a proposed regulation or guidance described in subsection (a), the
Comptroller General of the United States shall—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDe0bc6e4b3fbb48198dabb2cbcddb6e8a"><enum>(1)</enum><text display-inline="yes-display-inline">review and evaluate the report described in
(a) and report to Congress on the findings of the estimates and analysis in the
report;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDb8b957bb4e004867a060bb3b4a8457fc"><enum>(2)</enum><text display-inline="yes-display-inline">compare such proposed regulation or
guidance to similar regulations or guidance with respect to other regulated
foods, including a comparison of risks the Secretary may find associated with
seafood and the instances of those risks in such other regulated foods;
and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDddc03a360b6a41ebaac7ea51bc750f48"><enum>(3)</enum><text display-inline="yes-display-inline">evaluate the impact of post harvest
processing on the competitiveness of the domestic oyster industry in the United
States and in international markets.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idB8C684E652814EB9B39152379F54CD7C"><enum>(d)</enum><header display-inline="yes-display-inline">Waiver</header><text display-inline="yes-display-inline">The requirement of preparing a report under
subsection (a) shall be waived if the Secretary issues a guidance that is
adopted as a consensus agreement between Federal and State regulators and the
oyster industry, acting through the Interstate Shellfish Sanitation
Conference.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id76DA5A1163E54802A1925CC28343D262"><enum>(e)</enum><header display-inline="yes-display-inline">Public access</header><text display-inline="yes-display-inline">Any report prepared under this section
shall be made available to the public.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="idEF5F642A63B44815AF2412C26ADD7144" section-type="subsequent-section"><enum>115.</enum><header display-inline="yes-display-inline">Port shopping</header><text display-inline="no-display-inline">Until the date on which the Secretary
promulgates a final rule that implements the amendments made by section 308 of
the Public Health Security and Bioterrorism Preparedness and Response Act of
2002, (Public Law 107–188), the Secretary shall notify the Secretary of
Homeland Security of all instances in which the Secretary refuses to admit a
food into the United States under section 801(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381(a)) so that the Secretary of Homeland Security,
acting through the Commissioner of Customs and Border Protection, may prevent
food refused admittance into the United States by a United States port of entry
from being admitted by another United States port of entry, through the
notification of other such United States ports of entry.</text>
</section><section commented="no" display-inline="no-display-inline" id="id8AD9C177FBCC4A91AC9E9213104E1CD5" section-type="subsequent-section"><enum>116.</enum><header display-inline="yes-display-inline">Alcohol-related facilities</header>
<subsection commented="no" display-inline="no-display-inline" id="id1DAAF10F221C4636B91BABC2B434BDAB"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Except as provided by sections 102, 206,
207, 302, 304, 402, 403, and 404 of this Act, and the amendments made by such
sections, nothing in this Act, or the amendments made by this Act, shall be
construed to apply to a facility that—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID58006557db134ad6a1fdfe01421734c8"><enum>(1)</enum><text display-inline="yes-display-inline">under the Federal Alcohol Administration
Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle E of the Internal Revenue
Code of 1986 (26 U.S.C. 5001 et seq.) is required to obtain a permit or to
register with the Secretary of the Treasury as a condition of doing business in
the United States; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDc4893f2b49c54ad685ca590ff80e557a"><enum>(2)</enum><text display-inline="yes-display-inline">under section 415 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 350d) is required to register as a facility
because such facility is engaged in manufacturing, processing, packing, or
holding 1 or more alcoholic beverages, with respect to the activities of such
facility that relate to the manufacturing, processing, packing, or holding of
alcoholic beverages.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idF0B87691B8994A84ACEFA5DDEA7E77EF"><enum>(b)</enum><header display-inline="yes-display-inline">Limited receipt and distribution of
non-alcohol food</header><text display-inline="yes-display-inline">Subsection
(a) shall not apply to a facility engaged in the receipt and distribution of
any non-alcohol food, except that such paragraph shall apply to a facility
described in such paragraph that receives and distributes non-alcohol food,
provided such food is received and distributed—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idF1B8F143418C4F5C8BF35DE9ADD00290"><enum>(1)</enum><text display-inline="yes-display-inline">in a prepackaged form that prevents any
direct human contact with such food; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID600e3e233e704c7987fbc4143acd892a"><enum>(2)</enum><text display-inline="yes-display-inline">in amounts that constitute not more than 5
percent of the overall sales of such facility, as determined by the Secretary
of the Treasury.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idF44E6431E0344702AA4E67E9E0C992DD"><enum>(c)</enum><header display-inline="yes-display-inline">Rule of construction</header><text display-inline="yes-display-inline">Except as provided in subsections (a) and
(b), this section shall not be construed to exempt any food, other than
alcoholic beverages, as defined in section 214 of the Federal Alcohol
Administration Act (27 U.S.C. 214), from the requirements of this Act
(including the amendments made by this Act).</text>
</subsection></section><enum>II</enum><header display-inline="yes-display-inline">Improving capacity to detect and respond to
food safety problems</header>
<section commented="no" display-inline="no-display-inline" id="id45B9435345E64AFD85D0A89F6001A8DD" section-type="subsequent-section"><enum>201.</enum><header display-inline="yes-display-inline">Targeting of inspection resources for
domestic facilities, foreign facilities, and ports of entry; annual
report</header>
<subsection commented="no" display-inline="no-display-inline" id="idD7E330B45236489DB33424A7A990676D"><enum>(a)</enum><header display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id055A15F48D2145D589057858BE9CC248" section-type="subsequent-section"><enum>421.</enum><header display-inline="yes-display-inline">Targeting of inspection resources for
domestic facilities, foreign facilities, and ports of entry; annual
report</header>
<subsection commented="no" display-inline="no-display-inline" id="idD15E7F109F8B43418D068697B104EEFD"><enum>(a)</enum><header display-inline="yes-display-inline">Identification and inspection of
facilities</header>
<paragraph commented="no" display-inline="no-display-inline" id="id7F4DE00E39DB4A6D81D21F7E968214B6"><enum>(1)</enum><header display-inline="yes-display-inline">Identification</header><text display-inline="yes-display-inline">The Secretary shall identify high-risk
facilities and shall allocate resources to inspect facilities according to the
known safety risks of the facilities, which shall be based on the following
factors:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDdb5c834f6fac4122888a4a456511ab3d"><enum>(A)</enum><text display-inline="yes-display-inline">The known safety risks of the food
manufactured, processed, packed, or held at the facility.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id147D6FB311D94DF8896004B7708474D1"><enum>(B)</enum><text display-inline="yes-display-inline">The compliance history of a facility,
including with regard to food recalls, outbreaks of foodborne illness, and
violations of food safety standards.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA379DAF76EA54E5E8A2CBEF9604E758C"><enum>(C)</enum><text display-inline="yes-display-inline">The rigor and effectiveness of the
facility's hazard analysis and risk-based preventive controls.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idFC60BFEDFFF54C8997071BFCBCAB5EC4"><enum>(D)</enum><text display-inline="yes-display-inline">Whether the food manufactured, processed,
packed, or held at the facility meets the criteria for priority under section
801(h)(1).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6549DEA3D8AC4AF08D14CF872941C656"><enum>(E)</enum><text display-inline="yes-display-inline">Whether the food or the facility that
manufactured, processed, packed, or held such food has received a certification
as described in section 801(q) or 806, as appropriate.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id03AA2096EC00488D908BF1D14B2D97E2"><enum>(F)</enum><text display-inline="yes-display-inline">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 display-inline="yes-display-inline">Inspections</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id1DA378A436CD4A3ABFF513468D668218"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Beginning on the date of enactment of the
<short-title>FDA Food Safety Modernization
Act</short-title>, the Secretary shall increase the frequency of inspection of
all facilities.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idDA840C1F21594EBE89695DB9D8B038CF"><enum>(B)</enum><header display-inline="yes-display-inline">Domestic high-risk facilities</header><text display-inline="yes-display-inline">The Secretary shall increase the frequency
of inspection of domestic facilities identified under paragraph (1) as
high-risk facilities such that each such facility is inspected—</text>
<clause commented="no" display-inline="no-display-inline" id="ID6f0a1c32b2a94d0eba69b986c97f2935"><enum>(i)</enum><text display-inline="yes-display-inline">not less often than once in the 5-year
period following the date of enactment of the FDA Food Safety Modernization
Act; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID93f7b46d6d774e0ba9ebc04fb363276c"><enum>(ii)</enum><text display-inline="yes-display-inline">not less often than once every 3 years
thereafter.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD0A4D19D069246B487A0A2D117B46D80"><enum>(C)</enum><header display-inline="yes-display-inline">Domestic non-high-risk
facilities</header><text display-inline="yes-display-inline">The Secretary
shall ensure that each domestic facility that is not identified under paragraph
(1) as a high-risk facility is inspected—</text>
<clause commented="no" display-inline="no-display-inline" id="id27A607813B234697AF71D8BD99084732"><enum>(i)</enum><text display-inline="yes-display-inline">not less often than once in the 7-year
period following the date of enactment of the <short-title>FDA Food Safety Modernization Act</short-title>;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id540F5BB494A54931B67972D6A164F585"><enum>(ii)</enum><text display-inline="yes-display-inline">not less often than once every 5 years
thereafter.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id32FE7B0116524AB790721974B42278B0"><enum>(D)</enum><header display-inline="yes-display-inline">Foreign facilities</header>
<clause commented="no" display-inline="no-display-inline" id="id042ECDEFBFEA4123968EC7E897FAB549"><enum>(i)</enum><header display-inline="yes-display-inline">Year 1</header><text display-inline="yes-display-inline">In the 1-year period following the date of
enactment of the <short-title>FDA Food Safety
Modernization Act</short-title>, the Secretary shall inspect not fewer than 600
foreign facilities.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idEF6E116D9DA54E8EBB65C6A7313D72E7"><enum>(ii)</enum><header display-inline="yes-display-inline">Subsequent years</header><text display-inline="yes-display-inline">In each of the 5 years following the 1-year
period described in clause (i), the Secretary shall inspect not fewer than
twice the number of foreign facilities inspected by the Secretary during the
previous year.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF627783CA19148A285C8BA237FCA755A"><enum>(E)</enum><header display-inline="yes-display-inline">Reliance on Federal, State, or local
inspections</header><text display-inline="yes-display-inline">In meeting the
inspection requirements under this subsection for domestic facilities, the
Secretary may rely on inspections conducted by other Federal, State, or local
agencies under interagency agreement, contract, memoranda of understanding, or
other obligation.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id96914F64670F41FA851F130FB9852220"><enum>(b)</enum><header display-inline="yes-display-inline">Identification and inspection at ports of
entry</header><text display-inline="yes-display-inline">The Secretary, in
consultation with the Secretary of Homeland Security, shall allocate resources
to inspect any article of food imported into the United States according to the
known safety risks of the article of food, which shall be based on the
following factors:</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDe369ccb96bda4c06a61700b1e66adb94"><enum>(1)</enum><text display-inline="yes-display-inline">The known safety risks of the food
imported.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA27D9602595144CAB27CBABC08F0A172"><enum>(2)</enum><text display-inline="yes-display-inline">The known safety risks of the countries or
regions of origin and countries through which such article of food is
transported.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id80ACD3AE2C7146B489755152DACDEC70"><enum>(3)</enum><text display-inline="yes-display-inline">The compliance history of the importer,
including with regard to food recalls, outbreaks of foodborne illness, and
violations of food safety standards.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1A48749E46014441925D48FC2FACE09E"><enum>(4)</enum><text display-inline="yes-display-inline">The rigor and effectiveness of the
activities conducted by the importer of such article of food to satisfy the
requirements of the foreign supplier verification program under section
805.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8E942A2AE7DB48B496913D3834798525"><enum>(5)</enum><text display-inline="yes-display-inline">Whether the food importer participates in
the voluntary qualified importer program under section 806.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idEB7B56D8EF7F49C2B717874103695399"><enum>(6)</enum><text display-inline="yes-display-inline">Whether the food meets the criteria for
priority under section 801(h)(1).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID47e4cfb8dce649a9b78a9cd121f62653"><enum>(7)</enum><text display-inline="yes-display-inline">Whether the food or the facility that
manufactured, processed, packed, or held such food received a certification as
described in section 801(q) or 806.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idE5C1C968C86643DE86EED6D1D92FF329"><enum>(8)</enum><text display-inline="yes-display-inline">Any other criteria deemed necessary and
appropriate by the Secretary for purposes of allocating inspection
resources.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idB953447078B14760BE2F26853FD659A1"><enum>(c)</enum><header display-inline="yes-display-inline">Interagency agreements with respect to
seafood</header>
<paragraph commented="no" display-inline="no-display-inline" id="idFD6FD8AC4C4041B19C72EDEABD3599FA"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services,
the Secretary of Commerce, the Secretary of Homeland Security, the Chairman of
the Federal Trade Commission, and the heads of other appropriate agencies may
enter into such agreements as may be necessary or appropriate to improve
seafood safety.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id319C87EBB5174BC8A485022E85998F6A"><enum>(2)</enum><header display-inline="yes-display-inline">Scope of agreements</header><text display-inline="yes-display-inline">The agreements under paragraph (1) may
include—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id1A2307F8A3CA4DAC80653535AC65EC29"><enum>(A)</enum><text display-inline="yes-display-inline">cooperative arrangements for examining and
testing seafood imports that leverage the resources, capabilities, and
authorities of each party to the agreement;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id09531DF4A2A344D29C6D07368FAF02AD"><enum>(B)</enum><text display-inline="yes-display-inline">coordination of inspections of foreign
facilities to increase the percentage of imported seafood and seafood
facilities inspected;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9965FB174A0048F486AA7676C30BEE41"><enum>(C)</enum><text display-inline="yes-display-inline">standardization of data on seafood names,
inspection records, and laboratory testing to improve interagency
coordination;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idBF472928B0CF42A5908C8381533824B9"><enum>(D)</enum><text display-inline="yes-display-inline">coordination to detect and investigate
violations under applicable Federal law;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2C01F5C3F39A4B4298A6ED9D9FB65295"><enum>(E)</enum><text display-inline="yes-display-inline">a process, including the use or
modification of existing processes, by which officers and employees of the
National Oceanic and Atmospheric Administration may be duly designated by the
Secretary to carry out seafood examinations and investigations under section
801 of this Act or section 203 of the Food Allergen Labeling and Consumer
Protection Act of 2004;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id425C9326AB904E5EBD946D4FF2BDA687"><enum>(F)</enum><text display-inline="yes-display-inline">the sharing of information concerning
observed non-compliance with United States food requirements domestically and
in foreign nations and new regulatory decisions and policies that may affect
the safety of food imported into the United States;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id80D7869C6AEB407AA1B6927CBF3D3F89"><enum>(G)</enum><text display-inline="yes-display-inline">conducting joint training on subjects that
affect and strengthen seafood inspection effectiveness by Federal authorities;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idB0DE18416C3E48B8AC3060398698BB25"><enum>(H)</enum><text display-inline="yes-display-inline">outreach on Federal efforts to enhance
seafood safety and compliance with Federal food safety requirements.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id40423D47AB8040CD8E5ED152BAA6A4D2"><enum>(d)</enum><header display-inline="yes-display-inline">Coordination</header><text display-inline="yes-display-inline">The Secretary shall improve coordination
and cooperation with the Secretary of Agriculture and the Secretary of Homeland
Security to target food inspection resources.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idE29B68DA7DF842E0A7BDC919937A02F8"><enum>(e)</enum><header display-inline="yes-display-inline">Facility</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id94FA680F44AE4CB5AD94A7BDECDF8969"><enum>(b)</enum><header display-inline="yes-display-inline">Annual report</header><text display-inline="yes-display-inline">Section 1003 (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 commented="no" display-inline="no-display-inline" id="ID9224b7bd885943b38cb400a28f517d90"><enum>(h)</enum><header display-inline="yes-display-inline">Annual report regarding food</header><text display-inline="yes-display-inline">Not later than February 1 of each year, the
Secretary shall submit to Congress a report, including efforts to coordinate
and cooperate with other Federal agencies with responsibilities for food
inspections, regarding—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID581933ebf7d640cbbc4aeb70160d2997"><enum>(1)</enum><text display-inline="yes-display-inline">information about food facilities
including—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDdfce8f0fc4294dfe9a6968d88ede7aed"><enum>(A)</enum><text display-inline="yes-display-inline">the appropriations used to inspect
facilities registered pursuant to section 415 in the previous fiscal
year;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID9bf3025893ba4f75a3d27f2100fa312a"><enum>(B)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID4e7d55bb0d10447fa7338c064f55835d"><enum>(C)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID07a583868c7b4c459bf1c4afeca6aceb"><enum>(D)</enum><text display-inline="yes-display-inline">the number of domestic facilities and the
number of foreign facilities registered pursuant to section 415 that were
scheduled for inspection in the previous fiscal year and which the Secretary
did not inspect in such year;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDeb85711257e54f95b580727f798d6b21"><enum>(E)</enum><text display-inline="yes-display-inline">the number of high-risk facilities
identified pursuant to section 421 that the Secretary inspected in the previous
fiscal year; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID43b9292b8aba4dd2b714f01a22eaea9e"><enum>(F)</enum><text display-inline="yes-display-inline">the number of high-risk facilities
identified pursuant to section 421 that were scheduled for inspection in the
previous fiscal year and which the Secretary did not inspect in such
year.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID497657bf71554528927da849e88b209a"><enum>(2)</enum><text display-inline="yes-display-inline">information about food imports
including—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID1ab82983ebc645429c98d787ae20cdac"><enum>(A)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="IDc4825e1bb5a44f2b9ac15182fcb8cdc2"><enum>(B)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="IDb59c2068915041cca9e092302e567042"><enum>(C)</enum><text display-inline="yes-display-inline">the average cost of physically inspecting
or sampling a line of food subject to this Act that is imported or offered for
import into the United States; and</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDe95f7503d1074fb08c56404bf5a615f8"><enum>(3)</enum><text display-inline="yes-display-inline">information on the foreign offices of the
Food and Drug Administration including—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID965209d1324f4ea58b9698fdc1d34b8b"><enum>(A)</enum><text display-inline="yes-display-inline">the number of foreign offices established;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID902fa278da634b13b82e5fdede8d1c38"><enum>(B)</enum><text display-inline="yes-display-inline">the number of personnel permanently
stationed in each foreign office.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID4864a69cc1bf44ea9c7379cda43e74f1"><enum>(i)</enum><header display-inline="yes-display-inline">Public availability of annual food
reports</header><text display-inline="yes-display-inline">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><subsection commented="no" display-inline="no-display-inline" id="idAB80A93D6E4B45BF888AFBB6714B0951"><enum>(c)</enum><header display-inline="yes-display-inline">Advisory committee
consultation</header><text display-inline="yes-display-inline">In allocating
inspection resources as described in section 421 of the Federal Food, Drug, and
Cosmetic Act (as added by subsection (a)), the Secretary may, as appropriate,
consult with any relevant advisory committee within the Department of Health
and Human Services.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id8E396828E7384143987A74BCDEC5DF19" section-type="subsequent-section"><enum>202.</enum><header display-inline="yes-display-inline">Laboratory accreditation for analyses of
foods</header>
<subsection commented="no" display-inline="no-display-inline" id="id9323CCB809B5457587D1405AED569F24"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Chapter IV (21 U.S.C. 341 et seq.), as
amended by section 201, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id9B07FB262C174C7BBDD1F01CAE13764D" style="OLC">
<section commented="no" display-inline="no-display-inline" id="idD92F7DED9A0944E4947B0DC4153F3FA9" section-type="subsequent-section"><enum>422.</enum><header display-inline="yes-display-inline">Laboratory accreditation for analyses of
foods</header>
<subsection commented="no" display-inline="no-display-inline" id="ID7afb6bcd59d04a6586d55afb31f0d22f"><enum>(a)</enum><header display-inline="yes-display-inline">Recognition of laboratory
accreditation</header>
<paragraph commented="no" display-inline="no-display-inline" id="id5042CE8AD18E4941B47E8E2F9F6C9AA7"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id8998EEF14B2D412493625AB725ACF2BF"><enum>(A)</enum><text display-inline="yes-display-inline">establish a program for the testing of food
by accredited laboratories;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id581B5A76251A49CC86DBBAE12BB59FEC"><enum>(B)</enum><text display-inline="yes-display-inline">establish a publicly available registry of
accreditation bodies recognized by the Secretary and laboratories accredited by
a recognized accreditation body, including the name of, contact information
for, and other information deemed appropriate by the Secretary about such
bodies and laboratories; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDa4f3d1f3c51646ee9577bfad958d91fe"><enum>(C)</enum><text display-inline="yes-display-inline">require, as a condition of recognition or
accreditation, as appropriate, that recognized accreditation bodies and
accredited laboratories report to the Secretary any changes that would affect
the recognition of such accreditation body or the accreditation of such
laboratory.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD784FBB48AEF4F71A497AEA037EB754E"><enum>(2)</enum><header display-inline="yes-display-inline">Program requirements</header><text display-inline="yes-display-inline">The program established under paragraph
(1)(A) shall provide for the recognition of laboratory accreditation bodies
that meet criteria established by the Secretary for accreditation of
laboratories, including independent private laboratories and laboratories run
and operated by a Federal agency (including the Department of Commerce), State,
or locality with a demonstrated capability to conduct 1 or more sampling and
analytical testing methodologies for food.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id922A244ADEE94C4C9ED2871D157E2C57"><enum>(3)</enum><header display-inline="yes-display-inline">Increasing the number of qualified
laboratories</header><text display-inline="yes-display-inline">The Secretary
shall work with the laboratory accreditation bodies recognized under paragraph
(1), as appropriate, to increase the number of qualified laboratories that are
eligible to perform testing under subparagraph (b) beyond the number so
qualified on the date of enactment of the <short-title>FDA
Food Safety Modernization Act</short-title>.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id17B6338737784A7EA9B998614894EACE"><enum>(4)</enum><header display-inline="yes-display-inline">Limited distribution</header><text display-inline="yes-display-inline">In the interest of national security, the
Secretary, in coordination with the Secretary of Homeland Security, may
determine the time, manner, and form in which the registry established under
paragraph (1)(B) is made publicly available.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id961989DB823745E8AF5E2293D0EAF8C6"><enum>(5)</enum><header display-inline="yes-display-inline">Foreign laboratories</header><text display-inline="yes-display-inline">Accreditation bodies recognized by the
Secretary under paragraph (1) may accredit laboratories that operate outside
the United States, so long as such laboratories meet the accreditation
standards applicable to domestic laboratories accredited under this
section.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID5b4d5685cf94400bb87bcac5f80de9f2"><enum>(6)</enum><header display-inline="yes-display-inline">Model laboratory standards</header><text display-inline="yes-display-inline">The Secretary shall develop model standards
that a laboratory shall meet to be accredited by a recognized accreditation
body for a specified sampling or analytical testing methodology and included in
the registry provided for under paragraph (1). In developing the model
standards, the Secretary shall consult existing standards for guidance. The
model standards shall include—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id59948BBD06F3410080224CA661E01C83"><enum>(A)</enum><text display-inline="yes-display-inline">methods to ensure that—</text>
<clause commented="no" display-inline="no-display-inline" id="IDbba78bf178ee4c95974ef7f7554858f5"><enum>(i)</enum><text display-inline="yes-display-inline">appropriate sampling, analytical procedures
(including rapid analytical procedures), and commercially available techniques
are followed and reports of analyses are certified as true and accurate;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDe026264b9b134f49819f7c5e15d2cbcb"><enum>(ii)</enum><text display-inline="yes-display-inline">internal quality systems are established
and maintained;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID60077894c6bb40ab8f39823f8732ae0c"><enum>(iii)</enum><text display-inline="yes-display-inline">procedures exist to evaluate and respond
promptly to complaints regarding analyses and other activities for which the
laboratory is accredited; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDa61ad020471f4754ae66e1e12ccce177"><enum>(iv)</enum><text display-inline="yes-display-inline">individuals who conduct the sampling and
analyses are qualified by training and experience to do so; and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id599018FE1070497493DAF6B9C3A76E06"><enum>(B)</enum><text display-inline="yes-display-inline">any other criteria determined appropriate
by the Secretary.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDc4500f829219481c94cc647a9b29b11a"><enum>(7)</enum><header display-inline="yes-display-inline">Review of recognition</header><text display-inline="yes-display-inline">To ensure compliance with the requirements
of this section, the Secretary—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID38c74607823d42c9bf34402f74e7b9b0"><enum>(A)</enum><text display-inline="yes-display-inline">shall periodically, and in no case less
than once every 5 years, reevaluate accreditation bodies recognized under
paragraph (1) and may accompany auditors from an accreditation body to assess
whether the accreditation body meets the criteria for recognition; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDb8be62ee4ac640fb9fd28dcad0eb3b25"><enum>(B)</enum><text display-inline="yes-display-inline">shall promptly revoke the recognition of
any accreditation body found not to be in compliance with the requirements of
this section, specifying, as appropriate, any terms and conditions necessary
for laboratories accredited by such body to continue to perform testing as
described in this section.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idB1F34B07C43347BC9603F044E9549E6D"><enum>(b)</enum><header display-inline="yes-display-inline">Testing procedures</header>
<paragraph commented="no" display-inline="no-display-inline" id="id8E832C037D6E49C38D6BDAA8C54FACB1"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 30 months after the date of
enactment of the <short-title>FDA Food Safety
Modernization Act</short-title>, food testing shall be conducted by Federal
laboratories or non-Federal laboratories that have been accredited for the
appropriate sampling or analytical testing methodology or methodologies by a
recognized accreditation body on the registry established by the Secretary
under subsection (a)(1)(B) whenever such testing is conducted—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id33CA7595507E476AAB93194B74D14052"><enum>(A)</enum><text display-inline="yes-display-inline">by or on behalf of an owner or
consignee—</text>
<clause commented="no" display-inline="no-display-inline" id="id75F4BD0A2CCB4561B011C5A5B620BC72"><enum>(i)</enum><text display-inline="yes-display-inline">in response to a specific testing
requirement under this Act or implementing regulations, when applied to address
an identified or suspected food safety problem; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDa217fbe3cbf441569fbcba4a80021390"><enum>(ii)</enum><text display-inline="yes-display-inline">as required by the Secretary, as the
Secretary deems appropriate, to address an identified or suspected food safety
problem; or</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID050071102582426c8b3f77506b5fb126"><enum>(B)</enum><text display-inline="yes-display-inline">on behalf of an owner or consignee—</text>
<clause commented="no" display-inline="no-display-inline" id="id44709E7A7E2041D4B8F70F8E1B2A8FC3"><enum>(i)</enum><text display-inline="yes-display-inline">in support of admission of an article of
food under section 801(a); and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idD818806B5CDD4E499DED878FEBCB524D"><enum>(ii)</enum><text display-inline="yes-display-inline">under an Import Alert that requires
successful consecutive tests.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1E30668CDFA64F44A2739BC4E413D4D8"><enum>(2)</enum><header display-inline="yes-display-inline">Results of testing</header><text display-inline="yes-display-inline">The results of any such testing shall be
sent directly to the Food and Drug Administration, except the Secretary may by
regulation exempt test results from such submission requirement if the
Secretary determines that such results do not contribute to the protection of
public health. Test results required to be submitted may be submitted to the
Food and Drug Administration through electronic means.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID2b01f714d41f4b0480934aca53c5d2cb"><enum>(3)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">The Secretary may waive requirements under
this subsection if—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id4629972A626640A9A0734E0F7A8E5940"><enum>(A)</enum><text display-inline="yes-display-inline">a new methodology or methodologies have
been developed and validated but a laboratory has not yet been accredited to
perform such methodology or methodologies; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idE3010CE39DC94D35A08B0EF66A642107"><enum>(B)</enum><text display-inline="yes-display-inline">the use of such methodology or
methodologies are necessary to prevent, control, or mitigate a food emergency
or foodborne illness outbreak.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idEE9DB0D2E3374FAD984B3809CA17F89D"><enum>(c)</enum><header display-inline="yes-display-inline">Review by Secretary</header><text display-inline="yes-display-inline">If food sampling and testing performed by a
laboratory run and operated by a State or locality that is accredited by a
recognized 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><subsection commented="no" display-inline="no-display-inline" id="id3E44CB6C796D487782397575E9868668"><enum>(d)</enum><header display-inline="yes-display-inline">No limit on Secretarial
authority</header><text display-inline="yes-display-inline">Nothing in this
section shall be construed to limit the ability of the Secretary to review and
act upon information from food testing, including determining the sufficiency
of such information and
testing.</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 display-inline="yes-display-inline">Food emergency response
network</header><text display-inline="yes-display-inline">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 display-inline="yes-display-inline">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 display-inline="yes-display-inline">coordinates the food laboratory capacities
of State, local, and tribal food laboratories, including the adoption of novel
surveillance and identification technologies and the sharing of data between
Federal agencies and State laboratories to develop national situational
awareness;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idBA10C89F09B14DDE85ECFBCC0A14CFA8"><enum>(3)</enum><text display-inline="yes-display-inline">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 display-inline="yes-display-inline">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 display-inline="yes-display-inline">responds to food-related emergencies;
and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB82981BBEC864A54BAA41559FFA305CC"><enum>(6)</enum><text display-inline="yes-display-inline">is integrated with relevant laboratory
networks administered by other Federal agencies.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="ID433aff7c1b3a43438c684f5fe96ae267" section-type="subsequent-section"><enum>203.</enum><header display-inline="yes-display-inline">Integrated consortium of laboratory
networks</header>
<subsection commented="no" display-inline="no-display-inline" id="id8C99E613B5F14C9DA30CBA923119FD67"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary of Homeland Security, in
coordination with the Secretary of Health and Human Services, the Secretary of
Agriculture, the Secretary of Commerce, 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 commented="no" display-inline="no-display-inline" id="ID537e762c6b8a4d5e9186dd00aee03832"><enum>(1)</enum><text display-inline="yes-display-inline">agree on common laboratory methods in order
to reduce the time required to detect and respond to foodborne illness
outbreaks and facilitate the sharing of knowledge and information relating to
animal health, agriculture, and human health;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID676db943b7294d79a19057f31b47ae16"><enum>(2)</enum><text display-inline="yes-display-inline">identify means by which laboratory network
members could work cooperatively—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID2dc047ea485e4e3590d83d789c3dedc0"><enum>(A)</enum><text display-inline="yes-display-inline">to optimize national laboratory
preparedness; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID162f754e358c442c8b0de5169bc46b1a"><enum>(B)</enum><text display-inline="yes-display-inline">to provide surge capacity during
emergencies; and</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID2e7c5296ef7445da8a5c4429ab64b8df"><enum>(3)</enum><text display-inline="yes-display-inline">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 display-inline="yes-display-inline">Reporting requirement</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="IDe718af8a478f4dff88391c16cdad686a" section-type="subsequent-section"><enum>204.</enum><header display-inline="yes-display-inline">Enhancing tracking and tracing of food and
recordkeeping</header>
<subsection commented="no" display-inline="no-display-inline" id="IDc07f739d1b4b4d24839cc5b7176d2741"><enum>(a)</enum><header display-inline="yes-display-inline">Pilot projects</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID99d16a95cf544e4988c9003fcb469f3e"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 270 days after the date of
enactment of this Act, the Secretary of Health and Human Services (referred to
in this section as the <quote>Secretary</quote>), taking into account
recommendations from the Secretary of Agriculture and representatives of State
departments of health and agriculture, shall establish pilot projects in
coordination with the food industry to explore and evaluate methods to rapidly
and effectively identify recipients of food to prevent or mitigate a foodborne
illness outbreak and to address credible threats of serious adverse health
consequences or death to humans or animals as a result of such food being
adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 342) or misbranded under section 403(w) of such Act (21 U.S.C.
343(w)).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDb0fa06eefbfc4f4b9aa841e43ca51243"><enum>(2)</enum><header display-inline="yes-display-inline">Content</header><text display-inline="yes-display-inline">The Secretary shall conduct 1 or more pilot
projects under paragraph (1) in coordination with the processed food sector and
1 or more such pilot projects in coordination with processors or distributors
of fruits and vegetables that are raw agricultural commodities. The Secretary
shall ensure that the pilot projects under paragraph (1) reflect the diversity
of the food supply and include at least 3 different types of foods that have
been the subject of significant outbreaks during the 5-year period preceding
the date of enactment of this Act, and are selected in order to—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDaabd705b38bc4b39a1e4ae9373b7145b"><enum>(A)</enum><text display-inline="yes-display-inline">develop and demonstrate methods for rapid
and effective tracking and tracing of foods in a manner that is practicable for
facilities of varying sizes, including small businesses;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID84ec8f10f0ee4f549e54e451c603c020"><enum>(B)</enum><text display-inline="yes-display-inline">develop and demonstrate appropriate
technologies, including technologies existing on the date of enactment of this
Act, that enhance the tracking and tracing of food; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDd53ff63e178548aa80e1b37f609f6c57"><enum>(C)</enum><text display-inline="yes-display-inline">inform the promulgation of regulations
under subsection (d).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID4e2ec9a6f8c847f2a3c3a279a43a1cad"><enum>(3)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">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 projects under this subsection together with recommendations for
improving the tracking and tracing of food.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDdbfa3b8082d64ccf96b1f2a37938135a"><enum>(b)</enum><header display-inline="yes-display-inline">Additional data gathering</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID623fac164414469dab94d4c5d585a549"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary, in coordination with the
Secretary of Agriculture and multiple representatives of State departments of
health and agriculture, shall assess—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID0a1bbab9a4d0415f8b5227a5f8dc18a2"><enum>(A)</enum><text display-inline="yes-display-inline">the costs and benefits associated with the
adoption and use of several product tracing technologies, including
technologies used in the pilot projects under subsection (a);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID0b78dd701b8244e88a031a5ce8081ec2"><enum>(B)</enum><text display-inline="yes-display-inline">the feasibility of such technologies for
different sectors of the food industry, including small businesses; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDc2aaded5758f455884063bf0348c3bbd"><enum>(C)</enum><text display-inline="yes-display-inline">whether such technologies are compatible
with the requirements of this subsection.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDf83a3c9eac464e53aed9e5ffcd0d8841"><enum>(2)</enum><header display-inline="yes-display-inline">Requirements</header><text display-inline="yes-display-inline">To the extent practicable, in carrying out
paragraph (1), the Secretary shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID2a04c93adde347309ceac1ea415d3d2a"><enum>(A)</enum><text display-inline="yes-display-inline">evaluate domestic and international product
tracing practices in commercial use;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID22b6f7c505f4440491122bf86b1dd0d1"><enum>(B)</enum><text display-inline="yes-display-inline">consider international efforts, including
an assessment of whether product tracing requirements developed under this
section are compatible with global tracing systems, as appropriate; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID92288da9f660439abdf1d4cd9ccb3c44"><enum>(C)</enum><text display-inline="yes-display-inline">consult with a diverse and broad range of
experts and stakeholders, including representatives of the food industry,
agricultural producers, and nongovernmental organizations that represent the
interests of consumers.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDa7b2c078bd184b3b990c44ee867755c1"><enum>(c)</enum><header display-inline="yes-display-inline">Product tracing system</header><text display-inline="yes-display-inline">The Secretary, in consultation with the
Secretary of Agriculture, shall, as appropriate, establish within the Food and
Drug Administration a product tracing system to receive information that
improves the capacity of the Secretary to effectively and rapidly track and
trace food that is in the United States or offered for import into the United
States. Prior to the establishment of such product tracing system, the
Secretary shall examine the results of applicable pilot projects and shall
ensure that the activities of such system are adequately supported by the
results of such pilot projects.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID1b6079f1c1ab4d0c9ea4e6a99e2d891a"><enum>(d)</enum><header display-inline="yes-display-inline">Additional recordkeeping requirements for
high risk foods</header>
<paragraph commented="no" display-inline="no-display-inline" id="id8FDAD02A821D4B5C86E2A04D4843FEDC"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">In order to rapidly and effectively
identify recipients of a food to prevent or mitigate a foodborne illness
outbreak and to address credible threats of serious adverse health consequences
or death to humans or animals as a result of such food being adulterated under
section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under
section 403(w) of such Act, not later than 2 years after the date of enactment
of this Act, the Secretary shall publish a notice of proposed rulemaking to
establish recordkeeping requirements, in addition to the requirements under
section 414 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350c) and
subpart J of part 1 of title 21, Code of Federal Regulations (or any successor
regulations), for facilities that manufacture, process, pack, or hold foods
that the Secretary designates under paragraph (2) as high-risk foods. The
Secretary shall set an appropriate effective date of such additional
requirements for foods designated as high risk that takes into account the
length of time necessary to comply with such requirements. Such requirements
shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id2F3A30DDDE0A46D59A5FDE04AC057712"><enum>(A)</enum><text display-inline="yes-display-inline">relate only to information that is
reasonably available and appropriate;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idBB172C0F719E43FCBC599F97CC52B8C3"><enum>(B)</enum><text display-inline="yes-display-inline">be science-based;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9B9EDDE44AAF4B6FB3885CF31493664C"><enum>(C)</enum><text display-inline="yes-display-inline">not prescribe specific technologies for the
maintenance of records;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idAA293D37F13F49259E8554BCA8116267"><enum>(D)</enum><text display-inline="yes-display-inline">ensure that the public health benefits of
imposing additional recordkeeping requirements outweigh the cost of compliance
with such requirements;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id739EAAEA6C474921A773D3BC9EC2B396"><enum>(E)</enum><text display-inline="yes-display-inline">be scale-appropriate and practicable for
facilities of varying sizes and capabilities with respect to costs and
recordkeeping burdens, and not require the creation and maintenance of
duplicate records where the information is contained in other company records
kept in the normal course of business;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idEE6F9B7BB4EE4413AEFBEA48C9186DBB"><enum>(F)</enum><text display-inline="yes-display-inline">minimize the number of different
recordkeeping requirements for facilities that handle more than 1 type of
food;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1DEAD44BEF9948C6BF4E4F21CF571D7A"><enum>(G)</enum><text display-inline="yes-display-inline">to the extent practicable, not require a
facility to change business systems to comply with such requirements;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idC52B3C265AD441B1A1644532C254421E"><enum>(H)</enum><text display-inline="yes-display-inline">allow any person subject to this subsection
to maintain records required under this subsection at a central or reasonably
accessible location provided that such records can be made available to the
Secretary not later than 24 hours after the Secretary requests such records;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idC221DED8E98B4D36B60AEE5564A62E5D"><enum>(I)</enum><text display-inline="yes-display-inline">include a process by which the Secretary
may issue a waiver of the requirements under this subsection if the Secretary
determines that such requirements would result in an economic hardship for an
individual facility or a type of facility;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA0A5C42ACF8C4D48B1C998A93B10110E"><enum>(J)</enum><text display-inline="yes-display-inline">be commensurate with the known safety risks
of the designated food;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF3EF3A5DA93A4FDB947CCCD421B2DA2E"><enum>(K)</enum><text display-inline="yes-display-inline">take into account international trade
obligations;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD7721465B48542BFB931B745490D4A1C"><enum>(L)</enum><text display-inline="yes-display-inline">not require—</text>
<clause commented="no" display-inline="no-display-inline" id="idA8F946AE0EA045F993D9B36AF45C78A1"><enum>(i)</enum><text display-inline="yes-display-inline">a full pedigree, or a record of the
complete previous distribution history of the food from the point of origin of
such food;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idD0B4D2F6910D4F6F86A03E97D0AAE413"><enum>(ii)</enum><text display-inline="yes-display-inline">records of recipients of a food beyond the
immediate subsequent recipient of such food; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idC32BF0096A4C4D419CFCD711BF4302FA"><enum>(iii)</enum><text display-inline="yes-display-inline">product tracking to the case level by
persons subject to such requirements; and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idEDD70D34F26E44A2A99ACBCBA69974C3"><enum>(M)</enum><text display-inline="yes-display-inline">include a process by which the Secretary
may remove a high-risk food designation developed under paragraph (2) for a
food or type of food.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8B3FC39FD4F1416EAB19C3F9F3039BCF"><enum>(2)</enum><header display-inline="yes-display-inline">Designation of high-risk foods</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idBCC603B30FD64B949E613A78899EBBBE"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 1 year after the date of
enactment of this Act, and thereafter as the Secretary determines necessary,
the Secretary shall designate high-risk foods for which the additional
recordkeeping requirements described in paragraph (1) are appropriate and
necessary to protect the public health. Each such designation shall be based
on—</text>
<clause commented="no" display-inline="no-display-inline" id="id8A0152A7732A4929A8A251AC551FA525"><enum>(i)</enum><text display-inline="yes-display-inline">the known safety risks of a particular
food, including the history and severity of foodborne illness outbreaks
attributed to such food, taking into consideration foodborne illness data
collected by the Centers for Disease Control and Prevention;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id31AE37C0E69441708FC43EE80FFFCEBB"><enum>(ii)</enum><text display-inline="yes-display-inline">the likelihood that a particular food has a
high potential risk for microbiological or chemical contamination or would
support the growth of pathogenic microorganisms due to the nature of the food
or the processes used to produce such food;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id1F44DADD8B10439BA7A126ADF2CF8238"><enum>(iii)</enum><text display-inline="yes-display-inline">the point in the manufacturing process of
the food where contamination is most likely to occur;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idDCCA204AD2804298B690A4CD0FA16DF5"><enum>(iv)</enum><text display-inline="yes-display-inline">the likelihood of contamination and steps
taken during the manufacturing process to reduce the possibility of
contamination;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idC52419FF1B4A4138A67AEABA29BE87B5"><enum>(v)</enum><text display-inline="yes-display-inline">the likelihood that consuming a particular
food will result in a foodborne illness due to contamination of the food;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idBC5595FFCFA84CC9B76EFA5696ACE099"><enum>(vi)</enum><text display-inline="yes-display-inline">the likely or known severity, including
health and economic impacts, of a foodborne illness attributed to a particular
food.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3F50AB018B2244968FD1F5BCB1A6AA8B"><enum>(B)</enum><header display-inline="yes-display-inline">List of high-risk foods</header><text display-inline="yes-display-inline">At the time the Secretary promulgates the
final rules under paragraph (1), the Secretary shall publish the list of the
foods designated under subparagraph (A) as high-risk foods on the Internet
website of the Food and Drug Administration. The Secretary may update the list
to designate new high-risk foods and to remove foods that are no longer deemed
to be high-risk foods, provided that each such update to the list is consistent
with the requirements of this subsection and notice of such update is published
in the Federal Register.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2CA7A137A5D249088063108D9255A5FE"><enum>(3)</enum><header display-inline="yes-display-inline">Protection of sensitive
information</header><text display-inline="yes-display-inline">In promulgating
regulations under this subsection, the Secretary shall take appropriate
measures to ensure that there are effective procedures to prevent the
unauthorized disclosure of any trade secret or confidential information that is
obtained by the Secretary pursuant to this section, including periodic risk
assessment and planning to prevent unauthorized release and controls to—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id2608FF313DC549BAA87053DEC735F0D4"><enum>(A)</enum><text display-inline="yes-display-inline">prevent unauthorized reproduction of trade
secret or confidential information;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id868E643A2D324824B282AEA0101BB3A9"><enum>(B)</enum><text display-inline="yes-display-inline">prevent unauthorized access to trade secret
or confidential information; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idBC535944C7DA4169A0B12AA72BB894E8"><enum>(C)</enum><text display-inline="yes-display-inline">maintain records with respect to access by
any person to trade secret or confidential information maintained by the
agency.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID2e221777b3c849f59587052d58d05593"><enum>(4)</enum><header display-inline="yes-display-inline">Public input</header><text display-inline="yes-display-inline">During the comment period in 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 commented="no" display-inline="no-display-inline" id="id37DE4F314C1F4A4EAB25F08EFE323E38"><enum>(5)</enum><header display-inline="yes-display-inline">Retention of records</header><text display-inline="yes-display-inline">Except as otherwise provided in this
subsection, the Secretary may require that a facility retain records under this
subsection for not more than 2 years, taking into consideration the risk of
spoilage, loss of value, or loss of palatability of the applicable food when
determining the appropriate timeframes.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDb7e235d126e942cdb8315f2d395056bd"><enum>(6)</enum><header display-inline="yes-display-inline">Limitations</header>
<subparagraph commented="no" display-inline="no-display-inline" id="IDb54565064f6c4ef5b1aa744c5fd99f2c"><enum>(A)</enum><header display-inline="yes-display-inline">Farm to school programs</header><text display-inline="yes-display-inline">In establishing requirements under this
subsection, the Secretary shall, in consultation with the Secretary of
Agriculture, consider the impact of requirements on farm to school or farm to
institution programs of the Department of Agriculture and other farm to school
and farm to institution programs outside such agency, and shall modify the
requirements under this subsection, as appropriate, with respect to such
programs so that the requirements do not place undue burdens on farm to school
or farm to institution programs.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA124A019AA6046799C7311B70D13F096"><enum>(B)</enum><header display-inline="yes-display-inline">Identity-preserved labels with respect to
farm sales of food that is produced and packaged on a farm</header><text display-inline="yes-display-inline">The requirements under this subsection
shall not apply to a food that is produced and packaged on a farm if—</text>
<clause commented="no" display-inline="no-display-inline" id="idBC8063A88D55415791C830C023F8134A"><enum>(i)</enum><text display-inline="yes-display-inline">the packaging of the food maintains the
integrity of the product and prevents subsequent contamination or alteration of
the product; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idD91742B22D5A4D1DAE01A0E45D60827D"><enum>(ii)</enum><text display-inline="yes-display-inline">the labeling of the food includes the name,
complete address (street address, town, State, country, and zip or other postal
code), and business phone number of the farm, unless the Secretary waives the
requirement to include a business phone number of the farm, as appropriate, in
order to accommodate a religious belief of the individual in charge of such
farm.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDb32ee55def0446ee832193fd9d844c19"><enum>(C)</enum><header display-inline="yes-display-inline">Fishing vessels</header><text display-inline="yes-display-inline">The requirements under this subsection with
respect to a food that is produced through the use of a fishing vessel (as
defined in section 3(18) of the Magnuson-Stevens Fishery Conservation and
Management Act (16 U.S.C. 1802(18))) shall be limited to the requirements under
subparagraph (F) until such time as the food is sold by the owner, operator, or
agent in charge of such fishing vessel.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID61eddde3796c4d10bcb0cfee2a06827c"><enum>(D)</enum><header display-inline="yes-display-inline">Commingled raw agricultural
commodities</header>
<clause commented="no" display-inline="no-display-inline" id="ID8479d5fcbcc44fa683a23cc1e2c52e91"><enum>(i)</enum><header display-inline="yes-display-inline">Limitation on extent of
tracing</header><text display-inline="yes-display-inline">Recordkeeping
requirements under this subsection with regard to any commingled raw
agricultural commodity shall be limited to the requirements under subparagraph
(F).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID040e6884217544c89855f2e21cab0775"><enum>(ii)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">For the purposes of this
subparagraph—</text>
<subclause commented="no" display-inline="no-display-inline" id="IDf2319a64022d4e09ac5e52576b2ee1ab"><enum>(I)</enum><text display-inline="yes-display-inline">the term <term>commingled raw agricultural
commodity</term> means any commodity that is combined or mixed after
harvesting, but before processing;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID1ee112c024a94c0097a165de33087f79"><enum>(II)</enum><text display-inline="yes-display-inline">the term <term>commingled raw agricultural
commodity</term> shall not include types of fruits and vegetables that are raw
agricultural commodities for which the Secretary has determined that standards
promulgated under section 419 of the Federal Food, Drug, and Cosmetic Act (as
added by section 105) would minimize the risk of serious adverse health
consequences or death; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID18f99b3ac1aa4995850c1c541808a2da"><enum>(III)</enum><text display-inline="yes-display-inline">the term <term>processing</term> means
operations that alter the general state of the commodity, such as canning,
cooking, freezing, dehydration, milling, grinding, pasteurization, or
homogenization.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID12d228480c094baabe46462a223d5eae"><enum>(E)</enum><header display-inline="yes-display-inline">Exemption of other foods</header><text display-inline="yes-display-inline">The Secretary may, by notice in the Federal
Register, modify the requirements under this subsection with respect to, or
exempt a food or a type of facility from, the requirements of this subsection
(other than the requirements under subparagraph (F), if applicable) if the
Secretary determines that product tracing requirements for such food (such as
bulk or commingled ingredients that are intended to be processed to destroy
pathogens) or type of facility is not necessary to protect the public
health.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idCE0A89E2B25D41B4A7AAA702DBD4E2F9"><enum>(F)</enum><header display-inline="yes-display-inline">Recordkeeping regarding previous sources
and subsequent recipients</header><text display-inline="yes-display-inline">In
the case of a person or food to which a limitation or exemption under
subparagraph (C), (D), or (E) applies, if such person, or a person who
manufactures, processes, packs, or holds such food, is required to register
with the Secretary under section 415 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 350d) with respect to the manufacturing, processing, packing, or
holding of the applicable food, the Secretary shall require such person to
maintain records that identify the immediate previous source of such food and
the immediate subsequent recipient of such food.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID17b8b53ecf7b46e9860fcbda0520abc6"><enum>(G)</enum><header display-inline="yes-display-inline">Grocery
stores</header><text display-inline="yes-display-inline">With respect to a sale
of a food described in subparagraph (H) to a grocery store, the Secretary shall
not require such grocery store to maintain records under this subsection other
than records documenting the farm that was the source of such food. The
Secretary shall not require that such records be kept for more than 180
days.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF862F765E93745C3A85081F0E0095A21"><enum>(H)</enum><header display-inline="yes-display-inline">Farm sales to consumers</header><text display-inline="yes-display-inline">The Secretary shall not require a farm to
maintain any distribution records under this subsection with respect to a sale
of a food described in subparagraph (I) (including a sale of a food that is
produced and packaged on such farm), if such sale is made by the farm directly
to a consumer.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idEA5C006CF3A843E095B63AF0402ADF04"><enum>(I)</enum><header display-inline="yes-display-inline">Sale
of a food</header><text display-inline="yes-display-inline">A sale of a food
described in this subparagraph is a sale of a food in which—</text>
<clause commented="no" display-inline="no-display-inline" id="id8275A0E52FC24297BE7F1B1BA1B44CDF"><enum>(i)</enum><text display-inline="yes-display-inline">the food is produced on a farm; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idCCF78ADFA0934A5385339A7CC3F7E8CF"><enum>(ii)</enum><text display-inline="yes-display-inline">the sale is made by the owner, operator, or
agent in charge of such farm directly to a consumer or grocery store.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id970A7AD9F6D841E6923DBE5C69847C61"><enum>(7)</enum><header display-inline="yes-display-inline">No impact on non-high-risk
foods</header><text display-inline="yes-display-inline">The recordkeeping
requirements established under paragraph (1) shall have no effect on foods that
are not designated by the Secretary under paragraph (2) as high-risk foods.
Foods described in the preceding sentence shall be subject solely to the
recordkeeping requirements under section 414 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 350c) and subpart J of part 1 of title 21, Code of
Federal Regulations (or any successor regulations).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idE4E87CB811A74036932E6A5505B1650A"><enum>(e)</enum><header display-inline="yes-display-inline">Evaluation and recommendations</header>
<paragraph commented="no" display-inline="no-display-inline" id="idEBF202E79DB94CF6B73437FD11981A26"><enum>(1)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">Not later than 1 year after the effective
date of the final rule promulgated under subsection (d)(1), the Comptroller
General of the United States shall submit to Congress a report, taking into
consideration the costs of compliance and other regulatory burdens on small
businesses and Federal, State, and local food safety practices and
requirements, that evaluates the public health benefits and risks, if any, of
limiting—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDad0888ca5930435c8dc19d7a1850d986"><enum>(A)</enum><text display-inline="yes-display-inline">the product tracing requirements under
subsection (d) to foods identified under paragraph (2) of such subsection,
including whether such requirements provide adequate assurance of traceability
in the event of intentional adulteration, including by acts of terrorism;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID019bf9f20421467190813d73e92f3fad"><enum>(B)</enum><text display-inline="yes-display-inline">the participation of restaurants in the
recordkeeping requirements.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID22f22e0ef9b04e6c9bcb59db6f3cf1a3"><enum>(2)</enum><header display-inline="yes-display-inline">Determination and
recommendations</header><text display-inline="yes-display-inline">In conducting
the evaluation and report under paragraph (1), if the Comptroller General of
the United States determines that the limitations described in such paragraph
do not adequately protect the public health, the Comptroller General shall
submit to Congress recommendations, if appropriate, regarding recordkeeping
requirements for restaurants and additional foods, in order to protect the
public health.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id8CDF7B0F8D8642CE84D7B46E082A52D0"><enum>(f)</enum><header display-inline="yes-display-inline">Farms</header>
<paragraph commented="no" display-inline="no-display-inline" id="id41CE8D357C8D4A5F92C77ADCBC07AF12"><enum>(1)</enum><header display-inline="yes-display-inline">Request for information</header><text display-inline="yes-display-inline">Notwithstanding subsection (d), during an
active investigation of a foodborne illness outbreak, or if the Secretary
determines it is necessary to protect the public health and prevent or mitigate
a foodborne illness outbreak, the Secretary, in consultation and coordination
with State and local agencies responsible for food safety, as appropriate, may
request that the owner, operator, or agent of a farm identify potential
immediate recipients, other than consumers, of an article of the food that is
the subject of such investigation if the Secretary reasonably believes such
article of food—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idC89AFC06016545B7A32CA2095A0C9E3D"><enum>(A)</enum><text display-inline="yes-display-inline">is adulterated under section 402 of the
Federal Food, Drug, and Cosmetic Act;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6069E532FC734FBDA1D338F875CEF9B0"><enum>(B)</enum><text display-inline="yes-display-inline">presents a threat of serious adverse health
consequences or death to humans or animals; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idE1D26145DCC54B49B5EFF11B421F9195"><enum>(C)</enum><text display-inline="yes-display-inline">was adulterated as described in
subparagraph (A) on a particular farm (as defined in section 1.227 of chapter
21, Code of Federal Regulations (or any successor regulation)).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id39E287CAF4B84BC39D4401247182E2DE"><enum>(2)</enum><header display-inline="yes-display-inline">Manner of request</header><text display-inline="yes-display-inline">In making a request under paragraph (1),
the Secretary, in consultation and coordination with State and local agencies
responsible for food safety, as appropriate, shall issue a written notice to
the owner, operator, or agent of the farm to which the article of food has been
traced. The individual providing such notice shall present to such owner,
operator, or agent appropriate credentials and shall deliver such notice at
reasonable times and within reasonable limits and in a reasonable
manner.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB4E23ABA5177444482459CE0555A8CC8"><enum>(3)</enum><header display-inline="yes-display-inline">Delivery of information
requested</header><text display-inline="yes-display-inline">The owner,
operator, or agent of a farm shall deliver the information requested under
paragraph (1) in a prompt and reasonable manner. Such information may consist
of records kept in the normal course of business, and may be in electronic or
non-electronic format.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idBDAF38C7AAC54D27AFE49510D4A4E09C"><enum>(4)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">A request made under paragraph (1) shall
not include a request for information relating to the finances, pricing of
commodities produced, personnel, research, sales (other than information
relating to shipping), or other disclosures that may reveal trade secrets or
confidential information from the farm to which the article of food has been
traced, other than information necessary to identify potential immediate
recipients of such food. Section 301(j) of the Federal Food, Drug, and Cosmetic
Act and the Freedom of Information Act shall apply with respect to any
confidential commercial information that is disclosed to the Food and Drug
Administration in the course of responding to a request under paragraph
(1).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id065201F75FD44016ABB734778D338B0E"><enum>(5)</enum><header display-inline="yes-display-inline">Records</header><text display-inline="yes-display-inline">Except with respect to identifying
potential immediate recipients in response to a request under this subsection,
nothing in this subsection shall require the establishment or maintenance by
farms of new records.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID73efbd7609db4cb1a0b0f7de60fcf66c"><enum>(g)</enum><header display-inline="yes-display-inline">No limitation on commingling of
food</header><text display-inline="yes-display-inline">Nothing in this section
shall be construed to authorize the Secretary to impose any limitation on the
commingling of food.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="IDa45c1b14cfa94ca2ba7d70c323f2bd7a"><enum>(h)</enum><header display-inline="yes-display-inline">Small entity compliance guide</header><text display-inline="yes-display-inline">Not later than 180 days after promulgation
of a final rule under subsection (d), the Secretary shall issue a small entity
compliance guide setting forth in plain language the requirements of the
regulations under such subsection in order to assist small entities, including
farms and small businesses, in complying with the recordkeeping requirements
under such subsection.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID8a1ef385bf794b8789bfc409f99db4be"><enum>(i)</enum><header display-inline="yes-display-inline">Flexibility for small
businesses</header><text display-inline="yes-display-inline">Notwithstanding
any other provision of law, the regulations promulgated under subsection (d)
shall apply—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id394BF3A8140344DD9A3E765434A54D36"><enum>(1)</enum><text display-inline="yes-display-inline">to small businesses (as defined by the
Secretary in section 103, not later than 90 days after the date of enactment of
this Act) beginning on the date that is 1 year after the effective date of the
final regulations promulgated under subsection (d); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6B62EA3135E04EC89645E73E4A0C90BB"><enum>(2)</enum><text display-inline="yes-display-inline">to very small businesses (as defined by the
Secretary in section 103, not later than 90 days after the date of enactment of
this Act) beginning on the date that is 2 years after the effective date of the
final regulations promulgated under subsection (d).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID846fe74e1d354b5a8ccb3c585c9a2f5b"><enum>(j)</enum><header display-inline="yes-display-inline">Enforcement</header>
<paragraph commented="no" display-inline="no-display-inline" id="id1D8A142E266745EE9D09B115F562AFA5"><enum>(1)</enum><header display-inline="yes-display-inline">Prohibited acts</header><text display-inline="yes-display-inline">Section 301(e) (21 U.S.C. 331(e)) is
amended by inserting <quote>; or the violation of any recordkeeping requirement
under section 204 of the FDA Food Safety Modernization Act (except when such
violation is committed by a farm)</quote> before the period at the end.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC5E36A4995E74D448A617EEE7AD9A379"><enum>(2)</enum><header display-inline="yes-display-inline">Imports</header><text display-inline="yes-display-inline">Section 801(a) (21 U.S.C. 381(a)) is
amended by inserting <quote>or (4) the recordkeeping requirements under section
204 of the FDA Food Safety Modernization Act (other than the requirements under
subsection (f) of such section) have not been complied with regarding such
article,</quote> in the third sentence before <quote>then such article shall be
refused admission</quote>.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="IDc663c2f680d6450ca21c934c9ef74446" section-type="subsequent-section"><enum>205.</enum><header display-inline="yes-display-inline">Surveillance</header>
<subsection commented="no" display-inline="no-display-inline" id="ID06b87a7390f7458697ec7fbe76af4bb7"><enum>(a)</enum><header display-inline="yes-display-inline">Definition of foodborne illness
outbreak</header><text display-inline="yes-display-inline">In this Act, the
term <term>foodborne illness outbreak</term> means the occurrence of 2 or more
cases of a similar illness resulting from the ingestion of a certain
food.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID4ad397fba5be431a9ce7207b5441d09e"><enum>(b)</enum><header display-inline="yes-display-inline">Foodborne illness surveillance
systems</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID772a1ad7ac1342efae1096a116221b53"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall enhance foodborne
illness surveillance systems to improve the collection, analysis, reporting,
and usefulness of data on foodborne illnesses by—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID523816eb81ff45da8a19ecefbd365aa6"><enum>(A)</enum><text display-inline="yes-display-inline">coordinating Federal, State and local
foodborne illness surveillance systems, including complaint systems, and
increasing participation in national networks of public health and food
regulatory agencies and laboratories;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDc9a3b32f68454d25a6fcc05458f13f2a"><enum>(B)</enum><text display-inline="yes-display-inline">facilitating sharing of surveillance
information on a more timely basis among governmental agencies, including the
Food and Drug Administration, the Department of Agriculture, the Department of
Homeland Security, and State and local agencies, and with the public;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id73E27FC7297F42DBBD72866248D75ABC"><enum>(C)</enum><text display-inline="yes-display-inline">developing improved epidemiological tools
for obtaining quality exposure data and microbiological methods for classifying
cases;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID36bfe76b1eca4fd080f2884ce5d3d7e9"><enum>(D)</enum><text display-inline="yes-display-inline">augmenting such systems to improve
attribution of a foodborne illness outbreak to a specific food;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID59b7ab4029f14a858929672f37617be3"><enum>(E)</enum><text display-inline="yes-display-inline">expanding capacity of such systems,
including working toward automatic electronic searches, for implementation of
identification practices, including fingerprinting strategies, for foodborne
infectious agents, in order to identify new or rarely documented causes of
foodborne illness and submit standardized information to a centralized
database;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID099d3ea142934b4bb73605d1688a9cb1"><enum>(F)</enum><text display-inline="yes-display-inline">allowing timely public access to
aggregated, de-identified surveillance data;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID9d3379efa4b740b7af54881cbf2ef1d6"><enum>(G)</enum><text display-inline="yes-display-inline">at least annually, publishing current
reports on findings from such systems;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID199bba0ab03343ebac9e100df724cd8e"><enum>(H)</enum><text display-inline="yes-display-inline">establishing a flexible mechanism for
rapidly initiating scientific research by academic institutions;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID5a55acf6f30c4a72ac5a57cef2bc2017"><enum>(I)</enum><text display-inline="yes-display-inline">integrating foodborne illness surveillance
systems and data with other biosurveillance and public health situational
awareness capabilities at the Federal, State, and local levels, including by
sharing foodborne illness surveillance data with the National Biosurveillance
Integration Center; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6A588A88A40D4575AA995312B88854C7"><enum>(J)</enum><text display-inline="yes-display-inline">other activities as determined appropriate
by the Secretary.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID5c6019f4036349b79beaa0e4cd9c9467"><enum>(2)</enum><header display-inline="yes-display-inline">Working group</header><text display-inline="yes-display-inline">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 and food testing industries,
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 foodborne illness surveillance and implementation
of this section, including advice and recommendations on—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID83d4b14554fc47b1a52d2d387c444ae8"><enum>(A)</enum><text display-inline="yes-display-inline">the priority needs of regulatory agencies,
the food industry, and consumers for information and analysis on foodborne
illness and its causes;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID6b6d1f3837c348a683874da2924bc3cc"><enum>(B)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="IDf05d40009e0e48a9b3cabff6b83b0768"><enum>(C)</enum><text display-inline="yes-display-inline">improvement in the timeliness and depth of
access by regulatory and health agencies, the food industry, academic
researchers, and consumers to foodborne illness aggregated, de-identified
surveillance data collected by government agencies at all levels, including
data compiled by the Centers for Disease Control and Prevention;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID074826a7deb14ce8818be18bbbaaa0a7"><enum>(D)</enum><text display-inline="yes-display-inline">key barriers at Federal, State, and local
levels to improving foodborne illness surveillance and the utility of such
surveillance for preventing foodborne illness;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID1e43a327d80c409fbfb87b28fdf8caaa"><enum>(E)</enum><text display-inline="yes-display-inline">the capabilities needed for establishing
automatic electronic searches of surveillance data; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID3d1e9266055c4503a3d798adc0067865"><enum>(F)</enum><text display-inline="yes-display-inline">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><paragraph commented="no" display-inline="no-display-inline" id="idCEE9DA2BD5D64F82BA20458F92D9110E"><enum>(3)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">To carry out
the activities described in paragraph (1), there is authorized to be
appropriated $24,000,000 for each fiscal years 2011 through 2015.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID0108ed1912a743b2ab5d180e49cdd0a3"><enum>(c)</enum><header display-inline="yes-display-inline">Improving food safety and defense capacity
at the State and local level</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDd2cdeacc0baf4e75b1243b6b945234d8"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID35f84c2cf31e45b1acb6c2396fe786b3"><enum>(A)</enum><text display-inline="yes-display-inline">Improve foodborne illness outbreak response
and containment.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDa65e99e673a5483eafcbe78d1dadad3b"><enum>(B)</enum><text display-inline="yes-display-inline">Accelerate foodborne 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 commented="no" display-inline="no-display-inline" id="ID74ac85aba31344629e08492d6edfa18d"><enum>(C)</enum><text display-inline="yes-display-inline">Strengthen the capacity of State and local
agencies to carry out inspections and enforce safety standards.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID8778b365f65e4d6dab2e713446ee4485"><enum>(D)</enum><text display-inline="yes-display-inline">Improve the effectiveness of Federal,
State, and local partnerships to coordinate food safety and defense resources
and reduce the incidence of foodborne illness.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID29f0633475044eae8bff5bfda06c7201"><enum>(E)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID0ef1cf4b832d43ee9f01cf88df398d63"><enum>(F)</enum><text display-inline="yes-display-inline">Strengthen the capacity of State and local
agencies to achieve the goals described in section 108.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDb9c1967e444440a4af790c1a40ceb13a"><enum>(2)</enum><header display-inline="yes-display-inline">Review</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID636c99ead1c0443991b6e04b04931c8e"><enum>(A)</enum><text display-inline="yes-display-inline">staffing levels and expertise available to
perform food safety and defense functions;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID07a323b67f634ee991508bae876796fc"><enum>(B)</enum><text display-inline="yes-display-inline">laboratory capacity to support
surveillance, outbreak response, inspection, and enforcement activities;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDb297a8d2d9e04b31a0a7ae603a541986"><enum>(C)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID928f74cdb2c440998cab5fe91e2e644d"><enum>(D)</enum><text display-inline="yes-display-inline">other State and local activities and needs
as determined appropriate by the Secretary.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID7be0f1acc7ae4d41881a1af07ebaaf45"><enum>(d)</enum><header display-inline="yes-display-inline">Food safety capacity building
grants</header><text display-inline="yes-display-inline">Section 317R(b) of the
Public Health Service Act (42 U.S.C. 247b–20(b)) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id03A884040BD847E39E648648B3C593E7"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>2002</quote> and
inserting <quote>2010</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9F07268A20E641CFA94D22A2B42671F6"><enum>(2)</enum><text display-inline="yes-display-inline">by striking <quote>2003 through
2006</quote> and inserting <quote>2011 through 2015</quote>.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="idD7E1B29B11F940A988ADEE9B18241508" section-type="subsequent-section"><enum>206.</enum><header display-inline="yes-display-inline">Mandatory recall authority</header>
<subsection commented="no" display-inline="no-display-inline" id="idE7068A9E299D4D4D9706B97EA2E91F48"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Chapter IV (21 U.S.C. 341 et seq.), as
amended by section 202, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id45ADA24E01494A8ABC3996A8FCB242EA" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id5E8458818782404EB27A9BDF42BD15C1" section-type="subsequent-section"><enum>423.</enum><header display-inline="yes-display-inline">Mandatory recall authority</header>
<subsection commented="no" display-inline="no-display-inline" id="ID13baea3e74084fbd80b1cd84af39cc83"><enum>(a)</enum><header display-inline="yes-display-inline">Voluntary procedures</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID20a33b12433948b0bbd34a4b23b24e48"><enum>(b)</enum><header display-inline="yes-display-inline">Prehearing order To cease distribution and
give notice</header>
<paragraph commented="no" display-inline="no-display-inline" id="id76E36932F0B24250A07AB59A7BAF3758"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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>
<subparagraph commented="no" display-inline="no-display-inline" id="IDd9790193623f4bb5b4629ba2296bbb17"><enum>(A)</enum><text display-inline="yes-display-inline">immediately cease distribution of such
article; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID7c88319108cb4fcd8db8541af68657c5"><enum>(B)</enum><text display-inline="yes-display-inline">as applicable, immediately notify all
persons—</text>
<clause commented="no" display-inline="no-display-inline" id="ID97ba6f8dc3064363bc49c1582d6f9407"><enum>(i)</enum><text display-inline="yes-display-inline">manufacturing, processing, packing,
transporting, distributing, receiving, holding, or importing and selling such
article; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID25963b0bbe274aa88f106411dd7c1c3d"><enum>(ii)</enum><text display-inline="yes-display-inline">to which such article has been distributed,
transported, or sold, to immediately cease distribution of such article.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id557F5000E283419FB0C2CDA358E62A97"><enum>(2)</enum><header display-inline="yes-display-inline">Required additional information</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID2db09915f5c04318b69ea8d31e8baa87"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">If an article of food covered by a recall
order issued under paragraph (1)(B) has been distributed to a warehouse-based
third party logistics provider without providing such provider sufficient
information to know or reasonably determine the precise identity of the article
of food covered by a recall order that is in its possession, the notice
provided by the responsible party subject to the order issued under paragraph
(1)(B) shall include such information as is necessary for the warehouse-based
third party logistics provider to identify the food.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idEFDBD7EEC3F740A09E3D5B893B34D78D"><enum>(B)</enum><header display-inline="yes-display-inline">Rules of construction</header><text display-inline="yes-display-inline">Nothing in this paragraph shall be
construed—</text>
<clause commented="no" display-inline="no-display-inline" id="id46CC528531494718B5899E6B08551145"><enum>(i)</enum><text display-inline="yes-display-inline">to exempt a warehouse-based third party
logistics provider from the requirements of this Act, including the
requirements in this section and section 414; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id3DD12D02366C49D6BC65DE4723C90078"><enum>(ii)</enum><text display-inline="yes-display-inline">to exempt a warehouse-based third party
logistics provider from being the subject of a mandatory recall order.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6465CA753FBC4259AB60FE28A489FDC7"><enum>(3)</enum><header display-inline="yes-display-inline">Determination to limit areas
affected</header><text display-inline="yes-display-inline">If the Secretary
requires a responsible party to cease distribution under paragraph (1)(A) of an
article of food identified in subsection (a), the Secretary may limit the size
of the geographic area and the markets affected by such cessation if such
limitation would not compromise the public health.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID5ad942fa1c57494cadba472f86e2fe35"><enum>(c)</enum><header display-inline="yes-display-inline">Hearing on order</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="IDedb477b7f8ca49a0a69342d0fdd68cd8"><enum>(d)</enum><header display-inline="yes-display-inline">Post-hearing recall order and modification
of order</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDe9182f88f2bd49d59129c995a9725ce0"><enum>(1)</enum><header display-inline="yes-display-inline">Amendment of order</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID1534d5ac68d14ec8a15b50eb53c67d45"><enum>(A)</enum><text display-inline="yes-display-inline">amend the order to require recall of such
article or other appropriate action;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDd314f2ba139e44e788192bc3be241f3c"><enum>(B)</enum><text display-inline="yes-display-inline">specify a timetable in which the recall
shall occur;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID35e20306b16b49578a6c0509fac07624"><enum>(C)</enum><text display-inline="yes-display-inline">require periodic reports to the Secretary
describing the progress of the recall; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID3db5d0a8273546cd8fb526e72934680d"><enum>(D)</enum><text display-inline="yes-display-inline">provide notice to consumers to whom such
article was, or may have been, distributed.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID627d85dc241f4b23827663e62c8e5525"><enum>(2)</enum><header display-inline="yes-display-inline">Vacating of order</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id99F8009866914A8E8CE3397DFD01B9B3"><enum>(e)</enum><header display-inline="yes-display-inline">Rule regarding alcoholic
beverages</header><text display-inline="yes-display-inline">The Secretary shall
not initiate a mandatory recall or take any other action under this section
with respect to any alcohol beverage until the Secretary has provided the
Alcohol and Tobacco Tax and Trade Bureau with a reasonable opportunity to cease
distribution and recall such article under the Alcohol and Tobacco Tax and
Trade Bureau authority.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id134C07C75A014A0CB0436053A720831C"><enum>(f)</enum><header display-inline="yes-display-inline">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" display-inline="no-display-inline" id="idF797EE02B70A4940ACC6A82D0DA8D2FB"><enum>(g)</enum><header display-inline="yes-display-inline">Public notification</header><text display-inline="yes-display-inline">In conducting a recall under this section,
the Secretary shall—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id5B56F96927744EBCBB6F70922AAD1CD5"><enum>(1)</enum><text display-inline="yes-display-inline">ensure that a press release is published
regarding the recall, as well as alerts and public notices, as appropriate, in
order to provide notification—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id40A67FF77F9043DBAC72C818FFE6E70D"><enum>(A)</enum><text display-inline="yes-display-inline">of the recall to consumers and retailers to
whom such article was, or may have been, distributed; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idB3C712F9CCE942D481DD5C5338907832"><enum>(B)</enum><text display-inline="yes-display-inline">that includes, at a minimum—</text>
<clause commented="no" display-inline="no-display-inline" id="idD7CC8CF77FE24C8599F3AB866E8A4193"><enum>(i)</enum><text display-inline="yes-display-inline">the name of the article of food subject to
the recall;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id403AB7B733FB48C3A1750AAB1D5F3B0E"><enum>(ii)</enum><text display-inline="yes-display-inline">a description of the risk associated with
such article; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id5A5C724A7E6F40EE9A18FCC80B97A916"><enum>(iii)</enum><text display-inline="yes-display-inline">to the extent practicable, information for
consumers about similar articles of food that are not affected by the
recall;</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idDA1B1CA668C640DEB9CF747EEEF52423"><enum>(2)</enum><text display-inline="yes-display-inline">consult the policies of the Department of
Agriculture regarding providing to the public a list of retail consignees
receiving products involved in a Class I recall and shall consider providing
such a list to the public, as determined appropriate by the Secretary;
and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3C88B9251FD24CFABF0534E7FD268336"><enum>(3)</enum><text display-inline="yes-display-inline">if available, publish on the Internet Web
site of the Food and Drug Administration an image of the article that is the
subject of the press release described in (1).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id3C710EEC276546C0BF417AD49C283370"><enum>(h)</enum><header display-inline="yes-display-inline">No delegation</header><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="id20479ABD811545468A503C4CDE3CC9E9"><enum>(i)</enum><header display-inline="yes-display-inline">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, or
to issue an order to cease distribution or to recall under any other provision
of this Act or under the Public Health Service Act.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id6A94E031414E4AEA9107A7ABED725613"><enum>(j)</enum><header display-inline="yes-display-inline">Coordinated communication</header>
<paragraph commented="no" display-inline="no-display-inline" id="id53384BC7C22041C385E0A4D145E1BB50"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">To assist in carrying out the requirements
of this subsection, the Secretary shall establish an incident command operation
or a similar operation within the Department of Health and Human Services that
will operate not later than 24 hours after the initiation of a mandatory recall
or the recall of an article of food for which the use of, or exposure to, such
article will cause serious adverse health consequences or death to humans or
animals.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idF6DF2845DC394C82AD51E2E5832B2C7C"><enum>(2)</enum><header display-inline="yes-display-inline">Requirements</header><text display-inline="yes-display-inline">To reduce the potential for
miscommunication during recalls or regarding investigations of a food borne
illness outbreak associated with a food that is subject to a recall, each
incident command operation or similar operation under paragraph (1) shall use
regular staff and resources of the Department of Health and Human Services
to—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id72A0CD9EB70F421687543C3402FC38FC"><enum>(A)</enum><text display-inline="yes-display-inline">ensure timely and coordinated communication
within the Department, including enhanced communication and coordination
between different agencies and organizations within the Department;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2C9C0320881648758FF29824C67B810F"><enum>(B)</enum><text display-inline="yes-display-inline">ensure timely and coordinated communication
from the Department, including public statements, throughout the duration of
the investigation and related foodborne illness outbreak;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id466B059E19034289B7E933B0F6A74876"><enum>(C)</enum><text display-inline="yes-display-inline">identify a single point of contact within
the Department for public inquiries regarding any actions by the Secretary
related to a recall;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id069E1B49B8944EC0A4EEEC941BEB4ED2"><enum>(D)</enum><text display-inline="yes-display-inline">coordinate with Federal, State, local, and
tribal authorities, as appropriate, that have responsibilities related to the
recall of a food or a foodborne illness outbreak associated with a food that is
subject to the recall, including notification of the Secretary of Agriculture
and the Secretary of Education in the event such recalled food is a commodity
intended for use in a child nutrition program (as identified in section 25(b)
of the Richard B. Russell National School Lunch Act (42 U.S.C. 1769f(b));
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1DE5B6B1DFCE468E8C8C8617CF87CFAD"><enum>(E)</enum><text display-inline="yes-display-inline">conclude operations at such time as the
Secretary determines appropriate.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id428E99693CD24BD1BC222AB453822F44"><enum>(3)</enum><header display-inline="yes-display-inline">Multiple recalls</header><text display-inline="yes-display-inline">The Secretary may establish multiple or
concurrent incident command operations or similar operations in the event of
multiple recalls or foodborne illness outbreaks necessitating such action by
the Department of Health and Human
Services.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID43d32cfc0c164d81a35155bc478f28a7"><enum>(b)</enum><header display-inline="yes-display-inline">Search engine</header><text display-inline="yes-display-inline">Not later than 90 days after the date of
enactment of this Act, the Secretary shall modify the Internet Web site of the
Food and Drug Administration to include a search engine that—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDf03b6be678fc40e69fcd9da2a53d29c1"><enum>(1)</enum><text display-inline="yes-display-inline">is consumer-friendly, as determined by the
Secretary; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID08f1374a0a6745fba1dd505fd051b93e"><enum>(2)</enum><text display-inline="yes-display-inline">provides a means by which an individual may
locate relevant information regarding each article of food subject to a recall
under section 423 of the Federal Food, Drug, and Cosmetic Act and the status of
such recall (such as whether a recall is ongoing or has been completed).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id3EC5D67819DB4916B8C0949CF2BF4145"><enum>(c)</enum><header display-inline="yes-display-inline">Civil penalty</header><text display-inline="yes-display-inline">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 423</quote> after <quote>section
402(a)(2)(B)</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID42fdb50b3ab34a3fa71167941c840cb7"><enum>(d)</enum><header display-inline="yes-display-inline">Prohibited acts</header><text display-inline="yes-display-inline">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="id40593F898920447C88C7BACADEF7878B" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="ID9ee2af4e3a4444b5b5e3b51eac875620"><enum>(xx)</enum><text display-inline="yes-display-inline">The refusal or failure to follow an order
under section
423.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id28AE78E12CD54B03A47C80CE89FDE0A6"><enum>(e)</enum><header display-inline="yes-display-inline">GAO review</header>
<paragraph commented="no" display-inline="no-display-inline" id="id63DE64FCC043469EB33F66FFB6E14B44"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 90 days after the date of
enactment of this Act, the Comptroller General of the United States shall
submit to Congress a report that—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id1F704649BA214A598D7E01263B8C390D"><enum>(A)</enum><text display-inline="yes-display-inline">identifies State and local agencies with
the authority to require the mandatory recall of food, and evaluates use of
such authority with regard to frequency, effectiveness, and appropriateness,
including consideration of any new or existing mechanisms available to
compensate persons for general and specific recall-related costs when a recall
is subsequently determined by the relevant authority to have been an
error;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3D86EC5098164CF5BE4483B4A51395B0"><enum>(B)</enum><text display-inline="yes-display-inline">identifies Federal agencies, other than the
Department of Health and Human Services, with mandatory recall authority and
examines use of that authority with regard to frequency, effectiveness, and
appropriateness, including any new or existing mechanisms available to
compensate persons for general and specific recall-related costs when a recall
is subsequently determined by the relevant agency to have been an error;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2C4E902F247C4BE1B78817901E78BBEE"><enum>(C)</enum><text display-inline="yes-display-inline">considers models for farmer restitution
implemented in other nations in cases of erroneous recalls; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idAB720D7B12674766977D908824048370"><enum>(D)</enum><text display-inline="yes-display-inline">makes recommendations to the Secretary
regarding use of the authority under section 423 of the Federal Food, Drug, and
Cosmetic Act (as added by this section) to protect the public health while
seeking to minimize unnecessary economic costs.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6F27A09244054A119C98E7285743C339"><enum>(2)</enum><header display-inline="yes-display-inline">Effect of review</header><text display-inline="yes-display-inline">If the Comptroller General of the United
States finds, after the review conducted under paragraph (1), that the
mechanisms described in such paragraph do not exist or are inadequate, then,
not later than 90 days after the conclusion of such review, the Secretary of
Agriculture shall conduct a study of the feasibility of implementing a farmer
indemnification program to provide restitution to agricultural producers for
losses sustained as a result of a mandatory recall of an agricultural commodity
by a Federal or State regulatory agency that is subsequently determined to be
in error. The Secretary of Agriculture shall submit to the Committee on
Agriculture of the House of Representatives and the Committee on Agriculture,
Nutrition, and Forestry of the Senate a report that describes the results of
the study, including any recommendations.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id09757AF35CA44171B0BDA4346D3D4A63"><enum>(f)</enum><header display-inline="yes-display-inline">Annual report to Congress</header>
<paragraph commented="no" display-inline="no-display-inline" id="id983922D6BA104831A1F5AC48534D54BF"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 2 years after the date of
enactment of this Act and annually thereafter, the Secretary of Health and
Human Services (referred to in this subsection as the <quote>Secretary</quote>)
shall submit a report to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce of the House of
Representatives on the use of recall authority under section 423 of the Federal
Food, Drug, and Cosmetic Act (as added by subsection (a)) and any public health
advisories issued by the Secretary that advise against the consumption of an
article of food on the ground that the article of food is adulterated and poses
an imminent danger to health.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id927DCBEA2A3342A7BFF9EE62F21B4C32"><enum>(2)</enum><header display-inline="yes-display-inline">Content</header><text display-inline="yes-display-inline">The report under paragraph (1) shall
include, with respect to the report year—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idD7D7355E2754498190377696BA480E5E"><enum>(A)</enum><text display-inline="yes-display-inline">the identity of each article of food that
was the subject of a public health advisory described in paragraph (1), an
opportunity to cease distribution and recall under subsection (a) of section
423 of the Federal Food, Drug, and Cosmetic Act, or a mandatory recall order
under subsection (b) of such section;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id698DF1784BAF4E989A8C61834752AE94"><enum>(B)</enum><text display-inline="yes-display-inline">the number of responsible parties, as
defined in section 417 of the Federal Food, Drug, and Cosmetic Act, formally
given the opportunity to cease distribution of an article of food and recall
such article, as described in section 423(a) of such Act;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id18EA4211C89E47C69E6763CDDD7EDF10"><enum>(C)</enum><text display-inline="yes-display-inline">the number of responsible parties described
in subparagraph (B) who did not cease distribution of or recall an article of
food after given the opportunity to cease distribution or recall under section
423(a) of the Federal Food, Drug, and Cosmetic Act;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7C5BE96C0A254C55A1082D5169C789F2"><enum>(D)</enum><text display-inline="yes-display-inline">the number of recall orders issued under
section 423(b) of the Federal Food, Drug, and Cosmetic Act; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3277687A98ED49B88CB0F180BAA22BD9"><enum>(E)</enum><text display-inline="yes-display-inline">a description of any instances in which
there was no testing that confirmed adulteration of an article of food that was
the subject of a recall under section 423(b) of the Federal Food, Drug, and
Cosmetic Act or a public health advisory described in paragraph (1).</text>
</subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id27A2350148944A55BD794AA763ACF49A" section-type="subsequent-section"><enum>207.</enum><header display-inline="yes-display-inline">Administrative detention of food</header>
<subsection commented="no" display-inline="no-display-inline" id="ID0ebfa95a8b16499dbb510f0f55afbb71"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 304(h)(1)(A) (21 U.S.C.
334(h)(1)(A)) is amended by—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID3ff5da7d662343159a5c69e18d091aa5"><enum>(1)</enum><text display-inline="yes-display-inline">striking <quote>credible evidence or
information indicating</quote> and inserting <quote>reason to believe</quote>;
and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID049062411eb8400fad23d84a4f618eaf"><enum>(2)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="IDcd42421659f7411da757991e4b71dc4b"><enum>(b)</enum><header display-inline="yes-display-inline">Regulations</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID79c43ee77e77400bbbd5c729b4e3a70d"><enum>(c)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">The amendment made by
this section shall take effect 180 days after the date of enactment of this
Act.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="IDfc21a396983c4986aeff336a81a16758" section-type="subsequent-section"><enum>208.</enum><header display-inline="yes-display-inline">Decontamination and disposal standards and
plans</header>
<subsection commented="no" display-inline="no-display-inline" id="ID94d6715074a04c978fab19a9b4653000"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="ID95f6ad3af7c643a59ee3b99f42e9d9fc"><enum>(b)</enum><header display-inline="yes-display-inline">Development of standards</header><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="ID61eead938608433eb7b0ed5db60168e2"><enum>(c)</enum><header display-inline="yes-display-inline">Development of model plans</header><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="ID316da024367a41739353d035c57ecb41"><enum>(1)</enum><text display-inline="yes-display-inline">the decontamination of individuals,
equipment, and facilities following an intentional contamination of agriculture
or food; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID46e58d9e2f124b4ebf8d148e26b2cd15"><enum>(2)</enum><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="IDbe30bdeb76784cca8b5947900998ea76"><enum>(d)</enum><header display-inline="yes-display-inline">Exercises</header><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="ID1d7a765df99b4507bf872e082a72d761"><enum>(e)</enum><header display-inline="yes-display-inline">Modifications</header><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="IDb8938c6db4bd426c8f893929a924aaa1"><enum>(f)</enum><header display-inline="yes-display-inline">Prioritization</header><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="ID55a24d18d523467c9768218136e76a4a"><enum>(1)</enum><text display-inline="yes-display-inline">highest-risk biological, chemical, and
radiological threat agents;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID2727b511f8e849db9cdb303ddb211b0d"><enum>(2)</enum><text display-inline="yes-display-inline">agents that could cause the greatest
economic devastation to the agriculture and food system; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID40942f2277e74770948edd0b6f4754b3"><enum>(3)</enum><text display-inline="yes-display-inline">agents that are most difficult to clean or
remediate.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id719A23706BB34A1B827C69BAAD717CD8" section-type="subsequent-section"><enum>209.</enum><header display-inline="yes-display-inline">Improving the training of State, local,
territorial, and tribal food safety officials</header>
<subsection commented="no" display-inline="no-display-inline" id="id04675062919D4DE595E135C2FB5E0C9C"><enum>(a)</enum><header display-inline="yes-display-inline">Improving training</header><text display-inline="yes-display-inline">Chapter X (21 U.S.C. 391 et seq.) is
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id0B7FE3E387AE46549D66D769FD241BBE" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id4DD7619B276F4363B70E83EF91E7B01E" section-type="subsequent-section"><enum>1011.</enum><header display-inline="yes-display-inline">Improving the training of State, local,
territorial, and tribal food safety officials</header>
<subsection commented="no" display-inline="no-display-inline" id="idD7939F89316748549834082939BAC566"><enum>(a)</enum><header display-inline="yes-display-inline">Training</header><text display-inline="yes-display-inline">The Secretary shall set standards and
administer training and education programs for the employees of State, local,
territorial, and tribal food safety officials relating to the regulatory
responsibilities and policies established by this Act, including programs
for—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDa573a1fb6e6248289f65f4d8a982f041"><enum>(1)</enum><text display-inline="yes-display-inline">scientific training;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID7330d142d80a479da21cab218ce38471"><enum>(2)</enum><text display-inline="yes-display-inline">training to improve the skill of officers
and employees authorized to conduct inspections under sections 702 and
704;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID85307aa5172c4af1a4f9b3aab272677e"><enum>(3)</enum><text display-inline="yes-display-inline">training to achieve advanced product or
process specialization in such inspections;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID7ce7f6c36a2c4b7089a99fc2de4b65d2"><enum>(4)</enum><text display-inline="yes-display-inline">training that addresses best
practices;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID3840ca5d1a4b4bed95a5a9dca2795cfd"><enum>(5)</enum><text display-inline="yes-display-inline">training in administrative process and
procedure and integrity issues;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID26159fedb80b484080241f7a0f428aa0"><enum>(6)</enum><text display-inline="yes-display-inline">training in appropriate sampling and
laboratory analysis methodology; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDa3297e0bc2334b508e1ee1fda01cef88"><enum>(7)</enum><text display-inline="yes-display-inline">training in building enforcement actions
following inspections, examinations, testing, and investigations.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id3D51A31EC1CC4BDD871C24A9D4F4CF66"><enum>(b)</enum><header display-inline="yes-display-inline">Partnerships with State and local
officials</header>
<paragraph commented="no" display-inline="no-display-inline" id="idF8FBAF698CC749008FBBFEB39C87E736"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary, pursuant to a contract or
memorandum of understanding between the Secretary and the head of a State,
local, territorial, or tribal department or agency, is authorized and
encouraged to conduct examinations, testing, and investigations for the
purposes of determining compliance with the food safety provisions of this Act
through the officers and employees of such State, local, territorial, or tribal
department or agency.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idCB804D31D81740AEB0EA1A2FBAD75364"><enum>(2)</enum><header display-inline="yes-display-inline">Content</header><text display-inline="yes-display-inline">A contract or memorandum described under
paragraph (1) shall include provisions to ensure adequate training of such
officers and employees to conduct such examinations, testing, and
investigations. The contract or memorandum shall contain provisions regarding
reimbursement. Such provisions may, at the sole discretion of the head of the
other department or agency, require reimbursement, in whole or in part, from
the Secretary for the examinations, testing, or investigations performed
pursuant to this section by the officers or employees of the State,
territorial, or tribal department or agency.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id04B5B4C4A9E247A486222D1656E791A8"><enum>(3)</enum><header display-inline="yes-display-inline">Effect</header><text display-inline="yes-display-inline">Nothing in this subsection shall be
construed to limit the authority of the Secretary under section 702.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idB84C81B15D154496B38E0141A96FC74B"><enum>(c)</enum><header display-inline="yes-display-inline">Extension service</header><text display-inline="yes-display-inline">The Secretary shall ensure coordination
with the extension activities of the National Institute of Food and Agriculture
of the Department of Agriculture in advising producers and small processors
transitioning into new practices required as a result of the enactment of the
FDA Food Safety Modernization Act and assisting regulated industry with
compliance with such Act.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID9a9fc7ee0a3e4f5491b85631e645bd87"><enum>(d)</enum><header display-inline="yes-display-inline">National food safety training, education,
extension, outreach and technical assistance program</header>
<paragraph commented="no" display-inline="no-display-inline" id="id8BFDCD896BF4439C941A2F793ACCF69F"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">In order to improve food safety and reduce
the incidence of foodborne illness, the Secretary shall, not later than 180
days after the date of enactment of the FDA Food Safety Modernization Act,
enter into one or more memoranda of understanding, or enter into other
cooperative agreements, with the Secretary of Agriculture to establish a
competitive grant program within the National Institute for Food and
Agriculture to provide food safety training, education, extension, outreach,
and technical assistance to—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDa495870d090f4902914a92d90a116e8b"><enum>(A)</enum><text display-inline="yes-display-inline">owners and operators of farms;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID0d3103a6094c466dbf39829adf3f4ee5"><enum>(B)</enum><text display-inline="yes-display-inline">small food processors; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID9ed30e2a90304d38bd59081dfbdcbd8f"><enum>(C)</enum><text display-inline="yes-display-inline">small fruit and vegetable merchant
wholesalers.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4FF2E27B247A467FA2D4C84A420A4538"><enum>(2)</enum><header display-inline="yes-display-inline">Implementation</header><text display-inline="yes-display-inline">The competitive grant program established
under paragraph (1) shall be carried out in accordance with section 405 of the
Agricultural Research, Extension, and Education Reform Act of 1998.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id386793D952734504ABAE1D3C2BA5F015"><enum>(e)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">There are
authorized to be appropriated such sums as may be necessary to carry out this
section for fiscal years 2011 through
2015.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id92DC894D20B84C2B9583E86CF23282F2"><enum>(b)</enum><header display-inline="yes-display-inline">National food safety training, education,
extension, outreach, and technical assistance program</header><text display-inline="yes-display-inline">Title IV of the Agricultural Research,
Extension, and Education Reform Act of 1998 is amended by inserting after
section 404 (7 U.S.C. 7624) the following:</text>
<quoted-block display-inline="no-display-inline" id="idAD5853B690F94CDEA6B8AB0FF3F18F55" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id66965420C790478B9EBE1ABCC1A7BB5D" section-type="subsequent-section"><enum>405.</enum><header display-inline="yes-display-inline">National food safety training, education,
extension, outreach, and technical assistance program</header>
<subsection commented="no" display-inline="no-display-inline" id="ID0b7d8c0f92924a11b744aa60c923d454"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall award grants under this
section to carry out the competitive grant program established under section
1011(d) of the Federal Food, Drug, and Cosmetic Act, pursuant to any memoranda
of understanding entered into under such section.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id4143C77554F9465D9461FA9A1BC35007"><enum>(b)</enum><header display-inline="yes-display-inline">Integrated approach</header><text display-inline="yes-display-inline">The grant program described under
subsection (a) shall be carried out under this section in a manner that
facilitates the integration of food safety standards and guidance with the
variety of agricultural production systems, encompassing conventional,
sustainable, organic, and conservation and environmental practices.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID9707f6e344e6497f88c3bcff5e9ae83c"><enum>(c)</enum><header display-inline="yes-display-inline">Priority</header><text display-inline="yes-display-inline">In awarding grants under this section, the
Secretary shall give priority to projects that target small and medium-sized
farms, beginning farmers, socially disadvantaged farmers, small processors, or
small fresh fruit and vegetable merchant wholesalers.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID8ddb168182224e7499e57c2af449f146"><enum>(d)</enum><header display-inline="yes-display-inline">Program coordination</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID35730d791eeb4ebeb211c41944f603a7"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall coordinate
implementation of the grant program under this section with the National
Integrated Food Safety Initiative.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID4a161005dfc5467bb3b1097c97a0e3d9"><enum>(2)</enum><header display-inline="yes-display-inline">Interaction</header><text display-inline="yes-display-inline">The Secretary shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID05623dba4f904f0792ab59c8d1dd8277"><enum>(A)</enum><text display-inline="yes-display-inline">in carrying out the grant program under
this section, take into consideration applied research, education, and
extension results obtained from the National Integrated Food Safety Initiative;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDdeb4db8e9cfe4fe7a58a6502e6e4a75d"><enum>(B)</enum><text display-inline="yes-display-inline">in determining the applied research agenda
for the National Integrated Food Safety Initiative, take into consideration the
needs articulated by participants in projects funded by the program under this
section.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDce71f565f146499bb2b6eda51a3beda7"><enum>(e)</enum><header display-inline="yes-display-inline">Grants</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID3ae559992b3a4392a981419e7d1b5d6f"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">In carrying out this section, the Secretary
shall make competitive grants to support training, education, extension,
outreach, and technical assistance projects that will help improve public
health by increasing the understanding and adoption of established food safety
standards, guidance, and protocols.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID0790edb54bbf436b8cae302f180c5834"><enum>(2)</enum><header display-inline="yes-display-inline">Encouraged features</header><text display-inline="yes-display-inline">The Secretary shall encourage projects
carried out using grant funds under this section to include co-management of
food safety, conservation systems, and ecological health.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID3783ed9b11da4c8886a82d3ca61210a8"><enum>(3)</enum><header display-inline="yes-display-inline">Maximum term and size of grant</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID677f43439b3d40179bbd74ea982870d0"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A grant under this section shall have a
term that is not more than 3 years.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDf1c7e021d998495bad6dbb22ed512cdb"><enum>(B)</enum><header display-inline="yes-display-inline">Limitation on grant funding</header><text display-inline="yes-display-inline">The Secretary may not provide grant funding
to an entity under this section after such entity has received 3 years of grant
funding under this section.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID03dee2aa36824e6eb2456ebbea614b1e"><enum>(f)</enum><header display-inline="yes-display-inline">Grant eligibility</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID448a8e33b2d84372ae8eaacb322f1bbc"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">To be eligible for a grant under this
section, an entity shall be—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDb20c336673434d328f9602a8332669ba"><enum>(A)</enum><text display-inline="yes-display-inline">a State cooperative extension
service;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID09b17b91b63248d28c89e9c31ff50c2d"><enum>(B)</enum><text display-inline="yes-display-inline">a Federal, State, local, or tribal agency,
a nonprofit community-based or non-governmental organization, or an
organization representing owners and operators of farms, small food processors,
or small fruit and vegetable merchant wholesalers that has a commitment to
public health and expertise in administering programs that contribute to food
safety;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDa18165f6e423470f87f220582d5fe3f5"><enum>(C)</enum><text display-inline="yes-display-inline">an institution of higher education (as
defined in section 101(a) of the Higher Education Act of 1965 (20 U.S.C.
1001(a))) or a foundation maintained by an institution of higher
education;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID3c7e4c6c08344190b37a71541eabd1f4"><enum>(D)</enum><text display-inline="yes-display-inline">a collaboration of 2 of more eligible
entities described in this subsection; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDa5f09d79669b4f9d99564f42b41bade4"><enum>(E)</enum><text display-inline="yes-display-inline">such other appropriate entity, as
determined by the Secretary.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID39b196998e4247e480adf453dfbf4c6d"><enum>(2)</enum><header display-inline="yes-display-inline">Multistate partnerships</header><text display-inline="yes-display-inline">Grants under this section may be made for
projects involving more than 1 State.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID5d0e44eb6aae4d63bddc49d9e04f88cc"><enum>(g)</enum><header display-inline="yes-display-inline">Regional balance</header><text display-inline="yes-display-inline">In making grants under this section, the
Secretary shall, to the maximum extent practicable, ensure—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID588b0894b60d4307a9840b33e22f0c02"><enum>(1)</enum><text display-inline="yes-display-inline">geographic diversity; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDb1a6b4520be2465faf213a21c2491e16"><enum>(2)</enum><text display-inline="yes-display-inline">diversity of types of agricultural
production.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID602f600d24eb49dcb48516bf519143b8"><enum>(h)</enum><header display-inline="yes-display-inline">Technical assistance</header><text display-inline="yes-display-inline">The Secretary may use funds made available
under this section to provide technical assistance to grant recipients to
further the purposes of this section.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID473991ccac7e4f0191e9c5c0e04d3c72"><enum>(i)</enum><header display-inline="yes-display-inline">Best practices and model
programs</header><text display-inline="yes-display-inline">Based on evaluations
of, and responses arising from, projects funded under this section, the
Secretary may issue a set of recommended best practices and models for food
safety training programs for agricultural producers, small food processors, and
small fresh fruit and vegetable merchant wholesalers.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="IDcb7aae233b8f4af68fa9353be7dd49cd"><enum>(j)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">For the
purposes of making grants under this section, there are authorized to be
appropriated such sums as may be necessary for fiscal years 2011 through
2015.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id316584563BC446B9BB6FAB7418FC1D8F" section-type="subsequent-section"><enum>210.</enum><header display-inline="yes-display-inline">Enhancing food safety</header>
<subsection commented="no" display-inline="no-display-inline" id="id7E309D2B933E4576A834258963105AE0"><enum>(a)</enum><header display-inline="yes-display-inline">Grants To enhance food safety</header><text display-inline="yes-display-inline">Section 1009 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 399) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="id4D55FFA6C18645F3AC38B18FB1A3D792" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id3CCACE8945924E7BBF323D097DE3FCE6" section-type="subsequent-section"><enum>1009.</enum><header display-inline="yes-display-inline">Grants to enhance food safety</header>
<subsection commented="no" display-inline="no-display-inline" id="id495E28E38CDB4DD38FA0FF9DFA428B37"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary is authorized to make grants
to eligible entities to—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID1c3222fa5c394768b87daf5ce2ee40a5"><enum>(1)</enum><text display-inline="yes-display-inline">undertake examinations, inspections, and
investigations, and related food safety activities under section 702;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDce79af5f507542afa7a26498edf7e629"><enum>(2)</enum><text display-inline="yes-display-inline">train to the standards of the Secretary for
the examination, inspection, and investigation of food manufacturing,
processing, packing, holding, distribution, and importation, including as such
examination, inspection, and investigation relate to retail food
establishments;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID88703fdfddf64438a358bbb38d280c90"><enum>(3)</enum><text display-inline="yes-display-inline">build the food safety capacity of the
laboratories of such eligible entity, including the detection of zoonotic
diseases;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID4911089934d04511814bdbc011506e61"><enum>(4)</enum><text display-inline="yes-display-inline">build the infrastructure and capacity of
the food safety programs of such eligible entity to meet the standards as
outlined in the grant application; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID437d355a45464f0db0a277e56e738ccd"><enum>(5)</enum><text display-inline="yes-display-inline">take appropriate action to protect the
public health in response to—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDeb749527dec54cd78bde5c96e1d8a437"><enum>(A)</enum><text display-inline="yes-display-inline">a notification under section 1008,
including planning and otherwise preparing to take such action; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDcc136f4a89b84874932e00665d5ee616"><enum>(B)</enum><text display-inline="yes-display-inline">a recall of food under this Act.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idAEE5C5A0A1E64E5584AF56DFA0143067"><enum>(b)</enum><header display-inline="yes-display-inline">Eligible entities; application</header>
<paragraph commented="no" display-inline="no-display-inline" id="id22E76D0F95DA4E8EBF5EC75A49E1AEC7"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">In this section, the term <term>eligible
entity</term> means an entity—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id52F2852C8FA141D89368787CE8FB5C14"><enum>(A)</enum><text display-inline="yes-display-inline">that is—</text>
<clause commented="no" display-inline="no-display-inline" id="id16AEA26A322E40BC9DBFFF0F1B616726"><enum>(i)</enum><text display-inline="yes-display-inline">a State;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id0AB680CA470E450CA0EB73A384FBAD05"><enum>(ii)</enum><text display-inline="yes-display-inline">a locality;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idD495E4351CC7458FB80F5359FDC4BCC5"><enum>(iii)</enum><text display-inline="yes-display-inline">a territory;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id476CC90B054D428F94B20DC1323136F6"><enum>(iv)</enum><text display-inline="yes-display-inline">an Indian tribe (as defined in section 4(e)
of the Indian Self-Determination and Education Assistance Act); or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id63B2BC245CD244B5BA029E67C4A3A3AD"><enum>(v)</enum><text display-inline="yes-display-inline">a nonprofit food safety training entity
that collaborates with 1 or more institutions of higher education; and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id219E0511EA2C42C6B35F82B2D533907B"><enum>(B)</enum><text display-inline="yes-display-inline">that submits an application to the
Secretary at such time, in such manner, and including such information as the
Secretary may reasonably require.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id12CE363C21D240F8B63AE402B702FA44"><enum>(2)</enum><header display-inline="yes-display-inline">Contents</header><text display-inline="yes-display-inline">Each application submitted under paragraph
(1) shall include—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDe7e36c79cd884412adac52416bde1d19"><enum>(A)</enum><text display-inline="yes-display-inline">an assurance that the eligible entity has
developed plans to engage in the types of activities described in subsection
(a);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID5b1a565fecf8441cb77c0a63066355bb"><enum>(B)</enum><text display-inline="yes-display-inline">a description of the types of activities to
be funded by the grant;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID968f7f71b09240d98d5da1f1812dbe34"><enum>(C)</enum><text display-inline="yes-display-inline">an itemization of how grant funds received
under this section will be expended;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID34ad18f20acb42e2828f7769dec98baf"><enum>(D)</enum><text display-inline="yes-display-inline">a description of how grant activities will
be monitored; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID653fb56903c04c51ba059aeb0d621929"><enum>(E)</enum><text display-inline="yes-display-inline">an agreement by the eligible entity to
report information required by the Secretary to conduct evaluations under this
section.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idAD8739EDCD104C4BB43A5002FA3E0E9E"><enum>(c)</enum><header display-inline="yes-display-inline">Limitations</header><text display-inline="yes-display-inline">The funds provided under subsection (a)
shall be available to an eligible entity that receives a grant under this
section only to the extent such entity funds the food safety programs of such
entity independently of any grant under this section in each year of the grant
at a level equal to the level of such funding in the previous year, increased
by the Consumer Price Index. Such non-Federal matching funds may be provided
directly or through donations from public or private entities and may be in
cash or in-kind, fairly evaluated, including plant, equipment, or
services.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id56172BD4A52E4838B7D7EDD907A45C60"><enum>(d)</enum><header display-inline="yes-display-inline">Additional authority</header><text display-inline="yes-display-inline">The Secretary may—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDd28503f3af5c4ccfbee648c0549578ec"><enum>(1)</enum><text display-inline="yes-display-inline">award a grant under this section in each
subsequent fiscal year without reapplication for a period of not more than 3
years, provided the requirements of subsection (c) are met for the previous
fiscal year; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDc8336da319f842a6b1b68b4807c68366"><enum>(2)</enum><text display-inline="yes-display-inline">award a grant under this section in a
fiscal year for which the requirement of subsection (c) has not been met only
if such requirement was not met because such funding was diverted for response
to 1 or more natural disasters or in other extenuating circumstances that the
Secretary may determine appropriate.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id6CEE27855BDE4DA8AF8A0A12B6D20071"><enum>(e)</enum><header display-inline="yes-display-inline">Duration of awards</header><text display-inline="yes-display-inline">The Secretary may award grants to an
individual grant recipient under this section for periods of not more than 3
years. In the event the Secretary conducts a program evaluation, funding in the
second year or third year of the grant, where applicable, shall be contingent
on a successful program evaluation by the Secretary after the first
year.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id6BF276686F8E4E57AC5CD9FC6DA4B405"><enum>(f)</enum><header display-inline="yes-display-inline">Progress and evaluation</header>
<paragraph commented="no" display-inline="no-display-inline" id="idFFAE0E07F6B343BF83B4C1D7CAC26C6E"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall measure the status and
success of each grant program authorized under the
<short-title>FDA Food Safety Modernization
Act</short-title> (and any amendment made by such Act), including the grant
program under this section. A recipient of a grant described in the preceding
sentence shall, at the end of each grant year, provide the Secretary with
information on how grant funds were spent and the status of the efforts by such
recipient to enhance food safety. To the extent practicable, the Secretary
shall take the performance of such a grant recipient into account when
determining whether to continue funding for such recipient.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA43CF663FF0047C18168C686DCFD515A"><enum>(2)</enum><header display-inline="yes-display-inline">No
duplication</header><text display-inline="yes-display-inline">In carrying out
paragraph (1), the Secretary shall not duplicate the efforts of the Secretary
under other provisions of this Act or the <short-title>FDA
Food Safety Modernization Act</short-title> that require measurement and review
of the activities of grant recipients under either such Act.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idB48EF80F8C1A4ECF8DD76E3EC8D59B1B"><enum>(g)</enum><header display-inline="yes-display-inline">Supplement not supplant</header><text display-inline="yes-display-inline">Grant funds received under this section
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
section.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idCCC999D3EF764F69A293E0A13B504CD9"><enum>(h)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">For the
purpose of making grants under this section, there are authorized to be
appropriated such sums as may be necessary for fiscal years 2011 through
2015.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id8D22B9FCBE9E4210B75D0A06A2AB583A"><enum>(b)</enum><header display-inline="yes-display-inline">Centers of Excellence</header><text display-inline="yes-display-inline">Part P of the Public Health Service Act (42
U.S.C. 280g et seq.) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idCBF487784565470195F8F90EB8B8F821" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id33A08D2CC1E249AAADFDBDA3A60D7ED5" section-type="subsequent-section"><enum>399V–5.</enum><header display-inline="yes-display-inline">Food safety integrated centers of
excellence</header>
<subsection commented="no" display-inline="no-display-inline" id="idB9827917D1BE4654AEEAB0CCA94F481B"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 1 year after the date of
enactment of the <short-title>FDA Food Safety
Modernization Act</short-title>, the Secretary, acting through the Director of
the Centers for Disease Control and Prevention and in consultation with the
working group described in subsection (b)(2), shall designate 5 Integrated Food
Safety Centers of Excellence (referred to in this section as the <quote>Centers
of Excellence</quote>) to serve as resources for Federal, State, and local
public health professionals to respond to foodborne illness outbreaks. The
Centers of Excellence shall be headquartered at selected State health
departments.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idC66E3DCFC04945B0B6E98BBEC919BCC4"><enum>(b)</enum><header display-inline="yes-display-inline">Selection of centers of excellence</header>
<paragraph commented="no" display-inline="no-display-inline" id="id69E4D3F9B7824342805FEB60537B3860"><enum>(1)</enum><header display-inline="yes-display-inline">Eligible entities</header><text display-inline="yes-display-inline">To be eligible to be designated as a Center
of Excellence under subsection (a), an entity shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id54EE131342DC4F2CAEEDD6D1DECD3453"><enum>(A)</enum><text display-inline="yes-display-inline">be a State health department;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id92CA56FFC83C44DD80FB26CDECD1FFE9"><enum>(B)</enum><text display-inline="yes-display-inline">partner with 1 or more institutions of
higher education that have demonstrated knowledge, expertise, and meaningful
experience with regional or national food production, processing, and
distribution, as well as leadership in the laboratory, epidemiological, and
environmental detection and investigation of foodborne illness; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id92564FBD69B14DEAABF487BD0A2F4926"><enum>(C)</enum><text display-inline="yes-display-inline">provide to the Secretary such information,
at such time, and in such manner, as the Secretary may require.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8CF485C60D924CE6B70B6F2FF155D190"><enum>(2)</enum><header display-inline="yes-display-inline">Working group</header><text display-inline="yes-display-inline">Not later than 180 days after the date of
enactment of the <short-title>FDA Food Safety
Modernization Act</short-title>, the Secretary shall establish a diverse
working group of experts and stakeholders from Federal, State, and local food
safety and health agencies, the food industry, including food retailers and
food manufacturers, consumer organizations, and academia to make
recommendations to the Secretary regarding designations of the Centers of
Excellence.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idF2452F97FED9497E8242C1D9CEF64714"><enum>(3)</enum><header display-inline="yes-display-inline">Additional centers of
excellence</header><text display-inline="yes-display-inline">The Secretary may
designate eligible entities to be regional Food Safety Centers of Excellence,
in addition to the 5 Centers designated under subsection (a).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id6845E5DFF47D4CD48A2F2D11B3DAF0FF"><enum>(c)</enum><header display-inline="yes-display-inline">Activities</header><text display-inline="yes-display-inline">Under the leadership of the Director of the
Centers for Disease Control and Prevention, each Center of Excellence shall be
based out of a selected State health department, which shall provide assistance
to other regional, State, and local departments of health through activities
that include—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id7121B0DF267546FEB80007D13242C442"><enum>(1)</enum><text display-inline="yes-display-inline">providing resources, including timely
information concerning symptoms and tests, for frontline health professionals
interviewing individuals as part of routine surveillance and outbreak
investigations;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idDE4B14CB64374570978488EF0594D3FD"><enum>(2)</enum><text display-inline="yes-display-inline">providing analysis of the timeliness and
effectiveness of foodborne disease surveillance and outbreak response
activities;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id16C856BE71D24A6DA9E0DEA00F288261"><enum>(3)</enum><text display-inline="yes-display-inline">providing training for epidemiological and
environmental investigation of foodborne illness, including suggestions for
streamlining and standardizing the investigation process;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idEB56BBC323F44273A5CA58DCC438E650"><enum>(4)</enum><text display-inline="yes-display-inline">establishing fellowships, stipends, and
scholarships to train future epidemiological and food-safety leaders and to
address critical workforce shortages;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id99D7EFE92FCA4CD0B304882B694E1A71"><enum>(5)</enum><text display-inline="yes-display-inline">training and coordinating State and local
personnel;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idBECF1761614C423383B2230BA951C639"><enum>(6)</enum><text display-inline="yes-display-inline">strengthening capacity to participate in
existing or new foodborne illness surveillance and environmental assessment
information systems; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id61EE9E41E4354E64BF729BE985AE0C9E"><enum>(7)</enum><text display-inline="yes-display-inline">conducting research and outreach activities
focused on increasing prevention, communication, and education regarding food
safety.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id0A1C2353259F43F6B3D2EE04E761D659"><enum>(d)</enum><header display-inline="yes-display-inline">Report to Congress</header><text display-inline="yes-display-inline">Not later than 2 years after the date of
enactment of the <short-title>FDA Food Safety
Modernization Act</short-title>, the Secretary shall submit to Congress a
report that—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idBED5F011479B4933B1B26BD07CF61BC8"><enum>(1)</enum><text display-inline="yes-display-inline">describes the effectiveness of the Centers
of Excellence; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id597A60C2ED014535B41E6CA80C991755"><enum>(2)</enum><text display-inline="yes-display-inline">provides legislative recommendations or
describes additional resources required by the Centers of Excellence.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id4884F8354AE74BA3B4C387298AD3E0FA"><enum>(e)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">There is
authorized to be appropriated such sums as may be necessary to carry out this
section.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id0D3158D3A9764A1C9966CE49ED295346"><enum>(f)</enum><header display-inline="yes-display-inline">No duplication of effort</header><text display-inline="yes-display-inline">In carrying out activities of the Centers
of Excellence or other programs under this section, the Secretary shall not
duplicate other Federal foodborne illness response
efforts.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id65C22964A2724FFCBB4CA1454E047360" section-type="subsequent-section"><enum>211.</enum><header display-inline="yes-display-inline">Improving the reportable food
registry</header>
<subsection commented="no" display-inline="no-display-inline" id="idCE929170377D440C811AB9E08B578F90"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 417 (21 U.S.C. 350f) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idB9360C35918D43A08006C114AE8BCC6C"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating subsections (f) through
(k) as subsections (i) through (n), respectively; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC4C5C4DFED33410597771596F5B9ED7E"><enum>(2)</enum><text display-inline="yes-display-inline">by inserting after subsection (e) the
following:</text>
<quoted-block display-inline="no-display-inline" id="id310E99BCE1CF422CA5000EEEE63D3A20" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id1773C5EA3C244EE8ACE05AC18AD6D0B1"><enum>(f)</enum><header display-inline="yes-display-inline">Critical information</header><text display-inline="yes-display-inline">Except with respect to fruits and
vegetables that are raw agricultural commodities, not more than 18 months after
the date of enactment of the <short-title>FDA Food Safety
Modernization Act</short-title>, the Secretary may require a responsible party
to submit to the Secretary consumer-oriented information regarding a reportable
food, which shall include—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDb678237d9109436a94bc06b62e8e68de"><enum>(1)</enum><text display-inline="yes-display-inline">a description of the article of food as
provided in subsection (e)(3);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDc73c1ee0c27741b19ad04dd433fca8d2"><enum>(2)</enum><text display-inline="yes-display-inline">as provided in subsection (e)(7), affected
product identification codes, such as UPC, SKU, or lot or batch numbers
sufficient for the consumer to identify the article of food;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID935e88abbcc84a2dad89fc8199e152b9"><enum>(3)</enum><text display-inline="yes-display-inline">contact information for the responsible
party as provided in subsection (e)(8); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDc6f3d2cd198247438f16aeb23b500cde"><enum>(4)</enum><text display-inline="yes-display-inline">any other information the Secretary
determines is necessary to enable a consumer to accurately identify whether
such consumer is in possession of the reportable food.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id466E8E0F5D094F3DA91C289D1DDBC866"><enum>(g)</enum><header display-inline="yes-display-inline">Grocery store notification</header>
<paragraph commented="no" display-inline="no-display-inline" id="id4E28416CD814452F81E2ED5D9CC24E0E"><enum>(1)</enum><header display-inline="yes-display-inline">Action by Secretary</header><text display-inline="yes-display-inline">The Secretary shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id759556D2F6C24440B0B28A787249434D"><enum>(A)</enum><text display-inline="yes-display-inline">prepare the critical information described
under subsection (f) for a reportable food as a standardized one-page
summary;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id5E2B65831F6B4F7990014755C638D490"><enum>(B)</enum><text display-inline="yes-display-inline">publish such one-page summary on the
Internet website of the Food and Drug Administration in a format that can be
easily printed by a grocery store for purposes of consumer notification.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB8EC9A477A6646B18F7870B438D62E04"><enum>(2)</enum><header display-inline="yes-display-inline">Action by grocery store</header><text display-inline="yes-display-inline">A notification described under paragraph
(1)(B) shall include the date and time such summary was posted on the Internet
website of the Food and Drug Administration.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id9AFAE6029C5D42B48F7CE98E7EA5F251"><enum>(h)</enum><header display-inline="yes-display-inline">Consumer notification</header>
<paragraph commented="no" display-inline="no-display-inline" id="id8D4401D9B40144BCA4F2F5FC182BAAD2"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">If a grocery store sold a reportable food
that is the subject of the posting and such establishment is part of chain of
establishments with 15 or more physical locations, then such establishment
shall, not later than 24 hours after a one page summary described in subsection
(g) is published, prominently display such summary or the information from such
summary via at least one of the methods identified under paragraph (2) and
maintain the display for 14 days.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID92f202c497dd42de87115c9ab0d1596a"><enum>(2)</enum><header display-inline="yes-display-inline">List of conspicuous locations</header><text display-inline="yes-display-inline">Not more than 1 year after the date of
enactment of the <short-title>FDA Food Safety
Modernization Act</short-title>, the Secretary shall develop and publish a list
of acceptable conspicuous locations and manners, from which grocery stores
shall select at least one, for providing the notification required in paragraph
(1). Such list shall include—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID18bcfc1f7fa849f3a29b0fca6ca01a3e"><enum>(A)</enum><text display-inline="yes-display-inline">posting the notification at or near the
register;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDf39092875ae84d888a4131eb23c4eac3"><enum>(B)</enum><text display-inline="yes-display-inline">providing the location of the reportable
food;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID2e812d6f69b544f39531f12ec5e383f1"><enum>(C)</enum><text display-inline="yes-display-inline">providing targeted recall information given
to customers upon purchase of a food; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDb58cf505f9e34d6f9bca532949ee34c4"><enum>(D)</enum><text display-inline="yes-display-inline">other such prominent and conspicuous
locations and manners utilized by grocery stores as of the date of the
enactment of the <short-title>FDA Food Safety
Modernization Act</short-title> to provide notice of such recalls to consumers
as considered appropriate by the
Secretary.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idC99708FC217145A0881E4B893C8AB0F5"><enum>(b)</enum><header display-inline="yes-display-inline">Prohibited
act</header><text display-inline="yes-display-inline">Section 301 (21 U.S.C.
331), as amended by section 206, is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="id6900C7AAF6E949FDB21E86962AD69EFD" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="idEFB99BCBA7EC44808723381D5C93918E"><enum>(yy)</enum><text display-inline="yes-display-inline">The knowing and willful failure to comply
with the notification requirement under section
417(h).</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idE49A927FD1B94A4AA6F25E5C82CF7086"><enum>(c)</enum><header display-inline="yes-display-inline">Conforming amendment</header><text display-inline="yes-display-inline">Section 301(e) (21 U.S.C. 331(e)) is
amended by striking <quote>417(g)</quote> and inserting
<quote>417(j)</quote>.</text>
</subsection></section><enum>III</enum><header display-inline="yes-display-inline">Improving the safety of imported
food</header>
<section commented="no" display-inline="no-display-inline" id="id08B9B0CD755B4F9C97A00B7115DFB925" section-type="subsequent-section"><enum>301.</enum><header display-inline="yes-display-inline">Foreign supplier verification
program</header>
<subsection commented="no" display-inline="no-display-inline" id="idC395AF857243490CB53597097FFFDA99"><enum>(a)</enum><header display-inline="yes-display-inline">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="idC800838B7AA145068CEC8C891439CE53" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id0C0F227EC8B343ECB2C44E61B7A2A97F" section-type="subsequent-section"><enum>805.</enum><header display-inline="yes-display-inline">Foreign supplier verification
program</header>
<subsection commented="no" display-inline="no-display-inline" id="id31BC7A0299F84B1DB10426B3D5F4B6EF"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header>
<paragraph commented="no" display-inline="no-display-inline" id="id50FFF098B5714725826BD86FBBB962A0"><enum>(1)</enum><header display-inline="yes-display-inline">Verification requirement</header><text display-inline="yes-display-inline">Except as provided under subsections (e)
and (f), each importer shall perform risk-based foreign supplier verification
activities for the purpose of verifying that the food imported by the importer
or agent of an importer is—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id3E57E40F49364C8490F46FA586D187BA"><enum>(A)</enum><text display-inline="yes-display-inline">produced in compliance with the
requirements of section 418 or section 419, as appropriate; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id16103FC1A29B430B80E25787EB91866F"><enum>(B)</enum><text display-inline="yes-display-inline">is not adulterated under section 402 or
misbranded under section 403(w).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idECFBB944D76D4DF2BE340FE4705E17DE"><enum>(2)</enum><header display-inline="yes-display-inline">Importer defined</header><text display-inline="yes-display-inline">For purposes of this section, the term
<term>importer</term> means, with respect to an article of food—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id3648266B20F24F4CBF10CCFAFFD924FF"><enum>(A)</enum><text display-inline="yes-display-inline">the United States owner or consignee of the
article of food at the time of entry of such article into the United States;
or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id29416B51E46841A490F440BB1A39F324"><enum>(B)</enum><text display-inline="yes-display-inline">in the case when there is no United States
owner or consignee as described in subparagraph (A), the United States agent or
representative of a foreign owner or consignee of the article of food at the
time of entry of such article into the United States.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id693860BF4A95424E925800E2C151ED21"><enum>(b)</enum><header display-inline="yes-display-inline">Guidance</header><text display-inline="yes-display-inline">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
importers in developing foreign supplier verification programs.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idDD49B84C85C74C2EA6C9CD127F80A9DE"><enum>(c)</enum><header display-inline="yes-display-inline">Regulations</header>
<paragraph commented="no" display-inline="no-display-inline" id="id798C491A35E44FC981896E62BAB0B8D6"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7BFD27203F314A5C8636D537492285E3"><enum>(2)</enum><header display-inline="yes-display-inline">Requirements</header><text display-inline="yes-display-inline">The regulations promulgated under paragraph
(1)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id6B07A7A9DCF24885AED3EBD5408C98DF"><enum>(A)</enum><text display-inline="yes-display-inline">shall require that the foreign supplier
verification program of each importer be adequate to provide assurances that
each foreign supplier to the importer produces the imported food in compliance
with—</text>
<clause commented="no" display-inline="no-display-inline" id="id2E4831CB69D54CAAB3D62C6DE446C7B0"><enum>(i)</enum><text display-inline="yes-display-inline">processes and procedures, including
reasonably appropriate risk-based preventive controls, that provide the same
level of public health protection as those required under section 418 or
section 419 (taking into consideration variances granted under section 419), as
appropriate; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idBF039700711E403BAD403B2A17E5488B"><enum>(ii)</enum><text display-inline="yes-display-inline">section 402 and section 403(w).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1C24292F759B4D1296B8ED12A2D811D4"><enum>(B)</enum><text display-inline="yes-display-inline">shall include such other requirements as
the Secretary deems necessary and appropriate to verify that food imported into
the United States is as safe as food produced and sold within the United
States.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id59563E1FA02D4FC0B6DE985EE493304F"><enum>(3)</enum><header display-inline="yes-display-inline">Considerations</header><text display-inline="yes-display-inline">In promulgating regulations under this
subsection, the Secretary shall, as appropriate, take into account differences
among importers and types of imported foods, including based on the level of
risk posed by the imported food.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7F9F8F6C3125421C8FBBCA78CEE4C8BF"><enum>(4)</enum><header display-inline="yes-display-inline">Activities</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id4A3E0AE50E7F4023AA16D0FE7EF12909"><enum>(d)</enum><header display-inline="yes-display-inline">Record maintenance and access</header><text display-inline="yes-display-inline">Records of an importer 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" display-inline="no-display-inline" id="id16037349852247CBB0FE225CB4DBE85A"><enum>(e)</enum><header display-inline="yes-display-inline">Exemption of seafood, juice, and low-acid
canned food facilities in compliance with HACCP</header><text display-inline="yes-display-inline">This section shall not apply to a facility
if the owner, operator, or agent in charge of such facility is required to
comply with, and is in compliance with, 1 of the following standards and
regulations with respect to such facility:</text>
<paragraph commented="no" display-inline="no-display-inline" id="idBE7CF128F1D5474FBEA66EF2EF6BD759"><enum>(1)</enum><text display-inline="yes-display-inline">The Seafood Hazard Analysis Critical
Control Points Program of the Food and Drug Administration.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idAF626B45894642FC9C0CF4D67711CE39"><enum>(2)</enum><text display-inline="yes-display-inline">The Juice Hazard Analysis Critical Control
Points Program of the Food and Drug Administration.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9C2FD458D41249528648D1432EAE90BC"><enum>(3)</enum><text display-inline="yes-display-inline">The Thermally Processed Low-Acid Foods
Packaged in Hermetically Sealed Containers standards of the Food and Drug
Administration (or any successor standards).</text>
</paragraph><continuation-text commented="no" continuation-text-level="subsection">The exemption under paragraph (3)
shall apply only with respect to microbiological hazards that are regulated
under the standards for Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers under part 113 of chapter 21, Code of Federal
Regulations (or any successor regulations).</continuation-text></subsection><subsection commented="no" display-inline="no-display-inline" id="id39C855539747406FA8E8C4AABEF5CA84"><enum>(f)</enum><header display-inline="yes-display-inline">Additional exemptions</header><text display-inline="yes-display-inline">The Secretary, by notice published in the
Federal Register, shall establish an exemption from the requirements of this
section for articles of food imported in small quantities for research and
evaluation purposes or for personal consumption, provided that such foods are
not intended for retail sale and are not sold or distributed to the
public.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id66522F370C5745CCB5EC1B1AA2C79681"><enum>(g)</enum><header display-inline="yes-display-inline">Publication of list of
participants</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id0190EB6B9B2E4B02BDE8D5313A05D1B3"><enum>(b)</enum><header display-inline="yes-display-inline">Prohibited
act</header><text display-inline="yes-display-inline">Section 301 (21 U.S.C.
331), as amended by section 211, is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="id1E19C5362DF84FBA8B962E3127A40767" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="idE8EC91F76FDB4868AE6A7ABEE9C08696"><enum>(zz)</enum><text display-inline="yes-display-inline">The importation or offering for importation
of a food if the importer (as defined in section 805) does not have in place a
foreign supplier verification program in compliance with such section
805.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id54D33946DD00499C843E1B0B955FD886"><enum>(c)</enum><header display-inline="yes-display-inline">Imports</header><text display-inline="yes-display-inline">Section 801(a) (21 U.S.C. 381(a)) is
amended by adding <quote>or the importer (as defined in section 805) is in
violation of such section 805</quote> after <quote>or in violation of section
505</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id214212101B9C4740BFD4A4ED12FBC526"><enum>(d)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">The amendments made by
this section shall take effect 2 years after the date of enactment of this
Act.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id0A69B85DACDC4BD7B2BAB535D9F4B6DA" section-type="subsequent-section"><enum>302.</enum><header display-inline="yes-display-inline">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="idE7D669782AE14B6D82C862680F1F17CC" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id1918D1780E2843EFA544DDE6EAF69473" section-type="subsequent-section"><enum>806.</enum><header display-inline="yes-display-inline">Voluntary qualified importer
program</header>
<subsection commented="no" display-inline="no-display-inline" id="id254CD7AC0C614CCD967C4690A012D5D1"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Beginning not later than 18 months after
the date of enactment of the <short-title>FDA Food Safety
Modernization Act</short-title>, the Secretary shall—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id831D79BD836F4AF8AEBEB3EF33A74CD9"><enum>(1)</enum><text display-inline="yes-display-inline">establish a program, in consultation with
the Secretary of Homeland Security—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id7E5F30D1C78C465C80C974A3EEF53808"><enum>(A)</enum><text display-inline="yes-display-inline">to provide for the expedited review and
importation of food offered for importation by importers who have voluntarily
agreed to participate in such program; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2D12900C644A466194026115DAFC6C80"><enum>(B)</enum><text display-inline="yes-display-inline">consistent with section 808, establish a
process for the issuance of a facility certification to accompany food offered
for importation by importers who have voluntarily agreed to participate in such
program; and</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id33C572425806421BA5ED243DC59877CC"><enum>(2)</enum><text display-inline="yes-display-inline">issue a guidance document related to
participation in, revocation of such participation in, reinstatement in, and
compliance with, such program.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id5CD6C2F8743043EE95893C5C498F46F4"><enum>(b)</enum><header display-inline="yes-display-inline">Voluntary participation</header><text display-inline="yes-display-inline">An importer may request the Secretary to
provide for the expedited review and importation of designated foods in
accordance with the program established by the Secretary under subsection
(a).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id4B92A841FF0D4DEE927DF95A16FF0146"><enum>(c)</enum><header display-inline="yes-display-inline">Notice of intent To
participate</header><text display-inline="yes-display-inline">An importer that
intends to participate in the program under this section in a fiscal year shall
submit a notice and application to the Secretary of such intent at the time and
in a manner established by the Secretary.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id3400674A5B974D9583D767C8791ADAFC"><enum>(d)</enum><header display-inline="yes-display-inline">Eligibility</header><text display-inline="yes-display-inline">Eligibility shall be limited to an importer
offering food for importation from a facility that has a certification
described in subsection (a). In reviewing the applications and making
determinations on such applications, the Secretary shall consider the risk of
the food to be imported based on factors, such as the following:</text>
<paragraph commented="no" display-inline="no-display-inline" id="idEBC830CC43DA474C8AA3CE0267E7913E"><enum>(1)</enum><text display-inline="yes-display-inline">The known safety risks of the food to be
imported.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idE108B054420340C7942AEC1DFEFC5A58"><enum>(2)</enum><text display-inline="yes-display-inline">The compliance history of foreign suppliers
used by the importer, as appropriate.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idEE01286F000F4755A1DBD80A4344F17A"><enum>(3)</enum><text display-inline="yes-display-inline">The capability of the regulatory system of
the country of export to ensure compliance with United States food safety
standards for a designated food.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idE02BBD648B1F4905AC4E75CBBFEE197E"><enum>(4)</enum><text display-inline="yes-display-inline">The compliance of the importer with the
requirements of section 805.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4599EDFFD8D44047A41EFCEB26FD100A"><enum>(5)</enum><text display-inline="yes-display-inline">The recordkeeping, testing, inspections and
audits of facilities, traceability of articles of food, temperature controls,
and sourcing practices of the importer.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB1D38B056D854057A5EBF0705B03ECB8"><enum>(6)</enum><text display-inline="yes-display-inline">The potential risk for intentional
adulteration of the food.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0E870AA7003A4E64B8F0AD544A9A0C38"><enum>(7)</enum><text display-inline="yes-display-inline">Any other factor that the Secretary
determines appropriate.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id3346AE2909DB4DBC8E35AFD05FD682BA"><enum>(e)</enum><header display-inline="yes-display-inline">Review and revocation</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idDF087456EC6F405FA704DC3A56E5B67B"><enum>(f)</enum><header display-inline="yes-display-inline">False statements</header><text display-inline="yes-display-inline">Any statement or representation made by an
importer to the Secretary shall be subject to section 1001 of title 18, United
States Code.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id0E316481C43044539AB72C0325BB7FCF"><enum>(g)</enum><header display-inline="yes-display-inline">Definition</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id1BD56090EAD144E68DF5D39944D2EEB0" section-type="subsequent-section"><enum>303.</enum><header display-inline="yes-display-inline">Authority to require import certifications
for food</header>
<subsection commented="no" display-inline="no-display-inline" id="idBA4930D8CCE646339E4C7ED5B777C44F"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 (q) that such food be
accompanied by a certification or other assurance that the food meets
applicable requirements of this Act, then such article shall be refused
admission.</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id025BAED43F93489BA8190ACC9E5FBA33"><enum>(b)</enum><header display-inline="yes-display-inline">Addition of certification
requirement</header><text display-inline="yes-display-inline">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="id47DDEBC3AFB14BE6A32C921C9A460086" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id39204595BBDE4B8B89198ACC3EFBB4E5"><enum>(q)</enum><header display-inline="yes-display-inline">Certifications concerning imported
foods</header>
<paragraph commented="no" display-inline="no-display-inline" id="id1A885D019AD243629DCCA7215F07EF6A"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary 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 described in paragraph (3) provide a
certification, or such other assurances as the Secretary determines
appropriate, that the article of food complies with applicable requirements of
this Act. Such certification or assurances may be provided in the form of
shipment-specific certificates, a listing of certified facilities that
manufacture, process, pack, or hold such food, or in such other form as the
Secretary may specify.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9B78AA98C17345CEA64D36396E0F3764"><enum>(2)</enum><header display-inline="yes-display-inline">Factors to be considered in requiring
certification</header><text display-inline="yes-display-inline">The Secretary
shall base the determination that an article of food is required to have a
certification described in paragraph (1) on the risk of the food,
including—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id1EFBAAA6BFEB4ED59F572C6BBE47A7DB"><enum>(A)</enum><text display-inline="yes-display-inline">known safety risks associated with the
food;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idAB0727CA48B142E7947F31A954266A8B"><enum>(B)</enum><text display-inline="yes-display-inline">known food safety risks associated with the
country, territory, or region of origin of the food;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3EA304C6A96C4591B70DFC2EB89708F8"><enum>(C)</enum><text display-inline="yes-display-inline">a finding by the Secretary, supported by
scientific, risk-based evidence, that—</text>
<clause commented="no" display-inline="no-display-inline" id="id84AC16D18D5F416EB5DFAADBEA61DC53"><enum>(i)</enum><text display-inline="yes-display-inline">the food safety programs, systems, and
standards in the country, territory, or region of origin of the food are
inadequate to ensure that the article of food is as safe as a similar article
of food that is manufactured, processed, packed, or held in the United States
in accordance with the requirements of this Act; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id0B05178C2EE44201AD1057B75B721557"><enum>(ii)</enum><text display-inline="yes-display-inline">the certification would assist the
Secretary in determining whether to refuse or admit the article of food under
subsection (a); and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id28B794358FF24E59BA764E02B0E7631A"><enum>(D)</enum><text display-inline="yes-display-inline">information submitted to the Secretary in
accordance with the process established in paragraph (7).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id65B6F55C6A2A480BB4F916CEB6EAF542"><enum>(3)</enum><header display-inline="yes-display-inline">Certifying entities</header><text display-inline="yes-display-inline">For purposes of paragraph (1), entities
that shall provide the certification or assurances described in such paragraph
are—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idEA04DF2C335941C9ADF89AB7BC98F861"><enum>(A)</enum><text display-inline="yes-display-inline">an agency or a representative of the
government of the country from which the article of food at issue originated,
as designated by the Secretary; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA353D068AC674AD29D769E3E86D12224"><enum>(B)</enum><text display-inline="yes-display-inline">such other persons or entities accredited
pursuant to section 808 to provide such certification or assurance.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id771D7D80B3CC47A98E3786C8C539CCAE"><enum>(4)</enum><header display-inline="yes-display-inline">Renewal and refusal of
certifications</header><text display-inline="yes-display-inline">The Secretary
may—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id2F844773F298431FA9FBA4572FF2A9D6"><enum>(A)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idA17766D74D55496A824FBA760E09A7C7"><enum>(B)</enum><text display-inline="yes-display-inline">refuse to accept any certification or
assurance if the Secretary determines that such certification or assurance is
not valid or reliable.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id61093E021948471C8F2B5E009AC7E156"><enum>(5)</enum><header display-inline="yes-display-inline">Electronic submission</header><text display-inline="yes-display-inline">The Secretary shall provide for the
electronic submission of certifications under this subsection.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD6487FE381B94E03B2ECEF34B74BA759"><enum>(6)</enum><header display-inline="yes-display-inline">False statements</header><text display-inline="yes-display-inline">Any statement or representation made by an
entity described in paragraph (2) to the Secretary shall be subject to section
1001 of title 18, United States Code.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3890A09892DE474D87AAB73830443B78"><enum>(7)</enum><header display-inline="yes-display-inline">Assessment of food safety programs,
systems, and standards</header><text display-inline="yes-display-inline">If the
Secretary determines that the food safety programs, systems, and standards in a
foreign region, country, or territory are inadequate to ensure that an article
of food is as safe as a similar article of food that is manufactured,
processed, packed, or held in the United States in accordance with the
requirements of this Act, the Secretary shall, to the extent practicable,
identify such inadequacies and establish a process by which the foreign region,
country, or territory may inform the Secretary of improvements made to such
food safety program, system, or standard and demonstrate that those controls
are adequate to ensure that an article of food is as safe as a similar article
of food that is manufactured, processed, packed, or held in the United States
in accordance with the requirements of this
Act.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idC6D7713FD8FD448A94465065A4BE6DC3"><enum>(c)</enum><header display-inline="yes-display-inline">Conforming technical
amendment</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id29C3912027F642CE8506878C9DF5FFB7"><enum>(d)</enum><header display-inline="yes-display-inline">No limit on authority</header><text display-inline="yes-display-inline">Nothing in the amendments made by this
section shall limit the authority of the Secretary to conduct 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 commented="no" display-inline="no-display-inline" id="id0548CC28C0C84D2088A5F354F1CED941" section-type="subsequent-section"><enum>304.</enum><header display-inline="yes-display-inline">Prior notice of imported food
shipments</header>
<subsection commented="no" display-inline="no-display-inline" id="id249640820C5F4F08956B57489C4E40B7"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idFA0E31FB51F3478F8B9F9515D45F1C62"><enum>(b)</enum><header display-inline="yes-display-inline">Regulations</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id5566CDE8F28D4AB2B4D061F8269BC731"><enum>(c)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">The amendment made by
this section shall take effect 180 days after the date of enactment of this
Act.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id8951CCD7D046465D90E14A29FC8E6A2A" section-type="subsequent-section"><enum>305.</enum><header display-inline="yes-display-inline">Building capacity of foreign governments
with respect to food safety</header>
<subsection commented="no" display-inline="no-display-inline" id="idDE9DE3687A1A418BBB598474C44B5B5A"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 food safety capacity of foreign
governments, and their respective food industries, from which foods are
exported to the United States.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id97B1EAAF773144779C976D512AAAAA5A"><enum>(b)</enum><header display-inline="yes-display-inline">Consultation</header><text display-inline="yes-display-inline">In developing the plan under subsection
(a), the Secretary shall consult with the Secretary of Agriculture, Secretary
of State, Secretary of the Treasury, the Secretary of Homeland Security, the
United States Trade Representative, and the Secretary of Commerce,
representatives of the food industry, appropriate foreign government officials,
nongovernmental organizations that represent the interests of consumers, and
other stakeholders.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idC4CD59B6EC6C4EEE9195410135C2E5F5"><enum>(c)</enum><header display-inline="yes-display-inline">Plan</header><text display-inline="yes-display-inline">The plan developed under subsection (a)
shall include, as appropriate, the following:</text>
<paragraph commented="no" display-inline="no-display-inline" id="id6056782B3D1D43A4BDE45D503E57A513"><enum>(1)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id0D0D420C4C6C4709A566F4CE7BB2951C"><enum>(2)</enum><text display-inline="yes-display-inline">Provisions for secure electronic data
sharing.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0B425FE116BB4B2DB7FE40E6C1770ACB"><enum>(3)</enum><text display-inline="yes-display-inline">Provisions for mutual recognition of
inspection reports.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id00F3AC99CD5A4AC79C59A1129A780237"><enum>(4)</enum><text display-inline="yes-display-inline">Training of foreign governments and food
producers on United States requirements for safe food.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idF43A02190D5E4B8AB4A131B6338A3065"><enum>(5)</enum><text display-inline="yes-display-inline">Recommendations on whether and how to
harmonize requirements under the Codex Alimentarius.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idDA57F8E7A49F459DBD849A490E15B7CB"><enum>(6)</enum><text display-inline="yes-display-inline">Provisions for the multilateral acceptance
of laboratory methods and testing and detection techniques.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id6D6C4A7111A94783B12D1099A8AEBAA9"><enum>(d)</enum><header display-inline="yes-display-inline">Rule of construction</header><text display-inline="yes-display-inline">Nothing in this section shall be construed
to affect the regulation of dietary supplements under the Dietary Supplement
Health and Education Act of 1994 (Public Law 103–417).</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id733C8A33BED74F48B0E6F1090F35A602" section-type="subsequent-section"><enum>306.</enum><header display-inline="yes-display-inline">Inspection of foreign food
facilities</header>
<subsection commented="no" display-inline="no-display-inline" id="id2F4854C0B0E243D1B38D686D2306A0C8"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Chapter VIII (21 U.S.C. 381 et seq.), as
amended by section 302, is amended by inserting at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="idFDA09A5F9D514538934545BC045103BD" style="OLC">
<section commented="no" display-inline="no-display-inline" id="idEEAD5E5B699742C8892AD4197718F367" section-type="subsequent-section"><enum>807.</enum><header display-inline="yes-display-inline">Inspection of foreign food
facilities</header>
<subsection commented="no" display-inline="no-display-inline" id="id4FE7819BFC7B4143A1B96B477462447D"><enum>(a)</enum><header display-inline="yes-display-inline">Inspection</header><text display-inline="yes-display-inline">The Secretary—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idA61A851616104111B849B6664AE54E95"><enum>(1)</enum><text display-inline="yes-display-inline">may enter into arrangements and agreements
with foreign governments to facilitate the inspection of foreign facilities
registered under section 415; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2FBBC4CAF0744D0FB2215254C3349D86"><enum>(2)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idFAEFA12C501E4AC49338713978A24A26"><enum>(b)</enum><header display-inline="yes-display-inline">Effect of inability To
inspect</header><text display-inline="yes-display-inline">Notwithstanding any
other provision of law, food shall be refused admission into the United States
if it is from a foreign factory, warehouse, or other establishment of which the
owner, operator, or agent in charge, or the government of the foreign country,
refuses to permit entry of United States inspectors or other individuals duly
designated by the Secretary, upon request, to inspect such factory, warehouse,
or other establishment. 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 does not permit an inspection of a
factory, warehouse, or other establishment during the 24-hour period after such
request is submitted, or after such other time period, as agreed upon by the
Secretary and the foreign factory, warehouse, or other
establishment.</text>
</subsection></section><after-quoted-block>.
</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idBBB6214CCA9A43B09E960C461D5FD8D2"><enum>(b)</enum><header display-inline="yes-display-inline">Inspection by the Secretary of
Commerce</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDdad674c1a8c94f9e858c7ebcdfffa7e6"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary of Commerce, in coordination
with the Secretary of Health and Human Services, may send 1 or more inspectors
to a country or facility of an exporter from which seafood imported into the
United States originates. The inspectors shall assess practices and processes
used in connection with the farming, cultivation, harvesting, preparation for
market, or transportation of such seafood and may provide technical assistance
related to such activities.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9ABDB1A5521B42B69CEF29CE8C0878F8"><enum>(2)</enum><header display-inline="yes-display-inline">Inspection report</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id24787AB5832E4F55924F91ECC22F8F6E"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services,
in coordination with the Secretary of Commerce, shall—</text>
<clause commented="no" display-inline="no-display-inline" id="id8382B2ED1DAC4202925D0022CEE79966"><enum>(i)</enum><text display-inline="yes-display-inline">prepare an inspection report for each
inspection conducted under paragraph (1);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id11F0FE545BFF4A6DA4C77B2CA6D3E6FD"><enum>(ii)</enum><text display-inline="yes-display-inline">provide the report to the country or
exporter that is the subject of the report; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idA106336C209F423E95296CA00A8750A7"><enum>(iii)</enum><text display-inline="yes-display-inline">provide a 30-day period during which the
country or exporter may provide a rebuttal or other comments on the findings of
the report to the Secretary of Health and Human Services.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idB471CDFBB5944E6583985A0F9022FE9D"><enum>(B)</enum><header display-inline="yes-display-inline">Distribution and use of
report</header><text display-inline="yes-display-inline">The Secretary of
Health and Human Services shall consider the inspection reports described in
subparagraph (A) in distributing inspection resources under section 421 of the
Federal Food, Drug, and Cosmetic Act, as added by section 201.</text>
</subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="idEBA1068193AB46BCBC892E2D22ECC0D8" section-type="subsequent-section"><enum>307.</enum><header display-inline="yes-display-inline">Accreditation of third-party
auditors</header><text display-inline="no-display-inline">Chapter VIII (21
U.S.C. 381 et seq.), as amended by section 306, is amended by adding at the end
the following:</text>
<quoted-block display-inline="no-display-inline" id="id83738BFDADA24B0D82A9A8C2424CDD2D" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id43832C32204346EE956B5BDC76B62152" section-type="subsequent-section"><enum>808.</enum><header display-inline="yes-display-inline">Accreditation of third-party
auditors</header>
<subsection commented="no" display-inline="no-display-inline" id="idA0318F6366A94706B5DE847EF1AB3EEB"><enum>(a)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this section:</text>
<paragraph commented="no" display-inline="no-display-inline" id="idCE5E8921DFF94DA0B08A7DF3F0E3AE8C"><enum>(1)</enum><header display-inline="yes-display-inline">Audit agent</header><text display-inline="yes-display-inline">The term <term>audit agent</term> means an
individual who is an employee or agent of an accredited third-party auditor
and, although not individually accredited, is qualified to conduct food safety
audits on behalf of an accredited third-party auditor.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6572770BA47C48ECA6BEC2451CB5E3B1"><enum>(2)</enum><header display-inline="yes-display-inline">Accreditation body</header><text display-inline="yes-display-inline">The term <term>accreditation body</term>
means an authority that performs accreditation of third-party auditors.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6E7EC34C504B4F6582262DFBC222B7CB"><enum>(3)</enum><header display-inline="yes-display-inline">Third-party auditor</header><text display-inline="yes-display-inline">The term <term>third-party auditor</term>
means a foreign government, agency of a foreign government, foreign
cooperative, or any other third party, as the Secretary determines appropriate
in accordance with the model standards described in subsection (b)(2), that is
eligible to be considered for accreditation to conduct food safety audits to
certify that eligible entities meet the applicable requirements of this
section. A third-party auditor may be a single individual. A third-party
auditor may employ or use audit agents to help conduct consultative and
regulatory audits.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2593830D3D7146EBBD1EB6057C2ED2C7"><enum>(4)</enum><header display-inline="yes-display-inline">Accredited third-party
auditor</header><text display-inline="yes-display-inline">The term
<term>accredited third-party auditor</term> means a third-party auditor
accredited by an accreditation body to conduct audits of eligible entities to
certify that such eligible entities meet the applicable requirements of this
section. An accredited third-party auditor may be an individual who conducts
food safety audits to certify that eligible entities meet the applicable
requirements of this section.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id35DE5CBBDB8545F9B670B81BF0D93CA3"><enum>(5)</enum><header display-inline="yes-display-inline">Consultative audit</header><text display-inline="yes-display-inline">The term <term>consultative audit</term>
means an audit of an eligible entity—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idA4860BF3B8474014824AF4AA05881B22"><enum>(A)</enum><text display-inline="yes-display-inline">to determine whether such entity is in
compliance with the provisions of this Act and with applicable industry
standards and practices; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0B631C55302747E0B58E853FFD3F513F"><enum>(B)</enum><text display-inline="yes-display-inline">the results of which are for internal
purposes only.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id16B1541472B148149F377A7827DF5772"><enum>(6)</enum><header display-inline="yes-display-inline">Eligible entity</header><text display-inline="yes-display-inline">The term <term>eligible entity</term> means
a foreign entity, including a foreign facility registered under section 415, in
the food import supply chain that chooses to be audited by an accredited
third-party auditor or the audit agent of such accredited third-party
auditor.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA8CBDDB2CCCD4D74B5085BEFBF06E2E6"><enum>(7)</enum><header display-inline="yes-display-inline">Regulatory audit</header><text display-inline="yes-display-inline">The term <term>regulatory audit</term>
means an audit of an eligible entity—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id488422E78BD343C286FBD3ACF1C5696C"><enum>(A)</enum><text display-inline="yes-display-inline">to determine whether such entity is in
compliance with the provisions of this Act; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id5D1ED871ED1B4673AD67EDC065BE438F"><enum>(B)</enum><text display-inline="yes-display-inline">the results of which determine—</text>
<clause commented="no" display-inline="no-display-inline" id="id68925ADC022C4B2D938D3B54B9E980BD"><enum>(i)</enum><text display-inline="yes-display-inline">whether an article of food manufactured,
processed, packed, or held by such entity is eligible to receive a food
certification under section 801(q); or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idF24C9A1E52E84D0086D3CCAF64B2F6B9"><enum>(ii)</enum><text display-inline="yes-display-inline">whether a facility is eligible to receive a
facility certification under section 806(a) for purposes of participating in
the program under section 806.</text>
</clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id956DD065E5D344538C6E8966E2662ACD"><enum>(b)</enum><header display-inline="yes-display-inline">Accreditation system</header>
<paragraph commented="no" display-inline="no-display-inline" id="id26951CE994D04965BEC43ECD5AD7D6EF"><enum>(1)</enum><header display-inline="yes-display-inline">Accreditation bodies</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id6CCD9D646DA141F2B8677D22355B7BDE"><enum>(A)</enum><header display-inline="yes-display-inline">Recognition of accreditation
bodies</header>
<clause commented="no" display-inline="no-display-inline" id="id1E35FE64FD1A4584998803D8E5DAD054"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 2 years after the date of
enactment of the FDA Food Safety Modernization Act, the Secretary shall
establish a system for the recognition of accreditation bodies that accredit
third-party auditors to certify that eligible entities meet the applicable
requirements of this section.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idCBCB78774A364B368225132AA041C48C"><enum>(ii)</enum><header display-inline="yes-display-inline">Direct accreditation</header><text display-inline="yes-display-inline">If, by the date that is 2 years after the
date of establishment of the system described in clause (i), the Secretary has
not identified and recognized an accreditation body to meet the requirements of
this section, the Secretary may directly accredit third-party auditors.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idEAFCA8D13F41431FA36C64B31A0506F3"><enum>(B)</enum><header display-inline="yes-display-inline">Notification</header><text display-inline="yes-display-inline">Each accreditation body recognized by the
Secretary shall submit to the Secretary a list of all accredited third-party
auditors accredited by such body and the audit agents of such auditors.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD8E09752F7F544E0A6441A5FDD8F37B5"><enum>(C)</enum><header display-inline="yes-display-inline">Revocation of recognition as an
accreditation body</header><text display-inline="yes-display-inline">The
Secretary shall promptly revoke the recognition of any accreditation body found
not to be in compliance with the requirements of this section.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idDB88F5E495AF481FAE774E86D257BD5A"><enum>(D)</enum><header display-inline="yes-display-inline">Reinstatement</header><text display-inline="yes-display-inline">The Secretary shall establish procedures to
reinstate recognition of an accreditation body if the Secretary determines,
based on evidence presented by such accreditation body, that revocation was
inappropriate or that the body meets the requirements for recognition under
this section.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4F7D74897ED04409900FC569DB3FE738"><enum>(2)</enum><header display-inline="yes-display-inline">Model accreditation standards</header><text display-inline="yes-display-inline">Not later than 18 months after the date of
enactment of the <short-title>FDA Food Safety
Modernization Act</short-title>, the Secretary shall develop model standards,
including requirements for regulatory audit reports, and each recognized
accreditation body shall ensure that third-party auditors and audit agents of
such auditors meet such standards in order to qualify such third-party auditors
as accredited third-party auditors under this section. In developing the model
standards, the Secretary shall look to standards in place on the date of the
enactment of this section for guidance, to avoid unnecessary duplication of
efforts and costs.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idB449D7ACDD2E483481814DCB7055215A"><enum>(c)</enum><header display-inline="yes-display-inline">Third-party auditors</header>
<paragraph commented="no" display-inline="no-display-inline" id="id31F9AE83220B431CA64819BC95B2DF47"><enum>(1)</enum><header display-inline="yes-display-inline">Requirements for accreditation as a
third-party auditor</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id62F96328C8BF4AE0905BCF671AE084DA"><enum>(A)</enum><header display-inline="yes-display-inline">Foreign governments</header><text display-inline="yes-display-inline">Prior to accrediting a foreign government
or an agency of a foreign government as an accredited third-party auditor, the
accreditation body (or, in the case of direct accreditation under subsection
(b)(1)(A)(ii), the Secretary) shall perform such reviews and audits of food
safety programs, systems, and standards of the government or agency of the
government as the Secretary deems necessary, including requirements under the
model standards developed under subsection (b)(2), to determine that the
foreign government or agency of the foreign government is capable of adequately
ensuring that eligible entities or foods certified by such government or agency
meet the requirements of this Act with respect to food manufactured, processed,
packed, or held for import into the United States.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3AB15D5DF7EE4097AE7F5483262743CD"><enum>(B)</enum><header display-inline="yes-display-inline">Foreign cooperatives and other third
parties</header><text display-inline="yes-display-inline">Prior to accrediting
a foreign cooperative that aggregates the products of growers or processors, or
any other third party to be an accredited third-party auditor, the
accreditation body (or, in the case of direct accreditation under subsection
(b)(1)(A)(ii), the Secretary) shall perform such reviews and audits of the
training and qualifications of audit agents used by that cooperative or party
and conduct such reviews of internal systems and such other investigation of
the cooperative or party as the Secretary deems necessary, including
requirements under the model standards developed under subsection (b)(2), to
determine that each eligible entity certified by the cooperative or party has
systems and standards in use to ensure that such entity or food meets the
requirements of this Act.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id82FDEECBB4234F1BB66C63900A631E2F"><enum>(2)</enum><header display-inline="yes-display-inline">Requirement to issue certification of
eligible entities or foods</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idAA17016BC472466EAA48C777A2B6B306"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">An accreditation body (or, in the case of
direct accreditation under subsection (b)(1)(A)(ii), the Secretary) may not
accredit a third-party auditor unless such third-party auditor agrees to issue
a written and, as appropriate, electronic food certification, described in
section 801(q), or facility certification under section 806(a), as appropriate,
to accompany each food shipment for import into the United States from an
eligible entity, subject to requirements set forth by the Secretary. Such
written or electronic certification may be included with other documentation
regarding such food shipment. The Secretary shall consider certifications under
section 801(q) and participation in the voluntary qualified importer program
described in section 806 when targeting inspection resources under section
421.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id09CDB2B9286646E193571C3C3F5933D8"><enum>(B)</enum><header display-inline="yes-display-inline">Purpose of certification</header><text display-inline="yes-display-inline">The Secretary shall use certification
provided by accredited third-party auditors to—</text>
<clause commented="no" display-inline="no-display-inline" id="id427CAFBD3CA04C8084DCF84E669CDB91"><enum>(i)</enum><text display-inline="yes-display-inline">determine, in conjunction with any other
assurances the Secretary may require under section 801(q), whether a food
satisfies the requirements of such section; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id8BABEC5F277B47E5B5F78A9C58C55EF3"><enum>(ii)</enum><text display-inline="yes-display-inline">determine whether a facility is eligible to
be a facility from which food may be offered for import under the voluntary
qualified importer program under section 806.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4EB4A238129D4442B69BC155DCE85D3D"><enum>(C)</enum><header display-inline="yes-display-inline">Requirements for issuing
certification</header>
<clause commented="no" display-inline="no-display-inline" id="idA4FB433EBAC64CB2A81285499C83383F"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">An accredited third-party auditor shall
issue a food certification under section 801(q) or a facility certification
described under subparagraph (B) only after conducting a regulatory audit and
such other activities that may be necessary to establish compliance with the
requirements of such sections.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id3B8D6272DE2044B083DF467D7F9DC96B"><enum>(ii)</enum><header display-inline="yes-display-inline">Provision of certification</header><text display-inline="yes-display-inline">Only an accredited third-party auditor or
the Secretary may provide a facility certification under section 806(a). Only
those parties described in 801(q)(3) or the Secretary may provide a food
certification under 301(g).</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC45B133EEFCF49E1AEDB5B7E6FF4B507"><enum>(3)</enum><header display-inline="yes-display-inline">Audit report submission
requirements</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id61EADFB442044DD9BDED8F4920686A1E"><enum>(A)</enum><header display-inline="yes-display-inline">Requirements in general</header><text display-inline="yes-display-inline">As a condition of accreditation, not later
than 45 days after conducting an audit, an accredited third-party auditor or
audit agent of such auditor shall prepare, and, in the case of a regulatory
audit, submit, the audit report for each audit conducted, in a form and manner
designated by the Secretary, which shall include—</text>
<clause commented="no" display-inline="no-display-inline" id="id5AB56C9B4E634075BB67E73C3E8D7A00"><enum>(i)</enum><text display-inline="yes-display-inline">the identity of the persons at the audited
eligible entity responsible for compliance with food safety
requirements;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id0510ACEB0DFA455EB9E02D3BD15A4A6F"><enum>(ii)</enum><text display-inline="yes-display-inline">the dates of the audit;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id8179B15A0794465B9006B471F3BEF8B5"><enum>(iii)</enum><text display-inline="yes-display-inline">the scope of the audit; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id45853F4EEFE642D880DD9CA6030F1728"><enum>(iv)</enum><text display-inline="yes-display-inline">any other information required by the
Secretary that relates to or may influence an assessment of compliance with
this Act.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0EFFCDBED6A346D9A8736090FE2D9FEF"><enum>(B)</enum><header display-inline="yes-display-inline">Records</header><text display-inline="yes-display-inline">Following any accreditation of a
third-party auditor, the Secretary may, at any time, require the accredited
third-party auditor to submit to the Secretary an onsite audit report and such
other reports or documents required as part of the audit process, for any
eligible entity certified by the third-party auditor or audit agent of such
auditor. Such report may include documentation that the eligible entity is in
compliance with any applicable registration requirements.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idCD447FA5541646BAB04CB13502D7C58E"><enum>(C)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">The requirement under subparagraph (B)
shall not include any report or other documents resulting from a consultative
audit by the accredited third-party auditor, except that the Secretary may
access the results of a consultative audit in accordance with section
414.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idAC63EF1DD97B481FA54F8F311CF2785F"><enum>(4)</enum><header display-inline="yes-display-inline">Requirements of accredited third-party
auditors and audit agents of such auditors</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idF51D216B27D64DA28EECA83D1ECEAADD"><enum>(A)</enum><header display-inline="yes-display-inline">Risks to public health</header><text display-inline="yes-display-inline">If, at any time during an audit, an
accredited third-party auditor or audit agent of such auditor discovers a
condition that could cause or contribute to a serious risk to the public
health, such auditor shall immediately notify the Secretary of—</text>
<clause commented="no" display-inline="no-display-inline" id="id9FFCA9A668B840CE88BB9854D6826135"><enum>(i)</enum><text display-inline="yes-display-inline">the identification of the eligible entity
subject to the audit; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idE00A57E6782B435DBC93F40D0C20B2C2"><enum>(ii)</enum><text display-inline="yes-display-inline">such condition.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9B88A6B69E7A4712B9FFBBD0C551D0FB"><enum>(B)</enum><header display-inline="yes-display-inline">Types of audits</header><text display-inline="yes-display-inline">An accredited third-party auditor or audit
agent of such auditor may perform consultative and regulatory audits of
eligible entities.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD1A62C3F352B4139A82E91CA12C35249"><enum>(C)</enum><header display-inline="yes-display-inline">Limitations</header>
<clause commented="no" display-inline="no-display-inline" id="idDEF4F2A96B83411AA0D8EB4FE81E519F"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">An accredited third party auditor may not
perform a regulatory audit of an eligible entity if such agent has performed a
consultative audit or a regulatory audit of such eligible entity during the
previous 13-month period.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idA128B6F66C784018B417455E9A5AC57E"><enum>(ii)</enum><header display-inline="yes-display-inline">Waiver</header><text display-inline="yes-display-inline">The Secretary may waive the application of
clause (i) if the Secretary determines that there is insufficient access to
accredited third-party auditors in a country or region.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id24BB2EFB9ECC4D5496822EE4A8B0C531"><enum>(5)</enum><header display-inline="yes-display-inline">Conflicts of interest</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id44BDAE7406904D0F868805F6475240A7"><enum>(A)</enum><header display-inline="yes-display-inline">Third-party auditors</header><text display-inline="yes-display-inline">An accredited third-party auditor
shall—</text>
<clause commented="no" display-inline="no-display-inline" id="idE38E12339E9841A2B427B647A78D36EC"><enum>(i)</enum><text display-inline="yes-display-inline">not be owned, managed, or controlled by any
person that owns or operates an eligible entity to be certified by such
auditor;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id0DF123DFB3AA46038286520CCBAB0001"><enum>(ii)</enum><text display-inline="yes-display-inline">in carrying out audits of eligible entities
under this section, have procedures to ensure against the use of any officer or
employee of such auditor that has a financial conflict of interest regarding an
eligible entity to be certified by such auditor; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idF1FCA733341D41D7B8A65908593CF397"><enum>(iii)</enum><text display-inline="yes-display-inline">annually make available to the Secretary
disclosures of the extent to which such auditor and the officers and employees
of such auditor have maintained compliance with clauses (i) and (ii) relating
to financial conflicts of interest.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id37986763FC78484CBB1B8799F55D030A"><enum>(B)</enum><header display-inline="yes-display-inline">Audit agents</header><text display-inline="yes-display-inline">An audit agent shall—</text>
<clause commented="no" display-inline="no-display-inline" id="id08A4701B00A649D282281D2C8F2D85EC"><enum>(i)</enum><text display-inline="yes-display-inline">not own or operate an eligible entity to be
audited by such agent;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idCEB9C3394A28447C818E09933C099CE9"><enum>(ii)</enum><text display-inline="yes-display-inline">in carrying out audits of eligible entities
under this section, have procedures to ensure that such agent does not have a
financial conflict of interest regarding an eligible entity to be audited by
such agent; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idCA3B36032B984AEF88AC974F317903F1"><enum>(iii)</enum><text display-inline="yes-display-inline">annually make available to the Secretary
disclosures of the extent to which such agent has maintained compliance with
clauses (i) and (ii) relating to financial conflicts of interest.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idAF1D587710794EF49009507B84752816"><enum>(C)</enum><header display-inline="yes-display-inline">Regulations</header><text display-inline="yes-display-inline">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 implement this section and to ensure that there are
protections against conflicts of interest between an accredited third-party
auditor and the eligible entity to be certified by such auditor or audited by
such audit agent. Such regulations shall include—</text>
<clause commented="no" display-inline="no-display-inline" id="idE30BB81254AF47D08D3DC300B6BA19B3"><enum>(i)</enum><text display-inline="yes-display-inline">requiring that audits performed under this
section be unannounced;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id585369E3A1D848319FE19BCB76BBE1B7"><enum>(ii)</enum><text display-inline="yes-display-inline">a structure to decrease the potential for
conflicts of interest, including timing and public disclosure, for fees paid by
eligible entities to accredited third-party auditors; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id3E5E6AEF190947618A8892E147453BC2"><enum>(iii)</enum><text display-inline="yes-display-inline">appropriate limits on financial
affiliations between an accredited third-party auditor or audit agents of such
auditor and any person that owns or operates an eligible entity to be certified
by such auditor, as described in subparagraphs (A) and (B).</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id32364287E7714AF6A2F5DC5DA02ECEDB"><enum>(6)</enum><header display-inline="yes-display-inline">Withdrawal of accreditation</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idB8C22E5F43474AD989408A6EFE69A137"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall withdraw accreditation
from an accredited third-party auditor—</text>
<clause commented="no" display-inline="no-display-inline" id="idB4911AF23AD64BE5889EE8BB1E046003"><enum>(i)</enum><text display-inline="yes-display-inline">if food certified under section 801(q) or
from a facility certified under paragraph (2)(B) by such third-party auditor is
linked to an outbreak of foodborne illness that has a reasonable probability of
causing serious adverse health consequences or death in humans or
animals;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id5224D3B4793E42CF885E36E0617B6851"><enum>(ii)</enum><text display-inline="yes-display-inline">following an evaluation and finding by the
Secretary that the third-party auditor no longer meets the requirements for
accreditation; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idD4BC724B16954212981D66612479BB24"><enum>(iii)</enum><text display-inline="yes-display-inline">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>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9D3004548C984BBD8DE2E9C712D46023"><enum>(B)</enum><header display-inline="yes-display-inline">Additional basis for withdrawal of
accreditation</header><text display-inline="yes-display-inline">The Secretary
may withdraw accreditation from an accredited third-party auditor in the case
that such third-party auditor is accredited by an accreditation body for which
recognition as an accreditation body under subsection (b)(1)(C) is revoked, if
the Secretary determines that there is good cause for the withdrawal.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD714473F00E34949B6E7C8ECAF416864"><enum>(C)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">The Secretary may waive the application of
subparagraph (A)(i) if the Secretary—</text>
<clause commented="no" display-inline="no-display-inline" id="idB96D9B0EC359470CA767C8424B702E3D"><enum>(i)</enum><text display-inline="yes-display-inline">conducts an investigation of the material
facts related to the outbreak of human or animal illness; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id7A125EDDCA8A4DE9B90004477F45A71B"><enum>(ii)</enum><text display-inline="yes-display-inline">reviews the steps or actions taken by the
third party auditor to justify the certification and determines that the
accredited third-party auditor satisfied the requirements under section 801(q)
of certifying the food, or the requirements under paragraph (2)(B) of
certifying the entity.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idDB2CABCC20294DFFA64DC7674357DA2E"><enum>(7)</enum><header display-inline="yes-display-inline">Reaccreditation</header><text display-inline="yes-display-inline">The Secretary shall establish procedures to
reinstate the accreditation of a third-party auditor for which accreditation
has been withdrawn under paragraph (6)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idC49382C9D0D24EE784D0E687D38692B0"><enum>(A)</enum><text display-inline="yes-display-inline">if the Secretary determines, based on
evidence presented, that the third-party auditor satisfies the requirements of
this section and adequate grounds for revocation no longer exist; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3CF6B17D3726409F928605A7839C9E45"><enum>(B)</enum><text display-inline="yes-display-inline">in the case of a third-party auditor
accredited by an accreditation body for which recognition as an accreditation
body under subsection (b)(1)(C) is revoked—</text>
<clause commented="no" display-inline="no-display-inline" id="id23B6A8A05913427E9FE5D622BFC4BD30"><enum>(i)</enum><text display-inline="yes-display-inline">if the third-party auditor becomes
accredited not later than 1 year after revocation of accreditation under
paragraph (6)(A), through direct accreditation under subsection (b)(1)(A)(ii)
or by an accreditation body in good standing; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id3208946944924E8C9B1C54F818DB91B5"><enum>(ii)</enum><text display-inline="yes-display-inline">under such conditions as the Secretary may
require for a third-party auditor under paragraph (6)(B).</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1EFB7245785C467DBE0AE8533D3E3867"><enum>(8)</enum><header display-inline="yes-display-inline">Neutralizing costs</header><text display-inline="yes-display-inline">The Secretary shall establish by regulation
a reimbursement (user fee) program, similar to the method described in section
203(h) of the Agriculture Marketing Act of 1946, by which the Secretary
assesses fees and requires accredited third-party auditors and audit agents to
reimburse the Food and Drug Administration for the work performed to establish
and administer the accreditation system under this section. The Secretary shall
make operating this program revenue-neutral and shall not generate surplus
revenue from such a reimbursement mechanism. Fees authorized under this
paragraph shall be collected and available for obligation only to the extent
and in the amount provided in advance in appropriation Acts. Such fees are
authorized to remain available until expended.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idBE7B58E6269E463CB7E2E6B82212D201"><enum>(d)</enum><header display-inline="yes-display-inline">Recertification of eligible
entities</header><text display-inline="yes-display-inline">An eligible entity
shall apply for annual recertification by an accredited third-party auditor if
such entity—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idD1D4D2A444374D58A6FAA78E591CB691"><enum>(1)</enum><text display-inline="yes-display-inline">intends to participate in voluntary
qualified importer program under section 806; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id98C6D1B5566445B5A2AC9D47ABB8DF62"><enum>(2)</enum><text display-inline="yes-display-inline">is required to provide to the Secretary a
certification under section 801(q) for any food from such entity.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id0424FE30CFFD41D18F29AA1C2E5607E1"><enum>(e)</enum><header display-inline="yes-display-inline">False statements</header><text display-inline="yes-display-inline">Any statement or representation
made—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id223AFD91690D4ED380A08CC8A2C09C18"><enum>(1)</enum><text display-inline="yes-display-inline">by an employee or agent of an eligible
entity to an accredited third-party auditor or audit agent; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idF6399302AEAA415C98458E9F48831CD4"><enum>(2)</enum><text display-inline="yes-display-inline">by an accredited third-party auditor to the
Secretary,</text>
</paragraph><continuation-text commented="no" continuation-text-level="subsection">shall be subject to section 1001 of
title 18, United States Code.</continuation-text></subsection><subsection commented="no" display-inline="no-display-inline" id="id402065F3A27C401E9635A2B4C1B8A580"><enum>(f)</enum><header display-inline="yes-display-inline">Monitoring</header><text display-inline="yes-display-inline">To ensure compliance with the requirements
of this section, the Secretary shall—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idA431220A610B4F339F55512D649F6B40"><enum>(1)</enum><text display-inline="yes-display-inline">periodically, or at least once every 4
years, reevaluate the accreditation bodies described in subsection
(b)(1);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6950B54DE1A8419F9F6C41B8A1BCE84E"><enum>(2)</enum><text display-inline="yes-display-inline">periodically, or at least once every 4
years, evaluate the performance of each accredited third-party auditor, through
the review of regulatory audit reports by such auditors, the compliance history
as available of eligible entities certified by such auditors, and any other
measures deemed necessary by the Secretary;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6DACC48207D24EBEBC0146128004BC53"><enum>(3)</enum><text display-inline="yes-display-inline">at any time, conduct an onsite audit of any
eligible entity certified by an accredited third-party auditor, with or without
the auditor present; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idBCA5C13E7F6F4A93B3BF38F341951BDA"><enum>(4)</enum><text display-inline="yes-display-inline">take any other measures deemed necessary by
the Secretary.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idB065360831B04CB983AF87DDC43A3645"><enum>(g)</enum><header display-inline="yes-display-inline">Publicly available registry</header><text display-inline="yes-display-inline">The Secretary shall establish a publicly
available registry of accreditation bodies and of accredited third-party
auditors, including the name of, contact information for, and other information
deemed necessary by the Secretary about such bodies and auditors.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idA5DE3E262CFE480A85171C4C5C0B256F"><enum>(h)</enum><header display-inline="yes-display-inline">Limitations</header>
<paragraph commented="no" display-inline="no-display-inline" id="idA5AB54A049C24307BF4CF5D717770214"><enum>(1)</enum><header display-inline="yes-display-inline">No effect on section 704
inspections</header><text display-inline="yes-display-inline">The audits
performed under this section shall not be considered inspections under section
704.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id06EB341FEC48407AA5639532FBFCDD8E"><enum>(2)</enum><header display-inline="yes-display-inline">No effect on inspection
authority</header><text display-inline="yes-display-inline">Nothing in this
section affects the authority of the Secretary to inspect any eligible entity
pursuant to this
Act.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="id818D35169CF447B5A36A1F9A313803F6" section-type="subsequent-section"><enum>308.</enum><header display-inline="yes-display-inline">Foreign offices of the Food and Drug
Administration</header>
<subsection commented="no" display-inline="no-display-inline" id="idBCDC14AFC08A4E17A3B9FE3BA6EC61CD"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall establish offices of
the Food and Drug Administration in 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 commented="no" display-inline="no-display-inline" id="id35D9130E958F4A369FFB94348F145C06"><enum>(b)</enum><header display-inline="yes-display-inline">Consultation</header><text display-inline="yes-display-inline">In establishing the foreign offices
described in subsection (a), the Secretary shall consult with the Secretary of
State, the Secretary of Homeland Security, and the United States Trade
Representative.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id4E138D9EC5F74659A3DF41DFCBE42105"><enum>(c)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">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, 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 commented="no" display-inline="no-display-inline" id="idDDA31513DA7141EBA129319E804F58A1" section-type="subsequent-section"><enum>309.</enum><header display-inline="yes-display-inline">Smuggled food</header>
<subsection commented="no" display-inline="no-display-inline" id="id8A741E94C01F4EC19ADA62C5BBF0B18A"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 180 days after the enactment
of this Act, the Secretary shall, in coordination with the Secretary of
Homeland Security, develop and implement a strategy to better identify smuggled
food and prevent entry of such food into the United States.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id7EA74529EA9C4F5EB8B443B6FADB235F"><enum>(b)</enum><header display-inline="yes-display-inline">Notification to Homeland
Security</header><text display-inline="yes-display-inline">Not later than 10
days after the Secretary identifies a smuggled food that the Secretary believes
would cause serious adverse health consequences or death to humans or animals,
the Secretary shall provide to the Secretary of Homeland Security a
notification under section 417(n) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 350f(k)) describing the smuggled food and, if available, the names
of the individuals or entities that attempted to import such food into the
United States.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id55D3AEA7F8A1448A80CD8D4E995116F6"><enum>(c)</enum><header display-inline="yes-display-inline">Public notification</header><text display-inline="yes-display-inline">If the Secretary—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idABA8228F25C94002A478EDF846DA4F4B"><enum>(1)</enum><text display-inline="yes-display-inline">identifies a smuggled food;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID064dbf9b49444fd8be148d24db50ee26"><enum>(2)</enum><text display-inline="yes-display-inline">reasonably believes exposure to the food
would cause serious adverse health consequences or death to humans or animals;
and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID0977ee49afe04e4d9869e62f6f70a64b"><enum>(3)</enum><text display-inline="yes-display-inline">reasonably believes that the food has
entered domestic commerce and is likely to be consumed,</text>
</paragraph><continuation-text commented="no" continuation-text-level="subsection">the Secretary shall promptly issue a
press release describing that food and shall use other emergency communication
or recall networks, as appropriate, to warn consumers and vendors about the
potential threat.</continuation-text></subsection><subsection commented="no" display-inline="no-display-inline" id="id03BC414392F84E478CB6ED84FC2B427A"><enum>(d)</enum><header display-inline="yes-display-inline">Effect of section</header><text display-inline="yes-display-inline">Nothing in this section shall affect the
authority of the Secretary to issue public notifications under other
circumstances.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idA08AA459D6524399BFE20182D6108519"><enum>(e)</enum><header display-inline="yes-display-inline">Definition</header><text display-inline="yes-display-inline">In this subsection, the term
<quote>smuggled food</quote> means any food that a person introduces into the
United States through fraudulent means or with the intent to defraud or
mislead.</text>
</subsection></section><enum>IV</enum><header display-inline="yes-display-inline">Miscellaneous provisions</header>
<section commented="no" display-inline="no-display-inline" id="id9F57290E298B412684E242E1A07DB7C2" section-type="subsequent-section"><enum>401.</enum><header display-inline="yes-display-inline">Funding for food safety</header>
<subsection commented="no" display-inline="no-display-inline" id="id381B0FD838CE4688A42EFBD66C7F6211"><enum>(a)</enum><header display-inline="yes-display-inline">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 such sums as may be
necessary for fiscal years 2011 through 2015.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id58B9242EF0DB42BBA56BCC27D8B09DF3"><enum>(b)</enum><header display-inline="yes-display-inline">Increased number of field staff</header>
<paragraph commented="no" display-inline="no-display-inline" id="id9D255C033EF6466E84A7984D47AF42A9"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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>
<subparagraph commented="no" display-inline="no-display-inline" id="id10B281DF3CB04BDF8817165C4F8A256C"><enum>(A)</enum><text display-inline="yes-display-inline">4,000 staff members in fiscal year
2011;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idAD369B4A93D64FD2BD0D908CFFE00A5C"><enum>(B)</enum><text display-inline="yes-display-inline">4,200 staff members in fiscal year
2012;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id58E0E97FBFD44BA19D0AFA3DB63C9961"><enum>(C)</enum><text display-inline="yes-display-inline">4,600 staff members in fiscal year 2013;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idE314E6D5FC2348C0A183E468D052CD23"><enum>(D)</enum><text display-inline="yes-display-inline">5,000 staff members in fiscal year
2014.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9846985EEF8D4D1DA24D3521F8A980E0"><enum>(2)</enum><header display-inline="yes-display-inline">Field staff for food defense</header><text display-inline="yes-display-inline">The goal under paragraph (1) shall include
an increase of 150 employees by fiscal year 2011 to—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idE5122AE0289643CDB2E6F89C388C1CD4"><enum>(A)</enum><text display-inline="yes-display-inline">provide additional detection of and
response to food defense threats; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6E22BF7F2910414DB757F17C9E273D50"><enum>(B)</enum><text display-inline="yes-display-inline">detect, track, and remove smuggled food (as
defined in section 309) from commerce.</text>
</subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id176E6814913A4C129C3B342A27480687" section-type="subsequent-section"><enum>402.</enum><header display-inline="yes-display-inline">Employee protections</header><text display-inline="no-display-inline">Chapter X of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 391 et seq.), as amended by section 209, is further
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idA86E5C3C5B544E7C88CA16EB933054B2" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id38EB38400D2646F3B12730CE35B0AE72" section-type="subsequent-section"><enum>1012.</enum><header display-inline="yes-display-inline">Employee protections</header>
<subsection commented="no" display-inline="no-display-inline" id="id9D30B90101E04C41A702B04D42750AC9"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">No entity engaged in the manufacture,
processing, packing, transporting, distribution, reception, holding, or
importation of food may discharge an employee or otherwise discriminate against
an employee with respect to compensation, terms, conditions, or privileges of
employment because the employee, whether at the employee's initiative or in the
ordinary course of the employee's duties (or any person acting pursuant to a
request of the employee)—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idB36B9BD60D134A46AA38580DF50659E0"><enum>(1)</enum><text display-inline="yes-display-inline">provided, caused to be provided, or is
about to provide or cause to be provided to the employer, the Federal
Government, or the attorney general of a State information relating to any
violation of, or any act or omission the employee reasonably believes to be a
violation of any provision of this Act or any order, rule, regulation,
standard, or ban under this Act, or any order, rule, regulation, standard, or
ban under this Act;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8F6A7D0D83464A349F36DEC740B3755E"><enum>(2)</enum><text display-inline="yes-display-inline">testified or is about to testify in a
proceeding concerning such violation;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id08E8440FF20B4B9B8A292B19B48493B1"><enum>(3)</enum><text display-inline="yes-display-inline">assisted or participated or is about to
assist or participate in such a proceeding; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idEE4872F59EF0484A87894BFCA6B808C8"><enum>(4)</enum><text display-inline="yes-display-inline">objected to, or refused to participate in,
any activity, policy, practice, or assigned task that the employee (or other
such person) reasonably believed to be in violation of any provision of this
Act, or any order, rule, regulation, standard, or ban under this Act.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id45C7AB08979F4100B02A3D849F08AC94"><enum>(b)</enum><header display-inline="yes-display-inline">Process</header>
<paragraph commented="no" display-inline="no-display-inline" id="id768AAF186ADB41F3B6B26779B2C3848E"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A person who believes that he or she has
been discharged or otherwise discriminated against by any person in violation
of subsection (a) may, not later than 180 days after the date on which such
violation occurs, file (or have any person file on his or her behalf) a
complaint with the Secretary of Labor (referred to in this section as the
<term>Secretary</term>) alleging such discharge or discrimination and
identifying the person responsible for such act. Upon receipt of such a
complaint, the Secretary shall notify, in writing, the person named in the
complaint of the filing of the complaint, of the allegations contained in the
complaint, of the substance of evidence supporting the complaint, and of the
opportunities that will be afforded to such person under paragraph (2).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id86A4E22109534C7F8B33D9CF5A0A7525"><enum>(2)</enum><header display-inline="yes-display-inline">Investigation</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idDD53180FE2FF428B9DADD1BF0725C1AD"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 60 days after the date of
receipt of a complaint filed under paragraph (1) and after affording the
complainant and the person named in the complaint an opportunity to submit to
the Secretary a written response to the complaint and an opportunity to meet
with a representative of the Secretary to present statements from witnesses,
the Secretary shall initiate an investigation and determine whether there is
reasonable cause to believe that the complaint has merit and notify, in
writing, the complainant and the person alleged to have committed a violation
of subsection (a) of the Secretary's findings.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id31150A2597324F6FBD39C9CD34E44B22"><enum>(B)</enum><header display-inline="yes-display-inline">Reasonable cause found; preliminary
order</header><text display-inline="yes-display-inline">If the Secretary
concludes that there is reasonable cause to believe that a violation of
subsection (a) has occurred, the Secretary shall accompany the Secretary's
findings with a preliminary order providing the relief prescribed by paragraph
(3)(B). Not later than 30 days after the date of notification of findings under
this paragraph, the person alleged to have committed the violation or the
complainant may file objections to the findings or preliminary order, or both,
and request a hearing on the record. The filing of such objections shall not
operate to stay any reinstatement remedy contained in the preliminary order.
Any such hearing shall be conducted expeditiously. If a hearing is not
requested in such 30-day period, the preliminary order shall be deemed a final
order that is not subject to judicial review.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idC18717F2F8BD44359331C9E85678F6DF"><enum>(C)</enum><header display-inline="yes-display-inline">Dismissal of complaint</header>
<clause commented="no" display-inline="no-display-inline" id="id7C025318DFE9443D9E5A66C503C1EB57"><enum>(i)</enum><header display-inline="yes-display-inline">Standard for complainant</header><text display-inline="yes-display-inline">The Secretary shall dismiss a complaint
filed under this subsection and shall not conduct an investigation otherwise
required under subparagraph (A) unless the complainant makes a prima facie
showing that any behavior described in paragraphs (1) through (4) of subsection
(a) was a contributing factor in the unfavorable personnel action alleged in
the complaint.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idFD955F5213454DAFB3C57BE5DA1248C6"><enum>(ii)</enum><header display-inline="yes-display-inline">Standard for employer</header><text display-inline="yes-display-inline">Notwithstanding a finding by the Secretary
that the complainant has made the showing required under clause (i), no
investigation otherwise required under subparagraph (A) shall be conducted if
the employer demonstrates, by clear and convincing evidence, that the employer
would have taken the same unfavorable personnel action in the absence of that
behavior.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id2DF57415608041438F751731D28C1EA6"><enum>(iii)</enum><header display-inline="yes-display-inline">Violation standard</header><text display-inline="yes-display-inline">The Secretary may determine that a
violation of subsection (a) has occurred only if the complainant demonstrates
that any behavior described in paragraphs (1) through (4) of subsection (a) was
a contributing factor in the unfavorable personnel action alleged in the
complaint.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idE63EE4DF67394BB6A90F36FE62FDCF2F"><enum>(iv)</enum><header display-inline="yes-display-inline">Relief standard</header><text display-inline="yes-display-inline">Relief may not be ordered under
subparagraph (A) if the employer demonstrates by clear and convincing evidence
that the employer would have taken the same unfavorable personnel action in the
absence of that behavior.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA77B2A9C186E4BAF9489FAF6DA6857D4"><enum>(3)</enum><header display-inline="yes-display-inline">Final order</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id634A5E0E0840454EB6B7C4695230AE6A"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 120 days after the date of
conclusion of any hearing under paragraph (2), the Secretary shall issue a
final order providing the relief prescribed by this paragraph or denying the
complaint. At any time before issuance of a final order, a proceeding under
this subsection may be terminated on the basis of a settlement agreement
entered into by the Secretary, the complainant, and the person alleged to have
committed the violation.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id48FCFA6FAE124BA8AF8629B65CC1617F"><enum>(B)</enum><header display-inline="yes-display-inline">Content of order</header><text display-inline="yes-display-inline">If, in response to a complaint filed under
paragraph (1), the Secretary determines that a violation of subsection (a) has
occurred, the Secretary shall order the person who committed such
violation—</text>
<clause commented="no" display-inline="no-display-inline" id="ID8e849f82f0c14366889dfaa9da346c4b"><enum>(i)</enum><text display-inline="yes-display-inline">to take affirmative action to abate the
violation;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDe07242aedffe494fb5afdfc90f8b9c8a"><enum>(ii)</enum><text display-inline="yes-display-inline">to reinstate the complainant to his or her
former position together with compensation (including back pay) and restore the
terms, conditions, and privileges associated with his or her employment;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID63c4edeee5c448459de1acd99dfd2400"><enum>(iii)</enum><text display-inline="yes-display-inline">to provide compensatory damages to the
complainant.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idCC2D952D6B49401E9E25800621B9168F"><enum>(C)</enum><header display-inline="yes-display-inline">Penalty</header><text display-inline="yes-display-inline">If such an order is issued under this
paragraph, the Secretary, at the request of the complainant, shall assess
against the person against whom the order is issued a sum equal to the
aggregate amount of all costs and expenses (including attorneys' and expert
witness fees) reasonably incurred, as determined by the Secretary, by the
complainant for, or in connection with, the bringing of the complaint upon
which the order was issued.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF2323ED3CACB4A5A9607B65F72C28AE1"><enum>(D)</enum><header display-inline="yes-display-inline">Bad faith claim</header><text display-inline="yes-display-inline">If the Secretary finds that a complaint
under paragraph (1) is frivolous or has been brought in bad faith, the
Secretary may award to the prevailing employer a reasonable attorneys' fee, not
exceeding $1,000, to be paid by the complainant.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5E8D78A30BE4471BA26B3C0E4B55FBC5"><enum>(4)</enum><header display-inline="yes-display-inline">Action in court</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id6209447AF75B488EB0F25EACCD80F660"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">If the Secretary has not issued a final
decision within 210 days after the filing of the complaint, or within 90 days
after receiving a written determination, the complainant may bring an action at
law or equity for de novo review in the appropriate district court of the
United States with jurisdiction, which shall have jurisdiction over such an
action without regard to the amount in controversy, and which action shall, at
the request of either party to such action, be tried by the court with a jury.
The proceedings shall be governed by the same legal burdens of proof specified
in paragraph (2)(C).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id511A542C249C42CDB1E1CE41CBE98BF2"><enum>(B)</enum><header display-inline="yes-display-inline">Relief</header><text display-inline="yes-display-inline">The court shall have jurisdiction to grant
all relief necessary to make the employee whole, including injunctive relief
and compensatory damages, including—</text>
<clause commented="no" display-inline="no-display-inline" id="ID62d37c05a1a742b4a59edb29133a9595"><enum>(i)</enum><text display-inline="yes-display-inline">reinstatement with the same seniority
status that the employee would have had, but for the discharge or
discrimination;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID29aeeb8d83b146fb8bdda434361f6e85"><enum>(ii)</enum><text display-inline="yes-display-inline">the amount of back pay, with interest;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID5a31d49911fb45e5b892e0c0330ace27"><enum>(iii)</enum><text display-inline="yes-display-inline">compensation for any special damages
sustained as a result of the discharge or discrimination, including litigation
costs, expert witness fees, and reasonable attorney's fees.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idF710EA24792944A88E854E960E1A4234"><enum>(5)</enum><header display-inline="yes-display-inline">Review</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idF59B966FF53E4FE5A5EED2764EC5E77B"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Unless the complainant brings an action
under paragraph (4), any person adversely affected or aggrieved by a final
order issued under paragraph (3) may obtain review of the order in the United
States Court of Appeals for the circuit in which the violation, with respect to
which the order was issued, allegedly occurred or the circuit in which the
complainant resided on the date of such violation. The petition for review must
be filed not later than 60 days after the date of the issuance of the final
order of the Secretary. Review shall conform to chapter 7 of title 5, United
States Code. The commencement of proceedings under this subparagraph shall not,
unless ordered by the court, operate as a stay of the order.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id67107B5810EC4BBC8DF316D644BDEBF6"><enum>(B)</enum><header display-inline="yes-display-inline">No judicial review</header><text display-inline="yes-display-inline">An order of the Secretary with respect to
which review could have been obtained under subparagraph (A) shall not be
subject to judicial review in any criminal or other civil proceeding.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC9BD2E58947D449C9D7C51DE1D7E585D"><enum>(6)</enum><header display-inline="yes-display-inline">Failure to comply with order</header><text display-inline="yes-display-inline">Whenever any person has failed to comply
with an order issued under paragraph (3), the Secretary may file a civil action
in the United States district court for the district in which the violation was
found to occur, or in the United States district court for the District of
Columbia, to enforce such order. In actions brought under this paragraph, the
district courts shall have jurisdiction to grant all appropriate relief
including, but not limited to, injunctive relief and compensatory
damages.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD096BA2F9638400CACD1A876564F7DB9"><enum>(7)</enum><header display-inline="yes-display-inline">Civil action to require compliance</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idD332F473CDEE4ACAA0788731F22BA9A0"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A person on whose behalf an order was
issued under paragraph (3) may commence a civil action against the person to
whom such order was issued to require compliance with such order. The
appropriate United States district court shall have jurisdiction, without
regard to the amount in controversy or the citizenship of the parties, to
enforce such order.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA8D1315551774BDD8346B81A41E35C8A"><enum>(B)</enum><header display-inline="yes-display-inline">Award</header><text display-inline="yes-display-inline">The court, in issuing any final order under
this paragraph, may award costs of litigation (including reasonable attorneys'
and expert witness fees) to any party whenever the court determines such award
is appropriate.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id3AE545ABB2C148FC9ADA6466EBC5A21D"><enum>(c)</enum><header display-inline="yes-display-inline">Effect of section</header>
<paragraph commented="no" display-inline="no-display-inline" id="id945ACBE3946E4F368D2934D39C70F8FD"><enum>(1)</enum><header display-inline="yes-display-inline">Other laws</header><text display-inline="yes-display-inline">Nothing in this section preempts or
diminishes any other safeguards against discrimination, demotion, discharge,
suspension, threats, harassment, reprimand, retaliation, or any other manner of
discrimination provided by Federal or State law.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idACF8DD942B5B490B9BBE058C830BCC62"><enum>(2)</enum><header display-inline="yes-display-inline">Rights of employees</header><text display-inline="yes-display-inline">Nothing in this section shall be construed
to diminish the rights, privileges, or remedies of any employee under any
Federal or State law or under any collective bargaining agreement. The rights
and remedies in this section may not be waived by any agreement, policy, form,
or condition of employment.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id5E493F4FE8514205BDA2873D0A617C1A"><enum>(d)</enum><header display-inline="yes-display-inline">Enforcement</header><text display-inline="yes-display-inline">Any nondiscretionary duty imposed by this
section shall be enforceable in a mandamus proceeding brought under section
1361 of title 28, United States Code.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idC687A03B8C6841EE84E00DC7B02CD5D6"><enum>(e)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">Subsection (a) shall not apply with respect
to an employee of an entity engaged in the manufacture, processing, packing,
transporting, distribution, reception, holding, or importation of food who,
acting without direction from such entity (or such entity's agent),
deliberately causes a violation of any requirement relating to any violation or
alleged violation of any order, rule, regulation, standard, or ban under this
Act.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="id2BFA92B1F15748819DBE7882557CCF28" section-type="subsequent-section"><enum>403.</enum><header display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="IDada3f5563ef44d739f42c4045cfe2754"><enum>(1)</enum><text display-inline="yes-display-inline">alter the jurisdiction between the
Secretary of Agriculture and the Secretary of Health and Human Services, under
applicable statutes, regulations, or agreements regarding voluntary inspection
of non-amenable species under the Agricultural Marketing Act of 1946 (7 U.S.C.
1621 et seq.);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID555f6c1510774c1b8605d5d43c105b6d"><enum>(2)</enum><text display-inline="yes-display-inline">alter the jurisdiction between the Alcohol
and Tobacco Tax and Trade Bureau and the Secretary of Health and Human
Services, under applicable statutes and regulations;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDaa288aed2fc9497f9e5a19d5d066bb83"><enum>(3)</enum><text display-inline="yes-display-inline">limit the authority of the Secretary of
Health and Human Services under—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDd03b199b4638430f950c5f1565177486"><enum>(A)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID64e33f1042e0476e87640a3e1e8fcb7a"><enum>(B)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID09a6ab1807d845c891c5f3598bcae07b"><enum>(4)</enum><text display-inline="yes-display-inline">alter or limit the authority of the
Secretary of Agriculture under the laws administered by such Secretary,
including—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDd5360f98aefd407ca3010ab19345b3a9"><enum>(A)</enum><text display-inline="yes-display-inline">the Federal Meat Inspection Act (21 U.S.C.
601 et seq.);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID4f5ab877cd7e481bbad0b5c219ea4636"><enum>(B)</enum><text display-inline="yes-display-inline">the Poultry Products Inspection Act (21
U.S.C. 451 et seq.);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID1a07dad7ec77438f9e78e4a4d6e7f519"><enum>(C)</enum><text display-inline="yes-display-inline">the Egg Products Inspection Act (21 U.S.C.
1031 et seq.);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID663a8777fc7c4fdfbe998e761d7574c7"><enum>(D)</enum><text display-inline="yes-display-inline">the United States Grain Standards Act (7
U.S.C. 71 et seq.);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID5f641ae6535c45c5ac5b64533e1a51e9"><enum>(E)</enum><text display-inline="yes-display-inline">the Packers and Stockyards Act, 1921 (7
U.S.C. 181 et seq.);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID8386bc17cf3c466d8ad12151f9b2143e"><enum>(F)</enum><text display-inline="yes-display-inline">the United States Warehouse Act (7 U.S.C.
241 et seq.);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID6ebb71e7ea294a68a96e25c311b73f10"><enum>(G)</enum><text display-inline="yes-display-inline">the Agricultural Marketing Act of 1946 (7
U.S.C. 1621 et seq.); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID1c2f104f4d7c4260995c056304e0dfd7"><enum>(H)</enum><text display-inline="yes-display-inline">the Agricultural Adjustment Act (7 U.S.C.
601 et seq.), reenacted with the amendments made by the Agricultural Marketing
Agreement Act of 1937; or</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id86D70E0D403E474BB9D1D0CDD883C44B"><enum>(5)</enum><text display-inline="yes-display-inline">alter, impede, or affect the authority of
the Secretary of Homeland Security under the Homeland Security Act of 2002 (6
U.S.C. 101 et seq.) or any other statute, including any authority related to
securing the borders of the United States, managing ports of entry, or
agricultural import and entry inspection activities.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="idEDFC72F6675F417F943635F8F8EF2915" section-type="subsequent-section"><enum>404.</enum><header display-inline="yes-display-inline">Compliance with international
agreements</header><text display-inline="no-display-inline">Nothing in this Act
(or an amendment made by this Act) shall be construed in a manner 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>
</section><section commented="no" display-inline="no-display-inline" id="id0C885856C15749F8BE4598C9E4871B9F" section-type="subsequent-section"><enum>405.</enum><header display-inline="yes-display-inline">Determination of budgetary
effects</header><text display-inline="no-display-inline">The budgetary effects
of this Act, for the purpose of complying with the Statutory Pay-As-You-Go-Act
of 2010, shall be determined by reference to the latest statement titled
<quote>Budgetary Effects of PAYGO Legislation</quote> for this Act, submitted
for printing in the Congressional Record by the Chairman of the Senate Budget
Committee, provided that such statement has been submitted prior to the vote on
passage.</text>
</section>
Passed the Senate November 30,
2010.
Secretary