1.This Act may be cited as the
Food Safety Enhancement Act of
2009
.
2.The table of contents of this Act is as
follows:
Sec. 1. Short
title.
Sec. 2. Table of
contents.
Sec. 3. References.
Sec. 4. Rules of
construction.
Sec. 5. USDA
exemptions.
Sec. 6. Alcohol-related facilities.
Title I—Food
Safety
Subtitle
A—Prevention
Sec. 101. Changes in
registration of food facilities.
Sec. 102. Hazard
analysis, risk-based preventive controls, food safety plan, finished product
test results from category 1 facilities.
Sec. 103. Performance
standards.
Sec. 104. Safety
standards for produce and certain other raw agricultural
commodities.
Sec. 105. Risk-based
inspection schedule.
Sec. 106. Access to
records.
Sec. 107. Traceability of food.
Sec. 108. Reinspection and food recall fees applicable to
facilities.
Sec. 109. Certification and accreditation.
Sec. 110. Testing by
accredited laboratories.
Sec. 111. Notification, nondistribution, and recall of
adulterated or misbranded food.
Sec. 112. Reportable
food registry; exchange of information.
Sec. 113. Safe and
secure food importation program.
Sec. 114. Infant
formula.
Subtitle
B—Intervention
Sec. 121. Surveillance.
Sec. 122. Public
education and advisory system.
Sec. 123. Research.
Subtitle
C—Response
Sec. 131. Procedures
for seizure.
Sec. 132. Administrative detention.
Sec. 133. Authority
to prohibit or restrict the movement of food.
Sec. 134. Criminal
penalties.
Sec. 135. Civil
penalties for violations relating to food.
Sec. 136. Improper
import entry filings.
Title
II—Miscellaneous
Sec. 201. Food
substances generally recognized as safe.
Sec. 202. Country of
origin labeling.
Sec. 203. Exportation
certificate program.
Sec. 204. Registration for commercial importers of food;
fee.
Sec. 205. Registration for customs brokers.
Sec. 206. Unique
identification number for food facilities, importers, and custom
brokers.
Sec. 207. Prohibition
against delaying, limiting, or refusing inspection.
Sec. 208. Dedicated
foreign inspectorate.
Sec. 209. Plan and
review of continued operation of field laboratories.
Sec. 210. False or
misleading reporting to FDA.
Sec. 211. Subpoena
authority.
Sec. 212. Whistleblower protections.
Sec. 213. Extraterritorial jurisdiction.
Sec. 214. Support for
training institutes.
Sec. 215. Bisphenol A
in food and beverage containers.
Sec. 216. Lead
content labeling requirement for ceramic tableware and cookware.
3.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.).
4.
(a)Nothing in this Act or the amendments made
by this Act shall be construed to prohibit or limit—
(1)any cause of action under State law;
or
(2)the introduction of evidence of compliance
or noncompliance with the requirements of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.).
(b)Nothing in this Act or any amendment made
by this Act shall be construed to—
(1)alter the jurisdiction between the
Secretary of Agriculture and the Secretary of Health and Human Services, under
applicable statutes and regulations;
(2)limit the authority of the Secretary of
Health and Human Services to issue regulations related to the safety of food
under—
(A)the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.) as in effect on the day before the date of the
enactment of this Act; or
(B)the Public Health Service Act (42 U.S.C.
301 et seq.) as in effect on the day before the date of the enactment of this
Act; or
(3)impede, minimize, or affect the authority
of the Secretary of Agriculture to prevent, control, or mitigate a plant or
animal health emergency, or a food emergency involving products regulated under
the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products
Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21
U.S.C. 1031 et seq.).
5.
(a)Food is exempt from the requirements of
this Act to the extent that such food is regulated by the Secretary of
Agriculture under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the
Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products
Inspection Act (21 U.S.C. 1031 et seq.).
(b)Livestock and poultry that are intended to
be presented for slaughter pursuant to the regulations by the Secretary of
Agriculture under the Federal Meat Inspection Act or the Poultry Products
Inspection Act are exempt from the requirements of this Act. A cow, sheep, or
goat that is used for the production of milk is exempt from the requirements of
this Act.
(c)USDA-regulated facilitiesA facility is exempt from the requirements
of this Act to the extent such facility is regulated as an official
establishment by the Secretary of Agriculture under the Federal Meat Inspection
Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act or
under a program recognized by the Secretary of Agriculture as at least equal to
Federal regulation under the Federal Meat Inspection Act, the Poultry Products
Inspection Act, or the Egg Products Inspection Act.
(d)A farm is exempt from the requirements of
this Act to the extent such farm raises animals from which food is derived that
is regulated under the Federal Meat Inspection Act, the Poultry Products
Inspection Act, or the Egg Products Inspection Act.
6.Alcohol-related facilities
(a)With the exception of the amendments made
by section 101(a) and (b) and section 113 of this Act, nothing in this Act, or
the amendments made by this Act, shall be construed to apply to a facility
that—
(1)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. 5291 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
(2)under section 415 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by this Act, is required to
register as a facility because such facility is engaged in manufacturing,
processing, packing, or holding 1 or more alcoholic beverages.
(b)Limited receipt and distribution of
non-alcohol foodSubsection
(a) shall not apply to a facility engaged in the distributing of any
non-alcohol food, except that subsection (a) shall apply to a facility
described in paragraphs (1) and (2) of subsection (a) that receives and
distributes non-alcohol food provided such food is received and
distributed—
(1)in a prepackaged form that prevents any
direct human contact with such food; and
(2)in amounts that constitute not more than 5
percent of the overall sales of such facility, as determined by the Secretary
of the Treasury.
(c)This section shall not be construed to
exempt any food, apart from distilled spirits, wine, and malt beverages, as
defined in section 211 of the Federal Alcohol Administration Act (27 U.S.C.
211), from the requirements of this Act and the amendments made by this
Act.
<enum>I</enum><header display-inline="yes-display-inline">Food Safety</header>
<subtitle commented="no" id="HBBEFAF9BFE7E43389062C927263334FC" level-type="subsequent"><enum>A</enum><header display-inline="yes-display-inline">Prevention</header>
<section commented="no" display-inline="no-display-inline" id="H426344AB7FC849D89E407C316A9E5BDA" section-type="subsequent-section"><enum>101.</enum><header display-inline="yes-display-inline">Changes in registration of food
facilities</header>
<subsection commented="no" display-inline="no-display-inline" id="HC4CAF0781F414CE18747E9FDDCE0BC11"><enum>(a)</enum><header display-inline="yes-display-inline">Misbranding</header><text display-inline="yes-display-inline">Section 403 (21 U.S.C. 343) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H714DF01B685A45CABC021262AAA80032" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H5E685EF62975478AA1B07B168F2B0D40"><enum>(z)</enum><text display-inline="yes-display-inline">If it was manufactured, processed, packed,
or held in a facility that is not duly registered under section 415, including
a facility whose registration is canceled or suspended under such
section.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H62913DE0880049F7B75A7A53C066D5A2"><enum>(b)</enum><header display-inline="yes-display-inline">Annual registration</header>
<paragraph commented="no" display-inline="no-display-inline" id="H833448F24D8140FD8F2FD584B669F9E7"><enum>(1)</enum><header display-inline="yes-display-inline">Definition of facility</header><text display-inline="yes-display-inline">Paragraph (1) of section 415(b) (21 U.S.C.
350d(b)) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="HF9BE628E1FC943939CEC2D39FD731D68" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="HB1797AF08B0546C9ACF0C611D738ECAB"><enum>(1)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H30E39E964985437398FD944C087BBBB8"><enum>(A)</enum><text display-inline="yes-display-inline">The term <quote>facility</quote> means any
factory, warehouse, or establishment (including a factory, warehouse, or
establishment of an importer) that manufactures, processes, packs, or holds
food.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H79E59F8814644F629A4A2F3F75EF53D7" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">Such term does not include farms; private
residences of individuals; restaurants; other retail food establishments;
nonprofit food establishments in which food is prepared for or served directly
to the consumer; or fishing vessels (except such vessels engaged in processing
as defined in section 123.3(k) of title 21, Code of Federal Regulations, or any
successor regulations).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H03196882DF2B4E0696A5211C804A4E74" indent="up1"><enum>(C)</enum><clause commented="no" display-inline="yes-display-inline" id="HDD116656A9BA45038574250F2114E055"><enum>(i)</enum><text display-inline="yes-display-inline">The term <quote>retail food
establishment</quote> means an establishment that, as its primary function,
sells food products (including those food products that it manufactures,
processes, packs, or holds) directly to consumers (including by Internet or
mail order).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H8CB8DFA7639942B0878E6F06F2162AB5"><enum>(ii)</enum><text display-inline="yes-display-inline">Such term includes—</text>
<subclause commented="no" display-inline="no-display-inline" id="H8B39D9721FFF4AC1B9A284892B31794C"><enum>(I)</enum><text display-inline="yes-display-inline">grocery stores;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H507A49C4329347AF97CB9BE98E4072F6"><enum>(II)</enum><text display-inline="yes-display-inline">convenience stores;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H61C69B91860444C5AAD5152407D9CAAF"><enum>(III)</enum><text display-inline="yes-display-inline">vending machine locations; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H80C952D51147450FB499C96FA05EFBF4"><enum>(IV)</enum><text display-inline="yes-display-inline">stores that sell bagged feed, pet food, and
feed ingredients or additives over-the-counter directly to consumers and final
purchasers for their own personal animals.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="HE8037C5F615A4F2DBA82E6CC02A637FF"><enum>(iii)</enum><text display-inline="yes-display-inline">A retail food establishment’s primary
function is to sell food directly to consumers if the annual monetary value of
sales of food products directly to consumers exceeds the annual monetary value
of sales of food products to all other buyers.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0E59A3297A854EC7988AAA9DB39280A2" indent="up1"><enum>(D)</enum><clause commented="no" display-inline="yes-display-inline" id="H47710BC7B28E4991A5EEEF145E0C05EA"><enum>(i)</enum><text display-inline="yes-display-inline">The term <quote>farm</quote> means an
operation in one general physical location devoted to the growing and
harvesting of crops, the raising of animals (including seafood), or
both.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H3FE04BA18D4E4FB78FA7F620A5523BCA" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">Such term includes—</text>
<subclause commented="no" display-inline="no-display-inline" id="H71B4221D66E84D2E9E873F8DCF22FE4E"><enum>(I)</enum><text display-inline="yes-display-inline">such an operation that packs or holds food,
provided that all food used in such activities is grown, raised, or consumed on
such farm or another farm under the same ownership;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H18B26970FA8C4D51AC0545E281EF1FDB"><enum>(II)</enum><text display-inline="yes-display-inline">such an operation that manufactures or
processes food, provided that all food used in such activities is consumed on
such farm or another farm under the same ownership;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HBB6FC03C88644B5B8A98306B4082F7D3"><enum>(III)</enum><text display-inline="yes-display-inline">such an operation that sells food directly
to consumers if the annual monetary value of sales of the food products from
the farm or by an agent of the farm to consumers exceeds the annual monetary
value of sales of the food products to all other buyers;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HE3929AFE8BF64AFDBA45628FAE532935"><enum>(IV)</enum><text display-inline="yes-display-inline">such an operation that manufactures grains
or other feed stuffs that are grown and harvested on such farm or another farm
under the same ownership and are distributed directly to 1 or more farms for
consumption as food by humans or animals on such farm; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H61D54D9881F14BAB94542979026CDF65"><enum>(V)</enum><text display-inline="yes-display-inline">a fishery, including a wild fishery, an
aquaculture operation or bed, a fresh water fishery, and a saltwater
fishery.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H52EF10BF6A724D91A6C9C2AEF3B1560D" indent="up1"><enum>(iii)</enum><text display-inline="yes-display-inline">Such term does not include such an
operation that receives manufactured feed from another farm as described in
clause (ii)(IV) if the receiving farm releases the feed to another farm or
facility under different ownership.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HEB6A485687CB45EC9AF567B29E6B483C" indent="up1"><enum>(iv)</enum><text display-inline="yes-display-inline">The term <quote>harvesting</quote> includes
washing, trimming of outer leaves of, and cooling produce.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H10AD692C7C5D450890DF642DB1A2896E" indent="up1"><enum>(E)</enum><text display-inline="yes-display-inline">The term <quote>consumer</quote> does not
include a
business.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HA06DD7F11BBA48B69400EC746DB3B848"><enum>(2)</enum><header display-inline="yes-display-inline">Registration</header><text display-inline="yes-display-inline">Section 415(a) (21 U.S.C. 350d(a)) is
amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H00F4533FD3144912931ED2C21287567F"><enum>(A)</enum><text display-inline="yes-display-inline">in the first sentence of paragraph
(1)—</text>
<clause commented="no" display-inline="no-display-inline" id="HEDEB3F1F80C746158858542801F8332D"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>require that</quote> and
inserting <quote>require that, on or before December 31 of each year,</quote>;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H587AF25C94484A94819EFF3F78C958F1"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>food for consumption in
the United States</quote> and inserting <quote>food for consumption in the
United States or for export from the United States</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA95E57195E604A0ABCFB19A87C2398C4"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraphs (A) and (B) of paragraph
(1), by inserting <quote>and pay the registration fee required under section
743</quote> after <quote>submit a registration to the Secretary</quote> each
place it appears;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0BBBC91071EE4A0BA61FF4C4356CDC9A"><enum>(C)</enum><text display-inline="yes-display-inline">in the first sentence of paragraph (2), by
inserting <quote>in electronic format</quote> after <quote>submit</quote>;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HEDB881E009DF4F13ADC6489575CA9742"><enum>(D)</enum><text display-inline="yes-display-inline">in paragraph (4), by inserting after the
first sentence the following: <quote>The Secretary shall remove from such list
the name of any facility that fails to reregister in accordance with this
section, that fails to pay the registration fee required under section 743, or
whose registration is canceled by the registrant, canceled by the Secretary in
accordance with this section, or suspended by the Secretary in accordance with
this section.</quote>.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H524B8B597B924E0CBFA1D4A5915CB59B"><enum>(3)</enum><header display-inline="yes-display-inline">Contents of registration</header><text display-inline="yes-display-inline">Paragraph (2) of section 415(a) (21 U.S.C.
350d(a)), as amended by paragraph (1), is amended by striking <quote>containing
information</quote> and all that follows and inserting the
following:</text>
<quoted-block display-inline="yes-display-inline" id="H6BCB93DBA5A24331B8B91C30357D8CB3" style="OLC">
<text>containing information that
identifies the following:</text><subparagraph commented="no" display-inline="no-display-inline" id="H23E5C9B9A5D94B879C570064A2F446A3"><enum>(A)</enum><text display-inline="yes-display-inline">The name, address, and emergency contact
information of the facility being registered.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HBEE0F49D04CB4320ADDFF5A1720A36AE"><enum>(B)</enum><text display-inline="yes-display-inline">The primary purpose and business activity
of the facility, including the dates of operation if the facility is
seasonal.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4F7D5B101F8B47978271654DE004C481"><enum>(C)</enum><text display-inline="yes-display-inline">The general food category (as defined by
the Secretary by guidance) of each food manufactured, processed, packed, or
held at the facility.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0EC1E35984CA4C34BDB7C7515C26D284"><enum>(D)</enum><text display-inline="yes-display-inline">All trade names under which the facility
conducts business related to food.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H124B5C0421CB4C419EA4EED95D636660"><enum>(E)</enum><text display-inline="yes-display-inline">The name, address, and 24-hour emergency
contact information of the United States distribution agent for the facility,
which agent shall have access to the information required to be maintained
under section 414(d) for food that is manufactured, processed, packed, or held
at the facility.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H226AE875653E457699DA9B0AF4009556"><enum>(F)</enum><text display-inline="yes-display-inline">If the facility is located outside of the
United States, the name, address, and emergency contact information for a
United States agent.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H34AB6C8BCE2F4351B5BF73529E83388F"><enum>(G)</enum><text display-inline="yes-display-inline">The unique facility identifier of the
facility, as specified under section 1011.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC902386A0BAA430487469459CE80601F"><enum>(H)</enum><text display-inline="yes-display-inline">Such additional information pertaining to
the facility as the Secretary may require by regulation.</text>
</subparagraph><quoted-block-continuation-text quoted-block-continuation-text-level="paragraph">The registrant shall notify the
Secretary of any change in the submitted information not later than 30 days
after the date of such change, unless otherwise specified by the
Secretary.</quoted-block-continuation-text><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H96BF7E971FF74BE7A2082F0ABBB0E8A0"><enum>(4)</enum><header display-inline="yes-display-inline">Suspension and cancellation
authority</header><text display-inline="yes-display-inline">Section 415(a) (21
U.S.C. 350d(a)), as amended by paragraphs (1) and (2), is further amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HAAADBCCDD6EB4A8BADC8C66AFF038D16" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="HBA3ED386E44C4E9E87C7BD5BFA783B01"><enum>(5)</enum><header display-inline="yes-display-inline">Suspension of registration</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HF7578E94723E444FB77F03C598CA93A9"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary may suspend the registration
of any facility registered under this section for a violation of this Act that
could result in serious adverse health consequences or death to humans or
animals.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2330455A602747489AAEE8464813B684"><enum>(B)</enum><header display-inline="yes-display-inline">Notice of suspension</header><text display-inline="yes-display-inline">Suspension of a registration shall be
preceded by—</text>
<clause commented="no" display-inline="no-display-inline" id="H2D397E9D18DB4542A01D89B91C4BAEE9"><enum>(i)</enum><text display-inline="yes-display-inline">notice to the facility of the intent to
suspend the registration; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HB3DC71D1AC624EF4B240E0C5B8CCC625"><enum>(ii)</enum><text display-inline="yes-display-inline">an opportunity for an informal hearing, as
defined in guidance or regulations issued by the Secretary, concerning the
suspension of such registration for such facility.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5BB672F480D34532B9875A6831902FEB"><enum>(C)</enum><header display-inline="yes-display-inline">Request</header><text display-inline="yes-display-inline">The owner, operator, or agent in charge of
a facility whose registration is suspended may request that the Secretary
vacate the suspension of registration when such owner, operator, or agent has
corrected the violation that is the basis for such suspension.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H98DDF8344FCF42E89881331C9EE0CAC6"><enum>(D)</enum><header display-inline="yes-display-inline">Vacating of suspension</header><text display-inline="yes-display-inline">If, based on an inspection of the facility
or other information, the Secretary determines that adequate reasons do not
exist to continue the suspension of a registration, the Secretary shall vacate
such suspension.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF53D07B46E9C445996444F7DBA57677C"><enum>(6)</enum><header display-inline="yes-display-inline">Cancellation of registration</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HF26B51F23E4F472D8529B2C78A894D3A"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not earlier than 10 days after providing
the notice under subparagraph (B), the Secretary may cancel a registration if
the Secretary determines that—</text>
<clause commented="no" display-inline="no-display-inline" id="H3EF33AFA518E446498E68275FE794E6C"><enum>(i)</enum><text display-inline="yes-display-inline">the registration was not updated in
accordance with this section or otherwise contains false, incomplete, or
inaccurate information; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HABB2AA54F0124F7F84927A1BD48C9119"><enum>(ii)</enum><text display-inline="yes-display-inline">the required registration fee has not been
paid within 30 days after the date due.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H70AD0B5B8B554199A0FD951AD2FDB402"><enum>(B)</enum><header display-inline="yes-display-inline">Notice of cancellation</header><text display-inline="yes-display-inline">Cancellation shall be preceded by notice to
the facility of the intent to cancel the registration and the basis for such
cancellation.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9326A7A924874CF9BFCA1B213776294F"><enum>(C)</enum><header display-inline="yes-display-inline">Timely update or correction</header><text display-inline="yes-display-inline">If the registration for the facility is
updated or corrected no later than 7 days after notice is provided under
subparagraph (B), the Secretary shall not cancel such registration.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H66E0DB1F4F38464E875ECAFCAE65EA4C"><enum>(7)</enum><header display-inline="yes-display-inline">Report to Congress</header><text display-inline="yes-display-inline">Not later than March 30th of each year, the
Secretary shall submit to the Congress a report, based on the registrations on
or before December 31 of the previous year, on the following:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H4FB88A1AF3784607B4A520EA684801FB"><enum>(A)</enum><text display-inline="yes-display-inline">The number of facilities registered under
this section.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H84F60A1BA5204BB297B754DA833B0C32"><enum>(B)</enum><text display-inline="yes-display-inline">The number of such facilities that are
domestic.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA16957465C5444ACA6ADB33B80575C03"><enum>(C)</enum><text display-inline="yes-display-inline">The number of such facilities that are
foreign.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7F39FB2F38914500A3C9070D7A07665F"><enum>(D)</enum><text display-inline="yes-display-inline">The number of such facilities that are
high-risk.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H19CF558799C9414C9F130FC74740114B"><enum>(E)</enum><text display-inline="yes-display-inline">The number of such facilities that are
low-risk.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDC93AA81E0874011AEFBA8C97C83090F"><enum>(F)</enum><text display-inline="yes-display-inline">The number of such facilities that hold
food.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4AE03DEF76964853B89C533CEB418B99"><enum>(8)</enum><header display-inline="yes-display-inline">Limitation on delegation</header><text display-inline="yes-display-inline">The authority conferred by this subsection
to issue an order to suspend a registration or cancel a registration shall not
be delegated to any officer or employee other than the Commissioner of Food and
Drugs, the Principal Deputy Commissioner, the Associate Commissioner for
Regulatory Affairs, or the Director for the Center for Food Safety and Applied
Nutrition, of the Food and Drug
Administration.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H704D17A9AB9E43C59AF7664EFE3489CF"><enum>(c)</enum><header display-inline="yes-display-inline">Registration fee</header><text display-inline="yes-display-inline">Chapter VII (21 U.S.C. 371 et seq.) is
amended by adding at the end of subchapter C the following:</text>
<quoted-block display-inline="no-display-inline" id="HCC826B3B569F4E3D8D75DABBA3C510C5" style="OLC">
<part commented="no" id="HA63D91C5F8B4408EA4B17BD1F02392E8" level-type="subsequent"><enum>6</enum><header display-inline="yes-display-inline">Fees Relating to Food</header>
<section commented="no" display-inline="no-display-inline" id="H4C3ADAD13B76483BB63B93FC568AAC65" section-type="subsequent-section"><enum>743.</enum><header display-inline="yes-display-inline">Facility registration fee</header>
<subsection commented="no" display-inline="no-display-inline" id="HF627DD21E22F49E681855959A0DD6B94"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header>
<paragraph commented="no" display-inline="no-display-inline" id="HD0146DD9635D41CDA3A8B1803ACA5AD4"><enum>(1)</enum><header display-inline="yes-display-inline">Assessment and collection</header><text display-inline="yes-display-inline">Beginning in fiscal year 2010, the
Secretary shall assess and collect an annual fee for the registration of a
facility under section 415.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF2125AF453E04A18A1C619562DA72E20"><enum>(2)</enum><header display-inline="yes-display-inline">Payable date</header><text display-inline="yes-display-inline">A fee under this section shall be
payable—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HEDFF45E68B894853B0797C3044090BC1"><enum>(A)</enum><text display-inline="yes-display-inline">for a facility that was not registered
under section 415 for the preceding fiscal year, on the date of registration;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H78C36266099946358CD63018A34FDE4A"><enum>(B)</enum><text display-inline="yes-display-inline">for any other facility—</text>
<clause commented="no" display-inline="no-display-inline" id="H0F6B6B3FA5E64979B4A5793A5CAC9235"><enum>(i)</enum><text display-inline="yes-display-inline">for fiscal year 2010, not later than the
sooner of 90 days after the date of the enactment of this part or December 31,
2009; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H6ADDF9CDEC6A4097BD820CE7DA797388"><enum>(ii)</enum><text display-inline="yes-display-inline">for a subsequent fiscal year, not later
than December 31 of such fiscal year.</text>
</clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H9AA58AC871074F20BB7338698230B734"><enum>(b)</enum><header display-inline="yes-display-inline">Fee amounts</header><text display-inline="yes-display-inline"></text>
<paragraph commented="no" display-inline="no-display-inline" id="H01741C31F6E34507A88C043C859A02EC"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The registration fee under subsection (a)
shall be—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HB9B3AFB604184BA9957804368E8ADD99"><enum>(A)</enum><text display-inline="yes-display-inline">for fiscal year 2010, $500; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H971A0628ADF8451A86F83E200572B035"><enum>(B)</enum><text display-inline="yes-display-inline">for fiscal year 2011 and each subsequent
fiscal year, the fee for fiscal year 2010 as adjusted under subsection
(c).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H10942B53FD40409C9018ABE62085011D"><enum>(2)</enum><header display-inline="yes-display-inline">Annual fee setting</header><text display-inline="yes-display-inline">The Secretary shall, not later than 60 days
before the start of fiscal year 2011 and each subsequent fiscal year,
establish, for the next fiscal year, registration fees under subsection (a), as
described in paragraph (1).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HEF32E3D669DC482A8BC6168A0A993385"><enum>(3)</enum><header display-inline="yes-display-inline">Maximum
amount</header><text display-inline="yes-display-inline">Notwithstanding
paragraph (1), a person who owns or operates multiple facilities for which a
fee must be paid under this section for a fiscal year shall be liable for not
more than $175,000 in aggregate fees under this section for such fiscal
year.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H4E308F6AD2C34A00AA44B1E7C6DE5140"><enum>(c)</enum><header display-inline="yes-display-inline">Inflation adjustment</header><text display-inline="yes-display-inline">For fiscal year 2011 and each subsequent
fiscal year, the fee amount under subsection (b)(1) shall be adjusted by the
Secretary by notice, published in the Federal Register, to reflect the greater
of—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H83F6CE633FA0429CA0FB7588E7090094"><enum>(1)</enum><text display-inline="yes-display-inline">the total percentage change that occurred
in the Consumer Price Index for all urban consumers (all items; U.S. city
average) for the 12-month period ending June 30 preceding the fiscal year for
which fees are being established;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HAC58697DEF024BF48FBC634900A5F937"><enum>(2)</enum><text display-inline="yes-display-inline">the total percentage change for the
previous fiscal year in basic pay under the General Schedule in accordance with
section 5332 of title 5, United States Code, as adjusted by any locality-based
comparability payment pursuant to section 5304 of such title for Federal
employees stationed in the District of Columbia; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H133D1F6B675344698737B295B2C16EC0"><enum>(3)</enum><text display-inline="yes-display-inline">the average annual change in the cost, per
full-time equivalent position of the Food and Drug Administration, of all
personnel compensation and benefits paid with respect to such positions for the
first 5 years of the preceding 6 fiscal years.</text>
</paragraph><continuation-text commented="no" continuation-text-level="subsection">The adjustment made each fiscal year
under this subsection shall be added on a compounded basis to the sum of all
adjustments made each fiscal year after fiscal year 2010 under this
subsection.</continuation-text></subsection><subsection commented="no" display-inline="no-display-inline" id="HB5439D6DB1ED495A96C7409F74D7BC14"><enum>(d)</enum><header display-inline="yes-display-inline">Limitations</header><text display-inline="yes-display-inline"></text>
<paragraph commented="no" display-inline="no-display-inline" id="H95EBA348FA914CF2A63BAEBA128F8234"><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 appropriations for
salaries and expenses of the Food and Drug Administration for such fiscal year
(excluding the amount of fees appropriated for such fiscal year) are equal to
or greater than the amount of appropriations for the salaries and expenses of
the Food and Drug Administration for fiscal year 2010 (excluding the amount of
fees appropriated for such fiscal year) multiplied by the adjustment factor
applicable to the fiscal year involved.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0729BA391E204EB4B8483826887B9688"><enum>(2)</enum><header display-inline="yes-display-inline">Authority</header><text display-inline="yes-display-inline">If the Secretary does not assess fees under
subsection (a) during any portion of a fiscal year because of paragraph (1) and
if at a later date in such fiscal year the Secretary may assess such fees, the
Secretary may assess and collect such fees, without any modification in the
rate, for registration under section 415 at any time in such fiscal
year.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H06AD2FCE3CD2459881A863C70761F0A4"><enum>(3)</enum><header display-inline="yes-display-inline">Adjustment factor</header><text display-inline="yes-display-inline">In this subsection, the term
<term>adjustment factor</term> applicable to a fiscal year is the Consumer
Price Index for all urban consumers (all items; United States city average) for
October of the preceding fiscal year divided by such Index for October
2009.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H8527374EDC9F4F5B88F7B800082E6E69"><enum>(e)</enum><header display-inline="yes-display-inline">Crediting and availability of fees</header>
<paragraph commented="no" display-inline="no-display-inline" id="HA209EFEB198A4C3AAA1123B4336386AE"><enum>(1)</enum><header display-inline="yes-display-inline">In general</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 advance 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 appropriation account
without fiscal year limitation to such appropriation account for salaries and
expenses with such fiscal year limitation.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDD9BAB0B2314443596058CF90DE911AD"><enum>(2)</enum><header display-inline="yes-display-inline">Collections and appropriations
Acts</header><text display-inline="yes-display-inline">The fees authorized by
this section—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H733ADF2838BB44BDA5EBAB4E73DCF0A5"><enum>(A)</enum><text display-inline="yes-display-inline">shall be retained in each fiscal year in an
amount not to exceed the amount specified in appropriation Acts, or otherwise
made available for obligation, for such fiscal year; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H99F80CCB696143719A73E7075CE7AC62"><enum>(B)</enum><text display-inline="yes-display-inline">shall only be collected and available to
defray the costs of food safety activities.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H59EC7CE7F4414B9BB6E7F7950FD77B26"><enum>(3)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">For each of
fiscal years 2010 through 2014, there are authorized to be appropriated for
fees under this section such sums as may be necessary.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H56A77751642A4684ABE7784E8BFDD376"><enum>(4)</enum><header display-inline="yes-display-inline">Public meetings</header><text display-inline="yes-display-inline">For each fiscal year, the Secretary shall
hold a public meeting on how fees collected under this section will be used to
defray the costs of food safety activities in order to solicit the views of the
regulated industry, consumers, and other interested stakeholders.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H13654FFD323F42E49CA0F1E0AE11286A"><enum>(f)</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 subsection (a) within 30 days after it
is due, such fee shall be treated as a claim of the United States Government
subject to subchapter II of chapter 37 of title 31, United States Code.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H02AB9E048CB64A1784FA39E6DC7FBBEF"><enum>(g)</enum><header display-inline="yes-display-inline">Construction</header><text display-inline="yes-display-inline">This section may not be construed to
require that the number of full-time equivalent positions in the Department of
Health and Human Services, for officers, employees, and advisory committees not
engaged in food safety activities, be reduced to offset the number of officers,
employees, and advisory committees so engaged.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H472F9E0B144E49D6B67C89BD3AFF5640"><enum>(h)</enum><header display-inline="yes-display-inline">Annual fiscal reports</header><text display-inline="yes-display-inline">Beginning with fiscal year 2011, not later
than 120 days after the end of each fiscal year for which fees are collected
under this section, the Secretary shall prepare and submit to the Committee on
Energy and Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate a report on the
implementation of the authority for such fees during such fiscal year and the
use, by the Food and Drug Administration, of the fees collected for such fiscal
year.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HCB3FEBA568C84BA18FB1411D78C85E80"><enum>(i)</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="HC611698004FA4035B01B5D07EFFF6E2E"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>costs of food safety
activities</term> means the expenses incurred in connection with food safety
activities for—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H20755CA5653C4A80B0D4D7D294652AAC"><enum>(A)</enum><text display-inline="yes-display-inline">officers and employees of the Food and Drug
Administration, contractors of the Food and Drug Administration, advisory
committees, and costs related to such officers, employees, and committees and
to contracts with such contractors;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9129031B046F471693F1507BAF6BB70E"><enum>(B)</enum><text display-inline="yes-display-inline">laboratory capacity;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HCEEBE2666D0A433CB5500EBE72E89783"><enum>(C)</enum><text display-inline="yes-display-inline">management of information, and the
acquisition, maintenance, and repair of technology resources;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3AC5CFA9D7CE46D79B1FF8BE5662CAC0"><enum>(D)</enum><text display-inline="yes-display-inline">leasing, maintenance, renovation, and
repair of facilities and acquisition, maintenance, and repair of fixtures,
furniture, scientific equipment, and other necessary materials and supplies;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H705CE6AA92F84616B5EAFDC7A2173033"><enum>(E)</enum><text display-inline="yes-display-inline">collecting fees under this section and
accounting for resources allocated for food safety activities.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HA3AA001E02584BA8B904CA604243B81C"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>food safety
activities</term> means activities related to compliance by facilities
registered under section 415 with the requirements of this Act relating to food
(including research related to and the development of standards (such as
performance standards and preventive controls), risk assessments, hazard
analyses, inspection planning and inspections, third-party inspections,
compliance review and enforcement, import review, information technology
support, test development, product sampling, risk communication, and
administrative
detention).</text>
</paragraph></subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H2428F3E4F1ED48929980406B22BB1826"><enum>(d)</enum><header display-inline="yes-display-inline">Transitional provisions</header>
<paragraph commented="no" display-inline="no-display-inline" id="H67B138EC439245AAA2892174E376FE75"><enum>(1)</enum><header display-inline="yes-display-inline">Fees</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services
shall first impose the fee established under section 743 of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (c), for fiscal years beginning
with fiscal year 2010.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4FA6A98A9524491AB625D11AE42199A6"><enum>(2)</enum><header display-inline="yes-display-inline">Modification of registration
form</header><text display-inline="yes-display-inline">Not later than 180 days
after the date of the enactment of this Act, the Secretary of Health and Human
Services shall modify the registration form under section 415 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 350d) to comply with the amendments
made by this section.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H81F8356CD00F497BBDC4282877B8FB34"><enum>(3)</enum><header display-inline="yes-display-inline">Application</header><text display-inline="yes-display-inline">The amendments made by this section, other
than subsections (b)(2) and (c), shall take effect on the date that is 30 days
after the date on which such modified registration form takes effect, but not
later than 210 days after the date of the enactment of this Act.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE999E2A6486B4032B2C6ECC2F8B4FBFB"><enum>(4)</enum><header display-inline="yes-display-inline">Sunset date</header><text display-inline="yes-display-inline">Section 743 of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (c), does not authorize the assessment or
collection of a fee for registration under section 415 of such Act (21 U.S.C.
360) occurring after fiscal year 2014.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H4972EA898ABF4D539F8C802F8D43786F" section-type="subsequent-section"><enum>102.</enum><header display-inline="yes-display-inline">Hazard analysis, risk-based preventive
controls, food safety plan, finished product test results from category 1
facilities</header>
<subsection commented="no" display-inline="no-display-inline" id="HE3E0CA2AA7924F14A96115D9C90E5332"><enum>(a)</enum><header display-inline="yes-display-inline">Hazard analysis, risk-based preventive
controls, food safety plan</header>
<paragraph commented="no" display-inline="no-display-inline" id="H89BFB042EE764C219AC334855D4CFB39"><enum>(1)</enum><header display-inline="yes-display-inline">Adulterated food</header><text display-inline="yes-display-inline">Section 402 (21 U.S.C. 342) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HDCBCCD5074E74D86BEB4C1B2DA72D7C1" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HE16894D23CDA45D18E3EC685B42653B6"><enum>(j)</enum><text display-inline="yes-display-inline">If it has been manufactured, processed,
packed, transported, or held under conditions that do not meet the requirements
of sections 418 and
418A.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H02D9176E45F04EB0ACCAB720AB40B285"><enum>(2)</enum><header display-inline="yes-display-inline">Requirements</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="H63E05DC3AA2D4932922C303D2B892F69" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H3121B9E8CF434429975B1015342B0530" 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="HD4D46672DB3B47A48F4DCB469623B0E4"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The owner, operator, or agent of a facility
shall, in accordance with this section—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HF062D33015D7485B956AE9D8EC3B5BFC"><enum>(1)</enum><text display-inline="yes-display-inline">conduct a hazard analysis (or more than one
if appropriate);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HA376A1E4FB7E40EFBC4928BA86CB41FC"><enum>(2)</enum><text display-inline="yes-display-inline">identify and implement effective preventive
controls;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H263F2D1CC2F64907A699C9E15B18D883"><enum>(3)</enum><text display-inline="yes-display-inline">monitor preventive controls;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H57AD5D091DBA46D6B8C87CD681480817"><enum>(4)</enum><text display-inline="yes-display-inline">institute corrective actions when—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H8FB715F13A67428FBD992FE36C513253"><enum>(A)</enum><text display-inline="yes-display-inline">monitoring shows that preventive controls
have not been properly implemented; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HABB37B02F58C49C483B6A8D3A7A8ED78"><enum>(B)</enum><text display-inline="yes-display-inline">monitoring and verification show that such
controls were ineffective;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3DC5A0028C474DF69DD540C5E0C3A6CB"><enum>(5)</enum><text display-inline="yes-display-inline">conduct verification activities;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H582715FAE8354576B2F2A5B6DFF4CF6F"><enum>(6)</enum><text display-inline="yes-display-inline">maintain records of monitoring, corrective
action, and verification; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H777D71478BE24B7B8D8D7A1F535173E8"><enum>(7)</enum><text display-inline="yes-display-inline">reanalyze for hazards.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H1D1C4C2839D54338A91399946DC52967"><enum>(b)</enum><header display-inline="yes-display-inline">Identification of hazards</header>
<paragraph commented="no" display-inline="no-display-inline" id="H5CCEAD4D15574B18BE92EE003E086827"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The owner, operator, or agent of a facility
shall evaluate whether there are any hazards, including hazards due to the
source of the ingredients, that are reasonably likely to occur in the absence
of preventive controls that may affect the safety, wholesomeness, or sanitation
of the food manufactured, processed, packed, transported, or held by the
facility, including—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HB4B6998FAC6241DFB71A76ED05618428"><enum>(A)</enum><text display-inline="yes-display-inline">biological, chemical, physical, and
radiological hazards, natural toxins, pesticides, drug residues, filth,
decomposition, parasites, allergens, and unapproved food and color additives;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HAD92B19014F643D4B118F4D1813F5946"><enum>(B)</enum><text display-inline="yes-display-inline">hazards that occur naturally or that may be
unintentionally introduced.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBF99608F4A1D40DBA26E2D95F6F97F0A"><enum>(2)</enum><header display-inline="yes-display-inline">Identified by the Secretary</header><text display-inline="yes-display-inline">The Secretary may, by regulation or
guidance, identify hazards that are reasonably likely to occur in the absence
of preventive controls.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H11340395234A444187C449671AA81E68"><enum>(3)</enum><header display-inline="yes-display-inline">Hazard analysis</header><text display-inline="yes-display-inline">The owner, operator, or agent of a facility
shall identify and describe the hazards evaluated under paragraph (1) or
identified under paragraph (2), to the extent applicable to the facility, in a
hazard analysis.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HE77AF5D4E3DD45178D6B5A0055ECC25E"><enum>(c)</enum><header display-inline="yes-display-inline">Preventive controls</header>
<paragraph commented="no" display-inline="no-display-inline" id="H9DEFED6B01DA4291BFE3CA649DD8D72F"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The owner, operator, or agent of a facility
shall identify and implement effective preventive controls to prevent,
eliminate, or reduce to acceptable levels the occurrence of any hazards
identified in the hazard analysis under subsection (b)(3).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1710386ED9EF41CB8BC2109900DDE425"><enum>(2)</enum><header display-inline="yes-display-inline">Identified by the Secretary</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HADF203C7F86F42C99FA8EEDC888DA280"><enum>(A)</enum><header display-inline="yes-display-inline">Establishment</header><text display-inline="yes-display-inline">The Secretary may establish by regulation
or guidance preventive controls for specific product types to prevent
unintentional contamination throughout the supply chain. The owner, operator,
or agent of a facility shall implement any preventive controls identified by
the Secretary under this paragraph.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H49B6ECABC9C346F8B27C33D5B594E394"><enum>(B)</enum><header display-inline="yes-display-inline">Alternative Controls</header><text display-inline="yes-display-inline">Such regulation or guidance shall allow the
owner, operator, or agent of a facility to implement an alternative preventive
control to one established by the Secretary, provided that, in response to a
request by the Secretary, the owner, operator, or agent can present to the
Secretary data or other information sufficient to demonstrate that the
alternative control effectively addresses the hazard, including meeting any
applicable performance standard.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDEFAC090448746288D8068090FA292DC"><enum>(C)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">Subparagraph (B) shall not apply to any
preventive control described in subparagraph (A), (B), or (E) of subsection
(i)(2).</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H9FF08DF51DF6420090C39AC62B2B6114"><enum>(d)</enum><header display-inline="yes-display-inline">Monitoring</header><text display-inline="yes-display-inline">The owner, operator, or agent of a facility
shall monitor the implementation of preventive controls under subsection (c) to
identify any circumstances in which the preventive controls are not fully
implemented or verification shows that such controls were ineffective.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HD4DDE4440BFC49A8A3D2B82E2338D9EC"><enum>(e)</enum><header display-inline="yes-display-inline">Corrective actions</header><text display-inline="yes-display-inline">The owner, operator, or agent of a facility
shall establish and implement procedures to ensure that, if the preventive
controls under subsection (c) are not fully implemented or are not found
effective—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HAC03D3393F1A4E3986F38A145E947578"><enum>(1)</enum><text display-inline="yes-display-inline">no affected product from such facility
enters commerce; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3304C9A284054C27A2DF31A756CFF080"><enum>(2)</enum><text display-inline="yes-display-inline">appropriate action is taken to reduce the
likelihood of recurrence of the implementation failure.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H79FB02101D154C7392471BF4ECCDFB8E"><enum>(f)</enum><header display-inline="yes-display-inline">Verification</header><text display-inline="yes-display-inline">The owner, operator, or agent of a facility
shall ensure that—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H4A2D5E519F5C40DB9338B6FBBC9311A5"><enum>(1)</enum><text display-inline="yes-display-inline">the system of preventive controls
identified under subsection (c) has been validated as scientifically and
technically sound so that, if such system is implemented, the hazards
identified in the hazard analysis under subsection (b)(3) will be prevented,
eliminated, or reduced to an acceptable level;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H89F725F2A65F4F3788298C41E4DDC8DE"><enum>(2)</enum><text display-inline="yes-display-inline">the facility is conducting monitoring in
accordance with subsection (d);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2F6D1AD54FF847C9821E24B462625B82"><enum>(3)</enum><text display-inline="yes-display-inline">the facility is taking effective corrective
actions under subsection (e); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H548C52A7255F4B11A39E9DB8EE035359"><enum>(4)</enum><text display-inline="yes-display-inline">the preventive controls are effectively
preventing, eliminating, or reducing to an acceptable level the occurrence of
identified hazards, including through the use of environmental and product
testing programs and other appropriate means.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H0B51CC6803A54CBEBC8F09F86C44C0A3"><enum>(g)</enum><header display-inline="yes-display-inline">Requirement to reanalyze and
revise</header>
<paragraph commented="no" display-inline="no-display-inline" id="H2815ED19EEB5482DBC62E097BE8ED3AD"><enum>(1)</enum><header display-inline="yes-display-inline">Requirement</header><text display-inline="yes-display-inline">The owner, operator, or agent of a facility
shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H5FF3851314B84481A9AB85E277054D74"><enum>(A)</enum><text display-inline="yes-display-inline">review the evaluation under subsection (b)
for the facility and, as necessary, revise the hazard analysis under subsection
(b)(3) for the facility—</text>
<clause commented="no" display-inline="no-display-inline" id="H3AF6C522BEA247EE86A72DCD550D3DDD"><enum>(i)</enum><text display-inline="yes-display-inline">not less than every 2 years;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H94262A1188554E8A98D2BB5F0CF1B9B4"><enum>(ii)</enum><text display-inline="yes-display-inline">if there is a change in the process or
product that could affect the hazard analysis; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HD8B39862B01B419F9EA107E026B8E950"><enum>(iii)</enum><text display-inline="yes-display-inline">if the Secretary determines that it is
appropriate to protect public health; and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H13E5BC7DDA5A4FA986F3233492E1D98A"><enum>(B)</enum><text display-inline="yes-display-inline">whenever there is a change in the hazard
analysis, revise the preventive controls under subsection (c) for the facility
as necessary to ensure that all hazards that are reasonably likely to occur are
prevented, eliminated, or reduced to an acceptable level, or document the basis
for the conclusion that no such revision is needed.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB58600134D41479AA6470F7E2B03AC41"><enum>(2)</enum><header display-inline="yes-display-inline">Nondelegation</header><text display-inline="yes-display-inline">Any revisions ordered by the Secretary
under this subsection shall be ordered by the Secretary or an official
designated by the Secretary. An official may not be so designated unless the
official is the director of the district under this Act in which the facility
involved is located, or is an official senior to such director.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H3E4FB85612F6419C9F8D903DC967BAC6"><enum>(h)</enum><header display-inline="yes-display-inline">Recordkeeping</header><text display-inline="yes-display-inline">The owner, operator, or agent of a facility
shall maintain, for not less than 2 years, records documenting the activities
described in subsections (a) through (g).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HAE9C27BF52B1417A894E993BA1CFFAE3"><enum>(i)</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="H58E0FE4098394FCCA3D986DA7BC3486B"><enum>(1)</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 be registered under
section 415.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HA23A7729682A418ABCA954B009D1E1F8"><enum>(2)</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 procedures, practices, and processes that a person
knowledgeable about the safe manufacturing, processing, packing, transporting,
or holding of food would employ to prevent, eliminate, or reduce to an
acceptable level the hazards identified in the hazard analysis under subsection
(b)(3) and that are consistent with the current scientific understanding of
safe food manufacturing, processing, packing, transporting, or holding at the
time of the analysis. Those procedures, practices, and processes shall include
the following, as appropriate to the type of facility or food:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HE3C3B1B200DF463FBCE5E23BB258637C"><enum>(A)</enum><text display-inline="yes-display-inline">Sanitation procedures and practices.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC37D812609A34DAB80E6CBD0696E9B54"><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="H4A15E853A6984CBFB69488AC9F928FF2"><enum>(C)</enum><text display-inline="yes-display-inline">Process controls.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H25525D72B5AD4533B13647418A414E9C"><enum>(D)</enum><text display-inline="yes-display-inline">An allergen control program to minimize
potential allergic reactions in humans from ingestion of, or contact with,
human and animal food.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H1E1B52452BF74C9AB8472AEA00C1A2BD"><enum>(E)</enum><text display-inline="yes-display-inline">Good manufacturing practices.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9B2F347F1A8B410F9FDFC570E5FC4DBC"><enum>(F)</enum><text display-inline="yes-display-inline">Verification procedures, practices, and
processes for suppliers and incoming ingredients, which may include onsite
auditing of suppliers and testing of incoming ingredients.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H05E8C8EC7ECB497AACCE6B5D05409D23"><enum>(G)</enum><text display-inline="yes-display-inline">Other procedures, practices, and processes
established by the Secretary under subsection (c)(2).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF161E4C9A2FF487C95F82D6A739734AC"><enum>(3)</enum><header display-inline="yes-display-inline">Hazard that is reasonably likely to
occur</header><text display-inline="yes-display-inline">A food safety hazard
that is reasonably likely to occur is one for which a prudent person who, as
applicable, manufactures, processes, packs, transports, or holds food, would
establish controls because experience, illness data, scientific reports, or
other information provides a basis to conclude that there is a reasonable
possibility that the hazard will occur in the type of food being manufactured,
processed, packed, transported, or held in the absence of those
controls.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H06DFF723962A4CA6B6E250CB36C856D2" section-type="subsequent-section"><enum>418A.</enum><header display-inline="yes-display-inline">Food safety plan</header>
<subsection commented="no" display-inline="no-display-inline" id="H41089BE5F6814E78A1471C531C2407AC"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Before a facility (as defined in section
418(i)) introduces or delivers for introduction into interstate commerce any
shipment of food, the owner, operator, or agent of the facility shall develop
and implement a written food safety plan (in this section referred to as a
<quote>food safety plan</quote>).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H965B2CBBAE7A474A80D5598F35352DF6"><enum>(b)</enum><header display-inline="yes-display-inline">Contents</header><text display-inline="yes-display-inline">The food safety plan shall include each of
the following elements:</text>
<paragraph commented="no" display-inline="no-display-inline" id="HD10F7C3758014B7F83CC7B1C021C63F8"><enum>(1)</enum><text display-inline="yes-display-inline">The hazard analysis and any reanalysis
conducted under section 418.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H631A44A260984F6198EA8AA98B753B8C"><enum>(2)</enum><text display-inline="yes-display-inline">A description of the preventive controls
being implemented under subsection 418(c), including those to address hazards
identified by the Secretary under subsection 418(b)(2).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H69D12E01B54E4723990A7DAFBD9C79AB"><enum>(3)</enum><text display-inline="yes-display-inline">A description of the procedures for
monitoring preventive controls.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9656EA018E6544C09883EDFF551DAAB4"><enum>(4)</enum><text display-inline="yes-display-inline">A description of the procedures for taking
corrective actions.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3756D134BC014DEA8C32EC137205C326"><enum>(5)</enum><text display-inline="yes-display-inline">A description of verification activities
for the preventive controls, including validation that the system of controls,
if implemented, will prevent, eliminate, or reduce to an acceptable level the
identified hazards, review of monitoring and corrective action records, and
procedures for determining whether the system of controls as implemented is
effectively preventing, eliminating, or reducing to an acceptable level the
occurrence of identified hazards, including the use of environmental and
product testing programs.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7A5C6B63E52C4F3DBA4136FABFB11AA5"><enum>(6)</enum><text display-inline="yes-display-inline">A description of the facility’s
recordkeeping procedures.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6565AE351EE847C3A678577E5B858305"><enum>(7)</enum><text display-inline="yes-display-inline">A description of the facility’s procedures
for the recall of articles of food, whether voluntarily or when required under
section 422.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB9BBEBD988F04502B535B45A5D47B49E"><enum>(8)</enum><text display-inline="yes-display-inline">A description of the facility’s procedures
for tracing the distribution history of articles of food, whether voluntarily
or when required under section 414.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H41132C97259A4FE6A8908D0A9800FCB6"><enum>(9)</enum><text display-inline="yes-display-inline">A description of the facility’s procedures
to ensure a safe and secure supply chain for the ingredients or components used
in making the food manufactured, processed, packed, transported, or held by
such facility.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB62E8E6039D14633982B262DA7655ABD"><enum>(10)</enum><text display-inline="yes-display-inline">A description of the facility’s procedures
to implement the science-based performance standards issued under section
419.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H54921B8A34B040E98B188F2C007AD2FB"><enum>(3)</enum><header display-inline="yes-display-inline">Guidance or regulations</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H22F6CACE839044508B1688A41D996447"><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
(referred to in this subsection as the <quote>Secretary</quote>) shall issue
guidance or promulgate regulations to establish science-based standards for
conducting a hazard analysis, documenting hazards, identifying and implementing
preventive controls, and documenting the implementation of the preventive
controls, including verification and corrective actions under sections 418 and
418A of the Federal Food, Drug, and Cosmetic Act (as added by paragraph
(2)).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H1B4836DC00564663AA38DEECD681B790"><enum>(B)</enum><header display-inline="yes-display-inline">International standards</header><text display-inline="yes-display-inline">In issuing guidance or regulations under
subparagraph (A), the Secretary shall review international hazard analysis and
preventive control standards that are in existence on the date of the enactment
of this Act and relevant to such guidelines or regulations to ensure that the
programs under sections 418 and 418A of the Federal Food, Drug, and Cosmetic
Act (as added by paragraph (2) are consistent, to the extent the Secretary
determines practicable and appropriate, with such standards.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3E8F93C1ABA34CBF90F835929BE26BCF"><enum>(C)</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 and the amendments made by this section with respect to facilities that
are solely engaged in—</text>
<clause commented="no" display-inline="no-display-inline" id="HC715AE71AC2A40AD9CA28FEF9F785139"><enum>(i)</enum><text display-inline="yes-display-inline">the production of food for animals other
than man or the storage of packaged foods that are not exposed to the
environment; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HA0B31AED55264C5181A6EB4645F9E1D2"><enum>(ii)</enum><text display-inline="yes-display-inline">the storage of raw agricultural commodities
for further distribution or processing.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE5C210CC2C1745D5839D8119640E485D"><enum>(D)</enum><header display-inline="yes-display-inline">Small businesses</header><text display-inline="yes-display-inline">The Secretary—</text>
<clause commented="no" display-inline="no-display-inline" id="H6827A9A8C923453186682BF86754F4AE"><enum>(i)</enum><text display-inline="yes-display-inline">shall consider the impact of any guidance
or regulations under this section on small businesses; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HAA4344FC93A24DC4B98874A14F5B7218"><enum>(ii)</enum><text display-inline="yes-display-inline">shall issue guidance to assist small
businesses in complying with the requirements of this section and the
amendments made by this section.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6641119AFBA8494FB8374F8778DFDE05"><enum>(4)</enum><header display-inline="yes-display-inline">No effect on existing HACCP
authorities</header><text display-inline="yes-display-inline">Nothing in this
section or 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.), as in effect on
the day before the date of the enactment of this Act, 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>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H8D653657588C4EAE9CB24157736C865A"><enum>(5)</enum><header display-inline="yes-display-inline">Consideration</header><text display-inline="yes-display-inline">When implementing sections 418 and 418A of
the Federal Food, Drug, and Cosmetic Act, as added by paragraph (2), the
Secretary may take into account differences between food intended for human
consumption and food intended for consumption by animals other than man.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H41B697808A114358ADFEA06C9DAC7A59"><enum>(6)</enum><header display-inline="yes-display-inline">Effective date</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HFEA88E4959BD4D22B33A61C4985A5EEC"><enum>(A)</enum><header display-inline="yes-display-inline">General rule</header><text display-inline="yes-display-inline">The amendments made by subsection (a) and
this subsection shall take effect 18 months after the date of the enactment of
this Act.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H32C6D52BABE04177BDC3C2D3C594B84B"><enum>(B)</enum><header display-inline="yes-display-inline">Exceptions</header><text display-inline="yes-display-inline">Notwithstanding subparagraph (A)—</text>
<clause commented="no" display-inline="no-display-inline" id="H1179570331A6462BB1025846D690832F"><enum>(i)</enum><text display-inline="yes-display-inline">the amendments made by subsection (a) and
this subsection shall apply to a small business (as defined by the Secretary)
after the date that is 2 years after the date of the enactment of this Act;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H9BD3D1205D7C4B76A726D3AF83C20680"><enum>(ii)</enum><text display-inline="yes-display-inline">the amendments made by subsection (a) and
this subsection shall apply to a very small business (as defined by the
Secretary) after the date that is 3 years after the date of the enactment of
this Act.</text>
</clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HF3FD88C21F22469DAA4A87F9CD471289"><enum>(b)</enum><header display-inline="yes-display-inline">Finished product test results from category
1 facilities</header>
<paragraph commented="no" display-inline="no-display-inline" id="H50F0D5CC54344D1385F52EB463AB96A3"><enum>(1)</enum><header display-inline="yes-display-inline">Adulteration</header><text display-inline="yes-display-inline">Section 402 (21 U.S.C. 342), as amended by
subsection (a), is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HA12B5321348C45AC9E97953CFA305103" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H59FF0E5B973146CE86BD9BBC2D93FC35"><enum>(k)</enum><text display-inline="yes-display-inline">If it is manufactured or processed in a
facility that is in violation of section
418B.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9BEA619068624646A13551C9B5F05E8F"><enum>(2)</enum><header display-inline="yes-display-inline">Requirements</header><text display-inline="yes-display-inline">Chapter IV (21 U.S.C. 341 et seq.), as
amended, is further amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H73E0C0D03E474A4B96D5CD4B3881944B" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H34419D583ACC4D058D20474DE92BD047" section-type="subsequent-section"><enum>418B.</enum><header display-inline="yes-display-inline">Finished product test results from category
1 facilities</header>
<subsection commented="no" display-inline="no-display-inline" id="H2C046DDBF9534E0789A42E90B4E82221"><enum>(a)</enum><header display-inline="yes-display-inline">Authority</header><text display-inline="yes-display-inline">Beginning on the date specified in
subsection (c), the Secretary shall require, after public notice and an
opportunity for comment, the submission to the Secretary of finished product
test results by the owner, operator, or agent of each category 1 facility
subject to good manufacturing practices regulations documenting the presence of
contaminants in food in the possession or control of such facility posing a
risk of severe adverse health consequences or death.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H04974513794C40BE927E1287828629CC"><enum>(b)</enum><header display-inline="yes-display-inline">Considerations</header><text display-inline="yes-display-inline">The Secretary shall require submissions
under subsection (a)—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H3C2941A7101542F09EC9507BB5C22CE4"><enum>(1)</enum><text display-inline="yes-display-inline">as the Secretary determines feasible and
appropriate; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H22A45EED78A34068B2EB2780C9EA8274"><enum>(2)</enum><text display-inline="yes-display-inline">taking into consideration available data
and information on the potential risks posed by the facility.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H04F26A9CEB774DCB9E672359F01DF0B0"><enum>(c)</enum><header display-inline="yes-display-inline">Beginning
date</header><text display-inline="yes-display-inline">The date specified in
this subsection is the sooner of—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HDE09DA7A37FC4672BBB34A03D332A6AF"><enum>(1)</enum><text display-inline="yes-display-inline">the date of completion of the pilot
projects and feasibility study under subsections (d) and (e); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB451FAEDD98B4B95992D3DC0822C1163"><enum>(2)</enum><text display-inline="yes-display-inline">the date that is 2 years after the date of
the enactment of this section.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H349287BB45364D72B65321DC85EFF548"><enum>(d)</enum><header display-inline="yes-display-inline">Pilot
projects</header><text display-inline="yes-display-inline">The Secretary shall
conduct 2 or more pilot projects to evaluate the feasibility of collecting
positive finished product testing results from category 1 facilities, including
the value and feasibility of reporting corrective actions taken when positive
finished product test results are reported to the Secretary.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H794780185DEC40599E7A0314C8C5F8B0"><enum>(e)</enum><header display-inline="yes-display-inline">Feasibility study</header><text display-inline="yes-display-inline">The Secretary shall assess the feasibility
and benefits of the reporting by facilities subject to good manufacturing
practices regulations of appropriate finished product testing results from
category 1 facilities to the Secretary, including the extent to which the
collection of such finished product testing results will help the Secretary
assess the risk presented by a facility or product category.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H99E32033E52D4E0C9D873B424F8E03B0"><enum>(f)</enum><header display-inline="yes-display-inline">Limitations</header><text display-inline="yes-display-inline">Nothing in this section shall be
construed—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H8BA53895EF0B4071A45BDD3D2601F81F"><enum>(1)</enum><text display-inline="yes-display-inline">to require the Secretary to mandate testing
or submission of test results that the Secretary determines would not provide
useful information in assessing the potential risk presented by a facility or
product category; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6B1497425934485AA052F1B483E7572A"><enum>(2)</enum><text display-inline="yes-display-inline">to limit the Secretary’s authority under
any other provisions of law to require any person to provide access, or to
submit information or test results, to the Secretary, including the ability of
the Secretary to require field or other testing and to obtain test results in
the course of an investigation of a potential food-borne illness or
contamination incident.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H3A483B24E257410BBD303EBB257C4F2F"><enum>(g)</enum><header display-inline="yes-display-inline">Definition</header><text display-inline="yes-display-inline">In this section, the term <quote>category 1
facility</quote> means a category 1 facility within the meaning of section
704(h).</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HE89F98D6761445B8BE9F16A9E70B28C5"><enum>(c)</enum><header display-inline="yes-display-inline">Food defense</header>
<paragraph commented="no" display-inline="no-display-inline" id="HC1360289F29842B9BDD98041F08D2BC8"><enum>(1)</enum><header display-inline="yes-display-inline">Adulteration</header><text display-inline="yes-display-inline">Section 402(j), as added by subsection (a),
is amended by striking <quote>and 418A</quote> and inserting <quote>, 418A, or
418C</quote>.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H87BE3ED4598E47959D98C3E19037C337"><enum>(2)</enum><header display-inline="yes-display-inline">Requirements</header><text display-inline="yes-display-inline">Chapter IV (21 U.S.C. 341 et seq.), as
amended, is further amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H8C03109603B14A36902AED5E3278ECCA" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H5261AB137546438D943B10B8959271BC" section-type="subsequent-section"><enum>418C.</enum><header display-inline="yes-display-inline">Food defense</header>
<subsection commented="no" display-inline="no-display-inline" id="H7E497EE5D5E9472ABE68AE13CB65D00D"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Before a facility (as defined in section
418(i)) introduces or delivers for introduction into interstate commerce any
shipment of food, the owner, operator, or agent of the facility shall develop
and implement a written food defense plan (in this section referred to as a
<quote>food defense plan</quote>).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HC305537179D64F20BCD91FDACA3AF1F5"><enum>(b)</enum><header display-inline="yes-display-inline">Contents</header><text display-inline="yes-display-inline">The food defense plan shall include each of
the following elements:</text>
<paragraph commented="no" display-inline="no-display-inline" id="H2293293972AB4647B5F248A6ED24C67D"><enum>(1)</enum><text display-inline="yes-display-inline">A food defense assessment to identify
conditions and practices that may permit a hazard that may be intentionally
introduced, including by an act of terrorism. This assessment shall evaluate
processing security, cybersecurity, material security (including ingredients,
finished product, and packaging), personnel security, storage security,
shipping and receiving security, and utility security.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HEDFAF41B1D294E128816E34A5408D542"><enum>(2)</enum><text display-inline="yes-display-inline">A description of the preventive measures
being implemented as a result of such assessment to minimize the risk of
intentional contamination.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6F2BCEE19A614AB3888A221D201DD60C"><enum>(3)</enum><text display-inline="yes-display-inline">A description of the procedures to check
for and identify any circumstances in which the preventive measures are not
fully implemented or were ineffective.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HA47CA39D430246AF9FBFABBAE3B82DD8"><enum>(4)</enum><text display-inline="yes-display-inline">A description of the procedures for taking
corrective actions to ensure that when preventive measures have not been
properly implemented or have been ineffective, appropriate action is
taken—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HB0FC3F46EFB444B3B48E846EC3507064"><enum>(A)</enum><text display-inline="yes-display-inline">to reduce the likelihood of recurrence of
the failure; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HCA0EE0D6E6C04923AF2A1D8FB1D452F6"><enum>(B)</enum><text display-inline="yes-display-inline">to assess the consequences of the
failure.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2958C879EC76428391C271261E50E5C2"><enum>(5)</enum><text display-inline="yes-display-inline">A description of evaluation activities for
the preventive measures, including a review of records provided for under
paragraph (6) and procedures to periodically test the effectiveness of the
plan.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF929B9602ED74C28908EC11AA1E4FEF3"><enum>(6)</enum><text display-inline="yes-display-inline">A description of the facility’s
record-keeping procedures, including records documenting implementation of the
procedures under paragraphs (3), (4), and (5).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HF735E9F170864CD0B3273A6A9336AE55"><enum>(c)</enum><header display-inline="yes-display-inline">Hazard</header><text display-inline="yes-display-inline">For purposes of this section, the term
<quote>hazard that may be intentionally introduced, including by an act of
terrorism</quote> means a hazard for which a prudent person who, as applicable,
manufactures, processes, packs, transports, or holds food, would establish
preventive measures because the hazard has been identified by a food defense
assessment by application of—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H0323F9415D5746FDA0668E04D17A6F8B"><enum>(1)</enum><text display-inline="yes-display-inline">a targeting assessment tool recommended by
the Secretary by guidance; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H01AE5D0A3BD743B4936FD376EEFB2291"><enum>(2)</enum><text display-inline="yes-display-inline">a comparable targeting assessment
tool.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HA68605188A6F4BF8B4F5F69C587CAA9F"><enum>(d)</enum><header display-inline="yes-display-inline">Food defense hazards identified by the
Secretary</header>
<paragraph commented="no" display-inline="no-display-inline" id="HFCFF58E1E67A46BF9A3063E68D96C404"><enum>(1)</enum><header display-inline="yes-display-inline">Establishment</header><text display-inline="yes-display-inline">The Secretary may establish by regulation
or guidance preventive measures for specific product types to prevent
intentional contamination throughout the supply chain. The owner, operator, or
agent of a facility shall implement any preventive measures identified by the
Secretary under this paragraph.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H8EE9C5FE9532485EAE7F1C5FCD7F61BB"><enum>(2)</enum><header display-inline="yes-display-inline">Alternative measures</header><text display-inline="yes-display-inline">Such regulation or guidance shall allow the
owner, operator, or agent of a facility to implement an alternative preventive
measure to one established by the Secretary, provided that, in response to a
request by the Secretary, the owner, operator, or agent can present to the
Secretary data or other information sufficient to demonstrate that the
alternative measure effectively addresses the hazard.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HF22CF0B9FD8C434591DAD1A2BA7DE456"><enum>(e)</enum><header display-inline="yes-display-inline">Requirement to reassess and revise</header>
<paragraph commented="no" display-inline="no-display-inline" id="HF6A6F010AC2C4B5FB1D83CC468AAC040"><enum>(1)</enum><header display-inline="yes-display-inline">Requirement</header><text display-inline="yes-display-inline">The owner, operator, or agent of a facility
shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H13DBA10B37934D98B5F7C7855F3F4746"><enum>(A)</enum><text display-inline="yes-display-inline">review the food defense assessment under
subsection (b)(1) for the facility and, as necessary, revise the food defense
assessment under subsection (b)(1) for the facility—</text>
<clause commented="no" display-inline="no-display-inline" id="H7F54B29BD44D47F880F6EE06DA407968"><enum>(i)</enum><text display-inline="yes-display-inline">not less than every 2 years;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H97954D9DAFDA45F095661721D379C6AE"><enum>(ii)</enum><text display-inline="yes-display-inline">if there is a change in the process or
product that could affect the food defense assessment; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H3C5A5F6E1069451FBC6A8024234F888C"><enum>(iii)</enum><text display-inline="yes-display-inline">if the Secretary determines that it is
appropriate to protect public health; and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HAEDDA88C24DE417E944600B8F359DC60"><enum>(B)</enum><text display-inline="yes-display-inline">whenever there is a change in the food
defense assessment, revise the preventive measures under subsection (b)(2) for
the facility as necessary to ensure that for all hazards identified, the risk
is minimized, or document the basis for the conclusion that no such revision is
needed.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7AB6FC1433B845839A6A53059FBBFEBF"><enum>(2)</enum><header display-inline="yes-display-inline">Nondelegation</header><text display-inline="yes-display-inline">Any revisions ordered by the Secretary
under this subsection shall be ordered by the Secretary or an official
designated by the Secretary. An official may not be so designated unless the
official is the director of the district under this Act in which the facility
involved is located, or is an official senior to such director.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H98D4FB48DC104C329F69CB3BAC5B2349"><enum>(f)</enum><header display-inline="yes-display-inline">Recordkeeping</header><text display-inline="yes-display-inline">The owner, operator, or agent of a facility
shall maintain, for not less than 2 years, records documenting the activities
described in subsections (b) and (e).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HA8737B22C6EF4F08804AEEC2FF4C4BC4"><enum>(g)</enum><header display-inline="yes-display-inline">Access to plan</header>
<paragraph commented="no" display-inline="no-display-inline" id="HB11AF0EBC15F4F33A463FE96A5BA5283"><enum>(1)</enum><header display-inline="yes-display-inline">On inspection</header><text display-inline="yes-display-inline">An officer or employee of the Secretary
shall have access to the food defense plan of a facility under section 414(a)
only if the Secretary, through an official who is the director of the district
under this Act in which the facility is located or an official who is senior to
such a director, provides notice under section 414(a)(1)(C).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7F937A6970084ED9A06CE5E27AAE78A8"><enum>(2)</enum><header display-inline="yes-display-inline">Nondisclosure</header><text display-inline="yes-display-inline">A food defense plan, and any information
derived from such a plan, shall be exempt from disclosure under section 552 of
title 5, United States
Code.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HA013C6663D0E4B2280281B90907AD7CD"><enum>(3)</enum><header display-inline="yes-display-inline">Prohibition</header><text display-inline="yes-display-inline">Section 301(j) (21 U.S.C. 331(j)) is
amended by inserting after <quote>entitled to protection</quote> the following:
<quote>or a food defense plan, or any information derived from such a plan,
under section 418C</quote>.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H7FBECCB7AFD340359897E52D97D86364" section-type="subsequent-section"><enum>103.</enum><header display-inline="yes-display-inline">Performance standards</header>
<subsection commented="no" display-inline="no-display-inline" id="H50A313369E534D1AB794F12AA40D23A2"><enum>(a)</enum><header display-inline="yes-display-inline">Adulterated food</header><text display-inline="yes-display-inline">Section 402 (21 U.S.C. 342), as amended by
section 102, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H0AD63439EB864FCDA118585E307CB883" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H45C4F48EBEB3400EAE4FBEBEB268A454"><enum>(l)</enum><text display-inline="yes-display-inline">If it has been manufactured, processed,
packed, transported, or held under conditions that do not meet the standards
issued under section
419.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H8EA74CC9012F47E5A1AC1A4EEAC4281F"><enum>(b)</enum><header display-inline="yes-display-inline">Requirements</header><text display-inline="yes-display-inline">Chapter IV (21 U.S.C. 341 et seq.), as
amended by section 102(b), is further amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HD220E67E56714436947A05E6DA469642" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H839499F784654D0392B6D4D393E35CB5" section-type="subsequent-section"><enum>419.</enum><header display-inline="yes-display-inline">Performance standards</header>
<subsection commented="no" display-inline="no-display-inline" id="HA43BD5184A0F4F9C805BC354000B4727"><enum>(a)</enum><header display-inline="yes-display-inline">Performance Standards</header><text display-inline="yes-display-inline">The Secretary shall, not less frequently
than every 2 years, review and evaluate epidemiological data and other
appropriate sources of information, including research under section 123 of the
<short-title>Food Safety Enhancement Act of
2009</short-title>, to identify the most significant food-borne contaminants
and the most significant resulting hazards. The Secretary shall issue, as soon
as practicable, through guidance or by regulation, science-based performance
standards (which may include action levels) applicable to foods or food
classes, as appropriate, to minimize to an acceptable level, prevent, or
eliminate the occurrence of such hazards. Such standards shall be applicable to
foods and food classes. Notwithstanding the timelines set forth in this
paragraph, the Secretary shall as appropriate establish such science-based
performance standards for identified contaminants as necessary to protect the
public health.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H0D40210BF5CA47C9B26B24877B503D97"><enum>(b)</enum><header display-inline="yes-display-inline">List of contaminants</header><text display-inline="yes-display-inline">Following each review under subsection (a),
the Secretary shall publish in the Federal Register a list of food-borne
contaminants that have the greatest adverse impact on public health. In
determining whether a particular food-borne contaminant should be added to such
list, the Secretary shall consider the number and severity of illnesses and the
number of deaths associated with the foods associated with such
contaminants.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H902DC25569A0490A85A880D8766A5EDC"><enum>(c)</enum><header display-inline="yes-display-inline">Sampling program</header><text display-inline="yes-display-inline">In conjunction with the establishment of a
performance standard under this section, the Secretary may make recommendations
to industry for conducting product sampling.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HF814BD486E3D4777B00E39A1BF610AA0"><enum>(d)</enum><header display-inline="yes-display-inline">Revocation by Secretary</header><text display-inline="yes-display-inline">All performance standards of the Food and
Drug Administration applicable to foods or food classes in effect on the date
of the enactment of this section, or issued under this section, shall remain in
effect until revised or revoked by the
Secretary.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H0689AB28DC424035A8D207F5A4A684CE"><enum>(c)</enum><header display-inline="yes-display-inline">Report to Congress</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services
shall submit to the Congress by March 30th of the year following each review
under section 419 of the Federal Food, Drug, and Cosmetic Act, as added by
subsection (b), a report on the results of such review and the Secretary’s
plans to address the significant food-borne hazards identified, or the basis
for not addressing any significant food-borne hazards identified, including any
resource limitations or limitations in data that preclude further action at
that time.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="HFF2E9E9DB48E42C4B358AE98235B013D" section-type="subsequent-section"><enum>104.</enum><header display-inline="yes-display-inline">Safety standards for produce and certain
other raw agricultural commodities</header>
<subsection commented="no" display-inline="no-display-inline" id="H9AD2EFCD16D64F9582A49FDE853A688E"><enum>(a)</enum><header display-inline="yes-display-inline">Adulterated food</header><text display-inline="yes-display-inline">Section 402 (21 U.S.C. 342), as amended by
sections 102 and 103(a), is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HB629C31813B64B85804830A63CA0B5C9" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H4198B698F90E42E790BB4140CE1A7BF8"><enum>(m)</enum><text display-inline="yes-display-inline">If it has been grown, harvested, processed,
packed, sorted, transported, or held under conditions that do not meet the
standards established under section
419A.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H3E20688823754BA8A6E63B76EFDFF36E"><enum>(b)</enum><header display-inline="yes-display-inline">Standards</header><text display-inline="yes-display-inline">Chapter IV (21 U.S.C. 341 et seq.), as
amended by sections 102(b) and 103(b), is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HCC56271205B244CF87182113931188F4" style="OLC">
<section commented="no" display-inline="no-display-inline" id="HF944F69F1548421FB00C9D70399981C2" section-type="subsequent-section"><enum>419A.</enum><header display-inline="yes-display-inline">Safety standards for produce and certain
other raw agricultural commodities</header>
<subsection commented="no" display-inline="no-display-inline" id="H769026E3FB7D47B2B43B8426D2826495"><enum>(a)</enum><header display-inline="yes-display-inline">Standards</header><text display-inline="yes-display-inline">The Secretary, in coordination with the
Secretary of Agriculture, shall establish by regulation scientific and
risk-based food safety standards for the growing, harvesting, processing,
packing, sorting, transporting, and holding of those types of raw agricultural
commodities—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H6CC06718727144ECA0091AC69A862EE0"><enum>(1)</enum><text display-inline="yes-display-inline">that are a fruit, vegetable, nut, or
fungus; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE58D1D755B1A49099405C46773E0CC45"><enum>(2)</enum><text display-inline="yes-display-inline">for which the Secretary has determined that
such standards are reasonably necessary to minimize the risk of serious adverse
health consequences or death to humans or animals.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HD4A97AB7ED5C454A980187F8FDE42A71"><enum>(b)</enum><header display-inline="yes-display-inline">Contents</header><text display-inline="yes-display-inline">The regulations under subsection
(a)—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HC990DBEAC76B45B1838C14263A244708"><enum>(1)</enum><text display-inline="yes-display-inline">may set forth such procedures, processes,
and practices as the Secretary determines to be reasonably necessary—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HEA8D6D9325E947DF88E15CB8F672B359"><enum>(A)</enum><text display-inline="yes-display-inline">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 raw agricultural
commodities that are a fruit, vegetable, nut, or fungus; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H776D95EBD98F4CEFAB02B93835386AE7"><enum>(B)</enum><text display-inline="yes-display-inline">to provide reasonable assurances that such
commodity is not adulterated under section 402;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7077F19D2A5C4EEA8CBCCAF964F78564"><enum>(2)</enum><text display-inline="yes-display-inline">may include, with respect to growing,
harvesting, processing, packing, sorting, transporting, and storage operations,
standards for safety as the Secretary determines to be reasonably
necessary;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H108FC03DC683474E9AF539F9CCB2D037"><enum>(3)</enum><text display-inline="yes-display-inline">may include standards addressing manure
use, water quality, employee hygiene, sanitation and animal control, and
temperature controls, as the Secretary determines to be reasonably
necessary;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9ED7514C5274456F965671F855B5381A"><enum>(4)</enum><text display-inline="yes-display-inline">may include standards for such other
elements as the Secretary determines necessary to carry out subsection
(a);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H825685CE37A94CC1A961A5406A6250F9"><enum>(5)</enum><text display-inline="yes-display-inline">shall provide a reasonable period of time
for compliance, taking into account the needs of small businesses for
additional time to comply;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H82413A9110EF4694A3FFB7CAA46D6BFC"><enum>(6)</enum><text display-inline="yes-display-inline">may provide for coordination of education
and enforcement activities;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H99BD0D1F041B41C3BFA51DB26343C517"><enum>(7)</enum><text display-inline="yes-display-inline">shall take into consideration, consistent
with ensuring enforceable public health protection, the impact on small-scale
and diversified farms, and on wildlife habitat, conservation practices,
watershed-protection efforts, and organic production methods;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H39071545C92941FC97C5CB28399F0557"><enum>(8)</enum><text display-inline="yes-display-inline">may provide for coordination of education
and training with other government agencies, universities, private entities,
and others with experience working directly with farmers; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H66A46085DA764641A9E7AA1A8761E18E"><enum>(9)</enum><text display-inline="yes-display-inline">may provide for recognition through
guidance of other existing publicly available procedures, processes, and
practices that the Secretary determines to be equivalent to those established
under paragraph (1).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H068E76D1122146F58FDE4151B57992D7"><enum>(c)</enum><header display-inline="yes-display-inline">Education and compliance</header><text display-inline="yes-display-inline">The Secretary shall coordinate with the
Secretary of Agriculture to provide for effective implementation of education
and compliance activities. The Secretary may 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></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HE3A768E3EC0645EAB1479773E6296559"><enum>(c)</enum><header display-inline="yes-display-inline">Timing</header>
<paragraph commented="no" display-inline="no-display-inline" id="H9C2AD25785154698BA8E9CD77051E1DC"><enum>(1)</enum><header display-inline="yes-display-inline">Proposed rule</header><text display-inline="yes-display-inline">Not later than 18 months after the date of
enactment of this Act, the Secretary of Health and Human Services shall issue a
proposed rule to carry out section 419A of the Federal Food, Drug, and Cosmetic
Act, as added by subsection (b).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H232A7F64FD00475EA0C6146378DF3A5F"><enum>(2)</enum><header display-inline="yes-display-inline">Final rule</header><text display-inline="yes-display-inline">Not later than 3 years after such date, the
Secretary of Health and Human Services shall issue a final rule under such
section.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H779C2D1FC5C04D20B0D2638EB07140CF"><enum>(d)</enum><header display-inline="yes-display-inline">No effect on existing HACCP
authorities</header><text display-inline="yes-display-inline">Nothing in this
section or 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.), as in effect on
the day before the date of the enactment of this Act, to revise, issue, or
enforce product- and category-specific regulations, such as the Seafood Hazard
Analysis Critical Controls Points Program, the Juice Hazard Analysis Critical
Control Program, and the Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers standards.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HFF0FE6432502483980E07A26D849D3B4"><enum>(e)</enum><header display-inline="yes-display-inline">Update existing guidance</header><text display-inline="yes-display-inline">Not later than 1 year after the date of the
enactment of this Act, the Secretary of Health and Human Services shall update
the guidance document entitled <quote>Guidance For Industry: Guide To Minimize
Microbial Food Safety Hazards For Fresh Fruits And Vegetables</quote> (issued
on October 26, 1998) in accordance with this section and the amendments made by
this section.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H1DFC15367CF9471189DE41B4E5DC636A" section-type="subsequent-section"><enum>105.</enum><header display-inline="yes-display-inline">Risk-based inspection schedule</header>
<subsection commented="no" display-inline="no-display-inline" id="H17C59D142556457C91147E96F3646F94"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 704 (21 U.S.C. 374) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HDA6B0A887303407390A9A6949414567D" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H263937A946B64BEFB9AAEC239AF3DC32"><enum>(h)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H5AC06ABE9C2945F8BE697D7CC1F58243"><enum>(1)</enum><text display-inline="yes-display-inline">Each facility registered under section 415
shall be inspected—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H1F724AFCE6884B1D9B951255E8227E42" indent="up1"><enum>(A)</enum><clause commented="no" display-inline="yes-display-inline" id="HB1E15AA4FAD24E81BF7434EAEDAC7FAD"><enum>(i)</enum><text display-inline="yes-display-inline">by one or more officers duly designated
under section 702 or other statutory authority by the Secretary;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HCD485FC861A2444980B20F1709D4B316" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">for domestic facilities, by a Federal,
State, or local official recognized by the Secretary under paragraph (2);
or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HAB9DA495440B402AB4B2FB48978A6D08" indent="up1"><enum>(iii)</enum><text display-inline="yes-display-inline">for foreign facilities, by an agency or a
representative of a country that is recognized by the Secretary under paragraph
(2); and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDC7AC1A150264D1E8D833493016F1139" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">at a frequency determined pursuant to a
risk-based schedule.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6E7E0877704545FCA6675BA5640B6B22" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">For purposes of paragraph (1)(A), the
Secretary—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HB5102DE4D7594E0093A2BC153FBE56B3"><enum>(A)</enum><text display-inline="yes-display-inline">may recognize Federal, State, and local
officials and agencies and representatives of foreign countries as meeting
standards established by the Secretary for conducting inspections under this
Act; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HBA5FE77810D34CBAAEBFBD1CA569F593"><enum>(B)</enum><text display-inline="yes-display-inline">may limit such recognition to inspections
of specific commodities or food types.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H24493B8D53CB4B0BB24EFCA2313B0CC6" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">The risk-based schedule under paragraph
(1)(B) shall be implemented beginning not later than 18 months after the date
of the enactment of this subsection.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H93BC577B642B4E568165F556F535E7C5" indent="up1"><enum>(4)</enum><text display-inline="yes-display-inline">Such risk-based schedule shall provide for
a frequency of inspections commensurate with the risk presented by the facility
and shall be based on the following categories and inspection
frequencies:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H5F21E0E786DC47F0981631C5C24E9522"><enum>(A)</enum><header display-inline="yes-display-inline">Category 1</header><text display-inline="yes-display-inline">A category 1 food facility is a high-risk
facility that manufactures or processes food. The Secretary shall randomly
inspect a category 1 food facility at least every 6 to 12 months.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H072469002E484332AD7A7E0EFFF36888"><enum>(B)</enum><header display-inline="yes-display-inline">Category 2</header><text display-inline="yes-display-inline">A category 2 food facility is a low-risk
facility that manufactures or processes food or a facility that packs or labels
food. The Secretary shall randomly inspect a category 2 facility at least every
18 months to 3 years.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB22BD4B6900A4C3089733580256D59B2"><enum>(C)</enum><header display-inline="yes-display-inline">Category 3</header><text display-inline="yes-display-inline">A category 3 food facility is a facility
that holds food. The Secretary shall randomly inspect a category 3 facility at
least every 5 years.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2C7D8FCF8C5D494082EB7B6C5EE19245" indent="up1"><enum>(5)</enum><text display-inline="yes-display-inline">The Secretary—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H3850B80E733743BABAF1BCBFF133DBDF"><enum>(A)</enum><text display-inline="yes-display-inline">may, by guidance, modify the types of food
facilities within a category under paragraph (4);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H28FBEEEE6276436291F2CC6F8E580FD2"><enum>(B)</enum><text display-inline="yes-display-inline">may alter the inspection frequencies
specified in paragraph (4) based on the need to respond to food-borne illness
outbreaks and food recalls; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE2E4A1841E854C35A4E91F1B76EE4FB1"><enum>(C)</enum><text display-inline="yes-display-inline">may inspect a facility more frequently than
the inspection frequency provided by paragraph (4);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDE26D60E1B684621BA5BFA1BA78641F8"><enum>(D)</enum><text display-inline="yes-display-inline">beginning 6 months after submitting the
report required by section 105(b)(2) of the <short-title>Food Safety Enhancement Act of 2009</short-title>,
may—</text>
<clause commented="no" display-inline="no-display-inline" id="HC19085ED071A4CC5A2C157C883383969"><enum>(i)</enum><text display-inline="yes-display-inline">publish in the Federal Register adjustments
to the inspection frequencies specified in subparagraphs (B) and (C) of
paragraph (4) for category 2 and category 3 food facilities, which adjustments
shall be in accordance with the Secretary’s recommendations in such report;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HE23BBEB062514129A5BD06359948BA42"><enum>(ii)</enum><text display-inline="yes-display-inline">after such publication, implement the
adjustments; and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H319C3B3F104443ECA3936CA4C53F0D19"><enum>(E)</enum><text display-inline="yes-display-inline">except as provided in subparagraphs (B) and
(C), may not alter the inspection frequency specified in paragraph (4)(A) for
category 1 food facilities.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H10CF256ADFE34E49B652EFFFDABB034F" indent="up1"><enum>(6)</enum><text display-inline="yes-display-inline">In determining the appropriate frequency of
inspection, the Secretary shall consider—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H6312BB0689AA4A0EA6219640C3E342DD"><enum>(A)</enum><text display-inline="yes-display-inline">the type of food manufactured, processed,
packed, or held at the facility;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H30010E8E2D0848DCAF1A7C26ECC6187F"><enum>(B)</enum><text display-inline="yes-display-inline">the compliance history of the
facility;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8E6529B904D0469FAD5492ECB8FE9D29"><enum>(C)</enum><text display-inline="yes-display-inline">whether the facility importing or offering
for import into the United States food is certified by a qualified certifying
entity in accordance with section 801(q); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H74D95492590D4512B075FB7EF3EFB994"><enum>(D)</enum><text display-inline="yes-display-inline">such other factors as the Secretary
determines by guidance to be relevant to assessing the risk presented by the
facility.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD7375506A9AE4C7CAB6F604B42116F60" indent="up1"><enum>(7)</enum><text display-inline="yes-display-inline">Before establishing or modifying the
categorization under paragraph (4) of any food facility or type of food
facility, the Secretary shall publish a notice of the proposed categorization
in the Federal Register and provide a period of not less than 60 days for
public comment on the proposed
categorization.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H25200B43C997468A827E4697116B671A"><enum>(b)</enum><header display-inline="yes-display-inline">Reports on risk-based inspections of food
facilities</header>
<paragraph commented="no" display-inline="no-display-inline" id="H0BC2B1E620DD42BE878F21DF5479AA56"><enum>(1)</enum><header display-inline="yes-display-inline">Annual report</header><text display-inline="yes-display-inline">Not later than December 31 of each year,
the Secretary of Health and Human Services shall submit a report to the
Committee on Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the Senate
describing—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H1C6500AEC4D54334BE7AC884D725802F"><enum>(A)</enum><text display-inline="yes-display-inline">the number of foreign and domestic
facilities, by risk category, inspected under the risk-based inspection
schedule established under section 704(h) of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), in the preceding fiscal year;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC4673CAF1CAF475D923EAE3804AA2589"><enum>(B)</enum><text display-inline="yes-display-inline">the costs of implementing the risk-based
inspection schedule for the preceding 12 months.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0C05EF2FB6604AB2A72EA4A7ECD1FD88"><enum>(2)</enum><header display-inline="yes-display-inline">Third-year report</header><text display-inline="yes-display-inline">Not later than 3 years after the date of
the enactment of this Act, the Secretary of Health and Human Services shall
submit a report to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor, and Pensions of
the Senate describing recommendations on the risk-based inspection schedule
under section 704(h) of the Federal Food, Drug, and Cosmetic Act, as added by
subsection (a), including recommendations for adjustments to the timing of the
schedule and other ways to improve the risk-based allocation of resources by
the Food and Drug Administration. In making such recommendations, the Secretary
shall consider—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HC39FDC4434FA46B49FD8AD4CD2E6DEC8"><enum>(A)</enum><text display-inline="yes-display-inline">the nature of the food products being
processed, stored, or transported;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H90192962D3DA41ABBB9AE1223F1BBEEC"><enum>(B)</enum><text display-inline="yes-display-inline">the manner in which food products are
processed, stored, or transported;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7BAE4CF4934B46E89EB70B39F0FDAAB4"><enum>(C)</enum><text display-inline="yes-display-inline">the inherent likelihood that the products
will contribute to the risk of food-borne illness;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8C5E73E78E9C47E289FAF2A8BB42DD6C"><enum>(D)</enum><text display-inline="yes-display-inline">the best available evidence concerning
reported illnesses associated with the foods processed, stored, held, or
transported in the category of facilities; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7EC2F3611E034878B9599C0198E6C7C8"><enum>(E)</enum><text display-inline="yes-display-inline">the overall record of compliance with food
safety law among facilities in the category, including compliance with
applicable performance standards and the frequency of recalls.</text>
</subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H018C4D5BDD81441DA160FE16826BC246" section-type="subsequent-section"><enum>106.</enum><header display-inline="yes-display-inline">Access to records</header>
<subsection commented="no" display-inline="no-display-inline" id="H4A95B49845324B05BDDCE348C6B0CDB6"><enum>(a)</enum><header display-inline="yes-display-inline">Records
access</header><text display-inline="yes-display-inline">Subsection (a) of
section 414 (21 U.S.C. 350c) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H8BE98CD19942475591ED16761EA8BA4B" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HAB45A62535FC404A88C82DC6510B09F8"><enum>(a)</enum><header display-inline="yes-display-inline">Records access</header>
<paragraph commented="no" display-inline="no-display-inline" id="H59B9623C1372496A9B76AD42EC06C950"><enum>(1)</enum><header display-inline="yes-display-inline">Records access during an
inspection</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HA9E9AEF5278D425188EA147D5CEAF3EF"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Except as provided in paragraph (3), each
person who manufactures, processes, packs, transports, distributes, receives,
or holds an article of food in the United States or for import into the United
States shall, at the request of an officer or employee duly designated by the
Secretary, permit such officer or employee, upon presentation of appropriate
credentials, at reasonable times and within reasonable limits and in a
reasonable manner, to have access to and copy all records relating to such
article bearing on whether the food may be adulterated, misbranded, or
otherwise in violation of this Act, including all records collected or
developed to comply with section 418 or 418A.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2B4ED8B5651E4185A195AA6F022AB219"><enum>(B)</enum><header display-inline="yes-display-inline">Scope of records</header><text display-inline="yes-display-inline">The requirement under subparagraph (A)
applies to all records relating to the manufacture, processing, packing,
transporting, 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>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HADE89B5AF82A4AD4881D71F8884FA025"><enum>(C)</enum><header display-inline="yes-display-inline">Immediate availability with
notice</header><text display-inline="yes-display-inline">Records not required
to be made available immediately on commencement of an inspection under
subparagraph (A) shall nonetheless be made available immediately on
commencement of such an inspection if, by a reasonable time before such
inspection, the Secretary by letter to the person identifies the records to be
made available during such inspection. Nothing in this subparagraph shall be
construed as permitting a person to refuse to produce records required under
and in accordance with subparagraph (A) due to failure of the Secretary to
provide notice under this paragraph.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4BFF80F4AE5145B893082C0F640C6A33"><enum>(2)</enum><header display-inline="yes-display-inline">Additional authorities to access records
remotely; submission of records to the Secretary</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HC38262408079463C8373858F391B4F6E"><enum>(A)</enum><header display-inline="yes-display-inline">Remote access in emergencies</header><text display-inline="yes-display-inline">If the Secretary has a reasonable belief
that an article of food presents a threat of serious adverse health
consequences or death to humans or animals, the Secretary may require each
person who manufactures, processes, packs, transports, distributes, receives,
holds, or imports such article of food, or any article of food that the
Secretary determines may be affected in a similar manner, to submit to the
Secretary all records reasonably related to such article of food as soon as is
reasonably practicable, after receiving written notice (including by notice
served personally and outside normal business hours to an agent identified
under subparagraph (E) or (F) of section 415(a)(2)) of such requirement.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H545E5630966E42208BD1B63D1C2DC840"><enum>(B)</enum><header display-inline="yes-display-inline">Remote access to records related to food
safety plans</header><text display-inline="yes-display-inline">With respect to
a facility subject to section 418 and 418A, the Secretary may require the
owner, operator, or agent of such facility to submit to the Secretary, as soon
as reasonably practicable after receiving written notice of such requirement,
the food safety plan, supporting information relied on by the facility to
select the preventive controls to include in its food safety plan, and
documentation of corrective actions, if any, taken under section 418(e) within
the preceding 2 years</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H74C39DB7B7034BB38D0B5DA2B007F284"><enum>(C)</enum><header display-inline="yes-display-inline">Electronic submission</header><text display-inline="yes-display-inline">If the records required to be submitted to
the Secretary under subparagraph (A) or (B) are available in electronic format,
such records shall be submitted electronically unless the Secretary specifies
otherwise in the notice under such subparagraph.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE985164463724B88856ED17D2FAD471D"><enum>(3)</enum><header display-inline="yes-display-inline">Limited records access on farms</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H097A348DF12548D4AA4D2BBB50ACAE1A"><enum>(A)</enum><header display-inline="yes-display-inline">Application</header><text display-inline="yes-display-inline">Paragraphs (1) and (2) do not apply with
respect to farms, except as provided in this paragraph.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H91AB23A1CAD64D6B849B43584101DE23"><enum>(B)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A person who is the owner, operator, or
agent of a farm (as defined in section 415) shall, at the request of an officer
or employee duly designated by the Secretary, permit such officer or employee,
at reasonable times and within reasonable limits and in a reasonable manner, to
have access to and copy all records relating to an article of food produced,
manufactured, processed, packed, or held on such farm as specified in
paragraphs (1) and (2) if—</text>
<clause commented="no" display-inline="no-display-inline" id="H832B57B7AD594884BB22291F6F6B89CB"><enum>(i)</enum><text display-inline="yes-display-inline">such article of food is a fruit, vegetable,
nut, or fungus that is the subject of a standard issued under section 419A;
or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H431F6763CEC944CB87CF8CD9E4A8939F"><enum>(ii)</enum><text display-inline="yes-display-inline">such article of food is the subject of an
active investigation by the Secretary of a food borne illness outbreak and is
not a grain or similarly handled commodity as defined in subsection
(c)(4)(C)(ii).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB441C7F46654454A8B7C63D5152D4358"><enum>(C)</enum><header display-inline="yes-display-inline">Records access on farms prior to
rulemaking</header>
<clause commented="no" display-inline="no-display-inline" id="HA37B5DB2D6B144C794C1B5E069DD3956"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">As soon as practicable after the enactment
of this paragraph, the Secretary shall, in coordination with the Secretary of
Agriculture, identify 1 or more fruits, vegetables, nuts, or fungi for which
the Secretary shall have access to records on farms. Such identification shall
be made by guidance, following notice and public comment.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H7BC9F105101F4F8CAA101DC208ED0592"><enum>(ii)</enum><header display-inline="yes-display-inline">Identification of raw agricultural
commodities</header><text display-inline="yes-display-inline">The Secretary, in
coordination with the Secretary of Agriculture, shall make the identification
in clause (i), based on any past food borne illness outbreak attributed to the
fruit, vegetable, nut, or fungus—</text>
<subclause commented="no" display-inline="no-display-inline" id="H68EEC0567E7E497F96B24DCE85737280"><enum>(I)</enum><text display-inline="yes-display-inline">in the United States and the risk that a
similar outbreak could occur again in the United States; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H5365EF8D4982412788DB6084AF544FA8"><enum>(II)</enum><text display-inline="yes-display-inline">in a foreign country and the risk that a
similar outbreak could occur in the United States.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H91E96C7183C7415A9B881C53287138DB"><enum>(iii)</enum><header display-inline="yes-display-inline">Duration of authority</header><text display-inline="yes-display-inline">The authority to have access to records for
a fruit, vegetable, nut, or fungus under this subparagraph shall begin on the
date on which the Secretary identifies such fruit, vegetable, nut, or fungus
under clause (i) and shall terminate on the effective date of a final rule
issued by the Secretary under section 419A.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H2D4FB73DC0884DD99579C3237DF2C515"><enum>(iv)</enum><header display-inline="yes-display-inline">Scope of records access</header><text display-inline="yes-display-inline">In the guidance under clause (i), and for
the period specified in clause (iii), the Secretary, in coordination with the
Secretary of Agriculture, shall determine the scope of the records to which the
Secretary shall have access under this subparagraph.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H36299349975140B69546D2258E1EB5D1"><enum>(D)</enum><header display-inline="yes-display-inline">Rule of Construction</header><text display-inline="yes-display-inline">This paragraph shall not be construed as
limiting access to any records authorized under—</text>
<clause commented="no" display-inline="no-display-inline" id="H1E283D8AD1864BA1855C7F354D19071F"><enum>(i)</enum><text display-inline="yes-display-inline">this Act or the Public Health Service Act,
as in effect on the day before the date of the enactment of this paragraph;
or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HC59B53BE6A494527BE828D5F9CE67C9E"><enum>(ii)</enum><text display-inline="yes-display-inline">regulations issued under such Acts on any
date before the date of the enactment of this
paragraph.</text>
</clause></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H2A333BD5672E4B5AB39EE50FEF8276B4"><enum>(b)</enum><header display-inline="yes-display-inline">Regulations concerning
recordkeeping</header>
<paragraph commented="no" display-inline="no-display-inline" id="HCB15543B31974C47AC2812C51BBE1868"><enum>(1)</enum><header display-inline="yes-display-inline">Amendment</header><text display-inline="yes-display-inline">Subsection (b) of section 414 (21 U.S.C.
350c) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H8CB48853E3E9439F80C2F36B90BEFC5D" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HBFBC9FF92C784BE1871961367120BAA0"><enum>(b)</enum><header display-inline="yes-display-inline">Regulations concerning
recordkeeping</header><text display-inline="yes-display-inline">The Secretary,
in consultation and coordination, as appropriate, with other Federal
departments and agencies with responsibilities for regulating food safety,
shall by regulation establish requirements regarding the establishment and
maintenance, for not longer than 3 years, of records by persons who
manufacture, process, pack, transport, distribute, receive, or hold food in the
United States or for import into the United States. The Secretary shall take
into account the size of a business in promulgating regulations under this
subsection. The Secretary shall consult with the Secretary of Agriculture in
promulgating regulations with respect to farms under this subsection and shall
take into account the nature of and impact on farms in promulgating such
regulations. The only distribution records which may be required of restaurants
under this subsection are those showing the restaurant’s suppliers and
subsequent distribution other than to
consumers.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H99FB0D97BE0546BF890DAC6E0CB77DC0"><enum>(2)</enum><header display-inline="yes-display-inline">Application</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services
shall promulgate revised regulations to implement section 414(b) of the Federal
Food, Drug, and Cosmetic Act, as amended by this subsection. Section 414(b) of
the Federal Food, Drug, and Cosmetic Act and regulations thereunder, as in
effect on the day before the date of the enactment of this Act, shall apply to
acts and omissions occurring before the effective date of such revised
regulations.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HA296803C199A4F459A545011181F35C3"><enum>(c)</enum><header display-inline="yes-display-inline">Conforming amendments</header><text display-inline="yes-display-inline">Section 704(a)(1) (21 U.S.C. 374(a)(1)) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H66BC4676493B45C1B7D78A71D746F7FE"><enum>(1)</enum><text display-inline="yes-display-inline">in the second sentence—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HB21CBF0910894748B170A08CB7C49407"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>(excluding farms or
restaurants)</quote> and inserting <quote>(excluding farms, except as provided
in section 414(a)(3))</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H81215F3A0DC44859B926AF322DB9F09A"><enum>(B)</enum><text display-inline="yes-display-inline">by inserting <quote>receives,</quote>
before <quote>holds</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC3F8594F61614A6F963435ADFF56FA03"><enum>(C)</enum><text display-inline="yes-display-inline">by striking <quote>described in section
414</quote> and inserting <quote>described in or required under section
414</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H06E4C67B621141BD8657707145B4BD9A"><enum>(D)</enum><text display-inline="yes-display-inline">by striking <quote>when the Secretary has a
reasonable belief that an article of food is adulterated and presents a threat
of serious adverse health consequences or death to humans or animals</quote>
and inserting <quote>bearing on whether such food is adulterated, misbranded,
or otherwise in violation of this Act, including all records collected or
developed to comply with section 418 or 418A</quote>; and</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE606E3AED58A40A9AC191552318D01FF"><enum>(2)</enum><text display-inline="yes-display-inline">in the fourth sentence—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H0B3050BB692B4FF598993F64FED23090"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>the preceding
sentence</quote> and inserting <quote>either of the preceding two
sentences</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H86B64B9871D94E0F9BECFB2CD88F0D7C"><enum>(B)</enum><text display-inline="yes-display-inline">by inserting <quote>recipes for
food,</quote> before <quote>financial data,</quote>.</text>
</subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H7F1EA70B8C3E49CF8E21269B96F2BB54" section-type="subsequent-section"><enum>107.</enum><header display-inline="yes-display-inline">Traceability of food</header>
<subsection commented="no" display-inline="no-display-inline" id="H09FF508D22CD4A7194421920EF6FB178"><enum>(a)</enum><header display-inline="yes-display-inline">Prohibited
act</header><text display-inline="yes-display-inline">Section 301(e) (21 U.S.C.
331(e)) is amended by inserting <quote>, the violation of any requirement of
the food tracing system under section 414(c);</quote> before <quote>or the
refusal to permit access to or verification or copying of any such required
record</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HB342F6C5171A447FB33EC1590DC86120"><enum>(b)</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 requirements of section 414 have not
been complied with regarding such article,</quote> before <quote>then such
article shall be refused admission</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H417FF89433D740B7B73A18AC43863DA3"><enum>(c)</enum><header display-inline="yes-display-inline">Product tracing for food</header><text display-inline="yes-display-inline">Section 414 (21 U.S.C. 350c), as amended by
section 106, is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HE70F2B8526CE4C2F9CA5B7405387EC42"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating subsections (c) and (d) as
subsections (d) and (e), respectively; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF7FA99BEA1F748219D4A69A7F8003324"><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="H7E9C566158ED49F78919FDF52BB6233A" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H1642399E9AFB4E9B97826013990686DB"><enum>(c)</enum><header display-inline="yes-display-inline">Tracing system for food</header>
<paragraph commented="no" display-inline="no-display-inline" id="H4325D16DF15243A58302DA30C8F01FFE"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall by regulation establish
a tracing system for food that is located in the United States or is for import
into the United States.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6565691DBE27462BA4F06F5C3FC4630D"><enum>(2)</enum><header display-inline="yes-display-inline">Information gathering</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H606C3E1EFB0040F19760A6A4DBF6AB02"><enum>(A)</enum><header display-inline="yes-display-inline">Tracing Technologies</header><text display-inline="yes-display-inline">Before issuing a proposed regulation under
this subsection, the Secretary shall—</text>
<clause commented="no" display-inline="no-display-inline" id="HEFBD4CC6D88A47108E77885F6224C9B5"><enum>(i)</enum><text display-inline="yes-display-inline">identify technologies and methodologies for
tracing the distribution history of a food that are, or may be, used by members
of different sectors of the food industry, including technologies and
methodologies to enable each person who produces, manufactures, processes,
pack, transports, or holds a food to—</text>
<subclause commented="no" display-inline="no-display-inline" id="H62CD491F2CF74CDAB99EF33C9435146E"><enum>(I)</enum><text display-inline="yes-display-inline">maintain the full pedigree of the origin
and previous distribution history of the food;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HDB6CC7D4E26845AA9B2877D28B40F95F"><enum>(II)</enum><text display-inline="yes-display-inline">link that history with the subsequent
distribution of the food;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HE9BB624DCC27432FA7343E141DC9085B"><enum>(III)</enum><text display-inline="yes-display-inline">establish and maintain a system for tracing
the food that is interoperable with the systems established and maintained by
other such persons; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HE993465FD1914E6693665CA89ECE99B4"><enum>(IV)</enum><text display-inline="yes-display-inline">use a unique identifier for each facility
owned or operated by such person for such purpose, as specified under section
1011; and</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H4830174A7E4047E9B868EE5F8EE941D6"><enum>(ii)</enum><text display-inline="yes-display-inline">to the extent practicable, assess—</text>
<subclause commented="no" display-inline="no-display-inline" id="HBDA0F6E9B9824A28936C3BE12A043971"><enum>(I)</enum><text display-inline="yes-display-inline">the costs and benefits associated with the
adoption and use of such technologies;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H79D9164C03F5443FAC00B49B6C0533C8"><enum>(II)</enum><text display-inline="yes-display-inline">the feasibility of such technologies for
different sectors of the food industry; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HF8D4A3BB11124BDFB8DFC34D6A3AAFCB"><enum>(III)</enum><text display-inline="yes-display-inline">whether such technologies are compatible
with the requirements of this subsection.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8B5A682FED6C42428DE11929C8496832"><enum>(B)</enum><header display-inline="yes-display-inline">Public Meetings</header><text display-inline="yes-display-inline">Before issuing a proposed regulation under
this subsection, the Secretary shall conduct not less than 2 public meetings in
diverse geographical areas of the United States to provide persons in different
regions an opportunity to provide input and information to the
Secretary.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA43D189FECD843F9A92A503C54882C54"><enum>(C)</enum><header display-inline="yes-display-inline">Pilot
Projects</header><text display-inline="yes-display-inline">Before issuing a
proposed regulation under this subsection, the Secretary shall conduct 1 or
more pilot projects in coordination with 1 or more sectors of the food industry
to explore and evaluate tracing systems for food. The Secretary shall
coordinate with the Secretary of Agriculture in conducting pilot projects with
respect to farms under this subsection.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H31970C6C5ECE44D1954E0CE7548FB329"><enum>(3)</enum><header display-inline="yes-display-inline">Regulation</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H15AA368F6E524F5C8A3B884B71F0BEF7"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Taking into account information obtained
through information gathering under paragraph (2), the Secretary shall issue
regulations establishing a tracing system that enables the Secretary to
identify each person who grows, produces, manufactures, processes, packs,
transports, holds, or sells such food in as short a timeframe as practicable
but no longer than 2 business days.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0466329013A74ACFAFDBDA9D038306A2"><enum>(B)</enum><header display-inline="yes-display-inline">Scope of regulation</header><text display-inline="yes-display-inline">The Secretary may include in the
regulations establishing a tracing system—</text>
<clause commented="no" display-inline="no-display-inline" id="H24E8AB39EB5D4819BEC28EC21DAFFC21"><enum>(i)</enum><text display-inline="yes-display-inline">the establishment and maintenance of lot
numbers;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H3AAA99E52C614B5C98162555CE042FA5"><enum>(ii)</enum><text display-inline="yes-display-inline">a standardized format for pedigree
information; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H8B26FB00B70641CAB6FCB40F4ED75F94"><enum>(iii)</enum><text display-inline="yes-display-inline">the use of a common nomenclature for
food.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE8116F937D98462C8DA57881B9B53256"><enum>(C)</enum><header display-inline="yes-display-inline">Coordination regarding farm
impact</header><text display-inline="yes-display-inline">In issuing regulations
under this paragraph that will impact farms, the Secretary—</text>
<clause commented="no" display-inline="no-display-inline" id="H7E48D69964194B1780710E6093DC010E"><enum>(i)</enum><text display-inline="yes-display-inline">shall coordinate with the Secretary of
Agriculture; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H0A76EAA5AFA247C1A47D18162FAAD9D9"><enum>(ii)</enum><text display-inline="yes-display-inline">take into account the nature of the impact
of the regulations on farms.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0FF8D120026D469B9402A65CED0CE234"><enum>(4)</enum><header display-inline="yes-display-inline">Exemptions and limitations</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H61FB421F475C4F03B1EC4243166E7304"><enum>(A)</enum><header display-inline="yes-display-inline">Direct sales by farms</header><text display-inline="yes-display-inline">Food is exempt from the requirements of
this subsection if such food is—</text>
<clause commented="no" display-inline="no-display-inline" id="HDDCE0B4B847C4380A03C9696A7B55015"><enum>(i)</enum><text display-inline="yes-display-inline">produced on a farm; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HD39B6F5A228B4ADAA8E1E8812DF06304"><enum>(ii)</enum><text display-inline="yes-display-inline">sold by the owner, operator, or agent in
charge of such farm directly to a consumer or to a restaurant or grocery
store.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7893FE7B939B43A3B009D3017579D539"><enum>(B)</enum><header display-inline="yes-display-inline">Fishing vessels</header><text display-inline="yes-display-inline">Food is exempt from the requirements of
this subsection if such food is produced through the use of a fishing vessel as
defined in section 3(18) of the Magnuson-Stevens Fishery Conservation and
Management Act 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="HAF5AC6E65C084292BA9ED51225585ED3"><enum>(C)</enum><header display-inline="yes-display-inline">Grains and similarly handled
commodities</header>
<clause commented="no" display-inline="no-display-inline" id="H1317A2D6B6174A5783C91942D81E67F2"><enum>(i)</enum><header display-inline="yes-display-inline">Limitation on extent of
tracing</header><text display-inline="yes-display-inline">In addition to the
exemption under subparagraph (A), any tracing system established under this
subsection with regard to any grain or similarly handled commodity shall be
limited to enabling the Secretary to identify persons who received, processed,
packed, transported, distributed, held, or sold the grain or similarly handled
commodity from the initial warehouse operator that held the grain or similarly
handled commodity for any period of time to the ultimate consumer.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H09AF5F40D6B94029A4DDFD287A1AC2A0"><enum>(ii)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this subparagraph:</text>
<subclause commented="no" display-inline="no-display-inline" id="HD5B59DF63D7B4DB28688E1C375B6EC3E"><enum>(I)</enum><text display-inline="yes-display-inline">The term <quote>grain or similarly handled
commodity</quote> means wheat, corn, grain sorghum, barley, oats, rice, wild
rice, rye, soybeans, legumes, sugar cane, sugar beets, sunflower seed,
rapeseed, canola, safflower, flaxseed, mustard seed, crambe, sesame seed,
camelina, cottonseed, cocoa beans, grass hay, and honey. The term may include
any other commodity as determined by the Secretary in coordination with the
Secretary of Agriculture.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H284516BD379547129C3ECC17B9800368"><enum>(II)</enum><text display-inline="yes-display-inline">The term <quote>warehouse operator</quote>
has the meaning given that term in section 2 of the United States Warehouse Act
(7 U.S.C. 241), except that the term also includes any person or entity that
handles or stores agricultural products for other persons or entities or, in
the case of a cooperative, handles or stores agricultural products for its
members, as determined by the Secretary in coordination with the Secretary of
Agriculture.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5A07362940E043C1803674280E2810A9"><enum>(D)</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 exempt a food or a type of facility, farm, or restaurant from, or
modify the requirements with respect to, the requirements of this subsection if
the Secretary determines that a tracing system for such food or type of
facility, farm, or restaurant is not necessary to protect the public
health.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5D991BFB8D044D0B84ABE5E2F3664B5E"><enum>(E)</enum><header display-inline="yes-display-inline">Recordkeeping regarding previous sources
and subsequent recipients</header><text display-inline="yes-display-inline">For
a food or person covered by a limitation or exemption under subparagraph (B),
(C), or (D), the Secretary shall require each person who produces, receives,
manufactures, processes, packs, transports, distributes, or holds such food to
maintain records to identify the immediate previous sources of such food and
its ingredients and the immediate subsequent recipients of such food.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H12940CDC64014A1D982419AD0E2C6179"><enum>(F)</enum><header display-inline="yes-display-inline">Recordkeeping by restaurants and grocery
stores</header><text display-inline="yes-display-inline">For a food covered by
an exemption under subparagraph (A), restaurants and grocery stores shall keep
records documenting the farm that was the source of the food.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE8DB40A83D524FAB938B8550B50EFEF3"><enum>(G)</enum><header display-inline="yes-display-inline">Recordkeeping by farms</header><text display-inline="yes-display-inline">For a food covered by an exemption under
subparagraph (A), farms shall keep records, in electronic or non-electronic
format, for at least 6 months documenting the restaurant or grocery store to
which the food was
sold.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H8CC3F091FD2A434BA1BB9FE9CC483884" section-type="subsequent-section"><enum>108.</enum><header display-inline="yes-display-inline">Reinspection and food recall fees
applicable to facilities</header>
<subsection commented="no" display-inline="no-display-inline" id="H9B195F959155437D8293A5AB388F8BA5"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Part 6 of subchapter C of chapter VII (21
U.S.C. 371 et seq.), as added by section 101(c), is amended by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="HED0B9E3840B54E0B9A01FA28021BC006" style="OLC">
<section commented="no" display-inline="no-display-inline" id="HBA87CB32C7954E27A24CA41E96EB7983" section-type="subsequent-section"><enum>743A.</enum><header display-inline="yes-display-inline">Reinspection and food recall fees
applicable to facilities</header>
<subsection commented="no" display-inline="no-display-inline" id="H2D9B423AA0E8444BA81290BA14234C19"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall assess and collect fees
from each entity in a fiscal year—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H971F50692FF84911A8311DC042C2FD4C"><enum>(1)</enum><text display-inline="yes-display-inline">that—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H3B9EFE84C8F54E1290C23D68DFE167BE"><enum>(A)</enum><text display-inline="yes-display-inline">during such fiscal year commits a violation
of any requirement of this Act relating to food, including any such requirement
relating to good manufacturing practices; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0D24C62D538845AD93EB8F968132C281"><enum>(B)</enum><text display-inline="yes-display-inline">because of such violation, undergoes
additional inspection by the Food and Drug Administration; or</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF847BAAEB349406691ED0F80C8A05386"><enum>(2)</enum><text display-inline="yes-display-inline">during such fiscal year is subject to a
food recall.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H38FA1C7DA5CC47369467167BD5FCA6FD"><enum>(b)</enum><header display-inline="yes-display-inline">Amount
of fees</header><text display-inline="yes-display-inline">The Secretary shall
set the amount of the fees under this section to fully cover the costs
of—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H69F5E21F2B694D7EB4BD632B327C97BF"><enum>(1)</enum><text display-inline="yes-display-inline">in the case of fees collected under
subsection (a)(1), conducting the additional inspections referred to in such
subsection; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H072D52888B344ECCB3B27920A5051ECE"><enum>(2)</enum><text display-inline="yes-display-inline">in the case of fees collected under
subsection (a)(2), conducting food recall activities, including technical
assistance, follow-up effectiveness checks, and public notifications, during
the fiscal year involved.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H66AD6654E7534CD79A9B971851F157CC"><enum>(c)</enum><header display-inline="yes-display-inline">Crediting and availability of fees</header>
<paragraph commented="no" display-inline="no-display-inline" id="HBD8BC63E4C754738810D6AFD5B291AFC"><enum>(1)</enum><header display-inline="yes-display-inline">In general</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 advance 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 appropriation account
without fiscal year limitation to such appropriation account for salaries and
expenses with such fiscal year limitation.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H02E3486FABEC4D62B304674651013041"><enum>(2)</enum><header display-inline="yes-display-inline">Collections and appropriations
Acts</header><text display-inline="yes-display-inline">The fees authorized by
this section—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HCE7F321DC3A34ADE8F41ABC3393AE8FE"><enum>(A)</enum><text display-inline="yes-display-inline">shall be retained in each fiscal year in an
amount not to exceed the amount specified in appropriation Acts, or otherwise
made available for obligation, for such fiscal year; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H535EECEE9B044F1AAADA9C6851E25757"><enum>(B)</enum><text display-inline="yes-display-inline">shall only be collected and available to
defray the costs referred to in subsection (b).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H455EAA04AE8E4D4B9C821CCA65D61C20"><enum>(3)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">For each of
fiscal years 2010 through 2014, there are authorized to be appropriated for
fees under this section such sums as may be necessary.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HB620AD538B76422387BFDBE6EE6A8EBC"><enum>(d)</enum><header display-inline="yes-display-inline">Waiver</header><text display-inline="yes-display-inline">The Secretary shall waive and, if
applicable, refund the amount of any fee collected under this section from an
entity as a result of a food recall that the Secretary determines was
inappropriately
ordered.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H4851AD42B9A148CCA6468C5B740C3961"><enum>(b)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">The amendment made by
subsection (a) shall apply to additional inspections and food recall activities
occurring after the date of the enactment of this Act.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H414907E9EB7B4AF7A7C18C6B83D47E26" section-type="subsequent-section"><enum>109.</enum><header display-inline="yes-display-inline">Certification and accreditation</header>
<subsection commented="no" display-inline="no-display-inline" id="HAC0AAC79C6014AF59253643C2C741E1A"><enum>(a)</enum><header display-inline="yes-display-inline">Misbranding</header>
<paragraph commented="no" display-inline="no-display-inline" id="HE7B1726094444792ABB3F7899E23ADF3"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 403 (21 U.S.C. 343), as amended by
section 101(a), is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HE109819309BD485E9095996B4062E661" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H42EDB6B3997A4763A0C71357F78D7EAC"><enum>(aa)</enum><text display-inline="yes-display-inline">If it is part of a shipment offered for
import into the United States and such shipment is in violation of section
801(q) (requiring a certification of compliance for certain food
shipments).</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3D59B1E9074C4CE884AA5EA91FFF1B72"><enum>(2)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">The amendment made by
paragraph (1) shall apply to shipments offered for import on or after the date
that is 3 years after the date of the enactment of this Act.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H13C5C2630B6C4740ABD0808D3EC10E4B"><enum>(b)</enum><header display-inline="yes-display-inline">Certification of compliance for
imports</header><text display-inline="yes-display-inline">Chapter VIII (21
U.S.C. 381 et seq.) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HB66A876703D5415284A9241843B0B0E1"><enum>(1)</enum><text display-inline="yes-display-inline">in section 801(a), as amended by section
107(b), by inserting after the third sentence the following: <quote>If such
article is food being imported or offered for import into the United States and
is not in compliance with the requirement of subsection (q) (relating to
certifications of compliance with this Act), then such article shall be refused
admission.</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB6B3D6ADB18145F4852534FB5605C883"><enum>(2)</enum><text display-inline="yes-display-inline">in the second sentence of section 801(b),
by striking <quote>the fourth sentence</quote> and inserting <quote>the fifth
sentence</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0D82B856251F4815BDA5E8873659F8F6"><enum>(3)</enum><text display-inline="yes-display-inline">by adding at the end of section 801 the
following:</text>
<quoted-block display-inline="no-display-inline" id="HA2652A6B76B8472A950FA7419AFB5B33" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H4C1820FF1721459182D3411920C8B6B8"><enum>(q)</enum><header display-inline="yes-display-inline">Certifications Concerning Imported
Articles</header>
<paragraph commented="no" display-inline="no-display-inline" id="H5559A34556E949C5B6D80A41FD7ED506"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H62798E532C374591861A4717DC77BE49"><enum>(A)</enum><header display-inline="yes-display-inline">Requirement</header><text display-inline="yes-display-inline">The Secretary may require, as an additional
condition of granting admission to an article of food being imported or offered
for import into the United States, that a qualified certifying entity provide a
certification that the article complies with requirements of this Act as
specified by the Secretary if—</text>
<clause commented="no" display-inline="no-display-inline" id="H4443023AB18145888826B222C3BBA630"><enum>(i)</enum><text display-inline="yes-display-inline">for food imported from a particular
country, territory, or region, the Secretary finds, based on scientific,
risk-based evidence, that the government controls in such country, territory,
or region are inadequate to ensure that the article is safe and that
certification would assist the Secretary in determining whether to refuse to
admit such article under subsection (a);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HF6D24DC1D9F640CAAF42B816EAB705B4"><enum>(ii)</enum><text display-inline="yes-display-inline">for a type of food for which there is
scientific evidence that there is a particular risk associated with the food
that presents a threat of serious adverse health consequences or death, the
Secretary finds that certification would assist the Secretary in determining
whether to refuse to admit such article under subsection (a); or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H42415D1CC6944317A160CF3F15600DB3"><enum>(iii)</enum><text display-inline="yes-display-inline">for an article imported from a particular
country or territory, there is an agreement between the Secretary and the
government of such country or territory providing for such
certification.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H188BF1E27E07403D99066A98200A31B9"><enum>(B)</enum><header display-inline="yes-display-inline">Form of certification</header><text display-inline="yes-display-inline">A certification under subparagraph (A) may
take the form of a statement that the article or the facility or farm that
manufactured, processed, packed, held, grew, harvested, sorted, or transported
the article, as the case may be, complies with requirements of this Act as
specified by the Secretary, or any other form as the Secretary may specify,
including a listing of certified facilities or other entities. The Secretary
may require that the certification include additional information regarding
compliance.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0CDEC5B813E6410BA2E80BD0A47476B6"><enum>(C)</enum><header display-inline="yes-display-inline">Adequate government controls</header>
<clause commented="no" display-inline="no-display-inline" id="H58833739214C4AE096B4E9241FDC609A"><enum>(i)</enum><header display-inline="yes-display-inline">Process</header><text display-inline="yes-display-inline">Before requiring a certification under
clause (ii) of subparagraph (A) with respect to a food, the Secretary shall
establish a process by which a country or territory may demonstrate that its
government controls are adequate to ensure that such food exported from its
territory to the United States is safe.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H6912C9AD63054D1488ED3439A4E9B6DD"><enum>(ii)</enum><header display-inline="yes-display-inline">Demonstration</header><text display-inline="yes-display-inline">The Secretary shall not require a
certification under clause (ii) of subparagraph (A) for a food exported from a
country or territory, if that country or territory has demonstrated, pursuant
to the process established by the Secretary under clause (i), that its
government controls are adequate to ensure that such food exported from its
territory to the United States is safe.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H535913B4D42E4946BE935829958989B3"><enum>(D)</enum><header display-inline="yes-display-inline">Notice of cancellation or suspension of
certification</header><text display-inline="yes-display-inline">As a condition
on acceptance of certifications from a qualified certifying entity, the
Secretary shall require the qualified certifying entity to notify the Secretary
whenever the qualified certifying entity cancels or suspends the certification
of any facility or other entity included in a listing under subparagraph
(B).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HEDE6E6F3C31D4341AE2F65B4A53E9B6B"><enum>(E)</enum><header display-inline="yes-display-inline">Consistency with international
obligations</header><text display-inline="yes-display-inline">The Secretary
shall apply this paragraph consistently with United States obligations under
international agreements.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H59CCBD0E9F124CA4A09A8D7906904673"><enum>(2)</enum><header display-inline="yes-display-inline">Qualified certifying entity</header><text display-inline="yes-display-inline">For purposes of this subsection, the term
<term>qualified certifying entity</term> means—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H402D56E98608400392F213E975039233"><enum>(A)</enum><text display-inline="yes-display-inline">an agency or a representative of the
government of the country from which the article originated, as designated by
such government or the Secretary; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H630FFC728D684D809708DCC7562124D5"><enum>(B)</enum><text display-inline="yes-display-inline">an individual or entity determined by the
Secretary or an accredited body recognized by the Secretary to be qualified to
provide a certification under paragraph (1).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H21E0B42CE68A4D85B807CCF7E7FEDAAA"><enum>(3)</enum><header display-inline="yes-display-inline">No conflicts of interest</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HED34EF7D95174D75AD0A529DF885BB46"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall issue regulations to
ensure that any qualified certifying entity and its auditors are free from
conflicts of interest. In issuing these regulations, the Secretary may rely on
or incorporate international certification standards.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB618B92D47A24813913AA4A9BC3149C4"><enum>(B)</enum><header display-inline="yes-display-inline">Regulations</header><text display-inline="yes-display-inline">Such regulations shall require that—</text>
<clause commented="no" display-inline="no-display-inline" id="H360AA7C0EC1E446384B258F7E7E118F1"><enum>(i)</enum><text display-inline="yes-display-inline">the qualified certifying entity shall have
a committee or management structure for safeguarding impartiality;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H823586BE00C24F5181229B264FAB8F48"><enum>(ii)</enum><text display-inline="yes-display-inline">conflict of interest policies for a
qualified certifying entity and auditors acting for the qualified certifying
entity shall be written;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H78BD0F251BA24C659B5760F59AC1702C"><enum>(iii)</enum><text display-inline="yes-display-inline">the qualified certifying entity shall not
be owned, operated, or controlled by a producer, manufacturer, processor,
packer, holder, supplier, or vendor of any article of the type it
certifies;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HEF9A76BD0B6A4381A8ABBE9A692879EF"><enum>(iv)</enum><text display-inline="yes-display-inline">the qualified certifying entity shall not
have any ownership or financial interest in any product, producer,
manufacturer, processor, packer, holder, supplier or vendor of the type it
certifies;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HDE4B147420014D6D80179B1CA650A425"><enum>(v)</enum><text display-inline="yes-display-inline">no auditor acting for the qualified
certifying entity (or spouse or minor children) shall have any significant
ownership or other financial interest regarding any product of the type it
certifies;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H94E5EDA9432D414F99BAFF2CCA4E3AB4"><enum>(vi)</enum><text display-inline="yes-display-inline">the qualified certifying entity
shall—</text>
<subclause commented="no" display-inline="no-display-inline" id="H1D311E5E6D59464F9D282429A69A55E5"><enum>(I)</enum><text display-inline="yes-display-inline">obtain and maintain annual declarations
from all personnel who may be directly involved in the performance of audits as
to whether they do or do not have direct financial interests in any producer,
manufacturer, processor, packer, holder, supplier, or vendor of foods, and a
list of any such companies in which they do have financial interests or by
which they were employed in the past year; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HF167C7A4CDE24ABA934306D39D4DAEFB"><enum>(II)</enum><text display-inline="yes-display-inline">when an auditor is assigned to audit a
facility, require that individual to affirm that he or she has no financial
interest in the company that owns or operates that facility and was not
employed by that facility in the previous year;</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H54AB5C0D1E6D42E3A1DE91ED66DF8334"><enum>(vii)</enum><text display-inline="yes-display-inline">neither the qualified certifying entity nor
any of its auditors acting for the qualified certifying entity shall
participate in the production, manufacture, processing, packing, holding,
promotion, or sale of any product of the type it certifies;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H205D8CF728324086ABBFA6138FA86ED5"><enum>(viii)</enum><text display-inline="yes-display-inline">neither the qualified certifying entity nor
any of its auditors shall provide consultative services to any facility
certified by the qualified certifying entity, or the owner, operator, or agent
in charge of such a facility, unless the qualified certifying entity has
procedures in place, approved by the Secretary, to ensure separation of
functions between auditors providing consultative services and auditors
providing certification services under this subsection;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HF44D30B355D64B959380D08A19164B6D"><enum>(ix)</enum><text display-inline="yes-display-inline">no auditors acting for the qualified
certifying entity shall participate in an audit of a facility they were
employed by within the last 12 months;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H5C7D3AAE021E431A8BE466A8EE9E3D44"><enum>(x)</enum><text display-inline="yes-display-inline">fees charged or accepted shall not be
contingent or based upon the report made by the qualified certifying entity or
any personnel involved in the audit process;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HF95737CBC19644F0A160118F87E6B203"><enum>(xi)</enum><text display-inline="yes-display-inline">neither the qualified certifying entity nor
any of its auditors shall accept anything of value from anyone in connection
with the facility being audited other than the audit fee;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H896AD1C8D4CF4B6F8D028383F74705BB"><enum>(xii)</enum><text display-inline="yes-display-inline">the qualified certifying entity shall not
be owned, operated, or controlled by a trade association whose member companies
operate facilities that it certifies;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H643A1A7368154E21B4AEA3EA376E09AB"><enum>(xiii)</enum><text display-inline="yes-display-inline">the qualified certifying entity and its
auditors shall be free from any other conflicts of interest that threaten
impartiality;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H10658837DE314DEEBC1C70285DAFFAD1"><enum>(xiv)</enum><text display-inline="yes-display-inline">the qualified certifying entity and its
auditors shall sign a statement attesting to compliance with the conflict of
interests requirements under this paragraph; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HB6904B03A33E4557A7DE720895B24144"><enum>(xv)</enum><text display-inline="yes-display-inline">the qualified certifying entity shall
ensure that any subcontractors that might be used (such as laboratories and
sampling services) provide similar assurances, except that it shall not be a
violation of this subsection to the extent such subcontractors perform
additional nutritional testing services unrelated to the testing under this
subsection.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5D13AD1CF026432AA02DB1CB68F519E5"><enum>(C)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this paragraph:</text>
<clause commented="no" display-inline="no-display-inline" id="H5AE7E5B93881456488C978854F09A845"><enum>(i)</enum><text display-inline="yes-display-inline">The term <term>anything of value</term>
includes gifts, gratuities, reimbursement of non-audit-related expenses,
entertainment, loans, or any other form of compensation in cash or in
kind.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H2E753E25D68A4C64BB7FD61028F670F8"><enum>(ii)</enum><text display-inline="yes-display-inline">The term <quote>direct financial
interest</quote> does not include any ownership of mutual funds that have a
financial interest in a company.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4B2898B52C4A4BCC888509BB1E62BB06"><enum>(4)</enum><header display-inline="yes-display-inline">Renewal and refusal of
certifications</header><text display-inline="yes-display-inline">The Secretary
shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H79F3BE13B1A247F9BBA5EB4BD5662107"><enum>(A)</enum><text display-inline="yes-display-inline">require that, to the extent applicable, any
certification provided by a qualified certifying entity 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="HEB87ABA949864865B0DC71A7D98F439F"><enum>(B)</enum><text display-inline="yes-display-inline">refuse to accept any certification if the
Secretary determines that such certification is no longer valid or
reliable.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HADD387B0AAF64A1DA9874CFE03F864E1"><enum>(5)</enum><header display-inline="yes-display-inline">On-site
audits</header><text display-inline="yes-display-inline">In evaluating whether
an accreditation body meets, or continues to meet, the standards for
recognition under this subsection, or whether to accept certifications from a
qualified certifying entity, the Secretary may—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HA6BE4C389F5E42B5AA9BD64CB259BE57"><enum>(A)</enum><text display-inline="yes-display-inline">observe on-site audits of qualified
certifying entities by such accreditation body; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9F94B625F2BB4677BF68FC5761970C77"><enum>(B)</enum><text display-inline="yes-display-inline">for any facility that is certified by a
qualified certifying entity, upon request of an officer or employee designated
by the Secretary and upon presentation of appropriate credentials, at
reasonable times and within reasonable limits and in a reasonable manner,
conduct an on-site audit of the facility, which shall include access to, and
copying and verification of, any related records.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H259BD478832845EB9BB5F2D61F788EE4"><enum>(6)</enum><header display-inline="yes-display-inline">Electronic submission</header><text display-inline="yes-display-inline">The Secretary shall provide, in
coordination with the Commissioner responsible for Customs and Border
Protection, for the electronic submission of certifications under this
subsection.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7BE0551882A44E1C86C3F4AD49D1E418"><enum>(7)</enum><header display-inline="yes-display-inline">No limit on authority</header><text display-inline="yes-display-inline">This subsection shall not be construed to
limit the authority of the Secretary to conduct random inspections of imported
articles or facilities of importers, issue import alerts for detention without
physical examination, require submission to the Secretary of documentation or
other information about an article imported or offered for import, or to take
such other steps as the Secretary deems appropriate to determine the
admissibility of imported
articles.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H640816489AD74FCD8C125999EAA1FFA4" section-type="subsequent-section"><enum>110.</enum><header display-inline="yes-display-inline">Testing by accredited laboratories</header>
<subsection commented="no" display-inline="no-display-inline" id="HB2EE19D56B394C5BBC264C0E1F88B2EC"><enum>(a)</enum><header display-inline="yes-display-inline">Prohibited
act</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="HDD65BC052D2743AA82CD5B783F90FADA" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H95B73795A10A40CD8694CA34EFCF62B2"><enum>(uu)</enum><text display-inline="yes-display-inline">The violation of any requirement of section
714 (relating to testing by accredited
laboratories).</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H59CF213254BE47C5BEBC0999AD85F06A"><enum>(b)</enum><header display-inline="yes-display-inline">Laboratory accreditation</header><text display-inline="yes-display-inline">Subchapter A of chapter VII (21 U.S.C. 371
et seq.) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H0C447FB40F264E61B329EF8866CAB1EC" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H2A0114E89A664B01A2B85AA88267DE19" section-type="subsequent-section"><enum>714.</enum><header display-inline="yes-display-inline">Testing by accredited laboratories</header>
<subsection commented="no" display-inline="no-display-inline" id="H66FBDD689F9B4D46BD48B3767FA75B5B"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header>
<paragraph commented="no" display-inline="no-display-inline" id="H18667F12E2924004A3BC49F74D184B8C"><enum>(1)</enum><header display-inline="yes-display-inline">Requirement</header><text display-inline="yes-display-inline">Whenever analytical testing of an article
of food is conducted as part of testimony for the purposes of section 801(a),
or for such other purposes as the Secretary deems appropriate through
regulation or guidance, such testing shall be conducted by a laboratory
that—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H9966D939F394467A9F9940AAFD27FE94"><enum>(A)</enum><text display-inline="yes-display-inline">is accredited, for the analytical method
used, by a laboratory accreditation body that has been recognized by the
Secretary; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H527DCA74ADC64485B3F1451AD7BE8AA2"><enum>(B)</enum><text display-inline="yes-display-inline">samples such article with adequate controls
for ensuring the integrity of the samples analyzed.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6525AFEF4A534C0CA182B9506498DC69"><enum>(2)</enum><header display-inline="yes-display-inline">Independence of laboratory</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HD946460A5CF44B7C8ED3322DFE554CAC"><enum>(A)</enum><header display-inline="yes-display-inline">Certain tests</header><text display-inline="yes-display-inline">Tests required for purposes of section
801(a) or in response to a finding of noncompliance by the Secretary shall be
conducted by a laboratory independent of the person on whose behalf such
testing is conducted and analyzed.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB9B50273E5074A1692D2B26A4CA92B6A"><enum>(B)</enum><header display-inline="yes-display-inline">Certain products</header><text display-inline="yes-display-inline">The Secretary may require that testing for
certain products under paragraph (1) be conducted by a laboratory independent
of the person on whose behalf such testing is conducted.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H6E6A5355587E4BA7B7723BF043536CBC"><enum>(b)</enum><header display-inline="yes-display-inline">Recognition of laboratory accreditation
bodies</header><text display-inline="yes-display-inline">The Secretary shall
establish and implement a program for the recognition, based on standards the
Secretary deems appropriate, of laboratory accreditation bodies that accredit
laboratories to perform analytical testing for the purposes of this section.
The Secretary shall issue regulations or guidance to implement this
program.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H36D343DBAE0744479FDAB62D6EE50FFC"><enum>(c)</enum><header display-inline="yes-display-inline">Onsite audits</header><text display-inline="yes-display-inline">In evaluating whether an accreditation body
meets, or continues to meet, the standards for recognition under subsection
(b), the Secretary may—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H9491D7E3BB3B4E6B95C387C354F4B02A"><enum>(1)</enum><text display-inline="yes-display-inline">observe onsite audits of laboratories by
such accreditation bodies; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7722948E7A694DDCB24566A4896AFF1A"><enum>(2)</enum><text display-inline="yes-display-inline">for any laboratory that is accredited by
such accreditation body under this section, upon request of an officer or
employee designated by the Secretary and upon presentation of appropriate
credentials, at reasonable times and within reasonable limits and in a
reasonable manner, conduct an onsite audit of the laboratory, which shall
include access to, and copying and verification of, any related records.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HA451AD5D8F18427BB8ADB95045A38A2B"><enum>(d)</enum><header display-inline="yes-display-inline">Publication of list of recognized
accreditation bodies</header><text display-inline="yes-display-inline">The
Secretary shall publish and maintain on the public Web site of the Food and
Drug Administration a list of accreditation bodies recognized by the Secretary
under subsection (b).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H8F6464553A45447E9492526DE1A50986"><enum>(e)</enum><header display-inline="yes-display-inline">Notification of accreditation of
laboratory</header><text display-inline="yes-display-inline">An accreditation
body that has been recognized pursuant to this section shall promptly notify
the Secretary whenever it accredits a laboratory for the purposes of this
section and whenever it withdraws or suspends such accreditation.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H24BC5FAAF8DB4A05B9B89AD44C24C9D0"><enum>(f)</enum><header display-inline="yes-display-inline">Advance
notice</header><text display-inline="yes-display-inline">Whenever analytical
testing is conducted pursuant to subsection (a), the person on whose behalf the
testing is conducted shall notify the Secretary before any sample of the
article is collected. Such notice shall contain information the Secretary
determines is appropriate to identify the article, the location of the article,
and each laboratory that will analyze the sample on the person’s behalf.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HEA3D669AA7304814AC7BBA7949422B69"><enum>(g)</enum><header display-inline="yes-display-inline">Contents of laboratory
packages</header><text display-inline="yes-display-inline">Whenever analytical
testing is conducted pursuant to subsection (a), the laboratory conducting such
testing shall submit, directly to the Secretary—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H99CD2317B8A14339B3E0EE652BF608CA"><enum>(1)</enum><text display-inline="yes-display-inline">the results of all analyses conducted by
the laboratory on each sample of such article; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4581EDFB90F24EDA8B6D6862E7D5596D"><enum>(2)</enum><text display-inline="yes-display-inline">all information the Secretary deems
appropriate to—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H9AEF36727ACD4E45B88DF492A3B26098"><enum>(A)</enum><text display-inline="yes-display-inline">determine whether the laboratory is
accredited by a recognized laboratory accreditation body;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H726ED80914D44D96B138E777A64F34C5"><enum>(B)</enum><text display-inline="yes-display-inline">identify the article tested;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7C437AF774C5493EAD075BA575F87BA6"><enum>(C)</enum><text display-inline="yes-display-inline">evaluate the analytical results; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB46BD67C9F644D4BA0DE2720B3FCB0E1"><enum>(D)</enum><text display-inline="yes-display-inline">determine whether the requirements of this
section have been met.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HECD88F61CE5543AC98A394AA940ADA88"><enum>(h)</enum><header display-inline="yes-display-inline">Exigent circumstances</header><text display-inline="yes-display-inline">The Secretary may waive the requirement of
subsection (a)(1)(A) (relating to analytical methods) on a laboratory or method
basis due to exigent or other circumstances.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HEB875E45B99E4F4BB631854DDA769014"><enum>(i)</enum><header display-inline="yes-display-inline">Federal laboratory testing</header><text display-inline="yes-display-inline">If Customs and Border Protection laboratory
testing concludes that an article of food is adulterated or misbranded, the
Secretary shall consider and utilize as appropriate the testing results issued
by the Customs and Border Protection laboratories in making a decision about
the admissibility of the product.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HE66CF5451C0B4E79A28ADBF4923038BC"><enum>(j)</enum><header display-inline="yes-display-inline">No limit on authority</header><text display-inline="yes-display-inline">Nothing in this section shall be construed
to limit—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HB2E8EC979F4A46AC8A331A7B8F37DBA5"><enum>(1)</enum><text display-inline="yes-display-inline">the ability of the Secretary to review and
act upon information from the analytical testing of food (including under this
section), including determining the sufficiency of such information and
testing; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC7A2B20873A14A869B83FC4C1A09BFE1"><enum>(2)</enum><text display-inline="yes-display-inline">the authority of the Secretary to conduct,
require, or consider the results of analytical testing pursuant to any other
provision of
law.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" display-inline="no-display-inline" id="HE9578FF43C8E48DEBA9F4417BB143951" section-type="subsequent-section"><enum>111.</enum><header display-inline="yes-display-inline">Notification, nondistribution, and recall
of adulterated or misbranded food</header>
<subsection commented="no" display-inline="no-display-inline" id="H8777E18CFF284D0D992E915F17D94EB2"><enum>(a)</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 110, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HF88270E09CF54E51B3D9989011FC1626" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HB7511144087E4D34846A913C1943B277"><enum>(vv)</enum><paragraph commented="no" display-inline="yes-display-inline" id="HD769CB8411DA4498B53A1D1A1D2847FB"><enum>(1)</enum><text display-inline="yes-display-inline">The failure to notify the Secretary in
violation of section 420(a).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD2304D1F6172438C91B46ADFAE6C599D" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">The failure to comply with any order issued
under section
420.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HC9111AA0DE56406FA749FAA1F48AC8A3"><enum>(b)</enum><header display-inline="yes-display-inline">Notification, nondistribution, and recall
of adulterated or misbranded food</header><text display-inline="yes-display-inline">Chapter IV (21 U.S.C. 341 et seq.), as
amended by sections 102, 103, and 104, is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H017B1D7324BA492DB1B2E8E78D1CED72" style="OLC">
<section commented="no" display-inline="no-display-inline" id="HA0F0BCF2E629424EB4B16364751328ED" section-type="subsequent-section"><enum>420.</enum><header display-inline="yes-display-inline">Notification, nondistribution, and recall
of adulterated or misbranded food</header>
<subsection commented="no" display-inline="no-display-inline" id="H62FFC90EECE946B89EEE237F0658DE2B"><enum>(a)</enum><header display-inline="yes-display-inline">Notification, nondistribution, and recall
of adulterated or misbranded food</header>
<paragraph commented="no" display-inline="no-display-inline" id="HAEAF2A94D00F4033BD478957A223D6C1"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A responsible party as that term is defined
in section 417(a)(1) or a person required to register under section 801(s) that
has reason to believe that an article of food when introduced into or while in
interstate commerce, or while held for sale (regardless of whether the first
sale) after shipment in interstate commerce, is adulterated or misbranded in a
manner that presents a reasonable probability that the use or consumption of,
or exposure to, the article (or an ingredient or component used in any such
article) will cause a threat of serious adverse health consequences or death to
humans or animals shall, as soon as practicable, notify the Secretary of the
identity and location of the article.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HA016E79B5973405088416B55B6816F8C"><enum>(2)</enum><header display-inline="yes-display-inline">Manner of notification</header><text display-inline="yes-display-inline">Notification under paragraph (1) shall be
made in such manner and by such means as the Secretary may require by
regulation or guidance.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H53B6026BDAC7484280A7EEEE04D613FE"><enum>(b)</enum><header display-inline="yes-display-inline">Voluntary recall</header><text display-inline="yes-display-inline">The Secretary may request that any person
who distributes an article of food that the Secretary has reason to believe is
adulterated, misbranded, or otherwise in violation of this Act
voluntarily—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H79DF3F02E41446BE8BFDBE9A97CF0894"><enum>(1)</enum><text display-inline="yes-display-inline">recall such article; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6A0A9FDA0C784BD7AF26E1052E3378E4"><enum>(2)</enum><text display-inline="yes-display-inline">provide for notice, including to
individuals as appropriate, to persons who may be affected by the
recall.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H2D143AF0C71942C4AB18B299259634F7"><enum>(c)</enum><header display-inline="yes-display-inline">Order to cease distribution</header><text display-inline="yes-display-inline">If the Secretary has reason to believe that
the use or consumption of, or exposure to, an article of food may cause serious
adverse health consequences or death to humans or animals, the Secretary shall
have the authority to issue an order requiring any person who distributes such
article to immediately cease distribution of such article.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H8EBF9DB1CF8544AD9DF0CDB035E5B1A2"><enum>(d)</enum><header display-inline="yes-display-inline">Action following order</header><text display-inline="yes-display-inline">Any person who is subject to an order under
subsection (c) shall immediately cease distribution of such article and provide
notification as required by such order, and may appeal within 24 hours of
issuance such order to the Secretary. Such appeal may include a request for an
informal hearing and a description of any efforts to recall such article
undertaken voluntarily by the person, including after a request under
subsection (b). Except as provided in subsection (f), an informal hearing shall
be held as soon as practicable, but not later than 5 calendar days, or less as
determined by the Secretary, after such an appeal is filed, unless the parties
jointly agree to an extension. After affording an opportunity for an informal
hearing, the Secretary shall determine whether the order should be amended to
require a recall of such article. If, after providing an opportunity for such a
hearing, the Secretary determines that inadequate grounds exist to support the
actions required by the order, the Secretary shall vacate the order.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HF59FA82FC820425C9DDC3FFE11063937"><enum>(e)</enum><header display-inline="yes-display-inline">Order to recall</header>
<paragraph commented="no" display-inline="no-display-inline" id="H1DDC724B283E4D8099FF9A477C7D1E96"><enum>(1)</enum><header display-inline="yes-display-inline">Amendment</header><text display-inline="yes-display-inline">Except as provided under subsection (f), if
after providing an opportunity for an informal hearing under subsection (d),
the Secretary determines that the order should be amended to include a recall
of the article with respect to which the order was issued, the Secretary shall
amend the order to require a recall.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC1309222DFB142C8BF608720581AEF1C"><enum>(2)</enum><header display-inline="yes-display-inline">Contents</header><text display-inline="yes-display-inline">An amended order under paragraph (1)
shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H13A20B7679324765AB790474940248C1"><enum>(A)</enum><text display-inline="yes-display-inline">specify a timetable in which the recall
will occur;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H13A5D0F0060F402A9600B75700EB4554"><enum>(B)</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="H514F3E931EE34E8DA328EBD210990D38"><enum>(C)</enum><text display-inline="yes-display-inline">provide for notice, including to
individuals as appropriate, to persons who may be affected by the
recall.</text>
</subparagraph><continuation-text commented="no" continuation-text-level="paragraph">In providing for such notice, the
Secretary may allow for the assistance of health professionals, State or local
officials, or other individuals designated by the Secretary.</continuation-text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7B807DBB08B1476BAB0C0E154E5028B1"><enum>(3)</enum><header display-inline="yes-display-inline">Nondelegation</header><text display-inline="yes-display-inline">An amended order under this subsection
shall be ordered by the Secretary or an official designated by the Secretary.
An official may not be so designated unless the official is the director of the
district under this Act in which the article involved is located, or is an
official senior to such director.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HFA4830D0A87246A08982012DAC301BBC"><enum>(f)</enum><header display-inline="yes-display-inline">Emergency recall order</header>
<paragraph commented="no" display-inline="no-display-inline" id="H114C7B1AF1FA43928D468CF604CD2277"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">If the Secretary has credible evidence or
information that an article of food subject to an order under subsection (c)
presents an imminent threat of serious adverse health consequences or death to
humans or animals, the Secretary may issue an order requiring any person who
distributes such article—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HBF6242D421C74143B7BD44D75EFCF923"><enum>(A)</enum><text display-inline="yes-display-inline">to immediately recall such article;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H98422518791B42CCA33A9A8C0A136993"><enum>(B)</enum><text display-inline="yes-display-inline">to provide for notice, including to
individuals as appropriate, to persons who may be affected by the
recall.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB166185A64174ED99A16138AAE73D31C"><enum>(2)</enum><header display-inline="yes-display-inline">Action following order</header><text display-inline="yes-display-inline">Any person who is subject to an emergency
recall order under this subsection shall immediately recall such article and
provide notification as required by such order, and may appeal within 24 hours
after issuance such order to the Secretary. An informal hearing shall be held
within as soon as practicable but not later than 5 calendar days, or less as
determined by the Secretary, after such an appeal is filed, unless the parties
jointly agree to an extension. After affording an opportunity for an informal
hearing, the Secretary shall determine whether the order should be amended
pursuant to subsection (e)(1). If, after providing an opportunity for such a
hearing, the Secretary determines that inadequate grounds exist to support the
actions required by the order, the Secretary shall vacate the order.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1A6F55EDC8BC494BBC8ABB080445B2B1"><enum>(3)</enum><header display-inline="yes-display-inline">Nondelegation</header><text display-inline="yes-display-inline">An order under this subsection shall be
issued by the Commissioner of Food and Drugs, the Principal Deputy
Commissioner, or the Associate Commissioner for Regulatory Affairs of the Food
and Drug Administration.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H9E8110C4373046F4AE7EDEEAB434C88C"><enum>(g)</enum><header display-inline="yes-display-inline">Notice to consumers and health
officials</header><text display-inline="yes-display-inline">The Secretary
shall, as the Secretary determines to be necessary, provide notice of a recall
order under this section to consumers to whom the article was, or may have
been, distributed and to appropriate State and local health officials.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H1F1CDE888F09444D92DD9257D504BB67"><enum>(h)</enum><header display-inline="yes-display-inline">Savings
clause</header><text display-inline="yes-display-inline">Nothing contained in
this section shall be construed as limiting—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H7F3EEADF81C94A1F987090BB2E3C8DB1"><enum>(1)</enum><text display-inline="yes-display-inline">the authority of the Secretary to issue an
order to cease distribution of, or to recall, an article under any other
provision of this Act or the Public Health Service Act; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HA9BD45D10BE6476C8F1565C17C2B0BB0"><enum>(2)</enum><text display-inline="yes-display-inline">the ability of the Secretary to request any
person to perform a voluntary activity related to any article subject to this
Act or the Public Health Service
Act.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H276BD8774EBF4F9B94BCD43987E0C8F4"><enum>(c)</enum><header display-inline="yes-display-inline">Articles subject to refusal</header><text display-inline="yes-display-inline">The third sentence of subsection (a) of
section 801 (21 U.S.C. 381), as amended by section 107(b), is amended by
inserting <quote>or (5) such article is subject to an order under section 420
to cease distribution of or recall the article,</quote> before <quote>then such
article shall be refused admission</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H8C94B5FBC65F44A08409717324884F55"><enum>(d)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">Sections 301(vv)(1) and
420 of the Federal Food, Drug, and Cosmetic Act, as added by subsections (a)
and (b), shall apply with respect to articles of food as of such date, not
later than 1 year after the date of the enactment of this Act, as the Secretary
of Health and Human Services shall specify.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H3AA478E9E27D47AA93F9D95771B287FC" section-type="subsequent-section"><enum>112.</enum><header display-inline="yes-display-inline">Reportable food registry; exchange of
information</header>
<subsection commented="no" display-inline="no-display-inline" id="HA81469F0571C43A48AD8F915D2B8EED7"><enum>(a)</enum><header display-inline="yes-display-inline">Reportable food registry</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="H822A82B11E4D4DE7A94F3E85146D0C85"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)(1), by striking
<quote>means a person</quote> and all that follows through the end of paragraph
(1) and inserting the
following:</text>
<quoted-block display-inline="yes-display-inline" id="H80F838F987A2447F893D8658E3549878" style="OLC">
<text>means—</text><subparagraph commented="no" display-inline="no-display-inline" id="H5755644003364130BEF4D0B290137B7E"><enum>(A)</enum><text display-inline="yes-display-inline">a person who submits the registration under
section 415(a) for a food facility that is required to be registered under
section 415(a), at which such food is manufactured, processed, packed, or
held;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4380BE3624F140A4809A744562452A8B"><enum>(B)</enum><text display-inline="yes-display-inline">a person who owns, operates, is an agent
of, or is otherwise responsible for such food on a farm (as such term is
defined in section 1.227(b)(3) of title 21, Code of Federal Regulations, or
successor regulations) at which such food is produced for sale or distribution
in interstate commerce;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3A885D161C2D4738896D08459207E308"><enum>(C)</enum><text display-inline="yes-display-inline">a person who owns, operates, or is an agent
of a restaurant or other retail food establishment (as such terms are defined
in section 1.227(b)(11) and (12), respectively, of title 21, Code of Federal
Regulations, or successor regulations) at which such food is offered for sale;
or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H183C895D068F4089B9B2244CE0D13F24"><enum>(D)</enum><text display-inline="yes-display-inline">a person that is required to register
pursuant to section 801(s) with respect to importation of such
food.</text>
</subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3EF1E9ABD639498198DD7F90732F47A0"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b), by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HDBAB4628B6624D96850D5FB3CC4023CB" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H249C82744AA84AC7A26E487AF5C7CE92"><enum>(3)</enum><header display-inline="yes-display-inline">Reporting by farms, restaurants, and retail
food establishments</header><text display-inline="yes-display-inline">In
addition to the electronic portal described in paragraph (1), the Secretary
shall make available alternative means of reporting under this section with
respect to farms, restaurants, and other retail food establishments with
limited ability for such
reporting.</text>
</paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H646DD634B0324C8AA0E8A3D365D9CCF9"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (d)(1)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HA6AFE3C5926E4BA08EA2E796EC5C68A9"><enum>(A)</enum><text display-inline="yes-display-inline">in the matter preceding subparagraph (A),
by inserting <quote>following a timely review of any reasonably available data
and information,</quote> after <quote>reportable food,</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0EF63FD3CACB42439370F297442BCDC8"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (A), by striking
<quote>and</quote> at the end;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDB83DC4E06654D339E01047CA9F0E8F5"><enum>(C)</enum><text display-inline="yes-display-inline">by redesignating subparagraph (B) as
subparagraph (C); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF77544AAF79241EB9C6B905C1F7FC1FA"><enum>(D)</enum><text display-inline="yes-display-inline">by inserting after subparagraph (A) the
following:</text>
<quoted-block display-inline="no-display-inline" id="H925945D6E7004738A7C530079F52B387" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="H89DCE16D83F04BED91D9E029BB2BD7CE"><enum>(B)</enum><text display-inline="yes-display-inline">submit, with such report, through the
electronic portal, documentation of results from any sampling and testing of
such article, including—</text>
<clause commented="no" display-inline="no-display-inline" id="H835370972208468083CB201B7D47531F"><enum>(i)</enum><text display-inline="yes-display-inline">analytical results from testing of such
article conducted by or on behalf of the responsible party under section 418,
418A, 419, 419A, or 714;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H007E68D5E191478EB0C997770AF04645"><enum>(ii)</enum><text display-inline="yes-display-inline">analytical results from testing conducted
by or on behalf of such responsible party of a component of such
article;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H55AB572C3A6B4D1A9CDC7B2FD8F2A37F"><enum>(iii)</enum><text display-inline="yes-display-inline">analytical results of environmental testing
of any facility at which such article, or a component of such article, is
manufactured, processed, packed, or held; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H87EEFE505CEF4B0793B5EA55C8A0B62C"><enum>(iv)</enum><text display-inline="yes-display-inline">any other information the Secretary
determines is necessary to evaluate the adulteration of such article, any
component of such article, any other article of food manufactured, processed,
packed or held in the same manner as, or at the same facility as, such article,
or any other article containing a component from the same source as a component
of such article; and</text>
</clause></subparagraph><after-quoted-block>; and
</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H16A57BDBD68E409BB4F20CD7395C95ED"><enum>(4)</enum><text display-inline="yes-display-inline">in subsection (e)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HD576DE98FAFC434CB92203F85A38F517"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1), by inserting <quote>if
the responsible party is required to register</quote> after
<quote>415(a)(3)</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HEB2C4AA93C6446A78EDFE3DD5F42FA25"><enum>(B)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H200E47B9DB8941DAB0766EACCB0E09FD" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H1D6128CBE2654B5AB3570FABE99B2F5E"><enum>(12)</enum><text display-inline="yes-display-inline">Such additional information as the
Secretary deems
appropriate.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HBE078639C0AF46EEAE215DD7F3253CBD"><enum>(b)</enum><header display-inline="yes-display-inline">Exchange of information</header><text display-inline="yes-display-inline">Section 708 (21 U.S.C. 379) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H96470ABE476A4048AD93063A4071DF19"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>The Secretary</quote>
and inserting <quote>(a) The Secretary</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H22C315D7B35F4622B7A20EB38DE35C68"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H99A8D40BC67F4B2E949B62AD33820359" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H05101248EA6949079FF1E7F5FAB2E2BE"><enum>(b)</enum><paragraph commented="no" display-inline="yes-display-inline" id="HE91E8B0E55A74D0194F02ADA993418B0"><enum>(1)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HFB7ADCFA444F420196AB63CA5DF49155"><enum>(A)</enum><text display-inline="yes-display-inline">The Secretary may provide to any Federal
agency acting within the scope of its jurisdiction any information relating to
food that is exempt from disclosure pursuant to subsection (a) of section 552
of title 5, United States Code, by reason of subsection (b)(4) of such section,
or that is referred to in section 301(j) or 415(a)(4).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF524F56A94284BE38CBE911AFC7B3DCE" indent="up2"><enum>(B)</enum><text display-inline="yes-display-inline">Any such information provided to another
Federal agency shall not be disclosed by such agency except in any action or
proceeding under the laws of the United States to which the receiving agency or
the United States is a party.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HA7F28219D4E249F189E5FF4C50F44E78" indent="up1"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H573030E9CEE042B1A669E9B94CD035C0"><enum>(A)</enum><text display-inline="yes-display-inline">In carrying out this Act, the Secretary may
provide to a State or local government agency any information relating to food
that is exempt from disclosure pursuant to section 552(a) of title 5, United
States Code, by reason of subsection (b)(4) of such section, or that is
referred to in section 301(j) or 415(a)(4).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H54A0072D9BAD47D081042BFF8069D5AD" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">Any such information provided to a State or
local government agency shall not be disclosed by such agency.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9D28D8E1D1FD4FB69945873622178EFD" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">In carrying out this Act, the Secretary may
provide to any person any information relating to food that is exempt from
disclosure pursuant to section 552(a) of title 5, United States Code, by reason
of subsection (b)(4) of such section, if the Secretary determines that
providing the information to the person is appropriate under the circumstances
and the recipient provides adequate assurances to the Secretary that the
recipient will preserve the confidentiality of the information.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H80D8F34EC00941E3B863AFC6A894047D" indent="up1"><enum>(4)</enum><text display-inline="yes-display-inline">In carrying out this Act, the Secretary may
provide any information relating to food that is exempt from disclosure
pursuant to section 552(a) of title 5, United States Code, by reason of
subsection (b)(4) of such section, or that is referred to in section
301(j)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H596ADC4276C14A88A6B69E6C65CE686F"><enum>(A)</enum><text display-inline="yes-display-inline">to any foreign government agency; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H395D07C54F5C45A29C81E212D8DE8E6F"><enum>(B)</enum><text display-inline="yes-display-inline">any international organization established
by law, treaty, or other governmental action and having responsibility—</text>
<clause commented="no" display-inline="no-display-inline" id="H0D3EBBA8885B4682971CB9D05623060A"><enum>(i)</enum><text display-inline="yes-display-inline">to facilitate global or regional
harmonization of standards and requirements in an area of responsibility of the
Food and Drug Administration; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H6AF6905D1A4441C0A18AAD6683616E87"><enum>(ii)</enum><text display-inline="yes-display-inline">to promote and coordinate public health
efforts,</text>
</clause><continuation-text commented="no" continuation-text-level="subparagraph">if the agency or organization
provides adequate assurances to the Secretary that the agency or organization
will preserve the confidentiality of the information.</continuation-text></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HEEE957A43ADF4AA9BB057272A554A8C7"><enum>(c)</enum><text display-inline="yes-display-inline">Except where specifically prohibited by
statute, the Secretary may disclose to the public any information relating to
food that is exempt from disclosure pursuant to section 552(a) of title 5,
United States Code, by reason of subsection (b)(4) of such section, if the
Secretary determines that such disclosure is necessary to protect the public
health.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H60316233BC45418FA8DACEE0FB70FD5A"><enum>(d)</enum><text display-inline="yes-display-inline">Except as provided in subsection (e), the
Secretary shall not be required to disclose under section 552 of title 5,
United States Code, or any other provision of law any information relating to
food obtained from a Federal, State, or local government agency, or from a
foreign government agency, or from an international organization described in
subsection (b)(4), if the agency or organization has requested that the
information be kept confidential, or has precluded such disclosure under other
use limitations, as a condition of providing the information.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H0DF8F32DB06940A69DFE4BD4003F47CA"><enum>(e)</enum><text display-inline="yes-display-inline">Nothing in subsection (d) authorizes the
Secretary to withhold information from the Congress or prevents the Secretary
from complying with an order of a court of the United States.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H26D1358377A34C5994D486CE2A939DEE"><enum>(f)</enum><text display-inline="yes-display-inline">This section shall not affect the authority
of the Secretary to provide or disclose information under any other provision
of
law.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HDCAEF9FDE2DA453393F5554A32F99940"><enum>(c)</enum><header display-inline="yes-display-inline">Conforming amendment</header><text display-inline="yes-display-inline">Section 301(j) (21 U.S.C. 331(j)) is
amended by striking <quote>or to the courts when relevant in any judicial
proceeding under this Act,</quote> and inserting <quote>to the courts when
relevant in any judicial proceeding under this Act, or as specified in section
708,</quote>.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H396704E6A8FD4C7DB38DC722EC01A899" section-type="subsequent-section"><enum>113.</enum><header display-inline="yes-display-inline">Safe and secure food importation
program</header><text display-inline="no-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="H6751AB1E86BA4F0D95AA025D9E0B1506" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H613BF9AC31D9441CB39D78E6A90C7575" section-type="subsequent-section"><enum>805.</enum><header display-inline="yes-display-inline">Safe and secure food importation
program</header>
<subsection commented="no" display-inline="no-display-inline" id="HB27F3453AE9142D3A612C745D9E7E9ED"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary may establish by regulation
or guidance in coordination with the Commissioner responsible for Customs and
Border Protection a program that facilitates the movement of food through the
importation process under this Act if the importer of such food—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HB588A79054CA47728C0EA5B0B42E0B2A"><enum>(1)</enum><text display-inline="yes-display-inline">verifies that each facility involved in the
production, manufacture, processing, packaging, and holding of the food is in
compliance with the food safety and security guidelines developed under
subsection (b) with respect to such food;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9850EC4BE1DE47AD8A9D21F0F7384332"><enum>(2)</enum><text display-inline="yes-display-inline">ensures that appropriate safety and
security controls are in place throughout the supply chain for such food;
and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H92DE366E6E784F8D9CAA50972DA1CFDC"><enum>(3)</enum><text display-inline="yes-display-inline">provides supporting information to the
Secretary.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HDD2BB9FDD16E40598E552B1A101CA6A4"><enum>(b)</enum><header display-inline="yes-display-inline">Guidelines</header>
<paragraph commented="no" display-inline="no-display-inline" id="HEC027796A77C42729F694FC11B77FFB5"><enum>(1)</enum><header display-inline="yes-display-inline">Development</header><text display-inline="yes-display-inline">For purposes of the program established
under subsection (a), the Secretary shall develop in consultation with the
Commissioner responsible for Customs and Border Protection safety and security
guidelines applicable to the importation of food taking into account, to the
extent appropriate, other relevant Federal programs, such as the Customs-Trade
Partnership Against Terrorism (C-TPAT) programs under section 211 of the
Security and Accountability for Every Port Act of 2006.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4FDA035C2BEA45B989D9EBB7C6DF6E1E"><enum>(2)</enum><header display-inline="yes-display-inline">Factors</header><text display-inline="yes-display-inline">Such guidelines shall take into account the
following factors:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HED08BA49490B425594DFAFEFB2671C82"><enum>(A)</enum><text display-inline="yes-display-inline">The personnel of the person importing the
food.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA7D10A6413BF43228E51D6FF53A3B8D3"><enum>(B)</enum><text display-inline="yes-display-inline">The physical and procedural safety and
security of such person’s food supply chain.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H16C44C4F66CA46048AB5DDB35BB550F2"><enum>(C)</enum><text display-inline="yes-display-inline">The sufficiency of preventive controls for
food and ingredients purchased by such person.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE3EE7E8AFEE0431E8D29C01F2533A24E"><enum>(D)</enum><text display-inline="yes-display-inline">Vendor and supplier information.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8A5C93E1CB574264A35B9C1D34F3ACC5"><enum>(E)</enum><text display-inline="yes-display-inline">Other programs for certification or
verification by a qualified certifying entity used by the importer.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA4C099F2F14B4F61A958F7D413F20956"><enum>(F)</enum><text display-inline="yes-display-inline">Such other factors as the Secretary
determines
necessary.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H136622CF86444A75A531318A88034134" section-type="subsequent-section"><enum>114.</enum><header display-inline="yes-display-inline">Infant formula</header>
<subsection commented="no" display-inline="no-display-inline" id="HD0EB80DA2AD641C7A0A4E5CE9998E2C1"><enum>(a)</enum><header display-inline="yes-display-inline">Misbranding</header><text display-inline="yes-display-inline">Section 403 (21 U.S.C. 343), as amended by
sections 101(a) and 109(a), is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H47CB6F1A9F244F45B0022932C50B5F7B" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H4CDF2EF065A543DFBAD90BD6BEE58653"><enum>(bb)</enum><text display-inline="yes-display-inline">If it is a new infant formula and—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H02B0B32BBD3D4E828A4013E2B513DFFB"><enum>(1)</enum><text display-inline="yes-display-inline">it is not the subject of a registration
made pursuant to section 412(c)(1)(A);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7FC3B1250C8E411D8544521027ABBB55"><enum>(2)</enum><text display-inline="yes-display-inline">it is not the subject of a submission made
pursuant to section 412(c)(1)(B), or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H563564BC165147588EFF5D1729A7F2E3"><enum>(3)</enum><text display-inline="yes-display-inline">at least 90 days have not passed since the
making of such registration or of such submission to the
Secretary.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H8C80C732BE554CACAB0B6926A2BFFBB2"><enum>(b)</enum><header display-inline="yes-display-inline">Requirements</header><text display-inline="yes-display-inline">Section 412 (21 U.S.C. 350a) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H1A5E7D1A7BA34B17964BA6B0A0732D0E"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (c)(1)(B), by striking
<quote>(c)(1)</quote> at the end and inserting <quote>(d)(1), subject to
subsection (d)(2)(B)</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE56C6EC4F99F4AB49F1209BA3172F13B"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (d)(1)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H03184D57E7664510B67BE51A68CDF960"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>and</quote> at the end
of subparagraph (C);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB8D2B2EC67194E6382B798C76AB3004D"><enum>(B)</enum><text display-inline="yes-display-inline">by striking the period at the end of
subparagraph (D) and inserting <quote>, and</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4ACD5130CC384E4C8C55E98AAA50896E"><enum>(C)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H75958227D8D4405A9BD2FFE6879BB060" style="traditional">
<subparagraph commented="no" display-inline="no-display-inline" id="H9C5F5C9AFC2C4E9BB96CD9FC15110C8A"><enum>(E)</enum><text display-inline="yes-display-inline">information on any new ingredient in
accordance with paragraph
(2)(A).</text>
</subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H392AABB51A934ECF8A28B295870CFCD5"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (d), by redesignating
paragraphs (2) and (3) as paragraphs (3) and (4), respectively; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0DE4B9B8919542FAA12E65A05834B39C"><enum>(4)</enum><text display-inline="yes-display-inline">by inserting after paragraph (1) of
subsection (d) the following:</text>
<quoted-block display-inline="no-display-inline" id="HA03ACFCA88EF432B9E32EB95E5F211EE" style="traditional">
<paragraph commented="no" display-inline="no-display-inline" id="HF6A462E4511642FE849EACCE7DCE293E" indent="up1"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H0E7F657816944AF1B09159011F9D8259"><enum>(A)</enum><text display-inline="yes-display-inline">The description of any new infant formula
required under paragraph (1) shall include, for any new ingredient for use in
the formula—</text>
<clause commented="no" display-inline="no-display-inline" id="H019120A16DD941DA9681A98DDD76B84A" indent="up1"><enum>(i)</enum><text display-inline="yes-display-inline">a citation to a prior approval by the
Secretary of the new ingredient for use in infant formula under section
409;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HBDEF731A11B446D7913BD4614C067089" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">a
citation to or information showing a prior consideration of the new ingredient
for use in infant formula under any program established by the Secretary for
the review of ingredients used in food; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HA84C1EB9DBAE4D68BE148F4EA11C9E31" indent="up1"><enum>(iii)</enum><text display-inline="yes-display-inline">for a new ingredient that is not a food
additive or a color additive, information equivalent to that provided under any
program established by the Secretary for the review of ingredients used in
food.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB8B7B68D407B447484E88E8E413A0E4B" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">If the information submitted under
subparagraph (A) is the information described in clause (iii) of such
subparagraph, the 90 day period provided by subsection (c)(1)(B) shall not
commence until the Secretary has completed review of the information submitted
under such clause and has provided the submitter notice of the results of such
review.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection></section></subtitle><subtitle commented="no" id="H416B0E91601D40CA9CEEE30638C3CDFC" level-type="subsequent"><enum>B</enum><header display-inline="yes-display-inline">Intervention</header>
<section commented="no" display-inline="no-display-inline" id="H7884530A0CAA4C8DAF769F5C75054E77" section-type="subsequent-section"><enum>121.</enum><header display-inline="yes-display-inline">Surveillance</header>
<subsection commented="no" display-inline="no-display-inline" id="H7179D5CFCD614F8FBE02518F4E12D3F2"><enum>(a)</enum><header display-inline="yes-display-inline">Definition of Food-Borne Illness
Outbreak</header><text display-inline="yes-display-inline">In this section, the
term <quote>food-borne illness outbreak</quote> means the occurrence of 2 or
more cases of a similar illness resulting from the ingestion of a food.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H9C7381C61FAA4F5D941ED977D745DA8F"><enum>(b)</enum><header display-inline="yes-display-inline">Food-Borne Illness Surveillance
Systems</header><text display-inline="yes-display-inline">The Secretary of
Health and Human Services (in this subtitle referred to as the
<quote>Secretary</quote>), acting through the Director of the Centers for
Disease Control and Prevention, shall enhance food-borne illness surveillance
systems to improve the collection, analysis, reporting, and usefulness of data
on food-borne illnesses by—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HDFDDEA5DBAE34009893F48BFFFCA4B33"><enum>(1)</enum><text display-inline="yes-display-inline">coordinating Federal, State, and local
food-borne illness surveillance systems, including complaint systems, and
increasing participation in national networks of public health and food
regulatory agencies and laboratories;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H947DDCD3CBD34C17BF819621A20C0767"><enum>(2)</enum><text display-inline="yes-display-inline">facilitating sharing of findings on a more
timely basis among governmental agencies, including the Food and Drug
Administration, the Department of Agriculture, and State and local agencies,
and with the public;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD5644B1065604E04B8EF487C1A2C5D12"><enum>(3)</enum><text display-inline="yes-display-inline">developing improved epidemiological tools
for obtaining quality exposure data, and microbiological methods for
classifying cases;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2B435E4048284079A958E79B232A67A1"><enum>(4)</enum><text display-inline="yes-display-inline">augmenting such systems to improve
attribution of a food-borne illness outbreak to a specific food;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC4615F234E2248F6B584B93A5800314C"><enum>(5)</enum><text display-inline="yes-display-inline">expanding capacity of such systems,
including fingerprinting and other detection strategies for food-borne
infectious agents, in order to identify new or rarely documented causes of
food-borne illness;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H27F96E0B358045519D76F4939394FBFC"><enum>(6)</enum><text display-inline="yes-display-inline">allowing timely public access to
aggregated, de-identified surveillance data;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H28B3D2AC04BF4B8CA8807A4BB83AEE3D"><enum>(7)</enum><text display-inline="yes-display-inline">at least annually, publishing current
reports on findings from such systems;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1490CC373D30461DB90701B77841B63D"><enum>(8)</enum><text display-inline="yes-display-inline">establishing a flexible mechanism for
rapidly initiating scientific research by academic institutions;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE73D5FD20C504D51955083811E177136"><enum>(9)</enum><text display-inline="yes-display-inline">integrating food-borne illness surveillance
systems and data with other biosurveillance and public health situational
awareness capabilities at the Federal, State, and local levels; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H739AF45C1F1E4C91854A990D08520C79"><enum>(10)</enum><text display-inline="yes-display-inline">other activities as determined appropriate
by the Secretary.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H7D0B97566A8543EF9B5FCA607CD02960"><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="H410808FDEF72452389526A284E773795"><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="H610C0A8581F84306B46B31AC7E3C53AF"><enum>(A)</enum><text display-inline="yes-display-inline">Improve food-borne illness outbreak
response and containment.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC440A47C0B914EDF8BB98F852EA1F565"><enum>(B)</enum><text display-inline="yes-display-inline">Accelerate food-borne illness surveillance
and outbreak investigation, including rapid shipment of clinical isolates from
clinical laboratories to appropriate State laboratories, and conducting more
standardized illness outbreak interviews.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H1854BB97CD4B42DA941567196886C405"><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="HCF640DB04DDC4A999C5376C99F2E8E4E"><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 food-borne illness.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB80857D9BF4642049CBA1099D9160ECB"><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></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7B8B723299594B51B5E9909C1DBDC930"><enum>(2)</enum><header display-inline="yes-display-inline">Review</header><text display-inline="yes-display-inline">In developing the strategies required by
paragraph (1), the Secretary shall, not later than 1 year after the date of
enactment of this Act, complete a review of State and local capacities, and
needs for enhancement, which may include a survey with respect to—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HEDBE93D4AEF64E36BB434A2A4A61B85A"><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="H005F618000FA4C7F9C177C82E3FC87E3"><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="HCEEF9594F51249CBAF3C83609D67D97A"><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="H775804B66F70492586CBC84F8D7591C5"><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></section><section commented="no" display-inline="no-display-inline" id="H878F5FEF839E495A86BD4E80C88D3EDF" section-type="subsequent-section"><enum>122.</enum><header display-inline="yes-display-inline">Public education and advisory
system</header>
<subsection commented="no" display-inline="no-display-inline" id="HDF14D144B2894714AED88A07C289F37B"><enum>(a)</enum><header display-inline="yes-display-inline">Public education</header><text display-inline="yes-display-inline">The Secretary, in cooperation with private
and public organizations, including the appropriate State entities, shall
design and implement a national public education program on food safety. The
program shall provide—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H3128F6BE71E249638AF197A990403F90"><enum>(1)</enum><text display-inline="yes-display-inline">information to the public so that
individuals can understand the potential impact and risk of food-borne illness,
take action to reduce their risk of food-borne illness and injury, and make
healthy dietary choices;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB314E390CA524F958EC9BC7655A4C448"><enum>(2)</enum><text display-inline="yes-display-inline">information to health professionals so that
they may improve diagnosis and treatment of food-related illness and advise
individuals whose health conditions place them in particular risk; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE694663F547B415D8752109959B1C542"><enum>(3)</enum><text display-inline="yes-display-inline">such other information or advice to
consumers and other persons as the Secretary determines will promote the
purposes of this Act.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H8D766E26E7C04483B3AEFA2F3B9799D0"><enum>(b)</enum><header display-inline="yes-display-inline">Health advisories</header><text display-inline="yes-display-inline">The Secretary shall work with the States
and other appropriate entities to—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H260E117E0F594930B765F1BC686B2598"><enum>(1)</enum><text display-inline="yes-display-inline">develop and distribute regional and
national advisories concerning food safety;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H27CDC182FE0C4CFEAB4CE108B175403F"><enum>(2)</enum><text display-inline="yes-display-inline">develop standardized formats for written
and broadcast advisories; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3D5A59FAA24B44E4BC10CE6579B31CB0"><enum>(3)</enum><text display-inline="yes-display-inline">incorporate State and local advisories into
the national public education program required under subsection (a).</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="HA7A0162A80C941BE908FBF377EBD77F1" section-type="subsequent-section"><enum>123.</enum><header display-inline="yes-display-inline">Research</header><text display-inline="no-display-inline">The Secretary shall conduct research to
assist in the implementation of this Act, including studies to—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HE639978B33584AFC9164A83FBD4BAA27"><enum>(1)</enum><text display-inline="yes-display-inline">improve sanitation and food safety
practices in the production, harvesting, and processing of food
products;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC6450DBF3BEA4C6FAA02284279B00C0D"><enum>(2)</enum><text display-inline="yes-display-inline">develop improved techniques for the
monitoring of food and inspection of food products;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H80B5EF8ECF334444BE8F02927FDBCE1A"><enum>(3)</enum><text display-inline="yes-display-inline">develop efficient, rapid, and sensitive
methods for determining and detecting the presence of contaminants in food
products;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H11DFEFAFA4CD473B8227082FCAB43B0D"><enum>(4)</enum><text display-inline="yes-display-inline">determine the sources of contamination of
food and food products, including critical points of risk for fresh produce and
other raw agricultural commodities;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC34F96DD97474012B9CD93FBBA5DCB65"><enum>(5)</enum><text display-inline="yes-display-inline">develop consumption data with respect to
food products;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC301EAB800EC4C90B972915AFF0FF6A1"><enum>(6)</enum><text display-inline="yes-display-inline">draw upon research and educational programs
that exist at the State and local level;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB32B80A2CED249528CCE5C1209A888B3"><enum>(7)</enum><text display-inline="yes-display-inline">utilize the DNA matching system and other
processes to identify and control pathogens;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7AE6D1FCC1F04DB3BF0F1B10EEE7D725"><enum>(8)</enum><text display-inline="yes-display-inline">address common and emerging zoonotic
diseases;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H68D14931071445ABB018F32572B0EB73"><enum>(9)</enum><text display-inline="yes-display-inline">develop methods to reduce or destroy
pathogens before, during, and after processing;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE852E8FBF97C4497BD8A8AADC75CDA1D"><enum>(10)</enum><text display-inline="yes-display-inline">analyze the incidence of antibiotic
resistance as it pertains to the food supply and evaluate methods to reduce the
transfer of antibiotic resistance to humans; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H79C43D8F246E43BC8B25857BFD6B8E99"><enum>(11)</enum><text display-inline="yes-display-inline">conduct other research that supports the
purposes of this Act.</text>
</paragraph></section></subtitle><subtitle commented="no" id="H858F00344AC84B9087D6A18636509EAB" level-type="subsequent"><enum>C</enum><header display-inline="yes-display-inline">Response</header>
<section commented="no" display-inline="no-display-inline" id="H9F554793B9CE4FD9AA0377CE72D060F9" section-type="subsequent-section"><enum>131.</enum><header display-inline="yes-display-inline">Procedures for seizure</header><text display-inline="no-display-inline">Section 304(b) (21 U.S.C. 334(b)) is amended
by inserting <quote>and except that, with respect to proceedings relating to
food, Rule G of the Supplemental Rules of Admiralty or Maritime Claims and
Asset Forfeiture Actions shall not apply in any such case, exigent
circumstances shall be deemed to exist for all seizures brought under this
section, and the summons and arrest warrant shall be issued by the clerk of the
court without court review in any such case</quote> after <quote>in any such
case shall be tried by jury</quote>.</text>
</section><section commented="no" display-inline="no-display-inline" id="H56D45B5E34854F55AE95943BAC0C3E51" section-type="subsequent-section"><enum>132.</enum><header display-inline="yes-display-inline">Administrative detention</header>
<subsection commented="no" display-inline="no-display-inline" id="H3709E0F06480426DA5C15139D7578D3E"><enum>(a)</enum><header display-inline="yes-display-inline">Amendments</header><text display-inline="yes-display-inline">Section 304(h) (21 U.S.C. 334(h)) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H56DDE521380C418FBA5D85588B1BC5CA"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1)(A), by striking
<quote>credible evidence or information indicating</quote> and inserting
<quote>reason to believe</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H70B212CC591744098049324E724AE303"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (1)(A), by striking
<quote>presents a threat of serious adverse health consequences or death to
humans or animals</quote> and inserting <quote>is adulterated, misbranded, or
otherwise in violation of this Act</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H679F072E510C42A385759F6A1F6660F8"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (2), by striking
<quote>30</quote> and inserting <quote>60</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3DAA804CCC0845A7BA31FDE35D02F806"><enum>(4)</enum><text display-inline="yes-display-inline">in paragraph (3), by striking the third
sentence; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H275C903FA92E4A96AFC2EFB5EB17B43E"><enum>(5)</enum><text display-inline="yes-display-inline">in paragraph (4)(A) by striking the terms
<term>five</term> and <term>five-day</term> and inserting
<quote>fifteen</quote> and <quote>fifteen-day</quote>, respectively.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HA73C358A7703406B8B99701AAB06D6FD"><enum>(b)</enum><header display-inline="yes-display-inline">Regulations</header><text display-inline="yes-display-inline">The Secretary shall issue regulations or
guidance to implement the amendments made by this section.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H0DEA47174A9B41A497838E96F37FE0E1"><enum>(c)</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 180 days after the date of the enactment of this
Act.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H5EEE84E2C1A24A2FA8616A5A0F312B72" section-type="subsequent-section"><enum>133.</enum><header display-inline="yes-display-inline">Authority to prohibit or restrict the
movement of food</header>
<subsection commented="no" display-inline="no-display-inline" id="HAE56214AB00B4750ADA75414F48A3C22"><enum>(a)</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 sections 110 and 111, is amended by adding at the end by
adding the following:</text>
<quoted-block display-inline="no-display-inline" id="H3B5774E054E14B408FC570ACD44539FF" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H0DBAD0231E554E4A905675A009BE201C"><enum>(ww)</enum><text display-inline="yes-display-inline">The violation of a prohibition or
restriction under section
304(i).</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HB223B162565046D391DB4DB8AA8708DA"><enum>(b)</enum><header display-inline="yes-display-inline">In General</header><text display-inline="yes-display-inline">Section 304 (21 U.S.C. 334) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H2C19D85B869B4D7BA7E88E3508BF5998" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H2146A10DAF294247B2AC763DDBDEC17B"><enum>(i)</enum><header display-inline="yes-display-inline">Authority to Prohibit or Restrict the
Movement of Food within a State or Portion of a State</header>
<paragraph commented="no" display-inline="no-display-inline" id="H90EE48E83FB84DFB8C721ED464CDA492"><enum>(1)</enum><header display-inline="yes-display-inline">Authority to prohibit or restrict the
movement of food</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H8A3AD23F38054B08A58013FA11451CDF"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header>
<clause commented="no" display-inline="no-display-inline" id="H71FE99B8B538458687E444D6D90017A0"><enum>(i)</enum><text display-inline="yes-display-inline">After consultation with the Governor or
other appropriate official of an affected State, if the Secretary determines
that there is credible evidence that an article of food presents an imminent
threat of serious adverse health consequences or death to humans or animals,
the Secretary may prohibit or restrict the movement of an article of food
within a State or portion of a State for which the Secretary has credible
evidence that such food is located within, or originated from, such State or
portion thereof.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HC329FB1361E448F3B62589581665D316"><enum>(ii)</enum><text display-inline="yes-display-inline">In carrying out clause (i), the Secretary
may prohibit or restrict the movement within a State or portion of a State of
any article of food or means of conveyance of such article of food, if the
Secretary determines that the prohibition or restriction is a necessary
protection from an imminent threat of serious adverse health consequences or
death to humans or animals.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6AE1D50BE41F411880E15AFD18F36D46"><enum>(2)</enum><header display-inline="yes-display-inline">Notification procedures</header><text display-inline="yes-display-inline">Subject to paragraph (3), before any action
is taken in a State under this subsection, the Secretary shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H4B30CC63DC284DE4890C0D8700DC3F73"><enum>(A)</enum><text display-inline="yes-display-inline">notify the Governor or other appropriate
official of the State affected by the proposed action;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD36F566CA2704B89865D179B10A3F617"><enum>(B)</enum><text display-inline="yes-display-inline">issue a public announcement of the proposed
action; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC19BE3FBCB424DE99691D3540C9203B3"><enum>(C)</enum><text display-inline="yes-display-inline">publish in the Federal Register—</text>
<clause commented="no" display-inline="no-display-inline" id="H1DF5806909F34951BEF5D91B8DE65650"><enum>(i)</enum><text display-inline="yes-display-inline">the findings of the Secretary that support
the proposed action;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H1CC7D3599B764E039ED9AA38C4D00FD8"><enum>(ii)</enum><text display-inline="yes-display-inline">a statement of the reasons for the proposed
action; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HC7D0D86C2BE54ADEB846DA4A30AD20F9"><enum>(iii)</enum><text display-inline="yes-display-inline">a description of the proposed action,
including—</text>
<subclause commented="no" display-inline="no-display-inline" id="HDF7E515546CB4763A10F38241207DE4C"><enum>(I)</enum><text display-inline="yes-display-inline">the area affected; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H00266457C7DC4DCFBF668FCAEAB07A51"><enum>(II)</enum><text display-inline="yes-display-inline">an estimate of the anticipated duration of
the action.</text>
</subclause></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF91AFD52319C48A394069E962F55557C"><enum>(3)</enum><header display-inline="yes-display-inline">Notice after action</header><text display-inline="yes-display-inline">If it is not practicable to publish in the
Federal Register the information required under paragraph (2)(C) before taking
action under paragraph (1), the Secretary shall publish the information as soon
as practicable, but not later than 10 business days, after commencement of the
action.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H43A9351A692A40A8AA7DB14D071E9DB7"><enum>(4)</enum><header display-inline="yes-display-inline">Application of least drastic
action</header><text display-inline="yes-display-inline">No action shall be
taken under paragraph (1) unless, in the opinion of the Secretary, there is no
less drastic action that is feasible and that would be adequate to prevent the
imminent threat of serious adverse health consequences or death to humans or
animals.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H56C3FE1947734ADEAED95B9F052DFBAA"><enum>(5)</enum><header display-inline="yes-display-inline">Nondelegation</header><text display-inline="yes-display-inline">An action under paragraph (1) may only be
ordered by the Secretary or an official designated by the Secretary. An
official may not be so designated unless the official is the Commissioner of
Food and Drugs or the Principal Deputy Commissioner.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE3ACCA358A7942DD98B44B2071D1A039"><enum>(6)</enum><header display-inline="yes-display-inline">Duration</header><text display-inline="yes-display-inline">Fourteen days after the initiation of an
action under paragraph (1), and each 14 days thereafter, if the Secretary
determines that it is necessary to continue the action, the Secretary
shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HF5D2120746784489A846FC9AA57C430D"><enum>(A)</enum><text display-inline="yes-display-inline">notify the Governor or other appropriate
official of the State affected of the continuation of the action;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H74DD1C5B84A340BDB315385C918E42E7"><enum>(B)</enum><text display-inline="yes-display-inline">issue a public announcement of the
continuation of the action; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H69F011402F19440AB0B1457363896553"><enum>(C)</enum><text display-inline="yes-display-inline">publish in the Federal Register the
findings of the Secretary that support the continuation of the action,
including an estimate of the anticipated duration of the action.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2908C95D47804C79B7C8E8A8278CC06D"><enum>(7)</enum><header display-inline="yes-display-inline">Rulemaking</header><text display-inline="yes-display-inline">The Secretary shall, consistent with
national security interests and as appropriate for known hazards, establish by
regulation standards for conducting actions under paragraph (1), including, as
appropriate, sanitation standards and procedures to restore any affected
equipment or means of conveyance to its status prior to an action under
paragraph
(1).</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H9D9906ED66F54144B3DEF37A01A92743" section-type="subsequent-section"><enum>134.</enum><header display-inline="yes-display-inline">Criminal penalties</header><text display-inline="no-display-inline">Section 303(a) (21 U.S.C. 333) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HBED48CD23F4E4C9AAF66344C36961C88"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking
<quote>Any</quote> and inserting <quote>Except as provided in paragraph (2) or
(3), any</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1A1053EF72D647568EED4FF04642B2CF"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H2EFD6535A9F64FEFBD835E689F0AD14C" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H492C3FA26DD846DDB07913569BEEE556" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">Notwithstanding paragraph (1), any person
who knowingly violates paragraph (a), (b), (c), (k), or (v) of section 301 with
respect to any food that is misbranded or adulterated shall be imprisoned for
not more than 10 years or fined in accordance with title 18, United States
Code, or
both.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H90F78BC7ACEA45A2B39ED50A8E5A5F38" section-type="subsequent-section"><enum>135.</enum><header display-inline="yes-display-inline">Civil penalties for violations relating to
food</header>
<subsection commented="no" display-inline="no-display-inline" id="HBD7A80A8492047758B70BC2A87DA8A9F"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Paragraph (2) of section 303(f) (21 U.S.C.
331 et seq.) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="HD4B0BA545C2C44A2ACD1E9C0C2467532" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="HC74D66254B9549A8AF75DEF782DD0EE9"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H6DA04EDE7B134C7AB9D501D74C77DEC9"><enum>(A)</enum><text display-inline="yes-display-inline">Any person who violates a provision of
section 301 relating to food shall be subject to a civil penalty for each such
violation of not more than—</text>
<clause commented="no" display-inline="no-display-inline" id="H2CCD17F56A094FB39656D5F817968493" indent="up1"><enum>(i)</enum><text display-inline="yes-display-inline">$20,000 in the case of an individual, not
to exceed $50,000 in a single proceeding; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H16711797E8F3470CB8A472A5BA5F4742" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">$250,000 in the case of any other person,
not to exceed $1,000,000 in a single proceeding.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4EC77C09681F473EB31104F6CEFCA8A6" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">Any person who knowingly violates a
provision of section 301 relating to food shall be subject to a civil penalty
for each such violation of not more than—</text>
<clause commented="no" display-inline="no-display-inline" id="HC946054C57A144FDABAEE5B1CB053B01"><enum>(i)</enum><text display-inline="yes-display-inline">$50,000 in the case of an individual, not
to exceed $100,000 in a single proceeding; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H6527C199BFF34F19B142EEC0B9531255"><enum>(ii)</enum><text display-inline="yes-display-inline">$500,000 in the case of any other person,
not to exceed $7,500,000 in a single proceeding.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H362B587B9A014885AD49D5A4EC626239" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">Each violation described in subparagraph
(A) or (B) and each day during which the violation continues shall be
considered to be a separate
offense.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H98B2AEAE3245474C8E584A2C2D1F1D77"><enum>(b)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">The amendment made by
subsection (a) applies to violations committed on or after the date of the
enactment of this Act.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="HC0FCDC7ACA6C44A59776DF6A6840CF29" section-type="subsequent-section"><enum>136.</enum><header display-inline="yes-display-inline">Improper import entry filings</header>
<subsection commented="no" display-inline="no-display-inline" id="HF7F3ED907B254BCB937FEA8E56EE08A2"><enum>(a)</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
sections 110, 111, and 133, is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HD5CA980109DB4C6686FE299F970C4C5A" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H973D22108BB24D29915DBAAE1931EFAB"><enum>(xx)</enum><text display-inline="yes-display-inline">The submission of information relating to
food that is required by or under section 801 that is inaccurate or
incomplete.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HEF747C13E20B4D539B7259D72BE629DE"><enum>(yy)</enum><text display-inline="yes-display-inline">The failure to submit information relating
to food that is required by or under section
801.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H84F5C4BDCE274D289BEABAB42D7DBCA1"><enum>(b)</enum><header display-inline="yes-display-inline">Documentation for imports</header><text display-inline="yes-display-inline">Section 801 (21 U.S.C. 381), as amended by
section 109, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H7B6B50C150E148FC91E95C1E697260AF" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H119C8BFC601646F2921B097C1111FAEA"><enum>(r)</enum><header display-inline="yes-display-inline">Documentation</header>
<paragraph commented="no" display-inline="no-display-inline" id="HC8B1C139DABB4A82AC6C9672EC9B0651"><enum>(1)</enum><header display-inline="yes-display-inline">Submission</header><text display-inline="yes-display-inline">The Secretary may require by regulation or
guidance the submission of documentation or other information for articles of
food that are imported or offered for import into the United States. When
developing any regulation or guidance in accordance with this paragraph, to the
extent that the collection of documentation or other information involves
Customs and Border Protection efforts or resources, the Secretary shall consult
with Customs and Border Protection.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB47B2076323F4C289CDB57CE8C8D1DA8"><enum>(2)</enum><header display-inline="yes-display-inline">Format</header><text display-inline="yes-display-inline">A regulation or guidance under paragraph
(1) may specify the format for submission of the documentation or other
information.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section></subtitle><enum>II</enum><header display-inline="yes-display-inline">Miscellaneous</header>
<section commented="no" display-inline="no-display-inline" id="H017DDD08ACEC4F34A200DC22519843DE" section-type="subsequent-section"><enum>201.</enum><header display-inline="yes-display-inline">Food substances generally recognized as
safe</header><text display-inline="no-display-inline">Section 409 (21 U.S.C.
348) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HA3F7639B776040D59E57D069CBA8B3F4" other-style="archaic" style="other">
<subsection commented="no" display-inline="no-display-inline" id="HA12B0B216EA9431A8A04D7B8A1166ADE"><enum>(k)</enum><header>Substances generally recognized as safe</header><paragraph commented="no" display-inline="yes-display-inline" id="H6284F7BC049C4DE5AD4F6F820DAB7276"><enum>(1)</enum><text display-inline="yes-display-inline">Not later than 60 days after the date of
receipt by the Secretary, after the date of the enactment of this subsection,
of a determination that a substance is a GRAS food substance, the Secretary
shall post notice of such determination and the supporting scientific
justifications on the Food and Drug Administration’s public Web site.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7F1D988040EE4960858C0FA7F4ED520D" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">Not later than 60 days after the date of
receipt of a request under paragraph (1), the Secretary shall acknowledge
receipt of such request by informing the requester in writing of the date on
which the request was received.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0F7EED45324D45759015403AD1402975" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">In this subsection, the term <term>GRAS
food substance</term> means a substance excluded from the definition of the
term <term>food additive</term> in section 201(s) because such substance is
generally recognized, among experts qualified by scientific training and
experience to evaluate its safety, as having been adequately shown through
scientific procedures (or, in the case of a substance used in food prior to
January 1, 1958, through either scientific procedures or experience based on
common use in food) to be safe under the conditions of its intended
use.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H44D13851EF4C46588DA9F081397A778C" section-type="subsequent-section"><enum>202.</enum><header display-inline="yes-display-inline">Country of origin labeling</header>
<subsection commented="no" display-inline="no-display-inline" id="H20C8783A734641D0B2D4CA40A73FEF65"><enum>(a)</enum><header display-inline="yes-display-inline">Misbranding</header><text display-inline="yes-display-inline">Section 403 (21 U.S.C. 343), as amended by
sections 101(a), 109(a), and 114(a), is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H5793F27F6AA24AC48CE509DF6AC78E5C" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H4296B92E0DD94AB7968BD1E715819F30"><enum>(cc)</enum><text display-inline="yes-display-inline">In the case of a processed food, if the
labeling of the food fails to identify the country in which the final
processing of the food occurs.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HB5643B3948CC497DA7A943550C461807"><enum>(dd)</enum><text display-inline="yes-display-inline">In the case of nonprocessed food, if the
labeling of the food fails to identify the country of origin of the
food.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H6665DFACDFFB4CF1B255E5568F5F5E30"><enum>(b)</enum><header display-inline="yes-display-inline">Regulations</header>
<paragraph commented="no" display-inline="no-display-inline" id="H4A929EAF04314C56A488D789F0B8C804"><enum>(1)</enum><header display-inline="yes-display-inline">Promulgation</header><text display-inline="yes-display-inline">Not later than 180 days after the date of
the enactment of this Act, the Secretary of Health and Human Services shall
promulgate final regulations to carry out paragraphs (cc) and (dd) of section
403 of the Federal Food, Drug, and Cosmetic Act, as added by subsection
(a).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H69FB44CFF0DC4102AE05306CED043671"><enum>(2)</enum><header display-inline="yes-display-inline">Relation to other
requirements</header><text display-inline="yes-display-inline">Regulations
promulgated under paragraph (1) shall provide that labeling meets the
requirements of paragraphs (cc) and (dd) of section 403 of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a), if—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HA15A7C320E764E3A9F4B01F2BB871F8E"><enum>(A)</enum><text display-inline="yes-display-inline">in the case of a processed food, the label
of the food informs the consumer of the country where the final processing of
the food occurred in accordance with country of origin marking requirements of
the United States Customs and Border Protection; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H67452FEEA6B343E6A3F90AB98A856AB0"><enum>(B)</enum><text display-inline="yes-display-inline">in the case of a nonprocessed food, the
label of the food informs the consumer of the country of origin of the food in
accordance with labeling requirements of the Department of Agriculture.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H6F6CE6CFC676498494A921C88565FA13"><enum>(c)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">The requirements of
paragraphs (cc) and (dd) of section 403 of the Federal Food, Drug, and Cosmetic
Act, as added by subsection (a), take effect on the date that is 2 years after
the date of the enactment of this Act.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H48F461BD68574F18BDC1CC67F6035382" section-type="subsequent-section"><enum>203.</enum><header display-inline="yes-display-inline">Exportation certificate
program</header><text display-inline="no-display-inline">Section 801(e)(4) (21
U.S.C. 381) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H6E7D0345D4104BB2A79D443C7D22E975"><enum>(1)</enum><text display-inline="yes-display-inline">in the matter preceding clause (i) in
subparagraph (A)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HF03390CC87814BFE8A5830D434BC26B5"><enum>(A)</enum><text display-inline="yes-display-inline">by inserting <quote>from the United
States</quote> after <quote>exports</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD553CB8F3AFC48CCA15197760409B53E"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>a drug, animal drug, or
device</quote> and inserting <quote>a food (including animal feed), drug,
animal drug, or device</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H71E6F25059F848A5BC5A90FD5A3F1C94"><enum>(2)</enum><text display-inline="yes-display-inline">in subparagraph (A)(i)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H0CE617B7E9BF4A598054E6666522144A"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>in writing</quote>;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0FC6CFEA6BFD4E9893A56EA72CB71B55"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>exported drug, animal
drug, or device</quote> and inserting <quote>exported food, drug, animal drug,
or device</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBBF3D5D6AA4F465B8F43A793376701BE"><enum>(3)</enum><text display-inline="yes-display-inline">in subparagraph (A)(ii)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HDDE66981D87D4BA888EDAE2DB5D9F22F"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>in
writing</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9145203425794F67B67280D535EB4A13"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>the drug, animal drug,
or device</quote> and inserting <quote>the food, drug, animal drug, or
device</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H72D7001E6F614B47809A668A2027A822"><enum>(C)</enum><text display-inline="yes-display-inline">by striking <quote>the drug or
device</quote> and inserting <quote>the food, drug, or device</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HCF2E749CDD6A45FB85A91D174C1265A8"><enum>(4)</enum><text display-inline="yes-display-inline">by redesignating subparagraph (B) as
subparagraph (C);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H210DCC43C37040D9A77DCF6C1B480DF9"><enum>(5)</enum><text display-inline="yes-display-inline">by inserting after subparagraph (A) the
following:</text>
<quoted-block display-inline="no-display-inline" id="H435E279EDF634534B10ADC0A2E081AE8" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="H946BC6105D20433E9543862EC4536D67"><enum>(B)</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
(such as a publicly available listing) as the Secretary determines
appropriate.</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9B0E8B7E5B2846EB810CE6FF9F225ACF"><enum>(6)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HD420BA186D6D47C3975EAED0A3A4BF91" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="HC5859BBE95AA413A8C0469160BB1AFAB" indent="up2"><enum>(D)</enum><text display-inline="yes-display-inline">Notwithstanding subparagraph (C), if the
Secretary issues an export certification within the 20 days prescribed by
subparagraph (A) with respect to the export of food, a fee for such
certification shall not exceed such amount as the Secretary determines is
reasonably related to the cost of issuing certificates under subparagraph (A)
with respect to the export of food. The Secretary may adjust this fee annually
to account for inflation and other cost adjustments. Fees collected for a
fiscal year pursuant to this subparagraph shall be credited to the
appropriation account for salaries and expenses of the Food and Drug
Administration and shall be available in accordance with appropriations Acts
until expended, without fiscal year limitation. Such fees shall be collected in
each fiscal year in an amount equal to the amount specified in appropriations
Acts for such fiscal year and shall only be collected and available for the
costs of the Food and Drug Administration to cover the cost of issuing such
certifications. Such sums as necessary may be transferred from such
appropriation account for salaries and expenses of the Food and Drug
Administration without fiscal year limitation to such appropriation account for
salaries and expenses with fiscal year
limitation.</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="HC30A59FAB4064F9D994D47ACD4EE5A76" section-type="subsequent-section"><enum>204.</enum><header display-inline="yes-display-inline">Registration for commercial importers of
food; fee</header>
<subsection commented="no" display-inline="no-display-inline" id="H849BB31B5F1F4B0CB3437CCDE1BC2F06"><enum>(a)</enum><header display-inline="yes-display-inline">Registration</header>
<paragraph commented="no" display-inline="no-display-inline" id="HE8B9948D26F14D9AA2C1456E6399122A"><enum>(1)</enum><header display-inline="yes-display-inline">Prohibitions</header><text display-inline="yes-display-inline">Section 301 (21 U.S.C. 331), as amended by
sections 110, 111, 133, and 136, is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H62C6FBCC9FBA4FC6BB0E3A8F8FC35513" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HFC1EB5D777B1437B83A3D9C7143E5664"><enum>(zz)</enum><text display-inline="yes-display-inline">The failure to register in accordance with
section
801(s).</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9AD351C30E54468681F88F0368B9A7D6"><enum>(2)</enum><header display-inline="yes-display-inline">Misbranding</header><text display-inline="yes-display-inline">Section 403 (21 U.S.C. 343) as amended by
sections 101(a), 109(a), 114(a), and 202, is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HDA4380CF662A41D7B6845477B903D261" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H2260F181A5E34563AE7F20F6BB67B968"><enum>(ee)</enum><text display-inline="yes-display-inline">If it is imported or offered for import by
an importer not duly registered under section
801(s).</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H866EFEB85F124E50B4C52C3F9BD8CC96"><enum>(3)</enum><header display-inline="yes-display-inline">Registration</header><text display-inline="yes-display-inline">Section 801, as amended by sections 109 and
136, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H8CFD5DE018C748DA80B5BABCAB606F84" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H8B5D9909FB5840E7900C08D48448A1C0"><enum>(s)</enum><header display-inline="yes-display-inline">Registration of importers</header>
<paragraph commented="no" display-inline="no-display-inline" id="HACA2835168434BA69ABA0BA59A5237CB"><enum>(1)</enum><header display-inline="yes-display-inline">Registration</header><text display-inline="yes-display-inline">The Secretary shall require an importer of
food—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HD5CCBD12C10B4BA2BF3725D5E0854BA7"><enum>(A)</enum><text display-inline="yes-display-inline">to be registered with the Secretary in a
form and manner specified by the Secretary; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA126D6C4774B4F229BDC39CE6E34DFFF"><enum>(B)</enum><text display-inline="yes-display-inline">consistent with section 1011, to submit
appropriate unique facility identifiers as a condition of registration.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H40A2A3DDEC27406E8C1444A678C6BB75"><enum>(2)</enum><header display-inline="yes-display-inline">Good importer practices</header><text display-inline="yes-display-inline">The maintenance of registration under this
subsection is conditioned on compliance with good importer practices in
accordance with the following:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H109EB7982E6F4214A37DF7553D4D29C2"><enum>(A)</enum><text display-inline="yes-display-inline">The Secretary, in consultation with Customs
and Border Protection, shall promulgate regulations to establish good importer
practices that specify the measures an importer shall take to ensure imported
food is in compliance with the requirements of this Act.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4CBE8FCC799842B3982B09E22D0F8CFB"><enum>(B)</enum><text display-inline="yes-display-inline">The measures under subparagraph (A) shall
ensure that the importer of a food—</text>
<clause commented="no" display-inline="no-display-inline" id="H592385285970405897D7DF13DF37A27F"><enum>(i)</enum><text display-inline="yes-display-inline">has adequate information about the food,
its hazards, and the requirements of this Act applicable to such food;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HD082B81B467F4A5F9617D960684886A1"><enum>(ii)</enum><text display-inline="yes-display-inline">has adequate information or procedures in
place to verify that both the food and each person that produced, manufactured,
processed, packed, transported, or held the food, including components of the
food, are in compliance with the requirements of this Act; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HE0D62949CAC044618A8CCFACD30688DB"><enum>(iii)</enum><text display-inline="yes-display-inline">has adequate procedures in place to take
corrective action, such as the ability to appropriately trace, withhold, and
recall articles of food, if a food imported by the importer is not in
compliance with the requirements of this Act.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H25FD2415C92346EDB485DEC14A7F4470"><enum>(C)</enum><text display-inline="yes-display-inline">In promulgating good importer practices
regulations, the Secretary may, as appropriate—</text>
<clause commented="no" display-inline="no-display-inline" id="H58F31C1B683A453AB845A33E7CC67B6D"><enum>(i)</enum><text display-inline="yes-display-inline">incorporate certification of compliance
under section 801(q) and participation in the safe and secure food importation
program under section 805; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H951D52ADD4A748A59175BB4C9D2E8E9E"><enum>(ii)</enum><text display-inline="yes-display-inline">take into account differences among
importers and the types of imports, including based on the level of risk posed
by the imported food.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDAF91C9AA455497CA755C7B46F5645E0"><enum>(3)</enum><header display-inline="yes-display-inline">Suspension of registration</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H8BEA9A69F2D54B5189448B6E23C5EF21"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Registration under this subsection is
subject to suspension upon a finding by the Secretary, after notice and an
opportunity for an informal hearing, of—</text>
<clause commented="no" display-inline="no-display-inline" id="H0B00411005D14AAC8386305AEBB2F784"><enum>(i)</enum><text display-inline="yes-display-inline">a violation of this Act; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HFF8FE2FAED8247D7A53E8EADF120EFD6"><enum>(ii)</enum><text display-inline="yes-display-inline">the knowing or repeated making of an
inaccurate or incomplete statement or submission of information relating to the
importation of food.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF6E9794C736D4792ADF3B362D3CD3B4F"><enum>(B)</enum><header display-inline="yes-display-inline">Request</header><text display-inline="yes-display-inline">The importer whose registration is
suspended may request that the Secretary vacate the suspension of registration
when such importer has corrected the violation that is the basis for such
suspension.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H198F4FD31033472EA4ED5E4D0919A8F3"><enum>(C)</enum><header display-inline="yes-display-inline">Vacating of suspension</header><text display-inline="yes-display-inline">If the Secretary determines that adequate
reasons do not exist to continue the suspension of a registration, the
Secretary shall vacate such suspension.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBBE2088FDB73490EA099CA26BEBAC871"><enum>(4)</enum><header display-inline="yes-display-inline">Cancellation of registration</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H331C554C7B7D4A0380BE47F95B4F73B0"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not earlier than 10 days after providing
the notice under subparagraph (B), the Secretary may cancel a registration that
the Secretary determines was not updated in accordance with this section or
otherwise contains false, incomplete, or inaccurate information.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8B638E9B061C4DF58DA16D0F8302690B"><enum>(B)</enum><header display-inline="yes-display-inline">Notice of cancellation</header><text display-inline="yes-display-inline">Cancellation shall be preceded by notice to
the importer of the intent to cancel the registration and the basis for such
cancellation.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H61AA77452F4C43D6B585B31FC2F68555"><enum>(C)</enum><header display-inline="yes-display-inline">Timely update or correction</header><text display-inline="yes-display-inline">If the registration for the importer is
updated or corrected no later than 7 days after notice is provided under
subparagraph (B), the Secretary shall not cancel such registration.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6ADE155D87B74E3083923C75829D48F4"><enum>(5)</enum><header display-inline="yes-display-inline">Exemptions</header><text display-inline="yes-display-inline">The Secretary, by notice published in the
Federal Register—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H2EB026AC23B14D2E9EA1E6AC9563D64C"><enum>(A)</enum><text display-inline="yes-display-inline">shall establish an exemption from the
requirements of this subsection for importations for personal use; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H879FBE67E3B3404DB967302AD260BE9E"><enum>(B)</enum><text display-inline="yes-display-inline">may establish other exemptions from the
requirements of this
subsection.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD77F1B84D4254812A0C3ABD8140685D9"><enum>(4)</enum><header display-inline="yes-display-inline">Regulations</header><text display-inline="yes-display-inline">Not later than 36 months after the date of
the enactment of this Act, the Secretary of Health and Human Services in
consultation with the Commissioner responsible for Customs and Border
Protection shall promulgate the regulations required to carry out section
801(s) of the Federal Food, Drug, and Cosmetic Act, as added by paragraph (3).
In establishing the effective date of a regulation promulgated under section
801(s), the Secretary shall, in consultation with the Commissioner responsible
for Customs and Border Protection, as appropriate, provide a reasonable period
of time for importers of food to comply with good importer practices, taking
into account differences among importers and the types of imports, including
based on the level of risk posed by the imported food.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDD1C635D77544C2DA6375FFC4F771B99"><enum>(5)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">The amendments made by
this subsection shall take effect on the date that is 24 months after the date
of enactment of this Act.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H0F505D1BA7CA43C1AAC738FAFEACD092"><enum>(b)</enum><header display-inline="yes-display-inline">Fee</header><text display-inline="yes-display-inline">Subchapter C of chapter VII (21 U.S.C. 379f
et seq.) as added and amended by sections 101 and 108, is amended by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HD557B3879C2C4035AEE5BFE83256726D" style="OLC">
<part commented="no" id="H8D40A14E6B1F48EA9237DDC2D9CB1043" level-type="subsequent"><enum>7</enum><header display-inline="yes-display-inline">IMPORTERS OF FOOD</header>
<section commented="no" display-inline="no-display-inline" id="HF23DDC349C0349B8A74A79872C12AE1D" section-type="subsequent-section"><enum>744.</enum><header display-inline="yes-display-inline">Importers of food</header>
<subsection commented="no" display-inline="no-display-inline" id="H087A157F9139469DB2BF3BCD3F178032"><enum>(a)</enum><header display-inline="yes-display-inline">Importers</header><text display-inline="yes-display-inline">The Secretary shall assess and collect an
annual fee for the registration of an importer of food under section
801(s).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HCE42CE37B8FF4B00B51372ACAFDC9A6B"><enum>(b)</enum><header display-inline="yes-display-inline">Amount of fee</header><text display-inline="yes-display-inline"></text>
<paragraph commented="no" display-inline="no-display-inline" id="H1E9FCE17E9BF4DD38BD510D3B4A96AA9"><enum>(1)</enum><header display-inline="yes-display-inline">Base amounts</header><text display-inline="yes-display-inline">The registration fee under subsection (a)
shall be—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H6EC2999E9A91443C86D01009D51E0407"><enum>(A)</enum><text display-inline="yes-display-inline">for fiscal year 2010, $500; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA6539E9B446C44F2AE392373DC638F95"><enum>(B)</enum><text display-inline="yes-display-inline">for fiscal year 2011 and each subsequent
fiscal year, the fee for fiscal year 2010 as adjusted under paragraph
(2).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H8C4CC8390EF74840884228DCDC4FF3AC"><enum>(2)</enum><header display-inline="yes-display-inline">Adjustment</header><text display-inline="yes-display-inline">For fiscal year 2011 and subsequent fiscal
years, the fees established pursuant to paragraph (1) shall be adjusted by the
Secretary by notice, published in the Federal Register, for a fiscal year to
reflect the greater of—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H552BECA1DF334399AF188BF9317DA1D8"><enum>(A)</enum><text display-inline="yes-display-inline">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
for which fees are being established;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE391F45759A24BD3BC0B7796E2E5D664"><enum>(B)</enum><text display-inline="yes-display-inline">the total percentage change for the
previous fiscal year in basic pay under the General Schedule in accordance with
section 5332 of title 5, United States Code, as adjusted by any locality-based
comparability payment pursuant to section 5304 of such title for Federal
employees stationed in the District of Columbia; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9A0548F0F72242569B46AD5647E13F04"><enum>(C)</enum><text display-inline="yes-display-inline">the average annual change in the cost, per
full-time equivalent position of the Food and Drug Administration, of all
personnel compensation and benefits paid with respect to such positions for the
first 5 years of the preceding 6 fiscal years.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5FE5641F8E8B48FFA4A324578EC1EEB5"><enum>(3)</enum><header display-inline="yes-display-inline">Compounded basis</header><text display-inline="yes-display-inline">The adjustment made each fiscal year
pursuant this subsection shall be added on a compounded basis to the sum of all
adjustments made each fiscal year after fiscal year 2010 under this
subsection.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H707F9B6F805B4118A9B882D8AF1ED2C3"><enum>(4)</enum><header display-inline="yes-display-inline">Waiver for importers required to pay
registration fee</header><text display-inline="yes-display-inline">In the case
of a person who is required to pay both a fee under section 743 for
registration of one or more facilities under section 415 and a fee under this
section for registration as an importer of food under section 801(s), the
Secretary shall waive the fees applicable to such person under section 743 or
the fee applicable to such person under this section.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HAFEF816B0F3E4E449621F51D512164EA"><enum>(c)</enum><header display-inline="yes-display-inline">Crediting and availability of fees</header>
<paragraph commented="no" display-inline="no-display-inline" id="H23D7352E5B344F27914BBBCBDF1F27AE"><enum>(1)</enum><header display-inline="yes-display-inline">In general</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 advance 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 appropriation account
without fiscal year limitation to such appropriation account for salaries and
expenses with such fiscal year limitation.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H011A7245FF5E4DB1937033E5CD971AAE"><enum>(2)</enum><header display-inline="yes-display-inline">Collections and appropriations
Acts</header><text display-inline="yes-display-inline">The fees authorized by
this section—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HCA331D63115847FAB5464FCD1C890B80"><enum>(A)</enum><text display-inline="yes-display-inline">shall be retained in each fiscal year in an
amount not to exceed the amount specified in appropriation Acts, or otherwise
made available for obligation, for such fiscal year; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4740A76402D742DF9AD4FE1882330FF2"><enum>(B)</enum><text display-inline="yes-display-inline">shall only be collected and available to
cover the costs associated with registering importers under section 801(s) and
with ensuring compliance with good importer practices respecting food.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1890BF3454CB4652A1E807ACDA9F6865"><enum>(3)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">For each of
fiscal years 2010 through 2014, there are authorized to be appropriated for
fees under this section such sums as may be
necessary.</text>
</paragraph></subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H796D812C38E64AF194337F0FD353B094"><enum>(c)</enum><header display-inline="yes-display-inline">Inspection</header><text display-inline="yes-display-inline">Section 704 (21 U.S.C. 374), as amended by
section 105, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HD606EDD6171A4325AF7447F9319FD465" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HDBB665DF2593476897E4A88F32ECD780"><enum>(i)</enum><header display-inline="yes-display-inline">Importers</header><text display-inline="yes-display-inline">Every person engaged in the importing of
any food shall, upon request of an officer or employee designated by the
Secretary, permit such officer or employee at all reasonable times to inspect
the facilities of such person and have access to, and to copy and verify, any
related
records.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" display-inline="no-display-inline" id="HD73D36A4CF0041B7AC2759D5FEC7BA68" section-type="subsequent-section"><enum>205.</enum><header display-inline="yes-display-inline">Registration for customs brokers</header>
<subsection commented="no" display-inline="no-display-inline" id="H4F75C4B084FE491291CF9D299AEC1AD6"><enum>(a)</enum><header display-inline="yes-display-inline">Registration</header>
<paragraph commented="no" display-inline="no-display-inline" id="HC1D1C54E497D4FB082149AD00BB2B761"><enum>(1)</enum><header display-inline="yes-display-inline">Prohibitions</header><text display-inline="yes-display-inline">Section 301(zz) (21 U.S.C. 331), as added
by section 204, is amended by inserting <quote>or 801(t)</quote> after
<quote>801(s)</quote>.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H12594EBBA2B24757AC76C488C2D98CB8"><enum>(2)</enum><header display-inline="yes-display-inline">Misbranding</header><text display-inline="yes-display-inline">Section 403(ee) (21 U.S.C. 343), as added
by section 204, is amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HA77CE523FD734D8F93C773CA5D00E451"><enum>(A)</enum><text display-inline="yes-display-inline">by inserting <quote>or a customs
broker</quote> after <quote>by an importer</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4D9B115196DC468183921F4582FD68CC"><enum>(B)</enum><text display-inline="yes-display-inline">by inserting <quote>or 801(t)</quote> after
<quote>801(s)</quote>.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2F4F0327651C48FC93C86FEC0FFE43C1"><enum>(3)</enum><header display-inline="yes-display-inline">Registration</header><text display-inline="yes-display-inline">Section 801, as amended by sections 109,
136, and 204, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H4EEF3F533FDC4F9CA4A8BB4CBE9FAB69" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HAFA3885B494F414785FF4D36F14062E4"><enum>(t)</enum><header display-inline="yes-display-inline">Registration of customs broker</header>
<paragraph commented="no" display-inline="no-display-inline" id="H85AEF43DA3134F7882A062385D98DB76"><enum>(1)</enum><header display-inline="yes-display-inline">Registration</header><text display-inline="yes-display-inline">The Secretary shall require a customs
broker, with respect to the importation of food—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H7D8F30116B564E5B8D1A4527C204CEFE"><enum>(A)</enum><text display-inline="yes-display-inline">to be registered with the Secretary in a
form and manner specified by the Secretary; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC3799D14E9EF4F86A9F03F76402C7B1B"><enum>(B)</enum><text display-inline="yes-display-inline">consistent with section 1011, to submit
appropriate unique facility identifiers as a condition of registration.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD02E7290F5AA4C8198CC1146C6D4AA67"><enum>(2)</enum><header display-inline="yes-display-inline">Cancellation of registration</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H41835A53BD484913B88A77DA0C6230E0"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not earlier than 10 days after providing
the notice under subparagraph (B), the Secretary may cancel a registration that
the Secretary determines was not updated in accordance with this section or
otherwise contains false, incomplete, or inaccurate information.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA20C7787273F40BCA4FA67E0883F6595"><enum>(B)</enum><header display-inline="yes-display-inline">Notice of cancellation</header><text display-inline="yes-display-inline">Cancellation shall be preceded by notice to
the customs broker of the intent to cancel the registration and the basis for
such cancellation.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HAD9B73B67E174851B60854E9F588CEFE"><enum>(C)</enum><header display-inline="yes-display-inline">Timely update or correction</header><text display-inline="yes-display-inline">If the registration for the customs broker
is updated or corrected no later than 7 days after notice is provided under
subparagraph (B), the Secretary shall not cancel such registration.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF74F314AF9624175902336A74B4675DB"><enum>(3)</enum><header display-inline="yes-display-inline">Notification</header><text display-inline="yes-display-inline">The Secretary shall notify the Commissioner
responsible for Customs and Border Protection whenever the Secretary cancels a
registration under this subsection.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H21087031B20E47EE9AF1B4A17BC8F80A"><enum>(4)</enum><header display-inline="yes-display-inline">Exemptions</header><text display-inline="yes-display-inline">In consultation with the Commissioner
responsible for Customs and Border Protection, the Secretary, by notice
published in the Federal Register—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H8179AC37F3D04911A5237438C2D8072C"><enum>(A)</enum><text display-inline="yes-display-inline">shall establish an exemption from the
requirements of this subsection for importations for personal use; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC40C9C36C4A84B2FB8B65ADAD7244040"><enum>(B)</enum><text display-inline="yes-display-inline">may establish other exemptions from the
requirements of this subsection.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0B296D51078B4E3A9D1EB356C2E6B8A3"><enum>(5)</enum><header display-inline="yes-display-inline">Civil penalties</header><text display-inline="yes-display-inline">Notwithstanding any other provision in this
Act, a customs broker who violates section 301 because of a violation of
section 403(ee), or who violates section 301(xx), 301(yy), or 301(zz), shall
not be subject to a civil penalty under section
303(f)(2).</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE8C86DC7A6A741ABBAEEB76C7FB284D3"><enum>(4)</enum><header display-inline="yes-display-inline">Regulations</header><text display-inline="yes-display-inline">Not later than 24 months after the date of
the enactment of this Act, the Secretary of Health and Human Services, in
consultation with the Commissioner responsible for Customs and Border
Protection, shall promulgate the regulations required to carry out section
801(t) of the Federal Food, Drug, and Cosmetic Act, as added by paragraph
(2).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDCAEF0535F0344BAACEB83103B68539F"><enum>(5)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">The amendments made by
this subsection shall take effect on the date that is 24 months after the date
of enactment of this Act.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H99245CBF35C74D669BD303D4800B6946"><enum>(b)</enum><header display-inline="yes-display-inline">Inspection</header><text display-inline="yes-display-inline">Section 704 (21 U.S.C. 374), as amended by
sections 105 and 204, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H30A7519935244996B6206008F55D894B" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HFB2676F5EB324893B5A7A085837C1688"><enum>(j)</enum><header display-inline="yes-display-inline">Brokers</header><text display-inline="yes-display-inline">Every customs broker required to be
registered with the Secretary shall, upon request of an officer or employee
designated by the Secretary, permit such officer or employee at all reasonable
times to inspect the facilities of such person and have access to, and to copy
and verify, any related
records.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H94FB505AD6134410BDFD7F4259A40E1B" section-type="subsequent-section"><enum>206.</enum><header display-inline="yes-display-inline">Unique identification number for food
facilities, importers, and custom brokers</header><text display-inline="no-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="H3AF53E8C26734DB195F6EE3174D0A82D" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H30FD12DFE6844C2A8CA07FE647152666" section-type="subsequent-section"><enum>1011.</enum><header display-inline="yes-display-inline">Unique facility identifier</header>
<subsection commented="no" display-inline="no-display-inline" id="H2156651B391C4334B14D6682DFD82656"><enum>(a)</enum><header display-inline="yes-display-inline">Registration of facility or
establishment</header><text display-inline="yes-display-inline">A person
required to register a facility pursuant to section 415 shall submit, at the
time of registration, a unique facility identifier for the facility or
establishment.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H75DF10E43D06414EA940717CD7BE3525"><enum>(b)</enum><header display-inline="yes-display-inline">Registration of importers and custom
brokers</header><text display-inline="yes-display-inline">A person required to
register pursuant to section 801(s) or 801(t) shall submit, at the time of
registration, a unique facility identifier for the principal place of business
for which such person is required to register under section 801(s) or
801(t).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H04D5A957570B4448802322992C13FAC2"><enum>(c)</enum><header display-inline="yes-display-inline">Guidance</header><text display-inline="yes-display-inline">The Secretary may, by guidance, and, with
respect to importers and customs brokers, in consultation with the Commissioner
responsible for Customs and Border Protection, specify the unique numerical
identifier system to be used to meet the requirements of subsections (a) and
(b) and the form, manner, and timing of a submission under such subsections.
Development of such guidelines shall take into account the utilization of
existing unique identification schemes and compatibility with customs automated
systems, such as integration with the Automated Commercial Environment (ACE)
and the International Trade Data System (ITDS), and any successor
systems.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H7A66321AB4DD478E975AF16C898B6C79"><enum>(d)</enum><header display-inline="yes-display-inline"> Importation</header><text display-inline="yes-display-inline">An article of food imported or offered for
import shall be refused admission unless the appropriate unique facility
identifiers, as specified by the Secretary, are provided for such
article.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H1022525301884C399ADA8F76BFA126E6" section-type="subsequent-section"><enum>207.</enum><header display-inline="yes-display-inline">Prohibition against delaying, limiting, or
refusing inspection</header>
<subsection commented="no" display-inline="no-display-inline" id="HFA26479E1CA4434BAC0F59E7650D7E20"><enum>(a)</enum><header display-inline="yes-display-inline">Adulteration</header><text display-inline="yes-display-inline">Section 402 (21 U.S.C. 342), as amended by
section 102, 103(a), and 104(a), is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H7E51C368957540AAA59E1836D5276339" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H808D800368BB40688A76E2B89C09A798"><enum>(n)</enum><text display-inline="yes-display-inline">If it has been produced, manufactured,
processed, packed, or held in any farm, factory, warehouse, or establishment
and the owner, operator, or agent of such farm, factory, warehouse, or
establishment, or any agent of a governmental authority in the foreign country
within which such farm, factory, warehouse, or establishment is located, delays
or limits an inspection, or refuses to permit entry or inspection, under
section 414 or
704.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H01DBA615A8EE46259901332406305BC8"><enum>(b)</enum><header display-inline="yes-display-inline">Foreign inspections</header><text display-inline="yes-display-inline">Section 704(a)(1) (21 U.S.C. 374(a)(1)), as
amended by section 106(c), is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H65CF4390086D4D8F8F5A1FC2872075F1"><enum>(1)</enum><text display-inline="yes-display-inline">in the first sentence, by inserting
<quote>, including any such food factory, warehouse, or establishment whether
foreign or domestic,</quote> after <quote>factory, warehouse, or
establishment</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBF89C3C1B95045D887E3C393EFFFB213"><enum>(2)</enum><text display-inline="yes-display-inline">in the third sentence, by inserting
<quote>, including any food factory, warehouse, establishment, or consulting
laboratory whether foreign or domestic,</quote> after <quote>factory,
warehouse, establishment, or consulting laboratory</quote>.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="HF9EC527935224E0694259B8DCC569020" section-type="subsequent-section"><enum>208.</enum><header display-inline="yes-display-inline">Dedicated foreign
inspectorate</header><text display-inline="no-display-inline">Section 704 (21
U.S.C. 374), as amended by sections 105, 204, and 205, is amended by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H91456B4DF2CB4B64A254DF013EEF05CF" style="traditional">
<subsection commented="no" display-inline="no-display-inline" id="H9850B8EC9BB246588DBF800366CDE66B"><enum>(k)</enum><header display-inline="yes-display-inline">Dedicated foreign
inspectorate</header><text display-inline="yes-display-inline">The Secretary
shall establish and maintain a corps of inspectors dedicated to inspections of
foreign food facilities. This corps shall be staffed and funded by the
Secretary at a level sufficient to enable it to assist the Secretary in
achieving the frequency of inspections for food facilities as described in this
Act.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H1B6753C0721A4F0293046ADD3D5EC447" section-type="subsequent-section"><enum>209.</enum><header display-inline="yes-display-inline">Plan and review of continued operation of
field laboratories</header>
<subsection commented="no" display-inline="no-display-inline" id="HF139BB0265524D3DB4AB6A24D895869E"><enum>(a)</enum><header display-inline="yes-display-inline">Submission of plan</header><text display-inline="yes-display-inline">Not later than 90 days before the Secretary
terminates or consolidates any laboratory, district office, or the functions
(including the inspection and compliance functions) of any such laboratory or
district office, specified in subsection (b), the Secretary shall submit a
reorganization plan to the Comptroller General of the United States, the
Committee on Energy and Commerce of the House of Representatives, and the
Committee on Health, Education, Labor, and Pensions of the Senate.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HCAAF25FD7E3D4C10BC831CE800E03B92"><enum>(b)</enum><header display-inline="yes-display-inline">Specified laboratories and
offices</header><text display-inline="yes-display-inline">The laboratories and
offices specified in this subsection are the following:</text>
<paragraph commented="no" display-inline="no-display-inline" id="H9CF21D3EF9464D4FB81066141921B3D3"><enum>(1)</enum><text display-inline="yes-display-inline">Any of the 13 field laboratories
responsible for analyzing food that were operated by the Office of Regulatory
Affairs of the Food and Drug Administration as of January 1, 2007.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H31FCDE4E54964DC98E71B3D50DA1881F"><enum>(2)</enum><text display-inline="yes-display-inline">Any of the 20 district offices of the Food
and Drug Administration with responsibility for food safety functioning as of
January 1, 2007.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HAC49FB959B0548B08B36CCC448DFA5E6"><enum>(c)</enum><header display-inline="yes-display-inline">Congressional review</header><text display-inline="yes-display-inline">A reorganization plan described in
subsection (a) is deemed to be a major rule (as defined in section 804(2) of
title 5, United States Code) for purposes of chapter 8 of such title.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="HA353B515EE644AE2BBE671652B2E7AA0" section-type="subsequent-section"><enum>210.</enum><header display-inline="yes-display-inline">False or misleading reporting to
FDA</header>
<subsection commented="no" display-inline="no-display-inline" id="HEE52F345D0324C64AAF98332FC7AB658"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 301(q)(2) (21 U.S.C. 331(q)(2)) is
amended by inserting after <quote>device</quote> the following: <quote>,
food,</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HDAC0BD51C33449CD8304162AA01395F0"><enum>(b)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">The amendment made by
subsection (a) shall apply to submissions made on or after the date of the
enactment of this Act.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H8FE9B23C93D441AF971D42B28B38E4DD" section-type="subsequent-section"><enum>211.</enum><header display-inline="yes-display-inline">Subpoena authority</header>
<subsection commented="no" display-inline="no-display-inline" id="H617A0DC2CA9F4086961BBB341AF117D0"><enum>(a)</enum><header display-inline="yes-display-inline">Prohibited
Act</header><text display-inline="yes-display-inline">Section 301(f) is amended
by inserting before the period <quote>or the failure or refusal to obey a
subpoena issued pursuant to section 311</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H8DEBC71E009E4A8B9CE21B952E9743F5"><enum>(b)</enum><header display-inline="yes-display-inline">Amendment</header><text display-inline="yes-display-inline">Chapter III (21 U.S.C. 331 et seq.) is
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HECC1DBE6D79F414382EE832493988830" style="OLC">
<section commented="no" display-inline="no-display-inline" id="HCE01D5E5E9654F469FE4F35B1057247B" section-type="subsequent-section"><enum>311.</enum><header display-inline="yes-display-inline">Exercise of subpoena authority</header>
<subsection commented="no" display-inline="no-display-inline" id="H0292C98AA396459CBEDAE48E53702E94"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">For the purpose of—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H99033168CB194789A27D2F82F08D178A"><enum>(1)</enum><text display-inline="yes-display-inline">any hearing, investigation, or other
proceeding respecting a violation of a provision of this Act, the Public Health
Service Act, or the Federal Anti-Tampering Act, relating to food; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H665273FDAECF4AC6A44C5BB481EBFC45"><enum>(2)</enum><text display-inline="yes-display-inline">any hearing, investigation, or other
proceeding to determine if a person is in violation of a specific provision of
this Act, the Public Health Service Act, or the Federal Anti-Tampering Act,
relating to food,</text>
</paragraph><continuation-text commented="no" continuation-text-level="subsection">the Commissioner may issue subpoenas
requiring the attendance and testimony of witnesses and the production of
records and other things.</continuation-text></subsection><subsection commented="no" display-inline="no-display-inline" id="HCB8CA606332F425D8FC93F848C780205"><enum>(b)</enum><header display-inline="yes-display-inline">Timing of compliance</header><text display-inline="yes-display-inline">When the Commissioner deems that immediate
compliance with a subpoena issued under this section is necessary to address a
threat of serious adverse health consequences or death, the subpoena may
require immediate production.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H0525B4FA44AB42D28CEA63BFF577E611"><enum>(c)</enum><header display-inline="yes-display-inline">Service of subpoena</header>
<paragraph commented="no" display-inline="no-display-inline" id="H9805D2D2472E4B77B48E82857BC7D126"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Subpoenas of the Commissioner shall be
served by a person authorized by the Commissioner by delivering a copy thereof
to the person named therein or by certified mail addressed to such person at
such person’s last known dwelling place or principal place of business.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HA634497BC8464925AF324762A4C2C4FB"><enum>(2)</enum><header display-inline="yes-display-inline">Corporations and other
entities</header><text display-inline="yes-display-inline">Service on a
domestic or foreign corporation, partnership, unincorporated association, or
other entity that is subject to suit under a common name may be made by
delivering the subpoena to an officer, a managing or general agent, or any
other agent authorized by appointment or by law to receive service of
process.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HEBEE8D1A01B44459BECD50DD117E8115"><enum>(3)</enum><header display-inline="yes-display-inline">Person outside U.S.
jurisdiction</header><text display-inline="yes-display-inline">Service on any
person not found within the territorial jurisdiction of any court of the United
States may be made in any manner as the Federal Rules of Civil Procedure
prescribe for service in a foreign nation.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HEFC1CEC4EDAB49CF8D5D94D6E8F2E401"><enum>(4)</enum><header display-inline="yes-display-inline">Proof of service</header><text display-inline="yes-display-inline">A verified return by the person so serving
the subpoena setting forth the manner of service, or, in the case of service by
certified mail, the return post office receipt therefor signed by the person so
served, shall be proof of service.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HF90A076401644926810C98515F3D8318"><enum>(d)</enum><header display-inline="yes-display-inline">Payment of witnesses</header><text display-inline="yes-display-inline">Witnesses subpoenaed under subsection (a)
shall be paid the same fees and mileage as are paid witnesses in the district
courts of the United States.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H2358D027A6F648D0AC12178503964106"><enum>(e)</enum><header display-inline="yes-display-inline">Enforcement</header><text display-inline="yes-display-inline">In the case of a refusal to obey a subpoena
duly served upon any person under subsection (a), any district court of the
United States for the judicial district in which such person charged with
refusal to obey is found, resides, or transacts business, upon application by
the Commissioner, shall have jurisdiction to issue an order compelling
compliance with the subpoena and requiring such person to appear and give
testimony or to appear and produce records and other things, or both. The
failure to obey such order of the court may be punished by the court as
contempt thereof. If the person charged with failure or refusal to obey is not
found within the territorial jurisdiction of the United States, the United
States District Court for the District of Columbia shall have the same
jurisdiction, consistent with due process, to take any action respecting
compliance with the subpoena by such person that such district court would have
if such person were personally within the jurisdiction of such district
court.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H824473222AAC41D9ABE100CBC748B30D"><enum>(f)</enum><header display-inline="yes-display-inline">Nondisclosure</header><text display-inline="yes-display-inline">A United States district court for the
district in which the subpoena is or will be served, upon application of the
Commissioner, may issue an ex parte order that no person or entity disclose to
any other person or entity (other than to an attorney to obtain legal advice)
the existence of such subpoena for a period of up to 90 days. Such order may be
issued on a showing that the records or things being sought may be relevant to
the hearing, investigation, proceeding, or other matter and that there is
reason to believe that such disclosure may result in—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H9B4CB05F3FE243BF8798C73FDF37294F"><enum>(1)</enum><text display-inline="yes-display-inline">furtherance of a potential violation under
investigation;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H29D7D32B62854716AF87CEC7A5C5C29D"><enum>(2)</enum><text display-inline="yes-display-inline">endangerment to the life or physical safety
of any person;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDFFBDEB1B47F4596925315CFA95EBF37"><enum>(3)</enum><text display-inline="yes-display-inline">flight or other action to avoid prosecution
or other enforcement remedies;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H07ED93A8BAE54D4BA3B3CE4B1BD3980A"><enum>(4)</enum><text display-inline="yes-display-inline">destruction of or tampering with evidence;
or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5D75353040B1464482FBA3D53279F78F"><enum>(5)</enum><text display-inline="yes-display-inline">intimidation of potential witnesses.</text>
</paragraph><continuation-text commented="no" continuation-text-level="subsection">An order under this subsection may
be renewed for additional periods of up to 90 days upon a showing that any of
the circumstances described in paragraphs (1) through (5) continue to
exist.</continuation-text></subsection><subsection commented="no" display-inline="no-display-inline" id="H686F3343B63B412D855D92C4D5B200B9"><enum>(g)</enum><header display-inline="yes-display-inline">Relation to other provisions</header><text display-inline="yes-display-inline">The subpoena authority vested in the
Commissioner and the district courts of the United States by this section is in
addition to any such authority vested in the Commissioner or such courts by
other provisions of law, or as is otherwise authorized by law.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H611B179D086943B2A9AD8B9EB41C5294"><enum>(h)</enum><header display-inline="yes-display-inline">Nondelegation</header><text display-inline="yes-display-inline">The authority to issue a subpoena under
this section is limited to the Secretary or an official designated by the
Secretary. An official may not be so designated unless the official is the
director of the district under this Act in which the article involved is
located, or is an official senior to such
director.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" display-inline="no-display-inline" id="HCA138CBDCA1D40F7BD030CD049091F42" section-type="subsequent-section"><enum>212.</enum><header display-inline="yes-display-inline">Whistleblower protections</header><text display-inline="no-display-inline">Chapter X (21 U.S.C. 391 et seq.), as
amended by section 206, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H4B2F913DC43B44CE9C95F20F47CABCFE" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H43D017B90CDC42DA815025515FCC2203" section-type="subsequent-section"><enum>1012</enum><header display-inline="yes-display-inline">Protections for employees who refuse to
violate, or who disclose violations of, this Act</header>
<subsection commented="no" display-inline="no-display-inline" id="HFC8B91462461469EA93FE643966BA472"><enum>(a)</enum><header display-inline="yes-display-inline">In General</header><text display-inline="yes-display-inline">No person who submits or is required under
this Act or the Public Health Service Act to submit any information related to
a food, or any officer, employee, contractor, subcontractor, or agent of such
person may discharge, demote, suspend, threaten, harass, or in any other manner
discriminate against an employee in the terms and conditions of employment
because of any lawful act done by the employee, including within the ordinary
course of the job duties of such employee—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H8A7174D397914E83B058CFDE471DE1AB"><enum>(1)</enum><text display-inline="yes-display-inline">to provide information, cause information
to be provided, or otherwise assist in any investigation regarding any conduct
which the employee reasonably believes constitutes a violation of this Act, or
any other provision of Federal law relating to the safety of a food, if the
information or assistance is provided to, or an investigation stemming from the
provided information is conducted by—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HC6CDDB2EC76442E59DB19A83DCA843B2"><enum>(A)</enum><text display-inline="yes-display-inline">a Federal regulatory or law enforcement
agency;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB7AC842ACA3E4BD28F222DCF8CDD77C7"><enum>(B)</enum><text display-inline="yes-display-inline">any Member of Congress or any committee of
Congress; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H97667FFB3C124A539380D62E0F301A3C"><enum>(C)</enum><text display-inline="yes-display-inline">a person with supervisory authority over
the employee (or such other person working for the employer who has the
authority to investigate, discover, or terminate the misconduct);</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H85139B6B532642C2BF6809A902829563"><enum>(2)</enum><text display-inline="yes-display-inline">to file, cause to be filed, testify,
participate in, or otherwise assist in a proceeding filed, or about to be filed
(with any knowledge of the employer), in any court or administrative forum
relating to any such alleged violation; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5D3F701FD55E4647801E37B87AD6C8C9"><enum>(3)</enum><text display-inline="yes-display-inline">to refuse to commit or assist in any such
violation.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H71E2C0FFE9C14C5DB93B682A5CA982D2"><enum>(b)</enum><header display-inline="yes-display-inline">Enforcement Action</header>
<paragraph commented="no" display-inline="no-display-inline" id="H9CECAD46C0834E5499213C69858DC7B4"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">An employee who alleges discharge or other
discrimination in violation of subsection (a) may seek relief in accordance
with the provisions of subsection (c) by—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HA456BF0F868C43C0A11E31F25BE64816"><enum>(A)</enum><text display-inline="yes-display-inline">filing a complaint with the Secretary of
Labor; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H59623CF46FFE4434A58E72E569EB4465"><enum>(B)</enum><text display-inline="yes-display-inline">if the Secretary of Labor has not issued a
final decision within 210 days of the filing of the complaint and there is no
showing that such delay is due to the bad faith of the claimant, or within 90
days after receiving a final decision or order from the Secretary, bringing an
action at law or equity for de novo review in the appropriate district court of
the United States, which court shall have jurisdiction over such 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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H56522959B7334C88A94400D05758417B"><enum>(2)</enum><header display-inline="yes-display-inline">Procedure</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H732E239060FC43C7B2D8456D38B59EF4"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Any action under paragraph (1) shall be
governed under the rules and procedures set forth in section 42121(b) of title
49, United States Code.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE3B9A8E98D3341AD95EEFDA0F542798B"><enum>(B)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">Notification in an action under paragraph
(1) shall be made in accordance with section 42121(b)(1) of title 49, United
States Code, except that such notification shall be made to the person named in
the complaint, the employer, and the Commissioner of Food and Drugs.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB9608F3B701549EBBC08E23C4B2E7A3D"><enum>(C)</enum><header display-inline="yes-display-inline">Burdens of proof</header><text display-inline="yes-display-inline">An action brought under paragraph (1)(A) or
(1)(B) shall be governed by the legal burdens of proof set forth in section
42121(b) of title 49, United States Code.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H216B4C1BDB8C49EDAC73F4B785A2A1F6"><enum>(D)</enum><header display-inline="yes-display-inline">Statute of limitations</header><text display-inline="yes-display-inline">An action under paragraph (1)(A) shall be
commenced not later than 180 days after the date on which the violation
occurs.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H685AF234952B4870A8A4AAD193A7E12B"><enum>(c)</enum><header display-inline="yes-display-inline">Remedies</header>
<paragraph commented="no" display-inline="no-display-inline" id="HC87A07DC07B84DF78F6759EF1A2DD4F8"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">An employee prevailing in any action under
subsection (b)(1) shall be entitled to all relief necessary to make the
employee whole.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H940F0B518AB64EACAE83223BD340FAD1"><enum>(2)</enum><header display-inline="yes-display-inline">Issuance of order</header><text display-inline="yes-display-inline">If, in response to a complaint filed under
paragraph (b)(1), the Secretary of Labor or the district court, as applicable,
determines that a violation of subsection (a) has occurred, the Secretary or
the court shall order the person who committed such violation—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HB8E64350E9074698B25A63F02E7554E9"><enum>(A)</enum><text display-inline="yes-display-inline">to take affirmative action to abate the
violation;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD6FDC8559B4047AFB3A16FCE68DC7A13"><enum>(B)</enum><text display-inline="yes-display-inline">to—</text>
<clause commented="no" display-inline="no-display-inline" id="H54B8320852E444DDB6CC4A04DCF5E5F6"><enum>(i)</enum><text display-inline="yes-display-inline">reinstate the complainant to his or her
former position together with compensation (including back pay); and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H88D9BF7F77CC463EAD1556A3A0BCE71C"><enum>(ii)</enum><text display-inline="yes-display-inline">restore the terms, conditions, and
privileges associated with his or her employment; and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H53C155813CB8453790BB2BFC7A79BFE1"><enum>(C)</enum><text display-inline="yes-display-inline">to provide compensatory damages to the
complainant.</text>
</subparagraph><continuation-text commented="no" continuation-text-level="paragraph">If such an order is issued under this
paragraph, the Secretary or the court, 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 attorney 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.</continuation-text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HD15022367502435A8EE9DB67E658F42B"><enum>(d)</enum><header display-inline="yes-display-inline">Rights Retained by Employee</header><text display-inline="yes-display-inline">Nothing in this section shall be deemed 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>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H9F188A57333841AB8B6AABC89FD18AE1" section-type="subsequent-section"><enum>213.</enum><header display-inline="yes-display-inline">Extraterritorial jurisdiction</header>
<subsection commented="no" display-inline="no-display-inline" id="H59C4F9C2545544938154E879A316C897"><enum>(a)</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 sections 110, 111, 133, 136, and 204, is amended by adding
at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H6B396C84359845AC9D7F7940A2196B56" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HA02AB34FB84A484DBA235EE516909FDA"><enum>(aaa)</enum><text display-inline="yes-display-inline">The production, manufacture, processing,
preparation, packing, holding, or distribution of an adulterated or misbranded
food with the knowledge or intent that such article will be imported into the
United
States.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H35681860586B4CBCB32FA3EFFFEAED70"><enum>(b)</enum><header display-inline="yes-display-inline">Jurisdiction</header><text display-inline="yes-display-inline">Chapter III (21 U.S.C. 331 et seq.), as
amended by section 211, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HB64A51AE91CC43A8AE2D3BFBB8D21830" style="OLC">
<section commented="no" display-inline="no-display-inline" id="HF5C3411AC5A64919A9C9A02030EFA904" section-type="subsequent-section"><enum>312.</enum><header display-inline="yes-display-inline">Extraterritorial jurisdiction</header><text display-inline="no-display-inline">There is extraterritorial Federal
jurisdiction over any violation of this Act relating to any article of food if
such article was intended for import into the United States or if any act in
furtherance of the violation was committed in the United
States.</text>
</section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" display-inline="no-display-inline" id="HFDC67865D0EC4F32B5685EEB85AE0667" section-type="subsequent-section"><enum>214.</enum><header display-inline="yes-display-inline">Support for training
institutes</header><text display-inline="no-display-inline">The Secretary of
Health and Human Services, acting through the Commissioner of Food and Drugs,
shall provide financial and other assistance to appropriate entities to
establish and maintain one or more university-affiliated food protection
training institutes that—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HF79853C7E2564DE5BDB261A8D70FF848"><enum>(1)</enum><text display-inline="yes-display-inline">conduct training related to food protection
activities for Federal, State, local, territorial, and tribal officials;
and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5B5C0EE7393C43F18C8E84112F3D72B5"><enum>(2)</enum><text display-inline="yes-display-inline">meet standards developed by the
Secretary.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H3C2F948B52FF44F39817160BC01AAADF" section-type="subsequent-section"><enum>215.</enum><header display-inline="yes-display-inline">Bisphenol A in food and beverage
containers</header>
<subsection commented="no" display-inline="no-display-inline" id="HF8F359C910094D6187C9C093C6E08ACB"><enum>(a)</enum><header display-inline="yes-display-inline">Notice of determination</header><text display-inline="yes-display-inline">No later than December 31, 2009, the
Secretary of Health and Human Services shall notify the Congress whether the
available scientific data support a determination that there is a reasonable
certainty of no harm, for infants, young children, pregnant women, and adults,
for approved uses of polycarbonate plastic and epoxy resin made with bisphenol
A in food and beverage containers, including reusable food and beverage
containers, under the conditions of use prescribed in current Food and Drug
Administration regulations.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H1B6B09525C3545D4A533974F5F939615"><enum>(b)</enum><header display-inline="yes-display-inline">Notice of actions to be taken</header><text display-inline="yes-display-inline">If the Secretary concludes that such a
determination cannot be made for any approved use, the Secretary shall notify
the Congress of the actions the Secretary intends to take under the Secretary’s
authority to regulate food additives to protect the public health, which may
include—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HD4D68AEA33954E7893FDDECD1531409D"><enum>(1)</enum><text display-inline="yes-display-inline">revoking or modifying any of the approved
uses of bisphenol A in food and beverage containers, including reusable food
and beverage containers; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HEAC6C3B9AAEC474DB051C0496D353429"><enum>(2)</enum><text display-inline="yes-display-inline">ensuring that the public is sufficiently
informed of such determination and the steps the public may take in response to
such determination.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H5A869F57D7624DB19219B33DD40EDE3A"><enum>(c)</enum><header display-inline="yes-display-inline">Rule of construction</header><text display-inline="yes-display-inline">Nothing herein is intended or shall be
construed to modify existing Food and Drug Administration authority,
procedures, or policies for assessing scientific data, making safety
determinations, or regulating the safe use of food additives.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H0B21FE6A4CED4BDC94630D770438E579" section-type="subsequent-section"><enum>216.</enum><header display-inline="yes-display-inline">Lead content labeling requirement for
ceramic tableware and cookware</header>
<subsection commented="no" display-inline="no-display-inline" id="HFC879356E9C741A188757F10C534B2EB"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 403 (21 U.S.C. 343), as amended by
sections 101(a), 109(a), 114(a), 202, and 204, is amended by adding at the end
the following:</text>
<quoted-block display-inline="no-display-inline" id="H00B7AD3BB6E64D228DFE6ACA5B828999" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H11BCE5FD81D746469336B845A0FBD25A"><enum>(ff)</enum><text display-inline="yes-display-inline">If it is ceramic tableware or cookware and
includes a glaze or decorations containing lead for an intended functional
purpose, unless—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H46F6AC05210D43E2B42420EA2D37F92A"><enum>(1)</enum><text display-inline="yes-display-inline">the product and its packaging bear the
statement: <quote>This product is made with lead-based glaze consistent with
Food and Drug Administration guidelines for such lead.</quote>; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H02754B39D6DB4BA29A150E211AF8A02F"><enum>(2)</enum><text display-inline="yes-display-inline">the product is in compliance with the
requirements applicable to ornamental and decorative ceramicware in section
109.16 of title 21, Code of Federal Regulations (or any successor
regulation).</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HDB7AE760AE144DDCA70D66B7E3A20D82"><enum>(b)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">Section 403(ff) of the
Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall apply
only to ceramic tableware or cookware that is manufactured on or after the date
that is 1 year after the date of the enactment of this Act.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HDE073E02EDB44D1CAA6E35A099CF65A9"><enum>(c)</enum><header display-inline="yes-display-inline">Consumer education</header><text display-inline="yes-display-inline">Chapter IV (21 U.S.C. 341 et seq.), as
amended by sections 102, 103, 104, and 111, is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H0240B37527AB46C0B9E99FCBF1359396" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H0F4EA30D1EA8430A8F5D31C798DD569F" section-type="subsequent-section"><enum>421.</enum><header display-inline="yes-display-inline">Consumer education on the content of lead
in ceramicware and applicable labeling requirements</header>
<subsection commented="no" display-inline="no-display-inline" id="H8A5EB8187F4A482DBD1E22D3CEEEF9FB"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall educate consumers on
the safety of ceramicware for food use by posting information on the Web site
of the Food and Drug Administration with regard to—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HAE77E510CB584B3D8C42E9106B76CFE2"><enum>(1)</enum><text display-inline="yes-display-inline">the content of lead in ceramicware and its
glaze;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H778D39BECFB949BCBD017A7C5582D5E4"><enum>(2)</enum><text display-inline="yes-display-inline">existing Federal laws and regulations
governing lead in ceramicware;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H164C1F7C3F93419AB1530CBD9E17666E"><enum>(3)</enum><text display-inline="yes-display-inline">as appropriate, existing industry practices
and guidelines; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H899E0762475C42E7BD9F2B09EBEEB1CD"><enum>(4)</enum><text display-inline="yes-display-inline">the labeling requirements applicable under
this Act.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HA5E4F934DCCB4B7EA43573D3EF59C866"><enum>(b)</enum><header display-inline="yes-display-inline">Topics</header><text display-inline="yes-display-inline">The education under this section shall
address—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HED68CCC8B7514804A3F97231F0179C87"><enum>(1)</enum><text display-inline="yes-display-inline">the broad range of ceramicware types,
including traditional pottery, ornamental and decorative ceramicware, cookware,
and everyday dinnerware;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H47ACA969D5A3420785ADB6BB52E1A5F2"><enum>(2)</enum><text display-inline="yes-display-inline">the safety of ceramicware that is aged or
damaged;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9A273E71E9DA45C08216A5D1CD9305B0"><enum>(3)</enum><text display-inline="yes-display-inline">the use of ceramicware in microwave
ovens;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HAFE28724299E4DBB8AE1C2156349CBC4"><enum>(4)</enum><text display-inline="yes-display-inline">the storage of foods in ceramicware;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HEC1B3909F1414D02BE18EAE13D6AF0D0"><enum>(5)</enum><text display-inline="yes-display-inline">the use of home lead test kits by
consumers;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H89025E9E475144D88539F294D4B15EB7"><enum>(6)</enum><text display-inline="yes-display-inline">the use of ceramicware by children and
women of childbearing age; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H57C80F98D8244C1EB709E3B6EF6C18AC"><enum>(7)</enum><text display-inline="yes-display-inline">issues that are especially relevant to
subpopulations of consumers who may preferentially use certain types of
ceramicware made with
lead.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section>
Passed the House of
Representatives July 30, 2009.
Lorraine C. Miller,
Clerk.