1.Short title; references;
table of contents
(a)This Act may be cited
as the Food and Drug Administration
Globalization Act of 2009
.
(b)References to
the Federal Food, Drug, and Cosmetic ActExcept as otherwise
specified, whenever in this Act an amendment is expressed in terms of an
amendment to a section or other provision, the reference shall be considered to
be made to a section or other provision of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.).
(c)The table of contents of this Act is as follows:
Sec. 1. Short title; references; table of contents.
Sec. 2. Relationship to State law.
Title I—Food Safety
Subtitle A—Prevention
Sec. 101. Changes in registration of food
facilities.
Sec. 102. Hazard analysis, risk-based preventive controls, and
food safety plan.
Sec. 103. Performance standards.
Sec. 104. Safety standards for fresh produce.
Sec. 105. Risk-based inspection.
Sec. 106. Access to records.
Sec. 107. Traceability of food.
Sec. 108. Reinspection fee applicable to
facilities.
Sec. 109. Certification of food facilities.
Sec. 110. Safe and secure food importation program.
Subtitle B—Intervention
Sec. 111. Public health assessment system.
Sec. 112. Public education and advisory system.
Sec. 113. Research.
Sec. 114. Notification, nondistribution, and recall of
adulterated or misbranded articles of food.
Subtitle C—Response
Sec. 121. Administrative detention.
Sec. 122. Civil penalties relating to food.
Sec. 123. Failure to consent to investigation.
Subtitle D—Miscellaneous
Sec. 131. Labeling requirement for meat, poultry products, and
seafood that contain carbon monoxide.
Sec. 132. Food substances generally recognized as
safe.
Sec. 133. Country of origin labeling; disclosure of source of
ingredients.
Sec. 134. New food and animal feed export certification fee to
improve the ability of United States firms to export their
products.
Title II—Drug and Device Safety
Sec. 201. Registration of producers of drugs and devices;
applicable fee.
Sec. 202. Inspection of producers of drugs and active
pharmaceutical ingredients.
Sec. 203. Documentation for admissibility of drug
imports.
Sec. 204. Drug supply quality and safety.
Sec. 205. Delay, limitation, or denial of
inspection.
Sec. 206. Country of origin labeling.
Sec. 207. Nondistribution and recall of adulterated or
misbranded drugs.
Sec. 208. Destruction of adulterated, misbranded or counterfeit
articles offered for import.
Sec. 209. Administrative detention of drugs that appear to
violate the law.
Sec. 210. Penalties regarding counterfeit drugs.
Sec. 211. Civil money penalties for violative drugs and devices
and improper import entry filings.
Sec. 212. Human generic drug application and supplement fees to
cover pre-approval inspection costs.
Title III—Cosmetic Safety
Sec. 301. Registration of cosmetic establishments.
Sec. 302. Cosmetic and ingredient statements.
Sec. 303. Serious and unexpected adverse event reports for
cosmetics.
Sec. 304. Good manufacturing practices for
cosmetics.
Sec. 305. Authorization of appropriations.
Sec. 306. Effective date.
Title IV—Miscellaneous
Sec. 401. Registration for commercial importers of food, drugs,
devices, and cosmetics; fee.
Sec. 402. Unique identification number for food, drug, and
device facilities and establishments.
Sec. 403. Prohibition against delaying or limiting
inspection.
Sec. 404. Dedicated foreign inspectorate.
Sec. 405. Continued operation of field
laboratories.
Sec. 406. False or misleading reporting to FDA.
Sec. 407. Subpoena authority.
Sec. 408. Whistleblower protections.
2.Relationship to State
lawThis Act and the
amendments made by this Act may not be construed as modifying or otherwise
affecting any action or the liability of any person (as defined in section 201
of the Federal Food, Drug, and Cosmetic Act) under the law of any State.
<enum>I</enum><header>Food
Safety</header>
<subtitle id="H490A94E09F984A0EAD3023B9B280C5BA"><enum>A</enum><header>Prevention</header>
<section id="H2F7F20F22CB44F388B1EAF5955423B26"><enum>101.</enum><header>Changes in
registration of food facilities</header>
<subsection id="H016716DE78A24AB9BA0086BF4D3256A3"><enum>(a)</enum><header>Misbranding</header><text>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="H8BCBD69753FA4C049797A7CFA017673F" style="OLC">
<subsection id="HAD7B2B6A775A47DE9D51D86840188E45"><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 or is in
violation of section 741 (requiring payment of a fee for such
registration).</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H686B21C7AAA3432984D7DEE79377450"><enum>(b)</enum><header>Annual
registration and payment of registration fee</header>
<paragraph id="H7377E5208A5A4123A5E94512C2166CA"><enum>(1)</enum><header>In
general</header><text>Section 415(a) (21 U.S.C. 350d(a)) is amended—</text>
<subparagraph id="HFDDA7A7FF9A041979BC03DA322EA9100"><enum>(A)</enum><text>in the first
sentence of paragraph (1), by inserting <quote>annually</quote> after <quote>be
registered</quote>;</text>
</subparagraph><subparagraph id="H9736B3FC9AB4494700CBCDBF7B39FD80"><enum>(B)</enum><text>in paragraph (1),
by inserting <quote>and pay the registration fee required under section
741</quote> after <quote>submit a registration to the Secretary</quote> each
place it appears in subparagraphs (A) and (B); and</text>
</subparagraph><subparagraph id="H5EDEB78D17174E07A4C1576132E6CCF4"><enum>(C)</enum><text>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 and shall treat such removal as a suspension of
the facility’s registration.</quote>.</text>
</subparagraph></paragraph><paragraph display-inline="no-display-inline" id="H007E74938C594387B0DB004F9B27CDC"><enum>(2)</enum><header>Registration
fee</header><text>Chapter VII (21 U.S.C. 371 et seq.) is amended—</text>
<subparagraph id="H41096013433C4EEB911D001F2EB49835"><enum>(A)</enum><text>by redesignating
sections 741 and 742 as sections 744 and 745, respectively; and</text>
</subparagraph><subparagraph id="H67D4C5D31AA145C4BBE047693B177DBF"><enum>(B)</enum><text>by adding at the
end of subchapter C the following:</text>
<quoted-block display-inline="no-display-inline" id="H2E0ADB7199D743119F9604893CA32C81" style="OLC">
<part id="H32242B697BD24123B3DEECB4056BEDFD"><enum>5</enum><header>Fees
Relating to Food</header>
<section id="H4A4F123124FD492D8E31CF4CB7DAFA0"><enum>741.</enum><header>Facility
registration fee</header>
<subsection id="H2D76EADAD1E04C7AAE0062C17C96CAE"><enum>(a)</enum><header>In
General</header><text display-inline="yes-display-inline">The Secretary shall
assess and collect a fee for a facility registration under section 415 to
defray increases (as described in subsection (f)(2)(A)(ii)) in the costs of
inspecting establishments registered under section 415 and for related
activities to ensure compliance by such establishments with the requirements of
this Act relating to food (including increases in such costs for management of
information, and the acquisition, maintenance, and repair of information
technology resources).</text>
</subsection><subsection id="H3B5672B8A1D8486E92161B64C23F711F"><enum>(b)</enum><header>Fee revenue
amounts</header>
<paragraph id="HD42E9938495C44B49031026E7866FAF"><enum>(1)</enum><header>In
general</header><text>For each of fiscal years 2010 through 2014, fees under
subsection (a) shall, except as provided in subsections (c), (e), and (f), be
established to generate a total revenue amount under subsection (a).</text>
</paragraph><paragraph id="H73BC6E221D9444BA88A1115C524F7D82"><enum>(2)</enum><header>Total revenue
amount</header><text>Not later than September 1, 2009, the Secretary shall
transmit to the Congress the total revenue amount under paragraph (1) and how
such amount was calculated.</text>
</paragraph><paragraph id="H0697FAA1FE15414B0036C600DDC4DCDC"><enum>(3)</enum><header>Annual fee
setting</header><text>The Secretary shall, not later than 60 days before the
start of each fiscal year that begins after September 30, 2009, establish, for
the next fiscal year, registration fees under subsection (a) based on the total
revenue amount applicable under paragraph (1).</text>
</paragraph></subsection><subsection id="HB018F526711C4BD4B4E7C833EAECCD7"><enum>(c)</enum><header>Adjustments</header>
<paragraph id="H985E9265FD7647D78143245E6F77B3B"><enum>(1)</enum><header>Inflation
adjustment</header><text>For fiscal year 2011 and subsequent fiscal years, the
revenues established under subsection (b)(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 id="HA4F4A6A840B045F2A3FE35D148B2005C"><enum>(A)</enum><text>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>
</subparagraph><subparagraph id="H19841B4F8FC747AC909C37A6713BC7BD"><enum>(B)</enum><text>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 id="H75ECEB6977354D4BBE6C78B4F68D4F1B"><enum>(C)</enum><text>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><continuation-text continuation-text-level="paragraph">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 2009 under this subsection.</continuation-text></paragraph><paragraph id="H562BB232189143F2AEDE077314BF5810"><enum>(2)</enum><header>Workload
adjustment</header><text>For fiscal year 2011 and subsequent fiscal years,
after the fee revenues established under subsection (b)(1) are adjusted for a
fiscal year for inflation in accordance with paragraph (1), the fee revenues
shall be adjusted further for such fiscal year to reflect changes in the
workload of the Secretary for inspections and related activities described in
subsection (a). With respect to such adjustment:</text>
<subparagraph id="HE34DFDBA0BDC44099F03E0215FCB0048"><enum>(A)</enum><text>The adjustment
shall be determined by the Secretary based on a weighted average of the change
in the total amount of inspections and related activities described in
subsection (a). The Secretary shall publish in the Federal Register the fee
revenues and fees resulting from the adjustment and the supporting
methodologies.</text>
</subparagraph><subparagraph id="H463B369C39244125AEB5193D22806C4E"><enum>(B)</enum><text>Under no
circumstances shall the adjustment result in fee revenues for a fiscal year
that are less than the fee revenues for the fiscal year established under
subsection (b)(1), as adjusted for inflation under paragraph (1). Any
adjustment for changes in inspections and related activities described in
subsection (a) made in setting fees and revenue amounts for fiscal year 2011 or
any subsequent year may not result in the total workload adjustment being more
than 2 percentage points higher than it would have been in the absence of the
adjustment for changes in inspections and related activities.</text>
</subparagraph><subparagraph id="H32BFB8A85D624019B024A98173A10071"><enum>(C)</enum><text>The Secretary
shall contract with an independent accounting firm to study the adjustment for
changes in inspections and related activities described in subsection (a)
applied in setting fees and revenue amounts for fiscal year 2011 and to make
recommendations, if warranted, for future changes in the methodology for
calculating the adjustment. After review of the recommendations, the Secretary
shall, if warranted, make appropriate changes to the methodology, and the
changes shall be effective for each of fiscal years 2012 through 2014. The
Secretary shall not make any adjustment for changes in inspections and related
activities described in subsection (a) for any fiscal year after 2011 unless
such study has been completed.</text>
</subparagraph></paragraph><paragraph id="H54C49A22E2524E9696BCCF3E489EC0A3"><enum>(3)</enum><header>Rent and
rent-related cost adjustment</header><text>For fiscal year 2012 and each
subsequent fiscal year, the Secretary shall, before making adjustments under
paragraphs (1) and (2), decrease the fee revenue amount established under
subsection (b)(1) if actual costs paid for rent and rent-related expenses for
the preceding fiscal year are less than estimates made for such year in fiscal
year 2008. Any reduction made under this paragraph shall not exceed the amount
by which such costs fall below the estimates made in fiscal year 2008 for such
fiscal year, and shall not exceed $11,721,000 for any fiscal year.</text>
</paragraph><paragraph id="H88FC8A8628B4493894E406D412F88F27"><enum>(4)</enum><header>Final year
adjustment</header><text>For fiscal year 2014, the Secretary may, in addition
to adjustments under paragraphs (1), (2), (3), and (5), further increase the
fee revenues and fees established in subsection (b) if such an adjustment is
necessary to provide for not more than 3 months of operating reserves of
carryover user fees for inspections described in subsection (a) for the first 3
months of fiscal year 2015. If such an adjustment is necessary, the rationale
for the amount of the increase shall be contained in the annual notice
establishing fee revenues and fees for fiscal year 2014. If the Secretary has
carryover balances for such inspections in excess of 3 months of such operating
reserves, the adjustment under this paragraph shall not be made.</text>
</paragraph><paragraph id="H07998DC2889648AEA3009527B2A0BC8D"><enum>(5)</enum><header>Cost estimate
adjustment</header><text>For fiscal year 2011 and subsequent fiscal years, the
Secretary by notice, published in the Federal Register, shall—</text>
<subparagraph id="HE347E661C5CE44A098950009702F9135"><enum>(A)</enum><text display-inline="yes-display-inline">provide an estimate of the amount of the
total increases described in subsection (a) for such fiscal year; and</text>
</subparagraph><subparagraph id="H2BC4D7217FEE442D84F80309E02967E8"><enum>(B)</enum><text>after making
adjustments under paragraphs (1), (2), and (3), adjust the revenues established
under subsection (b)(1) to be equal to such amount.</text>
</subparagraph></paragraph><paragraph id="H094FAB301B204E538E2ECCB92DFB5DE3"><enum>(6)</enum><header>Limit</header><text>The
total amount of fees charged, as adjusted under this subsection, for a fiscal
year may not exceed the total increases described in subsection (a) for such
fiscal year.</text>
</paragraph></subsection><subsection id="H6A3233E76DF24511A07EF6D5DBEECD30"><enum>(d)</enum><header>Waivers</header><text>The
Secretary shall waive the fee under this section with respect to any facility
that is a small business, as defined by the Secretary.</text>
</subsection><subsection id="H8BB331B8AC544CEFB1672308BB6B1067"><enum>(e)</enum><header>Limitations</header>
<paragraph id="H76DC039D135342B188E852590D92234"><enum>(1)</enum><header>In
general</header><text>Fees under subsection (a) shall be refunded for a fiscal
year beginning after fiscal year 2010 unless appropriations for 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 the 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 id="H7D15BD469AB64C56BDC11CEFE5AAAB52"><enum>(2)</enum><header>Authority</header><text>If
the Secretary does not assess fees under subsection (a) during any portion of a
fiscal year because of paragraph (1) and if at a later date in such fiscal year
the Secretary may assess such fees, the Secretary may assess and collect such
fees, without any modification in the rate, for registration under section 415
at any time in such fiscal year.</text>
</paragraph></subsection><subsection id="H4D243C6474D7425FA3F102B1CBB5E36"><enum>(f)</enum><header>Crediting and
availability of fees</header>
<paragraph id="HC9AEE21C83AA46F0A4E1F8E492070D7"><enum>(1)</enum><header>In
general</header><text>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 id="HE5E53FA8F17A49F19C98B48EF726081B"><enum>(2)</enum><header>Collections and
appropriation acts</header>
<subparagraph id="H5FED10738CD44034865F88BC0006E319"><enum>(A)</enum><header>In
general</header><text>The fees authorized by this section—</text>
<clause id="HA0AE09B35E864AA1A609D189C5C28C1"><enum>(i)</enum><text>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>
</clause><clause id="HE3F34BAD40C143488E7BE2E9306402DC"><enum>(ii)</enum><text>shall only be
collected and available to defray increases in the costs of inspecting
establishments registered under section 415 and related activities to ensure
compliance by such establishments with the requirements of this Act relating to
food (including increases in such costs for an additional number of full-time
equivalent positions in the Department of Health and Human Services to be
engaged in such inspections and for management of information, and the
acquisition, maintenance, and repair of information technology resources) over
such costs, excluding costs paid from fees collected under this section, for
fiscal year 2009 multiplied by the adjustment factor.</text>
</clause></subparagraph><subparagraph id="HE40D4AB37929457E0037A929B680180"><enum>(B)</enum><header>Compliance</header><text>The
Secretary shall be considered to have met the requirements of subparagraph
(A)(ii) in any fiscal year if the costs funded by appropriations and allocated
for inspections described in subsection (a)—</text>
<clause id="H10A16F7E710A49EC942346E08FB3FE04"><enum>(i)</enum><text>are not more than
3 percent below the level specified in subparagraph (A)(ii); or</text>
</clause><clause id="H5BBDEA85C0C7496495E985E1ECA42CFE"><enum>(ii)</enum><subclause commented="no" display-inline="yes-display-inline" id="H18519A078C614FE2BFA7D444BE758E0"><enum>(I)</enum><text>are more than 3 percent
below the level specified in subparagraph (A)(ii), and fees assessed for the
fiscal year following the subsequent fiscal year are decreased by the amount in
excess of 3 percent by which such costs fell below the level specified in such
subparagraph; and</text>
</subclause><subclause id="HDF4C09942EE14E6885C903FF6FB15832" indent="up1"><enum>(II)</enum><text>such costs are not more than 5 percent
below the level specified in such subparagraph.</text>
</subclause></clause></subparagraph></paragraph><paragraph id="HA85CC7F9E9E9410B99E7E1A52461898D"><enum>(3)</enum><header>Authorization of
appropriations</header><text>For each of the fiscal years 2010 through 2014,
there is authorized to be appropriated for fees under this section an amount
equal to the total revenue amount determined under subsection (b)(1) for the
fiscal year, as adjusted or otherwise affected under subsection (c) and
paragraph (4) of this subsection.</text>
</paragraph><paragraph id="H26725E33B0F74524BE53C40257B8B5A3"><enum>(4)</enum><header>Offset</header><text>If
the sum of the cumulative amount of fees collected under this section for the
fiscal years 2010 through 2013 and the amount of fees estimated to be collected
under this section for fiscal year 2014 exceeds the cumulative amount
appropriated under paragraph (3) for the fiscal years 2010 through 2013, the
excess shall be credited to the appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall be subtracted from the
amount of fees that would otherwise be authorized to be collected under this
section for fiscal year 2014.</text>
</paragraph></subsection><subsection id="H54B51DE3DE9045A695E6A179D302B781"><enum>(g)</enum><header>Collection of
unpaid fees</header><text>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 id="H3B012C61071848BFB3CA59943593FA74"><enum>(h)</enum><header>Construction</header><text>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,
employers, and advisory committees not engaged in inspections described in
subsection (a), be reduced to offset the number of officers, employees, and
advisory committees so engaged.</text>
</subsection><subsection id="H1E0A55D2FA46409195619DCA4CB1BFBC"><enum>(i)</enum><header>Annual fiscal
reports</header><text>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 id="H57E89920C9AE423E8154D0000E57C13"><enum>(j)</enum><header>Definition</header><text>In
this section, 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>
</subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph></subsection><subsection id="HBF2AE4344E87443A91AD63EB948E94D4"><enum>(c)</enum><header>Contents of
registration</header><text display-inline="yes-display-inline">Paragraph (2) of
section 415(a) (21 U.S.C. 350d(a)) 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="HAF967CB670614EE18F6EFE21F8E99D3D" style="OLC">
<text>containing information that identifies the
following:</text><subparagraph display-inline="no-display-inline" id="HC765E569B011411295A21DE48580D147"><enum>(A)</enum><text display-inline="yes-display-inline">The name, address, and emergency contact
information of each facility engaged in manufacturing, processing, packing, or
holding food for consumption in the United States that the registrant
operates.</text>
</subparagraph><subparagraph id="H7614478389DB419EBDAEF2734FCCE8D"><enum>(B)</enum><text>The primary purpose
and business activity of each such facility, including the dates of operation
if the facility is seasonal.</text>
</subparagraph><subparagraph id="H285BFAAC973445679379B1B438C30978"><enum>(C)</enum><text>The general food
category (as listed under section 170.3(n) of title 21, Code of Federal
Regulations, or as the Secretary may otherwise designate for purposes of
evaluating potential threats to food protection) of any food manufactured,
processed, packed, or held at each such facility.</text>
</subparagraph><subparagraph id="H6B29FFD5B06D4A829500FD3FCBE5AA79"><enum>(D)</enum><text>All trade names
under which each such facility conducts business related to food.</text>
</subparagraph><subparagraph id="H11F95E8DB333423B85D287BCF6FA64C6"><enum>(E)</enum><text>The name, address,
and 24-hour emergency contact information of the United States distribution
agent for each such facility, which agent shall maintain information on the
wholesale and retail distribution of food.</text>
</subparagraph><quoted-block-continuation-text quoted-block-continuation-text-level="paragraph">The
registrant shall notify the Secretary of any change in the products, function,
or legal status of each such facility (including cessation of business
activities) not later than 30 days after the date of such
change.</quoted-block-continuation-text><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H925D5AD68F69425D867F373F12A56DAB"><enum>(d)</enum><header>Suspension
authority</header><text display-inline="yes-display-inline">Section 415(a) (21
U.S.C. 350d(a)), as amended by subsection (c), is further amended by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HBB4DFD8135F3440AA84D59505631D905" style="OLC">
<paragraph id="H33605AD603BB4052A3EDEB6F4DCA976C"><enum>(5)</enum><header>Suspension of
registration</header>
<subparagraph id="HEE4B3BCDFE7546B59C0182CF9B38F5B0"><enum>(A)</enum><header>In
general</header><text>The Secretary may suspend the registration of any
facility registered under this section, including the facility of an
importer—</text>
<clause id="HD661F97945994720B098417C55669F22"><enum>(i)</enum><text>for violation of
this Act that could result in serious adverse health consequences or death to
humans or animals; or</text>
</clause><clause commented="no" id="H86FE613CF1904B62BF23C837C152487"><enum>(ii)</enum><text>if the facility,
or an employee of the facility, delays or limits an inspection, or refuses to
permit entry or inspection, by the Secretary under this Act.</text>
</clause></subparagraph><subparagraph id="H726B378571A14CFC8C00B6CAE5AEF261"><enum>(B)</enum><header>Notice and
opportunity for hearing</header><text display-inline="yes-display-inline">Before suspending the registration of a
facility under this paragraph, the Secretary shall provide notice to a
registrant of an intent to suspend the registration and provide the registrant
with an opportunity for an informal hearing. The Secretary may issue a written
order of suspension following the hearing, if the Secretary finds that a
violation described in subparagraph (A) has occurred.</text>
</subparagraph><subparagraph id="H8AE03121598B49819FEEFAF3D5E16880"><enum>(C)</enum><header>Reinstatement</header><text>A
registration that is suspended under this section may be reinstated pursuant to
criteria published by the Secretary in the Federal Register and on a public
website of the Food and Drug Administration.</text>
</subparagraph><subparagraph id="H7A4FED43FD644AAEBC034CF3441943F6"><enum>(D)</enum><header>Appeal</header><text>Any
registrant whose registration is suspended under this section may appeal that
action in any appropriate district court of the United
States.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HE8D2D9C1D6064CAB9D01D085E0FE7900"><enum>(e)</enum><header>Effective
dates</header>
<paragraph id="H10D4ACB152A044CAA767951C93413979"><enum>(1)</enum><header>Fees</header>
<subparagraph id="H2A59340130F44775AB9EFCDAAD5FCA97"><enum>(A)</enum><header>Effective
date</header><text>The Secretary of Health and Human Services shall first
impose the fee established under section 741 of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (b)(2), for fiscal years beginning with
fiscal year 2010.</text>
</subparagraph><subparagraph commented="no" id="HB01A3EC348494FECB5FFB075BC136DBE"><enum>(B)</enum><header>Sunset
date</header><text display-inline="yes-display-inline">Section 741 of the
Federal Food, Drug, and Cosmetic Act, as added by subsection (b)(2), 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>
</subparagraph></paragraph><paragraph id="H7D214F002E044E97A0E060826099631C"><enum>(2)</enum><header>Modification of
registration form</header><text display-inline="yes-display-inline">Not later
than 30 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 subsection (c).</text>
</paragraph><paragraph id="H16740121547343DC84BCC869F21385D9"><enum>(3)</enum><header>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 60 days after the date of the enactment of this Act.</text>
</paragraph></subsection></section><section commented="no" id="H91569906C22240CAA8982BE5132508F8"><enum>102.</enum><header>Hazard
analysis, risk-based preventive controls, and food safety plan</header>
<subsection commented="no" id="H8E564ABABC9C4139BB00003CE3B95584"><enum>(a)</enum><header>Prohibited
act</header><text>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="H63A0E4027FB64E1D9B00F79682CE3F43" style="OLC">
<subsection commented="no" id="H7ECE17938CE24CB698E52F49E81DB6E0"><enum>(oo)</enum><text>The operation of
a facility that manufactures, processes, packs, transports, or holds food for
consumption in the United States if the owner, operator, or agent in charge of
such facility is not in compliance with sections 418 and
418A.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H3AFA62A9F70743438E1233C589377E31"><enum>(b)</enum><header>Requirements</header><text>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="HBB35912A6E4E490588E96DCE739BD7F6" style="OLC">
<section id="H0117C49321DF44089B7D8240E1F663A1"><enum>418.</enum><header>Hazard analysis
and risk-based preventive controls</header>
<subsection id="HF7F7EDEE65C14B16956F3508E800C6DF"><enum>(a)</enum><header>In
general</header><text>The owner, operator, or agent in charge of a facility
shall, in accordance with this section, evaluate the hazards that could affect
food manufactured, processed, packed, transported, or held by such facility,
identify and implement preventive controls to significantly minimize, prevent,
or eliminate the occurrence of such hazards, monitor the performance of such
controls, and maintain records of such monitoring.</text>
</subsection><subsection id="H78C46973D11E48BBA2EEC34073D2CBB"><enum>(b)</enum><header>Hazard
analysis</header><text>The owner, operator, or agent in charge of a facility
shall identify and evaluate known or reasonably foreseeable hazards that may be
associated with the facility, including—</text>
<paragraph id="H871EE138B5414B2C92E85592B17D0000"><enum>(1)</enum><text>biological,
chemical, physical, and radiological hazards, natural toxins, pesticides, drug
residues, decomposition, parasites, allergens, and unapproved food and color
additives;</text>
</paragraph><paragraph id="HE2A07A5A08F54C95B9CA476ED1C58BCC"><enum>(2)</enum><text>hazards that occur
naturally, may be unintentionally introduced, or may be intentionally
introduced, including by acts of terrorism; and</text>
</paragraph><paragraph id="H55662EBE93994BCE8D21CBBCDCE7EAB4"><enum>(3)</enum><text display-inline="yes-display-inline">relevant hazards identified under section
419.</text>
</paragraph></subsection><subsection id="HFEA93C34F8C94558A859ECF999453184"><enum>(c)</enum><header>Preventive
controls</header>
<paragraph id="HDCEF8FA52FA64F6882CFA629A1C3DB00"><enum>(1)</enum><header>In
general</header><text>The owner, operator, or agent in charge of a facility
shall identify, implement, and validate preventive controls, including at
critical control points, if any, to significantly minimize, prevent, or
eliminate hazards identified in the hazard analysis conducted under subsection
(b).</text>
</paragraph><paragraph id="H3648636EB9E446A6962B4454F4ADEAF3"><enum>(2)</enum><header>Specific product
types</header><text display-inline="yes-display-inline">The Secretary may
establish by regulation or guidance additional preventive controls under this
section for specific product types to prevent intentional or unintentional
contamination throughout the supply chain.</text>
</paragraph></subsection><subsection id="H2FC582FE9AA64CF480A87E00B07566DF"><enum>(d)</enum><header>Monitoring of
effectiveness</header><text>The owner, operator, or agent in charge of a
facility shall monitor the effectiveness of the preventive controls implemented
under subsection (c).</text>
</subsection><subsection id="H8EC27F5DE1DD4E629531ABBDE97DC6E6"><enum>(e)</enum><header>Corrective
actions</header><text>The owner, operator, or agent in charge of a facility
shall establish procedures that the facility will implement if the preventive
controls implemented under subsection (c) are found to be ineffective through
monitoring under subsection (d).</text>
</subsection><subsection id="H3301BA6A91A84DC6A39782FAAC33D5A3"><enum>(f)</enum><header>Verification</header><text>The
owner, operator, or agent in charge of a facility shall verify that—</text>
<paragraph id="H371073804683423CA3E7CCE0059CB4B"><enum>(1)</enum><text>the preventive
controls implemented under subsection (c) have been validated as adequate to
control the hazards identified under subsection (b);</text>
</paragraph><paragraph id="H200F6916F03846B9A3D88524993D5BB2"><enum>(2)</enum><text>the owner,
operator, or agent is conducting monitoring in accordance with subsection (d);
and</text>
</paragraph><paragraph id="H30B1E159D4E1451DB8621272E6B32ED0"><enum>(3)</enum><text>the owner,
operator, or agent is taking effective corrective actions under subsection
(e).</text>
</paragraph></subsection><subsection id="H4EE9AC3D946D45409F004400EA28DBC4"><enum>(g)</enum><header>Record
keeping</header><text>The owner, operator, or agent in charge of a facility
shall maintain, for not less than 2 years, records documenting the monitoring
and verification of the effectiveness of the actions described in subsections
(a) through (f).</text>
</subsection><subsection id="HFE5C98CC52D64896999D67F96615B87C"><enum>(h)</enum><header>Requirement To
reanalyze</header><text>Each owner, operator, or agent in charge of a facility
shall—</text>
<paragraph id="H0B658FFBFCDF446D8D52FD7DC1FF65A0"><enum>(1)</enum><text>conduct a
reanalysis under subsection (b)—</text>
<subparagraph id="H662FB617DC83416CB88C0066598F06FE"><enum>(A)</enum><text>whenever there is
a reasonable potential for a new hazard or a significant increase in a
previously identified hazard;</text>
</subparagraph><subparagraph id="H552B419B70914BF78CDC30C5BC7BD745"><enum>(B)</enum><text>not less
frequently than once every 2 years; and</text>
</subparagraph><subparagraph id="H38F79040F4974CFBA401D539F7B4F47C"><enum>(C)</enum><text>if the Secretary
determines it to be appropriate for the protection of the public health;
and</text>
</subparagraph></paragraph><paragraph id="HA3A68866FC1148C8A7EECFD67F20B4FB"><enum>(2)</enum><text>revise the
preventive controls under subsection (c) to significantly minimize, prevent, or
eliminate such hazard or document the basis for the conclusion that no such
revision is needed.</text>
</paragraph></subsection><subsection id="H1CC0DC4E23784CBF92319CB42F19D7A"><enum>(i)</enum><header>Definitions</header><text>For
purposes of this section:</text>
<paragraph id="HF7FFADB4A1DC4FC6A1E914E842247CB8"><enum>(1)</enum><header>Critical control
point</header><text>The term <term>critical control point</term> means a point,
step, or procedure in a food process at which control can be applied and is
essential to prevent or eliminate a food safety hazard or reduce it to an
acceptable level.</text>
</paragraph><paragraph id="H3BD3C363A2284593AFAB8D63233E59CA"><enum>(2)</enum><header>Facility</header><text>The
term <term>facility</term> means a domestic facility or a foreign facility that
is required to register under section 415.</text>
</paragraph><paragraph id="HAE6BDAAD006B443BBBB3953605BA14C"><enum>(3)</enum><header>Preventive
controls</header><text>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 have employed to significantly minimize, prevent, or eliminate the
hazards identified under the hazard analysis conducted under subsection (a) and
that are consistent with the current scientific understanding of safe food
manufacturing, processing, packing, transporting, or holding at the time of the
analysis. Those procedures, practices, and processes may include the
following:</text>
<subparagraph id="H791268A5CE884AAB9C02DDA62DBE813"><enum>(A)</enum><text>Sanitation
procedures for food contact surfaces and utensils and food-contact surfaces of
equipment.</text>
</subparagraph><subparagraph id="H2B02A069623D4914B35CF18E29B83611"><enum>(B)</enum><text>Supervisor,
manager, and employee hygiene training.</text>
</subparagraph><subparagraph id="H9CC40837B20D4478BCC59BB13137118C"><enum>(C)</enum><text>An environmental
monitoring program to verify the effectiveness of pathogen controls.</text>
</subparagraph><subparagraph id="H5FEEA0D4B2204590ACFF5AD056885A3"><enum>(D)</enum><text>An allergen control
program.</text>
</subparagraph><subparagraph id="H40D4A9378B28487EA8CFA081B629735D"><enum>(E)</enum><text>A recall
contingency plan.</text>
</subparagraph><subparagraph id="HBD789E26CAA44768AB27456E1737AAB3"><enum>(F)</enum><text>Good manufacturing
practices.</text>
</subparagraph><subparagraph id="H41C99FE423E74DE784E6443B6F10E9EF"><enum>(G)</enum><text>Supplier
verification activities.</text>
</subparagraph></paragraph></subsection></section><section display-inline="no-display-inline" id="H4A92C11370FA43A9A4A41945B1462855" section-type="subsequent-section"><enum>418A.</enum><header>Food safety
plan</header>
<subsection display-inline="no-display-inline" id="H51C689F9EAEF454A98E6B9EF5C3BC300"><enum>(a)</enum><header>Implementation
of food safety plan</header>
<paragraph id="H4482FE5A5B0C407FBA4D3BC27BFA5E37"><enum>(1)</enum><header>In
general</header><text>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 in charge 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>
</paragraph><paragraph id="HE746816A17BE429E8E10A940BD9D3314"><enum>(2)</enum><header>Contents</header><text display-inline="yes-display-inline">The food safety plan shall include each of
the following elements:</text>
<subparagraph id="H386EE493347747208018833DA4C7007F"><enum>(A)</enum><text>The hazard
analysis conducted under section 418.</text>
</subparagraph><subparagraph id="HB177A3BD61674AA58FD26CE66DFFF994"><enum>(B)</enum><text>A description of
the preventive controls being implemented under section 418(c), including any
those for specific product types under section 418(c)(2).</text>
</subparagraph><subparagraph id="H36CE20CF9E214035BCFF2CB193C1C143"><enum>(C)</enum><text>Validation that
such preventive controls are effective to reduce, control, or eliminate such
hazard.</text>
</subparagraph><subparagraph id="H1A0E122B0B10410CA5BE807E8139BEDE"><enum>(D)</enum><text>A description of
monitoring of such preventive controls being implemented, including sampling
and testing relating to the control of hazards where appropriate to verify that
the controls are effective.</text>
</subparagraph><subparagraph id="H67CEA29E2380498EB500EE2837D9D3F9"><enum>(E)</enum><text>A description of
the record keeping being conducted, including evidence of corrective actions,
sampling and testing records, monitoring and verification records, and
validation records.</text>
</subparagraph><subparagraph id="HA4F8400DD1E14353B607BA86ADB9ED91"><enum>(F)</enum><text>A description of
established procedures for the recall of articles of food, whether voluntarily
or when required under section 422.</text>
</subparagraph><subparagraph commented="no" id="H180F9B95557F4A24BD352C9FE57674A"><enum>(G)</enum><text>A description of
established procedures for the trace back of articles of food, whether
voluntarily or when required under section 403(g).</text>
</subparagraph><subparagraph commented="no" id="H6556C52B40594D2587AA7177924813E"><enum>(H)</enum><text>A description of
established procedures to ensure a safe and secure supply chain for the
ingredients or components used in making the food produced, processed, packed,
transported, or held by such facility.</text>
</subparagraph><subparagraph id="HFC22273FC8BE46C500161CDB54132E44"><enum>(I)</enum><text>A description of
established procedures to implement the science-based performance standards
issued under section 419.</text>
</subparagraph></paragraph></subsection><subsection id="H7196A280E4A842FD9869BF7976B5AD00"><enum>(b)</enum><header>Inspection of
food safety plan in course of facility inspection</header><text display-inline="yes-display-inline">In the course of a facility inspection
under section 704, the Secretary shall conduct a review of the food safety plan
to ensure the plan meets relevant requirements of section 418, this section,
and section 419 and is adequate to protect the public
health.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H25368B92E9F3467C8D1378D8F0EDD3A2"><enum>(c)</enum><header>Guidance or
regulations</header>
<paragraph id="HB99162D2E3234CC9B3AFD72F9621758B"><enum>(1)</enum><header>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 minimum standards for conducting a hazard analysis,
documenting hazards, implementing preventive controls, and documenting the
implementation of the preventive controls under sections 418 and 418A of the
Federal Food, Drug, and Cosmetic Act (as added by subsection (b)).</text>
</paragraph><paragraph id="HE04EC9181E4D4BD9BDF002FF22249752"><enum>(2)</enum><header>Consideration</header><text>In
issuing guidance or promulgating regulations under this section, the Secretary
shall consider the capacity of small businesses.</text>
</paragraph></subsection><subsection id="H308D8BE05E6F4319B7E655801FE1F0FE"><enum>(d)</enum><header>No effect on
HACCP authorities</header><text>Nothing in the amendments made by this section
limits the authority of the Secretary under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42
U.S.C. 201 et seq.) to revise, issue, or enforce product and category-specific
regulations, such as the Seafood Hazard Analysis Critical Controls Points
Program, the Juice Hazard Analysis Critical Control Program, and the Thermally
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
standards.</text>
</subsection><subsection id="H8119578A01F34953AB353002A2EC2240"><enum>(e)</enum><header>Effective
date</header>
<paragraph commented="no" id="H804DC401982D45D2A16D1681151ECF1F"><enum>(1)</enum><header>General
rule</header><text>The amendments made by this section shall take effect 18
months after the date of the enactment of this Act.</text>
</paragraph><paragraph id="H1EBDDA3278194424B376427400E725EB"><enum>(2)</enum><header>Exceptions</header><text>Notwithstanding
paragraph (1)—</text>
<subparagraph id="HF33EB05E222540EE8E22C771AEB69591"><enum>(A)</enum><text>the amendments
made by this section shall apply to a small business (as defined by the
Secretary) after the date that is 2 years after the date of the enactment of
this Act; and</text>
</subparagraph><subparagraph id="H2EDCEBBE1C174C95A5C8B36DED5BAB17"><enum>(B)</enum><text>the amendments
made by this section shall apply to a very small business (as defined by the
Secretary) after the date that is 3 years after the date of the enactment of
this Act.</text>
</subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H3C8F23CC9A1D468F839C605F314FCF4D" section-type="subsequent-section"><enum>103.</enum><header>Performance
standards</header><text display-inline="no-display-inline">Chapter IV (21
U.S.C. 341 et seq.), as amended by section 102, is further amended by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HBCFD75E8F78B449B87AD2B7DBB454CCD" style="OLC">
<section id="H65846B93356F402E8EDE49E9CCFB7598"><enum>419.</enum><header>Performance
standards</header><text display-inline="no-display-inline">The Secretary shall,
not less frequently than every 2 years, review and evaluate epidemiological
data and other appropriate sources of information, including research under
section 113 of the Food and Drug Administration Globalization Act of 2009, to
identify the most significant food-borne contaminants and the most significant
resulting hazards, and shall issue, through guidance or by regulation,
science-based performance standards (which may include action levels) to
significantly minimize, prevent, or eliminate the occurrence of such hazards.
Such standards shall be applicable to products and product classes and shall
not be specific to an individual
facility.</text>
</section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H3447AE56133E4B1E9F7E4E000020C03C"><enum>104.</enum><header>Safety
standards for fresh produce</header>
<subsection id="H74D3EA19A00948A9B800F7C00012600"><enum>(a)</enum><header>Prohibited
act</header><text display-inline="yes-display-inline">Section 301 (21 U.S.C.
331), as amended by sections 102 and 103, is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H17A4F1366F884608A2AD18AD2914D395" style="OLC">
<subsection id="H491222EFEE854ED78E2FE6CA208446F3"><enum>(pp)</enum><text display-inline="yes-display-inline">The production or harvesting of produce not
in accordance with minimum standards as provided by regulation under section
419A(a) or a variance issued under section
419A(e).</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HDC91EAB4A2664B5A82986BD9D1DD8B55"><enum>(b)</enum><header>Standards</header><text display-inline="yes-display-inline">Chapter IV (21 U.S.C. 341 et seq.), as
amended by sections 102 and 103, is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HBD73419C0AE3401FB27D716EF60500B2" style="OLC">
<section id="H891AD8D006C443AFA6ED1B30E6B98D5"><enum>419A.</enum><header>Standards for
produce safety</header>
<subsection id="H9E6B1D559FA2446CABDA9B391BBCAB29"><enum>(a)</enum><header>Standards</header><text display-inline="yes-display-inline">The Secretary shall establish by regulation
science-based minimum standards for the safe production and harvesting of those
types of fruits and vegetables that are raw agricultural commodities for which
the Secretary has determined that such standards minimize the risk of serious
adverse health consequences or death.</text>
</subsection><subsection id="HCAA9343A30394034ABB4C671F9C107A8"><enum>(b)</enum><header>Contents</header><text>The
regulations under subsection (a)—</text>
<paragraph id="H118E6975A63849FA80814247410360AE"><enum>(1)</enum><text display-inline="yes-display-inline">shall set forth such procedures, processes,
and practices as the Secretary determines to be reasonably necessary—</text>
<subparagraph id="H14DB1B6C9C9B4FF3A7AAC2DD47AC6FD2"><enum>(A)</enum><text>to prevent the
introduction of known or reasonably foreseeable biological, chemical, and
physical hazards, including hazards that occur naturally, may be
unintentionally introduced, or may be intentionally introduced, including by
acts of terrorism, into fruits and vegetables that are raw agricultural
commodities; and</text>
</subparagraph><subparagraph id="HD7DC3F2B94B046BF89F01E3C88EB5354"><enum>(B)</enum><text>to provide
reasonable assurances that the produce is not adulterated under section
402;</text>
</subparagraph></paragraph><paragraph id="H1914F6CB73524E1C8427CC28AFD39E59"><enum>(2)</enum><text>shall include,
with respect to growing, harvesting, packing, sorting, and storage operations,
minimum standards for safety;</text>
</paragraph><paragraph id="H618DF257AFC4426B97DC533200564C8B"><enum>(3)</enum><text>shall include
standards addressing manure use, water quality, employee hygiene, sanitation
and animal control, temperature controls, and nutrients;</text>
</paragraph><paragraph id="HAECA077DF9E147549DE8773FA50752CB"><enum>(4)</enum><text>may include
standards for such other elements as the Secretary determines necessary to
carry out subsection (a);</text>
</paragraph><paragraph display-inline="no-display-inline" id="H5B389D144EEC43D58FB16EF3B5799750"><enum>(5)</enum><text>shall provide a
reasonable period of time for compliance, taking into account the needs of
small businesses for additional time to comply; and</text>
</paragraph><paragraph id="HD9EAF14705D544C2A7A6225BDA9BA1E4"><enum>(6)</enum><text>shall provide for
coordination of education and enforcement activities by State and local
officials, as designated by the Governors of the respective States.</text>
</paragraph></subsection><subsection id="H8A4D76B0894B49C884B7B47612CE4D80"><enum>(c)</enum><header>Prioritization</header><text>The
Secretary shall prioritize the implementation of the regulations under
subsection (a) for specific fruits and vegetables that are raw agricultural
commodities and have been associated with food-borne illness outbreaks.</text>
</subsection><subsection id="H4DE79BE3D9A64412AF849E56E5790301"><enum>(d)</enum><header>Enforcement</header><text>The
Secretary may coordinate with the Secretary of Agriculture and shall contract
and coordinate with the agency or department designated by the Governor of each
State to perform activities to ensure compliance with this
section.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HB42968491D2C4210B47D5000A9DD956F"><enum>(c)</enum><header>Guidance;
rulemaking</header>
<paragraph id="HE15212BA640D448187FB423BDCBEADD9"><enum>(1)</enum><header>Guidance</header><text display-inline="yes-display-inline">Not later than 1 year after the date of
enactment of this Act, the Secretary shall publish, after consultation with the
Secretary of Agriculture and representatives of State departments of
agriculture, updated good agricultural practices and guidance for the safe
production and harvesting of specific types of fresh produce.</text>
</paragraph><paragraph id="H4910385332EA42CF99C3A025A3DA1317"><enum>(2)</enum><header>Proposed
rulemaking</header>
<subparagraph id="H757DB595B9E14780A400C28D437474D9"><enum>(A)</enum><header>In
general</header><text>Not later than 1 year after the date of the enactment of
this Act, the Secretary, in consultation with the Secretary of Agriculture and
representatives of State departments of agriculture, shall publish a notice of
proposed rulemaking under section 419A of the Federal Food, Drug, and Cosmetic
Act, as added by subsection (b).</text>
</subparagraph><subparagraph id="H39D22BB8410F40E9832B731F7300D7B1"><enum>(B)</enum><header>Public
input</header><text>During the comment period on the notice of proposed
rulemaking under subparagraph (A), the Secretary shall conduct not less than 3
public meetings in diverse geographical areas of the United States to provide
persons in different regions an opportunity to comment.</text>
</subparagraph></paragraph><paragraph id="HEFA63CEED5A244A79F2009DFAD5CA2B"><enum>(3)</enum><header>Final
regulation</header><text display-inline="yes-display-inline">Not later than 1
year after the close of the comment period for the proposed rulemaking under
paragraph (2), the Secretary shall adopt a final regulation under section 419A
of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b).</text>
</paragraph></subsection><subsection id="HF1E73F94635343D8827F8167B7D12F1C"><enum>(d)</enum><header>No effect on
HACCP authorities</header><text display-inline="yes-display-inline">Nothing in
the amendments made by this section limits the authority of the Secretary under
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public
Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce product
and category-specific regulations, such as the Seafood Hazard Analysis Critical
Controls Points Program, the Juice Hazard Analysis Critical Control Program,
and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed
Containers standards.</text>
</subsection></section><section id="H1DC915CE354C4449BA9549E332196F1E"><enum>105.</enum><header>Risk-based
inspection</header>
<subsection id="HCBC84143E7EE4DE9AA92510074ED35DC"><enum>(a)</enum><header>Risk-based
inspection schedule</header>
<paragraph id="H0250CD4F03DC4870ACF8C4CE67A8487B"><enum>(1)</enum><header>In
general</header><text>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="H940C3B80D7944D11B395A0CCBB549C00" style="OLC">
<subsection id="HF70619A805B74DB58CA854305B57F79B"><enum>(h)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H9B4F94BC0CCC414285F78E485B0973EB"><enum>(1)</enum><text>Each facility registered
under section 415 shall be inspected by one or more officers duly designated by
the Secretary at a frequency determined pursuant to a risk-based
schedule.</text>
</paragraph><paragraph id="HFA8C33BCCAA64058BC8E586BB1326E85" indent="up1"><enum>(2)</enum><text>The Secretary shall establish such
risk-based schedule not later than 18 months after the date of the enactment of
this subsection and may subsequently revise such schedule in accordance with
this section.</text>
</paragraph><paragraph id="H217533E41C4B414687CF46DC28FD47A0" indent="up1"><enum>(3)</enum><text>Such risk-based schedule shall
provide for a frequency of inspections commensurate with the risk presented by
the facility, but in no case shall inspections of a facility occur less than
once every 4 years beginning on the date of the facility’s initial registration
pursuant to section 415.</text>
</paragraph><paragraph id="HB424EC009DB14A3C0045E617A5D9D42" indent="up1"><enum>(4)</enum><text>In determining the appropriate
frequency of inspection, the Secretary shall consider—</text>
<subparagraph id="H07762FFB5E394C33A9A24C353D08931F"><enum>(A)</enum><text display-inline="yes-display-inline">the type of food manufactured, processed,
packed, or held at the facility;</text>
</subparagraph><subparagraph id="HC83D490916FD4ACA964374CEFF357E55"><enum>(B)</enum><text>the compliance history of the
facility;</text>
</subparagraph><subparagraph id="H0F5DB0AE91AC4A96A93EAD263CCFA64"><enum>(C)</enum><text>whether the facility is certified by a
certifying agent accredited pursuant to section 420(a); and</text>
</subparagraph><subparagraph id="HE6DD77D2999A4E629C6CD19E15BC7616"><enum>(D)</enum><text>such other factors as the Secretary
determines by guidance to be relevant to assessing the risk presented by the
facility.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="HFE2CD3E6B5DC46259238CDCCF1BA72B7"><enum>(2)</enum><header>Facilities
already registered</header><text>In section 704(h)(3) of the Federal Food,
Drug, and Cosmetic Act, as added by paragraph (1), the term <term>initial
registration pursuant to section 415</term> means, with respect to a facility
that is registered pursuant to section 415 of such Act as of the date of the
enactment of this Act, the first annual registration of the facility pursuant
to such section 415 that occurs on or after such date of enactment.</text>
</paragraph><paragraph id="HC2F44F589FE44023A9A93C7C976FF489"><enum>(3)</enum><header>Reports on
risk-based inspections of food facilities</header>
<subparagraph id="H754EF90BDFEE4EB189AA69D71ECB75F7"><enum>(A)</enum><header>Initial
report</header><text display-inline="yes-display-inline">Not later than 18
months 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 the risk-based inspection schedule
established under section 704(h)(2) of the Federal Food, Drug, and Cosmetic
Act, as added by paragraph (1). Such report shall include a description of the
frequency of inspections for different classes of risk, the number of
facilities in each class, and an estimate of the projected 5-year costs of
implementing such inspection schedule.</text>
</subparagraph><subparagraph id="H802CBFDE72D04464B8445206FD319E17"><enum>(B)</enum><header>Subsequent
reports</header><text display-inline="yes-display-inline">Annually after the
submission of the report required by subparagraph (A), the Secretary shall
submit a report to the Congress on—</text>
<clause id="HF6E4C5EF816D414BA6FE99D47C97159D"><enum>(i)</enum><text>the
number of foreign and domestic facilities inspected under the risk-based
inspection schedule established under section 704(h)(2) of the Federal Food,
Drug, and Cosmetic Act, as added by paragraph (1), in the preceding 12 months;
and</text>
</clause><clause id="H55CCA9A8C2644D0191C35588CCC4EB9C"><enum>(ii)</enum><text display-inline="yes-display-inline">the costs of implementing the risk-based
inspection schedule for the preceding 12 months.</text>
</clause></subparagraph></paragraph></subsection><subsection id="H19ADF4E3FC644055BB3306A08500C3BB"><enum>(b)</enum><header>Food offered for
import</header><text>The third sentence of subsection (a) of section 801 (21
U.S.C. 381) is amended by inserting <quote>or (4) such article is food that has
been processed, packed, or held at a facility that is in violation of section
301(f) (prohibiting the delay or limitation of an inspection, or the refusal to
permit entry or inspection, under section 704),</quote> before <quote>then such
article shall be refused admission</quote>.</text>
</subsection></section><section id="H81C4AF6329C147660023EE9FFD96A21C"><enum>106.</enum><header>Access to
records</header>
<subsection id="H7F766FFBFAF24632990796C305B7B2C2"><enum>(a)</enum><header>Records
inspection</header><text>Section 414(a) (21 U.S.C. 350c) is amended—</text>
<paragraph id="H39409AD6863344EB849D9E00DBCA41A"><enum>(1)</enum><text>by
striking <quote>If 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, each</quote> and inserting
<quote>Each</quote>;</text>
</paragraph><paragraph id="HF4DAD4C9B5D940088BBA9679EBCB2FC8"><enum>(2)</enum><text>by striking the
term <term>such article</term> the first place such term appears and inserting
<quote>an article of food</quote>;</text>
</paragraph><paragraph id="H387B42C7599F482B9164E3BCD5A8BABE"><enum>(3)</enum><text>by striking
<quote>and a written notice to such person</quote>; and</text>
</paragraph><paragraph id="H8FA0E102D1D344959BB74FEE94DF6E38"><enum>(4)</enum><text>by striking
<quote>and presents a threat of serious adverse health consequences or death to
humans or animals</quote> and inserting <quote>, misbranded, or otherwise in
violation of this Act</quote>; and</text>
</paragraph></subsection><subsection id="HD2705357185541CA8098C7B6B413D300"><enum>(b)</enum><header>Conforming
amendment</header><text>Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended 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</quote>.</text>
</subsection></section><section id="HC3FA8BDC6B2E4794A0AAA8F2B8B21146"><enum>107.</enum><header>Traceability of
food</header>
<subsection id="H448E11F1BFC946E9ACF8D339BF87F2DA"><enum>(a)</enum><header>Farm and
restaurant records</header>
<paragraph id="H1D5C6D0103904275AF7FDC47005CE9A5"><enum>(1)</enum><header>Inspection</header><text>Section
414(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350c(a)), as
amended by section 106, is amended by striking <quote>(excluding farms and
restaurants)</quote>.</text>
</paragraph><paragraph id="H9A2703E5D9E04C10A2BDBEEBEFC6C6F"><enum>(2)</enum><header>Maintenance of
records</header><text display-inline="yes-display-inline">Section 414(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350c(b)), as amended by section
106, is amended by striking <quote>(excluding farms and
restaurants)</quote>.</text>
</paragraph></subsection><subsection id="H5EAA7E8625234D27B7BAC09FE0C4B715"><enum>(b)</enum><header>Standardized
electronic format</header><text display-inline="yes-display-inline">Section 414
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350c(a)), as amended by
section 106 and subsection (a), is amended—</text>
<paragraph id="HAC12FD3E4D4B47B6BDA4758B9C2E7E06"><enum>(1)</enum><text>in subsection (a),
by striking <quote>in any format (including paper and electronic formats)
and</quote>; and</text>
</paragraph><paragraph id="H3817BD25C7024569A42C004C5C8EFA78"><enum>(2)</enum><text>in subsection (b),
by adding at the end the following: <quote>The Secretary shall require such
persons to maintain such records in a standardized electronic
format.</quote>.</text>
</paragraph></subsection><subsection id="H6FBF46868B124AF9999635FB727DBC00"><enum>(c)</enum><header>Identification
of source of raw agricultural products</header><text>Section 403 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at the end
the following:</text>
<quoted-block display-inline="no-display-inline" id="H56B4EBCBD825408B8327FABE45F22" style="OLC">
<subsection id="H81A6B192B3C749F1A6F53497EE88314F"><enum>(z)</enum><text display-inline="yes-display-inline">If it is a raw agricultural product, unless
each commercial shipment of the product contains information enabling the
Secretary to identify—</text>
<paragraph id="H7ED1D63DFB744067AAC417ED3DD5C0F9"><enum>(1)</enum><text>the grower of the
product;</text>
</paragraph><paragraph id="HC426ED3A33C84795B09CB916C9959311"><enum>(2)</enum><text>the lot on which
the product was produced;</text>
</paragraph><paragraph id="H40B6F3415C504248009CE227CAED6D00"><enum>(3)</enum><text>the harvesting and
packing dates of the product; and</text>
</paragraph><paragraph id="H53548B58F8D24006A8EEBE65E9F25BFB"><enum>(4)</enum><text>any other
information determined appropriate by the Secretary to facilitate
identification of the source of raw agricultural
products.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H17D40ED3FFD94D87003B54381C004D6E"><enum>(d)</enum><header>Study</header><text>Not
later than 2 years after the date of the enactment of this Act, the
Commissioner of Food and Drugs shall—</text>
<paragraph id="H0993F16C24BA4048A37610D665E6570"><enum>(1)</enum><text>complete a study on
the effectiveness of technologies for determining the source of raw
agricultural products; and</text>
</paragraph><paragraph id="H0AC24DC74E6D4279B46DC6C1F109CACA"><enum>(2)</enum><text>submit a report to
the Congress on the results of such study.</text>
</paragraph></subsection></section><section id="HBAD26395B2714488B9D497EB12DC56B4"><enum>108.</enum><header>Reinspection
fee applicable to facilities</header>
<subsection id="HF7402CD257D5469C8877A3FEE9B5822C"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Part 5 of subchapter
C of chapter VII (21 U.S.C. 371 et seq.), as added by section 101(b)(2), is
further amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H680E118CAE2446B18DCFEFC8394480A5" style="OLC">
<section id="H3B36F8C839194692878BC1D8B3FCC4FE"><enum>741A.</enum><header>Reinspection
fee applicable to facilities</header>
<subsection id="H6A2F5B3D3A9D4067A467D3E839C87179"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">The Secretary shall
assess and collect fees from each facility (as defined in section 415(b))
that—</text>
<paragraph id="H021529E414F44A24B3AC489500BC3FB6"><enum>(1)</enum><text>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>
</paragraph><paragraph id="HBF6C2BFE13934D11A872DFF750008F78"><enum>(2)</enum><text>because of such
violation, undergoes additional inspection by the Food and Drug
Administration.</text>
</paragraph></subsection><subsection id="HF3740DDACBBF4BE19594A1B684EA5560"><enum>(b)</enum><header>Amount of
fees</header><text>The Secretary shall set the amount of the fees under this
section to fully defray the costs of conducting the additional inspections
referred to in subsection (a)(2).</text>
</subsection><subsection id="H72F3545ACBA24977A59D61222C279565"><enum>(c)</enum><header>Use of
fees</header><text>The Secretary shall make all of the fees collected pursuant
to this section available solely to pay for the costs of additional inspections
referred to in subsection
(a)(2).</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HC28D187D177C45B0B175BB4C206749D0"><enum>(b)</enum><header>Effective
date</header><text>The amendment made by subsection (a) shall apply to
additional inspections occurring after the date of the enactment of this
Act.</text>
</subsection></section><section id="H23A63D95B93148BBA7C25200CACEF5"><enum>109.</enum><header>Certification of
food facilities</header>
<subsection id="HDD2155B4B16144B4A39C00CBF0075FA"><enum>(a)</enum><header>Misbranding</header>
<paragraph id="HB292BE316B3E4E20A200C07EBF51DED0"><enum>(1)</enum><header>In
general</header><text>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="H6B45FA56E2034222A72CF5DFEADB8391" style="OLC">
<subsection id="H86BD780F13874314B8401EC6113D7388"><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
420(b)(5) (requiring a certification to accompany certain food
shipments).</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" id="H780001F946FD4E10A5882B297E899EFA"><enum>(2)</enum><header>Effective
date</header><text>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 id="H0D311863E810410985D082F5300516C"><enum>(b)</enum><header>Accreditation of
certifying agents; certification of laboratories and accreditation of
laboratory certifying agents</header><text display-inline="yes-display-inline">Chapter IV (21 U.S.C. 341 et seq.), as
amended by sections 102(b), 103, and 104, is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HB582063AA37B47CAAAF201F6392FD0A9" style="OLC">
<section id="H25313AF5F3384D71BC9C019BB8BFD8D1"><enum>420.</enum><header>Accreditation
of certifying agents</header>
<subsection id="H73E2B0F24D2449C58E7BBFD265C369D1"><enum>(a)</enum><header>Accreditation as
certifying agent</header>
<paragraph id="HFDD2CEA17FB244588653F7035E6FC521"><enum>(1)</enum><header>In
general</header><text>Beginning not later than 2 years after the date of the
enactment of this section, the Secretary shall establish and implement an
accreditation system under which a foreign government, a State or regional food
authority, a foreign or domestic cooperative that aggregates the products of
growers or processors, and any other third party that the Secretary determines
appropriate, may request to be accredited as a certifying agent to certify
facilities as meeting the applicable requirements of this Act.</text>
</paragraph><paragraph id="HFDB45145D9014CE9ADC58D9714419381"><enum>(2)</enum><header>Qualifications
of certifying agents</header><text>Prior to accrediting an third party as a
certifying agent under paragraph (1), the Secretary shall perform such reviews
and audits of the training and qualifications of auditors used by the third
party, and conduct such reviews of internal systems and such other
investigation of the third party, as the Secretary deems necessary to determine
whether the third party—</text>
<subparagraph id="HB9467E30B3F64532B525CB7651D15FDB"><enum>(A)</enum><text>meets the
requirements of this section; and</text>
</subparagraph><subparagraph id="H0C416227A841466A91D378A088B804D"><enum>(B)</enum><text>is qualified to
evaluate the compliance of a facility with the applicable requirements of this
Act.</text>
</subparagraph></paragraph><paragraph id="HA8F5A9D44F744D18BA048293CFEB0868"><enum>(3)</enum><header>Limitation of
accreditation</header><text>The Secretary may limit the accreditation under
paragraph (1) of a certifying agent to the certification of facilities that
produce, manufacture, process, or hold only specified food products (or
categories of food products).</text>
</paragraph><paragraph id="H85C03A43F7CE48558302FB09FEFE7503"><enum>(4)</enum><header>Performance of
audits and renewal of accreditation</header><text>The Secretary shall audit the
performance of certifying agents on a periodic basis, but not less than every 4
years, for the purpose of renewing the accreditation of such agents.</text>
</paragraph><paragraph id="H7661FC5A56094159AB88F1BCB5B1036"><enum>(5)</enum><header>Withdrawal of
accreditation</header><text>The Secretary—</text>
<subparagraph id="H41C17D97ACBD423D83631319DEADF2A6"><enum>(A)</enum><text>may withdraw
accreditation under paragraph (1) from a certifying agent if—</text>
<clause id="HB26C66DC13C6467EB3269EA5EE8020AC"><enum>(i)</enum><text>a
facility certified by the agent is linked to an outbreak of human or animal
illness; or</text>
</clause><clause id="H5C78ECC5774D4AAABAB57D02F4199733"><enum>(ii)</enum><text>the Secretary
finds that the agent no longer meets the requirements for accreditation;
and</text>
</clause></subparagraph><subparagraph id="H3F68D56FC96E4F96A192CE1600598DDE"><enum>(B)</enum><text display-inline="yes-display-inline">shall withdraw accreditation under
paragraph (1) from a certifying agent if the Secretary finds that the
certifying agent has refused to allow the Secretary to conduct such audits and
investigations as may be necessary to ensure continued compliance with the
requirements of this section.</text>
</subparagraph></paragraph><paragraph id="HCAD7F0AB8CE94D899E804FEAB26F135F"><enum>(6)</enum><header>Publication of
list of certifying agents</header><text>The Secretary shall publish and
maintain on the website of the Food and Drug Administration a current list of
certifying agents accredited under this section, including—</text>
<subparagraph id="HF68B1896B89D466DAF49E0B000BBEF5"><enum>(A)</enum><text>each such agent’s
name and location; and</text>
</subparagraph><subparagraph id="H781AB4F52CDA450FBEFAFD73284FAB06"><enum>(B)</enum><text>any other
information deemed necessary by the Secretary.</text>
</subparagraph></paragraph></subsection><subsection id="HD8A631326FFD4A76BF83BE1772D0E5E2"><enum>(b)</enum><header>Additional
requirements applicable to certifying agents</header><text display-inline="yes-display-inline">As conditions of accreditation under
subsection (a), a certifying agent shall agree to the following:</text>
<paragraph id="H6ACE7BA8D68C4AF296C917116500C652"><enum>(1)</enum><header>Audit
requirements</header><text>A certifying agent shall not certify a facility
unless the certifying agent has—</text>
<subparagraph id="H7907993986AF4F9E883D2FC607C0C4ED"><enum>(A)</enum><text>conducted an
on-site audit of the facility, which shall be unannounced for a domestic
facility;</text>
</subparagraph><subparagraph id="H1D14DFA75E1C4D3D8CF87390DCCDD4BE"><enum>(B)</enum><text>reviewed the
facility’s food safety plan under section 418A to ensure the plan meets
applicable requirements of this Act and is adequate to protect the public
health;</text>
</subparagraph><subparagraph id="H16DC1947ACC84ED4BA725135C4F7F9BA"><enum>(C)</enum><text>prepared an audit
report in a form and manner designated by the Secretary; and</text>
</subparagraph><subparagraph id="H9ABFC88B90FD493DBB33A80006C0C924"><enum>(D)</enum><text>conducted any
other review, analysis, or testing determined by the Secretary to be
appropriate for determining such facility’s compliance with the applicable
requirements of this Act.</text>
</subparagraph></paragraph><paragraph id="HA2416F1817E04045BC9B9774A6009FA6"><enum>(2)</enum><header>Access to
reports and records</header><text>A certifying agent shall provide to the
Secretary, upon request—</text>
<subparagraph id="H530D7932BB704DF9AA6DD5A1687D77"><enum>(A)</enum><text>a copy of any audit
report prepared under paragraph (1)(C);</text>
</subparagraph><subparagraph id="HA5BF525809EB470BBFCFD9BA082D699B"><enum>(B)</enum><text>any records
relating to corrective actions planned or taken by the audited facility;
and</text>
</subparagraph><subparagraph id="HFB58E74C1017466B9ECC1EB58FFAA237"><enum>(C)</enum><text>any other records
related to—</text>
<clause id="H1DBBC16D199B4D36BBF541AD03582952"><enum>(i)</enum><text>the certification
or decertification of a facility;</text>
</clause><clause id="HEF34F6DE69984313BAD6006E4CCBCE59"><enum>(ii)</enum><text>compliance of a
facility with the requirements of this Act; or</text>
</clause><clause id="H37B2DDA907F44C1FBA647FEEEA0B8A4"><enum>(iii)</enum><text>the accreditation
of the certifying agent.</text>
</clause></subparagraph></paragraph><paragraph id="H967CF919438C433A9300278BF670AC"><enum>(3)</enum><header>Conflicts of
interest</header>
<subparagraph id="HE5F77F3BDB7A4B7C8977A5BE00E0C48C"><enum>(A)</enum><header>In
general</header><text>A certifying agent shall—</text>
<clause id="HAAB00B1A8C844838957C01145691A28B"><enum>(i)</enum><text>not have an
ownership, management, or other financial interest in any facility to be
certified by the certifying agent or in such facility’s suppliers or
vendors;</text>
</clause><clause id="H21B81AC2502B4538936ECEF8BF65C7F"><enum>(ii)</enum><text>have procedures to
ensure against the use, in carrying out audits of a facility under this
section, of any officer or employee who has a financial conflict of interest
regarding such facility; and</text>
</clause><clause id="HDF58FEBAFD71484FBAF69C5C3248009E"><enum>(iii)</enum><text>have written
conflict of interest policies that include prompt disclosure to the Secretary
of all conflicts or potential conflicts of interest.</text>
</clause></subparagraph><subparagraph id="HBACF0FA7029D4D3896C475AEE82005FA"><enum>(B)</enum><header>Regulations</header><text>Not
later than 18 months after the date of the enactment of this section, the
Secretary shall promulgate regulations to implement the requirements of
subparagraph (A). Such regulations shall include a structure, including timing
and public disclosure, for fees paid by facilities to certifying agents.</text>
</subparagraph></paragraph><paragraph commented="no" id="H96378209120C4B24B469F01EC314EA33"><enum>(4)</enum><header>Decertification
of facilities</header><text display-inline="yes-display-inline">A certifying
agent shall decertify a facility if the certifying agent, after providing a
reasonable opportunity for corrective action, finds that the facility no longer
meets the applicable requirements of this Act.</text>
</paragraph><paragraph id="HA6E8591B0BCE42DCBB1881BD8CF431BA"><enum>(5)</enum><header>Required
certification of imports</header><text display-inline="yes-display-inline">A
certifying agent shall issue a written and electronic certification to
accompany each shipment offered for import into the United States containing
food that was manufactured, processed, packed, or held by a facility certified
by the agent, subject to requirements set forth by the Secretary.</text>
</paragraph><paragraph commented="no" id="H3C2AE422DF7A4A00975BFF4022C6623D"><enum>(6)</enum><header>Risks to public
health</header><text display-inline="yes-display-inline">If, at any time during
an audit, an auditor of a certifying agent finds a condition at a facility that
could cause or contribute to illness or injury to an individual consuming an
article of food manufactured, processed, packed, or held by the facility, the
certifying agent shall immediately notify the Secretary of the identity of the
facility and such condition.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HFA1924F928E648899E8D9DF37CFF111C"><enum>(c)</enum><header>False or
misleading statements</header><text display-inline="yes-display-inline">For
purposes of section 301(q)(2), any statement or representation made by an
employee or agent of a facility to an auditor of a certifying agent or a
certifying agent is deemed to be a report required by or under this Act.</text>
</subsection><subsection id="HA73B3511C7364BB68B90DA55CFD58E58"><enum>(d)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph id="HCEB6D7C110944201A225F71286317103"><enum>(1)</enum><text>The term
<term>certifying agent</term> means a third party accredited as a certifying
agent pursuant to subsection (a)(1).</text>
</paragraph><paragraph id="H21488B10204642AB8934C6F88CACF085"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>facility</term> means a
facility required to be registered under section 415.</text>
</paragraph></subsection></section><section id="H0932C53311FF4511A6E83185EC00203D"><enum>421.</enum><header>Certification
of laboratories; accreditation of laboratory certifying agents</header>
<subsection id="HDC7B7087C9474B1C9CC0068FAE749083"><enum>(a)</enum><header>In
general</header><text>Not later than 2 years after the date of the enactment of
this section, the Secretary shall establish a program for the certification of
laboratories for the purpose of conducting sampling and testing of food to
ensure compliance with the requirements of this Act.</text>
</subsection><subsection id="HA93AE7AB914D4ABB8FC500FB003CEAEA"><enum>(b)</enum><header>Standards</header><text>Not
later than 18 months after the date of the enactment of this section, the
Secretary shall develop standards to certify laboratories under this section.
Such standards shall include—</text>
<paragraph id="H5FAA0680D1AC4133B06E62AD92C859B1"><enum>(1)</enum><text>standards for
sampling and analytical procedures;</text>
</paragraph><paragraph id="HD3A297140E1741EFA39FC769126BB452"><enum>(2)</enum><text>training and
qualification levels for individuals who conduct the analyses;</text>
</paragraph><paragraph id="H33EFE49ACA164C57BB6B2D2286B8FE06"><enum>(3)</enum><text>standards for
internal quality systems; and</text>
</paragraph><paragraph id="H1F4525D1AE0F48E08B6F95E8E642C4E8"><enum>(4)</enum><text>any other
standards determined appropriate by the Secretary.</text>
</paragraph></subsection><subsection id="H161B3B2A364D403C8382D17DC6133E7"><enum>(c)</enum><header>Accreditation of
third parties as laboratory certifying agents</header>
<paragraph id="HE1CD24DBBA354A4FA14703CFA5E32808"><enum>(1)</enum><header>In
general</header><text>The Secretary may establish an accreditation system under
which third parties, as determined appropriate by the Secretary, may request to
be accredited as a laboratory certifying agent to certify laboratories as
meeting the applicable requirements of this Act.</text>
</paragraph><paragraph id="H10922EE228B440F78FBDD25B3700CABE"><enum>(2)</enum><header>Application of
requirements relating to qualifications of agents, performance of audits and
renewal of accreditation, and withdrawal of accreditation</header><text>The
provisions of paragraphs (2), (4), and (5), other than paragraph (5)(A)(i), of
section 420(a) shall apply to the accreditation of laboratory certifying agents
with respect to laboratories in the same manner as such provisions apply to the
accreditation of certifying agents with respect to facilities.</text>
</paragraph><paragraph id="H79BF93FF60D04E5DB1D23425C81FB2F"><enum>(3)</enum><header>Application of
additional requirements</header><text>The provisions of paragraphs (1) (other
than subparagraph (B) and other than the requirement under subparagraph (A)
that an audit be unannounced), (2), (3), and (4) of section 420(b) shall apply
to laboratory certifying agents under this subsection with respect to
laboratories in the same manner as such provisions apply to the certifying
agents with respect to facilities.</text>
</paragraph><paragraph display-inline="no-display-inline" id="H5D684B82AE9F438195D5EA620086292E"><enum>(4)</enum><header>Laboratory
certifying agent defined</header><text>In this section, the term
<term>laboratory certifying agent</term> means a third party accredited as a
laboratory certifying agent under this subsection.</text>
</paragraph></subsection><subsection id="H5B18CE5045E14CD0A9306552FA4C74A3"><enum>(d)</enum><header>Publication of
list of certifying agents and certified laboratories</header><text display-inline="yes-display-inline">The provisions of paragraph (6) of section
420(a) shall apply to third parties accredited as laboratory certifying agents
under subsection (c) and to laboratories certified under subsection (a) in the
same manner as such provisions apply to third parties accredited as certifying
agents under such section.</text>
</subsection><subsection id="HFC8D8354A3FE486584FD5396BA672E73"><enum>(e)</enum><header>Food testing by
certified laboratories</header>
<paragraph id="H8B82E513214046C8BE47E8BC4F8E9B9C"><enum>(1)</enum><header>In
general</header><text>Beginning 3 years after the date of the enactment of this
section, testing of food described in paragraph (2) shall be conducted only by
Federal laboratories or by laboratories certified under subsection (a).</text>
</paragraph><paragraph id="H25CAC778A31F4598926459F094FC4498"><enum>(2)</enum><header>Testing of food
covered</header><text>The testing of food described in this paragraph is
testing of food—</text>
<subparagraph id="HA4DBD7B9D3644BE0B19BCD1D031679E"><enum>(A)</enum><text display-inline="yes-display-inline">conducted in support of an admission of an
article of food under section 801;</text>
</subparagraph><subparagraph id="HEEB932D4D2914729BD59DBEE99F62C1"><enum>(B)</enum><text>conducted in
support of a reoffer of food previously denied admission under section
402(h);</text>
</subparagraph><subparagraph id="H5C402638546143519716DC55438D3043"><enum>(C)</enum><text>conducted under an
import alert that requires successive consecutive tests;</text>
</subparagraph><subparagraph id="H0AD975BA85984686857120B7843173FD"><enum>(D)</enum><text>conducted to show
compliance with an order of the Secretary;</text>
</subparagraph><subparagraph id="HC0CBE7A436B046B5B32DAEF153B95FCA"><enum>(E)</enum><text>conducted in
support of an appeal of an order of the Secretary; or</text>
</subparagraph><subparagraph id="HF6BD12FE34CB4206AF0067DEFABDD901"><enum>(F)</enum><text>as otherwise
required to be conducted by the Secretary, as the Secretary deems
appropriate.</text>
</subparagraph></paragraph><paragraph id="H6C79A28E8C0546B300E46FB3F7809EDE"><enum>(3)</enum><header>Access to
testing results</header><text>The results of any testing of food described in
paragraph (2) by a laboratory certified under this section shall be promptly
transmitted by such laboratory in electronic format to the Secretary.</text>
</paragraph></subsection><subsection id="HADE0B075B07E4B9E827BA2A7CC8BCF35"><enum>(f)</enum><header>False or
misleading statements</header><text>For purposes of section 301(q)(2), as
amended by section 406, any statement or representation made by an employee or
agent of a laboratory to a laboratory certifying agent is deemed to be a report
required by or under this
Act.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H98446D08A3834FB58267AB5264527D26"><enum>(c)</enum><header>Fees</header><text display-inline="yes-display-inline">Part 5 of subchapter C of chapter VII, as
added by section 101(b) and amended by section 108(a), is amended by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HEF4061DA673E4470009D5CD1631C7EF2" style="OLC">
<section commented="no" id="H3B3FC4271B6F43D0BF462FDC2BF12EEB"><enum>741B.</enum><header>Certifying
agent fee</header>
<subsection commented="no" id="HADEA923C1AB74410AF250069A517188E"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">The Secretary shall
assess and collect a fee for the accreditation of an entity as a certifying
agent under section 420(a) for the purpose of defraying the costs of
implementing the system established for such accreditation.</text>
</subsection><subsection commented="no" id="HF8448931CC894520A300082838BEBA3"><enum>(b)</enum><header>Amount of
fee</header><text display-inline="yes-display-inline">The amount of a fee under
this section shall be as determined by the Secretary.</text>
</subsection></section><section commented="no" id="HFC93A51325D34BB681E55E59A0850021"><enum>741C.</enum><header>Laboratory
certifying agent accreditation fee</header><text display-inline="no-display-inline">The Secretary shall assess and collect an
annual fee, specified by the Secretary, for accreditation of laboratory
certifying agents under section 421 for the purpose of defraying the costs of
the accreditation activities under such
section.</text>
</section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" id="H68C1E0ADEC1E443EBFEE6BE263D0DD88"><enum>110.</enum><header>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="H9F216729BF0A42489FC09D5929CDDDEA" style="OLC">
<section commented="no" id="H0D17D4E107174FCEA7AFF86877B2DEB2"><enum>805.</enum><header>Safe and secure
food importation program</header>
<subsection commented="no" id="H9E07C70CA23042AFB1006530D0E6D190"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Beginning not later
than 2 years after the date of the enactment of this section, the Secretary
shall establish by regulation and carry out a program under which the Secretary
expedites the movement of food through the importation process under this Act
if each facility involved in the production, manufacture, processing,
packaging, and holding of the food—</text>
<paragraph commented="no" id="H7672C02F06F649F2B7FAB983565429C5"><enum>(1)</enum><text display-inline="yes-display-inline">is certified by a certifying agent
accredited pursuant to section 420(a)(1); and</text>
</paragraph><paragraph commented="no" id="H77C8D5B1CFD54EC2AAABE7F54D9E011B"><enum>(2)</enum><text>has agreed to
abide by, and has been determined by the Secretary to be in compliance with,
the food safety and security guidelines developed under subsection (b) with
respect to such food.</text>
</paragraph></subsection><subsection commented="no" id="H2F90C0F11EF749BCB6A977133D53007E"><enum>(b)</enum><header>Guidelines</header>
<paragraph commented="no" id="HFAD22E85AC9147FB81DB2DFF633DE5E7"><enum>(1)</enum><header>Development</header><text>For
purposes of the program established under subsection (a), the Secretary shall
develop safety and security guidelines applicable to the importation of
food.</text>
</paragraph><paragraph commented="no" id="H8543F1704ED746FAB73B00FC526DEAFE"><enum>(2)</enum><header>Factors</header><text>Such
guidelines shall take into account the following factors:</text>
<subparagraph commented="no" id="HADEC9BDE30BB4DD3BE7921F849399BA3"><enum>(A)</enum><text>The personnel of
the person importing the food.</text>
</subparagraph><subparagraph commented="no" id="H013D95BF38EF4DA0A63068489E9B6E01"><enum>(B)</enum><text>The physical and
procedural safety and security of such person’s food supply chain.</text>
</subparagraph><subparagraph commented="no" id="H63D208827A0D472EBC8524144705EC32"><enum>(C)</enum><text>The sufficiency of
access controls for food and ingredients purchased by such person.</text>
</subparagraph><subparagraph commented="no" id="HFFE023C7EBA749E6A4FBE16FBB84C6E0"><enum>(D)</enum><text>Vendor and
supplier information.</text>
</subparagraph><subparagraph commented="no" id="HBD6567EE99FD405696976FF492B8C093"><enum>(E)</enum><text>Such other factors
as the Secretary determines
necessary.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section></subtitle><subtitle id="HD53B31AF429E46039DBC2BC4D8BE2BD6"><enum>B</enum><header>Intervention</header>
<section id="HC893988BC2A041189089005DE8007BB1"><enum>111.</enum><header>Public health
assessment system</header>
<subsection id="HEBB7F8566E554624BE70DDF600420D0"><enum>(a)</enum><header>Active
surveillance system</header><text>The Secretary of Health and Human Services
(in this subtitle referred to as the <quote>Secretary</quote>), acting through
the Centers for Disease Control and Prevention, shall establish and implement
an active surveillance system for food, based on a representative proportion of
the population of the United States, to assess more accurately the frequency
and sources of human illness in the United States associated with the
consumption of food.</text>
</subsection><subsection id="H97F38E83D6AE4FCBA2E425516EEF4446"><enum>(b)</enum><header>Sampling
system</header>
<paragraph id="HBF866977F6494903B099B329BB892FCA"><enum>(1)</enum><header>In
general</header><text>The Secretary shall establish and implement a sampling
system under which the Secretary takes and analyzes samples of food
products—</text>
<subparagraph id="HFE5D2DC1B0E64BF1999C18EC88F8BBC4"><enum>(A)</enum><text>to assist the
Secretary in carrying out this Act and the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.); and</text>
</subparagraph><subparagraph id="H8FF5811D99CB40B9A5EC5CD73392AFDF"><enum>(B)</enum><text>to more accurately
assess the nature, frequency of occurrence, and amounts of contaminants in food
products.</text>
</subparagraph></paragraph><paragraph id="H7BF2A8518D7844D28224FAF4003EC1D7"><enum>(2)</enum><header>Requirements</header><text>Such
sampling system shall provide—</text>
<subparagraph id="HE3CD4566797749A2921C6FEAD03728E"><enum>(A)</enum><text>statistically valid
monitoring, including market-basket studies, on the nature, frequency of
occurrence, and amounts of contaminants in food products available to
consumers; and</text>
</subparagraph><subparagraph id="H190098FB8A1446ACA25CDBC8B36C9347"><enum>(B)</enum><text>at the request of
the Secretary, such other information, including analysis of monitoring and
verification samples, as the Secretary determines may be useful in assessing
the occurrence of contaminants in food products.</text>
</subparagraph></paragraph><paragraph id="H54C9A9C0D05B43EB00F966639284649D"><enum>(3)</enum><header>Guidelines</header><text display-inline="yes-display-inline">Within 12 months after the date of the
enactment of this Act, the Secretary shall establish guidelines for the
sampling system under this subsection.</text>
</paragraph></subsection><subsection id="HB3B04BF613A84E8280AF1D2FBAA18153"><enum>(c)</enum><header>Assessment of
health hazards</header><text>Through the surveillance system under subsection
(a) and the sampling system under subsection (b), the Secretary shall rank food
categories based on their hazard to human health and identify appropriate
industry and regulatory approaches to minimize hazards in the food supply. Such
analysis may include—</text>
<paragraph id="HDCEDAD72FA4B4BC9BD66FEF22FE1BDE9"><enum>(1)</enum><text>the safety of
commercial harvesting and processing, as compared with the health hazards
associated with food products that are harvested for recreational or
subsistence purposes and prepared noncommercially;</text>
</paragraph><paragraph id="H9396B296462E43358C8CC508E5A6C56B"><enum>(2)</enum><text>the safety of food
products that are domestically harvested and processed, as compared with the
health hazards associated with food products that are harvested or processed
outside the United States;</text>
</paragraph><paragraph id="H42CA5517B24044C08070CEFFC6498890"><enum>(3)</enum><text>contamination
originating from handling practices that occur prior to or after sale of food
products to consumers; and</text>
</paragraph><paragraph id="HF408E8EEEA034F06A2B42B03B1B10095"><enum>(4)</enum><text>use of comparative
risk assessments.</text>
</paragraph></subsection></section><section id="HC5CE373919BD46A2BD005E4C3E5172CE"><enum>112.</enum><header>Public
education and advisory system</header>
<subsection id="HA7F69536BC044A14BCF8FD39EE061120"><enum>(a)</enum><header>Public
education</header><text>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 id="H9032622505C64A53927755DC809E711"><enum>(1)</enum><text>information to the
public regarding Federal standards and good practice requirements and promotion
of public awareness, understanding, and acceptance of such standards and
requirements;</text>
</paragraph><paragraph id="H8838A28AC4BC49BC9ED0D3DD72B999F3"><enum>(2)</enum><text>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 id="H7B5CBBC3A21E4E8CBFBA88DB00CB1B87"><enum>(3)</enum><text>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 id="H6CD225100799412EA2BA4B79CB265984"><enum>(b)</enum><header>Health
advisories</header><text>The Secretary shall work with the States and other
appropriate entities to—</text>
<paragraph id="HC2BF2904618D4A60A816EBE9C241D8C9"><enum>(1)</enum><text>develop and
distribute regional and national advisories concerning food safety;</text>
</paragraph><paragraph id="H67F9CD4E97A6423DAE4409FB69EB4E22"><enum>(2)</enum><text>develop
standardized formats for written and broadcast advisories; and</text>
</paragraph><paragraph id="H9EEFB0AA7D5C497E96DA043E25D5582"><enum>(3)</enum><text>incorporate State
and local advisories into the national public education program required under
subsection (a).</text>
</paragraph></subsection></section><section id="H92B344A09F434A669E46E7E8909F953"><enum>113.</enum><header>Research</header>
<subsection id="H53089608066348ED8192EA3992A25B00"><enum>(a)</enum><header>In
general</header><text>The Secretary shall conduct research to assist in the
implementation of this Act, including studies to—</text>
<paragraph id="H4ECCB6F4519A41CDBE4C1C80022BA7F4"><enum>(1)</enum><text>improve sanitation
and food safety practices in the processing of food products;</text>
</paragraph><paragraph id="H56FC819827F740F5B39C631CEEBB6D57"><enum>(2)</enum><text>develop improved
techniques for the monitoring of food and inspection of food products;</text>
</paragraph><paragraph id="HB8DB69C8FF5B4C2292139DCEB535463"><enum>(3)</enum><text>develop efficient,
rapid, and sensitive methods for determining and detecting the presence of
contaminants in food products;</text>
</paragraph><paragraph id="H6642B21AC208436693B0BF1DF61BFB80"><enum>(4)</enum><text>determine the
sources of contamination of food and food products with contaminants;</text>
</paragraph><paragraph id="HEDAB76018CE94FF6896F564911DD06D0"><enum>(5)</enum><text>develop
consumption data with respect to food products;</text>
</paragraph><paragraph id="H02B37336492D466F8B83EF5FAD29E5EA"><enum>(6)</enum><text>draw upon research
and educational programs that exist at the State and local level;</text>
</paragraph><paragraph id="HA7CB0147B7454D75A74DAA13EEEFFB39"><enum>(7)</enum><text>utilize the DNA
matching system and other processes to identify and control pathogens;</text>
</paragraph><paragraph id="HCF3D278244E6484CBE4600C1005DB701"><enum>(8)</enum><text>address common and
emerging zoonotic diseases;</text>
</paragraph><paragraph id="HEF373AED8CAB40E8BDEB3D7320FF9F15"><enum>(9)</enum><text>develop methods to
reduce or destroy pathogens before, during, and after processing;</text>
</paragraph><paragraph id="H62444A6052BA44F79C7D36B6F17CE7E5"><enum>(10)</enum><text>analyze the
incidence of antibiotic resistance as it pertains to the food supply and
develop new methods to reduce the transfer of antibiotic resistance to humans;
and</text>
</paragraph><paragraph id="HC3FB009D0FAA4E40A446415D73778C12"><enum>(11)</enum><text>conduct other
research that supports the purposes of this Act.</text>
</paragraph></subsection><subsection id="H14B64108B7E04AE0AD00F74049C0B8C3"><enum>(b)</enum><header>Contract
authority</header><text>The Secretary is authorized to enter into contracts and
agreements with any State, university, government agency, or other person to
carry out this section.</text>
</subsection></section><section id="H2799D8C0737A456EAE63C9D7B0C300FD"><enum>114.</enum><header>Notification,
nondistribution, and recall of adulterated or misbranded articles of
food</header>
<subsection id="H7BACECA617B043309071D1EE84313C6"><enum>(a)</enum><header>Prohibited
acts</header><text>Section 301 (21 U.S.C. 331), as amended by sections 102 and
104, is amended by adding at the end the following:</text>
<quoted-block id="HA0E4062B2DF4436EAA56F3D741D384E9" style="OLC">
<subsection id="H1030DCA25B36431D009DF7D43618A2AF"><enum>(qq)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H6F478D43DACF4806B4A63944D5BA676"><enum>(1)</enum><text>The failure to notify the
Secretary in violation of section 422(a).</text>
</paragraph><paragraph id="H2EEE35E1C864493197A9F76E589F3D1" indent="up1"><enum>(2)</enum><text>The failure to comply with—</text>
<subparagraph id="H0F9ABC2203594E038B9D939028E6B0A5"><enum>(A)</enum><text>an order issued under section 422(b)
following any hearing requested under section 422(c); or</text>
</subparagraph><subparagraph id="HBD10CEC8C13B40359F72BEDCABA9C3BD"><enum>(B)</enum><text>an amended order issued under section
422(d)(1).</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HC1CBE38A389A4D9FB8B5CB1FDC9065"><enum>(b)</enum><header>Notification,
nondistribution, and recall of adulterated or misbranded articles of
food</header><text display-inline="yes-display-inline">Chapter IV (21 U.S.C.
341 et seq.), as amended by sections 102(b), 104, and 108(c), is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HA19F61890D3A4AD1958738FA03B04154" style="OLC">
<section id="HB86DADD437C04E888FABB037EEE0400"><enum>422.</enum><header>Notification,
nondistribution, and recall of adulterated or misbranded articles of
food</header>
<subsection id="H2E1E37A0645047A79BCEE65001133AA"><enum>(a)</enum><header>Notification to
Secretary of violation</header>
<paragraph id="H75D39F7C4CDC49A581309CDA048F5569"><enum>(1)</enum><header>In
general</header><text>A person (other than a household consumer or other
individual who is the intended consumer of an article of food) 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,
if consumed, may result in illness or injury shall, as soon as practicable,
notify the Secretary of the identity and location of the article.</text>
</paragraph><paragraph id="H7C19F304C3834A8789445E73DDC5D862"><enum>(2)</enum><header>Manner of
notification</header><text>Notification under paragraph (1) shall be made in
such manner and by such means as the Secretary may require by
regulation.</text>
</paragraph></subsection><subsection id="H455881E2A92844D500A9354C47CE3ED"><enum>(b)</enum><header>Recall and
Consumer Notification</header>
<paragraph id="HB9DFB9710E994828BBE53E2789D344E8"><enum>(1)</enum><header>Voluntary
actions</header><text>On receiving notification under subsection (a) or by
other means of a suspected adulteration or misbranding of food, if the
Secretary finds 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, if consumed, may result in illness or injury (as determined by the
Secretary), the Secretary shall provide all appropriate persons (including the
manufacturer, importer, distributor, or retailer of the article) with an
opportunity (as determined by the Secretary)—</text>
<subparagraph id="HD77441287F474AA8851CA18B91B9E1BF"><enum>(A)</enum><text>to cease
distribution of the article;</text>
</subparagraph><subparagraph id="H570C4E533A294B42826BAAC879C5FB46"><enum>(B)</enum><text>to notify all
persons—</text>
<clause id="H973E3DE44ADF48B5A4A002ABA50700C0"><enum>(i)</enum><text>that produce,
manufacture, pack, process, prepare, treat, package, distribute, or hold the
article, to cease immediately those activities with respect to the article;
or</text>
</clause><clause id="H5890440E41FD41FCBD9267E4996000C7"><enum>(ii)</enum><text>to which the
article has been distributed, transported, or sold, to cease immediately
distribution of the article;</text>
</clause></subparagraph><subparagraph id="HB0843E6C2A72486D9611F256C1FD00C0"><enum>(C)</enum><text>to recall the
article;</text>
</subparagraph><subparagraph id="H798749A71B214F639D8D45E176B8EA51"><enum>(D)</enum><text>in consultation
with the Secretary, to provide notice of the finding of the Secretary to all
consumers to which the article was, or may have been, distributed and to
appropriate State and local health officials; and</text>
</subparagraph><subparagraph id="HEA148F80183A4463B6739860EE1EF029"><enum>(E)</enum><text>to notify State
and local public health officials.</text>
</subparagraph></paragraph><paragraph id="H8AFB62338F7543488FDEB9C811385409"><enum>(2)</enum><header>Mandatory
actions</header><text>If the appropriate person referred to in paragraph (1)
does not carry out the actions described in that paragraph with respect to an
article within the time period and in the manner prescribed by the Secretary,
the Secretary—</text>
<subparagraph id="HFE395547F7CB428A87EDA00E3EB1529"><enum>(A)</enum><text>shall issue an
order requiring the person—</text>
<clause id="H82DD58C4167845D0A4B5FBF91271CDD3"><enum>(i)</enum><text>to
immediately cease distribution of the article; and</text>
</clause><clause id="H0376ECCBB8104D1497875DC3C9D44400"><enum>(ii)</enum><text>to immediately
make the notification described in paragraph (1)(B); and</text>
</clause></subparagraph><subparagraph id="H616A9F3FF77145F98194B862EB27C73E"><enum>(B)</enum><text>may take control
or possession of the article.</text>
</subparagraph></paragraph><paragraph id="H4FE4D5FECEF14ACF8BE6C8D2155F95C5"><enum>(3)</enum><header>Notice to
consumers and health officials</header><text>The Secretary shall, as the
Secretary determines to be necessary, provide notice of the finding of the
Secretary under paragraph (1) to consumers to which the article was, or may
have been, distributed and to appropriate State and local health
officials.</text>
</paragraph></subsection><subsection id="H6918E278E68C4C8EA6687E63F3C4824C"><enum>(c)</enum><header>Hearings on
Orders</header>
<paragraph id="HF53053A4E9B8415B861CD226216F7232"><enum>(1)</enum><header>In
general</header><text>The Secretary shall provide a person subject to an order
under subsection (b)(2) with an opportunity for a hearing on—</text>
<subparagraph id="HD1CE16EE030041A7A635B6299F7300F3"><enum>(A)</enum><text>the actions
required by the order; and</text>
</subparagraph><subparagraph id="H135FB83A83064CF4BA9CBD5E276818CE"><enum>(B)</enum><text>any reasons why
the article of food that is the subject of the order should not be
recalled.</text>
</subparagraph></paragraph><paragraph id="HFEF29A9D062443B6A531899D6EACF7FC"><enum>(2)</enum><header>Timing of
hearings</header><text>If a hearing is requested under paragraph (1) with
respect to an order, the Secretary shall hold the hearing as soon as
practicable, but not later than 2 business days, after the date of issuance of
the order.</text>
</paragraph></subsection><subsection id="H37753625C80847BD92FE7C3E2CAF590"><enum>(d)</enum><header>Post-Hearing
Recall Orders</header>
<paragraph id="HFBC5D994AFB5482CA403FFC4EEB3F68D"><enum>(1)</enum><header>Amendment of
orders</header><text>If, after providing an opportunity for a hearing (and a
hearing if requested) under subsection (c), the Secretary determines 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, if
consumed, may result in illness or injury, the Secretary may, as the Secretary
determines to be necessary—</text>
<subparagraph id="H3D3F052EDF7643AE9EE9AB1CCF947422"><enum>(A)</enum><text>amend the order
under subsection (b)(2)—</text>
<clause id="H4274C8B629E24E319BA2919C7E2B392F"><enum>(i)</enum><text>to
require recall of the article or other appropriate action; and</text>
</clause><clause id="HCF2CA7D425D14F9582BD1CE94C10F65B"><enum>(ii)</enum><text>to specify a
timetable during which the recall shall occur;</text>
</clause></subparagraph><subparagraph id="H9757968B75E948458B9F1FC300B5892"><enum>(B)</enum><text>require periodic
reports to the Secretary describing the progress of any such recall; and</text>
</subparagraph><subparagraph id="H0E5BFECF6D074C729F00FC266BBE0812"><enum>(C)</enum><text>provide notice of
such a recall to consumers to which the article was, or may have been,
distributed.</text>
</subparagraph></paragraph><paragraph id="H8A94932884FF4B7A98E1B71EDDFA58A"><enum>(2)</enum><header>Vacation of
orders</header><text>If, after providing an opportunity for a hearing (and a
hearing if requested) under subsection (c), the Secretary determines that
adequate grounds do not exist to continue the actions required by the order,
the Secretary shall vacate the order.</text>
</paragraph></subsection><subsection id="H268875A779E74C9B9182D2FFACF7B9D"><enum>(e)</enum><header>Remedies Not
Exclusive</header><text>The remedies authorized by this section shall be in
addition to any other remedies that may be
available.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HF3F07C910CE347628C7F6FA57B8F9CC0"><enum>(c)</enum><header>Effective
date</header><text>Sections 301(qq)(1) and 422 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></subtitle><subtitle id="H69D87AC964A14005BAE2331F31C4EBD0"><enum>C</enum><header>Response</header>
<section id="HB7CF8127ED8E424583C5DD85D7D573E4"><enum>121.</enum><header>Administrative
detention</header>
<subsection id="HB6BF561EB1464BB5A7735E81EA226C3"><enum>(a)</enum><header>In
general</header><text>Section 304(h)(1)(A) (21 U.S.C. 334(h)(1)(A)) is amended
by—</text>
<paragraph id="H7C5E6B67A15141919C6E52342E804FFD"><enum>(1)</enum><text>striking
<quote>credible evidence or information indicating</quote> and inserting
<quote>reason to believe</quote>; and</text>
</paragraph><paragraph id="H30AB2BBA9F7E4F2B96FFF0AAAFF07259"><enum>(2)</enum><text>striking
<quote>presents a threat of serious adverse health consequences or death to
humans or animals</quote> and inserting <quote>is adulterated or
misbranded</quote>.</text>
</paragraph></subsection><subsection id="H51FDD6C415974880AE49354C3F008CA8"><enum>(b)</enum><header>Regulations</header><text>Not
later than 120 days after the date of enactment of this Act, the Secretary
shall issue an interim final rule amending subpart K of part 1 of title 21,
Code of Federal Regulations, to implement the amendment made by this
section.</text>
</subsection><subsection id="H21433A411F684D96AA662B6C8DC9E765"><enum>(c)</enum><header>Effective
date</header><text>The amendments made by this section shall take effect 180
days after the date of enactment of this Act.</text>
</subsection></section><section id="H9B91B4E4B84B408A8E669C59BEAD994C"><enum>122.</enum><header>Civil penalties
relating to food</header>
<subsection id="H9896FF333E654FFF89EA379EC1EBB9A5"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Chapter III (21
U.S.C. 331 et seq.) is amended by adding after section 303 the
following:</text>
<quoted-block display-inline="no-display-inline" id="H59A75E6945E645A1AD9DFCD800E38E89" style="OLC">
<section id="H4EC197F16446419DBADB2FB7DB9300A3"><enum>303A.</enum><header>Civil
penalties relating to foods</header>
<subsection id="H87577EC411C9432B8E0096CFFC509280"><enum>(a)</enum><header>In
general</header>
<paragraph id="H727408C22E65400A8DC3CF519BBAD8AF"><enum>(1)</enum><header>Assessment</header><text>The
Secretary may assess against a person that commits an act prohibited by section
301 with respect to an article of food a civil penalty for each such act of not
more than—</text>
<subparagraph id="H0977660CB76642CB8DB12CA3D5C0094"><enum>(A)</enum><text>$100,000, in the
case of an individual; and</text>
</subparagraph><subparagraph id="H732F1FA0299742E2B6E42F62D8F76AB"><enum>(B)</enum><text>$500,000, in the
case of any other person.</text>
</subparagraph></paragraph><paragraph id="H79757503AA23439198D5D1003E371F41"><enum>(2)</enum><header>Separate
offenses</header><text>Each prohibited act described in paragraph (1) and each
day during which the act continues shall be considered to be a separate
offense.</text>
</paragraph><paragraph id="HAAB6705846E64088A6699CB16822D0E9"><enum>(3)</enum><header>Notice and
opportunity for hearing</header><text>The Secretary shall not assess a civil
penalty under this section against a person unless the person is given notice
and opportunity for a hearing on the record before the Secretary in accordance
with sections 554 and 556 of title 5, United States Code.</text>
</paragraph><paragraph id="HA0A6D55383334C21BFA22A43B51C200"><enum>(4)</enum><header>Determination of
civil penalty amount</header><text>The amount of a civil penalty under this
section—</text>
<subparagraph id="HD669824075BF431793C061B0F29761DA"><enum>(A)</enum><text>shall be assessed
by the Secretary by written order, taking into account—</text>
<clause id="HBD7E996D4DAF4530B1C61B29C200ED56"><enum>(i)</enum><text>the gravity of the
violation;</text>
</clause><clause id="H81C16F37B3D84D8F8DC7EE4FC7D810D4"><enum>(ii)</enum><text>the degree of
culpability of the person;</text>
</clause><clause id="H5D1A02C2EC5244F5AEC8153B2830007E"><enum>(iii)</enum><text>the size and
type of the business of the person; and</text>
</clause><clause id="H7E0299A8A9494318AC145DDE28CA7CB9"><enum>(iv)</enum><text>any history of
prior offenses by the person; and</text>
</clause></subparagraph><subparagraph id="H153A1F53655C43968BB9FEC020077C5"><enum>(B)</enum><text>shall be reviewed
only in accordance with subsection (b).</text>
</subparagraph></paragraph></subsection><subsection id="HE507E22F5900449B00D0FF39C66E2B99"><enum>(b)</enum><header>Judicial
review</header>
<paragraph id="H893B49207A1246F3A0322EC15CC1ABA5"><enum>(1)</enum><header>In
general</header><text>An order assessing a civil penalty against a person under
subsection (a) shall be final unless the person—</text>
<subparagraph id="HD4F156A04B7A476D8FF48EF460D2D15B"><enum>(A)</enum><text>not later than 30
days after the effective date of the order, files a petition for judicial
review of the order in—</text>
<clause id="HA0E59649059D47E3B5ADB500BCE0FE42"><enum>(i)</enum><text>the United States
court of appeals for the circuit in which the person resides or has its
principal place of business; or</text>
</clause><clause id="H2261951BC1BA4CBE957641DF2884BB6"><enum>(ii)</enum><text>the United States
Court of Appeals for the District of Columbia Circuit; and</text>
</clause></subparagraph><subparagraph id="H4A30F2FCE30744F6B23400A06BE6E1D4"><enum>(B)</enum><text>simultaneously
sends a copy of the petition by certified mail to the Secretary.</text>
</subparagraph></paragraph><paragraph id="H1BFBAB2FE9174FF59B117FE32387218C"><enum>(2)</enum><header>Filing of copy
of record</header><text>The Secretary shall promptly file in the court a
certified copy of the record on which the order was issued.</text>
</paragraph><paragraph id="HD7DA8F1DD5F14EE58F6BCEA22DFFBFAE"><enum>(3)</enum><header>Standard of
review</header><text>The findings of the Secretary relating to the order shall
be set aside only if the findings are found to be unsupported by substantial
evidence on the record as a whole.</text>
</paragraph></subsection><subsection id="H584F1950DB724C208E4936C825C73FCE"><enum>(c)</enum><header>Collection
actions for failure To pay assessment</header>
<paragraph id="H5E2DDAB6DBD24E1B93128D6E06D301DD"><enum>(1)</enum><header>Referral to
attorney general</header><text>If a person fails to pay a civil penalty
assessed under subsection (a) after the order assessing the civil penalty has
become a final order, or after the court of appeals has entered final judgment
in favor of the Secretary, the Secretary may refer the matter to the Attorney
General.</text>
</paragraph><paragraph id="HF32D79EC3C33450BBBA623277CEFCEC"><enum>(2)</enum><header>Action by
attorney general</header><text>The Attorney General shall bring a civil action
to recover the amount of the civil penalty in United States district
court.</text>
</paragraph><paragraph id="HD188F40444E7444980D036674FC9F3C0"><enum>(3)</enum><header>Scope of
review</header><text>In a civil action under paragraph (2), the validity and
appropriateness of the order of the Secretary assessing the civil penalty shall
not be subject to review.</text>
</paragraph></subsection><subsection id="HA6724D256B2045D69571CFAB98FF5C88"><enum>(d)</enum><header>Penalties
deposited in Treasury</header><text>All amounts collected as civil penalties
under this section shall be deposited in the Treasury of the United States and
shall be available to cover costs of the Administration in carrying out food
safety activities under this Act.</text>
</subsection><subsection id="HD5EBF5CEC1294D24BFB170298F716BF2"><enum>(e)</enum><header>Penalties in
lieu of other actions</header><text>Nothing in this Act requires the Secretary
to report for prosecution, or for the commencement of any libel or injunction
proceeding, any violation of this Act in any case in which the Secretary
believes that the public interest will be adequately served by the assessment
of a civil penalty under this section.</text>
</subsection><subsection id="HE0CAB41C05ED4B5CA171FFF019921997"><enum>(f)</enum><header>Remedies not
exclusive</header><text>The remedies authorized by this section shall be in
addition to any other remedies that may be
available.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H5BEAD97B8DAD4B3E89CF2F62D702A8ED"><enum>(b)</enum><header>Effective
date</header><text>The amendment made by subsection (a) shall apply to
prohibited acts committed on or after the date of the enactment of this Act
.</text>
</subsection></section><section id="H0B314068AB3B42B69F9164A390169532"><enum>123.</enum><header>Failure to
consent to investigation</header><text display-inline="no-display-inline">Section 801 (21 U.S.C. 381) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H5DBC3A1FE7EF4941A006636D5E09BEBE" style="OLC">
<subsection id="H64302D1C5A8B43FC00D7AFB7F100E33"><enum>(p)</enum><text display-inline="yes-display-inline">The Secretary may deny importation of food,
other than only for personal use, from any foreign country, or which is
manufactured, processed, packed, or held by a facility (as defined in section
415), if the government of such country, or such facility, respectively, does
not timely consent to an investigation by the Administration when food from
that country or facility is linked to a food-borne illness outbreak or is
otherwise found to be adulterated or
mislabeled.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section></subtitle><subtitle id="H36E95ECBC14C4D5FA9F11E820000BDD"><enum>D</enum><header>Miscellaneous</header>
<section id="H2279DFE09B4A473FB8D900A79B92B756"><enum>131.</enum><header>Labeling
requirement for meat, poultry products, and seafood that contain carbon
monoxide</header>
<subsection id="H9C81D0E738474563ADA7901C97589E00"><enum>(a)</enum><header>Labeling
requirement</header>
<paragraph id="HACCE75C7720A4AC99060AD155BDBB8AD"><enum>(1)</enum><header>In
general</header><text>Paragraph (t) of section 201 (21 U.S.C. 321) is amended
by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H31B1A45850374BAA959F2687F6521287" style="OLC">
<paragraph id="HE19D128E09A14BC2AF1C5800211673CB" indent="up1"><enum>(4)</enum><text display-inline="yes-display-inline">In the case of food that is meat within the
meaning of the Federal Meat Inspection Act, a poultry product within the
meaning of the Poultry Products Inspection Act, or seafood (including all fresh
or saltwater fish, molluscan shellfish, crustaceans, and other forms of aquatic
animal life) intended for human consumption as food within the meaning of
section 201(f) (referred to collectively in this paragraph as
<term>seafood</term>), the term <term>color additive</term> shall include
carbon monoxide under conditions of use that may impart, maintain, preserve,
stabilize, fix, or otherwise affect the color of fresh meat, poultry products,
or seafood, unless the label of such food bears, prominently and conspicuously
in such place and in such manner as to render it likely to be read and
understood by the ordinary person, the following statement to prevent consumer
deception and serious risks to the public health: <quote>CONSUMER NOTICE:
Carbon monoxide has been used to preserve the color of this product. Do not
rely on color or the “use or freeze by” date alone to judge the freshness of
the
product.</quote></text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="HDA7233DE3BA649A990EEF4828FAAEB4"><enum>(2)</enum><header>Effective
date</header><text display-inline="yes-display-inline">The amendment made by
this subsection shall apply to food labeled on or after the date that is 30
days after the date of the enactment of this Act.</text>
</paragraph></subsection><subsection id="H1CF5B0240B784716947E99ED5E81E34B"><enum>(b)</enum><header>Discretionary
authority</header><text>If, not earlier than 5 years after the effective date
described in subsection (a)(2), the Secretary of Health and Human Services
finds, based on competent and reliable scientific evidence, that the statement
prescribed in section 201(t)(4) of the Federal Food, Drug, and Cosmetic Act is
no longer required to prevent consumer deception and other harms, then the
Secretary is authorized to issue regulations establishing alternative labeling
requirements that are shown to be adequate and effective in preventing consumer
deception and other harms related to the conditions of use of carbon monoxide,
including with respect to preventing any consumer deception or other harm that
may result from the actual conditions of carbon monoxide use and its potential
to impart a persistent color to meat, poultry products, or seafood described in
such section through a reaction with natural pigment.</text>
</subsection></section><section id="H6E4C367B29FE4E83B5898B804233AF1B"><enum>132.</enum><header>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="H442CC71B4D0F40A0BA1671E168B4F96" other-style="archaic" style="other">
<subsection id="HE0902E84EE304A959BA9E1024BB56BA"><enum>(k)</enum><header>Substances generally recognized as safe</header><paragraph commented="no" display-inline="yes-display-inline" id="H3D906933A4DB44C0941D00410019BD31"><enum>(1)</enum><text>Not later than 60 days
after the date of receipt by the Secretary, after the date of the enactment of
this subsection, of a request for a substance to be determined by the Secretary
to be a GRAS food substance, the Secretary shall publish notice of such request
in the Federal Register.</text>
</paragraph><paragraph id="H672FF3EDBEEB45AA89DE5CDFC2F7E0D8" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">Not later than 90 days after the date of
publication of a notice under paragraph (1), the Secretary shall determine
whether the substance is a GRAS food substance.</text>
</paragraph><paragraph id="HEE780AD3158147AB95AE89FCEBBF0277" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">A
determination by the Secretary of whether a substance is a GRAS food substance
shall be published in the Federal Register.</text>
</paragraph><paragraph id="HA87ACDC61EC04E979BB26311FDBA6160" indent="up1"><enum>(4)</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 substances 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" id="H5C1512E0AA1E4304B738D3C0C5D37210"><enum>133.</enum><header>Country of
origin labeling; disclosure of source of ingredients</header>
<subsection commented="no" id="H31107E8924B3428CA2288CA1DF00000"><enum>(a)</enum><header>Food</header><text>Section
403 (21 U.S.C. 343), as amended by sections 101(a) and 108(b), is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H26F690A0AED8482E857C092F8B22C01C" style="OLC">
<subsection commented="no" id="HB68F50FFCBA34D19B3EA006FE1DABF6E"><enum>(bb)</enum><text>In the case of a
processed food if—</text>
<paragraph id="H12C918B1975E4EB3A42382FF97F226A3"><enum>(1)</enum><text>the labeling of
the food fails to identify the country in which the final processing of the
food occurs; and</text>
</paragraph><paragraph id="H84172AF74E98476890E8A3F15512C010"><enum>(2)</enum><text>the website for
the manufacturer of the food fails to identify the country (or countries) of
origin for each ingredient in the food.</text>
</paragraph></subsection><subsection id="HD66239979C934339A4BC7E772C780445"><enum>(cc)</enum><text>In the case of
non-processed food if—</text>
<paragraph id="HE35D8D1EE16B4E9F88159488402CD5C0"><enum>(1)</enum><text>the labeling of
the food fails to identify the country of origin of the food; and</text>
</paragraph><paragraph id="HF01E79AFB36F45FBA09009B33D6F00F1"><enum>(2)</enum><text>the website for
the original packer of the food fails to identify the country of origin for the
food.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="HCE1B0C9C60F64683A7D67F89DB2E4DF3"><enum>(b)</enum><header>Regulations</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 (bb) and (cc) of section
403 of the Federal Food, Drug, and Cosmetic Act, as added by subsection
(a).</text>
</subsection><subsection commented="no" id="HA62840303C3F431BBE498BBDAF453D42"><enum>(c)</enum><header>Effective
date</header><text>The requirements of paragraphs (bb) and (cc) 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 id="H8DD45169E93B40FE96EE532506173863"><enum>134.</enum><header>New food and
animal feed export certification fee to improve the ability of United States
firms to export their products</header><text display-inline="no-display-inline">Part 5 of subchapter C of chapter VII (21
U.S.C. 371 et seq.), as added by section 101(b) and amended by sections 108 and
109, is further amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H7B701D96A5904B9385B39599D4C99ECA" style="OLC">
<section id="H8643E0B502C64C2AAF875684E5419572"><enum>741D.</enum><header>New food and
animal feed export certification fee to improve the ability of United States
firms to export their products</header>
<subsection id="H731888BAB2684071BD80A67BE57256DE"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">If the Secretary
provides for the issuance of export certificates for foods and animal feeds in
cases where exportation is restricted without such a certificate, the Secretary
may impose a fee for the issuance of such a certificate.</text>
</subsection><subsection id="HC1D6C0A4FB954C36AD5128D7003042D9"><enum>(b)</enum><header>Amount</header><text>The
amount of the fee under this section shall be an amount that is reasonably
related to the cost of issuing such certificates.</text>
</subsection><subsection id="HAB867B58E96C40338800CB64D84CA8A9"><enum>(c)</enum><header>Use of
fees</header><text>The Secretary shall make all of the fees collected pursuant
to this section available solely to pay for the costs of issuance of such
certificates.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section></subtitle><enum>II</enum><header>Drug
and Device Safety</header>
<section commented="no" display-inline="no-display-inline" id="H1E93ABF1A93A41C7A61D8C00B6F99E88"><enum>201.</enum><header>Registration of
producers of drugs and devices; applicable fee</header>
<subsection id="HD2267D58AC8B4F2BBC65F0471297533D"><enum>(a)</enum><header>Registration</header>
<paragraph commented="no" id="H610A8DCBDC394BB7A400079539445862"><enum>(1)</enum><header>Misbranding</header><text display-inline="yes-display-inline">Paragraph (o) of section 502 (21 U.S.C.
352) is amended by striking <quote>in any State</quote>.</text>
</paragraph><paragraph commented="no" id="HE82E0BBF62834BFDB36DEF659F036D50"><enum>(2)</enum><header>Effective
date</header><text>The amendment made by paragraph (1) applies only with
respect to registration under section 510 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360) occurring on or after the date of the enactment of
this Act.</text>
</paragraph></subsection><subsection commented="no" id="HFFA06FA0B4CB4EDE829595008981233B"><enum>(b)</enum><header>Registration
fee</header>
<paragraph commented="no" id="HA381328054E141D292C4BA25E26B5FA"><enum>(1)</enum><header>Misbranding</header><text display-inline="yes-display-inline">Paragraph (o) of section 502 (21 U.S.C.
352), as amended by subsection (a)(2), is further amended by inserting after
<quote>not duly registered under section 510</quote> the following: <quote>or
in violation of section 736C for failure to pay a fee</quote>.</text>
</paragraph><paragraph id="H919A8A7A55364CB38FEA7FD97380EC00"><enum>(2)</enum><header>Establishment</header><text>Part
2 of subchapter C of chapter VII (21 U.S.C. 379g et seq.) is amended by adding
at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H30C56DE61468426782AC846F47C8FAB2" style="OLC">
<section commented="no" id="H640156E63AE74C8DB64982AFB338C952"><enum>736C.</enum><header>Registration
fee</header>
<subsection commented="no" id="H45354931429645F8A598E589AD79B35"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Except as provided in
subsection (b) of this section, the Secretary shall assess and collect an
annual fee for registration under subsection (b), (c), (d), or (i) of section
510 to defray increases (as described in subsection (g)(2)(A)(ii)) in the costs
of inspecting establishments registered under subsection (b), (c), (d), or (i)
of section 510 to ensure compliance by such establishments with the
requirements of this Act relating to drugs or devices.</text>
</subsection><subsection id="HECA0DB7D30EF4815A05C707BE225A6E3"><enum>(b)</enum><header>Exception</header><text>The
Secretary shall not assess or collect a fee under this section for registration
of an establishment under section 510 on the basis of such establishment’s
manufacture, preparation, propagation, or processing of an excipient of a
drug.</text>
</subsection><subsection id="H9DE127085CA5457F87ADF4A9FE7FE352"><enum>(c)</enum><header>Fee revenue
amounts</header>
<paragraph id="HAA984FD8B736407DA8235C9016D00840"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">For each of fiscal
years 2010 through 2014, fees under subsection (a) shall, except as provided in
subsections (d), (f), and (g), be established to generate a total revenue
amount under subsection (a).</text>
</paragraph><paragraph commented="no" id="HDEDDFB90A98940BEBEAAD9A5790032E5"><enum>(2)</enum><header>Total revenue
amount</header><text>Not later than September 1, 2010, the Secretary shall
transmit to the Congress the total revenue amount under paragraph (1) and how
such amount was calculated.</text>
</paragraph><paragraph id="HE9CEABC31DA3417B82F4CA95B47B476D"><enum>(3)</enum><header>Annual fee
setting</header><text display-inline="yes-display-inline">The Secretary shall,
not later than 60 days before the start of each fiscal year that begins after
September 30, 2009, establish, for the next fiscal year, registration fees
under subsection (a)—</text>
<subparagraph id="HE9183572B18F4798B89B8DADB8FAADDB"><enum>(A)</enum><text>based on the total
revenue amount applicable under paragraph (1); and</text>
</subparagraph><subparagraph id="H02E17DA7697846AFB8A53519D1EEAE37"><enum>(B)</enum><text>taking into
consideration the difference in costs of inspections between foreign and
domestic establishments.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="HC96A1F26E1304DCAA8ED466E1D6EC923"><enum>(d)</enum><header>Adjustments</header>
<paragraph commented="no" id="HE671913D21A04B64AAA1A83D6486296B"><enum>(1)</enum><header>Inflation
adjustment</header><text>For fiscal year 2011 and subsequent fiscal years, the
revenues established in subsection (c)(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" id="H5C85F63868384FB4004F18B79249B9A5"><enum>(A)</enum><text>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>
</subparagraph><subparagraph commented="no" id="HC2EB9FD9004C4E3AA09C7EADB5C8B340"><enum>(B)</enum><text>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" id="H75C9778E2B9947ED89225DBD81E42E39"><enum>(C)</enum><text>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><continuation-text commented="no" continuation-text-level="paragraph">The adjustment made each fiscal year
by this subsection will be added on a compounded basis to the sum of all
adjustments made each fiscal year after fiscal year 2009 under this
subsection.</continuation-text></paragraph><paragraph commented="no" id="H38CBB332AB0F4069B9B1BFDC00861C35"><enum>(2)</enum><header>Workload
adjustment</header><text>For fiscal year 2011 and subsequent fiscal years,
after the fee revenues established in subsection (c)(1) are adjusted for a
fiscal year for inflation in accordance with paragraph (1), the fee revenues
shall be adjusted further for such fiscal year to reflect changes in the
workload of the Secretary for inspections described in subsection (a). With
respect to such adjustment:</text>
<subparagraph commented="no" id="HE0811DF845C84E76B5ADA9F2D09592F"><enum>(A)</enum><text>The adjustment
shall be determined by the Secretary based on a weighted average of the change
in the total amount of inspections described in subsection (a). The Secretary
shall publish in the Federal Register the fee revenues and fees resulting from
the adjustment and the supporting methodologies.</text>
</subparagraph><subparagraph commented="no" id="H568A155458FB4E96BBB4407467C4CE27"><enum>(B)</enum><text>Under no
circumstances shall the adjustment result in fee revenues for a fiscal year
that are less than the fee revenues for the fiscal year established in
subsection (c)(1), as adjusted for inflation under paragraph (1). Any
adjustment for changes in inspection activities made in setting fees and
revenue amounts for fiscal year 2011 may not result in the total workload
adjustment being more than 2 percentage points higher than it would have been
in the absence of the adjustment for changes in inspection activities.</text>
</subparagraph><subparagraph commented="no" id="H406DCDD026A64F138772C3A15DE16922"><enum>(C)</enum><text>The Secretary
shall contract with an independent accounting firm to study the adjustment for
changes in inspection activities applied in setting fees and revenue amounts
for fiscal year 2011 and to make recommendations, if warranted, for future
changes in the methodology for calculating the adjustment. After review of the
recommendations, the Secretary shall, if warranted, make appropriate changes to
the methodology, and the changes shall be effective for each of the fiscal
years 2012 through 2014. The Secretary shall not make any adjustment for
changes in inspection activities for any fiscal year after 2011 unless such
study has been completed.</text>
</subparagraph></paragraph><paragraph commented="no" id="H508C9F64352D4090B91B6C4265F84957"><enum>(3)</enum><header>Rent and
rent-related cost adjustment</header><text>For fiscal year 2012 and each
subsequent fiscal year, the Secretary shall, before making adjustments under
paragraphs (1) and (2), decrease the fee revenue amount established in
subsection (c)(1) if actual costs paid for rent and rent-related expenses for
the preceding fiscal year are less than estimates made for such year in fiscal
year 2008. Any reduction made under this paragraph shall not exceed the amount
by which such costs fall below the estimates made in fiscal year 2008 for such
fiscal year, and shall not exceed $11,721,000 for any fiscal year.</text>
</paragraph><paragraph commented="no" id="H8D62932C142848E6BE871591B0BCEFF"><enum>(4)</enum><header>Final year
adjustment</header><text>For fiscal year 2014, the Secretary may, in addition
to adjustments under paragraphs (1), (2), (3), and (5), further increase the
fee revenues and fees established in subsection (c) if such an adjustment is
necessary to provide for not more than 3 months of operating reserves of
carryover user fees for inspections described in subsection (a) for the first 3
months of fiscal year 2015. If such an adjustment is necessary, the rationale
for the amount of the increase shall be contained in the annual notice
establishing fee revenues and fees for fiscal year 2014. If the Secretary has
carryover balances for such inspections in excess of 3 months of such operating
reserves, the adjustment under this paragraph shall not be made.</text>
</paragraph><paragraph commented="no" id="HBECEC3DE51E6426FB2D8E3FB65D01533"><enum>(5)</enum><header>Cost estimate
adjustment</header><text display-inline="yes-display-inline">For fiscal year
2011 and subsequent fiscal years, the Secretary by notice, published in the
Federal Register, shall—</text>
<subparagraph commented="no" id="H4C78F8C72B6243A78BDC691EEA4037D6"><enum>(A)</enum><text display-inline="yes-display-inline">provide an estimate of the amount of the
total increases described in subsection (a) for such fiscal year; and</text>
</subparagraph><subparagraph commented="no" id="H223CB503367948CD88005DBCC6AF25B8"><enum>(B)</enum><text>after making
adjustments under paragraphs (1), (2), and (3), adjust the revenues established
in subsection (c)(1) to be equal to such amount.</text>
</subparagraph></paragraph><paragraph commented="no" id="H0D1559BCCD1E46ADB6AB5D2230193009"><enum>(6)</enum><header>Limit</header><text>The
total amount of fees charged, as adjusted under this subsection, for a fiscal
year may not exceed the total increases described in subsection (a) for such
fiscal year.</text>
</paragraph></subsection><subsection id="H3F254A8E80D3443F998508DF6D996800"><enum>(e)</enum><header>Fee Waiver or
Reduction.</header>
<paragraph id="H7E36FFF55ADE44A79CB3F7EA18E3C122"><enum>(1)</enum><header>In
general</header><text>The Secretary may grant to a person a waiver from, or a
reduction of, one or more fees under this section if the Secretary finds
that—</text>
<subparagraph id="H81271A2D23D3445587D2004313A38822"><enum>(A)</enum><text>such waiver or
reduction is necessary to protect the public health; or</text>
</subparagraph><subparagraph id="H94621D56AAFE40E0B6FCDEB1DD1F1"><enum>(B)</enum><text>the assessment of the
fee would impose significant financial hardship because of limited resources
available to such person or other circumstances.</text>
</subparagraph></paragraph><paragraph id="H91E665A4CDDF4D8CA544AFB2F233C749"><enum>(2)</enum><header>Special rules
for positron emission tomography drugs</header>
<subparagraph id="H0DCF976D928B46329516F7A35495EA85"><enum>(A)</enum><header>In
general</header><text>Except as provided in subparagraph (B), each person who
is named as the applicant in an approved human drug application for a positron
emission tomography drug shall be subject under paragraph (a) to one-sixth of
an annual registration fee with respect to each establishment identified in the
application as producing positron emission tomography drugs under the approved
application.</text>
</subparagraph><subparagraph id="HB4B4D6781AC844B5AF4382F5B9AD241E"><enum>(B)</enum><header>Exception from
annual registration fee</header><text>Each person who is named as the applicant
in an application described in subparagraph (A) shall be granted a waiver under
paragraph (1) from an annual registration fee under subsection (a) for a fiscal
year if the person certifies to the Secretary, at a time specified by the
Secretary and using procedures specified by the Secretary, that—</text>
<clause id="HEC386D83A4B64C27B4A14D2C8EE1E241"><enum>(i)</enum><text>the person is a
not-for-profit medical center that has only 1 establishment for the production
of positron emission tomography drugs; and</text>
</clause><clause id="HEBE17BA5F27B44B297EF68EFA4FD54B8"><enum>(ii)</enum><text>at least 95
percent of the total number of doses of each positron emission tomography drug
produced by such establishment during such fiscal year will be used within the
medical center.</text>
</clause></subparagraph></paragraph><paragraph id="HFC5373615C9A40A6BDA21FA9F20618DF"><enum>(3)</enum><header>Designated
orphan drug</header><text display-inline="yes-display-inline">An establishment
registered under section 510 shall, with respect to the manufacture,
preparation, propagation, compounding, or processing of drugs, be granted a
waiver under paragraph (1) from a fee under subsection (a) if all drugs
manufactured, prepared, propagated, compounded, or processed by the
establishment are designated as a drug for a rare disease or condition pursuant
to section 526. The preceding sentence shall not apply if the application
approved under section 505 for any such drug includes an indication for a
disease or condition other than such a rare disease or condition.</text>
</paragraph></subsection><subsection commented="no" id="HF5926430BBB64E50BDD009029B58DAA"><enum>(f)</enum><header>Limitations</header>
<paragraph commented="no" id="HFEF92CD742184CE29722694FDEAFACD5"><enum>(1)</enum><header>In
general</header><text>Fees under subsection (a) shall be refunded for a fiscal
year beginning after fiscal year 2010 unless appropriations for 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 the 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" id="HEA93D6B07BEC4B3DB023BF89C69EBB60"><enum>(2)</enum><header>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 subsection (b), (c), (d), or (i) of section 510 at
any time in such fiscal year.</text>
</paragraph></subsection><subsection commented="no" id="HC1EE2325234E4EF6A2CD7E13E48FDC1C"><enum>(g)</enum><header>Crediting and
Availability of Fees</header>
<paragraph commented="no" id="HA61EA9655A6A4D43B53B31D64D709484"><enum>(1)</enum><header>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" id="HC8F13A1C1B9C4932A694131DFDFDCF66"><enum>(2)</enum><header>Collections and
appropriation acts</header>
<subparagraph commented="no" id="HADC8386123B34F3BAF37AAC55368B28"><enum>(A)</enum><header>In
general</header><text>The fees authorized by this section—</text>
<clause commented="no" id="H8BE412C7C97B483AA100AA1C9675864C"><enum>(i)</enum><text>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>
</clause><clause commented="no" id="HC3256472FD364010AF4F3275A2EF5EDB"><enum>(ii)</enum><text display-inline="yes-display-inline">shall only be collected and available to
defray increases in the costs of inspecting establishments registered under
subsection (b), (c), (d), or (i) of section 510 to ensure compliance by such
establishments with the requirements of this Act relating to drugs and devices
(including increases in such costs for an additional number of full-time
equivalent positions in the Department of Health and Human Services to be
engaged in such inspections) over such costs, excluding costs paid from fees
collected under this section, for fiscal year 2009 multiplied by the adjustment
factor.</text>
</clause></subparagraph><subparagraph commented="no" id="H2300F98E21C2470DA18000741152887C"><enum>(B)</enum><header>Compliance</header><text>The
Secretary shall be considered to have met the requirements of subparagraph
(A)(ii) in any fiscal year if the costs funded by appropriations and allocated
for inspections described in subsection (a)—</text>
<clause commented="no" id="H9408E47AE0524F429B004117A8163D33"><enum>(i)</enum><text>are not more than
3 percent below the level specified in subparagraph (A)(ii); or</text>
</clause><clause commented="no" id="H3C33B5057C824FD283AEDB968CB089F9"><enum>(ii)</enum><subclause commented="no" display-inline="yes-display-inline" id="H6DF0AA6E8B984C6FB8DCA74B4CA035B6"><enum>(I)</enum><text>are more than 3 percent
below the level specified in subparagraph (A)(ii), and fees assessed for the
fiscal year following the subsequent fiscal year are decreased by the amount in
excess of 3 percent by which such costs fell below the level specified in such
subparagraph; and</text>
</subclause><subclause commented="no" id="HC64E00E5C033412B9C5E0585B6E70000" indent="up1"><enum>(II)</enum><text>such costs are not more than 5 percent
below the level specified in such subparagraph.</text>
</subclause></clause></subparagraph></paragraph><paragraph commented="no" id="H357F51C6694C4F95A2049E90DA633400"><enum>(3)</enum><header>Authorization of
appropriations</header><text>For each of the fiscal years 2010 through 2014,
there is authorized to be appropriated for fees under this section an amount
equal to the total revenue amount determined under subsection (c)(1) for the
fiscal year, as adjusted or otherwise affected under subsection (d) and
paragraph (4) of this subsection.</text>
</paragraph><paragraph commented="no" id="HB8DD30214F6E402A9B69008BC6A6FE00"><enum>(4)</enum><header>Offset</header><text>If
the sum of the cumulative amount of fees collected under this section for the
fiscal years 2010 through 2013 and the amount of fees estimated to be collected
under this section for fiscal year 2014 exceeds the cumulative amount
appropriated under paragraph (3) for the fiscal years 2010 through 2014, the
excess shall be credited to the appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall be subtracted from the
amount of fees that would otherwise be authorized to be collected under this
section for fiscal year 2014.</text>
</paragraph></subsection><subsection id="H3919CFA47FDB4A87A428FE69BB8E1216"><enum>(h)</enum><header>Collection of
Unpaid Fees</header><text>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 id="H5672FBA872194A7185D65012AF6970D3"><enum>(i)</enum><header>Written Requests
for Waivers, Reductions, and Refunds</header><text>To qualify for consideration
for a waiver or reduction under subsection (e), or for a refund of any fee
collected in accordance with subsection (a), a person shall submit to the
Secretary a written request for such waiver, reduction, or refund not later
than 180 days after such fee is due.</text>
</subsection><subsection id="H8B09E164AF924D55939036EA70503074"><enum>(j)</enum><header>Construction</header><text>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,
employers, and advisory committees not engaged in inspections described in
subsection (a), be reduced to offset the number of officers, employees, and
advisory committees so engaged.</text>
</subsection><subsection id="H5D92CB58842543BC82B16235E03092AD"><enum>(k)</enum><header>Annual fiscal
reports</header><text>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" id="H98B8D9BBCD8B4062AB5FD1D5CFF7B020"><enum>(l)</enum><header>Definition</header><text display-inline="yes-display-inline">The term <term>costs of inspecting
establishments registered under subsection (b), (c), (d), or (i) of section 510
to ensure compliance by such establishments with the requirements of this Act
relating to drugs and devices</term> means the expenses incurred, in connection
with inspecting establishments registered under subsection (b), (c), (d), or
(i) of section 510 to ensure compliance by such establishments with the
requirements of this Act relating to drugs and devices, for—</text>
<paragraph commented="no" id="H874E5A3E161C4CEFB623D893F4787F82"><enum>(1)</enum><text>officers and
employees of the Food and Drug Administration, contractors of the Food and Drug
Administration, and costs related to such officers and employees and to
contracts with such contractors;</text>
</paragraph><paragraph commented="no" id="H3255712129C7439280102B4C4F685300"><enum>(2)</enum><text>management of
information, and the acquisition, maintenance, and repair of information
technology resources;</text>
</paragraph><paragraph commented="no" id="HD97562A8D1074C6AA2CB147FEF91164C"><enum>(3)</enum><text>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>
</paragraph><paragraph commented="no" id="H6730AC10ED1A49B000AC99A777F700D2"><enum>(4)</enum><text>collecting fees
under this section and accounting for resources allocated for such
inspections.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="HF39179DE5F2A4598B6DAD00C7229663"><enum>(3)</enum><header>Effective
date</header><text>The Secretary of Health and Human Services shall first
impose the fee established under section 736C of the Federal Food, Drug, and
Cosmetic Act, as added by paragraph (2), for fiscal years beginning with fiscal
year 2010.</text>
</paragraph><paragraph commented="no" id="H9194B23145924715999F9C00F85D1854"><enum>(4)</enum><header>Sunset
date</header><text display-inline="yes-display-inline">Section 736C of the
Federal Food, Drug, and Cosmetic Act, as added by paragraph (2), does not
authorize the assessment or collection of a fee for registration under section
510 of such Act (21 U.S.C. 360) occurring after fiscal year 2014.</text>
</paragraph></subsection></section><section id="H73FB14B03C634F4DABD5E6AEDBE34ED"><enum>202.</enum><header>Inspection of
producers of drugs and active pharmaceutical ingredients</header>
<subsection id="H36653D93BCE64116AA62EE78F2495257"><enum>(a)</enum><header>Inspection</header><text display-inline="yes-display-inline">Subsection (h) of section 510 (21 U.S.C.
351) is amended—</text>
<paragraph id="H3FB6F191B6B94E5FBDFE3EE49E6E092C"><enum>(1)</enum><text>by striking
<quote>(h)</quote> and inserting <quote>(h)(1)</quote>;</text>
</paragraph><paragraph id="HCF7483EF8B05480AA328F0BC00AA4376"><enum>(2)</enum><text>by striking
<quote>Every establishment in any State registered with the Secretary pursuant
to this section</quote> and inserting <quote>Every establishment registered
with the Secretary pursuant to subsection (b), (c), (d), or (i)</quote>;</text>
</paragraph><paragraph id="H4B1F4570D6DC4CB48905C117DFA06F75"><enum>(3)</enum><text>by striking
<quote>704(g), at least once</quote> and all that follows and inserting the
following:</text>
<quoted-block display-inline="yes-display-inline" id="HB7012DD6DD94440C00318B9D8C9F09FD" style="OLC">
<text>704(g)—</text><subparagraph id="HB99A36E7E51D476CAE128D501FDAFB4E" indent="up1"><enum>(A)</enum><text display-inline="yes-display-inline">at
least once in the 2-year period beginning with the date of registration of such
establishment pursuant to this section and at least once in every successive
2-year period thereafter; or</text>
</subparagraph><subparagraph commented="no" id="H2C6DD193C0F8467892B883D03944785" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">at
least once in the 4-year period beginning with the date of registration of such
establishment pursuant to this section and at least once in every successive
4-year period thereafter, if the Secretary determines that sufficient
information about the type of product produced in the establishment, inspection
history, compliance history, and such additional factors as the Secretary
determines, by guidance, exists to assess risk and to establish a risk-based
inspection schedule.</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="HA91EECFF8A324DEEA2202C7949EA0080"><enum>(4)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="HEA53573D98CB42D298CF18DC87DB7CC2" style="OLC">
<paragraph id="HBF377AFDF96A47910012126CCC8B60F1" indent="up1"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H1F738769BE184C74BF8995691E91E364"><enum>(A)</enum><text>The Secretary shall
conduct an inspection of a drug establishment when the establishment begins to
manufacture, prepare, propagate, compound, or process a drug or active
pharmaceutical ingredient of a drug before its introduction into interstate
commerce if the drug or ingredient is new or has undergone a major change
requiring prior approval by the Secretary of a supplement to an application
submitted under section 505. Notwithstanding the preceding sentence, the
Secretary may opt against conducting such an inspection if the Secretary
determines, based on the inspection history of the establishment, that such an
inspection is not necessary to verify the data contained in the application (or
supplement to the application) submitted under section 505, ensure compliance
with current good manufacturing practice, or otherwise ensure the safety of the
drug or ingredient.</text>
</subparagraph><subparagraph id="HD5C7AFD834D242FFBA3777E16309E6DE" indent="up1"><enum>(B)</enum><text>The Secretary shall annually submit a
report to the Congress on each instance during the preceding year in which the
Secretary determined under subparagraph (A) that an inspection was not
necessary.</text>
</subparagraph></paragraph><paragraph id="H8F998319FD3E4DE8873DC7ADE99226E4" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">The Secretary may, by regulation, provide
for a risk-based inspection schedule for establishments engaged in the
manufacture, propagation, compounding, or processing of an excipient of a drug
at a frequency different than the inspection schedule for an establishment
under paragraph (1).</text>
</paragraph><paragraph id="H543FB69D4F344820ACEA5BBFCFDF65E8" indent="up1"><enum>(4)</enum><text display-inline="yes-display-inline">Nothing in this subsection shall be
construed as limiting the authority of the Secretary to conduct inspections
under any other provision of the Act.</text>
</paragraph><paragraph id="H0576D74ED015420788AC4C0377E39800" indent="up1"><enum>(5)</enum><text>With respect to fiscal year 2010 and
each subsequent fiscal year, the Secretary shall submit an annual report to the
Congress on—</text>
<subparagraph id="H5E6CC08EA27A45FAAE553B68D78CF9B9"><enum>(A)</enum><text>funding dedicated to inspections under
this subsection; and</text>
</subparagraph><subparagraph id="HCA4BABA22103472389AEF61BDF009788"><enum>(B)</enum><text>the number of establishments for which
the frequency of such inspections has been modified pursuant to paragraph
(1)(B).</text>
</subparagraph></paragraph><paragraph id="HEAF113C846C4486B82AB4656E4009499" indent="up1"><enum>(6)</enum><text display-inline="yes-display-inline">For purposes of determining inspection
frequency under subparagraphs (A) and (B) of paragraph (1), the Secretary shall
establish information systems capacity sufficient to assess risk and shall
develop and maintain a risk-based system for conducting surveillance of current
good manufacturing practices by establishments registered with the Secretary
pursuant to subsection (b), (c), (d), or (i). The Secretary shall have such
capacity in place and begin implementation of such risk-based system not later
than 3 years after the date of the enactment of the Food and Drug
Administration Globalization Act of 2009. Such risk-based system shall include
consideration of the class of the establishment’s products and associated
risks, the date the establishment was last inspected, the establishment’s
compliance and safety history, the establishment’s shipping volume and history,
and such other factors as the Secretary determines relevant to assessing the
risk presented by the
establishment.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="H3D3422EB140E4A81A08733F529345E9C"><enum>(b)</enum><header>GAO
report</header><text>Not later than 3 years after the date of the enactment of
this Act, the Comptroller General of the United States shall submit a report to
the Congress on the risk-based process for conducting surveillance of current
good manufacturing practices developed and implemented under section 510(h)(6)
of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)(4) of
this section.</text>
</subsection><subsection id="HCA424A9EB46B43959964EE4200530092"><enum>(c)</enum><header>Effective
date</header><text>The amendments made by this section shall apply to drugs
introduced or delivered for introduction into interstate commerce on or after
the date of the enactment of this Act.</text>
</subsection></section><section id="H6A85EE2CC3984B1B96BDFD059F05E6FA"><enum>203.</enum><header>Documentation
for admissibility of drug imports</header><text display-inline="no-display-inline">Section 801 (21 U.S.C. 381), as amended by
section 123, is further amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H105821AD410A4A238DEDF6B8640BD83" style="OLC">
<subsection id="H6C5E84E6C6E740D09F7F2C83FD4CFAE"><enum>(q)</enum><text display-inline="yes-display-inline">Beginning 3 years after the date of the
enactment of this subsection, a drug shall not enter the United States unless
the party offering the drug for import provides the Secretary, at the time of
offering the drug for import, information demonstrating compliance with
applicable requirements pertaining to identity, strength, quality, purity,
approval, listing, labeling, registration, and such additional categories as
the Secretary, by guidance, determines are necessary for protection of the
public health. The Secretary may allow that such compliance be demonstrated
through verification by an accredited third party or through such other means
as determined, by guidance, by the
Secretary.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="HBF8474A653DD475BA2028267C29C5300"><enum>204.</enum><header>Drug supply
quality and safety</header>
<subsection commented="no" id="HBF487CBEA4DC47578C55F45900CCB71C"><enum>(a)</enum><header>Adulteration</header><text>Section
501 (21 U.S.C. 351) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H0F80ACD0BB6F4F0EA368ADD5209D089B" style="OLC">
<subsection commented="no" id="H30A2873FF90240BB9E5D10A8CDDFD9B5"><enum>(j)</enum><text display-inline="yes-display-inline">If it is drug that was manufactured,
prepared, propagated, compounded, or processed by an establishment that is or
was at the time of such manufacture, preparation, propagation, compounding, or
processing in violation of section 505–2 because of—</text>
<paragraph commented="no" id="H929AC22CFEEB477CA806E0B74B652469"><enum>(1)</enum><text display-inline="yes-display-inline">the failure to have in effect and implement
a quality risk management plan in accordance with section 505–2; or</text>
</paragraph><paragraph commented="no" id="H1C65FE1F96FC481484EF472CF580A287"><enum>(2)</enum><text>the failure to
transmit information in electronic form as requested by the Secretary under
section
505–2(f).</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H9497E9B56462412A822D7285D8E5924C"><enum>(b)</enum><header>Quality risk
management plans</header><text display-inline="yes-display-inline">Chapter V
(21 U.S.C. 351 et seq.) is amended by inserting after section 505–1 the
following:</text>
<quoted-block display-inline="no-display-inline" id="H5011C859182F42ACB0C2FA72FE1B7B00" style="OLC">
<section id="H7E04AFE165524795BA86A430D305965C"><enum>505–2.</enum><header>Drug supply
quality and safety</header>
<subsection id="HEF26000973304718A9F3B7CC6B801133"><enum>(a)</enum><header>Implementation
of quality risk management plan</header><text display-inline="yes-display-inline">An establishment required to be registered
with the Secretary pursuant to subsection (b), (c), (d), or (i) of section 510
for the manufacture, preparation, propagation, compounding, or processing of a
drug shall have in effect and implement an adequate quality risk management
plan that ensures the safety and quality of each such drug, including any
ingredients produced, manufactured, processed, packed, or held by another
person.</text>
</subsection><subsection id="H38C53E86C4B94ED98D951CBCE33D18D1"><enum>(b)</enum><header>Plan
provisions</header><text>A quality risk management plan required by subsection
(a) shall address risk assessment, risk control, risk communication, and risk
review and shall—</text>
<paragraph id="H90354A43901F4519B05497F3A7D33BD2"><enum>(1)</enum><text>provide for an
assessment, prior to contracting with a person to supply raw materials or
ingredients or to undertake any aspect of the manufacturing of the drug, of the
suitability and competence of such person to carry out such activity, using
audits, material evaluations, or qualification, as appropriate;</text>
</paragraph><paragraph commented="no" id="HDD67DFD1C1F440FFAD24002300618B00"><enum>(2)</enum><text>define
responsibilities and communication processes for manufacturing, quality
control, and quality assurance activities of any person referred to in
paragraph (1);</text>
</paragraph><paragraph commented="no" id="H6BDD2ECBA34D45EA8868E56568A75DAC"><enum>(3)</enum><text>provide for the
monitoring and review through periodic on-site audits of the facility
conditions, controls, and practices of any person referred to in paragraph (1)
and ensure the implementation of appropriate measures to improve such
conditions, controls, and practices;</text>
</paragraph><paragraph id="HE8BD62B79E2849D58EECE09B36B235B2"><enum>(4)</enum><text>provide for the
monitoring of incoming materials to ensure they are from a person that meets
the requirements in paragraphs (1) through (3);</text>
</paragraph><paragraph id="HBEF4FEDA2940498FA1232FB71C6FFA6D"><enum>(5)</enum><text display-inline="yes-display-inline">provide for implementation of effective
systems, including appropriate specifications and test methods and verification
of the drug ingredients’ identity, quality, strength, and purity, to detect any
hazard that has been, or is reasonably likely to be, present in or on the drug
during production, manufacturing, processing, packing, holding, or
transporting; and</text>
</paragraph><paragraph id="HDFB39A2AF4874F0AA6284E0418ABD773"><enum>(6)</enum><text>be periodically
reviewed and, as needed, updated.</text>
</paragraph></subsection><subsection id="H8158BB4C0A124990B06FBD25D7002819"><enum>(c)</enum><header>Additional
provisions</header><text>If the Secretary determines that provisions in
addition to those described in subsections (a) and (b) would be appropriate to
include in a quality risk management plan for protection of the public health,
including provisions for the prevention of intentional adulteration of a drug
or class of drugs, the Secretary may by regulation require the inclusion of
such provisions in a quality risk management plan.</text>
</subsection><subsection id="HAEEAF0CEE78846099025B261E4A01BE3"><enum>(d)</enum><header>Application of
specifications or test methods by order of the Secretary</header><text>Upon a
finding that there is a significant threat to public health, the Secretary may
order an establishment—</text>
<paragraph id="HEB7D8FB345D7434D9CACD714DE9FC8F"><enum>(1)</enum><text display-inline="yes-display-inline">to promptly revise its quality risk
management plan to include new or modified specifications or test methods for a
drug; and</text>
</paragraph><paragraph id="HEE0CA9EB006F4AD4B4994D1808C300F5"><enum>(2)</enum><text>to promptly
implement such specifications or test methods.</text>
</paragraph></subsection><subsection id="HE5B90264659C406CB79C1235C79E1485"><enum>(e)</enum><header>Inspection of
quality risk management plan</header><text display-inline="yes-display-inline">The Secretary shall, in the course of an
inspection of an establishment subject to this section or upon request by the
Secretary, conduct a review of the establishment’s quality risk management
plan.</text>
</subsection><subsection id="H70BB820CA93E4EC7B329B4BCF4941302"><enum>(f)</enum><header>Documentation of
supply chain</header>
<paragraph id="H53A88B6518034D09BD2934EB6EA31324"><enum>(1)</enum><header>In
general</header><text>Each establishment required to be registered with the
Secretary pursuant to subsection (b), (c), (d), or (i) of Section 510 for the
manufacture, preparation, propagation, compounding, or processing of a drug,
shall provide to the Secretary, upon request, adequate information transmitted
in electronic form, establishing—</text>
<subparagraph id="HEA22FD829C27406AA96DB08B6B1FA2CC"><enum>(A)</enum><text>where the drug,
including its raw materials, were produced, including all preceding producers,
manufacturers, distributors, and shippers; and</text>
</subparagraph><subparagraph id="HB549FEC4314443BC81E1A84477D578FC"><enum>(B)</enum><text>that the drug, its
ingredients and raw materials were manufactured, prepared, propagated,
compounded, processed, distributed, shipped, warehoused, brokered, imported,
and conveyed under conditions that ensure the identity, strength, quality, and
purity of the drug.</text>
</subparagraph></paragraph><paragraph id="H75E78451D49D4E1482E301E60085C241"><enum>(2)</enum><header>Repackagers</header><text>For
those establishments that are repackagers, paragraph (1)(A) requires only
information regarding the immediately preceding
establishment.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HDDE8D75919EC4161A5DC008FAB458827"><enum>(c)</enum><header>Effective
date</header>
<paragraph id="H35AF4F263D85418A9285FD237D2600F5"><enum>(1)</enum><header>In
general</header><text>The requirements of sections 501(j) and 505–2 of the
Federal Food, Drug, and Cosmetic Act, as added by subsections (a) and (b), take
effect 2 years after the date of the enactment of this Act.</text>
</paragraph><paragraph id="H02A812E68D85490D816EF61F001CF020"><enum>(2)</enum><header>Exception</header><text display-inline="yes-display-inline">Notwithstanding the effective date
specified in paragraph (1)—</text>
<subparagraph id="HF3E33820F86A40BBAD5DD50223EE8FDA"><enum>(A)</enum><text>the authority of
the Secretary to order an establishment to promptly implement new or modified
specifications or test methods for a drug, as described in section 505–2(d)(2)
of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (b),
shall take effect on the date of the enactment of this Act;</text>
</subparagraph><subparagraph id="HEEA04EA7311540BE9FE5E23FD248317C"><enum>(B)</enum><text>such authority
shall apply irrespective of whether the establishment has in effect a quality
risk management plan; and</text>
</subparagraph><subparagraph id="H8F824FE13299432BA50035261491CB9E"><enum>(C)</enum><text>a civil penalty
under section 303(f)(5) of the Federal Food, Drug, and Cosmetic Act, as added
by section 211 of this Act, shall apply to a violation of an order under this
paragraph to the same extent and in the same manner as such a penalty applies
to a violation of an order under such section 505–2(d)(2).</text>
</subparagraph></paragraph></subsection></section><section id="HDDB6CB3AC5F840A89F198211D9C6AAC8"><enum>205.</enum><header>Delay,
limitation, or denial of inspection</header>
<subsection id="HE579EC80047545BEA1FADE2292A07144"><enum>(a)</enum><header>Requirement</header><text display-inline="yes-display-inline">Subsection (h) of section 510 (21 U.S.C.
351), as amended by section 202(a), is further amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HF66B3576335342639200CB487E378698" style="OLC">
<paragraph id="HC48A090CA7444FE096005013DCA0914C" indent="up1"><enum>(7)</enum><text>The person who owns or operates an
establishment registered with the Secretary pursuant to subsection (b), (c),
(d), or (i), any agent or employee of such person, and any agent of a
governmental authority in the foreign country within which such establishment
is located shall not delay or limit an inspection, or refuse to permit entry or
inspection, authorized by this
subsection.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H31F67E11484D4976BC81B27815FE871E"><enum>(b)</enum><header>Reference to
prohibited act</header><text display-inline="yes-display-inline">For provision
making delay, limiting, or denying an inspection under section 510(h) of the
Federal Food, Drug, and Cosmetic Act a prohibited act under section 301(f) of
such Act, see the amendment made by section 403.</text>
</subsection><subsection id="H38F3B05E51CF4B16816B92967DBDA66F"><enum>(c)</enum><header>Drugs offered
for import</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 105(b),
is amended by inserting <quote>or (5) such article has been manufactured,
prepared, propagated, compounded, or processed by an establishment required to
be registered with the Secretary pursuant to subsection (b), (c), (d), or (i)
of section 510 and such establishment is in violation of section 510(h)(7)
(prohibiting the delay, limitation, or denial of an inspection under section
510(h)),</quote> before <quote>then such article shall be refused
admission</quote>.</text>
</subsection></section><section commented="no" id="H22F251EE2E8B4DA8A8BA8E00AB79927C"><enum>206.</enum><header>Country of
origin labeling</header>
<subsection commented="no" id="H83AC892D553B4CCAAC7F0082404689B8"><enum>(a)</enum><header>Misbranding</header><text display-inline="yes-display-inline">Section 502 (21 U.S.C. 352) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H5556EB30DA704055AD007FB6FA44D281" style="OLC">
<subsection commented="no" id="H84F74E05BD8F45D88738D09EB4E630B6"><enum>(aa)</enum><text>If it is a drug
and the website of the manufacturer of the drug does not list the country of
origin for each active pharmaceutical ingredient and finished dosage form of
such
drug.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H1880C54BD2304E7BBBD0B700784F43F"><enum>(b)</enum><header>Regulations</header><text display-inline="yes-display-inline">Not later than 1 year after the date of the
enactment of this Act, the Secretary shall promulgate final regulations to
carry out section 502(aa) of the Federal Food, Drug, and Cosmetic Act, as added
by subsection (a).</text>
</subsection><subsection commented="no" id="H63F403498C3E4992A70337CD3FC07785"><enum>(c)</enum><header>Effective
date</header><text>The requirement of section 502(aa) of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a), takes effect 2 years after
the date of the enactment of this Act.</text>
</subsection></section><section id="HF1749BF230DF495897EECCA1BBE70D3"><enum>207.</enum><header>Nondistribution
and recall of adulterated or misbranded drugs</header>
<subsection id="H2BD06224C5714022A222C2373677F984"><enum>(a)</enum><header>Prohibited
acts</header><text display-inline="yes-display-inline">Section 301 (21 U.S.C.
331), as amended by sections 102, 104, and 112 of this Act, is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H20B34EE0A7E841EB81BF180037E2FFAD" style="OLC">
<subsection id="H3A7CFBBE494A462B93D0E2BF5163E7E4"><enum>(rr)</enum><text display-inline="yes-display-inline">The failure to comply with—</text>
<paragraph id="HE0B1064904604930A137DB94D5A7D057"><enum>(1)</enum><text>an order issued
under section 568(a) following any hearing requested under section 568(b);
or</text>
</paragraph><paragraph id="H1C9A94A4FD164201872BE3E5E7E1E99"><enum>(2)</enum><text>an amended order
issued under section
568(c)(1).</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HACDB6B6EDD69407CAEDA8500F617E13D"><enum>(b)</enum><header>Nondistribution
and recall of adulterated or misbranded drugs</header><text display-inline="yes-display-inline">Subchapter E of chapter V (21 U.S.C. 360bb
et seq.) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H8B9776043BA14A1E9C06A3C852947654" style="OLC">
<section id="HFB9F1523BA8547C99775C778E898DC50"><enum>568.</enum><header>Nondistribution
and recall of adulterated or misbranded drugs</header>
<subsection id="H956E0ABAFFF74A32BC45FF5437238EA6"><enum>(a)</enum><header>Recall and
Consumer Notification</header>
<paragraph id="HE026F1C431394D02AF390511C134D0F4"><enum>(1)</enum><header>Voluntary
actions</header><text>On receiving information of a suspected adulteration or
misbranding of a drug, if the Secretary finds that there is a reasonable
probability that a drug intended for human use would cause serious, adverse
health consequences or death, the Secretary shall provide all persons
(including the manufacturer, importer, distributor, or retailer of the drug)
with an opportunity (as determined by the Secretary)—</text>
<subparagraph id="H61E793D784B0478D9C148535156486A3"><enum>(A)</enum><text>to cease
distribution of the drug;</text>
</subparagraph><subparagraph id="H5F9FB15F8EAE4C19807E654698D72DC0"><enum>(B)</enum><text>to notify all
entities—</text>
<clause id="H1ABB3AE1C1534306AA5F9CFDEE04E847"><enum>(i)</enum><text>that produce,
manufacture, pack, process, prepare, treat, package, distribute, or hold the
drug, to cease immediately those activities with respect to the drug; or</text>
</clause><clause id="H866ABF1C2D55480E9DB3ACFDD05D773"><enum>(ii)</enum><text>to
which the drug has been distributed, transported, or sold, to cease immediately
distribution of the drug;</text>
</clause></subparagraph><subparagraph id="HD61C4630C324454C90360327D5254249"><enum>(C)</enum><text>to recall the
drug;</text>
</subparagraph><subparagraph id="H1FE0BAAC3FB84D71B86CD5EF1E00B5F9"><enum>(D)</enum><text>in consultation
with the Secretary, to provide notice of the finding of the Secretary to all
consumers to which the drug was, or may have been, distributed and to
appropriate State and local health officials; and</text>
</subparagraph><subparagraph id="HCC67C6C534324D9DA1D9025E33634B00"><enum>(E)</enum><text>to notify State
and local public health officials.</text>
</subparagraph></paragraph><paragraph id="H1B1AF71938EB4EC38D54BDAB8D2215B1"><enum>(2)</enum><header>Mandatory
actions</header><text>If a person referred to in paragraph (1) does not carry
out the actions described in that paragraph with respect to a drug within the
time period and in the manner prescribed by the Secretary, the Secretary shall
issue an order requiring such person—</text>
<subparagraph id="H10EF512DB156494990A100A98DD43746"><enum>(A)</enum><text>to immediately
cease distribution of the drug; and</text>
</subparagraph><subparagraph id="HA8EE16AF2DB5477B8B5F7569733DD098"><enum>(B)</enum><text>to immediately
notify health professionals and drug user facilities of the order and to
instruct such professionals and facilities to cease use of such drug.</text>
</subparagraph></paragraph></subsection><subsection id="HD9B8560432E643A68879D136F5460058"><enum>(b)</enum><header>Hearings on
orders</header><text display-inline="yes-display-inline">The Secretary shall
provide a person subject to an order under subsection (a)(2) with an
opportunity for an informal hearing, to be held not later than 10 days after
the date of the issuance of the order, on—</text>
<paragraph id="HD355D3EE57804290B00283B6027B4770"><enum>(1)</enum><text>the actions
required by the order; and</text>
</paragraph><paragraph id="H110A524FD4A4408D99A509489BF4C1C9"><enum>(2)</enum><text>any reasons why
the drug that is the subject of the order should not be recalled.</text>
</paragraph></subsection><subsection id="H5D7D4ED4B7EA4680AF89790064545C9C"><enum>(c)</enum><header>Post-hearing
recall orders</header>
<paragraph id="HBBD7A1E40C6C48DFB4E02013B468671F"><enum>(1)</enum><header>Amendment of
orders</header><text>If, after providing an opportunity for an informal hearing
under subsection (b), the Secretary determines that an order under subsection
(a)(2) with respect to a drug should be amended to include a recall or other
appropriate action, the Secretary shall, except as provided in paragraph
(2)—</text>
<subparagraph id="H02638C4251284C338DD95536271BC19D"><enum>(A)</enum><text>amend the
order—</text>
<clause id="H49ACC0D4429B4507A3BA9055C08A4CF"><enum>(i)</enum><text>to
require recall of the drug or other appropriate action; and</text>
</clause><clause id="H71BB66128DFA455BAD6D68652482A6DE"><enum>(ii)</enum><text>to specify a
timetable during which any such recall shall occur; and</text>
</clause></subparagraph><subparagraph id="H678F1AE9443E464184FC119FC43884E"><enum>(B)</enum><text>require periodic
reports to the Secretary describing the progress of any such recall.</text>
</subparagraph></paragraph><paragraph id="HE4A44067337B477F8686F394BB00C63D"><enum>(2)</enum><header>Contents of
order</header>
<subparagraph id="HEAD438BAB7924142AEE230891B883451"><enum>(A)</enum><header>Individuals and
drug user facilities</header><text>An amended order under paragraph (1) shall
not include—</text>
<clause id="H28187D9393864800A6DAC666CA9B7FC"><enum>(i)</enum><text>a
recall of a drug from individuals; or</text>
</clause><clause id="H5C54FB93D2924F4694AC435063A52DFA"><enum>(ii)</enum><text>a
recall of a drug from drug user facilities if the Secretary determines that the
risk of recalling such drug from the facilities presents a greater health risk
than the health risk of not recalling the drug from use.</text>
</clause></subparagraph><subparagraph id="H2DCC0D78CB684D3998C0292BFF43EC5"><enum>(B)</enum><header>Notice to
individuals subject to risks</header><text>An amended order under paragraph (1)
shall provide for notice to individuals subject to the risks associated with
the use of such drug. In providing the notice required by this paragraph, the
Secretary may use the assistance of health professionals who prescribed or
dispensed such a drug for individuals. If a significant number of such
individuals cannot be identified, the Secretary shall notify such individuals
pursuant to section 705(b).</text>
</subparagraph></paragraph><paragraph id="H8B331D8EC54F481F84626BDD7B6C89F4"><enum>(3)</enum><header>Vacation of
orders</header><text>If, after providing an opportunity for an informal hearing
under subsection (b), the Secretary determines that adequate grounds do not
exist to continue the actions required by the order, the Secretary shall vacate
the order.</text>
</paragraph></subsection><subsection id="HC8A905C56108413780AB21B610A82110"><enum>(d)</enum><header>Remedies Not
Exclusive</header><text>The remedies authorized by this section shall be in
addition to any other remedies that may be
available.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" id="H729B48FC836F4ACEB607B06FC09B6CB7"><enum>208.</enum><header>Destruction of
adulterated, misbranded or counterfeit articles offered for import</header>
<subsection commented="no" id="H60E16497FE604509BBCA24CABF69A300"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">The fifth sentence of
subsection (a) of section 801 (21 U.S.C. 381), as amended by sections 105(b)
and 205(c), is further amended by inserting before the period at the end of the
following: <quote>, except that any article that is refused admission may, at
the discretion of the Secretary, be promptly (subject to the next sentence)
destroyed and not exported if it appears to pose a risk of injury or
death</quote>.</text>
</subsection><subsection commented="no" id="H96A0B4B6E76640DA9E5410B4BB92EF64"><enum>(b)</enum><header>Notice</header><text display-inline="yes-display-inline">Subsection (a) of section 801 (21 U.S.C.
381), as amended by sections 105(b) and 205(c) and subsection (a) of this
section, is amended by inserting after the fifth sentence the following:
<quote>Before causing the destruction of an article with a value greater than
$2,000 under the preceding sentence, the Secretary shall provide notice and an
opportunity for an informal hearing to the owner or consignee.</quote>.</text>
</subsection><subsection commented="no" id="H5A8461D9CD3F4CC8AF085B00FADB9F80"><enum>(c)</enum><header>Improper
destruction</header><text display-inline="yes-display-inline">Section 801 (21
U.S.C. 381), as amended by sections 123 and 203, is amended by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="HBC3759361F524FDAB9259CE84505642F" style="OLC">
<subsection commented="no" id="HA48C877169F847589FD9450025A33540"><enum>(r)</enum><text display-inline="yes-display-inline">Any person claiming any article which has
been destroyed under subsection (a) may, at any time within 3 months after the
date of destruction, apply to the Secretary for reimbursement of the value of
the article as determined by the Secretary. Upon the production of satisfactory
proof that the destruction of the article was not within the authority of the
Secretary as provided in this section, the Secretary shall order the value of
the article restored to the
applicant.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H4EF836D1C1534BEFB8B181BFF5E906F"><enum>(d)</enum><header>Samples of
destroyed articles</header><text display-inline="yes-display-inline">Section
801 (21 U.S.C. 381), as amended by sections 123 and 203 and subsection (c) of
this section, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H47E4C1D27D4B458CA44BB2501DE463ED" style="OLC">
<subsection commented="no" id="HC07D74BB10954EA9B4B2DF069FE065"><enum>(s)</enum><text display-inline="yes-display-inline">Where an article is caused to be destroyed
under subsection (a) the Secretary shall, upon request, provide a sample of the
article to the owner of the article, the owner’s attorney or agent, or if
applicable any person named on the label of the article, except that the
Secretary is authorized, by regulations, to make such reasonable exceptions
from, and impose such reasonable terms and conditions relating to, the
operation of this subsection as the Secretary finds necessary for the proper
administration of the provisions of this
Act.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H36864323C0CB4EAE8B66138CA7A34EB1"><enum>(e)</enum><header>Effective
date</header><text>The amendments made by subsections (a), (b), (c), and (d)
shall take effect 90 days after the date of the enactment of this Act.</text>
</subsection></section><section id="HB328367A6C5D486B83B43C8713CD82B9"><enum>209.</enum><header>Administrative
detention of drugs that appear to violate the law</header>
<subsection id="H4AF1DB6A869B497194CDDC4514F43E9D"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 304(g) (21
U.S.C. 334(g)) is amended—</text>
<paragraph id="HD60225B850E74E59A70962BEEAB1222E"><enum>(1)</enum><text>by inserting
<quote>drug or</quote> before <quote>device</quote> each place it appears;
and</text>
</paragraph><paragraph id="H0C26DD0E3A0143B2B68B8D9CCE746D48"><enum>(2)</enum><text>in paragraph (1),
by inserting after <quote>adulterated or misbranded</quote> the following:
<quote>or, in the case of a drug, which in the determination of the officer or
employee making the inspection appears to be in violation of section
505,</quote>.</text>
</paragraph></subsection><subsection id="H13F5FF5120A4444AA697DAD80BA76B8"><enum>(b)</enum><header>Effective
date</header><text display-inline="yes-display-inline">The amendments made by
subsection (a) shall take effect on a date, specified by the Secretary of
Health and Human Services, not later than 1 year after the date of the
enactment of this Act.</text>
</subsection></section><section commented="no" id="H5A9C77543B4B4B58878D062DF023FD48"><enum>210.</enum><header>Penalties
regarding counterfeit drugs</header><text display-inline="no-display-inline">Section 303(a) (21 U.S.C. 333(a)) is amended
by adding at the end the following paragraph:</text>
<quoted-block display-inline="no-display-inline" id="H9A7A2284B81A43BB897FDD566D826FDA" style="OLC">
<paragraph commented="no" id="H0495A964B9AB4F7ABE24FA5596678207" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">Notwithstanding paragraph (1) or (2), any
person who engages in any conduct described in section 301(i)(2) knowing that
the conduct concerns the rendering of a drug as a counterfeit drug, or who
engages in conduct described in section 301(i)(3) knowing that the conduct will
cause a drug to be a counterfeit drug or knowing that a drug held, sold, or
dispensed is a counterfeit drug, shall be fined in accordance with title 18,
United States Code, or imprisoned not more than 20 years, or both, except that
if the use of the counterfeit drug by a consumer is the proximate cause of the
death of the consumer, the term of imprisonment shall be any term of years or
for
life.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" id="HA9D3B95DB4B042DD9DB0300B81E3963"><enum>211.</enum><header>Civil money
penalties for violative drugs and devices and improper import entry
filings</header>
<subsection commented="no" id="HC4B29120488C46FC97003461CC1CDBAA"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 303(f) (21
U.S.C. 333) is amended—</text>
<paragraph commented="no" id="HF7A06BAB201D4925889E45BC56A9D369"><enum>(1)</enum><text>by redesignating
paragraphs (5), (6), and (7) as paragraphs (6), (7), and (8),
respectively;</text>
</paragraph><paragraph commented="no" id="H1875C27F17274EA2B71C358700EEF9F"><enum>(2)</enum><text>by inserting after
paragraph (4) the following:</text>
<quoted-block display-inline="no-display-inline" id="HE2EC3307F969405FBFCCBB13F20058CC" style="OLC">
<paragraph commented="no" id="HC3747AC7E8814607A1B0AA08DAD23797"><enum>(5)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H05158C77759448F4AB37EB869C53AFF4"><enum>(A)</enum><clause commented="no" display-inline="yes-display-inline" id="H60FE192A9CA2418BB3475145D36EA6F"><enum>(i)</enum><text>Any person that violates
a requirement of this Act that relates to drugs for human use (except a
requirement referred to in paragraph (4) or subsection (g)) shall be liable to
the United States for a civil penalty not to exceed—</text>
<subclause commented="no" id="H0B3508D106234DF7009C543559046F77" indent="up1"><enum>(I)</enum><text>$100,000 for an initial violation of such
a requirement; or</text>
</subclause><subclause commented="no" id="H8C870D03F9764997BBAA6C825FF9B871" indent="up1"><enum>(II)</enum><text>$200,000 for a subsequent violation of
the same requirement.</text>
</subclause></clause><clause commented="no" id="H961A95192C5745A2B7E1137D00B060BF" indent="up2"><enum>(ii)</enum><text>In clause (i)(I), the term
<term>initial violation</term> means the first violation by a person of a
requirement described in clause (i) that occurs on or after the date of the
enactment of the <short-title>Food and Drug Administration
Globalization Act of 2009</short-title>.</text>
</clause><clause commented="no" id="H77E822AA0E4D4638A6F319E0AE8D00D3" indent="up2"><enum>(iii)</enum><text>Each day during which a violation
continues shall be considered a separate violation under clause (i), except
that a continuing initial violation shall not be treated as a subsequent
violation for purposes of clause (i)(II).</text>
</clause></subparagraph><subparagraph commented="no" id="HD0A078E33D2D4A3383D5941786B07CED" indent="up1"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="HFFD19DB4714B44338B8467FD9205C0A3"><enum>(i)</enum><text>Any person that
knowingly reports or enters false or misleading data on documents related to
the importation of a drug shall be liable to the United States for a civil
penalty not to exceed $200,000.</text>
</clause><clause commented="no" id="H8289F27103F34C2100DF603C9776C2E2" indent="up1"><enum>(ii)</enum><text>Each act of reporting or entering
false data shall be considered a separate violation under clause (i).</text>
</clause></subparagraph><subparagraph commented="no" id="HF478A12DFA8E44FF91327BCC56E87D12" indent="up1"><enum>(C)</enum><text>Any manufacturer, importer,
distributer, or retailer who fails to comply with an order or an amended order
issued under section 568(a) or 568(c)(1), respectively, shall be liable to the
United States for a civil penalty not to exceed $250,000 per
day.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" id="H134C5C551C214CC7B6EDB67BCD869F1"><enum>(3)</enum><text>in paragraph (6),
as so redesignated, by striking <quote>, or (4)</quote> each place it appears
and inserting <quote>(4), or (5)</quote>;</text>
</paragraph><paragraph commented="no" id="H9DA436DC150C40CD9371261C79D96F70"><enum>(4)</enum><text>in paragraph (7),
as so redesignated, by striking <quote>(5)(A)</quote> and inserting
<quote>(6)(A)</quote>; and</text>
</paragraph><paragraph commented="no" id="H5C391DF90B1441E7B821C6B8D9D96EEA"><enum>(5)</enum><text>in paragraph (8),
as so redesignated, by striking <quote>paragraph (6)</quote> each place it
appears and inserting <quote>paragraph (7)</quote>.</text>
</paragraph></subsection><subsection commented="no" id="HB920FC0204254367AC3CD3413004C27"><enum>(b)</enum><header>Applicability</header><text>Section
303(f)(5) (as amended by subsection (a)), shall apply to violations described
in such section that occur after the date of the enactment of this Act.</text>
</subsection></section><section commented="no" id="H4CF05E12B86F41709E5CDA26E7152DAD"><enum>212.</enum><header>Human generic
drug application and supplement fees to cover pre-approval inspection
costs</header>
<subsection commented="no" id="HC8A956C1DB0B4F7FB247F4EA00ADC2BF"><enum>(a)</enum><header>Sense of
Congress</header><text display-inline="yes-display-inline">It is the sense of
the Congress that the amount of additional revenues generated from fees under
this section should be used to support pre-approval inspections of generic drug
establishments, in accordance with performance goals to be developed by the
Secretary of Health and Human Services in consultation with the entities listed
in subparagraphs (A) through (F) of section 736B(d)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h–2(d)(1)).</text>
</subsection><subsection commented="no" id="H48C04C74348C47CDA9D32972A382BFC"><enum>(b)</enum><header>Fee</header>
<paragraph commented="no" id="H8B0B6E415FE34598AC837601D371C573"><enum>(1)</enum><header>Misbranding</header><text display-inline="yes-display-inline">Paragraph (o) of section 502 (21 U.S.C.
352), as amended by subsections (a) and (b) of section 501, is further amended
by striking <quote>736C</quote> and inserting <quote>736C or 736D</quote>.</text>
</paragraph><paragraph commented="no" id="HC44C2F8F5B7B496BB700A69F968EBAF"><enum>(2)</enum><header>Establishment</header><text>Part
2 of subchapter C of chapter VII (21 U.S.C. 379g et seq.), as amended by
section 201(b), is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HA351A3552D384ED299EA72E0E020B1F" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H12DF65749165408CBA2077B727F96734" section-type="subsequent-section"><enum>736D.</enum><header> Human generic drug
application and supplement fees to cover pre-approval inspection costs</header>
<subsection commented="no" id="H58CF1067134246A388584C49D88DFCE"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">The Secretary shall
assess and collect a fee upon submission of any human generic drug application
or supplement to defray increases (as described in subsection (c)(2)(B)) in the
costs of resources allocated for conducting inspections in connection with the
review of human generic drug applications and supplements.</text>
</subsection><subsection commented="no" id="HCBEDFF38D6B040FCB4FF00BA6151D7CE"><enum>(b)</enum><header>Fee Revenue
Amounts</header><text display-inline="yes-display-inline">For each of fiscal
years 2010 through 2014, fees under subsection (a) shall be established,
subject to the provisions referred to in subsection (d), to generate a total
revenue amount.</text>
</subsection><subsection commented="no" id="HAD2EF232A1544940AA50B7A58943BED"><enum>(c)</enum><header>Crediting and
Availability of Fees</header>
<paragraph commented="no" id="H4C6E51729D1B49D284734BE61A41927"><enum>(1)</enum><header>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" id="HEBF875EE193242C7A9912465B080D898"><enum>(2)</enum><header>Collections and
appropriation acts</header><text>The fees authorized by this section—</text>
<subparagraph commented="no" id="HCE3B6D4B6F724B79A5B1CC0098D77DC"><enum>(A)</enum><text>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" id="HBA5A4791950046AC8B3F06B5C083CA00"><enum>(B)</enum><text>shall only be
collected and available to defray increases in the costs of resources allocated
for conducting inspections in connection with the review of human generic drug
applications and supplements (including increases in such costs for an
additional number of full-time equivalent positions in the Department of Health
and Human Services to be engaged in such review) over such costs, excluding
costs paid from fees collected under this section, for fiscal year 2009
multiplied by the adjustment factor.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="H228E98BDFDF3408C88B9B708F30EE5C"><enum>(d)</enum><header>Applicability of
certain provisions</header><text>To the extent determined by the Secretary to
be consistent with this section, the provisions of section 736 apply with
respect to human generic drug application fees and supplement fees under this
section to the same extent and in the same manner as such provisions apply with
respect to human drug application fees and supplement fees under section
736.</text>
</subsection><subsection commented="no" id="H8F5F501EB8BE4D2FB52127AEC926454C"><enum>(e)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this section:</text>
<paragraph commented="no" id="H0E58D517657649BF9C22BA71A53103A2"><enum>(1)</enum><text>The term
<term>costs of resources allocated for conducting inspections in connection
with the review of human generic drug applications and supplements</term> means
the expenses that are—</text>
<subparagraph commented="no" id="H03A63E98218B47F78BD3FDBA76B29CDA"><enum>(A)</enum><text>incurred in
connection with inspections undertaken as part of the Secretary’s review of
pending human generic drug applications and supplements; and</text>
</subparagraph><subparagraph commented="no" id="H17651D82CE23402AA246621746B4532D"><enum>(B)</enum><text display-inline="yes-display-inline">described in subparagraphs (A) through (D)
of section 735(7), except that the reference in section 735(7)(D) to section
736 is deemed to be a reference to this section, and the reference is section
735(7)(D) to human drug applications and supplements (as defined in section
735(2)) is deemed to be a reference to human generic drug applications and
supplements (as defined in this section).</text>
</subparagraph></paragraph><paragraph commented="no" id="H4BA7DEB179C4478BBE64004F9639DD63"><enum>(2)</enum><text>The term
<term>human generic drug application</term> means an application for approval
of a new drug submitted under section 505(j). Such term does not include an
application or a supplement to an application described in section
735(1).</text>
</paragraph><paragraph commented="no" id="H1E630DA5434C477B8D5607EF05C68EF1"><enum>(3)</enum><text>Notwithstanding
section 735(2), the term <term>supplement</term> means a request to the
Secretary to approve a change in a human generic drug application which has
been
approved.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" id="H4202A537D8C94074ADD7942F57EB26CE"><enum>(3)</enum><header>Effective
date</header><text display-inline="yes-display-inline">The Secretary of Health
and Human Services shall first impose the fee established under section 736D of
the Federal Food, Drug, and Cosmetic Act, as added by paragraph (2), for fiscal
years beginning with fiscal year 2010.</text>
</paragraph><paragraph commented="no" id="HED238EFDC88349CB8F1618931395F437"><enum>(4)</enum><header>Sunset
date</header><text display-inline="yes-display-inline">Section 736D, as added
by paragraph (2), does not authorize the assessment or collection of a fee for
submission of an application or supplement under section 505(j) of such Act (21
U.S.C. 355(j)) occurring after fiscal year 2014.</text>
</paragraph></subsection></section><enum>III</enum><header>Cosmetic
Safety</header>
<section id="H07C5DEF82B9E47C48544BE3828BFF"><enum>301.</enum><header>Registration of
cosmetic establishments</header>
<subsection id="H44775D4C10174BC38097065CABBA4876"><enum>(a)</enum><header>Misbranding</header><text>Section
602 is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HFD41A68EE8844EBAB80597F1A38D24D" style="OLC">
<subsection id="HDA6AC2D0E99740B7BF4687C6C3E9C307"><enum>(g)</enum><text display-inline="yes-display-inline">If it was manufactured or packaged in an
establishment that is not duly registered under section
604.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H28737EB4740843B0871E89A59D00F1B"><enum>(b)</enum><header>Annual
registration</header><text>Chapter VI is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H49DD93D84041464EA908732087617553" style="OLC">
<section id="H8008BD1A5A1A4183BCAA15D02FE74185"><enum>604.</enum><header>Registration of
cosmetic establishments</header>
<subsection id="HA04990D2B12B48A2A043498251B3CAA"><enum>(a)</enum><header>Registration</header>
<paragraph id="HCA4D0CE67FB04C89A6E47D86B2AFA726"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">The Secretary shall
by regulation require that any establishment engaged in manufacturing or
packaging cosmetics for use in the United States be registered annually with
the Secretary. To be registered—</text>
<subparagraph id="H8CCF32DBE4194346B0B6C2D106D3C76"><enum>(A)</enum><text>for a domestic
establishment, the owner, operator, or agent in charge of the establishment
shall submit a registration to the Secretary; and</text>
</subparagraph><subparagraph id="H20ADE8667A6B4C8099C630597E595CD3"><enum>(B)</enum><text>for a foreign
establishment, the owner, operator, or agent in charge of the establishment
shall submit a registration to the Secretary and shall include with the
registration the name of the United States agent for the establishment.</text>
</subparagraph></paragraph><paragraph id="HD4D8457B4BE648D1B38C66BC64B01400"><enum>(2)</enum><header>Registration</header><text>An
entity (referred to in this section as the <quote>registrant</quote>) shall
submit a registration under paragraph (1) to the Secretary containing
information necessary to notify the Secretary of the name and address of each
establishment at which, and all trade names under which, the registrant
manufactures or packages cosmetics. The registrant shall notify the Secretary
in a timely manner of changes to such information. The registrant shall notify
the Secretary of any change in the products, function, or legal status of each
such establishment (including cessation of business activities) not later than
30 days after the date of such change.</text>
</paragraph><paragraph id="H7621320167C54A0FA358C7664EF52D00"><enum>(3)</enum><header>Procedure</header><text>Upon
receipt of a completed registration described in paragraph (1), the Secretary
shall notify the registrant of the receipt of such registration and assign a
registration number to each registered establishment.</text>
</paragraph><paragraph id="H73CE7349DF1E4F4EA00023F546B4E86D"><enum>(4)</enum><header>List</header><text>The
Secretary shall compile and maintain an up-to-date list of establishments that
are registered under this section. The Secretary shall remove from such list
the name of any establishment that fails to reregister in accordance with this
section and shall treat such removal as a suspension of the establishment’s
registration. Such list and any registration documents submitted pursuant to
this subsection shall not be subject to disclosure under section 552 of title
5, United States Code. Information derived from such list or registration
documents shall not be subject to disclosure under section 552 of title 5,
United States Code, to the extent that such information discloses the identity
or location of a specific registered person.</text>
</paragraph></subsection><subsection id="H9DE7112E58554022BE152985B3FCA49C"><enum>(b)</enum><header>Establishment</header><text>For
purposes of this section:</text>
<paragraph id="HD5F38ED1EB8B4B15BF6CFB507BB4D925"><enum>(1)</enum><text>The term
<term>domestic establishment</term> means an establishment located in any State
(as defined in section 201).</text>
</paragraph><paragraph id="H4448436B81AD426A9EAFFCB4004F00A6"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H23AE0B7781144564BD3C3C90004BB915"><enum>(A)</enum><text>The term <term>foreign
establishment</term> means an establishment that manufactures or packages
cosmetics that are exported to the United States without further processing or
packaging outside the United States.</text>
</subparagraph><subparagraph id="H42577C6D4CFD48F3923DB76B22820165" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">A
cosmetic may not be considered to have undergone further processing or
packaging for purposes of subparagraph (A) solely on the basis that labeling
was added or that any similar activity of a de minimis nature was carried out
with respect to the
cosmetic.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section id="H37E62FBF9BA543679815B9B0137D73D"><enum>302.</enum><header>Cosmetic and
ingredient statements</header>
<subsection id="H76E508FF617D47F0BC65B33480A8EF1E"><enum>(a)</enum><header>Misbranding</header><text>Section
602, as amended by section 301 of this Act, is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HE4D7F34539034FE5A9635B5FAE00EA27" style="OLC">
<subsection id="HEACD0739EAF04B58864C1E3B07DF9358"><enum>(h)</enum><text display-inline="yes-display-inline">If its manufacturer is in violation of
section 605 for failure to submit a cosmetic and ingredient statement with
respect to the
cosmetic.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H31021089A6134996AB005033BFA2BA26"><enum>(b)</enum><header>Statements</header><text display-inline="yes-display-inline">Chapter VI, as amended by section 301 of
this Act, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H328BCE75FBD14688BAC6DB6E82B8CCEB" style="OLC">
<section id="H66636A4D3A2D42E3B91900ACE8A2A5E"><enum>605.</enum><header>Cosmetic and
ingredient statements</header>
<subsection id="H58EEBE1C2AE04C5C961CCC6484F001E5"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">The Secretary shall
require by regulation that every establishment engaged in the manufacture of a
cosmetic intended to be marketed in the United States submit to the Secretary
for each cosmetic manufactured in the establishment, within 60 days after
beginning manufacture of the product, a cosmetic and ingredient statement
containing—</text>
<paragraph id="H2D0E41F42B454C3EB53CF56B68063700"><enum>(1)</enum><text>the registration
number of the manufacturing establishment where the cosmetic is manufactured
or, if the same cosmetic is manufactured in more than one establishment, the
registration number of each establishment where it is manufactured;</text>
</paragraph><paragraph id="HCAE96395A99948C6B9C24E774C3CCD14"><enum>(2)</enum><text>the brand name or
names for the cosmetic;</text>
</paragraph><paragraph id="HBB65C761E02541F294E6D2D102AAE63E"><enum>(3)</enum><text>the applicable
cosmetic category or categories for the cosmetic;</text>
</paragraph><paragraph id="H1C1D2C2A8B87403892A47E8EFE54DABB"><enum>(4)</enum><text>the ingredients in
the cosmetic in descending order of predominance by weight, except that—</text>
<subparagraph id="HC299BEC9477E47C8B4B91907668D568C"><enum>(A)</enum><text>flavors and
fragrances may be designated as such; and</text>
</subparagraph><subparagraph id="HE74EF3F589F547FDA0C2A15585E7E648"><enum>(B)</enum><text>all variations in
color, flavor, or fragrance may be included in one statement; and</text>
</subparagraph></paragraph><paragraph id="HE5692CBC9F094988A6A0C74B6BF988D3"><enum>(5)</enum><text>the title and full
contact information for the individual or individuals responsible for
submitting and maintaining the statement.</text>
</paragraph><continuation-text continuation-text-level="subsection">The
registrant shall notify the Secretary in a timely manner of any change to the
information required to be in such statement.</continuation-text></subsection><subsection id="H010608EC0F1E40A4A79F5487000033F8"><enum>(b)</enum><header>Procedure</header><text>Upon
receipt of a completed cosmetic and ingredient statement described in paragraph
(a), the Secretary shall notify the registrant of the receipt of such statement
and assign a cosmetic and ingredient statement number.</text>
</subsection><subsection id="HF9C441F64D3F4FB6A985FBEBE98F1313"><enum>(c)</enum><header>List</header><text>The
Secretary shall compile and maintain an up-to-date list of cosmetics and
ingredients for which statements are submitted under this
section.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section id="HCA93813BCED6493D9636B11B25960342"><enum>303.</enum><header>Serious and
unexpected adverse event reports for cosmetics</header>
<subsection id="H96428C13C62044DCB7E738A28F801214"><enum>(a)</enum><header>Prohibited
acts</header><text>Section 301 is amended—</text>
<paragraph id="HDE826B2C0AF84680AE1E55BD93C1302C"><enum>(1)</enum><text>in paragraph (e),
by striking <quote>or 761</quote> each place it appears and inserting
<quote>761, or 762</quote>; and</text>
</paragraph><paragraph id="H8CE260C5FF924FAD8663A9E5968C9D34"><enum>(2)</enum><text>in paragraph
(ii)—</text>
<subparagraph id="H6B5607921AAB44EAAC9EA0168B3EB9D9"><enum>(A)</enum><text>by striking
<quote>or the</quote> and inserting <quote>, the</quote>; and</text>
</subparagraph><subparagraph id="H760FBBFC4FAF40FAAB2DE9592E49A2E"><enum>(B)</enum><text>by striking the
period at the end and inserting <quote>, or the falsification of a report
submitted under section 762 to the Secretary.</quote>.</text>
</subparagraph></paragraph></subsection><subsection id="H830921AA083A4EBD91A4FBD69CD9836"><enum>(b)</enum><header>Adverse event
reporting</header><text display-inline="yes-display-inline">Subchapter H of
chapter VII is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H0890C5E2C726419B8B4F046113DBB300" style="OLC">
<section id="HA9606CBB01144E1AAADCFB2DC62EF7F9"><enum>762.</enum><header>Serious and
unexpected adverse event reports for cosmetics</header>
<subsection id="H54928E0F3D2D441D87B6F8A1CF9864E9"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">The Secretary shall
require by regulation that the manufacturer, packager, or distributor whose
name appears on the label of a cosmetic marketed in the United States pursuant
to section 602(b)(1) submit to the Secretary under subsection (b) a report
containing information received concerning any serious and unexpected adverse
event in the United States associated with the use of the cosmetic.</text>
</subsection><subsection id="H88BE004093614633BE211EC57DA51717"><enum>(b)</enum><header>Submission of
reports</header>
<paragraph id="H44BB990D085E432D9324D5DAE4F4717E"><enum>(1)</enum><header>In
general</header><text>A report under subsection (a) shall be submitted to the
Secretary no later than 15 business days after information concerning the
adverse event is received at the place of business labeled on the cosmetic
under section 602(b)(1).</text>
</paragraph><paragraph id="H5AD1C551692D4C6B9CC461A465A034B0"><enum>(2)</enum><header>Contents</header><text>A
report under subsection (a) shall include the following information, to the
extent to which the person submitting the report has been able to verify the
information—</text>
<subparagraph id="H82D1283A24B84C63A6E2320047746570"><enum>(A)</enum><text>an identifiable
patient;</text>
</subparagraph><subparagraph id="H27416AE17F22412AA51EDCCE87E28872"><enum>(B)</enum><text>an identifiable
reporter;</text>
</subparagraph><subparagraph id="HEF6E31F3C9F6427D80E021EB3495C3CF"><enum>(C)</enum><text>a suspect
cosmetic; and</text>
</subparagraph><subparagraph id="H7831672AB3B84304815B0521BF1C68A4"><enum>(D)</enum><text>a serious and
unexpected adverse event.</text>
</subparagraph></paragraph><paragraph id="H5BCA5E89B2264CDAB39ED0CF451DB852"><enum>(3)</enum><header>Additional
information</header><text display-inline="yes-display-inline">The person
submitting a report under subsection (a) may include in the submission any
additional pertinent information and may supplement the report with additional
information at a later time.</text>
</paragraph></subsection><subsection id="H684B06FF8CBF4675A26D7BD44133F8D"><enum>(c)</enum><header>Relation to other
provisions</header><text>A report under subsection (a) (including all
information submitted in the initial report or added later) shall be considered
to be—</text>
<paragraph id="H0746EB6AF27744DEA4A21768CB985D2"><enum>(1)</enum><text>a safety report
under section 756;</text>
</paragraph><paragraph id="H5E1D5D0E26EB4A46AD72B3B63726BA29"><enum>(2)</enum><text>a record about an
individual under section 552a of title 5, United States Code; and</text>
</paragraph><paragraph id="H6D9F2C35C8414394876BC39395536667"><enum>(3)</enum><text>a medical or
similar file the disclosure of which would constitute a violation of section
552(b)(6) of such title 5, United States Codes, and shall not be disclosed
under section 552 of such title.</text>
</paragraph></subsection><subsection id="HBAE896425F414653AC9F008733716740"><enum>(d)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph id="HD726C440327B458686CBCED342669A0"><enum>(1)</enum><text>The term
<term>serious</term>, with respect to an adverse event, means—</text>
<subparagraph id="H8BBA05649EC14F17A184033E6C265523"><enum>(A)</enum><text>resulting
in—</text>
<clause id="H4B1B2DDDA31E49628181AF007B2FEC03"><enum>(i)</enum><text>death;</text>
</clause><clause id="H20917CC7874347EDB3C7BCE9DF591CB1"><enum>(ii)</enum><text>a
life-threatening experience;</text>
</clause><clause id="HAD1B024C0FB147759B31D8B6BECD1580"><enum>(iii)</enum><text>inpatient
hospitalization;</text>
</clause><clause id="H5472C9B8A88E4DFE96865357C8D984CE"><enum>(iv)</enum><text>a
persistent and significant disability or incapacity; or</text>
</clause><clause id="HB7134CE340424D19A86921094960207C"><enum>(v)</enum><text>a
congenital anomaly or birth defect; or</text>
</clause></subparagraph><subparagraph id="HD64E0DF878974C738D01AA4E346900D1"><enum>(B)</enum><text>requiring, based
on reasonable medical judgment, a medical or surgical intervention to prevent
an outcome described in subparagraph (A).</text>
</subparagraph></paragraph><paragraph id="H3321C3892570417FBBA81851AA80CFD1"><enum>(2)</enum><text>The term
<term>unexpected</term>, with respect to an adverse event, means not identified
in the current labeling for the
cosmetic.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section id="H172E0A7AE8114A2CB13EC575B27EA444"><enum>304.</enum><header>Good
manufacturing practices for cosmetics</header><text display-inline="no-display-inline">Section 601 is amended by adding at the end
the following:</text>
<quoted-block display-inline="no-display-inline" id="HCEC639F46FEF45DAA5E752ECAE507FC0" style="OLC">
<subsection id="HC7BF26C1718F4822A400F48C12F61BB"><enum>(f)</enum><text display-inline="yes-display-inline">If the methods used in, or the facilities
or controls used for, its manufacture, processing, packaging, storage, or
holding do not conform to current good manufacturing practice, as prescribed by
the Secretary in regulations, to ensure that the cosmetic is safe and otherwise
in compliance with this
Act.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H5568C6BA88E747AF90F1FCC153D21EF6"><enum>305.</enum><header>Authorization
of appropriations</header><text display-inline="no-display-inline">Chapter VI,
as amended by sections 301 and 302, is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HFAE97034322E4FE098FD47C7D1E1E4B1" style="OLC">
<section id="H3FB86676A2954C23B0C2F800B2001295"><enum>606.</enum><header>Authorization
of appropriations</header><text display-inline="no-display-inline">To carry out
this chapter and section 762, there is authorized to be appropriated
$10,000,000 for each of fiscal years 2010 through
2014.</text>
</section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H4C1DA9E8317142E3966E2D284FE3B3B2"><enum>306.</enum><header>Effective
date</header><text display-inline="no-display-inline">The amendments made by
sections 301, 302, 303, and 304 shall take effect 18 months after the date of
the enactment of this Act.</text>
</section><enum>IV</enum><header>Miscellaneous</header>
<section id="HDB04415D51844352B5B214353214B767"><enum>401.</enum><header>Registration
for commercial importers of food, drugs, devices, and cosmetics; fee</header>
<subsection id="H4D0ACFC0B1CF41AFAE740300F13B8D8F"><enum>(a)</enum><header>Prohibitions</header><text display-inline="yes-display-inline">Section 301 (21 U.S.C. 331), as amended by
sections 102, 104, 112, and 207, is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H934639CAC02E4A6096DE03ECCB4F4EC9" style="traditional">
<subsection id="H3F4CD2B6A69A477CAE688F2E3D63BD2B"><enum>(ss)</enum><text>The importation
of food, drugs, devices, or cosmetics other than only for personal use by an
importer that is not registered with respect to such food, drugs, devices, or
cosmetics under section 415, 510, or 604, respectively, unless the importer is
registered under section
801(t).</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H204EAC87C83B4749BD8B352E1F4CF454"><enum>(b)</enum><header>Registration</header><text display-inline="yes-display-inline">Section 801, as amended by sections 123,
203, and 208, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H1D9BC4C2F36A4997AF87E401CCABDBD6" style="traditional">
<subsection id="H0A23C30472624ADFBF6C7F35F3EBA06E"><enum>(t)</enum><text display-inline="yes-display-inline">The Secretary shall by regulation require
that an importer of food, drugs, devices, or cosmetics, other than only for
personal use, that is not required to be registered with respect to such food,
drugs, devices, or cosmetics under section 415, 510, or 604, respectively,
shall be registered with the Secretary in a form and manner specified by the
Secretary. The Secretary shall assign a unique identification number to each
importer so
registered.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HB89B74C418FF415D8EF8EDE6005CBCD"><enum>(c)</enum><header>Fee</header><text>Subchapter
C of chapter VII (21 U.S.C. 379f et seq.) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H2EB2FF6183A4499B86039571D5C7686" style="OLC">
<part id="H7B8DA3F5462B4085962427C9DE7C2D24"><enum>6</enum><header>Importers of food,
drugs, and devices</header>
<section id="H115C27E305A34A8786547D9E5B62EBA"><enum>742.</enum><header>Importers of
food, drugs, and devices</header>
<subsection id="HBB226D616E8744B9803DDA3F75A0E291"><enum>(a)</enum><header>In
General</header><text display-inline="yes-display-inline">The Secretary shall
assess and collect an annual fee for the registration of an importer of food,
drugs, or devices under section 801(t).</text>
</subsection><subsection id="H63F476A75916445FA6DD8268D397F0C6"><enum>(b)</enum><header>Amount of
fee</header><text display-inline="yes-display-inline">The amount of the fee
under this section shall be $10,000.</text>
</subsection><subsection id="H9F8C7A8A142A4875BDAC1C9422E90051"><enum>(c)</enum><header>Rule of
construction</header><text display-inline="yes-display-inline">This section
shall not be construed to authorize the assessment or collection of any fee
from an importer of food, drugs, or devices if, with respect to such food,
drugs, or devices, the importer is registered under section 415 or 510 and
required to pay a fee under section 736C or
741.</text>
</subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H1BEEA6B80B1F4D6F834205D480DF9EEB"><enum>(d)</enum><header>Effective
date</header>
<paragraph id="H4F5FD2F5600F4F17AF95357D58CAF35C"><enum>(1)</enum><header>Registration</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
establish procedures for the registration of importers under section 801(t) of
the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).</text>
</paragraph><paragraph id="HF7AFA243A64E4854AF12D064AE85DDFF"><enum>(2)</enum><header>Registration</header><text display-inline="yes-display-inline">The amendments made by this section shall
first apply not later than 1 year after the date of the enactment of this
Act.</text>
</paragraph></subsection></section><section id="H80BF2590DA4443DE9503B203670044E1"><enum>402.</enum><header>Unique
identification number for food, drug, and device facilities and
establishments</header>
<subsection id="H06E351F3A6344E5984804BE485CA1CA"><enum>(a)</enum><header>Food and
cosmetics</header><text display-inline="yes-display-inline">Section 415(a)(3)
(21 U.S.C. 350d(a)(3)) is amended by inserting <quote>unique</quote> before
<quote>registration number</quote>.</text>
</subsection><subsection id="H17C4AFA8F2E04999B8015055CCF8DF7E"><enum>(b)</enum><header>Drugs and
devices</header><text display-inline="yes-display-inline">Section 510(e) (21
U.S.C. 360(e)) is amended by adding after the first sentence the following:
<quote>The registration number shall be the unique identification number for
each such establishment.</quote>.</text>
</subsection><subsection id="H77C8731849EB4526ACDC66EEFB222F35"><enum>(c)</enum><header>Effective
date</header><text>The Secretary of Health and Human Services shall implement
the amendments made by this section not later than 1 year after the date of the
enactment of this Act.</text>
</subsection></section><section id="H51170D79117347C2A0AF5DD5E1932DAD"><enum>403.</enum><header>Prohibition
against delaying or limiting inspection</header><text display-inline="no-display-inline">Section 301(f) (21 U.S.C. 331(e)) is amended
to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H8354FF6FDEEF4BBE8BD6FAE4D72E51B3" style="OLC">
<subsection id="HD42CF659AF2345EA801100FC493D71F6"><enum>(f)</enum><text display-inline="yes-display-inline">The delay or limitation of an inspection,
or the refusal to permit entry or inspection, as authorized by section 510(h)
or 704, including any such delay, limitation, or refusal by an agent of a
governmental authority in a foreign country.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section display-inline="no-display-inline" id="HA3172C7BCC88435696EDB590D77DB017" section-type="subsequent-section"><enum>404.</enum><header>Dedicated foreign
inspectorate</header><text display-inline="no-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="HF11C97428A434BBEAC8BC2B20289E1D2" style="traditional">
<subsection id="HB0A704A92B794576A111D66104B1F457"><enum>(i)</enum><text display-inline="yes-display-inline">The Secretary shall establish and maintain
a corps of inspectors dedicated to inspections of foreign food, drug, device,
and cosmetics facilities and establishments. This corps shall be staffed and
funded by the Secretary at a level sufficient to allow it to conduct
inspections of foreign food, drug, device, and cosmetic facilities and
establishments at a frequency at least equivalent to the inspection rate of
domestic food, drug, device, and cosmetic facilities and
establishments.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H1CD7E3DAD7F543F2001BFF08CAEB50BB"><enum>405.</enum><header>Continued
operation of field laboratories</header>
<subsection id="H4D3F8A76601D46B8901376F4115C27CC"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Subject to
subsections (b) and (d), the Secretary of Health and Human Services (in this
section referred to as the <quote>Secretary</quote>) shall not—</text>
<paragraph id="H9134529253EA48038959CDD98C6CC84B"><enum>(1)</enum><text>terminate any of
the 13 field laboratories that were operated by the Office of Regulatory
Affairs of the Food and Drug Administration as of January 1, 2007;</text>
</paragraph><paragraph id="H50DE6922FAEB4B238FB937239B67C0BA"><enum>(2)</enum><text>consolidate any
such laboratory with any other laboratory;</text>
</paragraph><paragraph id="H589090D7A0C14CE5AED888A8E4966691"><enum>(3)</enum><text>terminate any of
the 20 district offices or any of the inspection or compliance functions of any
of the 20 district offices of the Food and Drug Administration functioning as
of January 1, 2007; or</text>
</paragraph><paragraph id="H95CB5F5408AC4706B337125FFAB0B1B9"><enum>(4)</enum><text>consolidate—</text>
<subparagraph id="HE296F4DDB17646F09127A6817FF469CC"><enum>(A)</enum><text>any such district
office with an office in any other district; or</text>
</subparagraph><subparagraph id="HE3474D49759343A09D147552F3500074"><enum>(B)</enum><text>transfer any of
the compliance or inspection functions of any such district office to any other
district.</text>
</subparagraph></paragraph></subsection><subsection id="H21E3894C09314B4D9752003516F825F"><enum>(b)</enum><header>Report by
Secretary</header>
<paragraph id="H0A2AB43B0C3A429AA389CB00004D4CE4"><enum>(1)</enum><header>Submission</header><text>The
Secretary shall submit a reorganization plan involving the termination or
consolidation of the laboratories, the district offices, or the functions of
such district offices specified in subsection (a) 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>
</paragraph><paragraph id="H778A76EE21B649940088F38BF5DB4D74"><enum>(2)</enum><header>Consultation</header><text>In
preparing the reorganization plan described in paragraph (1), the Secretary
shall consult with personnel and unions to be affected by the plan.</text>
</paragraph></subsection><subsection id="HA5F68ED8CF9D466699FAFF97FCEC5BD9"><enum>(c)</enum><header>Report by
GAO</header><text>The Comptroller General shall study the cost effectiveness of
the reorganization plan described in subsection (b) and its impact on the
safety of food, drug, and other products regulated under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and the Public Health Service
Act (42 U.S.C. 201 et seq.) and 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.</text>
</subsection><subsection id="H727522C2CA5549F498B7E6ED6094659C"><enum>(d)</enum><header>Reorganization</header>
<paragraph id="HB4DC1EFDEAB74939A4A34FAC87AEB9CD"><enum>(1)</enum><header>Congressional
review</header><text>The reorganization plan described in subsection (b) 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>
</paragraph><paragraph id="HBD1AFCF9BA0B4D9EB9F19C89911588B8"><enum>(2)</enum><header>Effective
date</header><text>Notwithstanding section 801(a)(3) of title 5, United States
Code, the reorganization plan described in subsection (b) shall take effect
(unless disapproved under section 802 of such title) on the date that is
specified in such plan, but not earlier than 180 days after the date on which
the Comptroller General submits the report required by subsection (c).</text>
</paragraph></subsection></section><section id="H66797927302841A3ADB6A62985C821FB"><enum>406.</enum><header>False or
misleading reporting to FDA</header>
<subsection id="H0EF37BB2C6804B1FBCFCE9FC00C906C3"><enum>(a)</enum><header>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, drug, or biological product</quote>.</text>
</subsection><subsection id="HA580F87554AF46F480FFAC5DE21B4054"><enum>(b)</enum><header>Effective
date</header><text>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" id="HC3EAC6FDA1A14C1DA691B09BA27BAE3C" section-type="subsequent-section"><enum>407.</enum><header>Subpoena
authority</header><text display-inline="no-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="H54289D56EE894D9E9329BCE831A713C5" style="OLC">
<section commented="no" id="H5515D5109ABB4C2499BC59F6EAFFCF87"><enum>311.</enum><header>Exercise of
subpoena authority</header>
<subsection commented="no" display-inline="no-display-inline" id="HE13F80E01DC343C8B0144264BF337CAB"><enum>(a)</enum><header>In
general</header><text>For the purpose of—</text>
<paragraph commented="no" id="HD6CF0063DF784E65BD771CA6B893B159"><enum>(1)</enum><text>any hearing,
investigation, or other proceeding respecting a violation of the Act, or</text>
</paragraph><paragraph commented="no" id="H507E4370964F4721A36919C9CF9A2D8"><enum>(2)</enum><text>any hearing,
investigation, or other proceeding to determine if a person is in violation of
a specific provision of the Act,</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
documentary evidence. Such attendance of witnesses and production of evidence
at the designated place of such hearing, investigation, or other proceeding may
be required from any place in the United States or in any territory or
possession of the United States. 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. 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.
Witnesses so subpoenaed shall be paid the same fees and mileage as are paid
witnesses in the district courts of the United States.</continuation-text></subsection><subsection commented="no" id="HF28B9C88F88A446C83B9CE00F49E6732"><enum>(b)</enum><header>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 requiring such
person to appear and give testimony or to appear and produce evidence, or both.
The failure to obey such order of the court may be punished by the court as
contempt thereof. Furthermore, the failure or refusal to obey such a subpoena
shall be treated as a prohibited act under section 301(a).</text>
</subsection><subsection commented="no" id="H7A572EC44A554739BFCE7BF7D37EDCD2"><enum>(c)</enum><header>Relation to
other provisions</header><text>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.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="HDC68709B91ED42E3AB7EE5A7F7D3A465"><enum>408.</enum><header>Whistleblower
protections</header><text display-inline="no-display-inline">Chapter IX (21
U.S.C. 391 et seq.) is amended by adding at the end the following:</text>
<quoted-block id="H7742D90F46994E9086CCD2E7DAEC34A8" style="OLC">
<section id="H62592A662771404A9DDD103D69ADD9AF"><enum>911.</enum><header>Protections for
employees who refuse to violate, or who disclose violations of, this act or
section 351 of the public health service act</header>
<subsection id="H00A4F82EF6BD4B4CA9DB9E4EE101A7B7"><enum>(a)</enum><header>In
general</header><text>No person that submits or is required to submit to the
Secretary, a registration under section 415, 510, or 604, a new drug
application under section 505(b), an abbreviated new drug application under
section 505(j), a biologics license application under section 351 of the Public
Health Service Act, an application for an investigational new drug exemption
under section 505(i), a new animal drug application under section 512(b), an
abbreviated new animal drug application under section 512(b), an application
under section 571, a request under section 572, an application or report for
premarket approval under section 515, an application for an investigational
device exemption under section 520(g), a report under section 510(k), an
application for a humanitarian device exemption under section 520(m), an
amendment, supplement, or other submission with respect to any such
registration, application, or report, or a record or report related to an
adverse event, a postapproval study, a postapproval clinical trial, a report,
or postmarket surveillance under section 505(k), 505(o), 519, 522, or 760, or
any officer, employee, contractor, subcontractor, or agent of such a 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 id="H00A257F429A94B08A7FA1D611781274F"><enum>(1)</enum><text>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 section 351 of the Public Health Service
Act, any other provision of Federal law relating to the safety or effectiveness
of a drug, biological product, or device or to the safety of a food or
cosmetic, or any provision of Federal law prohibiting fraud against the Food
and Drug Administration, if the information or assistance is provided to, or an
investigation stemming from the provided information is conducted by—</text>
<subparagraph id="HA8EA84812A4F4E649F7840C2D941451B"><enum>(A)</enum><text>a Federal
regulatory or law enforcement agency;</text>
</subparagraph><subparagraph id="H9C0BF36D085048B09D00E7CF4E9D3714"><enum>(B)</enum><text>any Member of
Congress or any committee of Congress; or</text>
</subparagraph><subparagraph id="H4D131C1C5BBA493297E8049E10BCBC64"><enum>(C)</enum><text>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 id="HD5D85DF63B10444BAFECA0F26360099E"><enum>(2)</enum><text>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) relating to any such
alleged violation; or</text>
</paragraph><paragraph id="H27E1CDCF5D22414D9EFA16B482C54DA7"><enum>(3)</enum><text>to refuse to
commit or assist in any such violation.</text>
</paragraph></subsection><subsection id="H71995DEBC2C34C5792371DA84900717B"><enum>(b)</enum><header>Enforcement
action</header>
<paragraph id="H5B2C8257FA3C469EA8E24F92B0DA839E"><enum>(1)</enum><header>In
general</header><text>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 id="H8B73DD928EDA489EA083C31F99225FC8"><enum>(A)</enum><text>filing a complaint
with the Secretary of Labor; or</text>
</subparagraph><subparagraph id="H637FA4CA59694E26B0CE8D090359E987"><enum>(B)</enum><text>if the Secretary
of Labor has not issued a final decision within 210 days of the filing of the
complaint, or within 90 days after receiving a final decision or order from the
Secretary, and there is no showing that such delay is due to the bad faith of
the claimant, 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 id="H1D341E8262E44DB780AA3B5E30E4E843"><enum>(2)</enum><header>Procedure</header>
<subparagraph id="HFCE0589CC20E4832AB7B54956209BF48"><enum>(A)</enum><header>In
general</header><text>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 id="H65C74B9C79B44A78A3E768E78360D67E"><enum>(B)</enum><header>Exception</header><text>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 and to the employer.</text>
</subparagraph><subparagraph id="H93D7082822A2445C9BF5EB4578DE1238"><enum>(C)</enum><header>Burdens of
proof</header><text>An action brought under paragraph (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 id="H7052536999B242AB912EBD918183A6B"><enum>(D)</enum><header>Statute of
limitations</header><text>An action under paragraph (1) shall be commenced not
later than 180 days after the date on which the violation occurs.</text>
</subparagraph></paragraph></subsection><subsection id="H0172E9D08A3C48CAAA132E18629DB1C4"><enum>(c)</enum><header>Remedies</header>
<paragraph id="H11E6F1B39E5247E4BEF0D4C3048B00C0"><enum>(1)</enum><header>In
general</header><text>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 id="H9E7EDD6F3CF94E718F1D1B9823DDF1B6"><enum>(2)</enum><header>Issuance of
order</header><text>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 id="H97B57D4D64BB4686A7B56E734800B28D"><enum>(A)</enum><text>to take
affirmative action to abate the violation;</text>
</subparagraph><subparagraph id="HC9654D10451A44E19BFAB000E1461728"><enum>(B)</enum><text>to reinstate the
complainant to his or her former position together with compensation (including
back pay) and restore the terms, conditions, and privileges associated with his
or her employment; and</text>
</subparagraph><subparagraph id="H1AA96AD7181340D9A3F200C7D0F0A157"><enum>(C)</enum><text>to provide
compensatory damages to the complainant.</text>
</subparagraph><continuation-text 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 id="H42B52FC713164DE9868BE85500BFACB"><enum>(d)</enum><header>Rights retained
by employee</header><text>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>