1.This Act may be cited as the
Consumer Right To Know Food Labeling
Act of 2010
.
2.The table of contents
of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Effective date.
Title I—Amendments to the Federal Food, Drug, and Cosmetic Act
regarding cloned products
Sec. 101. Labeling of products from cloned animals.
Title II—Amendments to the Federal Meat Inspection Act regarding
cloned products
Sec. 201. Requirements for labeling regarding cloned
products.
Title III—Amendments to the Federal Food, Drug, and Cosmetic Act
regarding genetically-engineered salmon
Sec. 301. Labeling of food products that contain
genetically-engineered salmon.
3.This Act and the
amendments made by this Act shall take effect upon the expiration of the
180-day period beginning on the date of enactment of this Act.
<enum>I</enum><header>Amendments to the
Federal Food, Drug, and Cosmetic Act regarding cloned products</header>
<section id="H7B798EF674A84F9BB9C0DC0436482834"><enum>101.</enum><header>Labeling of
products from cloned animals</header>
<subsection id="HB44B808F1DAD4A8D9E89F479E77D1704"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">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="H67C7B8CB67924AD491ED3870623D6CE6" style="OLC">
<subsection id="H942D5A23A1F74F45838D34E0EC85198F"><enum>(z)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H8C6CD66DD7134D8BB19249BCD519905A"><enum>(1)</enum><text>If it contains cloned
product unless it bears a label that provides notice in accordance with the
following:</text>
<subparagraph id="H09E06CEC5B174C29AD97858ABC6E99D2" indent="up1"><enum>(A)</enum><text>A notice as follows: <quote>THIS
PRODUCT IS FROM A CLONED ANIMAL OR ITS PROGENY</quote>.</text>
</subparagraph><subparagraph id="H90BC5B2A7E97466F86470CD0DF24B426" indent="up1"><enum>(B)</enum><text>The notice required in clause (A) is
of the same size as would apply if the notice provided nutrition information
that is required in paragraph (q)(1).</text>
</subparagraph><subparagraph id="H4CD8170DC36E4849953BFE9C0E2A4000" indent="up1"><enum>(C)</enum><text>The notice required under clause (A)
is clearly legible and conspicuous.</text>
</subparagraph></paragraph><paragraph id="H2C9200530FFF4DE691E87A231CF97842" indent="up1"><enum>(2)</enum><text>For purposes of this
paragraph:</text>
<subparagraph id="H427DD5868CDD46C992983ABBCD7DA006"><enum>(A)</enum><text>The term <term>cloned animal</term>
means—</text>
<clause id="H3DC87AA1F9EF45CE9E52819B8EB61650"><enum>(i)</enum><text>an animal produced as the result of
somatic cell nuclear transfer; and</text>
</clause><clause id="HA519CBF6F0CA4187B46EC44B8AD02494"><enum>(ii)</enum><text>the progeny of such an
animal.</text>
</clause></subparagraph><subparagraph id="HD8843792D932498EA3830999816540BC"><enum>(B)</enum><text>The term <term>cloned product</term>
means a product or byproduct derived from or containing any part of a cloned
animal.</text>
</subparagraph></paragraph><paragraph commented="no" id="H067F1B9F701C460D8BDE6D625C3643F9" indent="up1"><enum>(3)</enum><text>This paragraph does not apply to food
that is a medical food as defined in section 5(b) of the Orphan Drug
Act.</text>
</paragraph><paragraph commented="no" id="H69A2872E601B49F69FE50AD9AA813252" indent="up1"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H87D4322112C44731AD6C55500BE27172"><enum>(A)</enum><text>The Secretary, in
consultation with the Secretary of Agriculture, shall require that any person
that prepares, stores, handles, or distributes a cloned product for retail sale
maintain a verifiable recordkeeping audit trail that will permit the Secretary
to verify compliance with this paragraph and subsection (aa).</text>
</subparagraph><subparagraph commented="no" id="H840F5FB321994475AE58CA76025CB690" indent="up1"><enum>(B)</enum><text>The Secretary, in consultation with
the Secretary of Agriculture, shall publish in the Federal Register the
procedures established by such Secretaries to verify compliance with the
recordkeeping audit trail system required under clause (A).</text>
</subparagraph><subparagraph commented="no" id="H875D499C39444333A8561903B81E7BCF" indent="up1"><enum>(C)</enum><text>The Secretary, in consultation with
the Secretary of Agriculture, shall, on annual basis, submit to Congress a
report that describes the progress and activities of the recordkeeping audit
trail system and compliance verification procedures required under this
subparagraph.</text>
</subparagraph></paragraph></subsection><subsection id="HF85631BCE41E42E7AE41D637174DA4DF"><enum>(aa)</enum><text>If it bears a
label indicating (within the meaning of subsection (z)) that it does not
contain cloned product, unless the label is in accordance with regulations
promulgated by the Secretary. With respect to such regulations:</text>
<paragraph id="H984DF13E9F764DFC965A0C12D485ED5A"><enum>(1)</enum><text>The regulations
may not require such a label to include any statement indicating that the fact
that a food does not contain such product has no bearing on the safety of the
food for human consumption.</text>
</paragraph><paragraph id="H4A5F6487BA054C40854465F5D3AE3A78"><enum>(2)</enum><text>The regulations
may not prohibit such a label on the basis that, in the case of the type of
food involved, there is no version of the food in commercial distribution that
does contain such
product.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HF6C0C6C44E924FB2A2F21FC6C83B6F6C"><enum>(b)</enum><header>Civil
penalties</header><text>Section 303 of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (21
U.S.C. 333) is amended by adding at the end the following subsection:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="HA54F8B53C0ED40DAA48869870B4325AA">
<subsection id="H6E25F30699CA42FAA017BC9135814468"><enum>(g)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H6BB75D2F95704EBEB69A3B6CCCA94002"><enum>(1)</enum><text>With respect to a
violation of section 301(a), 301(b), or 301(c) involving the misbranding of
food within the meaning of section 403(z) or 403(aa), any person engaging in
such a violation shall be liable to the United States for a civil penalty in an
amount not to exceed $100,000 for each such violation.</text>
</paragraph><paragraph id="H72C90A17C6334C109F3749C8707EF877" indent="up1"><enum>(2)</enum><text>Paragraphs (3) through (5) of
subsection (f) apply with respect to a civil penalty under paragraph (1) of
this subsection to the same extent and in the same manner as such paragraphs
(3) through (5) apply with respect to a civil penalty under paragraph (1) or
(2) of subsection
(f).</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H88FF235F1333405B895DFE7B1F0C03B8"><enum>(c)</enum><header>Guaranty</header>
<paragraph id="H600AC2FEC95A42B58AC6796974A9A531"><enum>(1)</enum><header>In
general</header><text>Section 303(d) of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (21
U.S.C. 333(d)) is amended—</text>
<subparagraph id="H163BAB3EB1FD44A9AE77349D74C06919"><enum>(A)</enum><text>by striking
<quote>(d)</quote> and inserting <quote>(d)(1)</quote>; and</text>
</subparagraph><subparagraph id="HB16B1728189B483A87194B27E739CB38"><enum>(B)</enum><text>by adding at the
end the following paragraph:</text>
<quoted-block id="HC39D2576D23345AC819308D659E38722">
<paragraph id="HEFC701F6941F4134912A43ED99DA9B2C" indent="up1"><enum>(2)</enum><text>Subject to section 403(z)(4), no
person shall be subject to the penalties of subsection (a)(1) or (h) for a
violation of section 301(a), 301(b), or 301(c) involving the misbranding of
food within the meaning of section 403(z) and 403(aa) if such person (referred
to in this paragraph as the <quote>recipient</quote>) establishes a guaranty or
undertaking signed by, and containing the name and address of, the person
residing in the United States from whom the recipient received in good faith
the food to the effect that (within the meaning of section 403(z)) the food
does not contain any cloned
product.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H207C341C1DCA44E7AC519D1817A64227"><enum>(2)</enum><header>False
guaranty</header><text>Section 301(h) of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (21
U.S.C. 331(h)) is amended by inserting <quote>or 303(d)(2)</quote> after
<quote>303(c)(2)</quote>.</text>
</paragraph></subsection><subsection id="H59F37035F081469CB0691F6DC6CD9532"><enum>(d)</enum><header>Citizen
suits</header><text>Chapter III of the <act-name parsable-cite="FFDCA">Federal
Food, Drug, and Cosmetic Act</act-name> (21 U.S.C. 331 et seq.) is amended by
adding at the end the following section:</text>
<quoted-block display-inline="no-display-inline" id="H0C9998A5855941C787DC18C0745A98E1" style="OLC">
<section id="HD36ABD69F2884915B667781F33AC2F9E"><enum>311.</enum><header>Citizen suits
regarding misbranding of food with respect to product from cloned
animals</header>
<subsection id="HD6AEBBBD53A649A1A6A33111D9349D47"><enum>(a)</enum><header>In
general</header><text>Except as provided in subsection (c), any person may on
his or her behalf commence a civil action in an appropriate district court of
the United States against—</text>
<paragraph id="HCE96A2AAB7684A639533A44687492D47"><enum>(1)</enum><text>a person who is
alleged to have engaged in a violation of section 301(a), 301(b), or 301(c)
involving the misbranding of food within the meaning of section 403(z) or
403(aa); or</text>
</paragraph><paragraph id="HE22D89E697714478BC7E51C01D527CFC"><enum>(2)</enum><text>the Secretary
where there is alleged a failure of the Secretary to perform any act or duty
under section 403(z) or 403(aa) that is not discretionary.</text>
</paragraph></subsection><subsection display-inline="no-display-inline" id="H540A3ACD73F34733A5BA44CFAE393E86"><enum>(b)</enum><header>Relief</header><text>In
a civil action under subsection (a), the district court involved may, as the
case may be—</text>
<paragraph id="HC68E36C160E04C9C9C7B255AA6DDEDAB"><enum>(1)</enum><text>enforce the
compliance of a person with the applicable provisions referred to paragraph (1)
of such subsection; or</text>
</paragraph><paragraph id="H2EC09AE58669412C90C44F133C556D8F"><enum>(2)</enum><text>order the
Secretary to perform an act or duty referred to in paragraph (2) of such
subsection.</text>
</paragraph></subsection><subsection id="H72089F84DACA4F50A8643E596920B89E"><enum>(c)</enum><header>Limitations</header>
<paragraph id="H8807EBFEA6394C8FA6781ECE982CDD2E"><enum>(1)</enum><header>Notice to
Secretary</header><text>A civil action may not be commenced under subsection
(a)(1) prior to 60 days after the plaintiff has provided to the Secretary
notice of the violation involved.</text>
</paragraph><paragraph id="HD122416AA6484E1AB51A78254DE673AB"><enum>(2)</enum><header>Relation to
actions of Secretary</header><text>A civil action may not be commenced under
subsection (a)(2) if the Secretary has commenced and is diligently prosecuting
a civil or criminal action in a district court of the United States to enforce
compliance with the applicable provisions referred to in subsection
(a)(1).</text>
</paragraph></subsection><subsection id="H882E2071166A455290BFF3B830E2347D"><enum>(d)</enum><header>Right of
Secretary To intervene</header><text>In any civil action under subsection (a),
the Secretary, if not a party, may intervene as a matter of right.</text>
</subsection><subsection id="H65B8015213C4404EB67EE9EA54603FCB"><enum>(e)</enum><header>Award of costs;
filing of bond</header><text>In a civil action under subsection (a), the
district court involved may award costs of litigation (including reasonable
attorney and expert witness fees) to any party whenever the court determines
such an award is appropriate. The court may, if a temporary restraining order
or preliminary injunction is sought, require the filing of a bond or equivalent
security in accordance with the Federal Rules of Civil Procedure.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H0542AA2966A441FC90521071A8945989"><enum>(f)</enum><header>Savings
provision</header><text>This section does not restrict any right that a person
(or class of persons) may have under any statute or common law to seek
enforcement of the provisions referred to subsection (a)(1), or to seek any
other relief (including relief against the
Secretary).</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><enum>II</enum><header>Amendments to the
Federal Meat Inspection Act regarding cloned products</header>
<section id="H1A0247F6D05542E4A107577234F1872A"><enum>201.</enum><header>Requirements
for labeling regarding cloned products</header>
<subsection id="H17BA7C4B7C1947F8901815021373CA86"><enum>(a)</enum><header>Requirements for
labeling regarding cloned meat food products</header><text>The Federal Meat
Inspection Act is amended by inserting after section 7 (21 U.S.C. 607) the
following:</text>
<quoted-block id="HDC7281B566E64A5A99E6C9DA01A6C294">
<section id="H20B7D9EE757243C28DFE278F984D34A7"><enum>7A.</enum><header>Requirements for
labeling regarding cloned meat food products</header>
<subsection id="H3A618E804DE24205ABD110C14A90E072"><enum>(a)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph id="HDC4187DF592D4228A2DD4306159D3A0F"><enum>(1)</enum><header>Cloned
animal</header><text>The term <term>cloned animal</term> means—</text>
<subparagraph id="H16C7D6A0E6DF4459BC28C89D2F30BA10"><enum>(A)</enum><text>an animal produced
as the result of somatic cell nuclear transfer; and</text>
</subparagraph><subparagraph id="H2D26A1BD258545E8B4A9F2B07B08A07E"><enum>(B)</enum><text>the progeny of
such an animal.</text>
</subparagraph></paragraph><paragraph id="H911957C0D0014A67A28878BB14CAA112"><enum>(2)</enum><header>Cloned
product</header><text>The term <term>cloned product</term> means a product or
byproduct derived from or containing any part of a cloned animal.</text>
</paragraph><paragraph id="HFEF5DB2071394BF1845A4C2E84A062F0"><enum>(3)</enum><header>Cloned meat food
product</header><text>The term <term>cloned meat food product</term> means a
meat food product that contains a cloned product.</text>
</paragraph></subsection><subsection id="H077BEFA0ACA046E0BBB41101BDBA4F1D"><enum>(b)</enum><header>Labeling
requirement</header>
<paragraph id="H7BE37BA4C508457A9EC52ED7D80AC78F"><enum>(1)</enum><header>Required
labeling to avoid misbranding</header>
<subparagraph id="H42B4E9D4480B47FAABB37FE5E799A4A8"><enum>(A)</enum><header>Involvement of
cloned meat food product</header><text>For purposes of sections 1(n) and 10, a
meat food product is misbranded if the meat food product—</text>
<clause id="HECA23B59B59D4FDE89502E4809863ACB"><enum>(i)</enum><text>is
a cloned meat food product; and</text>
</clause><clause id="HE495424FDD1741909B1A5D8FCF6513BD"><enum>(ii)</enum><text>does not bear a
label (or include labeling, in the case of a meat food product that is not
packaged in a container) that provides, in a clearly legible and conspicuous
manner, the notice described in subsection (c).</text>
</clause></subparagraph><subparagraph id="H8670AFF2202C4342B0B28E8D2BB2814E"><enum>(B)</enum><header>No involvement
of cloned meat food product</header>
<clause id="H0C50434BE01A495FBAAD6BBEFEDE79A1"><enum>(i)</enum><header>In
general</header><text>For purposes of sections 1(n) and 10, a meat food product
is misbranded if the meat food product bears a label indicating that the meat
food product is not a cloned meat food product, unless the label is in
accordance with regulations promulgated by the Secretary.</text>
</clause><clause id="H180E83783A994A06838C3093D3A72A55"><enum>(ii)</enum><header>Requirements</header><text>In
promulgating regulations referred to in clause (i), the Secretary may
not—</text>
<subclause id="HC9DAFE40A093439BB2469C891720D054"><enum>(I)</enum><text>require a label to
include any statement indicating that the fact that a meat food product is not
a cloned meat food product has no bearing on the safety of the food for human
consumption; or</text>
</subclause><subclause id="HFEE56FFE8B4847A2AA76A0CA6D467211"><enum>(II)</enum><text>prohibit a label
on the basis that, in the case of the type of meat food product involved, there
is no version of the meat food product in commercial distribution that is not a
cloned meat food product.</text>
</subclause></clause></subparagraph></paragraph><paragraph id="H53C95613837A42E6A5C23EEA344E5408"><enum>(2)</enum><header>Audit
verification system</header>
<subparagraph id="H373810009C4C491F967A9F3406B4CC12"><enum>(A)</enum><header>In
general</header><text>The Secretary, in consultation with the Secretary of
Health and Human Services, shall require that any person that manufactures,
produces, distributes, stores, or handles a meat food product maintain a
verifiable recordkeeping audit trail that will permit the Secretary to verify
compliance with the labeling requirements described in paragraph (1).</text>
</subparagraph><subparagraph id="HB5D5A080F0874A50A07A2C4765CB235A"><enum>(B)</enum><header>Publication</header><text>The
Secretary, in consultation with the Secretary of Health and Human Services,
shall publish in the Federal Register the procedures established by the
Secretaries to verify compliance with the recordkeeping audit trail system
required under subparagraph (A).</text>
</subparagraph><subparagraph id="HA5BF34FE68A149BCB6FCF45D09A8D0C1"><enum>(C)</enum><header>Report</header><text>The
Secretary, in consultation with the Secretary of Health and Human Services,
shall, on an annual basis, submit to Congress a report that describes the
progress and activities of the recordkeeping audit trail system and compliance
verification procedures required under this paragraph.</text>
</subparagraph></paragraph></subsection><subsection id="HDD8DFEC7EA74408C9952FB3B8F585D81"><enum>(c)</enum><header>Specifics of
label notice</header>
<paragraph id="HBEFEB61E973140D9BEE81AF0A705020C"><enum>(1)</enum><header>Required
notice</header><text>The notice referred to in subsection (b)(1)(A)(ii) is the
following: <quote>THIS PRODUCT IS FROM A CLONED ANIMAL OR ITS
PROGENY</quote>.</text>
</paragraph><paragraph id="H7B52AAFC620342A893BCAEB9D927890C"><enum>(2)</enum><header>Size</header><text>The
notice required in paragraph (1) shall be of the same size as if the notice
provided nutrition information that is required under section 403(q)(1) of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(21 U.S.C. 343(q)(1)).</text>
</paragraph></subsection><subsection id="H4A63E23352C443AF93C87C83494BE28C"><enum>(d)</enum><header>Guaranty</header>
<paragraph id="H06EE3E0591DB48F48656023609B4E383"><enum>(1)</enum><header>In
general</header><text>Subject to subsection (b)(2) and paragraph (2), a person
engaged in the business of manufacturing or processing meat food products, or
selling or serving meat food products at retail or through a food service
establishment (referred to in this subsection as the <quote>recipient</quote>)
shall not be considered to have violated this section with respect to the
labeling of a meat food product if the recipient establishes a guaranty or
undertaking signed by, and containing the name and address of, the person
residing in the United States from whom the recipient received in good faith
the meat food product or the animal from which the meat food product was
derived, or received in good faith food intended to be fed to the animal, to
the effect that the meat food product, or the animal, or the meat food product,
respectively, does not contain a cloned product or was not produced with a
cloned product.</text>
</paragraph><paragraph id="H045B23C9C2E14A5B93E1AEC279855A74"><enum>(2)</enum><header>Audit
verification system</header><text>In the case of recipients who establish
guaranties or undertakings in accordance with paragraph (1), the Secretary may
exempt the recipients from the requirement under subsection (b)(2) regarding
maintaining a verifiable recordkeeping audit trail.</text>
</paragraph><paragraph id="H8A794E3B8DF24F299052970E9A6B9EEF"><enum>(3)</enum><header>False
guaranty</header><text>It is a violation of this Act for a person to give a
guaranty or undertaking in accordance with paragraph (1) that the person knows
or has reason to know is false.</text>
</paragraph></subsection><subsection id="H56BC56D4A173460DAAD8FB41F5BC68E3"><enum>(e)</enum><header>Civil
penalties</header>
<paragraph id="H66F3E029F91741FA931E131F984D0D22"><enum>(1)</enum><header>In
general</header><text>The Secretary may assess a civil penalty against a person
that violates subsection (b) or (c) in an amount not to exceed $100,000 for
each violation.</text>
</paragraph><paragraph id="HF0036ECE203344A1B24097DEF3EC3595"><enum>(2)</enum><header>Notice and
opportunity for hearing</header>
<subparagraph id="H7694E69A7F34487583B7703BC33954CA"><enum>(A)</enum><header>In
general</header><text>A civil penalty under paragraph (1) shall be assessed by
the Secretary by an order made on the record after opportunity for a hearing
provided in accordance with this paragraph and section 554 of title 5, United
States Code.</text>
</subparagraph><subparagraph id="HB473B72EA223415F947F38DE262E1663"><enum>(B)</enum><header>Written
notice</header><text>Before issuing an order under subparagraph (A), the
Secretary shall—</text>
<clause id="H373618D23AB8477C822A5DABD4FFC866"><enum>(i)</enum><text>give written
notice to the person to be assessed a civil penalty under the order of the
proposal of the Secretary to issue the order; and</text>
</clause><clause id="H6E2E55202A7940ABA0D46B11BDDEED4A"><enum>(ii)</enum><text>provide the
person an opportunity for a hearing on the order.</text>
</clause></subparagraph><subparagraph id="HBCA8C52675894BB09198FED52A01C58F"><enum>(C)</enum><header>Authorizations</header><text>In
the course of any investigation, the Secretary may issue subpoenas requiring
the attendance and testimony of witnesses and the production of evidence that
relates to the matter under investigation.</text>
</subparagraph></paragraph><paragraph id="H682FA12E726C4FBEA4CB6E71F3BE0EC0"><enum>(3)</enum><header>Considerations
regarding amount of penalty</header><text>In determining the amount of a civil
penalty under paragraph (1), the Secretary shall consider—</text>
<subparagraph id="HFF72BF0D524F4538AC2A79161B2EA1F1"><enum>(A)</enum><text>the nature,
circumstances, extent, and gravity of the 1 or more violations; and</text>
</subparagraph><subparagraph id="HAC4E6F8DA24C4231AE4E71CA6FD5666F"><enum>(B)</enum><text>with respect to
the violator—</text>
<clause id="H7432B3B5623946F3B7A30590D917AFC6"><enum>(i)</enum><text>ability to
pay;</text>
</clause><clause id="H0BCFA0137B584AB692DD07F91AA4D566"><enum>(ii)</enum><text>effect on ability
to continue to do business;</text>
</clause><clause id="HF265DF04DE444F44AD98B5A9F6CC3995"><enum>(iii)</enum><text>any history of
prior violations;</text>
</clause><clause id="HA2451DD4570548ECB5933597670689BC"><enum>(iv)</enum><text>the degree of
culpability; and</text>
</clause><clause id="HD6B36676A72A41458A9942D095D7A0C4"><enum>(v)</enum><text>such other matters
as justice may require.</text>
</clause></subparagraph></paragraph><paragraph id="H4F61B4399AE148A89AE9809994DA7D4E"><enum>(4)</enum><header>Certain
authorities</header>
<subparagraph id="H3B8E32096F15452BBC4475FAE4D64873"><enum>(A)</enum><header>In
general</header><text>The Secretary may compromise, modify, or remit, with or
without conditions, any civil penalty under paragraph (1).</text>
</subparagraph><subparagraph id="H955CF1979E224F599E37BAC5F0E87B74"><enum>(B)</enum><header>Deduction from
sums owed</header><text>The amount of a civil penalty under this subsection,
when finally determined, or the amount agreed upon in compromise, may be
deducted from any sums owing by the United States to the person charged.</text>
</subparagraph></paragraph><paragraph id="HCD05DB02B182499EA0EC19FDD76A22D9"><enum>(5)</enum><header>Judicial
review</header>
<subparagraph id="H8629689BC89C4B14ADCD73F2D0BB17FA"><enum>(A)</enum><header>In
general</header><text>Any person who requested, in accordance with paragraph
(2), a hearing respecting the assessment of a civil penalty under paragraph (1)
and who is aggrieved by an order assessing a civil penalty may file a petition
for judicial review of the order with—</text>
<clause id="H1AEBA8CB3B404E3087A68D894BD1643F"><enum>(i)</enum><text>the United States
Court of Appeals for the District of Columbia Circuit; or</text>
</clause><clause id="H6F6ECE0342BA40B28553D2947E7EBA2A"><enum>(ii)</enum><text>any other circuit
in which the person resides or transacts business.</text>
</clause></subparagraph><subparagraph id="H48A35F41CBF7466F8065DD8BFEEC2ECE"><enum>(B)</enum><header>Filing
deadline</header><text>A petition described in subparagraph (A) may only be
filed within the 60-day period beginning on the date the order making the
assessment was issued.</text>
</subparagraph></paragraph><paragraph id="H132313D462924C0E9821D9A0AFFE39B0"><enum>(6)</enum><header>Failure to
pay</header>
<subparagraph id="H89372088528F444497AC724937593DE4"><enum>(A)</enum><header>In
general</header><text>The Attorney General shall recover the amount assessed
under a civil penalty (plus interest at prevailing rates from the date of the
expiration of the 60-day period referred to in paragraph (5)(B) or the date of
the final judgment, as appropriate) in an action brought in any appropriate
district court of the United States if a person fails to pay the
assessment—</text>
<clause id="H68CD7B9D2F6847EDBF14A8387D523ED0"><enum>(i)</enum><text>after the order
making the assessment becomes final, if the person does not file a petition for
judicial review of the order in accordance with paragraph (5)(A); or</text>
</clause><clause id="H542E5BA842174D56853708B1D8FAEC87"><enum>(ii)</enum><text>after a court in
an action brought under paragraph (5) has entered a final judgment in favor of
the Secretary;</text>
</clause></subparagraph><subparagraph id="H9BE3D55D02094F308923FB736D5D8B9B"><enum>(B)</enum><header>Exemptions from
review</header><text>In an action described in subparagraph (A), the validity,
amount, and appropriateness of the civil penalty shall not be subject to
review.</text>
</subparagraph></paragraph></subsection><subsection id="H33674B575D944A72815F73D894A04101"><enum>(f)</enum><header>Citizen
suits</header>
<paragraph id="H1E52538AC9F947D28A5B1DBD0F87EA75"><enum>(1)</enum><header>In
general</header><text>Except as provided in paragraph (3), any person may on
his or her behalf commence a civil action in an appropriate district court of
the United States against—</text>
<subparagraph id="H88BC6458A9374CA5A2CF74C3FD43017F"><enum>(A)</enum><text>a person who is
alleged to have engaged in a violation of subsection (b) or (c); or</text>
</subparagraph><subparagraph id="H29204515277B446F97BCB537F7C24040"><enum>(B)</enum><text>the Secretary in a
case in which there is alleged a failure of the Secretary to perform any act or
duty under subsection (b) or (c) that is not discretionary.</text>
</subparagraph></paragraph><paragraph id="H7660F9913AEC4CDCAFB11B5B7EF1D195"><enum>(2)</enum><header>Relief</header><text>In
a civil action under paragraph (1), the district court involved may, as
appropriate—</text>
<subparagraph id="HCD9483A3B8D643CDBFC717EFB314A610"><enum>(A)</enum><text>enforce the
compliance of a person with the applicable provisions referred to paragraph
(1)(A); or</text>
</subparagraph><subparagraph id="H48DBA9868DAC4781AFDBD4A798D9A72E"><enum>(B)</enum><text>order the
Secretary to perform an act or duty referred to in paragraph (1)(B).</text>
</subparagraph></paragraph><paragraph id="H4180B590454F446EBD75BAFD97F21F14"><enum>(3)</enum><header>Limitations</header>
<subparagraph id="H08A3A5066ABC49908D9297C9CCC6450E"><enum>(A)</enum><header>Notice to
Secretary</header><text>A civil action may not be commenced under paragraph
(1)(A) prior to 60 days after the date on which the plaintiff provided to the
Secretary notice of the violation involved.</text>
</subparagraph><subparagraph id="H558E9F0C6704463081AAC58506641B75"><enum>(B)</enum><header>Relation to
actions of Secretary</header><text>A civil action may not be commenced under
paragraph (1)(B) if the Secretary has commenced and is diligently prosecuting a
civil or criminal action in a district court of the United States to enforce
compliance with the applicable provisions referred to in paragraph
(1)(A).</text>
</subparagraph></paragraph><paragraph id="H98F0CB5075544637A481CA51A27D45D7"><enum>(4)</enum><header>Right of
Secretary to intervene</header><text>In any civil action under paragraph (1),
the Secretary, if not a party, may intervene as a matter of right.</text>
</paragraph><paragraph id="H5251A309BA68471CA598245282BA5471"><enum>(5)</enum><header>Award of costs;
filing of bond</header>
<subparagraph id="H92B82C4EB30D4502B31ED9B8B58555A5"><enum>(A)</enum><header>Award of
costs</header><text>In a civil action under paragraph (1), the district court
involved may award costs of litigation (including reasonable attorney and
expert witness fees) to any party in any case in which the court determines
such an award is appropriate.</text>
</subparagraph><subparagraph id="HF96177E6F51C4512B9EDA71685EA625A"><enum>(B)</enum><header>Filing of
bond</header><text>The court may, if a temporary restraining order or
preliminary injunction is sought, require the filing of a bond or equivalent
security in accordance with the Federal Rules of Civil Procedure.</text>
</subparagraph></paragraph><paragraph id="H6D5D195ECB844C48990C398BAEE70A4B"><enum>(6)</enum><header>Savings
provision</header><text>This subsection does not restrict any right that a
person (or class of persons) may have under any statute or common law—</text>
<subparagraph id="H474F75A9EBAD4C3CBB877ACFF22FDBAF"><enum>(A)</enum><text>to seek
enforcement of the provisions referred to in paragraph (1)(A); or</text>
</subparagraph><subparagraph id="HEDE760682CDC4146886C879D593CD4CC"><enum>(B)</enum><text>to seek any other
relief (including relief against the
Secretary).</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H247AE17B4536448CA4EFDF8B5A93CA3F"><enum>(b)</enum><header>Inclusion of
labeling requirements in definition of misbranded</header><text>Section 1(n) of
the Federal Meat Inspection Act (21 U.S.C. 601(n)) is amended—</text>
<paragraph id="HB3D25E3EB8BB47C59D48387DCA333FAC"><enum>(1)</enum><text>by striking
<quote>or</quote> at the end of paragraph (11);</text>
</paragraph><paragraph id="H50549AA6BE344E0A9A0EFCE48DA81AF5"><enum>(2)</enum><text>by striking the
period at the end of paragraph (12) and inserting <quote>; or</quote>;
and</text>
</paragraph><paragraph id="H0121834E0D5A485FB12DC41CBE869825"><enum>(3)</enum><text>by adding at the
end the following:</text>
<quoted-block id="H843D1144EBC946848F43C7724C21008A">
<paragraph id="H6EDC666E0AC745348DF763A3CA6280D3"><enum>(13)</enum><text>if it fails to
bear a label or labeling as required by section
7A.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection></section><enum>III</enum><header>Amendments to
the Federal Food, Drug, and Cosmetic Act regarding genetically-engineered
salmon</header>
<section id="HCE81DD38FF374813A3D7CBF1131E0D65"><enum>301.</enum><header>Labeling of
food products that contain genetically-engineered salmon</header><text display-inline="no-display-inline">Section 403 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 343), as amended by section 3, is further amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H9CB66BFB397C43A59AB6B025C7CDCA12" style="OLC">
<subsection id="H2EB40C3E5EA14C7B84E7FB053E98CAB8"><enum>(bb)</enum><text display-inline="yes-display-inline">If it contains genetically-engineered
salmon unless the food bears a label stating that fact.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section>