1.Short title; table of
contents
(a)This Act may be cited as the Genetically Engineered Safety
Act
.
(b)The table of contents for this Act is as follows:
Sec. 1. Short title; table of contents.
Title I—Genetically engineered pharmaceutical and industrial crop
safety
Sec. 101. Short title.
Sec. 102. Findings.
Sec. 103. Definitions.
Sec. 104. Regulation of production of pharmaceutical crops and
industrial crops.
Sec. 105. Civil penalties for violation.
Sec. 106. Report to Congress on alternative methods to produce
pharmaceutical and industrial crops.
Title II—Genetically engineered food safety
Sec. 201. Short title.
Sec. 202. Findings.
Sec. 203. Federal determination of safety of genetically
engineered food; regulation as food additive.
Sec. 204. User fees regarding determination of safety of
genetic food additives.
Sec. 205. Embargo authority.
Sec. 206. Rulemaking; effective date; previously unregulated
marketed additives.
<enum>I</enum><header>Genetically
engineered pharmaceutical and industrial crop safety</header>
<section display-inline="no-display-inline" id="H581ABD2BF5D1448AAFD3BCEE6C6762E1" section-type="subsequent-section"><enum>101.</enum><header>Short
title</header><text display-inline="no-display-inline">This title may be cited
as the <quote>Genetically Engineered Pharmaceutical and Industrial Crop Safety
Act of 2011</quote>.</text>
</section><section id="H2C0C6B4C7B4A40979F1201B69BE6818F"><enum>102.</enum><header>Findings</header><text display-inline="no-display-inline">Congress finds the following:</text>
<paragraph id="HB5ED882E7F1A4C6DB828FAD6E6E4BD08"><enum>(1)</enum><text>A
pharmaceutical crop or industrial crop is a plant that has been genetically
engineered to produce a medical or industrial product, including a human or
veterinary drug, biologic, industrial, or research chemical, or enzyme.</text>
</paragraph><paragraph id="HFA122F35DCA64D0284D13959337A0138"><enum>(2)</enum><text display-inline="yes-display-inline">The Department of Agriculture has issued
more than 270 permits for more than 300 outdoor field trials of plants
genetically engineered to produce experimental pharmaceuticals, industrial
enzymes and novel proteins. More than 80 percent of the field trial permits
involved feed crops, including corn, soybeans, rice, safflower, barley,
alfalfa, mustard greens, peas, sugarcane, tomatoes, and wheat.</text>
</paragraph><paragraph id="H2C4679453FF34455BB0A053C3D0B6F94"><enum>(3)</enum><text>Many of the novel
substances produced in pharmaceutical crops and industrial crops exhibit high
levels of biological activity and are intended to be used for particular
medical or industrial purposes, under very controlled circumstances. None of
these substances is intended to be incorporated in food or to be spread into
the environment.</text>
</paragraph><paragraph id="HCA1ECAC226E347FDBB40D48236BB4C22"><enum>(4)</enum><text>The magnitude of
the risks posed by pharmaceutical crops and industrial crops depends on many
factors, including the chemicals involved, the organisms or environments
exposed, and the level and duration of the exposure. Humans, animals, and the
environment at large could be at risk from contamination, a major concern of
which is that bioactive nonfood substances, which have not been tested, will
contaminate or otherwise adversely affect the food supply. Substances intended
for use as human drugs are especially problematic because they are intended to
be biologically active in people.</text>
</paragraph><paragraph id="HED7EF817348B4986BC4A762C81E0FA76"><enum>(5)</enum><text>Pharmaceutical
crops and industrial crops also pose substantial liability and other economic
risks to farmers, grain handlers, food companies, and other persons in the food
and feed supply chain. These risks include liability for contamination
episodes, costly food recalls, losses in export markets, reduced prices for a
contaminated food or feed crop, and loss of confidence in the safety of the
American food supply among foreign importers and consumers of American
agricultural commodities.</text>
</paragraph><paragraph id="H6FBA8CEE135F4DA0BF21C1D08EF24809"><enum>(6)</enum><text>These risks
necessitate a zero tolerance standard for the presence of pharmaceutical crops
and industrial crops and their byproducts in crops used to produce human food
or animal feed.</text>
</paragraph><paragraph id="H523BEC16332A423E8EBD42FB7B068736"><enum>(7)</enum><text>While there
presently exists a pro forma zero tolerance standard, the Department of
Agriculture and experts in the field acknowledge that contamination of human
food and animal feed is inevitable due to the inherent imprecision of
biological and agricultural systems, as well as the laxity of the regulatory
regime. This is illustrated, for example, in the Department of Agriculture’s
regulations, which aim not for prevention (recognized as unattainable), but
rather mitigation of the gene flow that results in contamination of food/feed
crops with these substances. Some experts in the field are calling for
establishment of tolerances, despite the potential risks involved.</text>
</paragraph><paragraph id="H636219280CAA43168C560A4AEF99A069"><enum>(8)</enum><text display-inline="yes-display-inline">The rapidly emerging field of synthetic
biology is an extreme form of genetic engineering that has been heralded as a
remedy for numerous societal ills ranging from climate change to environmental
pollutants. The goal of synthetic biology is to create life from scratch with
synthetic DNA or without the use of DNA entirely. DNA is synthesized by a
computer is then inserted into organisms. There are a range of practices which
can be classified as synthetic biology, but such practices are more commonly
defined as the design and construction of new biological parts, devices and
systems that do not exist in the natural world and also the redesign of
existing biological systems to perform specific tasks.</text>
</paragraph><paragraph id="H59B21E3962E44CA382B379D17635243F"><enum>(9)</enum><text display-inline="yes-display-inline">Proponents of synthetic biology are
developing products that they may soon seek approval for entry into the food
supply of the United States.</text>
</paragraph><paragraph id="H2D2587D42CA64343969BD89616B1CAD9"><enum>(10)</enum><text display-inline="yes-display-inline">Therefore, appropriate regulatory controls,
as established by this title, are urgently needed to ensure that the byproducts
of pharmaceutical crops, industrial crops and organisms created as a result of
synthetic biology, as well as their byproducts, do not enter human food or
animal feed crops at any level.</text>
</paragraph></section><section id="H4347468206A745BFA3B099C75C121004"><enum>103.</enum><header>Definitions</header><text display-inline="no-display-inline">In this title:</text>
<paragraph id="H89F26C177B794458AA91317041154159"><enum>(1)</enum><text>The term
<term>genetically engineered plant</term> means a plant that contains a
genetically engineered material or was produced from a genetically engineered
seed. A plant shall be considered to contain a genetically engineered material
if the plant has been injected or otherwise treated with a genetically
engineered material (except that the use of manure as a fertilizer for the
plant may not be construed to mean that the plant is produced with a
genetically engineered material).</text>
</paragraph><paragraph id="H00A6A1D7B7B14A7FAFE9914B9FD38C50"><enum>(2)</enum><text>The term
<term>genetically engineered material</term> means material that has been
altered at the molecular or cellular level by means that are not possible under
natural conditions or processes (including recombinant DNA and RNA techniques,
cell fusion, microencapsulation, macroencapsulation, gene deletion and
doubling, introducing a foreign gene, and changing the positions of genes),
other than a means consisting exclusively of breeding, conjugation,
fermentation, hybridization, in vitro fertilization, tissue culture, or
mutagenesis.</text>
</paragraph><paragraph id="H841CDD265B104D7195410F1F077DC664"><enum>(3)</enum><text>The term
<term>genetically engineered seed</term> means a seed that contains a
genetically engineered material or was produced with a genetically engineered
material. A seed shall be considered to contain a genetically engineered
material or to have been produced with a genetically engineered material if the
seed (or the plant from which the seed is derived) has been injected or
otherwise treated with a genetically engineered material (except that the use
of manure as a fertilizer for the plant may not be construed to mean that any
resulting seeds are produced with a genetically engineered material).</text>
</paragraph><paragraph id="H86D36E83DD7C4D0C98574AB603264E0A"><enum>(4)</enum><text>The term
<term>pharmaceutical crop</term> means a genetically engineered plant that is
designed to produce medical products, including human and veterinary drugs and
biologics. The term includes a crop intentionally treated with genetically
engineered material that, in turn, produces a medical substance.</text>
</paragraph><paragraph id="HDE2E120C66C241B1944C81F12A0E55F7"><enum>(5)</enum><text>The term
<term>industrial crop</term> means a genetically engineered plant that is
designed to produce industrial products, including industrial and research
chemicals and enzymes. The term includes a crop intentionally treated with
genetically engineered material that, in turn, produces an industrial
substance.</text>
</paragraph></section><section id="H3B5A0B2282184D548013ECE3C0B8B05D"><enum>104.</enum><header>Regulation of
production of pharmaceutical crops and industrial crops</header>
<subsection id="H3DB33F6E8AB14F13857DD20D126A96A0"><enum>(a)</enum><header>Temporary
moratorium pending regulations</header><text>No pharmaceutical crop or
industrial crop may be grown, raised, or otherwise cultivated until the final
regulations and tracking system required by this section are in effect.</text>
</subsection><subsection id="H01898040C6604032832BF45AD92DE3F2"><enum>(b)</enum><header>Prohibition on
open-Air cultivation</header><text>No person may grow, raise or otherwise
cultivate a pharmaceutical crop or industrial crop in an open air
environment.</text>
</subsection><subsection id="H3F5B9B04FD424B08BC920D24B29432C0"><enum>(c)</enum><header>Prohibition on
use of common human foods or animal feeds</header><text>No person may grow,
raise, or otherwise cultivate a pharmaceutical crop or industrial crop in a
food commonly used for human food or domestic animal feed.</text>
</subsection><subsection id="HDDF154C209244F8BB1079A6F3D32781D"><enum>(d)</enum><header>Biotech tracking
system</header><text>The United States Department of Agriculture shall
establish a tracking system to regulate the growing, handling, transportation,
and disposal of all pharmaceutical and industrial crops and their byproducts to
prevent contamination.</text>
</subsection><subsection id="H749B79C59728453B8E56C1FF13936672"><enum>(e)</enum><header>Regulations</header><text>The
Secretary of Agriculture shall issue regulations—</text>
<paragraph id="HB69F7AC63E7E4462A7C2329507107A15"><enum>(1)</enum><text>to enforce the
prohibitions imposed by subsections (b) and (c);</text>
</paragraph><paragraph id="H3C0C654355934CF0BC40D01F7A9173C2"><enum>(2)</enum><text>to designate the
foods commonly used for human food or domestic animal feed, the use of which as
a source of a pharmaceutical crop or industrial crop is prohibited by
subsection (c); and</text>
</paragraph><paragraph id="H71B475DB4AB3447AB60DF0974AB7FD74"><enum>(3)</enum><text>to establish the
tracking system required by subsection (d).</text>
</paragraph></subsection></section><section id="H07CA8597C63B4343AC18834FD160612C"><enum>105.</enum><header>Civil penalties
for violation</header>
<subsection id="H24E6FBE069A24761B1CCC9759D5F267E"><enum>(a)</enum><header>Authority To
access penalties</header><text>The Secretary of Agriculture may assess, by
written order, a civil penalty against a person that violates a provision of
section 105, including a regulation promulgated or order issued under such
section. Each violation, and each day during which a violation continues, shall
be a separate offense.</text>
</subsection><subsection id="H8FBF0D52B58743669CEEE95CACE93502"><enum>(b)</enum><header>Amount and
factors in accessing penalties</header><text>The maximum amount that may be
accessed under this section for a violation may not exceed $1,000,000. In
determining the amount of the civil penalty, the Secretary shall take into
account—</text>
<paragraph id="H26217955E700487BB4CEA29A44D3A6D8"><enum>(1)</enum><text>the gravity of the
violation;</text>
</paragraph><paragraph id="H2FB12BF8FB8B47F2B37A348F63850EFA"><enum>(2)</enum><text>the degree of
culpability;</text>
</paragraph><paragraph id="HAFF9862C72834AA0A940675B58DF8E32"><enum>(3)</enum><text>the size and type
of the business; and</text>
</paragraph><paragraph id="HEF395FBCA7EE46A0A97F248BD64E61CD"><enum>(4)</enum><text>any history of
prior offenses under such section or other laws administered by the
Secretary.</text>
</paragraph></subsection><subsection id="H193E5AF04C204A9986FE7F6D81CFE9E8"><enum>(c)</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 company 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>
</subsection><subsection id="H7E8A66E31FE140138F67C72B2F517FED"><enum>(d)</enum><header>Judicial
review</header><paragraph commented="no" display-inline="yes-display-inline" id="H74535446872D407188E3309EC099BDCE"><enum>(1)</enum><text>An
order assessing a civil penalty against a person under subsection (a) may be
reviewed only in accordance with this subsection. The order shall be final and
conclusive unless the person—</text>
<subparagraph id="H1E99666DDA7F4A3B998648A010774CA4" indent="up1"><enum>(A)</enum><text>not later than 30 days after the
effective date of the order, files a petition for judicial review in the United
States court of appeals for the circuit in which the person resides or has its
principal place of business or in the United States Court of Appeals for the
District of Columbia; and</text>
</subparagraph><subparagraph id="H2D4A7FEB42624A59A35B38D02923D10F" indent="up1"><enum>(B)</enum><text>simultaneously sends a copy of the
petition by certified mail to the Secretary.</text>
</subparagraph></paragraph><paragraph id="H3F5035D6260C4052A038C9EE80743068" indent="up1"><enum>(2)</enum><text>The Secretary shall promptly file in
the court a certified copy of the record on which the violation was found and
the civil penalty assessed.</text>
</paragraph></subsection><subsection id="H8EAAA44F33F348AEA00A268BD514C7CB"><enum>(e)</enum><header>Collection
action for failure To pay assessment</header><text>If a person fails to pay a
civil penalty after the order assessing the civil penalty has become final and
unappealable, the Secretary shall refer the matter to the Attorney General, who
shall bring a civil action to recover the amount of the civil penalty in United
States district court. In the collection action, the validity and
appropriateness of the order of the Secretary imposing the civil penalty shall
not be subject to review.</text>
</subsection></section><section id="H50C9E03FD3D94B7AA2D277135444C4A0"><enum>106.</enum><header>Report to
Congress on alternative methods to produce pharmaceutical and industrial
crops</header><text display-inline="no-display-inline">The National Academy of
Sciences shall submit to Congress a report that explores alternative methods to
produce pharmaceuticals or industrial chemicals that have the advantage of
being conducted in controlled production facilities and do not present the risk
of contamination.</text>
</section><enum>II</enum><header>Genetically
engineered food safety</header>
<section display-inline="no-display-inline" id="H675874E3ED744EE893130A8BA6A82088" section-type="subsequent-section"><enum>201.</enum><header>Short
title</header><text display-inline="no-display-inline">This title may be cited
as the <quote><act-name>Genetically Engineered Food Safety
Act</act-name></quote>.</text>
</section><section id="HAC071416A59D4A488B2F35EF8FE72C10"><enum>202.</enum><header>Findings</header><text display-inline="no-display-inline">The Congress finds as follows:</text>
<paragraph id="H74BD5A3C77EC4CBF90BB464622C59318"><enum>(1)</enum><text>Genetic
engineering is an artificial gene transfer process wholly different from
traditional breeding.</text>
</paragraph><paragraph id="HA33258810A504704A9ADCC6CB46AD1A2"><enum>(2)</enum><text>Genetic
engineering can be used to produce new versions of virtually all plant and
animal foods. Thus, within a short time, the food supply could consist almost
entirely of genetically engineered products.</text>
</paragraph><paragraph id="H2CC2861AD49B4CEEBBEA56FCBB7DCF1C"><enum>(3)</enum><text>This conversion
from a food supply based on traditionally bred organisms to one based on
organisms produced through genetic engineering could be one of the most
important changes in our food supply in this century.</text>
</paragraph><paragraph id="HD8AA79F82C2649FEA392D88D3E6A61E1"><enum>(4)</enum><text>Genetically
engineered foods present new issues of safety that have not been adequately
studied.</text>
</paragraph><paragraph id="HCAA3CD43F8CF4EE39673C26A11F2AF94"><enum>(5)</enum><text>The Congress has
previously required that food additives be analyzed for their safety prior to
their placement on the market.</text>
</paragraph><paragraph id="H87B8229DC2B24D169CDCEE304F5F12F2"><enum>(6)</enum><text>Adding new genes
into a food should be considered adding a food additive, thus requiring an
analysis of safety factors.</text>
</paragraph><paragraph id="HA4739F7BE0874FC89DECA10F8E27DA93"><enum>(7)</enum><text>Federal agencies
have failed to uphold congressional intent of the Food Additives Amendment of
1958 by allowing genetically engineered foods to be marketed, sold and
otherwise used without requiring pre-market safety testing addressing their
unique characteristics.</text>
</paragraph><paragraph id="HBBB92CC41DDD4FAF8E7DFD149AAC4A57"><enum>(8)</enum><text>The food additive
process gives the Food and Drug Administration discretion in applying the
safety factors that are generally recognized as appropriate to evaluate the
safety of food and food ingredients.</text>
</paragraph><paragraph id="H58FD6027824D430BA860E4D77694B818"><enum>(9)</enum><text>Given the
consensus among the scientific community that genetic engineering can
potentially introduce hazards, such as allergens or toxins, genetically
engineered foods need to be evaluated on a case-by-case basis and cannot be
presumed to be generally recognized as safe.</text>
</paragraph></section><section id="H57C92A212D4946F8AD120A89A3D32F4E"><enum>203.</enum><header>Federal
determination of safety of genetically engineered food; regulation as food
additive</header>
<subsection id="HD739C0C1CAF043F89322FA571DAE41A5"><enum>(a)</enum><header>Inclusion in
definition of food additive</header><text>Section 201 of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(21 U.S.C. 321) is amended—</text>
<paragraph id="HBBD8A56BAE6C49F286CD2750A07CCAAF"><enum>(1)</enum><text>in paragraph (s),
by adding after and below subparagraph (6) the following sentence:</text>
<quoted-block id="HC0BEEC7252F148099C6DC9865810FE29" style="OLC">
<quoted-block-continuation-text quoted-block-continuation-text-level="subsection">Such term
includes the different genetic constructs, proteins of such constructs,
vectors, promoters, marker systems, and other appropriate terms that are used
or created as a result of the creation of a genetically engineered food (as
defined in paragraph (ss)), other than a genetic construct, protein, vector,
promoter, or marker system or other appropriate term for which an application
under section 505 or 512 has been filed. For purposes of this Act, the term
<term>genetic food additive</term> means a genetic construct, protein, vector,
promoter, or marker system or other appropriate term that is so
included.</quoted-block-continuation-text><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="HB6C894AAC65E4E888899FF50A6A61DC7"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block id="H39665AEE97F14D0897593F0E68D1C053">
<item id="H996159ACCD8E4E529BE9FFDDD81D8DF4" indent="up5"><enum>(ss)</enum><subitem commented="no" display-inline="yes-display-inline" id="H0DDE2B3122E94A89B61A41FA3D3F6037"><enum>(1)</enum><text>The term
<term>genetically engineered food</term> means food that contains or was
produced with a genetically engineered material.</text>
</subitem></item><paragraph id="HB950A479FB894451A6647785800F6E3C" indent="up1"><enum>(2)</enum><text>The term <term>genetically engineered
material</term> means material derived from any part of a genetically
engineered organism, without regard to whether the altered molecular or
cellular characteristics of the organism are detectable in the material.</text>
</paragraph><paragraph id="HE978DA303D1E426A8AB0EBB2DE24E91A" indent="up1"><enum>(3)</enum><text>The term <term>genetically engineered
organism</term> means—</text>
<subparagraph id="HCC11871539E34188A289AC2688B7F2F8"><enum>(A)</enum><text>an organism that has been altered at
the molecular or cellular level by means that are not possible under natural
conditions or processes (including but not limited to recombinant DNA and RNA
techniques, cell fusion, microencapsulation, macroencapsulation, gene deletion
and doubling, introducing a foreign gene, and changing the positions of genes),
other than a means consisting exclusively of breeding, conjugation,
fermentation, hybridization, in vitro fertilization, tissue culture, or
mutagenesis; and</text>
</subparagraph><subparagraph id="H86B1687BA0EA485EBBE6DF8B78B45BB5"><enum>(B)</enum><text>an organism made through sexual or
asexual reproduction (or both) involving an organism described in clause (A),
if possessing any of the altered molecular or cellular characteristics of the
organism so described.</text>
</subparagraph></paragraph><paragraph id="H25E2E5A20DE64C3EAC3934063B403FCD" indent="up1"><enum>(4)</enum><text>For purposes of subparagraph (1), a
food shall be considered to have been produced with a genetically engineered
material if the organism from which the food is derived has been injected or
otherwise treated with a genetically engineered material (except that the use
of manure as a fertilizer for raw agricultural commodities may not be construed
to mean that such commodities are produced with a genetically engineered
material).</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="H11FC84B74FA54BD1A5DC7EBC7FABEB27"><enum>(b)</enum><header>Petition To
establish safety</header>
<paragraph display-inline="no-display-inline" id="H217C727A252743B5B5B969E8C10AB194"><enum>(1)</enum><header>Data in
petition</header><text>Section 409(b)(2) of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (21
U.S.C. 348(b)(2)) is amended by adding after and below subparagraph (E) the
following sentence:</text>
<quoted-block display-inline="no-display-inline" id="H05A6528293C241CE931FB40CC2DB9C5D" style="OLC">
<quoted-block-continuation-text quoted-block-continuation-text-level="subsection">In the
case of a genetic food additive, such reports shall include all data that was
collected or developed pursuant to the investigations, including data that does
not support the claim of safety for
use.</quoted-block-continuation-text><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="H87EC1A4A14924AF193AACEB0AADF01D4"><enum>(2)</enum><header>Notices; public
availability of information</header><text>Section 409(b)(5) of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(21 U.S.C. 348(b)(5)) is amended—</text>
<subparagraph id="HD074AFB860DB4494BB751FF230DBD1A1"><enum>(A)</enum><text>by striking
<quote>(5)</quote> and inserting <quote>(5)(A)</quote>; and</text>
</subparagraph><subparagraph id="H1558C4B66F55462E9745FDBA0DD0C8E2"><enum>(B)</enum><text>by adding at the
end the following subparagraphs:</text>
<quoted-block id="H7A7A4A50B0BB48699829E2C50C857D1C">
<subparagraph id="HE95FE4EB63D341C186D1ED8E1E930E65" indent="up2"><enum>(B)</enum><text>In the case of a genetic food
additive:</text>
<clause id="H0EF10448A0CA4656A7A3F95E52C6D811"><enum>(i)</enum><text>Promptly after providing the notice
under subparagraph (A), the Secretary shall make available to the public all
reports and data described in paragraph (2)(E) that are contained in the
petition involved, and all other information in the petition to the extent that
the information is relevant to a determination of the safety for use of the
additive.</text>
</clause><clause id="H7A828D08A55D43E5A1E54987F409DBAB"><enum>(ii)</enum><text>Such notice shall state whether any
information in the petition is not being made available to the public because
the Secretary has made a determination that the information does not relate to
the safety for use of the additive. Any person may petition the Secretary for a
reconsideration of such a determination.</text>
</clause></subparagraph><subparagraph id="HEBC6ECB0D59C46A8AE2A36FBDF077547" indent="up2"><enum>(C)</enum><text>In the case of genetic food
additives:</text>
<clause id="HF24681DA58A44216A84399DCDAD5E5B7"><enum>(i)</enum><text>The Secretary shall maintain and make
available to the public through telecommunications a list of petitions that are
pending under this subsection and a list of petitions for which regulations
under subsection (c)(1)(A) have been established. Such list shall include
information on the additives involved, including the source of the additives,
and including any information received by the Secretary pursuant to clause
(ii).</text>
</clause><clause id="HFAD4C5418C8743289F9117D91EECCADB"><enum>(ii)</enum><text>If a regulation is in effect under
subsection (c)(1)(A) for a genetic food additive, any person who manufactures
such additive for commercial use shall submit to the Secretary a notification
of any knowledge of data that relate to the adverse health effects of the
additive, when knowledge is acquired by the person after the date on which the
regulation took effect. If the manufacturer is in possession of the data, the
notification shall include the data. The Secretary shall by regulation
establish the scope of the responsibilities of manufacturers under this clause,
including such limits on the responsibilities as the Secretary determines to be
appropriate.</text>
</clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="H143D8214825840E79BC13F842D3983A8"><enum>(3)</enum><header>Effective date
of regulation regarding safe use; opportunity for public
comment</header><text>Section 409(c)(2) of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (21
U.S.C. 348(c)(2)) is amended—</text>
<subparagraph id="HB50412BDDBB841CCA59466C55067DE34"><enum>(A)</enum><text>by striking
<quote>(2)</quote> and inserting <quote>(2)(A)</quote>; and</text>
</subparagraph><subparagraph id="H60D73B40DDD04235A118C8022453B6DE"><enum>(B)</enum><text>by adding at the
end the following subparagraph:</text>
<quoted-block id="H35BE725410D146BF92A9582753AF54BE">
<subparagraph id="HA5FAE884129D4B65B22D196D3E289F75" indent="up2"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="HA579E692A3EE4375A65ACE22B71EF896"><enum>(i)</enum><text>In the case of a genetic
food additive, an order under paragraph (1)(A) may not be issued regarding the
petition involved before the expiration of the applicable period under clause
(ii). During such period, and continuing until an order under paragraph (1) is
issued, the Secretary shall provide interested persons an opportunity to submit
to the Secretary comments on the petition. In publishing such notice, the
Secretary shall inform the public of such opportunity.</text>
</clause><clause id="H436FD1C785A747148800CE0F358D3489" indent="up1"><enum>(ii)</enum><text>For purposes of clause (i), the
applicable period under this clause regarding a petition is the 30-day period
beginning on the date on which the Secretary has under subparagraph (B)(i) of
subsection (b)(5) made information available to the public regarding the
petition, except that, if under subparagraph (B)(ii) of such subsection the
Secretary finds in favor of a person who files for reconsideration (relating to
a determination by the Secretary that information does not relate to safety),
such 30-day period is extended by an additional period of 30-days. For purposes
of the preceding sentence, a discrete 30-day extension applies to each such
reconsideration for which the Secretary finds in favor of the person filing for
reconsideration.</text>
</clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="HCA920784D397439FAD53E1439D11CF1F"><enum>(4)</enum><header>Consideration of
certain factors</header><text>Section 409(c) of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(21 U.S.C. 348(c)) is amended by adding at the end the following
paragraph:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="H22B388CA430846A99D64E5D439A6D2F0">
<paragraph id="H94BAC10B1C9A4171BD68E329DBDE529F" indent="up1"><enum>(6)</enum><text>In the case of a genetic food
additive, the factors considered by the Secretary regarding safety for use
shall include (but not be limited to) the results of the following
analyses:</text>
<subparagraph id="H291174F7414B484D992CD9BDF3D82E3D"><enum>(A)</enum><text>Allergenicity effects resulting from
the added proteins, including proteins not found in the food supply.</text>
</subparagraph><subparagraph id="H9A78AC522B9E4CF4883B8CF49333D3DF"><enum>(B)</enum><text>Pleiotropic effects. The Secretary
shall require tests to determine the potential for such effects (using
molecular characterization, biochemical characterization, mRNA profiling, or
other techniques, or as appropriate, combinations of such techniques).</text>
</subparagraph><subparagraph id="H26AF3850834E4322A5A0F849C8ADFC03"><enum>(C)</enum><text>Appearance of new toxins or increased
levels of existing toxins.</text>
</subparagraph><subparagraph id="H66C992201F1B4965B1446C289FF24A59"><enum>(D)</enum><text>Changes in the functional
characteristics of food.</text>
</subparagraph><subparagraph id="HEF659EDDA0DB4B529503F0394134DB3C"><enum>(E)</enum><text>Changes in the levels of important
nutrients.</text>
</subparagraph><subparagraph id="H3D566AB6456B4163999A87670068EC28"><enum>(F)</enum><text>Changes in the levels of
anti-nutrients.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="HD7175823C14C47A6949A9FFDE0AA19CE"><enum>(5)</enum><header>Certain
tests</header><text>Section 409(c) of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>, as
amended by paragraph (4), is amended by adding at the end the following
paragraph:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="HDD8D34A7759A42DBA56BEFC4FAB98CCE">
<paragraph id="H2926150B5E9843EA8A80046BB8F6CD76" indent="up1"><enum>(7)</enum><text>In the case of genetic food
additives:</text>
<subparagraph id="H0FFE79052FC74172BD3DDCA4412C0E51"><enum>(A)</enum><text>If a genetic food additive is a
protein from a commonly or severely allergenic food, the Secretary may not
establish a regulation under paragraph (1)(A) if the petition under subsection
(b)(1) fails to include full reports of investigations that used serum or skin
tests (or other advanced techniques) on a sensitive population to determine
whether such additive is commonly or severely allergenic.</text>
</subparagraph><subparagraph id="HDC7D4D470C3240878BC3141AAD457FE1"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="H3C423B4008DB46B58BE76FBA37A31707"><enum>(i)</enum><text>If a genetic food
additive is a protein that has not undergone the investigations described in
subparagraph (A), the Secretary may not establish a regulation under paragraph
(1)(A) if the petition under subsection (b)(1) fails to include full reports of
investigations that used the best available biochemical and physiological
protocols to evaluate whether it is likely that the protein involved is an
allergen.</text>
</clause><clause id="HD9E097FE2BD841649536BA6170FC4896" indent="up1"><enum>(ii)</enum><text>For purposes of clause (i), the
Secretary shall by regulation determine the best available biochemical and
physiological protocols. In carrying out rulemaking under the preceding
sentence, the Secretary shall consult with the Director of the National
Institutes of
Health.</text>
</clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="H25C1D5C0D7B946D3B37FC8306F505C5D"><enum>(6)</enum><header>Prohibited
additives</header><text>Section 409(c) of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>, as
amended by paragraph (5), is amended by adding at the end the following
paragraph:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="H7B99D124E254453CB8601FFDF0A54FD6">
<paragraph id="H4FC573725C0A416E84289DDBEB42AA42" indent="up1"><enum>(8)</enum><text>In the case of a genetic food
additive, the Secretary may not establish a regulation under paragraph (1)(A)
if—</text>
<subparagraph id="HD82CAF9D022E4CBD8A67012D15A37EF0"><enum>(A)</enum><text>the additive is a protein and a report
of an investigation finds that the additive is likely to be commonly or
severely allergenic;</text>
</subparagraph><subparagraph id="H8F65836BEDD746A5BF79BACD4A1D4A3E"><enum>(B)</enum><text>the additive is a protein and a report
of an investigation that uses a protocol described in paragraph (7)(B) fails to
find with reasonable certainty that the additive is unlikely to be an allergen;
or</text>
</subparagraph><subparagraph id="H1DF23D6AFF5A4AA5AA63550C69FF0738"><enum>(C)</enum><text>effective June 1, 2006, a selective
marker is used with respect to the additive, the selective marker will remain
in the food involved when the food is marketed, and the selective marker
inhibits the function of one or more
antibiotics.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="H7AAC9BEBAA314C30B7B3570A68F22DD2"><enum>(7)</enum><header>Additional
provisions</header><text>Section 409(c) of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>, as
amended by paragraph (6), is amended by adding at the end the following
paragraph:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="H8D3BF481B55946E7BF8187C3A2D8623D">
<paragraph id="H1F1F06668E334E02B0778D069038F3E1" indent="up1"><enum>(9)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H47F86DB9F7F74FC48D3D62210A18D4CD"><enum>(A)</enum><text>In determining the
safety for use of genetic food additives, the Secretary may (directly or
through contract) conduct investigations of such additives for purposes of
supplementing the information provided to the Secretary pursuant to petitions
under subsection (b)(1).</text>
</subparagraph><subparagraph id="H7CF0DB05D4B2424F8BE3F0ED0DFFC6F6" indent="up1"><enum>(B)</enum><text>To provide the Congress with a
periodic independent, external review of the Secretary’s formulation of the
approval process under paragraph (1)(A) that relates to genetic food additives,
the Secretary shall enter into an agreement with the Institute of Medicine.
Such agreement shall provide that, if the Institute of Medicine has any
concerns regarding the approval process, the Institute of Medicine will submit
to the Congress a report describing such
concerns.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="H001F339D6AB34E849BD5E86C6F7C65E4"><enum>(c)</enum><header>Regulation
issued on secretary’s initiative</header><text>Section 409(d) of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(21 U.S.C. 348(d)) is amended—</text>
<paragraph id="H662FC8F80F0043E0BEAE359E8E5D84CC"><enum>(1)</enum><text>by striking
<quote>(d) The Secretary</quote> and inserting <quote>(d)(1) Subject to
paragraph (2), the Secretary</quote>; and</text>
</paragraph><paragraph id="HD2B2CBA814EC4A43A7A9F68C25EFB837"><enum>(2)</enum><text>by adding at the
end the following paragraph:</text>
<quoted-block id="H2E8D86D8E504474DAC706E08AB59B9D5">
<paragraph id="H2D276A1D640F4FF088FBA27419CE31CB" indent="up1"><enum>(2)</enum><text>The provisions of subsections (b) and
(c) that expressly reference genetic food additives apply with respect to a
regulation proposed by the Secretary under paragraph (1) to the same extent and
in the same manner as such provisions apply with respect to a petition filed
under subsection
(b)(1).</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="HA118DE4180EE49289263B850879E79F0"><enum>(d)</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="H5540D605318E4C9094CAE0B61A01EB5C">
<subsection id="HFA2B2DEF1C58455D8FA8DCC262B57F7F"><enum>(h)</enum><paragraph commented="no" display-inline="yes-display-inline" id="HCA6F3996213C4ED89C6BA81D436C9A7A"><enum>(1)</enum><text>With respect to a
violation of section 301(a), 301(b), or 301(c) involving the adulteration of
food by reason of failure to comply with the provisions of section 409 that
relate to genetic food additives, 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="H8F3600B9F19944D194C42F7900216242" indent="up1"><enum>(2)</enum><text>Paragraphs (5) through (7) 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
(5) through (7) apply with respect to a civil penalty under paragraph (1), (2),
(3), (4), or (9) of subsection
(f).</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H53944FF22C344706ABA5706C0228E3DD"><enum>(e)</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="H8F3381D76DDB47ED9794177F962E8519" style="OLC">
<section id="H2A82510C9CA24D159E4BFDD6EA17A578"><enum>311.</enum><header>Citizen suits
regarding genetic food additives</header>
<subsection id="HB7AED8879EAD48BF867BFAAA0A727CC2"><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="H7EE48C9587C6469E95D12FF817427B67"><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 adulteration of food by reason of failing to comply with the
provisions of section 409 that relate to genetic food additives; or</text>
</paragraph><paragraph id="HD0779A53115F42E5B7302853D8582C22"><enum>(2)</enum><text>the Secretary
where there is alleged a failure of the Secretary to perform any act or duty
under section 409 that relates to such additives and is not
discretionary.</text>
</paragraph></subsection><subsection display-inline="no-display-inline" id="HA3195446A1294C0790C7B67C3BAA9837"><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="H3395DDB5EA2347E7A90E2EAC40809532"><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="H247E59958B40407DB6C1F97F9D165C35"><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="H2B020D7BD19244799660FAB31551C3CD"><enum>(c)</enum><header>Limitations</header>
<paragraph id="H720963283A7D44849B8E68C059BABC44"><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="HBD795D712D054F86B9911C4E2FB15501"><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="H26013D44AE504E2383B2D0751DE34448"><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="H04FCEB39CA274E1F99E101582EC93B40"><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 id="H49627FD1EE714FCA9A48DC373C5A9C0B"><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><subsection id="H69CE43D971864F6BA8ACEEFE02BD9B79"><enum>(f)</enum><header>Rule of
construction</header><text>With respect to section 409 of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
as amended by this section, compliance with the provisions of such section 409
that relate to genetic food additives does not constitute an affirmative
defense in any cause of action under Federal or State law for personal injury
resulting in whole or in part from a genetic food additive.</text>
</subsection></section><section id="H28C809FCBC8748FBB93B765AE9ADBD30"><enum>204.</enum><header>User fees
regarding determination of safety of genetic food additives</header><text display-inline="no-display-inline">Chapter IV of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(21 U.S.C. 341 et seq.) is amended by inserting after section 409 the following
section:</text>
<quoted-block display-inline="no-display-inline" id="HC20496156D954211B9A019D0211045D5" style="OLC">
<section id="HFDC3036A9C12493F960557F9FD5CC980"><enum>409A.</enum><header>User fees
regarding safety of genetic food additives</header>
<subsection id="H05EB54A608724F0193DA568EB986D118"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">In the case of
genetic food additives, the Secretary shall in accordance with this section
assess and collect a fee on each petition that is filed under section
409(b)(1). The fee shall be collected from the person who submits the petition,
is due upon submission of the petition, and shall be assessed in an amount
determined under subsection (c). This section applies as of the first fiscal
year that begins after the date of promulgation of the final rule required in
section 206 of the Genetically Engineered Food Safety Act (referred to in this
section as the <term>first applicable fiscal year</term>).</text>
</subsection><subsection id="HC9E483A1B8B94947B028199BA6D4EB59"><enum>(b)</enum><header>Purpose of
fees</header>
<paragraph id="H4C03E2103EE34E58B7B630ACFED0FECD"><enum>(1)</enum><header>In
general</header><text>The purposes of fees under subsection (a) are as
follows:</text>
<subparagraph id="H458D0E7BE325479D8FA3E1A4C78072C8"><enum>(A)</enum><text>To defray
increases in the costs of the resources allocated for carrying out section 409
for the first applicable fiscal year over the costs of carrying out such
section for the preceding fiscal year, other than increases that are not
attributable to the responsibilities of the Secretary with respect to genetic
food additives.</text>
</subparagraph><subparagraph id="HF5B9F80C3DDA439AA14A18DB0AA7C47D"><enum>(B)</enum><text>To provide for a
program of basic and applied research on the safety of genetic food additives
(to be carried out by the Commissioner). The program shall address fundamental
questions and problems that arise repeatedly during the process of reviewing
petitions under section 409(b)(1) with respect to genetic food additives, and
shall not directly support the development of new genetically engineered
foods.</text>
</subparagraph></paragraph><paragraph id="H3799DB18FF344321B7C87675AEED48F4"><enum>(2)</enum><header>Allocations by
Secretary</header><text>Of the total fee revenues collected under subsection
(a) for a fiscal year, the Secretary shall reserve and expend—</text>
<subparagraph id="HB7F4F31C3E964D76A757D9919F65E530"><enum>(A)</enum><text>95 percent for the
purpose described in paragraph (1)(A); and</text>
</subparagraph><subparagraph id="H257A27BFCE9C464D8AE91CFE8E722E84"><enum>(B)</enum><text>5 percent for the
purpose described in paragraph (1)(B).</text>
</subparagraph></paragraph><paragraph id="HFF661667E9EA4F86B8EF3E8460214672"><enum>(3)</enum><header>Certain
provisions regarding increased administrative costs</header><text>With respect
to fees under subsection (a):</text>
<subparagraph id="H5C685221530E42898AB33104CD160FA1"><enum>(A)</enum><text>Increases referred
to in paragraph (1)(A) include the costs of the Secretary in providing for
investigations under section 409(c)(9)(A).</text>
</subparagraph><subparagraph id="H46D813F96999436FA8476560E865EB64"><enum>(B)</enum><text>Increases referred
to in paragraph (1)(A) include increases in costs for an additional number of
full-time equivalent positions in the Department of Health and Human Services
to be engaged in carrying out section 409 with respect to genetic food
additives.</text>
</subparagraph></paragraph></subsection><subsection id="H44272A505B464980809571C320238D3D"><enum>(c)</enum><header>Total fee
revenues; individual fee amounts</header><text>The total fee revenues collected
under subsection (a) for a fiscal year shall be the amounts appropriated under
subsection (f)(2) for such fiscal year. Individual fees shall be assessed by
the Secretary on the basis of an estimate by the Secretary of the amount
necessary to ensure that the sum of the fees collected for such fiscal year
equals the amount so appropriated. In assessing the individual fees, the
Secretary shall by regulation provide for the assessment of reduced fee amounts
for entities that are small businesses, or nonprofit private entities, as
defined by the Secretary for purposes of this section.</text>
</subsection><subsection id="H49F6060DCEE94626995C0A64135DBF95"><enum>(d)</enum><header>Fee waiver or
reduction</header><text>The Secretary shall grant a waiver from or a reduction
of a fee assessed under subsection (a) if the Secretary finds that the fee to
be paid will exceed the anticipated present and future costs incurred by the
Secretary in carrying out the purposes described in subsection (b) (which
finding may be made by the Secretary using standard costs).</text>
</subsection><subsection id="HF681D84441FB4A0781AA44885705A8E1"><enum>(e)</enum><header>Assessment of
fees</header>
<paragraph id="H7A32F9B896CF466FBBA048D634C3517C"><enum>(1)</enum><header>Limitation</header><text>Fees
may not be assessed under subsection (a) for a fiscal year beginning after the
first applicable fiscal year unless the amount appropriated for salaries and
expenses of the Food and Drug Administration for such fiscal year is equal to
or greater than the amount appropriated for salaries and expenses of the Food
and Drug Administration for the first applicable fiscal year multiplied by the
adjustment factor applicable to the fiscal year involved, except that in making
determinations under this paragraph for the fiscal years involved there shall
be excluded—</text>
<subparagraph id="H2F5BA97FCBB0411D86AC27923619CF97"><enum>(A)</enum><text>the amounts
appropriated under subsection (f)(2) for the fiscal years involved; and</text>
</subparagraph><subparagraph id="H7AA120232722414B8D533DDA0D3BC8ED"><enum>(B)</enum><text>the amounts
appropriated under sections 736(g), 738(h), 740(g), and 741(g) for such fiscal
years.</text>
</subparagraph></paragraph><paragraph id="H79A83BBC619F4405BC914120A574751A"><enum>(2)</enum><header>Authority</header><text>If
under paragraph (1) the Secretary does not have authority to assess fees under
subsection (a) during a portion of a fiscal year, but does at a later date in
such fiscal year have such authority, the Secretary, notwithstanding the due
date under such subsection for fees, may assess and collect such fees at any
time in such fiscal year, without any modification in the rate of the
fees.</text>
</paragraph></subsection><subsection id="H135C4D9F6C1B4965B42A04F364BDC968"><enum>(f)</enum><header>Crediting and
availability of fees</header>
<paragraph id="HA8E97A3AB63C43298E71D7DD70CB1BBB"><enum>(1)</enum><header>In
general</header><text>Fees collected for a fiscal year pursuant to subsection
(a) shall be credited to the appropriation account for salaries and expenses of
the Food and Drug Administration and shall be available in accordance with
appropriation Acts until expended without fiscal year limitation. 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. The sums transferred shall be available solely for the purposes
described in paragraph (1) of subsection (b), and the sums are subject to
allocations under paragraph (2) of such subsection.</text>
</paragraph><paragraph id="HD2E1BFED6BF84D54963610D5C3174B80"><enum>(2)</enum><header>Authorization of
appropriations</header>
<subparagraph id="H80694F529E484898A470E58067BB20E9"><enum>(A)</enum><header>First fiscal
year</header><text>For the first applicable fiscal year—</text>
<clause id="HA0DF1D5DBA86418F86750A218FAEDA4D"><enum>(i)</enum><text>there is
authorized to be appropriated for fees under subsection (a) an amount equal to
the amount of increase determined under subsection (b)(1)(A) by the Secretary
(which amount shall be published in the Federal Register); and</text>
</clause><clause id="H72D7138811B94D50AB5AD2B0DD61310F"><enum>(ii)</enum><text>in addition,
there is authorized to be appropriated for fees under subsection (a) an amount
determined by the Secretary to be necessary to carry out the purpose described
in subsection (b)(1)(B) (which amount shall be so published).</text>
</clause></subparagraph><subparagraph id="H85666C7020A44DDF8226AD0EDD99E5AA"><enum>(B)</enum><header>Subsequent
fiscal years</header><text>For each of the four fiscal years following the
first applicable fiscal year—</text>
<clause id="H2B69B779285A45B2AB80A8B19C8D9AA0"><enum>(i)</enum><text>there is
authorized to be appropriated for fees under subsection (a) an amount equal to
the amount that applied under subparagraph (A)(i) for the first applicable
fiscal year, except that such amount shall be adjusted under paragraph (3)(A)
for the fiscal year involved; and</text>
</clause><clause id="H8828013AF51E458197D8B8EA3C2231F6"><enum>(ii)</enum><text>in addition,
there is authorized to be appropriated for fees under subsection (a) an amount
equal to the amount that applied under subparagraph (A)(ii) for the first
applicable fiscal year, except that such amount shall be adjusted under
paragraph (3)(B) for the fiscal year involved.</text>
</clause></subparagraph></paragraph><paragraph id="H77CFD1A0486245E7932816138F06AB55"><enum>(3)</enum><header>Adjustments</header>
<subparagraph id="HE83C9F68BB7D44F2AA0D2FFA05262DAD"><enum>(A)</enum><header>Agency cost of
resources</header><text>For each fiscal year other than the first applicable
fiscal year, the amount that applied under paragraph (2)(A)(i) for the first
applicable fiscal year shall be multiplied by the adjustment factor (as defined
in subsection (i)).</text>
</subparagraph><subparagraph id="HC112279935EE422DACB21CEC6BE649EF"><enum>(B)</enum><header>Research
program</header><text>For each fiscal year other than the first applicable
fiscal year, the amount that applied under paragraph (2)(A)(ii) for the first
applicable fiscal year shall be adjusted by the Secretary (and as adjusted
shall be published in the Federal Register) to reflect the greater of—</text>
<clause id="H5C7934F078B7486EBF8F7F101157DFD1"><enum>(i)</enum><text>the total
percentage change that occurred during the preceding fiscal year in the
Consumer Price Index for all urban consumers (all items; U.S. city average);
or</text>
</clause><clause id="H001E1A5A550247158EBCB098A546F001"><enum>(ii)</enum><text>the total
percentage change for such 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.</text>
</clause></subparagraph></paragraph><paragraph id="H9FCDE1B167174A6F86546BEA8B6C6FF1"><enum>(4)</enum><header>Offset</header><text>Any
amount of fees collected for a fiscal year under subsection (a) that exceeds
the amount of fees specified in appropriation Acts for such fiscal year 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 pursuant to
appropriation Acts for a subsequent fiscal year.</text>
</paragraph></subsection><subsection id="H9345A3278469425F80CCE24EE8622BFE"><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="H993282F5DA2B4C9FBDA8CF7DDEB45B9F"><enum>(h)</enum><header>Construction</header><text>This
section may not be construed as requiring 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 carrying out
section 409 with respect to genetic food additives be reduced to offset the
number of officers, employees, and advisory committees so engaged.</text>
</subsection><subsection id="H2FF4F9E9A392482FA2452961B85CC61F"><enum>(i)</enum><header>Definition of
adjustment factor</header><text>For purposes of this section, the term
<term>adjustment factor</term> applicable to a fiscal year is the lower
of—</text>
<paragraph id="HF4561021539D4EA59000C44A393287A6"><enum>(1)</enum><text>the Consumer Price
Index for all urban consumers (all items; United States city average) for April
of the preceding fiscal year divided by such Index for April of the first
applicable fiscal year; or</text>
</paragraph><paragraph id="H1856B9C39BD845068C336227C36CB08B"><enum>(2)</enum><text>the total of
discretionary budget authority provided for programs in categories other than
the defense category for the immediately preceding fiscal year (as reported in
the Office of Management and Budget sequestration preview report, if available,
required under section 254(c) of the Balanced Budget and Emergency Deficit
Control Act of 1985) divided by such budget authority for the first applicable
fiscal year (as reported in the Office of Management and Budget final
sequestration report submitted for such year).</text>
</paragraph><continuation-text continuation-text-level="subsection">For
purposes of this subsection, the terms <term>budget authority</term> and
<term>category</term> have the meaning given such terms in the Balanced Budget
and Emergency Deficit Control Act of
1985.</continuation-text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="HAD08AC1BA1534F9EAAFF11E37AA6D1F0"><enum>205.</enum><header>Embargo
authority</header>
<subsection id="H8FD89DC2C27B403F975C04E7F430EBB4"><enum>(a)</enum><header>Embargo</header>
<paragraph id="H1C9F8E4DF13446EE8556DA25BBBDA3B3"><enum>(1)</enum><header>Temporary
detention</header><text>Section 304(g)(1) of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(21 U.S.C. 334(g)(1)) is amended—</text>
<subparagraph id="H6405B184B51C4CB596227374E543FF1E"><enum>(A)</enum><text>in the first
sentence—</text>
<clause id="HAB56403030DC4FDDAE1430EE5933B8C0"><enum>(i)</enum><text>by
striking <quote>If during</quote> and all that follows through <quote>order the
device or tobacco product detained</quote> and inserting the following:
<quote>If, during an inspection conducted under section 704, an officer or
employee of the Department has reason to believe that a food, device, or
tobacco product is in violation of this Act, such officer or employee may order
the food, device, or tobacco product detained</quote>; and</text>
</clause><clause id="HD701D4F84BCA4CF188ACCBAB1AEA6AF0"><enum>(ii)</enum><text>by
striking <quote>he may authorize</quote> and inserting <quote>the Secretary may
authorize</quote>;</text>
</clause></subparagraph><subparagraph id="HBC3911FC5A5846159B34543C48328E93"><enum>(B)</enum><text>in the second and
third sentences, by striking <quote>device or tobacco product</quote> each
place it appears and inserting <quote>food, device, or tobacco
product</quote>;</text>
</subparagraph><subparagraph id="H5CC6CD64447846968578C7D57A9BA6F8"><enum>(C)</enum><text>by striking the
fourth and fifth sentences; and</text>
</subparagraph><subparagraph id="H5CA1C0546D0343978AA8DDF74F0D8AC0"><enum>(D)</enum><text>by adding at the
end the following sentence: <quote>A detention order under this paragraph shall
be considered final agency action.</quote>.</text>
</subparagraph></paragraph><paragraph id="H2AC0DABCB6A14B559190C628FEF8FF70"><enum>(2)</enum><header>Conforming
amendments</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—</text>
<subparagraph id="H233C75D9C77048B585AE309BF7B15536"><enum>(A)</enum><text>in section
301(r)—</text>
<clause id="H0C46E74C53D145048CD65C25C57A3A39"><enum>(i)</enum><text>by
striking <quote>device or tobacco product</quote> the first place such term
appears and inserting <quote>food, device, or tobacco product</quote>;
and</text>
</clause><clause id="HA59A6E528866434C892D9C9F678719CE"><enum>(ii)</enum><text>by
striking <quote>the device or tobacco product</quote> and inserting <quote>such
food, device, or tobacco product</quote>; and</text>
</clause></subparagraph><subparagraph id="H8B7F5A89DAF1485A989BCB9B4F4A95A0"><enum>(B)</enum><text>in section
304(g)(2)—</text>
<clause id="H021E368AF9B84F45ACE1BB34856023D1"><enum>(i)</enum><text>in
subparagraph (A), by striking <quote>device or tobacco product</quote> and
inserting <quote>food, device, or tobacco product</quote>; and</text>
</clause><clause id="H38610287986642989664961A3452BF7D"><enum>(ii)</enum><text>in
subparagraph (B), by striking <quote>device</quote> each place it appears and
inserting <quote>food or device</quote>.</text>
</clause></subparagraph></paragraph></subsection><subsection id="H76DF52BF97F14A2B836B27389E7F2ABB"><enum>(b)</enum><header>Date certain for
proposed and final rules</header><text>Within six months of the date of the
enactment of this title, the Secretary of Health and Human Services shall
propose a revision to the regulations in effect on such date under section
304(g) of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name> to include food. Within three months of the date such proposed
revision is published in the Federal Register, the Secretary shall issue a
final revision of such regulations.</text>
</subsection><subsection id="HD11BC522F3D54E9F91BB0BF9C423C54B"><enum>(c)</enum><header>Confidentiality</header><text>For
any food embargoed, seized, or recalled under the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name>, the Food and Drug Administration shall disclose all necessary
information without regard to business confidentiality, if such disclosure is
necessary to fully embargo, seize, or recall any adulterated food.</text>
</subsection><subsection id="H4313FDEFB3B4456F8AB3A8E644EABBAA"><enum>(d)</enum><header>Food retailer
registration</header><text>All food retailers shall register with the Food and
Drug Administration for the purpose of expediting recalls, embargoes, and
seizures under the <act-name parsable-cite="FFDCA">Federal Food, Drug, and
Cosmetic Act</act-name>.</text>
</subsection></section><section id="HC2DCB83E7D77486794C5373230E2E9B1"><enum>206.</enum><header>Rulemaking;
effective date; previously unregulated marketed additives</header>
<subsection id="H92391D612C254835AB1BD846BA516FF5"><enum>(a)</enum><header>Rulemaking;
effective date</header><text>Not later than one year after the date of the
enactment of this title, the Secretary of Health and Human Services shall by
regulation establish criteria for carrying out section 409 of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
in accordance with the amendments made by section 203, and criteria for
carrying out section 409A of such Act (as added by section 204). Such
amendments take effect upon the expiration of the 30-day period beginning on
the date on which the Secretary promulgates the final rule under the preceding
sentence, subject to subsection (b).</text>
</subsection><subsection id="H4F05F777272D4AC1B47F6085C8DCD811"><enum>(b)</enum><header>Previously
unregulated marketed additives</header>
<paragraph id="H1576159DAC39429A8417A4434B08A1BF"><enum>(1)</enum><header>In
general</header><text>In the case of a genetic food additive (as defined
pursuant to the amendments made by section 203) that in the United States was
in commercial use in food as of the day before the date on which the final rule
under subsection (a) is promulgated, the amendments made by this title apply to
the additive upon the expiration of the two-year period beginning on the date
on which the final rule is promulgated, subject to paragraph (2).</text>
</paragraph><paragraph id="H20A0AA7CD20047E29732F9C41977D5DC"><enum>(2)</enum><header>User
fees</header><text>With respect to a genetic food additive described in
paragraph (1), such paragraph does not waive the applicability of section 409A
of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name> to a petition under section 409(b)(1) of such Act that is filed
before the expiration of the two-year period described in such
paragraph.</text>
</paragraph></subsection></section>