113 HR 4432 IH: Safe and Accurate Food Labeling Act of 2014
U.S. House of Representatives
2014-04-09
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.This Act may be cited as the Safe and Accurate Food Labeling Act of 2014
.
2.The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Ensuring safety of food supply.
Title I—Food produced from, containing, or consisting of a bioengineered organism
Sec. 101. Definitions.
Sec. 102. Mandatory premarket biotechnology notification program.
Sec. 103. Labeling of whether food is bioengineered.
Sec. 104. Preemption.
Title II—Natural foods
Sec. 201. Labeling of natural foods.
Sec. 202. Regulations.
Sec. 203. Preemption.
Sec. 204. Effective date.
3.Ensuring safety of food supplyNothing in this Act (or the amendments made by this Act) is intended to alter or affect the
authorities or regulatory programs, policies, and procedures otherwise
available to the Food and Drug Administration to ensure the safety of the
food supply under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
et seq.).
<enum>I</enum><header>Food produced from, containing, or consisting of a bioengineered organism</header>
<section id="H1CBEF14C228144C19E75FD13492B39DE"><enum>101.</enum><header>Definitions</header><text display-inline="no-display-inline">Section 201 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321</external-xref>) is amended by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="HA847670368094AA3AEA31DB7D0E7D4AF" style="OLC">
<subsection id="H1007D19F77694D21B85A7E6AD422462D"><enum>(ss)</enum><text display-inline="yes-display-inline">The term <term>bioengineered organism</term> refers to an organism if—</text>
<paragraph id="H2A50F5DEC4E04F80856AF8C04A8FC16D"><enum>(1)</enum><text>the organism is a plant (or a seed, a fruit, or any other part thereof);</text>
</paragraph><paragraph id="HAC60304D0EBF4DD8989F157866DAB67C"><enum>(2)</enum><text>the organism contains genetic material that has been modified through in vitro recombinant
deoxyribonucleic acid (DNA) techniques; and</text>
</paragraph><paragraph id="H22C46EEE16394F77A1137E8F488DD1AD"><enum>(3)</enum><text display-inline="yes-display-inline">the modification could not otherwise be obtained using conventional breeding techniques.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="HAA2EE165882A4AE89C9EC006EB0FDF35"><enum>102.</enum><header>Mandatory premarket biotechnology notification program</header>
<subsection id="H56AA02FC8FC84FAEAB41DCDF6BDD6096"><enum>(a)</enum><header>Prohibited Act</header><text display-inline="yes-display-inline">Section 301 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/331">21 U.S.C. 331</external-xref>) is amended by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="H8BBFD55FF9D54E309FC87ADEBAE5A57D" style="OLC">
<subsection id="H064E48AB757F41D28474C967DF928E8F"><enum>(ddd)</enum><text display-inline="yes-display-inline">The initial introduction or delivery for introduction in interstate commerce of a bioengineered
organism intended for a food use or application, unless the developer of
the organism has complied with the notification requirements, to the
extent applicable, under section 424.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H68C275F799B94D60BB6C19FC3060381B"><enum>(b)</enum><header>Notification program</header><text>Chapter IV of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/341">21 U.S.C. 341 et seq.</external-xref>) is amended by adding
at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HDEFA1818C1934C77A593BB0985676AEB" style="OLC">
<section id="H33F73FF344784329AD67F14850B31D8D"><enum>424.</enum><header>Notification relating to certain bioengineered organisms</header>
<subsection id="H9E057649DCD941A184086A16C60D6713"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">A bioengineered organism shall not be introduced or delivered for introduction into interstate
commerce for a food use or application unless—</text>
<paragraph commented="no" id="H45FB103B5DF24181AEB5722668CB002C"><enum>(1)</enum><text display-inline="yes-display-inline">the use or application of the bioengineered organism in food has been addressed by the developer of
the bioengineered organism in a premarket biotechnology notification, to
which the Secretary has responded under subsection (d)(2)(A) by stating no
objections; or</text>
</paragraph><paragraph id="HD6431A075F634815979DEA41E2F3DD35"><enum>(2)</enum>
<subparagraph commented="no" display-inline="yes-display-inline" id="H3D3CF75867B94F33BEA38DFD0E01B357"><enum>(A)</enum><text>food produced from, containing, or consisting of the bioengineered organism was evaluated by the
Secretary pursuant to the Food and Drug Administration’s voluntary
consultation process for foods and food products from genetically
engineered plants in effect prior to the date of enactment of the <short-title>Safe and Accurate Food Labeling Act of 2014</short-title>; and</text>
</subparagraph><subparagraph id="H09A467AFEF9145B99DF90EFB647FD03C" indent="up1"><enum>(B)</enum><text>the Secretary informed the developer of the bioengineered organism that all questions about safety
have been resolved.</text>
</subparagraph></paragraph></subsection><subsection id="H09C78DFE4ACF425BB05537A11F36D9AF"><enum>(b)</enum><header>Exceptions</header><text display-inline="yes-display-inline">This section does not apply with respect to the introduction or delivery for introduction into
interstate commerce of a bioengineered organism—</text>
<paragraph id="HB1A7B52DD2344EB3BCFC6E2A951372B3"><enum>(1)</enum><text>for the purpose of development or testing conducted to generate data and information that could be
used in a premarket biotechnology notification or other regulatory
submission; or</text>
</paragraph><paragraph commented="no" id="H49ED6070C2384060BB724877763AFE7E"><enum>(2)</enum><text>solely because—</text>
<subparagraph commented="no" id="HF036D8D577B14C5990D4AC32F54FC547"><enum>(A)</enum><text display-inline="yes-display-inline">a processing aid or enzyme produced from the bioengineered organism is intended to be used to
produce food; or</text>
</subparagraph><subparagraph commented="no" id="H31EA94C63DC148A1A6E6DC4F4F0042C5"><enum>(B)</enum><text display-inline="yes-display-inline">food produced from, containing, or consisting of the bioengineered organism is intended to be fed
to an animal from which food is intended to be produced or derived.</text>
</subparagraph></paragraph></subsection><subsection id="H56EBB050461C45D2A28B35B9AA1FE12F"><enum>(c)</enum><header>Premarket Biotechnology Notification</header>
<paragraph id="H1DBD92A72BF640FCA05FB54F8D183EE5"><enum>(1)</enum><header>Submission</header><text display-inline="yes-display-inline">At least 210 days before a bioengineered organism is first introduced or delivered for introduction
into interstate commerce for a food use or application, a premarket
biotechnology notification shall be submitted to the Secretary by the
developer of the bioengineered organism. Such notification shall provide—</text>
<subparagraph id="HA391B6B59560493FA7DC45AC3564C3C6"><enum>(A)</enum><text display-inline="yes-display-inline">the basis for the notifier’s determination that food produced from, containing, or consisting of
such bioengineered organism is as safe for use by humans or animals, as
applicable, as one or more comparable marketed foods that are not produced
from, do not contain, or do not consist of such bioengineered organism;
and</text>
</subparagraph><subparagraph id="HC81B5B39BB38480B8759B3C1D0CB17F9"><enum>(B)</enum><text display-inline="yes-display-inline">whether any other Federal agency is conducting or has conducted any review of the bioengineered
organism and the status or conclusions of any such review.</text>
</subparagraph></paragraph><paragraph id="HD745633C36CD44B5AF87694400D87B81"><enum>(2)</enum><header>Consultation prior to submission</header><text display-inline="yes-display-inline">A prospective notifier may consult informally with the Secretary concerning a bioengineered
organism intended for a food use or application before submitting a
premarket biotechnology notification.</text>
</paragraph></subsection><subsection id="H70A6D0FFB00F43B3A01C3961C070E522"><enum>(d)</enum><header>Response to a Premarket Biotechnology Notification</header>
<paragraph id="HC42E43CF9D2B4C40BB3DF596E6C3BF6E"><enum>(1)</enum><header>Preliminary response</header><text display-inline="yes-display-inline">Within 30 days of receipt of a premarket biotechnology notification, the Secretary shall—</text>
<subparagraph id="HD60E17BC1C85493C8916BE00B8C55416"><enum>(A)</enum><text>inform the notifier in writing that the notification is complete and has been filed; or</text>
</subparagraph><subparagraph id="HA4FFCE6687FF474288482B1E82DD41EA"><enum>(B)</enum><text display-inline="yes-display-inline">inform the notifier in writing of any missing elements that prevent the Secretary from filing and
reviewing the notification.</text></subparagraph><continuation-text continuation-text-level="paragraph">The Secretary shall limit any request under subparagraph (B) to data or information necessary to
perform the evaluation specified in paragraph (2) and shall not delay
informing the notifier under paragraph (1)(A) for any other purpose.</continuation-text></paragraph><paragraph id="H7699BC9B101B4928B4EBB670F13686CA"><enum>(2)</enum><header>Substantive response</header><text display-inline="yes-display-inline">Within 180 days of the Secretary informing the notifier under paragraph (1)(A) that the premarket
biotechnology notification is complete, the Secretary—</text>
<subparagraph id="HC0CB7ABF49A54190943F6F5A61F7D1B7"><enum>(A)</enum><text display-inline="yes-display-inline">shall respond in writing to the notifier that the Secretary has evaluated the notification and has
no objections to the notifier’s determination that food produced from,
containing, or consisting of the bioengineered organism that is the
subject of the notification is as safe for use by humans or animals, as
applicable, as one or more comparable marketed foods that are not produced
from, do not contain, or do not consist of such bioengineered organism; or</text>
</subparagraph><subparagraph id="HD4933A4994564FBA918BFB1C8D9DA228"><enum>(B)</enum><text>shall—</text>
<clause id="HB67F32140EA144409DD3715746C2A68F"><enum>(i)</enum><text display-inline="yes-display-inline">respond in writing to the notifier that the Secretary has evaluated the notification and has
determined the notification does not provide an adequate basis for the
notifier’s determination; and</text>
</clause><clause id="HAE9C1E0DADE24A098152721797BAED9B"><enum>(ii)</enum><text display-inline="yes-display-inline">include in such response the Secretary's basis for the Secretary’s determination.</text>
</clause></subparagraph></paragraph><paragraph id="HA099CB0EC18046A9892746599C3D5C47"><enum>(3)</enum><header>Withdrawal by notifier</header><text>At any point before receiving a written response from the Secretary under subparagraph (A) or (B)
of paragraph (2), the notifier may withdraw a premarket biotechnology
notification without prejudice as to any future notifications.</text>
</paragraph><paragraph id="H40C9BA4822EE4258A2037D47BA8AA195"><enum>(4)</enum><header>Effective date</header><text display-inline="yes-display-inline">A notification submitted under subsection (c) shall become effective on the date that is 180 days
after the Secretary informs the notifier under paragraph (1)(A) that the
notification is complete, and as of such date the bioengineered organism
that is the subject of the notification may be introduced or delivered for
introduction into interstate commerce, unless the Secretary provides a
response under paragraph (2)(B).</text>
</paragraph></subsection><subsection id="H999A50ACFC954212827FE63D06D58249"><enum>(e)</enum><header>Labeling</header><text display-inline="yes-display-inline">If the Secretary determines that there is a material difference between a food produced from,
containing, or consisting of a bioengineered organism and its comparable
marketed food and that disclosure of such difference is necessary to
protect health and safety or to prevent the label or labeling of such food
from being false or misleading, the Secretary may, in a response under
subsection (d)(2)(A), specify labeling that would adequately inform
consumers of such material difference. The use of bioengineering does not,
by itself, constitute a material difference.</text>
</subsection><subsection id="H3992ED7C79AB4E1E8150F48A24C07F62"><enum>(f)</enum><header>Public Disclosure</header><text display-inline="yes-display-inline">The existence and contents of a premarket biotechnology notification shall be made available to the
public as of the date the Secretary issues a written response under
subsection (d)(2)(A), subject to review by the Secretary pursuant to the
provisions on exemptions from disclosure under <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/5">chapter 5</external-xref> of title 5,
United States Code.</text>
</subsection><subsection id="H41F35980D51A482A8619655C716B6CA4"><enum>(g)</enum><header>Definitions</header><text>In this section:</text>
<paragraph id="HFAA3D011FEA64766AC6004B3347872D9"><enum>(1)</enum>
<subparagraph commented="no" display-inline="yes-display-inline" id="HE9CA999AD6E744448BD0F1E0245C54F8"><enum>(A)</enum><text display-inline="yes-display-inline">The term <term>comparable marketed food</term> means, with respect to the food produced from, containing, or consisting of a plant that is a
bioengineered organism—</text>
<clause id="H5274A0DA6E634FE8844C3D435F355088" indent="up1"><enum>(i)</enum><text display-inline="yes-display-inline">the parental variety of the plant;</text>
</clause><clause id="H3F800B4774FA488989AA2C164D67F89A" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">another commonly consumed variety of the plant; or</text>
</clause><clause id="H34D037F9BC774983A243077CA8C3BE62" indent="up1"><enum>(iii)</enum><text display-inline="yes-display-inline">a plant variety from which is derived a commonly consumed food with properties comparable to the
food produced from, containing, or consisting of the plant that is a
bioengineered organism.</text>
</clause></subparagraph><subparagraph id="HBB62C7294FA24B889368A94A23178E15" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">A food produced from, containing, or consisting of a bioengineered organism may have more than one
comparable marketed food.</text>
</subparagraph></paragraph><paragraph id="HCB6C430D119348588772729F97EDEC80"><enum>(2)</enum><text>The term <term>notifier</term> means the person who submits a premarket biotechnology notification.</text>
</paragraph><paragraph id="H9998166C14AC440FBB754A1F5A91585B"><enum>(3)</enum><text>The term <term>premarket biotechnology notification</term>—</text>
<subparagraph id="HEE6BA63DE19D4F61BE410113FE018D82"><enum>(A)</enum><text>means a submission to the Secretary under subsection (c); and</text>
</subparagraph><subparagraph id="HEC41184FD99444F8AE3C4D31A864C2F1"><enum>(B)</enum><text>includes all scientific data and other information in the original submission and in any amendments
to the original submission.</text>
</subparagraph></paragraph><paragraph id="HBB383F7072DB43BDA9414B9085487BAB"><enum>(4)</enum><text>The term <term>material difference</term> means a difference that—</text>
<subparagraph id="H6CEF98D049BA4A64B15F480451B53CA4"><enum>(A)</enum><text>significantly alters the characteristics, including the functional or compositional
characteristics, of a food, such that the common or usual name no longer
adequately describes the food;</text>
</subparagraph><subparagraph id="HB815C683C5944E51B03D667C8C9411D8"><enum>(B)</enum><text display-inline="yes-display-inline">results in a significantly different nutritional property in the food produced from, containing, or
consisting of the bioengineered organism; or</text>
</subparagraph><subparagraph id="H6F7DA873E57F4B028B0FC62C0435B788"><enum>(C)</enum><text>results in the food containing an allergen that consumers would not expect to be present based upon
the name of the food.</text></subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HDE84514983D74BC2934C58F39E7C1C05"><enum>(c)</enum><header>Applicability</header><text>The amendments made by this section apply beginning on the date that is 30 days after the date of
enactment of this Act, irrespective of whether regulations or guidance
have been finalized or issued by such date to carry out such amendments.</text>
</subsection><subsection id="H8DE21F8B5A1641D6B090444869870E40"><enum>(d)</enum><header>Pending submissions</header><text>The Secretary shall—</text>
<paragraph id="HBA9D09B1D60943149D3C4619969393B1"><enum>(1)</enum><text display-inline="yes-display-inline">deem to be a premarket biotechnology notification under section 424 of the Federal Food, Drug, and
Cosmetic Act, as added by this section, any submission that—</text>
<subparagraph id="H1DD6172BD78745EC94F285A35BD9E8A4"><enum>(A)</enum><text>is pending as of the date of enactment of this Act; and</text>
</subparagraph><subparagraph id="H940A7DE7F47C4E069E1F8D0CC622F372"><enum>(B)</enum><text>is for voluntary consultation with respect to food produced from, containing, or consisting of a
bioengineered organism (as such term is used in section 301(ddd) of the
Federal Food, Drug, and Cosmetic Act, as added by subsection (a)); and</text>
</subparagraph></paragraph><paragraph id="HE515114F104E4875A652DCB73429AB1D"><enum>(2)</enum><text>evaluate such notifications expeditiously.</text>
</paragraph></subsection><subsection id="H25C4E33797884AE88FDC1E7F40AB4446"><enum>(e)</enum><header>Preemption</header><text display-inline="yes-display-inline">Section 403A(a) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/343-2">21 U.S.C. 343–2(a)</external-xref>) is amended—</text>
<paragraph id="H4C4CFFBBA7214CE0A86294DE9DB06957"><enum>(1)</enum><text>by striking <quote>or</quote> at the end of paragraph (4);</text>
</paragraph><paragraph id="HE93605FE8E9841E6B94CB12A8DDDBC9A"><enum>(2)</enum><text>by striking the period at the end of paragraph (5) and inserting a comma; and</text>
</paragraph><paragraph id="H99256F2813344EC9BC36BE92C6066BDB"><enum>(3)</enum><text>by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H4B46423BF05042729AB0A3C40B198594" style="OLC">
<paragraph id="H8D77FA5A78504F5387AAAAB20D9B24EF"><enum>(6)</enum><text display-inline="yes-display-inline">any requirement respecting, prohibition against, or restriction on, the sale, distribution, or
marketing of—</text>
<subparagraph id="HE95FAE9D360B4613AD117B48085332C4"><enum>(A)</enum><text>a bioengineered organism intended for a food use or application, or</text>
</subparagraph><subparagraph id="H1016755CBC634706A601984AF0790DD2"><enum>(B)</enum><text>food produced from, containing, or consisting of a bioengineered organism, as such term is used in
section 301(ddd), or</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="H4A0FBF60093746FA963D92B5AF03BDA7"><enum>(f)</enum><header>Technical corrections</header><text>Section 403A of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/343-1">21 U.S.C. 343–1</external-xref>) is amended—</text>
<paragraph id="H3B08824C0DEC4826886FAFD45B85C532"><enum>(1)</enum><text>by striking the section designation and enumerator and all that follows through <quote>(a) Except</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="HE4005852568440DAB1080C540D1A694B" style="OLC">
<section id="H216BB11096234C93A313C4C7027ED4EF"><enum>403A.</enum><header>State requirements</header>
<subsection id="H009E01625AE64E768C1C5C8FA494AA84"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Except</text></subsection></section><after-quoted-block>; and</after-quoted-block></quoted-block>
</paragraph><paragraph id="H88DFF5C7381F45BA9B5181E8B9502383"><enum>(2)</enum><text>in subsection (b), by striking <quote>(b) Upon petition</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="H68A4642019FB47088B637D6998ED9E5D" style="OLC">
<subsection id="H094025B9588045C8992EDD0F0FCDDC8E"><enum>(b)</enum><header>Petitions for exemptions</header><text display-inline="yes-display-inline">Upon petition</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection></section><section id="H9ABF964AFD8644AC8C4EFC162E36E45D"><enum>103.</enum><header>Labeling of whether food is bioengineered</header>
<subsection id="HA8B5F94547EF4E38A40A832ABF4A3BC6"><enum>(a)</enum><header>Misbranding</header><text display-inline="yes-display-inline">Section 403 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/343">21 U.S.C. 343</external-xref>) is amended by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="HC7B98C88C2C4426385C98FD9BAA1F4ED" style="OLC">
<subsection id="H0023ACED99304E888A2F62D38BC5F3B5"><enum>(z)</enum><text display-inline="yes-display-inline">If it bears labeling (indicating that bioengineering was or was not used in the production of the
food) in violation of section 425.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HB5D4283D38F04DA88624A57B2BA7C541"><enum>(b)</enum><header>Labeling requirements</header><text>Chapter IV of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/341">21 U.S.C. 341 et seq.</external-xref>), as amended by
section 102 of this Act, is further amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H16454C23C7414651A3C586868637B444" style="OLC">
<section id="H36DB98A636AC47F2976483E108C20A3E"><enum>425.</enum><header>Labeling of whether food is bioengineered</header>
<subsection id="H7BDB6801A0484089BE04FC43F7393485"><enum>(a)</enum><header>Claims that bioengineering was not used</header>
<paragraph id="H0F453BF2564D4D01AD7366B71F22FA73"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">If a claim in the labeling of food indicates, directly or indirectly, that bioengineering was not
used in the production of the food, such claim shall be subject to this
subsection.</text>
</paragraph><paragraph id="H2DEEF4999DC24879BB2D29266B4B460E"><enum>(2)</enum><header>Requirements</header><text>A claim described in paragraph (1)—</text>
<subparagraph id="H7E0FC18736F34C2488CD1DE81ACCE68B"><enum>(A)</enum><text display-inline="yes-display-inline">may be made only if the food bearing the claim is comprised of ingredients subject to supply chain
process controls that address—</text>
<clause id="HE4C1289E0B8F4FA7A980006993F7C87B"><enum>(i)</enum><text>the producer planting a seed developed by means other than through the use of bioengineering;</text>
</clause><clause id="H011721DA87CC4413B7A70827FBF05DA0"><enum>(ii)</enum><text>the producer keeping the crop separated during growth, harvesting, storage, and transportation; and</text>
</clause><clause id="HBF9033F5D9E74E4DA4D6FD4301AF05C8"><enum>(iii)</enum><text>persons in direct contact with such crop or foods derived from such crop during transportation,
storage, or processing keeping the product separated from foods or food
ingredients derived through bioengineering;</text>
</clause></subparagraph><subparagraph id="HE2B05357CD884AFABADC69BC71D5E3C5"><enum>(B)</enum><text display-inline="yes-display-inline">may be made for a food produced in accordance with subparagraph (A) in which food produced from,
containing, or consisting of a bioengineered organism is inadvertently
present;</text>
</subparagraph><subparagraph id="HDDA0B7EE6A0248D79453429FCDE74E81"><enum>(C)</enum><text display-inline="yes-display-inline">may not suggest either expressly or by implication that foods developed without the use of
bioengineering are safer than foods produced from, containing, or
consisting of a bioengineered organism;</text>
</subparagraph><subparagraph id="H2E4A88298050433785E08C4748896BC0"><enum>(D)</enum><text display-inline="yes-display-inline">may be made on dairy products derived from cows or other milk-producing animals, on shell eggs
derived from chickens and other birds, and on products consisting of or
derived from fish or animals (that are under the jurisdiction of the Food
and Drug Administration) that consumed feed or a feed ingredient, or
received a drug or biological product, that—</text>
<clause id="HFE4374B271B245BCA7CA84ACEC7631DB"><enum>(i)</enum><text>was developed with the use of bioengineering; and</text>
</clause><clause id="H050923BDA78F47A1A4974CC6C0AF4F04"><enum>(ii)</enum><text>has been authorized for such use by the Secretary;</text>
</clause></subparagraph><subparagraph id="H440464B3C85F4D9793E0695FBF3AEBBE"><enum>(E)</enum><text>may be made on a food produced with a bioengineered processing aid or enzyme; and</text>
</subparagraph><subparagraph id="H1288336A63984A23910E5BAA30B1359F"><enum>(F)</enum><text>shall comply with any other requirements established by the Secretary by regulation to ensure that
the food’s labeling is not false or misleading.</text>
</subparagraph></paragraph><paragraph id="H0E9A58D302EB4867A29FF9809B05A1CC"><enum>(3)</enum><header>Regulations</header>
<subparagraph id="HBFF8412C97784E54B567C5D4100DDCE9"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall promulgate regulations to carry out this section. Such regulations shall
specify a maximum permissible level of food produced from, containing, or
consisting of a bioengineered organism that may be inadvertently present
in food bearing claims under paragraph (1).</text>
</subparagraph><subparagraph id="H4279E90680A94A70B73D8FEF72CD0F42"><enum>(B)</enum><header>Separate categories</header><text>Such regulations may specify different permissible levels for separate categories of food.</text>
</subparagraph><subparagraph id="HC2B6DD8432EB471C9E345C1ABC87B654"><enum>(C)</enum><header>Claims prior to finalization of regulations</header><text>This section does not limit the ability of persons to make claims described in paragraph (1) before
the finalization of regulations under this paragraph.</text>
</subparagraph><subparagraph id="H3C11A5FC2D5E47908D0271852ED67564"><enum>(D)</enum><header>Initial regulations</header><text display-inline="yes-display-inline">The Secretary shall promulgate final regulations under this paragraph not later than 24 months
after the date of enactment of the <short-title>Safe and Accurate Food Labeling Act of 2014</short-title>.</text>
</subparagraph></paragraph></subsection><subsection id="H301A8585F2C0419B809E84919E1E6284"><enum>(b)</enum><header>Claims that bioengineering was used</header>
<paragraph id="H497C87392B8D475DA75ADBF766E4C9EA"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">If a claim in the labeling of food indicates, directly or indirectly, that bioengineering was used
in the production of the food, such claim shall be subject to this
subsection.</text>
</paragraph><paragraph id="H11ADD8A8B954465B8768A2A48263FBA1"><enum>(2)</enum><header>Regulations</header><text>A claim described in paragraph (1) may be made only in accordance with regulations promulgated by
the Secretary. Such regulations—</text>
<subparagraph id="HADF63BDBE2B843DE9C427E201B386FD4"><enum>(A)</enum><text display-inline="yes-display-inline">shall not require the labeling to declare the use of bioengineering solely because the food was
developed with the use of bioengineering;</text>
</subparagraph><subparagraph id="HB003A57910944C848038C3D11CFBB3DA"><enum>(B)</enum><text display-inline="yes-display-inline">shall not allow the labeling to expressly or impliedly claim that food developed with the use of
bioengineering is safer solely because the food is a food developed with
the use of bioengineering;</text>
</subparagraph><subparagraph id="H32EDD74B205D453695DDEEF0198AAA4C"><enum>(C)</enum><text>shall allow any claims which the Secretary deems necessary under section 424(e); and</text>
</subparagraph><subparagraph id="H5C780F94E28B4E938C5A344A75E76B92"><enum>(D)</enum><text display-inline="yes-display-inline">may contain other requirements established by the Secretary to ensure that the food’s labeling is
not false or misleading.</text>
</subparagraph></paragraph><paragraph id="H81A74014EC5140DD99D8C4C2EB7E25EC"><enum>(3)</enum><header>Prohibition against restricting certain disclosures</header><text>The regulations under this subsection shall not prevent a person—</text>
<subparagraph id="H60AEB37DA55645E987B3D3C8B2FD9612"><enum>(A)</enum><text display-inline="yes-display-inline">from disclosing voluntarily on the labeling of food developed with the use of bioengineering the
manner in which the food has been modified to express traits or
characteristics that differ from its comparable marketed food (as defined
in section 424); or</text>
</subparagraph><subparagraph id="HF477D6E537E24716ADCE54F4CCFCE6F9"><enum>(B)</enum><text>from disclosing in advertisements, on the Internet, in response to consumer inquiries, or on other
communications, other than in the labeling, that a food was developed with
the use of bioengineering.</text>
</subparagraph></paragraph></subsection><subsection id="H2C2DEE953E614EFBA71F739F568D73C2"><enum>(c)</enum><header>Definition</header><text display-inline="yes-display-inline">The term <term>bioengineered organism</term> means a bioengineered organism, as such term is used in section 301(ddd).</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section id="H9C3111FED1264AC3A5DF983C708D63E0"><enum>104.</enum><header>Preemption</header>
<subsection id="HCDE56D9A55464B0F9E137B689264686F"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 403A(a) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/343-2">21 U.S.C. 343–2(a)</external-xref>) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H34A58EDE72F24C0F87DC4A6EA1A9C87B" style="OLC">
<paragraph id="HE4C7727AC2E54894B8686590C745BF15"><enum>(7)</enum><text display-inline="yes-display-inline">any requirement for the labeling of food of the type described in subsection (a)(1) or (b)(1) of
section 425 that is not identical to the requirement of such section, or</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H70502DD9FCDA473BA5DAE1DD9C008352"><enum>(b)</enum><header>Prohibition against mandatory labeling</header><text>Section 403A of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/343-1">21 U.S.C. 343–1</external-xref>) is amended by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H67962B5ED8F14AAA8FB710AA7A9689AB" style="OLC">
<subsection id="H3E673848DEBA4838973207C947B8095C"><enum>(c)</enum><header>Prohibitions against mandatory labeling of food developed using bioengineering</header><text display-inline="yes-display-inline">Except for claims under subsection (a)(1) or (b)(1) of section 425, no State or political
subdivision of a State may directly or indirectly establish under any
authority or continue in effect as to any food in interstate commerce any
requirement for the labeling of a food by virtue of its having been
developed using bioengineering, including any requirements for claims that
a food is or contains an ingredient that was developed using
bioengineering.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><enum>II</enum><header>Natural foods</header>
<section commented="no" id="HF578038486294B27A3EB5D8F8A3DE56E"><enum>201.</enum><header>Labeling of natural foods</header><text display-inline="no-display-inline">Section 403 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/343">21 U.S.C. 343</external-xref>), as amended by section 103
of this Act, is further amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H609CD7D1B69042E693505F803A9CC1E2" style="OLC">
<subsection commented="no" id="H3827832B42A94CFE85056AF3F878FE2C"><enum>(aa)</enum>
<paragraph commented="no" display-inline="yes-display-inline" id="HDC99D197097B4BCB833693FE27DFA645"><enum>(1)</enum><text display-inline="yes-display-inline">If its labeling contains an express or implied claim that the food is <quote>natural</quote> unless the claim is made in accordance with subparagraph (2).</text>
</paragraph><paragraph id="H2D7C1748833B4811A65DD516FCE6A3EA" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">A claim described in subparagraph (1) may be made only if the claim uses terms that have been
defined by, and the food meets the requirements that have been established
in, regulations promulgated to carry out this paragraph.</text>
</paragraph><paragraph id="HE059F90A57A547E788D46F39BA6E84B1" indent="up1"><enum>(3)</enum><text>Notwithstanding subparagraph (2), prior to the finalization of regulations to carry out this
paragraph, the use of any claim that a food is <quote>natural</quote> shall be allowed if consistent with the Secretary’s existing policy for such claims.</text>
</paragraph><paragraph id="H732E736F6C834B928D635EF9112F9724" indent="up1"><enum>(4)</enum><text>In promulgating regulations to carry out this paragraph, the Secretary shall differentiate between
food for human consumption and food intended for consumption by animals
other than humans.</text>
</paragraph><paragraph id="H56A48E1E8BB7431ABBE060CEF295B61C" indent="up1"><enum>(5)</enum><text>For purposes of subparagraph (1), a natural claim includes the use of—</text>
<subparagraph id="H6E4B6D42396D4A4DBB5C6876E80FE532"><enum>(A)</enum><text>the terms <term>natural</term>, <term>100% natural</term>, <term>naturally grown</term>, <term>all natural</term>, and <term>made with natural ingredients</term>; and</text>
</subparagraph><subparagraph id="HAC831C438CED4D9F9D7B1EC4B617EBBB"><enum>(B)</enum><text>any other terms specified by the Secretary.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H837DF584164D4DD2B91D6C1CA7B5EACB"><enum>202.</enum><header>Regulations</header>
<subsection id="HF9B466B399D847D68282AA03A8587900"><enum>(a)</enum><header>Proposed regulations</header><text display-inline="yes-display-inline">Not later than 12 months after the date of enactment of this Act, the Secretary of Health and Human
Services shall issue proposed regulations to implement section 403(aa) of
the Federal Food, Drug, and Cosmetic Act, as added by section 201 of this
Act.</text>
</subsection><subsection id="HD6BAC0360D7941FCBB729C41B0D8CCB6"><enum>(b)</enum><header>Final regulations</header><text>Not later than 24 months after the date of enactment of this Act, the Secretary of Health and Human
Services shall issue final regulations to implement such section 403(aa).</text>
</subsection></section><section id="H7BA8B0BCAB8B433DB4B0400A378BE06A"><enum>203.</enum><header>Preemption</header><text display-inline="no-display-inline">Section 403A(a) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/343-1">21 U.S.C. 343–1(a)</external-xref>), as amended by
section 104 of this Act, is further amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H8FF01E6E8C9C481D914627866EB71363" style="OLC">
<paragraph id="H1077441700D54EAA8FC0561D36520A3A"><enum>(8)</enum><text display-inline="yes-display-inline">any requirement for the labeling of food of the type required by section 403(aa) that is not
identical to the requirement of such section.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H1585D9B6E4DE4DB1A85DEDBD71CB7A8C"><enum>204.</enum><header>Effective date</header><text display-inline="no-display-inline">The labeling requirements of section 403(aa) of the Federal Food, Drug, and Cosmetic Act, as added
by section 201 of this Act, shall take effect on the effective date of
final regulations promulgated under section 202(b) of this Act. The
provisions of section 403A(a)(8) of the Federal Food, Drug, and Cosmetic
Act, as added by section 203 of this Act, take effect on the date of
enactment of this Act.</text>
</section>