114 HR 1599 IH: Safe and Accurate Food Labeling Act of 2015
U.S. House of Representatives
2015-03-25
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 2015
. 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.
Title III—Non-bioengineered food certification
Sec. 301. Non-bioengineered food certification.
Sec. 302. Regulations.
Sec. 303. Preemption.
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="H3A07FB7C496E4711818BD8CDA914C59F"><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="H3493F40DC83F4222AA2CCDFACC283C7F" style="OLC">
<subsection id="H74E7E7B582C84598BD192A1BB17147E0"><enum>(ss)</enum><text display-inline="yes-display-inline">The term <term>bioengineered organism</term> refers to an organism if—</text> <paragraph id="H054F135B573A4031BC9DBE1BC0E5190C"><enum>(1)</enum><text>the organism is a plant (or a seed, a fruit, or any other part thereof);</text></paragraph>
<paragraph id="H7002248D33FB418C8484447189B0C7DB"><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="HBB80280B1ABC4BA6908DBC1F4C6D8A9E"><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="H83EF10ECA6FB4EB58800B0C8D47A23BB"><enum>102.</enum><header>Mandatory premarket biotechnology notification program</header>
<subsection id="H650C472095E34DF885BFAB187AD29DB9"><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="H402E6C165BE143B297A7A324C24EA7C8" style="OLC"> <subsection id="H1DE36B1AE18A4CC8A8BA29A413354938"><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="HB56F19A7FBD84C829834865D4828C005"><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="HBDBDE8489F1D4893A9200E2562CE9749" style="OLC"> <section id="HB40B9F801C9F48AF824D114A2B0459B2"><enum>424.</enum><header>Notification relating to certain bioengineered organisms</header> <subsection id="HB53F48476695404D80D5940FAC05C67D"><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="H325A70061C984126B6F7660E5659367D"><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="H7F5AB9443ED4433783E7DBB260E24010"><enum>(2)</enum> <subparagraph commented="no" display-inline="yes-display-inline" id="HD38C35B50D1B4D34B8ABFD15899A54A0"><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 2015</short-title>; and</text></subparagraph>
<subparagraph id="H58B80935A41842F4B8AA1DF2B794F409" 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="H46929C66AA0C4DBB8DF3280EB381C8C3"><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="H94A2DE0FD921448DBD37E5A75C8FF47C"><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 id="HAE4D31231CA843C4BBB3C78CAF710FDA" commented="no"><enum>(2)</enum><text display-inline="yes-display-inline">solely because a processing aid or enzyme produced from the bioengineered organism is intended to be used to produce food.</text></paragraph></subsection>
<subsection id="HC98BC6983F5F48E4AF49B9A8C21B3BF0"><enum>(c)</enum><header>Premarket Biotechnology Notification</header>
<paragraph id="H5500B80F57E642F8A79CE30FE824520D"><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="H9F0C749E54F4496793DDF6A67FCF3212"><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="H65B16D0C50F34D5987DD4EB8904886B1"><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="HA4A8C240D4E44A619B6F6E694306D2B3"><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="H36B249B150E2481F8B6818821F88402A"><enum>(d)</enum><header>Response to a Premarket Biotechnology Notification</header>
<paragraph id="H9A73CF7B28424FEB98C3D1327BEFF21E"><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="H08A249A7E7D04B6C88732301CC994103"><enum>(A)</enum><text>inform the notifier in writing that the notification is complete and has been filed; or</text></subparagraph>
<subparagraph id="HEDB51770354D429B8396DCDF36952CD0"><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="HF0B3711E888F444CAC0B635E47D7AB9E"><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="HEBE8E8C2D2FA48B79FC42E9B03CC97D4"><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="HAA13174131794F7480423D854E73B58D"><enum>(B)</enum><text>shall—</text>
<clause id="HC1EE280D2FBE430DBF2695D992565D93"><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="H2834956B63ED4DE5B1F15BC5F128AEB7"><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="H8520F02EF7394D929A71BA0BBD2BF5BE"><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="H76727B5045C64C01A04083280E9B96DB"><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="HE435FE618A204D0C98B0CCB57A1D5B78"><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="HD215556715154C2991E46866A4CD0D36"><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="H20357A778D0044EA94954BF0F84FC35D"><enum>(g)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="H6EBDAA24BADA46EA8FED1E267757234E"><enum>(1)</enum> <subparagraph commented="no" display-inline="yes-display-inline" id="H69A25792533D4CBEBDEFA33EEA434065"><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="HDE567909A1534EFDB52316259BAF081C" indent="up1"><enum>(i)</enum><text display-inline="yes-display-inline">the parental variety of the plant;</text></clause> <clause id="H7DE2D8C515B143CA9CF9717B1AEA8280" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">another commonly consumed variety of the plant; or</text></clause>
<clause id="H43B38F0CB0F74569ABFAA39836E377A7" 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="HB7BF89908C644BB7ABD5BC98458F66D0" 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="H0461476AA145423785EF9ECDCF24E7B5"><enum>(2)</enum><text>The term <term>notifier</term> means the person who submits a premarket biotechnology notification.</text></paragraph> <paragraph id="HC9EC569D379F495095FA56CA67AB7B9D"><enum>(3)</enum><text>The term <term>premarket biotechnology notification</term>—</text>
<subparagraph id="HC9E880A3A1B941B7A62E2B7C0B009B39"><enum>(A)</enum><text>means a submission to the Secretary under subsection (c); and</text></subparagraph> <subparagraph id="H7DA9A66AACED4CE7B19C01EEADE1B67E"><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="H5759DF52D9C6411C896893EC5125B263"><enum>(4)</enum><text>The term <term>material difference</term> means a difference that—</text> <subparagraph id="H483A9ED7A2C540148998CA0FF1D566FE"><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="H880F81E5BBC24DC49309A35AC7A9E800"><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="H56A6CDCFD7F84BD88E71D3D5BAE724B9"><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="H8D18E862F23D48B4AE6860C01E17F0FB"><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="H8238E91867D74062A1105E9D590F45B6"><enum>(d)</enum><header>Pending submissions</header><text>The Secretary shall—</text>
<paragraph id="HFE520D47CD68487EA4184A6DBCE9CAE0"><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="HFA4B90D573A94C63AD3CA09439EA6EE8"><enum>(A)</enum><text>is pending as of the date of enactment of this Act; and</text></subparagraph>
<subparagraph id="HB2F70C97139A467183957664523E1431"><enum>(B)</enum><text>is for voluntary consultation with respect to food produced from, containing, or consisting of a bioengineered organism (as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)); and</text></subparagraph></paragraph> <paragraph id="HDB4AFE50DF4743AA84465A2FF9E7AA56"><enum>(2)</enum><text>evaluate such notifications expeditiously.</text></paragraph></subsection>
<subsection id="HF71F3F890E6644C9B4BAE5B5A819B203"><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/21/343-1">21 U.S.C. 343–1(a)</external-xref>) is amended—</text> <paragraph id="H0B5F821A4FE042F68EA068E0DABC7B9A"><enum>(1)</enum><text>by striking <quote>or</quote> at the end of paragraph (4);</text></paragraph>
<paragraph id="H068A9B96EE9F4E9DAD503DFAFFA9CCC8"><enum>(2)</enum><text>by striking the period at the end of paragraph (5) and inserting a comma; and</text></paragraph> <paragraph id="HB85052BFF558495087F374196A696419"><enum>(3)</enum><text>by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H49F36046E24941E3B68BB2CBD5EDCC0B" style="OLC">
<paragraph id="H7BF8484BA6BE44B79D889AD34423CFE2"><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="H30751BC54820473388F9DF7D7DDF47BC"><enum>(A)</enum><text>a bioengineered organism intended for a food use or application, or</text></subparagraph>
<subparagraph id="H5F7FCAE1DF8E499B88E7B197EDF0492E"><enum>(B)</enum><text>food produced from, containing, or consisting of a bioengineered organism, or</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="HAD486B369179426995CF951C51CFA8A7"><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="H4610517029FC44D1A8828E5EF0C7101F"><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="H18B25A6124B84880BBCF0DDC8FE50E85" style="OLC"> <section id="H528217E516C5495C8E8912F3B9806C60"><enum>403A.</enum><header>State requirements</header> <subsection id="HB6A5ED32079C4E6CA6EA7FCD3C6DD7D0"><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="H06A59B0EC6184FAC965768FB72D79B70"><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="HD15A365820164BB08307C7DCC0B95A0D" style="OLC"> <subsection id="H948BE8943FAC4672AEFA8A16EFF955BC"><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="HB343FC5A47B94B249A126042544FDDF3"><enum>103.</enum><header>Labeling of whether food is bioengineered</header>
<subsection id="HB074FB9925BD4F7393A6D654350B62D8"><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="H375574FFE2AF4360BDDE8D3B81E63A4A" style="OLC"> <subsection id="H2CB62A6558E94884AE37D5C143B48F50"><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="H4C11E8E56464481E8CDF58D42F86A90D"><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="H44678DD4AB5E4B23BAD5AE75DB1613B1" style="OLC"> <section id="HDA6D113512A84B1E8B55D4C6A8396CD6"><enum>425.</enum><header>Labeling of whether food is bioengineered</header> <subsection id="HD2CC12339D61497F85362790D4CE73D0"><enum>(a)</enum><header>Claims that bioengineering was not used</header> <paragraph id="H799E030A686243AA92284C850B41C9A6"><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. <italic></italic></text></paragraph>
<paragraph id="H1DB705D8B37F4C3E8337CC554B021678"><enum>(2)</enum><header>Requirements</header><text>A claim described in paragraph (1)—</text> <subparagraph id="HB8BD12F62E784C2B8D865A0F47120BCF"><enum>(A)</enum><text>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="H6B97927423674190AF52CEA828B2681F"><enum>(i)</enum><text>the producer planting a seed developed by means other than through the use of bioengineering;</text></clause> <clause id="HD277D58373C045EB91405DB520549D39"><enum>(ii)</enum><text>the producer keeping the crop separated during growth, harvesting, storage, and transportation; and</text></clause>
<clause id="HB4E45A46636143A1AFACF33FF64E1527"><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="H2C7135E76BA64063987D5871DDDDB888"><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="H085E46B84C1041C4BFABDF674D4E5CE9"><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="HEACF916FA2B549E6A888805DD00103B0"><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="HFECBBA246AAB44E6A21D5089041A3523"><enum>(i)</enum><text>was developed with the use of bioengineering; and</text></clause> <clause id="H77CFE3EC85864ED6AF4C65BF4FA00F73"><enum>(ii)</enum><text>has been authorized for such use by the Secretary;</text></clause></subparagraph>
<subparagraph id="HA0651F9CCB0D4717BB7C2541430FBD29"><enum>(E)</enum><text>may be made on a food produced with a bioengineered processing aid or enzyme; </text></subparagraph> <subparagraph id="H2B9CF922BB4846E78F5AE4D16C7D4F75"><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; and</text></subparagraph>
<subparagraph id="HCEA43173715847FBB703CDB015E7140A"><enum>(G)</enum><text display-inline="yes-display-inline">may be made if—</text> <clause id="HE673C82907B34335BF064BA6B521217D"><enum>(i)</enum><text>the food is an agricultural product, as such term is defined in section 207 of the Agricultural Marketing Act of 1946; and</text></clause>
<clause id="H149982958B2A4C688F2DC3ADC4D7D568"><enum>(ii)</enum><text>such agricultural product has been certified as an agricultural product produced without the use of bioengineering under subtitle E of such Act.</text></clause></subparagraph> </paragraph> <paragraph id="H74EDEBAFA5184C42BC496B1BFC35BACE"><enum>(3)</enum><header>Regulations</header> <subparagraph id="HAEC2F5667F3543F083BE57D90C015F40"><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="H3B503A394A424BDB900EB77C3D107554"><enum>(B)</enum><header>Separate categories</header><text>Such regulations may specify different permissible levels for separate categories of food.</text></subparagraph> <subparagraph id="HC7D4404F7DE446B8BF1394D4FEBEF2EF"><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="HCC6A409331A6442A92D83A4D4ECD4DC6"><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 2015</short-title>.</text></subparagraph></paragraph></subsection> <subsection id="H127697F86D03430E802740020D45FA32"><enum>(b)</enum><header>Claims that bioengineering was used</header> <paragraph id="H79E0619C28DB49B98EEF1ABB89C63FC7"><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="HB5758D713942477AB3CC23070305745D"><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="HE8389CB3455F4B728926115392250F1B"><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="H6721E8D5727346FBA60F5451CB8BB125"><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="H1A998DE3BCB640679E54DC644C6DCE36"><enum>(C)</enum><text>shall allow any claims which the Secretary deems necessary under section 424(e); and</text></subparagraph>
<subparagraph id="HC218A8CF0D4E48A1B90F07E7E41480D5"><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="H0F6D7075D458471EA5729E1429BA77A1"><enum>(3)</enum><header>Prohibition against restricting certain disclosures</header><text>The regulations under this subsection shall not prevent a person—</text>
<subparagraph id="H6B96DE231A6E4E4287DF7C5DDB3F3799"><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="HA83420B294B84EFC8B1C232B658CE163"><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="HE9DBBCD5AA0749329ECA21BB9C3633BD"><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 201(ss).</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section> <section id="HD3F58602CFCB4FD98A796D2417AAF8FA"><enum>104.</enum><header>Preemption</header> <subsection id="HE9A057F65F864D4FA8D0622AD66B1FE3"><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/21/343-1">21 U.S.C. 343–1(a)</external-xref>) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H1540BFEB2F27459793E90D59677C980C" style="OLC">
<paragraph id="H5CB7588C593E45B7930DE83AF072D7B9"><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="HB930B218E7C3459093D99509815FA185"><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="H026D6EFF67DA41DD82C2E41431D53628" style="OLC">
<subsection id="H013BA7BAB17E40D6B6F056CE604A9354"><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="H897896AEB1D1484982BA5FF2B0382B5D"><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="H22A63A0136F14AA9AD88990683ECCE6A" style="OLC">
<subsection commented="no" id="H5480C0B7CEBF420B9C4EE5D2EAC8B6B8"><enum>(aa)</enum>
<paragraph commented="no" display-inline="yes-display-inline" id="H72A06FF341384760BCDE1CD21AD06DC8"><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="HEC658F03D89F4FBAA45BE5384E32195C" 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="HFFD8034A093546E1BC715A830BAE9640" 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="H3FEB87539FA24E818BEDCD6131D6FD87" 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="HAF2503B6B4644BA4A78B582F0615B8A2" indent="up1"><enum>(5)</enum><text>For purposes of subparagraph (1), a natural claim includes the use of—</text> <subparagraph id="H7A555A578B92463D981376316396517B"><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="HA3B20535A32D45018D81FA50F5601A14"><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="H436A140F3780442D8A8B59C2146538F6"><enum>202.</enum><header>Regulations</header> <subsection id="H60DB639D35EA429C9F3AA5EB138DF3F2"><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="HDAB6732D87A74229A959640DF7595249"><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="HF34AD4089A2E4F38895A0FEC6F3538AD"><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="HD86C1A7C68254515914171AE256CD4AF" style="OLC">
<paragraph id="H122247A2338949E3BDEDEB104CE0CFC8"><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="HBBD65BC198E84FEE84F789B2089084EF"><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>
<enum>III</enum><header>Non-bioengineered food certification</header>
<section id="HF4C36384E21D4412B3AEDDDA59A22633"><enum>301.</enum><header>Non-bioengineered food certification</header><text display-inline="no-display-inline">The Agricultural Marketing Act of 1946 (<external-xref legal-doc="usc" parsable-cite="usc/7/1621">7 U.S.C. 1621 et seq.</external-xref>) is amended by adding at the end the following new subtitle: </text> <quoted-block style="OLC" id="HF382C3EAD2CA4B7C88BC8BE0D8B2040B" display-inline="no-display-inline"> <subtitle id="H30031C9C5A01478BA5DE2E7B3DF9277F"><enum>E</enum><header>Non-bioengineered food certification</header> <section id="H6596247D7FF0400D8A7F52A2C1AF5F32"><enum>291.</enum><header>Definitions</header><text display-inline="no-display-inline">In this subtitle:</text>
<paragraph id="HEBADA481E1E0497B8D0B5DEA0264E0D7"><enum>(1)</enum><text display-inline="yes-display-inline">The term <quote>bioengineered organism</quote> refers to an organism if—</text> <subparagraph id="HF2E23EB6A26A4CA9941D0D6CEB6124FD"><enum>(A)</enum><text display-inline="yes-display-inline">the organism is a plant (or a seed, a fruit, or any other part thereof);</text></subparagraph>
<subparagraph id="H2321855D0EB940DF868F11EFB351B9A1"><enum>(B)</enum><text>the organism contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and</text></subparagraph> <subparagraph id="H59E0016F3C8E41FEB112018CA7C358D2"><enum>(C)</enum><text>the modification could not otherwise be obtained using conventional breeding techniques.</text></subparagraph></paragraph>
<paragraph id="H7B749B5306C54772994DF50A443FF9B8"><enum>(2)</enum><text display-inline="yes-display-inline">The term <quote>certifying agent</quote> means any person (including a private entity) who is accredited by the Secretary as a certifying agent for the purpose of certifying an agricultural product as a product to be labeled to indicate that the product is produced without the use of bioengineering.</text></paragraph> <paragraph id="HA252A4D12EB641F6B3E2E106D43E60EC"><enum>(3)</enum><text display-inline="yes-display-inline">The term<italic></italic><quote>comparable marketed food</quote> means with respect to an agricultural product produced from, containing, or consisting of a plant that is a bioengineered organism—</text>
<subparagraph id="H05023D5EE3CB4FF098C6F1A62461B2C0"><enum>(A)</enum><text>the parental variety of the plant;</text></subparagraph> <subparagraph id="H400175D09E5E4A1491C52D8998507A19"><enum>(B)</enum><text>another commonly consumed variety of the plant; or</text></subparagraph>
<subparagraph id="HE6C1DDC4FF62402EBE63825003984B24"><enum>(C)</enum><text display-inline="yes-display-inline">a plant variety from which is derived a commonly consumed agricultural product with properties comparable to the agricultural product produced from, containing, or consisting of the plant that is a bioengineered organism.</text></subparagraph></paragraph> <paragraph id="H6FEAA64B4E82449EA0C6E37544209FB3"><enum>(4)</enum><text display-inline="yes-display-inline">The term <quote>handle</quote> means to sell, process or package agricultural products.</text></paragraph>
<paragraph id="HE225DEB7E1824FFD925EA9723AE70D6A"><enum>(5)</enum><text display-inline="yes-display-inline">The term <quote>producer</quote> means a person who engages in the business of growing or producing agricultural products.</text></paragraph> <paragraph id="H95A7898000BA46D1A1F9A8AC7F6C864E"><enum>(6)</enum><text display-inline="yes-display-inline">The term <quote>Secretary</quote> means the Secretary of Agriculture, acting through the Agricultural Marketing Service.</text></paragraph></section>
<section id="H99CD1B0CA0874FA791B31B078F54FFB5"><enum>291A.</enum><header>National non-bioengineered food certification program</header>
<subsection id="H6750CF63AB6C4355907F59E8FC126FBC"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall establish a non-bioengineered food certification program for agricultural products with respect to the use of bioengineering in the production of such products, as provided for in this subtitle. The Secretary shall establish the requirements and procedures as the Secretary determines are necessary to carry out such program.</text></subsection> <subsection id="HD62F0A9EE43E48C8AAB5E67F53D12A1A"><enum>(b)</enum><header>Consultation</header><text display-inline="yes-display-inline">In developing the program under subsection (a), the Secretary—</text>
<paragraph id="H5BF3B9EE847642E58E366EAA56A97C25"><enum>(1)</enum><text>may consult with such other parties as are necessary to develop such program; and</text></paragraph> <paragraph id="HAF1599890406469E83E739DCC79F91E8"><enum>(2)</enum><text>shall coordinate with the Secretary of Health and Human Services to ensure that the program is consistent with any requirements established by the Secretary of Health and Human Services under section 425 of the Federal Food, Drug, and Cosmetic Act (relating to claims that bioengineering was not used in the production of food). </text></paragraph></subsection>
<subsection id="H2E3D45D480BF4DE29EBB0EC513F32BA0"><enum>(c)</enum><header>Certification</header><text>The Secretary shall implement the program established under subsection (a) through certifying agents. Such certifying agents may certify that agricultural products were produced without the use of bioengineering, in accordance with this subtitle.</text></subsection></section> <section id="H8E99EEC1B4C14CA7B522C1E17AE7ED56"><enum>291B.</enum><header>National standards for labeling non-bioengineered food</header> <subsection id="HDA080F932B2A4EEAA84E6E69A53B861E"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">To be sold or labeled as an agricultural product produced without the use of bioengineering—</text>
<paragraph id="H2A1856C2158F4B66BEBD869488848163"><enum>(1)</enum><text>the agricultural product shall—</text> <subparagraph id="H26840B5E73DA47FC99313A5648E6336C"><enum>(A)</enum><text display-inline="yes-display-inline">be subject to supply chain process controls that address—</text>
<clause id="H3448EFEE19394EB2895CDACF844AEDEB"><enum>(i)</enum><text display-inline="yes-display-inline">the producer planting a seed developed by means other than through the use of bioengineering;</text></clause> <clause id="H846A7E05F04E4466B6435120C05F08D7"><enum>(ii)</enum><text display-inline="yes-display-inline">the producer keeping the crop separated during growth, harvesting, storage, and transportation; and</text></clause>
<clause id="HF1AB32EA86F94A5A8422B0DA7930A431"><enum>(iii)</enum><text display-inline="yes-display-inline">persons in direct contact with such crop or agricultural products derived from such crop during transportation, storage, or processing keeping the agricultural product separated from other agricultural products derived through bioengineering; and</text></clause></subparagraph> <subparagraph id="H7DC7ABEC280041AC983570BA76A008E1"><enum>(B)</enum><text display-inline="yes-display-inline">be produced and handled in compliance with a non-bioengineered food plan developed and approved in accordance with subsection (c); and</text></subparagraph></paragraph>
<paragraph id="H59D0B94C3F4F4356B1F212E745B04756"><enum>(2)</enum><text display-inline="yes-display-inline">the labeling of such agricultural product may not suggest either expressly or by implication that agricultural products developed without the use of bioengineering are safer than agricultural products produced from, containing, or consisting of a bioengineered organism. </text></paragraph></subsection> <subsection id="H1649652F40C4460CAF83A293A0726B95"><enum>(b)</enum><header>Exceptions</header><text>An agricultural product shall not be considered as not meeting the criteria specified in subsection (a) solely because the agricultural product—</text>
<paragraph id="H87BA9C49EF8145BF901A1A35F7278326"><enum>(1)</enum><text display-inline="yes-display-inline">is derived from animals that consumed feed or a feed ingredient or received a drug or biological product that—</text> <subparagraph id="H8E66E9A78D0B4507A834B2827D2D055C"><enum>(A)</enum><text display-inline="yes-display-inline">was developed with the use of bioengineering; and</text></subparagraph>
<subparagraph id="HF7D6EB73799A49528212250978A975AA"><enum>(B)</enum><text display-inline="yes-display-inline">has been authorized for such use;</text></subparagraph></paragraph> <paragraph id="HDAEB21902D194D2DB4D2464FAA00C255"><enum>(2)</enum><text display-inline="yes-display-inline">contains minor amounts of a bioengineered organism due to the inadvertent presence of such organism;</text></paragraph>
<paragraph id="H92E829BB2F5E4517871CD114C891DB4C"><enum>(3)</enum><text display-inline="yes-display-inline">is produced with a bioengineered processing aid, enzyme, or microorganism; or</text></paragraph> <paragraph id="HFF404EA193AC4D698845B22F198E3E71"><enum>(4)</enum><text display-inline="yes-display-inline">is derived from microorganisms that consumed a nutrient source produced from, containing, or consisting of a bioengineered organism.</text></paragraph></subsection>
<subsection id="H5E5E3D98B54C42AB84EF91DA6107BAFE"><enum>(c)</enum><header>Non-Bioengineered food plan</header>
<paragraph id="H7C62AD396B914A1D96B3E1135EDCD899"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">A producer or handler seeking certification under this section shall submit a non-bioengineered food plan to the certifying agent and such plan shall be reviewed by the certifying agent who shall determine if such plan meets the requirements of this section.</text></paragraph> <paragraph id="H85AA01E2AB3540669CB0CE095E1ACD41"><enum>(2)</enum><header>Contents</header><text display-inline="yes-display-inline">A non-bioengineered food plan shall contain a description of—</text>
<subparagraph id="H0CF9808F34BA43CA9A2E10C1D3A7E3CD"><enum>(A)</enum><text>the procedures that will be followed to assure compliance with this section;</text></subparagraph> <subparagraph id="H24D0574963A54382BBFC67281F9C54DB"><enum>(B)</enum><text>a description of the monitoring records that will be maintained; and</text></subparagraph>
<subparagraph id="H3FC19024477F45E1A1AEE4D98AAB7A49"><enum>(C)</enum><text>any corrective actions that will be implemented in the event there is a deviation from the plan. </text></subparagraph></paragraph> <paragraph id="HF815EA6491134958AE4A476A2C63D89A"><enum>(3)</enum><header>Availability</header><text>The non-bioengineered food plan and the records maintained under the plan shall be available for review and copying by the Secretary or a certifying agent.</text></paragraph></subsection></section> </subtitle><after-quoted-block>.</after-quoted-block></quoted-block></section>
<section id="H51E72DACAEDD41F39BADF6AC16E09591"><enum>302.</enum><header>Regulations</header><text display-inline="no-display-inline">Not later than 2 years after the date of the enactment of this Act, the Secretary of Agriculture shall issue final regulations to carry out the amendments made by section 301.</text></section> <section id="H7D81F002307E4BC1A6C162CDBDAACBAD"><enum>303.</enum><header>Preemption</header><text display-inline="no-display-inline">No State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any agricultural product in interstate commerce any requirement for the labeling of agricultural products of the type described in section 291B of the Agricultural Marketing Act of 1946, as added by section 301, that is not identical to the requirement of such section.</text></section>