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[Discussion Draft]
[Discussion Draft]
July 15, 2015
114th CONGRESS
1st Session
Rules Committee Print 114-24
Text of H.R. 1599, the Safe and Accurate Food Labeling Act of 2015
[Showing the text of the bill as ordered reported by the Committee on Agriculture.]
1.
Short title; table of contents
(a)
This Act may be cited as the Safe and Accurate Food Labeling Act of 2015
.
(b)
The table of contents of this Act is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Savings clause.
Title I—Food Safety Affirmation for certain plant products
Subtitle A—Food and Drug Administration
Sec. 101. Consultation process.
Subtitle B—Department of Agriculture
Sec. 111. Regulation.
Sec. 112. Regulations.
Sec. 113. Preemption.
Sec. 114. Rule of construction.
Sec. 115. Implementation report.
Title II—Genetic engineering certification
Sec. 201. Genetic engineering certification.
Sec. 202. Regulations.
Sec. 203. Preemption.
Sec. 204. Applicability.
Title III—Natural foods
Sec. 301. Labeling of natural foods.
Sec. 302. Regulations.
Sec. 303. Preemption.
Sec. 304. Effective date.
2.
Nothing 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, or the definitions used by, the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Animal and Plant Health Inspection Service under the Plant Protection Act (7 U.S.C. 7701 et seq.), to ensure the safety of the food supply and the protection of plant health.
<enum>I</enum>
<header>Food Safety Affirmation for certain plant products</header>
<subtitle id="HFCFD247A5B1346B2ABA5866DF5F042B2">
<enum>A</enum>
<header>Food and Drug Administration</header>
<section id="H6AF99B3D0EE94D6A9D4117AD350FADF2">
<enum>101.</enum>
<header>Consultation process</header>
<text display-inline="no-display-inline">Chapter IV of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 423 of such Act (21 U.S.C. 350l) the following:</text>
<quoted-block style="OLC" id="H90962607AE6847B990815887CD15E51B" display-inline="no-display-inline">
<section id="H2B313C6C127C4E60BB9DE886046C00DA">
<enum>424.</enum>
<header>Food derived from new plant varieties</header>
<subsection id="H45987619DB674E4792F8CCAD0911A576">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary shall continue to administer the consultation process established under the Food and Drug Administration’s policy statement entitled <quote>Statement of Policy: Food Derived from New Plant Varieties</quote> published in the Federal Register on May 29, 1992 (57 Fed. Reg. 22,984).</text>
</subsection>
<subsection id="H35A88F7066464F8BBE4374315F6DD94B">
<enum>(b)</enum>
<header>Determination of material difference between food from genetically engineered plants and comparable foods</header>
<paragraph id="H4A6A1B74825140369BB3D94E516AB092">
<enum>(1)</enum>
<header>In general</header>
<text>For purposes of subsection (a), the use of genetic engineering does not, by itself, constitute information that is material for purposes of determining whether there is a difference between a food produced from, containing, or consisting of a genetically engineered plant and a comparable food.</text>
</paragraph>
<paragraph id="HE75A9D89EA39459198D82C1C5C2CC6DA">
<enum>(2)</enum>
<header>Labeling required</header>
<text display-inline="yes-display-inline">The Secretary may require that the labeling of a food produced from, containing, or consisting of a genetically engineered plant contain a statement to adequately inform consumers of a difference between the food so produced and its comparable food if the Secretary determines that—</text>
<subparagraph id="H98554DCB131F4B5FBF7182209C1D899F">
<enum>(A)</enum>
<text>there is a material difference in the functional, nutritional, or compositional characteristics, allergenicity, or other attributes between the food so produced and its comparable food; and </text>
</subparagraph>
<subparagraph id="H6B1D3E74286E44FEB8B48B470A5B6F68">
<enum>(B)</enum>
<text>the disclosure of such material difference is necessary to protect public health and safety or to prevent the label or labeling of the food so produced from being false or misleading in any particular.</text>
</subparagraph>
</paragraph>
</subsection>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</section>
</subtitle>
<subtitle id="H2EA972158A3A4968B4B8CBF4CA4AC2F4">
<enum>B</enum>
<header>Department of Agriculture</header>
<section id="H1A0F4D61885548B0B5CA412728F078E1">
<enum>111.</enum>
<header>Regulation</header>
<text display-inline="no-display-inline">The Plant Protection Act (7 U.S.C. 7701 et seq.) is amended by adding at the end the following new subtitle: </text>
<quoted-block style="OLC" id="H7AEEA65909DE43BD93DE898E358F82BB" display-inline="no-display-inline">
<subtitle id="HA7E6389799D4472292B7C63CE3C16E9B">
<enum>F</enum>
<header>Coordination of food safety and agriculture programs</header>
<section id="HBA1B3374D7964EF7AC83FC1D728D5BEC">
<enum>461.</enum>
<header>Notification relating to certain genetically engineered plants</header>
<subsection id="H114CF584B6E047BE864617446356D9E2">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Subject to subsection (b), it shall be unlawful to introduce or deliver for introduction into interstate commerce a nonregulated genetically engineered plant for use or application in food or a food produced from, containing, or consisting of a nonregulated genetically engineered plant unless—</text>
<paragraph id="H74B6A7A14D974F129E89D8AF10C17045">
<enum>(1)</enum>
<subparagraph id="H921C951C37424F118674578A05744564" display-inline="yes-display-inline">
<enum>(A)</enum>
<text display-inline="yes-display-inline">the Secretary of Health and Human Services notified the entity seeking evaluation of a food produced from, containing, or consisting of the genetically engineered plant in writing that the Secretary of Health and Human Services, in evaluating the food from the genetically engineered plant through the consultation process referred to in section 424(a) of the Federal Food, Drug, and Cosmetic Act, has no objections to the entity’s determination that food produced from, containing, or consisting of the genetically engineered plant that is the subject of the notification is as safe for use by humans or animals, as applicable, as one or more comparable foods; and</text>
</subparagraph>
<subparagraph id="H823E69B5B2864693B15D84B3F6AFE8A6" indent="up1">
<enum>(B)</enum>
<text display-inline="yes-display-inline">the entity seeking evaluation of a food produced from, containing, or consisting of the genetically engineered plant submits to the Secretary of Agriculture the notification of the finding of the Secretary of Health and Human Services under subparagraph (A); or</text>
</subparagraph>
</paragraph>
<paragraph id="H355E5CBE11F249158BCD834F9C38C3B3">
<enum>(2)</enum>
<text display-inline="yes-display-inline">before the date of the enactment of the <short-title>Safe and Accurate Food Labeling Act of 2015</short-title>, the Secretary of Health and Human Services—</text>
<subparagraph id="HE92C5BE7301A4B7D8DA1DB57EB993030">
<enum>(A)</enum>
<text display-inline="yes-display-inline">considered the consultation process referred to in section 424(a) of the Federal Food, Drug, and Cosmetic Act with respect to such genetically engineered plant to be complete;</text>
</subparagraph>
<subparagraph id="H6E4664CD628B44AAB5DA30F5F3764AA7">
<enum>(B)</enum>
<text>notified the consulting party in writing that all questions with respect to the safety of food produced from, containing, or consisting of the genetically engineered plant have been resolved; and</text>
</subparagraph>
<subparagraph id="HFEE00FD633D64E92ABCF24860482716F">
<enum>(C)</enum>
<text display-inline="yes-display-inline">published such notification on the public Internet website of the Food and Drug Administration.</text>
</subparagraph>
</paragraph>
</subsection>
<subsection id="H9B8935C46C3243948CA50CB78439B9C3">
<enum>(b)</enum>
<header>Exceptions</header>
<text display-inline="yes-display-inline">
<italic />Notwithstanding subsection (a), this section does not apply with respect to the introduction or delivery for introduction into interstate commerce of a genetically engineered plant—</text>
<paragraph id="H960B720C08F54AC186BA6E9773830E8D">
<enum>(1)</enum>
<text>for the purpose of research or development testing, including—</text>
<subparagraph id="H09E1622021A742E490D06CB95A8AC60C">
<enum>(A)</enum>
<text>testing conducted to generate data and information that could be used in a submission to the Secretary under this title or other regulatory submission; or</text>
</subparagraph>
<subparagraph id="HD8D886067906472D905A62060C97E772">
<enum>(B)</enum>
<text>research involving multiplication of seed or hybrid and variety development conducted before submitting a notification under subsection (a)(1)(B); </text>
</subparagraph>
</paragraph>
<paragraph id="H87D0D86B0370401CA164810A0F72739A" commented="no">
<enum>(2)</enum>
<text display-inline="yes-display-inline">solely because a processing aid or enzyme produced from the genetically engineered plant is intended to be used to produce food; or</text>
</paragraph>
<paragraph id="H661AEE752B50475F94C7C8F8918812D6">
<enum>(3)</enum>
<text>solely because the genetically engineered plant is used as a nutrient source for microorganisms.</text>
</paragraph>
</subsection>
<subsection id="HCA19F7F95DAC45509BEACC58B9E8FEA1">
<enum>(c)</enum>
<header>Rule of construction</header>
<text display-inline="yes-display-inline">Nothing in subsection (b)(1) may be construed as authorizing the introduction or delivery for introduction into interstate commerce of a nonregulated genetically engineered plant for use or application in food or a food produced from, containing, or consisting of a nonregulated genetically engineered plant. </text>
</subsection>
<subsection id="HC05CE735284449DD93F9A6BDBB04E107">
<enum>(d)</enum>
<header>Public Disclosure</header>
<paragraph id="HE94438AA0997492B8A03A0287F3E0CE5">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Subject to paragraph (2), the Secretary of Agriculture shall publish on the public Internet website of the Department of Agriculture, and update as necessary, a registry that includes—</text>
<subparagraph id="H88DFDBEFB3444C9A9B26575810EAB3CE">
<enum>(A)</enum>
<text>a list of each nonregulated genetically engineered plant intended for a use or application in food that may be introduced or delivered for introduction in interstate commerce, in accordance with subsection (a); </text>
</subparagraph>
<subparagraph id="H2C981C2FBDA54E6A9214F08B9AB71A61">
<enum>(B)</enum>
<text>the petitions submitted to, and determinations made by, the Secretary of Agriculture with respect to such a plant; and</text>
</subparagraph>
<subparagraph id="H7CB12EE722A648139341B1D4E91B0373">
<enum>(C)</enum>
<text display-inline="yes-display-inline">the notifications of findings issued by the Secretary of Health and Human Services with respect to such a plant or the use or application of such a plant in food.</text>
</subparagraph>
</paragraph>
<paragraph id="H47E40EA1E59C4A8BBB9171F485A1CDE9">
<enum>(2)</enum>
<header>Trade secrets and confidential information</header>
<text display-inline="yes-display-inline">Notwithstanding paragraph (1), nothing in this section shall be construed to alter the protections offered by laws, regulations, and policies governing disclosure of confidential commercial or trade secret information, and any other information exempt from disclosure pursuant to section 552(b) of title 5, United States Code, as such provisions would be applied to the documents and information referred to in subparagraphs (A) through (C) of paragraph (1).</text>
</paragraph>
</subsection>
<subsection id="HC73CC743AA9F413F8F2BA7A6EFEDE789">
<enum>(e)</enum>
<header>Imported food</header>
<text>In the case of food imported into the United States that is food produced from, containing, or consisting of a plant that meets the definition of a nonregulated genetically engineered plant or a plant that, if introduced in interstate commerce, would be subject to regulation under part 340 of title 7, Code of Federal Regulations (or any successor regulations), the provisions of this section shall apply to such food in the same manner and to the same extent as such provisions apply to a food that is not so imported. </text>
</subsection>
</section>
<section id="H3787457F086847B9AD2C4C7CC52C34D8">
<enum>462.</enum>
<header>Definitions</header>
<text display-inline="no-display-inline">In this subtitle:</text>
<paragraph id="H7F3E4190F9C847CE98BBE805BA30ADF1">
<enum>(1)</enum>
<header>Food</header>
<text>The term <term>food</term> has the meaning given such term in section 201(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(f)).</text>
</paragraph>
<paragraph id="HC0AD3F73148940E5ADF6D62AF3FD74DC">
<enum>(2)</enum>
<header>Nonregulated genetically engineered plant</header>
<text>The term <term>nonregulated genetically engineered plant</term> means a genetically engineered plant—</text>
<subparagraph id="H1934B882B82F46F895F0DE8FCED359CA">
<enum>(A)</enum>
<text>for which the Secretary of Agriculture has approved a petition under section 340.6 of title 7, Code of Federal Regulations (or any successor regulations), for a determination that the genetically engineered plant should not be regulated under this Act; or</text>
</subparagraph>
<subparagraph id="H64D0D0E774C64652B39C165B332DB1DC">
<enum>(B)</enum>
<text display-inline="yes-display-inline">that—</text>
<clause id="H1748487FFE094C5EBF60C0E6AE85B263">
<enum>(i)</enum>
<text>is not subject to regulation as a plant pest under this Act; </text>
</clause>
<clause id="HCC131CFF1C99475D8AD602440556D756">
<enum>(ii)</enum>
<text>contains genetic material from a different species; and</text>
</clause>
<clause id="H6A06F6CF3F834588A5CFE16E45E7CD26">
<enum>(iii)</enum>
<text>has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques.</text>
</clause>
</subparagraph>
</paragraph>
</section>
</subtitle>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</section>
<section id="HD93DE89138174B2693B4AE1C2F889751">
<enum>112.</enum>
<header>Regulations</header>
<text display-inline="no-display-inline">Not later than one year after the date of the enactment of this Act, the Secretary of Agriculture shall promulgate interim final regulations to carry out the amendments made by section 111.</text>
</section>
<section id="H721AD81362544C39AD1A9A2494885140">
<enum>113.</enum>
<header>Preemption</header>
<text display-inline="no-display-inline">Regardless of whether regulations have been promulgated under section 112, beginning on the date of the enactment of this Act, 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 with respect to genetically engineered plants for use or application in food that is not identical to the requirement of section 461 of the Plant Protection Act (as added by section 111 of this Act).</text>
</section>
<section id="HB32E98C7DDBC408FBB22D9420420D992">
<enum>114.</enum>
<header>Rule of construction</header>
<text display-inline="no-display-inline">Nothing in the amendments made by this subtitle is intended to alter or affect the ability of—</text>
<paragraph id="H3B64D8110B794A7E9B95523D918D6192">
<enum>(1)</enum>
<text>the Secretary of Health and Human Services to take enforcement actions with respect to a violation of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), including section 301 of such Act (21 U.S.C. 331); or</text>
</paragraph>
<paragraph id="HE6B9E023A8A14314A5126573BC23CCE2">
<enum>(2)</enum>
<text>the Secretary of Agriculture to take enforcement actions with respect to a violation of the Plant Protection Act (7 U.S.C. 7701 et seq.), including section 411 of such Act (7 U.S.C. 7711).</text>
</paragraph>
</section>
<section id="HC8AC9BA17F0A4D299936C46B479F8F75">
<enum>115.</enum>
<header>Implementation report</header>
<subsection id="H84B0E932EA82455289C4A94636611D8C">
<enum>(a)</enum>
<header>Study</header>
<text display-inline="yes-display-inline">Not later than 1 year after the date of the enactment of this Act, the Secretary of Agriculture and the Secretary of Health and Human Services shall jointly submit to Congress a report evaluating the progress made in the implementation of subtitle F of the Plant Protection Act, as added by section 111. Such report shall include—</text>
<paragraph id="H266F88A3F6D546CAB939A6CEC88DE4A8">
<enum>(1)</enum>
<text>an analysis of plants over which regulatory oversight under such subtitle is required; </text>
</paragraph>
<paragraph id="H9D6402B9218A47A7A0D758606AE9B54D">
<enum>(2)</enum>
<text>an analysis of the extent to which the provisions of such subtitle establish an appropriate scope of regulatory oversight for the Animal and Plant Health Inspection Service and the Food and Drug Administration, including their oversight of public research programs; and</text>
</paragraph>
<paragraph id="H6C97AEE9A79D4A6EA8DB268010E72BEB">
<enum>(3)</enum>
<text>any potential changes to the Plant Protection Act that would better facilitate implementation of a coordinated, predictable, and efficient science-based regulatory process. </text>
</paragraph>
</subsection>
<subsection id="H113013DB4CD44766957F0C27F1128571">
<enum>(b)</enum>
<header>Coordination with other efforts To modernize regulation</header>
<text display-inline="yes-display-inline">The report under subsection (a) shall be prepared, to the greatest extent practicable, in accordance with the process described in the memorandum issued by the Executive Office of the President on July 2, 2015, entitled <quote>Modernizing the Regulatory System for Biotechnology Products</quote>, including the directive specified in such memorandum to update the <quote>Coordinated Framework for Regulation of Biotechnology</quote> published by the Executive Office of the President, Office of Science and Technology Policy, in the Federal Register on June 26, 1986 (51 Fed.Reg. 23302). </text>
</subsection>
</section>
</subtitle>
<enum>II</enum>
<header>Genetic engineering certification</header>
<section id="HE36551FBCF5A44EFA5572B04478A82A9">
<enum>201.</enum>
<header>Genetic engineering certification</header>
<text display-inline="no-display-inline">The Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et seq.) is amended by adding at the end the following new subtitle: </text>
<quoted-block style="OLC" id="H2658D9A74DCD4A3FB7AC68D1CDA25340" display-inline="no-display-inline">
<subtitle id="HBF4ABF65A5604E1ABE601144423DE1C9">
<enum>E</enum>
<header>Genetic engineering certification</header>
<section id="HE2FA28AB4A9E441F8CD74067F5C33F10">
<enum>291.</enum>
<header>Definitions</header>
<text display-inline="no-display-inline">In this subtitle:</text>
<paragraph id="HDAC82BDF8C16482D9E61F4BF8B738D59">
<enum>(1)</enum>
<text display-inline="yes-display-inline">The term <term>certifying agent</term> means the chief executive officer of a State or, in the case of a State that provides for the statewide election of an official to be responsible solely for the administration of the agricultural operations of the State, such official, and any person (including a private entity) who is accredited by the Secretary as a certifying agent for the purpose of certifying a covered product as a product, the labeling of which may indicate whether the product is produced with or without the use of genetic engineering.</text>
</paragraph>
<paragraph id="HA6B4EDD479744D0091A2A401AE76EAD4">
<enum>(2)</enum>
<text display-inline="yes-display-inline">The term <term>covered product</term> means—</text>
<subparagraph id="H4CE5F5FD202340149F7489AA92D953C2">
<enum>(A)</enum>
<text display-inline="yes-display-inline">an agricultural product, whether raw or processed (including any product derived from livestock that is marketed in the United States for consumption by humans or other animals);</text>
</subparagraph>
<subparagraph id="H80788A0F5993452790EE1D80DBF16F26">
<enum>(B)</enum>
<text display-inline="yes-display-inline">any other food (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act) not derived from an agricultural product; and</text>
</subparagraph>
<subparagraph id="H3928AAEE09E54A29A5E2E38B1B66C5E5">
<enum>(C)</enum>
<text>seed or other propagative material.<italic /></text>
</subparagraph>
</paragraph>
<paragraph id="HC4FC88DFAAFD465EB424FCE177444996">
<enum>(3)</enum>
<text display-inline="yes-display-inline">The term <term>genetically engineered plant</term> refers to a plant or plant product (as those terms are defined in section 403 of the Plant Protection Act (7 U.S.C. 7702)), if—</text>
<subparagraph id="H0B5369BDD125466EB3C9B7BFAE341494">
<enum>(A)</enum>
<text>it contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and</text>
</subparagraph>
<subparagraph id="HCB955F33B9EE44C7A5EAFA04D436F661">
<enum>(B)</enum>
<text>the modification could not otherwise be obtained using conventional breeding techniques.</text>
</subparagraph>
</paragraph>
<paragraph id="H50162D9E6F604CBFA276E852B5E77D75">
<enum>(4)</enum>
<text display-inline="yes-display-inline">The term <italic /><quote>comparable food</quote> means, with respect to a covered product produced from, containing, or consisting of a genetically engineered plant—</text>
<subparagraph id="H00E6259A80F6423FBC0B25863DE41A17">
<enum>(A)</enum>
<text>the parental variety of the plant;</text>
</subparagraph>
<subparagraph id="HB1B419F2728E4D82B90EE9FA9E73A96F">
<enum>(B)</enum>
<text>another commonly consumed variety of the plant; or</text>
</subparagraph>
<subparagraph id="HE8606EBF1BB04DC19E292AD95D3B1C81">
<enum>(C)</enum>
<text display-inline="yes-display-inline">a commonly consumed covered product with properties comparable to the covered product produced from, containing, or consisting of the plant that is a genetically engineered plant.</text>
</subparagraph>
</paragraph>
<paragraph id="H1F69C1A2222442619181F0A27FE8A730">
<enum>(5)</enum>
<text display-inline="yes-display-inline">The term <term>handle</term> means to sell, process or package covered products.</text>
</paragraph>
<paragraph id="HF1185A71A1DB4FEF877FE14E89EAA778">
<enum>(6)</enum>
<text display-inline="yes-display-inline">The term <term>producer</term> means a person who engages in the business of growing or producing covered products.</text>
</paragraph>
<paragraph id="H489B89FF3B054E10A22EE71AE3131119">
<enum>(7)</enum>
<text display-inline="yes-display-inline">The term <term>Secretary</term> means the Secretary of Agriculture, acting through the Agricultural Marketing Service.</text>
</paragraph>
</section>
<section id="HFDF7694F4DD04AB587C89851D250D110">
<enum>291A.</enum>
<header>National genetically engineered food certification program</header>
<subsection id="HB10F693848B44B6890BED0974E48AF06">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary shall establish a voluntary genetically engineered food certification program for covered products with respect to the use of genetic engineering 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="HECF867766FEC41CA86FB336762A0BD62">
<enum>(b)</enum>
<header>Consultation</header>
<text display-inline="yes-display-inline">In developing the program under subsection (a), the Secretary shall consult with such other parties as are necessary to develop such program.</text>
</subsection>
<subsection id="H174B7D1882FF4E699B129529136FFC5B">
<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 covered products were or were not produced with the use of genetic engineering or a genetically engineered plant, in accordance with this subtitle.</text>
</subsection>
<subsection id="H710B45FD934140CCB819889E390ACDB4">
<enum>(d)</enum>
<header>Seal</header>
<text display-inline="yes-display-inline">The Secretary shall establish a seal to identify covered products in interstate commerce using terminology the Secretary considers appropriate, including terminology commonly used in interstate commerce or established by the Secretary in regulations. </text>
</subsection>
</section>
<section id="HEE3AA012F6864BC38B9A83D2327788B3">
<enum>291B.</enum>
<header>National standards for labeling nongenetically engineered food</header>
<subsection id="HA4821B740C3A40769B90CD289C4FD14D">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">To be sold or labeled as a covered product produced without the use of genetic engineering—</text>
<paragraph id="H1BDDCD376376468D9A9DF17BFD29375E">
<enum>(1)</enum>
<text>the covered product shall—</text>
<subparagraph id="H9012444E8676416282C3175A614C8EB8">
<enum>(A)</enum>
<text display-inline="yes-display-inline">be subject to supply chain process controls that address—</text>
<clause id="H3F4621362CB54A0DAFAD7542D98163D6">
<enum>(i)</enum>
<text display-inline="yes-display-inline">the producer planting seed that is not genetically engineered;</text>
</clause>
<clause id="H63133126070A4836B74607707975ABD7">
<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="H49878CDB9EFE415EBD2031E4D9327544">
<enum>(iii)</enum>
<text display-inline="yes-display-inline">persons in direct contact with such crop or products derived from such crop during transportation, storage, or processing keeping the product separated from other products that are or are derived from genetically engineered plants; and</text>
</clause>
</subparagraph>
<subparagraph id="H50A169B245DF46B29B4792B8B5EB7F57">
<enum>(B)</enum>
<text display-inline="yes-display-inline">be produced and handled in compliance with a nongenetically engineered food plan developed and approved in accordance with subsection (c); </text>
</subparagraph>
</paragraph>
<paragraph id="HE22D4EA64F6748CD9B1BFC34B40C5812">
<enum>(2)</enum>
<text display-inline="yes-display-inline">in the case of a covered product derived from livestock that is marketed in the United States for human consumption, the covered product and the livestock, products consumed by such livestock, and products used in processing the products consumed by such livestock shall be produced without the use of products derived from genetic engineering; and</text>
</paragraph>
<paragraph id="H8A205D9771DE44D992D2EC802243E713">
<enum>(3)</enum>
<text>labeling or advertising material on, or in conjunction with, such covered product shall not suggest either expressly or by implication that covered products developed without the use of genetic engineering are safer or of higher quality than covered products produced from, containing, or consisting of a genetically engineered plant.</text>
</paragraph>
</subsection>
<subsection id="H493B40493F1644839D27F10067E1042F">
<enum>(b)</enum>
<header>Exceptions</header>
<text>A covered product shall not be considered as not meeting the criteria specified in subsection (a) solely because the covered product—</text>
<paragraph id="HFE40B2FA7EF9485789725CB17FD6DF4D">
<enum>(1)</enum>
<text display-inline="yes-display-inline">is produced with a genetically engineered microorganism or a processing aid or enzyme; </text>
</paragraph>
<paragraph id="HDE03BCC233214B2FA0F9578E4218C319">
<enum>(2)</enum>
<text display-inline="yes-display-inline">is derived from microorganisms that consumed a nutrient source produced from, containing, or consisting of a genetically engineered plant; or</text>
</paragraph>
<paragraph id="HA1CB60BC8F394A46A12512145382F45D">
<enum>(3)</enum>
<text>is an approved substance on the National List established under section 2118 of the Organic Foods Production Act of 1990 (7 U.S.C. 6517).</text>
</paragraph>
</subsection>
<subsection id="H8E1D9820A537479CB4A7D8354F7C2C3B">
<enum>(c)</enum>
<header>Nongenetically engineered food plan</header>
<paragraph id="HB60C9591D13441FFA5A42E6A073B6475">
<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 nongenetically engineered 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="H33BA7FB63115498A82991E9C108904FF">
<enum>(2)</enum>
<header>Contents</header>
<text display-inline="yes-display-inline">A nongenetically engineered food plan shall contain a description of—</text>
<subparagraph id="HD80694657FB744F18B84DFED68951673">
<enum>(A)</enum>
<text>the procedures that will be followed to assure compliance with this section;</text>
</subparagraph>
<subparagraph id="H031C8D3D2D214FA4A25B72B822DCC8AE">
<enum>(B)</enum>
<text>a description of the monitoring records that will be maintained; and</text>
</subparagraph>
<subparagraph id="HB13BA2D62B134CCCADCB2F9347E87143">
<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="H28EB1CDF336C4351827AAF052AD921B7">
<enum>(3)</enum>
<header>Availability</header>
<text>The nongenetically engineered 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>
<section id="H5F0866DD833E41008704F047E0555E0B">
<enum>291C.</enum>
<header>National standards for labeling genetically engineered food</header>
<subsection id="H22178A1314BC4E979318CAE12FC16CE6">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">To be sold or labeled as a covered product produced with the use of genetic engineering—</text>
<paragraph id="H2376AE9CB77D4FAE8A3B5B7A498CC8BE">
<enum>(1)</enum>
<text display-inline="yes-display-inline">the covered product shall be produced and handled in compliance with a genetically engineered food plan developed and approved in accordance with subsection (b); and </text>
</paragraph>
<paragraph id="H4F4C9C4562534111964FD4C864B5016D">
<enum>(2)</enum>
<text display-inline="yes-display-inline">the labeling of or advertising material on, or in conjunction with, such covered product shall—</text>
<subparagraph id="H7B8051D51E964BB99009D35EF3F89D10">
<enum>(A)</enum>
<text display-inline="yes-display-inline">not expressly or impliedly claim that a covered product developed with the use of genetic engineering is safer or of higher quality solely because the covered product is a product developed with the use of genetic engineering;</text>
</subparagraph>
<subparagraph id="HB0439ABFE99F4C4281B022E55AAF9F31">
<enum>(B)</enum>
<text>not make any claims that are false or misleading; and</text>
</subparagraph>
<subparagraph id="HC553CA66684943058B376DE4650A70E9">
<enum>(C)</enum>
<text display-inline="yes-display-inline">contain such information as the Secretary considers appropriate.</text>
</subparagraph>
</paragraph>
</subsection>
<subsection id="HB90C46A96B494913B4B1FA1BCBFBAA1E">
<enum>(b)</enum>
<header>Genetically engineered food plan</header>
<paragraph id="HCD3AC9ECFAD445DAB0AD0054E08679D4">
<enum>(1)</enum>
<header>In general</header>
<text>A producer or handler seeking certification under this section shall submit a genetically engineered 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="HDA1C8A4FBA30449C8692AE51BD1F8D18">
<enum>(2)</enum>
<header>Contents</header>
<text display-inline="yes-display-inline">A genetically engineered food plan shall contain a description of—</text>
<subparagraph id="H47AE8CF1BC25445782048C3F9D9B1E67">
<enum>(A)</enum>
<text>the procedures that will be followed to assure compliance with this section;</text>
</subparagraph>
<subparagraph id="H0AC0243A4AD9452D90141CF188B32088">
<enum>(B)</enum>
<text>a description of the monitoring records that will be maintained; and</text>
</subparagraph>
<subparagraph id="HCE70C690B3084856B557AC546EF70ACA">
<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="H89D6EEEF96DC43999146A668FF33F2B3">
<enum>(3)</enum>
<header>Availability</header>
<text display-inline="yes-display-inline">The genetically engineered 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>
<subsection id="H8B3816E42A584D25A906C42D09E06BBF">
<enum>(c)</enum>
<header>Prohibition against restricting certain disclosures</header>
<text>With respect to a covered product that otherwise meets the criteria specified in subsection (a), the Secretary may not prevent a person—</text>
<paragraph id="H63A90528B839402985753304507126FE">
<enum>(1)</enum>
<text>from disclosing voluntarily on the labeling of such a covered product developed with the use of genetic engineering the manner in which the product has been modified to express traits or characteristics that differ from its comparable food; or</text>
</paragraph>
<paragraph id="H153CFF7E72294521BAED4FCCE630D875">
<enum>(2)</enum>
<text display-inline="yes-display-inline">from disclosing in advertisements, on the Internet, in response to consumer inquiries, or on other communications, other than in the labeling, that a covered product was developed with the use of genetic engineering.</text>
</paragraph>
</subsection>
</section>
<section id="H462645D5AFF740F1A0D1BC12412F914D" commented="no">
<enum>291D.</enum>
<header>Imported products</header>
<text display-inline="no-display-inline">Imported covered products may be sold or labeled as produced with or without the use of genetic engineering if the Secretary determines that such products have been produced and handled under a genetic engineering certification program that provides safeguards and guidelines governing the production and handling of such products that are at least equivalent to the requirements of this subtitle.</text>
</section>
<section id="H24D26F8FBE5D4AA1B177D1405C1AF84E">
<enum>291E.</enum>
<header>Accreditation program</header>
<subsection id="H2DE8B45041B24DC8AFD1A53229F06A37">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary shall establish and implement a program to accredit a governing State official, and any private person, that meets the requirements of this section as a certifying agent for the purpose of certifying a covered product as having been produced with or without the use of genetic engineering or a genetically engineered plant, in accordance with this subtitle. </text>
</subsection>
<subsection id="H519CAA0EF9744C1C9FA51D96D2A65FE5">
<enum>(b)</enum>
<header>Requirements</header>
<text display-inline="yes-display-inline">To be accredited as a certifying agent under this section, a governing State official or private person shall—</text>
<paragraph id="HBBCF2DCE060E407FA14A7F3291235C9D">
<enum>(1)</enum>
<text>prepare and submit to the Secretary an application for such accreditation;</text>
</paragraph>
<paragraph id="HA3B4C592F4EB49249EB2CEDE7DDA2107">
<enum>(2)</enum>
<text>have sufficient expertise in agricultural production and handling techniques as determined by the Secretary; and</text>
</paragraph>
<paragraph id="HEFF108F871E54D5EAE4A3DCC13EF2092">
<enum>(3)</enum>
<text>comply with the requirements of this section.</text>
</paragraph>
</subsection>
<subsection id="HF25216EB437F4BFFBF0AF5857B8F6C0D">
<enum>(c)</enum>
<header>Duration of accreditation</header>
<text display-inline="yes-display-inline">An accreditation made under this section shall be for a period of not to exceed 5 years, as determined appropriate by the Secretary, and may be renewed.</text>
</subsection>
<subsection id="H94E2BF1567EA4DFA85BA82B659EBC514">
<enum>(d)</enum>
<header>Coordination with existing organic program accreditation</header>
<text display-inline="yes-display-inline">A governing State official or private person who is accredited to certify a farm or handling operation as a certified organic farm or handling operation pursuant to section 2115 of the Organic Foods Production Act of 1990 (7 U.S.C. 6415) (and such accreditation is in effect) shall be deemed to be accredited to certify covered products under this subtitle.</text>
</subsection>
</section>
<section id="HB3763260B67D4DDDAD9ABD891F572B1A">
<enum>291F.</enum>
<header>Recordkeeping, investigations, and enforcement</header>
<subsection id="HAD53C86320DE4637B0E76D7B687F78C1">
<enum>(a)</enum>
<header>Recordkeeping</header>
<paragraph id="H18D50CA504ED4C98A2CDBDB008324A76">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Except as otherwise provided in this title, each person who sells, labels, or represents any covered product as having been produced without the use of genetic engineering or a genetically engineered plant or with the use of genetic engineering or a genetically engineered plant shall—</text>
<subparagraph id="H652268DDD18B49BEA844119CFA20F4F4">
<enum>(A)</enum>
<text>maintain records in a manner prescribed by the Secretary; and</text>
</subparagraph>
<subparagraph id="H9DEC20A047BC4053822F7D4305842FEE">
<enum>(B)</enum>
<text>make available to the Secretary, on request by the Secretary, all records associated with the covered product.</text>
</subparagraph>
</paragraph>
<paragraph id="H4173CBF63014477A85B8E83C9528135A">
<enum>(2)</enum>
<header>Certifying agents</header>
<subparagraph id="HFA2C5B1C1D6C4F018B8EFA0ED115F7BA">
<enum>(A)</enum>
<header>In general</header>
<text>A certifying agent shall— </text>
<clause id="H853808014B8645F186BBC0D00E8BD633">
<enum>(i)</enum>
<text display-inline="yes-display-inline">maintain all records concerning the activities of the certifying agent with respect to the certification of covered products under this subtitle in a manner prescribed by the Secretary; and</text>
</clause>
<clause id="H07987D79E42843B49614E9F8A71ED028">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">make available to the Secretary, on request by the Secretary, all records associated with such activities.</text>
</clause>
</subparagraph>
<subparagraph id="H706577BEC160463D8EEF5C6B2F6940FE">
<enum>(B)</enum>
<header>Transference of records</header>
<text display-inline="yes-display-inline">If a private person that was certified under this subtitle is dissolved or loses accreditation, all records and copies of records concerning the activities of the person under this subtitle shall be transferred to the Secretary.</text>
</subparagraph>
</paragraph>
</subsection>
<subsection id="HAC0B96AAB8114CA8B97ECB57C87ECAD2">
<enum>(b)</enum>
<header>Investigations</header>
<paragraph id="H9B46EEE962BB445DBFC4E1F0D73B4A68">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary may take such investigative actions as the Secretary considers to be necessary—</text>
<subparagraph id="HA98C2C19B9DF4234BE29AFA31EF057BE">
<enum>(A)</enum>
<text>to verify the accuracy of any information reported or made available under this subtitle; and </text>
</subparagraph>
<subparagraph id="HA110329396A2422F955969CB7BA09604">
<enum>(B)</enum>
<text>to determine whether a person covered by this subtitle has committed a violation of any provision of this subtitle, including an order or regulation promulgated by the Secretary pursuant to this subtitle.</text>
</subparagraph>
</paragraph>
<paragraph id="HF223718E79634FB9B562BDFCEE0594E3">
<enum>(2)</enum>
<header>Specific investigative powers</header>
<text>In carrying out this subtitle, the Secretary may—</text>
<subparagraph id="HECB4EB754F5C4C1B9647C99C6939D496">
<enum>(A)</enum>
<text>administer oaths and affirmations;</text>
</subparagraph>
<subparagraph id="H0E458FC48222476B803EBAC2E931B0C6">
<enum>(B)</enum>
<text>subpoena witnesses;</text>
</subparagraph>
<subparagraph id="HB59D04D36A61422891FE1209333BAB0C">
<enum>(C)</enum>
<text>compel attendance of witnesses;</text>
</subparagraph>
<subparagraph id="H6E89A061421E40E6BF288168A70EF1D6">
<enum>(D)</enum>
<text>take evidence; and</text>
</subparagraph>
<subparagraph id="H8F891EC2809B46EC8F47C7C49F5373F4">
<enum>(E)</enum>
<text>require the production of any records required to be maintained under this subtitle that are relevant to an investigation.</text>
</subparagraph>
</paragraph>
</subsection>
<subsection id="HDD76BF2A9FD34D74B1BEEC92F3D7D0B0">
<enum>(c)</enum>
<header>Violations of subtitle</header>
<paragraph id="H78DD2ECE58234C848CB2A18FE7BF79D8">
<enum>(1)</enum>
<header>Unlawful act</header>
<text display-inline="yes-display-inline">Any person covered by this subtitle who, after notice and an opportunity to be heard, has been found by the Secretary to have failed or refused to provide accurate information (including a delay in the timely delivery of such information) required by the Secretary under this subtitle, shall be subject to a civil penalty of not more than $10,000.</text>
</paragraph>
<paragraph id="H3ADC4AE1616D42FCBA8D26F7922FDF95">
<enum>(2)</enum>
<header>Misuse of label</header>
<subparagraph id="H19FC15242D8A40228953AB1A28917BE3">
<enum>(A)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Any person who knowingly sells or labels any covered product as having been produced without the use of genetic engineering or a genetically engineered plant or with the use of genetic engineering or a genetically engineered plant, except in accordance with this subtitle, shall be subject to a civil penalty of not more than $10,000.</text>
</subparagraph>
<subparagraph id="HB097D018B4BF43538D0107C6F0A60C76">
<enum>(B)</enum>
<header>Continuing violation</header>
<text>Each day during which a violation described in subparagraph (A) occurs shall be considered to be a separate violation.</text>
</subparagraph>
</paragraph>
<paragraph id="H108B186D11C3418DB49886BA84960B3B">
<enum>(3)</enum>
<header>Ineligibility</header>
<subparagraph id="H6854A38472FC4B4591C58307D2A7A323">
<enum>(A)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Except as provided in subparagraph (C), any person that carries out an activity described in subparagraph (B), after notice and an opportunity to be heard, shall not be eligible, for the 5-year period beginning on the date of the occurrence, to receive a certification under this subtitle with respect to any covered product.</text>
</subparagraph>
<subparagraph id="H6967971A93694673A16446AC03741754">
<enum>(B)</enum>
<header>Description of activities</header>
<text display-inline="yes-display-inline">An activity referred to in subparagraph (A) is—</text>
<clause id="H266791517E354431914B1C8176E9DDB2">
<enum>(i)</enum>
<text>making a false statement;</text>
</clause>
<clause id="H822281828DD542A0B82919BC4A796C23">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">a violation described in paragraph (2)(A);</text>
</clause>
<clause id="H9EC06FA2F7194F0DACA5792112B0C706">
<enum>(iii)</enum>
<text display-inline="yes-display-inline">attempting to have a label indicating that a covered product has been produced without the use of genetic engineering or a genetically engineered plant or with the use of genetic engineering or a genetically engineered plant affixed to a covered product that a person knows, or should have reason to know, to have been produced in a manner that is not in accordance with this subtitle; or </text>
</clause>
<clause id="HB01E83C4097E4E399F97515CBA546520">
<enum>(iv)</enum>
<text>otherwise violating the purposes of the genetically engineered food certification program established under section 291A, as determined by the Secretary.</text>
</clause>
</subparagraph>
<subparagraph id="HD09068912B6A411FBD4D0533F286A7FD">
<enum>(C)</enum>
<header>Waiver</header>
<text>Notwithstanding subparagraph (A), the Secretary may modify or waive a period of ineligibility under this paragraph if the Secretary determines that the modification or waiver is in the best interests of the genetically engineered food certification program established under section 291A.</text>
</subparagraph>
</paragraph>
<paragraph id="HDBB330E1408847D1ABDF222A2173378F">
<enum>(4)</enum>
<header>Reporting of violations</header>
<text>A certifying agent shall immediately report any violation of this subtitle to the Secretary.</text>
</paragraph>
<paragraph id="H7A15C8C3936846768E6D3C225A4FE949">
<enum>(5)</enum>
<header>Cease-and-desist orders</header>
<subparagraph id="HBC5ABA8E38CC44E180A53B576DA0FEC6">
<enum>(A)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary may, after providing notice and an opportunity to be heard, issue an order, requiring any person who the Secretary reasonably believes is selling or labeling a covered product in violation of this subtitle to cease and desist from selling or labeling such covered product as having been produced without the use of genetic engineering or a genetically engineered plant or as having been produced with the use of genetic engineering or a genetically engineered plant. <italic /></text>
</subparagraph>
<subparagraph id="HEDEC9B133E7840F089C85AC84AAD33D8">
<enum>(B)</enum>
<header>Final and conclusive</header>
<text>The order of the Secretary imposing a cease-and-desist order under this paragraph shall be final and conclusive unless the affected person files an appeal from the Secretary’s order with the appropriate district court of the United States not later than 30 days after the date of the issuance of the order.</text>
</subparagraph>
</paragraph>
<paragraph id="H96019277961B4843A637CF483A17CB56">
<enum>(6)</enum>
<header>Violations by certifying agent</header>
<text display-inline="yes-display-inline">A certifying agent that is a private person that violates the provisions of this subtitle or falsely or negligently certifies any covered product that does not meet the terms and conditions of the genetically engineered food certification program established under section 291A, as determined by the Secretary, shall, after notice and an opportunity to be heard—</text>
<subparagraph id="H63E28D4EB3A6465FA350277E41FA466F">
<enum>(A)</enum>
<text>lose accreditation as a certifying agent under this subtitle; and </text>
</subparagraph>
<subparagraph id="HA888233A4AA44D68B08C3DD6D6F34E06">
<enum>(B)</enum>
<text>be ineligible to be accredited as a certifying agent under this subtitle for a period of not less than 3 years, beginning on the date of the determination.</text>
</subparagraph>
</paragraph>
<paragraph id="HCD28F9610E58495BB099C4AAF1E43959">
<enum>(7)</enum>
<header>Suspension</header>
<subparagraph id="H5134CA0E6ECF475E88BA8EC788E37E8D">
<enum>(A)</enum>
<header>In general</header>
<text>The Secretary may, after first providing the certifying agent notice and an opportunity to be heard, suspend the accreditation of the certifying agent for a period specified in subparagraph (B) for a violation of this subtitle.</text>
</subparagraph>
<subparagraph id="HD911CEE2416940EA8F185EABD2E0327E">
<enum>(B)</enum>
<header>Period of suspension</header>
<text>The period of a suspension under subparagraph (A) shall terminate on the date the Secretary makes a final determination with respect to the violation that is the subject of the suspension.</text>
</subparagraph>
</paragraph>
<paragraph id="HD3690C0E0EAA42A58F972ACEC55D5B3F">
<enum>(8)</enum>
<header>Enforcement by Attorney General</header>
<text display-inline="yes-display-inline">On request of the Secretary, the Attorney General may bring a civil action against a person in a district court of the United States to enforce this subtitle or a requirement or regulation prescribed, or an order issued, under this subtitle. The action may be brought in the judicial district in which the person does business or in which the violation occurred.</text>
</paragraph>
</subsection>
</section>
<section id="H63ED9135435C476A8CDB3C5F0D13E169">
<enum>291G.</enum>
<header>Authorization of appropriations; fees</header>
<subsection id="H7C8B00F810E14FB5AA896C4F55DDC26E">
<enum>(a)</enum>
<header>Authorization of appropriations</header>
<text display-inline="yes-display-inline">There are authorized to be appropriated to establish the genetically engineered food program under section 291A, $2,000,000, to remain available until expended.</text>
</subsection>
<subsection id="HC757DFA2855C4953AA2338FAF34802B6">
<enum>(b)</enum>
<header>Fees</header>
<paragraph id="HB068D97E31D04036A8DC1451EE2FFC2B">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Upon establishment of the genetically engineered food certification program under section 291A, the Secretary shall establish by notice, charge, and collect fees to cover the estimated costs to the Secretary of carrying out this subtitle.</text>
</paragraph>
<paragraph id="HCABB03BFB350400BB0D98BA11542F7E0">
<enum>(2)</enum>
<header>Availability</header>
<text display-inline="yes-display-inline">Fees collected under paragraph (1) shall be deposited into a fund in the Treasury of the United States and shall remain available until expended, without further appropriation, to carry out this subtitle.</text>
</paragraph>
</subsection>
</section>
</subtitle>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</section>
<section id="H188B27882C2F42E4A8A73122A15D6D6B">
<enum>202.</enum>
<header>Regulations</header>
<text display-inline="no-display-inline">In promulgating regulations to carry out the amendments made by section 201, the Secretary of Agriculture shall—</text>
<paragraph id="HBDBB04753A2045AA942C93F892B19B91">
<enum>(1)</enum>
<text display-inline="yes-display-inline">provide a process to account for certified nongenetically engineered covered products containing material from genetically engineered plants due to the inadvertent presence of such material;</text>
</paragraph>
<paragraph id="H7EA927A50A7341BE8A7C4AAC0C78DA82">
<enum>(2)</enum>
<text display-inline="yes-display-inline">to the greatest extent practicable, establish consistency between the certification programs established under subtitle E of the Agricultural Marketing Act of 1946 (as added by section 201 of this Act), the organic certification program established under the Organic Foods Production Act of 1990 (7 U.S.C. 6501 et seq.), and other voluntary labeling programs administered by the Secretary; </text>
</paragraph>
<paragraph id="H9E7861E773FC4D89B05214E861692FC0">
<enum>(3)</enum>
<text display-inline="yes-display-inline">with respect to regulations for covered products intended for consumption by non-food animals, take into account the inherent differences between food intended for animal and human consumption, including the essential vitamins, minerals, and micronutrients required to be added to animal food to formulate a complete and balanced diet; and</text>
</paragraph>
<paragraph id="H6C2EC711256D4D4E9C04335247ADB4FD">
<enum>(4)</enum>
<text display-inline="yes-display-inline">provide a process for requesting and granting exemptions from the requirements of subtitle E of the Agricultural Marketing Act of 1946 (as added by section 201 of this Act) under conditions established by the Secretary.</text>
</paragraph>
</section>
<section id="HABC84919529F4612A43FC9E1B2BB1E22">
<enum>203.</enum>
<header>Effective date; preemption</header>
<subsection id="H4A6D33A2F2DE40DB9E365DFD9B2F4CF2">
<enum>(a)</enum>
<header>Effective date</header>
<text display-inline="yes-display-inline">Regardless of whether regulations have been promulgated under section 202 of this Act, the amendments made by section 201 shall take effect beginning on the date of the enactment of this Act.</text>
</subsection>
<subsection id="HA00D4A3D93C5434D9FE44FA51233F67F">
<enum>(b)</enum>
<header>Prohibitions against mandatory labeling of food developed using genetic engineering</header>
<text display-inline="yes-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 covered product (as defined in section 291 of the Agricultural Marketing Act of 1946, as added by section 201 of this Act) in interstate commerce, any requirement for the labeling of a covered product indicating the product as having been produced from, containing, or consisting of a genetically engineered plant, including any requirements for claims that a covered product is or contains an ingredient that was produced from, contains, or consists of a genetically engineered plant unless the State (or a political subdivision thereof) establishes either of the following programs for the regulation of such claims: </text>
<paragraph id="H543FC35EFD0540FDA6DEC9003606E4E0">
<enum>(1)</enum>
<text display-inline="yes-display-inline">A program that relates to voluntary claims to which paragraph (1) of section 204(a) of this Act applies.</text>
</paragraph>
<paragraph id="H77BDC48B238F4E58A11FEAE36087D930">
<enum>(2)</enum>
<text>A program that—</text>
<subparagraph id="H673C15822FE94F1ABE6542284E197598">
<enum>(A)</enum>
<text>is voluntary; </text>
</subparagraph>
<subparagraph id="HABDA67B1B05A47A0B1B3186C8A5AA614">
<enum>(B)</enum>
<text>is accredited by the Secretary pursuant to section 291E of the Agricultural Marketing Act of 1946 (as added by section 201 of this Act); and</text>
</subparagraph>
<subparagraph id="HA9DFC2E2C8154865B843687AAD162624">
<enum>(C)</enum>
<text display-inline="yes-display-inline">establishes standards that are identical to the standards established under section 291B or 291C of the Agricultural Marketing Act of 1946, as applicable (as added by section 201 of this Act).</text>
</subparagraph>
</paragraph>
</subsection>
</section>
<section id="HD817ED18825246BD832F22B4827F4E35">
<enum>204.</enum>
<header>Applicability</header>
<subsection id="H5F538C3E71AA41BE8CF25C273CBDB064">
<enum>(a)</enum>
<header>Existing claims</header>
<text display-inline="yes-display-inline">A voluntary claim made with respect to whether a covered product (as defined in section 291 of the Agricultural Marketing Act of 1946, as added by section 201 of this Act) was produced with or without the use of genetic engineering or genetically engineered plants before the date of the enactment of this Act—</text>
<paragraph id="HE8542EC103944B19B43CFB2E92577DD0">
<enum>(1)</enum>
<text>may be made for such a product during the 36-month period that begins on the date of the enactment of this Act; and</text>
</paragraph>
<paragraph id="H6339DED7B6BC4FFBAA2A510DBAFDC705">
<enum>(2)</enum>
<text>after the expiration of such 36-month period, may be made so long as the labels associated with such a claim meet the standards specified in section 291B or 291C of the Agricultural Marketing Act of 1946, as applicable (as added by section 201 of this Act).</text>
</paragraph>
</subsection>
<subsection id="H42B0D55784594CDF9FE102973CABB629">
<enum>(b)</enum>
<header>Organic certification</header>
<text display-inline="yes-display-inline">In the case of a covered product (as defined in section 291 of the Agricultural Marketing Act of 1946, as added by section 201 of this Act) produced by a farm or handling operation that is certified as an organic farm or handling operation under the Organic Foods Production Act of 1990 (7 U.S.C. 6501 et seq.), such product is deemed to be certified as a product produced without the use of genetic engineering under the genetically engineered food certification program established under section 291A of the Agricultural Marketing Act of 1946 (as added by section 201 of this Act).</text>
</subsection>
</section>
<enum>III</enum>
<header>Natural foods</header>
<section commented="no" id="HF1CCD0B336A54795B2DF94B99A52B154">
<enum>301.</enum>
<header>Labeling of natural foods</header>
<text display-inline="no-display-inline">Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H9F7636D8B0664FE083A9DB1893FDE3C4" style="OLC">
<subsection commented="no" id="H083824ECABDE43298955BDAA8BC57643">
<enum>(z)</enum>
<paragraph commented="no" display-inline="yes-display-inline" id="H5CC111C078A6425386616905C31E418E">
<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="H78CE2634BADD4EEA83A41FEBE039191A" 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="H0CABB835A5F440CA8EFFFE536F1C8B5E" 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="HAD402D8E0F0247338A34D34F6B416258" 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="H9646D0C55F55485DA03C0B7578AB0220" indent="up1">
<enum>(5)</enum>
<text>For purposes of subparagraph (1), a natural claim includes the use of—</text>
<subparagraph id="H0C5DB627F4A04899A149883483845389">
<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="H1B297562DF344A63BE296BC4C3020669">
<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="H11CF3951FBA9463B9686A5943F320622">
<enum>302.</enum>
<header>Regulations</header>
<subsection id="HAA55311B5EF14D2E935B10EFA01129BD">
<enum>(a)</enum>
<header>Proposed regulations</header>
<text display-inline="yes-display-inline">Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue proposed regulations to implement section 403(z) of the Federal Food, Drug, and Cosmetic Act, as added by section 301 of this Act.</text>
</subsection>
<subsection id="H85F186F6B78045F3910D23B912A5ADDF">
<enum>(b)</enum>
<header>Final regulations</header>
<text>Not later than 30 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(z).</text>
</subsection>
</section>
<section id="H55EEE4BE08BD4A309A0A5093EE5A1242">
<enum>303.</enum>
<header>Preemption</header>
<text display-inline="no-display-inline">Section 403A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343–1(a)) is amended—</text>
<paragraph id="HBDADC96854EC45B983C713D6E324FB96">
<enum>(1)</enum>
<text>in paragraph (4), by striking <quote>or</quote> at the end;</text>
</paragraph>
<paragraph id="HF48D12C52C68488E89D4F2F2289E56FA">
<enum>(2)</enum>
<text>in paragraph (5), by striking the period and inserting a comma; and</text>
</paragraph>
<paragraph id="H95EA4224EB2D450191D0EC7F2BC6DDA3">
<enum>(3)</enum>
<text>by inserting after paragraph (5) the following:</text>
<quoted-block display-inline="no-display-inline" id="H25957B46BA104F9A97EBC5E376E77564" style="OLC">
<paragraph id="H5C2B184D331341128F6C00F8A8F99B38">
<enum>(6)</enum>
<text display-inline="yes-display-inline">any requirement for the labeling of food of the type required by section 403(z) that is not identical to the requirement of such section.</text>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</section>
<section id="HCD43413AD8B749B58037AE954959EA5B">
<enum>304.</enum>
<header>Effective date</header>
<text display-inline="no-display-inline">The labeling requirements of section 403(z) of the Federal Food, Drug, and Cosmetic Act, as added by section 301 of this Act, shall take effect on the effective date of final regulations promulgated under section 302(b) of this Act. The provisions of section 403A(a)(6) of the Federal Food, Drug, and Cosmetic Act, as added by section 303 of this Act, take effect on the date of enactment of this Act.</text>
</section>