[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1599 Engrossed in House (EH)]

114th CONGRESS
  1st Session
                                H. R. 1599

_______________________________________________________________________

                                 AN ACT


 
To amend the Federal Food, Drug, and Cosmetic Act with respect to food 
 produced from, containing, or consisting of a bioengineered organism, 
         the labeling of natural foods, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Safe and Accurate 
Food Labeling Act of 2015''.
    (b) Table of Contents.--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.

SEC. 2. SAVINGS CLAUSE.

    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.

      TITLE I--FOOD SAFETY AFFIRMATION FOR CERTAIN PLANT PRODUCTS

                Subtitle A--Food and Drug Administration

SEC. 101. CONSULTATION PROCESS.

    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:

``SEC. 424. FOOD DERIVED FROM NEW PLANT VARIETIES.

    ``(a) In General.--The Secretary shall continue to administer the 
consultation process established under the Food and Drug 
Administration's policy statement entitled `Statement of Policy: Food 
Derived from New Plant Varieties' published in the Federal Register on 
May 29, 1992 (57 Fed. Reg. 22,984).
    ``(b) Determination of Material Difference Between Food From 
Genetically Engineered Plants and Comparable Foods.--
            ``(1) In general.--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.
            ``(2) Labeling required.--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--
                    ``(A) 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
                    ``(B) 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.''.

                 Subtitle B--Department of Agriculture

SEC. 111. REGULATION.

    The Plant Protection Act (7 U.S.C. 7701 et seq.) is amended by 
adding at the end the following new subtitle:

   ``Subtitle F--Coordination of Food Safety and Agriculture Programs

``SEC. 461. NOTIFICATION RELATING TO CERTAIN GENETICALLY ENGINEERED 
              PLANTS.

    ``(a) In General.--Subject to subsection (b), it shall be unlawful 
to sell or offer for sale in 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--
            ``(1)(A) 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 safe for use by 
        humans or animals, as applicable, and lawful under the Federal 
        Food, Drug, and Cosmetic Act; and
            ``(B) 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
            ``(2) before the date of the enactment of the Safe and 
        Accurate Food Labeling Act of 2015, the Secretary of Health and 
        Human Services--
                    ``(A) 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;
                    ``(B) 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
                    ``(C) published such notification on the public 
                Internet website of the Food and Drug Administration.
    ``(b) Exceptions.--Notwithstanding subsection (a), this section 
does not apply with respect to the sale or offering for sale in 
interstate commerce of a genetically engineered plant--
            ``(1) for the purpose of research or development testing, 
        including--
                    ``(A) 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
                    ``(B) multiplication of seed or hybrid and variety 
                development conducted before submitting a notification 
                under subsection (a)(1)(B);
            ``(2) solely because a processing aid or enzyme produced 
        from the genetically engineered plant is intended to be used to 
        produce food; or
            ``(3) solely because the genetically engineered plant is 
        used as a nutrient source for microorganisms.
    ``(c) Rule of Construction.--Nothing in subsection (b)(1) may be 
construed as authorizing the sale or offering for sale in 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.
    ``(d) Public Disclosure.--
            ``(1) In general.--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--
                    ``(A) a list of each nonregulated genetically 
                engineered plant intended for a use or application in 
                food that may be sold or offered for sale in interstate 
                commerce, in accordance with subsection (a);
                    ``(B) the petitions submitted to, and 
                determinations made by, the Secretary of Agriculture 
                with respect to such a plant; and
                    ``(C) 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.
            ``(2) Trade secrets and confidential information.--
        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).
    ``(e) Imported Food.--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 sold 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.

``SEC. 462. DEFINITIONS.

    ``In this subtitle:
            ``(1) Food.--The term `food' has the meaning given such 
        term in section 201(f) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 321(f)).
            ``(2) Nonregulated genetically engineered plant.--The term 
        `nonregulated genetically engineered plant' means a genetically 
        engineered plant--
                    ``(A) 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
                    ``(B) that--
                            ``(i) is not subject to regulation as a 
                        plant pest under this Act;
                            ``(ii) contains genetic material from a 
                        different species; and
                            ``(iii) has been modified through in vitro 
                        recombinant deoxyribonucleic acid (DNA) 
                        techniques.''.

SEC. 112. REGULATIONS.

    Not later than 1 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.

SEC. 113. PREEMPTION.

    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 the sale or 
offering for sale in interstate commerce of a genetically engineered 
plant 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).

SEC. 114. RULE OF CONSTRUCTION.

    Nothing in the amendments made by this subtitle is intended to 
alter or affect the ability of--
            (1) 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
            (2) 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).

SEC. 115. IMPLEMENTATION REPORT.

    (a) Study.--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--
            (1) an analysis of plants over which regulatory oversight 
        under such subtitle is required;
            (2) 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
            (3) any potential changes to the Plant Protection Act that 
        would better facilitate implementation of a coordinated, 
        predictable, and efficient science-based regulatory process.
    (b) Coordination With Other Efforts To Modernize Regulation.--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 ``Modernizing the Regulatory System for Biotechnology 
Products'', including the directive specified in such memorandum to 
update the ``Coordinated Framework for Regulation of Biotechnology'' 
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).

              TITLE II--GENETIC ENGINEERING CERTIFICATION

SEC. 201. GENETIC ENGINEERING CERTIFICATION.

    The Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et seq.) is 
amended by adding at the end the following new subtitle:

            ``Subtitle E--Genetic Engineering Certification

``SEC. 291. DEFINITIONS.

    ``In this subtitle:
            ``(1) The term `certifying agent' 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.
            ``(2) The term `covered product' means--
                    ``(A) 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);
                    ``(B) any other food (as defined in section 201 of 
                the Federal Food, Drug, and Cosmetic Act) not derived 
                from an agricultural product; and
                    ``(C) seed or other propagative material.
            ``(3) The term `genetically engineered plant' 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--
                    ``(A) it contains genetic material that has been 
                modified through in vitro recombinant deoxyribonucleic 
                acid (DNA) techniques; and
                    ``(B) the modification could not otherwise be 
                obtained using conventional breeding techniques.
            ``(4) The term  `comparable food' means, with respect to a 
        covered product produced from, containing, or consisting of a 
        genetically engineered plant--
                    ``(A) the parental variety of the plant;
                    ``(B) another commonly consumed variety of the 
                plant; or
                    ``(C) a commonly consumed covered product with 
                properties comparable to the covered product produced 
                from, containing, or consisting of the genetically 
                engineered plant.
            ``(5) The term `handle' means to sell, process, or package 
        covered products.
            ``(6) The term `producer' means a person who engages in the 
        business of growing or producing covered products.
            ``(7) The term `Secretary' means the Secretary of 
        Agriculture, acting through the Agricultural Marketing Service.

``SEC. 291A. NATIONAL GENETICALLY ENGINEERED FOOD CERTIFICATION 
              PROGRAM.

    ``(a) In General.--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.
    ``(b) Consultation.--In developing the program under subsection 
(a), the Secretary shall consult with such other parties as are 
necessary to develop such program to ensure that producers or handlers 
seeking to make claims under section 291B or 291C are certified to make 
such claims.
    ``(c) Certification.--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.
    ``(d) Seal.--The Secretary shall establish a seal to identify 
covered products in interstate commerce using terminology the Secretary 
considers appropriate for covered products certified under this title, 
including terminology commonly used in interstate commerce or 
established by the Secretary in regulations.

``SEC. 291B. NATIONAL STANDARDS FOR LABELING NONGENETICALLY ENGINEERED 
              FOOD.

    ``(a) In General.--To be sold or labeled as a covered product 
produced without the use of genetic engineering--
            ``(1) the covered product shall--
                    ``(A) be subject to supply chain process controls 
                that address--
                            ``(i) the producer planting seed that is 
                        not genetically engineered;
                            ``(ii) the producer keeping the crop 
                        separated during growth, harvesting, storage, 
                        and transportation; and
                            ``(iii) 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
                    ``(B) be produced and handled in compliance with a 
                nongenetically engineered food plan developed and 
                approved in accordance with subsection (c);
            ``(2) 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
            ``(3) 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.
    ``(b) Exceptions.--A covered product shall not be considered as not 
meeting the criteria specified in subsection (a) solely because the 
covered product--
            ``(1) is manufactured or processed using a genetically 
        engineered microorganism or a processing aid or enzyme;
            ``(2) is derived from microorganisms that consumed a 
        nutrient source produced from, containing, or consisting of a 
        genetically engineered plant; or
            ``(3) 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).
    ``(c) Nongenetically Engineered Food Plan.--
            ``(1) In general.--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.
            ``(2) Contents.--A nongenetically engineered food plan 
        shall contain a description of--
                    ``(A) the procedures that will be followed to 
                assure compliance with this section;
                    ``(B) a description of the monitoring records that 
                will be maintained; and
                    ``(C) any corrective actions that will be 
                implemented in the event there is a deviation from the 
                plan.
            ``(3) Availability.--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.
    ``(d) Treatment of Livestock.--In the case of a covered product 
derived from livestock that is marketed in the United States for human 
consumption, the covered product shall not be considered to be 
genetically engineered solely because the livestock consumed feed 
produced from containing, or consisting of a genetically engineered 
plant.

``SEC. 291C. NATIONAL STANDARDS FOR LABELING GENETICALLY ENGINEERED 
              FOOD.

    ``(a) In General.--To be sold or labeled as a covered product 
produced with the use of genetic engineering--
            ``(1) 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
            ``(2) the labeling of, or advertising material on, or in 
        conjunction with, such covered product shall--
                    ``(A) 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;
                    ``(B) not make any claims that are false or 
                misleading; and
                    ``(C) contain such information as the Secretary 
                considers appropriate.
    ``(b) Genetically Engineered Food Plan.--
            ``(1) In general.--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.
            ``(2) Contents.--A genetically engineered food plan shall 
        contain a description of--
                    ``(A) the procedures that will be followed to 
                assure compliance with this section;
                    ``(B) a description of the monitoring records that 
                will be maintained; and
                    ``(C) any corrective actions that will be 
                implemented in the event there is a deviation from the 
                plan.
            ``(3) Availability.--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.
    ``(c) Prohibition Against Restricting Certain Disclosures.--With 
respect to a covered product that otherwise meets the criteria 
specified in subsection (a), the Secretary may not prevent a person--
            ``(1) 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
            ``(2) 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.

``SEC. 291D. IMPORTED PRODUCTS.

    ``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.

``SEC. 291E. ACCREDITATION PROGRAM.

    ``(a) In General.--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.
    ``(b) Requirements.--To be accredited as a certifying agent under 
this section, a governing State official or private person shall--
            ``(1) prepare and submit to the Secretary an application 
        for such accreditation;
            ``(2) have sufficient expertise in agricultural production 
        and handling techniques as determined by the Secretary; and
            ``(3) comply with the requirements of this section.
    ``(c) Duration of Accreditation.--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.
    ``(d) Coordination With Existing Organic Program Accreditation.--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.

``SEC. 291F. RECORDKEEPING, INVESTIGATIONS, AND ENFORCEMENT.

    ``(a) Recordkeeping.--
            ``(1) In general.--Except as otherwise provided in this 
        title, each person who sells, labels, or represents any covered 
        product as having been produced with or without the use of 
        genetic engineering or a genetically engineered plant shall--
                    ``(A) maintain records in a manner prescribed by 
                the Secretary; and
                    ``(B) make available to the Secretary, on request 
                by the Secretary, all records associated with the 
                covered product.
            ``(2) Certifying agents.--
                    ``(A) In general.--A certifying agent shall--
                            ``(i) 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
                            ``(ii) make available to the Secretary, on 
                        request by the Secretary, all records 
                        associated with such activities.
                    ``(B) Transference of records.--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.
    ``(b) Investigations.--
            ``(1) In general.--The Secretary may take such 
        investigative actions as the Secretary considers to be 
        necessary--
                    ``(A) to verify the accuracy of any information 
                reported or made available under this subtitle; and
                    ``(B) 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.
            ``(2) Specific investigative powers.--In carrying out this 
        subtitle, the Secretary may--
                    ``(A) administer oaths and affirmations;
                    ``(B) subpoena witnesses;
                    ``(C) compel attendance of witnesses;
                    ``(D) take evidence; and
                    ``(E) require the production of any records 
                required to be maintained under this subtitle that are 
                relevant to an investigation.
    ``(c) Violations of Subtitle.--
            ``(1) Failure to provide information.--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 assessed a civil 
        penalty of not more than $10,000.
            ``(2) Misuse of label.--
                    ``(A) In general.--Any person who, after notice and 
                an opportunity to be heard, is found by the Secretary 
                to have knowingly sold or labeled any covered product 
                as having been produced with or without the use of 
                genetic engineering or a genetically engineered plant, 
                except in accordance with this subtitle, shall be 
                assessed a civil penalty of not more than $10,000.
                    ``(B) Continuing violation.--Each day during which 
                a violation described in subparagraph (A) occurs shall 
                be considered to be a separate violation.
            ``(3) Ineligibility.--
                    ``(A) In general.--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.
                    ``(B) Description of activities.--An activity 
                referred to in subparagraph (A) is--
                            ``(i) making a false statement;
                            ``(ii) a violation described in paragraph 
                        (2)(A);
                            ``(iii) attempting to have a label 
                        indicating that a covered product has been 
                        produced with or without 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
                            ``(iv) otherwise violating the purposes of 
                        the genetically engineered food certification 
                        program established under section 291A, as 
                        determined by the Secretary.
                    ``(C) Waiver.--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.
            ``(4) Reporting of violations.--A certifying agent shall 
        immediately report any violation of this subtitle to the 
        Secretary.
            ``(5) Cease-and-desist orders.--
                    ``(A) In general.--The Secretary may, after 
                providing notice and an opportunity to be heard, issue 
                an order, require 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 with or without the use of genetic 
                engineering or a genetically engineered plant. 
                    ``(B) Final and conclusive.--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.
            ``(6) Violations by certifying agent.--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--
                    ``(A) lose accreditation as a certifying agent 
                under this subtitle; and
                    ``(B) 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.
            ``(7) Suspension.--
                    ``(A) In general.--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.
                    ``(B) Period of suspension.--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.
            ``(8) Enforcement by attorney general.--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.

``SEC. 291G. AUTHORIZATION OF APPROPRIATIONS; FEES.

    ``(a) Authorization of Appropriations.--There are authorized to be 
appropriated to establish the genetically engineered food certification 
program under section 291A, $2,000,000, to remain available until 
expended.
    ``(b) Fees.--
            ``(1) In general.--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.
            ``(2) Availability.--Fees collected under paragraph (1) 
        shall be deposited into a fund in the Treasury of the United 
        States and shall remain available until expended, subject to 
        appropriation, to carry out this subtitle.''.

SEC. 202. REGULATIONS.

    In promulgating regulations to carry out the amendments made by 
section 201, the Secretary of Agriculture shall--
            (1) 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;
            (2) 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;
            (3) 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
            (4) 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.

SEC. 203. EFFECTIVE DATE; PREEMPTION.

    (a) Effective Date.--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.
    (b) Prohibitions Against Mandatory Labeling of Food Developed Using 
Genetic Engineering.--
            (1) In general.--Subject to paragraph (2), 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.
            (2) Exception.--Notwithstanding paragraph (1), a State (or 
        a political subdivision thereof) may establish either of the 
        following voluntary programs for the regulation of claims 
        described in such paragraph:
                    (A) A program that relates to voluntary claims to 
                which paragraph (1) of section 204(a) of this Act 
                applies.
                    (B) A program that--
                            (i) is voluntary;
                            (ii) 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
                            (iii) 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).
    (c) Rule of Construction.--For the sole purpose of subsection 
(b)(1), a covered product derived from livestock that consumed 
genetically engineered plants shall be deemed as having been produced 
from, containing, or consisting of a genetically engineered plant. 

SEC. 204. APPLICABILITY.

    (a) Existing Claims.--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--
            (1) may be made for such a product during the 36-month 
        period that begins on the date of the enactment of this Act; 
        and
            (2) 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).
    (b) Organic Certification.--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).

                        TITLE III--NATURAL FOODS

SEC. 301. LABELING OF NATURAL FOODS.

    Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
343) is amended by adding at the end the following:
    ``(z)(1) If its labeling contains an express or implied claim that 
the food is `natural' unless the claim is made in accordance with 
subparagraph (2).
    ``(2) 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.
    ``(3) Notwithstanding subparagraph (2), prior to the finalization 
of regulations to carry out this paragraph, the use of any claim that a 
food is `natural' shall be allowed if consistent with the Secretary's 
existing policy for such claims.
    ``(4) 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.
    ``(5) For purposes of subparagraph (1), a natural claim includes 
the use of--
            ``(A) the terms `natural', `100% natural', `naturally 
        grown', `all natural', and `made with natural ingredients'; and
            ``(B) any other terms specified by the Secretary.''.

SEC. 302. REGULATIONS.

    (a) Proposed Regulations.--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.
    (b) Final Regulations.--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).

SEC. 303. PREEMPTION.

    Section 403A(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 343-1(a)) is amended--
            (1) in paragraph (4), by striking ``or'' at the end;
            (2) in paragraph (5), by striking the period and inserting 
        a comma; and
            (3) by inserting after paragraph (5) the following:
            ``(6) 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.''.

SEC. 304. EFFECTIVE DATE.

    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.

            Passed the House of Representatives July 23, 2015.

            Attest:

                                                                 Clerk.
114th CONGRESS

  1st Session

                               H. R. 1599

_______________________________________________________________________

                                 AN ACT

To amend the Federal Food, Drug, and Cosmetic Act with respect to food 
 produced from, containing, or consisting of a bioengineered organism, 
         the labeling of natural foods, and for other purposes.