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114th Congress   }                                   {   Rept. 114-208
                        HOUSE OF REPRESENTATIVES
 1st Session     }                                   {          Part 1

======================================================================



 
              SAFE AND ACCURATE FOOD LABELING ACT OF 2015

                                _______
                                

                 July 16, 2015.--Ordered to be printed

                                _______
                                

Mr. Conaway, from the Committee on Agriculture, submitted the following

                              R E P O R T

                             together with

                            DISSENTING VIEWS

                        [To accompany H.R. 1599]

    The Committee on Agriculture, to whom was referred the bill 
(H.R. 1599) 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, having considered the same, report 
favorably thereon with an amendment and recommend that the bill 
as amended do pass.
    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

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 
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--
          ``(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 as safe for use by 
        humans or animals, as applicable, as one or more comparable 
        foods; 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 introduction or delivery for introduction 
into 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) research involving 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 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.
  ``(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 introduced or delivered for 
                introduction 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 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.

``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 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.

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 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).

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 plant that is a 
                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.
  ``(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, 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 produced with 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.

``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 without the use of genetic 
        engineering or a genetically engineered plant or with 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) Unlawful act.--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.
          ``(2) Misuse of label.--
                  ``(A) In general.--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.
                  ``(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 
                        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
                          ``(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, 
                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. 
                  ``(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 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, without further 
        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.--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:
          (1) A program that relates to voluntary claims to which 
        paragraph (1) of section 204(a) of this Act applies.
          (2) A program that--
                  (A) is voluntary;
                  (B) 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
                  (C) 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).

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.

                           Brief Explanation

    The Safe and Accurate Food Labeling Act of 2015 would 
ensure national uniformity regarding labeling of foods derived 
from genetically engineered plants by preventing a patchwork of 
conflicting State or local labeling laws which inherently 
interfere with interstate and foreign commerce.

                            Purpose and Need

    Agricultural biotechnology is one of the important tools 
available to producers to cope with an increasing world 
population and increasing production risks in the 21st century. 
Despite the need for this technology, an ever more vocal 
minority of citizens are creating doubt in the minds of many 
consumers and policymakers through misinformation regarding the 
safety and wise use of genetically engineered inputs.
    In Washington and across the country, we are hearing about 
``GMOs'' and the use of biotechnology in food and agricultural 
production. There is a great deal of misinformation that can be 
confusing to consumers and policymakers alike.
    This misinformation is influencing policymakers at the 
local, state, and federal levels and could threaten our 
farmers' ability to feed an ever growing population and 
increase the cost of food for consumers. Right now, 
biotechnology is helping farmers grow more food with less--less 
water, less land, and less energy.
    Over the past several years, political activists in a 
growing number of states have attempted to pass ballot 
initiatives and legislative proposals that would require 
labeling of certain foods that contain genetically engineered 
(GE) ingredients. In November 2014, voters in Oregon and 
Colorado defeated mandatory labeling initiatives. In previous 
years, voters in California and Washington have defeated 
similar proposals. To date, Vermont is the only state that has 
passed a unilateral labeling law, which is scheduled to take 
effect in 2016, although it is currently being challenged in 
court. Maine and Connecticut each have a labeling law that can 
be fully enacted if neighboring states pass similar 
legislation. Anti-biotechnology activists continue to advocate 
for these proposals despite the clear scientific consensus on 
the issue.
    State labeling initiatives would produce a state-by-state 
patchwork of laws that lead to misinformation and confusion for 
consumers as well as costly disruptions to the food supply 
chain. The exemptions that have been included in every proposal 
have raised questions about what, exactly, defines ``Right-to-
Know.'' Under Vermont's labeling law, for example, vegetable 
soup would be labeled ``GE'' while vegetable beef soup would 
not because it contains meat. A proposal pushed by anti-
biotechnology activists in California would have required 
``GE'' labels on soymilk but not cow's milk. In Colorado, 
chewing gum would have been exempt from ``GE'' labeling but 
breath mints would not.
    Food supply chain stakeholders are navigating the 
consequences of mandatory labeling laws. Farmers have to 
segregate non-GE crops from GE crops and use more water and 
pesticides. Food manufacturers have to set up separate food 
processing units and warehouse space--not to mention additional 
transportation routes for products. All of these additional 
steps would add up to higher costs for farmers, manufacturers, 
and consumers. According to a recent study out of Cornell, 
state labeling laws would lead to a $500 increase in grocery 
prices for the average family of four.
    In a June 17, 2015 letter to Vermont Governor Peter 
Shumlin, one food industry trade association laid out the high 
costs associated with compliance of the state's labeling law 
which is set to go into effect next July. The letter states 
that:
    In addition to the large costs associated with changing 
labels, companies will be subject to costly fines due to errors 
in the supply chain that are no fault of the manufacturer. 
Under the Vermont law, manufacturers are strictly liable for 
violations under the law for all instances of a product 
exhibiting the wrong label on store shelves--regardless of 
whether the violation was inadvertent; the violation was fault 
of some other participant in the supply chain; the 
manufacturers have no legal custody or any control over the 
product once it leaves their own distribution center; or the 
violation was a deliberate act by someone who purchased product 
out of state and placed it on shelves.
    The letter continues:
    Even with the best of intentions, excellent supply chain 
logistics and herculean efforts, product will be in the wrong 
place at any given time, resulting in millions upon millions of 
dollars in potential fines. For example, assume a 90-95% 
success rate that the properly labeled products are on shelves. 
This means that 5% to 10% of products will be mislabeled, or 
have ``slipped'' through the supply chain (i.e., slippage 
rate). Vermont's law imposes a $1,000 daily fine for each item 
that does not bear the legally designated label. For a company 
that has 2,500 items that require the Vermont label, that 
slippage rate of products would translate to a $125,000 to 
$250,000 daily fine. We estimate that industry wide, there 
could be over 100,000 items sold in Vermont that would require 
Vermont-specific labels. That means our industry could be 
facing fines as much as $10 million per day.

         THE SOLUTION: THE SAFE AND ACCURATE FOOD LABELING ACT

    The Safe and Accurate Food Labeling Act was introduced in 
the U.S. House of Representatives in March 2015.
    Participants in the market typically employ measures to 
promote and distinguish their products utilizing a number of 
marketing tools. Regarding the use or non-use of biotechnology, 
a voluntary marketing claim is permitted so long as the label 
is truthful and not misleading. There is, however, no standard 
definition for the terminology proliferating in commerce 
generating confusion and inconsistency which is inherently 
misleading to consumers.
    This legislation will create a consumer-friendly, science-
based, uniform food labeling framework for products produced 
using genetically engineered ingredients. By ensuring that food 
labeling is the sole purview of the federal government, the 
bill guarantees that state labeling mandates do not mislead and 
misinform consumers. Additionally, the bill will prevent the 
costly price hikes associated with a patchwork of state 
labeling laws.
    By creating a national non-GE certification program that is 
overseen by the U.S. Department of Agriculture (USDA), this 
bill brings transparency and consistency to an area of food 
labeling where it is urgently needed. This program mimics the 
widely popular National Organic Program and will provide those 
who prefer to buy non-GE foods a reliable means of doing so. 
Similar to organics, non-GE foods also are a small percentage 
of the U.S. food market. The USDA Certified Organic program is 
a successful precedent for labeling the exception rather than 
the rule.
    With the passage of this bill, farmers will feel confident 
an important technology they rely on is safe from unwarranted 
stigmatization; food producers will have the assurance that 
their interstate supply chains will remain intact and 
unhindered; and grocery shoppers across the United States will 
have the peace of mind that the costs associated with feeding 
their families are not increased due to misguided labeling 
laws.

   Section-by-Section Summary of the Manager's Amendment to H.R. 1599

    Section 1 is the short title of the bill and table of 
contents.
    The Committee intends that this legislation will provide 
consumers with assurance that the American food supply remains 
the safest in the world and that accurate, reliable information 
is readily available concerning the extent to which food is 
produced from, contains, or consists of genetically engineered 
plants. The Committee further intends to recognize and 
reinforce the valuable role that the Coordinated Framework for 
Regulation of Biotechnology (Coordinated Framework) and its 
nationally uniform, science-based regulatory review process 
have played and should continue to play in our national 
agricultural economy and in providing consumers with an 
adequate, wholesome, and economical food supply.

Sec. 2. Savings clause

    Section 2 preserves current jurisdiction and regulatory 
authority, regulations, policies, definitions, and procedures 
of the Food and Drug Administration (FDA) under the Federal 
Food, Drug, and Cosmetic Act (FFDCA) and Animal and the Plant 
Health Inspection Service (APHIS) under the Plant Protection 
Act (PPA). In particular, the Committee intends for the 
Secretary of Health and Human Services and the Secretary of 
Agriculture to retain and use their respective authorities 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

    Sec. 101 creates a new section 424 in the Federal Food, 
Drug, and Cosmetic Act (FFDCA) recognizing the Food and Drug 
Administration's (FDA's) current premarket consultation process 
for food derived from new plant varieties, including 
genetically engineered plants, and directing the Secretary of 
Health and Human Services (HHS) to continue to administer that 
process. The voluntary consultation process is derived from 
FDA's 1992 Statement of Policy (Policy), which provides 
guidance on how existing FDA authority related to food safety 
and food labeling should be applied to foods derived from 
genetically engineered plants. FDA states in that Policy that 
it does not believe that the ``method of development'' of a 
food is material information under the FFDCA ``and would not 
usually be required to be disclosed in labeling for the food.'' 
Under the Policy, such labeling would be required under the 
same circumstances as it would for any other food product. A 
possible example of such material information would be the need 
to disclose information about the potential allergenicity of a 
food product that was not previously recognized by consumers as 
being allergenic. Such material differences between food from a 
genetically engineered plant and comparable (i.e., non-
genetically engineered) food might also include those that 
alter the characteristics of a food product such that its 
common or usual name no longer adequately describes the food, 
or those that result in a significantly different nutritional 
property in the food. This section of the bill clarifies that 
the use of genetic engineering, by itself, is not information 
that is material for determining whether there is a difference 
between food from bioengineered plants and comparable food. FDA 
has the discretion to 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 produced and 
comparable food if the FDA determines 1) there is a material 
difference in the functional, nutritional, or compositional 
characteristics, allergenicity, or other attributes between the 
food produced and comparable food; and 2) the disclosure of the 
material difference is necessary to protect public health and 
safety or to prevent the label or labeling of the food from 
being false or misleading.
    The Committee intends that this subtitle recognize the 
FDA's 1992 Statement of Policy as to Foods Derived from New 
Plant Varieties and reinforce its purpose to provide consumers, 
the food industry, and trading partners with assurance that the 
foods reviewed under that Policy are as safe to eat as non-
genetically engineered foods.
    The Committee expects that, in continuing to administer the 
voluntary consultation process established by the 1992 policy, 
the FDA will continue to assess whether the use or application 
of a genetically engineered plant in the production of food 
raises any safety or regulatory issues under the FFDCA and, if 
no such issues are identified, promptly notify the consulting 
party that the FDA did not identify any such safety or 
regulatory issues that would require further evaluation, and 
considers the consultation to be complete, thereby providing 
affirmation of the safety of the foods reviewed.

                 SUBTITLE B--DEPARTMENT OF AGRICULTURE

Sec. 111. Regulation

    Subsection (a) amends the PPA by adding a new subtitle F, 
Coordination of Food Safety and Agriculture Programs, to 
further the objectives of the Coordinated Framework for 
Regulation of Biotechnology established in 1986 and provide 
consumers, the food industry, trading partners, and other 
interested parties with a clear affirmation of safety for food 
produced from, containing, or consisting of genetically 
engineered plants.
    A new section 461 is added to create a notification program 
for genetically engineered plants prior to use or application 
in food. Under this section, it is unlawful to introduce into 
interstate commerce a nonregulated genetically engineered plant 
for a use or application in food or a food produced from, 
containing, or consisting of such a plant unless: (1) FDA has 
notified the entity seeking evaluation of food from the 
genetically engineered plant in writing under FDA's 1992 policy 
statement that it has no objections to the entity's 
determination that the food is as safe for use by humans or 
animals as one or more comparable foods and the entity provides 
the notification of FDA's finding to USDA; or (2) FDA had 
previously evaluated the food pursuant to the voluntary 
consultation process established in FDA's 1992 policy 
statement, informed the entity in writing that all questions 
with respect to the safety of food from the genetically 
engineered plant have been resolved, and published the 
notification on the public website of the FDA. The USDA 
premarket notification program would not apply to genetically 
engineered plants that are introduced into commerce for the 
purpose of research testing, such as regulated field trials, or 
development activities, such as multiplication of seed. The 
notification program would also not apply solely because a 
processing aid or enzyme produced from a genetically engineered 
plant is intended to be used to produce food, or because the GE 
plant is used as a nutrient source for microorganisms.
    The Committee recognizes that the petition process 
established by APHIS for genetically engineered plants under 
the Coordinated Framework and the Plant Protection Act provides 
developers with the national clearance they need to 
commercialize their genetically engineered crops. It also 
provides farmers with confirmation that genetically engineered 
crops are as safe to grow as non-genetically engineered crops 
and gives them clarity with respect to the crops they can 
legally grow. The Committee further recognizes that the 
consultation process administered by FDA is an important step 
in obtaining national clearance to commercialize the crop from 
which genetically engineered foods are derived in conjunction 
with the petition process administered by the Secretary of 
Agriculture. The Committee intends that the notification and 
public disclosure process created by this Act will further the 
objectives of the existing processes already in place at APHIS 
and FDA.
    Nothing in section 461(b)(1) may be construed as 
authorizing the introduction or delivery 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.
    USDA is required to publish on its website a registry 
listing of each nonregulated genetically engineered plant 
intended for a use or application in food that may be 
introduced into commerce in accordance with section 461(a), the 
petitions to and determinations made by USDA related to the 
plants, and the FDA notifications related to the plants. 
Nothing in this section is intended to alter current 
confidential commercial or trade secrets protections.
    Congress intends that the provision of a public registry 
listing each nonregulated genetically engineered plant that has 
been cleared for introduction into commerce for use or 
application in food will further the goal of increased 
regulatory transparency set by this Congress and recently 
identified by the Office of Science and Technology Policy in 
its July 2, 2015 Memorandum for Heads of Food and Drug 
Administration, Environmental Protection Agency, and Department 
of Agriculture.
    The provisions of this section apply to foods imported into 
the United States that are produced from, contain, or consist 
of a plant that is 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, in the same 
manner and to the same extent as the provisions apply to a food 
that is not imported.
    A new section 462 is added to the PPA to re-designate and 
define terms and phrases within the PPA. The term ``food'' has 
the same meaning given to it under the FFDCA. A ``nonregulated 
genetically engineered plant'' is defined as a genetically 
engineered plant for which the Secretary of Agriculture has 
approved a petition under 7 C.F.R. 340.6 for a determination 
that the plant should not be regulated under the PPA; or that 
1) is not subject to regulation as a plant pest under the PPA, 
2) contains genetic material from a different species, and 3) 
has been modified through in vitro recombinant deoxyribonucleic 
acid (rDNA) techniques.

Sec. 112. Regulations

    Section 112 requires the Secretary of Agriculture to 
promulgate interim final regulations to carry out the premarket 
notification program within one year of enactment of the bill.

Sec. 113. Preemption

    Under Section 113, 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 regarding the use or application in food of 
genetically engineered plants that is not identical to the 
requirements established under Section 111 of this Act. This is 
true regardless of whether regulations have been promulgated 
under section 112.

Sec. 114. Rule of construction

    Section 114 clarifies that nothing in this Act is intended 
to alter the ability of the Secretary of Health and Human 
Services (HHS) to take enforcement actions with respect to a 
violation of the FFDCA or the ability of the Secretary of 
Agriculture to take enforcement actions with respect to a 
violation of the PPA.

Sec. 115. Implementation report

    Subsection (a) requires the Secretary of Agriculture and 
the Secretary of HHS, to submit a report to Congress evaluating 
the progress made in the implementation of subtitle F of the 
PPA, as added by section 111. The report should include 1) an 
analysis of plants requiring regulatory oversight under 
subtitle F; 2) an analysis of the extent to which the 
provisions of subtitle F establish an appropriate scope of 
regulatory oversight for APHIS and FDA, including their 
oversight of public research programs; and 3) any potential 
changes to the relevant provisions of the PPA that would better 
facilitate implementation of a coordinated, predictable, and 
efficient science-based regulatory process.
    The Committee recognizes that the development of valuable 
new breeding techniques is ongoing in both the public and 
private sectors and intends to exercise appropriate oversight 
to ensure that the regulation, if any, of products developed 
using these techniques is commensurate with any potential 
risks.
    Subsection (b) requires that the report should be prepared 
to the greatest extent possible 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 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).
    The Committee intends that implementation of Section 115 
will ensure that the Secretary of Agriculture and the Secretary 
of Health and Human Services are provided with an opportunity 
to encourage and promote further innovation using new breeding 
technologies. The Committee further recognizes that the smooth 
movement of food and feed crops and other agricultural products 
into, out of, or within the United States is vital to the 
United States economy and should be facilitated to the greatest 
extent possible.

              Title II--Genetic Engineering Certification


Sec. 201. Genetic engineering certification

    Section 201 establishes a voluntary genetically engineered 
food certification program within USDA to govern label claims 
with respect to the use or non-use of genetic engineering in 
the production and processing of food in a nationally uniform 
manner. Section 201 would amend the Agricultural Marketing Act 
of 1946 (AMA) to add new sections 291, 291A, 291B, 291C, 291D, 
291E, 291F, and 291G.
    The Committee intends this legislation to address the 
desires of some consumers to know, via food product labeling, 
whether they are purchasing or consuming food produced with or 
without genetic engineering. Some states and localities have 
attempted to mandate such labeling, creating the potential for 
a patchwork of regulatory approaches and increased costs of 
food for consumers and a substantial adverse economic effect on 
interstate commerce.
    The Committee recognizes that the interests of consumers 
are protected and advanced when consumers have access to 
truthful and non-misleading food product information, and that 
the FDA has consistently found no basis to require special 
labeling for food produced using genetic engineering. The 
Committee further recognizes that food should be labeled in a 
way that is meaningful, accurate, and not deceptive or 
confusing to consumers.
    A covered product is defined under this section as 
including a raw or processed agricultural product. The use of 
``processed'' in the definition is intended to apply to any 
food that contains an ingredient derived from an agricultural 
product, regardless of the level of the ingredient in the 
product. Highly processed foods that contain even small amounts 
of ingredients derived from agricultural products would be 
considered a ``processed'' agricultural product under this 
definition. In addition, ``covered products'' are defined to 
include any other foods as defined by Section 201 of the 
Federal Food, Drug, and Cosmetic Act (FFDCA) that are not 
derived from agricultural products, and seed or other 
propagative material.
    Section 201 requires the Secretary to implement the program 
through the use of certifying agents, who would certify that a 
covered product is or is not produced with the use of genetic 
engineering in accordance with the standards established under 
the certification program. The Committee supports the creation 
of a single, unified food labeling standard for the presence or 
absence of genetically engineered plants in food. The Committee 
intends for the program created in Section 201 to provide the 
sole standard by which all food producers, processors and 
handlers may make claims regarding the use of genetic 
engineering in the production and processing of food, including 
claims for foods that fall within the definition of raw or 
processed agricultural products and for those foods that do 
not, as well as for seeds.
            AMA Sec. 291. Definitions
    Section 291 of the AMA is amended by adding several new 
definitions to the Act. In this subtitle, the term ``certifying 
agent'' means the chief executive officer of a State or, in the 
case of an official to be responsible solely for the 
administration of the agricultural operations of the State, 
such official, or 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 whose 
label may indicate whether the product is produced with or 
without the use of genetic engineering.
    In this subtitle, the term ``covered product'' means A) any 
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 not derived from agricultural products; and C) seed or 
other propagative material.
    In this subtitle, the term ``genetically engineered plant'' 
means a plant or plant product (as defined in section 403 of 
the PPA) if it contains genetic material that has been modified 
through in vitro recombinant deoxyribonucleic acid (DNA) 
techniques and the modification could not otherwise be obtained 
using conventional breeding techniques.
    In this subtitle, the term ``comparable food'' means, with 
respect to a covered product produced from, containing, or 
consisting of a genetically engineered plant 1) the parental 
variety of the plant; 2) another commonly consumed variety of 
the plant; or 3) a commonly consumed covered product with 
properties comparable to the covered product produced from, 
containing, or consisting of the plant that is genetically 
engineered.
            AMA Sec. 291A. National genetically engineered food 
                    certification program
    Subsection (a) of section 291A of the AMA directs the 
Secretary of Agriculture to establish a voluntary genetically 
engineered food certification program for covered products to 
govern labeling with respect to the use of genetic engineering 
in the production of food in a nationally uniform manner. The 
Committee expects the Secretary to establish the requirements 
and procedures that the Secretary deems necessary to carry out 
the certification program such that entities seeking to make 
claims under section 291B or 291C receive the requisite 
certification.
    Subsection (b) requires the Secretary to consult with such 
other parties as are necessary to develop the certification 
program.
    Subsection (c) requires the Secretary to implement the 
certification program through the use of certifying agents, who 
would certify that a covered product is or is not produced with 
the use of genetic engineering or a genetically engineered 
plant, in accordance with the standards established under the 
program.
    Subsection (d) requires the Secretary to 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.
            AMA Sec. 291B. National standards for labeling non-
                    genetically engineered food
    Subsection (a) establishes the standards for entities that 
want to participate in the voluntary program for selling or 
labeling of a covered product as produced without the use of 
genetic engineering. To be sold or labeled without the use of 
genetic engineering, covered products must be: 1) subjected to 
supply chain process controls that address the producer 
planting seed that is not genetically engineered, the producer 
and other individuals keeping the crop separated during growth, 
harvesting, storage, processing, and transportation, and 
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 2) produced 
and handled in compliance with a nongenetically engineered food 
plan, described in subsection (c) below. In the case of covered 
products derived from livestock that are marketed in the U.S. 
for human consumption, the product, the livestock, the products 
consumed by the livestock, and the products used in processing 
the products consumed by such livestock must be produced 
without the use of products derived from genetic engineering. 
This section prohibits labeling or advertising material from 
suggesting, either expressly or by implication, that covered 
products developed without genetic engineering are safer or of 
higher quality than those produced from, containing, or 
consisting of a genetically engineered plant.
    Subsection (b) precludes a covered product from being 
considered as not meeting the criteria under subsection (a) 
solely because the product is 1) produced with a genetically 
engineered microorganism or a processing aid or enzyme; 2) 
derived from microorganisms that consumed a nutrient source 
produced from, containing, or consisting of a genetically 
engineered plant; or 3) an approved substance on the National 
List established under section 2118 of the Organic Foods 
Production Act of 1990 (7 U.S.C. 6517).
    Subsection (c) requires producers or handlers seeking 
certification under the non-GE labeling program to submit for 
review and approval by a certifying agent a non-GE food plan 
addressing the handling and processing procedures to be used. 
Producers and handlers are required to maintain the non-GE food 
plan and related records, which are subjected to review by USDA 
and certifying agents.
    The legislation requires the Secretary to establish 
national standards for labeling non-genetically engineered 
food. In the case of covered products consumed by or derived 
from livestock, the Committee intends that a covered product 
will not be labeled as a covered product produced without the 
use of genetic engineering unless livestock, feed, feed 
ingredients, feed additives (including pharmaceuticals) and any 
other products consumed by livestock are produced without the 
use of products derived from genetic engineering. Additionally, 
the Committee fully intends that products used in the 
processing of covered agriculture products derived from 
livestock are produced without the use of products derived from 
genetic engineering. Exceptions to this provision include those 
items found on the National List established under Section 2118 
of the Organic Foods Production Act of 1990 (7 U.S.C. 6517).
            AMA Sec. 291C. National standards for labeling genetically 
                    engineered food
    Subsection (a) establishes the standards for entities that 
want to participate in the voluntary program for selling or 
labeling of a covered product as having been produced using 
genetic engineering. To be sold or labeled as produced with 
genetic engineering, the covered product must be produced and 
handled in compliance with a genetically engineered food plan, 
and the labeling of or advertising material on, or in 
conjunction with such products may not claim that covered 
products produced with genetic engineering are safer or of 
higher quality than those produced without genetic engineering. 
Nor may the claims be false or misleading. The labeling of 
covered products produced with the use of genetic engineering 
also must contain any other information the Secretary considers 
appropriate.
    Subsection (b) requires producers or handlers of covered 
products with the use of genetic engineering who want to 
participate in the program to submit a genetically engineered 
food plan, which would be subject to review by the USDA and 
certifying agents. Producers must adhere to recordkeeping 
requirements and make such records available for review and 
copying by the Secretary or certifying agent.
    Subsection (c) prohibits the Secretary of Agriculture from 
preventing a person from: 1) disclosing voluntarily on the 
labeling of a covered product produced 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 labeling, that a covered product was 
developed with the use of genetic engineering. The Committee 
intends for persons to be able to disclose voluntarily that the 
products they develop or sell have been developed with the use 
of genetic engineering and to do so without regard to whether 
such persons elect to participate in the certification program 
under section 291C. As an example, seed companies that 
otherwise comply with the Federal Seed Act requirements that 
set accurate labeling and purity standards for seed in commerce 
would not be prohibited from disclosing the manner in which 
those seeds were developed to growers who intend to plant those 
seeds, as is standard practice today.
            AMA Sec. 291D. Imported products
    This section allows imported covered products to be sold or 
labeled as produced with or without the use of genetic 
engineering if the Secretary determines that they have been 
produced and handled under a genetic engineering certification 
program with safeguards and guidelines that are at least 
equivalent to the USDA labeling standards.
            AMA Sec. 291E. Accreditation program
    Subsection (a) directs the Secretary of Agriculture to 
establish and implement a program to accredit any State 
official or private person that meets the requirements of a 
certifying agent under the requirements set forth in this 
section.
    Subsection (b) sets forth requirements for a governing 
State official or private person to be accredited as a 
certifying agent under this section. In order to be accredited, 
a government State official or private person must 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.
    Subsection (c) states that the duration of an accreditation 
made under this section can only be for five years or less. The 
duration of accreditation is determined by the Secretary and 
the accreditation may be renewed once the accreditation 
expires.
    Subsection (d) requires that 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, be 
deemed to be accredited to certify covered products under this 
Section.
            AMA Sec. 291F. Recordkeeping, investigations, and 
                    enforcement
    Subsection (a) requires 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 to 1) maintain records in a manner prescribed 
by the Secretary; and 2) upon request by the Secretary, make 
available to the Secretary all records associated with the 
covered product. A certifying agent is required to 1) 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 2) 
upon request by the Secretary, make available to the Secretary 
all records associated with such activities. If a private 
person who was a certifying agent is dissolved or loses 
accreditation, all records or copies of records concerning the 
activities of the person shall be transferred to the Secretary 
as it relates to this subtitle. This subsection makes it 
unlawful for any person covered by this subtitle to fail or 
refuse to provide accurate information in a timely manner as 
required by the Secretary under this subtitle.
    Subsection (b) allows the Secretary to take investigative 
actions as the Secretary considers to be necessary in order to 
1) verify the accuracy of any information reported or made 
available under this subtitle; and 2) determine whether a 
person covered by this subtitle has committed a violation, 
including an order or regulation promulgated by the Secretary 
pursuant to this subtitle. In order to carry out this subtitle, 
the Secretary can, but is not required to, 1) administer oaths 
and affirmations; 2) subpoena witnesses; 3) compel attendance 
of witnesses; 4) take evidence; and 5) require the production 
of any records required to be maintained under this subtitle 
that are relevant to an investigation.
    Subsection (c) states that any person who, after notice and 
opportunity to be heard, is found to have knowingly sold or 
labeled any covered product as having been produced without or 
with the use of genetic engineering or a genetically engineered 
plant, except in accordance with this subtitle, would be 
subject to a civil penalty of not more than $10,000. Each day 
in which this violation occurs is considered to be a separate 
violation.
    If a person is found, after notice and an opportunity to be 
heard, to have carried out any of the following activities, the 
person, will 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: 1) makes a 
false statement; 2) performs a violation described in paragraph 
(1)(A) of this subtitle; 3) attempts 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 4) otherwise violates 
the purposes of the genetically engineered food certification 
program under section 291A, as determined by the Secretary. The 
Secretary may modify or waive a period of ineligibility if the 
Secretary determines that the modification or waiver is in the 
best interests of the genetically engineered food certification 
program.
    A certifying agent must immediately report any violation of 
this subtitle to the Secretary.
    After providing notice and an opportunity to be heard, the 
Secretary may 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. The order imposing a cease-and-desist order must be 
final and conclusive unless the affected person files an appeal 
from the Secretary's order with the appropriate district court 
in the U.S. within 30 days after the date of the issuance of 
the order.
    If a certifying agent that is a private person violates 
provisions of this subtitle or falsely or negatively 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, 
after notice and an opportunity to be heard, the certifying 
agent will lose accreditation as a certifying agent, and be 
ineligible to be accredited as a certifying agent for at least 
three years, beginning on the date of determination. The 
Secretary may suspend the accreditation of the certifying agent 
for a violation of this subtitle after providing notice and an 
opportunity to be heard until the Secretary makes a final 
determination with respect to the violation that is the subject 
of the suspension.
    The Attorney General may bring a civil action against a 
person in a district court of the U.S. to enforce this subtitle 
or a requirement under the subtitle, with the action being 
brought in the judicial district where the person does business 
or in which the violation occurred.
            AMA Sec. 291G. Authorization of appropriations, fees
    Subsection (a) authorizes $2 million to be appropriated to 
establish the genetically engineered food program under section 
291A.
    Subsection (b) directs the Secretary of Agriculture to 
notice, charge, and collect fees in order to cover the 
estimated costs to the Secretary of carrying out this subtitle 
after establishment of the genetically engineered food 
certification program. Fees collected under this subsection 
must be deposited into a fund in the Treasury of the United 
States and must remain available until expended, without 
further appropriations, to carry out this subtitle.

Sec. 202. Regulations

    Subsection (a) requires USDA, in promulgating regulations 
to carry out the amendments made in section 201, 1) to provide 
a process to account for certified non-genetically engineered 
covered products that contain genetically engineered plant 
material due to the inadvertent presence of such material, 2) 
to the greatest extent practicable, to establish consistency 
between the certification program established under section 201 
of this Act, the organic certification program, and other USDA 
voluntary labeling programs, and 3) regarding covered products 
intended for consumption by non-food animals, to 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) to 
provide a process for requesting and granting exemptions under 
conditions established by the Secretary.
    The Committee recognizes that cats and dogs rely on pet 
food as their primary source of nutrition, and that pet food 
manufacturers are required by law to include certain vitamins, 
minerals, amino acids, and fatty acids in their formulations to 
provide pets with a complete and balanced diet. This 
requirement exists without regard to the availability of these 
essential ingredients from any one specific source. The 
Committee expects that the Secretary, in promulgating 
regulations to carry out the amendments made by section 201, 
will ensure that such regulations strictly provide for animal 
well-being. Such regulations should authorize the use of 
alternative sources, as needed, for securing the essential 
vitamins, minerals and micronutrients. In providing for 
consistency between the NOP and the non-genetically engineered 
labeling program, the Secretary is expected to provide a 
process for requesting and granting exemptions from the 
requirements of subtitle E of the Agricultural Marketing Act of 
1946, without penalty to pet food manufacturers who choose to 
sell or label covered products as produced without the use of 
genetic engineering under the provisions of proposed Section 
291B of the AMA. The Committee also expects that such 
regulations promulgated by the Secretary will apply the same 
principles to food for other non-food animals.

Sec. 203. Preemption

    Subsection (a) requires that the amendments made by section 
201 of the Act take effect beginning on the date of enactment 
of this Act regardless of whether regulation have been 
promulgated under section 202.
    Subsection (b) prohibits States or political subdivisions 
of a State from directly or indirectly establishing under any 
authority, or continuing in effect, as to any covered products 
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, except 
that such State (or political subdivision thereof) may 
establish either of the following voluntary programs for the 
regulation of such claims: 1) A program that relates to a 
voluntary claim to which paragraph (1) of section 204(a) of the 
Act applies; or 2) a program that is A) voluntary, B) 
accredited by the Secretary pursuant to Section 291E of the 
Act, and C) identical to the standards established under 
section 291B or 291C of the Agricultural Marketing Act, as 
added by section 201 of the Act.
    The Committee recognizes the hardship the food industry 
would face if each state were to adopt a different standard or 
separate requirements for labeling whether or not a covered 
product contains a genetically engineered plant. Section 203 is 
intended to give preemptive effect to the single national 
standard for such labeling established by USDA. No state or 
political subdivision could create a different standard for the 
voluntary labeling of foods that have or have not been 
developed through genetic engineering. In addition to creating 
a single standard for voluntary claims regarding the use of 
genetic engineering, Section 203 also is intended to preempt 
any state laws, such as those in place in Vermont, Connecticut, 
and Maine, that would mandate the labeling of foods that 
contain genetically engineered plants. These state laws as 
written today would be in conflict with the national standard 
because they are creating state requirements for covered 
products that are not identical to the federal standard. States 
that want to establish their own programs for the labeling of 
whether a food has or has not been produced with genetic 
engineering would be allowed to do so provided the state 
program (1) is voluntary, (2) is accredited by the Secretary, 
and (3) is identical to the standards established by the 
Secretary.

Sec. 204. Applicability

    Subsection (a) states that a voluntary claim made with 
respect to whether a covered product was produced with or 
without the use of genetic engineering or a genetically 
engineered plant before this Act is enacted 1) may be made for 
such a product during the 36-month period beginning on the date 
of enactment of the Safe and Accurate Food Labeling Act; and 2) 
after the expiration of the 36-month period, may be made so 
long as the labels associated with such claims meet the 
standards specified in section 291B or 291C of the Agricultural 
Marketing Act of 1946. The Committee intends that covered 
products labeled with voluntary claims regarding genetic 
engineering should have a reasonable opportunity to clear the 
channels of trade prior to any changes made necessary in order 
to meet the national labeling standards established under this 
subtitle.
    Subsection (b) states that if a covered product is produced 
by a farm or handling operation certified 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.

                        Title III--Natural Foods


Sec. 301. Labeling of natural foods

    Section 301 of the Act amends section 403 of the FFDCA, to 
deem a food misbranded if its labeling contains an express or 
implied claim that the food is `natural' unless the claim uses 
terms that have been defined by, and the food meets the 
requirements that have been established in, regulations 
promulgated by FDA. Prior to finalization of regulations to 
carry out this section, the use of any claim that the food is 
`natural' is allowed if it is consistent with the Secretary's 
existing policy for such claims. This section directs the 
Secretary to differentiate between food for human consumption 
and food intended for consumption by animals other than humans 
when promulgating regulations to carry out this section. A 
`natural claim' includes 1) the use of the terms `natural,' 
`100% natural', `naturally grown', `all natural', `made with 
natural ingredients', and any other terms specified by the 
Secretary.

Sec. 302. Regulations

    Subsection (a) directs the Secretary of Health and Human 
Services (HHS) to issue proposed regulations to implement 
section 403(aa) of the FFDCA (as added by section 301 of this 
Act) not later than 18 months after the date of enactment of 
this Act.
    Subsection (b) directs the Secretary of HHS to issue final 
regulations to implement such Section 403(z) not later than 30 
months after the date of enactment of this Act.

Sec. 303 Preemption

    Section 303 of this Act amends Section 403(A) of the FFDCA, 
as amended by section 103 of this Act, by requiring that no 
State or political subdivision of a State may directly or 
indirectly establish under any authority or continue in effect 
as any food in interstate commerce any requirement for the 
labeling of food of the type required by section 403(z) that is 
not identical to the requirement by such section.

Sec. 304. Effective date

    The labeling requirements of section 403(z) of the FFDCA, 
as added by section 301 of this Act, will take effect on the 
effective date of final regulations promulgated under section 
302(b) of this Act. The provisions of section 403A(a)(7), as 
added by section 303 of this Act, take effect upon the date of 
enactment of this Act.

                        Committee Consideration


                              I. HEARINGS

    On June 25, 2015, the Subcommittee on Biotechnology, 
Horticulture, and Research held a public hearing to review USDA 
marketing programs.
    Members of the Subcommittee heard testimony and discussed 
programs that allow the Agricultural Marketing Service to help 
producers and processors address consumer demand through 
development of voluntary and unique marketing claims. During 
the hearing, the following witness testified on matters 
included in H.R. 1599:
           Mr. Craig Morris, Deputy Administrator, 
        Livestock Poultry and Seed Program, Agricultural 
        Marketing Service, USDA, Washington, D.C.

                           II. FULL COMMITTEE

    The Committee on Agriculture met, pursuant to notice, with 
a quorum present, on July 14, 2015, to consider H.R. 1599, the 
Safe and Accurate Food Labeling Act of 2015.
    H.R. 1599 was placed before the Committee for 
consideration. Without objection, a first reading of the bill 
was waived and it was open for amendment at any point. Mr. 
Davis was recognized to offer an Amendment in the Nature of a 
Substitute to H.R. 1599. Without objection, Davis's Amendment 
in Nature of a Substitute was considered as original text for 
purposes of amendment.
    Chairman Conaway, Mr. Peterson, and Mr. Davis were 
recognized for statements. There being no other amendments, Mr. 
Peterson was recognized to offer a motion that the Amendment in 
the Nature of a Substitute to H.R. 1599 be approved. The 
Amendment in the Nature of a Substitute was adopted by a voice 
vote. Mr. Peterson was then recognized to offer a motion that 
the bill H.R. 1599 be reported, as amended, favorably to the 
House with recommendation that it do pass. The motion was 
subsequently approved by voice vote.
    At the conclusion of the meeting, Chairman Conaway advised 
Members that pursuant to the rules of the House of 
Representatives Members had until July 16, 2015, to file any 
supplemental, minority, additional, or dissenting views with 
the Committee.
    Without objection, staff was given permission to make any 
necessary clerical, technical or conforming changes to reflect 
the intent of the Committee. Chairman Conaway thanked all the 
Members and adjourned the meeting.

                            Committee Votes

    In compliance with clause 3(b) of rule XIII of the House of 
Representatives, H.R. 1599 was reported by voice vote with a 
majority quorum present. There was no request for a recorded 
vote.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee on Agriculture's 
oversight findings and recommendations are reflected in the 
body of this report.

           Budget Act Compliance (Sections 308, 402, and 423)

    The provisions of clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives and section 308(a)(1) of the 
Congressional Budget Act of 1974 (relating to estimates of new 
budget authority, new spending authority, new credit authority, 
or increased or decreased revenues or tax expenditures) are not 
considered applicable. The estimate and comparison required to 
be prepared by the Director of the Congressional Budget Office 
under clause 3(c)(3) of rule XIII of the Rules of the House of 
Representatives and sections 402 and 423 of the Congressional 
Budget Act of 1974 were not received by the Committee prior to 
the filing of this report.

                    Performance Goals and Objectives

    With respect to the requirement of clause 3(c)(4) of rule 
XIII of the Rules of the House of Representatives, the 
performance goals and objectives of this legislation are to 
provide for a consistent, uniform, national standard for 
voluntary food marketing claims related to the use or non-use 
of genetic engineering. This free market alternative to a 50-
State patchwork of labeling requirements will allow consumers 
access to meaningful information, create market opportunities 
for those on the agricultural production and food processing 
side, and will facilitate future innovation.

                        Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee estimates that this 
bill would have no significant net effect on direct spending or 
revenues in this fiscal year or in each of the five fiscal 
years following this fiscal year. The Committee may revise this 
statement when the requested Congressional Budget Office cost 
estimate is received.

                      Advisory Committee Statement

    No advisory committee within the meaning of section 5(b) of 
the Federal Advisory Committee Act was created by this 
legislation.

                Applicability to the Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act (Public Law 
104-1).

                       Federal Mandates Statement

    The Committee adopted as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act (Public Law 104-4).

  Earmark Statement Required by Clause 9 of Rule XXI of the Rules of 
                        House of Representatives

    H.R. 1599 does not contain any congressional earmarks, 
limited tax benefits, or limited tariff benefits as defined in 
clause 9(e), 9(f), or 9(g) of rule XXI of the Rules of the 
House Representatives.

                    Duplication of Federal Programs

    This bill does not establish or reauthorize a program of 
the Federal Government known to be duplicative of another 
Federal program, a program that was included in any report from 
the Government Accountability Office to Congress pursuant to 
section 21 of Public Law 111-139, or a program related to a 
program identified in the most recent Catalog of Federal 
Domestic Assistance.

                  Disclosure of Directed Rule Makings

    The Committee estimates that H.R. 1599 specifically directs 
USDA to conduct two rule making proceedings within the meaning 
of 5 U.S.C. 551.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, and existing law in which no 
change is proposed is shown in roman):

                  FEDERAL FOOD, DRUG, AND COSMETIC ACT




           *       *       *       *       *       *       *
CHAPTER IV--FOOD

           *       *       *       *       *       *       *



                            misbranded food

  Sec. 403. A food shall be deemed to be misbranded--
  (a) If (1) its labeling is false or misleading in any 
particular, or (2) in the case of a food to which section 411 
applies, its advertising is false or misleading in a material 
respect or its labeling is in violation of section 411(b)(2).
  (b) If it is offered for sale under the name of another food.
  (c) If it is an imitation of another food, unless its label 
bears, in type of uniform size and prominence, the word 
``imitation'' and, immediately thereafter, the name of the food 
imitated.
  (d) If its container is so made, formed, or filled as to be 
misleading.
  (e) If in package form unless it bears a label containing (1) 
the name and place of business of the manufacturer, packer, or 
distributor; and (2) an accurate statement of the quantity of 
the contents in terms of weight, measure, or numerical count, 
except that under clause (2) of this paragraph reasonable 
variations shall be permitted, and exemptions as to small 
packages shall be established, by regulations prescribed by the 
Secretary.
  (f) If any word, statement, or other information required by 
or under authority of this Act to appear on the label or 
labeling is not prominently placed thereon with such 
conspicuousness (as compared with other words, statements, 
designs, or devices, in the labeling) and in such terms as to 
render it likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use.
  (g) If it purports to be or is represented as a food for 
which a definition and standard of identity has been prescribed 
by regulations as provided by section 401, unless (1) it 
conforms to such definition and standard, and (2) its label 
bears the name of the food specified in the definition and 
standard, and, insofar as may be required by such regulations, 
the common names of optional ingredients (other than spices, 
flavoring, and coloring) present in such food.
  (h) If it purports to be or is represented as--
          (1) a food for which a standard of quality has been 
        prescribed by regulations as provided by section 401, 
        and its quality falls below such standard, unless its 
        label bears, in such manner and form as such 
        regulations specify, a statement that it falls below 
        such standard;
          (2) a food for which a standard or standards of fill 
        of container have been prescribed by regulations as 
        provided by section 401, and it falls below the 
        standard of fill of container applicable thereto, 
        unless its label bears, in such manner and form as such 
        regulations specify, a statement that it falls below 
        such standard; or
          (3) a food that is pasteurized unless--
                  (A) such food has been subjected to a safe 
                process or treatment that is prescribed as 
                pasteurization for such food in a regulation 
                promulgated under this Act; or
                  (B)(i) such food has been subjected to a safe 
                process or treatment that--
                          (I) is reasonably certain to achieve 
                        destruction or elimination in the food 
                        of the most resistant microorganisms of 
                        public health significance that are 
                        likely to occur in the food;
                          (II) is at least as protective of the 
                        public health as a process or treatment 
                        described in subparagraph (A);
                          (III) is effective for a period that 
                        is at least as long as the shelf life 
                        of the food when stored under normal 
                        and moderate abuse conditions; and
                          (IV) is the subject of a notification 
                        to the Secretary, including 
                        effectiveness data regarding the 
                        process or treatment; and
                  (ii) at least 120 days have passed after the 
                date of receipt of such notification by the 
                Secretary without the Secretary making a 
                determination that the process or treatment 
                involved has not been shown to meet the 
                requirements of subclauses (I) through (III) of 
                clause (i).
For purposes of paragraph (3), a determination by the Secretary 
that a process or treatment has not been shown to meet the 
requirements of subclauses (I) through (III) of subparagraph 
(B)(i) shall constitute final agency action under such 
subclauses.
  (i) Unless its label bears (1) the common or usual name of 
the food, if any there be, and (2) in case it is fabricated 
from two or more ingredients, the common or usual name of each 
such ingredient and if the food purports to be a beverage 
containing vegetable or fruit juice, a statement with 
appropriate prominence on the information panel of the total 
percentage of such fruit or vegetable juice contained in the 
food; except that spices, flavorings, and colors not required 
to be certified under section 721(c) unless sold as spices, 
flavorings, or such colors, may be designated as spices, 
flavorings, and colorings without naming each. To the extent 
that compliance with the requirements of clause (2) of this 
paragraph is impracticable, or results in deception or unfair 
competition, exemptions shall be established by regulations 
promulgated by the Secretary.
  (j) If it purports to be or is represented for special 
dietary uses, unless its label bears such information 
concerning its vitamin, mineral, and other dietary properties 
as the Secretary determines to be, and by regulations 
prescribes as, necessary in order fully to inform purchasers as 
to its value for such uses.
  (k) If it bears or contains any artificial flavoring, 
artificial coloring, or chemical preservative, unless it bears 
labeling stating that fact, except that to the extent that 
compliance with the requirements of this paragraph is 
impracticable, exemptions shall be established by regulations 
promulgated by the Secretary. The provisions of this paragraph 
and paragraphs (g) and (i) with respect to artificial coloring 
shall not apply in the case of butter, cheese, or ice cream. 
The provisions of this paragraph with respect to chemical 
preservatives shall not apply to a pesticide chemical when used 
in or on a raw agricultural commodity which is the produce of 
the soil.
  (l) If it is a raw agricultural commodity which is the 
produce of the soil, bearing or containing a pesticide chemical 
applied after harvest, unless the shipping container of such 
commodity bears labeling which declares the presence of such 
chemical in or on such commodity and the common or usual name 
and the function of such chemical, except that no such 
declaration shall be required while such commodity, having been 
removed from the shipping container, is being held or displayed 
for sale at retail out of such container in accordance with the 
custom of the trade.
  (m) If it is a color additive, unless its packaging and 
labeling are in conformity with such packaging and labeling 
requirements, applicable to such color additive, as may be 
contained in regulations issued under section 721.
  (n) If its packaging or labeling is in violation of an 
applicable regulation issued pursuant to section 3 or 4 of the 
Poison Prevention Packaging Act of 1970.
  (q)(1) Except as provided in subparagraphs (3), (4), and (5), 
if it is a food intended for human consumption and is offered 
for sale, unless its label or labeling bears nutrition 
information that provides--
          (A)(i) the serving size which is an amount 
        customarily consumed and which is expressed in a common 
        household measure that is appropriate to the food, or
          (ii) if the use of the food is not typically 
        expressed in a serving size, the common household unit 
        of measure that expresses the serving size of the food,
          (B) the number of servings or other units of measure 
        per container,
          (C) the total number of calories--
                  (i) derived from any source, and
                  (ii) derived from the total fat,
        in each serving size or other unit of measure of the 
        food,
          (D) the amount of the following nutrients: Total fat, 
        saturated fat, cholesterol, sodium, total 
        carbohydrates, complex carbohydrates, sugars, dietary 
        fiber, and total protein contained in each serving size 
        or other unit of measure,
          (E) any vitamin, mineral, or other nutrient required 
        to be placed on the label and labeling of food under 
        this Act before October 1, 1990, if the Secretary 
        determines that such information will assist consumers 
        in maintaining healthy dietary practices.
The Secretary may by regulation require any information 
required to be placed on the label or labeling by this 
subparagraph or subparagraph (2)(A) to be highlighted on the 
label or labeling by larger type, bold type, or contrasting 
color if the Secretary determines that such highlighting will 
assist consumers in maintaining healthy dietary practices.
  (2)(A) If the Secretary determines that a nutrient other than 
a nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) 
should be included in the label or labeling of food subject to 
subparagraph (1) for purposes of providing information 
regarding the nutritional value of such food that will assist 
consumers in maintaining healthy dietary practices, the 
Secretary may by regulation require that information relating 
to such additional nutrient be included in the label or 
labeling of such food.
  (B) If the Secretary determines that the information relating 
to a nutrient required by subparagraph (1)(C), (1)(D), or 
(1)(E) or clause (A) of this subparagraph to be included in the 
label or labeling of food is not necessary to assist consumers 
in maintaining healthy dietary practices, the Secretary may by 
regulation remove information relating to such nutrient from 
such requirement.
  (3) For food that is received in bulk containers at a retail 
establishment, the Secretary may, by regulation, provide that 
the nutrition information required by subparagraphs (1) and (2) 
be displayed at the location in the retail establishment at 
which the food is offered for sale.
  (4)(A) The Secretary shall provide for furnishing the 
nutrition information required by subparagraphs (1) and (2) 
with respect to raw agricultural commodities and raw fish by 
issuing voluntary nutrition guidelines, as provided by clause 
(B) or by issuing regulations that are mandatory as provided by 
clause (D).
  (B)(i) Upon the expiration of 12 months after the date of the 
enactment of the Nutrition Labeling and Education Act of 1990, 
the Secretary, after providing an opportunity for comment, 
shall issue guidelines for food retailers offering raw 
agricultural commodities or raw fish to provide nutrition 
information specified in subparagraphs (1) and (2). Such 
guidelines shall take into account the actions taken by food 
retailers during such 12-month period to provide to consumers 
nutrition information on raw agricultural commodities and raw 
fish. Such guidelines shall only apply--
          (I) in the case of raw agricultural commodities, to 
        the 20 varieties of vegetables most frequently consumed 
        during a year and the 20 varieties of fruit most 
        frequently consumed during a year, and
          (II) to the 20 varieties of raw fish most frequently 
        consumed during a year.
The vegetables, fruits, and raw fish to which such guidelines 
apply shall be determined by the Secretary by regulation and 
the Secretary may apply such guidelines regionally.
  (ii) Upon the expiration of 12 months after the date of the 
enactment of the Nutrition Labeling and Education Act of 1990, 
the Secretary shall issue a final regulation defining the 
circumstances that constitute substantial compliance by food 
retailers with the guidelines issued under subclause (i). The 
regulation shall provide that there is not substantial 
compliance if a significant number of retailers have failed to 
comply with the guidelines. The size of the retailers and the 
portion of the market served by retailers in compliance with 
the guidelines shall be considered in determining whether the 
substantial-compliance standard has been met.
  (C)(i) Upon the expiration of 30 months after the date of the 
enactment of the Nutrition Labeling and Education Act of 1990, 
the Secretary shall issue a report on actions taken by food 
retailers to provide consumers with nutrition information for 
raw agricultural commodities and raw fish under the guidelines 
issued under clause (A). Such report shall include a 
determination of whether there is substantial compliance with 
the guidelines.
  (ii) If the Secretary finds that there is substantial 
compliance with the guidelines, the Secretary shall issue a 
report and make a determination of the type required in 
subclause (i) every two years.
  (D)(i) If the Secretary determines that there is not 
substantial compliance with the guidelines issued under clause 
(A), the Secretary shall at the time such determination is made 
issue proposed regulations requiring that any person who offers 
raw agricultural commodities or raw fish to consumers provide, 
in a manner prescribed by regulations, the nutrition 
information required by subparagraphs (1) and (2). The 
Secretary shall issue final regulations imposing such 
requirements 6 months after issuing the proposed regulations. 
The final regulations shall become effective 6 months after the 
date of their promulgation.
  (ii) Regulations issued under subclause (i) may require that 
the nutrition information required by subparagraphs (1) and (2) 
be provided for more than 20 varieties of vegetables, 20 
varieties of fruit, and 20 varieties of fish most frequently 
consumed during a year if the Secretary finds that a larger 
number of such products are frequently consumed. Such 
regulations shall permit such information to be provided in a 
single location in each area in which raw agricultural 
commodities and raw fish are offered for sale. Such regulations 
may provide that information shall be expressed as an average 
or range per serving of the same type of raw agricultural 
commodity or raw fish. The Secretary shall develop and make 
available to the persons who offer such food to consumers the 
information required by subparagraphs (1) and (2).
  (iii) Regulations issued under subclause (i) shall permit the 
required information to be provided in each area of an 
establishment in which raw agricultural commodities and raw 
fish are offered for sale. The regulations shall permit food 
retailers to display the required information by supplying 
copies of the information provided by the Secretary, by making 
the information available in brochure, notebook or leaflet 
form, or by posting a sign disclosing the information. Such 
regulations shall also permit presentation of the required 
information to be supplemented by a video, live demonstration, 
or other media which the Secretary approves.
  (E) For purposes of this subparagraph, the term ``fish'' 
includes freshwater or marine fin fish, crustaceans, and 
mollusks, including shellfish, amphibians, and other forms of 
aquatic animal life.
  (F) No person who offers raw agricultural commodities or raw 
fish to consumers may be prosecuted for minor violations of 
this subparagraph if there has been substantial compliance with 
the requirements of this paragraph.
  (5)(A) Subparagraphs (1), (2), (3), and (4) shall not apply 
to food--
          (i) except as provided in clause (H)(ii)(III), which 
        is served in restaurants or other establishments in 
        which food is served for immediate human consumption or 
        which is sold for sale or use in such establishments,
          (ii) except as provided in clause (H)(ii)(III), which 
        is processed and prepared primarily in a retail 
        establishment, which is ready for human consumption, 
        which is of the type described in subclause (i), and 
        which is offered for sale to consumers but not for 
        immediate human consumption in such establishment and 
        which is not offered for sale outside such 
        establishment,
          (iii) which is an infant formula subject to section 
        412,
          (iv) which is a medical food as defined in section 
        5(b) of the Orphan Drug Act (21 U.S.C. 360ee(b)), or
          (v) which is described in section 405(2).
  (B) Subparagraphs (1) and (2) shall not apply to the label of 
a food if the Secretary determines by regulations that 
compliance with such subparagraphs is impracticable because the 
package of such food is too small to comply with the 
requirements of such subparagraphs and if the label of such 
food does not contain any nutrition information.
  (C) If a food contains insignificant amounts, as determined 
by the Secretary, of all the nutrients required by 
subparagraphs (1) and (2) to be listed in the label or labeling 
of food, the requirements of such subparagraphs shall not apply 
to such food if the label, labeling, or advertising of such 
food does not make any claim with respect to the nutritional 
value of such food. If a food contains insignificant amounts, 
as determined by the Secretary, of more than one-half the 
nutrients required by subparagraphs (1) and (2) to be in the 
label or labeling of the food, the Secretary shall require the 
amounts of such nutrients to be stated in a simplified form 
prescribed by the Secretary.
  (D) If a person offers food for sale and has annual gross 
sales made or business done in sales to consumers which is not 
more than $500,000 or has annual gross sales made or business 
done in sales of food to consumers which is not more than 
$50,000, the requirements of subparagraphs (1), (2), (3), and 
(4) shall not apply with respect to food sold by such person to 
consumers unless the label or labeling of food offered by such 
person provides nutrition information or makes a nutrition 
claim.
  (E)(i) During the 12-month period for which an exemption from 
subparagraphs (1) and (2) is claimed pursuant to this 
subclause, the requirements of such subparagraphs shall not 
apply to any food product if--
          (I) the labeling for such product does not provide 
        nutrition information or make a claim subject to 
        paragraph (r),
          (II) the person who claims for such product an 
        exemption from such subparagraphs employed fewer than 
        an average of 100 full-time equivalent employees,
          (III) such person provided the notice described in 
        subclause (iii), and
          (IV) in the case of a food product which was sold in 
        the 12-month period preceding the period for which an 
        exemption was claimed, fewer than 100,000 units of such 
        product were sold in the United States during such 
        preceding period, or in the case of a food product 
        which was not sold in the 12-month period preceding the 
        period for which such exemption is claimed, fewer than 
        100,000 units of such product are reasonably 
        anticipated to be sold in the United States during the 
        period for which such exemption is claimed.
  (ii) During the 12-month period after the applicable date 
referred to in this sentence, the requirements of subparagraphs 
(1) and (2) shall not apply to any food product which was first 
introduced into interstate commerce before May 8, 1994, if the 
labeling for such product does not provide nutrition 
information or make a claim subject to paragraph (r), if such 
person provided the notice described in subclause (iii), and 
if--
          (I) during the 12-month period preceding May 8, 1994, 
        the person who claims for such product an exemption 
        from such subparagraphs employed fewer than an average 
        of 300 full-time equivalent employees and fewer than 
        600,000 units of such product were sold in the United 
        States,
          (II) during the 12-month period preceding May 8, 
        1995, the person who claims for such product an 
        exemption from such subparagraphs employed fewer than 
        an average of 300 full-time equivalent employees and 
        fewer than 400,000 units of such product were sold in 
        the United States, or
          (III) during the 12-month period preceding May 8, 
        1996, the person who claims for such product an 
        exemption from such subparagraphs employed fewer than 
        an average of 200 full-time equivalent employees and 
        fewer than 200,000 units of such product were sold in 
        the United States.
  (iii) The notice referred to in subclauses (i) and (ii) shall 
be given to the Secretary prior to the beginning of the period 
during which the exemption under subclause (i) or (ii) is to be 
in effect, shall state that the person claiming such exemption 
for a food product has complied with the applicable 
requirements of subclause (i) or (ii), and shall--
          (I) state the average number of full-time equivalent 
        employees such person employed during the 12 months 
        preceding the date such person claims such exemption,
          (II) state the approximate number of units the person 
        claiming the exemption sold in the United States,
          (III) if the exemption is claimed for a food product 
        which was sold in the 12-month period preceding the 
        period for which the exemption was claimed, state the 
        approximate number of units of such product which were 
        sold in the United States during such preceding period, 
        and, if the exemption is claimed for a food product 
        which was not sold in such preceding period, state the 
        number of units of such product which such person 
        reasonably anticipates will be sold in the United 
        States during the period for which the exemption was 
        claimed, and
          (IV) contain such information as the Secretary may 
        require to verify the information required by the 
        preceding provisions of this subclause if the Secretary 
        has questioned the validity of such information.
If a person is not an importer, has fewer than 10 full-time 
equivalent employees, and sells fewer than 10,000 units of any 
food product in any year, such person is not required to file a 
notice for such product under this subclause for such year.
  (iv) In the case of a person who claimed an exemption under 
subclause (i) or (ii), if, during the period of such exemption, 
the number of full-time equivalent employees of such person 
exceeds the number in such subclause or if the number of food 
products sold in the United States exceeds the number in such 
subclause, such exemption shall extend to the expiration of 18 
months after the date the number of full-time equivalent 
employees or food products sold exceeded the applicable number.
  (v) For any food product first introduced into interstate 
commerce after May 8, 2002, the Secretary may by regulation 
lower the employee or units of food products requirement of 
subclause (i) if the Secretary determines that the cost of 
compliance with such lower requirement will not place an undue 
burden on persons subject to such lower requirement.
  (vi) For purposes of subclauses (i), (ii), (iii), (iv), and 
(v)--
          (I) the term ``unit'' means the packaging or, if 
        there is no packaging, the form in which a food product 
        is offered for sale to consumers,
          (II) the term ``food product'' means food in any 
        sized package which is manufactured by a single 
        manufacturer or which bears the same brand name, which 
        bears the same statement of identity, and which has 
        similar preparation methods, and
          (III) the term ``person'' in the case of a 
        corporation includes all domestic and foreign 
        affiliates of the corporation.
  (F) A dietary supplement product (including a food to which 
section 411 applies) shall comply with the requirements of 
subparagraphs (1) and (2) in a manner which is appropriate for 
the product and which is specified in regulations of the 
Secretary which shall provide that--
          (i) nutrition information shall first list those 
        dietary ingredients that are present in the product in 
        a significant amount and for which a recommendation for 
        daily consumption has been established by the 
        Secretary, except that a dietary ingredient shall not 
        be required to be listed if it is not present in a 
        significant amount, and shall list any other dietary 
        ingredient present and identified as having no such 
        recommendation;
          (ii) the listing of dietary ingredients shall include 
        the quantity of each such ingredient (or of a 
        proprietary blend of such ingredients) per serving;
          (iii) the listing of dietary ingredients may include 
        the source of a dietary ingredient; and
          (iv) the nutrition information shall immediately 
        precede the ingredient information required under 
        subclause (i), except that no ingredient identified 
        pursuant to subclause (i) shall be required to be 
        identified a second time.
  (G) Subparagraphs (1), (2), (3), and (4) shall not apply to 
food which is sold by a food distributor if the food 
distributor principally sells food to restaurants or other 
establishments in which food is served for immediate human 
consumption and does not manufacture, process, or repackage the 
food it sells.
  (H) Restaurants, Retail Food Establishments, and Vending 
Machines.--
          (i) General requirements for restaurants and similar 
        retail food establishments.--Except for food described 
        in subclause (vii), in the case of food that is a 
        standard menu item that is offered for sale in a 
        restaurant or similar retail food establishment that is 
        part of a chain with 20 or more locations doing 
        business under the same name (regardless of the type of 
        ownership of the locations) and offering for sale 
        substantially the same menu items, the restaurant or 
        similar retail food establishment shall disclose the 
        information described in subclauses (ii) and (iii).
          (ii) Information required to be disclosed by 
        restaurants and retail food establishments.--Except as 
        provided in subclause (vii), the restaurant or similar 
        retail food establishment shall disclose in a clear and 
        conspicuous manner--
                  (I)(aa) in a nutrient content disclosure 
                statement adjacent to the name of the standard 
                menu item, so as to be clearly associated with 
                the standard menu item, on the menu listing the 
                item for sale, the number of calories contained 
                in the standard menu item, as usually prepared 
                and offered for sale; and
                  (bb) a succinct statement concerning 
                suggested daily caloric intake, as specified by 
                the Secretary by regulation and posted 
                prominently on the menu and designed to enable 
                the public to understand, in the context of a 
                total daily diet, the significance of the 
                caloric information that is provided on the 
                menu;
                  (II)(aa) in a nutrient content disclosure 
                statement adjacent to the name of the standard 
                menu item, so as to be clearly associated with 
                the standard menu item, on the menu board, 
                including a drive-through menu board, the 
                number of calories contained in the standard 
                menu item, as usually prepared and offered for 
                sale; and
                  (bb) a succinct statement concerning 
                suggested daily caloric intake, as specified by 
                the Secretary by regulation and posted 
                prominently on the menu board, designed to 
                enable the public to understand, in the context 
                of a total daily diet, the significance of the 
                nutrition information that is provided on the 
                menu board;
          (III) in a written form, available on the premises of 
        the restaurant or similar retail establishment and to 
        the consumer upon request, the nutrition information 
        required under clauses (C) and (D) of subparagraph (1); 
        and
          (IV) on the menu or menu board, a prominent, clear, 
        and conspicuous statement regarding the availability of 
        the information described in item (III).
          (iii) Self-service food and food on display.--Except 
        as provided in subclause (vii), in the case of food 
        sold at a salad bar, buffet line, cafeteria line, or 
        similar self-service facility, and for self-service 
        beverages or food that is on display and that is 
        visible to customers, a restaurant or similar retail 
        food establishment shall place adjacent to each food 
        offered a sign that lists calories per displayed food 
        item or per serving.
          (iv) Reasonable basis.--For the purposes of this 
        clause, a restaurant or similar retail food 
        establishment shall have a reasonable basis for its 
        nutrient content disclosures, including nutrient 
        databases, cookbooks, laboratory analyses, and other 
        reasonable means, as described in section 101.10 of 
        title 21, Code of Federal Regulations (or any successor 
        regulation) or in a related guidance of the Food and 
        Drug Administration.
          (v) Menu variability and combination meals.--The 
        Secretary shall establish by regulation standards for 
        determining and disclosing the nutrient content for 
        standard menu items that come in different flavors, 
        varieties, or combinations, but which are listed as a 
        single menu item, such as soft drinks, ice cream, 
        pizza, doughnuts, or children's combination meals, 
        through means determined by the Secretary, including 
        ranges, averages, or other methods.
          (vi) Additional information.--If the Secretary 
        determines that a nutrient, other than a nutrient 
        required under subclause (ii)(III), should be disclosed 
        for the purpose of providing information to assist 
        consumers in maintaining healthy dietary practices, the 
        Secretary may require, by regulation, disclosure of 
        such nutrient in the written form required under 
        subclause (ii)(III).
          (vii) Nonapplicability to certain food.--
                  (I) In general.--Subclauses (i) through (vi) 
                do not apply to--
                          (aa) items that are not listed on a 
                        menu or menu board (such as condiments 
                        and other items placed on the table or 
                        counter for general use);
                          (bb) daily specials, temporary menu 
                        items appearing on the menu for less 
                        than 60 days per calendar year, or 
                        custom orders; or
                          (cc) such other food that is part of 
                        a customary market test appearing on 
                        the menu for less than 90 days, under 
                        terms and conditions established by the 
                        Secretary.
                  (II) Written forms.--Subparagraph (5)(C) 
                shall apply to any regulations promulgated 
                under subclauses (ii)(III) and (vi).
          (viii) Vending machines.--
          (I) In general.--In the case of an article of food 
        sold from a vending machine that--
                          (aa) does not permit a prospective 
                        purchaser to examine the Nutrition 
                        Facts Panel before purchasing the 
                        article or does not otherwise provide 
                        visible nutrition information at the 
                        point of purchase; and
                          (bb) is operated by a person who is 
                        engaged in the business of owning or 
                        operating 20 or more vending machines,
                the vending machine operator shall provide a 
                sign in close proximity to each article of food 
                or the selection button that includes a clear 
                and conspicuous statement disclosing the number 
                of calories contained in the article.
          (ix) Voluntary provision of nutrition information.--
                  (I) In general.--An authorized official of 
                any restaurant or similar retail food 
                establishment or vending machine operator not 
                subject to the requirements of this clause may 
                elect to be subject to the requirements of such 
                clause, by registering biannually the name and 
                address of such restaurant or similar retail 
                food establishment or vending machine operator 
                with the Secretary, as specified by the 
                Secretary by regulation.
                  (II) Registration.--Within 120 days of 
                enactment of this clause, the Secretary shall 
                publish a notice in the Federal Register 
                specifying the terms and conditions for 
                implementation of item (I), pending 
                promulgation of regulations.
                  (III) Rule of construction.--Nothing in this 
                subclause shall be construed to authorize the 
                Secretary to require an application, review, or 
                licensing process for any entity to register 
                with the Secretary, as described in such item.
          (x) Regulations.--
                  (I) Proposed regulation.--Not later than 1 
                year after the date of enactment of this 
                clause, the Secretary shall promulgate proposed 
                regulations to carry out this clause.
                  (II) Contents.--In promulgating regulations, 
                the Secretary shall--
                          (aa) consider standardization of 
                        recipes and methods of preparation, 
                        reasonable variation in serving size 
                        and formulation of menu items, space on 
                        menus and menu boards, inadvertent 
                        human error, training of food service 
                        workers, variations in ingredients, and 
                        other factors, as the Secretary 
                        determines; and
                          (bb) specify the format and manner of 
                        the nutrient content disclosure 
                        requirements under this subclause.
                  (III) Reporting.--The Secretary shall submit 
                to the Committee on Health, Education, Labor, 
                and Pensions of the Senate and the Committee on 
                Energy and Commerce of the House of 
                Representatives a quarterly report that 
                describes the Secretary's progress toward 
                promulgating final regulations under this 
                subparagraph.
          (xi) Definition.--In this clause, the term ``menu'' 
        or ``menu board'' means the primary writing of the 
        restaurant or other similar retail food establishment 
        from which a consumer makes an order selection.
  (r)(1) Except as provided in clauses (A) through (C) of 
subparagraph (5), if it is a food intended for human 
consumption which is offered for sale and for which a claim is 
made in the label or labeling of the food which expressly or by 
implication--
          (A) characterizes the level of any nutrient which is 
        of the type required by paragraph (q)(1) or (q)(2) to 
        be in the label or labeling of the food unless the 
        claim is made in accordance with subparagraph (2), or
          (B) characterizes the relationship of any nutrient 
        which is of the type required by paragraph (q)(1) or 
        (q)(2) to be in the label or labeling of the food to a 
        disease or a health-related condition unless the claim 
        is made in accordance with subparagraph (3) or (5)(D).
A statement of the type required by paragraph (q) that appears 
as part of the nutrition information required or permitted by 
such paragraph is not a claim which is subject to this 
paragraph and a claim subject to clause (A) is not subject to 
clause (B).
  (2)(A) Except as provided in subparagraphs (4)(A)(ii) and 
(4)(A)(iii) and clauses (A) through (C) of subparagraph (5), a 
claim described in subparagraph (1)(A)--
          (i) may be made only if the characterization of the 
        level made in the claim uses terms which are defined in 
        regulations of the Secretary,
          (ii) may not state the absence of a nutrient unless--
                  (I) the nutrient is usually present in the 
                food or in a food which substitutes for the 
                food as defined by the Secretary by regulation, 
                or
                  (II) the Secretary by regulation permits such 
                a statement on the basis of a finding that such 
                a statement would assist consumers in 
                maintaining healthy dietary practices and the 
                statement discloses that the nutrient is not 
                usually present in the food,
          (iii) may not be made with respect to the level of 
        cholesterol in the food if the food contains, as 
        determined by the Secretary by regulation, fat or 
        saturated fat in an amount which increases to persons 
        in the general population the risk of disease or a 
        health related condition which is diet related unless--
                  (I) the Secretary finds by regulation that 
                the level of cholesterol is substantially less 
                than the level usually present in the food or 
                in a food which substitutes for the food and 
                which has a significant market share, or the 
                Secretary by regulation permits a statement 
                regarding the absence of cholesterol on the 
                basis of a finding that cholesterol is not 
                usually present in the food and that such a 
                statement would assist consumers in maintaining 
                healthy dietary practices and a requirement 
                that the statement disclose that cholesterol is 
                not usually present in the food, and
                  (II) the label or labeling of the food 
                discloses the level of such fat or saturated 
                fat in immediate proximity to such claim and 
                with appropriate prominence which shall be no 
                less than one-half the size of the claim with 
                respect to the level of cholesterol,
          (iv) may not be made with respect to the level of 
        saturated fat in the food if the food contains 
        cholesterol unless the label or labeling of the food 
        discloses the level of cholesterol in the food in 
        immediate proximity to such claim and with appropriate 
        prominence which shall be no less than one-half the 
        size of the claim with respect to the level of 
        saturated fat,
          (v) may not state that a food is high in dietary 
        fiber unless the food is low in total fat as defined by 
        the Secretary or the label or labeling discloses the 
        level of total fat in the food in immediate proximity 
        to such statement and with appropriate prominence which 
        shall be no less than one-half the size of the claim 
        with respect to the level of dietary fiber, and
          (vi) may not be made if the Secretary by regulation 
        prohibits the claim because the claim is misleading in 
        light of the level of another nutrient in the food.
  (B) If a claim described in subparagraph (1)(A) is made with 
respect to a nutrient in a food and the Secretary makes a 
determination that the food contains a nutrient at a level that 
increases to persons in the general population the risk of a 
disease or health-related condition that is diet related, the 
label or labeling of such food shall contain, prominently and 
in immediate proximity to such claim, the following statement: 
``See nutrition information for __ content.'' The blank shall 
identify the nutrient associated with the increased disease or 
health-related condition risk. In making the determination 
described in this clause, the Secretary shall take into account 
the significance of the food in the total daily diet.
  (C) Subparagraph (2)(A) does not apply to a claim described 
in subparagraph (1)(A) and contained in the label or labeling 
of a food if such claim is contained in the brand name of such 
food and such brand name was in use on such food before October 
25, 1989, unless the brand name contains a term defined by the 
Secretary under subparagraph (2)(A)(i). Such a claim is subject 
to paragraph (a).
  (D) Subparagraph (2) does not apply to a claim described in 
subparagraph (1)(A) which uses the term ``diet'' and is 
contained in the label or labeling of a soft drink if (i) such 
claim is contained in the brand name of such soft drink, (ii) 
such brand name was in use on such soft drink before October 
25, 1989, and (iii) the use of the term ``diet'' was in 
conformity with section 105.66 of title 21 of the Code of 
Federal Regulations. Such a claim is subject to paragraph (a).
  (E) Subclauses (i) through (v) of subparagraph (2)(A) do not 
apply to a statement in the label or labeling of food which 
describes the percentage of vitamins and minerals in the food 
in relation to the amount of such vitamins and minerals 
recommended for daily consumption by the Secretary.
  (F) Subclause (i) clause (A) does not apply to a statement in 
the labeling of a dietary supplement that characterizes the 
percentage level of a dietary ingredient for which the 
Secretary has not established a reference daily intake, daily 
recommended value, or other recommendation for daily 
consumption.
  (G) A claim of the type described in subparagraph (1)(A) for 
a nutrient, for which the Secretary has not promulgated a 
regulation under clause (A)(i), shall be authorized and may be 
made with respect to a food if--
          (i) a scientific body of the United States Government 
        with official responsibility for public health 
        protection or research directly relating to human 
        nutrition (such as the National Institutes of Health or 
        the Centers for Disease Control and Prevention) or the 
        National Academy of Sciences or any of its subdivisions 
        has published an authoritative statement, which is 
        currently in effect, which identifies the nutrient 
        level to which the claim refers;
          (ii) a person has submitted to the Secretary, at 
        least 120 days (during which the Secretary may notify 
        any person who is making a claim as authorized by 
        clause (C) that such person has not submitted all the 
        information required by such clause) before the first 
        introduction into interstate commerce of the food with 
        a label containing the claim, (I) a notice of the 
        claim, which shall include the exact words used in the 
        claim and shall include a concise description of the 
        basis upon which such person relied for determining 
        that the requirements of subclause (i) have been 
        satisfied, (II) a copy of the statement referred to in 
        subclause (i) upon which such person relied in making 
        the claim, and (III) a balanced representation of the 
        scientific literature relating to the nutrient level to 
        which the claim refers;
          (iii) the claim and the food for which the claim is 
        made are in compliance with clauses (A) and (B), and 
        are otherwise in compliance with paragraph (a) and 
        section 201(n); and
          (iv) the claim is stated in a manner so that the 
        claim is an accurate representation of the 
        authoritative statement referred to in subclause (i) 
        and so that the claim enables the public to comprehend 
        the information provided in the claim and to understand 
        the relative significance of such information in the 
        context of a total daily diet.
For purposes of this clause, a statement shall be regarded as 
an authoritative statement of a scientific body described in 
subclause (i) only if the statement is published by the 
scientific body and shall not include a statement of an 
employee of the scientific body made in the individual capacity 
of the employee.
  (H) A claim submitted under the requirements of clause (G) 
may be made until--
          (i) such time as the Secretary issues a regulation--
                  (I) prohibiting or modifying the claim and 
                the regulation has become effective, or
                  (II) finding that the requirements of clause 
                (G) have not been met, including finding that 
                the petitioner had not submitted all the 
                information required by such clause; or
          (ii) a district court of the United States in an 
        enforcement proceeding under chapter III has determined 
        that the requirements of clause (G) have not been met.
  (3)(A) Except as provided in subparagraph (5), a claim 
described in subparagraph (1)(B) may only be made--
          (i) if the claim meets the requirements of the 
        regulations of the Secretary promulgated under clause 
        (B), and
          (ii) if the food for which the claim is made does not 
        contain, as determined by the Secretary by regulation, 
        any nutrient in an amount which increases to persons in 
        the general population the risk of a disease or health-
        related condition which is diet related, taking into 
        account the significance of the food in the total daily 
        diet, except that the Secretary may by regulation 
        permit such a claim based on a finding that such a 
        claim would assist consumers in maintaining healthy 
        dietary practices and based on a requirement that the 
        label contain a disclosure of the type required by 
        subparagraph (2)(B).
  (B)(i) The Secretary shall promulgate regulations authorizing 
claims of the type described in subparagraph (1)(B) only if the 
Secretary determines, based on the totality of publicly 
available scientific evidence (including evidence from well-
designed studies conducted in a manner which is consistent with 
generally recognized scientific procedures and principles), 
that there is significant scientific agreement, among experts 
qualified by scientific training and experience to evaluate 
such claims, that the claim is supported by such evidence.
  (ii) A regulation described in subclause (i) shall describe--
          (I) the relationship between a nutrient of the type 
        required in the label or labeling of food by paragraph 
        (q)(1) or (q)(2) and a disease or health-related 
        condition, and
          (II) the significance of each such nutrient in 
        affecting such disease or health-related condition.
  (iii) A regulation described in subclause (i) shall require 
such claim to be stated in a manner so that the claim is an 
accurate representation of the matters set out in subclause 
(ii) and so that the claim enables the public to comprehend the 
information provided in the claim and to understand the 
relative significance of such information in the context of a 
total daily diet.
  (C) Notwithstanding the provisions of clauses (A)(i) and (B), 
a claim of the type described in subparagraph (1)(B) which is 
not authorized by the Secretary in a regulation promulgated in 
accordance with clause (B) shall be authorized and may be made 
with respect to a food if--
          (i) a scientific body of the United States Government 
        with official responsibility for public health 
        protection or research directly relating to human 
        nutrition (such as the National Institutes of Health or 
        the Centers for Disease Control and Prevention) or the 
        National Academy of Sciences or any of its subdivisions 
        has published an authoritative statement, which is 
        currently in effect, about the relationship between a 
        nutrient and a disease or health-related condition to 
        which the claim refers;
          (ii) a person has submitted to the Secretary, at 
        least 120 days (during which the Secretary may notify 
        any person who is making a claim as authorized by 
        clause (C) that such person has not submitted all the 
        information required by such clause) before the first 
        introduction into interstate commerce of the food with 
        a label containing the claim, (I) a notice of the 
        claim, which shall include the exact words used in the 
        claim and shall include a concise description of the 
        basis upon which such person relied for determining 
        that the requirements of subclause (i) have been 
        satisfied, (II) a copy of the statement referred to in 
        subclause (i) upon which such person relied in making 
        the claim, and (III) a balanced representation of the 
        scientific literature relating to the relationship 
        between a nutrient and a disease or health-related 
        condition to which the claim refers;
          (iii) the claim and the food for which the claim is 
        made are in compliance with clause (A)(ii) and are 
        otherwise in compliance with paragraph (a) and section 
        201(n); and
          (iv) the claim is stated in a manner so that the 
        claim is an accurate representation of the 
        authoritative statement referred to in subclause (i) 
        and so that the claim enables the public to comprehend 
        the information provided in the claim and to understand 
        the relative significance of such information in the 
        context of a total daily diet.
For purposes of this clause, a statement shall be regarded as 
an authoritative statement of a scientific body described in 
subclause (i) only if the statement is published by the 
scientific body and shall not include a statement of an 
employee of the scientific body made in the individual capacity 
of the employee.
  (D) A claim submitted under the requirements of clause (C) 
may be made until--
          (i) such time as the Secretary issues a regulation 
        under the standard in clause (B)(i)--
                  (I) prohibiting or modifying the claim and 
                the regulation has become effective, or
                  (II) finding that the requirements of clause 
                (C) have not been met, including finding that 
                the petitioner has not submitted all the 
                information required by such clause; or
          (ii) a district court of the United States in an 
        enforcement proceeding under chapter III has determined 
        that the requirements of clause (C) have not been met.
  (4)(A)(i) Any person may petition the Secretary to issue a 
regulation under subparagraph (2)(A)(i) or (3)(B) relating to a 
claim described in subparagraph (1)(A) or (1)(B). Not later 
than 100 days after the petition is received by the Secretary, 
the Secretary shall issue a final decision denying the petition 
or file the petition for further action by the Secretary. If 
the Secretary does not act within such 100 days, the petition 
shall be deemed to be denied unless an extension is mutually 
agreed upon by the Secretary and the petitioner. If the 
Secretary denies the petition or the petition is deemed to be 
denied, the petition shall not be made available to the public. 
If the Secretary files the petition, the Secretary shall deny 
the petition or issue a proposed regulation to take the action 
requested in the petition not later than 90 days after the date 
of such decision. If the Secretary does not act within such 90 
days, the petition shall be deemed to be denied unless an 
extension is mutually agreed upon by the Secretary and the 
petitioner. If the Secretary issues a proposed regulation, the 
rulemaking shall be completed within 540 days of the date the 
petition is received by the Secretary. If the Secretary does 
not issue a regulation within such 540 days, the Secretary 
shall provide the Committee on Commerce of the House of 
Representatives and the Committee on Labor and Human Resources 
of the Senate the reasons action on the regulation did not 
occur within such 540 days.
  (ii) Any person may petition the Secretary for permission to 
use in a claim described in subparagraph (1)(A) terms that are 
consistent with the terms defined by the Secretary under 
subparagraph (2)(A)(i). Within 90 days of the submission of 
such a petition, the Secretary shall issue a final decision 
denying the petition or granting such permission.
  (iii) Any person may petition the Secretary for permission to 
use an implied claim described in subparagraph (1)(A) in a 
brand name. After publishing notice of an opportunity to 
comment on the petition in the Federal Register and making the 
petition available to the public, the Secretary shall grant the 
petition if the Secretary finds that such claim is not 
misleading and is consistent with terms defined by the 
Secretary under subparagraph (2)(A)(i). The Secretary shall 
grant or deny the petition within 100 days of the date it is 
submitted to the Secretary and the petition shall be considered 
granted if the Secretary does not act on it within such 100 
days.
  (B) A petition under clause (A)(i) respecting a claim 
described in subparagraph (1)(A) or (1)(B) shall include an 
explanation of the reasons why the claim meets the requirements 
of this paragraph and a summary of the scientific data which 
supports such reasons.
  (C) If a petition for a regulation under subparagraph (3)(B) 
relies on a report from an authoritative scientific body of the 
United States, the Secretary shall consider such report and 
shall justify any decision rejecting the conclusions of such 
report.
  (5)(A) This paragraph does not apply to infant formulas 
subject to section 412(h) and medical foods as defined in 
section 5(b) of the Orphan Drug Act.
  (B) Subclauses (iii) through (v) of subparagraph (2)(A) and 
subparagraph (2)(B) do not apply to food which is served in 
restaurants or other establishments in which food is served for 
immediate human consumption or which is sold for sale or use in 
such establishments.
  (C) A subparagraph (1)(A) claim made with respect to a food 
which claim is required by a standard of identity issued under 
section 401 shall not be subject to subparagraph (2)(A)(i) or 
(2)(B).
  (D) A subparagraph (1)(B) claim made with respect to a 
dietary supplement of vitamins, minerals, herbs, or other 
similar nutritional substances shall not be subject to 
subparagraph (3) but shall be subject to a procedure and 
standard, respecting the validity of such claim, established by 
regulation of the Secretary.
  (6) For purposes of paragraph (r)(1)(B), a statement for a 
dietary supplement may be made if--
          (A) the statement claims a benefit related to a 
        classical nutrient deficiency disease and discloses the 
        prevalence of such disease in the United States, 
        describes the role of a nutrient or dietary ingredient 
        intended to affect the structure or function in humans, 
        characterizes the documented mechanism by which a 
        nutrient or dietary ingredient acts to maintain such 
        structure or function, or describes general well-being 
        from consumption of a nutrient or dietary ingredient,
          (B) the manufacturer of the dietary supplement has 
        substantiation that such statement is truthful and not 
        misleading, and
          (C) the statement contains, prominently displayed and 
        in boldface type, the following: ``This statement has 
        not been evaluated by the Food and Drug Administration. 
        This product is not intended to diagnose, treat, cure, 
        or prevent any disease.''.
A statement under this subparagraph may not claim to diagnose, 
mitigate, treat, cure, or prevent a specific disease or class 
of diseases. If the manufacturer of a dietary supplement 
proposes to make a statement described in the first sentence of 
this subparagraph in the labeling of the dietary supplement, 
the manufacturer shall notify the Secretary no later than 30 
days after the first marketing of the dietary supplement with 
such statement that such a statement is being made.
  (7) The Secretary may make proposed regulations issued under 
this paragraph effective upon publication pending consideration 
of public comment and publication of a final regulation if the 
Secretary determines that such action is necessary--
          (A) to enable the Secretary to review and act 
        promptly on petitions the Secretary determines provide 
        for information necessary to--
                  (i) enable consumers to develop and maintain 
                healthy dietary practices;
                  (ii) enable consumers to be informed promptly 
                and effectively of important new knowledge 
                regarding nutritional and health benefits of 
                food; or
                  (iii) ensure that scientifically sound 
                nutritional and health information is provided 
                to consumers as soon as possible; or
          (B) to enable the Secretary to act promptly to ban or 
        modify a claim under this paragraph.
Such proposed regulations shall be deemed final agency action 
for purposes of judicial review.
  (s) If--
          (1) it is a dietary supplement; and
          (2)(A) the label or labeling of the supplement fails 
        to list--
                  (i) the name of each ingredient of the 
                supplement that is described in section 
                201(ff); and
                  (ii)(I) the quantity of each such ingredient; 
                or
                  (II) with respect to a proprietary blend of 
                such ingredients, the total quantity of all 
                ingredients in the blend;
          (B) the label or labeling of the dietary supplement 
        fails to identify the product by using the term 
        ``dietary supplement'', which term may be modified with 
        the name of such an ingredient;
          (C) the supplement contains an ingredient described 
        in section 201(ff)(1)(C), and the label or labeling of 
        the supplement fails to identify any part of the plant 
        from which the ingredient is derived;
          (D) the supplement--
                  (i) is covered by the specifications of an 
                official compendium;
                  (ii) is represented as conforming to the 
                specifications of an official compendium; and
                  (iii) fails to so conform; or
          (E) the supplement--
                  (i) is not covered by the specifications of 
                an official compendium; and
                  (ii)(I) fails to have the identity and 
                strength that the supplement is represented to 
                have; or
                  (II) fails to meet the quality (including 
                tablet or capsule disintegration), purity, or 
                compositional specifications, based on 
                validated assay or other appropriate methods, 
                that the supplement is represented to meet.
A dietary supplement shall not be deemed misbranded solely 
because its label or labeling contains directions or conditions 
of use or warnings.
  (t) If it purports to be or is represented as catfish, unless 
it is fish classified within the family Ictaluridae.
  (u) If it purports to be or is represented as ginseng, unless 
it is an herb or herbal ingredient derived from a plant 
classified within the genus Panax.
  (v) If--
          (1) it fails to bear a label required by the 
        Secretary under section 801(n)(1) (relating to food 
        refused admission into the United States);
          (2) the Secretary finds that the food presents a 
        threat of serious adverse health consequences or death 
        to humans or animals; and
          (3) upon or after notifying the owner or consignee 
        involved that the label is required under section 801, 
        the Secretary informs the owner or consignee that the 
        food presents such a threat.
  (w)(1) If it is not a raw agricultural commodity and it is, 
or it contains an ingredient that bears or contains, a major 
food allergen, unless either--
          (A) the word ``Contains'', followed by the name of 
        the food source from which the major food allergen is 
        derived, is printed immediately after or is adjacent to 
        the list of ingredients (in a type size no smaller than 
        the type size used in the list of ingredients) required 
        under subsections (g) and (i); or
          (B) the common or usual name of the major food 
        allergen in the list of ingredients required under 
        subsections (g) and (i) is followed in parentheses by 
        the name of the food source from which the major food 
        allergen is derived, except that the name of the food 
        source is not required when--
                  (i) the common or usual name of the 
                ingredient uses the name of the food source 
                from which the major food allergen is derived; 
                or
                  (ii) the name of the food source from which 
                the major food allergen is derived appears 
                elsewhere in the ingredient list, unless the 
                name of the food source that appears elsewhere 
                in the ingredient list appears as part of the 
                name of a food ingredient that is not a major 
                food allergen under section 201(qq)(2)(A) or 
                (B).
  (2) As used in this subsection, the term ``name of the food 
source from which the major food allergen is derived'' means 
the name described in section 201(qq)(1); provided that in the 
case of a tree nut, fish, or Crustacean shellfish, the term 
``name of the food source from which the major food allergen is 
derived'' means the name of the specific type of nut or species 
of fish or Crustacean shellfish.
  (3) The information required under this subsection may appear 
in labeling in lieu of appearing on the label only if the 
Secretary finds that such other labeling is sufficient to 
protect the public health. A finding by the Secretary under 
this paragraph (including any change in an earlier finding 
under this paragraph) is effective upon publication in the 
Federal Register as a notice.
  (4) Notwithstanding subsection (g), (i), or (k), or any other 
law, a flavoring, coloring, or incidental additive that is, or 
that bears or contains, a major food allergen shall be subject 
to the labeling requirements of this subsection.
  (5) The Secretary may by regulation modify the requirements 
of subparagraph (A) or (B) of paragraph (1), or eliminate 
either the requirement of subparagraph (A) or the requirements 
of subparagraph (B) of paragraph (1), if the Secretary 
determines that the modification or elimination of the 
requirement of subparagraph (A) or the requirements of 
subparagraph (B) is necessary to protect the public health.
  (6)(A) Any person may petition the Secretary to exempt a food 
ingredient described in section 201(qq)(2) from the allergen 
labeling requirements of this subsection.
  (B) The Secretary shall approve or deny such petition within 
180 days of receipt of the petition or the petition shall be 
deemed denied, unless an extension of time is mutually agreed 
upon by the Secretary and the petitioner.
  (C) The burden shall be on the petitioner to provide 
scientific evidence (including the analytical method used to 
produce the evidence) that demonstrates that such food 
ingredient, as derived by the method specified in the petition, 
does not cause an allergic response that poses a risk to human 
health.
  (D) A determination regarding a petition under this paragraph 
shall constitute final agency action.
  (E) The Secretary shall promptly post to a public site all 
petitions received under this paragraph within 14 days of 
receipt and the Secretary shall promptly post the Secretary's 
response to each.
  (7)(A) A person need not file a petition under paragraph (6) 
to exempt a food ingredient described in section 201(qq)(2) 
from the allergen labeling requirements of this subsection, if 
the person files with the Secretary a notification containing--
          (i) scientific evidence (including the analytical 
        method used) that demonstrates that the food ingredient 
        (as derived by the method specified in the 
        notification, where applicable) does not contain 
        allergenic protein; or
          (ii) a determination by the Secretary that the 
        ingredient does not cause an allergic response that 
        poses a risk to human health under a premarket approval 
        or notification program under section 409.
  (B) The food ingredient may be introduced or delivered for 
introduction into interstate commerce as a food ingredient that 
is not a major food allergen 90 days after the date of receipt 
of the notification by the Secretary, unless the Secretary 
determines within the 90-day period that the notification does 
not meet the requirements of this paragraph, or there is 
insufficient scientific evidence to determine that the food 
ingredient does not contain allergenic protein or does not 
cause an allergenic response that poses a risk to human health.
  (C) The Secretary shall promptly post to a public site all 
notifications received under this subparagraph within 14 days 
of receipt and promptly post any objections thereto by the 
Secretary.
  (x) Notwithstanding subsection (g), (i), or (k), or any other 
law, a spice, flavoring, coloring, or incidental additive that 
is, or that bears or contains, a food allergen (other than a 
major food allergen), as determined by the Secretary by 
regulation, shall be disclosed in a manner specified by the 
Secretary by regulation.
  (y) If it is a dietary supplement that is marketed in the 
United States, unless the label of such dietary supplement 
includes a domestic address or domestic phone number through 
which the responsible person (as described in section 761) may 
receive a report of a serious adverse event with such dietary 
supplement.
  (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. 403A. (a) Except as provided in subsection (b), 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--
          (1) any requirement for a food which is the subject 
        of a standard of identity established under section 401 
        that is not identical to such standard of identity or 
        that is not identical to the requirement of section 
        403(g), except that this paragraph does not apply to a 
        standard of identity of a State or political 
        subdivision of a State for maple syrup that is of the 
        type required by sections 401 and 403(g),
          (2) any requirement for the labeling of food of the 
        type required by section 403(c), 403(e), 403(i)(2), 
        403(w), or 403(x) that is not identical to the 
        requirement of such section, except that this paragraph 
        does not apply to a requirement of a State or political 
        subdivision of a State that is of the type required by 
        section 403(c) and that is applicable to maple syrup,
          (3) any requirement for the labeling of food of the 
        type required by section 403(b), 403(d), 403(f), 
        403(h), 403(i)(1), or 403(k) that is not identical to 
        the requirement of such section, except that this 
        paragraph does not apply to a requirement of a State or 
        political subdivision of a State that is of the type 
        required by section 403(h)(1) and that is applicable to 
        maple syrup,
          (4) any requirement for nutrition labeling of food 
        that is not identical to the requirement of section 
        403(q), except that this paragraph does not apply to 
        food that is offered for sale in a restaurant or 
        similar retail food establishment that is not part of a 
        chain with 20 or more locations doing business under 
        the same name (regardless of the type of ownership of 
        the locations) and offering for sale substantially the 
        same menu items unless such restaurant or similar 
        retail food establishment complies with the voluntary 
        provision of nutrition information requirements under 
        section 403(q)(5)(H)(ix), [or]
          (5) any requirement respecting any claim of the type 
        described in section 403(r)(1) made in the label or 
        labeling of food that is not identical to the 
        requirement of section 403(r), except a requirement 
        respecting a claim made in the label or labeling of 
        food which is exempt under section 403(r)(5)(B)[.],
          (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.
Paragraph (3) shall take effect in accordance with section 6(b) 
of the Nutrition Labeling and Education Act of 1990.
  (b) Upon petition of a State or a political subdivision of a 
State, the Secretary may exempt from subsection (a), under such 
conditions as may be prescribed by regulation, any State or 
local requirement that--
          (1) would not cause any food to be in violation of 
        any applicable requirement under Federal law,
          (2) would not unduly burden interstate commerce, and
          (3) is designed to address a particular need for 
        information which need is not met by the requirements 
        of the sections referred to in subsection (a).

           *       *       *       *       *       *       *


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.

           *       *       *       *       *       *       *

                              ----------                              


                          PLANT PROTECTION ACT

TITLE II--AGRICULTURAL ASSISTANCE

           *       *       *       *       *       *       *


Subtitle E--Nutrition Programs

           *       *       *       *       *       *       *


    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 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--
          (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 as safe for use by humans or animals, 
        as applicable, as one or more comparable foods; 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 introduction or 
delivery for introduction into 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) research involving 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 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.
  (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 introduced or 
                delivered for introduction 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 
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.

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.

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                              ----------                              


                   AGRICULTURAL MARKETING ACT OF 1946

TITLE II

           *       *       *       *       *       *       *


Subtitle D--Country of Origin Labeling

           *       *       *       *       *       *       *


             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 
                plant that is a 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.
  (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, 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 produced with 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.

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 without the use 
        of genetic engineering or a genetically engineered 
        plant or with 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) Unlawful act.--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.
          (2) Misuse of label.--
                  (A) In general.--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.
                  (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 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
                          (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, 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. 
                  (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 
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, without further appropriation, to carry out 
        this subtitle.

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[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


                            DISSENTING VIEWS

    Recent polling shows that nine out of ten Americans want 
the right to know whether their food has been produced with 
genetically modified food ingredients. Vermont, Connecticut and 
Maine have acted to give consumers the right to know what is in 
their food and how it is grown.
    H.R. 1599 would preempt states from labeling GMO foods and 
would invalidate existing state laws.
    H.R. 1599 would make it virtually impossible for the Food 
and Drug Administration to craft a national mandatory GMO 
labeling system. It would codify the existing voluntary non-GMO 
labeling policy that causes confusion among consumers.
    H.R. 1599 also would allow ``natural'' claims on foods with 
GMOs, which adds to consumer confusion.
    Consumers have the right to know what is in their food and 
how it is grown. H.R. 1599 makes it more difficult for 
consumers to know that information.

                                         James P. McGovern.
                                         Ann McLane Kuster.

                                  [all]