[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4432 Introduced in House (IH)]

113th CONGRESS
  2d Session
                                H. R. 4432

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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 9, 2014

Mr. Pompeo (for himself, Mr. Butterfield, Mr. Matheson, Mrs. Blackburn, 
and Mr. Whitfield) introduced the following bill; which was referred to 
                  the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


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

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Safe and Accurate Food Labeling Act 
of 2014''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents of this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Ensuring safety of food supply.
      TITLE I--FOOD PRODUCED FROM, CONTAINING, OR CONSISTING OF A 
                         BIOENGINEERED ORGANISM

Sec. 101. Definitions.
Sec. 102. Mandatory premarket biotechnology notification program.
Sec. 103. Labeling of whether food is bioengineered.
Sec. 104. Preemption.
                        TITLE II--NATURAL FOODS

Sec. 201. Labeling of natural foods.
Sec. 202. Regulations.
Sec. 203. Preemption.
Sec. 204. Effective date.

SEC. 3. ENSURING SAFETY OF FOOD SUPPLY.

    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 the Food and Drug 
Administration to ensure the safety of the food supply under the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

      TITLE I--FOOD PRODUCED FROM, CONTAINING, OR CONSISTING OF A 
                         BIOENGINEERED ORGANISM

SEC. 101. DEFINITIONS.

    Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321) is amended by adding at the end the following:
    ``(ss) The term `bioengineered organism' refers to an organism if--
            ``(1) the organism is a plant (or a seed, a fruit, or any 
        other part thereof);
            ``(2) the organism contains genetic material that has been 
        modified through in vitro recombinant deoxyribonucleic acid 
        (DNA) techniques; and
            ``(3) the modification could not otherwise be obtained 
        using conventional breeding techniques.''.

SEC. 102. MANDATORY PREMARKET BIOTECHNOLOGY NOTIFICATION PROGRAM.

    (a) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(ddd) The initial introduction or delivery for introduction in 
interstate commerce of a bioengineered organism intended for a food use 
or application, unless the developer of the organism has complied with 
the notification requirements, to the extent applicable, under section 
424.''.
    (b) Notification Program.--Chapter IV of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at the 
end the following:

``SEC. 424. NOTIFICATION RELATING TO CERTAIN BIOENGINEERED ORGANISMS.

    ``(a) In General.--A bioengineered organism shall not be introduced 
or delivered for introduction into interstate commerce for a food use 
or application unless--
            ``(1) the use or application of the bioengineered organism 
        in food has been addressed by the developer of the 
        bioengineered organism in a premarket biotechnology 
        notification, to which the Secretary has responded under 
        subsection (d)(2)(A) by stating no objections; or
            ``(2)(A) food produced from, containing, or consisting of 
        the bioengineered organism was evaluated by the Secretary 
        pursuant to the Food and Drug Administration's voluntary 
        consultation process for foods and food products from 
        genetically engineered plants in effect prior to the date of 
        enactment of the Safe and Accurate Food Labeling Act of 2014; 
        and
            ``(B) the Secretary informed the developer of the 
        bioengineered organism that all questions about safety have 
        been resolved.
    ``(b) Exceptions.--This section does not apply with respect to the 
introduction or delivery for introduction into interstate commerce of a 
bioengineered organism--
            ``(1) for the purpose of development or testing conducted 
        to generate data and information that could be used in a 
        premarket biotechnology notification or other regulatory 
        submission; or
            ``(2) solely because--
                    ``(A) a processing aid or enzyme produced from the 
                bioengineered organism is intended to be used to 
                produce food; or
                    ``(B) food produced from, containing, or consisting 
                of the bioengineered organism is intended to be fed to 
                an animal from which food is intended to be produced or 
                derived.
    ``(c) Premarket Biotechnology Notification.--
            ``(1) Submission.--At least 210 days before a bioengineered 
        organism is first introduced or delivered for introduction into 
        interstate commerce for a food use or application, a premarket 
        biotechnology notification shall be submitted to the Secretary 
        by the developer of the bioengineered organism. Such 
        notification shall provide--
                    ``(A) the basis for the notifier's determination 
                that food produced from, containing, or consisting of 
                such bioengineered organism is as safe for use by 
                humans or animals, as applicable, as one or more 
                comparable marketed foods that are not produced from, 
                do not contain, or do not consist of such bioengineered 
                organism; and
                    ``(B) whether any other Federal agency is 
                conducting or has conducted any review of the 
                bioengineered organism and the status or conclusions of 
                any such review.
            ``(2) Consultation prior to submission.--A prospective 
        notifier may consult informally with the Secretary concerning a 
        bioengineered organism intended for a food use or application 
        before submitting a premarket biotechnology notification.
    ``(d) Response to a Premarket Biotechnology Notification.--
            ``(1) Preliminary response.--Within 30 days of receipt of a 
        premarket biotechnology notification, the Secretary shall--
                    ``(A) inform the notifier in writing that the 
                notification is complete and has been filed; or
                    ``(B) inform the notifier in writing of any missing 
                elements that prevent the Secretary from filing and 
                reviewing the notification.
        The Secretary shall limit any request under subparagraph (B) to 
        data or information necessary to perform the evaluation 
        specified in paragraph (2) and shall not delay informing the 
        notifier under paragraph (1)(A) for any other purpose.
            ``(2) Substantive response.--Within 180 days of the 
        Secretary informing the notifier under paragraph (1)(A) that 
        the premarket biotechnology notification is complete, the 
        Secretary--
                    ``(A) shall respond in writing to the notifier that 
                the Secretary has evaluated the notification and has no 
                objections to the notifier's determination that food 
                produced from, containing, or consisting of the 
                bioengineered organism that is the subject of the 
                notification is as safe for use by humans or animals, 
                as applicable, as one or more comparable marketed foods 
                that are not produced from, do not contain, or do not 
                consist of such bioengineered organism; or
                    ``(B) shall--
                            ``(i) respond in writing to the notifier 
                        that the Secretary has evaluated the 
                        notification and has determined the 
                        notification does not provide an adequate basis 
                        for the notifier's determination; and
                            ``(ii) include in such response the 
                        Secretary's basis for the Secretary's 
                        determination.
            ``(3) Withdrawal by notifier.--At any point before 
        receiving a written response from the Secretary under 
        subparagraph (A) or (B) of paragraph (2), the notifier may 
        withdraw a premarket biotechnology notification without 
        prejudice as to any future notifications.
            ``(4) Effective date.--A notification submitted under 
        subsection (c) shall become effective on the date that is 180 
        days after the Secretary informs the notifier under paragraph 
        (1)(A) that the notification is complete, and as of such date 
        the bioengineered organism that is the subject of the 
        notification may be introduced or delivered for introduction 
        into interstate commerce, unless the Secretary provides a 
        response under paragraph (2)(B).
    ``(e) Labeling.--If the Secretary determines that there is a 
material difference between a food produced from, containing, or 
consisting of a bioengineered organism and its comparable marketed food 
and that disclosure of such difference is necessary to protect health 
and safety or to prevent the label or labeling of such food from being 
false or misleading, the Secretary may, in a response under subsection 
(d)(2)(A), specify labeling that would adequately inform consumers of 
such material difference. The use of bioengineering does not, by 
itself, constitute a material difference.
    ``(f) Public Disclosure.--The existence and contents of a premarket 
biotechnology notification shall be made available to the public as of 
the date the Secretary issues a written response under subsection 
(d)(2)(A), subject to review by the Secretary pursuant to the 
provisions on exemptions from disclosure under chapter 5 of title 5, 
United States Code.
    ``(g) Definitions.--In this section:
            ``(1)(A) The term `comparable marketed food' means, with 
        respect to the food produced from, containing, or consisting of 
        a plant that is a bioengineered organism--
                    ``(i) the parental variety of the plant;
                    ``(ii) another commonly consumed variety of the 
                plant; or
                    ``(iii) a plant variety from which is derived a 
                commonly consumed food with properties comparable to 
                the food produced from, containing, or consisting of 
                the plant that is a bioengineered organism.
            ``(B) A food produced from, containing, or consisting of a 
        bioengineered organism may have more than one comparable 
        marketed food.
            ``(2) The term `notifier' means the person who submits a 
        premarket biotechnology notification.
            ``(3) The term `premarket biotechnology notification'--
                    ``(A) means a submission to the Secretary under 
                subsection (c); and
                    ``(B) includes all scientific data and other 
                information in the original submission and in any 
                amendments to the original submission.
            ``(4) The term `material difference' means a difference 
        that--
                    ``(A) significantly alters the characteristics, 
                including the functional or compositional 
                characteristics, of a food, such that the common or 
                usual name no longer adequately describes the food;
                    ``(B) results in a significantly different 
                nutritional property in the food produced from, 
                containing, or consisting of the bioengineered 
                organism; or
                    ``(C) results in the food containing an allergen 
                that consumers would not expect to be present based 
                upon the name of the food.''.
    (c) Applicability.--The amendments made by this section apply 
beginning on the date that is 30 days after the date of enactment of 
this Act, irrespective of whether regulations or guidance have been 
finalized or issued by such date to carry out such amendments.
    (d) Pending Submissions.--The Secretary shall--
            (1) deem to be a premarket biotechnology notification under 
        section 424 of the Federal Food, Drug, and Cosmetic Act, as 
        added by this section, any submission that--
                    (A) is pending as of the date of enactment of this 
                Act; and
                    (B) is for voluntary consultation with respect to 
                food produced from, containing, or consisting of a 
                bioengineered organism (as such term is used in section 
                301(ddd) of the Federal Food, Drug, and Cosmetic Act, 
                as added by subsection (a)); and
            (2) evaluate such notifications expeditiously.
    (e) Preemption.--Section 403A(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343-2(a)) is amended--
            (1) by striking ``or'' at the end of paragraph (4);
            (2) by striking the period at the end of paragraph (5) and 
        inserting a comma; and
            (3) by adding at the end the following:
            ``(6) any requirement respecting, prohibition against, or 
        restriction on, the sale, distribution, or marketing of--
                    ``(A) a bioengineered organism intended for a food 
                use or application, or
                    ``(B) food produced from, containing, or consisting 
                of a bioengineered organism, as such term is used in 
                section 301(ddd), or''.
    (f) Technical Corrections.--Section 403A of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 343-1) is amended--
            (1) by striking the section designation and enumerator and 
        all that follows through ``(a) Except'' and inserting the 
        following:

``SEC. 403A. STATE REQUIREMENTS.

    ``(a) In General.--Except''; and
            (2) in subsection (b), by striking ``(b) Upon petition'' 
        and inserting the following:
    ``(b) Petitions for Exemptions.--Upon petition''.

SEC. 103. LABELING OF WHETHER FOOD IS BIOENGINEERED.

    (a) Misbranding.--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) If it bears labeling (indicating that bioengineering was or 
was not used in the production of the food) in violation of section 
425.''.
    (b) Labeling Requirements.--Chapter IV of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 341 et seq.), as amended by section 102 of 
this Act, is further amended by adding at the end the following:

``SEC. 425. LABELING OF WHETHER FOOD IS BIOENGINEERED.

    ``(a) Claims That Bioengineering Was Not Used.--
            ``(1) In general.--If a claim in the labeling of food 
        indicates, directly or indirectly, that bioengineering was not 
        used in the production of the food, such claim shall be subject 
        to this subsection.
            ``(2) Requirements.--A claim described in paragraph (1)--
                    ``(A) may be made only if the food bearing the 
                claim is comprised of ingredients subject to supply 
                chain process controls that address--
                            ``(i) the producer planting a seed 
                        developed by means other than through the use 
                        of bioengineering;
                            ``(ii) the producer keeping the crop 
                        separated during growth, harvesting, storage, 
                        and transportation; and
                            ``(iii) persons in direct contact with such 
                        crop or foods derived from such crop during 
                        transportation, storage, or processing keeping 
                        the product separated from foods or food 
                        ingredients derived through bioengineering;
                    ``(B) may be made for a food produced in accordance 
                with subparagraph (A) in which food produced from, 
                containing, or consisting of a bioengineered organism 
                is inadvertently present;
                    ``(C) may not suggest either expressly or by 
                implication that foods developed without the use of 
                bioengineering are safer than foods produced from, 
                containing, or consisting of a bioengineered organism;
                    ``(D) may be made on dairy products derived from 
                cows or other milk-producing animals, on shell eggs 
                derived from chickens and other birds, and on products 
                consisting of or derived from fish or animals (that are 
                under the jurisdiction of the Food and Drug 
                Administration) that consumed feed or a feed 
                ingredient, or received a drug or biological product, 
                that--
                            ``(i) was developed with the use of 
                        bioengineering; and
                            ``(ii) has been authorized for such use by 
                        the Secretary;
                    ``(E) may be made on a food produced with a 
                bioengineered processing aid or enzyme; and
                    ``(F) shall comply with any other requirements 
                established by the Secretary by regulation to ensure 
                that the food's labeling is not false or misleading.
            ``(3) Regulations.--
                    ``(A) In general.--The Secretary shall promulgate 
                regulations to carry out this section. Such regulations 
                shall specify a maximum permissible level of food 
                produced from, containing, or consisting of a 
                bioengineered organism that may be inadvertently 
                present in food bearing claims under paragraph (1).
                    ``(B) Separate categories.--Such regulations may 
                specify different permissible levels for separate 
                categories of food.
                    ``(C) Claims prior to finalization of 
                regulations.--This section does not limit the ability 
                of persons to make claims described in paragraph (1) 
                before the finalization of regulations under this 
                paragraph.
                    ``(D) Initial regulations.--The Secretary shall 
                promulgate final regulations under this paragraph not 
                later than 24 months after the date of enactment of the 
                Safe and Accurate Food Labeling Act of 2014.
    ``(b) Claims That Bioengineering Was Used.--
            ``(1) In general.--If a claim in the labeling of food 
        indicates, directly or indirectly, that bioengineering was used 
        in the production of the food, such claim shall be subject to 
        this subsection.
            ``(2) Regulations.--A claim described in paragraph (1) may 
        be made only in accordance with regulations promulgated by the 
        Secretary. Such regulations--
                    ``(A) shall not require the labeling to declare the 
                use of bioengineering solely because the food was 
                developed with the use of bioengineering;
                    ``(B) shall not allow the labeling to expressly or 
                impliedly claim that food developed with the use of 
                bioengineering is safer solely because the food is a 
                food developed with the use of bioengineering;
                    ``(C) shall allow any claims which the Secretary 
                deems necessary under section 424(e); and
                    ``(D) may contain other requirements established by 
                the Secretary to ensure that the food's labeling is not 
                false or misleading.
            ``(3) Prohibition against restricting certain 
        disclosures.--The regulations under this subsection shall not 
        prevent a person--
                    ``(A) from disclosing voluntarily on the labeling 
                of food developed with the use of bioengineering the 
                manner in which the food has been modified to express 
                traits or characteristics that differ from its 
                comparable marketed food (as defined in section 424); 
                or
                    ``(B) from disclosing in advertisements, on the 
                Internet, in response to consumer inquiries, or on 
                other communications, other than in the labeling, that 
                a food was developed with the use of bioengineering.
    ``(c) Definition.--The term `bioengineered organism' means a 
bioengineered organism, as such term is used in section 301(ddd).''.

SEC. 104. PREEMPTION.

    (a) In General.--Section 403A(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343-2(a)) is amended by adding at the end the 
following:
            ``(7) any requirement for the labeling of food of the type 
        described in subsection (a)(1) or (b)(1) of section 425 that is 
        not identical to the requirement of such section, or''.
    (b) Prohibition Against Mandatory Labeling.--Section 403A of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343-1) is amended by 
adding at the end the following:
    ``(c) Prohibitions Against Mandatory Labeling of Food Developed 
Using Bioengineering.--Except for claims under subsection (a)(1) or 
(b)(1) of section 425, no State or political subdivision of a State may 
directly or indirectly establish under any authority or continue in 
effect as to any food in interstate commerce any requirement for the 
labeling of a food by virtue of its having been developed using 
bioengineering, including any requirements for claims that a food is or 
contains an ingredient that was developed using bioengineering.''.

                        TITLE II--NATURAL FOODS

SEC. 201. LABELING OF NATURAL FOODS.

    Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
343), as amended by section 103 of this Act, is further amended by 
adding at the end the following:
    ``(aa)(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. 202. REGULATIONS.

    (a) Proposed Regulations.--Not later than 12 months after the date 
of enactment of this Act, the Secretary of Health and Human Services 
shall issue proposed regulations to implement section 403(aa) of the 
Federal Food, Drug, and Cosmetic Act, as added by section 201 of this 
Act.
    (b) Final Regulations.--Not later than 24 months after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
issue final regulations to implement such section 403(aa).

SEC. 203. PREEMPTION.

    Section 403A(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 343-1(a)), as amended by section 104 of this Act, is further 
amended by adding at the end the following:
            ``(8) any requirement for the labeling of food of the type 
        required by section 403(aa) that is not identical to the 
        requirement of such section.''.

SEC. 204. EFFECTIVE DATE.

    The labeling requirements of section 403(aa) of the Federal Food, 
Drug, and Cosmetic Act, as added by section 201 of this Act, shall take 
effect on the effective date of final regulations promulgated under 
section 202(b) of this Act. The provisions of section 403A(a)(8) of the 
Federal Food, Drug, and Cosmetic Act, as added by section 203 of this 
Act, take effect on the date of enactment of this Act.
                                 <all>