[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4814 Introduced in House (IH)]







107th CONGRESS
  2d Session
                                H. R. 4814

  To amend the Federal Food, Drug, and Cosmetic Act, the Federal Meat 
Inspection Act, and the Poultry Products Inspection Act to require that 
   food that contains a genetically engineered material, or that is 
      produced with a genetically engineered material, be labeled 
                              accordingly.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 22, 2002

 Mr. Kucinich (for himself, Mr. Sanders, Ms. McKinney, Ms. Rivers, Mr. 
 Pallone, Mrs. Mink of Hawaii, Ms. Carson of Indiana, Mr. DeFazio, Mr. 
    Gutierrez, Mr. Nadler, Mr. Olver, Mr. Udall of New Mexico, Ms. 
Velazquez, Ms. Waters, Ms. Woolsey, Mr. Jackson of Illinois, Ms. Watson 
 of California, Mr. Rodriguez, Ms. Berkley, Mr. Owens, Ms. Solis, Mr. 
 George Miller of California, Mr. Hinchey, and Ms. Lee) introduced the 
following bill; which was referred to the Committee on Agriculture, and 
in addition to the Committee on Energy and Commerce, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL


 
  To amend the Federal Food, Drug, and Cosmetic Act, the Federal Meat 
Inspection Act, and the Poultry Products Inspection Act to require that 
   food that contains a genetically engineered material, or that is 
      produced with a genetically engineered material, be labeled 
                              accordingly.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Genetically 
Engineered Food Right to Know Act''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Labeling regarding genetically engineered material; amendments 
                            to Federal Food, Drug, and Cosmetic Act.
Sec. 4. Labeling regarding genetically engineered material; amendments 
                            to Federal Meat Inspection Act.
Sec. 5. Labeling regarding genetically engineered material; amendments 
                            to Poultry Products Inspection Act.
Sec. 6. Effective date.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) The process of genetically engineering foods results in 
        the material change of such foods.
            (2) The Congress has previously required that all foods 
        bear labels that reveal material facts to consumers.
            (3) Federal agencies have failed to uphold Congressional 
        intent by allowing genetically engineered foods to be marketed, 
        sold and otherwise used without labeling that reveals material 
        facts to the public.
            (4) Consumers wish to know whether the food they purchase 
        and consume contains or is produced with a genetically 
        engineered material for a variety of reasons, including the 
        potential transfer of allergens into food and other health 
        risks, concerns about potential environmental risks associated 
        with the genetic engineering of crops, and religiously and 
        ethically based dietary restrictions.
            (5) Consumers have a right to know whether the food they 
        purchase contains or was produced with genetically engineered 
        material.
            (6) Labels voluntarily placed on foods are insufficient to 
        provide consumers with adequate information on whether or not 
        all the food they are purchasing contains or was produced with 
        genetically engineered material.
            (7) Mandatory labeling provides a critical scientific 
        method necessary for the continual postmarket surveillance to 
        study long-term health impacts and enforcement of food safety 
        laws preventing adulterated foods from reaching consumers.
            (8) Many of the United States' key trading partners, 
        including countries in the European Union, Japan, and the 
        People's Republic of China, have established, or are in the 
        process of implementing, mandatory labeling requirements for 
        genetically engineered food.
            (9) Adoption and implementation of mandatory labeling 
        requirements for genetically engineered food produced in the 
        United States would facilitate international trade by allowing 
        American farmers and companies to export and appropriately 
        market their products--both genetically engineered and non-
        genetically engineered--to foreign customers.

SEC. 3. LABELING REGARDING GENETICALLY ENGINEERED MATERIAL; AMENDMENTS 
              TO FEDERAL FOOD, DRUG, AND COSMETIC ACT.

    (a) In General.--Section 403 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the 
following paragraphs:
    ``(t)(1) If it contains a genetically engineered material, or was 
produced with a genetically engineered material, unless it bears a 
label (or labeling, in the case of a raw agricultural commodity, other 
than the sale of such a commodity at retail) that provides notices in 
accordance with the following:
            ``(A) A notice as follows: `GENETICALLY ENGINEERED'.
            ``(B) A notice as follows: `THIS PRODUCT CONTAINS A 
        GENETICALLY ENGINEERED MATERIAL, OR WAS PRODUCED WITH A 
        GENETICALLY ENGINEERED MATERIAL'.
            ``(C) The notice required in clause (A) immediately 
        precedes the notice required in clause (B) and is not less than 
        twice the size of the notice required in clause (B).
            ``(D) The notice required in clause (B) is of the same size 
        as would apply if the notice provided nutrition information 
        that is required in paragraph (q)(1).
            ``(E) The notices required in clauses (A) and (B) are 
        clearly legible and conspicuous.
    ``(2) For purposes of subparagraph (1):
            ``(A) The term `genetically engineered material' means 
        material derived from any part of a genetically engineered 
        organism, without regard to whether the altered molecular or 
        cellular characteristics of the organism are detectable in the 
        material.
            ``(B) The term `genetically engineered organism' means--
                    ``(i) an organism that has been altered at the 
                molecular or cellular level by means that are not 
                possible under natural conditions or processes 
                (including but not limited to recombinant DNA and RNA 
                techniques, cell fusion, microencapsulation, 
                macroencapsulation, gene deletion and doubling, 
                introducing a foreign gene, and changing the positions 
                of genes), other than a means consisting exclusively of 
                breeding, conjugation, fermentation, hybridization, in 
vitro fertilization, tissue culture, or mutagenesis, and
                    ``(ii) an organism made through sexual or asexual 
                reproduction (or both) involving an organism described 
                in subclause (i), if possessing any of the altered 
                molecular or cellular characteristics of the organism 
                so described.
    ``(3) For purposes of subparagraph (1), a food shall be considered 
to have been produced with a genetically engineered material if--
            ``(A) the organism from which the food is derived has been 
        injected or otherwise treated with a genetically engineered 
        material (except that the use of manure as a fertilizer for raw 
        agricultural commodities may not be construed to mean that such 
        commodities are produced with a genetically engineered 
        material),
            ``(B) the animal from which the food is derived has been 
        fed genetically engineered material, or
            ``(C) the food contains an ingredient that is a food to 
        which clause (A) or (B) applies.
    ``(4) This paragraph does not apply to food that--
            ``(A) is served in restaurants or other establishments in 
        which food is served for immediate human consumption,
            ``(B) is processed and prepared primarily in a retail 
        establishment, is ready for human consumption, which is of the 
        type described in clause (A), and is offered for sale to 
        consumers but not for immediate human consumption in such 
        establishment and is not offered for sale outside such 
        establishment, or
            ``(C) is a medical food as defined in section 5(b) of the 
        Orphan Drug Act.
    ``(5) In the case of the transfer of food from manufacturers or 
producers to distributors, and from distributors to other distributors 
or to other persons in the chain of distribution, including persons who 
hold food for sale to consumers, regulations under this paragraph and 
paragraph (u) shall require periodic testing of foods by the Secretary 
for purposes of determining the accuracy of labels under such 
paragraphs. Such regulations shall require the use of the best 
available technology for such testing, and shall identify tests that 
meet such requirement. This subparagraph and subparagraph (6) do not 
apply to (A) foods that are certified and comply with the Organic Foods 
Production Act and its implementing regulations; or (B) foods produced 
with genetically engineered material if the Secretary has not through 
such regulations identified a validated method of testing for such 
material in the food; or (C) genetically engineered material contained 
in a food if the Secretary has not through such regulations identified 
a validated method of testing for such material in the food.
    ``(6) For purposes of this paragraph and paragraph (u), a food with 
respect to which a test has been identified under subparagraph (5) 
shall not be considered to contain a genetically engineered material 
if, as indicated by such a test--
            ``(A) the food does not contain any genetically engineered 
        material, or
            ``(B) the food contains an adventitious genetically 
        engineered material and the amount of the material in the food 
        is one percent or less, except that a lower percentage 
        designated by the Secretary shall apply for purposes of this 
        subparagraph if the Secretary determines that a test identified 
        under subparagraph (5) can detect a percentage lower than one 
        percent.
    ``(u) If it bears a label indicating (within the meaning of 
paragraph (t)) that it does not contain a genetically engineered 
material, or that it was not produced with a genetically engineered 
material, unless the label is in accordance with regulations 
promulgated by the Secretary. With respect to such regulations:
            ``(1) The regulations may not require such a label to 
        include any statement indicating that the fact that a food does 
        not contain such material, or was not produced with such 
        material, has no bearing on the safety of the food for human 
        consumption.
            ``(2) The regulations may not prohibit such a label on the 
        basis that, in the case of the type of food involved, there is 
        no version of the food in commercial distribution that does 
        contain a genetically engineered material.''.
    (b) Civil Penalties.--Section 303 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the 
following subsection:
    ``(h)(1) With respect to a violation of section 301(a), 301(b), or 
301(c) involving the misbranding of food within the meaning of section 
403(t) or 403(u), any person engaging in such a violation shall be 
liable to the United States for a civil penalty in an amount not to 
exceed $100,000 for each such violation.
    ``(2) Paragraphs (3) through (5) of subsection (g) apply with 
respect to a civil penalty under paragraph (1) of this subsection to 
the same extent and in the same manner as such paragraphs (3) through 
(5) apply with respect to a civil penalty under paragraph (1) or (2) of 
subsection (g).''.
    (c) Guaranty.--
            (1) In general.--Section 303(d) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 333(d)) is amended--
                    (A) by striking ``(d)'' and inserting ``(d)(1)''; 
                and
                    (B) by adding at the end the following paragraph:
    ``(2)(A) Subject to subparagraph (C) and section 403(t)(5), no 
person shall be subject to the penalties of subsection (a)(1) or (h) 
for a violation of section 301(a), 301(b), or 301(c) involving the 
misbranding of food within the meaning of section 403(t) and 403(u) if 
such person (referred to in this paragraph as the `recipient') 
establishes a guaranty or undertaking signed by, and containing the 
name and address of, the person residing in the United States from whom 
the recipient received in good faith the food (including the receipt of 
seeds to grow raw agricultural commodities), to the effect that (within 
the meaning of section 403(t)) the food does not contain a genetically 
engineered material or was not produced with a genetically engineered 
material.
    ``(B) In the case of a recipient who with respect to a food 
establishes a guaranty or undertaking in accordance with subparagraph 
(A), the exclusion under such subparagraph from being subject to 
penalties applies to the recipient without regard to the use of the 
food by the recipient, including--
            ``(i) processing the food,
            ``(ii) using the food as an ingredient in a food product,
            ``(iii) repacking the food, or
            ``(iv) growing, raising, or otherwise producing the 
        food.''.
            (2) False guaranty.--Section 301(h) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 331(h)) is amended by 
        inserting ``or 303(d)(2)'' after ``303(c)(2)''.
    (d) Unintended Contamination.--Section 303(d) of the Federal Food, 
Drug, and Cosmetic Act, as amended by subsection (c)(1) of this 
section, is amended by adding at the end the following paragraph:
    ``(3)(A) No person shall be subject to the penalties of subsection 
(a)(1) or (h) for a violation of section 301(a), 301(b), or 301(c) 
involving the misbranding of food within the meaning of section 403(t) 
or 403(u) if--
            ``(i) such person is an agricultural producer and the 
        violation occurs because food that is grown, raised, or 
        otherwise produced by such producer, which food does not 
        contain a genetically engineered material and was not produced 
        with a genetically engineered material, is contaminated with a 
        food that contains a genetically engineered material or was 
        produced with a genetically engineered material (including 
        contamination by mingling the two), and
            ``(ii) such contamination is not intended by the 
        agricultural producer.
    ``(B) Subparagraph (A) does not apply to an agricultural producer 
to the extent that the contamination occurs as a result of the 
negligence of the producer.''.
    (e) Citizen Suits.--Chapter III of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331 et seq.) is amended by adding at the end 
the following section:

     ``citizen suits regarding misbranding of food with respect to 
                    genetically engineered material

    ``Sec. 311. (a) In General.--Except as provided in subsection (c), 
any person may on his or her behalf commence a civil action in an 
appropriate district court of the United States against--
            ``(1) a person who is alleged to have engaged in a 
        violation of section 301(a), 301(b), or 301(c) involving the 
        misbranding of food within the meaning of section 403(t) or 
        403(u); or
            ``(2) the Secretary where there is alleged a failure of the 
        Secretary to perform any act or duty under section 403(t) or 
        403(u) that is not discretionary.
    ``(b) Relief.--In a civil action under subsection (a), the district 
court involved may, as the case may be--
            ``(1) enforce the compliance of a person with the 
        applicable provisions referred to paragraph (1) of such 
        subsection; or
            ``(2) order the Secretary to perform an act or duty 
        referred to in paragraph (2) of such subsection.
    ``(c) Limitations.--
            ``(1) Notice to secretary.--A civil action may not be 
        commenced under subsection (a)(1) prior to 60 days after the 
        plaintiff has provided to the Secretary notice of the violation 
        involved.
            ``(2) Relation to actions of secretary.--A civil action may 
        not be commenced under subsection (a)(2) if the Secretary has 
        commenced and is diligently prosecuting a civil or criminal 
        action in a district court of the United States to enforce 
        compliance with the applicable provisions referred to in 
        subsection (a)(1).
    ``(d) Right of Secretary to Intervene.--In any civil action under 
subsection (a), the Secretary, if not a party, may intervene as a 
matter of right.
    ``(e) Award of Costs; Filing of Bond.--In a civil action under 
subsection (a), the district court involved may award costs of 
litigation (including reasonable attorney and expert witness fees) to 
any party whenever the court determines such an award is appropriate. 
The court may, if a temporary restraining order or preliminary 
injunction is sought, require the filing of a bond or equivalent 
security in accordance with the Federal Rules of Civil Procedure.
    ``(f) Savings Provision.--This section does not restrict any right 
that a person (or class of persons) may have under any statute or 
common law to seek enforcement of the provisions referred to subsection 
(a)(1), or to seek any other relief (including relief against the 
Secretary).''.

SEC. 4. LABELING REGARDING GENETICALLY ENGINEERED MATERIAL; AMENDMENTS 
              TO FEDERAL MEAT INSPECTION ACT.

    (a) Requirements.--The Federal Meat Inspection Act is amended by 
inserting after section 7 (21 U.S.C. 607) the following section:

``SEC. 7A. REQUIREMENTS FOR LABELING REGARDING GENETICALLY ENGINEERED 
              MATERIAL.

    ``(a) Definitions.--In this section:
            ``(1) The term `meat food' means a carcass, part of a 
        carcass, meat, or meat food product that is derived from 
        cattle, sheep, swine, goats, horses, mules, or other equines 
        and is capable of use as human food.
            ``(2) The term `genetically engineered material' means 
        material derived from any part of a genetically engineered 
        organism, without regard to whether the altered molecular or 
        cellular characteristics of the organism are detectable in the 
        material (and without regard to whether the organism is capable 
        of use as human food).
            ``(3) The term `genetically engineered organism' means--
                    ``(A) an organism that has been altered at the 
                molecular or cellular level by means that are not 
                possible under natural conditions or processes 
                (including but not limited to recombinant DNA and RNA 
                techniques, cell fusion, microencapsulation, 
                macroencapsulation, gene deletion and doubling, 
                introducing a foreign gene, and changing the positions 
                of genes), other than a means consisting exclusively of 
                breeding, conjugation, fermentation, hybridization, in 
vitro fertilization, tissue culture, or mutagenesis; and
                    ``(B) an organism made through sexual or asexual 
                reproduction (or both) involving an organism described 
                in subparagraph (A), if possessing any of the altered 
                molecular or cellular characteristics of the organism 
                so described.
    ``(b) Labeling Requirement.--
            ``(1) Required labeling to avoid misbranding.--
                    ``(A) Involvement of genetically engineered 
                material.--For purposes of sections 1(n) and 10, a meat 
                food is misbranded if it--
                            ``(i) contains a genetically engineered 
                        material or was produced with a genetically 
                        engineered material; and
                            ``(ii) does not bear a label (or include 
                        labeling, in the case of a meat food that is 
                        not packaged in a container) that provides, in 
                        a clearly legible and conspicuous manner, the 
                        notices described in subsection (c).
                    ``(B) No involvement of genetically engineered 
                material.--For purposes of sections 1(n) and 10, a meat 
                food is misbranded if it bears a label indicating that 
                it does not contain a genetically engineered material, 
                or that it was not produced with a genetically 
                engineered material, unless the label is in accordance 
                with regulations promulgated by the Secretary. With 
                respect to such regulations:
                            ``(i) The regulations may not require such 
                        a label to include any statement indicating 
                        that the fact that a meat food does not contain 
                        such material, or was not produced with such 
                        material, has no bearing on the safety of the 
                        food for human consumption.
                            ``(ii) The regulations may not prohibit 
                        such a label on the basis that, in the case of 
                        the type of meat food involved, there is no 
                        version of the food in commercial distribution 
                        that does contain a genetically engineered 
                        material.
            ``(2) Rule of construction.--For purposes of subparagraphs 
        (A)(i) and (B) of paragraph (1), a meat food shall be 
        considered to have been produced with a genetically engineered 
        material if--
                    ``(A) the organism from which the food is derived 
                has been injected or otherwise treated with a 
                genetically engineered material;
                    ``(B) the animal from which the food is derived has 
                been fed genetically engineered material; or
                    ``(C) the food contains an ingredient that is a 
                food to which subparagraph (A) or (B) of this paragraph 
                applies.
            ``(3) Testing.--For purposes of sections 1(n) and 10:
                    ``(A) In the case of the transfer of meat foods 
                from manufacturers or producers to distributors, and 
                from distributors to other distributors or to other 
                persons in the chain of distribution, including persons 
                who hold meat food for sale to consumers, regulations 
                under subparagraphs (A)(i) and (B) of paragraph (1) 
                shall require periodic testing of meat foods by the 
                Secretary for purposes of determining the accuracy of 
                labels under such subparagraphs. Such regulations shall 
                require the use of the best available technology for 
                such testing, and shall identify tests that meet such 
                requirement. This subparagraph and subparagraph (B) of 
                this paragraph do not apply to (i) meat foods that are 
                certified and comply with the Organic Foods Production 
                Act and its implementing regulations; or (ii) meat 
                foods produced with genetically engineered material if 
                the Secretary has not through such regulations 
                identified a validated method of testing for such 
                material in the food; or (iii) genetically engineered 
                material contained in a meat food if the Secretary has 
                not through such regulations identified a validated 
                method of testing for such material in the food.
                    ``(B) A meat food with respect to which a test has 
                been identified under subparagraph (A) shall not be 
                considered to contain a genetically engineered material 
                for purposes of subparagraphs (A)(i) and (B) of 
                paragraph (1) if, as indicated by such a test--
                            ``(i) the food does not contain any 
                        genetically engineered material; or
                            ``(ii) the food contains an adventitious 
                        genetically engineered material and the amount 
                        of the material in the food is one percent or 
                        less, except that a lower percentage designated 
                        by the Secretary shall apply for purposes of 
                        this subparagraph if the Secretary determines 
                        that a test identified under subparagraph (A) 
                        can detect a percentage lower than one percent.
    ``(c) Specifics of Label Notices.--
            ``(1) Required notices.--The notices referred to in 
        subsection (b)(1)(B) are the following:
                    ``(A) A notice as follows: `GENETICALLY 
                ENGINEERED'.
                    ``(B) A notice as follows: `THIS PRODUCT CONTAINS A 
                GENETICALLY ENGINEERED MATERIAL, OR WAS PRODUCED WITH A 
                GENETICALLY ENGINEERED MATERIAL'.
            ``(2) Location and size.--(A) The notice required in 
        paragraph (1)(A) shall immediately precede the notice required 
        in paragraph (1)(B) and shall be not less than twice the size 
        of the notice required in paragraph (1)(B).
            ``(B) The notice required in paragraph (1)(B) shall be of 
        the same size as would apply if the notice provided nutrition 
        information that is required in section 403(q)(1) of the 
        Federal Food, Drug, and Cosmetic Act.
    ``(d) Exceptions to Requirements.--Subsection (a) does not apply to 
any meat food that--
            ``(1) is served in restaurants or other establishments in 
        which food is served for immediate human consumption; or
            ``(2) is processed and prepared primarily in a retail 
        establishment, is ready for human consumption, is offered for 
        sale to consumers but not for immediate human consumption in 
        such establishment, and is not offered for sale outside such 
        establishment.
    ``(e) Guaranty.--
            ``(1) In general.--Subject to subsection (b)(3)(A) and 
        paragraph (3), a packer, processor, or other person shall not 
        be considered to have violated the requirements of this section 
        with respect to the labeling of meat food if the packer, 
        processor, or other person (referred to in this subsection as 
        the `recipient') establishes a guaranty or undertaking signed 
        by, and containing the name and address of, the person residing 
        in the United States from whom the recipient received in good 
        faith the meat food or the animal from which the meat food was 
        derived, or received in good faith food intended to be fed to 
        such animal, to the effect that the meat food, or such animal, 
        or such food, respectively, does not contain genetically 
        engineered material or was not produced with a genetically 
        engineered material.
            ``(2) Scope of guaranty.--In the case of a recipient who 
        establishes a guaranty or undertaking in accordance with 
        paragraph (1), the exclusion under such paragraph from being 
        subject to penalties applies to the recipient without regard to 
        the use of the meat food by the recipient (or the use by the 
        recipient of the animal from which the meat food was derived, 
        or of food intended to be fed to such animal), including--
                    ``(A) processing the meat food;
                    ``(B) using the meat food as an ingredient in 
                another food product;
                    ``(C) packing or repacking the meat food; or
                    ``(D) raising the animal from which the meat food 
                was derived.
            ``(3) Testing.--In the case of recipients who establish 
        guaranties or undertakings in accordance with paragraph (1), 
        regulations under subsection (b)(3)(A) may exempt the 
        recipients from the requirement under such subsection regarding 
        testing of the meat food involved (relating to the accuracy of 
        labels regarding genetically engineered material). In 
        determining whether to establish such exemptions, the Secretary 
        shall, with respect to the meat food involved, take into 
        account the number of times the food has been transferred from 
        one recipient to another, the number of recipients who took any 
        of the actions described in paragraph (2), and such other 
        factors as the Secretary determines to be appropriate.
            ``(4) False guaranty.--It is a violation of this Act for a 
        person to give a guaranty or undertaking in accordance with 
        paragraph (1) that the person knows or has reason to know is 
        false.
    ``(f) Civil Penalties.--
            ``(1) In general.--The Secretary may assess a civil penalty 
        against a person that violates subsection (b) or (c)(2) in an 
        amount not to exceed $100,000 for each such violation.
            ``(2) Notice and opportunity for hearing.--A civil penalty 
        under paragraph (1) shall be assessed by the Secretary by an 
        order made on the record after opportunity for a hearing 
        provided in accordance with this subparagraph and section 554 
        of title 5, United States Code. Before issuing such an order, 
        the Secretary shall give written notice to the person to be 
        assessed a civil penalty under such order of the Secretary's 
        proposal to issue such order and provide such person an 
        opportunity for a hearing on the order. In the course of any 
        investigation, the Secretary may issue subpoenas requiring the 
        attendance and testimony of witnesses and the production of 
        evidence that relates to the matter under investigation.
            ``(3) Considerations regarding amount of penalty.--In 
        determining the amount of a civil penalty under paragraph (1), 
        the Secretary shall take into account the nature, 
        circumstances, extent, and gravity of the violation or 
        violations and, with respect to the violator, ability to pay, 
        effect on ability to continue to do business, any history of 
        prior such violations, the degree of culpability, and such 
        other matters as justice may require.
            ``(4) Certain authorities.--The Secretary may compromise, 
        modify, or remit, with or without conditions, any civil penalty 
        under paragraph (1). The amount of such penalty, when finally 
        determined, or the amount agreed upon in compromise, may be 
        deducted from any sums owing by the United States to the person 
        charged.
            ``(5) Judicial review.--Any person who requested, in 
        accordance with paragraph (2), a hearing respecting the 
        assessment of a civil penalty under paragraph (1) and who is 
        aggrieved by an order assessing a civil penalty may file a 
        petition for judicial review of such order with the United 
        States Court of Appeals for the District of Columbia Circuit or 
        for any other circuit in which such person resides or transacts 
        business. Such a petition may only be filed within the 60-day 
        period beginning on the date the order making such assessment 
        was issued.
            ``(6) Failure to pay.--If a person fails to pay an 
        assessment of a civil penalty--
                    ``(A) after the order making the assessment becomes 
                final, and if such person does not file a petition for 
                judicial review of the order in accordance with 
                paragraph (5); or
                    ``(B) after a court in an action brought under 
                paragraph (4) has entered a final judgment in favor of 
                the Secretary;
        the Attorney General shall recover the amount assessed (plus 
        interest at currently prevailing rates from the date of the 
        expiration of the 60-day period referred to in paragraph (5) or 
        the date of such final judgment, as the case may be) in an 
        action brought in any appropriate district court of the United 
        States. In such an action, the validity, amount, 
and appropriateness of such penalty shall not be subject to review.
    ``(g) Citizen Suits.--
            ``(1) In general.--Except as provided in paragraph (3), any 
        person may on his or her behalf commence a civil action in an 
        appropriate district court of the United States against--
                    ``(A) a person who is alleged to have engaged in a 
                violation of subsection (b) or (c)(2); or
                    ``(B) the Secretary where there is alleged a 
                failure of the Secretary to perform any act or duty 
                under subsection (b) or (c)(2) that is not 
                discretionary.
            ``(2) Relief.--In a civil action under paragraph (1), the 
        district court involved may, as the case may be--
                    ``(A) enforce the compliance of a person with the 
                applicable provisions referred to subparagraph (A) of 
                such paragraph; or
                    ``(B) order the Secretary to perform an act or duty 
                referred to in subparagraph (B) of such paragraph.
            ``(3) Limitations.--
                    ``(A) Notice to secretary.--A civil action may not 
                be commenced under paragraph (1)(A) prior to 60 days 
                after the plaintiff has provided to the Secretary 
                notice of the violation involved.
                    ``(B) Relation to actions of secretary.--A civil 
                action may not be commenced under paragraph (1)(B) if 
                the Secretary has commenced and is diligently 
                prosecuting a civil or criminal action in a district 
                court of the United States to enforce compliance with 
                the applicable provisions referred to in paragraph 
                (1)(A).
            ``(4) Right of secretary to intervene.--In any civil action 
        under paragraph (1), the Secretary, if not a party, may 
        intervene as a matter of right.
            ``(5) Award of costs; filing of bond.--In a civil action 
        under paragraph (1), the district court involved may award 
        costs of litigation (including reasonable attorney and expert 
        witness fees) to any party whenever the court determines such 
        an award is appropriate. The court may, if a temporary 
        restraining order or preliminary injunction is sought, require 
        the filing of a bond or equivalent security in accordance with 
        the Federal Rules of Civil Procedure.
            ``(6) Savings provision.--This subsection does not restrict 
        any right that a person (or class of persons) may have under 
        any statute or common law to seek enforcement of the provisions 
        referred to paragraph (1)(A), or to seek any other relief 
        (including relief against the Secretary).''.
    (b) Inclusion of Labeling Requirements in Definition of 
Misbranded.--Section 1(n) of the Federal Meat Inspection Act (21 U.S.C. 
601(n)) is amended--
            (1) by striking ``or'' at the end of paragraph (11);
            (2) by striking the period at the end of paragraph (12) and 
        inserting ``; or''; and
            (3) by adding at the end the following paragraph:
            ``(13) if it fails to bear a label or labeling as required 
        by section 7A.''.

SEC. 5. LABELING REGARDING GENETICALLY ENGINEERED MATERIAL; AMENDMENTS 
              TO POULTRY PRODUCTS INSPECTION ACT.

    (a) The Poultry Products Inspection Act is amended by inserting 
after section 8 (21 U.S.C. 457) the following section:

``SEC. 8A. REQUIREMENTS FOR LABELING REGARDING GENETICALLY ENGINEERED 
              MATERIAL.

    ``(a) Definitions.--In this section:
            ``(1) The term `genetically engineered material' means 
        material derived from any part of a genetically engineered 
        organism, without regard to whether the altered molecular or 
        cellular characteristics of the organism are detectable in the 
        material (and without regard to whether the organism is capable 
        of use as human food).
            ``(2) The term `genetically engineered organism' means--
                    ``(A) an organism that has been altered at the 
                molecular or cellular level by means that are not 
                possible under natural conditions or processes 
                (including but not limited to recombinant DNA and RNA 
                techniques, cell fusion, microencapsulation, 
                macroencapsulation, gene deletion and doubling, 
                introducing a foreign gene, and changing the positions 
                of genes), other than a means consisting exclusively of 
                breeding, conjugation, fermentation, hybridization, in 
                vitro fertilization, tissue culture, or mutagenesis; 
                and
                    ``(B) an organism made through sexual or asexual 
                reproduction (or both) involving an organism described 
                in subparagraph (A), if possessing any of the altered 
                molecular or cellular characteristics of the organism 
                so described.
    ``(b) Labeling Requirement.--
            ``(1) Required labeling to avoid misbranding.--
                    ``(A) Involvement of genetically engineered 
                material.--For purposes of sections 4(h) and 9(a), a 
                poultry product is misbranded if it--
                            ``(i) contains a genetically engineered 
                        material or was produced with a genetically 
                        engineered material; and
                            ``(ii) does not bear a label (or include 
                        labeling, in the case of a poultry product that 
                        is not packaged in a container) that provides, 
                        in a clearly legible and conspicuous manner, 
                        the notices described in subsection (c).
                    ``(B) No involvement of genetically engineered 
                material.--For purposes of sections 4(h) and 9(a), a 
                poultry product is misbranded if it bears a label 
                indicating that it does not contain a genetically 
                engineered material, or that it was not produced with a 
                genetically engineered material, unless the label is in 
                accordance with regulations promulgated by the 
                Secretary. With respect to such regulations:
                            ``(i) The regulations may not require such 
                        a label to include any statement indicating 
                        that the fact that a poultry product does not 
                        contain such material, or was not produced with 
                        such material, has no bearing on the safety of 
                        the product for human consumption.
                            ``(ii) The regulations may not prohibit 
                        such a label on the basis that, in the case of 
                        the type of poultry product involved, there is 
                        no version of the product in commercial 
                        distribution that does contain a genetically 
                        engineered material.
            ``(2) Rule of construction.--For purposes of paragraph 
        subparagraphs (A)(i) and (B) of paragraph (1), a poultry 
        product shall be considered to have been produced with a 
        genetically engineered material if--
                    ``(A) the poultry from which the food is derived 
                has been injected or otherwise treated with a 
                genetically engineered material;
                    ``(B) the poultry from which the food is derived 
                has been fed genetically engineered material; or
                    ``(C) the food contains an ingredient that is a 
                food to which subparagraph (A) or (B) of this paragraph 
                applies.
            ``(3) Testing.--For purposes of sections 4(h) and 9(a):
                    ``(A) In the case of the transfer of poultry 
                products from manufacturers or producers to 
                distributors, and from distributors to other 
                distributors or to other persons in the chain of 
                distribution, including persons who hold poultry 
                products for sale to consumers, regulations under 
                subparagraphs (A)(i) and (B) of paragraph (1) shall 
                require periodic testing of poultry products by the 
                Secretary for purposes of determining the accuracy of 
                labels under such subparagraphs. Such regulations shall 
                require the use of the best available technology for 
                such testing, and shall identify tests that meet such 
                requirement. This subparagraph and subparagraph (B) of 
                this paragraph do not apply to (i) poultry products 
                that are certified and comply with the Organic Foods 
                Production Act and its implementing regulations; or 
                (ii) poultry products produced with genetically 
                engineered material if the Secretary has not through 
                such regulations identified a validated method of 
                testing for such material in the food; or (iii) 
                genetically engineered material contained in a poultry 
                products if the Secretary has not through such 
                regulations identified a validated method of testing 
                for such material in the product.
                    ``(B) A poultry product with respect to which a 
                test has been identified under subparagraph (A) shall 
                not be considered to contain a genetically engineered 
                material for purposes of subparagraphs (A)(i) and (B) 
                of paragraph (1) if, as indicated by such a test--
                            ``(i) the product does not contain any 
                        genetically engineered material; or
                            ``(ii) the product contains an adventitious 
                        genetically engineered material and the amount 
                        of the material in the product is one percent 
                        or less, except that a lower percentage 
                        designated by the Secretary shall apply for 
                        purposes of this subparagraph if the Secretary 
                        determines that a test identified under 
                        subparagraph (A) can detect a percentage lower 
                        than one percent.
    ``(c) Specifics of Label Notices.--
            ``(1) Required notices.--The notices referred to in 
        subsection (b)(1)(B) are the following:
                    ``(A) A notice as follows: `GENETICALLY 
                ENGINEERED'.
                    ``(B) A notice as follows: `THIS PRODUCT CONTAINS A 
                GENETICALLY ENGINEERED MATERIAL, OR WAS PRODUCED WITH A 
                GENETICALLY ENGINEERED MATERIAL'.
            ``(2) Location and size.--(A) The notice required in 
        paragraph (1)(A) shall immediately precede the notice required 
        in paragraph (1)(B) and shall be not less than twice the size 
        of the notice required in paragraph (1)(B).
            ``(B) The notice required in paragraph (1)(B) shall be of 
        the same size as would apply if the notice provided nutrition 
        information that is required in section 403(q)(1) of the 
Federal Food, Drug, and Cosmetic Act.
    ``(d) Exceptions to Requirements.--Subsection (a) does not apply to 
any poultry product that--
            ``(1) is served in restaurants or other establishments in 
        which food is served for immediate human consumption; or
            ``(2) is processed and prepared primarily in a retail 
        establishment, is ready for human consumption, is offered for 
        sale to consumers but not for immediate human consumption in 
        such establishment, and is not offered for sale outside such 
        establishment.
    ``(e) Guaranty.--
            ``(1) In general.--Subject to subsection (b)(3)(A) and 
        paragraph (3), an official establishment or other person shall 
        not be considered to have violated the requirements of this 
        section with respect to the labeling of a poultry product if 
        the official establishment or other person (referred to in this 
        subsection as the `recipient') establishes a guaranty or 
        undertaking signed by, and containing the name and address of, 
        the person residing in the United States from whom the 
        recipient received in good faith the poultry product or the 
        poultry from which the poultry product was derived, or received 
        in good faith food intended to be fed to poultry, to the effect 
        that the poultry product, poultry, or such food, respectively, 
        does not contain genetically engineered material or was not 
        produced with a genetically engineered material.
            ``(2) Scope of guaranty.--In the case of a recipient who 
        establishes a guaranty or undertaking in accordance with 
        paragraph (1), the exclusion under such paragraph from being 
        subject to penalties applies to the recipient without regard to 
        the use of the poultry product by the recipient (or the use by 
        the recipient of the poultry from which the poultry product was 
        derived, or of food intended to be fed to such poultry), 
        including--
                    ``(A) processing the poultry;
                    ``(B) using the poultry product as an ingredient in 
                another food product;
                    ``(C) packing or repacking the poultry product; or
                    ``(D) raising the poultry from which the poultry 
                product was derived.
            ``(3) Testing.--In the case of recipients who establish 
        guaranties or undertakings in accordance with paragraph (1), 
        regulations under subsection (b)(3)(A) may exempt the 
        recipients from the requirement under such subsection regarding 
        testing of the poultry product involved (relating to the 
        accuracy of labels regarding genetically engineered material). 
        In determining whether to establish such exemptions, the 
        Secretary shall, with respect to the poultry product involved, 
        take into account the number of times the product has been 
        transferred from one recipient to another, the number of 
        recipients who took any of the actions described in paragraph 
        (2), and such other factors as the Secretary determines to be 
        appropriate.
            ``(4) False guaranty.--It is a violation of this Act for a 
        person to give a guaranty or undertaking in accordance with 
        paragraph (1) that the person knows or has reason to know is 
        false.
    ``(f) Civil Penalties.--
            ``(1) In general.--The Secretary may assess a civil penalty 
        against a person that violates subsection (b) or (c)(2) in an 
        amount not to exceed $100,000 for each such violation.
            ``(2) Notice and opportunity for hearing.--A civil penalty 
        under paragraph (1) shall be assessed by the Secretary by an 
        order made on the record after opportunity for a hearing 
        provided in accordance with this subparagraph and section 554 
        of title 5, United States Code. Before issuing such an order, 
        the Secretary shall give written notice to the person to be 
        assessed a civil penalty under such order of the Secretary's 
        proposal to issue such order and provide such person an 
        opportunity for a hearing on the order. In the course of any 
        investigation, the Secretary may issue subpoenas requiring the 
        attendance and testimony of witnesses and the production of 
        evidence that relates to the matter under investigation.
            ``(3) Considerations regarding amount of penalty.--In 
        determining the amount of a civil penalty under paragraph (1), 
        the Secretary shall take into account the nature, 
        circumstances, extent, and gravity of the violation or 
        violations and, with respect to the violator, ability to pay, 
        effect on ability to continue to do business, any history of 
        prior such violations, the degree of culpability, and such 
        other matters as justice may require.
            ``(4) Certain authorities.--The Secretary may compromise, 
        modify, or remit, with or without conditions, any civil penalty 
        under paragraph (1). The amount of such penalty, when finally 
        determined, or the amount agreed upon in compromise, may be 
deducted from any sums owing by the United States to the person 
charged.
            ``(5) Judicial review.--Any person who requested, in 
        accordance with paragraph (2), a hearing respecting the 
        assessment of a civil penalty under paragraph (1) and who is 
        aggrieved by an order assessing a civil penalty may file a 
        petition for judicial review of such order with the United 
        States Court of Appeals for the District of Columbia Circuit or 
        for any other circuit in which such person resides or transacts 
        business. Such a petition may only be filed within the 60-day 
        period beginning on the date the order making such assessment 
        was issued.
            ``(6) Failure to pay.--If a person fails to pay an 
        assessment of a civil penalty--
                    ``(A) after the order making the assessment becomes 
                final, and if such person does not file a petition for 
                judicial review of the order in accordance with 
                paragraph (5); or
                    ``(B) after a court in an action brought under 
                paragraph (4) has entered a final judgment in favor of 
                the Secretary;
        the Attorney General shall recover the amount assessed (plus 
        interest at currently prevailing rates from the date of the 
        expiration of the 60-day period referred to in paragraph (5) or 
        the date of such final judgment, as the case may be) in an 
        action brought in any appropriate district court of the United 
        States. In such an action, the validity, amount, and 
        appropriateness of such penalty shall not be subject to review.
    ``(g) Citizen Suits.--
            ``(1) In general.--Except as provided in paragraph (3), any 
        person may on his or her behalf commence a civil action in an 
        appropriate district court of the United States against--
                    ``(A) a person who is alleged to have engaged in a 
                violation of subsection (b) or (c)(2); or
                    ``(B) the Secretary where there is alleged a 
                failure of the Secretary to perform any act or duty 
                under subsection (b) or (c)(2) that is not 
                discretionary.
            ``(2) Relief.--In a civil action under paragraph (1), the 
        district court involved may, as the case may be--
                    ``(A) enforce the compliance of a person with the 
                applicable provisions referred to subparagraph (A) of 
                such paragraph; or
                    ``(B) order the Secretary to perform an act or duty 
                referred to in subparagraph (B) of such paragraph.
            ``(3) Limitations.--
                    ``(A) Notice to secretary.--A civil action may not 
                be commenced under paragraph (1)(A) prior to 60 days 
                after the plaintiff has provided to the Secretary 
                notice of the violation involved.
                    ``(B) Relation to actions of secretary.--A civil 
                action may not be commenced under paragraph (1)(B) if 
                the Secretary has commenced and is diligently 
                prosecuting a civil or criminal action in a district 
                court of the United States to enforce compliance with 
                the applicable provisions referred to in paragraph 
                (1)(A).
            ``(4) Right of secretary to intervene.--In any civil action 
        under paragraph (1), the Secretary, if not a party, may 
        intervene as a matter of right.
            ``(5) Award of costs; filing of bond.--In a civil action 
        under paragraph (1), the district court involved may award 
        costs of litigation (including reasonable attorney and expert 
        witness fees) to any party whenever the court determines such 
        an award is appropriate. The court may, if a temporary 
        restraining order or preliminary injunction is sought, require 
        the filing of a bond or equivalent security in accordance with 
        the Federal Rules of Civil Procedure.
            ``(6) Savings provision.--This subsection does not restrict 
        any right that a person (or class of persons) may have under 
        any statute or common law to seek enforcement of the provisions 
        referred to paragraph (1)(A), or to seek any other relief 
        (including relief against the Secretary).''.
    (b) Inclusion of Labeling Requirements in Definition of 
Misbranded.--Section 4(h) of the Poultry Products Inspection Act (21 
U.S.C. 453(h)) is amended--
            (1) by striking ``or'' at the end of paragraph (11);
            (2) by striking the period at the end of paragraph (12) and 
        inserting ``; or''; and
            (3) by adding at the end the following paragraph:
            ``(13) if it fails to bear a label or labeling as required 
        by section 8A.''.

SEC. 6. EFFECTIVE DATE.

    This Act and the amendments made by this Act take effect upon the 
expiration of the 180-day period beginning on the date of the enactment 
of this Act.
                                 <all>