[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 414 Introduced in Senate (IS)]







110th CONGRESS
  1st Session
                                 S. 414

To amend the Federal Food, Drug, and Cosmetic Act and the Federal Meat 
Inspection Act to require that food that contains product from a cloned 
         animal be labeled accordingly, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            January 26, 2007

 Ms. Mikulski introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act and the Federal Meat 
Inspection Act to require that food that contains product from a cloned 
         animal be labeled accordingly, 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 ``Cloned Food Labeling Act''.

SEC. 2. AMENDMENTS TO THE 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:
    ``(z)(1) If it contains cloned product unless it bears a label that 
provides notice in accordance with the following:
            ``(A) A notice as follows: `THIS PRODUCT IS FROM A CLONED 
        ANIMAL OR ITS PROGENY'.
            ``(B) The notice required in clause (A) is of the same size 
        as would apply if the notice provided nutrition information 
        that is required in paragraph (q)(1).
            ``(C) The notice required under clause (A) is clearly 
        legible and conspicuous.
    ``(2) For purposes of this paragraph:
            ``(A) The term `cloned animal' means--
                    ``(i) an animal produced as the result of somatic 
                cell nuclear transfer; and
                    ``(ii) the progeny of such an animal.
            ``(B) The term `cloned product' means a product or 
        byproduct derived from or containing any part of a cloned 
        animal.
    ``(3) This paragraph does not apply to food that is a medical food 
as defined in section 5(b) of the Orphan Drug Act.
    ``(4)(A) The Secretary, in consultation with the Secretary of 
Agriculture, shall require that any person that prepares, stores, 
handles, or distributes a cloned product for retail sale maintain a 
verifiable recordkeeping audit trail that will permit the Secretary to 
verify compliance with this paragraph and paragraph (aa).
    ``(B) The Secretary, in consultation with the Secretary of 
Agriculture, shall publish in the Federal Register the procedures 
established by such Secretaries to verify compliance with the 
recordkeeping audit trail system required under clause (A).
    ``(C) The Secretary, in consultation with the Secretary of 
Agriculture, shall, on annual basis, submit to Congress a report that 
describes the progress and activities of the recordkeeping audit trail 
system and compliance verification procedures required under this 
subparagraph.
    ``(aa) If it bears a label indicating (within the meaning of 
paragraph (z)) that it does not contain cloned product, 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 product 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 such product.''.
    (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:
    ``(g)(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(z) or 403(aa), 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 (f) 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 (f).''.
    (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) Subject to section 403(z)(4), 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(z) and 403(aa) 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 to the effect that (within the meaning of 
section 403(z)) the food does not contain any cloned product.''.
            (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) 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:

``SEC. 311. CITIZEN SUITS REGARDING MISBRANDING OF FOOD WITH RESPECT TO 
              PRODUCT FROM CLONED ANIMALS.

    ``(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(z) or 
        403(aa); or
            ``(2) the Secretary where there is alleged a failure of the 
        Secretary to perform any act or duty under section 403(z) or 
        403(aa) 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. 3. AMENDMENTS TO THE FEDERAL MEAT INSPECTION ACT.

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

``SEC. 7A. REQUIREMENTS FOR LABELING REGARDING CLONED MEAT FOOD 
              PRODUCTS.

    ``(a) Definitions.--In this section:
            ``(1) Cloned animal.--The term `cloned animal' means--
                    ``(A) an animal produced as the result of somatic 
                cell nuclear transfer; and
                    ``(B) the progeny of such an animal.
            ``(2) Cloned product.--The term `cloned product' means a 
        product or byproduct derived from or containing any part of a 
        cloned animal.
            ``(3) Cloned meat food product.--The term `cloned meat food 
        product' means a meat food product that contains a cloned 
        product.
    ``(b) Labeling Requirement.--
            ``(1) Required labeling to avoid misbranding.--
                    ``(A) Involvement of cloned meat food product.--For 
                purposes of sections 1(n) and 10, a meat food product 
                is misbranded if the meat food product--
                            ``(i) is a cloned meat food product; and
                            ``(ii) does not bear a label (or include 
                        labeling, in the case of a meat food product 
                        that is not packaged in a container) that 
                        provides, in a clearly legible and conspicuous 
                        manner, the notice described in subsection (c).
                    ``(B) No involvement of cloned meat food product.--
                            ``(i) In general.--For purposes of sections 
                        1(n) and 10, a meat food product is misbranded 
                        if the meat food product bears a label 
                        indicating that the meat food product is not a 
                        cloned meat food product, unless the label is 
                        in accordance with regulations promulgated by 
                        the Secretary.
                            ``(ii) Requirements.--In promulgating 
                        regulations referred to in clause (i), the 
                        Secretary may not--
                                    ``(I) require a label to include 
                                any statement indicating that the fact 
                                that a meat food product is not a 
                                cloned meat food product has no bearing 
                                on the safety of the food for human 
                                consumption; or
                                    ``(II) prohibit a label on the 
                                basis that, in the case of the type of 
                                meat food product involved, there is no 
                                version of the meat food product in 
                                commercial distribution that is not a 
                                cloned meat food product.
            ``(2) Audit verification system.--
                    ``(A) In general.--The Secretary, in consultation 
                with the Secretary of Health and Human Services, shall 
                require that any person that manufactures, produces, 
                distributes, stores, or handles a meat food product 
                maintain a verifiable recordkeeping audit trail that 
                will permit the Secretary to verify compliance with the 
                labeling requirements described in paragraph (1).
                    ``(B) Publication.--The Secretary, in consultation 
                with the Secretary of Health and Human Services, shall 
                publish in the Federal Register the procedures 
                established by the Secretaries to verify compliance 
                with the recordkeeping audit trail system required 
                under subparagraph (A).
                    ``(C) Report.--The Secretary, in consultation with 
                the Secretary of Health and Human Services, shall, on 
                annual basis, submit to Congress a report that 
                describes the progress and activities of the 
                recordkeeping audit trail system and compliance 
                verification procedures required under this paragraph.
    ``(c) Specifics of Label Notice.--
            ``(1) Required notice.--The notice referred to in 
        subsection (b)(1)(A)(ii) is the following: `THIS PRODUCT IS 
        FROM A CLONED ANIMAL OR ITS PROGENY'.
            ``(2) Size.--The notice required in paragraph (1) shall be 
        of the same size as if the notice provided nutrition 
        information that is required under section 403(q)(1) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(1)).
    ``(d) Guaranty.--
            ``(1) In general.--Subject to subsection (b)(2) and 
        paragraph (2), a person engaged in the business of 
        manufacturing or processing meat food products, or selling or 
        serving meat food products at retail or through a food service 
        establishment (referred to in this subsection as the 
        `recipient') shall not be considered to have violated this 
        section with respect to the labeling of a meat food product if 
        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 product or the animal from which the meat 
        food product was derived, or received in good faith food 
        intended to be fed to the animal, to the effect that the meat 
        food product, or the animal, or the meat food product, 
        respectively, does not contain a cloned product or was not 
        produced with a cloned product.
            ``(2) Audit verification system.--In the case of recipients 
        who establish guaranties or undertakings in accordance with 
        paragraph (1), the Secretary may exempt the recipients from the 
        requirement under subsection (b)(2) regarding maintaining a 
        verifiable recordkeeping audit trail.
            ``(3) 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.
    ``(e) Civil Penalties.--
            ``(1) In general.--The Secretary may assess a civil penalty 
        against a person that violates subsection (b) or (c) in an 
        amount not to exceed $100,000 for each violation.
            ``(2) Notice and opportunity for hearing.--
                    ``(A) In general.--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 paragraph and section 554 of 
                title 5, United States Code.
                    ``(B) Written notice.--Before issuing an order 
                under subparagraph (A), the Secretary shall--
                            ``(i) give written notice to the person to 
                        be assessed a civil penalty under the order of 
                        the proposal of the Secretary to issue the 
                        order; and
                            ``(ii) provide the person an opportunity 
                        for a hearing on the order.
                    ``(C) Authorizations.--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 consider--
                    ``(A) the nature, circumstances, extent, and 
                gravity of the 1 or more violations; and
                    ``(B) with respect to the violator--
                            ``(i) ability to pay;
                            ``(ii) effect on ability to continue to do 
                        business;
                            ``(iii) any history of prior violations;
                            ``(iv) the degree of culpability; and
                            ``(v) such other matters as justice may 
                        require.
            ``(4) Certain authorities.--
                    ``(A) In general.--The Secretary may compromise, 
                modify, or remit, with or without conditions, any civil 
                penalty under paragraph (1).
                    ``(B) Deduction from sums owed.--The amount of a 
                civil penalty under this subsection, 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.--
                    ``(A) In general.--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 the order 
                with--
                            ``(i) the United States Court of Appeals 
                        for the District of Columbia Circuit; or
                            ``(ii) any other circuit in which the 
                        person resides or transacts business.
                    ``(B) Filing deadline.--A petition described in 
                subparagraph (A) may only be filed within the 60-day 
                period beginning on the date the order making the 
                assessment was issued.
            ``(6) Failure to pay.--
                    ``(A) In general.--The Attorney General shall 
                recover the amount assessed under a civil penalty (plus 
                interest at prevailing rates from the date of the 
                expiration of the 60-day period referred to in 
                paragraph (5)(B) or the date of the final judgment, as 
                appropriate) in an action brought in any appropriate 
                district court of the United States if a person fails 
                to pay the assessment--
                            ``(i) after the order making the assessment 
                        becomes final, if the person does not file a 
                        petition for judicial review of the order in 
                        accordance with paragraph (5)(A); or
                            ``(ii) after a court in an action brought 
                        under paragraph (5) has entered a final 
                        judgment in favor of the Secretary;
                    ``(B) Exemptions from review.--In an action 
                described in subparagraph (A), the validity, amount, 
                and appropriateness of the civil penalty shall not be 
                subject to review.
    ``(f) 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); or
                    ``(B) the Secretary in a case in which there is 
                alleged a failure of the Secretary to perform any act 
                or duty under subsection (b) or (c) that is not 
                discretionary.
            ``(2) Relief.--In a civil action under paragraph (1), the 
        district court involved may, as appropriate--
                    ``(A) enforce the compliance of a person with the 
                applicable provisions referred to paragraph (1)(A); or
                    ``(B) order the Secretary to perform an act or duty 
                referred to in paragraph (1)(B).
            ``(3) Limitations.--
                    ``(A) Notice to secretary.--A civil action may not 
                be commenced under paragraph (1)(A) prior to 60 days 
                after the date on which the plaintiff 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.--
                    ``(A) Award of costs.--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 in any case in which 
                the court determines such an award is appropriate.
                    ``(B) Filing of bond.--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--
                    ``(A) to seek enforcement of the provisions 
                referred to in paragraph (1)(A); or
                    ``(B) 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:
            ``(13) if it fails to bear a label or labeling as required 
        by section 7A.''.

SEC. 4. EFFECTIVE DATE.

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