S. 414 (110th): Cloned Food Labeling Act

110th Congress, 2007–2009. Text as of Jan 26, 2007 (Introduced).

Status & Summary | PDF | Source: GPO

II

110th CONGRESS

1st Session

S. 414

IN THE SENATE OF THE UNITED STATES

January 26, 2007

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.

1.

Short title

This Act may be cited as the Cloned Food Labeling Act.

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:

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).

.

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:

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.

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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.