110th CONGRESS
1st Session
H. R. 992
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 HOUSE OF REPRESENTATIVES
February 12, 2007
Ms. DELAURO 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 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 subsection (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 subsection (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).'.
(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.
`(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 an 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)).
`(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.
`(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--
`(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.
`(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.
`(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.
`(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).
`(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.
END
