I 
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 Com-
mittee 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 juris-
diction 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 Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Cloned Food Labeling 
Act’’. 
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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 fol-
lowing: 
‘‘(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 nu-
trition 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 prod-
uct or byproduct derived from or containing any 
part of a cloned animal. 
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‘‘(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 Sec-
retary 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 Sec-
retary of Agriculture, shall publish in the Federal Register 
the procedures established by such Secretaries to verify 
compliance with the recordkeeping audit trail system re-
quired under clause (A). 
‘‘(C) The Secretary, in consultation with the Sec-
retary of Agriculture, shall, on annual basis, submit to 
Congress a report that describes the progress and activi-
ties of the recordkeeping audit trail system and compli-
ance verification procedures required under this subpara-
graph. 
‘‘(aa) If it bears a label indicating (within the mean-
ing of subsection (z)) that it does not contain cloned prod-
uct, unless the label is in accordance with regulations pro-
mulgated by the Secretary. With respect to such regula-
tions: 
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‘‘(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 con-
sumption. 
‘‘(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 com-
mercial distribution that does contain such prod-
uct.’’. 
(b) CIVIL PENALTIES.—Section 303 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend-
ed 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 en-
gaging 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 man-
ner as such paragraphs (3) through (5) apply with respect 
to a civil penalty under paragraph (1) or (2) of subsection 
(f).’’. 
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(c) GUARANTY.— 
(1) IN GENERAL.—Section 303(d) of the Fed-
eral 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 re-
cipient 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)’’. 
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(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) in-
volving the misbranding of food within the meaning 
of section 403(z) or 403(aa); or 
‘‘(2) the Secretary where there is alleged a fail-
ure of the Secretary to perform any act or duty 
under section 403(z) or 403(aa) that is not discre-
tionary. 
‘‘(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. 
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‘‘(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 sub-
section (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 com-
pliance 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 attor-
ney 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 in-
junction is sought, require the filing of a bond or equiva-
lent security in accordance with the Federal Rules of Civil 
Procedure. 
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‘‘(f) SAVINGS PROVISION.—This section does not re-
strict any right that a person (or class of persons) may 
have under any statute or common law to seek enforce-
ment of the provisions referred to subsection (a)(1), or to 
seek any other relief (including relief against the Sec-
retary).’’. 
SEC. 3. AMENDMENTS TO THE FEDERAL MEAT INSPECTION 
ACT. 
(a) REQUIREMENTS
FOR
LABELING
REGARDING 
CLONED MEAT FOOD PRODUCTS.—The Federal Meat In-
spection 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 ani-
mal’ 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. 
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unless the label is in accordance with regu-
lations promulgated by the Secretary. 
‘‘(ii) 
REQUIREMENTS.—In 
promul-
gating 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 bear-
ing 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 con-
sultation 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 per-
mit the Secretary to verify compliance with the 
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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 Sec-
retaries to verify compliance with the record-
keeping audit trail system required under sub-
paragraph (A). 
‘‘(C) REPORT.—The Secretary, in con-
sultation with the Secretary of Health and 
Human Services, shall, on an annual basis, sub-
mit 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 
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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 (re-
ferred 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 under-
takings in accordance with paragraph (1), the Sec-
retary may exempt the recipients from the require-
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ment 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 under-
taking 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 sub-
section (b) or (c) in an amount not to exceed 
$100,000 for each violation. 
‘‘(2) NOTICE
AND
OPPORTUNITY
FOR
HEAR-
ING.— 
‘‘(A) IN GENERAL.—A civil penalty under 
paragraph (1) shall be assessed by the Sec-
retary by an order made on the record after op-
portunity 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 
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order of the proposal of the Secretary to 
issue the order; and 
‘‘(ii) provide the person an oppor-
tunity for a hearing on the order. 
‘‘(C) AUTHORIZATIONS.—In the course of 
any investigation, the Secretary may issue sub-
poenas 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.— 
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‘‘(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 sub-
section, 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 re-
quested, in accordance with paragraph (2), a 
hearing respecting the assessment of a civil 
penalty under paragraph (1) and who is ag-
grieved by an order assessing a civil penalty 
may file a petition for judicial review of the 
order with— 
‘‘(i) the United States Court of Ap-
peals for the District of Columbia Circuit; 
or 
‘‘(ii) any other circuit in which the 
person resides or transacts business. 
‘‘(B) FILING
DEADLINE.—A petition de-
scribed in subparagraph (A) may only be filed 
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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 as-
sessment— 
‘‘(i) after the order making the assess-
ment 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 valid-
ity, amount, and appropriateness of the civil 
penalty shall not be subject to review. 
‘‘(f) CITIZEN SUITS.— 
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‘‘(1) IN GENERAL.—Except as provided in para-
graph (3), any person may on his or her behalf com-
mence a civil action in an appropriate district court 
of the United States against— 
‘‘(A) a person who is alleged to have en-
gaged 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 para-
graph (1), the district court involved may, as appro-
priate— 
‘‘(A) enforce the compliance of a person 
with the applicable provisions referred to para-
graph (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 ac-
tion 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. 
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‘‘(B) RELATION
TO
ACTIONS
OF
SEC-
RETARY.—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 Sec-
retary, 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 reason-
able 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 in-
junction is sought, require the filing of a bond 
or equivalent security in accordance with the 
Federal Rules of Civil Procedure. 
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‘‘(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 re-
lief against the Secretary).’’. 
(b) INCLUSION
OF LABELING REQUIREMENTS
IN 
DEFINITION OF MISBRANDED.—Section 1(n) of the Fed-
eral Meat Inspection Act (21 U.S.C. 601(n)) is amend-
ed— 
(1) by striking ‘‘or’’ at the end of paragraph 
(11); 
(2) by striking the period at the end of para-
graph (12) and inserting ‘‘; or’’; and 
(3) by adding at the end the following: 
‘‘(13) if it fails to bear a label or labeling as re-
quired 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 be-
ginning on the date of enactment of this Act. 
Æ 
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