(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 Fed-
eral Food, Drug, and Cosmetic Act. 
Sec. 4. Labeling regarding genetically engineered material; amendments to Fed-
eral 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 Con-
gressional intent by allowing genetically engineered 
foods to be marketed, sold and otherwise used with-
out 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 aller-
gens 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. 
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(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 insuf-
ficient to provide consumers with adequate informa-
tion on whether or not all the food they are pur-
chasing contains or was produced with genetically 
engineered material. 
(7) Mandatory labeling provides a critical sci-
entific 
method 
necessary 
for 
the 
continual 
postmarket surveillance to study long-term health 
impacts and enforcement of food safety laws pre-
venting 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 imple-
menting, mandatory labeling requirements for ge-
netically engineered food. 
(9) Adoption and implementation of mandatory 
labeling requirements for genetically engineered food 
produced in the United States would facilitate inter-
national trade by allowing American farmers and 
companies to export and appropriately market their 
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products—both genetically engineered and non-ge-
netically 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: 
‘‘(y)(1) If it contains a genetically engineered mate-
rial, or was produced with a genetically engineered mate-
rial, 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 GE-
NETICALLY ENGINEERED MATERIAL’. 
‘‘(C) The notice required in clause (A) imme-
diately precedes the notice required in clause (B) 
and is not less than twice the size of the notice re-
quired in clause (B). 
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‘‘(D) The notice required in clause (B) is of the 
same size as would apply if the notice provided nu-
trition 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 geneti-
cally engineered organism, without regard to wheth-
er the altered molecular or cellular characteristics of 
the organism are detectable in the material. 
‘‘(B) The term ‘genetically engineered orga-
nism’ means— 
‘‘(i) an organism that has been altered at 
the molecular or cellular level by means that are 
not possible under natural conditions or proc-
esses (including but not limited to recombinant 
DNA and RNA techniques, cell fusion, micro-
encapsulation, macroencapsulation, gene dele-
tion and doubling, introducing a foreign gene, 
and changing the positions of genes), other 
than a means consisting exclusively of breeding, 
conjugation, fermentation, hybridization, in 
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vitro 
fertilization, 
tissue 
culture, 
or 
mutagenesis, and 
‘‘(ii) an organism made through sexual or 
asexual reproduction (or both) involving an or-
ganism described in subclause (i), if possessing 
any of the altered molecular or cellular charac-
teristics of the organism so described. 
‘‘(3) For purposes of subparagraph (1), a food shall 
be considered to have been produced with a genetically en-
gineered material if— 
‘‘(A) the organism from which the food is de-
rived has been injected or otherwise treated with a 
genetically engineered material (except that the use 
of manure as a fertilizer for raw agricultural com-
modities may not be construed to mean that such 
commodities are produced with a genetically engi-
neered 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 establish-
ments in which food is served for immediate human 
consumption, 
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‘‘(B) is processed and prepared primarily in a 
retail establishment, is ready for human consump-
tion, which is of the type described in clause (A), 
and is offered for sale to consumers but not for im-
mediate human consumption in such establishment 
and is not offered for sale outside such establish-
ment, 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 manu-
facturers or producers to distributors, and from distribu-
tors 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 para-
graph (z) shall require periodic testing of foods by the Sec-
retary 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 sub-
paragraph and subparagraph (6) do not apply to (A) foods 
that are certified and comply with the Organic Foods Pro-
duction Act and its implementing regulations; or (B) foods 
produced with genetically engineered material if the Sec-
retary has not through such regulations identified a vali-
dated method of testing for such material in the food; or 
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(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 
(z), 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 geneti-
cally engineered material and the amount of the ma-
terial 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 Sec-
retary determines that a test identified under sub-
paragraph (5) can detect a percentage lower than 
one percent. 
‘‘(z) If it bears a label indicating (within the meaning 
of paragraph (y)) 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 ac-
cordance with regulations promulgated by the Secretary. 
With respect to such regulations: 
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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 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 com-
mercial 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 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(y) or 403(z), 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)(A) Subject to subparagraph (C) and section 
403(y)(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(y) and 403(z) if such person 
(referred to in this paragraph as the ‘recipient’) estab-
lishes a guaranty or undertaking signed by, and con-
taining 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(y)) 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 accord-
ance with subparagraph (A), the exclusion under such sub-
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paragraph from being subject to penalties applies to the 
recipient without regard to the use of the food by the re-
cipient, 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 (g) for a violation of section 301(a), 
301(b), or 301(c) involving the misbranding of food within 
the meaning of section 403(y) or 403(z) 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 
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material and was not produced with a genetically en-
gineered material, is contaminated with a food that 
contains a genetically engineered material or was 
produced with a genetically engineered material (in-
cluding contamination by mingling the two), and 
‘‘(ii) such contamination is not intended by the 
agricultural producer. 
‘‘(B) Subparagraph (A) does not apply to an agricul-
tural 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: 
‘‘SEC. 311. CITIZEN SUITS REGARDING MISBRANDING OF 
FOOD WITH RESPECT TO GENETICALLY ENGI-
NEERED MATERIAL. 
‘‘(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(y) or 403(z); or 
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‘‘(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. 
‘‘(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. 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: 
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‘‘SEC. 7A. REQUIREMENTS FOR LABELING REGARDING GE-
NETICALLY 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 geneti-
cally engineered organism, without regard to wheth-
er 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 proc-
esses (including but not limited to recombinant 
DNA and RNA techniques, cell fusion, micro-
encapsulation, macroencapsulation, gene dele-
tion and doubling, introducing a foreign gene, 
and changing the positions of genes), other 
than a means consisting exclusively of breeding, 
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conjugation, fermentation, hybridization, in 
vitro 
fertilization, 
tissue 
culture, 
or 
mutagenesis; and 
‘‘(B) an organism made through sexual or 
asexual reproduction (or both) involving an or-
ganism described in subparagraph (A), if pos-
sessing any of the altered molecular or cellular 
characteristics of the organism so described. 
‘‘(b) LABELING REQUIREMENT.— 
‘‘(1) REQUIRED
LABELING
TO
AVOID
MIS-
BRANDING.— 
‘‘(A) INVOLVEMENT OF GENETICALLY EN-
GINEERED
MATERIAL.—For purposes of sec-
tions 1(n) and 10, a meat food is misbranded 
if it— 
‘‘(i) contains a genetically engineered 
material or was produced with a geneti-
cally 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 man-
ner, the notices described in subsection (c). 
‘‘(B) NO INVOLVEMENT OF GENETICALLY 
ENGINEERED MATERIAL.—For purposes of sec-
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tions 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 en-
gineered material, unless the label is in accord-
ance with regulations promulgated by the Sec-
retary. With respect to such regulations: 
‘‘(i) The regulations may not require 
such a label to include any statement indi-
cating that the fact that a meat food does 
not contain such material, or was not pro-
duced with such material, has no bearing 
on the safety of the food for human con-
sumption. 
‘‘(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 dis-
tribution 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 pro-
duced with a genetically engineered material if— 
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‘‘(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 de-
rived has been fed genetically engineered mate-
rial; 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 dis-
tributors, and from distributors to other dis-
tributors or to other persons in the chain of dis-
tribution, including persons who hold meat food 
for sale to consumers, regulations under sub-
paragraphs (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 
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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 vali-
dated 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 subpara-
graphs (A)(i) and (B) of paragraph (1) if, as 
indicated by such a test— 
‘‘(i) the food does not contain any ge-
netically 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 per-
centage designated by the Secretary shall 
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apply for purposes of this subparagraph if 
the Secretary determines that a test identi-
fied 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 PROD-
UCT CONTAINS A GENETICALLY ENGI-
NEERED 
MATERIAL, 
OR 
WAS 
PRO-
DUCED WITH A GENETICALLY ENGI-
NEERED MATERIAL’. 
‘‘(2) LOCATION AND SIZE.—(A) The notice re-
quired in paragraph (1)(A) shall immediately pre-
cede the notice required in paragraph (1)(B) and 
shall be not less than twice the size of the notice re-
quired 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. 
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‘‘(d) EXCEPTIONS TO REQUIREMENTS.—Subsection 
(a) does not apply to any meat food that— 
‘‘(1) is served in restaurants or other establish-
ments in which food is served for immediate human 
consumption; or 
‘‘(2) is processed and prepared primarily in a 
retail establishment, is ready for human consump-
tion, is offered for sale to consumers but not for im-
mediate human consumption in such establishment, 
and is not offered for sale outside such establish-
ment. 
‘‘(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 
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such animal, or such food, respectively, does not con-
tain genetically engineered material or was not pro-
duced 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 pen-
alties 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 re-
quirement under such subsection regarding testing 
of the meat food involved (relating to the accuracy 
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of labels regarding genetically engineered material). 
In determining whether to establish such exemp-
tions, 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 ap-
propriate. 
‘‘(4) 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. 
‘‘(f) CIVIL PENALTIES.— 
‘‘(1) IN GENERAL.—The Secretary may assess 
a civil penalty against a person that violates sub-
section (b) or (c)(2) in an amount not to exceed 
$100,000 for each such violation. 
‘‘(2) NOTICE
AND
OPPORTUNITY
FOR
HEAR-
ING.—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 
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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 hear-
ing on the order. In the course of any investigation, 
the Secretary may issue subpoenas requiring the at-
tendance and testimony of witnesses and the produc-
tion of evidence that relates to the matter under in-
vestigation. 
‘‘(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 abil-
ity 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 deter-
mined, or the amount agreed upon in compromise, 
may be deducted from any sums owing by the 
United States to the person charged. 
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‘‘(5) JUDICIAL REVIEW.—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 aggrieved by an order as-
sessing 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 assess-
ment 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 judg-
ment in favor of the Secretary; 
the Attorney General shall recover the amount as-
sessed (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 
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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 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)(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 para-
graph (1), the district court involved may, as the 
case may be— 
‘‘(A) enforce the compliance of a person 
with the applicable provisions referred to sub-
paragraph (A) of such paragraph; or 
‘‘(B) order the Secretary to perform an act 
or duty referred to in subparagraph (B) of such 
paragraph. 
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‘‘(3) LIMITATIONS.— 
‘‘(A) NOTICE TO SECRETARY.—A civil ac-
tion 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
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.—In 
a civil action under paragraph (1), the district court 
involved may award costs of litigation (including rea-
sonable attorney and expert witness fees) to any 
party whenever the court determines such an award 
is appropriate. The court may, if a temporary re-
straining order or preliminary injunction is sought, 
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require the filing of a bond or equivalent security in 
accordance with the Federal Rules of Civil Proce-
dure. 
‘‘(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 in 
paragraph (1)(A), or to seek any other relief (includ-
ing relief 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 para-
graph: 
‘‘(13) if it fails to bear a label or labeling as re-
quired by section 7A.’’. 
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SEC. 5. LABELING REGARDING GENETICALLY ENGINEERED 
MATERIAL; 
AMENDMENTS 
TO 
POULTRY 
PRODUCTS INSPECTION ACT. 
(a) REQUIREMENTS.—The Poultry Products Inspec-
tion Act is amended by inserting after section 8 (21 
U.S.C. 457) the following section: 
‘‘SEC. 8A. REQUIREMENTS FOR LABELING REGARDING GE-
NETICALLY ENGINEERED MATERIAL. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) The term ‘genetically engineered material’ 
means material derived from any part of a geneti-
cally engineered organism, without regard to wheth-
er 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 proc-
esses (including but not limited to recombinant 
DNA and RNA techniques, cell fusion, micro-
encapsulation, macroencapsulation, gene dele-
tion and doubling, introducing a foreign gene, 
and changing the positions of genes), other 
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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 or-
ganism described in subparagraph (A), if pos-
sessing any of the altered molecular or cellular 
characteristics of the organism so described. 
‘‘(b) LABELING REQUIREMENT.— 
‘‘(1) REQUIRED
LABELING
TO
AVOID
MIS-
BRANDING.— 
‘‘(A) INVOLVEMENT OF GENETICALLY EN-
GINEERED
MATERIAL.—For purposes of sec-
tions 4(h) and 9(a), a poultry product is mis-
branded if it— 
‘‘(i) contains a genetically engineered 
material or was produced with a geneti-
cally 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 con-
spicuous manner, the notices described in 
subsection (c). 
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‘‘(B) NO INVOLVEMENT OF GENETICALLY 
ENGINEERED MATERIAL.—For purposes of sec-
tions 4(h) and 9(a), a poultry product is mis-
branded if it bears a label indicating that it 
does not contain a genetically engineered mate-
rial, or that it was not produced with a geneti-
cally 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 indi-
cating that the fact that a poultry product 
does not contain such material, or was not 
produced with such material, has no bear-
ing 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 com-
mercial distribution that does contain a ge-
netically engineered material. 
‘‘(2) RULE OF CONSTRUCTION.—For purposes 
of paragraph subparagraphs (A)(i) and (B) of para-
graph (1), a poultry product shall be considered to 
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have been produced with a genetically engineered 
material if— 
‘‘(A) the poultry from which the food is de-
rived 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 ma-
terial; 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 dis-
tributors or to other persons in the chain of dis-
tribution, including persons who hold poultry 
products for sale to consumers, regulations 
under subparagraphs (A)(i) and (B) of para-
graph (1) shall require periodic testing of poul-
try 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 
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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 establish-
ments in which food is served for immediate human 
consumption; or 
‘‘(2) is processed and prepared primarily in a 
retail establishment, is ready for human consump-
tion, is offered for sale to consumers but not for im-
mediate human consumption in such establishment, 
and is not offered for sale outside such establish-
ment. 
‘‘(e) GUARANTY.— 
‘‘(1) IN
GENERAL.—Subject to subsection 
(b)(3)(A) and paragraph (3), an official establish-
ment 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 es-
tablishment or other person (referred to in this sub-
section 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 poul-
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try 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, respec-
tively, does not contain genetically engineered mate-
rial or was not produced with a genetically engi-
neered 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 pen-
alties 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 in-
gredient 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 
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(b)(3)(A) may exempt the recipients from the re-
quirement under such subsection regarding testing 
of the poultry product involved (relating to the accu-
racy of labels regarding genetically engineered mate-
rial). In determining whether to establish such ex-
emptions, the Secretary shall, with respect to the 
poultry product involved, take into account the num-
ber 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 deter-
mines to be appropriate. 
‘‘(4) 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. 
‘‘(f) CIVIL PENALTIES.— 
‘‘(1) IN GENERAL.—The Secretary may assess 
a civil penalty against a person that violates sub-
section (b) or (c)(2) in an amount not to exceed 
$100,000 for each such violation. 
‘‘(2) NOTICE
AND
OPPORTUNITY
FOR
HEAR-
ING.—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 
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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 hear-
ing on the order. In the course of any investigation, 
the Secretary may issue subpoenas requiring the at-
tendance and testimony of witnesses and the produc-
tion of evidence that relates to the matter under in-
vestigation. 
‘‘(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 abil-
ity 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 deter-
mined, or the amount agreed upon in compromise, 
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may be deducted from any sums owing by the 
United States to the person charged. 
‘‘(5) JUDICIAL REVIEW.—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 aggrieved by an order as-
sessing 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 assess-
ment 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 judg-
ment in favor of the Secretary; 
the Attorney General shall recover the amount as-
sessed (plus interest at currently prevailing rates 
from the date of the expiration of the 60-day period 
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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 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)(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 para-
graph (1), the district court involved may, as the 
case may be— 
‘‘(A) enforce the compliance of a person 
with the applicable provisions referred to sub-
paragraph (A) of such paragraph; or 
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‘‘(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 ac-
tion 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
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.—In 
a civil action under paragraph (1), the district court 
involved may award costs of litigation (including rea-
sonable attorney and expert witness fees) to any 
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party whenever the court determines such an award 
is appropriate. The court may, if a temporary re-
straining order or preliminary injunction is sought, 
require the filing of a bond or equivalent security in 
accordance with the Federal Rules of Civil Proce-
dure. 
‘‘(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 in 
paragraph (1)(A), or to seek any other relief (includ-
ing relief against the Secretary).’’. 
(b) INCLUSION
OF LABELING REQUIREMENTS
IN 
DEFINITION OF MISBRANDED.—Section 4(h) of the Poul-
try Products Inspection Act (21 U.S.C. 453(h)) 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 para-
graph: 
‘‘(13) if it fails to bear a label or labeling as re-
quired by section 8A.’’. 
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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. 
Æ 
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