I
107TH CONGRESS
2D SESSION
H. R. 4814
To amend the Federal Food, Drug, and Cosmetic Act, the Federal Meat
Inspection Act, and the Poultry Products Inspection Act to require that
food that contains a genetically engineered material, or that is produced
with a genetically engineered material, be labeled accordingly.
IN THE HOUSE OF REPRESENTATIVES
MAY 22, 2002
Mr. KUCINICH (for himself, Mr. SANDERS, Ms. MCKINNEY, Ms. RIVERS, Mr.
PALLONE, Mrs. MINK of Hawaii, Ms. CARSON of Indiana, Mr. DEFAZIO,
Mr. GUTIERREZ, Mr. NADLER, Mr. OLVER, Mr. UDALL of New Mexico,
Ms. VELA´ZQUEZ, Ms. WATERS, Ms. WOOLSEY, Mr. JACKSON of Illinois,
Ms. WATSON of California, Mr. RODRIGUEZ, Ms. BERKLEY, Mr. OWENS,
Ms. SOLIS, Mr. GEORGE MILLER of California, Mr. HINCHEY, and Ms.
LEE) introduced the following bill; which was referred to the Committee
on Agriculture, and in addition to the Committee on Energy and Com-
merce, for a period to be subsequently determined by the Speaker, in
each case for consideration of such provisions as fall within the jurisdic-
tion of the committee concerned
A BILL
To amend the Federal Food, Drug, and Cosmetic Act, the
Federal Meat Inspection Act, and the Poultry Products
Inspection Act to require that food that contains a ge-
netically engineered material, or that is produced with
a genetically engineered material, be labeled accordingly.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Genetically Engineered Food Right to Know Act’’.
(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.
(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
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:
‘‘(t)(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).
‘‘(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
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,
‘‘(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 (u) shall require periodic testing of foods by the
Secretary for purposes of determining the accuracy of la-
bels 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
subparagraph and subparagraph (6) do not apply to (A)
foods that are certified and comply with the Organic
Foods Production Act and its implementing regulations;
or (B) foods produced with genetically engineered material
if the Secretary has not through such regulations identi-
fied a validated method of testing for such material in the
food; or (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
(u), 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.
‘‘(u) If it bears a label indicating (within the meaning
of paragraph (t)) 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:
‘‘(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:
‘‘(h)(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(t) or 403(u), 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 (g)
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
(g).’’.
(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(t)(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(t) and 403(u) 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(t)) 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-
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 (h) for a violation of section 301(a),
301(b), or 301(c) involving the misbranding of food within
the meaning of section 403(t) or 403(u) 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
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:
‘‘CITIZEN SUITS REGARDING MISBRANDING OF FOOD
WITH RESPECT TO GENETICALLY ENGINEERED MATERIAL
‘‘SEC. 311. (a) IN GENERAL.—Except as provided in
subsection (c), any person may on his or her behalf com-
mence 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(t) or 403(u); or
‘‘(2) the Secretary where there is alleged a fail-
ure of the Secretary to perform any act or duty
under section 403(t) or 403(u) 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.
‘‘(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.
‘‘(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:
‘‘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,
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-
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—
‘‘(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
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
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.
‘‘(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
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
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
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.
‘‘(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
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.
‘‘(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,
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
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
amended—
(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.’’.
SEC. 5. LABELING REGARDING GENETICALLY ENGINEERED
MATERIAL; 
AMENDMENTS 
TO 
POULTRY
PRODUCTS INSPECTION ACT.
(a) The Poultry Products Inspection 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
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).
‘‘(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
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
testing, and shall identify tests that meet such
requirement. This subparagraph and subpara-
graph (B) of this paragraph do not apply to (i)
poultry products that are certified and comply
with the Organic Foods Production Act and its
implementing regulations; or (ii) poultry prod-
ucts produced with genetically engineered mate-
rial if the Secretary has not through such regu-
lations identified a validated method of testing
for such material in the food; or (iii) genetically
engineered material contained in a poultry
products if the Secretary has not through such
regulations identified a validated method of
testing for such material in the product.
‘‘(B) A poultry product with respect to
which a test has been identified under subpara-
graph (A) shall not be considered to contain a
genetically engineered material for purposes of
subparagraphs (A)(i) and (B) of paragraph (1)
if, as indicated by such a test—
‘‘(i) the product does not contain any
genetically engineered material; or
‘‘(ii) the product contains an adven-
titious genetically engineered material and
the amount of the material in the product