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) Reasonably available technology permits the
detection in food of genetically engineered material,
generally acknowledged to be as low as 0.1 percent.
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 paragraph:
‘‘(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: ‘UNITED STATES
GOVERNMENT 
NOTICE: 
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, or tissue culture, 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.’’.
(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), any person engaging in
such a violation shall be liable to the United States for
a civil penalty in an amount not to exceed $100,000 for
each such violation.
‘‘(2) Paragraphs (3) through (5) of subsection (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) 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) if such person (referred to
in this paragraph as the ‘recipient’) establishes a guaranty
or undertaking signed by, and containing the name and
address of, the person residing in the United States from
whom the recipient received in good faith the food (includ-
ing the receipt of seeds to grow raw agricultural commod-
ities), 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) 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.’’.
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, or tissue culture; 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.—For purposes of sections 1(n) and 10,
a meat food is misbranded if it—
‘‘(A) contains a genetically engineered ma-
terial or was produced with a genetically engi-
neered material; and
‘‘(B) does not bear a label (or include la-
beling, in the case of a meat food that is not
packaged in a container) that provides, in a
clearly legible and conspicuous manner, the no-
tices described in subsection (c).
‘‘(2) RULE OF CONSTRUCTION.—For purposes
of paragraph (1)(A), a meat food shall be considered
to have been produced 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) ap-
plies.
‘‘(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: ‘UNITED
STATES GOVERNMENT NOTICE: THIS
PRODUCT CONTAINS A GENETICALLY
ENGINEERED 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.—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) 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)(3) 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
assessed (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.’’.
(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.
The Poultry Products Inspection Act is amended by
inserting after section 8 (21 U.S.C. 457) the following sec-
tion:
‘‘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, or tissue culture; 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.—For purposes of sections 4(h) and 9(a),
a poultry product is misbranded if it—
‘‘(A) contains a genetically engineered ma-
terial or was produced with a genetically engi-
neered material; and
‘‘(B) does not bear a label (or include la-
beling, in the case of a poultry product that is
not packaged in a container) that provides, in
a clearly legible and conspicuous manner, the
notices described in subsection (c).
‘‘(2) RULE OF CONSTRUCTION.—For purposes
of paragraph (1)(A), a poultry product shall be con-
sidered to have been produced with a genetically en-
gineered 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) ap-
plies.
‘‘(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: ‘UNITED
STATES GOVERNMENT NOTICE: THIS
PRODUCT CONTAINS A GENETICALLY
ENGINEERED 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
required 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 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.—An official establishment 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 establish-
ment or other person (referred to in this subsection
as the ‘recipient’) establishes a guaranty or under-
taking signed by, and containing the name and ad-
dress 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-
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) 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)(3) 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
assessed (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.’’.
(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
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 8A.’’.
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