adopted a text that indicates that governments can 
decide on whether and how to label foods produced 
with genetic engineering; and 
(6) mandatory identification of food produced 
with genetic engineering can be a critical method of 
preserving the economic value of exports or domesti-
cally sensitive markets with labeling requirements 
for genetically engineered foods. 
SEC. 3. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND 
COSMETIC ACT. 
(a) IN GENERAL.—Section 403 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 343) is amended by 
adding at the end the following: 
‘‘(z)(1) If it is a food that has been genetically engi-
neered or contains 1 or more genetically engineered ingre-
dients, unless such information is clearly disclosed, as de-
termined by the Secretary. 
‘‘(2) This paragraph does not apply to food that— 
‘‘(A) is served in restaurants or other similar 
eating establishments, such as cafeterias and 
carryouts; 
‘‘(B) is a medical food (as defined in section 
5(b) of the Orphan Drug Act); 
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‘‘(C) is a food that would be subject to this 
paragraph solely because it was produced using a ge-
netically engineered vaccine; or 
‘‘(D) is a food or processed food that would be 
subject to this paragraph solely because it includes 
the use of a genetically engineered processing aid 
(including yeast) or enzyme. 
‘‘(3) In this paragraph: 
‘‘(A) The term ‘genetic engineering’ means a 
process involving the application of— 
‘‘(i) in vitro nucleic acid techniques, includ-
ing recombinant deoxyribonucleic acid (DNA) 
and direct injection of nucleic acid into cells or 
organelles; or 
‘‘(ii) fusion of cells beyond the taxonomic 
family that— 
‘‘(I) overcome natural physiological 
reproductive or recombinant barriers; and 
‘‘(II) are not techniques used in tradi-
tional breeding and selection. 
‘‘(B) The term ‘genetically engineered’, used 
with respect to a food, means a material intended 
for human consumption that is— 
‘‘(i) an organism that is produced through 
the intentional use of genetic engineering; or 
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‘‘(ii) the progeny of intended sexual or 
asexual reproduction (or both) of 1 or more or-
ganisms that is the product of genetic engineer-
ing. 
‘‘(C) The term ‘genetically engineered ingre-
dient’ means a material that is an ingredient in a 
food that is derived from any part of an organism 
that has been genetically engineered, without regard 
to whether— 
‘‘(i) the altered molecular or cellular char-
acteristics of the organism are detectable in the 
material; and 
‘‘(ii) the organism is capable for use as 
human food.’’. 
(b) 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: 
‘‘(2)(A) No person shall be subject to the pen-
alties of subsection (a)(1) for a violation of sub-
section (a), (b), or (c) of section 301 involving food 
that is misbranded within the meaning of section 
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403(z) if such person (referred to in this paragraph 
as the ‘recipient’) establishes a guaranty or under-
taking that— 
‘‘(i) is signed by, and contains the name 
and address of, a 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); and 
‘‘(ii) contains a statement to the effect 
that the food is not genetically engineered or 
does not contain a genetically engineered ingre-
dient. 
‘‘(B) In the case of a recipient who, with re-
spect to a food, establishes a guaranty or under-
taking in accordance with subparagraph (A), the ex-
clusion under such subparagraph from being subject 
to penalties applies to the recipient without regard 
to the manner in which the recipient uses the food, 
including whether the recipient is— 
‘‘(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 pro-
ducing the food. 
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‘‘(C) No person may avoid responsibility or li-
ability for a violation of subsection (a), (b), or (c) 
of section 301 involving food that is misbranded 
within the meaning of section 403(z) by entering 
into a contract or other agreement that specifies 
that another person shall bear such responsibility or 
liability, except that a recipient may require a guar-
anty or undertaking as described in this subsection. 
‘‘(D) In this subsection, the terms ‘genetically 
engineered’ and ‘genetically engineered ingredient’ 
have the meanings given the terms in section 
403(z).’’. 
(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 ‘‘section 303(c)(2)’’. 
(c) UNINTENDED CONTAMINATION.—Section 303(d) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
333(d)), as amended by subsection (b), is further amended 
by adding at the end the following: 
‘‘(3)(A) No person shall be subject to the pen-
alties of subsection (a)(1) for a violation of sub-
section (a), (b), or (c) of section 301 involving food 
that is misbranded within the meaning of section 
403(z) if— 
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‘‘(i) such person is an agricultural pro-
ducer and the violation occurs because food that 
is grown, raised, or otherwise produced by such 
producer, which food does not contain a geneti-
cally engineered material and was not produced 
with a genetically engineered material, is con-
taminated with a food that contains a geneti-
cally engineered material or was produced with 
a genetically engineered material; and 
‘‘(ii) such contamination is not intended by 
the agricultural producer. 
‘‘(B) Subparagraph (A) does not apply to an 
agricultural producer to the extent that the contami-
nation occurs as a result of the negligence of the 
producer.’’. 
(d) PROMULGATION OF REGULATIONS.—Not later 
than 1 year after the date of enactment of this Act, the 
Secretary shall promulgate proposed regulations estab-
lishing labeling requirements for compliance in accordance 
with section 403(z) of the Federal Food, Drug, and Cos-
metic Act, as added by subsection (a). 
Æ 
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