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— 
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‘‘(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 (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 
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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 
(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-
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