high levels of biological activity and are intended to 
be used for particular medical or industrial pur-
poses, under very controlled circumstances. None of 
these substances is intended to be incorporated in 
food or to be spread into the environment. 
(4) The magnitude of the risks posed by phar-
maceutical crops and industrial crops depends on 
many factors, including the chemicals involved, the 
organisms or environments exposed, and the level 
and duration of the exposure. Humans, animals, and 
the environment at large could be at risk from con-
tamination, a major concern of which is that bio-
active nonfood substances, which have not been test-
ed, will contaminate or otherwise adversely affect the 
food supply. Substances intended for use as human 
drugs are especially problematic because they are in-
tended to be biologically active in people. 
(5) Pharmaceutical crops and industrial crops 
also pose substantial liability and other economic 
risks to farmers, grain handlers, food companies, 
and other persons in the food and feed supply chain. 
These risks include liability for contamination epi-
sodes, costly food recalls, losses in export markets, 
reduced prices for a contaminated food or feed crop, 
and loss of confidence in the safety of the American 
VerDate Aug 31 2005 
08:19 May 03, 2006
Jkt 049200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H5267.IH
H5267
cprice-sewell on PROD1PC66 with BILLS
food supply among foreign importers and consumers 
of American agricultural commodities. 
(6) These risks necessitate a zero tolerance 
standard for the presence of pharmaceutical crops 
and industrial crops and their byproducts in crops 
used to produce human food or animal feed. 
(7) While there presently exists a pro forma 
zero tolerance standard, the Department of Agri-
culture and experts in the field acknowledge that 
contamination of human food and animal feed is in-
evitable due to the inherent imprecision of biological 
and agricultural systems, as well as the laxity of the 
regulatory regime. This is illustrated, for example, in 
the Department of Agriculture’s regulations, which 
aim not for prevention (recognized as unattainable), 
but rather mitigation of the gene flow that results 
in contamination of food/feed crops with these sub-
stances. Some experts in the field are calling for es-
tablishment of tolerances, despite the potential risks 
involved. 
(8) Therefore, appropriate regulatory controls, 
as established by this Act, are urgently needed to 
ensure that pharmaceutical crops and industrial 
crops and their byproducts do not enter human food 
or animal feed crops at any level. 
VerDate Aug 31 2005 
08:19 May 03, 2006
Jkt 049200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H5267.IH
H5267
cprice-sewell on PROD1PC66 with BILLS
SEC. 3. DEFINITIONS. 
In this Act: 
(1) The term ‘‘genetically engineered plant’’ 
means a plant that contains a genetically engineered 
material or was produced from a genetically engi-
neered seed. A plant shall be considered to contain 
a genetically engineered material if the plant has 
been injected or otherwise treated with a genetically 
engineered material (except that the use of manure 
as a fertilizer for the plant may not be construed to 
mean that the plant is produced with a genetically 
engineered material). 
(2) The term ‘‘genetically engineered material’’ 
means material that has been altered at the molec-
ular or cellular level by means that are not possible 
under natural conditions or processes (including re-
combinant DNA and RNA techniques, cell fusion, 
microencapsulation, 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, fer-
mentation, hybridization, in vitro fertilization, tissue 
culture, or mutagenesis. 
(3) The term ‘‘genetically engineered seed’’ 
means a seed that contains a genetically engineered 
material or was produced with a genetically engi-
VerDate Aug 31 2005 
08:19 May 03, 2006
Jkt 049200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H5267.IH
H5267
cprice-sewell on PROD1PC66 with BILLS