(1) Genetic engineering is an artificial gene 
transfer process wholly different from traditional 
breeding. 
(2) Genetic engineering can be used to produce 
new versions of virtually all plant and animal foods. 
Thus, within a short time, the food supply could 
consist almost entirely of genetically engineered 
products. 
(3) This conversion from a food supply based 
on traditionally bred organisms to one based on or-
ganisms produced through genetic engineering could 
be one of the most important changes in our food 
supply in this century. 
(4) Genetically engineered foods present new 
issues of safety that have not been adequately stud-
ied. 
(5) The Congress has previously required that 
food additives be analyzed for their safety prior to 
their placement on the market. 
(6) Adding new genes into a food should be 
considered adding a food additive, thus requiring an 
analysis of safety factors. 
(7) Federal agencies have failed to uphold con-
gressional intent of the Food Additives Amendment 
of 1958 by allowing genetically engineered foods to 
VerDate Aug 31 2005 
20:12 May 07, 2006
Jkt 049200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H5268.IH
H5268
dsatterwhite on PROD1PC76 with BILLS
be marketed, sold and otherwise used without re-
quiring pre-market safety testing addressing their 
unique characteristics. 
(8) The food additive process gives the Food 
and Drug Administration discretion in applying the 
safety factors that are generally recognized as ap-
propriate to evaluate the safety of food and food in-
gredients. 
(9) Given the consensus among the scientific 
community that genetic engineering can potentially 
introduce hazards, such as allergens or toxins, ge-
netically engineered foods need to be evaluated on a 
case-by-case basis and cannot be presumed to be 
generally recognized as safe. 
SEC. 3. FEDERAL DETERMINATION OF SAFETY OF GENETI-
CALLY ENGINEERED FOOD; REGULATION AS 
FOOD ADDITIVE. 
(a) INCLUSION
IN DEFINITION
OF FOOD ADDI-
TIVE.—Section 201 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321) is amended— 
(1) in paragraph (s), by adding after and below 
subparagraph (6) the following sentence: 
‘‘Such term includes the different genetic constructs, pro-
teins of such constructs, vectors, promoters, marker sys-
tems, and other appropriate terms that are used or cre-
VerDate Aug 31 2005 
20:48 May 07, 2006
Jkt 049200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H5268.IH
H5268
dsatterwhite on PROD1PC76 with BILLS
ated as a result of the creation of a genetically engineered 
food (as defined in paragraph (rr)), other than a genetic 
construct, protein, vector, promoter, or marker system or 
other appropriate term for which an application under sec-
tion 505 or 512 has been filed. For purposes of this Act, 
the term ‘genetic food additive’ means a genetic construct, 
protein, vector, promoter, or marker system or other ap-
propriate term that is so included.’’; and 
(2) by adding at the end the following: 
‘‘(rr)(1) The term ‘genetically engineered food’ means 
food that contains or was produced with a genetically engi-
neered material. 
‘‘(2) The term ‘genetically engineered material’ 
means material derived from any part of a genetically en-
gineered organism, without regard to whether the altered 
molecular or cellular characteristics of the organism are 
detectable in the material. 
‘‘(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 processes (in-
cluding but not limited to recombinant DNA and 
RNA techniques, cell fusion, microencapsulation, 
macroencapsulation, gene deletion and doubling, in-
VerDate Aug 31 2005 
20:48 May 07, 2006
Jkt 049200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H5268.IH
H5268
dsatterwhite on PROD1PC76 with BILLS
troducing a foreign gene, and changing the positions 
of genes), other than a means consisting exclusively 
of breeding, conjugation, fermentation, hybridiza-
tion, in vitro fertilization, tissue culture, or 
mutagenesis; and 
‘‘(B) an organism made through sexual or asex-
ual reproduction (or both) involving an organism de-
scribed in clause (A), if possessing any of the altered 
molecular or cellular characteristics of the organism 
so described. 
‘‘(4) For purposes of subparagraph (1), a food shall 
be considered to have been produced with a genetically en-
gineered material if the organism from which the food is 
derived has been injected or otherwise treated with a ge-
netically engineered material (except that the use of ma-
nure as a fertilizer for raw agricultural commodities may 
not be construed to mean that such commodities are pro-
duced with a genetically engineered material).’’. 
(b) PETITION TO ESTABLISH SAFETY.— 
(1) DATA IN PETITION.—Section 409(b)(2) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 348(b)(2)) is amended by adding after and 
below subparagraph (E) the following sentence: 
‘‘In the case of a genetic food additive, such reports shall 
include all data that was collected or developed pursuant 
VerDate Aug 31 2005 
20:12 May 07, 2006
Jkt 049200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H5268.IH
H5268
dsatterwhite on PROD1PC76 with BILLS