[Federal Register Volume 60, Number 27 (Thursday, February 9, 1995)]
[Notices]
[Pages 7746-7747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3290]



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Notices
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.

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Federal Register / Vol. 60, No. 27 / Thursday, February 9, 1995 / 
Notices
[[Page 7746]]

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 94-139-1]


Receipt of Petition for Determination of Nonregulated Status for 
Genetically Engineered Cotton

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has received a petition from the Monsanto Company 
seeking a determination of nonregulated status for cotton lines 
genetically engineered for insect resistance. The petition has been 
submitted in accordance with our regulations concerning the 
introduction of certain genetically engineered organisms and products. 
In accordance with those regulations, we are soliciting public comments 
on whether these genetically engineered cotton lines present a plant 
pest risk.

DATES: Written comments must be received on or before April 10, 1995.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 94-139-1, Animal and Plant Health Inspection Service, Policy 
and Program Development, Regulatory Analysis and Development, 4700 
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your 
comments refer to Docket No. 94-139-1. A copy of the petition and any 
comments received may be inspected at USDA, room 1141, South Building, 
14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. 
and 4:30 p.m., Monday through Friday, except holidays. Persons wishing 
access to that room to inspect the petition or comments are asked to 
call in advance of visiting at (202) 690-2817.

FOR FURTHER INFORMATION CONTACT:
Dr. Keith Reding, Biotechnologist, Animal and Plant Health Inspection 
Service, Biotechnology, Biologics, and Environmental Protection, 
Biotechnology Permits, 4700 River Road Unit 147, Riverdale, MD 20737-
1237. The telephone number for the agency contract will change when 
agency offices in Hyattsville, MD, move to Riverdale, MD, during 
February. Telephone: (301) 436-7612 (Hyattsville); (301) 734-7612 
(Riverdale). To obtain a copy of the petition, contact Ms. Kay Peterson 
at (301) 436-7601 (Hyattsville) or (301) 734-7601 (Riverdale).

SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340, 
``Introduction of Organisms and Products Altered or Produced Through 
Genetic Engineering Which Are Plant Pests or Which There Is Reason to 
Believe Are Plant Pests,'' regulate, among other things, the 
introduction (importation, interstate movement, or release into the 
environment) of organisms and products altered or produced through 
genetic engineering that are plant pests or that there is reason to 
believe are plant pests. Such genetically engineered organisms and 
products are considered ``regulated articles.''
    The regulation in Sec. 340.6(a) provide that any person may submit 
a petition to the Animal and Plant Health Inspection Service (APHIS) 
seeking a determination that an article should not be regulated under 7 
CFR part 340. Paragraphs (b) and (c) of Sec. 340.6 describe the form 
that a petition for determination of nonregulated status must take and 
the information that must be included in the petition.
    On November 4, 1994, APHIS received a petition (APHIS Petition No. 
94-308-01p) from the Monsanto Company of St. Louis, MO, requesting a 
determination of nonregulated status under 7 CFR part 340 for a cotton 
line designated as 531, genetically engineered to produce an 
insecticidal protein for resistance to lepidopteran insect pests. On 
January 10, 1995, Monsanto amended the petition to add two additional 
lines designated as 757 and 1076. The three cotton lines, 531, 757, and 
1076, are trademarked by Monsanto as Bollagard<SUP>TM Cotton Lines. The 
Monsanto petition states that the subject cotton lines 531, 757, and 
1076, should not be regulated by APHIS because they do not present a 
plant pest risk.
    As described in the petition, the subject cotton lines were 
developed to produce an insect control protein derived from the common 
soil bacterium Bacillus thuringiensis subsp. kurstaki (Btk). This 
genetically engineered insect control protein is nearly identical 
(differing in only 6 of 1,178 nonessential amino acids) to one of the 
proteins encoded by the cryIA(c) gene. This protein is naturally 
produced by Btk and found in commercial microbial Btk formulations 
registered as pesticides with the Environmental Protection Agency 
(EPA). According to Monsanto, the protein is highly selective in 
controlling such lepidopteran cotton pests as cotton bollworm, tobacco 
budworm, and pink bollworm, and is expressed at a consistent level in 
the cotton plant throughout the growing season. The expression of this 
insect control protein is regulated by a promoter and terminating 
sequence. The promotors were either the 35S sequence derived from the 
cauliflower mosaic virus or a promoter from an alternate source. 
Terminating sequences used were either the 7S 3' non-translated region 
of the soybean alpha subunit of the beta-conglycinin gene or the E9 3' 
sequence from the pea ribulose-1,5,-bisphosphate carboxylase, small 
subunit (rbcS).
    The subject cotton lines also contain the nptII gene from the 
prokaryotic transposon Tn5 which encodes the enzyme neomycin 
phosphotransfease II. The expression of this gene in the subject cotton 
lines is regulated by the 35S promoter, as described above, and the 
nontranslated 3' region of the nopaline synthase gene derived from the 
plant pathogen Agrobacterium tumefaciens. The expression of this enzyme 
in the subject cotton lines allows for selective growth of transgenic 
plant cells on the antibiotic kanamycin during plant tissue culture. 
These genes were stably transferred into the genome of cotton plants 
using A. tumefaciens-mediated transformation utilizing a binary, 
single-border plant expression vector.
    Monsanto's cotton lines 531, 757, and 1076 are currently considered 
regulated articles under the regulations in 7 CFR part 340 because they 
contain gene sequences (vectors, promoters, and 
[[Page 7747]] terminators) derived from plant pathogenic sources. In 
cotton growing locations throughout the United States, cotton line 531 
was evaluated under 5 APHIS permits issued between 1991 and 1993, and 
cotton lines 757 and 1076 were tested under 6 APHIS permits or 
notifications in 1993 and 1994. After reviewing Monsanto's permit 
applications for field trials of cotton lines 531, 757, and 1076, APHIS 
determined that the vectors and other elements were disarmed and that 
the trials, which were conducted under conditions of reproductive and 
physical containment or isolation, would not present a risk of plant 
pest introduction or dissemination.
    In the Federal Plant Pest Act, as amended (7 U.S.C. 150aa et seq.), 
``plant pest'' is defined as ``any living stage of: Any insects, mites, 
nematodes, slugs, snails, protozoa, or other invertebrate animals, 
bacteria, fungi, other parasitic plants or reproductive parts thereof, 
viruses, or any organisms similar to or allied with any of the 
foregoing, or any infectious substances, which can directly or 
indirectly injure or cause disease or damage in any plants or parts 
thereof, or any processed, manufactured or other products of plants.'' 
APHIS views this definition very broadly. The definition covers direct 
or indirect injury, disease or damage not just to agricultural crops, 
but also to plants in general, for example, native species, as well as 
to organisms that may be beneficial to plants, for example, honeybees, 
rhizobia, etc.
    These genetically engineered cotton lines are also currently 
subject to regulation by other agencies. The EPA is responsible for the 
regulation of pesticides under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA 
requires that all pesticides, including insecticides, be registered 
prior to distribution or sale, unless exempt by EPA regulation. 
Accordingly, Monsanto has submitted to EPA an application for a 
conditional registration for a transgenic plant pesticide containing 
the new active ingredient Btk delta endotoxin protein as produced by 
the cryIA(c) gene and its controlling sequences. On September 29, 1994, 
EPA announced receipt of this application (EPA File Symbol 524-UTI) in 
the Federal Register (59 FR 49663, OPP-30373; FRL-4913-5).
    Under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.), pesticides added to raw agricultural commodities generally are 
considered to be unsafe unless a tolerance or exemption from tolerance 
has been established. Foods containing unsafe pesticides are deemed to 
be adulterated. Residue tolerances for pesticides are established by 
EPA under the Federal Food, Drug, and Cosmetic Act; the Food and Drug 
Administration (FDA) enforces the tolerances set by the EPA. Monsanto 
has also submitted to the EPA a pesticide petition (PP 4F4331) 
proposing to amend 40 CFR part 180 to establish a tolerance exemption 
for residues of the plant pesticide active ingredient Btk delta 
endotoxin protein as produced by the cryIA(c) gene and its controlling 
sequences. On September 14, 1994, EPA announced receipt of this 
petition in the Federal Register (59 FR 47136-47137, PF-605; FRL-4904-
7). Consistent with the ``Coordinated Framework for Regulation of 
Biotechnology'' (51 FR 23302-23350, June 26, 1986), APHIS and the EPA 
are coordinating their reviews of these genetically engineered cotton 
lines to avoid duplication and assure that all relevant issues are 
addressed.
    The FDA published a statement of policy on foods derived from new 
plant varieties in the Federal Register on May 29, 1992 (57 FR 22984-
23005). The FDA statement of policy includes a discussion of the FDA 
authority for ensuring food safety under the Federal Food, Drug, and 
Cosmetic Act, and provides guidance to industry on the scientific 
considerations associated with the development of foods derived from 
new plant varieties, including those plants developed through the 
techniques of genetic engineering.
    In accordance with Sec. 340.6(d) of the regulations, we are 
publishing this notice to inform the public that APHIS will accept 
written comments regarding the Petition for Determination of 
Nonregulated Status from any interested person for a period of 60 days 
from the date of this notice. The petition and any comments received 
are available for public review, and copies of the petition may be 
ordered (see the ADDRESSES section of this notice).
    After the comment period closes, APHIS will review the data 
submitted by the petitioner, all written comments received during the 
comment period, and any other relevant information. Based on the 
available information, APHIS will furnish a response to the petitioner, 
either approving the petition in whole or in part, or denying the 
petition. APHIS will then publish a notice in the Federal Register 
announcing the regulatory status of Monsanto's genetically engineered 
cotton lines and the availability of APHIS' written decision.

    Authority: 7 U.S.C. 150aa-150jj, 151-167, and 1622n; 31 U.S.C. 
9701; 7 CFR 2.17, 2.51, and 371.2(c).

    Done in Washington, DC, this 3rd day of February 1995.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-3290 Filed 2-8-95; 8:45 am]
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