[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 BollagardTM 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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