Monsanto Co. and Forage Genetics International; Availability Determination of Nonregulated Status for Alfalfa Genetically Engineered for Tolerance to the Herbicide Glyphosate, 36917-36919 [E5-3323]
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Federal Register / Vol. 70, No. 122 / Monday, June 27, 2005 / Notices
You may submit comments
by any of the following methods:
• EDOCKET: Go to https://
www.epa.gov/feddocket to submit or
view public comments, access the index
listing of the contents of the official
public docket, and to access those
documents in the public docket that are
available electronically. Once you have
entered EDOCKET, click on the ‘‘View
Open APHIS Dockets’’ link to locate this
document.
• Postal Mail/Commercial Delivery:
Please send four copies of your
comment (an original and three copies)
to Docket No. 05–046–1, Regulatory
Analysis and Development, PPD,
APHIS, Station 3C71, 4700 River Road
Unit 118, Riverdale, MD 20737–1238.
Please state that your comment refers to
Docket No. 05–046–1.
Reading Room: You may read any
comments that we receive on this
docket in our reading room. The reading
room is located in room 1141 of the
USDA South Building, 14th Street and
Independence Avenue, SW.,
Washington, DC. Normal reading room
hours are 8 a.m. to 4:30 p.m., Monday
through Friday, except holidays. To be
sure someone is there to help you,
please call (202) 690–2817 before
coming.
Other Information: You may view
APHIS documents published in the
Federal Register and related
information on the Internet at https://
www.aphis.usda.gov/ppd/rad/
webrepor.html.
ADDRESSES:
For
information regarding the Animal
Welfare Act regulations for guinea pigs,
hamsters, and rabbits, contact Dr.
Barbara Kohn, Senior Staff Veterinarian,
Animal Care, APHIS, 4700 River Road
Unit 84, Riverdale, MD 20737–1234;
(301) 734–7833. For copies of more
detailed information on the information
collection, contact Mrs. Celeste Sickles,
APHIS’ Information Collection
Coordinator, at (301) 734–7477.
SUPPLEMENTARY INFORMATION:
Title: Animal Welfare; Guinea Pigs,
Hamsters, and Rabbits.
OMB Number: 0579–0092.
Type of Request: Extension of
approval of an information collection.
Abstract: The U.S. Department of
Agriculture’s (USDA) Animal and Plant
Health Inspection Service (APHIS)
administers regulations and standards
that have been promulgated under the
Animal Welfare Act to promote and
ensure the humane care and treatment
of regulated animals under the Act. The
regulations in title 9, part 3, subparts B
and C, of the Code of Federal
Regulations (CFR) contain specifications
FOR FURTHER INFORMATION CONTACT:
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for the humane handling, care,
treatment, and transportation of guinea
pigs, hamsters, and rabbits. The
regulations require, among other things,
the documentation of specified
information concerning the
transportation of these animals.
The transportation standards for
guinea pigs, hamsters, and rabbits
require intermediate handlers and
carriers to accept only shipping
enclosures that meet the minimum
requirements set forth in the regulations
(§§ 3.36 and 3.61) or that are
accompanied by documentation signed
by the consignor verifying that the
shipping enclosures comply with the
regulations. If guinea pigs, hamsters, or
rabbits are transported in cargo space
that falls below 45 °F (7.2 C), the
regulations specify that the animals
must be accompanied by a certificate of
acclimation signed by a USDAaccredited veterinarian.
In addition, all shipping enclosures
must be marked with the words ‘‘Live
Animals’’ and have arrows indicating
the correct upright position of the
container. Intermediate handlers and
carriers are required to attempt to
contact the consignee at least once every
6 hours upon the arrival of any live
animals. Documentation of these
attempts must be recorded by the
intermediate handlers and carriers and
maintained for inspection by APHIS
personnel.
The above reporting and
recordkeeping requirements do not
mandate the use of any official
government form.
The burden generated by APHIS
requirements that all shipping
documents be attached to the container
has been cleared by the Office of
Management (OMB) under OMB control
number 0579–0036.
The reporting and recordkeeping
requirements of 9 CFR part 3, subparts
B and C, are necessary to enforce
regulations intended to ensure the
humane treatment of guinea pigs,
hamsters, and rabbits during
transportation in commerce.
We are asking OMB to approve our
use of this information collection
activity for an additional 3 years.
The purpose of this notice is to solicit
comments from the public (as well as
affected agencies) concerning our
information collection. These comments
will help us:
(1) Evaluate whether the collection of
information is necessary for the proper
performance of the functions of the
Agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of our
estimate of the burden of the collection
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of information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, through use, as
appropriate, of automated, electronic,
mechanical, and other collection
technologies; e.g., permitting electronic
submission of responses.
Estimate of burden: The public
reporting burden for this collection of
information is estimated to average
0.11555 hours per response.
Respondents: Intermediate handlers,
carriers, class ‘‘A’’ and ‘‘B’’ dealers (as
consignors), USDA-accredited
veterinarians.
Estimated annual number of
respondents: 1,470.
Estimated annual number of
responses per respondent: 1.5306.
Estimated annual number of
responses: 2,250.
Estimated total annual burden on
respondents: 260 hours. (Due to
averaging, the total annual burden hours
may not equal the product of the annual
number of responses multiplied by the
reporting burden per response.) All
responses to this notice will be
summarized and included in the request
for OMB approval. All comments will
also become a matter of public record.
Done in Washington, DC, this 21st day of
June, 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E5–3322 Filed 6–24–05; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. 04–085–3]
Monsanto Co. and Forage Genetics
International; Availability
Determination of Nonregulated Status
for Alfalfa Genetically Engineered for
Tolerance to the Herbicide Glyphosate
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
SUMMARY: We are advising the public of
our determination that the Monsanto
Company and Forage Genetics
International alfalfa lines designated as
events J101 and J163, which have been
genetically engineered for tolerance to
the herbicide glyphosate, are no longer
considered regulated articles under our
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36918
Federal Register / Vol. 70, No. 122 / Monday, June 27, 2005 / Notices
regulations governing the introduction
of certain genetically engineered
organisms. Our determination is based
on our evaluation of data submitted by
Monsanto Company and Forage
Genetics International in their petition
for a determination of nonregulated
status, our analysis of other scientific
data, and comments received from the
public in response to a previous notice
announcing the availability of the
petition for nonregulated status and an
environmental assessment. This notice
also announces the availability of our
written determination document and
our finding of no significant impact.
EFFECTIVE DATE: June 14, 2005.
ADDRESSES: You may read the petition
for a determination of nonregulated
status submitted by Monsanto Company
and Forage Genetics International, the
environmental assessment, all
comments received on the petition and
the environmental assessment, the
determination, and the finding of no
significant impact with attached
response to comments in our reading
room. The reading room is located in
room 1141 of the USDA South Building,
14th Street and Independence Avenue,
SW., Washington, DC. Normal reading
room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except
holidays. To be sure someone is there to
help you, please call (202) 690–2817
before coming.
You may view APHIS documents
published in the Federal Register and
related information on the Internet at
https://www.aphis.usda.gov/ppd/rad/
webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr.
Virgil Meier, Biotechnology Regulatory
Services, APHIS, 4700 River Road Unit
147, Riverdale, MD 20737–1236; (301)
734–3363. To obtain copies of the
petition, the determination, the
environmental assessment, or the
finding of no significant impact, contact
Ms. Ingrid Berlanger, at (301) 734–4885;
e-mail:
ingrid.e.berlanger@aphis.usda.gov.
Those documents are also available on
the Internet at https://www.aphis.
usda.gov/brs/aphisdocs/04_11001p.pdf
and https://www.aphis.usda.gov/brs/
aphisdocs/04_11001p_ea.pdf.
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
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Jkt 205001
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 regulations in § 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 § 340.6
describe the form that a petition for a
determination of nonregulated status
must take and the information that must
be included in the petition.
On April 16, 2004, APHIS received a
petition (APHIS petition number 04–
110–01p) from Monsanto Company of
St. Louis, MO, and Forage Genetics
International of West Salem, WI
(Monsanto/FGI), requesting a
determination of nonregulated status
under 7 CFR part 340 for alfalfa
(Medicago sativa L.) designated as
events J101 and J163, which have been
genetically engineered for tolerance to
the herbicide glyphosate. The
Monsanto/FGI petition states that the
subject alfalfa should not be regulated
by APHIS because it does not present a
plant pest risk.
On November 24, 2004, APHIS
published a notice in the Federal
Register (69 FR 68300–68301, Docket
No. 04–085–1) announcing that the
Monsanto/FGI petition and an
environmental assessment were
available for public review and
soliciting comments for 60 days ending
January 24, 2005. The notice also
discussed the role of APHIS, the
Environmental Protection Agency, and
the Food and Drug Administration in
regulating the subject alfalfa and
products developed from it. In a
subsequent notice, APHIS extended the
comment period until February 17, 2005
(see 70 FR 5601–5602, Docket No. 04–
085–2, published February 3, 2005).
APHIS received 663 comments by the
close of the extended comment period.
Comments came from alfalfa growers
and seed producers, organic growers,
animal producers, growers associations,
consumer groups, agriculture support
industries, university professionals, and
private citizens. Five hundred twenty
respondents did not support granting
nonregulated status to the events
identified in the petition, while 137
supported the petition. The majority of
the alfalfa growers and seed producers
who submitted comments supported
granting nonregulated status to alfalfa
events J101 and J163, citing market
demand for a weed-free product and
stating that glyphosate tolerant alfalfa
offered a tool to meet that demand. The
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majority of those academic
professionals, agricultural support
industries, and growers associations that
submitted comments also supported the
petition. Those commenters who did
not support the petition raised concerns
that certain domestic and foreign
markets may be closed to growers who
cannot guarantee a non-genetically
engineered product. Organic growers
generally opposed the petition because
of concerns that pollination of their
crops by the glyphosate tolerant variety
will result in the inadvertent generation
of unwanted genetically engineered
products, resulting in market loss.
APHIS has carefully considered these
comments and suggestions, and a
response to the issues raised in the
comments is included as an attachment
to the finding of no significant impact.
Alfalfa events J101 and J163 have
been genetically engineered to express a
5-enolpyruvyshikimate-3-phosphate
synthase protein from Agrobacterium
sp. strain CP4 (CP4 EPSPS), which
confers tolerance to the herbicide
glyphosate. Expression of the added
genes is controlled in part by the 35S
promoter derived from the plant
pathogen figwort mosaic virus. The
Agrobacterium tumefaciens
transformation method was used to
transfer the added genes into the
proprietary alfalfa line R2336.
Alfalfa events J101 and J163 have
been considered regulated articles under
the regulations in 7 CFR part 340
because they contain gene sequences
from plant pathogens. In the process of
reviewing the notifications for field
trials of the subject alfalfa, APHIS
determined that the vectors and other
elements were disarmed and that the
trials, which were conducted under
conditions of reproductive and physical
confinement or isolation, would not
present a risk of plant pest introduction
or dissemination.
Determination
Based on its analysis of the data
submitted by Monsanto/FGI, a review of
other scientific data, field tests of the
subject alfalfa, and comments submitted
by the public, APHIS has determined
that alfalfa events J101 and J163: (1)
Exhibit no plant pathogenic properties;
(2) are no more likely to become weedy
than the nontransgenic parental line or
other cultivated alfalfa; (3) are unlikely
to increase the weediness potential of
any other cultivated or wild species
with which it can interbreed; (4) will
not cause damage to raw or processed
agricultural commodities; (5) will not
harm threatened or endangered species
or organisms that are beneficial to
agriculture; and (6) should not reduce
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Federal Register / Vol. 70, No. 122 / Monday, June 27, 2005 / Notices
the ability to control pests and weeds in
alfalfa or other crops. Therefore, APHIS
has concluded that the subject alfalfa
and any progeny derived from hybrid
crosses with other non-transformed
alfalfa varieties will be as safe to grow
as alfalfa varieties in traditional
breeding programs that are not subject
to regulation under 7 CFR part 340.
The effect of this determination is that
Monsanto/FGI alfalfa events J101 and
J163 are no longer considered regulated
articles under APHIS’ regulations in 7
CFR part 340. Therefore, the
requirements pertaining to regulated
articles under those regulations no
longer apply to the subject alfalfa or its
progeny. However, importation of J101
and J163 alfalfa and seeds capable of
propagation are still subject to the
restrictions found in APHIS’ foreign
quarantine notices in 7 CFR part 319
and imported seed regulations in 7 CFR
part 361.
National Environmental Policy Act
An environmental assessment was
prepared to examine any potential
environmental impacts associated with
the determination of nonregulated status
for the subject alfalfa events. The
environmental assessment was prepared
in accordance with: (1) The National
Environmental Policy Act of 1969
(NEPA), as amended (42 U.S.C. 4321 et
seq.), (2) regulations of the Council on
Environmental Quality for
implementing the procedural provisions
of NEPA (40 CFR parts 1500–1508), (3)
USDA regulations implementing NEPA
(7 CFR part 1b), and (4) APHIS’ NEPA
Implementing Procedures (7 CFR part
372). Based on that environmental
assessment, APHIS has reached a
finding of no significant impact with
regard to the determination that
Monsanto/FGI J101 and J163 alfalfa
events and lines developed from them
are no longer regulated articles under its
regulations in 7 CFR part 340. Copies of
the environmental assessment and the
finding of no significant impact are
available from the individual listed
under FOR FURTHER INFORMATION
CONTACT.
Authority: 7 U.S.C. 1622n and 7701–7772;
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Dated: Done in Washington, DC, this 21st
day of June 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E5–3323 Filed 6–24–05; 8:45 am]
BILLING CODE 3410–34–P
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DEPARTMENT OF AGRICULTURE
Commodity Credit Corporation
Tobacco Transition Payment
Program—Successor-in-Interest
Contracts
Commodity Credit Corporation,
USDA.
ACTION: Notice and request for
comments.
AGENCY:
SUMMARY: This notice requests public
comment on the documents to be used
by the Commodity Credit Corporation
(CCC) in the administration of the
Tobacco Transition Payment Program
(TTPP) with respect to successor-ininterest contracts, which allow a
tobacco quota holder or a tobacco
producer who is participating in this
program to transfer their rights and
obligations to a third-party.
DATES: CCC requests comments on any
aspect of the documents, which are in
the Appendix to this notice and at
https://www.fsa.usda.gov/tobacco/.
Comments must be received by July 11,
2005.
ADDRESSES: CCC invites interested
persons to submit comments on these
documents. The preferred manner to
submit comments is by e-mail at:
tob_comments@wdc.usda.gov.
Comments may also be submitted by
any of the following methods:
• Fax: Send to (202) 720–1288.
• Mail: Send to Director, Tobacco
Division, Farm Service Agency, United
States Department of Agriculture
(USDA), STOP 0514, Room 4080–S,
1400 Independence Ave., SW.,
Washington, DC 20250–0514.
• Hand Delivery or Courier: Deliver to
the above address.
All comments, including names and
addresses, provided by respondents
become a matter of public record.
Comments may be inspected in the
Office of the Director, Tobacco Division,
FSA, at the above address. Make
inspection arrangements by calling (202)
720–7413.
FOR FURTHER INFORMATION CONTACT: Joe
Lewis, Tobacco Division (TD), Farm
Service Agency, United States
Department of Agriculture (USDA),
STOP 0514, Room 4080–S, 1400
Independence Avenue, SW.,
Washington, DC 20250–0514. Phone:
(202) 720–0795; e-mail:
Joe_Lewis@wdc.usda.gov.
Persons with disabilities who require
alternative means for communication
(Braille, large print, audiotape, etc.)
should contact the USDA Target Center
at (202) 720–2600 (voice and TDD).
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36919
CCC is
seeking comments on the forms relating
to successor in interest contracts,
consolidation of multiple contracts, and
the process flow relating to these
transactions.
An entity would submit to CCC form
CCC–962, ‘‘Agreement to Purchase
Tobacco Transition Payment Contract.’’
Required information includes the
contract number associated with the
transferor’s original contract, the
transferor’s and the successor’s names
and addresses and the signatures of both
parties. In addition, the value of
consideration provided by the successor
to the transferor and the date such
consideration will be paid must be
provided. This agreement, once
submitted to CCC, is non-revocable.
CCC will date and time stamp each form
upon receipt and will honor only the
first one received.
CCC will notify both parties as to the
approval or disapproval of the
succession. If approved, the transferor
no longer has any right to receive
payment from CCC under the TTPP
contract that was transferred. The
successor has all rights to such payment
upon execution of form CCC–957,
‘‘Successor in Interest Contract for
Quota Holders,’’ or form CCC–958,
‘‘Successor in Interest Contract for
Tobacco Producers,’’ as applicable. This
form is available at the FSA Web site or
at USDA Service Centers. It will be the
responsibility of the successor to submit
a signed CCC–957 or CCC–958 to CCC.
Successors desiring to consolidate
multiple contracts acquired from quota
holders and producers must submit the
‘‘Appendix to the Tobacco Transition
Payment Program Contract, Request for
Payment Consolidation Contract’’. The
appendix allows 60 existing contract
numbers to be consolidated; a
continuation form will allow unlimited
contracts to be consolidated. Quota
holder contracts and producer contracts
may not be consolidated on the same
form. Upon CCC approval, a new
contract number will be issued.
If a party succeeds to a tobacco
producer contract, the party must certify
on form AD–1026, ‘‘Highly Erodible
Land Conservation (HELC) and Wetland
Conservation (WC) Certification’’ to the
understanding of the conservation
compliance requirements under USDA
programs. It is not necessary to
complete this form if a previously filed
AD–1026 is on file with USDA and
there has not been a change in the
farming operation or the persons
affiliated with the operation from what
was previously reported.
The successor must also complete a
SF–1199A, ‘‘Direct Deposit Sign Up
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 70, Number 122 (Monday, June 27, 2005)]
[Notices]
[Pages 36917-36919]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-3323]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-085-3]
Monsanto Co. and Forage Genetics International; Availability
Determination of Nonregulated Status for Alfalfa Genetically Engineered
for Tolerance to the Herbicide Glyphosate
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public of our determination that the
Monsanto Company and Forage Genetics International alfalfa lines
designated as events J101 and J163, which have been genetically
engineered for tolerance to the herbicide glyphosate, are no longer
considered regulated articles under our
[[Page 36918]]
regulations governing the introduction of certain genetically
engineered organisms. Our determination is based on our evaluation of
data submitted by Monsanto Company and Forage Genetics International in
their petition for a determination of nonregulated status, our analysis
of other scientific data, and comments received from the public in
response to a previous notice announcing the availability of the
petition for nonregulated status and an environmental assessment. This
notice also announces the availability of our written determination
document and our finding of no significant impact.
EFFECTIVE DATE: June 14, 2005.
ADDRESSES: You may read the petition for a determination of
nonregulated status submitted by Monsanto Company and Forage Genetics
International, the environmental assessment, all comments received on
the petition and the environmental assessment, the determination, and
the finding of no significant impact with attached response to comments
in our reading room. The reading room is located in room 1141 of the
USDA South Building, 14th Street and Independence Avenue, SW.,
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except holidays. To be sure someone is there to
help you, please call (202) 690-2817 before coming.
You may view APHIS documents published in the Federal Register and
related information on the Internet at https://www.aphis.usda.gov/ppd/
rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Virgil Meier, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-3363. To obtain copies of the petition, the
determination, the environmental assessment, or the finding of no
significant impact, contact Ms. Ingrid Berlanger, at (301) 734-4885; e-
mail: ingrid.e.berlanger@aphis.usda.gov. Those documents are also
available on the Internet at https://www.aphis.usda.gov/brs/aphisdocs/
04_11001p.pdf and https://www.aphis.usda.gov/brs/aphisdocs/04_
11001p_ea.pdf.
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 regulations 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 a determination of nonregulated status must take and the
information that must be included in the petition.
On April 16, 2004, APHIS received a petition (APHIS petition number
04-110-01p) from Monsanto Company of St. Louis, MO, and Forage Genetics
International of West Salem, WI (Monsanto/FGI), requesting a
determination of nonregulated status under 7 CFR part 340 for alfalfa
(Medicago sativa L.) designated as events J101 and J163, which have
been genetically engineered for tolerance to the herbicide glyphosate.
The Monsanto/FGI petition states that the subject alfalfa should not be
regulated by APHIS because it does not present a plant pest risk.
On November 24, 2004, APHIS published a notice in the Federal
Register (69 FR 68300-68301, Docket No. 04-085-1) announcing that the
Monsanto/FGI petition and an environmental assessment were available
for public review and soliciting comments for 60 days ending January
24, 2005. The notice also discussed the role of APHIS, the
Environmental Protection Agency, and the Food and Drug Administration
in regulating the subject alfalfa and products developed from it. In a
subsequent notice, APHIS extended the comment period until February 17,
2005 (see 70 FR 5601-5602, Docket No. 04-085-2, published February 3,
2005).
APHIS received 663 comments by the close of the extended comment
period. Comments came from alfalfa growers and seed producers, organic
growers, animal producers, growers associations, consumer groups,
agriculture support industries, university professionals, and private
citizens. Five hundred twenty respondents did not support granting
nonregulated status to the events identified in the petition, while 137
supported the petition. The majority of the alfalfa growers and seed
producers who submitted comments supported granting nonregulated status
to alfalfa events J101 and J163, citing market demand for a weed-free
product and stating that glyphosate tolerant alfalfa offered a tool to
meet that demand. The majority of those academic professionals,
agricultural support industries, and growers associations that
submitted comments also supported the petition. Those commenters who
did not support the petition raised concerns that certain domestic and
foreign markets may be closed to growers who cannot guarantee a non-
genetically engineered product. Organic growers generally opposed the
petition because of concerns that pollination of their crops by the
glyphosate tolerant variety will result in the inadvertent generation
of unwanted genetically engineered products, resulting in market loss.
APHIS has carefully considered these comments and suggestions, and
a response to the issues raised in the comments is included as an
attachment to the finding of no significant impact.
Alfalfa events J101 and J163 have been genetically engineered to
express a 5-enolpyruvyshikimate-3-phosphate synthase protein from
Agrobacterium sp. strain CP4 (CP4 EPSPS), which confers tolerance to
the herbicide glyphosate. Expression of the added genes is controlled
in part by the 35S promoter derived from the plant pathogen figwort
mosaic virus. The Agrobacterium tumefaciens transformation method was
used to transfer the added genes into the proprietary alfalfa line
R2336.
Alfalfa events J101 and J163 have been considered regulated
articles under the regulations in 7 CFR part 340 because they contain
gene sequences from plant pathogens. In the process of reviewing the
notifications for field trials of the subject alfalfa, APHIS determined
that the vectors and other elements were disarmed and that the trials,
which were conducted under conditions of reproductive and physical
confinement or isolation, would not present a risk of plant pest
introduction or dissemination.
Determination
Based on its analysis of the data submitted by Monsanto/FGI, a
review of other scientific data, field tests of the subject alfalfa,
and comments submitted by the public, APHIS has determined that alfalfa
events J101 and J163: (1) Exhibit no plant pathogenic properties; (2)
are no more likely to become weedy than the nontransgenic parental line
or other cultivated alfalfa; (3) are unlikely to increase the weediness
potential of any other cultivated or wild species with which it can
interbreed; (4) will not cause damage to raw or processed agricultural
commodities; (5) will not harm threatened or endangered species or
organisms that are beneficial to agriculture; and (6) should not reduce
[[Page 36919]]
the ability to control pests and weeds in alfalfa or other crops.
Therefore, APHIS has concluded that the subject alfalfa and any progeny
derived from hybrid crosses with other non-transformed alfalfa
varieties will be as safe to grow as alfalfa varieties in traditional
breeding programs that are not subject to regulation under 7 CFR part
340.
The effect of this determination is that Monsanto/FGI alfalfa
events J101 and J163 are no longer considered regulated articles under
APHIS' regulations in 7 CFR part 340. Therefore, the requirements
pertaining to regulated articles under those regulations no longer
apply to the subject alfalfa or its progeny. However, importation of
J101 and J163 alfalfa and seeds capable of propagation are still
subject to the restrictions found in APHIS' foreign quarantine notices
in 7 CFR part 319 and imported seed regulations in 7 CFR part 361.
National Environmental Policy Act
An environmental assessment was prepared to examine any potential
environmental impacts associated with the determination of nonregulated
status for the subject alfalfa events. The environmental assessment was
prepared in accordance with: (1) The National Environmental Policy Act
of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of
the Council on Environmental Quality for implementing the procedural
provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations
implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing
Procedures (7 CFR part 372). Based on that environmental assessment,
APHIS has reached a finding of no significant impact with regard to the
determination that Monsanto/FGI J101 and J163 alfalfa events and lines
developed from them are no longer regulated articles under its
regulations in 7 CFR part 340. Copies of the environmental assessment
and the finding of no significant impact are available from the
individual listed under FOR FURTHER INFORMATION CONTACT.
Authority: 7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR
2.22, 2.80, and 371.3.
Dated: Done in Washington, DC, this 21st day of June 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E5-3323 Filed 6-24-05; 8:45 am]
BILLING CODE 3410-34-P
