Bayer CropScience; Availability of Petition and Draft Environmental Assessment for Determination of Nonregulated Status for Cotton Genetically Engineered for Glyphosate Herbicide Tolerance, 34698-34700 [E8-13736]
Download as PDF
<![CDATA[
34698
Notices
Federal Register
Vol. 73, No. 118
Wednesday, June 18, 2008
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.
DEPARTMENT OF AGRICULTURE
Submission for OMB Review;
Comment Request
rwilkins on PROD1PC63 with NOTICES
June 13, 2007.
The Department of Agriculture has
submitted the following information
collection requirement(s) to OMB for
review and clearance under the
Paperwork Reduction Act of 1995,
Public Law 104–13. Comments
regarding (a) 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;
(b) the accuracy of the agency’s estimate
of burden including the validity of the
methodology and assumptions used; (c)
ways to enhance the quality, utility and
clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on those who are to respond, including
through the use of appropriate
automated, electronic, mechanical, or
other technological collection
techniques or other forms of information
technology should be addressed to: Desk
Officer for Agriculture, Office of
Information and Regulatory Affairs,
Office of Management and Budget
(OMB),
OIRA_Submission@OMB.EOP.GOV or
fax (202) 395–5806 and to Departmental
Clearance Office, USDA, OCIO, Mail
Stop 7602, Washington, DC 20250–
7602. Comments regarding these
information collections are best assured
of having their full effect if received
within 30 days of this notification.
Copies of the submission(s) may be
obtained by calling (202) 720–8958.
An agency may not conduct or
sponsor a collection of information
unless the collection of information
displays a currently valid OMB control
number and the agency informs
potential persons who are to respond to
the collection of information that such
persons are not required to respond to
VerDate Aug<31>2005
18:01 Jun 17, 2008
Jkt 214001
the collection of information unless it
displays a currently valid OMB control
number.
Farm Service Agency
Title: Volunteer Programs.
OMB Control Number: 0560–0232.
Summary of Collection: Section 1526
of the Food and Agriculture Act of 1981
(7 U.S.C. 2272) permits the Secretary of
Agriculture to establish a program to use
volunteers to perform a wide range of
activities to carry out the programs of or
supported by the Department of
Agriculture. 5 U.S.C. 3111 grants
agencies the authority to establish
programs designed to provide
educationally related work assignments
for students in non-pay status. While
serving as a Farm and Foreign
Agriculture Service volunteer, each
individual is subject to the same
responsibilities and guidelines for
conduct to which Federal employees are
expected to adhere. These program(s)
will provide a valuable service to the
agencies while allowing the participants
to receive training, supervision and
work experience.
Need and Use of the Information:
Applicants accepted for the Volunteer
Programs will complete the ‘‘Service
Agreement and Attendance Record’’.
The Agency will use the recording
information to respond to the
Department of Agriculture and the
Office of Personnel Management request
for information on Agency Volunteers.
Without the information, the Farm
Service Agency would be unable to
document service performed without
compensation by persons in the
program.
Description of Respondents:
Individuals or households.
Number of Respondents: 60.
Frequency of Responses: Reporting:
On occasion.
Total Burden Hours: 30.
Farm Service Agency
Title: Transfer of Farm Records
Between Counties.
OMB Control Number: 0560–0253.
Summary of Collection: Most Farm
Service Agency (FSA) programs are
administered on the basis of ‘‘farm’’. For
program purposes, a farm is a collection
of tracts of land that have the same
owner and the same operator. Land with
different owners may be considered to
be a farm if all the land is operated by
one person and additional criteria are
PO 00000
Frm 00001
Fmt 4703
Sfmt 4703
met. A farm is typically administered in
the FSA county office where the farm is
physically located. A farm transfer can
be initiated if the farm is being
transferred back to the county where the
farm is physically located, the principal
dwelling on the farm operator has
changed, a change has occurred in the
operation of the land, or there has been
a change that would cause the receiving
administrative county to be more
accessible. Form FSA–179, ‘‘Transfer of
Farm Record Between Counties,’’ is
used as the request for a farm transfer
from one county to another initiated by
the producer.
Need and Use of the Information: The
information collected on the FSA–179 is
collected only if a farm transfer is being
requested and is collected in a face-toface setting with county office
personnel. The information is used by
county office employees to document
which farm is being transferred, what
county it is being transferred to, and
why it is being transferred. Without the
information, county offices will be
unable to determine whether the
producer desires to transfer a farm.
Description of Respondents: Farms.
Number of Respondents: 25,000.
Frequency of Responses: Reporting:
On occasion.
Total Burden Hours: 29,175.
Ruth Brown,
Departmental Information Collection
Clearance Officer.
Editorial Note: This document was
received in the Office of the Federal Register
on June 13, 2008.
[FR Doc. E8–13738 Filed 6–17–08; 8:45 am]
BILLING CODE 3410–05–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2007–0017]
Bayer CropScience; Availability of
Petition and Draft Environmental
Assessment for Determination of
Nonregulated Status for Cotton
Genetically Engineered for Glyphosate
Herbicide Tolerance
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
E:\FR\FM\18JNN1.SGM
18JNN1
rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 73, No. 118 / Wednesday, June 18, 2008 / Notices
SUMMARY: We are advising the public
that the Animal and Plant Health
Inspection Service has received a
petition from Bayer CropScience
seeking a determination of nonregulated
status for cotton genetically engineered
for tolerance to the herbicide glyphosate
derived from a transformation event
designated as GHB614. 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
comments on whether this genetically
engineered cotton is or could be a plant
pest. We are making available for public
comment the petition and draft
environmental assessment for the
proposed determination of nonregulated
status.
DATES: We will consider all comments
that we receive on or before August 18,
2008.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/fdmspublic/
component/main?main=
DocketDetail&d=APHIS–2007–0017 to
submit or view comments and to view
supporting and related materials
available electronically.
• Postal Mail/Commercial Delivery:
Please send two copies of your comment
to Docket No. APHIS–2007–0017,
Regulatory Analysis and Development,
PPD, APHIS, Station 3A–03.8, 4700
River Road, Unit 118, Riverdale, MD
20737–1238. Please state that your
comment refers to Docket No. APHIS–
2007–0017.
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: Additional
information about APHIS and its
programs is available on the Internet at
https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr.
Patricia Beetham, Biotechnology
Regulatory Services, APHIS, 4700 River
Road, Unit 147, Riverdale, MD 20737–
1236; (301) 734–0664, e-mail
patricia.k.beetham@aphis.usda.gov. To
obtain copies of the petition or the draft
environmental assessment, contact Ms.
Cindy Eck at (301) 734–0667, e-mail
cynthia.a.eck@aphis.usda.gov. The
VerDate Aug<31>2005
18:01 Jun 17, 2008
Jkt 214001
petition and the draft environmental
assessment are also available on the
Internet at https://www.aphis.usda.gov/
brs/aphisdocs/06_33201p.pdf and
https://www.aphis.usda.gov/brs/
aphisdocs/06_33201p_ea.pdf.
SUPPLEMENTARY INFORMATION:
Background
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 § 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 November 28, 2006, APHIS
received a petition seeking a
determination of nonregulated status
(APHIS No. 06–332–01p) from Bayer
CropScience (BCS) of Research Triangle
Park, NC, for cotton (Gossypium
hirsutum) designated as transformation
event GHB614, which has been
genetically engineered for tolerance to
the herbicide glyphosate, stating that
cotton line GHB614 does not present a
plant pest risk and, therefore, should
not be a regulated article under APHIS’
regulations in 7 CFR part 340. BCS
responded to APHIS’ subsequent
request for additional information and
clarification on May 11, 2007. The
petition is available for public review
and comment.
Analysis
As described in the petition, cotton
transformation event GHB614 utilizes
the enzyme 5-enolpyruvylshikimate-3phosphate synthase (EPSPS) gene
isolated from a previously deregulated
cotton event (Event GA21; APHIS
petition number 97–099–01) and
introduces two amino acid substitutions
within the EPSPS gene (designated
2mEPSPS). These modifications
decrease the binding affinity to
glyphosate, thus producing tolerance to
PO 00000
Frm 00002
Fmt 4703
Sfmt 4703
34699
the herbicide. The 2mEPSPS protein
allows the plant to tolerate applications
of the broad spectrum herbicide
glyphosate. Regulatory elements for the
transgenes were obtained from
Agrobacterium tumefaciens and were
introduced into cotton cells using
Agrobacterium-mediated transformation
methodology. These regulatory
sequences are not transcribed and do
not encode proteins.
Transformation event GHB614 has
been considered a regulated article
under the regulations in 7 CFR part 340
because it contains gene sequences from
a plant pathogen. GHB614 cotton has
been field tested in the United States
since 2002 under notifications
authorized by the U.S. Department of
Agriculture (USDA). APHIS has
presented three alternatives in the draft
environmental assessment (EA) based
on its analyses of data submitted by
BCS, a review of other scientific data, as
well as data gathered from field tests
conducted under APHIS oversight.
These are the three alternatives that
APHIS is considering: (1) Take no action
(GHB614 remains a regulated article),
(2) deregulate GHB614 in whole, or (3)
deregulate GHB614 in part.
In § 403 of the Plant Protection Act (7
U.S.C. 7701 et seq.), ‘‘plant pest’’ is
defined as any living stage of any of the
following that can directly or indirectly
injure, cause damage to, or cause
disease in any plant or plant product: A
protozoan, a nonhuman animal, a
parasitic plant, a bacterium, a fungus, a
virus or viroid, an infectious agent or
other pathogen, or any article similar to
or allied with any of the foregoing.
APHIS views this definition broadly to
cover direct or indirect injury, disease,
or damage not just to agricultural crops,
but also to other plants, for example,
native species, as well as to plant parts
and plant products whether natural,
manufactured, or processed.
GHB614 cotton is subject to regulation
by other Federal agencies. The U.S.
Environmental Protection Agency (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 herbicides, be registered prior
to distribution or sale, unless exempt
from EPA regulation. In order to be
registered as a pesticide under FIFRA, it
must be demonstrated that when used
with common practices, a pesticide will
not cause unreasonable adverse effects
in the environment. Under the Federal
Food, Drug, and Cosmetic Act (FFDCA),
as amended (21 U.S.C. 301 et seq.),
pesticides added to (or contained in)
raw agricultural commodities generally
E:\FR\FM\18JNN1.SGM
18JNN1
34700
Federal Register / Vol. 73, No. 118 / Wednesday, June 18, 2008 / Notices
rwilkins on PROD1PC63 with NOTICES
are considered to be unsafe unless a
tolerance or exemption from tolerance
has been established. Residue tolerances
for pesticides are established by EPA
under the FFDCA, and the U.S. Food
and Drug Administration (FDA)
enforces the tolerances set by EPA. BCS
submitted the appropriate regulatory
package to EPA for registering the use of
glyphosate herbicide on GBH614 cotton.
Safe use of glyphosate has been
established by the EPA through the
registration of glyphosate for use on
cotton and the setting of tolerances for
the herbicide.
FDA’s policy statement concerning
regulation of products derived from new
plant varieties, including those
genetically engineered, was published
in the Federal Register on May 29, 1992
(57 FR 22984–23005). Under this policy,
FDA uses what is termed a consultation
process to ensure that human and
animal feed safety issues or other
regulatory issues (e.g., labeling) are
resolved prior to commercial
distribution of a bioengineered food. In
compliance with the FDA policy, BCS
has submitted a food and feed safety
and nutritional assessment summary for
GHB614 cotton to the FDA. This
assessment is pending. As of May 29,
2008, FDA has not announced the
completion of BCS’ consultation for
cotton event GHB614 (see https://
www.cfsan.fda.gov/lrd/∼biocon.html).
The petition and the draft EA are
available for public review, and copies
of the petition and the draft EA are
available as indicated under ADDRESSES
and FOR FURTHER INFORMATION CONTACT
above.
After the comment period closes,
APHIS will review all written comments
received during the comment period
and any other relevant information. All
public comments received regarding the
petition and draft EA will be available
for public review. After reviewing and
evaluating the comments on the petition
and the draft EA and other data, APHIS
will furnish a response to the petitioner,
either approving (in whole or part) or
denying the petition. APHIS will then
publish a notice in the Federal Register
announcing the regulatory status of
BCS’ herbicide-tolerant cotton event
GHB614 and the availability of APHIS’
written regulatory and environmental
decision.
National Environmental Policy Act
A draft EA has been prepared to
provide the APHIS decisionmaker with
a review and analysis of any potential
environmental impacts associated with
the proposed determination of
nonregulated status for GHB614. The
draft EA 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).
In accordance with § 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 a determination of
nonregulated status from interested or
affected persons for a period of 60 days
from the date of this notice. We are also
soliciting written comments from
interested or affected persons on the
draft EA prepared to examine any
potential environmental impacts of the
proposed determination for the
deregulation of the subject cotton event.
DEPARTMENT OF AGRICULTURE
VerDate Aug<31>2005
18:01 Jun 17, 2008
Jkt 214001
Authority: 7 U.S.C. 7701–7772 and 7781–
7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
371.3.
Done in Washington, DC, this 12th day of
June 2008.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E8–13736 Filed 6–17–08; 8:45 am]
BILLING CODE 3410–34–P
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2007–0070]
Interstate Movement of Municipal Solid
Waste From Hawaii; Availability of an
Environmental Assessment and
Finding of No Significant Impact
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
SUMMARY: We are advising the public
that the Animal and Plant Health
Inspection Service has prepared a
regional programmatic environmental
assessment and finding of no significant
impact relative to the interstate
movement of municipal solid waste
from Hawaii to landfills in the States of
Idaho, Oregon, and Washington. The
environmental assessment contains a
general assessment of the potential
environmental effects associated with
moving garbage interstate from Hawaii
to Idaho, Oregon, and Washington
subject to certain pest risk mitigation
measures and documents our review
and analysis of the environmental
impacts associated with, and
PO 00000
Frm 00003
Fmt 4703
Sfmt 4703
alternatives to, such movements. Based
on its finding of no significant impact,
the Animal and Plant Health Inspection
Service has determined that an
environmental impact statement need
not be prepared.
FOR FURTHER INFORMATION CONTACT: Ms.
Shannon Hamm, Acting Deputy
Administrator, Policy and Program
Development, APHIS, 4700 River Road
Unit 20, Riverdale, MD 20737–1231;
(301) 734–4957.
SUPPLEMENTARY INFORMATION:
Background
The importation and interstate
movement of garbage is regulated by the
Animal and Plant Health Inspection
Service (APHIS) under 7 CFR 330.400
and 9 CFR 94.5 in order to protect
against the introduction into and
dissemination within the United States
of plant and animal pests and diseases.
On March 13, 2008, we published in
the Federal Register (73 FR 13525,
Docket No. APHIS–2007–0070) a
notice 1 in which we announced the
availability, for public review and
comment, of a regional programmatic
environmental assessment relative to
the interstate movement of municipal
solid waste from Hawaii to landfills in
the States of Idaho, Oregon, and
Washington.
The environmental assessment, titled
‘‘Regional Movement of Plastic-baled
Municipal Solid Waste from Hawaii to
Washington, Oregon, and Idaho’’
(February 2008), considers the
movement of a cumulative maximum
amount of baled municipal solid waste
from the State of Hawaii to any qualified
landfill in Washington, Oregon, or Idaho
under compliance agreements with
APHIS and in accordance with the
standards previously established by
APHIS regarding baling, handling, spill
response, and disposal.
We solicited comments on the
regional programmatic environmental
assessment for 30 days ending on April
14, 2008. We received three comments
by that date, from the State of Idaho, a
private citizen, and a law office. All of
the commenters raised specific issues
regarding the environmental
assessment. In an attachment to the
finding of no significant impact
determination, we respond to each of
the issues raised by the commenters.
Based on the information contained in
the regional programmatic
environmental assessment and
following our consideration of the
1 To view the notice and the comments we
received, go to https://www.regulations.gov/
fdmspublic/component/
main?main=DocketDetail&d=APHIS–2007–0070.
E:\FR\FM\18JNN1.SGM
18JNN1
]]>Agencies
[Federal Register Volume 73, Number 118 (Wednesday, June 18, 2008)]
[Notices]
[Pages 34698-34700]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-13736]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2007-0017]
Bayer CropScience; Availability of Petition and Draft
Environmental Assessment for Determination of Nonregulated Status for
Cotton Genetically Engineered for Glyphosate Herbicide Tolerance
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 34699]]
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has received a petition from Bayer CropScience
seeking a determination of nonregulated status for cotton genetically
engineered for tolerance to the herbicide glyphosate derived from a
transformation event designated as GHB614. 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 comments on
whether this genetically engineered cotton is or could be a plant pest.
We are making available for public comment the petition and draft
environmental assessment for the proposed determination of nonregulated
status.
DATES: We will consider all comments that we receive on or before
August 18, 2008.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://
www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2007-0017 to submit or view comments and
to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send two copies of
your comment to Docket No. APHIS-2007-0017, Regulatory Analysis and
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118,
Riverdale, MD 20737-1238. Please state that your comment refers to
Docket No. APHIS-2007-0017.
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: Additional information about APHIS and its
programs is available on the Internet at https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr. Patricia Beetham, Biotechnology
Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD
20737-1236; (301) 734-0664, e-mail patricia.k.beetham@aphis.usda.gov.
To obtain copies of the petition or the draft environmental assessment,
contact Ms. Cindy Eck at (301) 734-0667, e-mail
cynthia.a.eck@aphis.usda.gov. The petition and the draft environmental
assessment are also available on the Internet at https://
www.aphis.usda.gov/brs/aphisdocs/06_33201p.pdf and https://
www.aphis.usda.gov/brs/aphisdocs/06_33201p_ea.pdf.
SUPPLEMENTARY INFORMATION:
Background
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 November 28, 2006, APHIS received a petition seeking a
determination of nonregulated status (APHIS No. 06-332-01p) from Bayer
CropScience (BCS) of Research Triangle Park, NC, for cotton (Gossypium
hirsutum) designated as transformation event GHB614, which has been
genetically engineered for tolerance to the herbicide glyphosate,
stating that cotton line GHB614 does not present a plant pest risk and,
therefore, should not be a regulated article under APHIS' regulations
in 7 CFR part 340. BCS responded to APHIS' subsequent request for
additional information and clarification on May 11, 2007. The petition
is available for public review and comment.
Analysis
As described in the petition, cotton transformation event GHB614
utilizes the enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS)
gene isolated from a previously deregulated cotton event (Event GA21;
APHIS petition number 97-099-01) and introduces two amino acid
substitutions within the EPSPS gene (designated 2mEPSPS). These
modifications decrease the binding affinity to glyphosate, thus
producing tolerance to the herbicide. The 2mEPSPS protein allows the
plant to tolerate applications of the broad spectrum herbicide
glyphosate. Regulatory elements for the transgenes were obtained from
Agrobacterium tumefaciens and were introduced into cotton cells using
Agrobacterium-mediated transformation methodology. These regulatory
sequences are not transcribed and do not encode proteins.
Transformation event GHB614 has been considered a regulated article
under the regulations in 7 CFR part 340 because it contains gene
sequences from a plant pathogen. GHB614 cotton has been field tested in
the United States since 2002 under notifications authorized by the U.S.
Department of Agriculture (USDA). APHIS has presented three
alternatives in the draft environmental assessment (EA) based on its
analyses of data submitted by BCS, a review of other scientific data,
as well as data gathered from field tests conducted under APHIS
oversight. These are the three alternatives that APHIS is considering:
(1) Take no action (GHB614 remains a regulated article), (2) deregulate
GHB614 in whole, or (3) deregulate GHB614 in part.
In Sec. 403 of the Plant Protection Act (7 U.S.C. 7701 et seq.),
``plant pest'' is defined as any living stage of any of the following
that can directly or indirectly injure, cause damage to, or cause
disease in any plant or plant product: A protozoan, a nonhuman animal,
a parasitic plant, a bacterium, a fungus, a virus or viroid, an
infectious agent or other pathogen, or any article similar to or allied
with any of the foregoing. APHIS views this definition broadly to cover
direct or indirect injury, disease, or damage not just to agricultural
crops, but also to other plants, for example, native species, as well
as to plant parts and plant products whether natural, manufactured, or
processed.
GHB614 cotton is subject to regulation by other Federal agencies.
The U.S. Environmental Protection Agency (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 herbicides, be registered prior
to distribution or sale, unless exempt from EPA regulation. In order to
be registered as a pesticide under FIFRA, it must be demonstrated that
when used with common practices, a pesticide will not cause
unreasonable adverse effects in the environment. Under the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended (21 U.S.C. 301 et
seq.), pesticides added to (or contained in) raw agricultural
commodities generally
[[Page 34700]]
are considered to be unsafe unless a tolerance or exemption from
tolerance has been established. Residue tolerances for pesticides are
established by EPA under the FFDCA, and the U.S. Food and Drug
Administration (FDA) enforces the tolerances set by EPA. BCS submitted
the appropriate regulatory package to EPA for registering the use of
glyphosate herbicide on GBH614 cotton. Safe use of glyphosate has been
established by the EPA through the registration of glyphosate for use
on cotton and the setting of tolerances for the herbicide.
FDA's policy statement concerning regulation of products derived
from new plant varieties, including those genetically engineered, was
published in the Federal Register on May 29, 1992 (57 FR 22984-23005).
Under this policy, FDA uses what is termed a consultation process to
ensure that human and animal feed safety issues or other regulatory
issues (e.g., labeling) are resolved prior to commercial distribution
of a bioengineered food. In compliance with the FDA policy, BCS has
submitted a food and feed safety and nutritional assessment summary for
GHB614 cotton to the FDA. This assessment is pending. As of May 29,
2008, FDA has not announced the completion of BCS' consultation for
cotton event GHB614 (see https://www.cfsan.fda.gov/lrd/~biocon.html).
National Environmental Policy Act
A draft EA has been prepared to provide the APHIS decisionmaker
with a review and analysis of any potential environmental impacts
associated with the proposed determination of nonregulated status for
GHB614. The draft EA 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).
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 a determination of
nonregulated status from interested or affected persons for a period of
60 days from the date of this notice. We are also soliciting written
comments from interested or affected persons on the draft EA prepared
to examine any potential environmental impacts of the proposed
determination for the deregulation of the subject cotton event. The
petition and the draft EA are available for public review, and copies
of the petition and the draft EA are available as indicated under
ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
After the comment period closes, APHIS will review all written
comments received during the comment period and any other relevant
information. All public comments received regarding the petition and
draft EA will be available for public review. After reviewing and
evaluating the comments on the petition and the draft EA and other
data, APHIS will furnish a response to the petitioner, either approving
(in whole or part) or denying the petition. APHIS will then publish a
notice in the Federal Register announcing the regulatory status of BCS'
herbicide-tolerant cotton event GHB614 and the availability of APHIS'
written regulatory and environmental decision.
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 12th day of June 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E8-13736 Filed 6-17-08; 8:45 am]
BILLING CODE 3410-34-P
