[Federal Register Volume 65, Number 154 (Wednesday, August 9, 2000)]
[Notices]
[Pages 48701-48705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20174]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-30010; FRL-6598-5]
Time Extension for B.t. Corn and B.t. Cotton Plant-Pesticides
Expiring Registrations; Registration Process and Public Participation
Opportunity
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is currently engaged in a comprehensive reassessment of
the time-limited registrations for all existing Bacillus thuringiensis
(B.t.) corn and cotton plant-pesticides. This reassessment has been
designed to assure that the decisions on the renewal of these
registrations are based on the most current health and ecological data
(including recently reviewed non-target impact data), and incorporates
recommendations made by the FIFRA Scientific Advisory Panel (SAP). The
reassessment process has also been designed to assure maximum
transparency of the decision making process. In addition to
consideration of recommendations made by the SAP, this reassessment
will be guided by the findings of the 1999 National Academy of Sciences
(NAS) report on Genetically Modified Pest-Protected Plants and the
findings of the recently announced Administration-wide biotechnology
review led jointly by the Council on Environmental Quality (CEQ) and
the Office of Science and Technology Policy (OSTP). This CEQ/OSTP
review is focused on the existing federal regulatory review structures
to assess and regulate the environmental impacts of products of
biotechnology. It is EPA's intention to extend the existing B.t. corn
and cotton registrations until September 30, 2001. If not extended,
these registrations will expire in April and January of 2001,
respectively. EPA believes that in order to bring the results of all of
the aforementioned activities to bear on our final assessment and
renewal decisions, the additional time gained by extending the current
registrations is necessary. EPA has strengthened resistance management
requirements for both corn and cotton in the past year and believes
these strengthened requirements, along with the original registration
conditions, are more than adequate to be protective during the
extension period. This notice sets forth the process that EPA intends
to follow to reach regulatory decisions on the B.t. corn and B.t.
cotton expiring registrations and extension of the existing B.t.
product registrations. It also provides information on EPA's plans for
[[Page 48702]]
finalizing core components of the Plant-Pesticides Rule, that was
proposed on November 23, 1994.
FOR FURTHER INFORMATION CONTACT: Phil Hutton, Biopesticides and
Pollution Prevention Division (7511C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 308-8260; fax number:
(703) 308-7026; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general. This action may
be of particular interest to manufacturers/producers, distributors,
users, and other persons interested in the registrations listed below.
This action may also be of interest to other persons who have an
interest in the registration and/or the use of B.t. corn and B.t.
cotton plant-pesticides regulated under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and under the Federal Food, Drug
and Cosmetic Act (FFDCA). Since other entities may also be interested,
the Agency has not attempted to describe all the specific entities that
may be affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed in the FOR FURTHER INFORMATION CONTACT section.
B. Affected EPA Plant-Pesticides and Registrations
EPA plant-pesticides and registrations affected by the time
extensions and reassessments are listed below.
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EPA Product
Plant-Pesticide EPA Registration Chemistry Code
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Bacillus thuringiensis CryIA(b) Novartis Seeds 006458
Delta-endotoxin and the genetic 66736-1
material necessary for its Mycogen Corp.
production (Plasmid Vector 68467-1.
pCIB4431) in corn.
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Bacillus thuringiensis CryIA(b) Novartis Seeds 006444
Delta-endotoxin and the genetic 67979-1
material necessary for its Novartis Seeds
production (Plasmid Vector 65268-1.
pZ01502) in corn.
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Bacillus thuringiensis CryIA(b) Monsanto Crop. 524- 006430
Delta-endotoxin and the genetic 489
material necessary for its
production in corn.
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Bacillus thuringiensis Aventis 264-669 006466
subspecies tolworthi Cry9C
protein and the genetic
material necessary for its
production in corn
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Bacillus thuringiensis kurstaki Monsanto Corp. 524- 006445
Delta-endotoxin as produced by 478
the CryIA(c) gene and its
controlling sequences as
expressed in cotton.
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C. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
You may obtain electronic copies of this document, and certain
other related documents (including copies of EPA's fact sheets on each
registered B.t. plant-pesticide, workshop proceedings on resistance
management, EPA technical papers on regulation of agricultural
biotechnology including resistance management for B.t. plant-
pesticides, ecological effects data requirements for protein plant-
pesticides, allergenicity and health effects for protein plant-
pesticides, and Scientific Advisory Panel reports from the EPA's
Biopesticide Internet Home Page at http://www.epa.gov/pesticides/biopesticides and from the EPA's Scientific Advisory Panel Home Page at
http://www.epa.gov/scipoly/sap). To access this document, on the Home
Page select ``Laws and Regulations'' and then look up the entry for
this document under the ``Federal Register--Environmental Documents.''
You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.
D. Opportunities for Public Comment
The process that EPA will follow for the comprehensive reassessment
of B.t. plant-pesticides is set forth below in Unit III.D. EPA
encourages public comments for the Agency's consideration during the
comprehensive reassessment of the existing B.t. corn and B.t. cotton
registrations. Throughout the reassessment process, there will be
opportunities for public comment.
II. Actions Being Taken and Authority
A. What Action is the Agency Taking?
EPA is announcing its process for conducting a comprehensive
reassessment of the B.t. corn and B.t. cotton expiring registrations in
order to reach regulatory decisions related to registration renewal.
This process has been designed to allow for appropriate consideration
of all relevant information and to assure a robust public participation
process. EPA is announcing its intent to extend existing (B.t.) corn
and cotton plant-pesticide registrations to remain in effect until
September 30, 2001, providing time for the Agency to consider the
recommendations of the SAP, the CEQ/OSTP Biotechnology review and
public input. EPA is also announcing its plans for finalizing core
components of the Plant-Pesticides Rule, that was proposed on November
23, 1994 (59 FR 60495) (FRL-4755-2).
B. What is the Agency's Authority for Taking This Action?
EPA's comprehensive reassessments of the expiring B.t. corn and
cotton plant-pesticides will be conducted pursuant to its authority at
section 3 of FIFRA. Extension of the period of registration for the
expiring B.t. plant-pesticide registrations will be granted pursuant to
section 3 of FIFRA.
[[Page 48703]]
III. Background and Explanation of Actions Being Taken
A. What is the History of B.t. Plant-Pesticide Registrations?
Prior to registering B.t. plant-pesticides and starting in the mid
1980's, EPA held a series of scientific and public meetings.
Specifically, the Agency organized public meetings of the FIFRA
Scientific Advisory Panel (SAP) and the Biotechnology Scientific
Advisory Committee (BSAC) to consider technical issues related to
biotechnology products that act as pesticides. The focus of these
meetings was to discuss potential risks associated with this
technology, and to identify the appropriate data requirements that
would allow EPA to assess any risks associated with plant-pesticides.
These collaborative efforts resulted in the development of a rigorous
scientific review process and appropriate data requirements. Beginning
in 1995, EPA has registered 11 plant-pesticide products. B.t. plant-
pesticides are registered in corn, cotton, and potato. Two of the 11
original registrations have been or are in the process of being
voluntarily canceled. Seven of the original 11 plant-pesticide
registrations are for field corn, sweet corn, popcorn, and cotton. The
remaining two existing registrations are for potatoes. These seven B.t.
corn and cotton plant-pesticide registrations are time-limited
registrations, currently scheduled to expire in April and January of
2001, respectively. Data required by EPA includes characterization of
the active ingredient (to date, all pesticidal substances have been
proteins) and the genetic material including promoters, etc. used to
make the pesticidal substance in the plant, information on the donor
organism and the host plant, and extensive data on the protein itself.
In addition, studies are required on toxicity to mammals, non-target
organisms and beneficial species, and the fate of the substance in the
environment.
EPA has continued to hold SAP meetings to periodically reevaluate
the data requirements applied to plant-pesticides to ensure that all
appropriate health and safety aspects are covered in light of any new
data. Development of insect resistance to B.t. microbial pesticide
products from the wide-spread use of B.t. crops was one of the major
concerns that was expressed in these early and subsequent public
meetings. In registering B.t. plant-pesticides, EPA has taken extensive
and unprecedented measures to significantly reduce the likelihood that
insects exposed to B.t. plant-pesticides will develop resistance. Well
before registration of the first B.t. plant-pesticide in 1995, EPA
engaged in consultations regarding resistance management for B.t.
plant-pesticides with the U.S. Department of Agriculture (USDA),
potential registrants, academics, farmers, and public interest groups.
In addition, potential registration applicants had been conducting or
sponsoring research on the biology and ecology of the insect pests,
biology of resistance, and many other aspects of effective resistance
management. As a condition of the registrations, EPA required that all
applicants for B.t. plant-pesticide registrations provide EPA with
insect resistance management (IRM) plans, including monitoring and
submission of monitoring data. Subsequent to the registration of the
first B.t. crops in 1995, substantial information has been developed
that has enhanced EPA's understanding of the requirements of IRM plans.
Since 1995, EPA has modified the structured refuge requirements for
B.t. crops as indicated by the evolving science. Moreover, EPA has
mandated certain risk mitigation measures to ensure that selection
pressure is effectively managed and the risk of insect resistance
development to B.t. plant-pesticides is minimized. The Agency has
required or recommended generation of specific research data,
development and implementation of structured refuges, annual resistance
monitoring, remedial action plans, grower education, and sales and
research reporting for certain B.t. crops as part of the development
and implementation of long-term IRM strategies.
EPA is working closely with academia, other federal agencies,
public interest groups, industry, and growers to continue to refine and
implement effective insect resistance plans, based on the most current
science, that provide consistency, effectiveness, and flexibility.
B. What is EPA's Approach to Plant-Pesticides?
EPA has been and remains fully committed to assuring that the
review, assessment and registration of biotechnology products meet the
stringent standards required by FIFRA and the FFDCA, and are fully
protective of public health and the environment. Prior to the 2000
growing season, EPA worked with U.S. farmers and the manufacturers of
B.t. corn products, via the Agricultural Biotechnology Stewardship
Working group, to put strengthened resistance management plans in
place. This collaborative effort was undertaken in response to the
availability of new information regarding insect resistance and
potential non-target species impacts. EPA has worked similarly with the
B.t. cotton registrant and cotton growers to put strengthened
resistance management plans in place for the 2001 growing season.
It is EPA's goal to assure that we continue to make our regulatory
process and decisions within a sound and transparent process framework
and that we are fully informed by the most recent and scientifically
sound information. The Agency will assure a transparent and interactive
review process for its decisions and will make every effort to involve
all of our stakeholders--the manufacturers, the growers, and the
public--to provide the public with confidence in EPA's regulatory
decisions and provide U.S. farmers with the tools they need to continue
to produce a safe and healthy food supply.
C. What is the Rationale for the Action the Agency is Taking?
EPA is conducting a comprehensive reassessment of expiring B.t.
corn and cotton plant-pesticide registrations, including pest
management resistance requirements, to ensure public health and
environmental protection. This process will be scientifically based and
provide increased opportunities for public comment and participation on
both EPA's comprehensive risk assessment and risk management proposals.
EPA intends to extend the existing B.t. corn and cotton plant-pesticide
registrations to remain in effect until September 30, 2001. Absent
extension, these registrations will expire in April and January of
2001, respectively. EPA will extend these registrations to ensure that
the comprehensive reassessment can be completed and subsequent
regulatory decisions made, prior to expiration of the B.t. corn and
cotton registrations. EPA believes that such extensions are appropriate
and necessary to ensure that farmers are provided with adequate time to
evaluate their options for the 2002 growing season. EPA plans to
complete risk assessment recommendations in the late spring or early
summer of 2001. Without the extensions, farmers will have inadequate
information to make their seed buying decisions for the 2002 growing
season. The Agency also believes that such extensions are necessary to
assure that there is no confusion regarding the legal status of these
plant-pesticide products during their normal use period. Moreover, by
extending these registrations, EPA may more fully engage the public in
the comprehensive reassessment in a
[[Page 48704]]
manner that will ensure that adequate time and data are available to
support a thorough reassessment of original data; ensure that newly
submitted ecological data are factored into the assessment; provide
ample time for scientific peer review of EPA's assessment by the SAP;
provide ample time for public review and comment; allow consideration
of recommendations coming from the recent NAS study of genetically-
modified pest-protected plants and the recently announced
Administration-wide review of the adequacy of existing regulatory
structures to assess and regulate potential environmental impacts of
biotechnology products. Pursuant to its statutory obligations under
FIFRA, EPA has determined that the extension of these registrations
will not cause unreasonable adverse effects on the environment.
D. What Future Actions Will the Agency be Taking?
EPA worked with U. S. farmers and the manufacturers of B.t. corn
products to put in place strengthened insect resistance management
plans for the 2000 growing season. The Agency believes these
strengthened measures are necessary and will continue for the 2001
growing season. EPA has also worked with farmers and the B.t. cotton
registrant. The B.t. cotton product has been recently amended to
increase both the size and proximity requirements of the required
refuge, along with strengthening the educational program for users.
These measures provide for increased protection from the potential
onset of resistance. In addition, the Agency reserves the right to
ensure that any additional potential protections are implemented for
the 2001 season if additional information is received that would
warrant such action.
Over the coming months, EPA will be developing a comprehensive
updated risk assessment that will be used to assess whether existing
B.t. plant-pesticide registrations should be renewed, and if renewals
are appropriate whether they should be with or without modification.
That assessment will include not only data and information that was
reviewed for the original assessments, but will also incorporate new
data, including recently submitted monarch butterfly data, guidance
from SAP meetings, recommendations from the National Academy of
Sciences and the CEQ/OSTP biotechnology review, and all public
comments. The NAS report focused on investigating the risks and
benefits of genetically modified pest-protected plants and the
coordinated federal framework for regulation of biotechnology. The
Administration-wide review is a more focused effort, assessing the
present regulatory framework for all federal agencies involved with
biotechnology. This inter-agency review calls for the creation of case
studies that reflect the regulatory processes of each of the federal
agencies involved in the registration and sale and distribution of B.t.
plant-pesticides and other biotechnology products and will be used to
examine and possibly make recommendations to strengthen existing
regulatory structures.
EPA expects to complete that preliminary assessment by late summer
and have a rigorous public review of the assessment. EPA will include
in this process an opportunity for the manufacturers to provide EPA
with technical corrections to the preliminary risk assessment. The
registrants error correction comments and corrective actions taken by
the Agency will be placed in the docket established for B.t. crops.
After any corrections have been made, EPA will invite public comment on
the risk assessment through the Federal Register and the EPA website.
At that time the Agency will also announce a date and place for an SAP
meeting. All public comments received before the SAP meeting will be
given to the SAP for their consideration. The public is encouraged to
provide comments at the SAP meeting. The reassessment process has been
designed to assure maximum transparency of the decision making process
and the data and information that underlie final Agency decisions, and
to assure that all stakeholders have ample time for review and
participation in the process.
EPA's final assessment, renewal decisions and risk mitigation plans
will be completed after careful consideration of all comments and after
any recommendations coming from the Administration-wide review have
been evaluated. EPA intends to provide appropriate opportunities for
public input on the risk management plans before final decisions are
announced.
It is EPA's goal to adhere to a transparent and interactive review
process. The Agency is committed to working with all stakeholders to
provide the public with confidence in EPA's regulatory decisions and
provides U.S. farmers with the tools they need to continue to produce a
safe and healthy food supply.
Up-to-date fact sheets for all affected B.t. corn and B.t. cotton
plant-pesticides can be found on the Biopesticides web page at http://
www.epa.gov/pesticides/biopesticides/ai/plant--pesticides.htm.
E. What are the Process and Schedule for EPA's Reassessment of Existing
B.t. Corn and B.t. Cotton Plant-Pesticides?
It is EPA's goal to provide for an open and transparent public
process that incorporates sound and current science, public
involvement, and balanced decision making. As currently envisioned, the
major components of this process and time frames for action are as
follows:
1. Comprehensive risk assessments. EPA is currently in the process
of evaluating its scientific risk assessments for B.t. products. This
review will incorporate all available scientific information on B.t.
products, including results of recent scientific studies and
recommendations from various individuals and organizations. (Summer/
Fall 2000)
2. Scientific Peer Review and public comment. After completing our
scientific risk assessment, the Agency will provide the registrants of
the products an opportunity to review the risk assessment and suggest
technical corrections to the Agency. After any corrections are made,
EPA will release the risk assessments and invite public comment and
scientific peer review. That release will include EPA's regulatory
assessment and the underlying data, along with any registrants error
correction comments and the corrective actions taken by the Agency. All
of these materials will be placed in the docket established for B.t.
crops. (Fall 2000)
3. Recommendations from the Scientific Advisory Panel, National
Academy of Sciences, public comments, and the Administration-wide
review. Since there are many organizations providing regulatory and
scientific recommendations to EPA, this period will be used to consider
and incorporate as appropriate recommendations into our revised risk
assessment. This will include recommendations from the Scientific
Advisory Panel on insect resistance management, ecological and public
health aspects of our regulatory program, along with consideration of
issues identified in the report released by the National Academy of
Sciences titled: ``Genetically Modified Pest-Protected Plants, Science
and Regulation'' and the Administration-wide review. Any available
recommendation from the Administration-wide review will also be
addressed at this time. (Fall 2000, Winter 2000/1)
4. Revised risk assessments and propose registration requirements.
After incorporating the appropriate recommendations, the Agency will
[[Page 48705]]
revise its risk assessments, and develop registration decision
documents for future growing seasons. This will include any
strengthening measures for issues including insect resistance
management, the protection of non-target organisms, and other measures
necessary to ensure full public and environmental safety. The Agency
will ask for public comment on the revised risk assessment and any
proposed regulatory actions. (Winter 2000/1 to Early Spring 2001)
5. Final decisions on B.t. registrations. This will complete the
scientific and public process with EPA providing decisions on the B.t.
registrations for the 2002 growing season. At this time, EPA will
announce final regulatory conclusions regarding these registrations.
(Late Spring to Summer 2001)
IV. Status of Plant-Pesticide Rule
In concert with the Agency's commitment to keeping interested
parties informed, EPA is taking this opportunity to provide an update
on the plant-pesticide rules proposed on November 23, 1994 (59 FR
60495). While EPA continues to believe that specific registration
decisions can be made while the generic process is being developed, EPA
is using this notice as a vehicle for providing information on the
generic rules because many readers of this notice are also interested
in EPA's other plant-pesticide plans.
EPA plans to publish a final rule later this year establishing the
core components of the Agency's oversight of certain plant-pesticides
under FIFRA. This final rule would amend EPA's regulations at 40 CFR
152.20 pertaining to oversight of biological control agents. Generally,
this rule will clarify how EPA will regulate genetically engineered
plant-pesticides while exempting traditional plant breeding from EPA
oversight under FIFRA and FFDCA.
EPA also plans in that notice to solicit public comment on the
recommendations in the National Academy of Sciences report titled
``Genetically Modified Pest-Protected Plants: Science and Regulation''
as they relate to the parts of the rule that will not be made final. In
its report, the NAS recommended that EPA reconsider its proposed
exemptions for: modifications to sexually-compatible plants
accomplished using rDNA techniques; viral coat proteins, and plant
pesticides that act primarily through non-toxic modes of action (e.g.,
by affecting the physical properties of plants).
List of Subjects
Environmental protection, Plant-pesticides.
Dated: August 3, 2000.
Susan H. Wayland,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
[FR Doc. 00-20174 Filed 8-8-00; 8:45 am]
BILLING CODE 6560-50-F