[Federal Register Volume 65, Number 154 (Wednesday, August 9, 2000)]
[Pages 48701-48705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20174]



[OPP-30010; FRL-6598-5]

Time Extension for B.t. Corn and B.t. Cotton Plant-Pesticides 
Expiring Registrations; Registration Process and Public Participation 

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.


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: hutton.phil@epa.gov.


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 

B. Affected EPA Plant-Pesticides and Registrations

    EPA plant-pesticides and registrations affected by the time 
extensions and reassessments are listed below.

                                                          EPA Product
         Plant-Pesticide           EPA Registration     Chemistry Code
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.
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.
Bacillus thuringiensis CryIA(b)   Monsanto Crop. 524- 006430
Delta-endotoxin and the genetic    489
 material necessary for its
 production in corn.
Bacillus thuringiensis            Aventis 264-669     006466
 subspecies tolworthi Cry9C
 protein and the genetic
 material necessary for its
 production in corn
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.

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 
    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 
    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://

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 
    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]