[Federal Register Volume 62, Number 36 (Monday, February 24, 1997)]
[Notices]
[Pages 8242-8244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4621]


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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00470; FRL-5591-6]


Plant Pesticides Resistance Management; Notice of Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Meeting.

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SUMMARY: EPA will hold a public meeting on March 21, 1997, to solicit 
public comment on resistance management plans for plant pesticides, 
including the necessity for such plans, critical elements of resistance 
management plans and requirements for successful implementation.
DATES: The meeting will be held on March 21, 1997, from 8:30 am until 5 
pm. Written comments from interested parties not able to attend the 
meeting must be received on or before March 21, 1997. Persons who wish 
to speak at the public meeting are encouraged to register in advance by 
submitting a brief written request and abstract to EPA on or before 
March 14, 1997.

ADDRESSES: The meeting is open to the public and will be held in the 
EPA Auditorium at EPA Headquarters, 401 M St., SW., Washington, DC 
20460. Interested parties who cannot attend the public meeting but who 
wish to comment may do so by submitting written comments. Comments 
should be identified by the docket control number OPP-00470, and be 
submitted to: Public Response and Program Resources Branch, Field 
Operations Division (7506C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect 5.1 file format or ASCII file format. 
All comments and data in electronic form must be identified by the 
docket control number OPP-00470. No Confidential Business Information 
(CBI) should be submitted through e-mail. Electronic comments may be 
filed online at many Federal Depository Libraries. Additional 
information on electronic submissions can be found in Unit IV of this 
document.
FOR FURTHER INFORMATION CONTACT: By mail: Willie H. Nelson, 
Biopesticides and Pollution Prevention Division (7501W), Office of 
Pesticide Programs, U. S. Environmental Protection Agency, 401 M St., 
SW., Washington, DC 20460. Office location, telephone number and e-mail 
address: 5th Floor CS, 2800 Crystal Drive, Arlington, VA 22202, 
Telephone No: 703-308-8682, e-mail:[email protected].
SUPPLEMENTARY INFORMATION:

I. Background

    Resistance management has been a consideration for the registration 
of plant pesticides for some time. This is because plant pesticides 
tend to produce the pesticidal active ingredient throughout a growing 
season, increasing the selection pressure upon both the target pests 
and any other susceptible insects feeding on the transformed crop.
    Resistance management has become an issue particularly in relation 
to plant-pesticides based on the insecticidal proteins from the 
bacterium Bacillus thuringiensis (Bt). EPA recognizes the value of Bt 
as a safer pesticide and has determined that it is necessary to 
conserve this resource as appropriate by requiring resistance 
management plans. The Agency has reviewed initial strategies from 
registrants for managing resistance to Bt delta endotoxins produced in 
potato, corn, and cotton. EPA has worked with stakeholders (industry, 
public sector research and extension, growers, user groups, and 
government agencies) to address resistance management for primarily Bt-
based plant pesticides.
    In March of 1995, EPA held a Scientific Advisory Panel (SAP) 
meeting as part of the review for the first registered plant 
pesticides. This meeting primarily addressed issues related to the 
Bacillus thuringiensis (Bt) tenebrionis CryIII delta endotoxin in 
potato, although some issues related to Bt corn and Bt cotton were also 
discussed. The

[[Page 8243]]

Panel stated in their review that the submitted resistance management 
plan (RMP) is a ``scientifically credible Colorado potato beetle (CPB) 
resistance management protocol.'' For the Bt potato, the SAP 
recommended that the applicant should have specific monitoring plans 
for resistance which should be sent to the Agency for review. The SAP 
also requested that the applicant make specific recommendations on what 
course of action should be taken if resistance should be discovered. It 
was the opinion of the panel that EPA should work with the applicant in 
developing a long-term RMP, but that such plans should not be a formal 
condition of registration. EPA agreed with this assessment for Bt 
potato as the pesticide was only for the control of the Colorado Potato 
Beetle, the CryIII delta endotoxin was at a high dose, and existing Bt 
tenebrionis sprayable products only worked for early instars of this 
pest. In addition, the Colorado potato beetle has a limited host range 
of economic crops.
    The SAP further agreed with the seven elements, described by OPP, 
that need to be addressed to develop an adequate resistance management 
plan for plant-pesticides. These elements are: (1) Knowledge of pest 
biology and ecology, (2) Appropriate gene deployment strategy, (3) 
Appropriate refugia (primarily for insecticides, (4) Monitoring and 
reporting of incidents of pesticide resistance development, (5) 
Employment of Integrated pest management (IPM), (6) Communication and 
educational strategies for use of the product and (7) Development of 
alternative modes of action.
    Bt CryIA(b) delta endotoxin in corn was the second plant pesticide 
registered. This product was intended primarily for the control of the 
European corn borer. EPA noted in its review of the application that 
other lepidopterous pests that also feed on corn might be affected by 
the endotoxin, and therefore have the potential for the development of 
resistance to Bt. This review also noted that both the primary pests 
claimed on the label and those secondary pests may be controlled by the 
use of existing sprayable Bt products. Bt is considered to be a reduced 
risk pesticide and corn is planted in large acreages in the United 
States. Therefore the Agency required the development of a resistance 
management plan as a condition of the corn Bt registrations, so that 
such plans could be implemented if pest resistance was detected.
    Bt cotton containing CryIA(c) was the last plant pesticide crop to 
be registered. For Bt cotton, there was compelling evidence to require 
the implementation of a RMP as a condition of the registration. This 
was due to the fact that: (1) Bt was already used extensively on 
cotton, (2) corn earworm (a primary pest, known as the bollworm when 
feeding on cotton) moves from corn to cotton thus extending the period 
of exposure to the Bt toxin, and (3) that corn earworm feeds on many 
other crops that are treated with Bt in significant amounts. Cotton is 
also planted in large acreages in the United States. An RMP was 
therefore required as a condition of the registration for Bt Cotton.
    The Pesticide Program Dialogue Committee (PPDC) is a group 
representing various interests and points of view including public 
interest, industry, users, public health, legal, Congress, and the 
general public. The PPDC meeting in July of 1996 addressed the issue of 
resistance management. OPP asked the committee for their views on the 
best approach for the Agency to take in addressing the problem of pest 
resistance; the need for a new active ingredient screening process; 
whether OPP should address the problem of pest resistance to already 
registered pesticides; and whether resistance management 
recommendations should be required on pesticide labeling.
    Panelists agreed that EPA should have some role in resistance 
management, but disagreed as to what that role should be. Panelists 
indicated that EPA should not make resistance management mandatory in 
all cases.
    It was the general opinion of the PPDC that the Agency should 
function as a liaison or clearing house for RMP information, but only 
require resistance management plans as part of the registration when 
the development of resistance would cause the potential loss of a 
pesticide that was in the ``public good'', like Bt. The committee found 
it difficult to define ``public good'' parameters. Other panelists 
commented that EPA needed to provide more alternative tools for minor 
crops, and one panelist suggested that EPA could promote better 
resistance management by classifying pesticides according to their mode 
of action similar to Canadian requirements.
    During the 1996 season, there were numerous instances reported to 
EPA where Bt cotton failed to control a segment of the bollworm 
population. The registrant has submitted a report concerning these 
instances. The report is currently under review by the Agency to 
determine how pest populations, and crop performance is related to 
resistance management.

II. Information Sought by EPA

    EPA is required by law to ensure that pesticides have a reasonable 
certainty of no harm to people (including infants and children) and do 
not cause unreasonable adverse effects to the environment. As part of 
the evaluation process, the Agency collects information on the risks 
and benefits of pesticides. The Agency is interested in soliciting 
public comment regarding resistance management plans for plant 
pesticides because resistance management plans are a new requirement 
related to a novel technology.
    1. The requirement for resistance management plans. This will 
include information on the criteria for requiring a resistance 
management plan and whether such plans should be voluntary or mandatory 
(conditions of registration).
    2. Scientific needs for resistance management plans. Certain data 
may be required in order to adequately evaluate resistance management 
plans. EPA needs information on what kinds of data should be required 
to assess the potential for resistance and/or adequately evaluate 
proposed plans.
    3. ``Public good'' criteria. The Agency wants comment on whether 
this criteria should be used, and if so, information on the definition 
or determination of when a pesticide would be in the ``public good.''
    4. Performance failures for Bt cotton. Information concerning the 
control failures for Bt cotton, suggested evaluation tools concerning 
these failures, and implications on future resistance management 
efforts.

III. Registration For Purposes of Commenting

    Persons who wish to speak at the public meeting are encouraged to 
register in advance by submitting a brief written request to EPA on or 
before March 14, 1997. Those who do not register by March 14 may 
register in person, on March 21, to make a presentation if time 
permits. Register by mail with the person listed under FOR FURTHER 
INFORMATION CONTACT.

IV. Public Record

    The Agency encourages parties to submit data to substantiate 
comments whenever possible. A record has been established for this 
rulemaking under docket control number OPP-00470 (including comments 
and data submitted electronically as described below). A public version 
of this record, including printed, paper versions of electronic 
comments, which does not include any information claimed as CBI,

[[Page 8244]]

is available for inspection from 8:30 am to 4 pm, Monday through 
Friday, excluding legal holidays. The public record is located in Room 
1132 of the Public Response and Program Resources Branch, Field 
Operations Division (7506C), Office of Pesticide Programs, 
Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis 
Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:
    opp-D[email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer all comments received electronically into printed, 
paper form as they are received and will place the paper copies in the 
official rulemaking record which will also include all comments 
submitted directly in writing. The official rulemaking record is the 
paper record maintained at the Virginia address in ``ADDRESSES'' at the 
beginning of this document.
    Information submitted as part of any comment may be claimed as 
confidential by marking any or all of that information as Confidential 
Business Information (CBI). Information so marked will not be disclosed 
except in accordance with the procedures set forth in 40 CFR part 2. A 
copy of the comment that does not contain CBI must be submitted for 
inclusion in the public record. Information not marked confidential may 
be disclosed publicly by the Agency without prior notice. The Agency 
anticipates that most of the comments will not be classified as CBI, 
and prefers that all information submitted be publicly available. Any 
records or transcripts of the open meeting will be considered public 
information and cannot be declared CBI.

V. Structure of the Meeting

    EPA will open the meeting with brief introductory comments. EPA 
will then invite those parties who have registered by March 14 to 
present their comments. Those who register the day of the meeting will 
be offered the opportunity to present their comments if time permits. 
EPA anticipates that each speaker will be permitted about 10 minutes to 
make comments. After each speaker, Agency representatives may ask the 
presenter questions of clarification. The Agency reserves the right to 
adjust the time for presenters depending upon the number of speakers.
    Members of the public are encouraged to submit written 
documentation to EPA at the meeting to ensure that their entire 
position goes on record in the event that time does not permit a 
complete oral presentation. Written comments should include the name 
and address of the author as well as any sources used. Written 
documentation should be submitted to Willie H. Nelson at the address 
stated earlier in this notice.

    Dated: February 19, 1997.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

[FR Doc. 97-4621 Filed 2-20-97; 1:07 pm]
BILLING CODE 6560-50-F