[Federal Register Volume 62, Number 75 (Friday, April 18, 1997)]
[Notices]
[Pages 19115-19117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10111]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00478; FRL-5600-9]


Plant Pesticides Resistance Management; Notice of Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA will conduct a public meeting on May 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 May 21, 1997 from 9 am to 5 pm. 
Written comments from interested parties not able to attend the meeting 
must be received on or before May 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 May 
14, 1997.

ADDRESSES: The meeting is open to the public and will be held at Texas 
A & M University, College Station, Texas 77843-2475, in Rm. 301 of the 
Rudder Tower. 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-00478, 
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 of ASCII file format. 
All comments and data in electronic form must be identified by the 
docket control number OPP-00478. 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: Michael L. Mendelsohn, 
Biopesticides and Pollution Prevention Division 7501W, Office of 
Pesticide Programs, U. S. Environmental Protection Agency, 401 M St., 
SW., Washington, DC 20460. Office location and telephone number: 5th 
Floor CS, 2800 Crystal Drive, Arlington, VA, (703)-308-8715; Email: 
M[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 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 19116]]

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 company should have specific monitoring plans for 
resistance which should be sent to the Agency for review. The SAP also 
requested that the company 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 resistance management plan (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 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. 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 U.S. Therefore 
the Agency required the development of a resistance management plan as 
a condition of the corn registrations, so that such plans could be 
implemented if pest resistance was detected.
    Bt cotton was the last plant pesticide crop to registered. For Bt 
cotton, there was compelling evidence to require the implementation of 
a resistance management plan 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 cotton 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 labelling.
    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 dialogue committee 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 cotton bollworm 
population. The registrant has submitted a report concerning these 
instances. The report is currently under review by the Agency to 
determine how crop performance is related to resistance management.
    On March 21, 1997, EPA held an initial hearing on this subject in 
the EPA Auditorium in Washington, D.C. Approximately 30 individuals/
organizations submitted written comments or delivered presentations 
regarding the subject of resistance management. The information 
presented to EPA at both the March 21 and May 21 hearings will be 
compiled into a report available to the public after the Agency has had 
sufficient opportunity to review all of the submitted material.

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. The ``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 to Make Comments

    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 May 14, 1997. Those who do not register by May 14 may register 
in person, on May 21, to make a presentation if time permits. Register 
by mail with the person listed under FOR FURTHER INFORMATION CONTACT.

[[Page 19117]]

IV. Public Record

    The Agency encourages parties to submit data to substantiate 
comments whenever possible. All comments, as well as information 
gathered at the public meeting will be available for public inspection 
from 8:30 am to 4 pm, Monday through Friday (except legal holidays), at 
the Public Response and Program Resource Branch, Field Operations 
Division, Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis Highway, 
Arlington, VA 22202.
    Information submitted as part of any comment may be claimed as 
confidential by marking any or all of that information as 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 to the submitted. 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 May 14 to make 
their presentations. 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 or before 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 Michael L. Mendelsohn at the 
address stated earlier in this notice.

    Dated: April 11, 1997.

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

[FR Doc. 97-10111 Filed 4-17-97; 8:45 am]
BILLING CODE 6560-50-F