[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: opp-docket@epamail.epa.gov. 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:
Mendelsohn.mike@epamail.epa.gov.
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
