8242 Federal Register / Vol. 62, No. 36 / Monday, February 24, 1997 / Notices

points. The purpose of this peer-review

workshop is to review the comments

provided independently by the

reviewers and to receive further

comment based on their discussion.

The EPA has undertaken this task in

response to emerging scientific

knowledge of the biological, human

health, and environmental effects of

dioxin. Significant advances have

occurred in the scientific understanding

of mechanisms of dioxin toxicity, of the

carcinogenic and other adverse health

effects of dioxin in people, of the

pathways to human exposure, and of the

toxic effects of dioxin to the

environment.

In 1985 and 1988, the Agency

prepared assessments of the human

health risks from environmental

exposures to dioxin. These assessments

were reviewed by the Agency’s SAB. At

the time of the 1988 risk assessment,

there was general agreement within the

scientific community that there could be

a substantial improvement over the

existing response approach, but there

was no consensus as to a more

biologically defensible methodology.

The Agency was asked to explore the

development of such a method. The

current reassessment activities are in

part in response to this request.

The EPA is making each phase of the

current reassessment of dioxin an open

and participatory effort. It previously

has convened two public meetings (on

November 15, 1991, and April 28, 1992)

to inform the public of the Agency’s

plans and activities, to hear and receive

public comments and reviews of the

proposed plans for the reassessment,

and receive any current, scientifically

relevant information.

The Agency convened two peerreview workshops to review draft

documents related to EPA’s scientific

reassessment of the health effects of

dioxin. The first workshop was held

September 10 and 11, 1992, to review a

draft exposure assessment titled,

Estimating Exposures to Dioxin-Like

Compounds. The second workshop was

held September 22–25, 1992, to review

eight chapters of a draft health

assessment document. The

epidemiology chapter was also reviewed

in another workshop on September 8–9,

1993. It should be noted that outside

scientists have been heavily involved in

the writing and peer review of these

draft documents. Drafts of the health

and exposure documents were made

available for public review and

comment in the fall of 1994, both with

a formal public comment period and at

a number of public meetings that were

held around the country. The SAB

reviewed the documents in May 1995.

The purpose of the March 1997 peerreview workshop is to review the draft

of a revised and expanded doseresponse modeling chapter. The revised

chapter evaluates the scientific quality

and strength of the dose-response

modeling in the evaluation of toxic

health effects, both cancer and

noncancer, from exposure to dioxin,

with an emphasis on the specific

congener, 2,3,7,8-TCDD. A critical

analysis of all available data has been

performed. It is hoped that the peerreview workshop will provide a

thoughtful and critical review of the

dose-response portion of the dioxin

reassessment.

Dated: February 20, 1997.

William H. Farland,

Director, National Center for Environmental

Assessment.

[FR Doc. 97–4618 Filed 2–21–97; 8:45 am]

BILLING CODE 6560–50–P

[OPP–00470; FRL–5591–6]

Plant Pesticides Resistance

Management; Notice of Meeting

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of Meeting.

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: oppdocket@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 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, email:nelson.willie@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 plantpesticides 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 Btbased 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
Federal Register / Vol. 62, No. 36 / Monday, February 24, 1997 / Notices 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,
8244 Federal Register / Vol. 62, No. 36 / Monday, February 24, 1997 / Notices

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-Docket@epamail.epa.gov

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

[PF–710A; FRL–5591–4]

Appropriate Technology Limited;

Pesticide Tolerance Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of filing; Technical

amendment.

SUMMARY: EPA is correcting the time for

the submission of comments on the

notice of filing of a pesticide petition

proposing the establishment of a

regulation exempting from the

requirement of a tolerance residues of

extracts from Quercus falcata (red oak)

Rhus aromatic (sumac), Rhizophora

mangle (mangrove), and Opuntia

lindheimeri (prickly pear cactus). The

petition was submitted by Appropriate

Technology Limited.

FOR FURTHER INFORMATION CONTACT: By

mail: Teung F. Chin, Biopesticides and

Pollution Prevention Division, (7501W),

Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location, telephone number, and

e-mail address: 5th Floor, CS #1, 2800

Crystal Drive, Arlington, VA 22202,

703–308–1259, e-mail:

chin.teung@epamail.epa.gov.

In FR Doc. 97-3517, appearing at page

6777 in the issue for Thursday, February

13, 1997, the comment period under

‘‘DATES’’ is corrected to read as March

17, 1997.

List of Subjects

Environmental protection.

Dated: February 19, 1997.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

[FR Doc. 97–4622 Filed 2–21–97; 8:45 am]

BILLING CODE 6560–50–P

[FRL–5693–4]

Notice of Proposed Assessment of

Clean Water Act Class II Administrative

Penalty to A&D Plating, Inc. and

Opportunity To Comment

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of proposed

administrative penalty assessment and

opportunity to comment.

SUMMARY: EPA is providing notice of

proposed administrative penalty

assessment and proposed Consent

Agreement for alleged violations of the

Clean Water Act. EPA is also providing

notice of opportunity to comment on the

proposed assessment.

Under 33 U.S.C. Section 1319(g), EPA

is authorized to issue orders assessing

civil penalties for various violations of

the Act. EPA may issue these orders

after the commencement of either a

Class I or Class II penalty proceeding.

EPA provides public notice of the

proposed assessments pursuant to 33

U.S.C. Section 1319(g)(4)(a).

Class II proceedings are conducted

under EPA’s Consolidated Rules of

Practice Governing the Administrative

Assessment of Civil Penalties and the

Revocation and Suspension of Permits,

40 CFR part 22. The procedures through

which the public may submit written

comment on a proposed Class II order

or participate in a Class II proceeding,

and the Procedures by which a

Respondent may request a hearing, are

set forth in the Consolidated Rules. The

deadline for submitting public comment

on a proposed Class II order is thirty

days after publication of this notice.

On the date identified below, EPA

commenced the following Class II

proceeding for the assessment of

penalties:

In the Matter of A&D Plating, Inc., 2265

Micro Place, Suite A, Escondido, California;

EPA Docket No. CWA–IX–FY97–02; filed on

February 11, 1997, with Mr. Steven Armsey,

Regional Hearing Clerk, U.S. EPA, Region 9,

75 Hawthorne Street, San Francisco,

California 94105, (415) 744–1389; proposed

penalty of $35,000 for failure to comply with

the categorical pretreatment standards and

requirements for new source metal finishers

(40 CFR 433). EPA and A&D Plating, Inc.

have agreed to a proposed Consent