FIFRA SCIENTIFIC ADVISORY PANEL
MINUTES OF THE FIRST MEETING
DECEMBER 9-10,1976
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FIFRA SCIENTIFIC ADVISORY PANEL
Chairman
Dr. Dewayne C. Torgeson
Program Director, Bioregulant
Chemicals
Boyce Thompson Institute for Plant
Research, Inc.
1086 North Broadway
Yonkers, New York 10701
Members
Dr. John E. Davies
Chairman, Department of Epidemiology
and Public Health
University of Miami School of Medicine
1600 N.W. 10th Avenue, 1129A
Miami, Florida 33152
Dr. David E. Davis
Professor Emeritus, Zoology
Former Department of Zoology
North Carolina State University
777 Picacho Lane
Santa Barbara, California 93108
Dr. John Doull
Professor of Pharmacology and
Toxicology
University of Kansas Medical
Center
Kansas City, Kansas 66103
Secretariat
Dr. W. Wade Fowler, Jr.
Executive Secretary
Assistant for Scientific Liaison
Office of Pesticide Programs (WH-567)
U.S. Environmental Protection Agency
401 M. Street, S.W.
Washington, D.C. 20460
Dr. Robert Lee Metcalf
Professor of Entomology, Biology,
and Environmental Studies
Department of Entomology
University of Illinois
Urbana, Illinois 61801
Dr. Robert A. Neal
Director, Center in Environmental
Toxicology
Vanderbilt University School of
Medi ci ne
Nashville, Tennessee 37232
Dr. Edward A. Smuckler
Professor and Chairman
Department of Pathology
School of Medicine
University of California
San Francisco, California 94143
Ms. Ruth L. West
Management Liaison Specialist
Office of the Assistant for Scientific
Liaison
Office of Pesticide Programs (WH-567)
U.S. Environmental Protection Agency
401 M. Street, S.W.
Washington, D.C. 20460
Note:
Ms. Nancy V. Coon
Secretary
Office of the Assistant for
Scientific Liaison
Office of Pesticide Programs (WH-567)
U.S. Environmental Protection Agency
401 M. Street, S.W.
Washington, D.C. 20460
Additional copies of this document may be obtained by contacting the
Executive Secretary at the above address. Inquiries may be made by
telephone -
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FEDERAL INSECTICIDE, FUNGICIDE, AND. RODENTICIDE ACT
SCIENTIFIC ADVISORY PANEL
Minutes of Inaugural Meeting :
December 9-10, 1976
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
Scientific Advisory Panel held its Inaugural Meeting from 8:30 a.m.
through 4:30 p.m., December 9-10, 1976, in room 1112A, Crystal Mall
Building #2, 1921 Jefferson Davis Highway, Arlington, Virginia.
Dr. Dewayne Torgeson presided as Acting Chairman.
SUMMARY OF ACTION ITEMS
Dr. Dewayne Torgeson was elected to serve as Chairman of the Panel for
a period of one year. Dr. Robert Neal was elected Vice-Chairman.
The Panel waived scientific review and comment on proposed
Section 3(c)(l)(D) regulations which pertain to the Submission of
Test Data in Support of Application for Registration, Compensation
Claim for Use of Data; Rules of Practice for Claims Determinations.
The Panel was requested to review a recommendation pertaining to
intent to cancel registrations of Kepone products under
Section 6(b)(l) of FIFRA.
The Panel concluded that ex officio members from federal agencies
were not required or desired at this time.
ATTENDANCE
The following members attended on both December 9 and 10, 1976:
Dr. Dewayne C. Torgeson, Chairman
Dr. Robert A. Neal, Vice-Chairman
Dr. John E. Davies
Dr. David E. Davis
Dr. John Doull
Dr. Edward A. Smuckler
The following member attended only on December 9, 1976:
Dr. Robert L. Metcalf
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The following attended as Secretariat for the Panel:
Dr. H. Wade Fowler, Jr., Executive Secretary
Mrs. Ruth L. West, Staff Assistant
Mrs. Nancy V. Coon, Secretary
Mrs. Mary B. Cooper, Secretary
INTRODUCTION
Representatives of EPA and the general public who were present during
all or part of the meeting are listed in attachment 1. About 20
members of the general public attended; and although none submitted
formal statements, to the Panel in advance, several participated
in informal discussions regarding Section 3(c)(l)(D) proposed
regulations. The meeting was announced in the Federal Register on
November 22, 1976 and by announcement to persons and organizations
which had previously indicated an interest in being placed on the
FIFRA Scientific Advisory Panel mailing list.
A detailed agenda for the meeting is outlined in attachment 2. All
topics listed on the agenda were discussed, but not necessarily in
order due to last minute time conflicts of several speakers. However,
in general the meeting followed the agenda and all topics on the
detailed agenda were discussed during the meeting.
The Panel members met informally with EPA staff, representatives from
other government agencies, scientific societies, environmental interest
groups, trade associations, representatives of the pesticide industry,
and the general public for approximately thirty minutes prior to
consideration of topics on the agenda.
The meeting was called to order by Dr. H. Wade Fowler, Executive
Secretary of the Panel. After several administrative announcements,
the Acting Chairman, Dr. Torgeson, introduced members of the Panel
and certified that all members were present.
COMMENTS BY THE ADMINISTRATOR
ENVIRONMENTAL PROTECTION AGENCY
Mr. Russell Train, Administrator of the Environmental Protection Agency,
extended a general welcome to members of the Panel and commented on the
important role of the FIFRA Scientific Advisory Panel in the overall
Agency program for protection of public health and the environment.
Mr. Train expressed his warm appreciation to all members for agreeing
to give up their time to provide expertise to the Agency in essential
scientific disciplines for evaluation of pesticides.
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Mr. Train emphasized that advisory groups such as the FIFRA Scientific
Advisory Panel are integral parts of EPA policy development and program
implementation. The Agency in carrying out its pesticide regulatory re-
sponsibilities is directed by statute to give the highest priority to
protection of public health and the environment. There is a growing
recognition that a very large portion of human health problems are
environmentally related, including in particular the problems of
carcinogenesis. This puts an increased emphasis on the importance
of a group such as this Panel.
Matters pertaining to protection of public health and the environment
involve a difficult and complex job of assessment of health and
environmental risks and benefits; followed by an equally difficult and
delicate job of trying to weigh and arrive at an appropriate balance in
terms of a regulatory decision of those risks and benefits. Inevitably,
any regulatory decision in this area is going to be controversial.
There are no quantitative certainties, and there will be disagreements
and inevitable controversy. It is essential to the integrity of the
program and the integrity of the decision-making process, that we make
those decisions with the best available scientific data, evidence, and
advice that we can possibly obtain. I consider this group as a very
valuable and integral part of the decision-making process and to the
ultimate success and public acceptance of regulatory actions by the
Agency. .
: " _ COMMENTS'BY THE DEPUTY ASSISTANT ADMINISTRATOR
OFFICE OF PESTICIDE PROGRAMS, EPA
Mr. Edwin Johnson reviewed the legislative history of regulatory control
of pesticides by outlining the key features of the 1910, 1947, and 1972
statutes. The 1910 Act was basically a consumer protection law which
was more concerned with protection of consumers from adulterated products
than other aspects of pesticides. The statute was considerably expanded
in 1947 when the first federal insecticide act was passed by Congress.
Again, the 1947 Act was largely consumer oriented and in addition to
concerns about adulterated products, new concerns about efficacy and
acute safety hazards were added. Pesticides were registered under that
statute by the U.S. Department of Agriculture until 1970 when the
program was transferred to the Environmental Protection Agency (EPA).
In 1972 EPA was able to obtain amendments to the statute to implement
what amounted to a major change in responsibilities of the federal
government on pesticides.
Mr. Johnson stressed the following key provisions of the 1972 amendments:
1. Premarket clearance of pesticide products. Before pesticides can
be sold they must be registered with the Agency - not only for inter-
state commerce but also for intrastate commerce.
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2. Classification of pesticides as general or restricted. The
Agency was required to reregister approximately 32,000 products
registered in 1972 under a new requirement for determining safety
and to divide these into categories of restricted or general use.
3. Requirement for trained pesticide applicators. The statute
provided a restriction capability on the Agency to limit the use
of restricted pesticides to certified applicators who were
trained and certified as competent to deal with particularly
toxic materials.
4. Regulate the use of pesticides through instructions on the
label. In the past the label was merely a guideline to the user
which he was free to follow or not follow. The new statute
provides penalty provisions for misuse of pesticides, which
encompasses use inconsistent with the label.
Mr. Johnson emphasized that the statute is a relatively thin document
and that although Congress was explicit on certain key elements,
congressional intent was obscure in many aspects. This permits
discretion by the Agency which unfortunately is not always desirable.
In particular many difficulties have been encountered in trying to
interpret the intent of Congress among the various conflicting interest
groups who have vital concerns with pesticides. This spawned public
controversy in which practically every decision by the Agency is
challenged by some public interest or special interest group. As we
tried to implement the 1972 Act, we were caught in this type of
controversy and spent from six to eight months in oversight hearings
last year with the House and Senate Agriculture Committees.
Controversy over administration of amended FIFRA (1972), especially
in areas where congressional intent was not clear, led to the 1975
amendments which established the requirement for the Scientific
Advisory Panel and for special reviews by the U.S. Department of
Agriculture on benefits. Decisions which revolve around statutory
judgment of unreasonable adverse effects on man and the environment
are extremely difficult to administer. This is because people have
different views of what the values should be and they are not easily
measurable in dollars and cents. Every group tends to put different
weights on different factors which further complicates the decision-
making process. However, decisions must be made in a timely manner
based on existing scientific and economic information, irrespective
of the constraints of controversy.
Mr. Johnson reviewed key operational programs of the Office of
Pesticide Programs and highlighted several key aspects dealing with
public participation in the decision-making process; data validation;
trade secrets; pesticide monitoring; registration of pesticides; the
Office of Special Pesticide Reviews; and the Program for Rebuttable
Presumption Against Registration (RPARS).
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Mr. Johnson emphasized that the mission of the Scientific Advisory
Panel is to review the health and environmental effects of decisions
that the Agency is making, both in terms of regulatory requirements
and in terms of specific decisions to cancel particular pesticides.
In essence we will be submitting Section 6(b)(l) and Section 6(b)(2)
actions to the Panel for comment. In Section 6(b)(l) actions, the
Agency announces intent to go forward to cancel the registrati on(s)
of a pesticide, and will, in fact take it off the market unless the
matter is referred to an adversary hearing following appeal by the
manufacturer.
When we issue a Section 6(b)(2) action, the Agency goes into a formal
adjudic.atory hearing without necessarily a preconceived notice that
it is going to cancel, but rather that a formal adjudicatory hearing
is required to arrive at a decision on cancellation. In addition to
cancellation actions, all regulations under Section 25(a) of the
statute will be submitted to the Panel for comment as to impact on
public health and the environment. Mr. Johnson stressed that the
primary charge to the Panel would be to keep the Agency honest in this
area. In particular, the Agency needs advice on whether proposed
regulatory actions enhance improvements in health and the environment
and if proposals are excessive; adequate; or inadequate. Frankly, we
want an objective appraisal by the Panel and if we're wrong tell us.
On the other hand if we are making improvements, also let us know. I
would ask you to be independent in your actions and come back and tell
us what you think about our regulatory initiatives so we can react and
change our decisions as needed.
In respect to activities of the Panel, Mr. Johnson emphasized the
following:
1. The importance for meeting time constraints built into the
statute for responses by the Panel. In particular, Mr. Train
and Mr. Johnson commented on the need for early warning on
pending matters so the Panel would not be taken by surprise.
2. The requirement for development of specific procedures for
conducting business. Mr. Johnson suggested that a subcommittee
be appointed to work with Dr. Wade Fowler to establish a good
mechanism for keeping the Panel informed on EPA concerns;
activities; and pending regulatory actions.
3. The Panel should participate in the selection of a chairman.
This may be accomplished by election; nomination and election by
the Panel itself; or possibly by the Panel submitting suggestions
with ultimate selection by the Administrator. The chairman
probably will be called upon to spend at least an extra day per
month on Panel activities so please bear that in mind.
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4. The following regulatory actions will be submitted to the Panel
very soon:
a. Section 3(c)(l)(D) regulations on trade secrets.
b. The Guidelines for Registration of Pesticides.
c. Section 19 regulations on disposal and storage of pesticides.
dv Section 24(c) on state registrations for special local needs.
e. Section 5(f) regulations pertaining to state issuance of
experimental permits to gather data to support registrations.
f. Section 25(c)(3) regulations on special packaging of
pesticides.
g. Section 6(b) cancellation actions. A recommendation on
intent to cancel the registrations of Kepone insecticide
will be submitted to you during this meeting.
In closing Mr. Johnson expressed his desire to attend Panel meetings and
to work closely with the group in the future.
THE SCIENTIFIC ADVISORY PANEL
AND THE LAW
Mr. David Menotti and Mr. Donnell Nantkes
Office of General Counsel, EPA
Mr. Menotti reviewed the responsibilities of the Pesticides, Toxic
Substances, and Solid Waste Management Division of the Office of
General Counsel, EPA. He pointed out that he was the head of the
Litigation Office of the Division and has primary responsibility for
cancellation actions which will be referred to the Panel for comment.
His associate, Mr. Ed Grey, is the Head of the Program Support Office
of the Division and has responsibility for drafting and ultimate
promulgation of regulations. Another gentleman whom the Panel will
see frequently is Mr. Dick Denny, the Associate General Counsel for
Pesticides. Mr. Denny has responsibility for cancellation actions as
well as rulemarking activities. Mr. Menotti briefly discussed the
Toxic Substances Control Act and emphasized that a toxic substance was
defined in a manner as to not include a pesticide because Congress was
acutely aware that FIFRA adequately provided for regulatory action on
pesticides.
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Mr. Menotti reviewed FIFRA with special reference to provisions of the
1975 amendment which established the Scientific Advisory Panel and out-
lined the functional areas of the Panel which is to comment as to the
impact on health and the environment of proposed regulatory actions
under Sections 25(a) and 6(b) of the statute. Mr. Menotti stressed
the importance of complying with the statutory time constraints of 15
and 30 days for comment by the Panel on final and proposed actions.
Although some of the actions will be extremely complex it is extremely
important that we hold as closely as possible to deadlines to enable
effective regulatory action by the Agency since our actions also have to
be coordinated with the Department of Agriculture; Congress; and
finally prepared for publication in the Federal Register. In response
to a question by Dr. Davies, Mr. Menotti explained the requirement by
the Agency to apply the test for'unreasonable adverse effects on the
environment which requires EPA to quantify risks, quantify benefits,
and balance the two. Cancellation actions may be taken only where the
risks clearly outweigh the benefits of the continued use in question.
In essence proposed and final regulatory actions will be reviewed
simultaneously by the Scientific Advisory Panel to assess risks and
the Department of Agriculture to assess benefits. Ultimately, when
both risks and benefits are defined and properly appraised, the Agency
by statute is charged with the responsibility of taking appropriate
action to balance the equation.
Dr. Davies: What about the public health benefits in addition to the
Agricultural benefits?
Mr. Menotti: That is another area. The way the statute is written
it would seem to not have been considered, but that does not mean that
you cannot consider it because it is a very important aspect. I am
certain that we would be interested in hearing the views of the Panel
with respect to that question.
Mr. Johnson: As a matter of policy and responsibility of my office
we consult with the Department of Health, Education, and Welfare when
we run into a problem where cancellation might pose a threat to pro-
tection of public health due to elimination of an essential pesticide.
From the standpoint of the Panel you should assess both the positive
and negative impacts on health and the environment.
Mr. Menotti concluded by commenting on the following:
1. The essential role of the Panel and how comments would be
carefully weighed.
2. Discussed procedures under Rebuttable Presumptions Against
Registrations (RPARS).
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3. Outlined legal procedures involved in cancellation actions and
pointed out that when matters go to an adjudicatory hearing the
process may take from two and a half to three years for completion.
4. Stressed that the Panel has a specific requirement to provide
comments as to the impact on health and the environment of specific
regulatory actions. Additionally, the Panel is not precluded from
commenting on anything else of interest providing the response
period of 30 days is honored.
5. Commented that restrictions on public disclosure of tentative
decisions are restrictions which apply to EPA and not to the
Secretary of Agriculture or the Scientific Advisory Panel.
6. Emphasized that the burden of proof on safety is on the
proponent of a given use. Thus, the manufacturer has a
continuing obligation to prove to the Agency that his product
is safe.
7. In response to a question by Dr. Smuckler aspects of scientific
review by the Panel of a problem which involves disclosure of
confidential information (statement of formula, etc.) will have to be
held in camera to preclude disclosure to the public.
Mr. Nahtkes presented a comprehensive briefing on conflict of interest
laws. Members of the Panel are special government employees and, as
such, are not subject to the full penalty of restrictions which are
applicable to permanent government employees. Therefore unless you
work for more than 60 days during any particular calendar year, the
provisions of 18 US Code 203 and 205 respecting representation
activities in Federal Government matters do not apply to you. In
summary, you can participate in matters in which the Federal Government
is involved; you can act as an agent in negotiating a contract with
the Federal Government for your institution; and essentially carry
out your work just as if you were not a special employee of the
Federal Government so long as you do not work more than 60 days
during any one calendar year. However, in the event you should work
more than 60 days, then you are subject to the constraints of 18 DSC 203
and 205. Essentially this means that you cannot switch sides while you
are a special government employee regarding a particular matter such as
the particular questions that you are dealing with on this Panel. You
certainly cannot participate in Panel discussions on a particular
question and then act as someone's agent or attorney in negotiating
with the Federal Government on their behalf regarding that very same
question. That is one of the basic principles of conflict of interest.
On the other hand, you could negotiate with even EPA about a particular
government matter provided that you have not participated closely in
it and provided that you haven't worked more than 60 days during the
365 day period immediately proceeding.
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Mr. Nantkes then turned to possible conflict of interest situations which
involve substantial financial interests, including ownership of stock in
public corporations (18 DSC 208). He summarized his remarks by stating
that the regulations provide for a written determination as to whether
a financial interest is sufficiently substantial as to likely affect the
integrity of the services being rendered to the government. The basic
rule in such situations is to divest the interest or excuse yourself
from participation in deliberations by the Panel on matters affecting
that interest.
Thereafter a general question and answer session was held concerning
stock ownership, consultant activities, and research activities.
Mr. Nantkes then presented an overview of 18 USC 207 that deals with
conflicts of interests associated with post-employment activities. In
essence, at no time after your government employment has ceased may
you act as an agent or attorney for anyone other than the United States,
regarding the same particular matter with which you personally and
substantially dealt as a government authority. The 60-day rule applies
not only to 18 USC 203 and. 205, but also with regard to provisions in
EPA procurement regulations in respect to sole source contracts during
the first year after the person leaves government employment unless you
obtain a specific waiver of the provision by the Deputy Administrator.
The key elements are involvement in a particular matter previously acted
upon as a government employee and total government employment in a
calendar year of more than 60 days.
Mr. Nantkes concluded his presentation after a general discussion of the
Federal Advisory Act and the principal requirements for public notice of
meetings, public attendance at meetings, and to the degree practicable,
participation by the public in meetings.
OVERVIEW OF FIFRA ENFORCEMENT PROGRAMS
by
Mr. Jack Neyland
Pesticide and Toxic Substance Enforcement Division
Office of Enforcement, EPA
Mr. Jack Neyland briefed the Panel on Enforcement activities authorized
by FIFRA. He reviewed the operational programs of the Office of
Enforcement pertaining to pesticides and discussed specific problem
areas. In particular he mentioned that enforcement of uses inconsistent
with the label (Section 12(A)(2)(g) has been difficult to implement
because of a variety of problems including unclear instructions on
labels. The development of Pesticide Enforcement Policy Statements
(PEPS) has considerably alleviated some of the inherent difficulties
with labels. Basically, PEPS are statements of prosecutorial discretion
which enable EPA to apply a common sense approach to enforcement.
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Mr. Neyland went on to discuss several specific problems and commented
on how the new certified applicator program would greatly enhance proper
use and disposal of pesticides. In addition Mr. Neyland discussed the
pesticide misuse review committee; the state enforcement grants programs;
EPA regional activities; and memoranda of understanding with other Federal
agencies for cooperative enforcement programs.
INSTALLATION OF MEMBERS
The following were duly sworn in as members of the FIFRA Scientific
Advisory Panel by officials of the Agency: Dr. John E. Davies;
Dr. David E. Davis; Dr. John Doull, Dr. Robert L. Metcalf; Dr. Robert
A. Neal; Dr. Edward A. Smuckler; and Dr. Dewayne C. Torgeson.
COMMENTS BY THE ASSISTANT ADMINISTRATOR
FOR WATER AND HAZARDOUS MATERIALS, EPA
Dr. Andrew Breidenbach extended a general welcome to the new members of
the Panel and made specific comments on the important role of the FIFRA
Scientific Advisory Panel in the overall EPA program for protection of
public health and the environment. In particular he stressed that
Agency decisions must have a solid scientific basis and take into full
account the health and environmental ramifications of allowing or
removing specific chemicals from the environment. In closing he
expressed his warm appreciation to the members for their willingness
to serve on the Advisory Panel and gave assurance that the Agency will
be extremely interested in their opinions and recommendations.
REGISTRATION, REREGISTRATION, AND RENEWAL
by
Mr. John Ritch and Dr. Martin Rogoff
Registration Division, OPP, EPA
Mr. Ritch and Dr. Rogoff of the Registration Division presented a
summary of FIFRA requirements for registration of pesticides.
Mr. Ritch reviewed the requirements for support of registrations.. In
particular he stressed the following:
(a) efficacy data in support of claims must be provided by registrants;
(b) the active ingredients and inerts must conform to claims;
(c) the product must not create an unreasonable adverse effect on
the environment; and
(d) that a normal method of application must not create an unreasonable
adverse effect on man or the environment.
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Mr. Ritch reviewed the provisions of amended FIFRA in respect to the
1947 Act. In particular he pointed out that .the label was not only
an element of precaution on hazards and instructions for use, but in
addition is an enforcement tool for proper utilization of pesticides.
Mr. Ritch elaborated on Section 3 guidelines for registration that
would be submitted to the Panel for review in the near future;
Section 4 regulations on certified pesticide applicators; the require-
ment to reregister over 32,000 commercial products; potential problems
relative to trade secrets and compensation for use of data; classi-
fication of pesticides as general or restricted; difficulties
experienced in establishing an effective task force for reregistrati on;
establishment of tolerances under the Federal Food, Drug and Cosmetic
Act; and plans for development of guidance packages for reregistration
of pesticides.
Dr. Rogoff briefed the Panel on technical review of scientific data
submitted in support of registrations. In particular he reviewed
procedures for validation of data; the five-year renewal cycles;
participation of the Agency in establishment of international tolerances;
review of basic functions of the Chemistry and Toxicology Branches;
scientific expertise and disciplinary mix in the Division; hazard
evaluation requirements; and presented an excellent summary of present
and anticipated future scientific concerns of the Registration Division.
OVERVIEW OF TECHNICAL SERVICES DIVISION
by
Dr. William S. Murray
Technical Services Division, OPP, EPA
Dr. Murray and key members of his staff presented a general summary of
program activities in the Technical Services Division.
Dr. Frederick Kutz outlined the EPA pesticide monitoring program. He
pointed out that Section 20 of amended FIFRA calls for monitoring of
pesticide residues in a number of environmental components which in
part include monitoring for pesticides in human tissue and fluids;
soil and raw agricultural crops; surface water and sediments; air
estuarine fish; shellfish; and ocean fish. In addition, the Agency
is involved in a series of cooperative ventures with other federal
agencies on monitoring which in part will include development and
administration of a National Pesticide Monitoring Panel authorized by
FIFRA. Dr. Kutz concluded by reviewing results of on-going monitoring
programs with specific reference to mi rex.
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Dr. Jack Griffith then summarized the activities of the Human Effects
Branch. Originally this was the old community studies program on
pesticides which was transferred to EPA from the Center for Disease
Control (CDC) of the Department of Health, Education, and Welfare (DHEW).
Dr. Griffith then went on to explain the current program which encompasses
five field stations at three Centers of Excellence throughout the
continental United States and Hawaii.
Dr. Ronald Davis, Chief of the Chemical and Biological Investigations
Branch, stated that his basic mission was to provide laboratory support
to the Office of Pesticide Programs and to Regional Offices of EPA to
help them meet requirements for regulation of pesticides under the
statute. In summarizing his activities, Dr. Davis reported that he has
a total of 63 persons in his branch of which 37 were professionals
(plant and animal scientists, pharmacologists, microbiologists, and
chemists). Laboratory services include accident investigation support;
technical support at administrative hearings; inspections of establish-
ments under Section 9 of FIFRA which includes examination of individual
pesticides for compliance with the statute; and other mission-oriented
services.
Mr. Paul Fuschini outlined the support functions of the Information
Branch. He emphasized that his responsibilities include maintenance
of a central repository for data on pesticides. Mr. Fuschini elab-
orated that the principal functions of his group were to assess OPP
requirements for information and to provide necessary support to OPP
for decision-making on registration of pesticides.
Mr. Elgin Fry, Chief of the Systems Support Branch, explained the
computer support and automatic data retrieval services provided to
OPP. In particular, information was presented on services provided in
support of the Registration Division for basic information on individual
pesticide registrations.
Mr. Donald Marlow presented details on the newly emerging effort in OPP
to create a pesticide hazard evaluation system. In particular
Mr. Marlow emphasized the development of systematic records for
ascertaining risks resulting from authorized use and misuse of pesticides.
PESTICIDE USE CONTROL
by
Mr. James Boland
Operations Division, -OPP, EPA
Mr. Boland discussed regulations authorized under Section 4 of FIFRA
for certification of pesticide applicators and made specific comments
relative to training programs currently in process throughout the nation.
In the future pesticides will be classified as general and restricted.
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Only certified applicators will be permitted to purchase and use restricted
pesticides. In general the program is going extremely well. Some
difficulty has been experienced with certification of employees of Federal
Agencies; however most of the constraints are expected to be resolved in
the near future. Mr. Boland commented that a new list of presumptive
restricted pesticides is available for review. In summarizing other
activities of the Operations Division, Mr. Boland commented on pesticide
episode reporting on accidents and incidents involving pesticides;
cooperative efforts with enforcement; integrated pest management
activities; and specific liaison activities conducted on behalf of OPP
with state regulatory activities, universities, associations, state
governments, and Federal Agencies.
OVERVIEW OF PROGRAM ON
REBUTTABLE PRESUMPTIONS AGAINST REGISTRATION (RPAR)
by
Mr. Jeffrey Jones
Office of Special Pesticide Review, OPP, EPA
Mr. Jones presented an overview of activities of the Office of Special
Pesticide Review (OSPR) and made specific comments relative to Rebuttable
Presumptions Against Registration (RPAR). Mr. Jones reviewed the
importance of the Scientific Advisory Panel, and commented that the
Panel was a vital step to ensure legitimacy of regulatory actions by the
Agency. In particular the Advisory Panel will offer objective scientific
review of appraisals by the Agency of the severity of hazards to man and
the environment of certain pesticides. Specific comments were then made
on the'RPAR process which in essence is a public information gathering
process to evaluate the risks and benefits of new pesticides or the
continued use of previously registered pesticides. This process
obviously may lead to initiation of cancellation action on specific
pesticide products when such action is warranted. Currently there are 45
classes of compounds encompassing 170 active ingredients which are being
considered for the RPAR process. Compounds being considered for RPAR were
brought to the attention of the Agency by: (a) The Mrak Commission Report;
(b) Bionetics Screening Study; and (c) the Registration Division of OPP
as a result of reviews essential to the reregistrati on of pesticides.
The basic triggers for RPARS were outlined as (a) acute toxicity,
(b) chronic toxicity and (c) lack of emerging treatment. The various
phases of the RPAR process were explained as follows: (a) The Pre-
RPAR Risk Phase, which involves review for data that meets or exceeds
one of the RPAR triggers; (b) The Post-RPAR Risk Phase involves
evaluation of data submitted by registrants in rebuttal of the RPAR;
(c) Post-RPAR Risk Benefit Analysis Phase, which involves potential
balancing of risks with an in-depth analysis of benefits (should the
benefits exceed the risks, that particular action is referred back to
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the Registration Division for normal processing. Conversely when the
risks outweigh the benefits then we issue a notice of intent to cancel
under Section 6(b) of FIFRA); and (d) The External Review Phase, which
involves preliminary review by the Department of Agriculture and the
Scientific Advisory Panel of proposed Section 6(b) actions prior to
publication in the Federal Register.
Mr. Jones was asked a series of questions concerning the decision-
making process with particular emphasis on why the Panel would review
only actions where the risks outweighed the benefits. From the stand-
point of the Panel it would seem more appropriate to review all RPARS
before they are classified as positive or negative issues.
Dr. Smuckler summarized the matter by stating that the issue has a
fundamental bearing on the use of the Scientific Advisory Panel. The
Panel would be extremely limited if another scientific body is able to
approve whatever pleases them and only refer matters which are negative
issues to the FIFRA Scientific Advisory Panel for valued judgments.
NOTE: Mr. Dreer appeared on December 10th to clarify several issues.
In respect to scientists in the Office of Special Pesticide Review, there
are twenty-one project managers and staff with scientific degrees. For
this group, nine have masters degrees and nine have Ph.D.'s in disciplines
such as toxicology, physiology, chemistry, and entomology. OSPR has
scientific input from many sources. In particular we receive assistance
from the Criteria and Evaluation Division of OPP. Mr. Dreer further
commented on the development of position documents which are primarily
used for decisions on whether to issue an RPAR. He mentioned that these
would be sent to Dr. Fowler for distribution to Panel members on a
routine basis as background information. In addition, in instances
where new applications for registration are denied, position documents
will be sent to the Panel, especially where there may be controversy as
to evidence. In closing, Mr. Dreer extended a general invitation to
Panel members to visit OSPR for several days and see exactly how the
RPAR process operates.
ELECTION OF OFFICERS
Dr. Dewayne Torgeson and Dr. Robert Neal were elected unanimously to
serve as Chairman and Vice-Chairman of the Panel, respectively. Dr. Neal
and Dr. Smuckler agreed to work with Dr. Fowler on procedures for the
Panel. Although consideration was given to appointment of subcommittee
chairmen for health and the environment, action was deferred until later.
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- 15 -
ADVANCE PLANNING FOR MEETINGS
Panel members agreed to reserve the following time periods for possible
future meetings:
January: 6-7; and 27-28 (Washington, D.C.)
February: 17-18 (Washington, D.C.)
March: 17-18 (Washington, D.C.)
April: 7-8-9 (Chicago, Illinios)
In respect to the April meeting, members of the Panel suggested that the
meeting be held in Chicago because they would already be there attending
a medical science federation meeting. Dr. Fowler indicated that he would
determine if a meeting in Chicago would be feasible in view of the various
requirements of the Advisory Panel as well as the subject matter that
might be presented at that time. In regard to advance notice of topics
for review, Dr. Fowler indicated that he will be working with EPA officials
to identify pending actions from 40 to 100 days in advance.
DISCUSSION ON RECOMMENDATION TO ISSUE
A NOTICE OF INTENT TO CANCEL REGISTRATIONS
OF CHLORDECONE (KEPONE) INSECTICIDE
by
EPA Staff
Dr. William Upholt, Senior Science Advisor for the Office of Water and
Hazardous Materials, presented an overview of the scientific basis for
proceeding with a Section 6(b) action on Kepone. He explained that the
RPAR had been triggered on the basis of carcinogenicity. Since this
was the first topic to be presented to the Panel on the basis of carcin-
ogenicity, he explained the general philosophy and approach being used
by EPA for the regulation of carcinogens in the pesticide area. He
suggested review of the interim procedures published in the Federal
Register in May as a basic position document. Additionally, he
suggested that a detailed discussion could be presented on the subject
by Dr. Roy Albert of New York University, Chairman of the Cancer
Assessment Group of the Agency. In response to questions by the Panel,
Dr. Upholt gave a comprehensive briefing on the functions and compo-
sition of the Cancer Assessment Group. NOTE: At this point,
Dr. Ralph Ross of the Department of Agriculture attempted to make a
statement concerning cancer policy. Dr. Fowler interrupted and told
Dr. Ross that his statement could not be presented at this time, but
that time would be allotted at a later date. Dr. Upholt then went on
to respond to remarks made by Dr. Ross concerning the inappropriateness
of trying to link the DeLaney Clause to cancer policy of the Agency.
Mr. Fred Hageman and Mr. Dreer of OSPR then presented a proposal
recommending Section 6(b) cancellation action on chlordecone (Kepone).
The basic document is appended as attachment No. 3. The briefing team
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- 16 -
on Kepone reviewed the key points of the recommendation and explained
the basic rationale by the Agency for cancellation action and disposition
of existing stocks. In particular, they stressed the types of Kepone
products on the market and that certain packages were relatively
inaccessible to young children while others were readily accessible;
the basis for initiating an RPAR was onogenicity which was primarily
based on a bioassay conducted by the National Cancer Institute (NCI);
data was also available on reproductive and neurological effects; and
the NCI study had been validated by the Cancer Assessment Group.
Additionally, a packet of general assessment documents, and data
generated by Allied Chemical Company was presented to the Panel for
consideration. Information was also presented on hazard evaluation
and benefit analysis.
The Panel then posed a series of questions pertaining to packaging of
Kepone products; availability of various stocks of both accessible and
inaccessible products; dollar values associated with stocks; quantity
of Kepone remaining for formulation into inaccessible products;
quantity of Kepone in river sediment, in the James River; basis for
projection of number of cases of cancer; synchrony of submissions to
both U.S. Department of Agriculture and the FIFRA Scientific Advisory
Panel and that a response is due within 30 days; clarification that
genesis studies were from both NCI and Bionetics; concern over mortality
of Osborne-Mendel rats in the control group; the requirement in the
future to have basic investigators available to respond to questions
concerning laboratory procedures, protocols, examination of tissues,
and opinions of pathologists reviewing cases. Further discussion on
this topic was tabled until the next meeting to enable consideration of
other items on the agenda of this meeting. NOTE: The Panel appointed
Dr. Smuckler and Dr. Neal to a special work group to develop criteria
for building an accurate data base for making decisions concerning the
potential hazard or safety of agents being appraised by the Panel. In
particular, essential data for making valued judgments must be defined
so the Agency can concentrate on essentials.
DISCUSSION OF FIFRA SECTION 3(c)(l)(D)
PROPOSED REGULATIONS
by
Ms. Susan Lepow
Office of General Counsel, EPA
Ms. Lepow presented an overview of the proposed regulations to the
Panel. An outline of her presentation is appended as attachment No. 4.
Following several questions by the Panel it was apparent that the
Advisory Panel might wish to waive formal review and comment because
it appeared that there were no questions of scientific nature involved
in the regulations. -The floor was opened for comments by representatives
of the pesticide industry. Representatives from Monsanto Company and
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- 17 -
CIBA Geigy Company certified that the proposed regulations had little
to do with science and would not affect the availability or interpre-
tation of scientific data. A representative from Chemagro Corporation
discussed the controversial relationship created by the proposed
regulations between EPA and the pesticide industry, but agreed that the
Panel might wish to waive review and comment because there were sub-
stantially no scientific issues in the document. The Panel then
unanimously agreed to waive scientific review and comment on the pro-
posed regulations. A copy of the report transmitted to the Deputy
Assistant Administrator for Pesticide Programs is appended as attachment
No. 5.
PESTICIDE DISPOSAL
by
Mr. Harry Trask
Hazardous Waste Division
Office of"Solid Waste Management
EPA
Mr. Trask presented a comprehensive overview of the requirements of
Section 19 of FIFRA and discussed special problems associated with
disposal and storage of pesticides. He then discussed the adequacy of
plans for disposal of roughly 25,000 fifty-five gallon drums of
pesticides in Alkali Lake, Oregon. He elaborated on disposal pro-
cedures that were specifically not recommended for disposal of pes-
ticide containers anywhere such as, open dumping, open burning,
dumping in water, etc. Following a discussion of recommended
procedures, Mr. Trask indicated that approved disposal methods were
a part of Section 19 regulations which would be submitted for review by
the Panel in the near future. Other topics covered by Mr. Trask included
discussions on incineration of organic pesticides; advanced design for
secure burial pits with clay bottoms and impervious top and bottom
liners; disposal situations in California and Mississippi; disposal of
containers; shortcomings of sanitary landfills for disposal of pes-
ticides; research by Iowa State University on pit burial; and disposal
of Kepone in Hopewell, Virginia. The Panel then asked several questions
concerning the wisdom of storage of pesticide materials rather than
destruction. In particular Dr. Smuckler expressed concern that such an
approach might encourage massive contamination of the environment and
create environmental "time bombs" for future generations. Mr. Trask
commented that additional research is sorely needed to develop technology
for disposal of pesticides. He elaborated that about 240 million
containers were generated annually which required disposal. Of this
quantity, many were combustible paper bags which could be burned with-
out too much difficulty. However, special problems associated with
noncombustible containers, especially military surplus materials, pose
serious disposal problems for the nation.
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- 18 -
The presentation by Mr. Trask was concluded following expression of
concern by the Panel that appropriate disposal procedures for destruction
of materials should be established as a prerequisite to registration and
use of pesticides. Mr. Trask commented that FIFRA provides for specific
disposal procedures and that destruction per se would be. a factor under
the Solid Waste Act for hazardous wastes.
STATEMENT ON REGISTRATION
GUIDELINES
by
Dr. Jay Turin and Dr. William Preston
Office of Pesticide Programs, EPA
Dr. Turim and Dr. Preston presented a general briefing on the Guidelines
for Registration of Pesticides. In particular they discussed the evalua-
tion of the guideline document; key issues; contents of component sections;
and gave a forecast on when the document could be presented to the
Advisory Panel for review. FIFRA Section 3(c)(2) is the authority for
issuing guidelines; which in essence states that the Administrator shall
publish guidelines specifying the kinds of information which will be
required to support registrations of pesticides.
Work was started on the guidelines prior to establishment of the
Environmental Protection Agency. Several years ago we made the
decision to go through the rule-making procedure. This meant that the
document would be issued as proposed rule-making; then public comments
would be accepted and reviewed; and finally steps would be taken to
prepare a final document. The proposal stage was completed in June
1975 and close to 1,000 comments were received from approximately 100
public commentators. Currently we are in the process of amending the
proposed document, taking into account comments made by the public and
scientific knowledge that has come to our attention since publication
of the proposed guideline package. The guidelines document which will
be submitted to the Scientific Advisory Panel for review will be composed
of sections on labeling; efficacy; chemistry (with subsections on
general chemistry and environmental chemistry; and a section on hazard
evaluation (both human and fish and wildlife)).
In general, the guidelines will spell out the conditions under which
tests will be required with explicit details as to whether the conditions
are basic; where particular tests are required for every pesticide; or if
certain tests are conditionally required depending upon the type of
product and the intended use pattern, e.g., indoor versus outdoor use.
Other tests may be conditional upon results of previously submitted
tests submitted to the Agency. The guidelines will also address the
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- 19 -
minimum standards which must be met for any test submitted to comply
with the requirements for registration. Additionally, the guidelines
will contain examples of protocols which are acceptable by the Agency
to meet minimum standards. The guidelines in final form will be
published in the Federal Register in 1977. It will also be available
in looseleaf format which will facilitate periodic amendments to keep
current with developments in science.
Dr. Preston presented a general overview of the various sections of the
guideline package as follows:
1. The Human Hazard Evaluation Section will include acute, subacute,
and chronic studies.
a. Acute studies that are required will encompass acute oral
toxicity; acute dermal toxicity; primary dermal irritation;
primary eye irritation; and acute inhalation toxicity.
b. Subacute studies which are required include subacute oral
toxicity; subacute dermal toxicity; and subacute inhalation
toxicity.
c. Chronic studies which will be required under certain
conditions are as follows: teratogenicity; neurotoxicity;
metabolism; oncogenicity; chronic feeding studies;
reproductive studies; mutagenicity; potentiation; reentry;
emergency treatment; and domestic animal safety studies
2. In addition to hazard evaluation tests relating to human health,
certain fish and wildlife studies are required if the pesticide is
used outdoors.The types of studies which may be required under
certain conditions are LD and LC-50 tests on avian acute oral
toxicity, avian subacute dietary toxicity, acute toxicity for fish
(both warm and cold water species); avian reproduction; acute
toxicity to aquatic invertebrates; acute toxicity to estuarine and
marine organisms; life cycle and reproductive studies of fish and
aquatic invertebrates; and aquatic organism toxicity and residue
studies.
3. The Product Performance (Efficacy) Section will be one of the
largest sections of the guidelines and to a certain extent probably
the least controversial. This section will include a general
considerations subsection and specific subsections covering
antimicrobial agents; aquatic pest control agents; fungicides and
nematicides; herbicides; plant regulators; desiccants, defoiliants;
invertebrate control agents; and vertebrate control agents.
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- 20 -
4. The Label Development Section is divided into similar subsections
as the Product Performance Section. The biggest subsection will
be on general comments which will include the basic elements of the
label; how to handle brand and trademark names; procedures for
registration and producing establishments numbers; and the details
of preparing the ingredients statement, and warnings; and specifics
on preparation of statements on directions for use of the product.
5. The Chemistry Section is divided into subsections on Product
Chemistry and Environmental Chemistry. Product chemistry deals
principally with data and information requirements relative to
technical products, formulations, identification of chemicals,
and all chemical methods relative to identification of specific
chemicals, composition, manufacturing process of technical chemicals,
and basic chemical and physical properties such as boiling point,
melting point, etc. For environmental chemistry, data 'requirements
are tied to intended uses of the product. Outdoor and aquatic uses
are the major uses of pesticides which require environmental
chemistry data. In part, data will be required on physical-chemical
degradation; metabolism data, both aerobic and anerobic; in soil and
water, as well as microbial metabolism is required; mobility
information such as leaching, volatility, absorption, and water
dispersion; terrestrial and aquatic dissipation data; accumulation;
bioaccumulation as a result of fish accumulation studies and
accumulation studies that deal with rotational crops; field reentry
data; and other specific tests depending on the intented use of the
product.
In respect to scheduling, I can only give you our tentative plans. We
hope to present the product performance package in April; the label
development package in May; and the other packages several months later
or as soon as they are ready for review by the Advisory Panel and the
Secretary of Agriculture.
OTHER BUSINESS OF THE PANEL
The date and place of the next meeting was confirmed for January 6-7,
in Room 1112A, Crystal Mall Building #2, 1921 Jefferson Davis Highway,
Arlington, Virginia. For this meeting the Panel should complete review
of the Section 6(b) action on Kepone and review final Section 19
regulations.for storage and disposal of pesticides.
Ex Officio Members of the Scientific Advisory Panel. In response to a
specific query from the Food and Drug Administration, the Panel discussed
the possibility of having representatives from select Federal Agencies
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- 21 -
serve as ex officio members of the Panel. After careful consideration,
the Panel concluded that ex officio members from Federal Agencies were
not required or desired at this time. Hopefully, persons from Federal
Agencies interested in matters under review will attend meetings and as
appropriate submit written statements and oral summaries for consider-
ation by the Panel.
Public Participation in Panel Meetings. The Panel encourages maximum
participation by the scientific community, Federal. Agencies, associations,
and the private sector at large who wish to present relevant information
for consideration by the Panel during review of specific regulatory
actions. The Executive Secretary will take necessary action to advise
the public that preregistration will be required in order to present oral
summaries during meetings of the Panel. A maximum of one hour will be
allowed per meeting day for members of the public to address the Panel.
The Executive Secretary will publish specific instructions to the public
relative to submission of written statements and oral summaries as part
of the Federal Register notice of meetings.
Receipt of Written Statements and Other Communications to the Panel.
All communications should be routed to the Executive Secretary who in
turn will make distribution to all members of the Panel. In particular
requests for information on matters under review by the Panel should be
referred to the Executive Secretary for an appropriate response. In
order to save time, mail should be sent to the following address:
Dr. H. Wade Fowler, Jr., Executive Secretary, FIFRA Scientific Advisory
Panel, 12637 Bill ington Road, Silver Spring, Maryland 20904.
ADJOURNMENT
The meeting was adjourned at 3:55 p.m., December 10, 1976.
Prepared by:
-£*^
H. Wade Fowler, Jr., Ph.D. Dewayne Torgeson, Ph.D.
Executive Secretary Chairman
I certify that to the best of my
knowledge, the foregoing minutes
and attachments are complete and
accurate.
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Attachment No. 1
FIFRA SCIENTIFIC ADVISORY PANEL
INAUGURAL MEETING
December 9-10, 1976
ATTENDANCE LIST
Mr. James J. Boland
EPA
Dr. Fred Claytcn
NAS/NRC
Ms. Martha Boone
Stiptoe and Johnson
Dr.- Andrew W. Breidenbach
EPA
Mr. Nathan Chandler
EPA
Mr. James T. Conner
Chemagro
Ms. Cathy Cooper
Pesticide & Toxic Chemical News
Dr. Ronald Davis
EPA
Mr. Harold Day
EPA
Mr. Ronald E. Dreer
EPA
Mr. Joel L. Fisher
EPA
Mr. Elgin G. Fry
EPA
Mr. Paul Fuschini
EPA
Dr. John A. Gardiner
E. I. du Pont de Nemours & Co.
Mr. Herman J. Gibb
EPA
Dr. Jack D. Griffith
EPA
Mr. Frederick J. Hageman
EPA
Dr. Robert E. Hamman
CIBA-GEIGY Corporation
Ms. Suzanne Barker
EPA
Ms. Maureen Hinkle
Environmental Defense Fund
Dr. William L. Hollis
National Agr. Chemicals Assoc.
Mr. Anthony Inglis
EPA
Mr. Edwin L. Johnson
EPA
Mr. Raymond F. Krueger
EPA
Dr. Frederick Kutz
EPA
Ms. Susan Lepow
EPA
Mr. Ernst Linde
EPA
Mr. John Lindow
Law Offices, Richard Mehler
Mr. Donald A. Marlow
EPA
Mr. Thomas 0. McGarity
EPA
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FIFRA SCIENTIFIC ADVISORY PANEL
INAUGURAL MEETING
December 9-10, 1976
ATTENDANCE LIST
Mr. David E. Menotti
EPA
Mr. Pat Miller
EPA
Dr. William S. Murray
EPA
Mr. Donnell L. Nantkes
EPA
Mr. Joseph Nash
EPA
Mr. John J. Neylan
EPA
Mr. Frank W. Parson
EPA
Dr. Lawrence A. Plumlee
EPA
Mr. Robert Potrepka
EPA
Dr. William H. Preston, Jr.
EPA
Dr. Robert L. Riley
USDA
Mr. John B. Ritch, Jr.
EPA
Dr. William G. Roessler
EPA
Dr. Martin Rogoff
EPA
Dr. Ralph Ross
USDA
Mr.. Ralph Sherman
Consulting Entomologist
Dr. James V. Smith.
DREW
Dr. Philip J^ Spear
National Pest Control Assoc., Inc.
Dr. Earl C. Spurrier
Monsanto Agricultural Products Co.
Ms. Marrianne Thatcher
EPA
Ms. Gail Topscott
Pesticide & Toxic Chemical News
Mr. Russell E. Train
EPA
Ms. Anne Trontell
Energy Resources Company, Inc.
Dr. Jay Turim
EPA
Dr. William M. Upholt
EPA
Mr. Ford Williams
EPA,
Dr. Ronald D. Wilson
Rhodia, Inc.
William H. Wymer
Amer. Registry of Professional
Entomologists
- 2 -
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Attachment No. 2
DETAILED AGENDA
FIFRA SCIENTIFIC ADVISORY PANEL
INAUGURAL MEETING
December 9-10, 1976
ROOM 1112 A, Crystal Mall Building #2
1921 Jefferson Davis Highway
Arlington, Virginia
Morning Session — Thursday, December 9, 1976
8:00 a.m.
8t30 a.m.
8r40 a.m.
9^00 aaiu
9:40 a.m.
10:10 a.m..
10:20 a.m..
10:35 a.in.
Introduction of Special Guests and
Key EPA Staff
Congressional Committees
USDA
Environmental Interest Groups
Industry
Others
(Coffee will be available)
Call to order
Welcome and Administrative Announcements
The Science Advisory Panel and the Law-
Scientific Advisory Panel Under FIFRA
The Federal Advisory Committee Act
Conflicts of Interest
Overview of FIFRA Enforcement Programs
Break
Welcome and Special Remarks
Overview of Pesticide Program Objectives
Historical Review (1910, 1947, and
1972 Acts)
Key Features of 1972 Act and 1975
Amendments
Major Objectives and Operational Programs
The Scientific Advisory Panel
a. Mission
b. Importance to EPA
c. Expectations (Response periods)
d. Summary of pending actions to be
submitted to the Panel (Docket).
11:00 a.m. Welcome and Overview of EPA Programs
Dr. Fowler
Dr, Fowler.
Dr. Fowler.
Mr. Menottt
Mr.. Nantkes
Mr. Conroy
Dr. Breidenbach
Mr. Johnson
Mr. Train or
designated official
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- 2 -
11:20 a.m. Installation of Members
11:30 a.m. Group Photograph
11:40 a.m. LUNCff
Personnel
Management
Afternoon Session, Thursday, December 9, 1976
12:25 p-.m. Call to Order
12:30 p.m. Registration, Reregistration
and Renewals
1:30 p.m.
2:30 p.nu
1:10 p.m.
3i20 p.m.
4:15 p.m..
4t30 p.m.
Overview of Technical Services
Division Programs
Pesticide Use Control
-BREAK-
Hebuttable Presumption. Against
Registration (RPAR) Overview
Panel Discussion Period
Adjourn
Acting Chairman
Mr. Ritch
Dr. Rogoff
Dr. Paynter
Dr. Murray
and Staff
Mr. Holmberg
Mr. Boland
Mr- Dreer
and Staff.
Acting Chairman
A special social affair will be held in_Room 321 of the Marriott Hotel
in the Crystal City area. A cash bar and snacks will be available from 4:45 p.m.
until 6:30 p.m. All interested persons should contact Mrs. West at 755-4851,
prior to noon December 9, 1976 or during the meeting. Cost is $1.00 per person.
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- 3 -
Morning Session/ Friday, December 10, 1976
8:15 a.m. Coffee
8:30 a.m. Call, to Order Acting Chairman
8r35 a.m. Administrative Announcements Dr. Fowler
Review of Selected Regulatory Actions to be submitted to the Panel
8t40 a.m.. Registration Guidelines Dr. Turim
Dr. Preston
10:00 a.m., BREAK-
10:1.0 a.m. Compensation for use of Data Ms.. Lepow
11:30 a.m. LUNCH
Afternoon Session, Friday, December 10, 1976
12:30 p.m. Call to Order Acting Chairman
12:40 p.m. Pesticide; Disposal Mr. Trask
1:.30 p.m. Section 6(b) Action Mr. Dreer
and Staff
2:50 p.m. BPEAK-
3:00 p.m. Panel Discussion Period Acting Chairman
4:30 p.m. Adjournment
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wcTcacnmerrc
"This Notice and Summary of Reasons have not been reviewed
by the Secretary of Agriculture, and the Scientific Advisory
Panel as required: by Sections 6(b) and 25 of the Federal
Insecticide, Fungicide and Rodenticide Act, as. amended, and
they ar&: subject to- change in tigh:t of any comments rece-.iverd
front the Secretary af Agriculture and the Scientific Advisory
Eanel, or far any reasoas in the discretion: of the Agency_'*
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ENVIRONMENTAL PROTECTION. AGENCY
2 0 AUG 1976
[OPP - 66019]
NOTICE OF INTENT TO CANCEL REGISTRATIONS OF
PESTICIDE PRODUCTS CONTAINING CHLORDECONE (KEPONE)
The Environmental Protection Agency (EPA) promulgated
regulations (40 CFR 162) for the registration, reregistra-
tion, and classification of pesticides on July 3, 1975 (40
FR 28Z4Z). Section 162.11 of the regulations provides that
a rebuttable presumption against registration shall arise if
it is determined that a pesticide meets or exceeds any of
the criteria for risk set forth in Section 162.Tl(a)(3)~ On
March 19, 197fr, the Deputy Assistant Administrator for
Pesticide Programs issued a. notice (41 FR 12333 & 12334) of
presumption against registration and continued registration:
of pesticide products containing chlordecone (Kepone). Oir
April 16, 1976", an extension of time for the submission of
rebuttal information- and other comments was granted (41 FR
16612)..
The rebuttal information and other comments submitted
by the registrants and other interested parties have been
reviewed by the Office of Special Pesticide Review together
with analyses performed by Agency staff. As the result of
such review and for the reasons set forth in the attached
-------
Statement of Reasons, I find that the continued registration
and use of these pesticides appear to pose substantial
questions of safety amount-ing to an unreasonable risk to man
and the environment. I therefore serve and file this
Notice of Intent, together with the attached Statement of
Reasons, to cancel all registered uses of chlordecone
/•*
(Kepone) within 30 days, pursuant to Section 6 of the Federal
Insecticide, Fungicide:,, and Rodenticide Act (FIFRA), as.
amended (7 U,S.C. T36d). Any affected party may contest,
this action by requesting a hearing on specific registered
uses; within 30 days: of the date of publication of this
notice- Requests for hearings should be submitted in quin-
tuplicate. to the Hearing Clerk* Environmental Protection
Agencyr Rm. 1019, East Tower, 401 M St. SW> Washington DC
20460.
The proposed cancellation shall become final 30 days
from the date of publication of this notice with regard to
those registered uses for which a hearing is not requested-
The proposed cancellation shall not take effect regarding
any registered use for which a hearing is requested until
the hearing has been completed, unless there is a concur-
rence from all parties to the proceeding.
-------
Pursuant to Section 6(a)(l) of FIFRA, I have determined
that distribution, sale, and use of existing stocks of the
following inaccessible chlordecone (Kepone) products are not
inconsistent with the purposes of this Act and will not have
unreasonable'adverse effects on the environment. Inaccessible
Kepone products are all enclosed Kepone traps made from
metal or plastic as well as metal stakes containing enclosed
Kepone bait which are hammered into the ground. Therefore,.
if no hearing is requested, within 30 days from the date of
publication of this notice for any of the following products,
sale and use of these existing stocks will be allowed for a
period of up to 3 years from the effective date of cancell-
ation. Use of any of the foilowing-inaccessible products
which are distributed or sold prior to the effective date of
».
cancellation shall be allowed indefinitely.
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INACCESSIBLE PRODUCTS
EPA REG. NO.
PRODUCT NAME
REGISTRANT
5887-63
BLACK LEAF ANT
TRAP
Black Leaf Products, Co.
667 N. State Street
Elgin IL 60120
475-11
475-82
ANTROL ANT TRAP
BLACK FLAG ANT
TRAP
Boyle-Midway, Inc.
South Ave. & Hale St.
Cranford NJ 07016
3325-4
HIDE ROACH AND
ANT TRAPS
Clarence Boord &
Sons, Inc.
105 E. Commercial
PO Box 379
Leon IA 50144
460-17
LILLY'S ANT TRAP
WITH KEPONE
F. C. Sturtevant Co.
227 Shunpike Rd.
Cromwell CT 06416
2019-19
JOHNSTON'S NO-ROACH
TRAPS
Gaston Johnston Corp.
24-64 45th St.
Long Island NY 11103
1663-21
1663-22
GRANT'S ANT TRAP
GRANT'S ROACH TRAP
Grant Lab. Division
Leisure Enterprises, Inc.
6020 Adeline St.
Oakland CA 94608
1663-24
GRANT'S ANT CONTROL
-------
395-19
395-21
395-25
MYSTERIOUS ANT TRAP
WITH KEPONE
MAGIKIL ANT TRAP
WITH KEPONE
MAGIKIL ROACH TRAP
WITH KEPONE
Lethelin Products Co. Inc.
15 MacQuesten Pkwy. So.
Mount Vernon NY 10550
358-20
358-129
ANT-NOT ANT TRAP
NOTT ROACH TRAP
Nott Mfg. Co., Inc.
Pleasant Valley NY 12569
506-109
506-126
506-129
E-Z ANT TRAP
CONTAIN KEPONE
TAT ANT TRAP
ANTCHEK ANT TRAP
0. E. Linek Div.
Waico Link Corp.
1234 State Hwy. 46
Clifton NJ 07015
274-23
DEAD SHOT ANT
KILLER
Trager Mfg. Co. Inc.
1200 Wheeler Ave.
Scranton PA 18510
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I have further determined that use of existing stocks
of Allied Chemical 25% Kepone/Special Mixture (EPA Reg. No.
218-544) presently in the hands of formulators for the next
3 years for formulation into the above inaccessible Kepone
products is not inconsistent with the purposes of the Act
and will not have unreasonable adverse effects on man. This
notice shall serve as my notice of intent to stay any can-
cellation issued pursuant to this notice for such period of
time, not exceeding 3 years, as is necessary to formulate
the above inaccessible products from existing stocks of
Allied Chemical 25% Kepone/Special Mixture (EPA Reg. No.
218-544) presently in the possession of formulators, and to
distribute and sell such formulated products. Use of any of
the above inaccessible products which are produced and
distributed or sold prior to termination of the stay shall
be allowed. However, my finding that it would not be incon-
sistent with the Act to allow the distribution, sale, or use
of enclosed bait Kepone products to be formulated from
stocks of Allied Chemical 25% Kepone/Special Mixture [EPA
Reg. No. 218-544] currently in the hands of registrants of
-------
enclosed bait, products pertains solely to the quantity of
enclosed bait products which can be made- from these stocks
of this Kepone product which is for manufacturing use only.]/
This finding necessarily does not apply to additional quan-
tities of Kepone products for manufacturing use only or any
stocks of Kepone enclosed bait products which could be
formulated from them. Accordingly, I further intend to
limit the quantity of Kepone enclosed bait products which
can be formulated and distributed or sold during this 3-year
period to that quantity which can be formulated by each
registrant with the supplies of Allied Chemical 25% Kepone/ •
Special Mixture (• EPA Reg. No. 218-544) on hand as of the
date of this notice.2/
This notice shall also serve as my notice of intent not
to allow sale, distribution, or use of existing stocks of
the following accessible chlordecone (Kepone) products after
issuance of a final order of cancellation pursuant to this
notice of intent to cancel. Accessible products are those
which in normal use would be removed from their containers,
as well as foil or cardboard covered traps.
!_/ The Agency staff estimates that these stocks do not
exceed 515 Ib. of actual Kepone formulated into Allied
Chemical 25% Kepone/Special Mixture.
2/ Each registrant will be required to inform the Agency of
the quantity of Allied Chemical 25% Kepone/Special Mixture
which it had in its possession oh the date of this Notice.
-------
ACCESSIBLE PRODUCTS
EPA REG. NO.
PRODUCT NAME
REGISTRANT
6538-3
KIL-DED ROACH ANT
WATERBUG KILLER
Action Product Corp.
Box H
N. Miami FL 33161
3941-20
PEST GUARD ROACH,
ANT & WATERBUG
KILLER
Athena Corporation
4838 Woodall
Dallas TX 75247
6248-5
5545-2
BLACK MAGIC ROACH
KILLER
BLU-ROACH BAN
KILLS ROACHES
ANTS & WATER-
BUGS
Black Magic Co.
Box 16453
Jacksonville FL
32276
Brown Chemical Specialty
PO Box 14007
San Antonio TX 78214
401-26
COMMON SENSE COCK-
ROACH AND ANT*
PREPARATION #2
KEPONE
Common Sense Mfg.
Co., Inc.
1392 Niagara St.
Buffalo NY 14213
2019-18
JOHNSTON'S NO-ROACH
BAIT
Gaston Johnston Corp.
24-64 45th St.
Long Island NY 11103
3324-4
3324-5
DEKKO ROACH-ETTES
DEKKO SILVERFISH PAK
General Pest Service Co.
2015 Pontius Ave.
Los Angeles CA 90025
8
-------
6150-2
CAPITOL PUNISHMENT
ROACH, ANT & WATER-
BUG KILLER
J & F Mfg. Co.
PO Box 26363
Houston TX 77032
509-10
0-0 PASTE KILLS
ROACHES AND ANTS
John Opitz, Inc.
5014 39th St.
Long Island NY 11104
4825-17
ANT PAK
Judd Ringer Corp.
6860 Flying Cloud Dr.
Eden Prairie MN 55343
395-20
MAGIKIL JELLY WITH
KEPONE ANT-ROACH
BAIT
Lethe!in Products Co. Inc.
15 MacQuesten Pkwy. So.
Mount Vernon NY 10550
5880-1
LUCKY MACK ROACH AND
ANT KILLER
McCall Mfg. Co.
PO Box 145
Jasper FL • 32052
506-113
TAT ANT BAIT
CONTAINING KEPONE
0. E. Linek Div.
Waico Link Corp.
1234 State Hwy. 46
Clifton NJ 07015
267-19
OLD 97 ROACH AND
ANT KILLER
Old 97 Company
Box 5207
Tampa FL 33605
728-54
PEARSON'S WATER
BUG AND ROACH
KILLER BAIT
Pearson and Company
PO Box 7151
Mobile AL 36601
416-57
QUINN'S KEPONE ROACH
AND ANT BAIT
PELLETS
Quinn Drug and Chem-
ical Co.
Box 847
Greenwood MS 38930
-------
2095-2
T.N.T. ROACH AND
ANT KILLER
Vinson Chemical Products
Co.
13001 Port Said Road
Opalocka FL 33054
.7040-3
MINN'S WATERBUG
ROACH AND ANT
KILLER
Winn Chemical Co. Inc.
Box 94A, RFD 1
Blourttsville AL 35031
10
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" A position document prepared by an Agency working group
on chlordecone (Kepone) containing references, underlying
data, rebuttal evidence, and public comments pertaining to
the notice of presumption issued March 19, and this notice
of intent to cancel is available for public inspection in
the Office of Special Pesticide Review, Rm. 447, East Tower,
from 8:30 a.m. to 4 p.m. during normal working days.
Dated:
Deputy Assistant Administrator
for Pesticide Programs
11
-------
STATEMENT OF REASONS
I. Legal Authority
Section 6(b) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 135 et seq) as amended [7 U.S.C.
136a(c)(5)(D)] authorizes the Administrator of the Environ-
mental Protection Agency (or his designee) to issue a notice
of intent to cancel the registration of a pesticide or to
hold a hearing "[i]f it appears to the Administrator that a
pesticide or its labeling. . . does not comply with the
provisions of this act or, when used in accordance with
widespread and commonly recognized practice, generally
causes unreasonable adverse effects on the environment. ..."
The phrase "unreasonable adverse effects on the environment"
takes into account the economic, social, and environmental
costs and benefits of any pesticide.
12
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II. Structure and Characteristics of Chlordecone (Kepone)
Kepone is the trade name for the insecticide decachloro-
octahydro-l,3,4-metheno-2H-cyclobuta (cd) pentalen-2-one.
The common name is chlordecone. The technical product
(which is over 90% pure) sublimes at 350° and is relatively
soluble in water (0.4 at 100°) compared to most chlorinated
hydrocarbon pesticides. Kepone is soluble in strong alkali,
as well as in acetone and ethanol. Kepone is very stable jn_
vitro.
III. Uses
Except for manufacturing grade Kepone, which is used
solely in the formulation of other Kepone products, the only
current use of Kepone is in inaccessible metal and plastic
traps and accessible foil and cardboard traps and unenclosed
pastes, jellies, and other baits. Kepone is registered for
use only against ants, roaches, and other household pests."
IV. Alternative Pesticides
The only alternative to Kepone bait that is registered
in a bait formulation is Baygon. Baygon is registered for
use only in a bait against roaches. No alternatives are
registered for use in a bait formulation against ants and
other household pests. However, many alternatives to Kepone
baits are registered in spray and dust formulations for
13
-------
control of roaches, ants, and other household pests; these
include diazinon, Baygon, malathion, and ronnel. Although
perhaps not as convenient to the homeowner, many alternatives
exist for every use of Kepone.
V. Toxicity
Kepone has demonstrated toxic effects which may have
significant adverse effects on human health. "The Report on
Carcinogenesis Bioassay of Technical Grade Chlordecone",
prepared by the Carcinogenesis Program, Division of Cancer
Cause and Prevention, National Cancer Institute, released in
January 1976, reports the results of a long-term study on
the oncogenic effects of chlordecone on both sexes of
Osborne-Mendel rats and B6C3F1 mice. Chlordecone was admin-
istered orally at average dosages ranging from 8 to 26 parts
per million (ppm) for rats and from 20 to 40 ppm for mice
for a period of 80 weeks. The mice were sacrificed after 90
weeks and the rats after 112 weeks; moribund animals were
sacrificed and necropsied. None of the 225 control rats
developed hepatocellular carcinomas. Fourteen of the 68
male control mice developed hepatocellular carcinomas. None
of the 50 female control mice developed hepatocellular
carcinomas. Pathological diagnosis revealed a statistically
significant increase (P less than 0.05) in the incidence of
14
-------
hepatocellular carcinomas in rats fed an average of 24 ppm
(males) and 26 ppm (females) arid in mice fed an average of
20 and 23 ppm (males) and 20 and 40 ppm (females). Exten-
sive hyperplasia of the liver was also reported in both
species.
Data submitted to EPA by Allied Chemical Company enti-
tled, "lexicological Studies on Decachloro-octahydro-1,3,4-
metheno-2H-cyclobuta [cd] pentalen-2-one" (Document No.
108253, July 1, 1961), also indicate that chlordecone is
oncogenic in rats. Six groups of male and female albino
rats were fed 0, 5, 10, 25, 50, and 80 ppm chlordecone,
respectively, for periods of up to 2 years. Oncogenic
effects appeared only in rats receiving chlordecone in their
diets for between 1 and 2 years. None of the 23 control
rats examined developed hepatocellular carcinomas. Of the
7 male rats examined at the 25 ppm dose level, liver lesions
in l.rat were diagnosed as hepatocellular carcinoma by two
pathologists and "evolving carcinoma" by one pathologist,
who also found "evolving carconoma" in a second male rat fed
this dosage. Of the 16 surviving female rats fed 10 ppm,
liver lesions in 3 were diagnosed as heptocellular carcinoma
by one pathologist. Of the 9 surviving female rats fed 25
ppm, liver lesions in one was diagnosed as "evolving car-
cinoma" by one pathologist.
15
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VI. Human Exposure to Chlordecome (Kepone)
No significant research has been done on human exposure
to Kepone through its use in inaccessible traps and access-
ible pastes and jellies. Pesticide Episode Report System
(PERS) information indicates that Kepone used in these ways
is occasionally ingested by children. Although Kepone has a
low volatility, inhalation exposure to Kepone can be expec-
ted when it is used in traps, pastes, and jellies in house-
holds. Kepone use in pastes and jellies presents a higher,
but unquantifiable, risk of dermal, inhalation, and oral
exposure.
VII. Risk to Humans from Exposure to Chlordecone (Kepone) _._
Under 40 CFR 162.11(2)(4), my inquiry must focus on
whether the registrants (or parties seeking registration)
have rebutted the presumption by sustaining the burden of
proving: (1) the determination that chlordecone (Kepone)
meets the criteria set forth in Section 162.11(a)(3)(ii) was
in error or, (2) when considered with proposed restrictions
on use and widespread and commonly recognized practices of
use, chlordecone (Kepone) will not concentrate, persist, or
accrue to levels in man or the.environment likely to result
in significant chronic adverse effects. No registrant or
16
-------
applicant for registration has attempted to show that the
determination that chlordecone (Kepone) induces oncogenic
effects in both sexes of mice and rats as a result of oral
exposure was in error. Several registrants attempted to
show that current use of Kepone will not result in signifi-
cant chronic adverse effects to man. However, the regis-
trants and Agency staff have been unable, on the basis of
current data, to determine the extent to which humans are
exposed to Kepone as a result of its current registered
uses. The registrants and applicants for registration,
therefore, have not met the burden of proving that use of
chlordecone (Kepone) into the indefinite future in accor-
dance w.ith its'current registrations will not result in
significant chronic adverse effects to man.
VIII. Economic Impacts of Cancellation
Because of the abundance of less expensive alternatives,
the macro-economic and micro-economic impacts of the can-
cellation of Kepone are estimated to be negligible.
IX. Balance of Risks and Benefits
The Agency staff has prepared a preliminary analysis,
balancing the risks and benefits for use of registered
Kepone products, and I have exercised my discretion to take
into account these staff recommendations. Based on this
17
-------
analysis I have determined that both the risks and the
benefits of use of chlordecone (Kepone) into the indefinite
future under existing labels are small. However, the regis-
trants and applicants for registration have not shown that
the risks are insignificant. When the risks presented by
the continued use of Kepone are weighed against the bene-
fits, it appears that continued use poses an unreasonable
risk to man.
X. Existing Stocks
The responses to the notice of rebuttable presumption
received from registrants indicate that there are an esti-
mated 20 Ib. of actual Kepone formulated into existing
stocks of the end use Kepone products which are the subject
of the present notice of intent to cancel. In addition,
these responses indicate that formulators have limited
stocks, estimated to total no more than 515 Ib. of actual
Kepone formulated into Allied Chemical 25% Kepone/Special
Mixture (EPA Reg. No. 218-544), which they are holding for
formulation into Kepone products whose registrations are the
subject of the present notice of intent to cancel.
18
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Although I have determined that use of chlordecone
(Kepone) into the indefinite future will result in unrea-
sonable adverse effects to man, the preliminary staff
analysis indicates that use of existing stocks of formulated
inaccessible traps for the next 3 years will result in a
very small risk of human exposure. I have, therefore,
determined that distribution and sale of existing stocks of
the inaccessible Kepone products for a period of up to 3
years from the effective date of cancellation is not incon-
sistent with the purposes of the Act and will not have
unreasonable adverse effects on man, and that use of in-
accessible products which are distributed or sold prior to
the effective date of cancellation should be allowed indef-
initely.
Furthermore, I find that use of existing stocks of
Allied Chemical 25% Kepone/Special Mixture (EPA Reg. No. -
218-544) presently in the hands of formulators for the next
3 years for formulation into inaccessible Kepone products is
not inconsistent with the purposes of the Act and will not
have unreasonable adverse effects on man. I therefore
intend to stay any cancellation issued pursuant to this
notice for such period of time, not exceeding 3 years, as
19
-------
is necessary to formulate the inaccessible products from
existing stocks of Allied Chemical 25% Kepone/Special Mix-
ture (EPA Reg. No. 218-544) presently in the possession of
formulators and to distribute and sell such formulated
products. Finally, I intend to allow the use of any of the
above inaccessible products which are produced, distributed,
or sold prior to the termination of the stay. However, my
finding that it would not be inconsistent with the Act to
allow the distribution, sale, or use of enclosed bait Kepone
products to be formulated from stocks of Allied Chemical 25%
Kepone/Special Mixture (EPA Reg. No. 218-544) currently in
the hands of registrants of enclosed bait products pertains
solely to the quantity of enclosed bait products which can
be made from these stocks of this manufacturing-use only
Kepone product.!/ This finding necessarily does not apply
to additional quantities of Kepone products for manufacturing-
use only, or any stocks of enclosed Kepone bait products
]_/ The Agency staff estimates that these stocks do not
exceed 515 Ib. of actual Kepone formulated into Allied
Chemical 25% Kepone/Special Mixture.
20
-------
which could be formulated from them. Accordingly, I. further
intend to limit the quantity of enclosed Kepone bait products
which can be formulated and distributed or sold during this
3 year period to the quantity which can be formulated by
each registrant with the supplies of Allied Chemical 25%
Kepone/Special Mixture (EPA Reg. No. 214-544) which that
registrant has on hand as of the date of this notice.27
Since use of existing stocks of the accessible formu-
lated products will result in a greater risk of oral,
inhalation, and dermal exposure to Kepone, I have determined
that such use will have unreasonable adverse effects on man.
Therefore, I do not intend to allow the distribution, sale,
or use of existing stocks of accessible Kepone products.
For the same reason, I do not intend to allow formulation of
existing stocks of Allied Chemical 25% Kepone/Special Mix-
ture (EPA Reg. No. 218-544) into the accessible formulated
products.
XI. Affected Registrants and Products
All registrants of products containing chlordecone
(Kepone) affected by this notice are listed below:
2/ Each registrant will be required to inform the Agency of
the quantity of Allied Chemical 25% Kepone/ Special Mixture
which it had in its possession on the date of this notice.
21
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EPA REG. NO.
PRODUCT NAME
REGISTRANT
6538-3
KIL-DED ROACH ANT
WATERBUG KILLER
Action Product Corp,
Box H
N. Miami FL 33161
3941-20
PEST GUARD ROACH,
ANT & WATERBUG
KILLER
Athena Corporation
4838 Woodall
Dallas TX 75247
5887-63
BLACK LEAF ANT
TRAP
Black Leaf Products, Co.
667 N. State Street
Elgin IL 60120
6248-5
BLACK MAGIC ROACH
KILLER
Black Magic Co.
Box 16453
Jacksonville FL
32276
475-11
475-82
ANTROL ANT TRAP
BLACK FLAG *AMT
TRAP
Boyle-Midway, Inc.
South Ave. & Hale St.
Cranford NJ 07016
5545-2
BLU-ROACH BAN
KILLS ROACHES
ANTS & WATER-
BUGS
Brown Chemical Specialty
PO Box 14007
San Antonio TX 78214
3325-4
HIDE ROACH AND
ANT TRAPS
Clarence Boord &
Sons, Inc.
105 E. Commercial
PO Box 379
Leon IA 50144
22
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EPA REG. NO.
6538-3
PRODUCT NAME
KIL-DED ROACH ANT
WATERBUG KILLER
REGISTRANT
Action Product Corp,
Box H
N. Miami FL 33161
3941^20
PEST GUARD ROACH,
ANT & WATERBUG
KILLER
Athena Corporation
4838 Woodall
Dallas TX 75247
5887-63
BLACK LEAF ANT
TRAP
Black Leaf Products, Co.
667 N. State Street
Elgin IL 60120
6248-5
BLACK MAGIC ROACH
KILLER
Black Magic Co.
Box 16453
Jacksonville FL
32276
475-11
475-82
ANTROL ANT TRAP
BLACK FLAG ANT
TRAP
Boyle-Midway, Inc.
South Ave. & Hale St.
Cranford NJ 07016
5545-2
BLU-ROACH BAN
KILLS ROACHES
ANTS & WATER-
BUGS
Brown Chemical Specialty
PO Box 14007
San Antonio TX 78214
3325-4
HIDE ROACH AND
ANT TRAPS
Clarence Boord &
Sons, Inc.
105 E. Commercial
PO Box 379
Leon IA 50144
22
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•401-26
COMMON SENSE COCK-
ROACH AND ANT
PREPARATION #2
KEPONE
Common Sense Mfg.
Co., Inc.
1392 Niagara St.
Buffalo NY 14213
460-17
LILLY'S ANT TRAP
WITH KEPONE
F. C. Sturtevant Co,
227 Shunpike Rd.
Cromwell CT 06416
2019-18
2019-19
JOHNSTON'S NO-ROACH
BAIT
JOHNSTON'S NO-ROACH
TRAPS
Gaston Johnston Corp.
24-64 45th St.
Long Island NY 11103
3324-4
3324-5
DEKKO ROACH-ETTES
DEKKO SILVERFISH PAK
General Pest Service Co.
2015 Pontius Ave.
Los Angeles CA 90025
1663-21
1663-22
1663-24
GRANT'S ANT TRAP
GRANT'S ROACH TRAP
GRANT'S ANT CONTROL
Grant Lab. Division
Leisure Enterprises, Inc.
6020 Adeline St.
Oakland CA 94608
6150-2
CAPITOL PUNISHMENT
ROACH, ANT & WATER-
BUG KILLER
J & F Mfg. Co.
PO Box 26363
Houston TX 77032
509-10
J-0 PASTE KILLS
ROACHES AND ANTS
John Opitz,. Inc.
5014 39th St.
Long Island NY 11104
4825-17
ANT PAK
Judd Ringer Corp.
6860 Flying Cloud Dr.
Eden Prairie MN 55343
23
-------
395-19
395-20
395-21
395-25
MYSTERIOR ANT TRAP
WITH KEPONE
MAGIKIL JELLY WITH
KEPONE ANT-ROACH
BAIT
MAGIKIL ANT TRAP
WITH KEPONE
MAGIKIL ROACH TRAP
WITH KEPONE
Lethelin Products Co. Inc.
15 MacQuesten Pkwy. So.
Mount Vernon NY 10550
5880-1
LUCKY MACK ROACH AND
ANT KILLER
McCall Mfg. Co.
PO Box 145
Jasper FL 32052
358-20
358-129
ANT-NOT ANT TRAP
NOTT ROACH TRAP
Nott Mfg. Co., Inc.
Pleasant Valley NY 12569
506-109
506-113
506-126
506-129
E-Z ANT TRAP
CONTAIN KEPONE
TAT ANT BAIT
CONTAINING KEPONE
TAT ANT TRAP
ANTCHEK ANT TRAP
0. E. Linek Div.
Waico Link Corp.
1234 State Hwy. 46
Clifton NJ 07015
267-19
OLD 97 ROACH AND
ANT KILLER
Old 97 Company
Box 5207
Tampa FL 33605
728-54
PEARSON'S WATER
BUG AND ROACH
KILLER BAIT
Pearson and Company
PO Box 7151
Mobile AL 36601
24
-------
416-57
QUINN'S KEPONE ROACH
AND ANT BAIT
PELLETS
Quinn Drug and Chem-
ical Co.
Box 847.
Greenwood MS 38930
274-23
DEAD SHOT ANT
KILLER
Trager Mfg. Co. Inc.
1200 Wheeler Ave.
Scranton PA 18510
2095-2
T.N.T. ANT KILLER
Vinson Chemical Products
Co.
13001 Port Said Rd.
Opalocka FL 33054
7040-3
WINN'S WATERBUG
ROACH AND ANT
KILLER
Winn Chemical Co. Inc.
Box 94A, RFD 1
Blountsville AL 35031
25
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Attachment No. 4
UNITED STATES ENVIRONMENTAL PROTECTION. AGENCY
DATE: :-_•
1,' —
SUBJECT:,
-Rev lev; of FIFPA Section 3(c)(l)(D) Processed Regulations
rROM:D80uty Assistant Administrator
for Pesticide Programs
TO-
Dr. H. Wade Fowler', Jr.
Executive Secretary
FI?J3\ Scientific Advisory Panel
Proposed Section 3(c)(l)(D) regulations are hereby transmitted for
review by trie Scientific Advisory Panel at their December 9-10, 1976,
meeting. These regulations pertain to the submission of test data,
assertion of claims for compensation and rules of practice for claims
determinations.
FIFRA, Section 25(d) requires that all proposed and final regulations
issued under Section 25(a) be submitted to the Scientific Advisory
Panel for comments as to the impact, if any, on health and the
environment. In our opinion, there are no scientific issues presented
in these proposed regulations. They do not pertain to what data shall
be submitted to support a pesticide registration, but rather propose
rules on how the data that is required shall be submitted aid who shall
pay the cost of producing the data.
The statute provides that the Panel may waive comment in certain cases'
where there are no questions of scientific nature involved. It appears
that these regulations represent one of those cases. Tne Agency has
many regulations and decisions coining along to be reviewed by the Panel
which have considerable scientific substance and aspects of health and
environmental iirpact. I accordingly suggest that the Panel review this
proposed regulation quickly and decide whether to waive consent or to
take the option to comment. In any case, we request that the Panel
respond to 'the Aaencv as ouicklv as cossible.
Edwin L. Johnson
Enclosure
Proposed Section 3(c)(l)(D) Regulations
-------
Section 3(c)(l)(D): Subnij:ssion_of_da t£2_CoiripensatJ.on_f or
I. Provision first included in 1972 FIFPA. Amended by 1975 FIFPA.
Various policy statements have implemented provision. Agency
involved in several law suits concerning these policy statements.
These proposed regulations will expedite the registration process
and improve the Agency's position before the federal courts.
II. Section 3(c)(l)(D) as amended in 1975 provides that:
1. An applicant must submit such data in support of an
application as is required by the Administrator.
2. Data first submitted to the Agency on or after
January 1, 1970 may not be considered in support of
any application submitted on or after October 21, 1972
unless the applicant either has the consent of the owner
of the data or has offered to pay reasonable compensa-
tion for producing the test data.
3. If the parties cannot agree on the terms of reason-
able compensation, the Administrator shall make that
determination after an adjudicatory hearing. His
decision may be appealed to a Federal district court.
s"
4. Registration shall not be delayed pending the
determination of reasonable compensation.
III. These regulations do three things:
1. propose rules for the submission of test data
. 2. propose rules for the assertion of a claim for
compensation
3. propose rules of practice for the adjudicatory hearings
IV. Submission_of_test_data , 162.9(b)
See, Supporting Data Citation form, page 39(a) and (b)
1. The applicant is required to identify the application
supported .
2. The applicant is required to identify the specific test
performed. If the item of data has not previously been
submitted to the Agency or is not in the EPA Data
Catalogue, the applicant must also identify the person(s)
who performed the test and the substance tested. If the
item of data was previously submitted to the Agency but
is not yet included in the Data Catalogue, the applicant
must give the references for the previous submission.
-------
-2-
3. The applicant is required to identify the Data
Category and sign the appropriate statement.
Data Category I - all data first submitted before
January 1, 1970
Data Category II - all data not within data category I
which was produced at the expense
of the applicant alone
Data Category III - all data not within data category I
or II for which the applicant has
the consent of the owner
Data Category IV - all other data
As to data in data categories I, II or III, there are
no other requirements.
As to data in data category IV, the regulations propose
procedures to encourage negotiation between the parties
of the terms of reasonable compensation.
*•
a. The applicant must make offer to pay reasonable
compensation directly to persons known by him
to have first submitted the data to the Agency,
162.9(b)(4)(iii)
b. The Agency will publish notice of receipt of
the application, 162.9(c)
V. Assert^on_of_Claim_^or_Compensation
Preliminary claim — 162.9(d)
Notice of approval — 162.9(f)
Final claim — 162.9(g); Rules of practice
VI. 5yl.e^_of_P£act^ce_for_Adjud^catorY_Hear ings
VII. Amount of entitlement
Case by case determination by the Administrative Law Judge
and the Administrator.
Various factors which may be relevant are included in the
preamble, page 13 through 16.
-------
Attachment No. 5
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
SUBJECT: Review of FIFRA Section 3(c)(l)(D)
Proposed Regulations
FROM-. Executive Secretary
FIFRA Scientific Advisory Panel
TO: Deputy Assistant Administrator
for Pesticide Programs (WH-566)
DATE: January 4, 1977
Proposed Section 3(c)(l)(D) regulations of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) were presented for
consideration by the FIFRA Scientific Advisory Panel on
December 10, 1976.
The FIFRA Scientific Advisory Panel waives scientific review and
comment on proposed Section 3(c)(l)(D) regulations. This action
was deemed appropriate in consideration of the certification by
the U.S. Environmental Protection Agency that there were no
questions of scientific nature involved in the regulations; and
a determination made by the Panel following discussions in open
session with representatives of both the Agency and the Pesticide
Industry that the proposed regulations would not affect the
availability or interpretation of scientific data.
H. Wade Fowler, Jr., Ph.D.
EPA Form 1320-6 (Rev. 6-72)
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