FIFRA SCIENTIFIC ADVISORY PANEL MINUTES OF THE FIRST MEETING DECEMBER 9-10,1976 ------- 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 - ------- 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 ------- - 2 - 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. ------- - 3 - 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. ------- - 4 - 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). ------- - 5 - 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. ------- - 6 - 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. ------- - 7 - 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). ------- - 8 - 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. ------- . 9 _ 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. ------- - 10 - 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. ------- - 11 - 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. ------- - 12 - 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. ------- - 13 - 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 ------- - 14 - 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. ------- - 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 ------- - 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 ------- - 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. ------- - 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 ------- - 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. ------- - 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 ------- - 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. ------- 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 ------- 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 - ------- 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 ------- - 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. ------- - 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 ------- 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_'* ------- 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. ------- 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 ------- 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 ------- " 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 ------- 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 ------- 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 ------- 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 ------- 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 ------- 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 ------- •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 ------- 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) ------- |