The foregoing label would permit these products to be used in factories, laundries, retail department stores, and other commercial establishments that may require constant insect control. At the same time, it offers some prospect of limiting the availability of this product to consumers. While individuals may typically disregard a label, professional merchandisers are less apt to do so if a warning is directed specifically at them. 26 As already indicated, I feel constrained not to cancel this product in view of the fact that registrants, on the one hand, have submitted proof that it causes no harm to normal, healthy individuals exposed for an eight hour day, and, because, on the other hand, it may have significant uses for commercial pest control. It should, however, be noted that the penalty provisions of the Act create a Hobson's choice. Under the Act there is no penalty for selling, as such, not in accordance with the requirements of a label; penalties attach for distributing an improperly labeled product or one that is not registered." It is particularly unfortunate that registrants can with impunity disregard the terms of a label. As registrants' own witness, Dr. Zavon, remarked, labels protect distributors, not the public, at least under the FIFRA scheme. While the Pesticides Regulation Division has disclaimed jurisdiction over advertising of economic poisons, it is hoped that the partnership with the Federal Trade Commission established by the Division's interpretation 9 can be a fruitful collaboration for protecting the public.28 B. "One-Shot" Vaporizers 1. I turn next to Southern's Model O Bugmaster, a "one-shot" device registered for home, use. The box containing the Model O suggests 1 gram/1,000 cubic feet of room with instructions to "use proportionately more or less as space dictates." The package suggests that no more than 2 grams be used per unit and recommends additional units for space larger than 1,500 feet. The label instructs the user to vacate the room and allow two hours before returning. It is recommended that fumigation not occur more frequently than once every two weeks. Counsel for the Agency has emphasized the higher degree of possible danger incidental to home use of lindane, and contends that there is no adequate safety margin. Again, he stresses persistence and the possibility of exposure to lingering fumes, contamination of food, and possibility of accidental ingestion. In footnote 16, I pointed out some of the unknowns with regard to home use of lindane that are less troublesome in connection with commercial use of lindane. There is no study showing the effect of 24-hour exposure, certainly a possibility in the home. The Milby Report suggests only that frequent exposure to lindanè, with intermittent respites, will not produce ill health effects. There is. moreover, no evidence in the record establishing the concentration of lindane released by the one-shot device. If it be assumed, as the Advisory Committee did, that the yield of a "one-shot" device is identical to that of a vaporizer, then it is possible that its by-product exceeds the 0.1 mg./cubic meter tolerance which Dr. Zavon thought would be acceptable for 24-hour exposure based on extrapolation from the Threshold Limits Committee's eight hour figure. Dr. Zavon, moreover, remarked as to the high degree of danger associated with one-shot fumigation devices: "One-shot fumigation devices. . . constitutes too great a hazard . . . for the householder or the lay person to apply" (Tr. 186). 26 The warning "NOT FOR HOME USE" may well be sufficient on products sold in bulk or a form so as not to be susceptible of resale to consumers. This is not true of the products involved in this case, as demonstrated by the record. Attention should be given to the possibility of devising by way of regulation a warning that might be sufficient to prevent home use of restricted products that are packaged in such a way as to make them attractive and convenient for resale to consumers. 27 The success of. keeping lindane out of the home, because the Agency has no enforcement authority under the FIFRA over distribution, will depend essentially on the voluntary compliance of the manufacturer and the distributor in order to accomplish the stated objective. Should the proposed label not prevent the home use of lindane vaporizer products registered only for use in commercial establishments, the Agency would be justified in again cancelling or suspending. 25 Labeling, as noted at n. 20, supra, includes only "graphic matter" (1) "upon the economic poison (2) "accompanying the economic poison or device at any time" (emphasis added). The Pesticides Regulation Division in an interpretation rendered in 1965 has taken the view that advertising such as "counter displays, window displays, or handouts distributed with the product" falls within 2x (2), but that radio and newspaper advertising does not fall within its jurisdiction. 7 C.F.R. 362.107. See 1941 Hearings, u. 24, supra. 2. Given registrants' failures to demonstrate the safety of the "one-shot" device, it would require a compelling demonstration of benefits to justify noncancellation. To the extent that this record touches the question of alternatives to lindane, the evidence, in this content, weighs against the registrant. As noted earlier, Dr. Zavon testified as to the existence of alternatives." This testimony looms larger against the inconclusive proof regarding safety around the home than it did when it was viewed in the positive light of the Milby Report. The determination to cancel is taken in view of the greater unknowns surrounding home use and the apparent availability of alternatives. EDF v. Ruckelshaus, supra. Southern's registration No. 4782-3 is hereby cancelled. CHARLES L. FABRIKANT, Judicial Officer. ENVIRONMENTAL PROTECTION AGENCY [40 CFR Part 164] RULES GOVERNING ADVISORY COMMITTEES AND RULES OF PRACTICE GOVERNING HEARINGS UNDER FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT NOTICE OF PROPOSED RULEMAKING Notice is hereby given that Part 164 of Chapter I of Title 40 of the Code of Federal Regulations, issued pursuant to sections 4 and 6 of the Federal Insecticide Fungicide, and Rodenticide Act, as amended (7 U.S.C. 135b, 153d), is proposed to be revised to read as set forth below. Any person may file comments on this proposal within 30 days from the date of publication of this notice in the Federal Register. Such comments should be filed in duplicate and addressed to the Hearing Clerk, Environmental Protection Agency, Room 3125, South Agriculture Building, 11th and Independence Avenue SW., Washington, D.C. Al written submissions filed pursuant to this notice will be available for public inspection. It is proposed that these rules when adopted in final form, will govern all future cancellation and suspension proceedings under this part and shall apply to any proceeding now underway insofar as it is practicable and will not be prejudicial to any party. In developing these rules this Agency has taken into account prior experience under this part and also recent judicia! pronouncements. Dated: January 19, 1972. DAVID D. DOMINICK, Assistant Administrator for Categorical Programs. Explanatory statement. This explanatory statement should assist interested persons in the preparation of comments on one aspect of the proposed rules, viz, the sections dealing with the relationship between the Agency's decisions whether to issue or continue in effect notices of cancellation and the right of persons adversely affected by such decisions to take administrative appeals (§§ 164.4 (b) and 164.12 (j)). Recent judicial decisions have underscored the importance of bringing "the public into the decision-making process, and creat[ing] a record that facilitates judicial review" of decisions concerning the registration and carcellation of pesticides. Environmental Defense Fund v. Ruckelshaus, 439 F. id 594 (C.A.D.C., 1971); Wellford v. Ruckelshaus, 439 F. 2d 598 (C.A.D.C., 1971). Of particular concern to the courts was the absence of any procedure whereby administrative appeals could be taken from the Agency's refusal to issue notices of cancellation. These rules represent an attempt by the Agency to be responsive to those decisions and to insure that the public voice is heard in the decision-making process. The rules provide that, in considering whether to issue notices of cancellation initially or continue them in effect after review by an advisory committee, the Agency staff will weigh benefits against risks and make a determination on the 29 Dr. Zavon noted the general availability of registered substitites for lindane. He noted that the alternative chemicals for use in vaporizers was limited; this would presumably be true of fumigating devices as well. The range of alternatives is not, however, vaporizing products or "one-shot" fumigators; it is, rather, an alternative mode of household pest control. See In re King Poison Co., I.F. & R. Docket No. 46, 2, LRC 1819, 1823 n. 16 (1971). merits of the registration. If that determination is for cancellation, administrative review will proceed as it has previously. If, on the other hand, the determination is for continued registration, the Agency will at the same time state whether that registration presented at least a substantial question of safety. If it did, persons who oppose that determination will be able to demand the issuance, or continuation in effect, of the notices of cancellation as a means of triggering further administrative review. Adoption of this procedure now, to govern the Agency's broad review of registrations, will result in a more reasonable approach to cancellation decisions. That approach should be satisfactory, on the one hand, to registrants and users of pesticides, for they will not be faced with cancellation decisions which have the support of neither the Agency nor other interested persons. On the other hand, it will afford to persons who oppose registration a mechanism, not previously available, for insuring that a full public hearing is held when necessary. In addition, this approach will assist the office of the General Counsel in taking a position at the administrative hearings consistent with the Agency's policy determinations, for it is difficult to make the initial decision to cancel in vacuum that ignores overriding benefits which this Agency's staff would, itself, wish to emphasize at a public hearing. Scope and applicability of this part. 164.4 164.5 164.11 Administrative review of determinations respecting economic poisons. Subpart B-Rules Governing the Advisory Committees 164.10 Docketing of request for advisory committee. Appointment of advisory committee. Procedure for advisory committee. 164.12 Subpart C-Rules of Practice Governing Hearings Docketing of request for hearing. Contents of document setting forth objections. Filing copies of notification respecting registration. Motions and requests. Intervention. Depositiors. Fees of w tnesses. Consolidation. Prehearing conference. Qualification and duties of examiner. Procedure for a public hearing. Order of procedure and burden of proof. 164.24 164.25 164.26 164.27 164.28 164.29 164.30 164.31 164.32 164.33 164.34 Transcrip ́s. 164.35 Proposed indings of fact, conclusions and order. Application for reopening hearings; for rehearing; or reargument of proceeding or for reconsideration of order. Procedure for disposition of petitions. Computation and extensions of time. Subpart A-General § 164.1 Meaning of words. As used in ths part, words in the singular form shall be deemed to import the plural, and vice-versa, as the case may require. § 164.2 Definitions. For the purposes of this part, the following terms shall be construed, respectively, to mean: (a) The term 'Act" means the Federal Insecticide, Fungicide, and Rodenticide Act (61 Stat.163, et seq. as amended, 7 U.S.C. 135–135k). (b) The term "Administrator" means the Administrator, Environmental Protection Agency, or any officer or employee of the Agency to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act in his stead. When used in Subpart C of this part the term Administrator shall be interchangeable with judicial officer. (c) The term "Advisory Committee" means a group of qualified scientists referred by the National Academy of Sciences and designated to submit an independent report to the Administrator regarding the registration of an economic poison. (d) The term "Agency", unless otherwise specified, means Environmental Protection Agency. (e) The term "applicant" means any person who has made application to have an economic poison registered pursuant to the provisions of the Act. (f) The term "examiner" means a hearing examiner appointed pursuant to section 3105 of title 5 of the United States Code. (g) The term "hearing" means a public hearing which is conducted pursuant to the provisions of the Administrative Procedure Act and the regulations in this part. (h) The term "hearing clerk" means the Hearing Clerk, Environmental Protection Agency, Washington, D.C. (i) The term “judicial officer" shall mean an officer or employee of the Agency appointed pursuant to these rules and who shall perform functions as herein provided. (1) Office. There may be designated for the Agency one or more judicial officers, one of whom may be Chief Judicial Officer. As work requires, there may be a judicial officer designated to act for the purpose of a particular case. All prior designations of judicial officer shall stay in force until further notice. (2) Qualifications. A judicial officer may be a permanent or temporary employee of the Agency who performs other duties for the Agency. Such judicial officer shall not be employed by the office of pesticides, or have any connection with the preparation or presentation of evidence for a hearing. (3) Functions. The Administrator may delegate any or part of his authority to act in a given case under Subpart C of this part to a judicial officer. The Administrator can separately delegate his authority to rule on interlocutory orders and motions, and may also delegate his authority to make findings of fact and draw conclusions of law in a particular proceeding, providing that this delegation shall not preclude the judicial officer from referring any motion or case to the Administrator when the judicial officer determines such referral to be appropriate. The Administrator, in deciding a case himself, may consult with and assign the preliminary drafting of conclusions of law and findings of fact to any judicial officer. (4) Other duties. The chief judicial officer shall supervise the hearing clerk in the performance of the duties assigned by these rules, and be responsible for scheduling hearings. (j) The term "party" means any person, group, organization, or any Federal agency or department that participates in a hearing. (k) The term "person" includes any individual, partnership, association, corporation, or any organized group of persons, whether incorporated or not. (1) The term "recommended decision" means a report made by an examiner to the Administrator containing (1) proposed findings of fact and conclusions regarding all material issues of fact, law or discretion, as well as the reasons or basis therefor and (2) a proposed order. (m) The term "registrant" means any person who has registered an economic poison pursuant to the provisions of the Act. § 164.3 Scope and applicability of this part. The provisions of Subpart B of this part shall be applicable to the appointment, compensation, and proceedings of an advisory committee; and the provisions of Subpart C of this part shall govern hearings conducted pursuant to the provisions of the Act. The rules in this part upon adoption in final form shall apply to remaining phases of all proceedings underway insofar as practicable and fair, provided that once commenced or passed, any phase of a proceeding which might have been conducted differently under the rules in this part shall not be affected. For the purpose of the rules in this part, the advisory committee proceeding and Administrator's determination thereafter, pleading, prehearing discovery, the hearing, post-hearing objections and briefs, final and interlocultory appeals to the Administrator shall each constitute a separate phase. § 164.4 Administrative review of determinations respecting economic poisons. (a) Applications for registration of an economic poison under the Act. Whenever the Administrator determines, in connection with an application for registration of an economic poison under the Act, that it does not appear that the 85-424-72-18 article or its labeling or other material required to be submitted complies with the provisions of the Act, the Administrator shall notify the applicant of the manner in which the article, labeling or other material required to be submitted fails to comply with the Act and the applicant shall have an opportunity to make the necessary corrections, where possible. If the applicant does not make the corrections, or if no corrections are possible, the Administrator will refuse to register the article. An applicant may, within 30 days after service of notice of refusal to register and the reasons therefor: (1) File a petition with the hearing clerk requesting that the matter be referred to an advisory committee, or (2) File objections with the hearing clerk and request a public hearing respecting the matter. (b) Cancellation of the registration of an economic poison under the Act. The Administrator may, upon his own initiative or in response to a petition filed by any person with him, review the registration of an economic poison to determine whether such registration should be canceled. The Administrator may cancel any registration whenever he determines that the article or its labeling or other material required to be submitted does not comply with the provisions of the Act. (1) When cancellation or suspension action is requested by petition, immediate notice of receipt of the petition shall be given in the FEDERAL REGISTER and the Administrator shall act on such petition within 120 days of its receipt by the Agency Hearing Clerk. (2) Whenever, after review of the registration of an economic poison, the Administrator determines that a registration of an economic poison should be canceled, he will notify the registrant of his action and state the reasons therefor. He may at the same time, or at any time thereafter, suspend the registration, pursuant to paragraph (c) of this section. A cancellation of registration shall be effective 30 days after service of the cancellation notice on the registrant unless within such time the registrant: (i) Makes the necessary corrections, if possible in light of the reasons for cancellation; (ii) Files a petition with the hearing clerk requesting that the matter be referred to an advisory committee and serves a copy on the Administrator; or (iii) Files objections with the hearing clerk and requests a public hearing and serves a copy on the Administrator. (3) (i) Whenever, following either the filing of a petition by any person pursuant to the opening language of this paragraph or any major, intensive review of a registration undertaken on his own initiative, the Administrator determines that, considering all relevant factors, an economic poison is entitled to retain its registration, he shall within 120 days of the receipt of the petition publish a notice of his decision in the FEDERAL REGISTER and, if his review was occasioned by the filing of a petition, shall notify the person filing such petition directly. In his decision the Administrator shall state whether he found, in the course of evaluating the registration, the existence of a substantial question of safety. (ii) Within 30 days after such publication or notification, whichever occurs later, any person may file a petition requesting that, notwithstanding the decision that the product is entitled to retain its registration, the Administrator issue a notice of cancellation of the registration of the product on the ground that its continued registration presents a substantial question of safety. If the Administrator has stated in his decision that such a question exists, he shall forthwith issue the notice of cancellation. In such case, the registrant shall have the same opportunity to correct his registration or request administrative review as is provided under subparagraph (I) of this paragraph. If the registrant requests a hearing, the hearing shall proceed on the same basis as a hearing held pursuant to subparagraph (1) of this paragraph, except with respect to the position taken by counsel for the Agency. The burden to establish all the elements necessary to continued registration shall be on the registrant at the hearing: Provided, That no person appears at the hearing to oppose registration, the examiner shall order that the notice of cancellation be withdrawn. (iii) If the Administrator's order finds that no substantial question of safety arises in connection with the registration, that shall be a final Agency order. (c) Suspension of the registration of an economic poison under the Act. Whenever the Administrator finds that such action is necessary to prevent an |