tions by seasonal farmworkers, be they men or women. Further, the fact that this ban applies only to this year is unlikely to have any significant affect on the employment or economic status of the women in this region. The short duration of this Order and the limited acreage to which it applies reduce any problems of impracticability or enforceability. While a ban on all female exposures to dinoseb would clearly be impractical, a ban on female mixer/loader/applicators for this growing season should be no less enforceable or more impractical than the other restrictions in this order. EPA is well aware that the effectiveness of most of these measures depends in large measure on voluntary compliance by growers. Voluntary compliance, in turn, depends on (1) technical feasibility, (2) awareness of the restrictions, and (3) grower attitudes toward the importance and efficacy of the restrictions. This ban, taken alone or together with the other restrictions herein, will not eliminate risks to women. However, they should significantly increase the margin of safety in the majority of situations where EPA is concerned about the risk posed by the high exposure levels. Nonapplicator exposures of dinoseb to (through washing dinoseb-contaminated clothing, for example) should generally be much lower than applicator exposure levels. The bans on aerial application and ground application at windspeeds above 10 mph should reduce those high exposures due to drift. In short, the ban on female mixer/loader/applicators will not eliminate risks to unborn children, but the risks will be significantly lower with the ban than without. I conclude that similar measures are not necessary to reduce the risks of male reproductive effects and acute toxicity to acceptable levels for the duration of this order. The level of dinoseb exposure that causes concern for acute toxicity is much higher than the levels that cause concern for either developmental or reproductive toxicity. While the dose-per-day levels of concern are similar for male reproductive effects and fetotoxic effects, there is less concern that a onetime exposure or an exposure of limited duration will actually cause a serious reproductive effect in males. Also, as compared with the risks of fetotoxicity, such male reproductive effects that might occur as a result of the 1987 dinoseb spraying season are likely to be temporary or reversible. Because of these differences, it is reasonable Consequently, a separate restriction on female workers seems both justified and necessary. At the same time, this restriction is the least restrictive alternative, short of a continuation of the suspension, capable of reducing the risks to levels for the duration of this order. While an action that imposes different restrictions on men and women is unusual and not to be taken casually, it is not unprecedented. (See Federal Radiation Protection Guidance for Occupational Exposure, 52 Fed. Reg. 2822 et seq., January 27, 1987.) C. Term of Order and Conditions For Extension Although Judge Greene recommended that dinoseb be permitted to be used on these crops for the pendency of the cancellation proceedings (Rec. Dec., p.32), I agree with EPA Counsel in their recommendation to limit the term of this Order to the 1987 growing season, and to make consideration of any Section 18 emergency exemption request for 1988 contingent on efforts by the Petitioners to sponsor or conduct tests on alternative pesticide treatments during 1987. Given the serious nature of the risks posed by any use of dinoseb, and the importance of demonstrating alternatives as soon as possible, I believe that it is reasonable to ask the Petitioners to be at least partially responsible for demonstration testing. Similarly, should a request for use of dinoseb for these crops in these States be made for the 1988 growing season, my consideration of that request will be influenced by evidence regarding good faith compliance with the restrictions contained in this Order. D. Protective Clothing in Tractor Cab I have modified Judge Greene's recommendations regarding protective clothing in two respects. First, I find convincing Petitioner's objection that requiring protective clothing to be worn while inside the tractor cab may contaminate the cab with dinoseb. However, to reduce risks of acute toxicity stemming from application equipment malfunction and repair, I am requiring that applicators carry a new set of protective gloves and coveralls (Tyvek suits) in the tractor cab for use in such situations. (See Respondent's Objections to Recommended Decision, p.7, fn.2; Petitioner's Objections, p.5.) E. Limitations on Sales of Dinoseb (R) In objections filed to Judge Greene's Recommended Decision to me, EPA Counsel recommended that restrictions be placed on the sale or transfer of dinoseb products subject to the Section 18 emergency exemptions. Specifically, EPA Counsel recommended "(1) a requirement that each purchaser of a dinoseb product subject to the § 18 emergency exemption must be a dry pea, lentil, or chickpea grower in Washington or Idaho, and (2) a limitation that each grower who wishes to purchase a dinoseb product subject to the § 18 emergency exemption may only purchase the quantity required to treat his dry pea, lentil, and chickpea acreage at the maximum legal application rate." (p. 15) Despite Judge Greene's concerns about such restrictions (Rec. Dec., p.33), I believe the need to ensure that dinoseb exposures are as low as called for by this Order warrants the effort and inconvenience involved. F. Other Restrictions Adopted Based on the findings of Judge Greene, I accept the other restrictions contained in her Recommended Decision to me. G. Other Restrictions Recommended But Not Adopted I have not agreed with Respondent's recommendation to lower dinoseb application rates to 1.5 ai/A for all three crops. Petitioner's concerns about the efficacy of dinoseb at the lower levels for dry peas and chickpeas makes this recommended measure seem unnecessary in view of the other risk reduction measures imposed herein. Instead, I accept the recommendations of the Administrative Law Judge on this matter. VI. JUDICIAL REVIEW Under Section 136n(b) of FIFRA (7 U.S.C. § 136n(b)), petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit within 60 days of the entry of this Order. Only persons adversely affected by this Order and who have been a party to the proceedings may obtain judicial review. IN THE MATTER OF ROHM AND HAAS COMPANY FIFRA Docket No. 613 FINAL DECISION Decided May 29, 1987 Before the Administrator, U.S. Environmental Protection Agency Opinion by Ronald L. McCallum, Chief Judicial Officer: INTRODUCTION Respondent, U.S. Environmental Protection Agency, seeks to reverse the March 27, 1987 Accelerated Decision by the presiding officer, Administrative Law Judge Spencer T. Nissen, in which he denied EPA's Motion to Dismiss and Opposition to Petitioner's Motion for Expedited Hearing and Accelerated Decision. He held that (1) Rohm and Haas Company has met the Agency's requirements for the conditional registration of its pesticide product Kelthane Technical; (2) EPA's withholding of the registration constitutes an "effective denial" of Rohm and Haas' application for registration; (3) Rohm and Haas may challenge the effective denial by means of a hearing pursuant to FIFRA § 6(d) of the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. § 136 et seq.; (4) Rohm and Haas is entitled to judgment as a matter of law that its registration was improperly denied; and (5) therefore, the registration of Kelthane Technical should be approved forthwith. For the reasons stated below, I am reversing the decision of the Administrative Law Judge, and denying Rohm and Haas' request for a hearing. I. BACKGROUND A. Statute and Regulations The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) makes it unlawful to sell or distribute an unregistered pesticide. FIFRA §§ 3(a), 12(a)(1)(A). The Administrator is authorized to register pesticides unconditionally pursuant to FIFRA § 3(c)(5) or conditionally pursuant to FIFRA § 3(c)(7). A pesticide may be unconditionally registered if the Administrator determines that: (A) its composition is such as to warrant the pro- (B) its labeling and other material required to be (C) it will perform its intended function without un- (D) when used in accordance with widespread and EPA will not issue an unconditional registration until it has reviewed all available and relevant data and has determined that no additional information is necessary to make the statutory findings. 40 CFR §§ 162.7(d)(2). Notwithstanding the provisions of FIFRA §3(c)(5), the Administrator may conditionally register a pesticide pursuant to FIFRA §3(c)(7)(A) if: (i) the pesticide and proposed use are identical or (ii) approving the registration * * * would not sig nificantly increase the risk of any unreasonable ad- EPA's regulations at 40 CFR § 162.167(a) establish four criteria for conditional registration, and state that the Agency "will approve a request for conditional registration" if the regulatory conditions are satisfied.1 1The regulation provides that: The Agency will approve a request for conditional registration Continued |