"(1) against any person (including (A) the United States, and (B) any other governmental instrumentality or agency to the extent permitted by the eleventh amendment to the Constitution) who is alleged to be in violation of any regulation, order, condition of registration, or other requirement under this Act, or "(2) against the Administrator where there is alleged a failure of the Administrator to perform any act or duty under this Act which is not discretionary with the Administrator. The district courts shall have jurisdiction, without regard to the amount in controversy or the citizenship of the parties, over suits brought under this section. "(b) No civil action may be commenced "(1) under subsection (a) (1)— “(A) prior to sixty days after the plaintiff has given notice of the violation (i) to the Administrator, and (ii) to any alleged violator of the regulation or order, or "(B) if the Administrator has commenced and is diligently prosecuting a civil action in a court of the United States to require compliance with the regulation or order, but in any such action any person may intervene as a matter of right; "(2) under subsection (a) (2) prior to sixty days after the plaintiff has given notice of such action to the Administrator. Notice under this subsection shall be given in such manner as the Administrator shall prescribe by regulation. "(c) In any action under this section, the Administrator, if any party, may intervene as a matter of right. "(d) The court, in issuing any final order in any action brought pursuant to subsection (a) of this section, may award costs of litigation (including reasonable attorney and expert witness fees) to any party, whenever the court determines such an award is appropriate. "(e) Nothing in this section shall restrict any right which any person (or class of persons) may have under any other statute or under common law to seek enforcement of any regulation or order or to seek any other relief. "(f) For purposes of this section, the term 'person' means an individual, corporation, partnership, association, State, municipality, or political subdivision of a State." Renumber the remaining sections of the bill accordingly. Amendment No. 11 On page 50, line 22, immediately after "purchaser" insert ", except that (1) if a statement would be required to be submitted under section 3 (c) (1) if such pesticide were produced for domestic use, a statement which complies with paragraphs (A) through (E) of such section shall be submitted to the Administrator, (2) such pesticide shall be subject to section 8, and (3) no pesticide may be exported unless the Administrator determines that the pesticide will perform its intended function without unreasonable adverse effects on the environment of the United States. If the Administrator determines that such adverse effects will result, any person adversely affected by such determination shall have the same remedies as provided for registrants in section 6." On page 50, beginning with line 23, strike out all down through line 4 on page 51, and insert in lieu thereof the following: "(b) Notices Furnished to Foreign Governments.-The Administrator shall furnish to the government of the foreign nations to which any pesticide may be exported (1) a notice of the availability of the statement required under section 3 (c) (1), (2) all labels approved under section 3, and (3) all orders of suspension and all notices of cancellation or change in classification issued pursuant to section 6." STATEMENT OF DAVID D. DOMINICK, ASSISTANT ADMINISTRATOR FOR CATEGORICAL PROGRAMS, ENVIRONMENTAL PROTECTION AGENCY Mr. DOMINICK. Senator, I am the next witness here and I would be very happy to respond to some of your stated concerns while you are still here. Senator NELSON. Who are you? Senator NELSON. With the EPA? Mr. DOMINICK. Yes, Mr. Chairman and Senator Curtis and Senator Nelson, at the outset, I would like to respond quickly and simply to the concerns that you raised, Senator Nelson in the initial part of your testimony with respect to the memorandum that you will provide to the committee. I would like to state categorically that neither Mr. Ruckelshaus nor myself saw that memorandum, much less approve of it, sanction it, or condone it, and it in no way represents the policy or the position of EPA or of the administration. The gentleman over whose name that memorandum was prepared, as you know, has resigned at the request of Mr. Ruckelshaus from EPA and, indeed, if any further questions arise concerning the administration's position on pesticide legislation, I hope that those questions will be very thoroughly answered in the testimony that I will give here this morning. It is our desire to seek the strongest kind of pesticide legislation and we welcome the support, the expertise, and the experience that you bring to bear on this problem. Indeed, I believe that, with a quick review of your testimony, we are in agreement with several of the propositions that you put forward. I did want to lay that to rest with you, Senator, and with the committee in a direct and very forthright manner. Senator NELSON. I wonder if the chairman will permit me a brief comment. Senator ALLEN. Yes. Senator NELSON. As you know, since you were here, I stated that I did not think that memorandum, though it came out over the signature of the congressional liaison man, I did not think it represented the Department of Mr. Ruckelshaus. It may have represented some other views of other people in the administration, that I don't know. Secondly, I have, as you perhaps know, several times stated that I thought that Mr. Ruckelshaus was vigorously pursuing his responsibilities as Administrator and doing a good job. Mr. DOMINICK. Thank you. Senator NELSON. Is that all? Mr. DOMINICK. Yes. Sentor ALLEN. Thank you, Senator Nelson. Mr. Dominick, if you will proceed then, bearing in mind that we do have a number of witnesses and we are placing a limitation on them, but we feel, however, that the testimony of EPA is so important that we should not impose a time limit on it. Proceed, please. Mr. DOMINICK. Mr. Chairman, and Senator Curtis, I will try to summarize the testimony as I go through, in the interest of time, and I believe the court reporter has a copy of the testimony and can follow as we go along. Senator ALLEN. Let me make this request. If you do not touch on each one of Senator Nelson's and Senator Hart's amendments, I would appreciate it if you would for the benefit of the committee prepare and submit to the committee the EPA's official position with regard to each of these amendments. Mr. DOMINICK. We would be happy to do so. Senator ALLEN. Thank you. (The information is as follows:) EPA COMMENTS ON AMENDMENTS TO H.R. 10729 PROPOSED BY SENATOR NELSON AND SENATOR HART 1. AMENDMENT No. 1012 This amendment would add a new definition to the definitions section of the bill. The proposal is to add a term: "unreasonable adverse effects on the environment." In conjunction with this new definition, the same amendment would change the criteria for registration and classification. At present the Administrator is directed to register a pesticide if it will perform its impact without "substantial adverse effects on the environment." He shall not, moreover, make any lack of essentiality a criterion for denying registration of any pesticide. Amendment No. 1012 would make the pivotal criterion for registration the new term, "unreasonable adverse effects on the environment" and strike those references in section 3(b) (5) to essentiality. The new term defined by the amendment does not, in our view, differ in substance from the present definition of "substantial adverse effects on the environment" now found in section 2(bb). The present subsection (bb) refers to "injury to man or substantial adverse effects on environmental values, taking into account the public interest and benefits. . ." The proposed subsection (dd) refers to "any risk to man or the environment, taking into account . . ." We do not believe the difference in language between the two sections amounts to one of substance. Both appear to adopt the present risk/benefits approach of the existing FIFRA and the Agency's present body of law. The difference between "any risk" and "any injury or substantial adverse effects" is slight. Perhaps, if read literally, no pesticide would be registered because all present some "risk." In applying a section like that proposed, we would in practice look at the likelihood of injury and the anticipated benefits, which is what subsection (bb) of H.R. 10729 seeks to achieve. We note it might be desirable to strike section 2 (bb) of the present bill, in the event Amendment No. 1012 is accepted. This would add clarity to the drafting in H.R. 10729. Section 3(d) (1) (C) makes "substantial adverse effects" on the environment" the linchpin of classification as well as registration. (Obviously the term means something different in section 3(d) (1) (C) from what it means in section 3(b) (5). If risks in use outweigh benefits, a product will not be registered under any classification. Where, on the other hand, a risk is apparent but acceptable because of countermaking benefits, the use based on the adverse impact will be restricted to minimize those risks). Turning to that part of the amendment which would strike the reference to non-essentiality as a criterion for registration, we believe the present language of section 3(b) is preferable since it states Agency policy. Where two products pose the same degree of risk and are equally necessary and effective, one should not be registered in preference to the other. Of course, where the same control can be achieved more safely than with a product which is being examined, the definition of "substantial adverse effects" in section 2(bb) would itself mandate consideration of the alternatives. 2. AMENDMENT No. 1003 The amendment would make submission to the Administrator of safety and effectiveness test data by every registration applicant mandatory; permit public access to non-trade secret data in support of a registration application once it has been submitted to the Administrator (and before he has made his determination) and could be interpreted to leave the determination of what constitutes a trade-secret with the applicant rather than with the judgment of the Administrator. The amendment also specifies those persons to whom a trade secret may be revealed. As drafted, this amendment would also require the holder of a registration to submit his entire file with a new application, even if his only point were to seek approval to use a registered product on a related crop or pest. Requiring the submission of test data with every registration application is unnecessary since this Agency in many cases already has sufficient information to make a judgment consistent with the purposes of the Act. We therefore do not recommend enactment of this provision, and endorse retention of the present concept in section 3 (c) (1) (D). We also do not concur with the amendment which would provide public access to registration application information before a registration decision by the Ad ministrator. Since access could lead to interminable delay of the entire registration process. We are promulgating new rules which establish procedures under which an interested person can seek review of a registration if new evidence bears on it or the registration is inconsistent with present agency policy and the chemical in question is a significant problem. We feel that the public under present law and the proposed bill would have, in accordance with those rules, all necessary and reasonable access to registration decisions. We believe the language in section 10 of H.R. 10729 with regard to the protection of trade secrets and other information is preferable to that proposed by amendment No. 1003. The provisions of H.R. 10729 provide that in submitting data required by the Act, the applicant may mark any portions of it which he believes are trade secrets or confidential commercial or financial information. It is treated as such if the Administrator in his judgment concurs with the opinion of the applicant. The last part of Amendment No. 1003 states the terms and conditions under which trade secrets may be disclosed. While data which is determined to be a trade secret may not be revealed on request, this amendment establishes six instances where trade secret information may be opened to public scrutiny. As drafted, we feel the amendment is too broad. We suggest the following language in lieu of the pertinent provision of the proposed amendment. "(b) Disclosure.-If requested by a registrant or applicant for registration furnishing such information, the Administrator or any officer or employee of the Environmental Protection Agency shall not disclose any information which contains or might reveal information referred to in section 1905 of title 18 of the United States Code, and is otherwise unavailable to the public, except that such information may be disclosed- "(1) to other government officials; "(2) to duly authorized committees of Congress; "(3) in camera in any judicial proceedings if ordered by a court; "(4) in camera if relevant in any proceeding under this Act to carry out the purposes of this Act; and "(5) to offer officers and officials concerned with carrying out the Act. 3. AMENDMENT No. 1004 This amendment would delete from section 3(c) (1) (D) the provision which prohibits the Administrator from considering certain test data submitted in support of a registration; and would insert a provision which would explicitly state his authority to consider any test data submitted to determine the adequacy of an applicant's test data. We agree that the present language in 3(c)(1) (D) should be deleted for a number of reasons already presented to the Subcommittee in our testimony. We do not believe that it is necessary for the Administrator to have specific authority to use available data if there is no prohibition against his using it. Thus, deletion is sufficient and the grant of affirmative authority is unnecessary. In making the recommendation, it is our understanding that where testing is specifically required by the Administrator a subsequent applicant is not relieved of his burden to test simply because another had previously conducted the same or similar tests. However, we feel the Administrator should be able to refer to any previously submitted test data when considering the test data of a subsequent applicant. 4. AMENDMENT No. 1005 This would amend section 3(d)(1) (B) and 3(d) (1) (C) so as to clarify the Administrator's authority to classify highly dangerous products for restricted use. A common problem is that a pesticide if misused could cause injury to the user or the environment. As drafted section 3 (d) would permit a restricted classification to be placed only on those products which are highly dangerous even when used as directed, but not classify as restricted highly dangerous products which are apt to be dangerous if misused. In concrete terms, section 3 (d) literally read would not classify a substance like dynamite for restricted use if labeling could render it safe for use. While we believe paragraphs 3(d)) (1) (A) & (B) are susceptible of a more sensible construction, based on the language "may cause, without additional regulatory restrictions ***", the proposed amendment language would clarify the Agency's flexibility to determine that some products, no matter how labeled, cannot be rendered safe for unrestricted use. We agree with Senators Hart and Nelson that the intent of Congress could be clarified. Under their proposed language a pesticide which qualifies for registration but *** is likely to be used ***" so as to produce adverse effects on the environment would be classified restricted. While we believe language along these lines is desirable, we would prefer the language from the present FIFRA: “in accordance with commonly recognized practice." Thus, after the phrase "in accordance with its directions for use, warnings and cautions and for the use for which it is registered," which is in both subsections, we would add the phrase "or in accordance with a commonly recognized practice." We view this change as supplemental and complementary to our proposed amendment to the "misbranding" definition in section 2(g) which would also restore the "commonly recognized practice" language which is part of the present FIFRA definition of "misbranding" in section 2(z) (2) (G), and which was discussed in our testimony. 5. AMENDMENT No. 1006 The proposed amendment would emphasize the right of any interested person to participate as a party to any hearing requested following an order of the Administrator cancelling a registration. The amendment would also authorize the Administrator to impose conditions or limitations on the hearing. We agree that any interested person should be able to intervene in a hearing. This is the practice under the present law and that practice is, we believe, carried forward by H.R. 10729 and no further language is necessary. The present section refers to "objections by applicants or other interested parties." Indeed, our proposed rules of practice make clear the rights and status of intervenors. The deletion by Amendment No. 1006 of the provision authorizing the Administrator to determine sua sponte that a hearing should be held is undesirable as is deletion of the provision governing issuance of subpoenas by the Hearing Examiner to compel testimony. We view both as important means for the resolution of issues involving pesticides. One further aspect of this amendment is undesirable. As drafted it might compel a hearing on any finding made by the Administrator. For the purpose of delay a party might seek to challenge immaterial findings. 6. AMENDMENT No. 1007 This amendment would eliminate the right of any party to insist that relevant scientific issues be submitted to a scientific committee by deleting "Upon request of any party or." This would give the Hearing Examiner the exclusive authority to determine what questions of scientific fact should be submitted to a scientific advisory committee at a hearing on a pesticide registration action. We oppose deletion of this provision from the bill. We favor discretion of the Examiner to determine what issues of fact should be submitted to advisory committees. If literally read H.R. 10729 might require the Examiner to refer certain "relevant" scientific questions, even though he is capable of passing on the point. Obviously an Examiner would not have to refer to a committee a question of established fact, even if relevant; e.g., is DDT a chlorinated hydrocarbon. We believe section 6(d), as drafted, would permit the exercise of this kind of discretion. On this assumption we favor the present language rather than Amendment No. 1007 which would give an Examiner absolute freedom to ignore a request by a party to refer a scientific question to an expert body. In our testimony on H.R. 10729, we suggested an amendment which would require all questions of scientific fact to be submitted at the outset of the hearing. We still support that amendment. The amendment would also prescribe the makeup of an advisory committee and would provide that the recommendations of an advisory committee report are not binding on the Administrator. We object to the proposed amendment concerning the membership of the advisory committee, particularly as to the phrase "substantially equal number of." It would usually be difficult to meet that requirement, especially when a small committee is forced. The requirement of obtaining individuals of varied disciplines could consume a great deal of time and thus delay the hearing. We do not regard the third part of Amendment No. 1007 as necessary since at present the bill does not make the advisory committee report's recommendations binding on the Administrator, nor in practice are those recommendations so regarded. |