Document ykJ1V42b11EMrqwmKar1Y9a3n

1 -3;^ "- :: 4 >-> 6 7 V 9 BEFORE THE ADMINISTRATOR : ENVIRONMENTAL PROTECTION AGENCY of the iJWTEo States of America ; In Re: )' it ) THE DOW CHEMICAL COMPANY, ) 12 . et al. . ) ' FIFRA Docket NosV 415 , e h 13 ORDER ' 14 Ihtervnor Northwest Coalition for Alternatives to Pesticides has filed 15 a motion dated February 23, 1982 for more definitive statements in response to their 16 January 11, 1982 motion to refer questions to the National Academy Of Sciences. 17 18 NCAP's motion is granted in its entirety. Th respondents to the January 11, 1982 19 motion are directed to respond in the detail requested in NCAP1s February 23, 1982 motion. ' 20 21 IT IS SO ORDERED this day of . 1982. 22 3 23 ADMINISTRATIVE LAW JUDGE 25 Presented by: 26 STEVENS VAN STRUM Authorized Representative 27 Northwest Coalition for Alternatives to Pesticides 28 Route 2, Box 190 Tidewater, Oregon 97390 29 Telephone: 503-528-7153' 30 31 32 1 STEVENS VAN STRUM Authorized Representative 2 Northwest Coalition for Alternatives to Pesticides 3 Route 2, Box 190 4 Tidewater, Oregon 97390 telephone; 503-528-7153 5 6 7 8 BEFORE THE ADMINISTRATOR ENVIRONMENTAL PROTECTION AGENCY 9 OF THE UNITED STATES OF AMERICA 10 11 In Re; THE DOW CHEMICAL COMPANY, 12 ; et al. )) ) ) FIFRA Docket Nos. 415, et al. 13 14 INTERVENOR!NCAP *S MOTION FOR MORE DEFINITE STATEMENTS 15 OR REPLY BRIEF 16 1. Intervenor Northwest Coalition for Alternatives to Pesticides reques 17 the parties to note the change of address above for NCAP's Authorized Representative. 18 2. Intervenor NCAP has filed a motion for referral of pertinent scientific 19 questions to a standing committee of the National Academy of Sciences. After an 20 exchange of motions and reply for more time, it now appears that NCAP has received 21 the last response from the parties. 22 1. INTRODUCTION; 23 3. Pursuant to Federal Rules of Civil Procedure 8(3)(2), NCAP replies 24 to the responsive pleadings of EPA, Dow, USDA, and NFPA in the alternative: (a). 25 NCAP moves pursuant to Federal Rules of Civil Procedure 12(e) that the Adminis26 trative Law Judge Order the respondents to make more definite responses before 27 NCAP is required to further reply on grounds that the responsive pleadings are so 28 vague or ambiguous that NCAP cannot reasonably be required to frame responsive 29 pleadings; or (b). If the Administrative Law Judge should not so order, this 30 memorandum be construed throughout as NCAP's reply to the responsive pleadings. 31 / 32 / Page 1 -- INTERVENOR NCAP MOTION OR REPLY BRIEF 1 II. DEFECTS COMPLAINED OF AND DETAILS DESIRED: 2 4. Respondents' pleadings are so vague or ambiguous that NCAP cannot 3 reasonably be required to frame responsive pleadings. The following defects are 4 complained of Pursuant to Federal Rule 12(e). Following each defect complained 5 of, NCAP lists the details desired. 6 A. Failure to substantively respond to averments: 7 5. Perhaps no respondent noticed the elephant walking by their offices, 8 but NCAP's motion for referral to the N.A.S. (hereafter "NCAP's motion") made 9 averments of material facts, application of facts to law, and conclusions of law. 10 The averments of material facts were based on evidence, including the averment that 11 "NCAP believes that where remarks or positions are attributed to parties in the 12 exhibited documents, those reamrks or positions represent the parties' opinions 13 as to material facts, application of facts to law, [and] ... conclusions of law." 14 The respondents' attention is drawn to Fdral Rules of Civil Procedure 8(a), 15 (b), (c), (d), and L2(b).* NCAP seeks the following detils: 16 1. Do the respondents desire that NCAP's 17 unrebutted averments of fact be taken as established? 18 Do the respondents desire that NCAP's 19 averments of application of fact to law be taken as established? 20 3. Do the respondents agree that NCAP's unrebutted conclusions of law be taken 21 as established? 22 B. Conflicting claims of unsubstantiated fact: 23 6. EPA respondent "is hopeful that a negotiated settlement can be 24 achieved. [EPA response, page 3.] USDA respondents argue that referral "would 25 _ 26 * NCAP states that it is without sufficient knowledge to form a belief as to the 27 truth of every averment of material fact and conclusion of law made by each respondent which is not specifically admitted in this pleading, unless such 28 averments ate undisputed fact appearing of record or irrelevant to NCAP's motion NCAP's reason for making a blanket denial are so that the motion not be further 29 delayed. Should any party desire a more specific answer, NCAP will attempt to provide such specific answers at the earliest possible moment. 30 / 31 / 32 / Page 2 -- INTERVENOR NCAP MOTION OR REPLY BRIEF X be inutile, particularly if a negotiated settlement Can be reached by the parties." 2 [USDA response, page 2, emphasis provided.] "Dow believes negotiations have been 3 4,productive, and that a settlement can be achieved." [Dow response, page emphasis 4 provided.] "NFPA believes, however, that this matter is close to settlement." 5 [NFPA.response, page 1.] As discussed later, EPA also believes that referral at 6 this time would be undesirable. All claims are conclusory in nature and unsub- 7 stantiated by any evidence. This is particularly inappropriate in the present 8 situation. NCAP believes that it is not genuinely disputed that it was summarily 9 ejected from the secret negotiations for a purported breach of confidentiality. 10 NCAP brought to the record in its motion evidence which has not been denied and 11 is therefore admitted that a high executive officer of Dow Chemical Company has 12 appeared in NCAP's turf making claims that should be taken'as either: (a). a 13 statement of true material fact which could only have come out of the same negotia14 tions in which NCAP was ejected for purported breach of confidentiality, or (b). 15 highly unethical litigation in the press based entirely on false or misleading 16 information. (Perhaps the respondents can offer another explanation which NCAP 17 might accept as true.) NCAP believes that it is time that the progress of nego18 tions be revealed if the respondents intend to make that the main basis of their 19 opposition to the motion, particularly if their claims on the state of negotiations 20 conflict. NCAP therefore seeks more detail on the following: 21 1. On what matters have the parties been able 22 to tentatively agree? 23 2. On what matters have the parties been unable to tentatively agree? 24 3. What are the remaining negotiation obstacles 25 other than (a) and (b) above? 26 A. In the alternative to providing answers to the above, are the respondents willing to set some 27 non-extendable, binding deadline for completion of negotiations so that there is some evidence 28 on the state of negotiations? 29 C. Conflicting claims on potential referral desirability: 7. Dow, USDA, and NFPA all apparently are of the unsubstantiated opini 31 . that N.A.S. referral would be of no probative value, a waste of taxpayer money, -, and untimely by reason of NCAP failure to raise the question at the prehearing Page 3 __ INTERVENOR NCAP m o t i o n o r r e p l y b r i e f X conference. But respondent EPA apparently is of the belief the N.A.S. referral 2 is only unnecessary or untimely "at this time." [EPA response, page 3.] All 3 respondents apparently believe that NAS referral would unduly disrupt negotiations. 4 While NCAP has specified that it is primarily the human risk questions that it 5 would like to see referred, no party responded with an alternative specification 6 of issues that they would desire to see referred should the Administrative Law 7 Judge determine that such referral would be proper. NCAP believes that the 8 parties hve a duty to construct such alternative referral issues so that the 9 Administrative Law Judge can weigh the worth of referral objectively. At the 10 same time, NCAP is without sufficient information and knowedge to frame questions 11 without knowledge of the progress of negotiations. The respondents would merely 12 oppose referral. NCAP believes that if there are unresolved issues in the negoti- 13 ations, many of those issues might be resolved through referral of relevant 14 questions of scientific fact to the NAS. NCAP therefore seeks the following detail: 15 1. What issues Of scientific material fact 16 are still unresolved in negotiations which might be resolved or clarified 17 through referral to the NAS? 18 P. Failures to note "good cause" shown: 19 8. All respondents contend that a referral may not be made because NCAP is purported to have made no showing of "good cause." All apparently attempt 20 to read 40 CFR 5164.50(e) (.4) as requiring that the movant must include introductory 21 22 matter, reasons, arid evidence under a heading titled "showing of good cause," or 23 some similar legalism. The actual wording of the rule is not so crabbed. It 24.:. provides that th Administrative Law Judge may refer such questions "if he finds 25 that good cause exists. ..." The test should not be whether or not NCAP fails to 26 - .label a portion of its motion under a heading of "good cause shown," but father 27 :should be whether or not the ALJ can find good cause in the record. In the instant 28 . . ,case, NCAP has submitted unrebutted evidence and reasons. By admission of the 29 petitioner in this heating, Dow Chemical Company, the subject of these hearings ate 30 extremely controversial,, there is public concern,r,arid there is a need "to move, 31 toward the science experts..." [Exhibit 1 to NCAP January 11 motion,] 32 Page 4 -- INTERVENOR NCAP MOTION OR REPLY BRIEF 1 9/ No respondent has proposed any alternative remedy for alleviating 2 that concern or controversy. Instead, respondents invoke the scientific infalli3 bility of the secret negotiations process. This is nonsense and not to point, 4 Secret negotiations will not be accepted by the public as a definitive explanation 5 of risk, nor could the result of any such negotiations meet the National Environ- 6 mental Policy Act requirement of an environmental statement in its section 102(2)(C). 7 Certainly USDA respondents would not seriously expect to long sustain NEPA court 8 challenges to use of 2,4,5-T and silvex (assuming reregistration for the sake of 9 argument only) if there is no concise definitive document available to summarize 10 the risks of use.Federal user agencies (and federal funding or permitting agencies) 11 have a duty under NEPA to study the effects of use and to make underlying documents 12 relied upon in making the decision available to the public pursuant to th FOIA. : 13 [NEPA 102(2)(C).] Unless there is a concise document which would satisfy most 14 requestors, federal User, funding, or permitting agencies would be required to 15 make all underlying documents in the registration decision available to the public 16 without charge to the extent practicable. [NEPA 102(2)(C), 5 USC 552(a)(4)(A), 17 40 CFR 1506.6(f).] Surely the expense of an NAS referral pale by comparison. 18 Dow cannot reasonably plead the the Scientific Advisory Panel report could meet 19 that need, since the SAP report was prepared before most of the testimony was 20 introduced. NGAP therefore seeks the following detail: 21 1. Do the respondents view NCAP's averment 22 of the necessity for a concise document for the benefit of the public as being so 23 irrelevant that no response is required? 24 2. How do the respondents propose that federal agencies meet their NEPA disclosure duties 25 without such a document? 26 3. How will public concerns be alleviated without such a document? 27 E. Failures to come to point on the value of the 28 NAS report to the Administrative Law Judge: 29 10. NCAP made a point that the NAS "report would aid the parties and 30 the Administrative Law Judge in separating matters oi`fact from matters of law, and 31 would likely help in simplifying the proceedings." NCAP believes that respondent 32 Dow is close to the mark, the record in this proceeding is voluminous. The risk Page 5 __ INTERVENOR NCAP MOTION OR REPLY BRIEF P 1 models used, the fine points of the scientific studies, the the opinions of a great 2 number of experts are all in the record. NCAP did not intend to lead the respondents 3 to believe that the witnesses were biased, but instead intended to merely point out 4 that based on the same record, opposing parties have come to opposing opinions on 5 the risk to human health. This is not unusual at all in contested cases, in fact 6 there would be no contested cases if society could somehow guarantee that everyone 7 would come to the same conclusions based on the same information. The point NCAP 8 raises is that raised by Dow: 9 ... we should try to move toward the science 10 experts, trying to size up a risk at the start of a regulatory proceeding, then let the proceeding 11 focus more on what should be done about it. [NCAP January 11, 1982 memorandum, page 6.] 12 NCAP agrees with Dow* particularly in the instance where the parties have apparently 13 been deadlocked in negotiations for nearly a year. NCAP still believes that an NAS 14 report could enhance negotiations, lend to the weight of the decision in this case, 15 simplify the proceedings, and aid the parties and the Administrative Law Judge in 16 sifting the essentials from a voluminous record. NCAP therefore seeks the following 17 detaili' 18 1. Do the parties believe that an NAS study 19 would not help in "trying to size up [the] risk?" 20 II. CONCLUSION: n 21 9. For grounds stated in this memorandum or motion and NCAP's January 22 11, 1982 motion, Intervenr NCAP respectfully requests that either its January 11 23 or todayfs motion be granted in their entireties. ^ 24 DATED this c L s 3 ^ day of February, 1982. 25 26 27 STEVENS VAN STRUM ' 28 Authorized Representative Northwest Coalition for 29 Alternatives to Pesticides 30 CERTIFICATE OF SERVICE 31 I CERTIFY that copies of this motion or reply brief were mailed first class postage prepaid on February 7^1982 to the persons named oil the service list attached to 32 NCAP's January 11, 1982 motion to refer questions to the National Academy of Sciences Page 6 -- INTERVENOR NCAP MOTION OR REPLY BRIEF UNITED STATES, ENVIRONMENTAL PROTECTION AGENCY . BEFORE THE ADMINISTRATOR " - .'' ' In re: The Dow Chemical Company, ) ) ) et al. ) ) :) FIFRA Docket Nos. 415, et al EPA RESPONSE TO NCAP MOTION FOR REFERRAL TO THE NATIONAL ACADEMY OF SCIENCES . INTRODUCTION;- - If On January 11, 1982, the Northwest Coalition for Alternatives to Pesticides (herefter NCAP) moved the Administrative Law Judge to initiate procedures leading to a referral to the National Academy of Sciences (hereafter N A S ) of questions relating to the risk phase of the above-captioned proceeding. NCAP has not sub mitted specific questions for referral, and has failed to show that referral is "necessary or desirable" as required by both FIFRA and the Rules of Practice for this hearing. Accordingly, the NCAP motion should be denied. DISCUSSION 1. NCAP hajs Failed to Meet the Requirements of FIFRA 6(d) .' Section 6(d) of FIFRA permits the ALJ to refer relevant questions of scientific fact to a Committee of the NAS upon the request of a party to the hearings:- - Upon the request of any party to the public hearing and when in the Hearing Examiner's judgment, it is necessary or desirable, the Hearing Examiner shall at any time before the hearing record is closed, refer to a Committee of the National Academy of Sciences, the relevant questions of scientific fact involved in the public h e a r i n g . FIFRA 6 ( d ). 1 -2 - In order to refer questions to the NAS, the Administrative Law Judge must find that the referral is either necessary or d e s i r a b l e . T h u s , referral of scientific questions to the NAS is not an automatic p rocedure. Indeed, in amending FIFRA in 1972, Congress added the requirement that a request for referral be subject to co n c u r r e n c e 1of the Administrative Law J u d g e , */ and expressly required that referral be based on his finding that referral is either necessary or d e s i r a b l e . * / >' Here, while NCAP, a party to the hearing, has requested referral, it has not demonstrated that a referral to the NAS is either necessary or desirable at this t i m e . a) NCAP Has not Established the Necessity for a Referral to the NAS Any "necessity" for a referral to the NAS arises from the potential utility of NAS comment to resolution of^ relevant questions of scientific fact. In this case, Respondent believes that current negotiations may lead to settlement of this case. Such a conclusion to the hearing renders referral less useful and thus less necessary than if the hearing were to continue. If negotiations break down and the hearing r e s u m e s , the Admini- . strative Law Judge can, of c o u r s e , reevaluate the necessity of referral to the N A S . Even if the hearing does resume, referral is optional, depending on the necessity or desirability of such referral. 5 T T h e 1964 version of FIFRA, 78 S t a t . 190, 7 U.S.C. 135-135K at section 4(c) permitted referrals on the request of a registrant without a demonstration of necessity or desirability. **/ The 1972 Amendments to FIFRA added the necessary and desirable requirement to the statute. 86 S t a t . 973, 7 U.S.C. 1 3 6 -136y. -3If NCAP's view that only the NAS can provide an unbiased evalua tion of certain issues is intended to demonstrate necessity (or desirability), NCAP's position ignores a key fact. These issues, which might be r e f e r r ed, have been fully ventilated in a public hearing, and all parties to the proceeding have had an opportunity to establish bias on the part of any w i t n e s s , if p o s s i b l e Nonetheless, neither NCAP nor any other party to the hearing has moved to strike the testimony of any witness on the ground of improper bias. It is unseemly for NCAP to suggest at this stage of the proceedings that the record in this proceeding is infected with improper bias, since NCAP never once alleged bias during the t r i a l . */ b. NCAP has not Shown that a Referral to the NAS is D e s i r a b l e . FIFRA 6 (d) also permits a referral to the NAS if the Administrative Law Judge finds that referral would be desirable. Respondent believes that a referral to the NAS at this time would be undesirable for the reasons discussed below. Referral to the NAS at this time may be^wastei?t|l in v i e ^ o f the progress which the parties hav^fkade during thj^surren^1 intensive negotiations aimed at settlement of this proceeding. Respondent is hopeful that a negotiated settlement can be a c h i e v e d . Under these circumstances, where NAS referral would not contribute to the outcome of the case, it is pointless to require the Agency V NCAP has a l s o a r g u e d that an NAS review would provide information of significant probative value. Since NCAP has not specified the questions it would propose for r e f erral, it is impossible to respond to the substance of this allegation. J. : ~4~- to expend resources to brief a referral, financially underwrite N A S 's s e r v i c e s , and require the NAS to undertake such a dubious project. This unjustifiable use of government funds and resources would appear particularly wasteful under current Agency budget limitations. Again, the more prudent course would be to wait to determine if there will be a settlement. If there is no se t t l e ment, the case is certain to continue in hearings for at least six months to a y e a r . This would allow more than enough time to refer questions to the NAS. Furthermore, a referral to the NAS would needlessly delay the settlement negotiations. The parties engaged in active nego tiations are expending substantial resources in these negotiations If a referral were m a d e , Respondent and probably other parties would be required to divert manpower from the settlement effort and devote a substantial effort to the proposal of questions and briefing of i s s u e s , making it difficult to conduct serious n e g o t i a t i o n s . In short, the motion to refer questions to the NAS would seriously interfere with the negotiation process. M. NCAP has Failed to Meet the sir Mit 'W Requirements of the Rules of.Practice d*\PH'i-, 40 CFR 164. 50(e) (4) amplifies the provisions of FIFRA 6(6.) with an additional test based on the timing of the request for a referral. If the request for a referral is not made during the prehearing conference stage, this regulation requires that in addition to meeting the statutory test that the referral be nec essary and desirable, the movant also show "good cause" in support ffia iBOtion for referral. */ This additional requirement has the . iveffect of encouraging the requesting parties to make their request for referral during the prehearing phase of the proceeding. This allows the other parties and the Administrative Law Judge to plan and prepare for the major undertaking involved in a referral to the NAS. NCAP fails to allege good cause for requesting a referral at this late stage of the p r o c eeding. Indeed, it neither explains why it did not make this request for referral to the NAS during the prehearing stage of the proceding, nor claims that it could not have done so. N C A P 1s motion must fail in the absence of a showing of good cause for the late filing of this request. CONCLUSION For all of the foregoing r e a s o n s , N C A P 1s motion should be denied. Respectfully submitted, /Wi 4--L Dorothy E <(JPatton Kevin M . Lee Patricia A. Roberts Timothy D. Backstrom Counsel for Respondent February 8, 1982 U.S. Environmental Protection Agency 401 M Street, SW. Washington, DC 20460 '*/ 40 CFR 164. 5 0 ( e ) (4) provides the following : "Request and Submission Subsequent to Prehearing C o n ference . At any time before the hearing is closed, the Administrative Law Judge or a party by motion may request that questions of fact not previously referred be referred, or that questions previously referred be amended or expanded. The Administrative Law Judge may refer such questions if he finds that good cause exists and that reference of such questions is necessary or d e s i r a b l e ." J U N I T E D STATES' ENVIRONMENTAL P R O T E C T I O N AGENCY .BEFORE THE ADMINISTRATOR In the matter of The Dow Chemical Company, et al., FI FRA D o c k e t No. 415 RESPONSE OF SECRETARY OF AGRICULTURE FOR THE UNITED STATES TO NCAP'S MOTION TO REFER QUESTIONS TO THE NATIONAL ACADEMY OF SCIENCES On J a n u a r y 11, 1982, the N o r t h w e s t C o a l i t i o n for Altern a t i v e s to Pesticides filed "Intervenor NCAP's Motion to Refer Questions to The National Academy of Sciences," (hereinafter Motion) and moved the Administrative Law Judge (ALJ) to "determine that there is an affirmative intent of the parties to refer questions of s c i e n t i f i c f a c t to a c o m m i t t e e d e s i g n a t e d b y the. N a t i o n a l A c a d e m y of S c i e n c e s ." ( N A S ) M o t i o n at 1. T h e t i m e in w h i c h to r e s p o n d to the m o t i o n w a s e x t e n d e d to F e b r u a r y 8, 1972, b y t h e O r d e r G r a n t i n g M o t i o n for E x t e n s i o n of Time, J a n u a r y 22, 1982. O n b e h a l f of the Secretary of Agriculture, we oppose NCAP's proposal that the ALJ issue an order at this time which would permit the parties to submit proposed questions. The Environmental Protection Agency Rules of Practice issued pursuant to FIFRA provide that the ALJ may refer questions of scientific fact to a committee of the NAS if he determines that submission o f questions is "necessary or d e s i r a b l e . " 40 C.F.R. 164.5 0 ( e ) (2). Referral at this time could lead to substantial delay. Submission of questions to a committee would be a time-consuming process. Following NCAP's suggested timetable, questions would not be submitted until 30 days after the ALJ issued an order inviting such submissions. Any questions which might then be proposed would require careful consideration by the A L J . If he then did decide to refer a question to the NAS for committee consideration, the committee, after formation, would have 60 days to report. 7 U.S.C. 1 3 6 ( d ) . Submission of questions to a committee of the NAS is unnecessary at this t i m e . Questions proposed to be referred likely would be duplicative of scientific testimony already presented at the hearing. A report from a committee would be unduly cumulative if it merely constitutes another- analysis of documents already discussed in detail at the hearings. See Motion at 4, item 9. If q u e s t i o n s of s c i e n t i f i c fact are r a i s d for referral subsequent to prehearing conferences, the agency regulations require the ALJ to find that "good cause exis t s " for referral in addition to determining that the referral is necessary o r d e s i r a b l e . 40 C.F.R. 164.5 0 ( e ) (4). NCA P has p r o f f e r e d no reasons for its failure to request a referral of such a question early in the hearing or at the time when other parties were d i s c u s s i n g t h e - i s s u e s -it n o w s u g g e s t s ~to r ^ r e f e r r a l T - F u r t h e r , ~ N C A P shows no compelling reasons for referral at this juncture. The topics discussed by NCAP in its memorandum have been dealt with at some length in the hearing. Additional consideration would be inutile, particularly if a negotiated settlement can be reached by the parties. Going through the referral process would entrail increased expense for the government and additional commitments of already scarce resources. Therefore, referral at this time is neither ne c e s s a r y nor Y W desirable. For these reasons, the Secretary of Agriculture opposes the Motion of N C A P . Respectfully submitted, / / -7?^ s'r / vy ' / MARGARET"M. BREINHOLT Attorney Office of the General Counsel U.S. Department of Agriculture Washington, D.C. 20250 (202) 447-2713 BEFORE THE ENVIRONMENTAL PROTECTION AGENCY OF THE UNITED STATES OF AMERICA In re: The Dow Chemical Company, et al. " 5 ) ) ) ) FIFRA Docket Nos. 415, et al. ~~ THE D O W C H E M I C A L C O M P A N Y 'S RESPONSE TO N C A P 'S MOTI O N FOR REFERRAL TO T H E N A T I O N A L A C A D E M Y .OF SCIENCES INTRODUCTION The D o w C hemical C o m p a n y (Dow) submits this r esponse in op p o s i t i o n to Intervenor N C A P 's M o t i o n To Refer Quest i o n s to the National Academy of Sciences, dated January 11, 1982. Dow moved to extend the time for this response to coincide w i t h the timing of E P A 's resp o n s e to the N C A P motion. M o t i o n for Exten s i o n of Time (Jan. 25, 1982). N C A P 's m o t i o n should be denied because it does not mee t the statutory standard for National Academy of Sciences (NAS) r e f e r r a l , b e cause it is untimely:, and be c a u s e N C A P has not even attempted to meet the "good cause" showing required by E P A s hearing regulations for late NAS referral requests. 2 argument A. Referral to an NAS Commi t t e e Is Not "Necessary or Desirable," but Would Merely Duplicate the Risk Hearings and Cause Unnecessary Delay. Under FIFRA, "questions of scientific fact" may be referred to an NAS committee only when the Administrative Law Judge determines that such reference is "necessary or desirable." 7 U.S.C. 136d(d). In the circumstances presented h e r e , reference to an NAS committee would serve no useful purpose, would disrupt ongoing settlement discussions, and would delay these proceedings. The requested reference is therefore neither "necessary" nor " d e s i r a b l e ." NCAP's motion, in essence, seeks to reargue before an NAS committee the risk evidence already addressed in e x haustive detail in a year of risk hearings before the Administrative Law Judge. Through the testimony of more than 100 witnesses, filling more than 20,000 pages of hearing transcript, as well as more than 1,000 documentary exhibits, the scientific evidence on 2,4,5-T, silvex, and TCDD has been explored thoroughly and carefully from all perspectives. The witnesses included many of the research ers who conducted the key studies on these compounds, as well as other prominent scientific experts from around the world. The risk evidence was also subjected' to intensive scrutiny by EPA's Scientific Advisory Panel, which concluded that E P A should not even initiate F I F R A Section 6 ( b ) (2) hearings on 2,4,5-T and silvex. Review of Notices of Intent 3 to H o l d FIFRA Section 6 ( b ) (2) H e aring on 2 , 4 , 5-T and Silvex (September 26, 1979). The reconsideration of the risk evidence by an NAS committee would not advance knowledge or understanding of the issues, but would merely require NAS scientists to perform a needless and duplicative task. For e x a m p l e , it is hard to imagine a more wasteful use of scientific talent than a n o t h e r re e x a m i n a t i o n of the Al s e a II s t u d y , the study m o s t p r o m i n e n t l y featured in N C A P 's motion. At least eight Dow and EPA witnesses testified concerning Alsea II.--^ Numerous scientific reviews discussed during the hearings found the A l s e a II c o n clusions invalid. (S e e , e . g . , Exhibits 1159, 1168, 815, 1164, 1169, 1170, 1154). The other toxi cology and exposure issues addressed in the risk hearings were subjected to similarly rigorous examination. > Moreover, referral to NAS would be cumbersome, ex pensive and time-consuming. The proposed order submitted by NCAP with its motion would require all parties to f i l e , w i thin -30 d a y s , "proposed q u e s t i o n s of scientific fact accompanied by reasons supporting their submission to the [NAS] c o m m i t t e e . . . . " Under EPA's hearing r e g u l a t i o n s , all parties would then have an opportunity to file responses to the pro p o s e d q u e s t i o n s . 40 C.F.R. 164.50 (e) (2). 1/ D o w presented the t e s t i m o n y of Dr. S t even L a m m (WS 853), Dr. Sh e l d o n W a g n e r (WS 855) , Dr. A l a n Ag r e s t i (WS 856) and Dr. E . G. M c Q u e e n (WS 854). E P A p r e s e n t e d the tes t i m o n y of Dr. R o bert Dunc a n (WS 476) , Dr. T h omas Keefe (WS 473), Dr. Jack G r i f f i t h (WS 468) and Mr. Robe r t Hea t h (WS 938). / 4 Thereafter, the Administrative Law Judge would be required to review the proposed questions and responses, to d e t e r m i n e w h ether reference is "necessary or d e s i r a b l e ," and to "prepare in his d i s c retion appropriate q u e s t i o n s . " Id. If the Administrative Law Judge decided to refer questions to the NAS, the burdensome preliminary process of preparing questions would be followed by lengthy consideration at the NAS, with the costs of the NAS committee borne by EPA and, ultimately, the taxpayers of the United States. Participation in the referral process would divert time and resources from the ongoing settlement negotiations. Dow believes negotiations have been productive, and that a settlement can be achieved. Inevitably, the negotiations and these proceedings would be delayed by NAS referral. In light of the com p r e h e n s i v e exam i n a t i o n of t)ie risk evidence in the hearings, the dubious benefits of recon sideration by the N A S , and the inevitable delay which would ) a c c o m p a n y any r e f e r r a l , N C A P 's proposal for referring questions to the NAS cannot meet the statutory "necessary or desirable" standard, and must be denied. B. N C A P 's M o t i o n Is Untimely, and Does Not Meet the "Good Cause" Requirement for Late Referral Requests. EPA*s hearing regulations encourage parties who wish to request NAS referral to do so at an early stage of the proceedings. T h u s , the regulations make requests for NAS reference one of the ten specific matters to be considered at a prehearing conference. 40 C.F.R. 1 6 4 . 5 0 (a). The Administrative Law Judge specifically directed the parties' attention to this provision of the regulations, in setting the first prehearing conference at the outset of these p r o c e e d i n g s . Notice of Prehearing Con f e r e n c e (May 11, 1979). NCAP. did not respond to this notice by requesting NAS referral prior to the risk hearings. In addition, the hearing regulations require a special showing of "good cause" where a request for NAS referral is made late in the p r o c e e d i n g s . Where the request is made at a prehearing conference or prior to the public hearing, the parties are directed to file proposed questions for con sideration by the Administrative Law Judge under the "neces sary or desirable" standard. 40 C.F.R. 1 6 4 .50(e) (1), (2). S u b s equent requests for NAS referral -- like N C A P 's m o t i o n here -- are subject to the "good cause" requirement, in addition to the "necessary or desirable" standard. 40 C.F.R. 1 6 4 . 5 0 ( e ) (4). NCAP offers no excuse for filing its request for NAS reference now, nearly three years after the initiation of these p r o c e e d i n g s . M o r e o v e r , N C A P 's m o t i o n does not atte m p t to make the "good cause" showing required at this stage of the proceedings. N C A P !s m e m o r a n d u m in support of its m o t i o n is bas e d on 40 C.F.R. 164.50 (e) (2) , and does not even cite s u b s ection ( e ) (4), w h i c h imposes the "good cause" r e q u i r e ment on late requests. Memorandum of Points and Authorities 6- in Support of Intervenor NCAP's Motion To Refer Questions to the N ational A c a d e m y of Sciences at 2 (Jan. 11, 1982). CONCLUSION For all the foregoing reasons, NCAP's motion for NAS referral fails to satisfy either the "necessary or desir able" standard established by FIFRA, or the "good cause" requirement for late requests found in EPA's hearing regula tions. Accordingly, the motion should be denied. Respectfully submitted, Of Counsel: Charles H . G oodman, Esq. Dow Chemical U.S.A. 2030 Dow Center Midland, Michigan 48640 W <W XN'U-- ViC. E d ward W. Warren, P.C. L . Mark Wine Richard L. M c C onnell John A. Zackrison KIRKLAND & ELLIS 1776 K Street, N.W. Washington, D.C. 20006 (202) 857-5000 Counsel for The Dow Chemical Company February 8, 1982 BEFORE THE ENVIRONMENTAL PROTECTION AGENCY OF THE UNITED STATES OF AMERICA In re: The Do w Chemical Company, et al. .....................................................'.............................................................................. ) ) ) ) ) F IFRA Docket Nos. 415, et al. NATIONAL FOREST PRODUCTS ASSOCIATION'S MEMORANDUM IN OPPOSITION TO THE NCAP MOTION FOR REFERRAL TO THE NATIONAL ACADEMY OF SCIENCES F e b r u a r y 5, 1982 R i c h a r d J. W e r t h e i m e r ARNOLD & PORTER 1200 New Hampshire A v enue, N.W. Washington, D.C. 20036 (202) 872-6824 Richard S . Wasserstrom National Forest Products Association . 1619 Massachusetts Avenue, Washington, D.C. 20036 (202) 7 9 7 - 5 8 6 0 N.W. Counsel for the National Forest Products Association ' wf N A T I O N A L F O R E S T P R O D U C T S A S S O C I A T I O N 'S MEMORANDUM IN OPPOSITION TO THE NCAP MOTION FOR REFERRAL TO THE NATIONAL ACADEMY OF SCIENCES' National F orest Products Association (NFPA) opposes the NCAP motion to refer certain questions to the National Academy of Sciences. The NCAP m o t i o n is, to say the least, untimely. It comes a b o u t th r e e ye a r s after, this p r o c e e d i n g b e g a n , two years after hearings in this proceeding b e g a n , and almost one year after this proceeding was stayed for purposes of settlement. The NCAP motion is also pointless. It would gener/ a t e , at great expense, a report for the Administrative Law Judge which will be of no use to the Administrative Law J u d g e . A reference to the National Academy of Sciences (NAS) is designed to provide expert guidance to the Adm i n i s trative Law Judge on scientific questions which the Adminis trative Law Judge must decide in a FIFRA hearing. NFPA believes, h o w e v e r , that this matter is close to settlement. There will be no scientific questions for the Administrative Law Judge to decide if this matter is settled, a n d , there fore no need whatsoever for any report from the NAS. Accordingly, we submit that the NCAP motion should be denied. A reference to the NAS is not "necessary or desirable", within the meaning of FIFRA, 7 U.S.C. 1 6 4 . 5 0 ( e ) (2). M o r e o v e r , N C A P has not sho w n "good cause" for this out-of-time and useless diversion. See 40 C.F.R. 1 6 4 . 5 0 ( e ) (4). 1. T h e m o t i o n is u n t i m e l y . As the C o u r t is w e l l a w a r e , this proceeding commenced on Febru a r y 28, 1979 -- about three years ago -- when EPA issued emergency suspen sion orders and notices of intent to cancel certain regis trations for 2 , 4 , 5-T and silvex. 44 Fed. Reg. 15874 e t s e q . Hearings before this Court began in March of 1980 -- about two years ago. At the outset of these h e a r i n g s , the Court directed the attention of all parties -- including NCAP -- to those matters which, in accordance with EPA hearing regulations, are to be considered at the outset, including any reference to the N A S . See Notice of Prehearing Conference (May 11, 1979). Neither NCAP nor any other party requested any such reference. Sj l 3 On M a r c h 20, 1981 -- n e a r l y one y e a r ago- -- h e a r i n g s were suspended, to permit negotiation of a settlement. At no time prior to the suspension of hearings for settlement did NCAP request any NAS reference. Now three years after this proceeding began, two years after hearings commenced, and one year after hearings were suspended for purposes of settlement -- NCAP moves for a reference to the N A S . To say that this request is u n timely is to understate matters considerably. 2. The r e q u e s t is p o i n t l e s s . The N C A P m o t i o n is not only out-of-time, it is g r o u n d l e s s . A reference at this point to the National Academy of Sciences^ would accomplish nothing. FIFRA and EPA hearing rules provide for reference to the NAS of "relevant questions of scientific fact in volved in the public h e a r i n g ." 7 U.S.C. 136d(d). The obvious purpose of such a reference is to provide expert guidance to the Administrative Law Judge on scientific questions which the Administrative Law Judge will have to decide in the course of the hearing. 4 In this, case, h owever, w e e x p e c t t h e r e to b e n o t h i n g for the Administrative Law Judge to decide. Hearings have been suspended for purposes of settlement. Settlement negotiations have been extensive and productive. NFPA believes that the parties are not far from a settlement agreement. And a settlement agreement will make it unneces sary for the Court to decide any of the questions which NCAP proposes to refer to the NAS. T h u s , reference to the NAS would waste scarce scientific resources, waste considerable taxpayer money, and divert the parties from prompt completion of a disposi tive settlement, all for the purpose of providing advice to the Administrative Law Judge on questions which the Administrative Law Judge will not have to decide. The NCAP motion bears high cost for no benefit. CONCLUSION NFPA respectfully suggests that reference to the NAS is neither necessary nor d e s i r a b l e , within the meaning of FIFRA and EPA hearing regulations, and that NCAP has I 5 failed to demonstrate good cause for such a reference. Accordingly, NFPA urges that NCAP's motion be denied. Respectfully submitted, ARNOLD & PORTER 1200 New Hampshire Avenue, Washington, D.C. 20036 (202) 872-6824 N.W. \ National Forest Products Association 1619 Massachusetts Avenue, Washington, D.C. 20036 N.W. Counsel for the National Forest Products Associatin F e b r u a r y 5, 1982 / - Y : " ' * ... ; V; 'A :v; ":yW : ^ :' ; '' 7 ?'' ` ' - , ;/ V \ ' : V v" ^ .. '' 1 ;2 3 4 stevns van strum ".Authorized Representative ; ; Northwest Coalition for Alternatives fo Pesticides 454 Willamette Street Eugene, Oregon 97401 Telephone : 503-344-5044 5 Intervenors 6 7 8 9 ; 10 11 12 13 14 15 16 17 18 19 20 ' BEFORE THE ADMINISTRATOR ENVIRONMENTAL PROTECTION AGENCY: . OF THE UNITED STATES OF AMERICA \ )In Re: ; j) ''THE DOW CHEMICAL COMPANY, ` ),et; ale - .' . . FIFRA Docket ; ; . Nosv 415,,et al. .. _ ' NCAP RESPONSE TO' EPA MOTION- FOR EXTENSION OF TIME A;; ^ . v. . \ L Intervenor Northwest Coalition for Alternatives vtc^ Pesticides, has filed a motion for referral ofpertinentscientific questions to "a standing committee of the National Academy -o'f/Hcierices>.i.r;: yRespondemt. Environmental Protection Agency filed a motion dated January 21, 198;2 for an extension of time, through and including February 8, 1982, to respond to the NCAP motion. 2. Interverior NCAP does not object to EPA's requested extension in this instance only* .NCAP reserves the right to. argue that a stronger showing of necessity : / b t : is necessary,should any party seek further delay in disposition of the NCAP motion. 22 3. NCAP is concerned that their motion not be further delayed. 23 DATED this 30th day of January, 1982. 24 .'"..'/Respectfully submitted, . 25 26 27 '\y. " .' STEVENS VAN STRUM . : Authorized Representative 28 ' -, Northwest Coalition for Alternatives to Pesticides 29 CERTIFICATE OF SERVICE . 30 ,1 CERTIFY that copies of this.. Response ;were mailed first class postage prepaid on * January 30, 1982 to the persons on the attached list. 31 .V :'. ' . , .,v /''.':,f;A ... .\ /' ' , . .-. 32 .. .. STEVENS VAN STRUM : Page 1 -- NCAP RESPONSE. TO EPA MOTION FOR MORE TIME 1 ACTIVE SERVICE LIST 2 SONIA G. ANDERSON. V Hearing Clerk (A-110) 3 U.S. Environmental Protection Agency 4 401 M Street S .W. Washington, D.C. 20460 5 g ELIZABETH M, WHELAN American Council on m :Science & Health 1995 Broadway g New York, NY 10023 9 ALLEN T, MALONE, Esquire jQ Counsel for Vertac, ine. Apperson, Crump,, Dzane :&Maxwell -- 2610 -- 100 North Main Building . Memphis , TN 38103 : 12 jg RICHARD J WERTHEIMER, Esquire . Arnold.& Porter ; - - 1200 New Hampshire Avenue N.W.*. Washington, D>Ce 20036 :; 15 ' jQ JOSEPH E STEVENS, JR* , Lathrop, Koontz, Righter, Clagett, Parker & Norquist ; 2600 Mutual Benefit Life Building jg P*0* Box 120. , 2345 Grand Avenue ; jg Kansas City, MO 64108 WILLIAM A. BUTLER, Esquire Environmental Defense Fund, Inc, 1525: 18th Street N.*W* ; Washington, D i,C. 2Q036 , ' MARGARET M. BRIENHOLT Room 2036, South Agriculture Building Office of the General Counsel . IL S * Department of Agriculture Washington, D.C.. 20250 ; ALLEN A. LAUTERBACH ; JOHN J . RADEMACHER American Farm Bureau Federation 425 13th Street N.W, Washington, D.V 20004 . DOROTHY E * PATTON ; - ;; Office of General Counsel Environmental Protect!on Agency 4 0 M Street S,W* Washington, D*C. . 20460 EDWARD W. WARREN. Kirkland & Ellis 1776 K Street N.We, 12th Floor Washington, D .C, 20006 20 21 22 : 23 'V 24 25 26 27 28 29 30 31 32 Page . NCAP. SERVICE LIST :'..F IMITEE STATES ENVIEONMENTAL PROTECTION AGENCY BEFORE THE AEMINISTRATOR In re: The Dow Chemical Company, Et. al. ) ) ) } ) Fifra Docket Nos. 415 et. al. . MOTION FOR EXTENSION OF TIME Respondent Environmental Protection Agency requests a 14 day extension Ij . of time to respond to Intervener NCAP's Motion to Refer Questions to the National Academy of Sciences, received by Respondent on January 18, 1982. The additional time is necessary because of reductions in the trial staff assigned, to this case and the press of activities relating to the ongoing settlement negotiations. The requested extension would move the filing deadline for Respondent's response to February 8, 1981. Respectfully submitted January 21, 1982 Kevin Lee Counsel for Respondent Environmental Protection Agency 401 M Street, S.W. Washington, D.C. 20460 CERTIFICATE OF SERVICE I hereby certify that copies of the foregoing Motion for Extension of Time were hand delivered or mailed first class postage prepaid on January 21 1982 to the following persons. Edward W. Warren L. Mark Wine Richard L. McConnell, Jr. Kirkland & Ellis Counsel for Dow Chemical Company 1776 K Street, N.W., 12th Floor Washington, D.C. 20006 William A. Butler, Esq. Jacqueline M. Warren, Esq. Counsel for Environmental Defense Fund, Inc. 1525 - 18th Street, N. ,W. Washington, D.C. 20036 Margaret M. Brieriholt Judith A. Weriker Terrence G. Jackson Roan 2036, South Ag. Bldg. Office of the General Counsel U.S. Department of Agriculture Washington, D.C. 20250 Allen T. Malone, Esq. Counsel for Vertac, Inc. Apperson, Crump, Duzane & Maxwell 2610 - 100 North Main Building Memphis, Tennessee 38103 Richard J. Wertheimer, Esq. Arnold & Porter Counsel for National Forest Products Association 1200 New Hampshire Avenue, N.W. Washington, D.C. 20036 Joseph E. Stevens, Jr. William Ray Price, Jr. Lathrop, Koontz, Righter, Clagett, Parker & Norquist 2600 Mutual Benefit Life Bldg. P.O. Box 1200 2345 Grand Avenue Kansas City, Missouri 64108 Judy Kahle Northwest Coalition for Alternatives to Pesticides, P.O. Box 375 454 Willamette Street Eugene, Oregon 97401 Inc. Allen A. Lauterbach John J. Fademacher American Farm Bureau Federation 425 13th Street, N.W. Washington, D.C. 20004 Sonia G. Anderson Hearing Clerk (A-110) U.S. Environmental Protection Agency 401 M Street, S.W. Washington, D.C. 20460 Elizabeth M. Whelan, Sc.D., M.P.H. Executive Director American Counsel on Science and Health 'J' 1995 Broadway :.i New York, New York 10023 Ak.-v a Kevin M. Lee January 21, 1982 :1 STEVENS V A N STRUM ,7 j. 2 Authorized. Representative 1 Northwest Coalition for Alternatives to Pesticides 3 A 5 4 Wi l l a m e t t e Street 4 Eugene, Oregon 97401 | Telephone : 503-344-5044 5 Intervenors ' 1. 8 t . BEFORE THE ADMINISTRATOR 9 ENVIRONMENTAL PROTECTION AGENCY OF TH UNITED STATES OF AMERICA 10 11 In Re : ` THE DOW CHEMICAL COMPANY, 12 a l ..et )))) . ' 415 . ..FIFRA Docket Nos . , et 13 I N T R V E N O R N C A P 'S M O T I O N T O REPER Q U E S T I O N S TO 14 THE N A T I O N A L A C A D E M Y OP S C I ENCES 15 Pursuant to the F e d e r a l Insecticide, F u n g icide, & R o d e n t i c i d e 16 Act 6(d) and 40 .CPR 1 6 4 . 5 0 (e), Int e r v e n o r N o r t h w e s t C o a l i t i o n for' 17 Altern a t i v e s to Pesticides moves the A d m i n i s t r a t i v e Law Judge to 18 determine that there is an a f f i r m a t i v e intent of the p a rties to refer 19 questions of scientific fact to a committee d e s i g n a t e d by the N a t i o n a l 20 Academy o f Sciences'. 21 The subject r e f e r r a l is j u s t i f i e d because: (1), The r e f e r r a l 22 will not in any way u n r e a s o n a b l y delay the p r oceedings; (2). The infor 23 m a tion to be o b t a i n e d is not otherwise o b t a i n a b l e ; and (3). Such infor 24 m a t i o n has s i g nificant proba t i v e value, 25 This m o t i o n is b a s e d on its a c c o m p a n y i n g m e m o r a n d u m of points 26 qnd a u t h o r i t i e s . 27 DATED this day of January, 1982. 28 ' R e s p e c t f u l l y submitted, 29 30 ' . . 3X ` S T EVENS VAN S T R U M 32 A u t h o r i z e d R e p r e s e n t a t i v e NCAP Page , 1-- NCAP' M O T I O N FOR R E F E R R A L TO N.A.S. ' 1 STEVENS VAN STRUM' Authorized Representative 2 Northwest,Coalition for Alternatives to Pesticides 3 454 Willamette Street Eugene, Oregon 97401 4 .Telephone: 503-344-5044 5 Intervenors 6 7 8 BEFORE THE ADMINISTRATOR 9 ENVIRONMENTAL PROTECTION.AGENCY OF THE UNITED STATES OF AMERICA 10 In Re : . 11 THE DOW CHEMICAL COMPANY,^' 12 et a l . ) ) ) ) ; FIFRA Docket . Nos., 415, 'et al. 13 MEMORANDUM OF POINTS & AUTHORITIES IN SUPPORT OF INTERVENOR NCAP'S MOTION TO REFER QUESTIONS TO 14 THE N A T I O N A L A C A D E M Y OF S C I ENCES 15 -1. Intervenor N o r t h w e s t C o a l i t i o n for A l t e r n a t i v e s to Pesti c i d e s 16 in a m o t i o n filed c o n c u r r e n t l y w i t h this m e m o r a n d u m has m o v e d the 17 .Administrative Law Judge to d e t e rmine th a t ^ t h e r e is an af f i r m a t i v e 18 .intent of the p a rties to ref e r questions of scientific fact to a commit19 t e e - d e s i g n a t e d by the N a t i o n a l A cademy o f Sciences. This m e m o r a n d u m 20 of p o i n t s and a u t horities is int e n d e d to support that motion. 21 .I , ' S TATEMENT OF THE CASE : 22 2. This is an a d m i n i s t r a t i v e p r o c e e d i n g c a l l e d to examine the 23 a c tion taken by the A d m i n i s t r a t o r of the U.-S. E n v i r o n m e n t a l P r o t e c t i o n 24 Agency in i ssuing an e m e r g e n c y su s p e n s i o n of certain r e g i s t e r e d uses 25 of the h e r b icides 2, 4 , 5 - T and silvex and to r e v i e w the A d m i n i s t r a t o r ' s 26 notice of intent to cancel r e g i s t r a t i o n s for all- r e m a i n i n g r e g i s t e r e d 27 lises of those herbicides. M a j o r por t i o n s of the risk hear i n g s have 28 been completed, f o l l owing whi c h the p r o c e e d i n g s have b e e n i n d e f i n i t e l y 29 r e c e s s e d while the parties explore the p o s s i b i l i t i e s of a n e g o t i a t e d 30 settlement. 31 / 32 / Page '1 -- INTERVENOR'S MEMORANDUM t ~STATE M E N T OF M A T E R I A L E A C T S r ^ \ v~ : 3 . Intervenor NCAP believes that the statement of facts made 3 in this memorandum are not genuinely in dispute. NCAP believes there 4 is no genuine dispute as to the authenticity of exhibited d o c u m e n t s . 5 NCAP believes that where remarks or positions are attributed to parties 6 in the exhibited documents, those remarks or positions represent the 7 ' 'p a r t i e s opinions as to m a t e r i a l facts, a p p l i c a t i o n of facts to law, 8 the conclusions of law. 9 4. These p r o c e e d i n g s have b e e n s u r r o u n d e d by c o n t r o v e r s y on the 10 effects, of the d i o x i n - c o n t a m i n a t e d he r b i c i d e s 2 , 4 , 5 - T and silvex on 11 humans and the human environment. [Exhibit 1, 11.] This c o n t r o v e r s y : 12 has cr e a t e d c o n c e r n on the part of citizens who 1 ive in areas w here 13 those he r b i c i d e s are used or have b e e n used. [Exhibit 1, *11. ] The 14 various e p i d e m i o l o g i c a l studies e n t e r e d in the r e c o r d of this p r o c e e d - 15 ing have b e e n p a r t i c u l a r l y c o n t r oversial, n o t a b l y the Alsea II study of 16 the coin c i d e n c e of "sponta n e o u s " a b o r t i o n s and the use of 2, 4 , 5 - f and 17 silvex in the Coast R a n g e ;of O r e g o n . [Exhibit 1.] 18 19 III. ARGUM E N T : ^ 5. A r eferral of questions to the Nat i o n a l Ac a d e m y of Sciences 20 21 is p r oper under 40 CFR 1 6 4 . 5 0 ( e ) (2) if the A d m i n i s t r a t i v e Law J udge determines that such referral is "necessary or desirable." 22 . 23 The requested referral will not in any way V-V unreasonably delay the proceedings: : ; - ^ 6 . Because the hearings are in recess and the date for resumption 26 is u n k n o w n if not nebulous, the short p e r i o d p r o v i d e d by r e g u l a t i o n for 27 referral of questions to the N a t i o n a l A c ademy of Sciences w i l l not in 28 any way u n r e a s o n a b l y delay the p r o c e e d i n g s . E v e n if the h e a r i n g s should 29 :resume, there r e m a i n m o nths of ben e f i t s h e a r i n g s whi c h could p r o c e e d 30 w i thout c a using any delay in the risk p r o c e e d i n g s . f ". :r 31 7 . " Page 2 -- INTERVENOR'S MEMORANDUM I B. Info r m a t i o n to be obtai n e d is not otherwise obtainable: 7. Contrary to the claim of Dow C hemical Company's d i r e c t o r of 37 ; ' ' . r e g u l a t o r y and legislative issues [Exhibit 1, 114],, NCAP bel i e v e s that 4. ' 7; 5 ' . >: :the EP A has riot called t h e - A l s e a . i l study invalid., There has b e e n no agreement among the parties on the scientific validity of the various 6' >' human epidemiological studies proffered in evidence, nor is there 7 . 7 . ' , : 7- 7V agreement on the risk to humans elicited from other evidence. While 8 a . ' 77'. ':.. ..-.7=i-7 . a number of witnesses have supported the validity of the Alsea II study 9 . ' ' 7 77 .1 :" ;-v 10 and oth e r e p i d e m i o l o g i c studies , it is true that : [n]o scientific group that has made a 11 study of the situation has supported . 12 that report [the Alsea II s t u d y ] . [Exhibit 1, 115.] J ; 13 There is no evidence in these p r o c e e d i n g s whi c h was not e n t e r e d by 14 parties a d v o c a t i n g a position. It may be that no scientific group has 15 s u p p o r t e d the Als e a II s t u d y , but NCAP bel i e v e s that no s c i e ntific g roup 10 has b e e n asked to make such an e v a l u a t i o n by p a rties o p p o s i n g r e g i s t r a 17 t i o n . The p a r t i e s , the A d m i n i s t r a t i v e Law Judge* t h e , A d m i n i s t r a t o r 18 (and ul t i m a t e l y the c o u r t s ) wou l d benefit from inclu s i o n of an open 19 o p inion by a p r e s t i g i o u s body such as the N a t i o n a l A cademy of Sciences. 20 Such a report would aid the pa r t i e s and the A d m i n i s t r a t i v e Law J udge 2 1 in separating matters of fact from matters of law, and would likely 22 help in s i m p l i f y i n g the proceedings. At the same time, no other inde- 23 pendent s c i e ntific body is in the p o s i t i o n of the N.A.S. to b r i n g . t o 24 the record of these p r o c e e d i n g s scientific op i n i o n w h i c h is free from 25 the bias of the parties. 26.' - - V 7 7 '- 27 .C.- Such i n f o r m a t i o n has significant probative value : 28 8 . Simply stated, these p r o c e e d i n g s are e x a m i n i n g quest i o n s of 29 life and death: the p o t e n t i a l for a c o m m o n l y - u s e d p e s t i c i d e to cause 30 cancer, birth defects, " s p o n t aneous" abortions, s h o r t e n e d life spans, 31 and other serious effects. The dec i s i o n to be r e a c h e d then, must not 32 only be p r o p e r as a m a t t e r of law, but also as a m a t t e r of fact. Page 3 -- INTRVENOR* S M E M O R A N D U M As 1 a m a t t e r of law, the A d m i n i s t r a t o r is r e q u i r e d to take a "hard look" 2 at tire consequences of her d e c i s i o n in this m a t t e r u n d e r prov i s i o n s 3 of the National Environmental Policy Act of 1 9 6 9 42 U.S.C. 4321 et 4 se quit o r . ' Kleppe v. Sierra C l u b , .96 3. C t . 2718, 2731 n. 21 (1976 ). 5 The mere fact that a program involves use of substances registered 5 under FIFRA does not exempt the program from the requirements of 7 NEPA. -CATS v. B ergland (USDC Oregon) Civil. No,. 76-436, O p i n i o n of 8 March 7 a 1977 at 33, with citation to Environmental Defense Fund y .; ~ 9 H a r d i n , 325 F. Supp. 1401, 1407 (D. D.C. 1971). An A g ency is r e q u i r e d 10 und e r N E P A to u n d e r t a k e r e s e a r c h a dequate to e x pose t h e p o t e n t i a l 11 e n v i r o n m e n t a l i m p a c t . E n v i r o n m e n t a l De f e n s e F u n d v. H a r d i n , i b i d , 12 17 ALR Fed 33 4 at 82, .7 . / ;1 7 ,: 13 9. The q u e s t i o n of the vali d i t y of the h u m a n e p i d e m i o l o g i c a l : 14 studies, the risk m o d e l s , and other evidence on the effects of 2 , 4 , 5 -T, 15 silvex, and T C D D des e r v e s a d i s i n t e r e s t e d viewpoint. It a ppears likely 16 that the requested referral would be supported by at least one other 17 party to this proceeding: 18 There is a g r o w i n g f e e l i n g a m o n g a 19 ", v ; n u m b e r of p e ople in this country ... that we should try to move toward the - science experts, trying to size up a 20 risk at the start of a regul a t o r y proceeding, then let the regulatory 21 proceeding focus more on what should ' be done about it. [Exhibit 1, 17.] 22 23 If they are confident of their positions, no parties' should object to 24 r e f e r r i n g q u e s t i o n s on the s c i e ntific v a l i d i t y of those p o s i t i o n s to the National Academy of Sciences. As a matter of daw, the Administrator 25 \ ; 7 . . / ;i. 26- of the U S E P A is r e q u i r e d to u n d e r t a k e r e s e a r c h a dequate t o e x pose the ' . : / . 7 . . 7 -\.77 potential environmental impact and must assure herself that the risks 27 : . ; ' v'^7`'VV V-'0 28 7 ' , :are not un d e r s t a t e d should any uses of the h e r bicides not be canceled. 29 D. Gr a n t i n g the referral is in the public i n t e r e s t : 10. There is public concern about the effects of the subject herbicides: [Statement of Facts, H4, supra.] That public concern will 32 7; .y. 'i-d/-'--.; ' Page '4 --.INTERVENOR S MEMORANDUM 1 likely be ameliorated by a referral of relevant questions to a body 2 perceived by the public as disinterested. . S u c h a referral will likely 3 lead to wider public acceptance of the Administrator's decision in this 4 proceeding. Such acceptance is in the public interest. 5 6' '? IV. CONCLUSION: . 11. For grounds stated in this m e m o r a n d u m and its a c c o m p a n y i n g 7 motion, Intervenor NCAP respectfully requests that its motion be granted 8 9 in its e n t i r e t y , and that the parties be instructed to submit their proposed questions of scientific fact for referral to the National 10 11 Academy of S c i e n c e s . DATED this ff/K day of January, 1982. 12 13 R e s p e c t f u l l y submitted, 14 15 STEVENS VAN S T R U M 16 Au t h o r i z e d R e p r e s e n t a t i v e Northwest Coalition for 17 Alt e r n a t i v e s to Pesticides 18 19 C E R T I F I C A T E OF SERVICE I C E RTIFY that, copies of this m e m o r a n d u m of points and a u t h o r i 20 ties, its accompanying motion, and proposed order were mailed first 21 class p o stage p r e p a i d on Ja n u a r y ____ , 1 9 8 2 to the p ersons on the a t t ached 22 23 l i s t . 24 25 STEVENS VAN S TRUM 26 27 28 29 30 31 32 Page 5 -- IN T E R V E N O R S M E M O R A N D U M - 3M THEOREGONIAN,THURSDAY, SEPTEMBER24,1981 2 3 i *r ;'4 s; 6 :7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 Page 6-- ByANN SULLIVAN $1T]h*pngonlan Mf . An official of the Dow Chemical Co. s a y i research into a herbicide made Jay Dow .has not shown U is harmful to humans, an.d the controversy surround in g It-shows the need to "get science up front1st the start of a regulatory prps Er-ed D. Hoerger, Dow'sdirector of - regulatory and legislative issues in the health and environment sciences divi sion, referred to concerns raised by resi dents: around Alsea about the herbicide 2,4,5-T. The herbicide figured in a 1977-7% Study, originally done by the, U.S. Envi- . ronmental Protection Agency bn re search from the University of Florida, FREDP. HOERQER- which'was an effort to determine if a ! seriesTof miscarriages, in the Aisea area were-more than usual and could be linked to use of the herbicide in nearby ceding focus, more on what should be forests. .' done about it." : ' , - (th e EPA, Hoerger said in an inter view Wednesday, calls the report inval id "and does not show what its authors, said it did. They basically had raw data andCthey drew conclusions, that, have been entirely discredited,. *`No scientific group that has made a study, of the situation has supported that original report," he said.' r "Two things are important there," he continued. "The first is that the gen eral of miscarriages in the ' population is perhaps 25 to 30 percent t of pregnancies.. . . The second factor in the'Alsea area, where I believe eight l miscarriages were reported, is that the jncidence for that population area is no lgorfeiratnterAVtOhQaCn for othef compariable popu- , Hoerger, \yho holds a Ph.D. in or ganic chemistry and has been with Dow for 26 years, said that in his opinion, 2,4,5-T "is definitely pot a human car cinogen." / He said that jn extensive studies on animals, a few have suggested that there might, be a light carcinogenic (cancer-causing) response. But Hie her bicide does contain an impurity, TCDD' (tetrachlorodioxin) that has caused fetal defects in animals. < It used to be present in several parts per million, but today the specification is 1/lQth of one part per million, he said, "That is definitely not a hazard, to humans under the conditions used, based on all the information we have," he said. : " .' "There is a growing feeling among a Dow has spent. $10 million to $15 number of people in this country," he million on research into the health^f- said, "that we should try to move to fects of 2,4,5-T and TCDD, he said, And ward the science experts, trying to size many universities and government up a'risk at the start of .a regulatory agencies around (he world also have proceeding, then let the regulatory pro,- done research on it. I 'N T E R V E N Q R S M E M O R A N D U M , E X H I B I T 1 PESTICIDE CONTRO!: AO ''CHM'-Ih <31:0217. . tious. completion of the remdies provided' by that paragraph and the. ' issuance of a final order orr suspension, and (ii) no party other ;than the registrant arid the. Agency shall participare except Unit any person adversely affected may file briefs within the time allotted by.; the Agency's rules. Any person so filing briefs shall be considered a party to such proceeding for the purpose.of section 1 6 (b)'. " (4) J udicial bevjew.--A final order on. the question of suspension ; following a hearing shall He revicwable in accordance with Section 16 of this Act, notwithstanding the fact that any related cancellation proceedings have not beerr completed..Petiti9 ns to review-orders on th issue; of suspension shall be advanced on the docket of. the courts of appeals. Any order of suspension entered* prior to a hearing before the Administrator shall be subjectto immediate review in an action by the ( ( registrant or other interested person with the concurrence of the : registrant; in an appropriate district court, solely to determine whether . the order, of suspension was arbitrary, capricious"; or an --abit se' of dis cretion, or whether the order was issued in accordance with the proce dures established by law. The effect of any order of the court will, be only to. stay the effectiveness of the suspension order, pending the Administrator-s final decision with-respect to. cancellation or change in classification. This action may be maintained simultaneously* with any . administrative review proceeding under this section. The. commence ment of proceedings under this paragraph shall not operate as a stay of order, unless ordered by the court. " (d) Public 'Hearings and Scientific R f.view.--In .the event a hearing is requested pursuant to subsection (hi or determined upon by the Administrator pursuant to subsection ( h i, such hearing'shall be-.held* after due notice for the purpose of receiving evidence relevant and material to the issues raised by the objections filed by the applicant or other interested parties, c.r to the issues stated by the Administrator, if the hearing is called by the Administrator rather than by the filing of objections. Upon a show ing of relevance and reasonable scope of evidence sought by any party to a public hearing, the Hearing Examiner shall issue subpena to compel testi mony or production of documents from any person. The Rearjng Examiner shall be guided by the principles of the Federal Rules of Civil Procedurein making any order for the protection of the witness or the content of documents produced arid shall order the payment of reasonable fees and expenses as a conditioh to.Tequiring testimony of the witness: On contest, the subpna may be enforced by an appropriate tinited,States district court . r^in accordance with the principles stated herein^ Upon. th request of any ; party, to a public -hearing., and.'w-hen in the Hearing Examiner's judgment it is necessary or desirable, the 1Icaring.'Examiner, .shall''at .any time before thehearirig record is closed -refer to .a 'Commit-tee of ih.e National Academy of Sciences the relevant questions of scientific fact involved in the public hearing. No member of any committee o f trie National .Academy of Sciences established to carry out .tlie functions of this section shall have (a financial or other conflict of interest With respect to any matter considered by such committee. Th-.-'.Comirittec of the National Academy of Sciences shall report in .writing to the .Hearing Examiner .within -60 (jTys after cmch referral on. these questions of scientific fact 1 he report, shall, he .made-' public and shall be considered as part ol the hearing record. The .Administrator shall enter into appropriate arrangeme.nts with, the National .Academy of Sciences.' to assure air 'objective- and competent scientific ' review .-of the questions presented to Committees of'the Academy and 1 0 .provide such other; scientific ' advisory services as may be required by the. Adminixirator for carrying out the purposes of this -Act. As soon as practicable after completion of the hearing (including the report of the Academy) but not later than 90 days, thereafter, the-Acl ministra tor shall evaluate the data and reports before him - and issue an order either revoking his notice oh in lent ion issued pursuant to this section, or shall issue.an order either canceling the registration, chang ing th classification, denying tlie..'registration, or requiring modification of the labeling or packaging o l t he article. Sudi order shall be based only on substantial evidence of record o f such hearing and shall set forth detailed findings of fact, upon which the order is based ^ "(e) Conditional Registration.-- "(1) Th Administrator shall issue a notice of intent to cancel a registration issued, under section .3 .(c) (7) of this Act if (A) the Administrator, ai any time during the period provided tor satisfaction of any condition imposed, determines that the registrant has failed to initiate and pursue appropriate action toward fulfilling any condition imposed, or (B) at the end of the period, pro vided for satisfaction of any condition imposed, that condition'has not been met: P ro v id e d That the Administrator may permit the continued sale and use of existing stocks of a pesticide whose conditional registration has been canceled under this subsection to such extent, under such conditions, and Subpena. 28 USC app. R ep o rt. 7 USC 136d. Notice. Ante. p. 825. 11-10-78 P u b lish e d by THE BUR EAU OF NATIONAL AFFA IR S, INC., WASHINGTON, D .C . 2G037 97 PESTICIDES HEARINGS 71:0505 Thereafter; witnesses, documents, or ex hibits may toe added and narrative sum maries of expected testimony amended upon motion by a party. (c) Record of the prehearing confer (3) Reference and report. Not less than 30 days after he has informed the Na tional Academy that questions of scien tific fact will be referred to it, the Ad ministrative Law Judge shall refer the hearing or as otherwise provided by this part, shall be in writing and shall state with particularity the grounds therefor, shall set forth the relief or order sought, and shall be filed with the hearing clerk ence. No transcript of any prehearing questions of scientific fact as prepared. and served on all parties. conference shall be made unless a request The committee shall report in writing to (b) Response to motions. Within 10 therefor by one of the parties is granted' the Administrative Law Judge within 60 days after service of any motion filed by the Administrative Law Judge, Such days after such referral on these ques pursuant to this part* or within such party shall bear the cost of the taking tions of scientific fact and the report, its other time as may be fixed by the Ad of the transcript unless otherwise or record and any other matter transmitted ministrator, his designee, or the Admin dered by the Administrative Law Judge. / as provided for by the Administrator's istrative Law Judge, any party may serve The Administrative Law Judge shall pre agreement with the National Academy and file an answer to the motion. The pare and file for the record a written re of Sciences shall be made public and con movant shall, if requested by the Admin port of the action taken at each confer sidered as part of the hearing record. istrator, his designee, or the Adminis ence, which shall incorporate any stipu ~ (4) Rquest and submission subsequent trative Law Judge, serve and file reply lations or agreements made by the to prehearing conference. lAt any time papers within the time set by the request. parties at or as a result of such confer before the hearing is closed, the Adminis (c) decision. The Administrative Law ence, all rulings upon matters considered trative Law Judge or a party by motion Judge shah rule upon all motions filed at such conference and appropriate may request that questions of scientific or made prior to the filing of his initial orders. ' ' C-;V fact not previously referred be referred, or accelerated decision at the time of (d) Unavailability of a prehearing con or that questions previously referred be filing oh ex parte motions or where the ference. Upon a finding that circum amended or expanded. movant has stated that no party objects stances render a prehearing conferenc< unnecessary, or impracticable, or upon a ^ [39 FR 11884, April 1,1974 ] to the granting of such motion. Other wise, such decision shall await the an finding th at a prehearing conference swering papers and reply papers if per would serve primarily to delay the pro ceedings rather than to expedite them-, the Administrative Law Judge, on motion or sua sponte, may order that the prehearing conference not be held. In these circumstances he may request the parties to correspond with him f^r the purpose of accomplishing any of the objectives set forth in this sction. Such corre spondence shall not be made a part -of the record, but the Administrative Law Judge shall submit a written summary for the record if any action is taken. (e) Submission of questions to an ad visory committee-- (1) General. At any prehearing conference, or if none is held prior to the public hearing, except as herein provided, the Administrative Law Judge shall determine whether any party desired that questions of scientific fact be referred to a/committee designated by the National Academy of Sciences (2) Preparation of questions. On de termining an affirmative intent, the Ad ministrative Law Judge shall direct all parties to file and serve, within a time period subject to his discretion, proposed questions of scientific fact accompanied by reasons supporting their submission to said committee. Within 10 days of the service of such proposed questions, to gether with their supporting reasons, any party may respond in writing to the pro posed submission of the questions to the said committee. The Administrative Law Judge shall determine whether or not a reference of questions of scientific fact to said committee is necessary or desir 164.51 Other discovery. (a) General. Except as so provided by 164.50 (to) supra, further discovery, under this subpart, shall be permitted , only Upon determination by the Admin istrative Law Judge (1) that such dis covery shall not in any way unreasonably delay the proceeding, (2) that the in formation to be obtained is not other wise obtainable and (3) that such in formation has significant probative value. The Administrative Law Judge shall be guided by the procedures set forth in the Federal Rules of Civil Pro cedure, where practicable, and the prec edents thereunder, except that no dis covery shall be undertaken except upon order of the Administrative Law J udge or upon agreement of the parties, (b) Depositions upon oral questions. The Administrative Law Judge shall order depositions upon oral questions only upon a showing of good cause and upon a finding that (1) the information sought cannot be obtained by alternative methods, or (2) there is a substantial reason to believe that relevant and pro bative evidence may otherwise not be preserved for presentation by a witness at the hearing. (c) Procedure. (1) Any party to the proceeding desiring discovery shall make a motion or motions therefor. Such a mo tion shall set forth (i) the circumstances warranting th taking of the discovery, (ii) the nature of the information ex pected to . be discovered and (iii) the mitted. The Administrator or the Judi cial Officer shall rule upon all motions filed after the filing of the initial or ac celerated decision. Oral argument of motions will be permitted only if the Ad ministrative Law Judge or Administrator or the j udicial officer deems it necessary. S ubpoenas and Witness Fees 164.70 Subpoenas. (a) The attendance of witnsses or th e production of documentary evidence may, by subpoena, be required at any des ignated place of hearing or place of dis covery. Subpoenas may be issued by the Administrative Law Judge sua sponte or upon a showing by an applicant th at evidence sought for hearing is relevant and material to the issues involved in the hearing r th at the sought discovery pur< suant to 164.51 meets the standards set forth therein. The Administrative Law Judge shall be guided Jay the prin ciples of the Federal Rules of Civil Pro cedure in making any order for the pro tection of a witness or the content of the documents produced. (to) Motion for subpoena duces tecum. Subpoenas for the production of docu, mentary evidence, unless issued by the Administrative Law Judge sua sponte, shall be issued only upon a written motion. Such motion shall specify, as ex actly as possible, the documents desired. (c) Service of subpoenas. Subpoenas shall be served as provided by the Federal Rules of Civil Procedure. able. In the event he decides such refer proposed time and place where it will be 164.71 Fees f witnesses. ence is necessary or desirble, he shall so inform the National Academy in writing, and shall prepare in his discretion ap propriate questipns. If any of the ques tions prepared are not in substance based taken.; (2) If the Administrative Law Judge determines the motion should be granted, he shall issue an order and appropriate subpoenas, if necessary, for the taking Witnesses summoned before the Ad ministrative Law Judge shall be paid the same fees and milage th at are paid wit nesses in the courts of the United States, upon the submissions of the parties, th of such discovery together with the con and persons whose depositions are taken, `Administrative Law Judge shall permit any party 10 days after their prepara ditions and terms thereof. tion to respond in TOitittg to the pro M otions posed submission of questions. He shall said question or then determine r 164.60 Motions. - and the persons taking the same, shall be entitled to the same fees as are paid for like services in the courts of the United States. Fees shall be paid by the whether such questions should be (a) General. All motions, except thoseparty at whose instance the witness ap referred to the committee. made orally during the course of a public pears or th deposition is taken. Copyright 1977 by The Bureau of National Affairs, Inc. [Sec. 164.711