40 CFR PART 167 ------- REFERENCE: Binding Effect of Rules on Agency CASE NAME: S. W. Cowley & Sons Mfg. Co. (arsenic trioxide) DOCKET #: 341 TITLE: Initial Decision DATE: May 28, 1976 PRESIDING OFFICIAL: Finch, Administrative Law Judge ABSTRACT: Basic rule of administrative law that an agency is bound by its own rules. Therefore, EPA should either (1) disapprove labels which require removal of water sources when it is shown it is not possible in field conditions or cannot be simulated in laboratory tests or (2) establish another test method which eliminates requirement that test is to be conducted according to instructions on labels. CROSS REFERENCES: ------- REFERENCE: Collateral estoppel CASE NAME: Velsicol Chemical Corp. (Heptachlor/Chlordane) DOCKET #: 336 TITLE: Order on Incorporation DATE: April 27, 1976 PRESIDING OFFICIAL: Penman, Administrative Law Judge ABSTRACT: Suspension and cancellation proceedings are inextricably intertwined. (FIFRA §6(c)(l)). In reality suspension proceedings are but a phase or part of cancellation proceeding. Merely the period of concern which is different. Record of suspension proceeding not hearsay in cancellation proceedings. Reference to criminal proceedings inapposite. Velsicol has same interest, motives and position in both proceedings. No inability to cross—examine in suspension proceeding as compared to cancellation proceeding. CROSS REFERENCES: Incorporation of Suspension Record 40 CFR §164.81(e) 40 CFR §164.81(a) ------- REFERENCE: Data Production Requirement-By-ALJ CASE NAME: Velsicol Chemical Corp. (Heptachlor/Chlordane) DOCKET #: 336 TITLE: Collaborative Study DATE: May 6, 1976 PRESIDING OFFICIAL: Penman, Administrative Law Judge ABSTRACT: AU lacks authority to order a collaborative study. Also, lacks authority to require respondent to expend substantial sums which are not available for data gathering. This is a matter for technical people of Velsicol and Respondent to work out. CROSS REFERENCES: 40 CFR §164.40(d) ------- REFERENCE: Motion to Dismiss for Failure to Prosecute CASE NAME: Chapman Chem. Co. (Mercury) DOCKET #: 246 TITLE: Order on Respondent’s Motion to Dismiss as to Certain Parties DATE: March 5, 1975 PRESIDING OFFICIAL: Levinson, Administrative Law Judge ABSTRACT: Respondent’s motion to dismiss (for failure to file motions to dismiss or proposed findings and conclusions of law) denied because none of the parties was required to file a motion to dismiss (one party inactive, the other a limited participant). Under prior order they are not required to file proposed findings or conclu- sions. Other parties’ interests adequately represented by other registrants. CROSS REFERENCES: 40 CFR §164.80(c) ------- 40 CFR Part 167 ------- REFERENCE: 40 CFR Part 167 CASE NAME: Velsicol Chemical Corp. (Heptachior/Chiordane) DOCKET #: 336 TITLE: Order Granting Motions DATE: February 3, 1977 PRESIDING OFFICIAL: Penman, Administrative Law Judge ABSTRACT: Velsicol alleges much of the data is already available by reason of §7 reporting form. Held that information on reporting form is inadequate to meet needs herein. CROSS REFERENCES: FIFRA §7 ------- 40 CFR PART 180 ------- 40 CFR Part 180 ------- REFERENCE: 40 CFR Part 180 CASE NAME: Shell Chemical Co. (Aldrin/Dieldrin Cancellation) DOCKET #: 145 TITLE: Order Partially Granting Motion DATE: July 24, 1973 PRESIDING OFFICIAL: Perlman, Administrative Law Judge ABSTRACT: Proceeding divided into two phases: 1) consideration of uses, including risks and benefits; 2) considera- tion of tolerances by Administrator after cancellation decision made. Such a procedure avoids duplication of evidence since §406 only applies if there is a cancellation. Previous order of Administrator had consolidated tolerance (rulemaking) proceeding into cancellation (adjudicatory) proceedings. Bifurcation insulates at least FIFRA cancellation proceedings from possible serious procedural questions. Persons concerned with tolerances will have opportunity to participate in registration segment of this proceeding as it relates to tolerances. CROSS REFERENCES: FDCA §406 FDCA §408 FIFRA §6(b) (Relation to FDCA) ------- 40 CFR §180.6(c) ------- REFERENCE: 40 CFR §180.6(c) CASE NAME: Bio—Labs Inc. (Consolidated into #245) DOCKET #: 297 TITLE: Initial Decision DATE: May 19, 1975 PRESIDING OFFICIAL: Denniston, Administrative Law Judge ABSTRACT: While FDCA §408 ostensibily relates only to additives for “raw agricultural commodities,” the Administrator has asserted authority by regulation to pesticides purposely added to poultry drinking water. CROSS REFERENCES: FDCA §408 ------- •REFERENCE: 40 CFR §180.6(c) CASE NAME: Mason Chemical Co., Bio—Lab, Saisbury Labs (Science Products, Inc.) DOCKET #: 245 (Including Nos. 296, 297, 298) TITLE: Initial Decision Re QAC DATE: May 19, 1975 PRESIDING OFFICIAL: Denniston, Administrative Law Judge ABSTRACT: While FDCA §408 ostensibly relates only to additives for “raw agricultural commodity” the Administrator has asserted authority by regulation to pesticides purposely added to poultry drinking water. CROSS REFERENCES: FDCA §408 ------- 40 CFR §180.7(d) ------- REFERENCE: 40 CFR §180.7(d) CASE NAME: Science Products Co. et al. (Zero Tolerance) DOCKET #: 245 - TITLE: Report of Prehearing Conference and Order DATE: November 27, 1974 PRESIDING OFFICIAL: Denniston, Administrative Law Judge ABSTRACT: Requires Administrator to act within 90 days of issuance of certificate of usefulness. CROSS REFERENCES: FDCA §408 ------- 40 CPR §180.8 ------- REFERENCE: 40 CFR §180.8 CASE NAME: Science Products Co. et al. (Zero Tolerance) DOCKET #: 245 TITLE: Order Denying Motions to Dismiss DATE: November 1, 1974 PRESIDING OFFICIAL: Denniston, Administrative Law Judge ABSTRACT: Provided for notifying petitioner when petitions were inadequate and for withdrawal of petition pending its clarification. EPA has at least three times suggested petition be withdrawn due to deficiencies. CROSS REFERENCES: ------- 5 CFR PART 930 ------- 5 CFR §930.212 ------- REFERENCE: 5 CFR §930.212 CASE NAME: Velsicol Chemical Corp. (Heptachior/Chiordane) DOCKET #: 336 TITLE: Notice of Denial of Request for Interlocutory Review and Reconsideration by the Administrator DATE: Oc tober2, 1975 PRESIDING OFFICIAL: . Russell Train, Administrator ABSTRACT: Ve1sicbt c1aims EPA has violated provision of Administrative Procedure Act and its regulations which require that AU’s be assigned cases in rotation so far as practicable. CROSS REFERENCES: Administrative Procedure Act, 5 USC §3105 40 CFR §164.121(b) ------- FEDERAL RULES OF EVIDENCE ------- Federal Rules of Evidence, Rule 701 ------- REFERENCE: Federal Rules of Evidence, Rule 701 CASE NAME: Dow Chemical Company (2,4,5—T and Silvex Cancellation) DOCKET #: 415 TITLE: Order Granting Motion to Strike DATE: July 7, 1980 PRESIDING OFFICIAL: Finch, Administrative Law Judge ABSTRACT: Motion to strike lay opinion testimony granted. Submission of expert opinion by non—experts does not assist court in reaching decision and leaves poten- tially unsubstantiated evidence in the record——denies all parties opportunity for meaningful cross—exami- nation. CROSS REFERENCES: 40 CFR §164.81(a) ------- Federal Rules of Evidence, Rule 803(8) ------- REFERENCE: Federal Rules of Evidence, Rule 803(8) CASE NAME: Velsicol Chemical Corp. (Heptachior/Chiordane) DOCKET #: 336 TITLE: Statement as to Basis for Settlement DATE: March 6, 1978 PRESIDING OFFICIAL: Douglas Costle, Administrator ABSTRACT: Interim decision by R. Train is not a finding within the purview of Rule 803(8). CROSS REFERENCES: ------- FEDERAL RULES OF APPELLATE PROCEDURE ------- Federal Rules of App. Pro Rule 18 ------- REFERENCE: Rule 18 Federal Rules of Appellate Procedure 5 U.S.C. 705 CASE NAME: Chapman Chem. Co. (Mercury) DOCKET #: 246 TITLE: Order Granting Temporary Stay DATE: March 2, 1976 PRESIDING OFFICIAL: Russell Train, Administrator ABSTRACT: Request for stay pending judicial review of Administrator’s order dated 2/17/76 on basis of economic hardship to petitioners (registrants). Find substantial likelihood of irreparable harm and showing of good cause for stay. Does not agree with objections of parties to 2/17/76 order. Stay ordered to 6/30/76 or conclusion of judicial proceedings, whichever occurs first. No stockpiling or increase in production during period of stay. CROSS REFERENCES: ------- NATIONAL ENVIRONMENTAL POLICY ACT ------- NEPA ------- REFERENCE: NEPA CASE NAME: Stevens Industries, et al. (DDT) DOCKET #: 63 TITLE: Recommended Decision DATE: March 14, 1973 PRESIDING OFFICIAL: Penman, Administrative Law Judge ABSTRACT: AJH holds against registrant’s contentions with respect to NEPA. CROSS REFERENCE: ------- FEDERAL RULES OF CIVIL PROCEDURE ------- FRCP Rule 26(b)(3) ------- REFERENCE: Federal Rules of Civil Procedure, Rule 26(b 3) CASE NAME: Dow Chemical Co. (2,4,5—T & Silvex Cancellation) DOCKET #: 415 TITLE: Order Denying Dow’s Motion for Production of Documents DATE: April 2, 1981 PRESIDING OFFICIAL: Finch, Administrative Law Judge ABSTRACT: EPA bases its refusal to hand over document, requested by EPA from author after trial preparation was under- way and prepared at request of OGC, not app, on “work product” doctrine of Rule 26(b)(3). This rule protects documents prepared in anticipation of liti- gation. Release of docunuent would arguably reveal directly or indirectly mental impressions of EPA attorneys. Factual data in report available in the public literature. Hard to segregate factual material from opinions and conclusions. To overcome “work product” qualified immunity, Dow must show document contains evidence essential to the preparation of its case and not otherwise available. Stringent standard of good cause not shown here by Dow. CROSS REFERENCES: 40 CFR §164.51(a) ------- FRCP Rule 45 ------- REFERENCE: Federal Rules of Civil Procedure, Rule 45 CASE NAME: Dow Chemical Co. (2,4,5—T & Silvex Cancellation) DOCKET *: 415 TITLE: Order Granting in Part and Denying in Part Motion to Quash Subpoenas Duces Tecum Against Dr. Allen and Mr. Van Miller DATE: February 26, 1980 PRESIDING OFFICIAL: Finch, Administrative Law Judge ABSTRACT: Two incomplete studies involved. Order requires production. Overriding factor is desire of parties to have before them at outset any and all relevant evidence which might bear on final decision. Material involved here unquestionably relevant. No determina- tion yet as to its probative value. CROSS REFERENCES: ------- REFERENCE: Federal Rules of Civil Procedure, Rule 45 •CASE NAME: Dow Chemical Co. (2,4,5—T & Silvex Cancellation) DOCKET #: 415 TITLE: Order Granting in Part and Denying in Part Motion for Compulsory Document Production Against Dr. James Allen DATE: February 1, 1980 PRESIDING pFFICIAL: Finch, Administrative Law Judge ABSTRACT: Subpoenas issued pursuant to 40 CFR §164.70 which states AU shall be guided by Federal Rules of Civil Procedures. In spirit of Rule 45 FRCP, AU will entertain motion to quash or modify if filed timely and contains specific statements as listed in Order. Issuance of subpoenas not considered as precedent for discovery. Uncertainties are the overriding factor. Motion for Compulsory Document Production as to one study denied since study was nonsubstantive as to probative value. CROSS REFERENCES: 40 CFR §164.70 FIFRA §6(d) (Subpoenas) ------- FRCP Rule 65(a)(2) ------- REFERENCE: FRCP Rule 65(a)(2) CASE NAME: DBCP Cancellation DOCKET #: 401 TITLE: Dismissal of Appeal of Order Denying Motion to Disqualify DATE: April 7, 1980 PRESIDING OFFICIAL: Douglas Costle, Administrator ABSTRACT: Any evidence received upon an application for a preliminary injunction which would be admissible upon the trial on the merits becomes a part of the record on the trial and need not be repeated upon the trial. CROSS REFERENCES: 40 CFR §164.81 ------- ADMINISTRATIVE PROCEDURE ACT ------- APA, 5 U.s.c. §500 et seq. ------- REFERENCE: Administrative Procedure Act, 5 U.S.C. §500 et seq. (Informal rulemaking) CASE NAME: S. W. Cowley & Sons Mfg. Co. (arsenic trioxide) DOCKET #: 341 TITLE: Initial Decision DATE: May 28, 1976 PRESIDING OFFICIAL: Finch, Administrative Law Judge ABSTRACT: Issue is whether old FIFRA was self—implementing and therefore not subject to APA rulemaking procedures. Does EPA’S attempt to enforce subject test methods constitute informal rulemaking? Held: it does constitute informal rulemaking and since Administrator did not comply with requirements of APA that he permit public participation and accept data and other comments from interested parties, Notice of Intent to Cancel should be vacated. CROSS REFERENCES: ------- APA, 5 U.S.C. ------- REFERENCE: Administrative Procedure Act, §553 CASE NAME: S. W. Cowley & Sons Mfg. Co. (arsenic trioxide) DOCKET #: 341 TITLE: Order of Remand DATE: July 27, 1976 PRESIDING OFFICIAL: Russell Train, Administrator ABSTRACT: Here 90% mortality was challengable and challenged and was not the only issue regarding Registrant’s product. 90% standard was not used as a legal standard with which registrant was forced to comply. Rulemaking vs. adjudication under APA not the issue here. Registrant was afforded full procedural rights of adjudication under APA. Cases relied on by AU do not preclude an agency from enforcing a proposed standard through case—by—case adjudication under APA as long as the reasonableness and appropriateness of such standard are at issue in each adjudication. While rulemaking may be preferable to adjudication for issues such as the 90% standard, an agency’s choice to proceed through adjudication does not render its action statutorily or constitutionally infirm. Choice is within discretion of the agency. Therefore Initial Decision reversed and remanded to AU with instructions to determine on merits whether Registrant has satisfied its burden of showing efficacy. CROSS REFERENCES: ------- REFERENCE: Administrative Procedure Act, 5 U.S.C. §553 CASE NAME: S. W. Cowley & Sons Mfg. Co. (arsenic trioxide) DOCKET #: 341 TITLE: Initial Decision DATE: May 28, 1976 PRESIDING OFFICIAL: Finch, Administrative Law Judge ABST ACT: (1) Reasonable and proper for EPA to establish test methods for determining efficacy, (2) Such tests necessary to proper administration of F I F RA, (3) These test methods must be established on basis of lab techniques which simulate field condi- tions, (4) Test methods must be established and promulgated under informal rulemaking requirements of APA §553, (5) Procedures are presently being utilized by EPA to establish test methods for acute rat liquid bait in compliance with APA, and (6) Test methods which form basis of intent to cancel were not established under informal rulemaking requirements of APA and are therefore invalid and unenforceable. (Decision reversed on other grounds by Administrator——see Order on Remand, 7/27/76). CROSS REFERENCES: 40 CFR S162.8 (Test methods) ------- REFERENCE: Administrative Procedure Act, 5 U.S.C. §553 (Rulemaking vs. adjudication) CASE NAME: S. W. Cowley & Sons Mfg. Co. (arsenic trioxide) DOCKET #: 341 TITLE: Initial Decision DATE: May 28, 1976 PRESIDING OFFICIAL: Finch, Administrative Law Judge ABSTRACT: As general proposition, administrative rulemaking must permit some public participation in decision— making and in generalized way it must articulate its bases and purposes. Distinction between individual adjudication (concerned with determina- tion of liabilities of parties) and rulemaking (prescription of law to effect broad policy concerns). This case not within informed discretion of Agency, i.e., to proceed either by adjudication of rulemaking. AU distinguishes decision in S.E.C. v. Chenerery Corp . since EPA has proposed test methods or proto- cols in the Federal Register. Establishment of test methods to determine efficacy is rulemaking as is determination as to reasonableness and appropriate- ness of test methods. Public participation and record necessary; otherwise administrative agencies would nullify federal courts’ function of admini- strative review. AU discusses leading cases in point re adjudication vs. rulemaking. “Rule” in dispute here is substantive. APA compliance is prerequisite to enforceability. CROSS REFERENCES: ------- REFERENCE: Administrative Procedure Act, 5 U.S.C. §553 et seq. CASE NAME: S. W. Cowley & Sons Mfg. Co. (arsenic trioxide) DOCKET #: 341 TITLE: Initial Decision DATE: May 28, 1976 PRESIDING OFFICIAL: Finch, Administrative Law Judge ABSTRACT: Issue is whether old FIFRA (pre—1972) was self— implementing and, therefore, administrative due process was served by notice and hearing before AU (i.e, guidelines or criteria for classification or registration not required). CROSS REFERENCES: ------- APA, 5 U.s.c. §553(b) ------- REFERENCE: Administrative Procedure Act, 5 U.S.C. §553(b)(a) CASE NAME: DBCP Suspension DOCKET #: 485 - TITLE: Denial of Petition for Withdrawal of Suspension Notice DATE: September 10, 1979 PRESIDING OFFICIAL: Douglas M. Costle, Administrator ABSTRACT: Change re intervention is procedural and prior notice and comment rulemaking is not required by APA, 5 U.S.C. §553(b) (a). CROSS REFERENCES: ------- 5 U.S.C. §554 ------- REFERENCE: Administrative Procedure Act, 5 U.S.C §554(b) CASE NAME: Environmental Defense Fund (Chlorobenzilate) DOCKET #: 411—414 TITLE: Final Decision DATE: August 23, 1979 PRESIDING OFFICIAL: Douglas Costle, Administrator ABSTRACT: Purpose of notice is to inform registrant of what action agency intends to take (not what action EDF intends to take). CROSS REFERENCES: FIFRA §6(b) (Purpose of notice) ------- APA, 5 U.S.C. §554(d, ------- REFERENCE: Administrative Procedure Act, 5 U.S.C. §554(d) CASE NAME: Shell Chemical Co. (Aldrin/Dieldrin Cancellation) - DOCKET #: 145 TITLE: Recommended Decision DATE: September 20, 1974 PRESIDING OFFICIAL: Penman, Administrative Law Judge ABSTRACT: Suspension proceedings are not but a phase or part of the cancellation proceedings, even though Notice to Suspend based largely upon evidence adduced in cancel- lation hearing. Does not violate 5 U.S.C. 554(d) (APA). CROSS REFERENCES: FIFRA §6(c) ------- REFERENCE: Administrative Procedure Act, 5 U.S.C. §554(d) CASE NAME: Shell Chemical Co. (Aldrin/Dieldrirt Cancellation) DOCKET #: 145 TITLE: Recommended Decision DATE: September 20, 1974 PRESIDING OFFICIAL: Penman, Administrative Law Judge ABSTRACT: Requires separation of adjudicatory and prosecutorial functions in an agency, but does not prohibit combination thereof in determination as to whether a proceeding should be initiated. CROSS REFERENCES: ------- APA, 5 U.S.C. §556(c) ------- REFERENCE: Administrative Procedure Act, 5 U.S.C. §556(c)(5) CASE NAME: DBCP Suspension DOCKET #: 485 TITLE: Suspension Order and Final Decision DATE: October 29, 1979 PRESIDING OFFICIAL: Douglas Costle, Administrator ABSTRACT: Question is whether bifurcation of proceeding into risks and benefits resulted in exclusion of important evidence. 5 U.S.C. §556(c)(5) gives presiding officer power to regulate course of the hearing, including bifurcation. Held: no error. Standard would be stricter in cancellation proceeding than in suspension proceeding which is expedited in nature. CROSS REFERENCES: 40 CFR §164.40(d) ------- APA, 5 U.s.c. §556(d) ------- REFERENCE: Administrative Procedure Act, 5 U.S.C. §556(d) CASE NAME: S. W. Cowley & Sons Mfg. Co. (arsenth trioxide) DOCKET #: 341 TITLE: Order Cancelling Registration DATE: October 28, 1976 PRESIDING OFFICIAL: Russell Train, Administrator ABSTRACT: Placing burden of persuasion on registrant is proper and does not violate registrants’ right to due process or violate APA §556(d). CROSS REFERENCES: 40 CFR §164.80(b) ------- APA, 5 U.S.C. §556(e) ------- REFERENCE: Administrative Procedure Act, 5 U.S.C. §556(e) CASE NAME: S. W. Cowley & Sons Mfg. Co. (arsenic trioxide) DOCKET #: 341 TITLE: Order Cancelling Registration DATE: October 28, 1976 PRESIDING OFFICIAL: Russell Train, Administrator ABSTRACT: Reports of tests performed under the supervision of a testifying expert are admissible in administrative hearings. Any oral or documentary evidence may be received but the agency, as a matter of policy, shall provide for exclusion of irrelevant, immaterial, or unduly repetitious evidence. CROSS REFERENCES: ------- APA, 5 U.S.C. § 5 5 7 (c) ------- REFERENCE: Administrative Procedure Act, 5 U.S.C. §557(c) CASE NAME: DBCP Suspension DOCKET #: 485 TITLE: Suspension Order and Final Decision DATE: October 29, 1979 PRESIDING OFFICIAL: Douglas Costle, Administrator ABSTRACT: 5 U.S.C. §557(c) and 40 CFR §164.121(j) require that Recommended Decision include statement of findings and conclusions. Held: presiding officer’s “narrative” discussion meets this requirement. Purposes of findings and conclusions is to advise parties and reviewing court of basis for decision. “Narrative” not precluded. CROSS REFERENCES: 40 CFR 164.121(j) ------- APA, 5 U.S.c. § 5 5 8 (c) ------- REFERENCE: Administrative Procedure Act, 5 U.S.C. §558(c) CASE NAME: Mason Chemical Co., Bio-Lab, Salsbury Labs (Science Products, Inc.) DOCKET #: 245 (Including Nos. 296, 297, 298) -TITLE: Initial Decision re QAC DATE: May 19, 1975 PRESIDING OFFICIAL: Denniston, Administrative Law Judge ABSTRACT: While it need not here be determined, there is a question whether APA does not require the continued registration pending consideration of the tolerance petition. CROSS REFERENCES: ------- APA, 5 U.S.C. §704 ------- REFERENCE: Administrative Procedure Act, 5 U.S.C. §704 CASE NAME: Environmental Defense Fund (Chlorobenzilate) DOCKET #: 411—414 TITLE: Final Decision DATE: August 23, 1979 PRESIDING OFFICIAL: Douglas Costle, Administrator ABSTRACT: Administrator’s refusal to impose unconditional cancellation on citrus uses of chlorobenzilate once finalized (after exhausting available administrative remedies) amounts to 1t final agency action” within terms of APA (5 U.S.C. §704) and is judicially review— able under §16 of FIFRA. CROSS REFERENCES: FIFRA §16 ------- APA, 5 U.S.C. §705 ------- REFERENCE: Administrative Procedure Act, 5 U.S.C. §705 CASE NAME: S. W. Cowley & Sons Mfg. Co. (arsenic trioxide) DOCKET #: 341 TITLE: Stay of Order Cancelling Registration DATE: November 11, 1976 PRESIDING OFFICIAL: Harriet Marple, Judicial Officer ABSTRACT: When an agency finds that justice so requires, it may postpone the effective date of action taken by it, pending judicial review. Four tests for issuance of a stay ( Virginia Petroleum Jobbers Ass’n V. FPC) : (1) has petitioner made strong showing it is likely to prevail on appeal, (2) showing that without such relief there will be irreparable harm, (3) would issuance of stay substantially harm other parties? and (4) where does the public interest lie? Based on showing of irreparable harm (even though case on appeal is weak), stay granted. CROSS REFERENCES: ------- APA, 5 u.s.c. §3105 ------- REFERENCE: Administrative Procedure Act, 5 U.S.C. §3105 CASE NAME: Velsicol Chem. Co. (Heptachlor/Chlordane Suspension) DOCKET #: 384 TITLE: Notice of Denial of Request for Interlocutory Review and Reconsideration By the Administrator DATE: October 2, 1975 PRESIDING OFFICIAL: Russell E. Train, Administrator ABSTRACT: Velsicol objects to appointment of Judge Penman as presiding officer in suspension because of his role in H/C cancellation and aldrin/dieldnin suspension and also claims failure to rotate AU’s. Reconsidera- tion of appointment of Judge Penman denied. Makes good sense to use Penman because he has benefit of experience in H/C cancellation. CROSS REFERENCES: 40 CFR §164.40 ------- REFERENCE: Administrative Procedure Act, 5 USC §3105 CASE NAME: Velsicol Chemical Corp. (Heptachior/Chiordane) DOCKET #: 336 TITLE: Notice of Denial of Request for Interlocutory Review and Reconsideration by the Administrator DATE: October 2, 1975 PRESIDING OFFICIAL: Russell Train, Administrator ABSTRACT: Velsicol claims EPA has violated provision of Administrative Procedure Act and its regulations which require that AU’s be assigned cases in rotation so far as practicable. CROSS REFERENCES: 40 CFR §164.121(b) 5 CFR §930.212 ------- FOOD, DRUG, AND COSMETIC ACT ------- FDCA 4O2 ------- REFERENCE: FDCA §402 CASE NAME: Dexol Industries DOCKET #: 255 TITLE: Recommended Order of Dismissal DATE: March 22, 1973 PRESIDING OFFICIAL: Penman, Administrative Law Judge ABSTRACT: Pesticide chemical which is defined as unsafe under FDCA, the use of which on raw agricultural commodities results in adulteration is a violation of FIFRA §2(q)(l)(F). CROSS REFERENCES: FIFRA §2(q)(1)(F) FIFRA §12(a)(1)(E) ------- FDCA §402(a) ------- REFERENCE: FDCA §402(a)(1) CASE NAME: Dexol Industries DOCKET #: 255 TITLE: Recommended Order of Dismissal DATE: March 22, 1973 PRESIDING OFFICIAL: Penman, Administrative Law Judge ABSTRACT: Pesticide chemicals which cause adulteration of food under FDCA when used as directed are not per se misbranded and therefore, issues of fact in this regard may be raised in this forum ( Continental Chemiste Corp. v. Ruckeishaus) . This case distin- guished from Continental Chemiste on the facts and therefore respondent’s Motion for Summary Entry of a Recommended Decision Affirming Cancellation granted. CROSS REFERENCES: FIFRA S2(q) FIFRA §12(a)(1)(E) ------- REFERENCE: FDCA §402(a)(2)(B) CASE NAME: Dexol Industries DOCKET #: 255 TITLE: Recommended Order of Dismissal DATE: March 22, 1973 PRESIDING OFFICIAL: Penman, Administrative Law Judge ABSTRACT: Provides a food is adulturated if it is a raw agricultural commodity and bears or contains a pesticide chemical which is unsafe within meaning of §408(a). CROSS REFERENCES: FDCA §408(a) ------- FDCA §406 ------- REFERENCE: FDCA §406 CASE NAME: Shell Chemical Co. (Aldrin/Dieldrin Cancellation) DOCKET #: 145 TITLE: Order Partially Granting Motion DATE: July 24, 1973 PRESIDING OFFICIAL: Penman, Administrative Law Judge ABSTRACT: Proceeding divided into two phases: 1) consideration of uses, including risks and benefits; 2) considera- tion of tolerances by Administrator after cancellation decision made. Such a procedure avoids duplication of evidence since §406 only applies if there is a cancellation. Previous order of Administrator had consolidated tolerance (rulemaking) proceeding into cancellation (adjudicatory) proceedings. Bifurcation insulates at least FIFRA cancellation proceedings from possible serious procedural questions. Persons concerned with tolerances will have opportunity to participate in registration segment of this proceeding as it relates to tolerances. CROSS REFERENCES FDCA §408 40 CFR Part 180 FIfRA §6(b) (Relation to FDCA) ------- FDCA §408 ------- REFERENCE: _FD.CA §4-Q8 (Zero tolerance) CASE NAME: Bio—Labs Inc. (Consolidated into #245) DOCKET #: 297 TITLE: Initial Decision DATE: May 19, 1975 PRESIDING OFFICIAL: Dennistort, Administrative Law Judge ABSTRACT: No residue—zero tolerance phase out issue (PR Notice 72—4). “No fault” clause. Bio—Labs found not to be at fault for delay in issuance of tolerance and therefore proceeding for cancellation dismissed. CROSS REFERENCES: FIFRA §6(b) (Relationship to FDCA §408) ------- REFERENCE: FDCA §408 CASE NAME: Bio—Labs Inc. (Consolidated into #245) DOCKET #: 297 TITLE: Initial Decision DATE: May 19, 1975 PRESIDING OFFICIAL: Denniston, Administrative Law Judge ABSTRACT: While FDCA S408 ostensibily relates only to additives for “raw agricultural conunodities,” the Administrator has asserted authority by regulation to pesticides purposely added to poultry drinking water. CROSS REFERENCES: 40 CFR §180.6(c) ------- REFERENCE: FDCA §408 CASE NAME: Mason Chemical Co., Bio—Lab, Saisbury Labs (Science Products, Inc.) DOCKET #: 245 (Including Nos. 296, 297, 298) TITLE: Initial Decision Re QAC DATE: May 19, 1975 PRESIDING OFFICIAL: Denniston, Administrative Law Judge ABSTRACT: While FDCA §408 ostensibly relates only to additives for “raw agricultural commodity” the Administrator has asserted authority by regulation to pesticides purposely added to poultry drinking water. CROSS REFERENCES: 40 CFR §180.6(c) ------- REFERENCE: FDCA §408 CASE NAME: Science Products Co. et al. ( Zero Tolerance) DOCKET #: 245 TITLE: Report of Prehearing Conference and Order DATE: November 27, 1974 PRESIDING OFFICIAL: Denniston, Administrative Law Judge ABSTRACT: Requires Administrator to act within 90 days of issuance of certificate of usefulness. CROSS REFERENCES: 40 CFR §180.7(d) ------- REFERENCE: FDCA §408 CASE NAME: Science Products Co. et al. (Zero Tolerance) DOCKET #: 245 TITLE: Order Denying Motions to Dismiss DATE: November 1, 1974 PRESIDING OFFICIAL: Dennis€on, Administrative Law Judge ABSTRACT: This proceeding may not be utilized to determine what might be safe or acceptable limits of residue. §408 is the vehicle for that purpose. In this pro- ceeding if any residues are shown to be likely, by operation of law the product violates FIFRA and cancellation may result. CROSS REFERENCES: FIFRA §6(b) (Relationship to FDCA §408) ------- REFERENCE: FDCA §408 CASE NAME: Science Products Co. et al. (Zero Tolerance) DOCKET #: 245 TITLE: Order Denying Motions to Dismiss DATE: November 1, 1974 PRESIDING OFFICIAL: Denniston, Administrative Law Judge ABSTRACT: Closely related; but each represents a separate portion of the statutory scheme and each is governed by separate rules of procedure. Registrants may not forestall operation of cancellation provisions of FIFRA merely because they have succeeded in frustrating conclusive action on their tolerance petitions. CROSS REFERENCES: FIFRA §6(b) (Relationship to FDCA §408) ------- REFERENCE: FDCA §408 CASE NAME: Science Products Co. et al. (Zero Tolerance) DOCKET #: 245 TITLE: Order Denying Motions to Dismiss DATE: November 1, 1974 PRESIDING OFFICIAL: Denniston, Administrative Law Judge ABSTRACT: Case involves registered uses for which no tolerances have been established. Registration of enumerated substances and indicated usages were directed to be cancelled unless all directions for such usages were deleted from labels. U.S. v. Ewig Bros . held that any pesticide chemicals used on raw agricultural commodities are declared “unsafe” under §408 unless exempted or used within prescribed tolerance limits (same conclusion as Dexol) . CROSS REFERENCES: FIFRA §6(b) (Relationship to FDCA §408) ------- REFERENCE: FDCA §408 CASE NAME: Science Products Co. et al. (Zero Tolerance) DOCKET #: 245 TITLE: Order Denying Motions to Dismiss DATE: November 1, 1974 PRESIDING OFFICIAL: Denniston, Administrative Law Judge ABSTRACT: Found close relationship between §408 of FDCA and FIFRA. Registration cancelled. Question whether Dexol is applicable to current cases (Docket #245). Dexol agrees with holding in U.S. V. Ewig Bros . CROSS REFERENCES: FIFRA §6(b) (Relationship to FDCA §408) ------- REFERENCE: FDCA §408 (Zero tolerance) CASE NAME: Scjence Products Co. et al. (Zero Tolerance) DOCKET #: 245 TITLE: Order Denying Motions to Dismiss DATE: November 1, 1974 PRESIDING OFFICIAL: Denniston, Administrative Law Judge ABSTRACT: Allowed continuation of registration for pesticide use patterns accepted on a “no residue” or “zero tolerance” basis pending petitions for finite tolerances where lack of established tolerances not the fault of petitioners. Series of PR Notices phasing out no residue or zero tolerance registrations. “No fault” saving clause not applicable since fault for non—completion of these tolerance petitions lies with petitioners. CROSS REFERENCES: FIFRA §6(b) (Zero tolerance) ------- REFERENCE: FDCA §408 CASE NAME: Science Products Co. et al. (Zero Tolerance) DOCKET #: 245 TITLE: Order Denying Motions to Dismiss DATE: November 1, 1974 PRESIDING OFFICIAL: Denniston, Administrative Law Judge ABSTRACT: As a matter of law, use of any pesticide chemical for which no tolerances have been established under §408 of FDCA is deemed unsafe, and that as to any product containing it, “misbranding” necessarily results under FIFRA §2(q)(l)(F). CROSS REFERENCES: FIFRA §2(q)(l)(F) ------- REFERENCE: FDCA §408 CASE NAME: Shell Chemical Co. (Aldrin/Dieldrin Cancellation) DOCKET #: 145 TITLE: Order Partially Granting Motion DATE: July 24, 1973 PRESIDING OFFICIAL: Penman, Administrative Law Judge ABSTRACT: Proceeding divided into two phases: 1) consideration of uses, including risks and benefits; 2) considera- tion of tolerances by Administrator after cancellation decision made. Such a procedure avoids duplication of evidence since §406 only applies if there is a cancellation. Previous order of Administrator had consolidated tolerance (rulemaking) proceeding into cancellation (adjudicatory) proceedings. Bifurcation insulates at least FIFRA cancellation proceedings from possible serious procedural questions. Persons concerned with tolerances will have opportunity to participate in registration segment of this proceeding as it relates to tolerances. CROSS REFERENCES: FDCA 406 40 CFR Part 180 FIFRA §6(b) (Relation to FDCA) ------- REFERENCE: FDCA §408 CASE NAME: Dexol Industries DOCKET #: 255 TITLE: Recommended Order of Dismissal DATE: March 22, 1973 PRESIDING OFFICIAL: Penman, Administrative Law Judge ABSTRACT: Two related statutes should, whenever possible, be blended to reinforce their common purpose. Congressional intent that issuance or continuance of a tolerance under FDCA would usually be a con- dition precedent to issuance or continuance of a registration under FIFRA. Registrant cannot do indirectly (through registration) what he failed to do directly (get a tolerance established). CROSS REFERENCES: FIFRA §6(b) (Relationship to FCDA §408) ------- REFERENCE: FDCA §408 (Claim of Financial Inability to Obtain Residue Tolerance) CASE NAME: Dexol Industries DOCKET #: 255 TITLE: Recommended Order of Dismissal DATE: March 22, 1973 PRESIDING OFFICIAL: Penman, Administrative Law Judge ABSTRACT: Registrant’s claim of financial inability does not alter decision to cancel registration. CROSS REFERENCES: FIFRA §6(b) (No tolerance) ------- FDCA §408(a) ------- REFERENCE: FDCA §408(a) CASE NAME: Dexol Industries DOCKET #: 255 TITLE: Recommended Order of Dismissal DATE: March 22, 1973 PRESIDING OFFICIAL: Penman, Administrative Law Judge ABSTRACT: Provides a food is adulturated if it is a raw agricultural commodity and bears or contains a pesticide chemical which is unsafe within meaning of §408(a). CROSS REFERENCES: FDCA §402(a)(2)(B) ------- REFERENCE: FDCA §408(a) CASE NAME: Dexol Industries DOCKET #: 255 TITLE: Recommended Order of Dismissal DATE: March 22, 1973 PRESIDING OFFICIAL: Penman, Administrative Law Judge ABSTRACT: Requires establishment of tolerances. Contains procedures, standards and considerations different from and additional to those contained in FIFRA and a registration proceeding would not necessarily resolve or satisfy all of the necessary conditions for a residue tolerance under §408. CROSS REFERENCES: ------- REFERENCE: FDCA §408(d)(3) CASE NAME: Science Products Co. et al. (Zero Tolerance) DOCKET #: 245 TITLE: Order Denying Motions to Dismiss DATE: November 1, 1974 PRESIDING OFFICIAL: Denniston, Administrative Law Judge ABSTRACT: Right to an advisory committee under §408 of FDCA has not been restricted provided it has been exercised within 90 days after a certificate of usefulness has been issued. CROSS REFERENCES: ------- FDCA §409 ------- REFERENCE: FDCA, §409 (Delaney Amendment) CASE NAME: Shell Chemical Co. (Aldrin/Dieldrin Cancellation) DOCKET #: 145 TITLE: Recommended Decision DATE: September 20, 1974 PRESIDING OFFICIAL: Penman, Administrative Law Judge ABSTRACT: Delaney Amendment indicates magnitude of Congressional concern about carcinogens and places heavy burden on Administrative Officer to explain basis for decision to permit use of chemical known to produce cancer in test animals. CROSS REFERENCES: ------- FDCA $409(c) ------- REFERENCE: FDC.AS409(c)(3)(A) (Delaney Amendment) CASE NAME: Shell Chemical Co. (Aldrin/Dieldrin Suspension) DOCKET #: 145 TITLE: Opinion of the Administrator and Order DATE: October 1, 1974 PRESIDING OFFICIAL: Russell E. Train, Administrator ABSTRACT: Administrator, in deciding to suspend, is obliged to follow Congressional policy of keeping carcinogens out of the food supply. Although pesticides are not “food additives” under Delaney amendment, it does indicate Congressional concern. Pesticide residues in processed foods are “food additives” within meaning of other sections of FDCA. Since Delaney Amendment does prohibit setting of tolerances of carcinogenic food additivies, and since aldrin/dieldrin is present as residue in processed foods, Administrator has particular burden to explain decision permitting continued use of a chemical known to be carcinogenic in laboratory animals. CROSS REFERENCES: ------- 40 CFR PART 167 ------- OTHER ------- REFERENCE: Stare Decisis CASE NAME: Environmental Defense Fund (Chlorobenzilate) DOCKET #: 411—414 TITLE: Accelerated Decision DATE: May 22, 1979 PRESIDING OFFICIAL: Penman, Administrative Law Judge ABSTRACT: Administrator bound by stare decisis to follow recent holding in Shell case that complaint or objections contesting failure of a notice of conditional cancellation to go farther may not be heard in a proceeding under §6(b)(1). CROSS REFERENCES: 40 CFR §164.91(a)(6) ------- REFERENCE: Stare decisis CASE NAME: Velsicol Chemical Corp. (Heptachior/Chiordane) DOCKET #: 336 TITLE: Order Denying Motion DATE: June 24, 1975 PRESIDING OFFICIAL: Penman, Administrative Law Judge ABSTRACT: Velsicol’s motion filed within framework and background of other FIFRA cases involving issue of chemical carcinogenesis. EPA’s “principles” were utilized and fashioned in these prior proceedings. The doctrine of stare decisis to extent applicable is as appropriate to the decisions of the Administrator under the Act as it is to decisions in other administrative agencies. CROSS REFERENCES: ------- REFERENCE: Carcinogen Policy CASE NAME: Mirex DOCKET #: 293 TITLE: Administrator’s Decision on Interlocutory Appeal Affirming Denial of Respondent’s Request to Take Official Notice DATE: April 22, 1976 PRESIDING OFFICIAL: Russell Train, Administrator ABSTRACT: Administrator comments on commitment to basic cancer policy principles like extrapolation from animal data, malignant vs. benign tumors, and “no effect” levels. CROSS REFERENCES: 40 CFR §162.l1(a)(3)(ii) ------- REFERENCE: Carcinogen Policy CASE NAME: Velsicol Chemical Corp. (Heptachlor/Chlordane) DOCKET #: 336 TITLE: Notice of Intent to Suspend and Findings of Imminent Hazard Posed by Registrations of Pesticides Containing Heptachior or Chlordane DATE: August 1, 1975 PRESIDING OFFICIAL: Russell Train, Administrator ABSTRACT: Sets forth bases for evaluating carcinogenicity of pesticides. Positive oncogenic effect in test animals sufficient to characterize a pesticide as posing a cancer risk to man. Negative results have only limited significance. No scientific basis exists for establishing a no effect level for carcinogens. Distinction between benign and malignant tumors not meaningful in determining cancer hazard to men on basis of tests conducted on laboratory animals. As to benefits, because of expected and provisional nature of suspension process, it is not necessary to explore all available information on alternative pest control methods to same degree as in cancellation proceedings. Responsibility to show benefits of continued registra- tion during cancellation proceeding outweigh risks is on proponents of continued registration. CROSS REFERENCES: 40 CFR §162.l1(a)(3)(ii)(A) 40 CFR S164.l21(c) ------- REFERENCE: Dismissal with prejudice CASE NAME: Stevens Industries, Inc., et al. (DDT) DOCKET #: 63 TITLE: Order Denying Motion DATE: January 16, 1973 PRESIDING OFFICIAL: Penman, Administrative Law Judge ABSTRACT: Dismissal with prejudice is a drastic sanction to be applied only in extreme situations and is not warranted herein (failure of registrant to supply witness list). CROSS REFERENCES: 40 CFR §164.50 ------- REFERENCE: Deference to AU findings CASE NAME: Stevens Industries, Inc., et al. (DDT) DOCKET #: 63 TITLE: Opinion of the Administrator and Order DATE: June 14, 1972 PRESIDING OFFICIAL: William D. Ruckleshaus, Administrator ABSTRACT: Nowhere does Examiner state his conclusions are based on credibility choices. Whatever extra weight that might be due findings based on credi- bility, judgment is not appropriate in this case. Agency is free to make its own findings and Examiner’s findings and report only comprise part of the record which a court will then evaluate. CROSS REFERENCE: 40 CFR §164.103 40 CFR §164.81(a) (Credibility of witnesses) ------- REFERENCE: Orders Adding Use Requirements Beyond Labelling CASE NAME: Mirex DOCKET #: 293 TITLE: Order DATE: March 1, 1974 PRESIDING OFFICIAL: John R. Quarles, Deputy Administrator ABSTRACT: Orders restricting use during §6(b)(2) hearing. Extends order permitting USDA’s Mirex spray application program and monitoring for data on aquatic hazards. Includes conditions beyond labelling regarding pilot actions, required USDA findings before spraying, acreage limitations and surveillance, including EPA monitors. CROSS REFERENCES: FIFRA §6(b)(2) ------- REFERENCE: Lay Testimony CASE NAME: Mirex DOCKET #: 293 TITLE: Order DATE: August 20, 1975 PRESIDING OFFICIAL: D. Harris, Administrative Law Judge ABSTRACT: Order holds that testimony of 672 lay witnesses with personal Mirex experiences is not cumulative and repetitious of expert testimony and should not be excluded. CROSS REFERENCES: ------- REFERENCE: Burden of Proof on Alternatives CASE NAME: Chapman Chem. Co. (Mercury) DOCKET #: 246 TITLE: Ruling With Respect to Rebuttal Evidence On Substitutes DATE: July 2, 1975 PRESIDING OFFICIAL: Levinson, Administrative Law Judge ABSTRACT: Registrants entitled to opportunity to present rebuttal evidence regarding substitutes listed in Respondent’s Notice of Substitutes. . .“ Cites Administrator’s Opinion in Stevens Industries (Docket #63) re burden of proof. No previous opportunity for adequate rebuttal. Scope of rebuttal as defined in Stevens Opinion. Registrants may choose to show non—viability of alternatives and non—desirability (or risk) of alternatives. CROSS REFERENCES: 40 CFR §164.80 ------- REFERENCE: Burden of Proof on Alternatives CASE NAME: Chapman Chem. Co. (Mercury) DOCKET #: 246 TITLE: Order to File DATE: May 30, 1975 PRESIDING OFFICIAL: Levinson, Administrative Law Judge ABSTRACT: Respondent has not made clear its position regarding substitutes or alternatives to mercurial pesticides. Ordered to do so and specifically address: (1) whether respondent is relying on fact preferable substitutes are available, (2) position re: respondent’s obliga- tion to show availability of substitutes, and (3) whether respondent as part of its affirmative case has offered evidence to show availability of all preferable substitutes or alternatives for each of the uses subject to the hearing, (4) respondent’s position regarding recommendations of substitutes. Cites Administrator s opinion re: burden of proof in Stevens Industries (Docket #63). CROSS REFERENCES: 40 CFR §164.80 ------- REFERENCE: Benefits in Suspension Proceedings CASE NAME: DBCP Suspension DOCKET #: 485 TITLE: Suspension Order and Final Decision DATE: October 29, 1979 PRESIDING OFFICIAL: Douglas Costle, Administrator ABSTRACT: As a matter of general principle, attentive consideration should be given to economic effects of suspension on individual growers and other microeconomic considerations to extent feasible in expedited hearing. However, heptachlor/chlordane precedent cited by USDA not controlling. Each suspension or cancellation proceeding is unique. Because of available information, DBCP cancellation proceeding should take less time than others. Therefore, suspension period will be shorter and losses will be less. Also, multiple risks involved here (in H/C only cancer risk involved). No exemption of minor uses. CROSS REFERENCES: ------- REFERENCE: Benefits in Suspension Proceedings CASE NAME: DBCP Suspension DOCKET #: 485 TITLE: Denial of Petition for Withdrawal of Suspension Notice DATE: September 10, 1979 PRESIDING OFFICIAL: Douglas M. Costle, Administrator ABSTRACT: Since California has indefinitely banned use of DBCP, unavailability of DBCP in California on an interim basis not a relevant consideration as to impact of suspension in California. Even if DBCP were available in California, risks would outweigh benefits. CROSS REFERENCES: ------- REFERENCE: Settlement CASE NAME: Velsicol Chemical Corp. (Heptachior/Chiordane) DOCKET #: 336 TITLE: Statement as to Basis for Settlement DATE: March 6, 1978 PRESIDING OFFICIAL: Douglas Costle, Administrator ABSTRACT: Results of negotiated settlement do not constitute findings by EPA or admissions by Registrants of allegations in Notice of Intent to Cancel. CROSS REFERENCES: ------- REFERENCE: Settlement CASE NAME: Mirex DOCKET #: 293 TITLE: Administrator’s Decision to Accept Plan of Mississippi Authority and Order Suspending Hearing DATE: October 20, 1976 PRESIDING OFFICIAL: Russell Train, Administrator ABSTRACT: Order accepting plan cancelling all end—use registrations of Mirex and suspending hearing. CROSS REFERENCES: ------- REFERENCE: Existing Stocks CASE NAME: Chapman Chem. Co. (Mercury) DOCKET #: 246 TITLE: Decision of the Administrator and Order DATE: February 17, 1976 PRESIDING OFFICIAL: Russell Train, Administrator ABSTRACT: Sale and use of mercury compounds cancelled herein which are formulated into products on or before date of D&O shall be permitted in view of enormous diff i— culties which would be involved in collecting and disposing of them. CROSS REFERENCES: FIFRA §6(a)(1) ------- |