Document xj0k8aGe2rq454E3o776xa1D6

PATTON BOGGS. L.L.P. 2550 M STREET. N.W. WASHINGTON. O.C. 20037-1350 (02) /liiV-eOOO rMtiHlil: (*0M7-UJI8 W*ITr*5 OIMKCT (202) 457-5270 November 21, 1994 MEMORANDUM FOR THE VINYL CHLORIDE PANEL Re: EPA Solicitation of Voluntary Testing Proposals for ATS PR Tost Rule During the conference call on November 7, it was agreed that the Panol would look more ciosoly at the option of offering to conduct reproductive and developmental toxicity studios of vinyl chloride to meet ATSDR's data needs, dim Barter agreed to give somo tnougnt to arguments for a one- as opposed to a two-species developmental study. At the same time, it was decided to investigate whether it might be possible to address certain neurotoxicity endpoints in a way that might also satisfy EPA. In this regard, it was agreed that Jim Knaak and Frank Hawk would look at how a reproductive toxicity study protocol might be modified to provide information relovant to neurotoxicity, and I was asked to learn moro about tho basis for the neurotoxicity study roquirement proposed by the EPA Air Office. After the conference coll, I spoke with Brian Riedel and Gary Timm about vinyl chloride. Riedel, as you know, is the EPA project manager for tho tost rule. Timm, who used to be in charge of the Test Rules Branch, has boon seconded to ORD to holp the Air Office como up with its data needs for the hazardous air pollutants. Timm indicated that, because ATSDR's referral was received first by OPPT, the Air Office needs for those chemicals were added to the ATSDR test rule proposal. Apparently, tho Air Office needs were not very well researched, and it was decided that the Air Office needed assistance from ORD. Timm said that there is no question about the acute toxicity of vinyl chloride, but there were certain questions as to its neurotoxicity. He was not able to toll mo more than this. He said that he would need to consult with Bob McPhail and Kevin Crofton (who are I believe with ORD at Research Triangle Pork), and that they would need to get "up to speed" before talking to us. Timm indicated that he thought it mado sonsc to sit down and talk about these issues before any kind of tosting program was submitted, as it might be possible to design a CMA 115608 PATTON BOGGS. L.L.P. 2- - subchronic study that could covor somo neurotoxicity endpoints without the need for a full neurotoxicity guidolinos study. Both Timm and Riedel said that, since EPA's solicitation of testing proposals for the ATSDR data needs was published on September 30, there has been somo rothinking at EPA as to the respective roles of EPA and ATSDR with regard to voluntary testing programs. In particular, Timm indicated that EPA is sonsilive to the problem that would be posed for ATSDR if the public were to perceive that there is no point in participating in the ATSDR voluntary testing program. I also spoko with Bill Cibulas, the ATSDR Research Implementation Branch Chiof. I told Cibulas that I did not think the Panol would bo able at this time to offer anything more specific than an intent to moot with scientists from ATSDR and EPA in the first half of Dccomber to learn more about the needs of oach agency and to discuss a voluntary tosting program that might be acceptable to all sidos. Last week, Cibulas told me that, as a result of discussions with EPA and the affected industry, ATSDR and EPA had decided to issuo a policy stetement clarifying the respective roles of ATSDR and EPA in connection with voluntary testing of four of the chemicals that were referred to EPA by ATSDR including vinyl chloride. The effect of this policy statement, a copy of which is attached, is to extend the deadline for developing testing programs with ATSDR. As a rosult of tho policy statement, the Panel will have the opportunity to try to dovolop a voluntary testing program that satisfies both ATSDR and EPA. Should this prove impossible, EPA rosorves tho right (as it did in the September 30 notice) to move forward with a tost rulo to roquiro the tosting identified in the notice. If it wishes to dp so, the Panol will need to indicate by November 29 its intent to enter into negotiations that would load to a memorandum of understanding (MOU) to fill at loast tho data needs identified by ATSDR being oxocutod by May 31, 1995. A draft response to the EPA solicitation notice is attached for your review. Submitting such a response will commit the Panel, in principle, to meeting the data noods identified by ATSDR for vinyl chloride by conducting Inhalation studies of reproductive and developmental toxicity, and to working with EPA to see if its need for nouroloxicity data can also be met as part of the voluntary testing program. The response also seeks to hold opon tho possibility of conducting whatever kind of neurotoxicity study might ultimately be agreed under an enforceable consent agroomont with EPA. It is a question of judgment whether the Panel should, in this response, put forward its proposal to conduct a ono-spocics as opposod to a two-species developmental study. I would prefer to avoid surprises but others may have a different view. CMA 115609 PATTON BOGGS, L.L.P, -3- Dan Kracov and I look forward to discussing this matter and the propos d response with you on a conference call later this wook. In any event, we will need your comments by Monday, November 28, so that the letter can be submitted by November 29. UL W. Caffey Norman, III Attachments CMA 115610 UNITED STATES BNVWCNMENTAl PROTECTION AGENCY WASHINGTON, O.C. 20460 NOV 18 1994 W. Caffey Norman, Esq. Patton, Boggs k Blow, L.L.P. 2550 M street, N.w. Washington, D.C- 20037 omceop pwvwoN.Nnaoawc TQQCKJMTANOS* Deer Mr. Fortran; in the interest of coordinating the processes and clarifying several issues associated with the voluntary research program of the Agency for Toxic Substances and Disease Registry (ATSDR) and the Enforceable Consent Agreement (ECA)/test rule program of the Environmental Protection. Agency (EPA), we have developed and plan to follow the approach outlined in the enclosed policy statement. As the policy indicates, the testing proposals under the ATSDR voluntary testing research program or under SPA'a ECA program must address all testing needs identified in the solicitation notice of September 30, 1994 or BPA intends to prcceed with a test rule to meet these needs. The chemical endpoints identified for testing in the solicitation notice are the product of a considerable amount of coordination among EPA programs and Federal Agencies. ATSDR and EPA strongly encourage submission of testing proposals under either program and look forward to working with you. Sincerely, Dr. Christopher DeRosa Director, Division of Toxicology Agency for Toxic 9ubstances and Disease Registry Enclosure Director, Chemical Control Division Environmental Protection Agency CMA115611 NOV \ 8 1991 Development and Finalization of Agreements-Under the Voluntary Research Program of the Agency for Toxic Substances and Disease Registry (ATSDR) versus Development and Submittal to the Environmental Protection Agency (EPA) of Proposals for Enforceable Consent Agreements (ECAs) in Response to EPA's 5/10/94 Notice of Solicitation Section 104 (i) of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) provides that ATSDR will develop a substance-specific research program to fill data needs identified for chemicals that are most commonly found at Superfund sites and that are posing the most significant potential threat to human health. Under CERCLA, section 104 (i) (5) (D), Congress contemplates that authorities under the Toxic Substances Control Act (TSCA) would be utilized to collect needed health effects data. In October, 1992, ATSDR referred 38 chemicals to EPA for testing under TSCA authorities. See Notice, Status of the Superfund Substance-Specific Applied Research Program, Federal Register. March 10, 1994 (59 FR 11434-11435). As required under CERCLA, section 104 (i), ATSDR's substance-specific research program was coordinated with testing programs under TSCA/Federal Insecticide, Fungicide, Rodenticide Act and with the National Toxicology Program. Such coordination was required "to avoid duplication of effort" and to assure that the chemicals are tested "thoroughly at the earliest practicable date." ATSDR also considered the recommendations of the Interagency Testing Committee established under TSCA, section 4(e) on the types of research to be done, as required under CERCLA. In addition, EPA considered and coordinated the data needs of its program offices and other Federal Agencies on these chemicals. Thus, the resulting list of chemicals and endpoints identified by EPA for testing under TSCA is the product of considerable coordination and represents the current federal testing priorities for these chemicals. On September 30, 1994, EPA published a notice in the Federal Reg:ster (59 FR 49934) soliciting testing proposals from manufacturers and processors that wish to participate in negotiations for an ECA on chemicals which ATSDR referred to EPA for testing under TSCA. These chemicals are vinyl chloride, benzene, trichloroethylene, tetrachloroethylene, hydrogen cyanide, sodium cyanide, toluene, methylene chloride, and chloroethane. CMA 115612 EPA understands that ATSDR is anticipating concluding voluntary agreements for testing of certain ch micals listed in the solicitation. ATSDR and EPA agree that the scope of each agency's testing program should be clearly defined. Accordingly, ATSDR and EPA have developed the following approach to meeting the identified testing priorities for the chemicals on the solicitation list: Application. This policy applies to development of testing proposals on methylene chloride, trichloroethylene, tetrachloroethylene, and vinyl chloride. Testing proposals for the other chemicals on the solicitation list will fall under the auspices of EPA's' testing program and will be governed by the procedures set forth in the solicitation notice. Methylene Chloride. The Halogenated Solvents Industry Alliance, Inc. (HSIA) has submitted a voluntary research proposal to ATSDR on methylene chloride and, as of this date, is revising the proposal to meet ATSDR's concerns. If HSIA concludes a Memorandum of Understanding (MOU) with ATSDR for voluntary testing of methylene chloride by December 30, 1994, ATSDR will within 30 days notify EPA of the specific testing included in the voluntary agreement. In considering whether to remove methylene chloride from the solicitation list EPA will consider whether the ATSDR voluntary research agreement addresses all testing needs identified in the solicitation notice. Pursuant to the process described in the solicitation notice, HSIA may submit a proposal to conduct testing of methylene chloride under an ECA for testing needs identified in the solicitation notice but not included under the voluntary research plan. HSIA may request a reasonable extension for such submission. If HSIA and ATSDR do not conclude a MOU on methylene chloride by December 30, 1994, EPA will proceed with development of an ECA or, if an acceptable response to the solicitation notice has not been received, with a test rule. Trichloroethylene. Tetrachloroethylene. and Vinyl Chloride. In order to participate in ATSDR's voluntary research program for trichloroethylene, tetrachloroethylene, or vinyl chloride, a party must submit, by November 29, 1994, a "statement of intent" to enter into a MOU with ATSDR for voluntary testing of trichloroethylene, tetrachloroethylene, or vinyl chloride. If a party and ATSDR conclude a MOU for voluntary testing of trichloroethylene, tetrachloroethylene, or vinyl chloride by May 31, 1995, ATSDR will within 30 days notify EPA of the specific testing included in the voluntary agreement. In considering whether to remove trichloroethylene, tetrachloroethylene, or vinyl chloride from the solicitation list EPA will consider whether the ATSDR research proposal addresses all testing needs identified in the solicitation notice. Pursuant to the process described in the solicitation notice, a party may submit a testing proposal to conduct testing of trichloroethylene, tetrachloroethylene, or vinyl chloride under an ECA for testing needs identified in the solicitation notice but not included CMA 115613 12:2 / 2022S0Sl$i +JTA/ v-.** under the voluntary research plan. A party may .request, a reaeoaabl extension for euch submission. If a party do s not submit a "statement of intent* by November 23, 1994, or does not enter into a MOU with ATSDR by May 31, 1995 ,K5A will proceed with development of an BCA or, if an acceptable response' to. the solicitation notice has not been received, with'a test nils. 10 V 1 0 4:24i??lf CMA 115614 Print T:ae Nov IS, PATTON BOGGS, L.L.P. 2550 M STREET, N.W. WASHINGTON, D.C. 20037-1350 (02) -457-6000 FACSIMILE'(202) 457-6315 WRITER'S DIRECT DIAL November 10, 1994 (202) 457-5270 MEMORANDUM FOR THE VINYL CHLORIDE PANEL Re: ATSDR Test Rule During the conference call on November 7, it was agreed that the Panel would look more closely at the option of offering to conduct reproductive and developmental toxicity studies of vinyl chloride to meet ATSDR's data needs, and to determine whether it might be possible to address certain neurotoxicity endpoints in a way that might also satisfy EPA. It was agreed that Jim Knaak and Frank Hawk would look at how a reproductive toxicity study protocol might be modified in this regard. I was asked to learn more about the basis for the neurotoxicity study requirement proposed by the EPA Air Office. I have now spoken with Brian Riedel and Gary Timm about vinyl chloride. Riedel, as you know, is the project manager for the test rule. Timm, who used to be in charge of the Test Rules Branch, has been seconded to ORD to help the Air Office come up with its data needs for the hazardous air pollutants. Timm indicated that, because ATSDR's referral was received first by OPPT, the Air Office needs for those chemicals were added to the ATSDR test rule proposal. Apparently, the Air Office needs were not very well researched, and it was decided that the Air Office needed assistance from ORD. Timm said that for vinyl chloride, there was no question about its acute toxicity, but there were certain questions about its neurotoxicity. He was not able to tell me more than this. He said that he would need to consult with Bob McPhail and Kevin Crofton, and that they would need to get "up to speed" before talking to us. Timm volunteered that he thought it made sense to sit down and talk about these issues before any kind of testing program was submitted, as it might be possible to design a CMA 115615 PATTON BOGGS, L.L.P. 2 subchronic study that could cover some neurotoxicity endpoints without the need for a full neurotoxicity guidelines study. Both Timm and Riedel indicated that, since the solicitation of testing proposals was published on September 30, there has been some rethinking at EPA as to the respective roles of EPA and ATSDR with regard to voluntary testing programs. In particular, Timm indicated that EPA is sensitive to the problem that would be posed for ATSDR if people were to perceive that they need not deal with ATSDR on voluntary proposals because they could submit proposals directly to EPA. Riedel suggested that a notice or memorandum of some kind may be issued shortly to clarify the role of EPA and ATSDR with regard to voluntary testing efforts. Timm indicated that it would not be possible to resolve all the scientific issues before November 29. I am hopeful that EPA will be able to clarify its position by next week. In the meantime, in light of the current uncertainty, I propose that the conference call be postponed until next week. Perhaps we will then have a better indication as to whether a response is necessary by November 29 and what the form of any such response should be. Both Timm and Bill Cibulas of ATSDR expressed interest in a meeting or conference call between representatives of the Panel, ATSDR, and EPA to discuss a voluntary testing program that would be acceptable to all sides. W. Caffey Norman, III CMA 115616 49934 Federal Register / VoL 59, No, 189 / Fnoay, Sepiemoer ju, / i^ouccs Table 2. -- Registrants Requesting Voluntary Cancellation epa Corn- pony No. Company Name and Address 000264 Rhone-Poulenc Ag Co.. Box 12014, Research Triangle Park, NC 27709. 000499 Whitmire Research Laboratories, Inc.. 3568 Tree CL, Industrial-Bivd, St Louis, MO 63122. 001864 002935 003125 004822 Central Petroleum Co., 1449 W. 117th St Cleveland, OH 44107. Witour Ellis Co.. 191 W. Shaw Ave., Fresno, CA 93704. For Distribution bv CM A Miles Inc., Agrioulture Division. 8400 Hawthorn RcL, Box 4913, Kansas City. MO 64120. CHiMSI>'\F. DIVTvr^"' S.C. Johnson 8 Son Inc., 1525 Howe Street. Racine. Wl 53403. From_i>OK ) fit 005905 008590 009444 Helena Chemical Co, 6075 Poplar Ave., Sutte 500, Menphts. TN 38119. Agway Inc., e/o Universal Cooperatives Inc., Box 460, Minneapolis, MN 55440. Watertxiry Companies Inc., Box 640, Independence. LA 70443. Ref No__________ n.-reO'-T 3. I <&U 035900 Ionics, Inc.. 3039 Washington Pike, Bridgeville, PA 15017. 037425 Smithkime Beecham Animal Health, 1600 Paoli Pike, West Chester, PA 19380. 044716 Fearing Mfg. Co Inc., 490 Viltaume Ave. So., St. Paul, MN 55075. 050534 ISK Biosciences Corp., 5966 Heisiey Rd.. Box 8000, Mentor, OH 44061. 059639 Valent U.S.A. Corp.. 1333 N. Ca&toma Btvd. Ste 600, Walnut Creek. CA 94596. 111. Procedures for Withdrawal of Request Registrants who choose to withdraw a request for cancellation must submit such withdrawal in writing to James A. Hollins, at the address given above, postmarked before December 29,1994. This written withdrawal of the request for cancellation will apply only to the applicable 6(f)(1) request listed in this notice. If the product(s) have been subject to a previous cancellation action, the effective date of cancellation and all other provisions of any earlier cancellation action are controlling. The withdrawal request must also include a commitment to pay any reregistration fees due, and to fulfill any applicable unsatisfied data requirements. TV. Provisions for Disposition of Existing Stocks The effective date of cancellation will be the date of the cancellation order. The orders effecting these requested cancellations will generally permit a registrant to sell or distribute existing stocks for 1-year after the date the cancellation request was received. This policy is in accordance with the Agency's statement of policy as prescribed in Federal Register No. 123, Vol. 56, dated June 26.1991. Exceptions to this general rule wiil be made if a product poses a risk concern, or is in noncompliance with reregistration requirements, or is subject to a data callin. In all cases, product-specific disposition dates will be given in the cancellation orders. Existing stocks are those stocks of registered pesticide products which are currently in the United States and which have been packaged, labeled, and released for shipment prior to the effective date of the cancellation action. Unless the provisions of an earlier order apply, existing stocks already in the hands of dealers or users can be distributed, sold or used legally until they are exhausted, provided that such further sale and use comply with the EPA-approved label and labeling of the affected product(s). Exceptions to these general rules will be made in specific cases when more stringent restrictions on sale, distribution, or use of the products or their ingredients have already been imposed, as in Special Review actions, or where the Agency has identified significant potential risk concerns associated with a particular chemical. List of Subjects Environmental protection. Pesticides and pests, Product registrations. Dated: September 22.1994. Daniel M. Barolo, Director, Office ofPesticide Programs. IFF Doc. 94-24247 Filed 9-29-94: 8:45 am) BIUJNG COOf ino 10 w [OPPTS-42052P; FRL-4756-5] Notice of Opportunity to Initiate Negotiations for TSCA Section 4 Enforceable Consent Agreements; Solicitation of Testing Proposals for ATSDR Chemicals agency: Environmental Protection Agency (EPA) ACTION: Notice. SUMMARY: This notice invites manufacturers and processors of certain chemical substances who wish to participate in testing negotiations for various chemicals to develop and submit testing program proposals to EPA. The chemicals are hazardous substances identified for data needs by the Agency fbr Toxic Substances and Disease Registry (ATSDR). National Toxicological Program (NTP) and EPA pursuant to section 104(i)(5) of the Comprehensive Environmental Response, Compensation and Liability Act of 1980 (CERCLA or Superfund)(42 U.S.C 9601-0675). These 12 chemical substances are vinyl chloride, benzene, trichloroethylene, tetrachloroethylene. hydrogen cyanide, sodium cyanide, toluene, methylene chloride, chloroethane, mercury, chromium, and beryllium. These substances and associated data needs appear in Table 1 below. The specific forms of the metals mercury, chromium, and beryllium to be tested are yet to be determined; EPA will solicit testing proposals for the specific forms of these metals at a later date. Testing proposals should cover all identified data needs of a substanceJot multiple substances) in order to be considered for Enforceable Consent Agreement (ECA) negotiation. If, after receiving testing proposals. EPA elects to pursue negotiations for one or more EGAs applicable to specific chemicals, EPA will solicit requests to be designated an interested parly at that point. EPA has authority to require testing for these 12 chemical substances under section 4 of the Toxic Substances i * * ( ,? '1 / Vf CMA 115622 Federal Register / Vol. 59, No. 189 / Friday, September 30, 1994 / Notices 4993d Control Act (TSCA)(15 U.S.C. 26012692) and if an ECA-based approach does not prove viable, EPA would proceed with rulemaking to require th needed testing. DATES: Written testing proposals must be received by November 29,1994. EPA may extend the deadline for receipt of testing proposals upon a showing of good aith efforts to develop testing proposals by the initial deadline. ADDRESSEES: Submitthree copies of written testing proposals to TSCA Docket Receipts (7407), Office of Pollution Prevention and Toxics, Environmental Protection Agency, Rm. NE B607,401M St., SW., Washington, DC 20460. Submissions should bear the document control number (OPPTS42052P; FRL-4756-5). The public record supporting this action, including comments, is available for public inspection at the above address from 12 noon to 4 p.m., Monday through Friday, except iegai holidays. FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, Environmental Assistance Division (7408), Rm. E-543B, 401M St, SW., Washington. DC 20460. (202) 354-1404, TDD (202) 554-0551. For specific information regarding this action or related activities, contact Brian P. Riedel, Project Manager. Chemical Testing and Information Branch (7405), Rm. NE--1606,401M St., SW., Washington, DC 20460. (202) 260-0321. SUPPLEMENTARY INFORMATION; I. Background A. Solicitation for Testing Proposals EPA's procedures for requiring the testing of chemical substances under section 4 of TSCA include the adoption of ECAs and the promulgation of test rules. On numerous occasions, chemical companies have approached EPA to negotiate ECAs for testing chemicals which are likely to become the subject of proposed test rules. EPA will follow the procedures outlined in unit II of this notice to develop ECAs. B. Chemical Data Needs The data needs which are the subject of this notice were determined in accordance with the requirements of the Superfund Amendments and Reauthorization Act (SARA) of 1986 which amended and extended CERCLA. Section 104(i) of CERCLA requires ATSDR and EPA to prepare and revise a list of hazardous substances which are most commonly found at facilities on the CERCLA National Priorities List (NPL) and which ATSDR and EPA, in their sole discretion, determine are posing the most significant potential threat to human health. The lists of these 275 hazardous substances were published in the Federal Register on April 17,1987 (52 FR12866); October 20.1988 (53 FR 41280); October 26, 1989 (54 FR 43615): October 17,1990 (55 FR 42067); October 17,1991 (55 FR 52166): October 28.1992 (57 FR 48801); and October 18,1993 (58 FR 53739). Section 104(i) of CERCLA also directs ATSDR to prepare toxicological profiles of each listed hazardous substance. Section I04(i)(3) outlines the content of these profiles. Each profile is required to include an examination, summary and interpretation of available toxicological information and epidemiologic evaluations in order to ascertain the levels of significant human exposure far the substance and the associated health effects. The profiles must also include a determination of whether adequate information on the health effects of substance is available or in the process of development ATSDR has prepared 110 toxicological profiles covering 195 substances. (One toxicological profile may cover several related substances). Under CERCLA. section 104(i)(5), when adequate information is not available on the health effects of each . substance, ATSDR. in cooperation with the National Toxicology Program (NTP), is required to assure the initiation of a research program designed to determine such health effects (and techniques far developing methods to determine such health effects). As the first step in developing its health effects research program, ATSDR identified data needs for each substance in the toxicological profiles. These data needs were reviewed by scientists from ATSDR. NTP, EPA and the Centers for Disease Control, peer reviewed by an external review panel, and made available for public comment. Prior to final publication of the toxicological profiles, ATSDR considered all public comments it received regarding identification of data needs for the substances. The next step in the development of the health effects research program (or the substance-specific research program) involved the creation of the "Decision Guide for Identifying Substance-Specific Data Needs Related to Toxicological Profiles" (Decision Guide), published in the Federal Register on September 11, 1989 (54 FR 37618). Applying the principles discussed in the Decision Guide, ATSDR published the "Identification of Priority Data Needs for 38 Priority Hazardous Substances" in the Federal Register on October 17, 1991 (56 FR 52178). As required by CERCLA, section 104(i)(5), ATSDR considered recommendations from the Interagency Testing Committee (ITC), and. with EPA. coordinated development of these priority data needs with NTP and with programs of toxicological testing established under TSCA and the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)(7 U.S.C. 136). The purpose of such coordination is to avoid duplication of effort and to assure that the listed hazardous substances are tested thoroughly at the earliest practicable date. ATSDR also considered public comments on identification of the priority data needs. On November 16.1992. ATSDR published the "Announcement of Final Priority Data Needs for 38 Priority Hazardous Substances" in the Federal Register (57 FR 54150). Copies of the FR actions cited above are available in th docket established for this action (OFPTS-42052P; FRL-4756-5). CERCLA. section i04(i)(5)(C) provides that TSCA authorities may be used to cany out the health effects research program. CERCLA, section 104(i)(5)(D) dedans that lilt is the sense of the Congress that the costs at loonducting health effects research programs] be borne by the manufacturers ud processors of the hazardous substances in question, as required in programs of toxicological testing under the Toxic Substance* Control Act. In October 1992, ATSDR requested that EPA test 38 substances using authorities under TSCA and FIFRA. EPA coordinated extensively with other Federal agendes (inducting the Occupational Safety and Health Administration, National Institute for Occupational Safety and Health, Mine Safety and Health Administration, and the Consumer Product Safety Commission) and among its own programs (including Office of Air and Radiation, Office of Water, Office of Solid Waste and Emergency Response, and Office of Research and Development) to evaluate ATSDR's. request for testing. In addition. EPA, ATSDR, and the National Institute of Environmental Health Sciences (NIEHS) met as members of the Tri-Agency Superfund Applied Research Committee (TASARC) to discuss ATSDR's data needs and EPA's response. Copies of the minutes of the TASARC meetings an , available in the docket established for this action. In response to ATSDR's initial request to test 38 substances, EPA deleted substances from the initial list and deleted and added associated data needs baaed on various factors including, but not limited to,'the appropriateness of using TSCA authority to require testing CMA115623 Federal Register / Vol. 59, No. 189 / Friday. September 30, 1994 / Notices 49937 Table l.--Data Needs and Testing GuiDEUf^--Continued Chemical and CAS No. Piupoaad Testing Guideline (40 CFR) Oevetopmertal Matattn --____________________________________________ NiutuuMcny s&ocnrorvc nwtoon ---------- -------------- --- Functional observational battery 0 N Motor activity Neuropathology Sodium cyarde (143-33-9) ....._... newelnymMfwiftl yfi D Toluene (KM-M-3).......................... Comparative phatT--oofclnaHr ............ ..... ImmunotoxiCJty oral. _________ PK 1 Methylene chloride (75-09-2) _______ Subchronic oral HevalPpmarval oral........ 7982650 D Nauratoxieity subehranic oral _ _N Functional observational battery Motor activity Netropathotogy , Immunotoxxaty oral _1 Chloroethane* (Ethyl chloride) (75-00- Comparative pharmacokinetic 3). Mercury**(TBD) ______ __ PK Chromium**(TBD) _____ Beryliium**(TBD)........................... ,,...... Notes: `Note that a soon-to-be-published Ssed test rule on hazardous air ants (HAPs) will cover chloroethane. "A workgroup set up by TASARC Is in the process of identifying the specific forms of these metals. TBD - The Chemical Abstract Service Registry Numberls) for the chemical(s) to be tested is yet to be determined- R - Proposed revised EPA guidelines for reproductive toxicity testing are under development and are anticipated to be finalized in the near future. Copies of the latest draft to date are available in the docket established for this action. D - Proposed revised EPA guidelines for developmental toxicity testing are under development and are anticipated to be finalized in the near future. Copies of the latest draft to date are available in the docket established for this action. N - EPA intends for parties subject to neurotoxicity testing requirements under this rule to follow the 1991 Neurotoxicology Testing Guidelines which are available in the docket established for this action. I - A workgroup established by the TriAgency Superfund Applied Research Committee (TASARC) is developing immunotoxicitv tesung guidelines. A -- Revised EPA guidelines for acute inhalation testing are under development and will soon be published with a proposed test rule on HAPs. Copies of the latest draft to date are available in the docket established for this action. PK - EPA has developed testing guidelines which may be used for conducting comparative phaimokinetic testing. These final guidelines are awaiting publication and are available in the docket established for this ection. n. Procedures for Development of EGAs EPA will follow the procedures outlined below to develop ECAs for the chemical substances listed in Table 1 above. l. Submission of testing proposals for ECA negotiations. Following publication of this Notice, manufacturers and processors have 60 days to develop testing proposals for the chemical substances listed in Table 1 above that they wish EPA to consider as candidates for ECA negotiations. EPA may extend the deadline for receipt of testing proposals upon a showing of good faith efforts to develop testing proposals by the initial deadline. The testing proposals should describe the testing to be performed in detail (test guideline or protocol, including route of administration, species, etc.) and explain in detail where there are deviations from tests proposed by EPA in Table l above. The Agency suggests as a model the testing proposal submitted on N-methylpyiToUdone (NMP) by the NMP Producers Group on September 11,1992 found in the docket established for this action. In order for a testing proposal to be eligible for consideration, the proposal should cover all identified data needs of a substance (or multiple substances). 2. Agency selection of most likely candidates for the ECA program. EPA will review the submissions and select the most promising submissions as candidates for negotiation. Submissions which fully address EPA's concerns will have a higher chance of success than those which do not fully address all data needs issues. 3. Formal solicitation of "interested parties" in the Federal Register. If EPA selects a proposal as a candidate for negotiations, such negotiations will be conducted pursuant to procedures described in 40 CFR 790.28. * Accordingly. EPA will publish a notice in the Federal Register soliciting persons interested in participating in or monitoring negotiations for the development of an ECA, to so notify the Agency in writing. Those individuals and groups who respond to EPA's notice by the deadline established in the notice will have the status of "interested parties" and will be afforded opportunities to participate in the negotiation process. Designation as an "interested party" will not incur any obligations. Submitters of testing proposals will be considered interested parties with regard to the subject(s) f their proposals and need not respond to the solicitation notice. 4. Negotiation of testing program and development of an ECA. Negotiations will be conducted in meetings open to CMA115624 1 49936 Federal Register / Vol. 59. No. 189 / Friday. September 30. 1994 / Nouces t of certain substances and the needs of . submission of testing guidelines for other Federal Agencies and EPA these endpoints Which may be used as The preferred method for performing route-to-route extrapolation involves the programs for certain test data. Relevant part of a testing proposal. development of a physiologically-based correspondence between EPA and EPA realizes that under certain pharmacokinetic (PBPK) model that ATSDR regarding these selections is circumstances, as outlined below, route* describes the disposition (deposition, available in the docket established for to-route extrapolation based an valid - absorption, distribution, metabolism, this action. In a letter dated November pharmacokinetic (PK) data can offer a and elimination) of the chemical for the S, 1993. EPA informed ATSDR that EPA useful and less expensive alternative to routes of interest PBPK models must be would pursue testing of ATSDR retesting by another route of exposure to used in conjunction with toxidty and substances under section 4 of TSCA. The ATSDR list of 38 substances was modified to contain the 12 substances shown in Table 1 below with a summary description of data needs. These substances will be added to the next edition of the Office of Pollution Prevention and Toxics' Master Testing List scheduled for release in FY *95. Further description of the data needs are available in the docket established for this action. Note that TASARC has set up a workgroup to identify the specific forms of the metals mercury, chromium and beryllium to be tested. This workgroup wilt consider the needs of other Federal Agencies and EPA programs. In addition, EPA will solicit testing proposals for the specific forms of these metals at a later date. Note also that EPA has not yet developed testing guidelines for certain endpoints indicated in Table chemical substances that have already been tested by one route. Therefore, EPA will consider entering into EGAs for PK testing under protocols proposed by prospective test sponsors. EPA will consider route-to-route extrapolation of toxicity data from routes other than those proposed in Table 1 below when it is scientifically reasonable to empirically derive the risk. Derivation of the risk is only reasonable when portal-of-entry effects and first-pass effects can be ruled out or adequately characterized. Regardless of the toxic endpoint considered, EPA's ability to perform quantitative route-toroute extrapolation is critically dependent on the amount and type of data available. The minimum information needed includes both the nature of the toxic effects and a description of the relationship between mechanistic studies-in order to relate the effective dose associated with an effect for the test species and conditions to other scenerios. The primary purpose of this ASTDR/ EPA health effects testing program is to meet the substance-specific information needs of the public and the scientific community, and, consistent with the guidelines discussed in the Decision Guide, this testing program will supply toxicity and exposure information which will assist in the development of Superfund health assessments by AfTTDR. In addition, because of the involvement by other Federal Agencies and EPA offices in reviewing the testing needs identified for these chemicals, this testing program will supply test dsta which will also meet the needs of other Federal Agencies end EPA 1 below. EPA particularly encourages exposure and the toxic effect programs. Table i.--Data Needs and Testing Guidelines Chenmca) and CAS No. Proposed Testing Guideline (40 CFR) Rsfvyvtvtiuak inhatetwi ......... ............. .... ............ .. R Developmental inhalation .. Neurotoxicity inhalation ____ --. -- _______ --------------- D N S"bcbronic oral............ ..... ......................... ~ -.......... -........... 798.2650 Subchronic mhalation _______ ___ -------------,---------- 798.2450 Neurotoxicity inhalation --------------- -------------- ------------ --------------------- _-------- N * Functional observational battery Motor activity Neuropathology Reproductive inhalation_______ _______ ______ ___________ ______ --_ R TriAhlomAthyictne ................. Acute ora' .... ,...... ...... ...... ....... ..................................... --- ... Subchronic oral --.......--............... .......... .................. ....... -------------- - Immunotoxicity oral________________ ______ ____ ___ ___________ _____ 798.1175 798.2650 1 Tetrachtnrnrthyiene (157-18--4) , Hydrogen cyanide (74-90-8) ______ _ Acute inhalation ............................... ....... ......... ................ Reproductive inhalation............--- --_________------- -----------Neurotoxicity subchronic inhalation _________________ _______ ______________ Functional observational battery Motor activity Neuropathology Developmental inhalation________ _________________ _____________________ Immunotoxicity inhalation -------------------- ,----- ---------------------------------------- Acute inhalation .. ..... ~ ....................- ............ Subchronic inhalation...______________ _ ............______ _ ... _____ A R N D 1 A 7982450 CMA115625 49938 ` Federal Regieter / Vol. 59, No. 189 / Friday, September 30, 1994 / Notices the public. Notification of meetings will be given only to persons identified as interested parties. The first negotiation meeting will establish the period for negotiation. If agreement is not readied within this prescribed time limit and EPA chooses not to extend the negotiation period, negotiations will be terminated and testing will be required under a rule. 5. Approval ofthe ECA by interested parties and EPA and publication of a notice in the Federal Register. After EPA and interested parties have agreed in principle on the terms of the ECA, the ECA text will be sent for approval to interested parties who are actual participants in the negotiation. Subsequent to approval of the ECA, EPA will publish a notice in the Federal Register summarizing the testing program and announcing that in lieu of a test rule, the Agency has issued a testing Consent Order that incorporates the ECA. m. Public Record EPA has established a record for this action (docket control number OPPTS-- 42052P; FRL-4756-5). The record includes basic information considered by EPA in developing this action. EPA will supplement the record with additional information as it is received. A public version of this record is available in the TSCA Nonconfidential Information Center (NQC) from 12 noon to 4 p.m., Monday through Friday, except legal holidays. The NQC is located in Rm. NE-B607, Mail Code 7407,401M St, SW,, Washington, DC, 20460. Written requests for copies of documents contained in thi record may be sent to the above address or faxed to (202) 260-9555. Authority: 15 U.S.C. 2603. Dated: September 21,1994. Otarles M. Auer, Director. Chemical Control Division, Office ofPollution Prevention and Toxics. (FR Doc. 94-24250 Filed 9-29-94; 8:45 sml men men COOf HID Ifrf FEDERAL COMMUNICATIONS COMMISSION Public Information Collection Requirement Submitted to Office of Management and Budget for Review September 27,1994. The Federal Communications Commission has submitted the following information collection request to OMB for review and clearance under the Paperwork Reduction Act of 1980, 44 U.S.C. Section 3507. Persons wishing to comment an this information collection should contact Timothy Fain, Office of Management and Budget. Room 10102, New Executive Office Building, Washington, D.C. 20503, (202) 395-3561. For further information, contact Judy Boley, Federal . Communications Commission, (202) 418-0214. Please note: The Commission has requested expedited review of this collection by September 30,1994, under the provisions of 5 CFR 1320.18. Title: Implementation of Section 309(j) of the Communications Act-- Competitive Bidding. Second Report and Order and Second Memorandum Opinion and Order, PP Docket No. 93-253. OMB Control Number: 3060-0600. Action: Revised Collections. Respondents: Individuals, State or local governments, Non-profit institutions. Business or other for-profit, including small businesses. Frequency ofresponse: On occasion and recordkeeping requirements Estimated Annual Burden: Secfroo/torms Section 1.2105 ...................................... ................. ........ ......, ............................... Section 1.2107 ............................................................. ............. .......................................................... Section 1.2108_______ __ _______ ____ _ _________________________ __ ______________ Section 1 2110 ................................................ ............................................................ Section 1.2110* .......................................... ..............................._ .................................................... ...................... Section 1.2111 ................. ...........,,................ .................. ....... ... . ...... Microfiche.......................... .................................... ................ FCC Form 175 ................... ........ FCC Form 175--S ............... ............ ...................................... ............................. ........,, .............................. ' Recordkeeping requirement. Total Annual Burden: 100,925 Hours. No. of Ra-^ apond- ents Estimatad average hrepar rosponaa matad annual bwdan 13,400 104)00 ?icn 1,000 1,000 100 13,400 13,400 6,400 A0 1 20 2 1 A0 2 A0 .25 6,700 10,000 47,000 2.000 1,000 50 26,800 6,700 675 Needs and Uses: in the Second Memorandum Opinion and Order the Commission modified and supplemented several of its generic rules governing the auctioning of all licenses subject to competitive bidding. Applicants are required to file certain information so that the Commission can determine whether the applicants are legally, technically and financially qualified to be licensed and also whether applicants are entitled to receive certain benefits. Affected public are any member of the public who wants to become or remain a licensee. The foregoing estimates include the time for reviewing instructions. searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding the burden estimates or any other aspect of the collection of information, including suggestions for reducing the burden, to the Federal Communications Commission, Records Management Branch, Paperwork Reduction Project, Washington, D.C. 20554 and to the Office of Management and Budget Paperwork Reduction Project, Washington. D.C. 20503. Federal Communications Commission. Williams F. Caton, Acting Secretory. Subpart O--Competitive Bidding Proceedings Authority: 47 UA.C. 309(j). General Procedures Section lJlOi Purpose The provisions of this subpart implement Section 309(f) of the Communications Act of 1934, as added by the Omnibus Budget Reconciliation Act of 1993 (P.L. 103-66), authorizing the Commission to employ competitive bidding procedures to choose from among two or mote mutually exclusive applications for certain Initial licenses. CMA115626 49934 Federal Register / Vol, 59, No. 189 / Friday, September 30, 1994 / Notices TABLE 2. -- REGISTRANTS REQUESTING VOLUNTARY CANCELLATION EPA Com pany No. Company Name and Address 000264 Rhone-Poulenc Aq Co., Box 12014. Research Triangle Park, NC 27709. 000499 Whitmire Research Laboratories, Inc., 3568 Tree CL, IndustriaLBtvd, St Louis, MO 63122 001864 Central Petroleum Co., 1449 W. 117th St. Cleveland, OH 44107. 002935 Wilbur Ellis Co., 191 W. Shaw Ave,, Fresno, CA 93704. for Distribution bv C1.' A 003125 004822 005905 008590 009444 Miles Inc., Agriculture Division, 8400 Hawthorn Rd., Box 4913, Kansas City, MO 64120. S.C. Johnson & Son Inc., 1525 Howe Street, Racine, Wl 53403. ji rom_ ^ou_.6u'Sr w Helena Chemical Co, 6075 Poplar Ave., Suite 500, Memphis, TN 35119. Agway Inc., c/o Universal Cooperatives Inc., Box 460, Minneapolis, MN 55440. Waterbury Companies Inc., Box 640, Independence. LA 70443. R,\f \ -Qcjr_ 035900 Ionics, Inc., 3039 Washington Pike, Bndgeville, PA 15017. 037425 Smithktine Beecham Animal Health, 1600 Paoli Pike, West Chester, PA 19360. 044716 Feanng Mfg. Co Inc., 490 Villaume Ave, So., St. Paul, MN 55075. 050534 ISK Biosciences Corp., 5966 Heisley Rd,, Box 8000, Mentor, OH 44061. 059639 Valent U.S.A. Corp.. 1333 N. California Blvd. Ste 600, Walnut Creek, CA 94596. III. Procedures for Withdrawal of Request Registrants who choose to withdraw a request for cancellation must submit such withdrawal in writing to James A. Hollins, at the address given above, postmarked before December 29,1994. This written withdrawal of the request for cancellation will apply only to the applicable 6(f)(1) request listed in this notice. If the product(s) have been subject to a previous cancellation action, the effective date of cancellation and all other provisions of any earlier cancellation action are controlling. The withdrawal request must also include a commitment to pay any reregistration fees due. and to fulfill any applicable unsatisfied data requirements. IV. Provisions for Disposition of Existing Stocks The effective date of cancellation will be the date of the cancellation order. The orders effecting these requested cancellations will generally permit a registrant to sell or distribute existing stocks for l-year after the date the cancellation request was received. This policy is in accordance with the Agency's statement of policy as prescribed in Federal Register No. 123, Vol. 56, dated June 26,1991. Exceptions to this general rule will be made if a product poses a risk concern, or is in noncompliance with reregistration requirements, or is subject to a data callin. In all cases, product-specific disposition dates will be given in the cancellation orders. Existing stocks are those stocks of registered pesticide products which are currently in the United States and which have been packaged, labeled, and released for shipment prior to the effective date of the cancellation action. Unless the provisions of an earlier order apply, existing stocks already in the hands of dealers or users can be distributed, sold or used legally until they are exhausted, provided that such further sale and use comply with the EPA-approved label and labeling of the affected product(s). Exceptions to these general rules will be made in specific cases when more stringent restrictions on sale, distribution, or use of the products or their ingredients have already been imposed, as in Special Review actions, or where the Agency has identified significant potential risk concerns associated with a particular chemical. List of Subjects Environmental protection, Pesticides and pests. Product registrations. Dated; September 22.1994. Daniel M. Barelo. Director, Office ofPesticide Programs. |FR Doc. 94-24247 Filed 9-29-94; 8:45 amj BIIUNQ CODE M4O-S0-X02 [OPPTS-42052P; FRL-4756-5] Notice of Opportunity to Initiate Negotiations for TSCA Section 4 Enforceable Consent Agreements; Solicitation of Testing Proposals for ATSDR Chemicals AGENCY: Environmental Protection Agency (EPA) ACTION: Notice. summary: This notice invites manufacturers and processors of certain chemical substances who wish to participate in testing negotiations for various chemicals to develop and submit testing program proposals to EPA. The chemicals are hazardous substances identified for data needs by the Agency fbr Toxic Substances and Disease Registry (ATSDR), National Toxicological Program (NTP) and EPA pursuant to section 104(i)(5) of the Comprehensive Environmental Response. Compensation and Liability Act of 1980 (CERCLA or Superfund)(42 U.S.C. 9601--9675). These 12 chemical substances are vinyl chloride, benzene, trichloroethylene, tetrachloroethylene, hydrogen cyanide, sodium cyanide, toluene, methylene chloride, chloroethane, mercury, chromium, and beryllium. These substances and associated data needs appear in Table 1 below. The specific forms of the metals mercury, chromium, and beryllium to be tested are yet to be determined; EPA will solicit testing proposals for the specific forms of these metals at a later date. Testing proposals should cover all identified data needs of a substance Jor multiple substances) in order to be considered for Enforceable Consent Agreement (EGA) negotiation. If, after receiving testing proposals. EPA elects to pursue negotiations for one or more EGAs applicable to specific chemicals, EPA will solicit requests to be designated an interested party at that point. EPA lias authority to require testing for these 12 chemical substances under section 4 of the Toxic Substances CMA 115627 Federal Register /Vol. 59, No. 189 / Friday, September 30, 1994 / Notices 49935 Control Act (TSCA){15 U.S.C. 26012692) and if an ECA-based approach does not prove viable, EPA would proceed with rulemaking to require the needed testing. OATES: Written testing proposals must be received by November 29,1994. EPA may extend the deadline for receipt of testing proposals upon a showing of good faith efforts to develop testing proposals by the initial deadline. ADDRESSEES: Submit three copies of written testing proposals to TSCA Docket Receipts (7407), Office of Pollution Prevention and Toxics, Environmental Protection Agency, Rm. NE B607, 401 M St., SW.. Washington, DC 20460. Submissions should bear the document control number (OPPTS42052P; FRL-4756-5). The public record supporting this action, including comments, is available for public inspection at the above address from 12 noon to 4 p.m., Monday through Friday, except legal holidays. FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, Environmental Assistance Division (7408), Rm. E-543B, 401 M St., SW,, Washington, DC 20460, (202) 554-1404, TDD (202) 554-0551. For specific information regarding this action or related activities, contact Brian P. Riedel, Project Manager, Chemical Testing and Information Branch (7405), Rm. NE--1606, 401 M St., SW.. Washington, DC 20460, (202) 260-0321. SUPPLEMENTARY INFORMATION: I. Background A. Solicitation for Testing Proposals EPA's procedures for requiring the testing of chemical substances under section 4 of TSCA include the adoption of ECAs and the promulgation of test rules. On numerous occasions, chemical companies have approached EPA to negotiate ECAs for testing chemicals which are likely to become the subject of proposed test rules. EPA will follow the procedures outlined in unit D of this notice to develop ECAs. B. Chemical Data Needs The data needs which are the subject of this notice were determined in accordance with the requirements of the Superfund Amendments and Reauthorization Act (SARA) of 1986 which amended and extended CERCLA. Section 104(i) of CERCLA requires ATSDR and EPA to prepare and revise a list of hazardous substances which are most commonly found at facilities on the CERCLA National Priorities List (NPL) and which ATSDR and EPA, in their sole discretion, determine are posing the most significant potential threat to human health. The lists of Interagency Testing Committee (ITC). these 275 hazardous substances were and, with EPA, coordinated published in the Federal Register on development of these priority data April 17,1987 (52 FR12866): October needs with NTP and with programs of 20,1988 (53 FR 41280); October 26, toxicological testing established under 1989 (54 FR 43615); October 17,1990 TSCA and the Federal Insecticide, (55 FR 42067); October 17,1991 (55 FR Fungicide and Rodenticide Act 52166); October 28,1992 (57 FR 48801); (FIFRA)(7 U.S.C. 136). The purpose of and October 18,1993 (58 FR 53739). such coordination is to avoid Section 104(1) of CERCLA also directs duplication of effort and to assure that ATSDR to prepare toxicological profiles the listed hazardous substances are of each listed hazardous substance. tested thoroughly at the earliest Section 104(i)(3) outlines the content of practicable date. ATSDR also these profiles. Each profile is required to considered public comments on include an examination, summary and identification of the priority data needs. interpretation of available toxicological On November 16.1992. ATSDR information and epidemiologic published the "Announcement of Fmal evaluations in order to ascertain the Priority Data Needs for 38 Priority levels of significant human exposure for Hazardous Substances" in the Federal the substance and the associated health Register (57 FR 54150). Copies of the FR effects. The profiles must also include a actions cited above are available in the determination of whether adequate docket established for this action information on the health effects of each (OPFTS-42Q52P; FRL-4756-5). substance is available or in the process CERCLA. section 104(i)(5)(C) provides of development. ATSDR has prepared that TSCA authorities may be used to 110 toxicological profiles covering 195 cany out the health effects research substances. (One toxicological profile program. CERCLA, section 104(i)(5)(D) may coveT several related substances). declares that: Under CERCLA, section I04(i)(5), when adequate information is not available on the health effects of each substance, ATSDR, in cooperation with the National Toxicology Program (NTP), is required to assure the initiation of a [i)t is the sense of the Congress that the costs of (conducting health effects research programs] be borne by the manufacturers and processors of the hazardous substances in question, as required in programs of toxicological testing under the Toxic research program designed to determine Substances Control Act. such health effects (and techniques for developing methods to determine such In October 1992, ATSDR requested health effects). that EPA test 38 substances using As the first step in developing its authorities under TSCA and FIFRA, health effects research program. ATSDR EPA coordinated extensively with other identified data needs for each substance Federal agencies (including the in the toxicological profiles. These data Occupational Safety and Health needs were reviewed by scientists from Administration. National Institute for ATSDR, NTP, EPA and the Centers for Occupational Safety and Health, Mine Disease Control, peer reviewed by an external review panel, and made Safety and Health Administration, and the Consumer Product Safety available for public comment. Prior to final publication of the toxicological Commission) and among its own programs (including Office of Air and profiles. ATSDR considered all public Radiation, Office of Water, Office of comments it received regarding Solid Waste and Emergency Response, identification of data needs for the and Office of Research and substances. The next step in the development of the health effects research program (or Development) to evaluate ATSDR's request for testing. In addition, EPA, ATSDR, and the National Institute of the substance-specific research program) Environmental Health Sciences (NIEHS) involved the creation of the "Decision met as members of the Tri-Agency Guide for Identifying Substance-Specific Superfund Applied Research Committee Data Needs Related to Toxicological (TASARC) to discuss ATSDR's data Profiles" (Decision Guide), published in needs and EPA's response. Copies of the the Federal Register on September 11, minutes of the TASARC meetings are , 1989 (54 FR 37618). Applying the available in the docket established for principles discussed in the Decision this action. Guide, ATSDR published the In response to ATSDR's initial request "Identification of Priority Data Needs to test 38 substances, EPA deleted for 38 Priority Hazardous Substances" substances from the initial list and in the Federal Register on October 17, deleted and added associated data needs 1991 (56 FR 52178). As required by based on various factors including, but CERCLA. section 104(i)(5), ATSDR not limited to, the appropriateness of considered recommendations from the using TSCA authority to require testing CMA115628 49936 Federal Register / Vol, 59. No. 189 / Friday. September 30, 1994 / Notices of certain substances and the needs of . 6ther Federal Agencies and EPA programs for certain test data. Relevant correspondence between EPA and ATSDR regarding these selections is available in the docket established for this action. In a letter dated November 9,1993, EPA informed ATSDR that EPA would pursue testing of ATSDR substances under section 4 of TSCA. The ATSDR list of 38 substances was modified to contain the 12 substances shown in Table 1 below with a summary description of data needs. These substances will be added to the next edition of the Office of Pollution Prevention and Toxics' Master Testing List scheduled for release in FY '95. Further description of the data needs are available in the docket established for this action. Note that TASARC has set up a workgroup to identify the specific forms of the metals mercury, chromium and beryllium to be tested. This workgroup will consider the needs of other Federal Agencies and EPA programs. In addition. EPA will solicit testing proposals for the specific forms of these metals at a later date. Note also that EPA has not yet developed testing guidelines for certain endpoints indicated in Table 1 below. EPA particularly encourages submission of testing guidelines for these endpoints which may be used as part of a testing proposal. EPA realizes that under certain circumstances, as outlined below, route- to-route extrapolation based on valid pharmacokinetic (PK) data can offer a useful and less expensive alternative to retesting by another route of exposure to chemical substances that have already been tested by one route. Therefore, EPA will consider entering into ECAs for PK testing under protocols proposed by prospective test sponsors. EPA will consider route-to-route extrapolation of toxicity data from routes other than those proposed in Table 1 below when it is scientifically reasonable to empirically derive the risk. Derivation of the risk is only reasonable when portal-of-entry effects and first-pass effects can be ruled out or adequately characterized. Regardless of the toxic endpoint considered, EPA's ability to perform quantitative route-toroute extrapolation is critically dependent on the amount and type of data available. The minimum information needed includes both the nature of the toxic effects and a description of the relationship between exposure and the toxic effect. The preferred method for performing route-to-route extrapolation involves the development of a physiologically-based pharmacokinetic (PBPK) model that describes the disposition (deposition, absorption, distribution, metabolism, and elimination) of the chemical for the routes of interest. PBPK models must be used in conjunction with toxicity and mechanistic studies-in order to relate the effective dose associated with an effect for the test species and conditions to other scenarios. The primary purpose of this ASTDR/ EPA health effects testing program is to meet the substance-specific information needs of the public and the scientific community, and, consistent with the guidelines discussed in the Decision Guide, this testing program will supply toxicity and exposure information which will assist in the development of Superiund health assessments by ASTDR. In addition, because of the involvement by other Federal Agencies and EPA offices in reviewing the testing needs identified for these chemicals, this testing program will supply test data which will also meet the needs of other Federal Agencies and EPA programs. Table i.--Data needs and Testing Guidelines Chemical and CAS No. Proposed Testing Guideline (40 CFR) Vinyl chloride (75-01-4) ..... ........... Benzene (71-43-2).............................. Reproductive inhalation ....................-.................... - -.............. ,,,,...... Developmental inhalation .................................................................................... Neurotoxicity inhalation ........................................................................................ Suhchronic oral .... ..... ..... ........ ....... Subchronic inhalation ............................................................................... ............ Neurotoxicity inhalation ................... ..................................................................... Functional observational battery Motor activity Neuropathology Reproductive inhalation........................................................................................ R D N 798.2650 798.2450 N R Trichloroethylene (79-01-6)................ Acute oral ................................................... -..................................................... 798.1175 Subchronic oral....................................................................................................... 798.2650 Immunotoxicrty oral..........-...............................-.........-....................................... 1 Tetrachloroethylene (127-18-4) Aflite inhalation ..... ...... ..... A Reproductive inhalation................ ................................................................... .. R Neurotoxicity subchronic inhalation...................................................................... N Functional observational battery Motor activity Neuropathology Hydrogen cyanide (74-90-6)............... Developmental inhalation...................................................................................... Immunotoxictty inhalation..................................................................................... Acute inhalation ..... ........................................ D 1 A Subchronic inhalation ............................................................................................ 7982450 CMA115629 Federal Register / Vol. 59, No. 189 / Friday, September 30, 1994 / Notices 49937 Table 1.--Data Needs and Testing Guidelines--Continued Chemical and CAS No. Proposed Testing Guideline (40 CFR) Rorttyim cyamdn (ia$-33-9) ............ Developmental inhalation__ __________________ ___________ _ Neurotoxicity subchronic inhalation------------------- --........ ............................... Functional observational battery D N Motor activity Neuropathology Developmental oral ...... ............ D Toluene (108-88-3) ............................. Comparative pharmacokinetic ............................. .............. PK Immunotoxicity oral....................... ................................................ ..................... 1 Methylene chtonde (75-09-2).............. Subchronic oral............................... ..................................................................... 798-2650 Developmental oral.................................................. ............................................. Neurotoxicity subchronic oral ............................................................................... Functional observational battery Motor activity D N Neuropathology Immunotoxicrty oral....... .......... ............................................................................ 1 Chloroethane* (Ethyl chloride) (75-00- Comparative pharmacokinetic...................................,,..................................... .. 3). Mercury**(TBD) ............................... .. PK Chromium"(TBD)................................. Berylliiim**(TBD)................................... --.... ........................................ ............... ........................................... ..... Notes: Note that a soon-to-be-publisbed proposed test rule on hazardous air pollutants (HAPs) will cover chloroethane. **A workgroup set up by TASARC is in the process of identifying the specific forms of these metals. TBD -- The Chemical Abstract Service Registry Numberfs) for the chemical(s) to be tested is yet to be determined. R -- Proposed revised EPA guidelines for reproductive toxicity testing are under development and are anticipated to be finalized in the near future. Copies of the latest draft to date are available in the docket established for this action. D - Proposed revised EPA guidelines for developmental toxicity testing are under development and are anticipated to be finalized in the near future. Copies of the latest draft to date are available in the docket established for this action. N - EPA intends for parties subject to neurotoxicity testing requirements under this rule to follow the 1991 Neurotoxicology Testing Guidelines which are available in the docket established for this action. 1 -- A workgroup established by the TriAgency Superfund Applied Research Committee ITASARC) is developing immunotoxicity testing guidelines. A -- Revised EPA guidelines for acute inhalation testing are under development and will soon be published with a proposed test rule on HAPs. Copies of the latest draft to date are available in the docket established for this action. PK - EPA has developed testing guidelines which may be used for conducting comparative pharmokinetic testing. These final guidelines are awaiting publication and are available in the docket established for this action. 11. Procedures for Development of ECAs EPA will follow the procedures outlined below to develop ECAs for the chemical substances listed in Table 1 above. 1. Submission of testing proposals for ECA negotiations. Following publication of this Notice, manufacturers and processors have 60 days to develop testing proposals for the chemical substances listed in Table 1 above that they wish EPA to consider as candidates for ECA negotiations. EPA may extend the deadline for receipt of testing proposals upon a showing of good faith efforts to develop testing proposals by the initial deadline. The testing proposals should describe the testing to fc* performed in detail (test guideline or protocol, including route of administration, species, etc.) and explain in detail where there are deviations from tests proposed by EPA in Table 1 above. The Agency suggests as a model the testing proposal submitted on N-methylpyrrolidone (NMP) by the NMP Producers Group on September 11,1992 found in the docket established for this action. In order for a testing proposal to be eligible for consideration, the proposal should cover all identified data needs of a substance (or multiple substances). 2. Agency selection of most likely candidates for the ECA program. EPA will review the submissions and select the most promising submissions as candidates for negotiation. Submissions which fully address EPA's concerns will have a higher chance of success than those which do not fully address all data needs issues. 3. Formal solicitation of "interested parties" in the Federal Register. If EPA selects a proposal as a candidate for negotiations, such negotiations will be conducted pursuant to procedures described in 40 CFR 790.28, Accordingly, EPA will publish a notice in the Federal Register soliciting persons interested in participating in or monitoring negotiations for the development of an ECA, to so notify the Agency in writing. Those individuals and groups who respond to EPA's notice by the deadline established in the notice will have the status of "interested parties" and will be afforded opportunities to participate in the negotiation process. Designation as an "interested party" will not incur any obligations. Submitters of testing proposals will be considered interested parties with regard to the subject(s) of their proposals and need not respond to the solicitation notice. 4. Negotiation of testing program and development of an ECA. Negotiations will be conducted in meetings open to CMA 115630 > 49938 Federal Register / Vol. 59, No. 189 / Friday, September 30, 1994 / Notices the public. Notification of meetings will oe given only to persons identified as interested parties. The first negotiation meeting will establish the period for negotiation. If agreement is not reached within this prescribed time limit and EPA chooses not to extend the negotiation period, negotiations will be terminated and testing will be required under a rule. 5. Approval of the ECA by interested parties and EPA and publication of a notice in the Federal Register. After EPA and interested parties have agreed in principle on the terms of the ECA, the ECA text will be sent for approval to interested parties who are actual participants in the negotiation. Subsequent to approval of the ECA, EPA will publish a notice in the Federal Register summarizing the testing program and announcing that in lieu of a test rule, the Agency has issued a testing Consent Order that incorporates the ECA. III. Public Record EPA has established a record for this action (docket control number OPPTS42052P; FRL-4756-5). The record includes basic information considered by EPA in developing this action. EPA will supplement the record with additional information as it is received. A public version of this record is available in the TSCA Nonconfidential Information Center (NQC) from 12 noon to 4 p.m., Monday through Friday, except legal holidays. The NQC is located in Rm. NE-B607, Mail Code 7407,401 M St., SW., Washington, DC, 20460. Written requests for copies of documents contained in this record may be sent to the above address or faxed to (202) 260-9555. Authority: 15 U.S.C. 2603. Dated: September 21,1994. Charles M. Auer, Director. Chemical Control Division, Office ofPollution Prevention and Toxics. (FR Doc. 94-24250 Filed 9-29-94; 8:45 am) biujno coos esao-M> FEDERAL COMMUNICATIONS COMMISSION Public Information Collection Requirement Submitted to Office of Management and Budget for Review September 27,1994. The Federal Communications Commission has submitted the following information collection request to OMB for review and clearance under the Paperwork Reduction Act of 1980, 44 U.S.C. Section 3507. Persons wishing to comment on this information collection should contact Timothy Fain, Office of Management and Budget, Room 10102, New Executive Office Building, Washington, D.C. 20503, (202) 395-3561. For further information, contact Judy Boley, Federal . Communications Commission, (202) 418-0214. Please note: The Commission has requested expedited review of this collection by September 30,1994, under the provisions of 5 CFR 1320.18. Title: Implementation of Section 309(j) of the Communications Act-- Competitive Bidding, Second Report and Order and Second Memorandum Opinion and Order, PP Docket No. 93-253. OMB Control Number: 3060-0600. Action: Revised Collections. Respondents: Individuals, State or local governments, Non-profit institutions, Business or other for-profit, including small businesses. Frequency of response: On occasion and recordkeeping requirements Estimated Annual Burden: SectxxVforms NO. Of Re spond ents Estimated average hrsper response Esti mated annual burden Section 1.2105 ........................................................................................................... .............................................. Section 1.2107 ................................................................................................................................... ............. ............ Section 1.2108.............................................................................................................................................................. Section 1.2110 ..................................... ............ ....................................................... .................................................... Section 1.2110* .......... ................... ................................... ............................................................ Section 1.2111 .................................................................... .............................................................. Microfiche................................ ,,.................................................. ........................................................ .......... FCC Form 175 ............................................................................................ ;.............................................................. FCC Form 17^*S ................................................................ ........................... .................... ........................................ * Recordkeeping requirement Total Annual Burden: 100,925 Hours. 13.400 10,000 2,350 1,000 1,000 100 13.400 13,400 6,400 A0 1 20 2 1 A0 2 A0 25 6.700 10,000 47,000 2,000 1,000 50 26,800 6.700 675 Needs and Uses: In the Second Memorandum Opinion and Order the Commission modified and supplemented several of its generic rules governing the auctioning of all licenses subject to competitive bidding. Applicants are required to file certain information so that the Commission can determine whether the applicants are legally, technically and financially qualified to be licensed and also whether applicants are entitled to receive certain benefits. Affected public are any member of the public who wants to become or remain a licensee. The foregoing estimates include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding the burden estimates or any other aspect of the collection of information, including suggestions for reducing the burden, to the Federal Communications Commission, Records Management Branch, Paperwork Reduction Project, Washington, D.C. 20554 and to the Office of Management and Budget Paperwork Reduction Project, Washington, D.C. 20503. Federal Communications Commission. Williams F. Caton, Acting Secretary. Subpart Q--Competitive Bidding Proceedings Authority: 47 UA.G 309(j). General Procedures Section 12101 Purpose The provisions of this subpart implement Section 309(j) of the Communications Act of 1934, as added by the Omnibus Budget Reconciliation Act of 1993 (P.L. 103-66), authorizing the Commission to employ competitive bidding procedures to choose from among two or more mutually exclusive applications for certain initial licenses. CMA 115631 JUN 24 '94 Z)9:44 rR GEGN-ENv-ShFE-tiEnLlm 4lc 4-> o--" 4j"" J ATSDR Chemicals Added to MTL F.PA is adding .12 chemicals to the Master Testing Cist in response to a request for testing by the Agency for Toxic Substances and Disease Registry (ATSDR). The chemicals are: benzene, Ix:ryIlium, chloroerhane. chromium, cyanide, di (2erhylhcxyl) phthalate, mercury, methylene chloride, tetrachloroethyienc, toluene, trichloroethyl ene, and vinyl chloride. ATSDR is required to identify the hazardous substances most commonly found at Superfund sites, prepare toxicological pro files, and identify priority data needs for those substances, ATSDR is also required to initiate a research program to meet the priority data needs it identifies. In October 1992, ATSDR requested F.PA to use its authorities under TSCA and FIFRA to fill some of the data needs it identified on 37 chemicals. In its response to ATSDR, EPA agreed to develop a test rule under section 4 of TSCA to obtain data on 12 of the chemi cals, but noted that a TSCA test rale would not be an appropriate mechanism for obtaining data on the other 25 chemicals. Before initiating rulemaking, EPA is inviting manufacturers of the 12 chemicals listed in the following table to submit testing plans and enter into consent agreements for testing, EPa intends to issue a test rule in late 1994 for any of the 12 substances which are not covered by a consent order or a voluntary testing agreement. Chemical Mercury Vinyl chloride Benzene Tichloroethylene Chromium Tetrachioroethylene Cyanide Beryllium Toluene Methylene chloride Chloroethane PWX sta*--ift- | Testing to be Proposed | Immunotoxicity oral j Chronic oral | Reproductive oral l Acute oral j Reproductive innalation Developmental inhalation , Subchronic oral Neurotoxicity oral i 1 Subchronic oral 1 Neurotoxicity oral , Acute oral I Reproductive oral : Immunotoxicity oral Reproductive inhalation I Neurotoxicity inhalation i immunotoxicity inhalation I Developmental inhalation ' Acute inhalation Subchronic inhalation Developmental inhalation Pate in soil Acute inhalation Subchronic inhalation with reproductive and pulmonary pathology Developmental inhalation Immuotoxicity inhalation Bioavailability Fate in air Comparative Pharmacokinetics Immunotoxicity oral Subchronic oral Immunotoxicity oral Developmental oral Neurotoxicity oral Comparative Pharmacokinetics Immunotoxicity oral 12 CHEMICALS IN PROGRESS CMA 115632