Document DGjqqra0O4jVMq88ogJRDBxRN

a 4738_____________ Federal Ragistor / Vol. 37, No. 28 / Friday, February 7. 1992 / Notices pursuant to tha applicable tariff, notwithstanding demand for payment This proceeding has been assigned to Administrative Law Judge Charles E. Morgan ("Presiding Officer"). Hearing in this matter, if any ia held, shall commence within the time limitations prescribed in 46 CFR 502.61. The hearing shall include oral testimony and crossexamination in the discretion of the Presiding Officer only upon proper showing that there are genuine issues of material fact that cannot be resolved on the basis of sworn statements, affidavits, depositions, or other documents or that the nature of the matter in issue is such that an oral hearing and cross-examination are necessary for the development of an adequate record. Pursuant to the further terms of 46 CFR 502.61, the initial decision of the Presiding Officer in this proceeding shall be issued by February 3,1983. and the final decision of the Commission shall be issued by June X 1993. Joseph C taking. Stentary. (FR Doc. #2~28M Filed 2-6-92; 8:45 am] eaiaw coos sne-SMi FEDERAL RESERVE SYSTEM Carloa Salman, et aL; Change In Bank Control Nolle*; Acquisition of Shars* of Banks or Bank Holding Companto* The notificant listed below has applied under the Change in Bank Control Act (12 U&C. I617(j)) and | 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire a bankor bank holding company. The factor* that are considered in acting on notices are set forth in paragraph 7 of the Act (12 UAG I6l7(j)(7)). The notice is available for immediate inspection at the Federal Reserve Bank indicated. Once the notice has been accepted for processing, it will also be available for inspection at the offices of the Board of Governor*. Interested persons may express their views in writing to the Reserve Bank indicated for the notice or to the offices of the Board of Governors. Comments must be received not later than March 11992. A. Federal Reserve Bank of Adnata (Robert E. Heck. Vice President) 104 Marietta Street NW,, Atlanta. Georgia 30303: 1. Carlo* Salman. Miami. Florida; to acquire an additional 11.30 percent of the voting share* of Terrabank Holding Corporation. Miamt Florida, for a total of 20.57 percent and thereby indirectly acquire Tambank, N.A.. Miami. Florida. Board of Governor* of the Federal Reserve System. February 3,1992 Jennifer |. lofcsaee, Associate Secretary oftht Board IFR Doc. 92-2M6 Filed 2-0-92 8:45 am) Mima coee ssioewe DAB. HoMng Co, Me, et at; Formation* of; Acquisitions by; and Merger* of Bank HoMng Companies The companies listed in this notice have applied for the Board's approval under section 3 of the Bank Holding Company Act (12 U.S.C. 1642) end | 225.14 of the Board's Regulation Y (12 CFR 225.14) to become e bank holding company or to acquire e bank or bank bolding company. Tht factors that are considered in acting on the applications are set forth in section 3(c) of the Act (12 UAG 1642(c)). Each application is available for immediate inspection at the Federal Reserve Bank indicated. Once the application has been accepted for processing, it will also ba available for inspection at tfaa offices of the Board of Governor*. Intsrsstsd persons ray express their views in writing to the Reserve Bank or to the office* of the Board of Governors. Any comment on en application that requests t hearing must include t statement of why a written presentation would not suffice in lieu of a hearing, identifying specifically any questions of fact that ar* in dispute and summarising the evidence that would be presented at a hearing. Unless othsrwiae noted, comments regarding each of these applications must be received not later than March X 1992. A. Federal Iiiatve Bank of New Ywh (William L Rutledge. Vice Resident) 33 Liberty Strset Naw York. New York 10048: 1. USA Holding Company, Inc. Nenuet New York; to acquire 29 percent of the voting shares of New Milford Bank end Triist Company. Inc.. New Milford. Connecticut A Fedmel Raamve Bank of Richmond (Uoyd W. Bostian. Jr,, Senior Vico President) 701 East Byrd Street Richmond. Virginia 23291: l FS AtNational Corporation, Winchester. Virginia: to acquire 100 percent of the voting shares of Fanners 6 Merchants Bank of Keyset. Keyset. West Virginia. C Federal Reserve Bank of Atlanta (Robert A Hack. Vic* President) 104 Marietta Strset N.W- Atlanta, Georgia 30903* 1. Village* Banoorporation. Inc.. Lady Leke. Florida; to become a bank holding company by acquiring 100 percent of the voting shares of First Bank of the Villages. Lady Laks. Florida. D. Federal Raserv* Bank of Chicago (David A Epstein. Vic* President) 230 South LaSalle Street Chicago. Illinois 60690: f. Fairmount Banking Company. Feirmount Indiana: to become a bank holding company by acquiring 100 percent of the voting share* of The Fairmount Stats Bank, Fairmount. Indians. Board of Covamort of tbt Federal Reaerve System. February 219B2. Jeoeifet).)ehaiow. Associate Stentery ofthe Board. (FR Doc. 92-2867 Filed 2-8-02 MS am| MLsm com eweve DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substances and Dlsssss Registry (AT90R-47) Procedure for Conducting Voluntary AOSMCr: Agency for Toxic Substances end Disease Registry (ATSDR). Public Health Service (PHS), Department of Haalth and Human Service* (HHS). acnoie Notice. 6UWMSWV This notice announces the procedure for volunteering to conduct research as pert of the ATSDR Substance-Specific Applied Research Program authorised by the Comprehensive Environmental Response. Compensation, end Liability Act (CERCLA). a* amended. The voluntary research will be conducted by the privet* sector to fill priority data needs for hazardous substances that are the subjects of the ATSDR Toxicological Profiles. To data, tha priority data needs for 36 hazardous substances have been identified and announced by ATSDR in tha Federal RegfetM (56 FR 52178) on October 17.1991. As pert of this procedure for conducting voluntary research, the Agency has developed a model agreement Memorandum of Understanding (MOU). that will be signed by ATSDR and the interested private sector organization)*) (hareinaftar referred to as tha Company, although multiple companies or a consortium may be signstonas to a ingle MOU) prior to the initiation of the voluntary research- The public is invited to comment on this procedure for conducting voluntary research, and the model MOU. 5EWC 005293 Federal Register / Vol. 57, No. 26 / Friday. February 7, 1982 / Notice 4759 datu: The AT5DR considers this voluntary research effort to be of significant importance to the continuing development of the Substance-Specific Applied Research Program. Therefore, public comments concerning this Federal Register notice will be accepted throughout the Agency's involvement with voluntary research. AOMCSSiS: Comments on this notice shouid bear the docket control number ATSDR-4" and should be submitted to the Division of Toxicology. Research Implementation Branch. Agency for Toxic Substances end Disease Registry. Ma.'atop E-29,1000 Clifton Road NIL, Atlanta. Georgia 30333. Requests for a copy of the model Memorandum of Understanding should be addressed similarly. Comments on this notice will be available for public inspection at the Agency for Toxic Substances and Disease Registry. Building 33. Executive Park Drive. Atlanta. Georgia (not a mailing address), from 8 a.m. until 4:30 p.m.. Monday through Friday, except for legal holidays. SO* FUNTNtN INFORMATION CONTACT: The Division of Toxicology. Research Implementation Branch, Agency for Toxic Substance* and Disease Registry, Mailstop E-29,1600 Cifton Road NIL, Atlanta. Georgia 30333. Telephone: 404839-4015 or FTS 230-6015. fUmiMCNTANV INFORMATION: Background The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) (42 U.S.C 9604(i)), as amended by the Superfund Amendments and Reauthorization Act (SARA) (Pub. L 99-499). requires that ATSDR: (1) Develop jointly with the Environmental Protection Agency (EPA) a Ust of hazardous substances found at National Priorities List (NPL) sites, (in order of priority), (:) prepare Toxicological Profiles of these substances, and (3) assure the initiation of a research program to fill identified date needs associated with the substance*. The identification of the priority data needs for 38 priority hazardous substance* was desaibed in the Federal Register (October 17,1991.88 PR 82178). public comment* were invited, and Companies were invited to volunteer to conduct research to fill specific priority date needs during the public comment period for that notice. Future Federal Register notices will announce (1) the final list of priority date needs for the 88 hazardous substance* after public comments on these priority date needs have been addressed. (2) e second call for voluntarism to conduct research to fill priority date needs, end (3) the names of Companies that have volunteered to fill specific priority date needs. The major purpose of this ATSDR Applied Research Program ia to supplement the substance-specific informational needs of the public and scientific community: and to eupply necessary information for conducting comprehensive public health assessments for populations living in the vicinity of hazardous waste sites. This program will also provide data that can be generalized to other subatancea or areas of science, including risk assessments of chemicals, thus creating scientific base for filling broader range of data needs. Procedure tor Conducting Voluntary Research CERCLA. as emended in section 104(i)(S)(D). states that it is the sense of Congress that the costs for conducting this research program be borne by the manufacturers end processors of the hazardous substances under the Toxic Substances Control Act (TSCA) end registrants under the Federal Insecticide. Fungicide, end Rodentiride Act (FIFRA). or by cost recovery from responsible parties under CERCLA. To effectuate this statutory intent the ATSDR has developed a plan whereby portions of this CERCLA SubstanceSpecific Applied Research Program will be conducted via regulatory mechanisms (TSCA/FIFRA). private sector voluntarism, and through the direct use of CERCLA funds. ATSDR intends to enter into voluntary research projects in ways that lead only to high quality scientific work. This necessitates peer review of study protocols ana results consistent with CERCLA section 104(i)(13). CERCLA requires the peer review panel to consist of three to seven peer reviewers wbo (a) are selected by the Administrator of ATSDR. (b) are disinterested scientific experts, (c) have a reputation for scientific objectivity, and (d) who lack inedtutiooal ties with any person involved (n the conduct of the study or research under review. The ATSDR is aware of concerns within soaks segments of the public regarding voluntary research conducted by Compeniee with vetted interests In the research. To this end, the Agency encouragee the public to comment on ATSDR** procedure far conducting voluntary teeeerch In this notice. Additionally, for aedi teeeerch project conducted voluntarily, the MOU (signed by ATSDR end the Interested Company), the ATSDR approved study plan, pear reviewers' comments, and the final research report will be available for public inspection at the location a times indicated in the snowealM section of this notice. The ATSDR encourages Companies to volunteer to conduct research on priority data needs that were announced in the Federal Register notice "Identification of Priority Data Needa for 38 Priority Hazardous 5ub*tances" (October 17,1991. 56 FR 52178] and on priority date needs to be subsequently announced by the Agency. Interested Companies are asked to submit concept proposals (1-2 pages, not detailed protocols) during the October 17,1991fanuary 15,1982 public comment penod tor the above-mentioned notice, and for subsequent Federal Register notices. The concept proposal should include (1) the name of the interested Company, 12) the specific priority date need(s) to be filled. (3) a summary of the Company's experience in conducting research similar to that in the concept proposal, and (4) a statement about the laboratory and other resource capabilities for conducting the proposed research. Interested Compeniee may submit concept proposals that address substance-specific data needs or. where appropriate, concept proposals for research that will provide information relevant to elassea of chemical subatanoaa or which may be generalized to other areas of science. A tri-agency review committee comprised of adantists from ATSDR Nationel Toxicology Program (NTPL end the EPA will review these concept proposals. The committee, chaired by the Director of the Division of Toxicology. ATSDR. fa charged with coordinating and assuring the appropriate evaluation of research conducted to fill priority data needs of ATSDR's priority hazardous substances relevant to the objectives of CERCLA. at amended. The prineipel responsibilities of the committee are to (1)provide e forum to diacuas substance-specific research activities being carried out via TSCA/FIFRA. private sector voluntarism, or CERCLA hinds, (2) coordinate knowledge of research activities to avoid duplication of research being conducted in other programs end under other authorities, and (3) maintain a scheduled forum that provides an overall review of the ATSDR Superfund Applied Research Program. Based an the review committee's recommendations. ATSDR will determine which, end how, specific voluntary research projects will be pursued with volunteering Companies. In Instances where volunteered research initiatives era considered by the tri GENC qQ5'2'?4 4780 ,Federal Register / Vol 57 No. 20 / Friday, February 7. 1902 / Notices agency committee to be more appropriate for EPA responac. EPA may negotiate directly with the iotereeted Company. If ATSDR decides to pursue a specific voluntary research project submitted in a concept proposal by a Company, the Agency will enter into a MOU with the interested Company, or where appropriate, a single MOU will be entered into with multiple Companies. ATSDR recognizes that two or more companies or a consortium of interested firms may elect to enter into collaborative efforts in pursuing one or more concept proposals. Following the signing of the MOU and prior to the initiation of the research, the interested Company will negotiate with ATSDR to agree upon an approved study plan including testing protocols. The content of the MOU is described below. (1) Identification of the party or parties comprising the Company which enters into the MOU--this section consists of the name and address of each party responsible for the conduct of the research. (2) Identification of the substance(s) subject to research requirements under the MOU--this section consists of the name and Chemical Abstract Service (CAS) Number of the chemical substance(s) that is the subject of the MOU. The chemical substance(s) to be tested shall be as pure as reasonably can be attained. Alternate language will be substituted when the subject of the research is a human population, as in epidemiologic studies. (3) Identification of the effects or characteristics for which research is to be conducted--in this section, the health effects, environmental fate or other characteristics for which research is to be conducted under the MOU shall be listed. (4) Schedule for submission of study plans, initiation of research and submission of interim and final reports--the Company shall submit to ATSDR a study plan for each test six weeks after signing the MOU. The study plan shall include test protocols and a schedule with reasonable timetable and deadlines for initiation and completion of each test and submission of interim and final report*. The teat protocol* will be reviewed by an ATSDR-eppointed peer review panel If ATSDR disapprove* the study plan, it will inform tht Company of the defitiendee of the plan. The Company may request reconsideration of the study plan, resubmit a modified study plan, or elect to terminate the MOU with no further obligation of either party under the MOU. In the event that the Company resubmits a modified study plan and ATSDR disapproves it ths Agency may elect to terminate the MOU. The starting date of the research project may ba negotiated depending on the type of research being conducted. However, as general guideline, ths research effort shall be initiated within eight weeks of ths approval of ths study plan end attendant test protocols. Written notification of the starting date of the test will be submitted to ATSDR by the Company. The completion date of the study will be established from the approved study plan. Interim progress reports shell be submitted to ATSDR within six months after ths initiation of tasting and thereafter within six months after submission of each previous interim report Ths final report on the results of testing shell be submitted to ATSDR no mors then 20 weeks ____ following ths and of the study. ATSDR acceptance of the final report will be contingent upon approval by ATSDR following the peer reviewers' recommendations, consistent with CERCLA section I04(i)(13) peer review requirements. All results of research conducted pursuant to the MOU end all supporting data associated with the research report will be provided to ATSDR end made available by the Agency to the public as pert of its implementation of sections 104(i) (3) and (S) of CERCLA. Final report* will not be accepted if the date is designated Confidential Business Information (CBI) or otherwise restricted from public disclosure. (5) Modifications of study plane, guidelines, and schedules--if e Company intends to modify e study plan, protocol or schedule that was approved by ATSDR. it must notify ATSDR in writing of the proposed modifications and reasons therefor. If ATSDR approves of the modifications, the time schedule established for completion of the teats shell be re negotiated and appended to the existing MOU. If ATSDR disapproves the Company's request and the Company does not accept ATSDR's decision to disapprove the modified study plan, the Company may terminate the MOU. (6) Observance of Good Laboratory Practices--all research agreed to in the MOU shall ba conducted in accordance with the Good Laboratory Practice (GLP) standards codified in 40 CFR 782, to the extent that such CLP standards apply. Should tha Company's Good Epidemiology Practices be relevant to a ressarch prelect, tfaoss Practices should be affixed to the study protocoL (7) Inspections the Company shell ensure that an authorized employee of ATSDR is permitted, at reasonable times and in e reasonable manner, to (i) inspect any research or testing facility that it conducting research pursuant to tha MOU. and (ii) inspect (and in the case of records, copy) any records and specimens required to be maintained in connection with research performed pursuant to the MOU. (8) Submission and publication of date--ell data end reports submitted to ATSDR pursuant to the MOU shall be sent to ATSDR. in duplicate, at the address indicated in the aoomssu section. Acceptance of the final report is contingent upon approval by ATSDR following the peer reviewers' recommendations, consistent with CERCLA peer review requirements. The Company maintains all rights to publication of date and results, however ell results of research conducted pursuant to the MOU and all supporting date associated with the final research report will ba provided to ATSDR and mode available by the Agency to the public as part of its implementation of Section 104(i)(S) of CERCLA. The final report will not be accepted by ATSDR if the data is designated Confidential Buainesa Information (CBI) or is otherwise restricted from public disclosure. (S) Payments of costs end expenses-- each company shall agree to pay all coats, direct and indirect associated with the research programs snd which are not considered pert of ATSDR's administrative costs. (10) Events constituting a breach of the MOU--Failure by the Company to: (a) Submit a study plan that receives ATSDR's approval following the peer reviewers, recommendations: (b) Initiate any test agreed to in the MOU by the date established pursuant to the MOU; (c) Adhare to CLP standards, established teat procedures or accepted practices of good sdence to the extent that these standards snd practices ppfy; (d) Submit any interim report required under the MOU by the date established pursuant to the MOU; or (a) Submit any final report that receives ATSDR's approval following peer review conducted by the Agency, shall constitute a breach of tha MOU. In tha event of e breach. ATSDR will not imput any to damages, but at tha Agency's discretion may terminate the MOU. (11) Termination--since the MOU is entered into voluntarily by ATSDR and the Company, termination by ATSDR i* not considered reviewable agency action pursuant to tha Administrative Procedure Act or any other applicable Federal law. and there will be no appeal GENC 005295 Federal Register / Vol 57. No. 28 / Friday. February 7, 1982 / Notice* 4781 procete beyond that let out in the MOU. The Company may elect to terminate the MOU at any time. (12) Statutory compliance--consistent with eection 10l(i)(l2) of CERCLA. as emended (42 U.S.C. 9612). nothing in the MOU (hall be construed to delay or otherwise affect or impair the authority of the President, the Administrator of ATSDR or the Administrator of EPA to exercise any of their authority under any other provision of law. including TSCA and FIFRA. or the response and abatement authorities of CERCLA. The results of the research conducted via this ATSDR Substance-Specific Applied Research Program will be used for public health assessment purposes and to reassess ATSDR's substancespecific priority data needs. It is the intention of the Agency, at this time, to re-evaluate the priority data need* for the listed hazardous substances every three year*. Dated: February 3.1962. Welter R. Dawdle. Acting Administrator, Agtncyfor Toxic Substance* and Disease Registry (FR Doc. *2-297* Filed 2-6-92. 945 am) Alcohol, Drug Abuse, and Mental Health Administration Suspension Uftad; Laboratory Again Meets Minimum Standarda To Engage in Urine Drug Tasting for Federal AOSMCV; National Institute on Drug Abuse. HHS. action: Notice. Summahv: The Department of Health and Human Services notifies Federal Agencies of the laboratories currently certified to meet standards of Subpart C of Mandatory Guidelinea for Federal Workplace Drug Testing Programs (S3 FR 11966) dated April 11.1968. The following laboratory's certification to engage in urine drug tasting for Federal Agencies was suspended on October IS. 1991 (S6FR 54982, October 22,1991) and was reinstated effective February 4. 1992. HealthCars/Preferred Laboratories. 244S1 Telegraph Road. Southfield. MI 4*034. *00225-9414 (outside MI). S00-32S-4142 (insid* Ml). FOR FUSTM8R INFORMATION CONTACT Mona W. Brown. Presa Officer. National Institute on Drug Abuse, room 10-A-39, 5000 Fisher* t-*na. Rockville. Maryland 20857; Telephona (301M43-8Z45. Rkheid A SOIMsda. Acting Director. National institute on Drug Abuse. [FR Doc. 02-30S5 Filed 2-4-02: 945 am) National Instttuta of Mental Health; Pursuant to Public Law 92-463. notice is hereby given of the meetings of the advisory committees of the National Institute of Mental Health for February/ March 1992. The initial review groups will be performing review of applications for Federal aeaiitancr. therefore, portions of these meetings will be doted to the public as determined by the Administrator, ADAMHA, in accordance with S U.S.C. 552b(c)(6) and SU.S.C app. 210(d). Summaries of the meetings and rosters of committee members may be obtained from: Me. Joanna L. Kiener, NIMH Committee Management Officer. Alcohol Drug Abuse, and Mental Health Administration. Paiklawn Building, room 9-105.5000 Fisher* Lane. Rockville. MD 20857 (Telephone: 301443-4333). Substantive program information may be obtained from the contacts whose names, room numbers, and telephone numbers are lilted below. Committee Name: Mantel Health Smell Business Research Review Committee. Meeting Date: March 2-3.1992. Place: Washington Marriott 122122nd Street NW, Washington. DC 20037. Open. March 2.9-1030 un. Closed: Otherwise. Contact Gloria Levin, room 9014. Parklawn Building, Telephone (301) 443-1367. Committee Name: Treatment Assessment Review Committee. Meeting Date: Merch 2-3.1992. Place: Embassy Suita*. 4300 Military Road. NW. Washington, DC 20015. Open: March 2.839-9:30 a.m. Closed: Otherwise. Contact Barbara Campbell room 90412, Paridawn Building, Telephone (301) Contact Doris lee Robb, room 9015. Parklawn Building, Telephone (301) 443-8470. Committee Name: Behavioral Clinical^ and Psychoeocial Subcommittee of the Mental Health AIDS and Immunology Review Committee. Meeting Date: March 11-12.1992. Place: Holiday Inn Chevy Chase. 5520 Wisconsin Avenue, Chevy Chase, MD 20815. Open: Merch 11.830-930 a.m. Closed: Otherwise. Contact Regina M. Thomas, room 90 15. Parklawn Building. Telephone (301)443-8470. Committee Name: Psychobiological. Biological and Neuroscience Subcommittee of the Mental Health AIDS and Immunology Review Committee. Meeting Date: March 11-12.1992. Place: Holiday Inn Chevy Chase. 5520 Wisconsin Avenue, Chevy Chase. MD 20815. Open: March 11.830-930 a.m. ' Closed: Otherwise. Contact Rehana A. Chowdhury. room 9015. Parklawn Building, Telephone (301) 443-6470. Committee Name; Clinical Subcommittee, Mental Health 5pecial Project Review Committee. Meeting Date: February 28.1992. Place: Holiday Inn Crown* Plaza. 66 Hale Avenue, White Plains. NY 106M^ Open: February 28.830-9 aju. Closed: Otherwise. Contact Gewn Artie, room 9-C1B. Parklawn Building. Telephone (301) Dated February 4.UK Psggy W. Ceahiffl. Committee Management Officer. Alcohol. Drug Abuse, endMental Health Administration. (FR Doc 91-3024 Filed 2-6-K 945 am] Centers for Bison# Control National Committee on Vital and Health Statistics (NCVMS) Subcommittee on State and Community Health Statistics; Cancelation of Meeting Committee Name: Child Psychopathology and Treatment Review Committee Meeting Dote: March 9-11.1983. Place: Holiday Inn Chevy Chase. 5820 Wisconsin Avenue. Chevy Chase. MD 20818. Open: Merch 9.9-10 un. Closed: Otherwise. This notice announces the cancellation of a previously announced meeting. Federal Register Citation ofPrevious Announcement ST FR SOM January ST. IMS Previously Announced timet and Dates: 1 p.m.-5 p.m- February 20.1992.9 a.m.-5 pm- February 21.1992. t 04/l5'92 14:26 2022606166 EPA/ECAO CVA *002 007 Mil wtttlnq sumary CATS! March 4, 1992 SUBJ1CT* Screening-Level Tasting of TRI Chemicals CKAXRMAVt Charlie Auer COODiXATORi carol Glasgow SUPPORTING DOCS.t Briefing papar on TRI Tasting Proposal BACKGROUNDI Tha RMl meeting was hold to discuss options for acquiring screening-level tasting data on high-production-volume highralaasa (HP/R) chemicals listad on ths Toxics Ralaasa Inventory (TRI). Tha goal of this effort is to identify and acquire a consistent minimum sat of screening data on tha HP/R TRI chemicals to help sat priorities for further tasting, assassm nt, and risk reduction activities, as needed, on TRI chemicals. HP/R TRI chemicals were defined by applying the proposed section 4(a)(1)(B) policy release criteria to the TRI list of chemicals (l.e., production volume over one million pounds, and release over one million pounds or over 10% of production). Th list will be adjusted to reflect any changes in the final published "B policy" criteria. The original list of 90 HP/R TRI entries, was pared d vn to 73 chemicals at an initial RMl meeting on April 3, 1991, by excluding the metals categories, inorganic acids and bases, and cyanides category. This list was reviewed to determine th availability of test data of various types. Data gaps for the chemicals were estimated from a matrix, prepared by OPPT's Health and Environmental Review Division, showing the availability of endpoint data on TRI chemicals (attached). This document includes a discussion of the method used to construct the matrix; judgments of data availability and adequacy would need confirmation to support formal section 4 rulemaking. The list was annotated to Indicate high-priority chemicals included on the CAA's Air Toxics list (5 TRI chemicals), the Superfund Amendments and Reauthorization Act $110 (ATSDR) list (10 TRI chemicals), or sehikhiled for handling under phases 1 to 3 of the Organization for Economic cooperation and Development's (OECD's) Screening Information Data Set (SIDS) program to obtain screening-level testing on international high production v lume chemicals (9 TRI chemicals). The resulting table (attached) was considered at the March 4, 1993 RMl meeting. GENC 005297 04/15/82 14:28 202280*198 EPA/ECA0 C%A 001 007 2 Decisions/Racommandationn a. The SIDS test set was selected for tha TRI screening effort. b. . For tha 9 TRI chemicals being handled under tha OECD's SIDS program, there is no need for action at this time beyond that which is underway with OECD. c. Fourteen (14) cheaicals are high priority for testing under Che Air Toxics and ATSDR efforts. Pending development of the testing needs for these chemicals under those efforts (principally health effects and some fate testing), they should be included within th TRI screening testing effort for those endpoints (m st likely ecotox and possibly some fate testing) not covered by these other programs. The chemicals identified for the TRI screening effort should be added to the Master Testing List. d. The remaining 64 chemicals will be handled as described in (e) and (f). e. A SIDS "dossier" (KFV form 1) needs to be prepared for each of the chemicals to summarise the available data and to match data gaps with the SIDS test set. Options for this step are: 1 * Approach industry about voluntarily handling this responsibility, either independently or as an adjunct to the OECD SIDS program. 2 - use ZPA contractor resources to determine the availability and adequacy of the data. f. Following this step, testing needs to be undertaken to provide a full SIDS set on the HP/R TRI chemicals. This could be realized via voluntary testing link d to the OECD SIDS effort, one or more consent orders, or a test rule. No decision was made at the RK1 meeting as to the course of action for obtaining the testing. g. Following discussion with industry, item (e) (SIDS dossier preparation) should be initiated in son form, after which steps will be taken to ensure the development of the needed SIDS data using one or more of the options noted under (f). GENC 005293 hoo oo a z u r" V' 9 t* UUl Y** M* A* Ul ft*'*9)'/ iHin iilitH Invmtory (ltl) OmMi 9ra4*a4 at *"* f"* "< **<" 1 ! (rtli, 1 i (cl* kMN i cyailiw tin Mtlatai fra ito Initial I (at In tfea f(rat Ml Mtht)) 49III4C >1 1MW.' MS 1-MU 1,1,11111 KC14M19ILI rff" 1,914,444 S.MS.MB ur.iu.iM 20.419,999 8,M,W M.MS.MS a,M,m 2.444,10 41.UI.M4 9.MI.MT 1,714, H4 W.SU.M9 9.141.44$ 41194 941199* fiHP M9ICIT9 HW* 229 * * 294 291 m 99 9* / 1* 44 * 199 199* 4* * * 4 91.91 Cl.t.l.tf 99f.91.il c.at.at.M.ci.K 9M.91 fiLf 9M.C1 941 91.91 C.M.9V,4V,M,91 M1.4I.Ct M1.CUJI.9f tLuufiuaxn M1.fi 9f,if,CT.M nw Mall taatai 10-yrferity 4IM4 1 4 iMmIiwI MtrpM 994 Mh 14 UaUral 9npaaal MM yrlarlty 4fM4 Ctafaaai 4 MM prlartty 41M4 I 4 t4talcal CMC* 79aaa 2 I 4 aSaalcat 410 friarIty 41M9 Ip-trltriti 41M9 9M4 99aaa 2 IMMHW2 o fi /V ' ^ miccmm MM CMMM IIMMK MMin nantac mim nmnwt NomM mim nowmu itai-aum M.i 119,941,144 99.9U.4U 1,979,492 2,974,791 2.494,414 12* MUI.C1.9f 129 * C.4f *9 *4 9,41,91,41,0,91,91 MIM phUlf 4M99 410-frferity CM 1 4 (4m)cal, MB 4 dwalcal "1 o GENC 0 4 /1 5 /9 2 14:29 O 20J200410* E P A /tC A D -- CIA 8|00& 00 $!n 10.oo2.orr n,m,m0 3,30.012 W* Mlt, 1.00.042 1.00.04 0.01.01 4,430,127 0,100,00 O,W,0 t,m,m I.9M.SW s,r.ao o,0o,m 0.H2, m 0,722,119 31,211,111 1.10.7a 210,031, 240 4,202.04 -2- c.ir.tf.H.n.n 01,Cl OC.M.H uu jju U U CfC; ntmiw tn(i"l Or Wotfi IW0M1 mjm c,oi.oi.n C,0I,01.0I.CT,M C.OT.OI.Of mjujujm C.01,01 Mi,n K,n^i K^n.n 01,01.01 M1,CIJO 01,01,01 M u.n.ti n C.01,01.01,01,0 c.oi.ii.oi.ot OC,01,01,01,Cl 0,11.01 0T.tLWU 0.oi.i,oi iwn4 2 0l*pHr1ty 0100 I 4 dMrfcol 05: 00  a o 33 Si MIAMI wn JVV-` J// ` ^ MIAMI Z-AEIMTEIMAAl MilAM liiaamnwan /5w-0 ^ AAttMAir cmwHK' ^ //,, '6 ; V 1 J Vr . 1 /r ' t * /V ' AAA11Hit tlttMIM M11M71 MtalM* AAAIITAir AKI-tlMtUni MM MAPI AAAUMt t ,1,4-mcataMMMI s,;x iT' - 1l.Mt.il* I.IB.1TI i.ma.cas I2.M1.49I I.M.JW O.SM.Ati I.M.M t.MMAt iji Hz / -3- At H AC C.At.AI.Et AC.AT.lt MZ CAT C.*tatt.AT,CT. c^t.tt^tt.ct.at.ct M* * MS AM.tlJH.IJt "^T.At KaT.*1.AT.CT,*l t.n.At.a.At^v H t.n 22* M AI-AT-AI-CtJ c^tair^fan(it 2AS AC.At At At.At.At at * AAT.CT t 4 chantcal; hf*h-*riarltr CAA 1 4 chantcal, final In ******** MAC thaaa 2 Algb-Artarltp AIM I4MM AM thaaa 2 AM thaaa 2; M rarlan II* *rt*rlt* CAA M*-*rtarlty AIM Ml M AM Mm* I| 4 chadcat 1 4 HiM lit UU 1/U U C,Af.tT.AT.AIan CM X>* C.ai.tf.Al.CT.AT C.AT.Cf.At.Ef Ml 3a n r talc Mctc i taalatry i |Im hatan ara tha prlarlty n3H attar A* > aaan Car lint teatin*- A arima In tha aaiunt ilalfln that (ha tat thta tlat. t> Ctaan Air Act chaatcata. A ptua In tha cattail hatan Inritcata* Hhattar thaaa ara llatat hi tha CM far taatlng, a *a*a*4 ptM racaM a prlarlty far taatlas. * tha fnfarnat Ian prnaMaC in tbta catan uaa takan Iran tha taata (ahalliaCl. tact Ian 111 1wildly ftatria Hat fr i, ar Itw tha Hat at ATM prlarlty C * Wncaaanictty U NA 2 r GENC 00530! 14007 007 -4- 1 iMtqmlil Iwldtr *1 lyiitatiw laalctty M ami* talcity CT chranlc laalcttr n - tourataalcitv Cl CnalraMaadal taatcity W * ^w^4a. MmIIM hr MM N DtaM lM*?i|klMtlcs 1 hwMwlc)ly Mrti iNhnrtla MMMt hr CTh tattoi 4 M M ndw d ' *hM ctadcda mbtb iWi< irwm IktllMd cMn() ta ha laMl hr Mm * taatb* r^drad m rrml hr M, ad tha rMhaMpM* * MMd Far hawdl In why iht ladtortad |*mm d tha hr--rtwtt-- far Fraan IU, I a# Midhr pdlll ^ uu L\] If (j -- CA' EP.VEC.4D 0 4 / l & 'i 2 14; JO 2 0 2 2 8 0 4 1 6 8 GENC 005302 f SUPPORT DOCUMENTATION FOR THI SARA TITLE XXX. SECTIONS 3X3/322 TOXICITY MATRIX Fraparad by: Claaant Aasoclataa, Xac. 9300 Ua Highway Fairfax. VA 22031 Auguac 17. 1911 TXGTSlATTVt RAOtGROOMP The Toxle Eaission* Inventory was established by Cen|rm under Title 111, Section 313 of the Superfund Amendments end Reauthorlsation Act (SABA). Tha Inventory is conposed of chanicals on cho list appearing in Ceslttee Frint Number 99*169 of tha Sanata Committee on Environaent and Public Works ontitlad Toxic Chanicals Subject to Saetlon SIS of tha Emergency Planning and Counity Right*to'Know Act of 1916." Tha Inventory includes tonic chanicals originally listed under tha authorities of the States of Bow Jersey and Maryland. Any parson aay petition tha Atelnistracor of the Environmental Protection Agency (EPA) to add or delate a eheaieal fron the Invontory. Chanicals nay be added to tha Eaisslons Inventory If tha Adalnlstrater determines that there is sufficient evidence to establish that the eheaieal is known to cause or can bo reasonably anticipated to cause one of the following: # Adverse acute huaan health effects at levels reasonably llkaly to exist beyond site boundaries as a result of continuous or frequently recurring releases; Cancer or developmental toxicity or serious or Irreversible Reproductive dysfunctions, Neurological disorders. Heritable genetic nutations and chronosomel nutations, and .- Other chronic health affects; or effects on the environaent caused by a chemical's JWnieity, Tjxieity and persistence in cho environaent, and Tjxieity and bloaceuaulaclon In the environaent. I 1 PROJECT FEOFOSAL Section 322 of SARA Allows manufacturers sad processors Co declare ehemiqgl identity crodo secret sad further roqulros choc whan a chemical identity is declared trodo oocrot, EFA oholl Identify tho adverse boolch and environmental offocto casoclAtod with tho toxic chemical. In providing this hazard Intonation. I7A is obligated to provide this infonotion in a aannor in which trade secret information can not bo revoalod. Description* of tests, effective dose levels, citations, end certain other information are believed capable of fingerprintin** chemical Identity. and therefore, these types of data can net bo provided in fulfillment of Section 322. In an effort to analyze tho few available options possible under Section 322. the A*ency utilized tho results of an early screening exercise conducted by ETA in October 19SS to capture and describe the rationale used by Hew Jersey and Maryland in the development of choir respective lists and developed an expanded toxicity data matrix for tho combined list of 329 toxic chemicals (ETA 1987). The matrix was intended to identify those adverse health and dnvironaental effects that have been reported to be associated with each toxic chemical. For the purposes of analysis, chemicals wore separated into the EFA * trade secret categories proposed In the Federal teglster notice of June A, 1987 and listed by CAS registry lumber and name. The health and environmental endpoints iarffcft* in this analysis were limited to those indicated in Section 313: carclimSj&clty, heritable genetic and chromosomal nutations, developmental toxicity (including teratogenicity), reproductive toxicity, aeute and chronic toxicity, neurotoxicity, envlronmen'al toxicity, and persistence end bioaccumulation in the environment. 2 GEHq 0 05.305 Th* original toxic ley aatrlx w au^ary pruinutlM of Information publicly available through number of oeeooolblo databaaea [Haiardoua Subatancea Databank (H3D). XTICS. GtNtTGX, MQD1U. IHV1I0FATI. Log F database, and CHEHTXACX]. Agent* for which available data auggeeted auffielent evidence choc txposuro to tho |int potentially roaulto In or la "reaaonably anticip*tad" to roaule in ono or aero health or environmental offoot war* Indicated with an *X* In tho appropriate field* on the aatrlx. Tho abeence of an *X* for a particular health or eorlronaeatal offoot did not auggeat that a eheolcal la not a potential huaan or environmental toxicant hut that cither data to aupport a concern war* not available at thla tin* or that the available data did not auggeet aufflelonc evidence of potonelal toxicity. Tho aour e(a) of data froa which tho *1* vaa detarnined waa dooiaontad a* that It waa poaalble to alter tho Hat If now data arc Identified or if It vaa determined that any particular data aourco waa Inappropriate or Inadequate. Xt ahould be noted thae Cleoent did nee validate the data reported In tho databaaea and that one of the databaaea exaalned war* not poor reviewed. An *X* Indicated the availability of data relative to an effect; it did not indicate aoverlcy or validity of concern. Xn addition, a print number program waa developed with whleh an analyala of 'ualquenaaa* within each trade aecret category could be conducted. Thla allowed the Agency to deteralne whether It would be revealing trade aecre^flgtetlty by giving requeatera a category name and the apeclfie toxieltlea emanated with a apeclfie chenlcal within that category. Xn an effort to provide a uaeful tool la developing optiona for meeting e the requlreaenta of SAXA 322 and In dlaaealnatlng raeary toxlelty Information of releaaed chealeala, Cloaent updated the original toxlelty aatrlx eo enaure that the information presented In the aatrlx la confirmed, documented, and 3 GENC 005306 reflects currant Information and Agency decisions. This entailed assuring the Ageney that an "XB Is listed when appropriate by exaalnlng additional, recent soureta. of Information net previously examined when the original toxicity natrix was prepared. Further, the updated natrlx Includes a review of toxlelty data on eheeleal coapounds within ehe 21 Section 313 chemical categories defined by XPA (CPA 1917). PREPARATION OF TH1 UPDATED TOXICITY MATCH The health and environmental concerns examined are chose stated In Section 313 of SAHA [carcinogenicity, heritable genetic and chromosomal mutation, developmental toxlelty (Including teratogenicity). reproductive toxicity, acute toxlelty, chronic (systenie) toxlelty, nourotoxlcley, environmental toxlelty. tendency to bloaccumulate In the environment, add persistence In ehe environment]. The updated toxlcley natrlx is a icmary of toxicology information available In a mnber of recent review documents prepared primarily by CPA and ehe Ageney for Toxic Substances Disease Registry (ATSDR). These documents provided data from which to confirm that an *Xa is * listed where appropriate and to add an *X* to the matrix if the data suggest that there Is a concern. The documents reviewed by Clement include CPA Health Assesseent Documents, Drinking Veter Criteria Documents, Health and fn-1 rnninntafcgfacta Documents,, Health and Environmental effects Profiles, Ambient VatojSjtallty Criteria Documents, and Health Effects Assessment Documents and ATSDA Draft Toxleologleal Profiles. When am "X" was confirmed i for a e.ienlcal from data available in the review document, the original database reference was replaced with the appropriate document reference. If the original "X* could not be confirmed from data in the review document, the 4 GENC 005307 original diubu* reference u riulMd, a detailed discussion of chs criteria uiid to list i|sc for ooeb tndpolnt and thi ditibuii char war* originally s*areb*d follows. HEALTH AND EHVUONHEHIAL IHDPOIHTS For th* purposes of generating and updating eb* toxicity matrix for SaIa Sections 313 and 322, thresholds or 1inieacions war* oseshlishod for aaeh of cha health and environmental ondpoints ovaluatod. Thasa thresholds or llaicacions war* used to determine If tho available data potentially support coneem for a given chaoieal haaard. A. ClKlmtnlUB This eatagory provides Information on eh* taown or potential hunaa eareinoganieity of a ehaaleal. For this ondpolnt, an *Xa indleatas that th* available data support a eonearn for a ehaaleal'a eareinoganie potential if on* or nor* of the following applied: (a) A positive result was reported for that ehaaleal in ana or aore aniaal apoelas in an MCI or RTF blosssay; (b) Th* ehaaleal was classified by RTF as a known earelnegen or as a ehaaleal anticipated to be a earelnegen; (e) The IilC carcinogen classification for that ehaaleal is 1. 2A, 21, or 3 (jgOfe limited evidence froa aniaal studies) or the LAIC earelnegen cInvocation is huaan positive or huaan suspected and/or aniaal pocJE|s or aniaal suspoetad; (d) The EFA earelnegen elasslfleaelen for that ehaaleal Is A (huaan earelnegen). II or 12 (probable huaan earelnegta), or C (potential huaan carcinogen); or (e) Th* C*n*Tox earelnegen evaluation of that ehaaleal is sufficient positive or Halted positive evidence of eareinoganieity. 3 &ENC 005303 The RTF bioasaay result*, NT? classification, aad IAIC, EPa. and Cono-Tox classifications for aaeh agent art presented la cha toxicity matrix wdar tht appropriate column haada. Tha carcinogen bloassay raaulea and olaaalfleatloaa vara ebcalnad froa cha following sources: NT? bloassay resultsCHEKTlACX daeabaaa; NT? carcinogen classification*-NT? Fourth Annual Report on Carcinogens; XARC elassiflcatlon--RTICS daeabaaa, XARC Degrees of Evidence for Carcinogenicity la Humana and Experimental Aniaala and Overall Evaluetiona of Carcinogenicity to Huaanj for Aganta Evaluated In IaAC Monographa Volunoa 1*42 (1ARC Monographs Suppleaenc 7), aad Llae of NT? and IAAC Careinogana Issued aa Appendix to OSHA Frograa Directive C?L 2-2.3SA; E?A (Carcinogen Aaaeasnene Group) classification--CHZKTIACX database, IRIS daeabaae. Technical gackground Docment to Support Ruleaaklng Pursuant to CERC1A Section 102; and Cene-Tox carcinogen evaluation--GENtTQX daeabaaa. The NT?, EFA. 1ARC, and Cene-Tox carcinogen elaaslflcatlona are based on weight-of-evidence achenes in which the carcinogenic potential of a cheaieal is evaluated. The NT? bioasaay evaluation Is llnlesd to the results of carcinogen bioassaya in experimental animals conducted by NT? and reflect whether a chemical was found eb bo positive or negative In the bioasaay. B. Heritable Genetic and Chromosomal Mutation For ehlo endpoint, an aX* indicates that the available data support concern thaejt^ chemical has the potential to produce heritable mtetlons in human germ cmSt* Valid positive results from studies on heritable mutation events (of any kind) In gem cells.were sufficient evidence to Indicate a potential positive responso. In addition, evidence that aa agent interacts with germ-cell DMA or other chromatin constituents or that It Induces sueh endpoints such as unscheduled DMA synthesis, sister-chromatid exchange, r f GENC 00530? chromosomal aberrations la germinal cells u sufficient evidence eo indicate * potential positive response. The criterion. used eo indicate a poiltlvi response for on ogsne vu o positive result la one or aero of the following bioassays u reported la the rosuleo table for ooeh ehaaleal la eho 6DIIT0X diubaie or in the epproprloeo ooecloa of aa CPA or AXSDt renew docvaent: * (a) Droionhlla nalanofaetar sex`linked recessive lethal coat; (b) Drosophila eleneeeeter heritable (roelprooal) traaaloeatloa teat; (e) Mouse heritable tranaloeaClea teat; (d) Drsioohlle aelewaeeeter aex ehroaoaone gala/loaa (aaeuploldy); (e) Cedent doalnant lethal teat; (f) Unscheduled OKA synthesis. slster>chromatld exchange, or chromosomal aberrationa in germinal cells; and (g) Mouse specific locus teat (germ colls). C. Developmental Taxlelrv For this endpoint; aa *X* Indicates that the available data support concern that the ehemlcal la known to cause or eaa reasonably be anticipated to eause developmental toxicity In humans. Developmental toxicity la any detrimental effeet produced by exposures to developing organisms during embryonic stages of development aad Includes embryotoxicity, fetocoxlelty. and teratogenicity. The major manifestations of developmental toxlelty Include: (1) prenatal Bffbrly peatnatal death; (2) structural abnormalities; (3) altered g^vth (usually la the form of growth retardation); aad (4) functional deficits vhleh may include reduced pulmonary function, reduced immunological competence, neurobehavloral deficits such as learning dls rders or mental retardation, etc. The exposure period may bo prior eo conception (either parent), during prenatal development, or postnatally to the time of 7 sexual naturatlon. Developmental effects, however, nay be detected at any tine in tha lifespan of cht organism. la "X* Is Indicated for an agont if the available data provide evidence chat the agent predueea developmental toxicity at body doaaa of loaa than or equal to 1 g/kg/day. The KSDI and appropriate sections of the IPA and ATSDIt review documents were examined for data on the developmental toxicity of an agent following inhalation, oral, or dernal exposure. flhen neceaaary, expoeure doses were converted to body doaaa using the reference values for body weight, inhalation rate, water consumption, and food factors for each species reeonended by ETA (19*5). D. Reproductive Toxicity For this endpoint, an "X" indicates that the available data support concern Chet the chealcal has adverse effects on male or faaale reproductive performance. Endpoints of concern Include, but are net Halted to, effeees on gonadal function, estrous eycle, acting behavior, conception, parturition, lactation, and weaning. An *X" is indicated for an agent if the available data provide evidence that the agent causes reproductive dysfunction or reproductive dosage at body doses less than or equal to 1 g/kg/day. The HIDE and appropriate sections of the ETA and JgMR review docunenta were exanlned for data on the reproductive toxicity of Assent following Inhalation, oral, or dernal exposure. Whan neeessery, exposure doses were converted to body doses using the reference values for body weight, inhalation rata, water consumption, and food factors for eaeh species recommended by ETA (19*5). S GENC 005311 c. Acuta Toxicity For chit endpoint, an *X* indicates ehtt cht available data support concern chat there* com exposure ee che eheaieal by cht inhalation, ertl, or dermal route htt been determined ce etute detch. An "X" It indleteed for on agent if Che tveileble data provide evidence ehae the reported aedlaa of che lechtl concentration (lj0) f*r *k* *t*nc .following inhalation exposure for I houra or lata oat lata than or equal eo 5 og/llter (5,000 ag/n*); che reported aeditn of Cho lethal dote (U>so) f r the agent following oral exposure wat leat than or equal to 250 ag/kg; or the IDjq for che agent following dermal exposure wat lata than or equal to 500 ag/kg. The RTSCS databaae and appropriate eectlene of the tfA and ATSDt review docuaenta were exaalned for data on the acute toxicity of agenda <"50 " "50 valuta) In aamala following short*texm inhalation, oral, or dermal expoaure. When neeeaaary, doaea expraaaed in ppm were converted to ag/a* uaing the ideal gaa law (FVnXT). f. Chignlc Toxicity Chronic effeeta for the purpoaea of Section 313 (SARA) reporting are any ' adverse effeeta ocher than eaneer observed in humans or aniaala resulting from long*term exposure to a eheaieal. In chronic toxicity studies, animals are A by inhalation, dermal, or oral routaa for Thus the observed adverse effects are due to continuous or frequently recurring Insult of target organa with relatively o small doses or low concentrations for a prolonged period of time. An "Xa la Indicated for an agent if the available data provide evidence that the eheaieal produces adverse health effaces ec body doaea of loss than or equal to 1 g/kg/day following inhalation. oral, or dermal exposure for aori than 90 days. The HSDB and appropriate tact Iona of the BA and ATSDR review documents wore examined for data on the chronic toxicity of an agent. When necessary, exposure doses were converted to body doses using the reference values for body weight, inhalation rate, water consumption, and food factors for each species recomnended by EVA (1915). C. NturotoxlclET Neurotoxicity is any adverse effect on the structure or function of the central and/or peripheral nervous system related to exposure to a ehealcal substance. Neurotoxle effects nay be norphologleal (neuropathsLogical effects, bloehenieal changes) or functional (behavioral, electrophyslologlcal, or neurochenieal effects). An *XB is Indicated for an agent if the available data provide evidence that ehronlc (at least 90-days) Inhalation, oral, or dermal exposure to the cheaical is reported to result In norphologleal or functional neurotoxle effects at body doses of less than or equal to 1 g/kg/day. Reported bloehenieal changes in the absence of functional or histopethologieal effects was not considered an adequate basis for listing a ehenleal. The HSD1 and appropriate sections of the ETA and ATIDR review documents wore examined for data on the n^geotoxlelty of an agent following long-term exposure, tthen necessary, ax^ggnre doses were converted to body doses using the reference values for body weight, inhalation rats, water consumption, and food feet rs o for eaeh species recoBended by SPA (1915). I 10 SENt 005313 H. Invlronmantal Toxicltv Section 313 of SABA allow* cho Agency eo add a ehoaleal to cha Inlaalona Inventory if It la known to eauao or can raaaonably bo anticipated to cauae a aerioua, algnifleant adverae affoct on tha environment. Tha Judgment nay ba baaad on toxicity alona er toxicity and a eonaidaratlon ef althar peralatence in tha environment or tendency to bioaecumulate la tha enrlronaont. Tha roT< riry Atrix contain* information on tha acuta toxicity, bloacetaulaelon, and perslatenea of an a|ant. An LCjg value af laaa than or oqual eo 100 ppo waa conaiderod to iu||tit auffielent evidence that a ehoaleal la a potential environmental toxicant. For aquatic epeclea. an *Z" la Indicated for an agent baaad on onvlronaoncal toxicity If the available data provide evidence that the reported LCJ0 for an agent- for laaa than or equal to PC houra la leaa than or equal to 100 ppm; if ehe reported LCW for an agent la laaa than or equal to 100 ppo and the eheolcal hae a half-life of greater than or equal to 4 daya: of if tha reported IC}Q for an agent la laaa than ar equal to 100 ppo and tha ehenleal haa a log bloconeentraelon factor greater than or equal to 3, a neaeured log P of greater than or equal eo 4.39. or an eatlooted log t of greaeer than or equal to 3.3. The envlronaental toxlelty eolun chat Indicator LCJ0 valuer of leaa than or equal to 10 ppo la Ineluded In tha matrix becauae chenleala that are reported eo hgqrlM valuer of leaa than or equal to 10 ppm are of greaeer concern aa pc^glel texlcanta. and chla Information may be uaed to aet prlorltlea for further review. The data In thla column are not Ineluded in eh algorithm analyala. Tha data for environmental toxlelty were obtained from ehe following data barer: AQU1B1 (acute aquatic toxlelty), ENV1B0FATB (bioconcentraeion factor*, half-llvea) and log F (neaeured log t value*) and 11 GENC 00531A fro* the Appropriate soetlont of cho l?A and ATSDA review documents. The aQUIM daeabaja contains raviava of aquatic toxicity atudiaa and ranks che reliability of aach aeudy on a oealo of 1 to 4. * study rollabllity of i lndicataa that tha aeudy ia reliable, rollabllity 2 Indicates that tba study la generally satisfactory, rollabllity 3 Indicates that che study Is not reliable, and reliability 4 indicates that the AQUIXI entry is a review of a study abstract or euaary froo a foreign paper. Tha reliability of the data obtained fron the AQUIRI database used to detornino an aX" for an enviromental toxicant is doevaented on the natrlcos; when possible, the asst reliable data were used to determine an "X." DOCIMINTATIOS The sources of the data found In che toxicity matrix are documented (coded) so that it is possible to alter the list If now data are Identified or if it is determined that any particular data source Is Inappropriate or inadequate. 4 list of notes detailing the sources of data and the XT?, ZAXC, X?A, and Csne-Tox carcinogen evaluations accompanies the toxicity matrix provided to tha Agency. ftATA SOURCES For thv'jps^mraclon of the. Initial matrix, a number of databases wore searched for'tjgm that met the appropriate criteria to lndlcato a positive response on che matrix for an agent. The search strategy for each database is o presented below. Sard copy rf each of che database searches and cho appropriate sections of each I?A or ATSDR review document were manually reviewed for health or environmental data chat met the XfA-proposed criteria 12 GENC 005315 for a pealelve raaponae. RTECS SEARCHING SYSTEM (VERSION t.S/14.2 JANUARY 1*M) The RTECS databaee vu icetini and aoarehod for IARC earelneten elaaalfleatlon and aeute toxicity data (oral or dorsal LDjq or inhalation "50>- CEMETOX (VERSION 1.3/2.0 AUGUST IfBA) CENETOX vac aeeoaaad and aoarehod for cho roaulta of blouityi indicative of heritable (onocle or ehronoaomal mutatlona. Tho roaulta cablo la a tumary of genetic aaaaya conducted on eaeh ehooieal and cho reported roaulta. In oddlclon, cho cablo provided cho Gone-Tox carcinogen ovaluatlon. AQUIR1 DATABASE (VERSION l.d/3.0 APRIL 1915) Tho AQUIRt dacabaao vaa aeeoaaad for acute aquatic toxlelcy. Tho number of oncrloa vaa United to thoaa oatrlea that reported leebal eoneoncraciona (LC50 voluoa). Study rollability and oxpoauro reglaen voro alae roportod. ENVIROFATE (VERSION 1.3/1.0 APRIL 19S4) Tho ENVIROfATE databaao vaa aeeoaaad and aoarehod for bloaeetaulatlon * (bloeoneenttaafodk factor) and poralatanea in tho environment (half*life). hazardous SUBSTANCES databank o HSDB vaa auarehod for roportod Information on developmental toxicity, reproductive toxieiey, chronic toxicity, and nourotoxieiey for oath ehooieal. Tho toxicity excerpea and toxieiey valuea flolda reported daaerlptlona of 13 studios in which eh* toxicity of **ch ch*xlcl vu exaainod. LOG P UTA1ASI (POMONA COLLEGE AMD TECHNICAL OATAlASE SERVICE, XXC.) For **ch ehealcal on eh* BalesIons Inventory for which * bloconcentracion faetor chat aac eh* acceptable criterion waa aoe found, eha leg P daeabaaa vai searched. The log P is the log of tho octanol/vater partition eooffielone which has been eorralaeed with bloceneencraelon. CHEHTSACX (TESTING STATUS OP CHEMICALS OH THE SAHA 313 UST PKOM THE TESTING PRIORITY COMMITTEE DATABASE) The CHEMIRACX database for the Eaisslono Inventory cheaicals was supplied by eha task aanagsr. Mark Townsend of EPA. The database was annually searched for eaeh ehealcal for the EPA (CMS) carcinogen classification and NT? bloasaay results. MATRIX ANALYSES The nuabsr of cheaicals llstad under each endpoint Is suaaod and presantsd on the last line of tho table. If eh* 'Lotus spreadsheet is accessed with autoaatic recalculation (a feature of the Lotus prograa), the sta of the cheaicals under each endpoint will be autoaatlcelly recalculated to reflect eh* addition or deletion of a positive response or the listing or delisting of cheaicals. Aafctalysls of `uniqueness" was also conducted for the aaerlx to dec#rain* uniqftr patterns of eoxleley. Each endpoint exeept for onvlronaeneal toxicity based on an LCjQ value of .less than or equal to 10 ppa (envlronaental toxieley coluan 1) was assigned a prime nuaber ether than 1. For each ehealcal, the algorithm assigns the appropriate prim* nuabers for each recorded positive response and aultlplies the series of prime nuabers. Hher* no QENC 005317 positive response u recorded, the number on* (l) u uil|n*d for chat endpoint. Similar patterns result In identical values; unique patterns result In unique numbers. The results of this analysis are presented la tabular format in a column at the far right of each table. If the Lotus spreadsheet la accessed with automatic recalculation, the product of prime numbers will be automatically recalculated to reflect the addition or deletion of a positive response. CONCUJSIQHS It should be noted that there are Inherent lladtatlons In the use of the information provided In the toxicity matrix, txlstlng databases were used to conplete the original matrix. Some of the Information contained In the databases is not peer*reviewed. `Toxielty data In the matrix Indicate thee a particular endpoint was reported following exposure to given chemleal under certain conditions. However, no lnformstlon la provided regarding the severity of the effeet, the number of species in whieh the effect was observed, the appropriateness of the study method, or whether there are conflicting results. Determination of overall hazard potential will require review of available infornatlon and the development of ehemlcal-specific hazard assessments. fjErafflCK ENVIRONMENTAL PROTECTION AGENCY (EPA). l85. Reference Values _or Risk Assessnent. Environmental Criteria end Assessnent Office. Cincinnati, Ohio. Septeaber 1985. ECA0*CZV*477 ENVIRONMENTAL PROTECTION AGENCY (A>. 1*87. Tonic chealeal release reporting; covuaity rlght*to*kaov. Pod. Reg. 52:21152*21208 (June A. 1987) 16 6ENC 005319 TOXICITY NAIUX GENl 005321 Sactien m iMltilr Mtrlc ItoUrt IncluM) ra 2 / uni i\m i issitu i ill{ "W > v' ft cft c o' ? **/ v" y -<Vo' < * S' ,, Vi y v?: >>* II I iha I rw irmiMi 1:11 I El I fediiwwiw imutii ft.v ** ,v JF M:::l i mm m* S KA > MA i I t [ MM IrMMvMl Ir left I I I- I. ' A' r ,*<)1 /? i *2 ? >!> II I IM * I. I twylllw cMerMt (INKni IwylllM llwMi (WHWI hryllha MrwiHi itlUIUI) Mryltlw nitrate (IH5H| Mrylllw eel* Icytlim matin ItMMMn wylllai MltMi IWIMMI Ilac taryltt* cllleele IJNIWII HI MW> clUMrUlfc--I Mr* acrylate a-Myl alcafcel MC-Cuayl CeM tert-Myl elcahel Mfl kmylfMMM. I.Maytac eel* mtp M2 I t tMlIn St) talilif NMrla Ihlwmci M loci 4* ' !> ." <i .* c 1 J* v** K5* fAt ft f ; i >^ <- 5* i<* <> ?i* o` /^/<f f** <? *; ,,><* <? ff S* * /- ? * t S 4? jkc f <t >* till I I I III urn NHttl WWW a c.i MM C.I, MM C.I. MM N9I|CUM tilMHIIHM i Mil t MM WSH C.I, C.I, MIcMI C.I. . MIm I C.I. IMH U. IMI fell j> tnaj IINM UM* imi C.I. C.I. Mwl Mt M c.i. MM Mllwl c.i. wm Mia! ill Ir fMNMI IDIKJII i OMMMII a CS a a a a a a a aa > u ai l a ai m aM a a la inn tMiir IUMI HIM nm CiliM MIM tit P /W /#c* ** f * r 1 I Ml Pan N * Ia *h an mM sum CklarlM CMavtn* Dal alWMCilW i<mmm Is In hi II --IL1 --Pr -ITi -" la n a * Ml |l Ml GENC 005323 Wet Ian Ml laatelly Mrli IMtrwca 4at IncluMI thpai. MU. Jt* J ? *.V **' c< * A4* * I <3 A* ///////// / / // /////jf v if, v f \.f i' Ii .-aMl, i ii * <* / +* *i y v' v4'*, / ii i 1iiii i1 , aSs' . I1 i1 IWM ttlif*awllm MU CMareathana 111444 MUt-WmMM mn i turn MaldMi Wtll'CM iri-timnw ur Nrt-tl L PL-f-u aaTn mmT >NttfiS mm |a nccsl | la awctl I la atccsla am I a aw i ir (>aaaaaamiiMtauMMaiitaaaaMM laaac. a aai Svscs, a aw a aw a air cm Calc hat lilhlw trmmt la (nWHI i* oimmi oumM) trmmt cfimu a ata a anaa a aai a m cmm> uc line IMm rtraaMtai 14444$ |)t*m wnv mm inn IMUI 4/V7 It4im 7 Wit44 yCraaal Craaal MrmwiMl C^Cartan cyani CrtlaWaana 7.4-0 M Wcakran 0itlM LI I a mm r- tit:|a aneap am |a tm |a am |a ate |a almja m ^ i((r^ S R: la atm a Mm|a anaala aimia im| a am I a mE m la aao a am I I | la f fa a |a am J I air la am fa am btf-JC 005324 t. rm a AtMM MnMir WMH wnr mi Mt Mint IWUM mi nm I i,i-wionmniiiM ! mi ir !* Mil MM um man M I1HII tan iimi MipaqMM HtdMMtMlM umm mUmi mi-ii>ii>MiUM>iiiit iifm rw mm rrm Mill IIMtl M k|*Nl liiMm tliMtk|ilari MltMlqrtntliM rr*! /4 J ' +JP ulibicu|cun j1 jr II I* K0 ^ // * <// / 2> ,/O'* <?f / / I ill E\El\F EiF II I C A i la ! GENC 005325 la la \ I % a ct a mi a tact tan 111 laatrtty NMrla (tafaranca *ti ImIiMI * I : M NMM unit MU NN HU la 4.4*-la HSMfl laa* acatala (IMMII MtMari* tHWH) taal Uaata imtMtl Itaialuala (MWM iaMMMaHUUm u!mi i rtMarMa OIMU ttraaMi lUimf) DUI mm nt-i tails MMtU mil MU* Natty* acrytaaa Natkyl tart-batyt Natty* ttkyl Mai Nttttyl Mratlat Bt .* y '' .< / ^ ?' // ** `/ (0l f i | // / 'J* 4J J ; laV // j? '* '* */ -* II I I I I* K I |B M| M | |B MM | ;:V /* *.*% -.*V*> t j* -5 , * 5m /J- / A* /> ' } ^ 0, |i atta |a ft MM* a B MM a mm a atm mm a atm a Mm a a aim a atm a au am la 1I I am a ua EZ.C =-FssISI.-i: -E sr "*C l\T-P f :m=f: U an Ut |a Mtr |a net GENC 005327 Mtttan HI taitllr wrta (hltwc* Jl,ltt ** ^ 2' 4 ,/ */4 * ?5* ? r * *# >c / / ^ ? J^. CAsV? * V V,* 0*,f S T .? .> -f i/ O i .*r ^ / S' g t% 7 + v * r? ? * 't 11 I II I I <* % *; <r? .f .y I t $ j;*s 5 j;>' 5$* nf* ** ? <* * <S / * tf * / * / o' / ; ^ ` v' i; .?* II imh mm ii MV) HIM I miif mmi--i Mi mm 4,4* mm mil <iicMr' ` unm IKK? mi liar* \ WKT NI|CUM4 "' ,iw*,,t*1: l l K I* I I I IIL ILL 1=1 Eit III f= n:n ! * la mm mtr i mmtta (tMDMl ictol imMI) cnnw) (MMH) tUWMW) NVcM MlvM* IDIWMI mm mi* oinmi Ictel wIMry MM MMlMt mMM* mm MMiuMi itmtmi llcM MIM* IflMMI wllMai mnn mm urn mvi mi niric km miriiMriKMif nt VllirrrmIiMm mic*hm *- MIUH Mlwm )1IU Hiram miM cr is IS |m it IS I Cl. la nml ^ i Simla mm ,s=s SSI. mJ" "``I' r " r -1 I GENC 00-532S iI tMtiw 111 teaIcily Mill (htitiM *I*m IkIiMI 4 /y /, ,* a' v .# S / // / / / *' / / // // / * i .?n .f / ^ */ / > <** J' f .fs /<? / / i? *nr~* I MSI |CUM ll l l l 1MM NltnylyMrl* II I-- I ^ 1 ^ it nmii w 11 ll" |" |t mat // .O : . n c ' .4 <S 4I i * 1 * / " A' ? * ^ * & .c . tO <Ci I MltlHIWtimtMM>--!--I :|l Ml ll Ml I MM If MM FPf-fi J_ .L II t =t it MM It Mil t* It Mir rmu* rui HHI IIMM IIMM UWI ItllM IHMt Merle act MuMwl MpM HltM Mrlr^lillctM If WO ill: f '14 -f it * It Man It* It ~f~ 1-1nf-iili mat 1 gehc ImIIm Ml laalclty BMrlm (Mwmi <> .V >ImIuM) 3* V ' o' *' ///V/ /////////?///?' /*J .f ? /. v' // // / / *^ -s7 ,v A c 5> j: 5* /f*>*fA# 4 // /,*<* *. ^<f * O man mnrtwa IMM nm IH MUM ItlMr ? * y v! " * v *% t *? .? 'i v. *r #*; I tSt|a*M II I I I III nnrr crrmrr u J itiu:=tai kk I U I l k k * k k ARM k l-l l. I I.HAHaaiiaBiiaaiiiuMaaMsauMiiUMasiMiiBi MR la a* I Rif Ml owns MMA IlfTM MMk as is H u- |a am IIM unit WIB ASM I.U.lIMIlw IMMt AIM* I1HM BMW *.** ffL KL.H Izm :Eiff ri'i'i a I HA A HA A HR WH AMttS Mini ----- VMM IrlcMwIn IIMI1 l,t,t'1rtdril -m Jla ra la au la ha irrI'll r brF=l"4:rl fcstssL-ta. bENL 005.-;30 Sfcliai sis Iwkllr Mrti nttWMN 4m (ml *. 11 J* * // / /// A** j? 4v s.** / / /" % O A 4 f / *>7 * */* ,5.O* 0^* q /_u <>if .%\ vo / .? J Vlii?^><? ;?.0<* V / < /" *.v / >- v' J y ,* " ' * * * A-f# / ? f vr * * i..................i....... L.LJ.......... *............ * lift i nut 1.1,1-lrtcM ------ IWM IflUlwilHil-- l,(,VI(lMt fvlilMralln SUM mu nsM MUl MM1S issanr Mir HUM wain m-Wftmm -- I(*ty<t~~ lb Hm r m__ Il Ml* |ISMISIS KlM I n l*vr IttflCUM Ur I I* le I I p f | |5 S | | s | E "am******** IS FFFI F3-.FFF I Ml Ml M r cuum-i-mu.EIC m |i isl mt* M nr III rt:l II t:t MA MIT MI Im, llwln It M M MM Im, 111I* to Mr Ml (Mr Mi 6EN'iCL 0 G 53.:; j rootaons to imio tancm mahix i 2A 2B 3 A A? AQ1 AQ2 AQ3 AQ4 AS ATSDR AWQC >1 >2 C XAftC classification. Sufficient evidence to establish ecussl relationship between tbo agent And huson cancer; sufficient btacn evidence and/or bo doto. Inadequate data, or limited doto of carcinogenicity in anlaals. 1ARC classification. Probable ovidoaeo of earclaogeAlclty to huaans; ot Xooat Halted evidence of earclaogenlclty in bunaas. IARC classification. Proboblo ovidoaeo of carcinogenicity to buBoao; tuffleloBt ovidoaeo la aaiaolo oad Inadequate dote la tnaaas. IARC cloAolfleotlOB. Chooleol could aot bo eloealflod oe to ito carcinogenicity in buaona; ehoaleeLo wore listed for eareinege&lcity if tboro was llaitod ovidoaeo of earclaogenlclty la oalaolo. EPA classification--Hunan CorclaegeB. Suffieloot ovidoaeo froa opldoaiologlc otudloo to support a cauaaI ooooelstloa boeveoa exposure sad eoaeor. Aalasl, positive. AQUIIU dAtsbssa (Version 1.i/3.0 April 1913, Choalesl laforasclon SystOB). Reliability 1 * rollsblo study. AQUlltX dAesboso (Version 1.i/3.0 April 1913, Chooicsl laforasclon Syseoa). Reliability 2 - geaorslly sstlsfAecory study. AQUIU dACsbsse (Vorslea 1.i/3.0 April 1913, Cboalesl Information Syseoa). Reliability 3 not rollsblo study. AQUIU database (Version 1.i/3.0 April 1913, CboBleal laforaAClon Syseoa). Reliability 4 abstract of a study or ouaaary of a foreign paper. Anlaal, suspected. wy for Toxic Substances Draft Toxicological Profile. DIP AAableat Vatb : Quality Criteria Dociaeat. CPA classification*-Probable Huaaa Carcinogm. United evidence of carcinogenicity In huaans froa epldeolologl. studios. CPA classification*-Probable Huaaa Carelaogea. Sufficient evidence of carelnogenielty la anlaals, inadequate evidonee of carcinogenicity la huaans. CPA classification--Possible Hunan Carcinogen. Llaitod evidence of carcinogenicity la anlaals. bENC 005332 CA CS -- DtfCD cv C HAD HXA HEED HEEF KF HS HSDB HSDS* LF logF F RTECS SF Cheaical consId*rad toy NT? to to* * known eorelnoton. Chonleol con*Id*rad toy NT? to to* * auapaet carcinogen, l.*.. My reasonably to* anticipated to too a eerelnogen. IfA Drinking Veter Crltarla Doevent. ENVXXOFATI (Version l.3/2.0 April 1914, Cheaical Infernatlen Sysco*). CENETOX (Vorslon 1.3/2.0 August 1914, Ch**le*l Information Sysco*). 1?A Haalth tffsecs Asseasaent Docuaont. EFA Haalch tffoots Assaasaant Docvant. EFA Haalch and lavlrovantal tffacts Dowont. EFA Haalch and Environaental tffacts Froflla. Huaan, poslelwo. Huaan, suspaccad. * Haxardous Subscsneas Databank (Available through TOXXXT of the National Library of Modlclao). Hazardous Subscsneas Databank (Available through TOXXXT of the National Library of Xadiclna). Effective doao not specified. Llaltad positive: Indicates results obtained In Can*-To* carcinogenicity panel tests show Indication of tuaor Induction but chat teats were too linltod to to* conclusive. log F Data toss* (Available through Foaona Collage and Technical Database Service Xne. 1913, 19SS). Indicates a positive response In at least ona anlaal species la an NT? or NCI bloaaaay. data base (Version C. 5/14.2. Chealcal Information Systsa). icl*nt positive; Indicates results obtained In Gene*To* carcinogenicity panel tests show Indication of tuaor Induction and that sufficient tests have been performed to bo conclusive. GENC 005333