Document DMD1jbYVZa5VQkG4JxzL3be7B

CHEMICAL MANUFACTURERS ASSOCIATION TO: FROM: EDC, VDC Panel Members Robert R. Romano u SUBJECT: Implementation of Title 1 Provisions of SARA DATE: May 22, 1987 The attached document was put together by Dr. Elizabeth Moran, Program Manager in CMA's Special Programs division. As 1-1, Dichloroethene (VDC) and 1,2-Dichloroethane (EDC) will be affected under the implementation of Title 1 of SARA, this should be important to you. Please review the document and provide comments to me within the next two weeks. I can be reached at (202) 887-1198. Formerly Manufacturing Chemists Association--Serving the Chemical Industry Since 1872. 2501 M Street NW Washington, DC 20037 Telephone 202/887-1 '00 Telex 89617 (CMA WSH) SL 063023 To From Subject Members of Affected Special/Frog^Anf/Panels Elizabeth J. Moran, Ph,D Implementation of Title ^Provisions of SARA The Superfund Amendments and Reauthorization Act (SARA), signed into law October 17, 1986, contains extensive new provisions on health related authorities which could result in enormous cost to affected member companies. The Agency for Toxic Substances and Disease Registry (ATSDR), which has primary responsibility for the health related authorities, issued its first notice toward implementing these provisions on April 17, 1987. The notice contains a list of the 100 most hazardous substances found at waste sites. For the first 25 chemicals, toxicological profiles will be developed by October 17, 1987. Profiles on the remaining chemicals will be developed over a three year period. Your chemical is on the priority list, and will be one of the first affected by the new provisions. The toxicological profiles will identify data needs which ATSDR has authority to fill. ATSDR has not yet determined the mechanism for filling data gaps. One possible outcome is that the cost of Health Effects Research will be borne by the manufacturers and processors of the listed chemical. Another outcome of the toxicological profiles is the establishment of a significant human exposure level (SHEL). This level would be used to determine populations at risk near waste disposal sites and could have significant liability implications. ATSDR has not yet determined criteria for setting SHELs. The April 17, 1987 notice does not request public comments, but does solicit unpublished key studies on the first 100 chemicals. Data should be submitted if they would "substantially affect the determination of levels of significant human exposure or the identification of toxicological data needs." The first 25 profiles are already in development and data submitted to EPA will be used in revisions. There will be a 90-day comment period following publication of the first profile; however, ATSDR has made no commitment to modify the profiles as a result of comments. Data submissions on the other 75 chemicals could substantially affect the outcome of the Agency's review and should be submitted as soon as possible. The first 25 toxicological profiles are being developed by EPA contractors and will be reviewed by both EPA and ATSDR and a three to seven member peer review panel set up by the contractor for each SL 063024 chemical. Contractors are instructed to start with the latest EPA review document and use more recent published data to supplement the review. What to Do We recommend that key studies, both published and unpublished, be sent directly to the contractor along with any nominations for peer reviewers. These nominees should have a substantial knowledge of a given chemical and must not have a conflict of interest. There is no guarantee that contractors will use data submitted or accept nominees for peer review. However, it is to your advantage to submit this information as soon as possible. A<list of contractors and assigned chemicals is attached. Contact your program manager if you wish to make a submission to the contractor. CMA's Hazard Assessment Task Group will comment on the format for the toxicological profiles and make recommendations for determining SHELs. If you have any comments on these issues, please contact your program manager. A summary of Title I of SARA and the April 17 Federal Register notice are enclosed. SUPERFUND AMENDMENTS AND REAUTHORIZATION ACT, TITLE I Section 110 SUMMARY OF HEALTH RELATED AUTHORITIES The Superfund Amendments and Reauthorization Act (SARA) added new provisions on health related authorities (Section 110 of Title I, amending Section 104(1) of CERCLA). The Agency for Toxic Substances and Disease Registry (ATSDR) has primary responsibility for implementing the health related authorities, with input from EPA's Office of Toxic Substances. Section 110 gives ATSDR and EPA responsibility in four areas: 1. Hazardous Substances List and Toxicological Profile A list of the 100 most hazardous substances found at waste sites was published on April 17, 1987 (52 Fed. Reg. 12866). The Act requires listing 200 substances during the first two years and 25 substances per year for the next three years. The initial list will set precedents for the criteria used in listing. For each listed substance a toxicological profile will be prepared which identifies necessary additional testing and establishes significant human exposure levels (SHELs). The toxicological profiles on the first 25 substances, due to be published October 17, 1987, will establish precedents for data evaluation, determination of data needs and methods for setting SHELs. 2. Health Effects Research Where adequate information is not available on the health effects or listed substances, ATSDR must initiate a research program that includes laboratory and other studies to determine short and long-term health effects. One possible outcome is that the costs of health effects research will be borne by the manufacturers and processors of the hazardous substances in question. These costs could be enormous and could dwarf current toxicological testing costs under Section 4 of TSCA. 3. Health Assessments ATSDR must perform a health assessment for every site on the National Priorities List by December 1988. A health assessment is a preliminary assessment of potential risk to human health posed by individual sites. The purpose of a SL 063026 health assessment is to help determine (i) whether the Precedent should take action to reduce human exposure and (ii) whether additional information on human exposure and health risks is needed. ATSDR estimates that the average cost of a health assessment is $4,000 per site. Cost of conducting health assessments may be paid initially from the Superfund trust fund and subsequently recovered from responsible parties. 4. Further Health Studies ATSDR may conduct pilot or full scale epidemiological studies based on the results of the health assessments. ATSDR estimates the average cost of a pilot study to be $30,000 and the average cost of a full scale epidemiological study to be at least $100,000. Like health assessments, the costs of health studies may be paid initially from the Superfund trust fund and recovered from subsequently responsible parties. All information developed in connection with toxicological profiles, health effects research, health assessments and epidemiological studies will be available to the public. The broad scope of activities that may be undertaken under Section 110 of SARA could have wide-ranging impact both in terms of potential testing costs and legal liabilities litigation costs. SL 063027 WPsubatinc** These eel the requirements of ton UAL as wall aa the general defining *"" health risk in : Hnridty and human atential of a chemical to afHasard Scoring Ranking Chemical Under the Toxicity Criterion step in prioritizing the eobiet u substance* was the >{ existing hazard scoring 1 the selection of systems atest applicability to the ng requirements in section V In reviewing different ng systems. ATSDR and i on the evaluation of the dng components of the exposure components of lystems were norireviewed '-ause they were considered ! in their applicability to lemical risk under section ion. various approaches for ig frequency-of-occurrence 1 for human exposure were tside the context of the mes. These different ire discussed more fully in xULE. of this notice. reviewed a number systems for their Disability to the ranking Dxicity. Three general types inng systems were g schemes, which use a nplex submodels to toxicological :s and environmental persistence of a substance risk number, which takes chemical concentration at ooint (dose) and the f an effect as a function of al schemes, which assign >seore to the inherent and physical properties of ind then combine the subie or more hazard score(s). classification schemes, chemical substances to tries rather than assigning i-scores. The defining y hazard category can be r qualitative and most e s separate criteria r toxicity, which could be ie a general grouping of tances on the beats of and EPA review of plicable scoring systems categories was a two- itially, scaring systems were aaaaaed toafcnxaate those systems that *a act faeaible becauae of large. site aparifir data requizamanls Us requited with modeling schemes). ac mat addmaed only aas type of toxic aflad (esuaily acute toxicity). Each cS ftaae lwg elements was cooaidarad to ha a allical hmitmtion of a partbslar adasmt far Ua use in the toxicity --ktwg of aabeteacae under section 110 of SARA. In addition, systems which address only one type of toxic affect ware eliminated from consideration. Hazard scoring systems not eliminated by the initial seamen were then evaluated in greater detail, baaed on the degree to which a substance s toxidty was duractarizad by each system, data quality and availability, the relevance of the scoring scheme for the toxidty ranking of hazardous substance* under section 110. and any methodological flews in the approach used to wmbine toxidty data. An ideal toxidty criterion ranking adteme should evaluate a wide range of toxic response*, distinguish between sdld and severe toxic responses, have a readily available data base containing peer reviewed toxicology Information, and use a relevant and plausible approach to combine toxidty data. C. Selection ofReportable Quantity at the Hazard Scoring Syttmn foe Ranking Substances Under the Toxidty Criterion Baaed upon a comparison of the strength* and limitation* of each scoring system reviewed, XjTsng ^yt bpa selected the ReportaEla Quantity IRQ) scorine schema for the taxidtv ranking of fttzardoaa substances under section ilb of saka The dU schema is described {nseveral Fsslam) Register documents (50 FR13450. 01 F& 34535. and 52 FR 8140). CERCLA section 103(a) requires that the parson in chaige of a vassal or facility notify the National Ramxxise Canter immediately wfasn than is a release of a hazardous substance in an amount equal to or greater than the reportable quantity Dor that substance. Section 102(b) of CERCLA establishes RQs for releases of hazardous substances at 1 pound, anlaaa other reportable quantities wsre assignwi to the substances under the Clean Water Act. CERCLA sacboo 102(a) authorizes EPA to adjust all reportabis quantities by regulation, and the Agency baa dona so for most of the 717 CERCLA hazardous substances. ATSDR and EPA selectad the RQ approach as a hazard scoring system for several reasons. It provides the moat complete characterization of toxidty of all hazard scoring systems reviewed by r.ln qpMi * farirad from famary. peer mntemsd hmatarn and aadi date akufay as pnceerad to a mUt farm fa all baiMitfiea ndntora frrptnT'T (tetenateathm af RQ health effad valuta amfidmtkteTtolheondaetion at data. TfaftQeaategayatea operates by corral*bag taotidty value* to a tiered acala of RQ vulnea (1,10,100,1000. and RflOO pi--lie). Pur purposes of preparing the first prioeity list of hazardous aubatanoea. ATSDR and EPA used the favaet RQ valaa (representing the most severe famm health hazard) for all candidate substaooes baaed upon acute menunellan toxidty. dtronic memiaatiin toxidty, and cardnogenidty. Hie agencies did not use available RQ values for ignitsbility, reactivity, end aquatic toxidty of the substances, bacauaa these criteria were not conaidend relevant to the requirements and objectives of SARA action lia Certain of the RQ health (fact valaes wan adjusted based on considerations of environmental persistence. The adjusted RQ value was the final figure for toxidty ranking under SARA asetion 110. D. Selection of a Data Source Relating to the Criterion ofFrequency-ofOccumnce The second criterion used by ATSDR and EPA to prapare the first priority list of hazardous substance* under section 110 of SARA was the frequency-ofoccurranoe of hazardous substances at NPL sites. The agendas evaluated various source* of data assodated with this criterion. Ideally, frequency-ofoccumnoe data would include standardized monitoring data from sites on the NPL and would contain sitespecific data on the frequency-ofdetaction and medium-specific location of hazardous auhataners at sites. Using these data parameters for guidance. ATSDR and EPA dedded to sat Contract Laboratory Program oat* for ransflan substance* undertfae frequency-qf-occurrence criterion. The CLP is an EPA program which auppmfe that Agency's hazardous waste activities by providing a range of stateof-the-art chemical analysis Servians of knows quality. Many af tbs waste sample* analyzed aa pert af tits inspections and rniaerilel investigations are part of the CLP. EPA's mitral SL 063028 idant guylit / VoL^SX No. 74 / Friday. Aprt 17,1987 / Notices mctaia and rovlde legally Jta. Therefore, araace and aonrporated ttvttia*. ted aunray of a LP survey) was program CLP. The CLP im, stratified i (ample* from lalyxad under i. TTta survey tentage of siteu i detected at t (i.e., and the centra tiona (e.g., toil, ). Data from 358 ipies were ' laboratory i computerized a addition, rganica have data from 1981 number of ; jf the priority a survey jpresentauve iea not ireaentative r all hazardoua the agencies occurrence m-NPL sites, LA requires a ltly occurring only, vey information and lfa to of occurrence s at NKL sues t moat nlabie for ius substances t~those slfea. spreaentitive that has been iured and methods. The d thus provides application to irminadons trees Relating to li for Human slderod e third is first priority new under a potential for ic subataaces. varima aoeroae this criteria*, iracterizatlon of exposure potential at hazardous waste altea would contain detailed, site* specific information on hazardous substance contaminants, as well as identification of known or potential human exposure pathways, characterization of potentially exposed populations, and a determination of expected exposure levels and duration at aach exposure point Using these data parameters for guliiidance, ATSDR and EPA selected the ffooUllowing sources of data for usa in ranking substances under the criterion of human exposure potential. 1. Surface water data, groundwater data, and indicator chemical substance*. ATSDR and EPA used the HJ> iiirvoy date to derive a rough estimate of potential for human exposure to hazardoup T* NFL {acuities. The agendas considered 3 types oi exposure*related data from the CLP survey in prioritizing the list of 100 hazardoua substances under SARA: the average concentration of the candidate substances detected 5 groundwater and surface water across the 385 NFL sitss Included in the <*3J> survey; the fraquanrv af nf. those substances in groundwater and surface water acrota the 385 aites; and whether die substances had been selected for detailed exposurt' ftfltf'Hak assessment at .iu.r:r:,irr.;nnn;tnnt (i.e.. indicator substances). The agencies believe that theta data are the beat readily available measure* of potential human exposure. Groundwater and surface water are considered to be measures of mobility from the site and indicators of drinking water expocuree. Many of the Superfund remedial actions to data have focused on protection from human health risks associated with contaminated drinking water. In addition, EPA has focused on indicator substances identified under CERCLA as substances for which tha potential for human exposure has been determined to exist: ATSDR and EPA therefore recognized that the list of indicator substances should be used for the preparation of the first priority list under section 110 at SARA. The use of CLP survey data for exposure characterization necessarily excluded considerations af environmental fate mnhtHte, exposure patawsvs, and population cnaractensBcs. In addition, some estimates ol concentration derived from the CLP survey data were made from only a limited number of samples. However, the agencies believe that these fimitatJona are outweighed by the fact that no other available data provide as accurate a measure of the potential for human exposure to hazardous substances at NPL sites. Z AdiuttfdRQ VQ]uei nod u Unit ILC. of this notice. RQ values cuj be adjusted for consideration! of environmental persistence. This prouse involves adjusting the RQ values based on biodegradation, hydrolysu. and photolyaia, collectively referred to *s BHP. The BMP criteria are secondary *0 the primary RQ criteria of acute and chronic toxicity and carcinogenicity Tha BHP criteria were used bv Atsna and EPA. where appropriate, to chZiStt tha Rq value one level from the ary -..i value calculated with the primary criteria alone. Tne agencies use of these secondary criteria on '.he tact mat substances whicn nave a ~ tendency to degrade to innocuous product! poses less serious healiF. concern than equally toxic sutmariv. that have las* tendency to degrade ATSDft andEPA aiso used o'her secondary criteria such as bioaccumulation, hiah reactivity, and nazaroous qegradauon products to determine if an adjustment oi RQValues was appropriate tor a given substance. In cases where a degradation was more toxic than the parent compound, me kO value wantiiusted downwardT 1-- The use of adjusted RQ values in the preparation of the first priority list ensured the consideration of a number of relevant exposure factors in this scoring exercise. However, the extent of this adjustment for eech candidate substance was either "no change" or a one-level adjustmc t in the primary RQ value. The RQ adjustment thus served only as a crude indicator of the human exposure potential of those substances. F. Generation of the Priority Lst ATSDR and EPA used the ranking factors described above to represent the three criteria for determining the potential human health risk of the candidate eubatancea. Toxicity was prindpally represented ipv no naaith effect values; frequencv-of-occurence was principally represented by CLP site percent data: the potential for human exposure waa principally representedhy data nn groundwater, surface waterand in^jjr.ator chemical substances. The agencies generated an algontftm to calculate a hazard index value for eech candidate subatanot. for purposes of placing the sttbatances on tha first priority list The starting point for the hazard index calculation was the subset of hazardous substances which EPA hsd identified et NPL sites by means of site percent data from the CLP survey. The vale hag RQ cut pete rite sod sab* The *xp< rsnfc expc ct( step site ralu sub: pro indi T1 hz, data noti file des< set! Gui' of C Sep Fi tub. and can sub ano oth< are res; occ anc pric tut: he; ale DD (Bi G.. toe T ha: gro am wit Ch Re, sor alg urn hig sul tu' the un m SL 063029 172 Fa*ral legMor / VoL It, Ng 74 / Friday, April 17, 1987 / Noticaa oi Profiles ihnnld be am the relevant for nanhuH-- \mvmU human expaeure and tha ia. SUOaCU ait"' ' cts of the (U.I wifi aBaEEnnjtfEmgHTC :a represents aimi of potential }urt thaf would cooeatutaT public th concern baseo an available dtli). agencie* wul conitdermulBBll " l of exposure fur each subatance. will evaluate more thanone routaof sure (derma], oral, and tnfalaBofl Bora than one exposure Juration 1 and long tarn). Tbs profuse Will sb key ttudies which palate to the TiUnation of significant lewis oT n exposure. Inara baa been deraoie discussion between )R and EPA on how theee ninations ahould be made, and it ia that the concepta will erolva aa st toxicological profiles are 3ea'aTao must on important data Dead* that de the datermination of significant of human exposure or contribute ntially to the uncertainty of such With regard to the identification e data needs, the agencies will the quality of the data which mi the determination of significant .sure levels and. SMB thy supportingJMrtl / qi5se data needs in the ogical profiles. wseTaiScusalons will be the the profiles. ATSDR and EPA most of the public comments or : 25 toxicological profiles to focus e subject areas. Each profile will a non-technicel summery of the nt's principal findings and ions. ort Data in tha Profiles rat 25 toxicological profiles will 1 pnmanly on publicly available its. studies, reports, and other e agencies and their contractors I identify key studies which can ateiy serve aa the basis for ting exposure levels which i significant human health risk, my of the first 29 hazardous e* that are the subject of there have been recent assessments dome by EPA or oaes which will eeeest ATSDR m identifying key studies fee ee of drafting the taxiooiogteal n addition, there an extensive levant at*diee within EPA end eraj egnbee wittefc will ba and evaluated. studies which euppeat thf lirlirmleilliin irfliplftrent htaisn exposure levels or the idantifinatiae at data nanda. bat which havn not previously baea pear reviewed, in the caee of each truth**. the contractors will arrange far expert peg review to evaluate the data tn thg mrut datamine the veilditv of thestadtoe. Thane expert panels also will evaluate -the adequacy of the date for charecterttlhg toxicity and serving ee xey data In toidcoWcal profiles. It ia poaefble that hm n unpublished studies, currently unknown to ATSDR and EPA. which could ba key ttudie* for tha development of certain toxicological profiles. Tha Federal Register nodes containing the first priority list of hazardous aubatsacat. published elsewhere in today's issue of the Fsdanl RegieWe. dlacuasea the procedures fra handling the voluntary submission of such data to support tha development of toxicological profiles. VI. Scientific Pew Review of Toxicological Profiles In order to ensure that the toxicological profiles developed under section 110 of SARA art of high _____ scientific and technical quality, ATSDR and EPA have taken steps to ensure that the toxicological profiles themselves era properly peer reviewed. The contractors responsible far the preparation of toxicoloeical profiles will tssamSTs a peer review panel for each hazardous substance which is the subject of a toxicological protoe. Each peer review panel will consist of no less than 3 and experts who collectively have knowledge of the substance's and chemical properties, toxicokinetics. key health end points n nimai and Humana, mechanism* of action, human exposure, and quantum**TM riak to human*. The experts will have distinguished themselves throngh rasseruh. publications, and pew recognttitm aa being highly qualified to serve as pew reviewers of studies and evaluadoos of tha subatance in question. ATSDR end EPA will ensure that the chosen experts do not have a conflict of interest in their pew review of Undcoiogteai profiles of specific ubetaneae. ThwcoBlrectnr-cnnductedpeg review, phis an Interne! rrrWw by scientific aspects within ATSDfLnmf EFA will be owsdacTOd before the firal yiovifntnmcal arofii-i iff gj'S available foraubtic commit. A. Comments on the Process in Ccswra/ ATSDR and EPA solidt comments aa their implementation of the entire toxicoiogical profile process under section 110 of SARA, including the preparation of the priority lists of hazardous substances, the quidelines for preparing the profiles, and the content, format and scope of the profiles. (For details an the methodology for preparing the priority lists of hazardous substances, see the joint notice published elsewhere in today's issue of the Federal Register. Unfortunately, the agendee will not be able to tnaka use of public comments in preparing the initial priority list of 100 substances and the first 29 toxicological profiles of substances on that list, because the time-constraints of SARA section 110 require ATSDR and EPA to take extraordinary steps to expedite policy development and preparation of the first list and profiles. However, public comments on the process wifi be used to revise the process, if necessary, prior to the preparation of subsequent lists and profiles. All public comments wifi be available for review in the public file for this notice. B. Comments on the Pint 25 Profiles The Federal Register notice announcing the availability of the first 25 toxicological profiles (scheduled to be published no later than detober 17, 1987) will aolidt public comments on those profiles, end is expected to estapltan a 90-dsv comment period to ensure that them will be adequate time for the public'to review end comment on the initial toxicological profiles. vm. Administrative Record Although both ATSDR and EPA are issuing this notice, the agendee are establishing a single administrative record for ma notice. ATSDRhas established the public record of materials pertaining to this notice (docket control number ATSDR-1). The record is available for public inspection from a IA to 4JO pmL, Monday through Friday, except legal Hobdays, at the Agency for Toxic Substance* and Disease Registry, Building 28 Sooth, Room 1109,477D Buford llghway, NE, durables, GA. The record tadudea support documents for the toxicologics) profile process. Rer the Agency far Toxic Subetanow and Dianas Rngwfly SL 063030 Federal Rniltr / Vol 52. No. 74 / Friday, April 17, 1WO I Notice* MB71 timetable for revising the ad preparing toxicological izardous substances on the }f no Inver than 25 0 Use first priority list must 1 within 1 year of the f SARA (by October 17. ideologies] profile* will be he States and made the public, with a notice of and a request for public be published in the Federal s profiles will be revised as response to the public ad additional data that y become available to tion 110 requires that the I profiles be prepared in with guideline* developed md EPA. This notice the guidelines being used lopment of the initial set of rhe 2 agencies may modify ines for purposes of ibsequent profiles, based on snee in preparing the first 25 on public comments response to this notice. Responsibilities of ATSDR nd EPA jointly developed irity list of hazardous as well as the guidelines for tion of the first 25 il profiles. ATSDR has sole ty under SARA for the it and publication of ail il profiles. However, gv atutory time period for he first 25 profiles, the 2 ve agreed to develop the les jointly, and will draw on ;e of available chemical data been submitted to EPA agency's various statutory 0 support the development of igency Agreement between 1 EPA will provide the chanism to support the : who wifi assist in the i of the first 25 profiles. The ill use approximately 5 i (for wtueft oontract is airsaay are m piece) to d provide for peer review of irofliea. This lointTffort le 2 agencies is intended to t the toxicological profile ita of SARA section 110 will i timely and cost-efficient ompetitive bids will be >r contractor assistance in the n of subeequent sets of :al profiles. SDR and EPA will review and oducts of the contractors' efforts, as necessary, to aoaure their scientific accuracy and their conformance to the requirements of SARA section 110 end die guidelines discussed in this notice. After the profiles an completed end made available for public comment, the agendas will jointly review the comments which an received and make necessary changes in the profiles with the assistance of the contractors. m. General Piimiplae far the Development of Tadeotogteel Profiles ATSDR and EPA have agreed that the following general principle* will apply to the preparation nf the first 25 toxicological profile*: 1. The prindpal eudnTMf far profiles wui pa naanh mofessionals at the Federal State, and local levels and members of the public involved with Sunerfund aites: ATSDR end EPA will make a special effort to solicit comments from the States, because the agenda* are required by section 110 of SARA to provide profiles to the States. 2. Each profile will have a summary, written tn now-regrwH^TliHBUijgTftff distribution to jntereated professionals and the general public," 3. ill* profiles will be developed In suffident detail to meet the need* of health officials for current toxicological Information on individual hazardous substances. 4. A primary function of the profiles will be to present and interpret the~ available toxicological and human data on tne substances being profiled; these data may be tiled to evaluate ihe significance to individuals and the public-at-large of current or potential exposures to the subject hazardous substances. The profiles also will review the adequacy of evailable data on the substances end will identify toxicological gate needs for which research *11001(1 be designed and Iniriatedpursuant to the requirements of section 110 of SARA. 5. The profile* will use existing assessment documents to the fullest extent consistent with the intent of SARA, plus new studies which subsequently become available to ATSDR and EPA Studies which are key to the profile* will be critically reviewed. 6. Aa part of the development of the profile*, each profile will be peer viewed in manner ranaiatant with the definition of peer review given in echos 110 of SARA. 7. Toxicity data tu" in mini tn supportIhe principal conclusions of a profile and which have not previously been peer reviewed will be aubiect to an Independent pear reri< oonairteot with actionIMo/baRaT 1. Geowelly, the levai of detefl in the nrofilae Wtn*m timHaH tn mnammtriae the ntlndpal findtna* and cotndnsWma of the stadias which aw bund to be artdeal to --b--n-- ihe acuta. --hawrte, amt rftmnle health effects of the auDffcthazardona anhotancea. these general principle* for the development of tmdoowgical profiles are reflected in the discussion below of the content of the profile* and the pracedtuaa fat their development IV. Content at the Tadnaiogical Profiles Under section 110 of SARA, the toxicological profile* mutt contain, at a minimum, the following information: (A) An examination, summary. and interpretation of available toxicological Information and epidemiologic evaluation* on a hazardous substance In order to ascertain the levels of significant human exposure for th* sub*Lane* and ths associated acuta, subacute. and chronic health effects. (B) A determination of whether adequate tefaraation on the health effects of each --is available or in th* process of development to determine level* of exposure which present a riwiiflcant risk to human health of acute, subacute, end chronic health dhets (Cl Where appropriate, an identification of toxicological tasting needed to identify the typos or level* of exposure that may present *ignlflr*nt risk of advws* health affect* in human*. Congress stated further that the development and implementation of a research program under section 110 of SARA must be coordinated "with the National Toxicology Program and with programs of toxicological testing established under the Toxic Substances Control Act and the Federal Insecticide, Fungicide, and Rodentidde Act. The purpose of such coordination shall be to avoid duplication of effort and to assure that the hazardous substance* bated pursuant to [section 110 of SARA] are tested thoroughly at the earliest practicable date." ATSDR and EPA have developed detailed format which will serve ae the [pifajwUn-- for the content of the first 25 toxicological profiles. The format la presented in outline form In Appendix A to this notice. The antneiot do aoT rmhmm u u naneaaaryiar 4a Initial profiles to include or rater to every major study ol tne Prat 25 aubotenoea. because such a comprehensive overview mould repeat work that alreadyhas been dona elsewhere and therefore I* not necessary far dm aadlanoa and purpose intendxL ATSDR EPA have determined that the primary focus of me Fwhral Bitot* / Voi 52. Na 74 / Friday. April 17. 1987 / Notic Me mandated bv ration of the first m orrvtntg the aa_or other data --ton of EPA He my other lifted ATSDR end ! begun - review of the Brat mg to tubmit mthe~firat 25 thould note thet considered by filea after timer iwever, ATSDR id to n any submitted any necessary $ profiles in a sderal Register mausttea key ) priority list ly if the submitter would g determination nf iman exposure or oncological data lould be submitted A the l^^ttice. The of such data ion of the first 25 or the remaining 75 i on the first amentary data that ATSDR will i its possession the time ATSDR toxicological 1 to ATSDR and n of toxicological hat are submitted ide sufficient detail >at methods, and rmit proper evtew. ll tfie study r reviewed the i to identify the ovide copies of d DR and EPA are agendas an dministntlve EPA has 'trsian of this daatial materials ca (dockat control t). The public Slaw an bom 9 a-m. to 4 *y. except , bgai holidayt. in the OTS Reading Room. NB-G001401M St. SW. WaaMngton. DC 3048Q. At this time there an no confidential mat*rials in the record Tba record includes support documents for the first priority list. Any noa-confidential public comments on the listing methodology or other nanconfidential data or studies will be available for public inspection. If a parson intends to submit commants. data, or studies which contain buainaaa information (CBf). the parson must tubmit the materials in triplicate and mark the submissions as "confidential,** "trade secret," or a similar designation. Any material which is marked as CB1 will be bandied in accordance with the procedures in 40 CFR Part 2. Any material which ia not marked aa C8I at the time it ia aubmittod to EPA will be placed m the public file for this notice. ATSDR and EPA request that persona who submit CBI in response to this notice also submit a sanitized version of the materials which can be pieced in the public file. For tha Agency for Toxic Substances and Disease Registry. Deted- April 10.1987. lamaaO. Mason. Administrator. Agency for Toxic Substanom and Disease Registry. For the Environmental Protection Agency. Dated April 14.1987. Lee M. Thomas, Administrator. Environmental Protection Agency. (FR Doc. 87-8753 Filed 4-18-87; 8:48 am] (ATSDR-1; FRL-3174-8(b) QuMotinoo for Dwotopmont of ToxJcologicnl ProAoo aoswoea: Department of Health and Human Services (DHHS) and Environmental Protaction Agency (EPA). acnote Notice. sumaairv: Under taction lio of tha Superfund Amendments and Reauthorization Act (SAKS), EPA and the Agency for Toxic Substances and Disease Registry (ATSDR) of DHHS are required to prepare guidelines for the development of toxicological profiles of hazardous substances fitted under that Act This notice describes the procedures and criteria to b uaod by ATSDR and ETA in developing toxicological profiles, and solicits public comment on these guideline*. DAIS Written comment* on this notice rimuld be submitted by July id 1987. UOtBBC Written comments and atiwr data submitted in response to this ootim should bear the docket control number ATSDR-1. end should be submitted to; Director. Office of External Affairs, Agency for Toxic Substances and Disease Registry, Chamblee 28 South, 1000 Clifton Rd. Atlanta, CA 30333. All written comments on this notice will be available for public inspection at the Agency for Toxic Substances and Disease Registry, Building 28 South. Room 1103,4770 Buford Highway, NE. rambles, GA, from 8 a.m. to 4:30 p.m. Monday through Friday, except legal holidays. PM PUNTMin MFMMAT1M CONTACT: Ms. Georg) Jones, Director, Office of External Affair*. Agency for Toxic Substances and Disease Registry. Chamblee 28 South. 1800 Clifton. Rd.. Atlanta. GA 30333. Telephone: (404-1544820). UPPUMVMTanv information: L Background On October 17,1988, the President signed the Superfund Amendments and Reauthorization Act of 1988 (Pub. L 99499), which extends and amends the Comprehensive Environmental Response. Compensation, and Liability Act of I960 (CERCLA or Superfund. 42 U.S.C 9801 ft seq.). Section 110 of SARA amends section 104(i) of CTRCLA by establishing requirements for the preparation of: (l) Lists of hazardous substances in order of priority, (2) toxicological profiles of those substances, and (3} a research program to fill data gaps associated with the substances. Although the new statutory provisions are being added to CERCLA, this notice will refer to them aa tha section 110 requirements of SARA, to maintain a clear distinction in this notice between the new provisions and tha existing requirements of CERCLA. Section 110 requires ATSDR and EPA to prepare a priority-order list of the hazardous substance* which are moat commonly found at facilities on the CERCLA National Priorities List (NPLJ and which poae tha moat significant potential threat to human health. The agencies are required to revise the fiat on a periodic basis. The first priority Usi of 100 hazardous substance* and a summary of tha methodology used to prepare that fiat is published elsewhere in today's issue of the Federal Register. After compiling the first priority fiat ATSDR must prepare toxicological profiles of the fisted substance*. SARA Fedors! Register / VoL 52. No. 74 / Friday. April 17, tM7 f Undoes agencies divided the site percent data value for each eubetanoe (representing frequency-of-occarroocn) by the lowest RQ value for the adbstence (baaed on acute toxidty. Uranic toxidty, or potential i errlnngwirily) to generate a site index for sea substance. ATSDR and EPA ranked the candidate substances based on their site indices. The agencies then calculated an exposure index for each substance by ranking them based on the three exposure-related factors (with each factor receiving equal weight). The final step in the algorithm was to combine the site index rank and the exposure index value to obtain a hazard index for each substance. The substances were prioritized based on their hazard indices. The algorithm for calculating the hazard index is described in greater detail in the support document for this notice, which is contained in the public file notice. Note that the hazard index as described in this notice is not the same as the hazard index described in the Guidelines for Health Risk Assessment of Chemical Mixtures (51 FR 34014, September 24.1986). For purposes of assessing hazardous substances in toxicity profiles. ATSDR and EPA combined some onhe~ ' candidate substances into groups. If substances are stereoisomers of one another, are readily metabolized to other substances on the list, or generally are characterized as mixtures with respect to toxicity and/or frequency-ofi occurence, they were grouped together and occupy only one position on the priority list. Examples of these types of substances include: heptachlor and heptachlor epoxide; endrin and endnn aldehyde; aldrin and dieldnn; DDT. DDE and DDD; isomers of lindane (BHC) and PCB's. C. Prioritization Within the First List of 100 Hazardous Substances The list of 100 prioritized substances has been separated into 4 priority groups of 25 substances each. ATSDR and EPA have listed the substances within each group in order of their Chemical Abstracts Services (CAS) Registry numbers, to reflect the somewhat inexact nature of the ranking algorithm and the uncertainties of the underlying data bases. The first (and hiahestl priority aroun of 25 hazardous substances is composed of the substances which will be the subject of the lirst toxicological profiles developed under section 110 of SARA. ID. List of Substances The following 100 hazardous substances comprise the first priority list of substances that will be the sebfect of toxicological preflies prepend by ATSOR. The substances an listed In 4 groups of 29 substances each. The four poups an listed in descending order of priority, with the first poop haring the highest priority substances of the first priority Hat The substances within each group an listed in CAS number order. Priority Group i CAS NO. nm 50328 Oenzolatpyrana 53703 Dfcenzo|a).h)anthrscene 66553 Benzolpanlhrausne 57125 Cyanide 0571 OMdrri/ildrln 7863 CNoroform 71432 06flZ6O6 75014 Vinyl chloride 75002 Msvnywnv craonov 78448 HspttcNor/hsptschlor spowds 79018 TndSoroethene 88306 N-nrtroeodRhenytamne 106467 l,4^chlorotoen*ene 117817 Bis(2-emyewxyi)pnthalsts 127184 Teirecriluroethene 205992 Bsnzo|b)fluoranmsns 218019 Chryssins 1745018 P-Oioxw 7439921 Lead 7440020 Nttkel 7440382 Arsenic 7440417 Beryllium 7440439 Cadmwm 7440473 Chromium 11196825 PC8-1260,54,48,42,32^1,1016 Priority Group 2 CAS No. Substance name 56235 Carbon tsbacnionde 57749 Chlordene 82758 N-nreoeodimelhylemine 72559 4.4'OOE. DOT, DOO 75003 CNoroeOiane 75274 BromodfcNoromtthini 75354 1.1-Oichioroethene 78591 Isophorone 78875 U-Deasonxxopens 78005 1.1 g-TncNoroethene 78435 1.1 ,22-Teeachloroetnene 87885 Ptntichkyophtnol 1841 3.7 ucnwu0tn99nv 82875 107082 1J-OcmoroaOwne 108883 108852 TInTotHluneOnIie 111444 BR|2-d* rihyOriher 121142 2.4-Omrc j*r 319848 BHOripr smma. beta, delta 542881 BisIctSor nyOetfwr 821847 N-nhroso. -propylemne 7438978 Mercury 7440866 ZkK 7782482 Seiervum - Priority Group 3 CAS Nol teManoeMse 71886 74873 7821* 71282 78343 84742 M062 W2ta 4144141 >*Tf0i1-iO--P--O--6----WGMoromaVtan* i.1-Qri*xoMhane DhN-buiyl riuhalate 2.4,8-TrtcMorophenol 100414 107028 107131 108807 118741 122887 124481 188808 193396 808202 1310207 7221834 7440224 7440808 7884417 001352 Gmyrieraens AssIS Si AaylonIWIe CMenbmztnt 1 ISMCfSorobenjsns 1.2-OtphanytiyWszine 1 ,2-Trane-dfchioroethene Mano(l.2.3-cd)pyrena 2A0Mbololuena Tfltti lyfiPM CJ0V1 Moanyov/vnonn w**8i Gcpptt Ammonia Tonphini Priority Group 4 CAS No. StManet nanw 51285 58907 82533 00650 87721 74838 75150 75884 75718 78933 64663 5018 7883 6487 6601 106678 108101 120821 120832 123811 131113 208440 8*4521 941731 7440280 OCMrophanri P-CNoro-m-oreari Arrins OsnzoK arid Hauchioroethana Bromomethana Cartandeuffida DteNorodifluoromamene 2-Bwenons DMhyl pnmsiate Phmmthfinp HesacNorobutadiene RwnoU-methyl 1,2-OloMorohenzane 2.4-OimeShybrienot 1-PsnWnona, 4-Methyl 1 jt.4-TrlriSoiobemens 2.4-OichiQfOphenol 1.4-Ooxane DSnetfiyl pMhalete Ftuorantfwne 4,S-OMtro-2-mothy1phanoi IJ^khkniripesbeiMmrzisimfMn ThaMum As stated in the notice describing the toxic* .'Ogical profile development proca published elsewhere in today's issue ri the Fedaeel Register. ATSDR and EPA will prepare profiles of the 25 tbstaneet to the first priority group inter this year. That notice solicits comments on the toxicological profile development process; such comments SL 063033 Friday April 17, 1M7 Part III Department of Health and Human Services Environmental Protection Agency Notice of the First Priority Uet of Hazardous Substances That Will Be the 8ubject of Toxicological Profiles and Guidelines for Development of Toxicological Profiles SL 063034 Federal Register / Vol. 52, No.. 74 / Friday, April 17. 1987 / Notice* 4LTH AMD tion Agency -<*)] xlty Uet of That Win Be ogtcal Profiles ; Health and S) and on Agency (EPA). .id Amendment* ri (SARA) :ive te, bility Act ) by establishing r EPA and the ances and )R) ofDHHS it substances ily found at A National long these is a mandate for iare a list of at stances, in order ost commonly ind which the posing the most ret to human VRA requires oo later than ie contains that nces. and 7 of the semble the list this notice :ontrol number !d be submitted : Document i. Office of Toxic ital Protection . 401 M Street >400. ain confidential 31) should ntain CBI and ite to the r further e submission of II see Unit V of itial versions of will be action in Room given above aday through lays. om comact. ir.TSCA }), Office of mmental v-$43. 401 M St, SW., Washington, DC 20480, Telephone: (202-554-1404).. umxMBNTAitv mpormatmhc LBadcground On October 17.1886, the President signed the Superfund Amendments and Reauthorizatios Act of 1986 (Pub. L 98486), which extend* and amends the Comprehensive Environmental Response. Compensation, and Liability Act of I960 (42 U.S.C. 9801 et seq.). Section 110 of SARA amends section 104(1) of CERCLA by establishing requirements for the preparation of: (1) A list of hazardous substances found at NPL sites (in order of priority), (2) toxicological profile* of those substances, and (3) a research program to fill data gaps associated with the substances. The purpose of this notice is to identify the first 100 priority list substances and to provide e short summary of the methodology used by ATSDR end EPA to compile that list. Although the new statutory provisions have been added to ulkCLA, this notice will refer to them as the section 110 requirements of SARA, to maintain a dear distinction in the notice between the new provisions and the existing requirements of CERCLA With regard to the priority list requirement, section 110 of SARA states that ATSDR and EPA: hall prepare Ust. in order of prior. " of at least 100 hazardous substance* which are most commonly found at facilities os the [CERCLA] National Prioribee Uet end which, in their sole discretion, they determine are poeing the moat siptifieant potential threat to human haaltfa due to their known or suspected toxicity to human health due to their known or suspected toxicity to human* and the potential for human exposure to such substances et faalltiea on the National Priorities list or at facilities to which a response to e release or a threatened release under [CHtCLAJ is under consideration. Section 110 further require# that the agencies prepare the first priority Ust within 6 months of the enactment of SARA (i.e.. no later than April 17.1987). After compiling the first priority list ATSDR must prepare toxicological profiles of tha listed substances. Section 110 of SARA establishes a timetable for revising the priority Ust and preparing toxicological profilts of hazardous substances on the Ust; profiles of no fewer than 25 substances on the first priority list must be completed within 1 year of the enoctment of SARA (by October 17,1987). The profiles will be. made available to the public, with a notice of availabiUty and a request for public comment to be published in the Federal Register. The profiles will tm revised as necessary in response to the pubUc comments and additional data that subsequently become available to ATSDR (but no leas often than once very three years). The toxicological profile process is described in greater detail in a notice which is published elsewhere in today's issue of the Federal Register. The first priority Ust of 100 hazardous substances was prepared within 6 months of the enactment of SARA, as required by section 110. Unfortunately. ATSDR and EPA have noTSeen able to follat public comment* on the ~ preparation of the first priority list, because trie time-constraints ofSARA section 110 require the agencies to take extraordinary steps to expedite policy development and preparationoithe first Ust ana profiles. However. ATSDR and EpAnave been as thorough ss possible in compiling the first priority list, given the tight statutory timetable within which the agencies had no operate. The methodology used to prepare the first priority ust is summarized below. iTie agencies solicit public comment on this approach; such comments should be submitted in accordance with the instructions given in this notice. The listing process will be refined as future revisions of the list are prepared under leas severe time-constraints. Later changes in the listing methodology will be based on comments received in response to this notice and on further evaluation of the process by ATSDR and EPA. All nonconfidential comments will be placed in the public file for this notice. A more detailed description of the listing methodology is contained ' support documents which have beer placed in the public file and are available for public review (see Unit V of this notice). . Methodology for Selecting Subetaacee on the Tint Priority Ust A. Centra/ Approach Taken by ATSDR and EPA The hazardous substances listed in this notice were drawn from s list of 717 hazardous substances currently identified under section 102 of CERCLA. ATSDR and EPA used the CERCLA list to create a subset of hazardous substances which EPA has identified at National Priority List (NPL) sites. The two agencies then began a process of prioritise.- hat subset of hazardous substance, read on the 1allowing"three criteria fo? ennining the degree to ~ which ear.. .Dstance poses a potential human hca f naz: (i) tJiemlcal toxicity. (2) fregutncy-ot-occuirenca of subset substances at NPL sites or other facilities, end (3) potential tor human Ftdfil Register / Vol. 52. No. 74 / FrkUy, April IT. M87 / Notices Dated: April 10. H87. |mO. Masoa. Administrator. Agtncyfor Taxx Stbmtancas o/itf Dittos* Htgulry For the Envtinnmantal Protect*#!! Agency: Dated: April 14.HB7. Lae M. Tliw. Administrator. Stmnmmtntal Proucuon Agency. APPENDIX--TOXICOLOGICAL PROFILES OUTLINE I. Introduction A. Purpose. A description of the purpose/intent for this profile as outlined in SARA. B. Objectives. Contains a brief discussion of the objectives for this profile, including the intended audience, ss outlined in SARA. C. Responsible parties/agencies. n. Health Effects Statement This section of the profile, if removed from the rest of the document, should still be capable of conveying to the general lay public the substantive public health concerns associsted with this substance. This section should be a health effects summary, writlelnn layman s terms, to addreas issues such as: A. Whether the substance is naturally occumng. synthetic only, or both. B. How it is commonly used and where it is commonly encountered. C. What its toxicity and hazards are (signs and general symptoms; acute, chronic, carcinogenicity, birth defects, etc.) D. The potential for exposure via water, air. foodstuffs, commercial products, etc. E. General statement on persistence in the environment. F. Whether the substance is essential to human health; i.e., an essential nutrient. G. A discussion of the relative benefit to society versus the risk. H. A discussion or explanation of certain areas that may affect the layman's interpretation of the risk imposed by that particular substance. For example, vinyl chloride in ita pure gaseous or liquid form it an extremely toxic (acute and chronic) and carcinogenic agent. However, it is most commonly encountered in polymeric form in plastics and. as such, is relatively inert and therefore harmless. A brief explanation of such would be appropriate here to avoid any misconception by the general public regarding risk through the use of vinyl chloride-containing plastics. I. General discussion. This subsection should serve as a fairly complete and concise elateaeot of the panerml health risks aaeocietod with the subject hazardous substance. PL Cfcanricnl MaHty A. Structure 1. CAS Regmtry number. 2. Molecular formula. 3. Chemical structure. 4. Chemical name (using current Collective Index). 8. Synonyms. 8. Trade names: To indude names end makeup of commercial preparations utilizing this particular substance. B. Analytical Methods Should include an up-to-date listing of analytical methods (with detection limits and degree of accuracy) available for analysis in the following: 1. Environmental media. a. Air. b. Water. c. Soil. d. Food/food products. 2. Biomedical samples. a. Fluids/exudates: i. Blood/serum/plasma. ii. Urine. iii. Saliva. iv. Seminal fluid. v. Sebaceous fluid. vi. Cerebrospinal fluid (CSF). b. Tissues: i. Adipose. ii. Muscle. iii. Hair, nails, skin. iv. Other biopsy material as available. C. General Discussion IV. Environmental Fate and Hteoan Exposure Poiential A. Environmental Background Levels 1. Water. 2. Air. 3. Soil. 4. Foodstuffs. 5. Other products. B. Release to Environment 1. Point source. 2. Non-point source. C. Environmental Fate 1. Transport and partitioning. a. Within media. b. Between media. 2. Transformation and degradation. a. Chemical degradation (or transformation). b. Biodegradation (or biotransforraation). c. Bioaccumulation/bioconcentration. D. Human Exposure 1. Normal background exposure. 1 Medla-apedfic expoenre (ootam foodstuffs, water in certain areas, etc.). 1 Special risk populations. 4. Occupational exposures. R. General Discussion V. jga A Absorption Various exposure roelea inhalation, oral, dermal. 1. Animal studies. 2. Human. A Distribution Identifies specific storage sites end depots1. Animal studies. 2. Human. G Metabolism Identifies biotranafonoation pathways, metabolic products. 1. Animal studiea. 2. Human. D. Excretion Identifies routes, time, products. 1. Animal studies. 2. Human. General Discussion VL Toxicity A. In Vitro Toxicity 1. Enzyme systems (e.g.. AChEl. MAOI). 2. Biochemical alterations (e.g.. free radical formation). 3. Cellular system (eg., mooolayer cell culture systems). 4. Toxicity of metabolic products. 5. Proposed mechanism(s) of toxicity. B. Animal Toxicity The following subsections should sll Include a listing and discussion of the various toxic effects produced, the relative potency (dose-effect), the target organs/systems, and the mechaniam(s) of action, if known. 1. Acute toxicity. 2. Subacute/tubchronic toxicity. 3. Chronic toxicity. 4. Mutagenicity. 5. Reproductive and developmental toxicity. 8. Carcinogenicity. 7. Toxicity of metabolic (biotranafonoation) products. A Mechaniam(s) of toxicity. C Human Toxicity 2. Case reports. a. Synopsis of findings. b. Synopsis of conclusions. 2. Epidemiological studies, a. Acute toxicity. SL 063036 12874 Federal Ragiatar / Vol, 52. No. 74 / Friday. April 17. 1967 / Notice* b. Subacute/subchronic toxicity. c. Chronic toxicity. d. Reproductive and developmental toxicity. e. Carcinogenicity. f. Toxicity of metabolic (biotransformation) products. g. Mechaniim(s) of toxicity. 3. Experimental expoeur* ttudie*. a. Acute toxicity. b. Subacute/subchronic toxicity. c. Chronic toxicity. d. Reproductive and developmental toxicity. e. Carcinogenicity. f. Toxicity of metabolic (biotransformation) products. g. Mechanism(s) of toxicity. D General Discussion 1. Potential for human toxicity. 2. Comparison of long-term, low level exposure to short-term, high level exposure. 3. What is the relevance of these findings to the potential for human toxicity? VII. Level* of Significant Human Expoeur* Specific guidance for this section will be provided in a follow-up report. A. Conclusions Regarding Levels of Significant Human Exposure. 1 Acute health effects. 2. Subacute/subchronic health effects. 3. Chronic health effects. B General Discussion Vin. Adequacy of Available Information Specific guidance for this section to be provided in a follow-up report. A. Conclusions Regarding Adequacy/ Inadequacy of Existing Information B. Discussions Regarding Information Currently Under Development C General Discussion IX Physical Chemical Information A. Physical/Chemicai Properties 1. Molecular weight. 2. Color. 3. Physical state. 4. Odor/odor threshold. 5. Melting/boiling points. 8. Autoignition temperature. 7. Solubility; water, organic solvent*. 8. Density; vapor density. 9. Specific gravity. 10. Partition coefficient(a). 11. Vapor pressure. 12. Henry's Law constant. 13. Refractive index. 14. Flashpoint 15. Flammable limits. B. General Discussion X. Manufacture, Importation, and Use A. Production 1. Process. 2. Volume. 3. Sites of production. 4. Disposal. B. Importation C. Uses D. General Discussion XI. Regulatory and Advisory Status A. Regulatory (Enforceable) Standards 1. Definition. 2. Purpose and use. 3. Regulatory (promulgating) agency. 4. Definitive levels/quantity, units, media. B. Advisory (Non-Enforceabiej Guidance 1. Definition. 2. Purpose and use. 3. Advising agency. 4. Definitive levela/quannty. un,ia media. 7 C. General Discussion XU. Summary and RecommendateM Provides a summary review and discussion of all the preceding Genera discussion" aubsections. A. Synopsis Of relevant in vitro. ammaL and human research findings. 1. Includes a review of homologous, inter-species toxic mechanisms. 2. Includes an assessment of the potential for adverse human health effect* based on in vitro and/or nonhuman in vivo toxicity evaluations. B. Assessment Of potential exposure scenarios. Recommendations For future research, as deemed eppropriate and necessary. Note: Specific guidance for developing this subsection will be provided in a followup report. XIQ. Appendices to Toxicological Profiles A. Data Bases Reviewed B. Unpublished Documents Cited C. Peer Review Process 1. A description of the peer review procedures followed. 2. Identification of peer review members (and their affiliation). 3. A listing of those peer review comments not incorporated into the profile, with a brief explanation of the rationale for their exclusion. D. Reference'Section [FR Doc. 87-8754 Filed 4-18-87: 6:45 am) VLUMQ GOOt MHMI SL 063037 OCNTOflCTCRS FOR TOXIOOLOCICAL PROFILE DEVELOFVENT Oak Ridge National Laboratories P. 0.Box X Oak Ridge, TN 37831 615/576-5454 TOP 25 PRIORITY CHEMICALS UNDER SECTION 110 OF SARA * benzene ICF-CI ement 1515 Wilson Boulevard Suite 700 Arlington, VA 22209 703/828-2500 benzo(a)pyrene dibenzo(a),h)anthracene benzo(a)anthracene benzo(b)fluoranthene chrysene Syracuse Research Corporation (SRC) Merri11 Lane Syracuse, NT 13210 315/425-5100 beryl 1 inn chloroform chraniun N-nitrosodipheny1 am ine PCBs p-dioxin nieke 1 (The SRC chemicals are currently undergoing drinking water health advisory preparation; these profiles wi 11 be reviewed by CRD.) Technical Resource, Inc. 3202 Monroe St. Suite 200 Rockvi1le, VO 20852 301/231-5250 cyanide lead tetrachlorethene trichloroethene vinyl chloride Dynamac 11140 Rockvilie Pike Rockville, VO 20852 301/468-2500 dieldrin/aldrin heptach1 or/heptach1 or epoxide Li fe Systems ICAIR 1725 Jefferson Davis Hwy. Suite 803 Arlington, VA 22202 703/553-9500 arsenic bis(2-ethyl hexyl)phthalate cadni im methylene choride 1,4-dichlorobenzene A draft benzene toxicological profile is being prepared by all six contractors; the "best" one will be used as a model for preparation of the other profiles. SL 63038 % ATSDR Priority List of 25 Hazardous Substances Priority Group 1 CAS No. Substance name 50328 Benzolalpyrene 53703 Dibenzo<a).h)anthracene 56553 Benzo<a)anthracene 57125 CyanIda 60571 Dieldnn/aldnn 67663 Chloroform 71432 Benzene 75014 Vinyl chloride 75092 Methylene cnlonda 76448 Heptachtor/heptachior epoxide 79016 TncWoroethene 86306 N-mtroaodipnenylamme 106467 1,4-Dichlorobenzene 117817 0is(2-ethylhexyl)phthalate 127184 Tetrachloroethene 205992 8enzo(b)fiuoranthene 218019 Chrysene 1745016 P-Oioxin 7439921 Laad 7440020 Nickel 7440382 Arsenic 7440417 Satyllitifli 7440439 Cadmium 7440473 , Chromium 11196825 PC8-1260,54,48,42.32.21,1016 / Priority Group 3 CAS No Substance name 71556 74873 75218 75252 -- 75343 84742 88062 91203 98953 100414 107028 107131 108907 118741 122667 124481 156606 193395 606202 1330207 7221934 7440224 7440508 7664417 8001352 1,1,1 -Tnchloroethane Chioromethana Oxxane Bromolorm ,v l.l-OtcMoroethane ' Oi-N-butyl phthaiate 2.4.8-Tnchlorophenol Napthalane Nitrobenzene Ethytbenzane Acrolein Acrylonitrile Chlorobenzene Hexachiorobenzene 1,2-Oiphenyihydrazine Chiorodibromomethane 1,2-Trans-dichloroethene Indenol 1,2,3-cd)pyrene 2.6.Dinitrotoluene Total xylenes Endnn aldehyde/endrm Stiver Copper Ammonia Toxaphene Priority Group 2 CAS No. Substance name 56235 57749 62759 72559 75003 75274 -- 75354 78591 7887 790C5 7947 : 8786 9194 92873 -107062 108883 108952 111444 121142 319846 542881 621647 7439976 7440688 7782492 Carbon tetrachlonda Chlordana N-mtrosodimethylamine 4,4'-ODE, DOT, DOO Chloroathana Bromodwnioromethane 1,1 -DtcWoroethene Nrlaophorona 1,2-Owhloropropana 1, i 2-Tncnioroathana 1,1,2.2-Tetrachloroethane Pentachlorophenot 3.3'-Oichlorobenzidine Benzidine 1,2-Dichloroethane ^ J Toluene Phenol 8is<2-chloroethyl)etner 2,4-Oinitrotoluene BHC-alpha. gamma, beta, delta Bis(chioromethyl)ether N-mtroaodi-n-propylam'ne Mercury Zinc Selenium Priority Group 4 CAS No. Substance name 51285 59507 62533 65850 67721 74839 75150 75694 75718 78933 84662 850 IB 87683 95487 95501 105679 108101 120821 120832 123911 131113 206440 534521 541731 7440260 2,4-DiitrophenoJ P-Chloro-m-creaol Aniline Benzoic acid Hexechloroethane Bromomethene Carbondisulfide Fluorotnchloromethane Oichlorodifluorometnane 2-Butanone Oiethyl phthaiate Phenanthrene Hexachlorobutadiene Phenol,2-methyl 1,2-Oichlorobenzene 2.4-Dimethylphenol 2-Pentanone. 4-Methyl 1,2,4-Tnchlorobenzene 2.4-0ichiorophenoi i ,4-Oioxane Dimethyl phthaiate Fluoranthene 4.6-Dmitro-2-memyiphenol 1,3-Oichlorobenzene Thallium SL 063039