Document ppdKk7OErBzod622dG1RJx5y6

A TO: Distribution TSc.fl/sc-fi ^ FROM: DATE: T. G. Grumbles May 28, 1987 iterofflc SUBJ: jmmunicatJon TSCA SECTION 8 PROCEDURES This memo is to reemphasize and update the Vista Section 8 procedures. Posters for in-plant use and forms for use in recording Section 8(c) and 8(e) allegations are enclosed, A copy of the 8(c) regulation and a summary of Section 8(c) are also included for your reference. Some key points are below. 1. Section 8(c) requires the recording of allegations, that a chemical substance has caused harm to humans or the environment. Allegations are "statements made without formal proof or regard for evidence". 2. Ttje only allegations not recordable are those that are known hedlth effects. Known health effects are defined in the regulation (717.3(c)(i)). 3. The 8(c) corporate file is kept in Houston Environmental, 4. Houston will review the Section 8 allegations to determine the extent of any follow-up investigation needed. This investigation will assure the disposition of the allegation as indicated on the back page of the long form. To illustrate EPA's enforcement activity in TSCA Section 8 matters a recent BNA article is enclosed. Additional forms and posters are available in Houston if needed. \o T. G. Grumbles ajo .18 Attachments DISTRIBUTION: Environmental Coordinators Safety Directors cc V. L. McClain yEV-141283 S^== dss? fc/e-T7<9 CHEMICAL MANUFACTURERS ASSOCIATION VIA FEDERAL EXPRESS May 1, 1991 TO: Ad Hoc TSCA fife) Group Health and Safety Committee Chemical Reporting Task Group Chemical Control Task Group Chemical Testing Task Group RE: Draft Case Studies to Clarify Reporting Requirements for TSCA Section 8(e) and the CAP FOR IMMEDIATE ATTENTION irtririrkltk k k k->rtfk!tirkirlrkirtrir`kkiffrlrk'tt** Enclosed FOR YOUR IMMEDIATE REVIEW are the draft case studies developed at last weeks working sessions. Each one is at a different stage of development and some follow the outline we established more than others. I suggest we work towards following this outline, as much as posible and a copy of it is enclosed for reference as you review the cases. To keep with our intention of submitting them to EPA as early next week as possible (ideally they will he submitted on Monday, May A). I will need your comments ASAP, with an absolute deadline of 9:00 A.M. Monday, May 6. Please fax your comments to my direct attention at 2.0 2/RA7-1282. If additional wcrk Is needed, [ will contact the d f.scu3Sioii lenders from last week's, sessions. Thanks again for all your help. Sincerely, Enclosures Ttfltl. KSf h'ry^ ARosica Director Health and Safety $. Conti, CMA G. Strickland, CMA E. Currie, CMA L. Spurlock, CMA V. Ughetta, API C. Bell, Sibley & Austin S. O'Conner, PPG B. Farran, Rhone-Poulenc F. Marashi, Phillips J. Blum, Allied Signal M* Barth, Mobil J. Barter, PPG M. Dean, Georgia Pacific J. Sepesi, Shell D. Layne, CMA D. Zoll, CMA S. Tirey, CMA M. Price, API C. Morton, SOCMA R. Sussman, Latham & Watkins K. Dille, Texaco D. Erisman, Quantum D. Hall, Proctor & Gamble I.. Hamilton, DuPont B. Lynch, Rohm and Haas K. Hazer, Northrop C. Haider, Mobay G. Roundtree, Aerospace Industries 2501 M Street. NW, Washington, DC 20037 202-887-1100 Panafax 202-887-1237 Telex 89617 (CMA WSH) VEV-141292 Attachment I April 19,1991 TSCA Section 8(e) Compliance Audit Program Draft Outline for Case Studies A Section I: Study Specific Information This section will detail the information specific to the study/report in question. Information on the type of material tested, study purpose and design, and study results that are relevant to consider in evaluating reportability should all be included. Section II: Other Relevant Information This section will describe other information that is relevant to consider in evaluating study results. This could include information on structurally similar materials, current or anticipated uses, exposure potential, magnitude of the available database on the material, etc. In some cases (particular health effects endpoints) it may not be appropriate to consider any additional information relevant; if so, this should be stated. In other cases, there will be extensive information that is appropriate to consider. If there is information that' has already been 'made available' to EPA (non TSCA 8e), it would be appropriate to include it in this section. Section III: Existing EPA Guidance This section will discuss existing Agency guidance on the reportability of the study results. The guidance should be specifically referenced, and if no guidance is available, it should be stated as such. Relevant Agency guidance that should be reviewed include guidance specific to TSCA 8(e), i.e., 1978 Policy Statement, two Q & A's, the subpoena letters (others? which ones?), as well as Agency guidance that has been published for other programs, such as RCRA, FIFRA, CWA (others?). If guidance over time appears to he contradictory, this should be explicitly discussed. Section IV; Evaluation Discussion This section will, in essence, be 'the answer', but careful discussion of all relevant information should be included. {While not yet discussed, it may be a good idea to include cases where the discussion supports submitting the study, and cases where the discussion leads to a conclusion that ^mediate reporting is unnecessary. Section V: Magnitude of Study Type This section will generally describe the relative frequency of these kind of studies and/or results, in order to place 'substantial risk' reporting in the proper perspective. Section VI: Conclusion This section will have a very clear and concise response to the question of reportability. VEV-141293 {intern ether* i Cq%- t>fudtc6 C C(Me I VEV-141294 STUQV 3.\ ACurg' t>TUDl> / Numerical Cui opr* VEV-141295 / dwft TSCA SECTION 8(e) OOMPLIAWCE AUOIT PHXUUM CASE STUDY: NUMERICAL CUTOFFS Section X: RSO Chemleal; Pesticide Candidate An aeuta oral(gavage) LD50 study was eenduetad In mala rata. Following admlnlatratlon of tha taat material, rata war# obsarvad for 14 days for clinical aigna of toxicity. At tha and of this obaarvation period, all surviving rata were sacrificed and examined for gross pathological ehangss. Rats found dsad wars also subjected to gross pathological examination. Tha oral LD50 was calculatad to ba 40 mg/kg; tranalant non-specific clinical signs wars obsarvad In all traatad rats. Cross pathology rsvaalsd nothing unaxpactad. Sactlon XI: Othar Relevant Information Tha RAO material has bean synthesized In small quantity (<S gm) and has always bean handled within a fume hood. Sactlon XXX: Existing ERA Ouldance Agency guidance [ERA 1078 6(a) statement of Interpretation and Enforcement Rollcy; 43 FR 11110 (March 18,1978)] 'States that Information that shows a taatad chemical to ba extremely toxic (eg. causes lethality at very low doses) by, for example inhalation, dermal application or oral admlnlatratlon should ba reported. Section XV: Evaluatlon/Dlacusslon EPA in Its 1876 Polley Statement refers to three categories> namely, extremely. jCflsrsUlY. and sllahtlY BLJ0lfl.tiS.11l tflKlfi. There are numerous classification schemes whleh have been published (eg. EPA FIFRA, TSCA SNUR, EEC 6th Amendment for Classification and Labeling, United Nations Transportation Criteria, SARA Section 302, 0SMA, DOT, Casserett and Doull, Deichmann and Oerarde etc.). There la soma variation amoungst tha classification schemes end several which differentiate between extremely toxic and highly toxic, several of those which differentiate between extremely and highly toxic use a cut-off of lees than or equal to 25 mg/kg (oral LD60). CMA strongly believes that the Agency should consider domestle/natlonal consistency as well as international harmonization. This would minimize the number of inconsistent written notifications that by law must be submitted and reduce reporting errors. In addition, verbal guidance from EPA to numerous companies and Industry associations has been consistent with a cut-off of leas than or equal to 25 mg/kg for oral administration, z taction V: Magnitude of Study Typo toetlon VI: Conclusion In tho sbovo esso study, tho information would not bo consldorod roportsblo undor TC8A toetlon 6(e) crltorls for tho following reasons. First, tho threshold for "extremely toxic" Is consldorod to bo loss thsn or equal to 26 mg/kg (oral) by sovoral soureos [eg. SARA; SNUR; EEC] which dlfforontlsto botwoon oxtromoly and highly toxic. While wo aro aware of other schemas that use loss thsn or equal to SO mg/kg (oral) as hlohlv toxic. |PA should not equate this to oxtromoly toxic. Regarding dermal and inhalation toxicity testing, similar arguoments ean bo made for each typo of testing. Tho numberlcal eut-offa wo believe would constitute reportabl11ty as "oxtromoly toxic" aro as follows: Oral LD50 Dermal LD60 Inhalation LC50 Vapors Aeroaols/Partlculate loss than or equal to 25 mg/kg loss than or equal to 60 mg/kg loss than or equal to 0.6 mg/L loss than or equal to 2 mg/L References: SARA Emergency Planning and Community Rlght-To-Know Programs, 61 FR 221, 11/17/86, 41870-41510. TSCA Section 5(a) significant New Use Rule (8NUR) 62 FR S2, 4/29/67, 15603-15604, 79/631/EEC, Council Olrectlve 9/11/79, Amending for the 6TH Time 67/646/EEC. * Z 9 z z vevh41297 M5r sri\Qj z.* A hut*- yudlei Lini T-es^ - *J0 APR 30 '91 10:52 CORPORATE TRAC LSI 9144784839 Pag* 1 of 5 P.10/11 A Hunan Haalth Effects Casa study Acuta Toxicity - Linit Taat - "Neurotox" Draft 3 - 4/39/91 I. Study Specific Information The purpose of this casa study is to dascriba the critaria nacassary to assass the reportability of acuta toxicity tests under TSCA 8(e) that contain various signs and symptoms that might be indicative of neurotoxicity. A company conducts acuta toxicity limit tasting (oral dose is 3000 mg/kg; dermal dose is 3000 mg/kg; inhalation dose is 200 mg/1 or highest achievable nominal concentration). General signs and symptoms reported include piloerection, hunched posture, dyspnea, exophthalmos, reduced locomotor activity, tremor, tonic convulsions/spasms and ataxia. No animals died. II. other Relevant Information DOT, EEC, Japanese classification schemas EPA Neurotoxicity Testing Guidelines under FIFRA III. Existing EPA Guidance EPA has published a number of QfcA's and Status Reports regarding TSCA 8(e). The following Q&As appeared in an EPA document dated July 3, 1989: Q. what criteria should be used in determining if the results of acute toxicity studies constitute information that reasonably supports a conclusion of substantial risk? A. criteria used to determine section 8(e) reporting in the case of acute/subacute findings will depend on the nature of the effects observed and the dose at which the effects occurred. For example, information that shows a tested chemical to be extremely toxic (e.g., causes lethality at very low doses) by, for example, inhalation, dermal application, or oral administration should be reported. On the other hand, the reporting of information shoving a chemical to be moderately toxic will depend on the degree of actual or potential exposure to the tested chemical. Information shoving a chemical to be slightly or minimally toxic on an acute/subacute basis is not considered typioally to be reportable. In addition to extreme toxicity, certain other serious toxicological effects (e.g., neurotoxicity, adverse reproductive system effects) seen in an acute r subacute animal study should be reported und r S cti n 8(e). VEV-141299 APR 30 '91 10 = 51 CORPORATE TRAC LSI 9144784839 R.9^11 Page 2 of 5 Lisle Test - "Neurotox" Draft 3 - 4/29/91 Q. What criteria constitute evidence of reportable neurotoxicity in animal studies? For example, are reversible effects such as narcosis or effects observed in the presence of marked systemic toxicity considered reportable? A. Typically, neurotoxic effects that are observed in dying animals are not, in and of themselves, considered by EPA to be reportable under Section 8(e) of TSCA. In many cases, however, already reportable data regarding extremely or highly toxic (lethal) substances will be accompanied by information concerning observed neurotoxic effects. In short or long term exposure studies in which serious neurotoxic signs and symptoms (e.g., convulsions, sleep induction, motor dysfunction, narcosis, behavioral dysfunction) are seen in non-moribund animals, however, specific reporting of the neurotoxic effects should take place. EPA's guidelines also suggest that, while LD50 and other acute screening data may often be outside the scope of section 8(e), there may be circumstances where reporting is required. The following comment appears in 43 Fed. Reg. 11114, March 18, 1978, "statement of Interpretation and Enforcement Policy": Comment 14: How are reportable data distinguished from routine tests including range tests such as LD50*s. Response: This policy statement directs the reporting of specified effects when unknown to the Administrator. Many routine tests are based on a knowledge of toxicity associated with a chemical; unknown effects occurring during such a range test may have to be reported if they are those of concern to the Agency and if the information meets the criteria set forth in Parts v and vi. In reviewing EPA's Status Reports it appears that routine screening tests qualify for reporting only if they demonstrate a significant level of acute toxicity and involve chemicals to which there is significant exposure. In 1980 (status Report 8EHG-0479-0282 S, January 9, 1980), EPA explained that its "interest in receipt of acute toxicity studies under Section 8(e) is, in general, fairly limited" but that "under certain circumstances the results of acute studies can provide reasonable support for a conclusion of substantial risk." "Submitters are expected to consider such factors as the lethal dose, the route of administration, occurrence of unexpected effects in the animals (obtained via "cage side" bservaticns, during n cropsy, and s n), and the extant VEV-141300 APR 30 '91 10=50 CORPORATE TRAC LSI 9144704839 P.8/11 Page 3 of 5 Limit Teat - "Neurotox" Draft 3 - 4/29/91 and pattern of tha chemical's axpoaura (Insofar as known to the submitter). In general, whan mvalusting such information under Section 8(a) tha greater tha aeuta toxicity of a compound tha lass heavily one weighs the axpoaura criteria and vice versa." In tha aama Status Report EPA has concluded that acuta data demonstrating "extrema dermal lethality" vara reportable under Section 8(e) because of the substance's potential for exposure. In another status Report, EPA stated that data demonstrating that an R6D chemical was "highly toxic" did not trigger section 8(e) reporting because "acute toxicity data on R&D chemicals which presumably have very limited exposure do not appear to be sufficient to indicate that the material poses a substantial risk to health or the environment." (Status. Report 8EHQ-0578-0162 S, June 15, 1978), Thus, it appears that EPA is uninterested in receiving acute toxicity data under 8(e) unless the effects occur at extremely low doses and involve compounds with significant exposure potential or are associated with more serious, incapacitating effects likely to manifest themselves at a later date. i It should also be noted that in the late 1970's SPA also warned a Chicago based company that they were engaging in "malicious compliance" following the company's submission of large volumes of acute studies under TSCA 8(e). (NOTE: THE GROUP WAS UNABLE TO CITE A REFERENCE - ANYONE FAMILIAR WITH THIS?) IV. Evaluation Discussion The study described in Section 1 should not be submittable under TSCA 8(e) since: 1. the test was a short term study involving a relatively high dose and does not constitute a substantial risk (For example, a 2000 mg/kg oral dose equates to a 40 gram dose for a 20 kg child or 140 gram dose for a 70 kg adult before these effects might be seen). 2. the observations are relatively common signs reported in animals stressed by administering large volumes of test material, as is done in this kind of test. Therefore, they do not reasonably support a conclusion of "serious neurotoxic effects" as outlined by EPA. 3. in limit t sts, if n lethality occurs the material would be classifi d as n n-toxic (at the dos used in this example DOT, OECD and Japan would classify this material 4 VEV/-141301 f&P. 30 '91 10:50 CORPORATE TRAC LSI 9144704839 P.7/11 P*g4 A of 5 Limit lost - "Naurotox" Draft 3 - 4/29/92 as non-toxic) regardless of the clinical signs and symptoms obsarvad. Thus, SPA would ba receiving information that is unlikely to be useful since such signs and symptoms lack significance at large doses. 4. Because of the relatively high dose, the symptoms displayed are generally considered to be reflective of stress on the animal or of "system overload" of the body rather than manifestations of specific toxicological effects due to the particular substance studied. 9. Acute toxicity tests are not sensitive enough or designed to measure neurotoxicity. While signs and symptoms from exposure.are recorded, these observations by technicians are visual evaluations. The study design does not generally entail handling or manipulation of the animal to assess the reliability of a subjective visual observation. The SPA, under FIFRA, has established neurotoxicity guidelines that are not addressed by acute toxicity studies. Under these and other guidelines, there are specific tests that are conducted to determine neurotoxicity. These tests typically can include acute neurotoxicity in hens, behavioral testing (mazes, Skinner box), righting reflex, startle reflex, pupillary reflex, hot plate test, etc. The endpoint of acute toxioity testing (limit, LD50) is death. As such, signs and symptoms are gathered to assist the tester in designing additional studies. While the signs and symptoms outlined in this case study cannot be ignored, the relevance to "substantial risk" is not known unless further testing is conducted. 6. If the scenario changed slightly, and some animals died but the signs and symptoms remained the same the study would still not be submittable as it could be interpreted that the animals were moribund (iei in a dying state) and there would be no way to assess from the information presented which animals died and which recovered. 7. if the route of administration were parenteral (ie: sc, iv, ip) the study would not be submittable as it is not a route of potential exposure in the workplace or general environment. As such, these routes would not qualify as routes of high exposure as outlined in EPA's QtAs. V. Magnitude of Study Type Limit tests are commonly conducted tests and observations of non-specific signs of toxicity are commonly observed. If such tests are deemed submittable SPA is likely to receive in excess of one hundred thousand studies for evaluation from all sectors of industry. A VEV-141302 APft 30 '31 10:50 UJKPOKHft TftHC i_=>1 3144704033 P.6^11 Pi| 5 of 5 Limit Tost - "Nturotox" Draft 3 - 4/29/91 VI. Conclusions Limit tssts in which observations such as lethargy, ataxia and convulsions are recorded are not reportable under TSCA 8(e) since, according to ZPA guidance, "intonation shoving a chemical to be slightly or minimally toxic on an acute/subacute basis is not considered typically to be reportable." A VEV-141303 AaiV'IdXiafy -- ( box-- hklircrfaxiotf VEV-IA1304 =P 30 '91 10:49 CORPORATE TRAC LSI 9144784839 Page 1 of 5 P.5^11 Human Health Effects Casa Study Acuta Toxicity Testa - Nora than Ona Dose - "Neurotox" Draft 3 - April 29, 1991 I. Study specific Information The purpose of this case study is to describe the criteria necessary to assess the reportability of acuta toxicity tests under TSCA 8(e) that contain various signs and symptoms that might be indicative of neurotoxicity. An oral LD50 study is conducted in which animals are given 50, 200, 500, 1000 or 2000 mg/kg. Shortly after dosing intermittent lethargy, ataxia and convulsions are described in the 1000 and 2000 mg/kg groups. Salivation, tremors and lethargy are described for animals in the 200 and 500 mg/kg group. No effects were observed at the 50 mg/kg dose group. All rats die at 2000 mg/kg. The rest survive. II. Other Relevant Information ERA Neurotoxicity Testing Guidelines under FIFRA. III. Existing ERA Guidance EPA has published a number of Q8As and status Reports regarding TSCA 8(e). The following QfcAs appeared in an EPA document dated July 3, 1989: Q. What criteria should be used in determining if the results of acute toxicity studies constitute information that reasonably supports a conclusion of substantial risk? A. Criteria used to determine section 8(e) reporting in the case of acute/subacute findings will depend on the nature of the effects observed and the dose at which the effects occurred. For example, information that shows a tested chemical to be extremely toxic (e.g., causes lethality at very low doses) by, for example, inhalation, dermal application, or oral administration should be reported. On the other hand, the reporting of information showing a chemical to be moderately toxic will depend on the degree of actual or potential exposure to the tested chemical. Information showing a chemical to be slightly or minimally toxic on an acute/subacute basis is not considered typically to be reportable. In addition to extreme toxicity, certain other serious toxicological effects (e.g., neurotoxicity, adverse reproductive system effects) seen in an acute or subacute animal study should be reported under Section 8(e). Q. what criteria constitute evidence of reportable neurotoxicity in animal studies? For example, are APR 30 '91 10:48 CORPORATE TRAC LSI 9144784839 7t|i 2 of 5 Acut - Mort than Draft 3 - 4/29/91 P.4/11 n d st - "Nurotox" reversible effects such ee narcosis or effects observed in the presence of narked systemic toxicity considered reportable? A. Typically, neurotoxic effects that are observed in dying animals are not, in and of themselves, considered by EPA to be reportable under Section 8(e) of T8CA. Xn many cases, however, already reportable data regarding extremely or highly toxic (lethal) substances will be accompanied by information concerning observed neurotoxic effects. In short or long term exposure studies in which serious neurotoxic signs and symptoms (e.g., convulsions, sleep induction, motor dysfunction, narcosis, behavioral dysfunction) are seen in non-moribund animals, however, specific reporting of the neurotoxic effects should take place. EPA's guidelines also suggest that, while LD50 and other acute screening data may often be outside the scope of section 8(e), there may be circumstances where reporting is required. The following comment appears in 43 fed. Reg. 11114, March 16, 1978, "Statement of Interpretation and Enforcement Policy": Comment 14: How are reportable data distinguished from routine tests including range tests such as LDSO's. Response: This policy statement directs the reporting of specified effects when unknown to the Administrator. Many routine tests are based on a knowledge of toxicity associated with a chemical; unknown effects occurring during such a range test may have to be reported if they are those of concern to the Agency and if the information meets the criteria set forth in Farts V and VI. In reviewing EPA's Status Reports it appears that routine screening tests qualify for reporting only if they demonstrate a significant level of acute toxicity and involve chemicals to which there is significant exposure. in 1980 (status Report 8EHG-0479-0282 s, January 9, 1980), EPA explained that its "interest in receipt of acute toxicity studies under Section 8(e) is. In general, fairly limited" but that "under certain circumstances the results of acute etudles can provide reasonable support for a conclusion of substantial risk." "Submitters are expected to consider such factors as the lethal dose, the route of administration, occurrence of unexpected effects in the animals (obtained via 'cage side" observations, during necropsy, and so on), and the extent and pattern of th chemical's exp sure (ins far as known to the submitt r). In g neral, wh n valuating such VEV-141306 APR 30 '91 10:48 CORPORATE TRRC LSI 9144784839 Pag* 3 of 5 Acuta - Mora than Draft 3 - 4/29/91 P.3/11 na doaa - "Naurotox" information undar Section (a) tha greater tha acuta toxicity of a compound tha less heavily one veighe the exposure criteria and vice versa." in the same status Report SPA has concluded that acute data demonstrating "extreme dermal lethality" were reportable under Section S(e) because of the substance's potential for exposure. In another Status Report, EPA stated that data demonstrating that an RAD chemical was "highly toxic" did not trigger section 8(e) reporting because "acute toxicity data on RAD chemicals which presumably have very limited exposure do not appear to be sufficient to indicate that the material poses a substantial risk to health or the environment." (Status Report 8EHQ-0578-0162 S, June 15, 1978). Thus, it appears that EPA is uninterested in receiving acute toxicity data undar 8(e) unless the effects occur at extremely low doses and involve compounds with significant exposure potential or are associated with more serious, incapacitating effects likely to manifest themselves at a later date. It should also be noted that in the late 1970's EPA also warned a Chicago based company that they were engaging in "malicious compliance" following the company's submission of large volumes of acute studies under TSCA 8(e). (NOTE: THE GROUP WAS UNABLE TO CITE A REFERENCE - ANYONE FAMILIAR WITH THIS?) IV. Evaluation Discussion The study described should not be submitted under TSCA 8(e) since: 1. the observations are relatively common signs of dying animals or from animals stressed by dosing of large volumes of test material in non-emetic species in this kind of test. Therefore, it is not possible to determine whether they reasonably support a conclusion of "serious neurotoxic effects" as outlined by EPA. 2. In this specific example, it is not possible to determine whether one animal or all animals in the dose groups sxhibitsd this affect and whether the observations persisted for the entire length of the study. 3. Acute toxicity tests are not sensitive enough or designed to measure neurotoxicity. While signs and symptoms fr m exp sure are r c rded, these bservations by technicians ar visual valuati ns. Th study design do s A APR 30 '91 10=4? CORPORATE TRAC LSI 9144784039 P(t A of 5 Acutt - Mora chan Draft 3 - A/29/91 P.2/11 nt dote - "Nturotox" \ A not generally entail handling or aanipulation of tha animal to asaaaa tha raliability of a aubjactive viaual observation. Tha ERA# under FXFRA# haa aatablishad neurotoxicity guidelines that are not addressed by acute toxicity studies. Under these and other guidelines/ there are specific tests that are conducted to determine neurotoxicity. Theee tests typically can include acute neurotoxicity in hens, behavioral testing (mazes, Skinner box)/ righting reflex, startle reflex# pupillary reflex# hot plate test# etc. The endpoint of acute toxicity testing (limit# LD50) is death. As such# signs and symptoms are gathered to assist the tester in designing additional studies. while the signs and symptoms outlined in'this case study cannot be ignored# the relevance to "substantial risk" is not known unless further testing is conducted. 4. If the study were conducted as above and the observations stated "convulsions began on day 2 and persisted for the entire length of the study in all surviving animals at the 200# 500 and 1000 mg/kg dose levels" the study would be submittable as it constitutes a "serious neurotoxic effect" as described by EFA. Conversely# if a dose-response relationship was not observed the report would not be submittable. 5. If the study were conducted as above and information were available to indicate that less than four of ten animals per group exhibited convulsions# and the results were seen in one group# the report would not be submittable as the signs and symptoms described are not significant. Conversely# if four or more out of ten animals per group exhibited these symptoms# or dose-related convulsions were noted in several groups in which no deaths occurred, the report would be submittable. 6. If the doses were changed to 10# 25, 100# 1000 mg/kg and convulsions and hind-limb paralysis were observed in a dose-dependent manner the report would be submittable as it would constitute a "serious neurotoxic effect" as described by EPA. Conversely# if the signs and symptoms reported were salivation# piloerection# lacrimation# ataxia# sleep induction # miosis/ptosis# chromodacyorrhea# decreased or increased movement# or any combination of these# and NO DEATHS OCCURRED# the study would not be submittable as these symptoms are relatively common in acute toxicity studies and it would not be possible to conclude that these effects constitute "serious neurotoxic effects" as described by ERA. However# if deaths occurred and the oral LD50 was reported as less than r qual t 50 mg/kg (d rmal LD50 less than or equal to 200 mg/kg and inhalati n LC50 1 ss than or equal to 20 mg/1)# th material would b classifi d as extremely toxic and should be r p rt d as it me ts the criteria utlin d by ERA'S Q&As and Status Reports. VEV-141308 APR 30 '91 10:47 CORPORATE TRAC LSI 9144784839 P*g# 5 of 5 P.1'11 Acut* - Mort than ent dost - "Nturotox" Draft 3 - 4/29/91 4 V. Magnitude of study Typo Acuta toxicity toots oro commonly conducted toots and observations of non-specific signs of toxicity are commonly observed. If all teats are deemed subaittable without regard to route of exposure or toxic potential EPA is likely to receive in excess of a hundred thousand of these studies for evaluation. 9 VI. Conclusions 1. In general, acute 1DS0/LC50 studies in which signs and symptoms that include ataxia, lethargy and narcosis are not reportable under TSCA 8(e) as these are relatively common effects reported in acute studies and their significance cannot be determined without additional testing. 2. Convulsions and/or hind-limb paralysis reported in four of ten animals per group or greater would constitute a reporting obligation as these constitute a "serious neurotoxic effect" as described by EPA. 3. When effects are observed only at the highest dose and no clear dose-response relationship is established the study would not be 8(e) reportable. 4. Other signs and symptoms that might be indicative of neurotoxic effects (eg: salivation, piloerection, lacrimation, ataxia, sleep Induction, miosis/ptosis, chromodacyorrhea or any combination of these), are only reportable if the material is extremely toxic (ie: has an oral LD50 of less than or equal to 50 mg/kg; dermal LD50 of less than or equal to 200 mg/kg; inhalation LC50 of less than or equal to 20 mg/1). VEV-141309 _ c/15T 5T(ia/ 4- * U I h1 VEV-141310 tQmt/ i53i Dr nueril kJV . I OA i '.UL^l i imetn vnen j 03 I KlCj 4 X. --ilia UfaMitlaa A repeat acute oral study (using rats) was oenduetsd on an organephoaphorus compound and raaultad In an acuta oral U)SO value of 2 mg/kg. Tha first study on this compound, using tho same strain Of rat, reported an LDSO of 1 mg/kg, and the results were submitted to IPA under TtCA t(e) based on the high acute toxicity. Clinical signs in both studies .included salivation, lacrimatlon, incontinence of urine and feces, twitching of muscles and deersased physical activity, l.e., typical of the clinical signs expected for this class of chemicals. xx. Mjpy Mlsraat Uftnatlu Xn light of the ohemleal class and the results obtained on structurally similar materials, these results were considered typical and expected. The definition of "corroborative1* needs to be clarified in discussing the issue of reporting "expected" findings. The only formal guidance of "corroborative adverse effects" are contained in the original TSCA 9(e) Interpretation Policy document (March 19, 1979) and suggests that corroborative studies are MOT reportable. The document, however, addresses only published literatur and, furthermore, it does not dsfine Pegs 1 f 4 VEV-141311 xMtly what constitute "eembontivt* Tha;t(en> it it not clear how to rapart corroborative results undar TSCh t(a), whether published or not. ZV. Itaction . li tinea tha firat study in tha sbova-mantioned acanario vaa submitted to tha *X undar TSCX 8(e), tha eoneluaion ia that tha raaulta of tha repeat atudy ara NOT raportabla. Thia ia bacauaa tha affaeta aaan ware antiraly expected, ware eorroborativa with tha raaulta of the firat atudy, and ware eovarod under any reporting obligations by tha eubatiasien of tha first study. aituatlon Mo. 2i Ha now assume the second atudy was conducted on tha original compound, but using a different rat strain. The raaulta ara exactly tha same aa thoaa described previously. Hith this situation, wo eoncluda that tha raaulta of thia subsequent atudy are still MOP raportabla far tha same reasons, i.e., they wore expected, were eorroborativa with tha results of tha first study, and ware covered by tha submission of the first study under Tiex S(o). situation Mo. l Ha assume that the second atudy was conducted on tha origins! eompound, but mica rather than rats ware used. Tha resulting LDSO value was la mg/kg (vs. 1 mg/kg) but tha clinical signs ware similar. Zn this situation, despite tha different species tasted, we concluded that this second report is still MOT reportable because it d as not provlda new inf motion and is lass toxic than tha riginal rat 4 Page 2 of 4 VEV-141312 wv- + yj + w w' * * * iuDfi i wwf\r . w/'s * w 07> 7^4^ r . A result*. If th* results had been ravsrasd in this sxampla, l.s., ths LDIO valus f*r th* nwaa study wti 1 mg/kg vs. 12 mg/kg tor tbs rat study, indicating t higher degree of sensltivity/suseeptlblllty in the seeend tested specie, the second study results would be considered for possible reporting under TfCh a<e). lituation no. M assume that the second study was conducted in th* see strain of rate but was administered dermelly. The reeultant U>SO value was 40 eg/kg (vs. 1 mg/kg orally) but th* clinical signs were similar. In this situation, knowledge of the intended/actual usee and potential esposures would need to be considered to determine whether th* results warrant reporting as a separate TSCA 8(e) submission. situation uo. it if use the first scenario again, but now assume that the structure of the chemical in tho second test was siiahtlv modified. *.g. the addition of a methyl group, we conclude the result* to be sen-reportable ainee this new ehemieel is from the seme class of ehemieels, and the results are atlll typical, and axpectad, of this class of ehemieel. v. Result* confirming previously observed effects occur frequently. For example, even though a einglo econario is used her* ss an exemple, it should be recognised thst this conespt sppllos to many dlfferant toxic endpoints. Other exsaiples includei irreversible ey* damage resulting from compounds having high or lew pH values, cancer caused by polycyclic Pegs 3 of 4 VEV-141313 aromatic hydrocarbons, positive results from tbs um of positive control eompounda, pulmonary eenattisation cauaad by isocyanataa, etc. vx. A Aeeulte of otudloo of eorroborativo or expected nature for well documented endpoints are NOT raportable under TSCA t(a) as aubatantlal risk findings. Thla la baeauaa submission of reaulte which oorroborata information which tha *PA haa previoualy received dome not add significantly to the baaa of new toxicity information, nor doaa not reporting there expected reaulta within tha expedited timeframe Of Section *<e) impede the ability of tha CPA to adequately regulate these aubstanoee. Page 4 of 4 vEV-14l314 TfiTOI P RC CA>r snuoy c fr|c (Sfrr> rr\kbrK* &yv<- fAvvnw>f) Sfcm \fir*>ior\ X Grv*- ^'1413,5 FROM (TUE) 4,30,'91 7:40 NO.2068ii8f35f SflSE 2 Case Study I. Skin and Eve Irritation and Skin Sensitization Section Ii Study Specific Information This case study deals with short-term skin and eye irritation studi s and skin sensitization studies in animals. Section lit Other Relevant Information Exposure potential, severity, predictability and reversibility of the observed effect, and pH of test substance. Section III: Existing.EPA Guidance 1. The 1978 policy statement and its reporting criteria of "...serious or prolonged incapacitation". 2. Various EPA 8(e) status reports which say skin and eye irritation and corrosion are not reportable, in these reports, EPA elaborated "Submitters are expected to consider such factors as the lethal dose, r ute of administration, occurrence of unexpected effects in the animals (obtained via 'cage side' observations, during necropsy, and so on), and the extent and pattern of the chemical's exposure (insofar as known to the submitter). In general, when evaluating such information under Section 8(e), the greater the acute toxicity of a compond, the less heavily one weighs the exposure citeria and vice versa." section IV; Evaluation Discussion Th endpoints of skin irritation/corrosion and skin sensitization usually are not substantial risk information. The information is not "any pattern of effects or evidence which resonably supports the conclusion that the chemical substance or mixture can produce canc r, mutation, birth defects, or toxic effects resulting in death, or seri us or prolonged incapacitation." Severe skin effects are not reportable even if vide exposure potential is present unless the effect is unsuspected. Eye irritation studies which produce reversible eye effects or eye ffects which are irreversible only in the absence of eye washing are not reportable even if vide exposure potential is present. Unless th effect is unsuspected, this information is not reportable because it does not support the conclusion of substantial risk to human health. Irreversible eye effects may be reportable if coupled with vide exposure potential or if the effect is unsuspected. The factors in Section hi.2. sh uld be considered when determining reportability. VEV-141316 FROB (TUE) 4.30.'91 7140 NO. 2060113537 PflSE 3 A 3 of 4 Section Vi Magnitude of Study Type Eye and skin irritation studies, and skin sensitivity studies are among the most common type of toxicity testing conducted. Considering mixture testing as well as studies on neat or industrial grad chemicals, these studies have probably been run several times for every chemical that has either been commercialized or to which there has been a potential for worker exposure. Section VI;Conclusion Th endpoints of skin irritation/corrosion and skin sensitization usually are not substantial risk information. Severe skin effects ar not reportable even if wide exposure potential is present unless the ffect is unsuspected. Irreversible eye effects may be r portable when considered with other relevant information, other clinical effects observed in these studies may trigger reporting. VEV-141317 (THE) 4,30,'91 7:41 NO.286811858? PflSE 4 A FRO!! 4 of 4 IiJgfcia aod-Eyt Irritation,and. skin sensitiration Section -It Study Specific Informatian This case study deals with short-tern skin end eye irritation studies and skin sensitization studies in animals. SlStiflll II; OtfteSUSglfiYflnt Information Exposure potential, severity and predictability of observed effect, and pH of test substance. Section IIT: Existing EPA Guidance 1. The 1978 policy statement and its criteria of "...serious or prolonged incapacitation". 2. various EPA 8(e) status reports which say skin and eye irritation and corrosion arc not reportable. In these status reports, EPA considered exposure potential and expected effects of the chemical. Stellpn-IYi Eva lua.tj.sn- Discuss ten The endpoints of skin and eye irritation/corrosion and skin sensitization studies are not substantial risk information. They ar not "any pattern of effects or evidence which rcsonably supports the conclusion that the chemical substance or mixture can produce cancer, mutation, birth defects, or toxic effects resulting in death, or serious or prolonged incapacitation." other clinical observations may trigger reporting especially if the effects observed are unsuspected. Section V: Magnitude, of Study Type Eye and skin irritation studies, and skin sensitivity studies are among the most common type of toxicity testing conducted. Considering mixture testing as well as studies on neat or industrial grade chemicals, these studies have probably been run several times for every chemical that has either been commercialized or to which there has been a potential for worker exposure. Section. VI: Conclusion In the absence of other clinical observations which may trigger reporting, information from skin and eye irritation and skin sensitization studies is not reportable. VEV-141318 SIT'D/ U 04' & 51 10:41 lZ wiUM-jrr-E 0&. A TSCA 8(e) CASE STUDY Buhchronio Btudlaa saetion n__QtudY Specific Infcrnaticn A subohronic darmal repeat dose study in rats was eonduetad at dosss of 0, 100, 300, and 1,000 mg/kg. Tha chemical studisd is sxtsnsively ussd in consumer products and xposura to tha chamical is axclusivaly daraal. A statistically significant 29% increase in liver weight has observed at the high dose. A statistically significant incidence of clear signs of liver pathology typical of liver cirrhosis was observed at the mid and high doses. The Noael is 100 mg/kg. .No tumors, effects on reproductive organs or clear indications of neurotoxicity were observed in the study. Section III__Other Relevant Information Acute and range finding data on the chemical indicate that it is relatively non-toxic, therefore the high dose chosen for the subchronie study was the OECD recommended limit of 1 g/Kg. section im__ BKletlng EPA guidance Relevant definitions for reportable health studies in the 1978 EPA Guidance Document are in Section IV, paragraphs (a)(1) and (a)(2). In addition, the July 3, 1989 EPA guidance states the following in regard to serious toxic effects observed in a subohronlc studyt wincludes readily observable serious effects or serious effects seen only as the result of gross and/or histopathological examination. As is the ease for acute subacute toxicity studies, the degree of the observed toxicity is important. The more serious (or significant) the observed effect, the less heavily one should considsr actual/potential exposure for reporting and vice versa." section IVi__ Evaluation Dlaouaalon The study may be reportable because of the pathological finding directly related to human disease, in order to determine if the study is reportable, the regulatee should consider the magnitude of exposure in the population and the seriousness of the observed effect. If the exposure to the chemical was expected to be less severe, eg. the uses were industrial or R8D, these findings may not be reportable because the experimental dose levels mployed may not indicate an effect sufficiently serious based on the total exposure potential. This follows EPA guidance which has stated that the degree of toxicity and xposur potential should be considered in determining Secti n 8( ) r portability. In these cases, these r suits may not be r portable uni ss they w re be rved at doses ne r mor orders f magnitude lower. VEV-141320 A If the same results were obtained in an oral study rather than a dermal study# ths routs of experimental sxposurs and any Information relevant to ths actual expected routs of sxposurs (so. if ths sxpsctsd or actual sxposurs is dermal, is ths chemical substanos known or sxpsctsd to ba absorbsd through ths skin) would also nasd to be considsrsd bsfors deciding that ths study is rsportabls. in ths svsnt ths livsr weight findings wars obssrvad in ths abssnco of concurrsnt histopathological findings, ths study would not bs rsportabls undsr most sxposurs scsnarios since thars is a strong likalihood that ths obssrvations rsprsasnt nly an adaptivs respond by ths animal to a xsnobiotic load. N n-histopathological findings which ars obssrvad in isolation, such as body weight affects, organ wsight ffacts, rexcept reproductive organ affects) changes in a single clinical chemistry parameter, would not constitute a r asonable finding of a serious offset at any doss. Without histopathological findings, multiple obssrvations would need to occur in mechanistically related groups (eg, multiple electrolyte changes indicating renal insufficiency) in order to become "a pattern of effects" which supports a reasonable finding of a serious effect. in reviewing subchronic studies, the regulates may be faoed with determining whether certain histopathological findings r present true toxicological responses or constitute mere "phenomenology" unique to the test animal species. Controversial examples which exist today are peroxisome formation in the liver and alpha-2-globulin deposition in the kidneys of male rats. The regulates should gauge the scientific consensus of opinion about the nature of the effect at the time the study needs to be considered for reporting. Although true histopathological findings alone may indicate a serious effect, some are more serious than others. The reguiatee may wish to establish a sliding scale of dosage levels at which various effects are considered serious. section Vi Maonltudo of Study Tvne Many large companies have hundreds of subacute or subchronic r peat dose studies. Increases in various organ weights are ften seen without concurrent histopethology or functional changes. Criteria are necessary to determine which of the studies indicate a reasonable finding of substantial risk to k ep Section 8(e) reporting as useful indicator of unusual, serious findings as opposed to common findings not indicative of substantial risk. Section VIt Conclusion Studies where histopathological findings representing serious toxicological events may be reportable, other factors including dose and actual expected exposure must be xamlned to determine if the study supports a reasonable finding of a serious effect. Under most circumstances# isolated observations in the abs nee f cncurr nt pathology or mechanistically related observations r functi nal changes, should not be considered f r r porting. '"*-14.32, CAS fffbpi ' J4r>wn 'Jb'tfa- A i *i t dn* Vision 3J1 s&i-W*2* APR 30 '91 14:04 CORPORATE TRAC LSI 9144784839 CI0A.QCIQY Corporation A/dJ*y. N*w York 10903-2999 IWaoltono 914 479 3111 P.2/9 CIBA-GBOY FACSIMILE TRANSMISSION! (2021 817-1237 A April 30, 1991 Kathryn A. Roaica Chemical Manufacturers Association 3501 M Street, nw Washington, DC 20037 RE.: Case Study(ies) on Health Effects "Known to the Administrator11 Dear Ms. Rosica: The group felt there was a need to break this into two case studies (attached)t one for information learned from government agencies or scientific journals/meetings (Case 1) and another for information previously submitted to either EPA/OTS or epa/ppo (Case 2). Some of the points/arguments made in our Case 2 may overlap with the Environmental case study regarding "known to the Administrator." The blanks for numbers of the various types of submissions in case 2 (Magnitude of Study Type) need to be filled in yet. X xpect other member companies will be able to estimate these r asonably accurately* Thanks for your efforts in organising and directing this fast-track, Herculean task. Sincerely, A. Di Battista R gulatory Affairs a Toxic Substances Compliance TRAC AD04261a.DOC/dch Attachm nts VEV-141323 APR 30 '91 14:04 CORPORATE TRAC LSI 9144784839 P. 3/9 A A. Di Battista: phone - <914) 479-2776 fax - (914) 478-4939 TOWN TO THE ADWrarSTBATOtt - WEIT/TH EFFECTS SECTION I: study Specific Information A toxicologist in Company A becomes aware of a positive cancer result (or any serious toxicological effect) for chemical X, which it manufactures, via one of the following sources: a) a phone conversation from a National Toxicology Program (NTP) scientist conducting a bioassay study, which is at the draft report stage; b) reading a published report in a well-known, peer reviewed, American scientific publication; c) a presentation at a national society of Toxicology (SOT) meeting or other widely attended scientific informational meeting. SECTION II: Other Relevant Information None SECTION III/IV: "Existing EPA Guidance/Evaluation Discussion la) - No specific written guidance is available from EPA regarding obtaining oral information from other government agencies. EPA is a sister agency of NTP. As a sponsoring or participating Agency, EPA should reoeive this information in as timely a manner as industry personnel. It can therefore be xpected that the information is known to EPA. comment 2- of the 1978 guidance addressed the issue of information reported to other government Agencies, and vice v rsa, as baing unduly burdensome and duplicative. EPA's r Bponse was essentially that, when coordination with other Agencies is successfully completed, the policy statement will be amended. CMA suggests that, aft r 13 years of TSCA impl m ntati n, th policy states nt should be amended t not require industry to rep rt studi s that EPA, r s me other federal Agency, is sponsoring or that are publicly available to anyone. VEV-141324 APR 30 '91 14:05 CORPORATE TRAC LSI 9144784839 P.4^9 A -2- II a) - Saction VII c) of EPA's 1978 Policy statement states that information need not be reported if it has been published in the scientific literature AUd referenced by the following abstract services ... (six are listed, including NTI8.) Such abstracting, however, would normally occur well past the 15-day deadline. (It could talcs 3 to 12 months for such abstracts to actually appear in the literature.) CMA suggests that the wording in the 1978 guidance be modified by changing the word "and" to "will be" referenced ... . Alternatively, the wording can be changed to "... scientific journals which are routinely referenced by the following abstracting services... ." This would resolve the 15-day timing dileaaa, which cannot otherwise be met, as a practical matter, es the 1978 guidance now reads. If EPA does not wish to actually change or modify the 1978 guidance, the Agency could merely publish a clarification in the Federal Register or the new guidance to the effect that what we are recommending above is what EPA actually means. Also, EPA should clarify that "reference by the . . . abstracting services" means that it is sufficient that the study be printed in a journal which is routinely abstracted and not that the specific information must also be abstracted. Ill c) - EPA toxicologists, as well as industry toxicologists, routinely attend Society of Toxicology meetings and hear the same information at the same time. Additloanlly, they are equally oapable of appreciating the significance of such information. We know of no written guidance on this issue. CMA views SOT meetings in the same vein as widely read, well-known scientific publications and recommends that EPA exempt industry from having to separately report such information as being publicly available information. V - Magnitude of Study Type There are many credible and well recognised scientific j uraals in the field of toxicology that are (at some point in time) abstracted into one or more of the Abstracting Indices, c llectively, they cover many chemicals and studies. The situations that have been discussed previously, therefore, are quite common and pose a substantial redundant burden on reporting compliance activities, particularly in view of the fact that EPA would ultimately aequir aoo sit th same information. VEV-141325 APR 30 '91 14:05 CORPORATE TRAC LSI 9144794839 P.5^9 A -3- VI - Conclusion Hone of the three examples given above require 8(e) reporting. If reports are required, much duplicative reporting of publicly available information will unnecessarily burden both Industry and EPA. 004261a.DOC/dch VEV-141326 APR 30 '91 14:06 CORPORATE TRAC LSI 9144784839 P.6/9 A A. Di Battista: phone - (914) 479-2776 fax * (914) 478-4839 KNOWN TO THE ADMINISTRATOR * HEALTH EFFECTS CASE.,2 SECTION 1: Study Specific Information Studies or information have previously bean submitted to either EPA/OTS or ZFA Pesticide Office under: a) an FYI submission; b) a Section 4 Test rule; c) Section 8(d); d) a PMN; e) a 5(e) consent order; or f) a FIFRA registration for R&D pesticides. SECTION II: other Relevant Information None SECTION III: Existing EPA Guidance The 1978 policy statement does not specifically address any of the above examples except the straightforward case where significant adverse effects information is obtained on an R&D pesticide after an application for an Experimental Use Permit or FIFRA registration is filed. In such cases, no 8(e) notice is required. Question 20 of SPA'S Q&A summary document following its May 5, 1987 Seminar on Industry Obligations under T8CA addresses the relationship between TSCA Section 8(c) reporting and the reporting of results of studies (l) required to be conducted under Sections 4 or 5 of TSCA, or (2) "listed1* under section 8(d) f TSCA. Essentially, the answer stipulates that "Section 8(e) r porting, in these cases, typically occurs when a section 8(e) bligation is incurred before reporting of a study is required under Section 4, 5, or 8(d). If other required reporting occurs b fore or coincidental with incurring a Section 8(e) r quirement, the study does not have to be submitted to the 8(e) d cket. The purpose of this exemption is not to change substantially the 8(e) obligation, but merely t avoid r quiring duplicative rep rting, except vh re timeliness consid rations b come paramount." VEV-141327 APR 30 '91 14:06 CORPORATE TRAC LSI 9144704839 P.7/9 A -2- There is no written guidance (to my knowledge) regarding the submission of 8(e) intonation aa PYX. section ivx evaluation piicutjgn Thar* ara at laaat two aaparata isauaa hara: a) vhathar information can ba submitted under any of the above authorities in lieu of an 8(a) submission and b) whether information previously (i.a., already) submitted under any of the above examples is "known to the Administrator." The first issue deals primarily with the issue of timeliness while the second one deals with whether "such person has actual knowledge that the Administrator has been adequately infoned of such information.M We are concerned in this ease study primarily with information that has already bean submitted to EPA, particularly for purposes of auditing under the 8(e) CAP program. CMA believes that information that has already been submitted should be x mpt from auditing and 8(e) reporting under the CAP and would fulfill any 8(e) reporting requirements. However, for future reporting purposes, CMA believes that certain types of submissions would not fulfill 8(e) reporting requirements. a) An PYX submission would not satisfy an 8(e) reporting obligation. It is a voluntary submission and may not b reviewed on a timely enough basis by the Agency receiving it. However, for the purposes of the CAP, we believe any previous FYI submissions submitted to SPA should be viewed as "known to the Administrator" and not be required to be resubmitted under the 8(e) CAP. The issue of timeliness is moot at this point* b) Information being developed under a Section 4 test rule is patently under the direction and oontrol of EPA. The Agency sets the requirements by rule or consent order agreement of when and how often (interim) results are to be reported. Since the information is being developed in concert with the appropriate EFA office, both the issue of "timeliness" and "known to the Administrator" should be viewed by EPA as requirements that are met in this case* A 15-day deadline should not be required here since the information will be going directly to th EPA office that has responsibility for acting upon the study information. c) CMA views Health and Safety Studies submitted under mandatory reporting requirements of Section 8(d) as fulfilling 8( ) r porting bligati ns. since EPA is n t involved in th process, exc pt at the receiving nd, and it ould take up to 60 days from Fed ral Regist r listing f r EPA to get the studies, we bellev , in th;.* APR 30 '91 14:07 CORPORATE TRAC LSI 9144784839 P.8/9 A -3case, that requiring a 15-day deadline (and identifying the information ae 1(e)) is appropriate. For 8(e) CAP reporting purposes, however, the timeliness issue is moot and any studies previously submitted under Section 8(d) should be viewed by CPA as "known to the Administrator.N d) For PMN submissions, our arguments are similar to those for 8(d) reports* Although all health and safety studies carried out by or known to the submitter are required to be reported with any PMN submission, EPA has no control over when the submission is made and how much earlier the potential 8(e) information was obtained. PMN submissions therefore would not satisfy 8(e) reporting obligations unless the information was submitted timely, i.e., within 15 working days (and identified as potential 8(e) information?) Again, for 8(e) CAP reporting purposes, the timeliness issue is moot and any studies previously submitted in a PMN should be viewed by EPA as "known to the Administrator." e) Toxicity information developed under a 5(e) consent order is developed with CPA's knowledge and direction. Whatever requirements the consent order stipulates regarding timing and submission of test results should be sufficient for CPA's purposes. A 15-day deadline is unnecessary for reports submitted under 5(e) Consent Orders since EPA is already plugged into the process. Any reports, either in the past or in the future, submitted as a consequence of a 5(e) consent order therefore should be deemed to be "known to the Administrator." f) TSCA exempts pesticides from the Act and section 8(e) reporting. WO pesticides, prior to filing of an Experimental Use Permit or FIFltA Registration, are regulated under TSCA. Because of unclear guidance in the past, certain studies on R&D pesticides may not hav been 8(e) reported. Subsequently, some of these R&D pestioides have been registered under FIFRA and all the studies have been submitted with this registration to EPA's Office of Pesticide Programs. Since EPA now actually has all these reports, the ones carried out while the now registered pesticides were in the R&D stage (and subject to TSCA) should be viewed by EPA/OTS as being "known to the Administrator." Consequently, such studies should not be required to be audited and possibly submitted under the 8(e) CAP. To do otherwise w uld be duplicative r porting and t tally unnac ssary in CMA's vi w. VEV-141329 APR 30 '91 14:07 CORPORATE TRAC LSI 9144784039 P.9/9 A -4- SECTION V: Magnitude of study Type CMA expects there would be a significant number of these types of studies that are already "known to the Administrator.11 An approximate number of the various types of submissions already mad to EPA is indicated below. It is likely that some 8(e) r p rtable studies would be included among them. ) Til Submissions b) Section 4 Test Rules, studies submitted c) Section 8 Id) chemicals, health and safety studies submitted d) PKNS > 5(e) Consent Orders t) Experimental Use Permits and FIFRA registrations with respect to RfcD pesticides, one major chemical company alone filed several hundred registrations under FIFRA. By improving internal communications within EPA, a significant burden could be lifted from the Agency and from industry due to limination of duplicate reporting requirements. SECTION VI: Conclusion In those areas, such as Section 4 test rules or consent order Agreements and 5(e) Consent Orders, where EPA is directly involved in and aware of the type of testing being conducted, the 15-day reporting requirement should be waived. Whatever timing requirements are set by EPA/s rule or consent order agreements should suffice. Any studies submitted in these two r as would be deemed to be "known to the Administrator." / In the areas of Til and PMN submissions, the 15-day reporting r quirement should be maintained for future reporting. For retroactive enforcement and 8(e) CAP reporting purposes, however, such previously reported studies should now be considered to be "known to the Administrator." studies on R&D pesticides, which have subsequently been FIFRA registered (or an EUP has been filed), are "known to the Administrator" and do not have to be addressed in the 8(e) CAP. AD04261a.DOC/dch VEV-141330 CAt>r S7*py Sr\eu* / CAM TUOY TO BtPLOMB TUB OCTOMMATION OF *MNOUS ON FMOLONQBO MCAPACtTATIQN' mOAnOtNO HUMAN HEALTH IFF1CT0 The QocupaUonsI MsPlains unit of a manufacturer HoMitM nun el the following Intormabon: In a manufacturing environment, 16 ehomtoal operators. aV working In the aama ehomleal operation wan the tubieeta of msdlool eutvelllenee Ineluding aoHsotlan ot a Meed (Hill. Nettle finding# Included: BUN OQT SOOT FIV1 SOU above normal )nt) 00% above normal fri0) 40% above normal (n>2) marginally (10%) lower than prodieted piof) Copts*--d pteptfo--ptlen ffaot) and moratory sonaadon (knee and anMa) !) Qthtf MtYlfTt jnt8QBf**an Several a* tha chsmleels used m tha prgaaaa art ait tha TSCA Inventory. Occupational aspaaufi lavalt tar aavaraI are below ettabHahed aaeaptabla nmite. Several at thaaa ahamlaata ara known to preduoe liver Injury to rodents In repeated dose toiieity etudiaa by the oral or Inhalation routoa, but only at eapertmental level* far m aaoaaa at tha occupational standarda. Nana of these ehemleel* ere known to produce human INer or kidney effects. One ohamieai la a human pulmonary aSergan. Employee aicahal and drug Intake ware reported aa negative In the few days prior to the testa. Nana at tha Individuals ware known to have diabetes. None ot the ehamlaals am known to produce neurofoslahy In humane ar animats. Briallno SPA Outdance The Marsh, 1S7S Pafley Stetemant/Outdanee Daeumant Indleatee that Information shaidd be reported It It la passible that affects less serious than dtesa described In Fart V(a) may be preliminary mantksstatlona at the mars serious atlaata and. SQa^aVaWiLtVa*t WIWI WvVtVi w Tip^flnQsi astailpsliam--sdiRlaniawiBITkialMMvanai The foliowing status reports Indteats that h la *nof oompletefy dear that tha Informatien praMdad-.ta Of tha type required far submission...under Section (#),* oven te the Agency regarding the submission a# ease studies and medical turvtUlanoe data: SEHQ QSId paiQSi SIH047SS4S1S: WO OSSS OOMfii SCHOg7SS4811i SCHO01ST4SS1- Further guidance has bean given In the 197S Q E A statement* Issued by tha Ageney Indtaatlng a dependsnoe upon avldaneo `strongly impileedng ana far a few ehamlaals)* but without defining "strongly Implicating.* ***i"-Im "``""Ytan In the epeeffie study dasenbad above, there haa boon no ehnleal determination of oaueatlan regarding any at thaaa findings. Further study ot each effect would appear to be warranted before teaching a dtraahald at fSpOfteDHty. 0) The refotaly high SUN level la a single aaaunpnea among a group of similarly aapaaad wpdrara and Star* la no previous avfdartas at renal seatalfy aaaaalatad with any of tha preoaaa ahamlaala. b) Tha Ivor ensyma paramatara arc an tha high side of the --posted tango but aWt within the norm. Furdtor, the animal tedolty studies provide no rooaonobia putdanoo In that Bver eftsot* ware only seen at vary high does levels with a wide margin ef safety te tha confirmed ooaupadanal levels the markers have been exposed to. o) Tha F1V1 valuee arc only marginally daaroasad and not consistent with poet evidence at doaa response (l.o., far lower than ta NOCL) aeon ter e human respiratory adorgen used in tha presses. d) Tha singular Incidence at a neurological disorder is ot little diagnostic value wMteut further confirmatory tvahiatlena ar correlation la a confirmed human nourasaatn. A A von d ana of m `mMUhT ttodtoga waa dotatmlnad to ba rotated to cHamtoto aapoouro. auoft finding would not 5a Iwrtoart. to allaat a latmn fit prrrtnnQtH "* **" *"T*"y ""I ff* T1** --t imty tft "ittlf --"* t(r> and not Wad undar aaotton b|a). Informationauabaa dUa la notnonwadyaonaldatoda>ruaatudy,butoftenaaaaareportoraurvoManoerodew. ft la eetfmetod toot Morally hundroda of toouaonda M not mWtona of auon flndinga ara mado annually by mo U S. Oaoupattonal HeaHh fratonfanala Thue, too oonoopt of >reftmlnary manMewadone of too mom aattoua aftaoto* aould load to anontioua reporting eoneequenoea without dear guidance. The trdermadon of tola type la not {udgad to prortde raaaonabla aaauranoe tost a cfterntM oan bo aaongly Impilertad aa to aauaadon and toua too Judged not to ba reportable undar Section i|a). Iron If datormlnad to bo aauaaHy related to chemical axpeaure. we do not boNtoto tooao oitocto altoetd taoaonably ba aonaldarad In toa contort of aartoua f a., toaa of organ function) or prolonged Innapaoltotton M,, aattoua Impairment) and tout would not requite TSCA S(e) cubtwlaaton. 4 April 30,1SS1 a ZmtZONMF/VTAL CJrbE &hD)ES CP&esntDH q ffttinb)v<~l WlctispKtteC m\ no+i itk\ VEV-1^1335  APR-30-'91 TUE 14:56 ID: 517-630-9564 TEL NO: STH FLOR LErt_ 8581 P02------------------- 4 CASE STUDY TO EXPLORE THE DETERMINATION OF "WIDESPREAD DISTRIBUTION IN ENVIRONMENTAL MEDIA" Study Specific Information The manufacturer of a volatile liquid chemical aubatance, which is a known human carcinogen, becomes aware of the following information: At multiple sites throughout the United States and with various own rships, the ehemical substance is stored in storage tanks. All of the tanks are vented to the atmosphere. Emissions into the air have not been measured, but have been calculated using a model. At one of the sites, the owner or a nearby, off-site well monitoring groundwater determines that the well is contaminated with the same chemical substance. However, monitoring wells on the customer's site are not contaminated with the chemical substance. A soil boring sample from the area Immediately adjacent to that particular tank shows the presence of the chemical substance at high levels in the soil. Othar Relevant Information The hydrogeology of the area is not known. Therefore, the manufacturer has not determined that the contamination in the nearby well is due to the same source as the contamination in the soil near the tank. There has been no affect upon the vegetation on any surrounding property not owned by the site-owner. Technology exists to c mpletely remediate the small area of soil contamination. The manufacturer is not aware of similar circumstances at other sites. Exlatlag-fiPA guidance The March, 1978 Policy statement/Guidance Document states information must be reported when there is "[w]idespread and previously unsuspected distribution in environmental media, as indicated in studies." Status Reports indicate that contamination of groundwater and soil is information which EPA believes may be reportable under TSCA S 8(e): 8EHQ-0487-0662, 8EHQ-1Q88-0759, 8EHQ-1177-0013, 0EHQ-O178-OO37. Additionally, in Status Report 8EHQ-11B2-0466, EPA states that "releases of less than the reportable quantity of a (ehemical substance] should be considered for reporting pursuant to Section 8(e) f TSCA." The March 1985 issue of Chemicals In Progress, issued by EPA, stated that groundwater is considered a part of the environmental media. EPA restates the 1978 guidance in the July, 1986 QtA. Evaluation Mwiniilnn There is no indication of human exposure. Therefore, the information would be reportable only as an environmental effect, if at all. To be reportable as an environmental effect, the manufacturer must consider wh ther the distributi n in the environmental media is "widespread" (provid d other criteria are met). In determining whether the distribution is "widespread," four criteria should b consider d: 1) whether the distribution is due to a singl VEV-141336 APR-30-'91 TUE 14:57 Iff: 517-638-9564 TEL NO: 8TH FLOR LEGAL #581 P03 ------A point source, or multiple point sources which are over a large geographic area; 3) Whether the distribution is manageable (or containable) by known and available technology; 3) Whether the distribution extends beyond the property owned by the manufacturer, distributor or processor considering the information; and 4) Whether the extent of the distribution is known from actual data or is pr dieted/suspected based upon modeling or assumptions. Here, distribution is described at only one location, although there are multiple potential point sources. Soil contamination is limited to an area immediately adjacent to the storage tank. This soil could be r moved and disposed of using available technology. The air emissions are not known from actual data, but are based upon assumptions and modeling. The contamination in the nearby well has not been shown to be due to the tank; on-site monitoring wells indicate no contamination. This indicates the groundwater has not been affected by the tank and that the distribution is contained within a small area, on the property of the customer. Under these circumstances, the information would not be considered "widespread" for purposes of TSCA 5 9(e). The distributions in groundwater and soil appear to be very localized. The distribution in eir is unknown b cause actual data do not exist. The chemical substance here is a known human carcinogan; however, toxicity should be considered only after a determination of "widespread." Thus, this determination as to whether the distribution is widespread would not change if the compound were innocuous. The distribution (or potential distribution) described exists on e site(a) owned by a customer(s) of the manufacturer. However, due to the localized nature of this distribution, the result would not have been different if the distribution had bean on property owned by the manufacturer. Magnitude,.of Study Type information such as this is gathered through monitoring required by various permitting agencies, as well as through self-initiated inv stigations. Examples of common gathering of this information would be the gasoline stations and other underground storage tank facilities around the nation; above-ground tank areas; soil, water and air sampling at manufacturing sites; and landfills ("appropriate diap sal facilities'* and otherwise). it is estimated that perhaps mor than 390,000 such bits of information are known in Industry. The r porting of this information would result in the dilution of significance for reports under TSCA $ 8(e). Further, these matters are managed as required under other statutes regulating air, water, and waste handling. Conclusion For the reasons given above, the information of this type does not satisfy the four considerations listed above relevant to determining whether distribution in environmental media is "wldaspread." Therefore, consideration of oth r criteria for reporting potential environmental eff cts under TSCA $ 8(e) are not nec ssary. This Specific Study has not addressed any potential human health considerations. 141337 CA5BTSW0i 16 ' PfzVI0U5kj C v\vi/onw*ftkl 3 VEV-141338 WWW n t n W . ^ s w fc < * w Jl IJ< i NM 0 Pnat 2 'I t TSCA 8(e) Comp iance Audit Program Case Study It "PrevtnuOvUniuip+ftgH" Criteria \* Assumption; Whether contamination is "previously unsuspected" will not, of itself, trigger TSCA 8(e) reporting. Other factors (including, for example, a determination that the contamination is "widespread") must also be present to reasonably support t conclusion of "substantial risk" so as to trigger an 8(e) report. Hypothetical f'Casa Study'!: i At a 1600 acre plant site used for various industrial purposes over a period of years, soil and groundwater monitoring confirm the presence of an oxygenated organic solvent in an area where this chemical was known by the site ownjr/operator to have been manufactured (used or stored). Because this contamination is proximately related to the site use-history, the test boring and groundwater results'obtained by the ownc r/operator are not "previously unsuspected" for TSCA 8(e) purposes. j I !I In contrast, monitoring well and soil borings a mile away ijt the same site confirm the presence of the same oxygenated organic solvent id the site soil and groundwater. The site owner/operator has po reason to believe that the oxygenated organic solvent was manufactured (used or stored) at this other area. Availa >le information does not support a conclusion that the contaminated areas are related, (ie, either esulted from the same spill/release or represent migration of the solvent from one area of the site to the other). Because of this, the confirmed contamination at the second area is "previously unsuspected" for TSCA 8(e) purposes. Existing EPA giuida nce TSCA Section 8(e) (Joes not use the phras t, "previously unsuspected". The 1978 EFA Policy Statement is the origin of this phrase but < oes not interpret|or Refine it. However, In implementing RCRA, Congress and the E 'A presume that ^industrial properties are contaminated; that contamination will be dentified and remedied while the site is still operating. Illustrative of thjs presumption Is the broad range of "corrective action" requirements under RCRA Section 3004(u). CMA believes that whether contamination is "previously unsuspected" under TSCA 8(e) depends on whether the contamination occurs at a location where contamination can bp presumed because or chemical usage (sitp history) or whether contamination owuih in a location where no such presumption.can reasonably be made. Factors that should be considered by the site owner/operator include; (1) site history (ie, the manufacture, storagd, or use of a particular chemical at a p4rtic;ular site location); (2) mn-MHM iliwaiMioiiimiiiiiloiowledge ofthe contaminating chemicals' migration and/or degradation potential in a where contaminatioij is found present. 141339 tOH UCC HEALTH <i i An EPA interpretation of the term "previously unsuspected" which presumes that (current or former) industrial properties are uncontai ninated (pristine) or Which imposes an "actual knowledge" standard by either the EPA Administrator or fcPA-OTS would be an unreasonable and unworkable compliance standard. WctO *//?! SJ&- CAbg bTUoy (/ A&Mwdhftbr' 'f.-S'-*;' APR-30'1991 05:03 PROM ALLIED EMS HS&ES MTO t*EY4 TO CMA P.02 A Environmental Case Study - Known to the Administrator Draft 3 - 4/30/91 suction l; Study specific-information This cas will focus on information that va fsal is "known to the administrator." A typical U$ industrial site which makes, uses or stores chemieals for disposal will, on a daily basis, be required to comply with a host of state and Federal requirements, many of which require that environmental data/reports will be generated and either retained for inspection or submitted to the governmental agency having primacy. In some cases this will be the EPA (Headquarters od Region); however, in other cases this will be a state or local agency acting under a (a grant of) federal authority. Federal programs that require the generation of data include CWA, FIFRA, RCRA, TSCA, SARA/CERCLA, CAA, Safe Drinking Hat r Act, and Marine Protection Research and Sanctuaries Act. The purpose of such programs is to identify environmental concerns and to take action to remediate them in a timely manner. These programs have their own reporting requirements and enforcement proc dures associated with them. The goals of these other programs are consistent with TSCA section 8(e) in that they are designed so that EPA may receive information enabling it to determine if further action is needed to protect human health and/or the environment. Therefore, there is an overlap in the responsibilities of TSCA 8(e) and these other Federal programs. Section Hi Other Relevant Information Since the implementation of TSCA 8(e) in 1977, the EPA has dev loped numerous databases and tracking systems that enable the Agency to share data among its federal offices and between the states, some examples include the Toxic Release Inventory under SARA Title III, IRIS, the Discharge Monitoring Report inventory under CWA and others. With the proliferation of environmental laws and regulations, section VH(b)(l) and (2) of the 1978 TSCA 8(e) "statement of interpretation and enforcement policy" (43 FR 11110-1$) is now obsolete, duplicative and unnecessary. Seotioa Hit Existing WX Guidance The current guidance is outlined in EPA's 1978 TSCA 8(e) "statement of interpretation and enforcement policy, section vxi." Included in that document is the following: "Comment 21: information exchange systems with oth r Fed ral agencies should b imm diately stablished so that r spondents APR-30-1991 05:03 rKUfl fU_lED EMS HS&ES nTQ HEM TO CMS P.03 A n ed not report to EPA information already reported to other Agencies, and vice versa. Such duplicative reports are unduly burdensome. Response: EPA is coordinating this program with other agencies now. When the coordination is successfully c mpleted, the policy statement will be amended to exempt from the reporting requirement information that has been submitted to other specified agencies. In the meantime, substantialrisk information must be reported directly to SPA; such a report does not discharge any reporting obligation to other agencies." It appears that the amendment of that policy is long overdue. EPA has, in the past (e.g. March 1985 Chemicals-In Progress Bulletin and EPA Status Report 8EHQ-1182-0466, January 4, 1983), advised reporting companies that submission of information to the Ag ncy under other EPA programs satisfies any TSCA 8(e) notice so that unnecessary duplicative reporting to EPA-OTS is avoided. (Vote: For the sake of brevity, X have removed the detailed discussion from the above cited guidance. They are attached if the group feels that they are needed,] section IP: Evaluation Discussion The following are examples of activities that may generate information reportable under section 8(e) of TSCA but which is pr vided to the EPA under other regulations: 1. Under RCRA corrective action program, facilities are required to investigate spills, leaks, and releases to the environment at their plant. Corrective measures need to be developed, and remediation measures and actions undertaken in a timely manner under RCRA. For example, contaminants from a plant or disposal site have contaminated a drinking water source (e.g. drinking water aquifer or surface water) and concentrations are above acceptable health based levels. Humans may or may not be currently using the water for drinking and other household use. Data are provided to EPA in monthly reports per an approved workplan developed under CERCLA/SARA or RCRA, and as such is typically reported within 30 days of validation. 3. Under NFDE5, program reporting can be weekly, monthly, yearly or once every two years depending on the parameter and test. Data are provided directly to EPA in certain states; in NPDES delegated states the data are provided to the state (which administers the program in lieu of EPA). Using the guidance provided by EPA as outlined above, these data should n t b r p rt d to EPA'a Offic of Toxic Substances gtV'l*l3A3 rpiirfii bo I-OAM I'l I u /Kim lu i_MH P.04 A under TSCA 8(e). Based on these EPA communications, it is fait that it is the intent of the Agency to minimize duplicative communications and that data already submitted to other Federal agencies in a timely manner should be "Known to the Administrator." As such, it should not be necessary to identify these data as TSCA 8 ( ) nor should it be necessary to submit these data within the 15day time limit as specified under TSCA 8(e). section , Magnitude of study Tree The following are estimates of the number of plants and/or sites that generate environmental data which could require audits under CAP: - 15000 POTWs and 45,000 direct discharges; - 10,000 RCRA Corrective Actions; - 1200 Federal CERCLA sites; and unknown number of state "Superfund" sites; - unknown number of state corrective actions; UST remediations. There are tens of thousands of reporting opportunities that fall under the auspices of the various EPA sections. The task of reviewing such studies would be enormous, redundant, repetitive, and quite probably counterproductive to the needs of the Agency. section VI: Conclusion In conclusion, environmental studies, reports of accidents, r p rts of spills or releases to the MAC and fish kills that are submitted to other offices or agencies with authority to administer a F d ral program (ie: state agencies and some local POTW's) of the EPA should not be reported to EPA's Office of Toxic Substances und r 8(e) if they are provided in a timely manner as required by other EPA environmental regulations. In addition, submissions to state or local agencies that are either required to be submitted or are voluntarily submitted to the EPA should be exempt from submission under 8(e). Therefore, the requirements specified in sect! n VII (b)(1) and (2) of the 1978 TSCA 8(e) "statement of interpretation and enforcement policy" should not apply. VEV-141344 1. EPA Xarob less Chemioals-xn-Progress Bulletin stated that "information need not be submitted under Section 8(e) if th information has already been reported to SPA pursuant to a mandatory reporting provision of another authority administered by SPA..." The Bulletin does not refer to the need to identify submission under other laws as "Section 8(e) notices" or the need to report within the TSCA 8(e) 15-day time limit. 2. IPX status Beport 8EBQ-1182-04M, January 4, 1983 In describing the relationship between the release notification requirements in Section 103 of CERCLA and section 8(e), spa noted that emergency incidents of environmental contamination need not be reported under section 8(e) "if the information has already been formally reported to EPA pursuant to mandatory requirements contained in other authorities....". EPA then indicated that "chemical release-related reporting requirements contained in such ther authorities are, for the most part, triggered by incidents involving releases of specified amounts (i.e., reportable quantities (RQs) of specific (i.e., listed chemical substances)). In those cases involving a release of less than a reportable quantity of a listed chemical or a release of a chemical not listed in such other authorities, companies should consider the need for reporting pursuant to section 8(e) of TSCA. EPA concluded that sect! n 8(e) notification was unnecessary because, "(1) the duPont chi rine gas release involved a release of a reportable quantity of a listed chemical substance, and (3) the incident was immediately reported by the company to EPA pursuant to the notification provisions of CERCLA. A VEV-141345 TOTAL P.05 CAf>r sfitoi f z ipo5>uro f NurY)i\iCA( CuJ* o$s (&mYw/wurk*Jj L Study Specific Information Tlit purpose of this cue history development is to describe the criteria necessary to assess the reponabllity of environmental effects under 8(e). IL Case Study Q: Companies conduct routine environmental toaridty studies (Le., aquatic) typically run for product hazard evaluation. These studies only represent the toSridiy of the product and not use or exposure patterns. These studies can at best represent hazard if spilled during transport. These studies do not Indude information on the degradation, half-life, or chemical reaction potential. Similarly, end of pipe environmental bioassays are run for compliance with state permitting programs. A: Environmental tenacity studies alone do not qualify as an 8(e) report As EFA said in its 1978 Statement of Interpretation, exposure is die other necessary consideration. End of pipe bioassays like industrial hygiene monitoring only demonstrate compliance with permit regulations and is not reportable. Q: A Substance "X" is found at trace levels exclusively in the soil or ground water of the facility. After further evaluation, it is later detected at trace levels downstream from the facility. This stream feeds a larger waterway. The toxicity of Substance "X* is unknown, but toaddty data is available for a similar substance which has an established federal water quality criteria. Substance "X" in fee waterway is detected at levels below die federal water quality criteria for the similar substance. The similar compound is highly toxic. Substance *X" does not bioaccumulate or there is no data to confirm bioaccuxnulation and no non-trivia! adverse effects are recognized to any flora or fauna in the stream containing the compound. A This is not a substantial risk notice since the evaluation of both the toxicity and exposure demonstrate no substantial risk. If Substance "X* is toxic at levels found in the waterway and the substance bioaccumulates and/or causes non-trivial advene effects to flora or fauns, reporting would be required. Q: A compound containing a known animal carcinogen is released into a public drinking water source, its presence is detected in surface water beyond your operating site. Its detection level is above die acceptable federal levels set for drinking water. A Since tids compound would demonstrate potential human risk, reporting under 8(e) would be required. If the level detected in the drinking water source is below the acceptable federal levels set for drinking water standards, then reporting is not required. A 1 J3L Existing EPA Guidance la EPA's 1978 Policy Statement Part V (b) environmental effects of any non-trivial adverse effect, previously unknown to the Administrator, known to have a pronounced bioaccumuladon and to be widespread and previously unsuspected distribution in environmental media, or (c) emergency incidents of environmental contamination require notice to the Administrator. EPA states that environmental effects must also involve the potential for significant levels of exposure. It is dear that environmental effects alone or a compounds presence does not require reporting under 8(e). The environmental effects and exposure must both be considered. V Magnitude of Study Type Thousands of environmental effect studies are conducted yearly. This information itself does not assess environmental exposure as required in the 1978 Statement of Interpretation, and assessment of environmental effects is futile without evaluation of exposures. VL Conclusion Toxicity data or the presence of a compound in environmental media is insufiitient to warrant 8(e) reporting. The degree of exposure and effect to environmental species must be erolnated and both must be present to require reporting. If the exposure from contamination causes serious threat to humans, then reporting is required. John J. Kaspcr/Nalco Chemical Company (70S) 305-1454 FAX (708) 305-2986 UK004S9 Her. 440>91 4 VEV'l41348 2 i-v a icauj. A To kbcp ) - V>r*f> fU pkr*s. "Trace Uvelt" fre~ -tt E-^T Awl SC*aJ C^"v*.<ue* of* ^.XL . ^ X- Sd^Ct^cc. )n Aa T* v*&oJ(: *____ ... 2?aCu>^u [atio,\ rxu. iuiitenc*. sWx f>rocucea P\&\/e 0n r\~<2<fao\/iOcter pctrT/f>a Cj*^ >*</**f of. greater ~tU<** 2,stooo a^j u^. Ctfu-cCtf* *ox-tnvkJl IZF^ fPA Auicig> ngg A^sl Tfc< -o\(uJ* USEPA \eZt ijA Zn^prefaf pu\o)i\U&f & Mar<h J<Sp*ft j>rO*\OUK.C*J j* *Q&*4JL**.U.lc&\ Ok TZ> i^cuiox^u.U/trow. >A ^cco %'^t^ vOorar c&iAc&%Zttnatt&i* )V\ ^ 0-- Op&S^crva, ^p ** ^octroi/hotter pa.rT&'o* greaNf tU 25,000. If fu*tL*r /AJt'c*i** Ike# f>foy\Oti*c&d biOicU".o<l<ztrcy )' rcfcritihl^ &n[a u/Acm CJufle.4 *j/M. potaMh*) -icpo%uj'^ o,aJ no* -"in'*/* <aJ cu/v^etv^ 'effect'. In Ever. tbine We Dot VEV-141349 <w\rwiP -mn a 'titdnm L The purpose of this oese history development i to describe the criteria necessary to asms the repoxtabflhy of environmental effect! under 8(e). JL Cox Study Q: Companies conduct routine environmental toxicity studies (Lc, aquatic) typically run far product hazard cvaTnatinn. These studies only represent the toxicity of the product and sot use or exposure pattens. These studies can atJ>esE4*pMeat hazardj^gpfllcd during transport, These studies do not aA*i'"!**' --<----tt^Sde intomitoragTnc degradation, half-life, or chemical reaction ^ Simflarty^end of pgc^wvirouinental^btoaisays are run for r compliance with state permitting program (y*?> A: Environmental toxicity studies alone do not qualify as an 8(e) report. AsEPA said in its 1978 Statement of Interpretation, exposure is the other necessary consideration. End of pipe bioassayHflce industrial hygiene nmnitoriptfcinly demonstrate conq>liance with penmrreguladons and is not rcpoitab&r Q: c>jH& 4 V A Substance 'X' is found at trace levels exclusively in the soil or ground water of the facility. After farther evaluation. It Is later detected at trace levels down----1 from die fedtfty. This stream foeds a larger waterway. The toxicity of Substance *X" Is unknown, but tooddty data is available for a similar substance which has an established federal water quality criteria. Substance TT in the waterway is detected at levels below the federal water quality criteria for the timber substance. The similar compound Is highly toxic Substance "3T does not bloaocmnulata or there is no data to confirm bioaocumnlatfoa and no nontrivial advene effects ere recognized to auy flora or flume in the stream containing the compound. A: This is not a substantial risk notice since the evaluation of both the tooddty and exposure demonstrate no substantial risk. If Substance "XT is toade at levels found in the waterwayand the substance bloaocumulates and/or causes non-trtviai advene effects to flora or flume, reporting would be required. Q: A compound containing a known animsl cardnogea is released into a public drinking water source. Us presence is detected in surface water beyond your operating sits. Its detection level is above the acceptable federal levels set for drinking water. UL Existing EPA Guidance la EPA's 1978 Policy Statement Put V (b) environmental effects of any nan-trivial advene effect, previously unknown to the Administrator, known to have a pronounced bioaccumulation and to be widespread and previously unsuspected distribution in environmental media, or (c) emergency incidents of environmental contamination require notice to the Adndaistnuor. EPA states that environmental effects must also involve the potential for levels of exposure. It Is clear that environmental effects alone or a compounds presence docs cot require reporting under 8(e), The environmental effects and exposure must both be considered. V. Maffdtude ofStuff Type Thousands of environmental effect studies are conducted yearly. This information itself does not assess environmental exposure as required in the 1978 Statement of Interpretation, and assessment of environmental effects is futile without evaluation Toxicity data or the presence of a lent to warrant 8(e) reporting. The degree of exposure and effect to environmental spedes must be evaluated and both must be present to require reporting. If the exposure from contamination causes serious threat to humans, than reporting Is required. John J. Kaspcr/Nalco Chemical Company (708) 385-1454 FAX (708) 305-298$ VEV-141351 z BfWi ffmaM Qm. MCicUyj IS J M |Ub6?||(l|yt^lA4> &ubrr)4Jk fVt VEV-141352 Proposition fl (Water case study) faction I. Study flpacific Information Proposition $5 is a California lav that raqulrss that individuals bs warnod prior to bsing exposed to carcinogens or raproduetivs toxins abovs tha "no significant risk laval (NSR)." Proposition 6S also prohibits tha discharga of any listad carcinogen or reproductive toxin in an amount above tha NSR to any drinking water or source of drinking water. The NSR level has been established as one in 100,000 for carcinogens and 1/1000 of the No Observable Effect Level (NOIL) for reproductive toxins. Air dispersion modelling using the standard Z8CST model of these air emissions predicts ground level concentration at specific distances radiating from the emission source. The air c noentrations of chemicals are converted to cancer risk by multiplying the air concentrations by the unit cancer risk factor established for the carcinogen by 1PA or the California Department of Health Services. For some chemicals which are emitted as particulates, multipathway risk assessment must also be conducted because these particulates will eventually be deposited on land, a water body, or a "source of drinking water." Guidance from CPA is requested regarding the modelling of these particulates which fall on "sources of drinking water." section XX. Other Relevant Information Virtually all the land and all the waters in the state of California, with exception of the Salton Sea and the Pacific Ocean, have been defined as "sources of drinking water*" This has resulted in reports which describe the potential contamination of a dry creek bed (in many cases, dry for this century) or flood control plain as contamination of "drinking water sources". There are no provisions in California regulations dealing with whether or n t a "drinking water source" could actually be used for drinking water. For several carcinogens, l.e. bencene, hexavalent chromium, and methylene chloride, the unit risk factors are approximately 10 fold higher in California than in other states which use the EPA unit risk factore. In addition, the N8R level for thoroughly d cumentad reproductive toxins (such as lead) is 1/1000 of the NOEL. This risk level is 10 times lover than the 1/1000 of the noel which Is commonly used in developing a variety of reference standards . For instance, the drinking water standards are in the ppm range but the no significant risk levels under Prop sltlon 65 are in the ppb range. The impact of these m re stringent standards in calif rnia is that when one tries t evaluate "substantial risk VEV-141353 4 t health" on* finds that nor* risk* aro significant risks in California than thsy would ba if tha same laval of carcinogen or raproduotiva toxins contamination vara found in othar states. Sactlon III. Existing EPA Guidance Mona Section IV. Ivaluation Discussion If th* carcinogenic unit risk factors and no significant risk 1avals for raproduotiva toxins davalopad by California aganclas ara usad to astabllshad risk* there will ba nor* cases of risk in California than in othar statas with tha same laval of c ntanlnation. California industry will be asking aora submissions to tha EPA than would b* required from othar statas* Mora importantly, these submissions will create "substantialN risks from risks which ara not substantial. XPA should indicate that EPA carcinogenic risk factors and othar reference standards should ba usad to maintain a "laval playing field" within tha statas and with regard to tha substantial risk information that XPA must assimilate, analyze and prioritize. Th* laval of risk that EPA c nsidars "substantial" should also ba established by XPA. xpa should also indicate that only legitimate bodies of water that are used as sources of drinking water, or for fishing need be considered for tha 8(a) notification* Section v. Magnitude of Study Type Every quarter, more chemicals are added to tha Proposition 65 list of chemicals. Soma companies will ba conducting a risk assessment that frequently in order to determine if their discharges ara in compliance or their air amissions are in compliance. VEV-141354 AB1588 (Air amissions Case study) Section I. study Specific interaction California lev AB2588 requires that businesses quantify and c nduot health risk asssssaents on approximately 300 cheaieals on the AB25B8 list. The list contains carcinogens, non-carcinogens, and acutely toxic cheaieals* Chemicals with emissions above a threshold quantity, which ranges from 0.1 lbs/year to 100 lbs/year, must have a health risk assessment performed* Modelling of these emissions are used to predict ground level concentrations at specific distances radiating from the emission sources. The air concentrations of chemicals are converted to cancer risk by multiplying the air concentration by the unit cancer risk factors stablished for the carcinogen by SPA or the California Department of Health Services. For some chemicals, multipathvay analysis is required in the risk assessment. The eanoer risk from emissions from the facility is the sum of the individual cancer risks of all chemicals emitted from all sources at the facility. The individual excess oancsr risk is determined for the maximum exposed individual. The total excess lifetime cancer risk is also determined for the worker and residential population within the one-in-a-million-risk ions surrounding the facility. The total population excess cancer burden is calculated as the product of the exposed population and th estimated risk from the ambient air concentration. The risk assessment must also include an evaluation of the potential non-cancer effects of both short term and long term exp sures to facility emission. The short term and long term exp sure levels are oompared to acceptable exposure levels determined by the California Department of Health Services. Adverse health effects are assumed to occur when the acceptable exposure levels are exceeded. In cases where multiple ohsmloals can affect the same target organ, the hazard index approach is used. The estimated exposure to a given substanoe is divided by th acceptable exposure level for that substance. For a given target organ, this ratio (the hazard index) is summed for all substances which affect that target organ, zf the hazard index equals or exceeds 1.0, a potential health hasard is assumed to exit. Based on these risk aaaesements, facilities with a cumulative cancer risk and a cumulative hazard Index that exceed certain thresholds established by the local Air Pollution Control Districts will have t ntify the public of the risks. u *. A to 1 u i ; ^ c vl MAO * r r O to A Guidance is requested from IPA regarding interpretation of "significant levels of exposure," "widespread", and "previously unsuspected" contamination. Section XI. Other Relevant information The poor quality of the air in Los Angeles is both well known and well documented. Xn 19*7, the South Coast Air Quality Management District (8CAQKD) published a study on the magnitude of the ambient air toxics impacts in the air basin. This study was funded under CPA's Multiple Air Toxics exposure Study Program (MATES), and the study results have been submitted to the EPA under the Clean Air Act. The study Integrates ambient concentration, population distribution, and health risk data into regional estimates of inhalation exposure, risk, and number of excess oanoer cases. The AB2588 risk assessments provide exposure and risk information that is similar to what is contained in the scaqmd document. However, the A82588 risk assessments Indicate that a given business la responsible for a part of the widespread contamination of the air in the Los Angeles area* Although the wid spread contamination is previously known to SPA (via submission of documents under Clean Air Act) what may not have been known (and documented) previously, is which businesses contributed to the air t xics and the extent of their individual contribution. Xn the instances for which permits were required, the flCAQKD is knowledgeable of the businesses involved as well as type and quantity of emissions. Xn the instances for which permits have not been required, the SCAQND would not have direct knowledge of business and emissions. Xf the 8CAQKD does not have direct knowledge, it might be argued that the Information presented in the risk assessment Involves "previously unsuspected" contamination. Por several carcinogens, i.e., bentens, hexavalent chromium, and methylene chloride, the unit risk fmotors are approximately 10 f Id higher in California than in other states whioh use the spa unit risk factors. Xn addition, for this regulation, hexavalent chromium ia carcinogenic by the Ingestion route, which tends to cause hexavalent chromium to dominate the risk assessment tor certain industries. The Impact of applying these more stringent r gulatlons is that when one tries to evaluate "substantial risks t health" one finds that mere risks are substantial risks in California than they would be if the same level of carcinogenic c ntamination were postulated in other states. section XXX. Existing SPA Guidance None Section XV. Evaluation Discuss! n %. &1 Q 1 : 4B & M. nao * r * H PO7 A Xf the carcinogenic unit risk factors developed by California Agencies ars ussd to sstablish risk, there will bs more oasss of "substantial risk to health" in California than in othar statas with tha sana lsvals of contamination. California businassas will ba Baking nora submissions to tha EFA than would ba required from othar statas. Mora importantly, thass submissions will oraata substantial risks from risks which ars not substantial. SPA should indioats that SPA carcinoganic risk factors and othar SPA rafaranca standards should bs usad to maintain a "level playing field" within tha statas and with regard to tha substantial risk information that SPA must assinlists, analyse and prloritsa. Tha laval of risk for carcinogsns and tha rafaranca standards for non-carcinogens (eg, STD, TLV/420) that SPA eonsidars "substantial" should also ba sstablishad by SPA. Xntarprstation of "widaspraad" contamination should focus on th dlffarantiation (if any) bstwaan a larga gaographical araa and a larga population that is exposed. For lnatanca, tha 8CAQMD r gulatlons atfact 5 counties, soma of which ara heavily populated, and soma of which ara primarily vast expanses of sparsely populated desert. If one must consider "widespread" in conjunction with "substantial risk to health", additional guldanoa is needed. For example, if the residents within a radius of one quarter mils of a facility ara at a risk of 10 (-4), ars tha "widespread" and "substantial risk" criteria satisfied? Xf 1 million parsons within th 25-30 mile radius of a facility arc at a risk of 10 (->), ara tha "widsspraad" and "Substantial risk" criteria satisfied? Xf one is lucky enough to have documentation, such as tha 19S7 SCAQMD study conducted for KATZS, of concentrations of chemicals in environmental madia, how should one compare those concentrations with tha concentrations in a risk assessment such as AB358S? It s eme reasonable to coma to tha judgement that in situations in which tha environmental concentrations predicted from a risk assessment do not exceed the concentration documented (as in a MATES study) by some factor (such as by a factor of 2 which is tha accuracy of a Oausslan-darlvad modal such as tha XSC8T model), that tha criteria for "previously unsuspected" contamination have not bean mat, and tha risk assessment results would, therefore, not ba required to be submitted under (a). Section V. Magnitude of Study Type The AB258S risk assessments will ba required every two years. VEV-141357