Documents

1971 Haskell Laboratory Report

Mar. 24 2017 — 3:07p.m.

/15
1/15

'3 3 V. 1.6.4573 9189 a ?j . Contains No cm .383 3013.63.01 q. i333 5:2: 2] Pit 7-.- LEGAL Wilmington, Delaware 19898 3., i CdiC 21 No CBI Certi?ed Mail Return Receipt Requeaed October 15, 1992 Document Processing Center (TS-790) Of?ce of Pollution Prevention and Toxics Environmental Protection Agency 401 Street? S.W. Washington. DC. 20460 Attn: Section 8(a) Coordinator (CAP Agreement) Dear Coordinator: On behalfofthe Regulatee and pursuantto Unit II 3.1.1). and Unit of the Agreement, 5.1. Du Pont de Nemours and Co. hereby submits (in arbitrate) the attached studies. Submission of this information is voluntary and is occasioned by unilateral changes in EPA's sundard as to whet EPA now considers as reportable information. Regulatee's submission of information is made solely in response to the new EPA reporting standards and is not an admission: (1) of TSCA violation or liability; (2) tint Regulatee?s activities with the study compounds reasonably support a conclusion of substantial health or environmental risk or (3) that the studies themselves reasonably support a conclusion of substantial health or environmental risk. The ?Reporting Guide" creates new TSCA reporting criteria which were not. previously announcedby EPA in its 1978 1. -: - - - 43 Fed Reg 11110 (March 16,1978). The ?Reporting Guide states criterui which expands upon and con?icts with the 1978 W. Absent amendment of the W, the informal balance of the ?Reporting Guide" raises signi?cant can assure TSCA Section 8(e) compliance. Counsel Legal D4158 1007 Market Street Wilmington, DE 19898 (302) 7744443 1'1! .v r) WI .555 a ib?iS?jJ Better Things for Better Living

ATTACHMENT 1 Submission of information is made under the 6/28/91 CAP Agreement, Unit II. This submission is made voluntarily and is occasioned by recent changes in TSCA reporting standard; such changes made, for the ?rst time in 1991 and 1992 without prior notice and violation of Regulatee' conStitutional due process rights. Regulatce' submission of information under this changed standard 15 not a waiver of its due process rights; an admission of TSCA violation or liability, or an admission that Regulatee' activities with the study compounds reasonably support a conclusion of substantial risk to health or to the environment. Regulatee has historically relied 1n good faith upon the 1978 criteria for determining whether study information 1s reportable under TSCA 43 (March 16,1978). EPA has not, to date, amended this Wm. After CAP registration, EPA provided the Regulatee the June 1, 1991 Section 8(e) Reporting Guide". This ?Guide" has been further amended by EPA, EPA letter, April 10, 1992. EPA has not indicated that the "Reporting Guide? or the April 1992 amendment supersedes the 1978 W. The "Reporting Guide? and April 1992 amendment substantively lowers the WW '5 TSCA reporting standard? This is particularly troublesome as the ?Reporting Guide? states criteria, applied retroactively, which expands upon and con?icts with the Absent amendment of the Won. the informal issuance of the "Reporting Guide? and the April 1992 amendment clouds the appropriate standard by which regulated persons must assess information for purposes of TSCA 21a sharp contest to the Agency'sl917 and 1978 actions to soliciting public comment on the proposed and ?nal Policy, EPA has unilaterally pronounced 98(e) substantive reporting criteria in the 1991 Section 8(e) Guide without public notice and comment, See 42 ?51.35: 45362 ?Noti?cation of Substantial Risk under Section Proposed Guidance". 3A comparison of the 1973 and the 1992 'Repotting Guide" is a appended.

Throughout the CAP, EPA has rnischaracterized the 1991 guidance as re?ecting ?longstanding" EPA policy concerning the standards by which toxicity information should be reviewed for purposes of compliance. Regulates recognizes that experience with the 1978 may cause a review of its criteri.Regu1atee supports and has no objection to the Agency' amending reporting criteria provided that such amendment rs not applied to the regulated community in an unfair way. However, with the unilateral announcement of the CAP under the auspices of an OCM enforcement proceeding, EPA has wrought a terri?c unfairness since much of the criteria EPA has espoused 1n the June 1991 Reporting Guide and in the Agency' April 2,1992 amendment is new criteria which does not exist in the 1978 Wm Policy.- The following examples of new criteria contained in the "Reporting Guide" that is not contained in the WW follow: 0 even though EPA expressly disclaims each? status report' as being preliminary evaluations that should am be regarded as ?nal EPA policy or intern?. the "Reporting Guide" gives the' status reports" great weight as "sound and adequate basis? from which to determine mandatory reporting obligations. Guide" at page 20). the ?Reporting Guide" contains a matrix that establishes new numerical reporting 'cuto?" concentrations for acute lethality information(' Guide? at p.31). Neither this matrix nor the cutoff values therein are contained the W. The regulated community was not made aware of these cutoff values prior to issuance of the 'Reporting Guide" in June, 1991. othe "Reporting Guide" states new speci?c de?nitional criteria with which the Agency, for the ?rst time. de?nes as 'distinguishable neurotoxicological effects'; such criteria/guidance not expressed tn the 1978 othe ?Reporting Guide? provides new review! reporting criteria for irritation and sensitization studies; such criteria not previously found in the 1978 Wm- othe ?Reporting Guide" publicizes certain EPA criteria issued to the Monsanto Co. in 1989 which are not in the have never been published in the or distributed by the EPA to the Regulatee. Such establishes new reporting criteria not previously found in the 1978 ?The 'status reports' address the signi?cance, if any. of particular information reported to the Agency. rather than stating EPA's interpretation of 58(e) reporting criteria In the infrequent instances in which the status reports connin discussion of reportability. the analysis is invariably quite limited. without substantial supporting scienti?c or legal rationale. 5 See, e. 3. 10/2/91 letter from Du Pont to EPA regarding the de?nition of' serious and prolonged effects' as this term may relate to transient anesthetic effects observed at lethal levels; 10/1/91 letter from the American Petroleum institute to EPA regarding clari?cation of the Wide criteria.

In discharging its responsibilities, an administrative agency must give the regulated community fair and adequate warning to as what constitutes noncompliance for which penalties may be assessed. Among the myriad applications of the due process clause is the fundamental principle that statutes and regulations which purport to govern conduct must give an adequate warning of what they command or Even a regulation which governs purely economic or commercial activities, if its violation can engender penalties, adequatewarningtothosewhose activities are governed. Wall 585 F.2d 1327 1335- 36 (D. C. Cir. 1978). also, W, 937 F. 2d 649 (DC. Cir. 1991). While neither the are rules, This principle has been applied to hold that agency 'clari?cation', such as the SEW, the "Reporting Guide" nor the April 1992 amendments will not applied retroactively. federal court will not reuoactively apply an unforeseeable interpretation of an administrative regulation to the detriment of a regulated party on the theory that the post hoc interprention asserted by the Agency is generally consistent with the policim underlying the Agency's regulatory program, when the semantic meaning of the regulations, as previously drafted and construed by the appropriate agency. does not support the interpretation which that agency urges upon the court. 453R Supp. 203,240 (N Ohio 1978). af?d sub mm Energy 596 F.2d 1029 (Em. App. 1978): The 1978 Wm does not provide adequate notice of, and indeed con?icts with, the Agency's current position at requires reporting of all 'positive' toxicological ?ndings without regard to an assessment of their relevance to human health. In accordance with the statute, EPA's 1978 requires the regulated community to use scienti?c judgment to evaluate the signi?cance of toxicological ?ndings and to determining whether they reasonably support a conclusion of a substantial risk. Part of the W911 urges persons to consider ?the fact or probability" of an effect' occurrence. Similarly, the 1978 stresses that an animal study is reportable only when "it contains reliable evidence ascribing the effect to the chemical." 43 EecLRes. at 11112. Moreover, EPA's Interpretation de?nes the substantiality of risk as afunction of both the seriousness of the effect and the probability of its occurrence. 43 12:13:; 11110 (1978). Earlier Agency interpretation also emphasized the "substantial" nature of a determination. See 42 EecLReg 45362, 45363

(1977). [Section 8(e) ?ndings require "extraordinary exposure to a chemical critically imperil human health or the environment"]. The recently issued "Reporting Guide? and April 1992 Amendment guidance requires reporting beyond and inconsistent with that required by the Witch. Given the statute and the W's explicit focus on substantial human or environmental risk, whether a substance poses a "substantial risk" of injury requires the application of scienti?c judgment to the available data on a case- by-case basis. If an overall weight~of~evidence analysis indicates that this classi?cation is unwarranted, reporting should be unnecessary under because the available data will not ?reasonably support the conclusion? that the chemical presents a subm?al risk of serious adverse consequences to human health. Neither the legislative history of nor the plain meaning of the statute support EPA's recent lowering of the reporting threshold that TSCA was intended to be a sweeping information gathering mechanism. In introducing the new version of the toxic substances legislation, Representative Eckhart included for the record discussion of the speci?c changes from the version of H. R. 10318 reported by the Consumer Protection and Finance Subcommittee in December 1975. One of these changes was to modify the standard for reporting under The standard in the House version was changed from "causes or contributes to an unreasonable risk" to I'causes or significantly contributes to a substantial risk". This particular change was one of several made in TSCA ?8 to avoid placing an undue burden on the regulated community. The ?nal changes to focus the scope of Section 8(e) were made in the version reported by the Conference Committee. The word ?substantial" means "considerable in importance, value, degree, amount or extent". Therefore, as generally understood, a "substantial risk? is one which will affect a considerable number of people or portion of the environment, will cause serious injury and is based on reasonably sound scienti?c analysis or data. Support for the interpretation can be found in a similar provision in the Consumer Product Safety Act. Section 15 of the CPSA de?nes a l'substanlzial product hazard" to be: "a product defect which because of the pattern of defect, the number of defective products distributed in commerce, the severity of the risk, or otherwise, creates a substantial risk of injury to the public.?

Similarly, EPA has interpreted the word 'substantial' as a quantitative measurement. Thus, a 'substantial risk' is a risk that can be quanti?ed, See, 56 @3292, 32297 (7/15/91). Finally, since information pertinent to the exposure of humans or the environment to chemical substances or mixtures may be obtained by EPA through Sections 8(a) and 8(d) regardless of the degree of potential risk, has specialized function. Consequently, information subject to reporting should be of a type which would lead a reasonable man to conclude that some type action was required immediately to prevent injury to health or the environment.

Attachment Commu?son: Reporting triggers found in the 1978 "Statement of Interpretation} Enforcement Policy",43 E91363 11110 (3/16/78) and the June 1991 Secu'on 8(e) Guide. TEST TYPE 1978 POLICY New 1991 GUIDE ACUTE Oral - Dermal Inhalation (Vapors) }7 aerosol dusts] particles SKIN IRRITATION Y3 SKIN SENSITIZATION (mum Y9 EYE IRRITATION Y10 SUBCIIRONIC (ORAUDERMAUINHALATION) REPRODUCTION STUDY Yli? DEVELOIMENTAI. Tox Y13 Y14 643mu11114,mu4: 'This policy mtements directs the reporitng of speci?c: effects when whom to the Adminimtor. Many routine tests are hosed on a knowledge of toxicity associated with a chemical}. unknown effects occurring during such a range test may have to be reported if Pens and 7am; In ?3.22. 29-31. 3m at pp-34-36. 9am; at pp-34-36. 10mm a pp-34-36. 11m at pp-22; 36-37. ??uid: at W22 1343 mm at 11112 'Birth Defects" listed. ?gm; at pp-22

NEUROTOXICITY 1'16 MUTAGENICITY In Vito In Wm ENVIRONMENTAL Biomumulation y} Bioconcentmion Ochater Pm. Cocff. Acute Fish Acute Daphnia Subchronic Fish Subchronic Daphnia Chronic Fish AVIAN Acute Reproductive Reprodcutiv: ?gum; .1 pp-23; 33-34. 11112 ?Cancer? listed 17m supp-21. 134315513311111112; 1111s .1 Comment 15 'Mutagenicity' listed! in max: inn'a'o discussed; discussion of "Arms test". 199mg; app-23. 3043 at 11112; 11115 at Comment 15. 22222222 222

P-81 HLR 0. 295-71 CAS 126-99-8 . Chem: 1,3-Butadiene, 2?chloro Title: Class poison test Date: 9/13/71 Summary 01' Effects: head tremors, incoordl- nation of legs 79

E. I. du Pont de Nemours and Company Haskell Laboratory for Toxicology and Industrial Medicine HASKELL LABORATORY REPORT NO. 295-71 MR N0. 1; Material Tested: 1,3-Butadiene, 2-chloro Haskell No.: 6580 Eaterial Submitted by: F. D. Griffith, Haskell Laboratory Other Codes: Chloroprene CLASS POISON Purpose: Previously, chloroprene was found not to be a Class Poison by Haskell Laboratory. This result is not in agreement with the data from literature.$ Therefore, another Class Poison Test was conducted, using the same grade material as before. Procedure: Ten male rats, weighing 250 to 280 grams, were exposed to the test material in a 16-liter bell jar for one hour. A weighed sample of the test compoond was put in a midget impinger through which 2.4 lein. 32 was passed to carry the vapor into the exposure chamber. Oxygen, to give 20% 02 in the chamber atmosphere, was added to the stream prior to entering the exposure chamber. The oxygen concentration was measured periodically during the exposure. The nominal concentration was calculated on the basis of gas flow and weight of material used. The chamber atmosphere was also analyzed for chloroprene by a gas chromatographic method. The rats were held 14 days post-exposure for observation, 12 days longer than required by the standard Class Poison protocol. Rgsuigs: Nominal Analytical Mortalit Concentration Concentration During 48 Hours Clinical Signs ggpoaure Post-Egposurg During Exposure Post?Exposure 150 72,4 oflo 0/10. Irregular reapiration, Down to 771 of their initial body slight lacrimation, weight on the 2nd day post-exposure. head tremors, All except 2 animals gained weight on incoordination of the 3rd day; the average body weight legs approached the pre-exposure value on the 4th day. All animals again lost weight from 5-8 days post-exposure wit 2 deaths on the 6th day and 3 deaths 0 the 7th day. All survivors had starte to gain weight by the 14th day post- exposure. ..

Chloroprene is not a Class 8 Poison by inhalation administration.$ The above test was run at approximately 36 times the concentration required for Class Poison labelling. As defined in the Hazardous Materials Regulations of Transportation, Agent T. C. George's Tariff No. 23, September 3, 1969, Subpart G, Section 73.343 i a) Von Oettingen, et al., J. Indus. Hyg. Toxicol., l?:240 (1936) b) Chemical Abstracts, Vol. 63, 15438d (1965) c) Patty, F. A., Ind. Hyg. Toxicol., Second Revised Edition, Vol. II, pp. 1319-1321. Interscience Publishers, New York (1963) Report by: 6:"va . Pew-?4 Approvad by; 64W @?ad Charles F. Reinhardt KB 935, p. 65 Assistant Director FOngh Date: 8 ate: 13 1971

Ln 1% UNITED sures smmomsuw. Psorscnou AGENCY WASHINGTON. ac. 20460 Mark H. Christman Counsel -, 7 . I: E. I. Du Pont De Nemours and. Company '6 Legal D-7010-1 . mm?; - 1007 ~rke' Street Delaware 19898 1 8 1995 EEK acknowledges the receipt of?information submitted by . 1 tion under section o. the moxie iubEtances i ?Maire: {saw-tom: genome-0000) assignedby912.. EPA ?tO'Your subnmipnmthe?roverseuside'of?this page All TSGA 8(e) submissions are placed in the public files 'unless confidentiality is claimed accordin to the procedures .. outlined in Part of EPAFs TSCA 58(e) pol cy statement (43 11110, March 16, 1978). Confidential submissions received pursuant to the TSCA Compliance Audit Program (CAP) should q.a1ready contain information supporting confidentiality claims; 'Thie information is required and should be submitted if.not done: so previously. To substantiate claims, submit responses to the questions in the enclosure "Support Information for Confiden- tiality Claims". This same enclosure is used-to support confidentiality claims for non~CAP submissions. .- Please address any further correspondence with the Agency related to this TSCA to:' Document Processing Center (7407) Attn: TSCA Section 8(a) Coordinator Office of Pollution Prevention and Toxics U.S. Environmental Protection Agency Washington, . . 20460-0001 EPA looks forward to continued cooperation with your organization in its ongoing efforts to evaluate and manage potential risks posed by chemicals_to health and the environment. SinCerely, 825% R. O'Bry~ . Enclosure. [217 (0/4 - Riel: Analysis Branch 4? X) m~ew50swuw

Triage of ale) Subm isglons? a? Date sent to triage: APR 2 NON-CAR CAB) Submission: number: TSCA InVehtory: Study type (circle appropriate): GroUp 1 - Dick Clements (1 copy total) ECO AQUATO - Group 2 Ernie Falke (1 copy total) . WA) - ATO I SBTOX SEN Group 3 - Elizabeth Margoschee (1 copy each) I I STOX CTOX EPI GTOX IMMUNO CYTO NEUR Other (FATE, EXPO, MET. etc.): Notes: THIS IS THE ORIGINAL 8(6) PLEASE REFILE AFTER TFIIAGE DATABASE ENTRY Contractor reviewer

TRACKING DBASE ENTRY FORM 550. F) 0501 NOIINFO ill-Qua?" . Type,- @505? FLWP 0502 INFO REQUESTED (115m) mum's mm A) - 0503 INFO REQUESTED (VOL ACTIONS) 0003 NunnrA?tm mum 0500 0m mum in .5 'suaMm'ER NAME: E. I A A . 0:00 APPJUSB 0m raooucnoumscoamNuun 0403 0001mm mom )IS?qa IjmspAm (3m DATE Oa-?Ig?alcl5 Mag??143 . nut-m Lu. "0201 oncomumy I 010204 0216 . A 0102? ow 010204 0202 4 0mm A0217 Mummaaoncomm 010204 0242 mm) 010204 - 0203 m0) - 01.0204 02:: 0102M m3 mum lino: 010204 020: vrmoy 010204 0219f 0102M - 0244 Cannon V1130) 0:020; 0205 MUTAGNVIVO) .1020: me new 0 02:5 mwumAL) 010200 ?12me (ANIMAL) mam 5m: 020204: 0041 DNA mmemn 010204 4 - . A usuno (HUMAN) . 01 . 0m mama: DELAY 01 02M 02:: rnonmsatmoc 0: 02 044 sauna (mama . -. 02%)2 022A manna-9mm 01 not 0251 M595 - 01 02 04 1020 (HUMAN) - 0225 mm RAW 01 an 0299 amen .- 0 02 04 can 10mm a _?0226 mm 3010200. A - ACUTE 10): (MM) . A 0221 mammal) 01020: 0223 0239 m0 sun ACUTE 02 04 - Anna (ANIMAL) 01 nu sun CHRONIC mx (AN1MAL) M0204 . MarmuARMAoo (ANIMAL) 0102M . mnomc TOX (ANIMAL) 01 02 04 'mm (HUMAN) 01 MM I MEDI no (mum! mu 5 A - HIGH 0200 010204 022! 0102M 0240 A 0(0204

8 (E) -12176A ACUTE INHALATION TOXICITY IN MALE CD RATS IS OF LOW CONCERN. DOSAGE (NOMINAL, AND MORTALITY DATA ARE AS FOLLOWS: 150 (0/10) . SIGNS OF TOXICITY INCLUDED IRREGULAR RESPIRATION, HEAD TREMORS, INCOORDINATION, AND SLIGHT LACRIMATION.

Filters SVG