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Testing Consent Order on Alkyl Phthalates (PDF) 618 Federal Register I VoL 54, No. 5 / Monday, January 9, 198t / Rules and Regulations 4OCFR Part 799 I. ITC Recommendation Testing under this negotiated testjr.~ In its Initial Report to EPA, published agreement (NTA) was suspended ~ [OPTS-42092A FRL-3503-7J in the Federal Register of October 4~ in August 1984, a suit brought against EPA by the Natural Resources Defe~ 1977 (42 FR 55028), the ITC Testing Consent Order on Atkyf Council (NRDC) resulted in the ru~ir.g Phtha(ates recommended that the alkyl phthalates chemical category be considered for that such negotiated testing prog~.~ were riot legal substitutes for a te5t rcle AOENCY~Environmental Protection environmental effects testing.. under section 4 of the ToxicSubsta~~ Agency IEPA). The recommended environmental Control Act (TSCA) [A’RDC cjpd ~ effects testing included chronic and ACT1ON Final rule. CXC) v. EPA,. 595 F Supp. 1255 (S.D~y reproductive effects testing with aquatic 1984)j, Furthermore, BBP wa~ SUMMARY: This document announces organisms, especially fish. EPA’s health specifically mandated for rulern~j~~ that EPA has signed an enforceable effects testing concerns for these for notice explaining why testing wa~ testing Consent Order with Aristech chemicals are being examined not necessary. As a result, the Ageacy Chemical Corporation (Aristech), BASF separately and are not addressed in this published a proposed rulefor BBP Corporation (BASF). Exxon Chemical notice. requiring environmental effectsand Company (Exxon), Eastman Kodak EPA responded to the ITCs chemical fate testing (50FR 3844e Company (Kodak), and Witco designation of the alkyl phthalates September 8, 1985). The proposed test~ Corporation, Humko Chemical Division category by issuing a notice in the for BBP was completed and submitte~i~ (Witco). These companies have agreed Federal Register (October 30, 1981; 46 FR EPA by Monsanto Company, andthe to perform certain chemical fate and 53775) announcing that it had decided Agency has issued a Federal Regists~ environmental effects tests on dimethyl not to require testing. EPA instead notice withdrawing the proposed rule accepted a testing program sponsored phthalate (DMP CAS No. 131—11—31, di- (52 FR 41593; 29 October, 1987). n-butyl phthalate (DnBP~CAS No. 84— by the Phthalate Eaters Program Panel Forthe remaining phthalate esters (PEPP) of the Chemical Manufacturers 74—2), dthexyl phthalate, (DHP~CAS No. recommended by the ITC, several of the Association (CMAJ. The program 68515—50-4 and 84—75—3), di—2— Phase II tests noted in the NTA are itili included testing for both health and needed; namely, earlylife stage testing ethyihexyl phthalate (DEFIP CAS No. environmental effects; however, in 117—81—7), di-(heptyl, nonyl, undecyl) with fish and sediment transport keeping with the subject of this notice, (adsorption). EPA, in this final rule, phthalate (D711P CAS No.88515-42—4), discussion will focus on the diisodecy) phthalate (DIDP CAS No. announces that these environmentaj and environmental effects portion. chemical fate testing needs are being 66515—49-1 and 26761-40-0), diundecyl CMA proposed phased testing for phthalate (DUP GAS No. 3648—20—2), addressed by consent order, Health environmentaleffects for 13 alkyl and ditridecylphthalate (DTDP~CAS effects testing for this chemical cate~ry phthalates identified as being annuafly will be the subject of a future notics~ No. 68515-47-9 and 119-06-2). These produced in quantities greaterthan ten chemicals are added to the list of testing million pounds, and for benzyl butyl IL Testing Consent OrderNegotiations Consent Orders in 40 CFR 799.5000 for phthalate (BBP}. CMA’s proposal In the Federal Register of December which the export notification included testing for aquatic toxicity; requirements of 40 CFR Part 707 apply. 24. 1986 (51 FR 46718), and in environmental transport and fate, and accordance with the procedures Depending on theresult.s of these biodegradation of the alkyl phthalates established In 40 CFR 790.28, EPA tests, two additional chemical and 881’. These were the environmental requested persons interested in substances, diethyl phthalate (DEP GAS testing areas of concern to the Agency participating in or monitoring testing No. 84-66-2) and diisononyl phthalate and to the ITC. negotiations on alkyl phthalates to (DINP GAS No.88515-48-0 and 28553-. The program was designed to contact the Agency. EPA held public 12—0), may also be tested, and if so complete testing in two phases. Phase 1 meetings with interestedparties on would also be made subject to export tests were performed to determine acute January 7, 1987, February 12, 1987, June notification requirements. toxicity to fish, aquatic invertebrates. 3, 1987, and September 29, 1987 to EFFECTIVE DATE: January 9~1989.. and algae, and chronic toxicity to discuss the testing appropriate for the aquatic invertebrates. Biodegradation alkyl phthalate chemicalcategory. On FOR FURTHER INFORMATIONCONTACT tests and tests to determinevapor November 11, 1988, EPA, Aristech. Michael M. Stahl, Acting Director, TSCA pressure, water solubiity and Koctanol/ BASF, Exxon, Kodak, and Witco signed Assistance Office (TS.-799), Office of water were also performed. Phase I of a testing Consent Order for certain alkyt Toxic Substances, Rrn. EB-44, 401 M St.. testing has been completed. All of the phthalate esters. A Consent Orderis ~ SW., Washington, DC 20460, (2021 554— data from these studies have been based on a formal finding and expeditel 1404, TDD (202) 554-0551. placed in the public file on alkyl testing, while retaining the same TSCA SUPPLEMENTARY fNFORMAT1OPC Under phthalates and BBP (OPTS-42005) and penalty provisions applicable under procedures described in 40 CFR Part 790, are available for public inspection. rulemaking. Under the Order, these Aristech, BASF, Exxon, Kodak, and In Phase 11 of the testing, more companies have agreed to conduct or Witco have entered into a testing advanced tests, including early life stage provide for the conduct of fish early iiie Consent Order with EPA in which they testing with fish, bioconcentration tests stage toxicity tests and adsorption have agreed to perform certain chemical with oysters, soil and water isotherm tests. The specific test fate and environmental effects tests for biodegradation tests, and tests of soil standards to be followed and the test;u~ DMP, DnBP, DHP, DEHP, D7I1P, D~DP, transport were to be performed, if the schedule for each test are includedin DUP, and DTDP. This rule amends 40 results of the Phase I tests Indicated a the Order. Procedures for submitting CFR 799.5000 by adding these eight need for further testing. The tests and study plans, modifying the Order, chemical substances to the list of chemicals selected for Phase 11 testing monitoring the testing and other chemical substances and mixtures were to be determined primarily by the provisions are also included in the subject to testing Consent Orders. results of the Phase I tests. Order. Federal Register / Vol. 54, No. 5 / Monday, January 9, 1989 I Rules and Regalations 619 m. u~and Exposure Phase I of the NTA and other available signatory manufacturers have therefore data to estimate the water solubility. agreed in this Consent Order to double The alkyl phthalatea are a chemical volatility and aerobic biodegradability (under the conditions described in the category consisting of alkyl diesters of of the phthalate esters and to test standard applicable to this Consent 1,2-benzenedicarboxylic acid. They sufficiently predict the acute toxicity of Order) the normal length of exposure to typically areformed by esterifying the phthalate esters to fish, the chemical substance in the early life phthalic acid anhydride with various invertebrates and algae and their stage toxicity test. Doing so will akohols. The compounds vary in size, chronic toxicity to aquatic invertebrates. strengthen any potential conclusion of depending on the alcohols used, from However, the Agency believes It has no toxic response for some or all of the the short chain compound dimethyl Insufficient data to predict chronic long-chain compounds. phthalate to long-chain compounds such toxicity of the phthalate esters to fish, as ditridecyl phthalate. Mixed alcohols Depending on the results of the testing and to reliably predict adsorption of of these five compounds, additional. may also be used in the esterification these chemicals to sediments. EPA process giving a combination of phthalate esters may be tested. Diethyl intends that testing be conducted under phthalate (DEP) may also be tested if its unsymmetrical alkyl diester compounds, this Consent Order to fill those data such as D711 phthalate, whose side toxicity cannot be reliably estimated deficiencies. EPA believes that these from the test data on DMP and DriB?. chains may consist of alkyl groups of 7, data will, with the earlier data on the 9, or 11 carbons. Furthermore, if D7IIP produces a toxic alkyl phthalates and BBP, be sufficient reponse. diisononyl phthalate (DINP) Phthalate esters are used as to reliably assess current risks that the plasticizers in plastic products at may be tested; positive results for DINP dialkyl and alkyl benzyl phthalates may may further lead to testing on diisodecyl different percentages depending on the present to the environment. The testing mutual compatibilities of each and the phthalate (DIDP). If DUP produces a will examine chronic toxicity to fish positive result, ditridecyl phthalate degree of flexibility desired in the (through early life stage toxicity testing (DTDP) may be tested. Testing of these plastic product (Ref. 1). The chain with rainbow trout) and adsorption of additional compounds (DEP, DIN?, lengths affect the properties of the these chemicals to sediments. EPA compounds in a fairly predictible way DIDP, and DTDP) would be indicated in intends to gatherdata by having a follow-up Federal Register noticefor a8 the chain gets longer, water solubility manufacturers test a subset of the 14 and vapor pressure decrease, and K.~ notification purposes, but is considered alkyl phthalates tested under Phase I of part of this Consent Order.
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