Document qdvbObmGVBqy4bv2w109ZexzG

CHEMICAL MANUFACTURERS TO: SUBJECT: June 5, 1981 Ethylene Program Panel Ethylene Dichloride Reporting Rule Proposal Enclosed please find an advance copy of an EPA draft proposal on TSCA, Section 8(a) Reporting Rule for Ethylene Dichloride. Publication in the Federal Register is expected to occur shortly at which time we will have the opportunity to formally comment. Please let Mr. John Murphy or me know if you think it is advisable to respond to the proposal when it comes out in the Federal Register, Mr. John Murphy can be reached at (203)222-3493 and I can be reached at (202)887-1192. Sincerely, Hasmukh C. Director Biomedical Special Shah, Ph.D and Environmental Programs RECEIVED 1961 Environmental Affairs Formerly Manufacturing Chemists Assn nation--Serving the Chemical i-dusuy Since 1872 2501 M Street, NW Washington DC 2007' Telephone 202/887-; 100 Taiex 39617 (CMA WS SL 080608 (40 CFR PART 704) [OPTS-82006] 1,2-DICHLOROETHANE (ETHYLENE DICHLORIDE, EDO) REPORTING OF PROCESSING INFCRKATrOET AGENCY; Environmental Protection Agency (EPAJ-. - ACTION: Proposed Rule. " `` -- SUMMARY.; This rule, proposed under section 58 (a )'of the.-Toxic - .S.ubstances- Control Act (TSCA), 15 U.S.C. 2601(a) L would require . .certain processors of 1,2-dichloroethane (ethylene di'chl-oride, ; ; - f EDO) CAE #107-06-2, to identify themselves and to.' report -the - - - . intended? uses of the EDC-containing products, .their -make - : These- 5 ' :r paroce-ssors^ would also~report quantities of 2DC ^obtained 'and used r = for each of their processes or products. : - - i - ` t. .. : r . - i; - _ i = . EPA: wishes to evaluate whether dispersive uses of :ZDG pose - . .an-.unreasonable risk to health or the envircnaent^ = -'Information reported under this rule will be considered .'by XPAf in. 'assessing ' .. --potential risks ana determining whether regulation =of .'certain " dispersive uses of EDC is needed. DATES;- Written comments on this proposal muatTTbe postmarked: on = or before (insert cate 60 days after date of .publication in the FEDERAL REGISTER). Written comments should bear the document control number (OPTS-82006) and should be submitted to: Document Control Officer, Office of.Pesticides and Toxic Substances (TS-793), 80T-155 2 SL 080609 -s r-v Environmental Protection Agency, draft Rm. E-105, 401 M Street, SW, Washington, DC 20460. All written comments filed pursuant to this notice- will be* available' for public inspection at the above address from ` - - 8:00 a.m. to 4:00 p.m. Monday through Friday, except legal holidays.Interested persons may also request- time to meet with EPA staff' responsible for developing this proposed rule. Such meetings will be held (insert date 5 days after the end of written, comment period), in Room , Environmental Protection Agency, 401 M St., S.W., Washington, D.C. 20'4"60*." FOR FURTHER INFORMATION CONTACT: " John B. Pitch, *- Industry Assistance Office (TS-799), - 7 ` *' * - - ' *-1 Environmental Protection Agency, : Rm. E-125, 401 M S , SW, Washington, D.C. 20460, -- Toll free: (800-424-9065), ` :*-' In Washington, DC: (5 54-1404). - :: SUPPLEMENTARY INFORMATION: I. BACKGROUND A. Production ar.d Use 1,2-dichloroethane (EDC) is a high volume chemical with an estimated annual production of ever five billion kilograms. Most of the EDC is manufactured domestically and used as a $(_ 09DloOlft  ' : - ' draft feedstock in the production of other chemicals, with the vast . majority used in the production of vinyl chloride monomer, and other organic chemicals, including trichloroethylene, * . perchloroethlyene, vinylidene chlcride and ethylene -amines. ' In addition,.EDC has.been.employed.for several miscellaneous, - "dispersive" uses.- "Dispersive" uses are those :in which -seme, or all, of the substance is eventually released into :the ` 1 - .envirorrent. Such uses include additives for rootor-~vehicle ; fuels, .grain fumigants, other pesticiaal applications, solvents','- penetrating oils, extractants, and cleaning agents.-- ..Data, available from the National Institute for--Occupational - -Safety ^and Health (NIOSH),- the Consumer Product`-Safety`Commission ;(.CPSClr a^d from commercial product data bases :indica-te :that EDC * has been..us,ed in a number of diverse product '"categories'.' -However it-is unknown whether EDC is presently used * in-these- ways ,* and'if Q* - "n . ^ i--V e'*^"T* r*" -- ---- * * . * " ,, . * TT ~ B. Toxic Effects ^ - . There is evidence that exposure to EDC may present -'risks ^to` * health and the environment. Toxic effects of-EDC to- humans and; -'animals have been reported in the scientific literature by _:a .number cf investigators and the data have been extensively reviewed by NIOSH. In 1975, NIOSH recommended that the present Occupational Safety and Health Administration (OSHA) exposure standard cf SO pen be reduced to 5 ppm over a 40-hour workweek to prevent, or minimire, disorders cf the skin, eye, lung, liver. SL 080610 DRAFT kidney and heart which could result from exposure to EDC. CSee "Criteria for a Recommended Standard -- Occupational Exposure to Ethylene Dichloride (1,2-Dichlorcethane)", DHSW (NIOSK) Publication No. 76-129, 1976], 1 . More recently, EDC was found to be carcinogenic in two rodent species in National Cancer Institute (NCI) bioass&y studies* aXdvfnutacit/*LrAother/'stup 1 ss\. On the bar of these findings, in September 1978, NICSH issued a recomint cion to lower the occupational exposure standard for EDC still further to 1 ppm. [See "Revised Recommended Standard -- Occupational Exposure to Ethylene Dichloride (1,2-Dichloroethane)", DHSW (NIOSH) Publication No. 78-211, September, 1978.J - The Office of Pesticides and Toxic Substances (OPTS) and caver,al other program offices within EPA are currently assessing .the. potential for human exposure to EDC and "for its release into the .environment. The information to be collected under this rule will contribute significantly to these assessments. -- II. THIS RULE The production, release, and potential for exposure to EDC during its manufacture and use as a feedstock -- particularly in the production of vinyl chloride -- have been fairly well characterized in existing data available to EPA. However, few data are available to the Agency on the miscellaneous dispersive uses of EDC. The purpose of this rule is to identify persons who process EDC for dispersive uses, the nature of such uses and the quantity of EDC associated with each use, so that subsequent SlO?0(olOPt -3- Di\ *FT assessments'of'the risks associated with dispersive- uses of EDC - can be focused-on the most significant of these uses.-- . E?A, other Federal agencies, and their -contractor* have conducted, a number of studies cf EDC and its uses.' " The studies revealed that current information concerning mo-st 'specific uses of_ EDC (other than as a feedstock) is not re'aci-ly available in the trade and technical literature- or from either- publi-c data sources, partly due to the fact that miscellaneous dispersive uses, of EDC represent only a small fraction of the EDC market. Also, industry has been reluctant to provided-data necessary for" these studies in large part because the use 'axsf'distribution *patterns cf EDC are often" considered proprietary.--*- The -- contractors have documented numerous previous^ ciVperVrve uses- 'cf EDC, but have been unable to substantiate whether and -ta whfat extent EDC is still so used. - ~=- *- -- -- - --The specific use of approximately five million k-i'1'ocrams df the annual EDC domestic production remains unidentified-.- TheseM ` five, million kilograms are believed to go into 'dispersive -users' (other than pesticide! and fuel additive applications'-} and may ' present a potential for widespread exposure 'Srbnf 'released 'in- the workplace and into the environment. The GCA"'^Corporation, -iri a - * study for E?A (see PUBLIC RECORD -- Item 4),-`estimated that dispersive uses of EDC, including pesticidal and- leaded gasoline additive applications, may account for as much as 33% of the total annual amount of EDC released to the environment. However, GCA was unable to substantiate specific dispersive uses or to verify this estimate. Similarly, a study by Bactelle SL 080611 -5- DRAFT Laboratories, under contract to the C?SC, identified several categories of consumer products which formerly contained EDC. However, Battelle was unable to verify current usage of EDC in consumer products because products may have been reformulated to eliminate EDC and because this information is considered proprietary by industry. Other contractor studies of EDC conducted for E?A were also unable to adequately document dispersive uses, exposures, and releases of EDC. These studies included a review of EDC as an environmental pollutant prepared ty Oak Riace National Laboratory in April 1979, ana a Level 1 Materials Balance Study prepared by JR3 Associates in February 1980. These documents are available in the public record for this rule. Information'about EDC usage was also obtained from NIOSK. Some time aco, NIOSK conducted a National Occupational Hazard Survey (NQHS). The survey indicated widespread exposure to EDC in a large number of diverse processing or industrial operations. The following table, "EDC -- Dispersive Uses and Industrial Applications'', summarizes po-er.zial EDC usage identified by the Survey. SL D?ouIA i. ;aft EDC -- DISPERSIVE USES AND INDUSTRIAL APPLICATIONS Examples of Dispersive Uses of EDC Identified in the~ National Occuoational*~Hazard Survey"(NOHS) Addi tive1 Adhesive Aerosol cleaners Carburetor cleaners Cement-glue Cleaning compounds Coatings Cutting oils Degreasers Disinfectants Drain openers Enamels Fabric rust removers Fumigants In)c removers Insecticides Lubricants Paints Penetrating oils Pigments Reagents Rust inhibitors Sealants Solvents Examples of Industrial Processing Applications m Which EDC mav be Utilized Adhesives Formulators Asphalt Processing Bakelite Processing Bitumen Processing Camphor Processing Cosmetics Manufacture Cellulose Acetate Dispersion Cellulose Ester Dispersion Dry Cleaning Applications Degreasing Operations Textile industry Petroleum industry Electronics industry Extractant Soybean oil Fish protein Caffeine Dyes Camphor Milk Preservation Ore Processing Paint Solvation anal Stripping Pesticide Processing Petroleum Refining Pharmaceuticals Photocopying Processes Photography Resins Processing Rubber Processing Textile Processing Nylon Viscose rayon Varnish Diluent Water Softening SL 080612 DRAFT On the basis of that survey, NIOSH estimated that ". . . approximately 1.5 million workers in more than 148,000 workplaces are potentially"exposed to EDC -- some 200,000 of whom are estimated to be continuously exposed to EDC in the workplace." However, the NOKS survey was not designed to specifically quantify use and exposure of EDC in the workplace. Rather, based on a large sample of observations of chemicals used in the workplace, the survey was intended to serve as a statistical projection of potential use and exposure to chemicals generally, including EDC, in plant sites throughout the country. From observations of EDC in the workplace as reported in the survey, it appears that approximately 90 percent of the reported use *was determined by "generic,,resolution" which consisted cf accepting the product use category noted by the investigator and then making a "best guess" estimate cf which chemicals might be present in such products. For example, where an observed substance might have been a solvent, all likely solvent possibilities were recorded by the investigator. If the specific solvent could net be positively identified at the plant site or by subsequent manufacturer verification, the exposures to this solvent may have been counted as exposure to each of the possible solvent substances. Therefore, the N'CHS data may represent an overestimate of EDC use. III. USES OF REPORTED INFORMATION Data reported under this rule will be used by the Office of Pesticides and Toxic Substances to support further investigation of the need for TSCA control action. SLD20UZ/4 URAFT Under this rule, processors of EDC [other than for feedstock and other exempted uses specified in 704.85(d)(2)3 will identify themselves, the amount of bulk EDC they obtain, the mixtures or other products into which they incorporate the EDC, the' function EDC serves in those products, and the amount of EDC, contained in such products. The Agency will use these data in several ways. The processor and product identity information will be valuable in itself. It will show the breadth of the EDC processor population and the variety of mixtures and"products currently produced. From" the processor and product identity information, EPA can develop a more detailed picture than presently' exists to determine and quantify points of potential environmental release resulting from dispersive EDC usage. The reports of amounts of EDC obtained, when taken together with ether available data, will assist the Agency in drawing a comprehensive picture of EDC consumption. Quantity information will also be helpful in estimating potential worker and general population exposure from dispersive uses and in assessing the potential impact of any control action. Finally, knowing the kinds of mixtures and other products which contain EDC and the function EDC serves in these products will permit assessments cf the availability of substitutes. The section 8(a) data may also be used by other EPA program offices and ether Federal agencies. For example, the Office of Air, Noise, and Radiation, and the Office, cf Water and Waste Management are both assessing the need for new or revised SL 080613 draft standards for environmental release of EDC. The inventory of processors and plant sites which will result from this rule will be useful in identifying potential sources of EDC release from sites other than those of EDC manufacturers. CPSC, through contract efforts, has been unable to identify any -substantial current use of EDC in consumer products 1. If the data reported under this rule should identify products containing EDC which might have potential consumer use, this information will be shared with CPSC. QSKA has expressed interest in data identifying the number and location of sites where EDC is actually processed and data relating to quantities used in the workplace. Such data may be used in a review of 'the EDC occupational exposure standard. IV. WHAT MUST BE REPORTED Processors are required to report EDC processing for each plant site and each EDC-containinc product on EPA Form , "Processing of 1,2-Dicnloroethane (Ethylene Dichloride, EDC)". Processors would identify the company, plant site address where EDC is processed,.telephone number, Dun & Bracstreet Number, SIC numbers, and the name of a technical contact person. In addition, they must report the intended function of EDC in the > mixture or ether product, whether the product is intended fer industrial or consumer use, and identify any mixtures or products into which-EDC is incorporated. Processors would also list quantities of EDC obtained, the number of product units produced, the size and type of containers SL oMblM -II- L ;AFT or packages in which the EDC-containinc product is distributed, and the weight of EDC in each product unit. V. '"'HO HZ?CRTS This rule applies, with certain exclusions, to persons who processed EDC anytime during 1978-1980. These are persons who prepare EDC, after its manufacture, for distribution in commerce, in the same or a different form as they receive'it, or as part of a product that contains EDC. Persons who themselves manufacture or import bulk EDC and subsequently process it, must report as processors. The following are hypothetical examples cf EDC processors and the subject of their reports. They are included here for illustrative purposes.. 1. A person who manufactures EDC and incorporates it into a paint remover to be sold to consumers would report about the incorporation of the EDC into the paint remover. 2. A person who obtains EDC and incorporates it as a solvent or ink carrier in the wick cr cartridge of felt tip pens would report abouf incorporation cf the chemical into the felt. 3. A person who obtains EDC and incorporates it into a chemical mixture to be sold as an industrial cleaning agent would report about incorporation cf EDC into the mixture. 4. A person who obtains bulk EDC and repackages it in smaller containers for distribution in commerce would report about the EDC repackaging activity. Several classes of processors are excluded from reporting under this rul . The major class of processors who are-excluded SL 080614 draft-12- are' those who react EDC to make other chemical substances. Thus, for example, persons who produce vinyl chloride monomer from EDC, are excluded from this rule. Also excluded are persons who process EDC for use in "umigants or other pesticides registered under the Federal Insecticide, Fungicide ana Rodenticide Act or for use as an additive to motor vehicle fuels reported under the Clean Air Act, 42 U.S.C. 1857f-6c and 1857c. However, persons who process EDC as a fuel additive (e.c., in aviation fuels or consumer products) and do not report under the Clean Air Act are subject to this rule. Additional exclusions from reporting include persons who process EDC solely for research and development, who process EDC as an impurity, cr who process a formulated mixture containing EDC. Small processors of EDC who employed ten or fewer full-time employees in i960, are also exempt from the rule. We estimate that over 40 percent of the potential respondents who are not otherwise excluded will be exempted as a result of this provision, while firms that account for approximately 95 -percent of employees and sales will still be included. This estimate is cased upon figures compiled by Dun & Sradstreet for the Small Business Administration. The estimate is further explained in a memorandum titled "Small Business Analysis", which is part of the public record of this rule. The Agency believes that this exemption, in conjunction with the other exclusions above, will greatly reduce the reporting burden, yet enable E?A to obtain sufficient information to develop a reasonably comprehensive -13- draft picture of EDC uses and determine exposures and release potentials in- processing EDC. Section S(a) of TSCA states that reporting by manufacturers or processors cf mixtures may be required only when the Administrator determines that it is "necessary for the effective enforcement" of TSCA. This regulation will require reporting from persons who mix EDC with other chemicals to formulate products that are then sold for dispersive uses. For purposes of this rule, E?A views these persons as processors of the chemical substance EDC since they prepare the chemical for distribution in commerce in the same or in a different form or physical state from that in which it was received. The Agency is not focusing its investigation on the potential health effects of these mixtures per se, but on the effects cf the chemical substance, EDC. The Agency, therefore, is net required to determine whether the information on EDC to be collected from these persons is "necessary for effective enforcement" of TSCA. EPA has nevertheless made this determination fer this rule. The Agency preposes to require the reporting of information essential to completing the picture of the sources, utilization, and environmental release of EDC. Without this information, the Agency would be unable to fill gaps in its assessment of the risks associated with EDO. Therefore, to the extent that this rule would .require information about EDC to be reported by persons who use EDC to formulate mixtures, the Administrator finds that it is necessary for the effectiveness of this rule and, therefore, for effective enforcement of TSCA. SL 080615 -14- draft VI. REPORTING YEAR The reporting years are 1978, 1979, and 1980. Persons who processed EDC during 1980 would report only for 1980. However, batch processors who did not process EDC during 1980 would report about the most recent year in which they processed EDC, i.e., 1978 or 1979. VII. REPORTING BURDEN The composition of the EDC processing industry subject to this rule is not defined in any source available to EPA. Therefore, the Agency can only estimate the number of EDC processors and the costs which may result from reporting EDC processing. The industry-wide NOKS survey conducted several years ago indicated that EDC might be widely used in many industrial applications and processes. Based un the survey, NIOSH projected that EDC may be used in approximately 148,000 plant sites. Reasons for believing that the NCHS data may be an overestimate are discussed elsewhere in this preamble. It is also important to note that the NOH5 survey was concerned with the number of plant sites at which EDC might be used. This number of users of EDC is expected to be considerably greater than the number of processors of EDC -- the only persons to whom this rule applies. While the NOKS data are primarily estimates of occupational exposures to EDC, identifying only a few specific EDC products, the survey does provide information about potential uses in industrial applications and processes. In order to obtain a SL OSOIoiSW DRAFT better estimate of numbers of potential EDC processors, we studied data from the Bureau of Census, 1977 Census of Manufactures. We examined Standard Industrial Classification (SIC) Categories of Manufactures to identify those SIC categories of manufactures which represent the industrial applications identified by NIOSH/NOHS. We identified approximately 30 categories as those most likely to include establishments where EDC may be processed. Given the small percentage (about-10 percent) of plant sites where EDC use was ac tually identified by the NCHS survey. and given the classes of processors excluded from this rule. we concluded that it is reasonable to'assume that 10 percent of the establishments within the 30 selected SIC categories would be a maximum estimate cf the number of processors of EDC. Census of Manufactures data indicate that there are approximately 10,000 establishments with 20 or more employees within the selected SIC categories. For proprietary reasons, Census of Manufactures data are not available to EPA for establishments with fewer than 20 employees. Therefore, the actual number of establishments in the selected SIC categories is probably somewhat greater than 10,000. However, on the basis of the available Census data about numbers of establishments (approximately 10,000), we estimate that a maximum of 1,000 processors not otherwise exempt may be subject to this rule. This figure could be as much as a ten--fold overestimate. The fact that E?A and its contractors have been unable to discover the extent cf the dispersive use of EDC may reflect a significant decline in processing for these uses. SL 080616 draft Comment is requested on the potential number of respondents to this rule. Since only a small segment of industrial activity involving EDC will be affected by this reporting requirement, the reporting burden is expected to be small. The following cost estimates are based on the assumption that each respondent will submit only one form. This assumption and cost estimate will be revised if necessary based on comments received during the comment period. We estimate that completing the one-page form will take- no more than 4.5 hours/form at a cost of 5135 per form. This would result in a maximum estimated overall cost of 5135,000, for 4500 reporting hours based on an estimate of 1000 respondents, and a minimum of 513,500 and 450 hours if there are 100 respondents. A more detailed description cf the reporting burden calculations is contained in the "Reports Impact Analysis", an internal EPA report that is included in the public record for this rule. Copies may be obtained from the Industry Assistance Office at the address and telephone number given at the beginning of this notice. Comment is requested on these reporting estimates. EPA recognizes that the total reporting hour and cost projections are estimates based on scanty and incomplete data. The Agency will consider any evidence of the size cf the respondent group, the number of forms to be submitted per respondent, and of the costs to complete the form that are submitted in response to this proposal, when developing the final reporting impact analysis- St draft This rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. Therefore, it is net subject to the requirements of'the Regulatory Flexibility Act, PL 96-154. As required by the. statute, EPA is consulting the Office of Advocacy, Small Business Administration. As described above in Section V, the Agency is proposing to exempt small businesses from the requirements of this rule. The proposed definition of small businesses would exempt approximately 40 percent of the entities which would otherwise be subject to the rule. The Agency is' requesting public comment on whether this exemption is appropriate for this information gathering activity. Should the Agency adopt this small business exemption, or an alternative exemption after consideration of comments, then the rule will have no impact on the exempted small entities. Moreover, the Agency believes that the cost of reporting under this rule is not liXely to have a substantial impact on any entity potentially subject to the rule. VIII. CONTI TENT I All TV Firms may assert a claim of business confidentiality for any information submitted in response to this rule. EPA is aware' of the need to maintain the conf identiality of any legitimate trace secret. Confidential information will be safeguarded as provided in the "TSCA Confidential Business Information Security Manual" which can be obtained by calling the information number given at the beginning of this notice. Specific provisions for making confidentiality claims are contained in the proposed rule and form. SL 080617 -IS- IX. SUNSET PROVISIONS draft Internal' EPA regulations state that any new reporting requirement will contain a provision for its repeal within five years after promulgation. This' reporting requirement will terminate within five years after its promulgation. X. PUBLIC MEETINGS Following the written comment period, EPA personnel responsible for developing this proposal'will be available to meet on (insert date 5 cays after close of written comment period) with interested persons from companies, organized labor, trade associations, and citizens organizations to discuss this proposed rule. These meetings will be held in Room , Environmental Protection Agency, 401 M St., S.W., Washington, D.C. 20460. The Agency will make transcripts cr summaries of such meetings for inclusion in the public record for this rule. All meetings will be cper. to the public. EPA intends to limit active participatier, in the meetings to these persons requesting the session and EPA personnel designated for the session. To request time for a meeting, interested persons should call EPA's Industry Assistance Office, roll-free at 00-424-9065, cr 554-1404 in the Washington, D.C. area. XI. PUBLIC RECORD EPA has established a public record for this rulemaking (Docket Number OPTS-62006). The record, along with a complete index, is available for inspection in the OPTS Reading ucm; SL o$oLnA -19- > 3AFT Rm.' Z-105, 401 M St., SW, Washington, DC 20460, from 8:00 a.m. to 4:00 p.m. on Monday through Friday, except legal holidays. This record contains the basic information that the Agency considered in developing this proposed rule. The Agency will supplement the record with additional information as it is received. The record includes the following: 1. This proposed rule. 2. NIOSH "Occupational Exposure to Ethylene Dichloride (1,2-Dichloroethane)", DKEW (NIOSH) Publication No. 76--139, 1976. 3. NIOSH "Revised Recommended Standard -- Occupational Exposure to Ethylene Dichloride (1,2-Dichlcroethane) ", DEiW (NIOSH) Publication No, 78-211, September 197S. 4. EDC Status Report from Rules Development Branch, dated July I960. 5. Draft Final Report, "1-2-Dichloroethane -- Technical Control Options Analysis", submitted to EPA, OPTS, Control Action Division by GCA Corporation, April 1980. 6. Final Draft -- "Report on 1,2-Dichloroethane* submitted to EPA, OPTS, PID, by Koba Associates, August 12, 1980. 7. "Investigations of Selected Environmental Pollutants: 1,2-Dichloroethane", submitted to EPA, OPTS, Assessment Division, by Oak Ridge National Laboratory, April 1979. S. "Materials Balance Study -- 1,2-Dichloroethane, Level 1 -- Preliminary", submitted to EPA, OPTS, Survey & Analysis Division, by JR3 Associates, Inc., February 1960. SL 080618 -20- draft 9. Reports Impact Analysis: Reporting Processing of 1,2-- Dichloroethane.(Ethylene Dichloride, EDC). 10. Small Business Analysis Memo, prepared by OPTS, AD, C1RB dated November 1980. EPA anticipates adding to the rulemaking record the following types of information: 1. All- comments on the proposed rule. 2. All relevant support documents and studies. 3. "Records of all substantive communications between EPA personnel and persons outside the Agency concerning the proposed reporting rule. (This does not include inter- or intra-agency memoranda unless specifically noted in the index of the `rulemaking record.) 4. Minutes, summaries, or transcripts of any public meetings, if held. 5. Any factual information considered by the Agency in developing the rule. EPA will designate the complete rulemaking record, as prescribed by section 19(a)(3) cf TSCA, cn' or before the cate the regulation is promulgated, and will accept additional material for inclusion in the record at any time between this proposal and such designation. The final rule will also permit persons to point cut any errors or omissions ir. the record. EPA has determined that this document dees not contain a major proposal that requires preparation of a Regulatory Analysis under Executive Order No. 12044. SL DVObiSA -21 draft Under Executive Order 12044, EPA is required to judge whether a regulation is "significant" and therefore subject to the procedural requirements of the Order, or whether it may follow other specialized development procedures. EPA labels these other regulations "specialized". I have reviewed this regulation and determined that it is a specialized regulation, not subject to the procedural requirements of Executive Order 12044. Date Administrator It is proposed that proposed 40 CFR Part 704. be amended by * adding a proposed new section to read as follows: Sec. 3(a). PL 94-469, 90 Stat. 2029 (15 U.S.C. 2607(a)). SL 080619 DRAFT 704.85 1.2-Dichloroethane (Ethylene Dichlorice, EDC); Reportinc of Processing Information (a) Scope. This rale requires processors of EDC, except as noted in paragraph (d)(2) of this section, to identify themselves and report: the identity of any mixtures or other products into which they incorporate ZDC; the function that EDC serves in such mixtures or products; the quantity of EDC processed; and the number of product units produced annually. (b) Compliance. Section 15(3) of TSCA makes it unlawful for any person to fail or refuse to submit information required under this rule. Violation of the requirements of this rule may result in civil penalty or-criminal prosecution, as provided under sections 15 anc 16 of TSCA. In addition, under section 17, the Government may seek judicial relief to compel submission of required information. (c) Definitions. The definitions set forth in the.Toxic_ Substances Control Act section 3 apply for this rule. In addition, the following definitions are provided for the purposes of this rule: (1) "EDC" means all physical forms of the chemical substance, 1,2-dichlcrcethane (ethylene dichlorice), CAS Registry .Vo. 107-06-2, and induces all commercially available grades. (2) "EPA" means the .United States Environmental Protection Ace -cy. (3) "Feedstock" use means these uses in which EDC is transformed by chemical reaction in the synthesis of other chemical substances. (4) "Impurity" means a chemical substance which is unintentionally present with another chemical substance. (5) "Known to-or reasonably ascertainable" means all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or Know, or could obtain without unreasonable burden or cost. (6) "Person" means any individual, firm, company, corporation, joint venture, partnership, proprietorship, association, or any other business entity, any State or political subdivision thereof, any municipality, any interstate body, and any department, agency, or instrumentality of the Federal Government. (7) "Process for commercial purposes" means the preparation of a chemical substance or mixture, after its manufacture, for distribution in commerce with the purpose of obtaining an immediate or eventual commercial advantage for the processor. Processing of any amount of a chemical substance or mixture is included. If a chemical substance cr mixture containing impurities is processed for commercial purposes, then those impurities are also processed for commercial purposes. (3) "Processor of ZDC" for purposes of this rule means any person who processes EEC by incorporating it into a mixture or other product, or repackages it for distribution in commerce. (9) "Site" means a contiguous property unit. Property divided by a public richt-of-way shall be considered one site. SL 080620 UKAi" 1 There may be more than one manufacturing plant on a single site. (10) "Small processor" means for this rule a company which employed no more than 10 full-time employees at any one time in 1980. (11) "TSCA" means the Toxic Substances Control Act. (d) Who Must Report. (1) Processors of EDC who processed EDC at any time during 1978-1980, except as noted in paragraph (d)(2) of th-s section, must fill out and submit a separate form for each EDC containing mixture or product they make. The information on the form shall be information that is known to or reasonably ascertainable bv the submitter. Persons who processed EDC during 1980 shoul'd report only for 1980. Persons who are batch processors and did not process EDC during 1980 should r port the required information for the most recent year (i.e., 1978 or 1579) in which they processed EDC. (2) The following processors of EDC are not subject to this section: (i) Persons who process EDC solely as a feedstock in their production of other chemical substances including polymers. (ii) Persons who process EDC solely for use as a motor veh ole fuel additive subject to reporting under the Clean Air Act, 42 U.S.C. 165 7f-6c and 1857c. SL iDmaD/4 -2 5- DRAFT (iii) Persons who process EDC solely for use in f-umigants or other pesticidal products registered under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.s.C 136 et. seo. (iv) Persons who are small processors of EDC. (v) Persons who process EDC solely as an impurity. (vi) Persons who process EDC solely for research and development purposes. (vii) EDC. Persons who process formulated mixtures which contain (e) Schedule for reportir.c. ____________ ________ (1) Persons subject to reporting under paragraph (d) of this section must submit the ..required data cn EPA Form within 30 days after the effective date of the rule. (f) Where to obtain and submit forms. ...___________ . __ (1) EPA Form ______ can be obtained by writing or telephoning: _____ Industry Assistance Office, Office of Pesticides and Toxic Substances (7S-799), Environmental Protection Agency, Rm. -125, 401 M St., SW, -Washington, DC 20460, Toll free: (S00-424-9O65), In Washington, DC: (554-1404). SL 080621 -2 5- draft ' (2) Completed EPA Form must be mailed to: Document Control Officer, Office of Pesticides and Toxic Substances (TS-793), Environmental. Protection Agency, Rm. E-105, 401 M St., SW, Washington, DC 20460, Attn: EDC .Reporting. (g) Confidentiality. ......... (1) Any person submitting a document under this rule may assert a business confidentiality claim covering all or any part of the submitted material.' Any information covered by a claim will be disclosed by EPA only as provided in procedures* .set forth in 40 CFR Part 2. (2) A business confidentiality claim for any item reported on EPa Form must be made by checking the appropriate- box on Form and by signing the certification statement as specified in the form. Rv signing the certification statement, the : , ainant attests to the truth ar.c accuracy of the four state, .ents contained in the form instructions. (3) If no claim accompanies the notice at the time it is submitted to EPA, the notice will be placed in an open file available to the public without further notice tc the respondent. (h) Recortinc processing of EDC. The following EPA Form "Processing of 1,2-Dichlorcethane (Ethylene Dichlorice, EDC), must be completed and submitted to EPA as required in paragraphs (a), (e), and (f) of this section. St cwkaiA -27Information must toe reported on this form to the extent that it is hncvn to or reasonably ascertainable by the respondent. (i) Sunset prevision. All requirements of this rul-e viii terminate five years from the effective date of this rule. SL 080622 REPORTS IHPACT ANALYSIS brafi 1,2-Dichloroethane (Ethylene Dichloride, EDC) Reporting of Processing Information 1. LEGAL AUTHORITY Section 8(a) of the Toxic Substances Control Act (90 Stat. 2027, 15 U.S.C. 2607(a)). Section 9(a) of TSCA authorizes EPA to promulgate rules under which manufacturer's and processors of chemical substances must submit reports that the Agency may reasonably require. Information submitted must be known or reasonably ascertainable by the person reporting. To extent feasible, the Administrator should not require unnecessary or duplicative reporting. tc the 2-. BACKGROUND a. Purpose - EDC is one of the high volume chemicals produced domestically for feedstock uses and for a number of other-miscellaneous, dispersive uses. There is evidence that EDC is toxic to humans and that it is carcinogenic in animals. EPA is concerned that widespread EDC exposure and release may present unreasonable risks to health anc to the environment. The purpose of this rule is to obtain information about the processing of EDC into products intended for dispersive uses -- these in which seme or all the substance is eventually released into the environment. Such products may have widespread applications in the workplace and by consumers, and thus may present widespread exposure and release potential. b. Procedural Requirements - Under this rule, persons who process, "DC- into a mixture, article, or other product, or repackage "DC for distribution in commerce, are required to submit a one-time report of EPC usage, quantities processed per unit of product and number of product units produced nnuall'y. This information must be retorted by the processor on "PA "cm - , "Processing of 1,2-Pichlcroethane (Ethylene Dichloride, EDO". Processors who react "dc tc make other chemical substances, who process EDC for use in FIFRA-recistered pesticides or as rotor vehicle fuel additives, and small processors (as defined by this rule) are not subject to this rule. Persons who process EDC sclelv for research and development purposes, .as an impurity in other substances, or who process formulated mixtures SL 080623 DRAFT containing EDC also are exempted from reporting under this rule, c. Unavailability From other Data Sources - Agency efforts, as well as those of its contractors, have been unable to substantiate current, riEcellanects uses of EDC, partly due to the fact that such uses represent only a small percentage (although the quantity of EDC used aispersively is believed to be large) of total domestic "DC production and partly due to proprietary considerations. Distribution of EDC for miscellaneous uses appears to be highly fragmented and end use data are often considered proprietary. 3. ALTERNATIVES a. . Voluntary Report inn - As noted above, several efforts to obtain voluntary information by contract have been unsuccessful. Basically, we nave been unable to identify EDC processors. In cases where processors are known, they have been reluctant to provide the necessary information for convenience or proprietary reasons. Therefore, the only viable alternative for obtaining necessary information concerning EDC dispersive uses is to seek information directly from- processors upder this section S(a) rule. b. 5mall Pus moss Definition - Section 0(a)(3) requires that small businesses ns exempted from reportina requirements unless a chemical substance or mixture is subject to a rule proposed cr promulgated under TSCA section A, 5(b)(4), or 6. No "DC rule under these sections has yet been proposed, although such actions could be proposed depending on the results of this section 8(a) rule. This rule exempts "small processors" who employ ten or fewer full-time workers frc~ the reporting requirements under this rule. "his exemption, in conjunction with other reporting exclusions in this rule, will greatly reduce the reporting burden of this rule and yet should obtain sufficient information about the dispersive uses of "DC to meet the meeds of t'-'e TSCA regulatory investigation. It is estimated that the small processor exclusion would eliminate about 40% oc the potential respondents and reduce the reporting costs to industry by 354,000, or IS0O reporting hours. 4. IMPACT ANALYSIS a. work Hour "ecuiremer. ts/Ccsts - Dispersive uses of "Pc are believed to represent a small percentage of tctal annual EDC production. since only a snail segment of industrial use of EDC will be affected-by this SL OZOU3/9 . DRAFT reporting requirement, the overall reporting burden is expected to. be minimal. The Agency can only estimate the number of EDO processors subject to this rule and the resultant reporting costs. N'o known existing source of information identifies the number of EDC processors. This rule is designed to obtain this information. An industry-wide survey was conducted by MIOSII some time ago to identify chemical usage in the workplace. According to this survey, the use of EDC appeared to be widespread at a large number of industrial sites (projected to be approximately 148,000). For reasons discussed in the preamble to this proposed rule, EPA does not believe the number of processors who will be required to report is anywhere near the number of work sites where EDC might be used as projected in the N10SH survey. In order to obtain a better estimate of numbers of potential EDC processors, data from the Bureau of Census, 1977 Census of 'Manufactures, were analyzed. Standard Industrial Classification (SIC) Categories of Manufactures were examined to identify those SIC categories of manufactures which represent the industrial, applications believed to be typical for "DC based cn the NOMS survey. On this basis, "PA estimates that "DC could potentially be used in approximately 30 Standard Industrial Classification Categories of Manufactures. Analysis of census of Manufactures data indicates that there are approximately 10,000 plant sites (with 30 cr more employees) within those categories of manufactures. The number of plant sites at which ET>C is processed to prepare products for dispersive use is expected to be much smaller than the number of industrial sites at which EOC contai'-iinc products or mixtures are present. Furthermore, this rule would exclude those sites using EDC as a chemical reactant and those processing EDO for pesticidal uses or as motor vehicle fuel additives. Therefore, only a small fraction of sites where "DC is present would actually be subject to this rule. while the data needed to estimate that fraction are not available, the NIOSH survey referred to previously was able to verify- the presence of EDC in orly about 1D% of the sites where its investigators found the types of products being used that were considered in our analysis of the Census of Manufacturers data. Therefore, we assume for this analysis that as many as 10% of 10,000 sites (1000 sites) may potentially be subject to r porting requirements under this proposed rule. SL 080624 (1) Respondents (a) Number of Respondents - As discussed above we have es tima ten that "a's many as 1000 plant sites may be subject to reporting under this proposed rule* However, the fact that ERA and its contractors have been unable to discover the extent of the dispersive uses cf EDC may reflect a sicnificant.decline in processing for these uses and indicate that the actual number cf respondents that would have to report under this rule could be fewer than 1000*. (b) Frequency of Report - The section 8(a) information on dispersive uses"cf "DC will be gathered on a one-time basis. (c) Work Hour Requirements and Costs - We estimate that each subject plant site wiLl submit one report. An estimated maximum total of 1,000 reports are to be submitted under this section 8(a) rule, requiring 4.5 hours/form (for a total of 4500 hrs.) to complete at an estimated cost to industry cf 5125/form (or a total of 5135,000). Work-hour reporting estimates are based primarily on the cost analyses for the asbestos Secondary Processor Renorting Form (DP A Form 7710-3'). These estimates were used for comparison because of the similarity in scope and data elements to he reported on both forms* Fart II (company information) of the EDC reporting form is quite similar to Fart I of the asbestos secondary form,, and it is estimated to require one-half hour to complete- The balance cf the "DC form is estimated to require four hours to complete, based cn the data required, including cre-ha; f hour of legal scrutiny. Thus, the EDC Reporting Form is estimated to take a total of four and one-haIf hours to complete. The cnehalf hour difference in total completion times between the ETC and asbestos forms is due to a slight increase in mumper of data elements to be reported or. the F.DC form. A weighted-avereoe cost of S30 per hour for all .personnel was used to calculate the overall costs of each section of the "DC Reporting Form. The reasons for this choice are: (1) Clerical hours could not be separated from technical staff hours required to complete each section. Clerical time costs are estimated to be S10 per hour, while technical time costs- are estimated to be S30 per hour. scorn qv/? > (2) Some legal and upper management time (costinc more than $50 per hour) should also he required. ~The amount of clerical time at less than $30 per hour and legal and upper management at more than $30 per-hour are assumed to combine with technical staff time to give a weighted average of $30 per hour. ft <6 The underlying rationale for determining reporting costs was presented in a report to the Agency, preoar by Arthur Young and Company entitled, "r.ccnomic Impac Analysis for the TSCA Section 8(a) Rule. Reporting Commercial and Industrial Uses of Asbestos". The rollowing is a tabulated estimate of costs to industry and to the Agency for completing the one-pace "Processing of EDC" reporting form: " SL 080625 ESTIMATED REPORTING COSTS PROCESSING Or EDC PROPOSED SECTION 8(a) INFORMATION GATHERING RULE Industry Costs a. Maximum number of respondents b. Frequency of report* c. Work hours required for each respondent to collect data and complete a cne-time reporting form .Part I Part II Part III Part IV Legal Review Total d. Cost at estimated 530/hr.***.x 4/2 nrs. 1000 1 * V2 hr. V2 hr. 3 hr s. 4? hr. hrs. 5135/form e. Total cost (Cost/forr. x Est. respondents) S135,000 II. Agency (SPA) Costs a. Work-hours to process each form (compile, document control, distribute, etc.) b. Est. labor costs/hr. c. Other associated costs (ADP, etc.) d. Total ccst/form processed 3 S15.00 5.00 50.00 e. Total costs (1000 respondents) x ($50.OC/fcrm) $50,000 'Rest s MW r.cents must s mate included . Clerical Technical Legal emit a one-time report in legal review. = $1 0/hr. = 30/hr. Estimated = 50/hr. of EDC usage Average Cost $30/hr. SC 08DL25# (2) Acencv (EPA) Impacts .Implementation of the 8 (a) rule will require the following Agency resources: - - - - - (a) Receipt of Data, Editing, and Processing - The ' - -Management Support Division (MSD) .will be responsible - -for receiving and processing the reporting forms.* - The '* total anticipated number of forms returned by' respondents is expected to be small- .j (b) Evaluation - The Chemical Control Division has-- ~ ' - 7* . ; . . .estimated person/year will be required -to- evaluate the data generated by this rule. -i-- '- i. ' (c) 1 Enforcement - The Office of-Enforcement -intends' ter______ - actively enforce this rule. -it- i. (b) Secondary Impacts -i ~ 1~ ~ (1) Recordkeeoir.c Chances -- Since this rule- does 'not: - ' ~ ' contain a" recordkeeping requirement, there should-'be no '' . . t: changes in either Agency or respondent recordjcee'pi'ng- s-v. practices., -"i-"-- (2) ^Effects cr. Acencv Procram Operations -- -The 'Acencv has - ' ~ .. : sufficient resources budgeted to implement this, -r-nl-e -- 5. RESPONDENT COORDINATION No-respondent coordination has been done since 1Wt`dtf-'not know the identity of.EDC processors. EPA and CPSC - - *`t-~ r: contractors were unable to identify such prodes'sOrsV- - Usual -r. i sources of coordination, such as with trade b'ssWriafibns','* i * were unavailable for EDC processors. Unlike-''some `industries : which are represented almost entirely by one or- two' -trade' r-- associations, there is no comparable association for-EDC processors. This is cue to the fact that EDC processors are scattered throughout a number of diverse industries?. We ' expect to identify seme of the respondents since- they -will - .* ? comment on the proposed rule. 11"' r- i*-i SL 080626 DRAFT REPORTING PROCESSING OF 1,2-DICKLOROETKANE (ETHYLENE DICHLORIDS, EDC) INSTRUCTIONS . GENERAL: Use a* separate form for each product you process.. and-for. each-, ... _ , plant * site `where you process EDC. Different! formulations^of the ....* same'product are considered to be different products, for purposes . _, of this rule. .... * CONFIDENTIALITY CLAIMS: Any information submitted may be claimed confidential- in. ;. . . - _ . accordance with the following ins tructions. LTO-assert a' claim I. forinformation in this form, you must check, the^ appropria-te' closed box for each item claimed as confidential-and-sign, thfiCertification Statement in .Part I . " The Agency--understands^ that. *. ` checking"company or product name is actually.ai claim" for-the link. between these items and EDC. For information...which may.be. . ; submitted in attachments, to the f orm, provide a_ copy, which__ - . _ _ _ clearly indicates (e.g., bv circl ir.g, bracketing, etc-k the^; information you wish to claim con fidential. ---------- ..... In certifying this form,, the person in Part I. attests, to. the. : ... truth of "the following four statements concerning all. information! _. which is claimed confidential: -- ; - ------* -- 1i'My' company has taken measures tc protect the. confidentiality. . 'T'6f;the information, and it intends to continue to. take, sbph- 1 . measures. reas.Tii 2. The information is not, anc has net been, reasonably.... .. 'obtainable without cur consent bv other* persons, (other' than. government bodies) by use of legitimate means, (p-ther than. . ` `discovery based on a showing of special need- in.a. judicial.' . or quasi-judicial proceeding). -I i 3. The information is not publicly available elsewhere... 4. Disclosure of the information would cause substantial harm to our competitive position. Part I -- Certification Statement Self-Explanatory. This statement must be signed whether or not you claim information as confidential. SL 080627 Part II Comoanv Information DRAf 'o' * Enter the name and plant site address of your-company. `o' - f "Enter the unique Dun & Bradstreet number for. the-plant site that is reported here. If you do not know the Dun . - -- ' 'Bracstreet number for the plant site, leave this? block . blank. __i.. .- o' Enter the name and telephone number of the pr-incipal. - "technical contact who is either responsible for- comp let-in^. - 17`"-"this form, or has sufficient knowledge of its-contents -to - -T ' "-'respond to any questions posed by EPA concerning- your- - _i--_ - reDort. - -- Part III -- Processinc Information EDC Function - The-purpose of this section is to characteri-ae; the-Ajse of EDC in-. your process and prccuct(s). Several- functions-a-re- listed.. You _ "may-check more than cr.e, if applicable. If you do; not- find- e-n^appropriate function_ already listed, check "ether"-and. give- .a _ word ~:cr'-phrase that characterizes the functi.cn-that EDC-. serves- in. your product. -. Product Tvoe 'The -coir-rose of this xoi." ViuiTiEn of,-"the EDC in your disposal. question is to obtain iinformation.; about- the exposure tc, or release to-the_ environment product curi-c ics anticioated^ use- and - - The product types are described below: "Chemical Substance" means all physical forms-of-EDC . --ichloroethane , ethylene cichloride), and includes- aid * ccmmercially available grades. This product-type-should be -checked only by repackacers cf EDC for distribution in commerce. "Mixture" means a mixture containing EDC that the user-will directly contact, e.g., cleaners, paints, inks, solvents, etc. This includes mixtures in containers or other articles whose purpose is to release EDC (e.g., cans of spray paint, ink pens, and other applicaters). "Articles with i'o Release" are articles constructed in a way to prevent human exposure cr release to the environment cf EDC during normal use and storage, e.c., chemical coatings cn internal components and chemicals inside scale" articles as in thermometers and batteries. ( SL 08DLZ14 *. 3 " - - ",cftrticles With Some Release" are articles whose material. components are made of chemicals which come in direct 7 7' "contact with persons using the article, the atmosphere, land or water, i.e., exposure can come from leaching, r evaporation, or surface contact. This includes such . ' articles as plastic containers, chemically treated,textiles, " printed paper, coated appliances, etc. If EDC itself; is ; sol'd in a bottle or other container it should:be reported, under "Mixture", not as an article. Only the. container `.itself is an article for purposes of this form,,and the. .. ----- -substance it contains is not a component of i-t.;. Different! . . -` ""formulations of the same product are considered to. be. aifferent products for purposes of this rule. . - .. Users 'Th-cpiirpcVe of this question is to obtain a characterization of the persons who are the major users of your product. If your product is intended for use by. individuals for - household,.. . 'recreational, or other personal purposes, check-"consumer". If :ycur -product is intended for use by industry, .crl institutions,.... . check "industrial". If both, check "both". j -r_* Product Identitv - ?----- Enter the'-trade name (or names) under which you; sell, your product. .. and a brief description of the kind of product it is, such as'., "wood finish remover, textile finish, cleaning-compound, -etc. ?rr. tv -- Quantity Information __ 1. Reoortina Year r _ -ft you processed EDC during the calendar year -1980, . report --"'..for 1980 and check the 1980 box. If you are la. batch processor, report for the most recent year (i.e., .1978 or.... :.--:::Vg7*9-y in which you processed EDC and check the-appropriate box. -* 2, Total Amount of EDC Obtained/Year : "Enter 'the amount of EDC obtained (in metric weight, units) for the reporting year. 7 3. Amount of Product Processed -o Number of Units: Enter the number of units of each size for the product you produced in the reporting year. o Unit Site: Enter each unit size for the product. For example, if you produce cne product in3-ounce size, a 5.-gallon size, and a SS-callcn size, enter each product size on a separate line. SL 080628 draft . .o Description of Product Unit: Enter a word or -------- that best describes your product unit. For _exaiaple-, a tube, can, bottle, bolt of cloth, drum, etc.'"" 4. Weieht of EDC per Product Unit ' ---------------- :------------- _F,,or each unit, give the amount of EDC (in metrec weight' units_)_ Tper `uhi'f; for example, 5 mg. EDC/3-oz. tube.' '' SC D?OUM EPA Fora i (See instructions on refers* sloe pricr to ciruletinq this fc:t .Proraaaing cf 1.2-DichlcroethAne (F.thylene Dichieride. O Part I -- Certification Statement hereby certify that to the beat of my Vncwledge and belief (1) ell inferaatien reported an this fora is complete end tmrate, end (2) the confidentiality statements cn the bec't on this fora ere true es to that information for '-*u<Sn I :ve essertod a =nfidenti*liry elaint 1 agree to perait access to. erd copying of. records bf a duly authorized presents tive ci the E?A Administrator, in accordance with the Toxic Substances Control Act. to don Bent any \foraatlcn reportai here. SIGNATURE . Company Nan*: . Plant Site Acer ass L Dun 1 Eradstreet i (Fcr Plant Site)* DAIE - - SAhZ/TIXLE- or Print) - -- Caraarv In ferae ticn Part II 4. Tera-mcal Contact*-------------- *------ *-------- - - _ s. Telep-enej 6. Startdard Industrial Cnde'JSo. (SIC)i . . Part III -- Process ire Information -- 1. EC runotion 2. Prcdoctr|- j - - * : 3 Adhesion Promoter : 3 Antistaininc Agent ; 3 Beneficiating Agent : 3 binder # Elending Agoit Carrier Curing Agent Degreaser 3 Diluent Ll- Cixperxioa. Agent l 3 Drier LX. teracr--,r . . 3 rinishine Acent Flotation Agent Greasepraofin? Agent Latex expounding Agent Lubricating Ageit Paint t Varnisfi Remoter Penetrant --' Plastics Additive Prespotting Aceit Pust Sercver Securing Agent Sell Release Agent Soil Retardent Solvent Textile Specialties water Arpeiler.t C3 C3 C3 i3 C3 [3 E3 E3 C3 C3 E3 C3 E3 C3 E3 (a) Product Type (t) Users C '3 Chcnical Substance -C 3 Mixture C 3 Article v/seme rwleas 3 Article w/no release C 3 Industrial C 3 Constrair C 3 abet (c) Prod-art Identity! 3 OTHER (Specify) - Total Amount 2 (by ueicht) 1 * EX Cttair.ed/ i Year Part TV -- Quantity Znftraaticn 1. Reporting Year: 1993 t 3. 197? [ ], i?7G ' C'3 I Units 3. Aacunt cf Product Processed Unit Site Deocrinticn cf Product Unit ................................ * 4. Weight cf EEC/ Product unit ESC/Prcduct Unit *a* / ***** ** ' * 4 / i SL 080629 ANNUAL REPORT TO SPAC ON ETHYLENE DICHLORIDE FOR DISCUSSION AND REVIEW ONLY ' NOT FOR RELEASE 1.0 Charter FOR BISTRiSlIM 31' CUA REF. V&.bC-/? The Program Panel will appraise and evaluate the adequacy of knowledge relating to ethylene dichloride (EDC). Hie Panel will recommend and sponsor research in order to ascertain conditions necessary to assure the safety of workers involved in the production, handling and use of EDC and the safety of communities where such plants are located. Hie EDC Panel will represent the interests of its members before Federal and State agencies in all matters relating to safety and health issues arising out of production distribution and use of EDC. ' *' The Panel will function as a special committee under CMA bylaws, and as such will be subject to the Special Program Guidelines. 2.0 Uses Approximately 80 per cent of the annual production of EDC is used for the synthesis of vinyl chloride, EDC also finds application as a constituent in lead-containing antiknock additives for gasoline, in fumigant-insecticide SL 080630 TE9080 TS ? &> formulations, and as a component of metal degreasing mixtures. It is used as an intermediate in the synthesis of the chlorinated solvents, 1,1,1-trichloroethane, trichloroethylene, and perchloroethylene, and as a constituent of rubber cement and acrylic-type adhesives. 7 3.0 Background and Objectives In December, 1974, representatives of thirteen producers and users of EDC requested CMA to administer a research program to increase the toxicological data base for EDC. The scope of the program was to include at least: a literature survey and interpretation, mutagenic and teratogenic studies, and chronic inhalation studies. The Research Program on Ethylene Dichloride was approved on February 24, 1975. ' The Panel initiated a chronic inhalation study, a metabolic study, and a teratogenic study in experimental animals. The chronic inhalation study was completed, although the final report is not satisfactory to the Panel. N; The researchers have been requested to provide additional information to clarify several issues in the report and the Panel is still awaiting a satisfactory response. The metabolic research had to be terminated because the Panel was unable to provide compounds which were necessary for continuation of the research. The teratogenic study was satisfactorily completed. r 2"- The Panel decided not to initiate th mutagenic testing since EDC was shown to be weakly mutagenic in the Ames test. In addition, there did not appear to be the need for the literature search. In July 1980, the Panel voted by ballot to disband itself since no further activities were identified as necessary. However, by November of that year, the Panel reversed its decision to disband, principally because it was learned that EPA was formulating a proposed rule under TSCA Section 8(a). The Panel subsequently revised its charter to pursue an advocacy program. 4.0 Membership See Attachment A. * 5.0 Research Programs a. Completed and Ongoing Studies (See Attachment B) A. EDC 1.0-LT/Ihl/MS While developing the research program for EDC, the Panel learned that a consortium of European chemical manufacturers under the leadership of Montedison, intended to have Dr. Maltoni conduct a long-term inhalation study on EDC. Hie ee9080 is , --- ranfel d cided to participate in the European study under CMA auspices. In January 1976/ an agreement was executed with Montedison to administer a research project which would investigate the potential toxicological effects and pharmacodynamics of inhaled ethylene dichloride in laboratory animals. Professor Maltoni and Dr. Spreafico were the subcontractors to the agreement. A Hie following studies were included in the project: 1. Experimental investigations on the effects of EDC by inhalation on Sprague-Dawley rats. 2. Experimental investigation on the effects of ->DC by inhalation on Swiss mice. Originally the animals were to be treated for 12 months and observed until death. The treatment period was later expanded to 18 months. A final report on the long-term effects on rats and mice from inhaled EDC was sent to the w Panel in May 1979. On October 18f 1979/ CMA wrote to Montedison indicating that the Panel had numerous questions relating to the final report by Drs. Spreafido and Maltoni. Dr. Maltoni decided to answer these questions through his presentation at a November f[E9080 IS 1979 Cold Spring Harbor Symposium and its subsequ nt publications. The proceedings from the meeting were not published until 1980 and in addition, did not answer all the questions raised by CMA in the October 1979 letter. Montedison wrote to CMA in March 1981, indicating that Maltoni's presentation at Cold Spring Harbor and the subsequent proceedings did not answer all CMA's questions and submitted a detailed report by Maltoni addressing most of the Panel's questions. In July 1981, CMA wrote back to Montedison indicating that an adequate response was still not received and supplemental information was needed before final payment would be made. To date, a response has not been received. In July 1980, CMA sent the f^nal report submitted by Maltoni to selected government agencies indicating that many points relating to the research were still unresolved. Additional research on the chronic effects of EDC has been conducted by the National Cancer Institute (NCI). In September 1980, NCI released a carcinogenesis bioassay which found that orally administered EDC was carcinogenic in rats and mice. Male rats exposed developed forestoroach cancers, hemangiosarcomas of multiple organs, and subcutaneous fibromas. Mammary cancers were found in female rats xposed to EDC. The chemical also caused breast cancer as well as uterine cancers in female mice and respiratory tract cancers in both male and female mice. =S 9 0 8o as In September, 1979, the Panel approv d funds for an on-site review of both the CMA sponsored research and the then recently released NCI sponsored gavage study. Because of recalcitrance on the part of the Italian investigator, these reviews could not take place. EDC 2.0 An agreement was executed in October 1977 between CMA and "Mario Negri" to conduct metabolic studies on EDC. In the first phase of the study, Sprague-Dawley rats were administered EDC intervaneously and orally to evaluate its m tabolic fate. Following this phase, the study was to be repeated by the inhalation route. This agreement was terminated in July 1979 and the m tabolic study cancelled because of the unavailability of the six cysteine compounds which were necessary to continue the research. CMA disbursed $30,000 towards the metabolic study out of $60,000 which was originally committed. A report was sent to CMA in July 1978 describing the work already completed on the distribution and metabolism of EDC in laboratory animals. This report was sent to the appropriate government agencies. 9080 as EDC 3.0-Ter-Ihl In the Fall of 1977/ CMA contracted with Dow Chemical Company to conduct a teratologic study on the effects of maternally inhaled EDC on rat and rabbit embryonal and fetal development. Hie final report was received by CMA in April 1979 and submitted to the appropriate government agencies in March 1980* EDC 4.0-Rep-Ihl In the Fall of 1977/ an agreement was signed with Dow Chemical Company to conduct a single generation reproduction study on inhaled EDC in rats. Hie protocol for this study ' was revised and signed by Dow in February 1979. Hie final report was submitted to CMA in January 1980 and released to the appropriate government agencies in May 1980. b. Future Studies None Planned c. Ongoing Monitoring by Task Groupos Noire d. Auditing ? Z.C9080 7S None. e. Complimentary Research Programs None. 6.0 Advocacy a. Existing Regulations/Recommendations Bie current Federal standard for ethylene dichloride is 50 parts of ethylene dichloride per million parts of air (ppm) averaged over an eight-hour work shift, with a ceiling level of 100 ppm and a maximum acceptable peak of 200 ppm for 5 minutes in any three-hour period. NXOSH has recommended that the permissible exposure limit be reduced to 5 ppm averaged over a work shift of 10 hours per day, 40 hours per week, with & ceiling level of 15 ppm averaged over a 15-minute period. ACGIH TWA: 10ppm (40mg/m3) . STEL: 15ppm (60mg/m3) b. Proposed and Anticipated Regulations * The Panel received a TSCA Section 8(a) draft proposed rule from EPA. ,8e908o rrs This rule would require certain processors of EDC to identify themselves and to report the intended uses of the EDC-containing products they make. These processors would also report quantities of EDC obtained and used for each of their processes or products. EPA wishes to evaluate whether dispersive uses of EDC pose an unreasonable risk to health or the environment. Information reported under this rule will be considered by EPA in assessing potential risks and determining whether regulation of certain despersive uses of EDC is needed. * mH As of September 1981, EPA has not taken any action with regard to the draft proposed rule. CMA has learned that EPA's Environmental Criteria and Assessment Office is updating their health assessment document on EDC. The document compiled will be used to determine whether EDC should be regulated as a hazardous air pollutant. These health assessment documents are also used by other offices within EPA for making regulatory decisions. # 7.0 Key Issues None ? .9080 TS 8*0 Liaison with Other Associations and Interest Groups None 9.0 Controversial Issues None 10.0 Critical Dates None 11.0 Future Needs None * 12.0 Financial Status See Attachment C 13.0 Summary Hie EDC Program Panel has undertaken four research projects: 0^9080 qs 1. Die chronic inhalation study in rats and mice was completed. However, two questions still remain unanswered by the researchers. 2. Die metabolic study in rats was terminated in mid-stream because of the unavailability of six cysteine compounds which were necessary to continue the research. A report describing the work completed was submitted to appropriate government agencies. 3. Die teratology study on the effects of maternally . inhaled EDC on rat and rabbit embryonal and fetal development was completed and the final report was submitted to appropriate government agencies. ** 4. Die single generation reproductive study on inhaled EDC in rats was completed and the final report was submitted to appropriate government agencies. No additional research is planned. However, the Program Panel recently added an advocacy amendment to its charter and may be pursuing an advocacy program. 1 I SL 080641 ETHYLENE DICHLORIDE SPECIAL PROGRAM FINANCIAL STATEMENT Period Endinq - August 31, 1981 Phase I and II - 14 Companies Amount Invoiced: Amount Received: Budget Authorized: $384,964 $384,964 $439,5521 Setvice/Program Category Budget Authorized Actual Commitment Disbursement Unpaid Balance Research EDC i.O-TOX-Ihl-MA/SP EDC 2.0-MET-Intra/Or1/SP EDC 3.0--TER-Ihl-Dow EDC 4.0-REP-Ihi-Dow Subtotal Research $137,500 30.000 28.000 92,600 $288,ldd $137,500 30.000 28.000 29,600 $288,loO $118,350 30.000 28.000 92,600 $268,95$ $ 19,150 -0- -0- -0- $ 19,150 Administration Ditect Charges (8/31/81) Ttavel Charges Miscellaneous Subtotal Administration $121,45212 3 $121,452 $121,452 $121,452 $ 62,200 1,274 976 $ 64,450 $ 57,0o2 Contingency $ 30,0003 $ -0- $ -0- $ 30,000 Authorized Funds Available $ -0-0-0-0- $ -0- $ -0$ -0- TOTAL $439,552 $439,552 $333,400 $106,152 $ -0- 1. $54,588 has not been invoiced. 2. Difference between total amount committed to program and total amount committed to research 3. $30,000 paid to MET, $30,000 transferred to contingency. SL 080642 Report Title and Contract Number Studies on Long-term Effects on Rats and Mice of Ethylene Dichloride, Administered by Inhalation (18 months) (EDC 1.0-LT/Ihl/M.S.) Distribution and Metabolism of 1,2 Dichloroethane (EDC) in Experimental Animals (EDC 2.0) The Effect of Inhaled EDC on Embryonal and Fetal Development in Rats and Rabbits (EDC 3.0) EDC: Single Generation Inhalation Reproduction Study in Rats (EDC 4.0) BTHYL1 BICHLORIDE Contractor Montedison, S.p.A. Contract Execution Date Jan. 16, 76 Mario Negri Oct. 6, 77 The Dow Chemical Company The Dow Chemical Company Oct. 31, 77 Oct. 31, 77 Present Level of Funding $137,500 30,000 28,000 92,600 `1 Comments Released July 11, 80 Terminated. Interim report released June 25, 80 Released March 25, 80 Released May 30, BO * 9-22-00 BIOMEDICAL AND ENVIRONMENTAL SPECIAL PROGRAMS ADVISORY COMMITTEE William C. Becker Curtis w. Smith, Ph.D. Vice President Senior Consultant Employee Relations and Health, Safety and Environment Public Affairs Shell Chemical Company The BFGoodrich Company P.O. Box 2463 Chemical Group Houston, Texas 77001 6100 Oak Tree Boulevard (7.13) 241-0578 Cleveland, Ohio 44131 (216) 524-0200 Jerry M. Smith Director of Toxicology Calvin J. Benning, Ph.D. Rohm and Haas Company Director, Regulatory Affairs Spring House, Pennsylvania 19477 Essex Chemical Corporation (215) 641-7536 1401 Broad Street Clifton, New Jersey 07015 Otto Sturzenegger, Ph.D., Chairman (20U 773-6300 Chairman of the Board and Chi f Executive Officer H. Donald Feeney CIBA-GEIGY Corporation Vice President Ardsley, New York 10502 External Affairs (914) 478-3131 Borg-Warner Chemical Corporation International Center Gary Sunshine Parkersburg, West Virginia 26101 General Manager (304) 424-5414 Health and Environmental Affairs ICI Americas Conrad Kent, Esquire Wilmington, Delaware 19897 Vice President-Law (302) 575-4516 Stauffer Chemical Company Westport, Connecticut 06880 Gary Ter Haar, Ph.D- (203) 222-4369 Director, Toxicology and Industrial Hygiene Department George J. Levinskas, Ph.D. Ethyl Corporation Director, Environmental Assessment 451 Florida Avenne and Toxicology Baton Rouge, Louisiana 70801 Monsanto Company (504) 388-7855 800 North Lindbergh Boulevard St. Louis, Missouri 63166 Carl Umland (314) 694-8809 Environmental Health Coordinator Exxon Chemical Americas Myr1 E. Miller, Ph.D. P.O. Box 3272 Occupational Health Houston, Texas 77001 Consultant (713) 870-6762 IMC Chemical Group 421 East Hawley Street Joan E. Young Mundelein, Illinois 60060 Product Registration Specialist (312) 566-2600 Petrolite-Tretolite Division 369 Marshall Avenue Noble Robinson St. Louis, Missouri 63119 Director of Environmental (314) 961-3500 Affairs Mallinckrodt, Inc. P.O. Box 5840 St. Louis, Missouri 63134 (314) 895-2703 SL 08064 John J. Zimmerman (Jeff) Manager, Regulatory and Legislative Affairs ARCO Chemical Company 3801 West Chester Pike Newtown Square, Pennsylvania 19073 (215) 359-2202 Ex-Officio Members Robert Neal, Ph.D. President Chemical Industry Institute of Toxicology P.O. Box 12137 Research Triangle Park, North Carolina 27709 (919) 541-2070 Thomas W. Mooney Manager, Technical-Government Relations The Proctor & Gamble Company Ivorydale Technical Center Room 2N54 Spring Grove & June Streets Cincinnati, Ohio 45217 (513) 763-5187 CMA Ex-Officio Members Geraldine V. Cox, Ph.D. Vice President, Technical Director Chemical Manufacturers Association 2501 M Street, N.W. Washington, D.C. 20037 (202) 887-1260 Edmund B. Frost, Esquire Vice President-General Counsel Chemical Manufacturers Association 2501 M Street, N.W. Washington, D. C. 20037 (202) 887-1350 Hasmukh C. Shah, Ph.D., Staff Executive Director, Special Programs Chemical Manufacturers Association 2501 M Street, N.W. Washington, D.C. 20037 (202) 887-1192