Testing Consent Order on Refractory Ceramic Fibers

Federal Register / Vol. 58, No. 92 I Friday, May 14, 1993 / Rules and Regulations 28517

40 CFR Part 799 data was worker exposure to RCFs. II. Use and Exposure Under section 4 of TSCA, EPA may LOPPTS-42166A; FRL-4575--8] RCFs are defined as amorphous man- require the testing of chemical made fibers produced from the melting Testing Consent Order for Refractory substances and mixtures by adopting and “blowing” or “spinning” of Ceramic Fibers enforceable consent agreements or calcined kaolin clay or a combination of promulgating test rules.In light of three alumina (Al 0 ) and silica (Sb ). AGENCY: Environmental Protection of the primary producers’ willingness to Oxides such2as3 zirconia oxide, ferric2 Agency (EPA). work with EPA on the development of oxide, titanium oxide, magnesium ACTION: Final rule. this type of data, EPA decided to oxide, calcium oxide, and alkali oxides develop an enforceable testing consent may be added. The approximate SUMMARY: This that notice announces order according to the procedures percentage of components (by weight) EPA has signed an enforceable testing outlined in 40 CFR part 790. consent order under the Toxic may varyas follows: alumina, 20 to 80 Accordingly, on August 17, 1992 (57 FR percent; silica, 20 to 80 percent; Substances Control Act (TSCA), 15 36997), EPA issued a Federal Register zirconia, 0 to 20 percent; and other U.S.C. section 2601 at seq., with three notice requesting that persons interested ofthe primary producers of refractory oxides in lesser amounts, approximately in participating in exposure testing 1 to 5 percent (CAS number 142844—00— ceramic fibers(RCF), who have agreed negotiations for RCFs, identify to perform workplace exposure 6). monitoring of RGFs for all workplace themselves to EPA. The notice RCFs are processed by two different activities, and report this information to announced the date for a public meeting methods: The “spinning” process and to initiate testingnegotiations for RCFs. the “blowing” process. The resultant the Agency. Pursuant to 40 CFR 790.22, The primary goal of the negotiations the R~Fstesting consent order is being fiber is vitreous and non-crystalline. added to the list of Testing Consent was to develop an exposure testing RCFs are fabricated into a wide variety Orders In 40 CFR 799.5000. program to monitor workplace of forms. Fiber diametersvary within Accordingly, the export notification exposures throughout the RCFlifecycle the product, ranging from requirements of 40 CFRpart 707 apply (i.e., manufacturing, fabrication, approximately 0.06 micron to greater processing, installation, and removal) than 3 microns. Lengths in the final toRCFs. for all workplace activities. Negotiations product also vary and are dependent EFFECTIVE DATE: May 14, 1993. began in September 1992 with the upon the processing used. FOR FURTHER INFORMATION CONTACT: RefractoryCeramic Fibers Coalition RCFs are used primarily for high Susan B. Hazen, Director, (RCFC), a trade organization that focuses temperature industrial insulation Environmental Assistance Division (TS— on research, product stewardship, and applications, most frequently as 799), Office of Pollution Prevention and regulatory Issues relevant to RCFs; refractory lining in high temperature Toxics, Environmental Protection primary manufacturers of RCFs; and furnaces, heaters, and kilns in industries Agency, Rm. E—543, 401 M St., SW., other interested parties (e.g., labor and such as ethylene, steel, aluminum, Washington, DC 20460, (202) 554—1404, user groups). The negotiation ceramics, and glass production. RCFs TDD: (202) 554—0551. participants developed workplace and are also used in automotive SUPPLEMENTARY INFORMATION: worker sampling schemes, protocols for applications, aerospace uses, and in I. Regulatory History the collection and analysis of fibers, and certain commercial appliances such as provisions for evaluation of the self-cleaning ovens. On November 21, 1991, the Agency resulting data. The negotiations were RCFs are currently produced by six concluded that, based on animal completed on November 10, 1992. companies in the United States at eight inhalation data submitted to the Agency ThisFederal Register document locations. The Carborundum Company, under section 8(e) of TSCA, RCFs may Premier Refractories and Chemicals, present an unreasonablerisk of cancer announces the completion of the enforceable testingconsent order which Inc., and Thermal Ceramics Inc., to human health. After conducting an is the final product of negotiations, and together account for the bulk of U.S. accelerated review of RCF under section represents the consensus of EPAand production of RCFs. The threeother 4(f), the EPA Administrator concluded domestic producers, A.P. Green there was not sufficient data available to negotiation participants.. Industries, ELTECH Thermal Systems determinewhether or not RCFs present In addition todeveloping the Corporation, and Industrial Insulation, an unreasonablerisk. However, there exposure monitoring consent order with Inc. produce RCFs inrelatively small was sufficientbasis for concern to EPA, RCFC has developed and quantities. Approximately 80 million initiate a regulatory investigation of implemented a Product Stewardship pounds of RCFs were produced in the RCFs to determine whether action under Program (PSP). The program consists of U.S. in 1990. TSCA section 6 was appropriate. The seven elements: Health effects research, regulatory investigation of RCFs workplace exposure monitoring, III. Health Effects includes a thorough review of a recently workplace exposure control measures, Several studies show that RCFs are an completed multiple dose animal exposure assessments, product research, animal carcinogen, and EPA has inhalation study, an update of the special studies, and a communications classified RCFas a probable human findings from an ongoing worker program. EPA is particularly encouraged carcinogen. A major animal inhalation epidemiology study, an analysis of by the commitment of R~FCto monitor study usingkaolin, the most common substitutes, and comprehensive workplace exposurestoRCFs, and to type ofRCF, has shown a positive exposure data. This is an ongoing look for ways to reduceexposures. EPA tumorigenic response in rats and investigation that will notbe complete believes that such a program is a hamsters, with 35 percent of the until the Agency has sufficientdata to significant step towards the reduction in hamsters exposed to kaolin RCFs determinewhether RCFs pose an the risk of RCFs. Results from the developing pleural mesothelioma, and unreasonablerisk. exposure testingconsent order should 13 percent of the rats exposedto kaolin During the acceleratedreview, one help determine the effectiveness of RCFs developing adenoma-carcinomas. area identified as needing additional industry’s stewardship of RCFs. Additional results from this study also 28518 Federal Register I Vol. 58, No. 92 / Friday, May 14, 1993 I Rules and Regulations indicate the development of pleural and samples) as well as from their silica sample will be analyzed by pulmonary fibrosis in both rats and customers’ facilities (400 samples). The NIOSH Method 7500 which specifies hamsters exposed to kaolin RCFs. In samples will be collected from the procedures to follow for determining addition, this studyhas shown employees engaged in all aspects of RCF silica exposure. fibrogenic and tumorigenic responses in production and use. All testing will be conducted in rats exposed to other types of RCF. See Eight functional activity categories accordance with the samplingand the docket for the November 21, 1991 have been defined for the monitoring. analytical protocols set forth in section 4(f) Federal Register Notice, 56 The eight categories are: Fiber Appendices 1, 2,3,4,5, and 6 of the FR 58693, for references to these production (manufacturing sector only), Consent Order. RCFC has agreed to meet studies. finishing, installation, removal, with EPA every 6 months to review data assembly operations, mixing/forming, submissions and discuss whether test IV. Testing Consent Order Negotiations auxiliary operations, and other activities standard modifications are necessary. On September 2, 1992, EPA held a (which include papermaking, Modifications to the Consent Order will public meeting to initiate negotiations of production of textiles, and automotive be governed by 40 CFR 790.68. the Consent Order, pursuant to 40 CFR activities). The last seven categories are part 790. The meeting brought together for manufacturing, processing, and end- VII. Reporting Requirements the three primary domestic use sectors, These categories were The signatories of this Consent Order, manufacturers of RCFs (the RCFC intended to cover all RCF-related through RcFC. will submit monitoring member companies), as well as workplace activities. The customers to data every 6 months beginning 6 months representatives from processor and user be selected will include those selected after the initiation of testing. The groups, organized labor, and fiberglass at random and those who specifically signatories agree to meet with EPA no and rock wool manufacturers. request monitoring. later than 45 days after the submission The primary goals for the workplace RCFC has also agreed to monitor silica of the data to review the data exposure monitoring program (as well as R~Fs)exposuresto workers submission collected according to the developed in the Consent Order, are to involved in the after-service removal of Consent Order. The signatories will provide a baseline for occupational RCF RCFs from high temperature ovens and conduct the exposure monitoring for a exposure, a study of trends in exposure furnaces. minimum of 5 years. Data submitted to levels overtime (the Consent Order VI. Standards and Methodologies EPA under the Consent Order will be requires testing for a minimum of 5 available in the Public Docket and will years), and a study of differences in RCF inhalation exposures for workers be identified by DocketNumber workplace concentrations among will be measured using phase contrast OPPTS-42166A and Refractory Ceramic - microscopy (PCM). The analytical employers engaged in various tasks. Fibers - Exposure Monitoring Data. While the parties have agreed to protocol which will be employed was conduct the monitoring for a minimum developed for fiber measurement by the VIII. Export Notification of 5 years, EPA is notprecluded from National Institute for Occupational The signatories of this Consent Order taking regulatory action at any time Safety and Health (NIOSH) and is called are required tocomply with the should EPA receive information that the NIOSH Method 7400. Analysis of notification requirements of section indicates a need to do so. Additionally, the RCFs will follow the alternate 12(b)(1) of TSCA and 40 CFR part 707 if testing under the ConsentOrder is counting rules for this method if they export or intend to export RCFs. invalidated, notconducted, or EPA (commonly referred to as the “B rules”). Any other person who exports or determines that additional testing is RCFC will analyze a subset of samples intends toexport RCFs is also subject to necessary, EPA may initiate rulemaking (6 percent) on an annualbasis by these export requirements as a result of procedures under TSCA section 4. As transmission electron microscopy (TEM) this testingconsent order under TSCA part of any such rulemaking toensure that the phase contrast section 4. Chemicals subject to testing proceedings, EPA would make statutory microscope is capable of resolving the consent orders are listed at 40 CFR findings pursuant to section 4. predominance of fibers. This data will 799.5000. This servesas notification to This ConsentOrder and the resultant be analyzed and reported to EPA for persons who export or who intend to data will be representative of worker evaluation. export chemical substances or mixtures exposures for the participating RCF Due to exposure tohigh temperature which are the subject of testing consent manufacturers and some of their over time, it is possible for RCFs to ordersthat 40 CFRpart 707 applies. customers. EPA does nothave undergo a partial transformationto Section 12(b)(1) of TSCA-reads: “If information necessary todemonstrate cristobalite, a form of crystalline silica. any personexports or intends to export whether the exposure data would be Concern was expressed in the to a foreign country a chemical representative of workplace conditions negotiationsthat silica exposures substance or mixture for which the for employees of non-participating should be measured inthe workplaces submission of data is required under manufacturers,.processors, or end-users where RCFs might be severely section 4 or 5(b), such person shall of RCFs. The following units (V., VI., disturbed, as in removal activities. The notifythe Administrator of such Vii., and VIII.) summarize the terms and Consent Order contains an appendix exportation or intent to export and the conditionsof the RGF Testing Consent requiringRCFC to monitor the after- Administrator shall furnish to the Order. The full Consentorder is service removal of RCFs from end-user governmentof such country notice of included in the record for this applications. Specifically, RCFC will the availability of the data submitted to rulemaking. monitor workers involved in removing the Administrator under such section RCFs from high temperature ovens and for such substance or mixture.” V. Monitoring Program furnaces for both RCFand silica 40 CFRpart 707 includes the The threeprimary producers of RCFs exposures. Two samples will be following sections that govern notices of have agreed toobtain 720 air monitoring collected from the workers to be export under section 12(b) of TSCA: samples to monitor RCFexposures monitored. The RCF sample will be § 707.60 discusses applicability and annually from their own facilities that analyzed by NIOSH Method 7400 to compliance of TSCA section 12(b); manufacture and process RCFs (320 determine the fiberconcentration. The § 707.63 discusses pertinent definiticas; Federal Register / Vol. 58, No. 92 / Friday, May 14, 1993 / Rules and Regulations 28519

§ 707.65 deals with submissions of a. Meeting notes from September 2, staff member) dated November 13, 1992, export notification to the EPA; § 707.67 1992, September 16, 1992, September re: Selection of firms to be monitored in outlines the required contents of export 24, 1992, October 8, 1992, October 21, RCF study. notification; § 707.69 addresses the 1992, and November 10, 1992. n. EPA Memorandum from M. notification EPA must send to the b.”Sampling Plan and Associated Conomos and B. Dutrow (EPA staff importing foreign governments; § 707.72 Analytical Protocol for Monitoring members) to RCFs Negotiation states procedures fortermination of Workers Engaged inthe Manufacture or Participants and Interested Parties, reportingrequirements; and § 707.75 Processing of RCFs,” draft November 2, dated October 22, 1992, re: Number of discusses confidentiality. 1992 (D. Maxim/Everest Consulting). TEM Analyses to be conducted as part c. “Sampling Plan and Associated IX, Other Regulatory Requirements of RGFs Workplace Monitoring Study. Analytical Protocol for Monitoring o. EPA Memorandum from Joseph S. To the extent this collection of Workers Engaged in the Manufacture or Carra (Deputy Director, Office of information is covered by the Processing of RCFs,” final November 25, Pollution Prevention and Toxics) to Paperwork Reduction Act of 1980, 44 1992 (D. Maxim/Everest Consultin File, dated December 23, 1992, re: U.S.C. 3501 et seq., data will be d. “Responses to Protocol Relate Recording conversation with William P. collected under 0MB Gontrol No. 2070— Issues,” October 8, 1992 (D. Maxim/ Kelly. President of RCFC and Robert 0033. EverestConsulting). Malone, President of Carborundum Public reportingburden for the e. “Proposed Sampling Plans for collection of information from Discussions with EPA and Other p. EPA Memorandum from A. Jellinek customers of the three primary Interesteds,” October 21, 1992 (D. (EPA-RCF Project Coordinator) to manufacturers Is estimated to average 10 Maxim/Everest Consulting). Negotiation Participants dated March minutes perresponse (approximately 43 f. “Background and Concepts for 15, 1992,: “Response to Comments hours peryear). The estimated average ‘Scope’ Discussions with EPA and Other submitted by Dan Maxim, NAIMA, and includes time for answering a list of Interesteds,” October 8, 1992 (D. Denny Christensen, for RCF Exposure questionsthat an industrial hygienist Maxim/Everest Consulting). Monitoring Consent Order Final Draft.” will routinely ask with regard to the g. EPA Memorandum “EPA Proposal B. References exposure monitoring program. for the Selection of Firms tobe Send comments regarding the burden Monitored,” November 18, 1992 (M. a. “Nomenclature of Man-Made estimate or any other aspect of this HenshallJEPA-RCF Project Coordinator Vitreous Fibers;” April 15, 1991 (TIMA). collection of information, including toNegotiation Participants). b. “Air Sampling Protocol - Fibers end suggestions for reducingthis burden, to h. Two EPA Memoranda, December 7, Free Silica;” revised November 1991 Chief, Information Policy Branch, PM— 1992, from M. Henshall (EPA-RCF (Dept. of Health, University of 223, U.S. Environmental Protection Project Coordinator) to RCF Negotiation Cincinnati). Agency, 401 M St., SW,, Washington, Participants requesting comments on c. “RCF Emissions from Domestic DC 20460; and tothe Office of final background document. - Production Facilities and Landfill: Data Management and Budget, Paperwork 1. EPA Memorandum“EPA Response Quality Objectives;” 1990 (M. Conomos Reduction Project (2070—0033), to RCFC Proposed Sampling Plans for and B. Dutrow, EPA). Washington, DC 20503. Discussionswith EPA and Other d. “EPA Office of Toxic Substances Interesteds,’ DatedOctober 21, 1992,” Guidance Document for Preparation of X. Record from M. Henshall (EPA-RCF Project the Quality Assurance Project Plan,” EPA has established a record for this Coordinator) to RCF Negotiation November 1, 1987 (EPA). testing consent order under Docket Participants, November 29, 1992. j. North American Insulation Dated:Aprll 26, 1993. NumberOPPTS.-42166A, This record Victor J. Klmm, contains the information EPA Manufacturers Association (NAIMA) considered in developing this Consent letter, datedFebruary 16. 1993, to Ms. Acting Assistant Administratorfor Order and includes the following Jellinek (EPA-RCF Project Coordinator) Prevention,Pesticides and ToxicSubstances. information. re: Comments on the RCF Consent Therefore, 40 CFR Chapter 1, Agreement; facsimile referenced in subchapter R, part 799 is amended as A. Support Documents NAI}viA letter to Chuck Axten, et al. follows: 1. Testing consent order for RCFs and from WalterEastes (Ownes-Corning) re: Appendices 1 through 6. Airborne Fiber Counting Rules. PART 799—(AMENDED] 2. Federal Register notices consisting k. Letter from D. Maxim (Everest 1. The authority citation for part 799 of: Consulting), dated February 22, 1992, to continues to read as follows: a. August 17, 1992 Notice announcing EPAstaff member Ms. Jellinek re: a public meeting for September 2, 1992, Comments on the RCFs Consent AuthorIty: 15 U.S.C. 2603, 2611. 2625. and soliciting interested parties to Agreement. 2. SectIon 799.5000 is amendedby develop a consent order for RCFs (57 FR 1. Memorandumfrom D. Cox (Cox adding refractory ceramic fibers to the 36997). Associates/EPA consultant) to EPA staff table inCAS Number order, to read as b. November 21, 1991 Notice member BetsyDutrow, et al. dated follows: announcing 4(f) decision on RCFs (58 October 7, 1992, re: Comparison of “A” FR 58693). Rules and “B” Rules and number of § 199.5000 Testing consent orders for 3. EPA’s May 20, 1992 Decision TEM samples needed. substances and mixtures with Chemical Memorandum for RCFs. m. EPA Memorandum from D. Cox Abstract ServiceRegistry Numbers. 4. Communications consisting of: (Cox Associates) to M. Conomos (EPA 28520 Federal Register / Vol. 58, No. 92 / Friday, May 14, 1993 / Rules and Regulations

CAS Number Substance or mIxture name Testhg FR Publication Date

142844—O0-.6 Refractory ceram~c~bers Exposure monitoring May 1 4, 1993.

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1FF Doc. 93—11495 Filed 5—13--93; 8:45 aml BILLiNG CODE s5~G-6O-f