Document o9dzBN67k6mN1kMrKg6QwOw4w

PRESENTATION TO THE ASBESTOS INFORMATION ASSOCIATION OF NORTH AMERICA BY JOHN P. DEKANY DEPUTY ASSISTANT ADMINISTRATOR FOR CHEMICAL CONTROL ENVIRONMENTAL PROTECTION AGENCY JUNE 13, 1979 R00003942 MMRE00012617 Regulatory Investigation of Asbestos Under TSCA Thank you for inviting me to speak to you today about our work on asbestos in the Office of Toxic Substances. We at EPA have been concerned about the risks associated with human exposure to asbestos. These risks have been well documented. At the workplace we have seen increased incidences of lung cancer, pleural mesothelioma, gastrointestinal cancer, and peritoneal mesothelioma. Asbestos-related diseases have been reported in nonworker populations living and working in the vicinity of asbestos plants. We also have some evidence that the amount of asbestos fibers in the air has increased in some major cities. Regulations promulgated to date by EPA and other Federal agencies have only addressed selected asbestos exposure sources. Unfortunately more and more exposure problems are being recognized in the universe of unregulated asbestos products and uses. For example, the Federal government is now having to deal with two newly identified and unregulated exposure risks--- asbestos-sprayed materials already in place in all kinds of buildings and asbestos in hair dryers and other appliances. It is evident that our current case-by-case regulatory approach is not adequately addressing the total risk problem that we have with asbestos. 1 R 00003943 MMRE00012618 EPA believes that a coordinated regulatory program to deal with asbestos is necessary. The Toxic Substances Control Act (which we call TSCA) with its comprehensive and all-encompassing authority over chemical substance activities provides the appropriate regulatory tool for handling asbestos exposure hazards. Therefore we in OTS recently began an extensive regulatory investigation under TSCA of asbestos. During this investigation we plan to evaluate the exposure problems associated with all types of asbestos activities from mining'; milling, and primary manufacturing to end product use and disposal. .You are already familiar with the EPA school asbestos guidance program. We have sent a package of materials to public school districts and private schools throughout the United States to inform them of the problems that may exist in school buildings where sprayed asbestos-containing materials have been applied to structural building surfaces. We are also providing'technical assistance to the States and school districts through our Regional Offices as part of this program. Over the summer months we look forward to an aggressive inspection program of schools. By mid-fall we will have collected and compiled preliminary data on the number of schools inspected and the number of problem schools where corrective action is required. Based on the outcome of our guidance program, we will be able to decide whether further action by EPA is required to assist the States in dealing with sprayed materials. 2 MMRE00012619 EPA was petitioned in December 1978 by the Environmental Defense Fund (EDF} to require the inspection of all public school buildings in the country and to require corrective action where necessary.. The Agency determined that it would be unwise to take immediate regulatory action and denied the petition. We beleived that a regulatory program with its many legal ramifications would not have been as immediately effective in controlling problems as the non-regulatory guidance program which the Agency initiated. *EDF has now sued EPA in The United States District Court in Washington, D.C., challenging our denial of its petition and failure to initiate a rulemaking on asbestos-sprayed materials in school buildings. While it would not be appropriate for me to discuss this case in more detail at this time, clearly the resolution of EDF's suit will have bearing on any future EPA regulatory action on asbestos. There are primarily six Federal Agencies involved in the regulation of asbestos--EPA, the Department of Transportation (DOT), the Consumer Product Safety Commission (CPSC), the Occupational Safety and Health Administration (OSHA), the Mine Safety and Health Administration (MSHA), and the Food and Drug Administration (FDA). Among these six agencies, approximately 20 regulations have been promulgated to control exposure to asbestos from various sources. OSHA and the MSHA have established standards for workplace exposure; CPSC has banned the sale of consumer patching compounds . MMRE00012620 and artificial emberizing materials, FDA has banned consumer use of garments made from asbestos textile and regulates the use of asbestos filters by the drug industry; DOT regulates the transport in interstate commerce of bulk asbestos fibers and asbestos-containing products. EPA has established visible air emission standards from major asbestos sources; prohibited the .application of certain materials such as sprayed asbestoscontaining material in buildings and has prescribed certain work practice rules for sprayed asbestos-containing material removal; EPA has also set effluent limitations guidelines for manufacturing sources of a variety of asbestos product categories including asbestos cement pipe, asbestos cement sheet, asbestos paper, and asbestos roofing products. These many regulations have helped to correct specifically identified-health and environmental asbestos hazards. However, they constitute case-by-case solutions to recognized hazards. We believe that with such a piecemeal regulatory approach, some significant exposure sources may have been overlooked and the risks posed by some regulated sources may not be adequately reduced. Asbestos poses a difficult problem for the regulator. Because of its versatility and its many desirable performance characteristics, asbestos is present in thousands of commercial and consumer products. The multitude of diverse uses creates a large universe of different kinds of exposure risks to address. Asbestos also poses a difficult problem for the regulator in view 4 R 00003946 MMRE00Q12621 of the current technological limitations on measurement methodology coupled with the difficulties of determining precisely which physical or chemical characteristics of asbestos lead to unreasonable health hazards. Exposure is not limited to the workplace but is associated with consumer products, foods, drugs, and drinking water. Nature itself contributes to the contamination of our air and water by asbestos. Natural erosion and other natural processes cause asbestos to enter the environment, thus compounding our control problem particularly in the area of exposure source identification. EPA is concerned that the current Federal regulatory posture for such a ubiquitous substance may not be the most effective and reasonable way for the government to protect the public health. In this regard TSCA offers a way to deal with the asbestos .t exposure problem in its entirety, building upon the successes achieved by previous regulatory actions and bridging gaps with . complementary controls where these regulations have not met with success. Under TSCA, EPA will be able to examine all activities and the inherent risks, particularly the combined risks posed by the manufacturing and end use of asbestos-containing products. There are many approaches that we can take under TSCA--bans on primary and secondary manufacturing of products containing asbestos; bans on uses of asbestos-containing products; requirements for disposal of asbestos-containing products; and labeling requirements for asbestos-containing products. We intend to review the whole universe of asbestos 5 W1W1RE00012622 products. Considering the number of existing products, our investigation will-be conducted in phases. Since we are still in the investigation stage, I cannot comment in detail at this time on the phasing schedule or on the scope of each of the phases. For each regulatory phase we may take only one product category or we may cross several product category lines to regulate a collection of different products and uses. Among the criteria we plan to apply to select potential candidates for regulation will be high asbestos content, high releasability rate, nonessential products or uses, and availability of substitutes. If you apply these criteria, potential candidates for the first regulatory phase clearly include products in the asbestos paper product category. After we select potential candidates for regulation, we will prepare a risk assessment to determine whether the asbestos exposure risk poses a public health hazard. Source emission data, fiber size and shape for fibers released from products, conditions under which fibers are released, and the populations at risk will be evaluated using a life cycle analysis approach. By life cycle analysis we mean an evaluation of all -f*iM f } . exposures/beginning with mining and milling activities through end product use and disposal activities. We will look at exposures omanabi-ng7 from any of the activities covered m Section 6 of TSCA--manufacturing activities which in the language of TSCA are mining and milling of asbestos; processing activities which are primary and secondary manufacture of asbestos-containing 6 MMRE00012623 products; distribution in commerce of asbestos-containing products, and use and disposal activities. For all of these activities we will consider the exposures of asbestos workers and their families; the exposures of the populations living and working in the vicinity of asbestos plants; and the exposures of product users. Obviously, with the thousands of products in use today and the accumulation of asbestos products in the environment over the past 40 years, large, diverse populations may be affected. For any given product or use unreasonable exposure risks occurring during the life cycle will be evaluated in light of the total, cumulative exposure risks occuring over the life cycle. For example, if the production steps for a product pose serious risks although the end product is found not to pose a. high risk, we may determine, using the life cycle approach, that the risk is sufficient to consider.the product for regulation. In the investigation of asbestos we intend to coordinate with the other concerned Federal agencies to ensure that there is no duplication of effort. EPA will lead the investigation under TSCA and will look to other agencies, particularly CSHA and CPSC, for assistance and cooperation in our investigation and for ways in which we can assist them in their regulatory programs. The same will hold true within EPA where several program offices have regulated asbestos or are reviewing some aspect of the asbestos exposure problem--the Office of Air Quality Planning and Standards, the Office of Water Planning and Standards, the Office ? R 00003949 MMRE00012624, of Drinking Water, the Office of Solid Waste, and the Office of Research and Development. We are interested in minimizing the duplication of data and in assuring data quality and uniformity particularly in view of the difficulties with which we are faced of measuring exposure levels in the air and water and establishing releasability rates for asbestos products. In this regard we intend to pursue a coordinated effort among the responsible EPA offices as well as with other agencies. We will engage both technical and economic contractors to gather and compile data during our investigation. The technical contractor will have responsibility for conducting exposure and emission studies and evaluating methods and procedures for reducing asbestos exposure. The technical contractor will also conduct performance evaluation studies of potential substitutes. The economic contractor will prepare industry profiles and prepare the socio-economic impact studies required by Section 6 of TSCA. These studies will include an evaluation of the benefits and availability of substitutes and an estimate of the social and overall economic impact of different types of control programs. By late summer we intend to publish an Advanced Notice of Proposed Rulemaking or what we call an ANPRM. This ANPRM will briefly state our intention to initiate a comprehensive regulatory investigation of all kinds of asbestos exposures and will describe the basis for our concern and set out our internal 8 MMRE00012625 priorities. A list of questions addressing key issues will be included. We invite you to respond to the ANPRM by providing answers to or comments on these questions and any relevant information that has bearing on our investigation. In order to gather all the information and data necessary to complete our regulatory investigation we may promulgate a TSCA Section 8(a) reporting rule. With an 8(a) rule we can require manufacturers and processors to submit information and data on the types of products they manufacture, intended uses, fiber content and fiber type, and emission and exposure data for the different stages of the product life cycle. We hope that the contractor studies, responses and comments to the ANPRM, and informal acquisition of data will preclude the need to promulgate an 8(a) reporting rule. We are, however, planning to require under Section 8(d) of TSCA that manufacturers, processors, and distributors of asbestos-containing products submit unpublished or ongoing health and safety studies to OTS. This requirement will enable us to obtain a comprehensive compilation of exposure, health effecs, and epidemiological data. The Section 8 (d- rule is scheduled for proposal this summer. We seek your cooperation in dealing with this serious environmental and health problem. We`recognize that many asbestos products may not have suitable substitutes or may have essential uses. We look to industry to help us identify these products. OTS is interested in developing an effective 9 MMRE00012626 regulatory program that will address the asbestos exposure problem as a whole and serve to protect the large populations which may be at risk from unnecessary exposures. We hope to carry out our goal in a reasonable manner without causing any undue hardship on industry or the public. Therefore, EPA would like to rely on industry cooperation to provide us with the best information possible in this difficult task ahead of us so that we might strike just such a reasonable balance. Thank you for the opportunity to speak to you. I will be glad to answer any questions you might have. MMRE0001262/