Document 3L3dmLLkzrkOQMnrE2nKeyxx

A/C Pipe Producers Association" . Board of Directors y ernational Affairs Committee -------------- F. Welch, Vice-President June 28, 1984 U.S. Environmental Protection Agency (EPA) - Drinking Water Standards for Volatile Organic Chemicals (VOCs) ACTION REQUIRED: Review for information On June 12, 1984, EPA proposed recommended maximum contaminant levels (RMCLs) for nine organic chemicals found in drinking water, among them vinyl chloride and tetrachloroethylene. RMCLs are non-enforceable health goals set to prevent any known or anticipated adverse health effects in humans. They have no legal impact on public water systems or the public. Proposal of the RMCLs will be followed by a ninety day comment period, public hearings and, eventually, final RMCLs. Enforceable maximum contaminant levels (MCLs), monitoring and reporting requirements will be proposed at the same time RMCLs are finalized. Vinyl Chloride The proposed RMCL for vinyl chloride is zero. This decision was based on the fact that vinyl chloride is carcinogenic in humans and animals. There is no mention in the enclosed Federal Register notice of vinyl chloride being released from PVC water pipe although this may be referenced in EPA's Draft Criteria Document for Vinyl Chloride. MCLs will be set as close to RMCLs as feasible. Tetrachloroethylene The proposed RMCL for tetrachlorethylene also is zero, based on an IARC assessment that the data suggests a carcinogenic effect in animals, but lacks confirmation in humans. EPA and the Office of Management and Budget (OMB), the agency that reviews the rationale for and costs of regulations, were known to be at odds over the proposed drinking water standards. OMB felt that the proposal should take into account costs of monitoring, reporting and treatment and, therefore, should be realistic by not setting "zero-risk" levels. Further, OMB was concerned about the policy implications of recommending zero levels for all VOC's because they vary in potency and confirmation of carcinogenicity. EPA disagreed, even knowing that the decision to set zero RMCLs may impact standards-setting by EPA offices other than the Office of Drinking Water. Since the proposed standards are not enforceable, however, OMB could not disapprove them by authority of Executive Order 12291. CAPCO JEN 0033087 < Page 2 The Chemical Manufacturers Association and the Vinyl Institute a segment oC t;, Society of Plastics Industry, are expected to comment on the vinyl chloride proposal. JFW/bwm Enclosure cc: A. H. Kahn, Esq. Timothy S. Hardy, Esq. copies to: Board of Directors L. Ambler F. Layton L. Taylor L. Cejudo J. M. Couture International Affairs Committee E. van der Rest A. Junes G. Zaviezo C. Barton H. Hudson P. Hart V. Pattabhi S. Al-Tarkait C. Saeng-Xuto J. Glanville M. Delcourt L. Dolbeau D. Dorner E. Costa J. Schmaus F. Mansour. R. Hobbs A. Saoulis R. Jalan B.-Dubois R. Cairns M. Elola B. Giboin A. Llueh 0172062107 Chrono 1 CAPCO JEN 0033088 24330 Federal Register / VoL 49, No. 114 / Tuesday, June 12, 1984 / -Proposed Rules ENVIRONMENTAL PROTECTION addresses: Send written comments to - SUPPLEMENTARY INFORMATION: AGENCY 40 CFR Part 141 [OW-FHL-2514-3] Comment Clerk. Criteria and Standards'' ' L Statutory Requirements Division, Office of Drinking Water . n. Regulatory Framework (WH-550), Environmental Protection in.- Background and Summary of Comments Agency, 401 M Street, S.W., IV. -VOCs in Drinking Water Washington, D.C. 20460. A copy of the:.. Occurrence of VOCs in Drinking Water National Primary Drinking Water Regulations; Volatile Synthetic Organic Chemicals agency: Environmental Protection Agency (EPA).. . action: Proposed rulemaking.!/ comments and supporting documents.;. .. -Human Health Considerations will be available for review during.". ,r --Development of RMCLs for Non- normal business hours at the EPA, Room'55EB, 401M Street, S.W., Washington,-'' D.C. 20460. The public hearing wifi .be held in Room 3908, EPA, 401 M. SL S.W,, carcinogens ' ' --Development of RMCLs for Carcinogens --Toxicology of VOCs V. RMCL Development Rationale ' " Washington, .D.C. It is requested that:. - VOCs: Regulatory Approach summary: This proposed rule under the anyone planning to attend the public:': hearing (especially those who plan to Regulations for Which VOCs RMCLs: Regulatory Approach Safe Drinking Water Act (42 U.S.C. 300f make statements) register in advance by \. VL Other Considerations for Public Comment el seq.) establishes Recommended calling or writing M3. Arnetta Davis at-.-. . -VII. References - Maximum Contaminant Levels (RMCLs) 202/382-7575, EPA, WH-550.401M St;v:'.':'. , VIIL Request for Comments for the following volatile synthetic - S.W.; Washington, D.C. 20460. Persons - I.Statutory Requirements organic chemicals (VOCs) in drinking planning to make statements at the '? water: trichloroethylene, . hearings are encouraged to submit. P ". The Safe Drinking Water Act (42 USC ' tetrachlorb'ethylene, carbon written copies of their remarks at the 300f, et seq.) ("SDWA" or "the Act") tetrachloride, l,l,l-trichloroethane,.vinyF jddqride, 1.2-dichloroethane, time of the hearing. - References cited on section VII will be ' requires the EPA to establish primary drinking water regulations which: (1) benzene, 1,1-dichloroethylene, end p- . available for inspection at the Drinking Apply to public water systems: (2) dichlorobenene. RMCLs (goals) for non* Water Supply Branches of EPA's specify contaminants which in the carcinogens are proposed based upon' Regional Offices. judgment of the Administrator, may chronic toxicity data, and RMCLs (goals) for carcinogens are proposed at the zero level. VOCs that are not included in this proposal may be ......... considered for subsequent rulemaking as appropriate. ' RMCLs are non-enforceable health goals which are to be set at levels which would result in no known or anticipated I. JFK Federal Bldg., Boston, MA 02203,' Phone: (617) 223-6486, Jerome Healy II. 26 Federal Plaza, Room 824, New York. NY 10278, Phone: (212) 284-1800. Walter Andrews HI. 6th & Walnut Sts., Philadelphia, PA 19106, Phone: (215) 597-9873, Bemie Samowski IV. 345 Courtland Street, Atlanta, GA have any adverse effect on the health of persons; (3) specify for each . * contaminant either (a) maximum contaminant levels (MCLs) or (b) treatment techniques. See section 1401(1), 42 U.S.C. 3OOf. A treatment technique requirement would only be set if "it is not economically or technologically feasible" to ascertain, adverse health effects with an adequate .. 30365, Phone: (404) 881-3781, Robert the level of a contaminant in drinking margin of safety. This proposal is the ' Jourdan water. initial stage in rulemaking for the V. 230 S. Dearborn St., Chicago, IL 60604, The SDWA includes provisions for establishment of primary drinking water Phone: (312) 886-6176, Joseph interim and revised regulations. See regulations for the VOCs. Following this Harrison section 1412,42 U.S.C. 300g-l. Interim proposal, Maximum Contaminant Levels VI. 1201 Elm St., Dallas, TX 75270, regulations were to be established (MCLs) and monitoring/reporting Phone:'(214) 767-2620, James Graham within 180 days of enactment of the. requirements will be proposed when the VII. 324 East 11th St,, Kansas City, MO SDWA. Revised regulations are to be RMCLs are promulgated. MCLs are - .. 64106, Phone: (816) 374-6514, Gerald developed in two steps: the Agency i3 to enforceable standards and are to be set- R.Foree establish recommended maximum as close to the RMCLs as is feasible and VIII. I860 Lincoln St., Denver, CO 80295, contaminant levels (RMCLs) and then are based upon health, treatment Phone: (303) 837-2731, Dean Chaussee - establish maximum contaminant levels. technologies, cost and other factors. . IX. 215 Fremont St., San Francisco, CA (MCLs) as close to the RMCLs as Public comments are solicited oirthe-*, 94105, Phone: (415) 974-8076, Leslie feasible. MCLs are to be proposed at the approach.to setting.RMCLs as proposed.-*,. Ragle time of promulgation of the RMCLs. lin-this notice as welT.'as on..the;.,\.i.\.;.iv!! X. 1200 Sixth Ave., Seattle, WA 98101, RMCLs are non-enforceable health .'alternatives presented. Specifically, Phone: (206) 442-1225', Jerry Opatz goals. RMCLs are to be set at a level comments are requested on the following: Should the RMCLs for ' carcinogens be zero or a level of Copies of the nine draft health criteria documents will be available for a fee from the National Technical Information which, in the Administrator's judgment, "no known or anticipated adverse effects on the health of persons occur exposure considered to constitute a Service, U.S. Department of Commerce, and which allows an adequate margin of negligible incremental lifetime risk, say one in one million, based upon a 5285 Port Royal Road, Springfield, Virginia 22161. The toll free number is safety". Section 1412(b)(1)(B). The House Report on the 1974 legislation conservative risk estimate calculation 800/335-4700; local: 703/487-4650. provides congressional guidance on procedure: or should the RMCLs for FOR FURTHER INFORMATION CONTACT: developing RMCLs: carcinogens be established at the limits Contact Joseph A. Cotruvo, Ph. D,, * * the recommended maximum of analytical detection? Director, Criteria and Standards [contaminant] level must be set to prevent dates: Written comments should be submitted by September 10,1984. A public hearing will be held in Division, Office of Drinking Water , (WH-550), Environmental Protection Agency, 401M Street, S.W., the occurrence of any known or anticipated adverse effect It must include an adequate margin of safety, unless there is no safe threshold for a contaminant. In such a case, Washington, D.C. on Augusta and 7," ' Washington, D.C. 20460, telephone (202) the recommended maximum contaminant 1984, if needed beginning at 9:00 a.m.. 382-7575. level should be set at zero level. (> CAPCO JEN 0033089 Federal Register / Vol. 49, No. 114 / Tuesday, June 12, 1984' / Proposed Rules - 24331' Hous* Report No. 93-1185, July 10,1974, imminent and substantial endangerment As the third step, section 1412(b)(1)(B) at 20. to the health of persons. provided that EPA must propose and - MCLs are the enforceable standards. MCLs must be set as close to RMCLs as IL Regulatory Framework promulgate National Revised Primary Drinking Water Regulations (NPDWR) is feasible. Feasible means "with the use The issuance of Revised Primary that would include RMCLs, MCLs and of the best technology, treatment Drinking Water Regulations is the third monitoring and reporting requirements techniques and other means, which the ' step in the evolution of the primary for those contaminants that may haVe Administrator finds are generally drinking water regulations mandated by an adverse effect on human health. .'... available (taking costs into the SDWA.- consideration)." Section 1412(b)(3)..., In thefirst step, the National Interim RMCLs of themselves'have no impact . Primary Drinking Water Regulations Regulatory Development Approach Development of the NPDWR will be on public water systemsorthe public:.-^ (NIPDWR) were promulgated on accomplished in four phases: By promulgating RMCLsTno system is December 24,1975, with an effective -. Phase I Volatile Synthetic Organic ... forced to reduce contaminants to this date of June 24,1977. Amendments were Chemicals, level or to take other action regarding issued in 1976, and 1979 and 1980. See 40 - Phase II Synthetic Organic '.' contaminants. RMCLsserveas goals fora? CFR141. Maximum contaminant levels ' Chemicals, Inorganic Chemicals arid 7 '\V. the'Agency in thecoimsftbfsetting (MCLs) and monitoring and reporting Microbiological Contaminants,. 7; MCLs and are therefore -initial'steps the MCL rulemaking thatwiil followlThLr come cases, the MCLs will be set very'4'-:; close to the RMCLs; in.other cases .-"; control processes or economics- considerations may-dictate-an MCLtKaV is not as close. Public water systems - must comply with the MCL; non- compliance with an RMCL cannot be the basis of an enforcement action under section 1414 of the Safe Drinking Water -. Act. ' '' - - In addition, the SDWA specifies that -; primary drinking water regulations contain criteria and procedures to - assure a supply of water that complies - with the MCLs (i.e., monitoring and requirements were set for numerous- microbiological, inorganic, organic, and radionuclide contaminants (40 CFR, Part ` 141, Subpart B). At the direction of the' Congress, EPA based the NIPDWR in 'large part on the 1962 U.S. Public Health Service (PHS) Standards for drinking water which in turn were derived from previous standards dating as far back as 1915 for the microbiological standards and the 1940's for the MCLs for some of the inorganic chemcials. As the second step, section 1412(e) of the SDWA directed EPA to arrange for ' the National Academy of Sciences -. (NAS) or an equivalent organization to conduct a study to assess the health Phase III Radionuclides, . 7_ . Phase IV Disinfectant By-Products' ~{ - including Trihalomethanes. ' In generalihe approach for all four phases will be similar. . . " ...... ;L. Initially an ANPRM will be published followed by a comment period and a public meeting. Public technical v workshops will also be held. The... workshops provide an opportunity for - EPA to present the issues that must be- addressed in. development of the '. - , - regulations and to receive information.-,- on scientificand technical matters as well as receive comments on regulatory approaches. reporting requirements). Section . effects of contaminants in drinking ` . RMCLs will then be proposed ' 1401(1)(D). Section 1445(a) authorizes , water and to provide proposals for EPA to require by regulation any public RMCLs at levels at which there were followed by a public comment period. and a public hearing(s). r' water supplier to keep records, make "no known or anticipated effects on the RMCLs will then be promulgated, reports, conduct monitoring and provide health of persons * * and a list of and proposals published for MCLs or such other information as may be contaminants whose levels in drinking treatment techniques, monitoring and - ' required to assist in determining water cannot be determined but which reporting, and other requirements ~ compliance with the SDWA. in may have an adverse effect on the followed by a public comment period ' y evaluating health risks of unregulated health of persons. The NA!J submitted'" and a public hearing(s). Technologies - -" contaminants, or in advising the public its initial report, "Drinking Water and will be identified that were used as the '' of such health risks. Health," to EPA in 1977 which was basis of determining the MCLs; in . The SDWA also requires that the published in the Federal Register for addition, generally available treatment revised primary drinking water public comment; four additional reports technologies (GAT) will be identified for regulations be reviewed every three have been received. While Congress - use in compliance-with the MCLs and ' years and amended whenever changes envisioned that the NAS would provide the issuance of variances. ' in technology, treatment techniques or proposals for RMCLs in the report, the The MCLs or treatment techniques, other factors permit greater health NAS stated essentially that it would do monitoring and reporting, and other - , protection. toxicological assessments of . requirements including GAT wiil then In addition to the regulatory . contaminants in drinking water but that be promulgated. ' . mandates, the SDWA provides developing proposals for RMCLs was An ANPRM for Phase I (VOCs) was authorities for ensuring the safety of the not an NAS responsibility but an EPA issued on March 4,1982 (47 FR 9350, et nation's drinking water in a non- regulatory function. In the words of the seq.), and a public meeting was held in regulatory contest. Section 1442(a)(2)(B) Academy, "determining safe levels to Washington, D.C., on April 28,1982. In authorizes EPA to provide technical protect die health of persons' drinking addition, four public technical assistance to States and publicly owned water containing contaminants requires workshops were conducted across the water systems in response to and consideration of other factors in country (June-August 1982) on volatile alleviation of any emergency situation addition to the harmful properties of the synthetic organic chemicals (VOCs) in which the Administrator determines to contaminants" (John S. Coleman, drinking water. be a substantial danger to public health. In the absence of appropriate State or local action, section 1431 authorizes Executive Officer, NAS, Feb. 20,1975). The NAS reports have provided EPA"'.with toxicological assessments of " " - III. Background and Summary of Comments EPA to take such actions as the contaminants in drinking water and. The ANPRM identified the VOCs /} administrator deems necessary to based upon this information and data '' listed below as among those most; protect public health from a from other scientific sources, EPA is * commonly detected in drinking water contaminant that may present an developing the RMCLs. based upon data available at that time.;' CAPCO JEN 0033090 i 24332 Federal Register / Vol. 49, No. 114 / Tuesday, June 12, 1984 / Proposed Rules trichloroethylene industry associations and public interest implemented for all-water supplies, tetrachloroo'hylene groups, comments submitted by the preferably using the purge and trap carbon tetrachloride American Water Works Association procedure (EPA Method 502.1 or 1.1.1- trichloroethane and Natural Resources Defense Council equivalent), but requirements for 1,2-dichloroethane (NRDC), respectively, are also - . systems serving less than 10,000 people vinyl'chloride' summarized. would be at the discretion of the State. dichloromethane benzene chlorobenzene ' Sumrhdry^fCdmme'nis'FfonlPubiic? Workshops* dichlorobenzene r Overall; it was concluded that-; trichlorobenzene contamination by VOCs is a.national' 1.1- dichloroethylene problem warranting actiom There was cis-l,2-dichloroethylene trans-1.2-dichloroethylene sentiment in favor of establishing MCLs and some sort of monitoring program, The purpose of the ANPRM was to provided the health effects data are solicit comments on the many scientific, , valid and indicate the need to reduce . technical, legal and economic questions ; human exposure.. associated with determining the proper The health effects work groups approach under the Safe Drinking Water believed that there are sufficient data to The initial monitoring frequency should be similar to the trihalomethane (THM) rule. In addition, guidance in the form of contamination levels, and action categories for five of the VOCs (i.e., vinyl chloride, trichloroethylene, tetrachloroethylene, carbon tetrachloride, 1,2-dichloroethane) should be established for all water Supplies. NaturalResources Defense Council (NRDC). \ '.... :.V ;! Act (SDWA) to limit human exposure to cause concern. Three groups suggested The NRDC recommended ' - VOCs. that MCLs be set. However, every group comprehensive national standards for ; The ANPRM was published to initiate qualified its recommendation by saying, . volatile organic chemicals (VOCs) discussions that would assist the - variously, that the data are limited, more saying that the occurrence and health - Agency in determining the proper studies are needed, and that the effects data show a significant national approach under the SDWA for difference between genotoxic and non- problem that warrants action under the - minimizing human exposure to VOCs. genotoxic carcinogens should be SDWA. NRDC stated the EPA should " The public was invited to comment on addressed by EPA. establish RMCLs and MCLs for the 14 the following broad issues:' ' Aeration and granular activated VOCs addressed in the ANPRM as well What is the significance of carbon were identified as generally as an RMCL and MCL for total VOCs contamination of drinking water by available technologies, effective in supported by mandatory national . VOCs? -. . . reducing VOC levels to 10 pg/1 monitoring requirements. Other Should national standards be set for ' (micrograms per liter or parts per billion VOCs? - - (ppb)) or lower. Cost projections If standards are appropriate, how presented by EPA were considered to be should levels be established? reasonable but they should be updated. In addition to the above broad The proposed analytical methods questions, comments were requested on were found to be suitably accurate and specific technical and scientific the best available at this time. questions. Also, available reference Concerning monitoring, the consensus materials on occurrence, health effects, seemed to be,that EPA should provide analytical methods, and treatment costs minimum requirements within which.' of VOCs in drinking water were States could develop.their own. - -. . ' .1 provided for technical and scientific monitoring plans; if.data snow'that VOC! comments by NRDC included: " Recommended Maximum Contaminant Levels (RMCLs) should be set at zero for carcinogens. RMCLs for non-carcinogens may be set at a no- observed-effect-level with an adequate margin of safety because RMCLs are health goals and are net intended to reflect feasibility of attainment. The multi-stage model as modified by the Carcinogen Assessment Group ; review. Summary ofPublic Comments contamination'can be adequately predicted; EPA would provide criteria and guidance to assist States in (CAG) should not be used in establishing RMCLs for carcinogens. Mathematical models at best provide A total of 136 public written predicting which systems were crude estimates of the risks resulting comments were received with the vulnerable to contamination by VOCs from exposure to a carcinogen. comment period ending on September and thus be monitored._ Calculations of exposure levels 30.1982; corresponding to lifetime cancer risks of The National Drinking Water American Water Works Association 10'* should provide the upper limit for Advisory Council [NDWAC] met in (AWWA) . MCLs. That is, contaminant levels Washington, D.C., on September 23-24, ~. The AWWA recommended that 1982, to discuss the VOC ANPRM and contaminants be controlled at their should be set at concentrations corresponding to lifetime cancer risks of its related issues. The NDWAC provided source through EPA's existing statutory no greater than 10"*. MCLs for non its recommendations to the authorities. They believed MCLs are not carcinogens should be set at Administrator in a letter dated January appropriate at this time, since "safe" correspondingly conservative levels. S. 1983. Public comments pertinent to this levels of VOCs cannot be determined from existing health-effects data.. NDWAC Recommendations proposal are summarized in this section However, when the health effects data The National Drinking Water and in Appendix A. Comments pertinent have been evaluated by a recognized Advisory Council (NDWAC) provided to proposal of the MCLs and independent scientific organization [i.e.. the following recommendations and monitoring/reporting'requirements will National Academy of Sciences (NAS]), analyses. be summarized in that proposal. The the AWWA felt that MCLs should be 1.The occurrence data derived public workshops conclusions and ' established if a significant health risk primarily from the random surveys recommendations and the NDWAC exists. conducted by EPA and selected data recommendations are briefly In the interim, AWWA recommended produced by the States in conjunction summarized below. As representative of that national monitoring for specific with the health risk data, warrant comments received by drinking water compound identification should be establishing controls for 5 of the VOCs f, * CAPCO JEN 0033091 Federal Register / Vol. 49, No. 114 / Tuesday, June 12, 1984 / Proposed Rules 24333 found in drinking water. These are: trichloroethylene, tetrachloroethylene, found in the references listed in section VII. Rural Water Survey (RWS) Ground Water Supply Survey carbon tetrachloride, 1,2-dichloroethane and l.l.l-tricfdoroethane. 2. Regulations under the Safe Drinking Water Act should be established for those 5 chemicals at this time. Additional data would be needed before b decision could be made on other volatile organics found in drinking water. Health advisory type guidance should be provided for these compounds in lieu of establishing MCLs. 3. Sufficient animal toxicology does Occurrence of VOCs in Drinking Water One or more VOC3 have been. detected in numerous public water . systems across the country. Typically, contamination is at low levels (i.e., less than 1 part per billion, pg/I) but some systems have found higher levels. The VOCs are man-made chemicals, their presence may indicate that a pollution incident has occurred, and some of them are among the most frequently detected exist at this time for establishing RMCLs contaminants around hazardous waste for those 5 chemicals noted in 1. above. sites. Several of these chemicals are Quantitative risk calculations using a suspected carcinogens, with differing' linearized multi-stage model should be degrees of evidence, while certain of used for establishing RMCLs for the these are mutagens'and/or teratogens in carcinogens. A1 in 100.000 target risk is some test systems. recommended as the RMCL. For 1,1,1- In 1982, EPA conducted a national trichloroethane, which the current data sampling (Ground Water Supply Survey indicate is not carcinogenic, the RMCL (GWSS)) of almost 1000 drinking water should be calculated from the No systems using ground water; 500 were Observed Effect Level (NOEL) for ' selected at random and 500 were neurotoxicity with appropriate safety * selected by the States as having high factors. potential for VOC contamination (non- 4. The analytical methodology for random). Table 1 presents results of the detecting and quantitating VOCs is well random portion of the GWSS. established (i.e., EPA Method 502.1 .. - Approximately 21 percent of the using the Purge and Trap technique and systems in'the random set had one or similar procedures). No information was more of the VOCs at detectable levels' provided to the Council on the (mostly in the sub pg/l range). The data availability of laboratory services: . showed a distinct difference in the however, it is assumed that services frequency of occurrence of VOCs would be-available to meet ultimate, between larger and smaller systems;- demand. The Council believes that approximately 28 percent of samples in monitoring is technically and systems serving over 10,000 detected economically feasible. 5. Sufficient data exists at this time to determine that granular activated carbon and aeration are "generally available technologies" for central treatment application. Appropriately designed point of use devices, when shown to be effective for VOC control, can also be considered for some small water systems if they are cost/effective and properly managed. one or more VOCs in the drinking water whereas 17 percent of samples in systems serving less than 10,000 detecfed VOCs. Six tenths percent of all public water systems serving less than 10,000 were sampled in the survey whereas 15 percent of systems greater than 10.000 were sampled. Six national surveys have been .., conducted by EPA since 1975. These include: IV. Volatile Synthetic Organic Chemicals in Drinking Water Hundreds of chemicals have been detected at one time or another in drinking water in the U.S., but the vast majority have been detected" infrequently and at very low concentrations. Selection of candidate ". National Organics Reconnaissance Survey (NORS) National Organics Monitoring Survey (NOMS) National Screening Program for Organics in Drinking Water (NSP) Community Water Supply Survey (CWSS) (GWSS) Based upon the above six surveys, projections of national occurrence and human exposure potential for the VOCs are summarized in Table 2 for levels.. associated with various risk rates. These surveys were conducted for. various purposes over an eight year period which saw a rapidly developing state-of-the-art in water analytical methods. Different analytical procedures were used and, consequently, some . surveys were able to detect and - . measure particular VOCs at lower -". concentrations than other surveys were able to do. The most significant portion .. of the data base on VOCs, however, is derived from the Ground Water Supply" Survey and the Community Water . . Supply Survey. v- " ' In combining the survey data, the. .national projections of the frequency of occurrence of VOCs at various concentrations can be provided only for those concentrations at or above the level at which all of the surveys were capable of detecting and measuring them. This level, referred to as the lowest common quantifiable concentration, is generally the highest detection limit or minimum quantifiable concentration from among the surveys that are combined. Table 2 shows the estimated frequency of occurrence of the VOCs at or above the lowest common quantifiable concentration. Individual surveys using detection limits or . minimum quantifiable concentrations less than the lowest common quantifiable concentration may report a higher frequency of occurrence of some VOCs: For example, according to Table 2,3.6% of the nation's ground water supplies are projected to have ", " trichloroethlyene at or above the lowest common quantifiable concentration of 0.5 pg/1, whereas the GWSS (random . sample), using a minimum quantifiable nominal concentration of 0.2 pg/L reported trichloroethylene to be present in 6.4% of the supplies sampled (Table 1). (Note; The GWSS random sample was found to have 4.1% at or above 0.5 PS/I-} chemicals for revised national primary drinking water regulations is made from an analysis of data on the occurrence Table 1.--Summary of GWSS Occurrence Data tRandom sample: n~*663 frequency, concentrations detected, size of the exposed populations and the toxicology of the chemicals. This section Parameter Ouantfh bm>t ng-1 Positives Median of No. Percent 1*9* briefly summarizes the available " occurrence data,' provides an overview of population exposure estimates, and discusses the health effects data for the VOCs. Additional information can be Ort>00 totr*r>Avrf4* 02 34 73 0.5 23 2 30 6.4 1 78 2 27 5.8 .8 16 18 3.9 S 32 16 3.4 1.1 2 ---------- .. --... 2 15 3.2 .4 16 t. f 1- -1 CAPCO JEN 0033092 24338. Federal Register / Vol. 49, No, 114 / Tuesday, June 12, 1984 / Proposed Rules for chemicals considered to be potential assigned where the chemical was serve as guidance to EPA when carcinogens, but are provided to add known to bioaccumulate to a lesser assessing the irreversible effects of long some perspective on the chemical's total degree. In "Drinking Water and Health" term exposure to non-threshold toxicity including potential hon- (1977). the National Academy of substances at low doses: carcinogenic end-points. Sciences provided projections of 1 Principle 1; Effects in animals, In addition, these values may have . percent and 20 percent as illustrations of properly qualified, are applicable to some practical application as guidance drinking water contributions. In the man. on the levels at which no adverse health National Interim Primary Drinking Principle 2: Methods do not now exist effects would be expected to occur Water Regulations for six organic to establish a threshold for long term based upon non-carcinogenic data. This chemicals, drinking water was assumed effects of toxic agents. would be especially usefrtl for to contribute 20 percent of the total daily Principle 3: The exposure of substances considered to be "weak" intake.' experimental animals to toxic agents in carcinogens. Comment is'requested on Because of the wide range of high doses is a necessary and valid . these values. environmental exposure distributions method of discovering possible The AADI's were calculated by: that would occur across urban and rural carcinogenic hazards in man. Determining the highest No- populations as well as because of age Principle 4: Malerial should be Observed-Adverse Effect Level and occupationally-related differences, assessed in terms of human risk, rather (NOAEL), or the lowest observed assumption of a 20 percent contribution than "safe" or "unsafe".. adverse effect level (LOAEL) in mg/kg, body weight/day, ' Dividing by appropriate safety or" from drinking,water would be reasonably conservative and protective. Thus, in this case-, if an AADI value for a Tumors appear spontaneously in experimental animals, at different rates and different sites depending upon the uncertainty factor(s) (U.F.), non-carcinogen were to be the basis for species and strain. It is unlikely that any Multiplying by the weight of an an RMCL, it would be reduced by 80 increased tumor incidence could be adult (70 kg}," and Dividing by the amount of water consumed by an adult per day (2 liters/ day). (This allocates the ADI totally to drinking water which would have to be modified to consider other routes of exposure when the RMCL or MCL is computed.) The formula for this calculation is-as follows: ................... ....... (NOAEL in mg/kg/day) (70 ---------------------- ----------------------- =AADi mg/1 U.F.(s) X 2 Iiters/day percent to- account for up to 20 percent contribution, from drinking water to the total daily, burden. , , Development ofRMCEs-for; Carcinogens; Evaluations of the texicology'of substances which may possess carcinogenic-potential is a two- phase process. In the first phase, the .toxicologicaLdata.base.focnon-.. . carcinogenic end-points-of toxicity was evaluated in the same manner as described above for "non-carcinogens" (Table 6). In the second phase, assessment was made of the evidence of the carcinogenic potential (e.g., long- detected following exposure of experimental.animals to most carcinogens at dose levels occurring in the ambient environment. Very large numbers of animals would be required to distinguish between treated and control groups. It is possible, as was shown in the 24,000 animal "mega- mouse"'study on 2-acetylaminofiuorene at the National Center for Toxicology Research (NCTR), that a definitive answer would not necessarily be . forthcoming at the low dose levels. Mathematical extrapolation still would term bioassays in rodents and human be required to project human risk. Table 6.--Suggested Adjusted Acceptable epidemiology) as well as information Relying on this type of study for Daily Intake:-VOC'sv which provides indirect evidence (e.g., individual assessments is impractical (Does not consider eaftinogenidty and excludes** mutagenicity and other short-term test because of its great expense and comnbubons (tom t* end food] results). This process is complex since lingering scientific uncertainty. Compound* ' - AAOT the production of cancer probably is a multi-stage event, determined by a ' In order to produce quantitative estimates, the assumption has been O.O0S rog/k . multiplicity of mechanisms, the nature of made that estimated excess cancer risk 0.26 mg/t * 0025 mg/L . 1.0 rog/L / which remain, for the most part, hypothesized rather than identified. in humans at low dose levels can be extrapolated using various techniques 026 mg/L To date, scientists have been unable from results observed in animals at high 0.025 mg/l - - * * to demonstrate- experimentally a dose levels. Conventionally, designed 3.75 mg/C threshold of effect for "carcinogens," acording to the 1977 report of the NAS carcinogenicity bioassay studies are conducted using both sexes of two Safe Drinking Water Committee. This species of test animals (usually rat and The calculatedAADIs above assume ' leads to the assumption that since no mouse) with each group of 50 animals that the total exposure was from threshold dose can be demonstrated for exposed at the maximum tolerated dose drinking water. Since normally exposure carcinogens, any exposure might or one-half the maximum tolerated dose. also comes from air and food,, in addition to drinking,water, and since represent some finite level of risk. Depending upon the potency of the In addition to the possible existence of thresholds, other sources of uncertainty drinking water is frequently a minor specific carcinogen and the level, such a in high to low dose extrapolation contributor to the total exposure, the- risk could be-vanishingly small at very include: (1) heterogeneity of sensitivity RMCL or MCL should be modified to low doses. in the exposed populations, (2) the take into account the relative source Human.epidemiology data.are.: .. . . pharmacokinetic behavior of the toxic contributions. The World Healtlj, extremelylimited in their ability to agent in animals vs. the human and (3). Organization, in "Guidelines for identify carcinogenic risks. Thus, animal mechanisms of action (i.e., whether the Drinking Water Quality" (1933), experiments are conducted from which agent initiates the process or acts at a assigned as little as 1 percent-of the ADI potential human risk is extrapolated. In ' later stage). Classification of to drinking water where the chemical the first volume of Drinking Water and carcinogens into genotoxic vs. non- was known to bioaccumulate to a high Health (1977), the NAS Safe Drinking genotoxic carcinogens based on possible degree, while greater proportions were Water Committee provided principles to mechanisms has also been considered li I,, - -- *1 CAPCO JEN 0033093 Federal Register / Vol. 49, No. 114' / Tuesday, June 12, 1984 / Proposed Kuies ....:..... .. but a scientific consensus has not been . ' fewer arbitrary assumptions, (3) the- ' Shown alongwith the risk estimates"-*' achieved. Fundamental changes in - assumption of low dose linearity is not in Table 7 is a qualification of the degree, normal cells are the most probable basis - essential in the use of the model and (4) of evidence of carcinogenicity exhibited " for the conversion of normal cells to It incorporates data from all of the- by the chemicals. The International . cancer cells; however, the nature of dosage groups which are consistent with Agency for Research on Cancer (IARC)'; these changes and how they are brought the multi-stage model. At the same time, provides guidance for categorizing ' _ about is still a scientific uncertainty,. it is conceptually consistent with the chemicals having sufficient or limited Many scientists believe that the most linear, non-threshold concept. With this likely mechanism involves direct - model, CAG estimated the upper bound alteration of DNA by carcinogens. Many - excess cancer risk rate at a specific ; definition for sufficientevidence.foc^?^ carcinogens are capable of altering " exposure level for a 70 kg adult who pahcuiogenicity:indicates.that.thefe^hee(F DNA; chemically-induced alteration of ' - consumes Z liters of drinking water per Bh an mcreased.mcidence.ofmalignant/ -- DNA in germinal cells can also cause - ' day, every day over a 70 year lifespan. tumors: (a) In mulitple species or strains, heritable changes, dr mutations; thus,''" - These calculated risk rates have 'of(B) in multiple experiments, or (c) to when a chemical shows a positive-'-- "associated uncertainties. This an unusual degree with regard to.' response in short-term mutagenicity-1" ' uncertainty has many sources, including tests, there is concern that it could also such uncertainties as the shape of the be a carcinogen. Scientists also , . . -j_---- dose-response relationship at low doses, - carcinogeiudty indicates.a.causal generally believe that cancer results- differences in responses between ~:. assodationbetween-exposure ancbsi&V. 'A from a multi-stage process. However, -; f humans and laboratory animals, and the .' ' human cancer. Limited evidence of . "5"^. ... these processes are not well understood- '(effects of artificial dosing regimens. A. ; . carcinogenicity means that the' data and available evidence is insufficient to-'-' relatively minor source of uncertainty is ... . suggest acarcinogemc effect but are *; diffsrentiate between carcinogens on :: statistical fluctuation that results from- if- limited because: (a) The studies involve-'., the basis of mechanism (IARC, 1983). ; the. finitesample size necessarily used a single species, strain; or experiment; of .7 Therefore in this proposal EPA did not "'1 ' in any experimental study. This is the : (b) the-experiments have an inadequate 'j'; make a differentiation based upon -- .only uncertainty that can be readily ; period of follow-up, poor survival, too - _ potential mechanisms. ' -.......... : -quantified; it is expressed in EPA's " few-animals,!,or inadequate reporting;.or.,,,, Thus, quantitative risk extrapolation S' ' methodology by giving the upper-95%-^^'.' ;(cj the neoplasms produced often occur \ procedures can provide only a rough confidence limit of the observed ' - ' :v spontaneously or are difficult to classify ' projection of carcinogenic hazard response. Other confidence limits could '-y- as malignant by histological criteria-'^-'-' because of the many unknown factors--;-- also be calculated. [In more technically . which enter into these estimates-1- s-'i-i- precise terms, the confidence limit is = ; Models using different assumptions may-''"'calculated on the coefficient of the "* " produce estimates ranging over several : ' linear term in the multi-stage model, /" orders of magnitude. Since there is- " assuming that all the statistical -- ''v-v:-.-' dem6hstrate'a''cau8al assbciationfln , currently no way to demonstrate the -' uncertainty is loaded on that term.) r general, although a single study may be accuracy of any model at low doses, this Excess cancer risk rates also can be-.'. ' indicative of a cause-effect relationship, process is a subject of debate in the projected using variations within a ---- -- .' confidence in inferring a causal-' scientific community. However, in spite- ' - specific model or other models, such as - - association is increased when several of these difficulties, quantitative risk the one-hit model, the Weibull model, independent studies are concordant in estimation does provide the decision- - and logit and probit models. There showing the association, when the-- ' maker one means of setting priorities - exists no solid basis in the current association is strong, when therer is a among pollutants and some gauge of the understanding of the biological -. -' dose-response relationship, or when a potential seriousness of environmental - mechanisms involved in cancer to say,:- reduction in exposure is followed by a' hazards [see NCI Subcommittee report .-- that one model-provides'a better^ - reduction in the incidence of cancer. referenced in section VII). . ' estimate of the true risk. The estimates ' The National Academy of Sdences in - EPA's Carcinogen-Assessment Grou - of risk at low doses for these models can their report. Drinking Water and Health, employs a multi-stageroodelamong's&r , "differ by several orders of magnitude. >.'. VoL I, (1977) dassified chemical' ; .. various others to extrapblatepotentialf However, the linear non-threshold - carcinogens into four categones: human - excess cancer risk expected-'at doses of ' model usually has the best, even if . . ' carcinogens, suspected human .' the chemical found in the-environment'-;? limited, scientific biological basis of any"' 'carcfnogens.'animal carcinogens and from results in high dose-animalstudies of the currently available models for (U.S. EPA, 1980). Equivalent human giving an upper limit estimate. The suspected animal cardnogens. Figure 2 presents a typical dose-^ . . doses are established either on a body ;mulli-stage model is presumed to ' response curve for animal experiments weight basis (mg/kg) such that the ratio ; ' - usually given conservative risk estimate dealing with carcinogens. Usually only- of human to animal body weights is (i.e,, less likely to underestimate the....... two data points are available either raised to the Vh powen - ,*: - - actual risk) and thus would usually be . from an NTP bioassay or other chronic consistent with a protective regulatory study. Points At amd Aj represent the human body weight animal body weight VS ' philosophy. A similar model was used'by the NAS Safe Drinking Water . Committee in the calculations provided ` to EPA in "Drinking Water and Health". The NDWAC recommended that the tumor incidence observed in the animal experiment at the high and low dose levels, respectively. Point B representsthe mathematically extrapolated-tumor. incidence esimated to occur at an i . multi-stage model be used in the exposure level below those or on a body surface area comparison. estimation of cancer risk associated ,. experimentally applied. This exposure The multi-stage model is used for with the VOCs. Various calculations, level would correspond to a level likely several reasons; [1) it is more systematic using multi-stage models are presented to exist in the ambient environment than the one-hit model, (2) it invokes in Table 7. (usually far below the experimental CAPCO JEN 0033094 24340 Federal Register / Vol. 49, No. 114 / Tuesday, June 12, 1984 / Proposed Rules- d-ise). Identification of this point (B) and others along the extrapolated lower end of the curve-then allows for the projection of an ass' 'ted excess human earner risk. Table i,--Cancer Risk Estimates for VOCs; Projected Upper Limit Lifetime Cancer - ., Risks . Compound ^ Pro jected upper hmrtr excess lifetime etmneker Concentration in drinking water 0*0/1) CAG CAG* NAS Quality of evidence ** TricMOfoathyfene____ Tetrschtoroethyieoe-- Cajtron tetrachloride. 1^.-.Oichio,?r~ouethene* ^ Vinyl chloride Jr*___ I,1-Dichkxoethyteo*_!__ 1.1,1-Trichloroethtne (1). p-t>chlorobenieoe 10** a r* 24 18 14- 45 limited 44 (tnimaI). to-* 10 35 Limited ter* 1 34 (animal). io*# 4 2.7 45 Suftoent io** 0.4 027 44 (animal). -t1o0-*** 0.5 50 0.95 0.5 7.0 Sufficient 0.7 (animal). 103* Wzxik 5^0:15^ SESSION Sufficientr 10** 2 0.015 1 (human). 10** Z3 2.4 United 10`* 023 024 (animal). to-* 6.7 10-* 0.67 Sufficient (human). 10-* 217 168 Limited**" 10"* 21.7 16.8 (animal). Inadequate. . r 95% confidence fcmrt. - * tt vinty chloride and benzene classified as human and suspected human carcinogens, respectively, by NSA. Goth have been classified human carcinogens by IARC (1982). CAG-EPA Carcinogen Assessment Group; NASNationat Academy of Sciences Safe Drinking Water Committee: JARC-Intemaliona) Agency tor Research on Cancer. - .. * Recent draft updated calculations by CAG. * Based upon (ARC unless otherwise noted. Indicates strength of evidence as an animal carcinogen. *** Assessment made by EPA Carcinogen Assessment Group (CAG). end (ARC. **** limited evidence as determined by the NAS Safe Drinking Water Committee (1983) and CAG (1983) from preliminary date- '* (t) Not considered In tf proposal as a carcinogen. Risk estimates are provided for perspective. Developing data may Dose Toxicology of VOCs The following are short discussions of the toxicity of VOCs for which RMCLs are proposed. Detailed assessments are found in the draft health criteria documents that have been prepared for each VOC and are provided for public comment; see section VII, References. Trichloroethylene. Trichloroethylene has been shown to exhibit noncarcinogenic bioeffects at high (nonenvironmental) doses in humans and several other animal species, including , dogs, rabbits, guinea pigs, rats and mice. The major effects demonstrated are liver and kidney damage, central nervous system effects and depression in myocardial contractility. In the calculation of a suggested adjusted ADI for trichloroethylene, liver toxicity was used as the most sensitive . end-point with respect to adverse health- . effects, not including the potential carcinogenic risk that may result from. .: exposure to the chemical. A study in . .- which rats were exposed to trichloroethylene through inhalation with resulting elevation of liver weights-. was used to calculate a suggested Adjusted ADI of 0.257 mg/1. This value was calculated based upon a minimal-... effect-level of 300 mg/m3 (55 ppm), since rats exposed to this dose level (5 days a week for 14 weeks) showed elevation of liver weights. An uncertainty factor of. ... 1000 was applied due to the fact that an ' animal study, where the no-observed- adverse-effect-level was not identified, was used and because the study was only of 14 weeks duration. One hundred percent exposure from drinking water ' and a 70 kg adult consuming 2 liters of - water per day .were assumed in the calculations.. The NAS has not calculated a chronic non-carcinogenic Suggested No- Adverse-Response Level (equivalent to an Adjusted ADI) for trichloroethylene, because every long-term study, with the ; exception of the National Cancer Institute (NCI) carcinogenesis investigation, involves trichloroethylene administration by inhalation. The NCI bioassay did not determine a **no-effect. level" and thus it was not considered appropriate for use in the deviation of a chronic, noncarcinogenic value. . Bacterial mutagenicity studies have- shown trichloroethylene to be mutagenic in several, systems, including ; ` metabolically activated Salmonella typhimurium and K coll K12 strain; however, a later study reported trichloroethylene to be non-mutagenic in the Ames test system.- Commercial grade trichloroethylene was tested by the National Cancer Institute (NCI) (1976) and was reported to induce hepatocellular carcinomas in - male and female mice by oral gavage. A repeat bioassay by the National Toxicology Program (1983) using purified trichloroethylene in corn oil found it to cause hepatocellular carcinomas in both sexes of mice, at a dose of 1,000 mg/kg per day, five days per week for 2 years, administered by gavage. Trichloroethylene was not carcinogenic in female rats under the test conditions and the results in male rats were determined to be insufficient to make an I :l Ii CAPCO JEN 0033095 Federal Register-/ Vol..'49,No.--114 / Tuesday, June 12,-1984 / Proposed Rules- 24341 adequate evaluation of the- ` : k- percent and 40 percent, respectively. be determined from'this study. A repeat" carcinogenicity. The doses administered ; Because of an excessive dose related carcinogenesis bioassay ef 1,1,1- to the rat were 1.000 and 500 mg/kg/day. mortality in the gavage experiment and trichloroethane was conducted in which The International Agency for low dose level in the inhalation study, doses of 3,000 or 1,500 mg/kg'vyere - Research on Cancer (IARC) has no conclusion can be made about the . administered by gavage to both sexes of concluded that trichloroethylene has -. carcinogenicity of tetrachloroethylene in - mice, and rates were given does of 750 - - limited evidence of carcinogenicity, rats. Data from the recent gavage studyy or 375 mg/kg. In the preliminary report " based upon experimental animal studies . has been withdrawn for the time being of this study, 1,1,1-trichloroethane was ' and inadequate evidence from available pending the results of an indepth audit - > carcinogenic in both male and female human data. This means that.the data by the NTP due to unresolved problems -- mice showing an increased incidence of suggest a carcinogenic effect in one with the study as conducted. -- - hepatocellular carcinomas but not in - J species, butlack of confirmation in . The majority of mutagenicity studies- rats; however, these initial results have others. The World Health Organization. on tetrachloroethylene were negative. been questioned.'V (1901) has recommended a tentative Two positive studies have been - 1,1,1-Trichloroethane has been tested guideline value of 30 jxg/1 for ..' reported; however, the purity of the ; '" for mutagenicity in several test systems.- trichloroethylene in drinking water. / Vvv. tetrachloroethylene-was questioned in- Both negative and positive results were/' EPA's Carcinogen Assessment Group . these cases.' 1 i-.--.v--'' ; reported in mutagenicity tests in various-- has used the lingarized non-threshold ' ' jThetlAROhasiconcluded.thataw^SS^i Salmonella typhimurium strains, and - multi-stage model to calculate projected \;t tdtfachloroethylene;ha3.:li^led'eyidencftn: 1,1,1-trichloroethane was not shown to ' excess cancer risk estimates ..V 6Fcarcin6gemcity:in_ahim'als;and4^i^^.>- be mutagenic in studies using yeast as ;U' extrapolated from high dose animal ihadequateevidencefrpja.nvailablei;^^i;. an indicator organism. studies. For trichloroethylene, these' .... / '/, KumamdataTThismearis that"the'data- i.-.i--' EPA's Carcinogen Assessment group estimates were based upon the NCL//,. suggest a carcinogenic effect in one has used the linearized non-threshold ? bioassay data. Calculated risks'. species, but lack confirmation in others.,-/' multi-stage model to calculate correspondingly to various doses are The World Health Organization has preliminary excess cancer risk estimates listed in Table_7...-__-v recommended a tentative guideline m.-- extrapolated from the preliminary ' Tetrachloroethylene:The principal'"'' value of 10 pg/1 for tetrachloroethylene v reported incidence of hepatocellular 7 non-carcinogenic effects of . in drinking water..... :-. ^ carcinomas in female mice in the study - tetrachloroethylene in humans and other / animals from both acute and longer-term / exposures at relatively high (non- "' . environmental] doses include central "' ; nervous system depression and fatty infiltration of the liver and kidney with concomitant changes in serum enzyme activity levels indicative of tissue damage. ' " "' A suggested adjusted ADI for tetrachloroethylene, considering adverse EPA's Carcinogen.Assessment Group/ hmcaaosndcueeslretrodisctkhaeelcsluitnilmaetaaertiepzsreodejexmctrtuaelpdtio-eslatxatetced efrosmsv'lj} high-does animal studies. For -.- ' tetrachloroethylene, these estimates .- were based upon the 1977 NCI bioassay in mice. Calculated risks corresponding-1 to various doses are listed in Table 7.' - 1,1,1-Trichloroethane. The principal toxic-effects of 1,1,1-trichloroethane cited above. Calculated risks corresponding to-various doses.are- --/-/' listed in Table 7.r; f.'/;-" V:' Similar calculations were made by the. NAS {Drinking Water andHealth, Vol. ' V) except that the average of the results in both male and female mice were used as the basis.' -'.'v ' The latest bioassay data, on 1.1,1--' - '' trichloroethane is currently undergoing health effects other than the potential from which (non-environmental) dose - audit by the NTP and a final report has' carcinogenic risk, was calculated based - exposure in animals and humans are '. not been issued. Therefore this proposal upon a series of studies in which rats' v/ere exposed by inhalation to depression of the central nervous - system, increase in liver weight and . will use the noncancer inhalation data ' as the basis for the proposed RMCL.. ; ' tetrachloroethylene with effects cardiovascular changes. ' ' Thi3 notice`will be amended if the final - observed on the central nervous system, Liver toxicity was .used as the most. NTP report determines that 1,1,1- immune system and certain blood sensitive end-point with respect to .- _. trichloroethane was carcinogenic under components. The value of0.085 mg/1..-' adverse health effects, not including the -- ' the conditions of the tests. r was derived from these studies, based - -'* ' potential carcinogenic risk,, in the .-:T . Carbon Tetrachloride. Carbon upon a no-observed-adverse-effect level calculation of an adjusted ADI for 1,1,1- -'tetrachloride (CC14) has been-shown to -; of 10 mg/m3 (1.5 ppm) and an - trichloroethane. An inhalation study. . exhibit non-carcinogenic effects in uncertainty factor of 100. This -~- which examined exposure of mice to ..-. humans and animals following acute '' uncertainty factor was considered - - .1,1,1-trichloroethane was used to . * and chronic exposures. The principal appropriate for use with a no-observed-' calculate a suggested Adjusted ADI of , effects seen at high doses are liver '* ' adverse effect level from an animal .- 1.0 mg/1. This study demonstrated - changes such as fatty liver with study with no comparable human data. changes in the livers of the mice at. centrilobular necrosis developing if Daily exposure of a 70 kg adult drinking various dose levels. exposure is continued. 2 liters of water per day was assumed in Two animal bioassays by the National A chronic AADI fnrCCl, of 0.025 mg/ the calculations. Cancer Institute (NCI) have been 1 was calculated from a recent report of Tetrachloroethylene in com oil was - completed in rats and mice (1977;.1983). a study (Bruckner, et al,, 1983) which has tested for carcinogenic potential in mice . In the earlier bioassay, rats and mice ' not yet been published or peer reviewed and rats by gavage in the NCI Bioassay - ' were treated with 1,1,1-trichloroethane at this juncture. Program (1977). In these bioassays, it in com oil by gavage. Because only 3 " Rats weighing 200-500 g were was shown that tetrachloroethylene percent of the animals survived to the ' randomly divided into groups of 15 to 16 increased the incidence of . end of the experiment, due in part to animals each. The animals were given . hepa tocellular carcinomas in both sexes chronic murine pneumonia which was by gavage 0.1,10.33 mg CCl4/kg bw of mice, but not in rats. A dose rate of determined to be the most probable - (in com oil), pie animals were dosed on 531 mg/kg per day, 5 days/week in male cause of the high incidence of natural a daily basis. 5 times weekly, for a total mice and 3B6 mg/'kg in female mice deaths among the animals, it was . . ' period of 12 weeks. Blood samples were resulted in a tumor incidence rate of 65 concluded that carcinogenicity could not- obtained from alternate animals at the CAPCO JEN 0033096 24342 Federal Register / Vol. 49, No. 114 / Tuesday, June 12, 1984 / Proposed Rule's following intervals: 2,4,6, 8,10 and 12 A series of inhalation studies in which >f the central nervous system, weeks pos (-treatment. The serum was a variety of animal species were pulmonary insufficiency, cardiovascular analyzed for BUN, GPT, SDH and OCT. exposed for up to 8 months to 1,2- manifestations, gastrointestinal At 1 mg/.'/g, there were no significant - dichloroethane were used to calculate symptoms and acroosteolysis. biochemlcal/histopathological changes. a suggested Adjusted ADI for 1,2- A suggested Adjusted ADI for vinyl SDH, the most sensitive index of dichloroethane. The most sensitive end chloride of 0.06 mg/1 considering hepatotoxicity, was elevated (p <0.05) points, not including the potential adverse health effects not including- in rats receiving 10 mg/kg for 12 weeks. carcinogenic risk, identified in these' carcinogenic risk, was calculated based Also, these rats exhibited mild studies were pulmonary congestion, .upon an oral toxicity study in rats in centrilobular vacuolization. At 33 mg/ diffused myocarditis, and fatty which a variety of carcinogenic and kg. levels of GPT, SDH. and OCT were degeneration of the liver, kidney, non-carcinogenic effects were observed increased (p <0.01) and marked hepatic adrenal and heart. A value of 0.260 mg/1 at all dose levels. A minimal-effect-level lesions were apparent. There was no was calculated, based upon a no of 1.7 mg/kg was used in the ' evidence that CCi, was nephrotoxic.. observed-adverse-effect-level of 405 mg/ calculations, as histopathological Comments on the experimental ms (100 ppm). A variety of animal . changes in the liver including clear-cell protocols and interpretations of the data species exposed to this dose level for 6 foci, extensive necrosis, cysts and liver- ' are requested. ....... to 7 hours/day, 5 days/week yielded no cell polymorphism'were observed at this Carbon tetrachloride has been shown . adverse effects as measured by general dose level. Anuncertaintyjfactor'qf4000^' to be carcinogenic in rats, mice and appearance, behavior, mortality rates, ' '. was-applied to accdiint for an animalH$; hamsters through oral administration. In growth rates, organ function and blood study where the-no-obs'erved-adverse-^ the NCI (1976) bioassay for : chemistry. An undertainty factor of 1000 effect level'was not identified'. One . '. ^ trichloroethylene, carbon tetrachloride was used to account for an animal study hundred percent exposure from drinking was used as the positive control. Carbon with no equivalent human data, and for water and a 70 kg adult consuming 2 . .':^ tetrachloride was administered in com the use of a study of less than lifetime liters of water per day were assumed in.! oil by gavage to rats at two dose levels: exposure. One hundred percent the calculations. ' ' il.V 47 and 94 mg/kg for males and 80 and exposure from drinking water and a 70 Vinyl chloride has been shown to 159 mg/kg for females. In mice, the kg adult consuming 2 liters of water per have carcinogenic effects in animals and . chemical was administered at 1,250 and ' 2,550 mg/kg. Carbon tetrachloride was determined to increase carcinomas of the liver in both rats and mice in this bioassay. Carbon tetrachloride has not been shown to be mutagenic in any of the . reported Salomonella (Ames) assays. . However, mutagenic activity associated with carbon tetrachloride has been observed in a test system using the yeast Saccharomyces cerevisiae. The IARC has concluded that sufficient evidence of carcingenicity in animals exists for carbon tetrachloride. The NCI has also identified carbon tetrachloride as an animal carcinogen day were assumed in the calculations: ' 1,2-Dichloroethane has been shown to significantly increase, tumor incidences- ' at several sites in both rats and mice when administered by gavage, but not following inhalation exposure. In the NCI bioassay, doses of 47 or 95. mg/kg in corn oil administered by gavage to rats and 97 or 195 mg/kg given to male mice and 149 or 299 mg/kg given to female mice were shown to increase the incidence of several types of tumors. 1,2Dichloroethane has also been shown to be mutagenic in a number of biological systems, including Drosophila ' melanogaster. Salmonella typhimurium and E. coll. The IARC has concluded that and has used it as a positive control in - sufficient evidence of carcinogenicity in humans. Animal studies have . "r, demonstrated the production of liver . - angiosarcomas, mammary carcinomas,. . pulmonary angiosarcomas and other.. tumor types in rats following oral exposure and carcinogenic effects in mice, rats and hamsters by inhalation exposure have been reported. In . . humans, studies have-linked vinyl chloride with angiosarcoma of the liver and other forms of neoplasm. The IARC. . has concluded that sufficient evidence of carcinogenicity exists for vinyl chloride from animal studies and human studies, and that vinyl chloride should - be considered a human carcinogen with target organs of the liver, brain, lungs and haemo-lymphopoietic system. several bioassays. The World Health . animals exists for 1,2-dichloroethane. Vinyl chloride was shown to be Organization (1981) has recommended a The World Health Organization (1981) mutagenic in the test system using tentative guideline value of 3 pg/1 for has recommended a tentative guideline metabolically activated Salmonella carbon tetrachloride in drinking water. value of 10 ug/1 for 1,2-dichloroethane in typhimurium. E. coli K12 strain, in germ EPA's Carcinogen Assessment Group drinking water. cells of Drosophila and Chinese hamster has used the linearized non-threshold ' EPA's Carcinogen Assessment Group V79 cells. .- multi-stage model to calculate projected has used the linearized non-threshold EPA's carcinogen assessment Group - excess cancer risk estimates multi-stage model to calculate projected has used the linearized non-threshold extrapolated from high dose animal excess cancer risk estimates multi-stage model to calculate projected studies. For carbon tetrachloride, the extrapolated from high-dose animal excess cancer estimates extrapolated latest draft estimates were based upon studies. For 1,2-dichloroethane, these from high dose animal studies. For vinyl the geometric mean of the four cancer estimates were based upon the NCI chloride, these estimates were based studies. Calculated risks corresponding bioassay data. Calculated risks upon an inhalation study in rats in to various doses are listed in Table 7. corresponding to various doses are which vinyl chloride concentrations 1,2-Dichloroethane. The toxic effects listed in Table 7. ranging from 50 to 10,000ppm resulted in of 1,2-dichioroethane in humans and Vinyl chloride. Acute and chroic a total tumor incidence rate of 17 other animals from both acute and toxicity studies with vinyl chloride have percent to 62 percent, respectively. The longer-term exposures at relatively high shown the major non-carcinogenic NAS has also used the multi-stage levels include central nervous system effects resulting from high dose model to calculate excess cancer risk depression, liver and kidney damage, exposures to be congestion and edema values. They based their estimates upon gastrointestinal distress, adrenal and of the lungs and hyperemia of the kidney the same study as did CAG (Maltoni, at pulmonary effects and circulatory and liver. Other non-carcinogenic effects al. 1975). except ingestion data instead disturbances. have been noted, including disturbances of inhalation data were used. The NAS -C & ^r I1 CAPCO JEN 0033097 6. None of the above. van der Rest requested that AACPP Staff intervene on behalf of Eternit and appear at a special public hearing before the Subcommittee on Environmental Health of the Batasang Pambansa (Philippine Legislature) (Attachment 3). He was especially concerned about potential "ripple effects" from this adverse action affecting Far Eastern markets for A/C pipe. Eternit Corp.-Manila agreed to cover Staff expenses. Temporary Lifting of Ban On November 17, 1982, Eternit and Italit petitioned President Marcos to lift the ban until such time that an independent scientific and medical study was conducted (Attachment 4). This petition, coupled with the realization that prohibiting the use of A/C pipe would not only increase the cost of pipe currently being installed, but also would cost the Phillipine government billions of pesos to replace the 20,000 kilometers of water pipe in the metro Manila area, prompted President Marcos to lift the ban for 90 days and create a special Presidential Advisory Committee to gather data and assess the safety of A/C pipe. The cabinet level committee will be comprised of the Minister of Health, the Executive Director of the National Environmental Protection Council, the Director General of the National Science and Technology Authority, the Director of the Product Standard Agency and President of the Phillipine Chamber of Commerce and Industry (Attachments 5 and 6). The Advisory Committee study would be separate and distinct, though coordinated with Batasang hearings. The temporary lifting of the ban and establishment of the Presidential Advisory Committee received widespread media coverage (Attachments 7, 8, 9,10 and 11). There were some unfortunate side effects of this coverage, notably the misperception or misrepresentation of the asbestos content of A/C water pipe (5%) and a statement that drinking water did not come in contact with the fiber. It is not known whether these resulted from reporters' misunderstandings or MWSS zeal in defending the product. . Liaison with CDM, Inc. (U.S.) Prior to departure, Staff contacted David Doran of CDM (Boston, Massachusetts) to obtain additional information on the situation. A meeting was set up with Deputy Resident Manager Elwood (Rich) Richardson in Manila. Development of Strategy and Tactics On November 22, 1982, Staff met with Jacques Cartuyvels (President) and Carlos Borromeo (Vice President-Marketing) of Eternit-Manila. Complete background information was provided; the positions of potential allies and adversaries were discussed along with the desirability of media contacts. The possibility of a comprise position i.e., asphaltic lining of A/C pipe, also was discussed and dismissed on economic grounds. (Competition between pipe suppliers is so high that the small increase in the cost of coating pipe would make A/C non-competitive.) Initial lobbying efforts were directed towards the Subcommittee on Environmental Health. Lobbying - Subcommittee on Environmental Health A brief meeting was held with Assemblyman Ramas at the Batasang. This' meeting adjourned and reconvened at the offices of Assemblyman Narciso Monfort. Monfort is a physician and it was felt that his input, if favorable to the industry's position, would be most influential in Subcommittee deliberations. Also attending was '1 * -2- CAPCO JEN 0033098 Monfort's wife who was performing special study responsibilities for the Assemblyman. Staff gave a 45 minute briefing on the asbestos in drinking water issue. Although Monfort appeared to be impressed by the strength and cohesiveness of the animal and epidemiologic studies, he was quick to see the potential release (by corrosion) of asbestos from A/C pipe. He was particularly interested in how and when such release might occur. Staff stated it understood Manila's water was not highly corrosive based on the description of a 25 year old pipe sample removed from the San Juan section. According to Borromeo, the sample is said to exhibit calcium carbonate deposition on the interior surface. Monfort went off on a tangent about occupational exposures to asbestos in A/C pipe factories and incidental exposures from the use of A/C sheet and corrugated products. It appeared as if he saw the A/C pipe controversy "dead ending" with the substantial medical evidence supporting product safety, so he was looking for another area for Subcommittee study. Staff and Eternit attempted to redirect his thinking to resolution of the matter at hand. It was recommended that studies of occupational exposures or other products be handled by another legislative resolution. A scientific/medical backgrounder was left for Assemblyman and Mrs. Monfort. Liaison with CDM, Inc. (Manila) Staff, Cartuyvels and Borromeo then met with Rich Richardson, Deputy Resident Manager, CDM, Inc. Richardson was fully aware of the situation but was unable to provide any information about its cause. He did say that the information provided to CDM - Boston by AACPP had been forwarded regularly to Oscar Illustre, General Manager of MWSS. Briefing - Local Water and Utilities Administration (LWUA) and MWSS We then met with Carlos Leano, Director of LWUA. The meeting was cordial and timely as Leano had directed a staff member to prepare a position paper on the asbestos and drinking water issue. AACPP Staff offered to review the LWUA internal files to determine their completeness and to provide additional information. Leano counterproposed that AACPP brief the staffs of LWUA and MWSS that afternoon. However, the MWSS General Manager and Staff were at the Batasang Pambansa so the briefing proceeded without them. Shortly after the briefing began, Marcial Manlaysay, Assistant General ManagerEngineering and Special Projects, MWSS, appeared and directed that the meeting be moved to his office. Unfortunately, this all but destroyed the continuity of the briefing as Manlaysay, who was dramatically argumentative, criticized the A/C pipe industry for not providing MWSS with current information on the health issue and for not mounting an effective defense on its own behalf. He vented considerable spleen saying, "We are not going to defend your product." He also underlined the importance of obtaining nonpartisan, independent data supporting the safety of A/C pipe. Staff found much of Manlaysay's criticism hollow and misdirected because (a) he failed to acknowledge the inherent credibility problems raised by an industry defending . its product before the media, and (b) in spite of his criticisms about the weakness of A/C pipe industry-generated data, a quick glance at a MWSS briefing package for President Marcos showed it to be packed with issues of A/C Advisory, "A/C Pipe and Drinking Water" and other information provided to CDM, Inc. by the A/C Pipe Producers Association. -3- CAPCO JEN 0033099 The meeting adjourned amicably. Staff advised that a more comprehensive briefing would be given in its testimony before the Subcommittee on Environmental Health the next morning. LWUA and MWSS staffs were scheduled to monitor the hearing. Cancellation of Public Hearing Late in the day of November 22, the leadership of the Batasang and the Presidential Advisory Committee decided to cancel the public hearing. There had been rumors earlier of rescheduling the hearing until November 25. Staff heard the cancellation on the late evening news. The broadcast gave no explanation for the cancellation, nor was there any mention in the morning newspapers. It is likely that the Presidential Advisory Committee and Subcommittee on Environmental Health were concerned about the hearing causing more media coverage, prolongation and exacerbation of the controversy. By that time, a number of Subcommittee members knew that Eternit/AACPP would vigorously defend the industry's position. It is also likely that the Batasang leadership and the Presidential Advisory Committee realized the need for coordinating data collection, review and assessment so the findings of the Committee and Subcommittee were in accordance with the facts, as well as the wishes of President Marcos. There is little doubt in Staff's mind that problems raised by the presence of 20,000 kilometers of existing A/C pipe loomed very large in this decision-making process. On November 23, Eternit and AACPP appeared at the Batasang just to be sure the reported cancellation was true. We were advised by Assemblymen Monfort and Ramos and Dr. Priscilla Tablan (Officer in Charge, Lung Center of the Phillipines) that the public hearing was indeed cancelled and that the the Presidential Advisory Committee and Subcommittee on Environmental Health would meet jointly in executive (closed) session. Monfort stressed the need to coordinate the groups' activities and to set ground rules on how a study or hearing might proceed. He implied that the Subcommittee would defer to the Presidential Advisory Committee (which is reasoftable) and that the entire matter of occupational exposures to asbestos and other carcinogens would be a matter of present and future discussions. We also met with Minister of Health Azurin and expressed the industry's desire to cooperate with the government studies. Azurin was gracious and pledged a fair hearing of all sides but declined persistent offers by AACPP and Cartuyvels to appear before the joint meeting. It was interesting to note the absence of anti-A/C pipe advocates and the presence of that ubiguitous parasite to field problems -- the home water filter manufacturer. At least one such manufacturers' representative appeared for the obvious purpose of gathering information to promote its product for filtering asbestos fibers. (Note: Member companies should be aware that the U.S. Environmental Protection Agency does not recommend the use of such filters for the filtration of asbestos fibers or other chemical contaminants for that matter.) Preparation of Industry Position Paper Staff prepared a transmittal letter, scientific/medical brief and complete references supporting the industry's position on the safety of A/C pipe (Attachment12). Copies were transmitted to all members of the Presidential Advisory Committee, the -4- CAPCO JEN 0033100 Subcommittee on Environmental Health, and the General Managers of MWSS and LWUA. Informal Meeting with MWSS On the evening of November 23, Staff attended a dinner hosted by Italit. Although this was originally represented to be a small dinner between Italit officials and Staff, the General Manager of MWSS, a number of Assistant Managers, three World Bank officials from Washington and another consulting engineer also were in attendance. Staff took the opportunity to update Ilustre and advise him of industry intentions with respect to transmittal of medical evidence. Ilustre heartily endorsed this approach and was most appreciative of the fact that he also would receive copies. Additional Lobbying On November 24, a meeting was held with Assemblyman Gualberto Lumauig of the Subcommittee on Environmental Health. Again, data supporting the industry's position was presented. Lumauig was particularly impressed by Borromeos' argument that a ban on A/C pipe would reduce competition between materials and necessarily increase pipe prices. Moreover, he persuasively argued that 85% of the raw materials used in A/C pipe were Phillipine made whereas raw materials in steel and PVC pipe were imported and thus added to the country's trade deficit. Staff Analysis To the credit of Eternit, AACPP Staff was used effectively as a resource in defending the industry's position in this matter. What strategies or tactics were not already conceived prior to Staff's arrival were soon resolved in productive discussions. The Eternit operation appears to be extremely well managed by Cartuyvels. Borromeo, an ex-government official, appears comfortable and well connected in necessary political circles. Both factors will be important in the successful resolution of this field problem. In spite of the age of the plant, occupational exposure levels to asbestos and general appearance compare favorably with more modern facilities. The data Staff reviewed showed occupational exposures at all work stations to be below 0.5 f./cc. (TWA). It is not likely that this plant would be found wanting were legislators to be given a tour, as may be desirable in the future. Conditions at the Italit are said to be worse; Staff did not visit that plant. Although the situation with respect to A/C pipe is stabilized, it is likely that occupational exposures to asbestos as well as installation or incidental exposures from A/C sheet or corrugated, asbestos in schools, etc. will soon be a matter of concern to the Batasang and Ministry of Health. This probably will not occur until 1983 and hopefully will not impede resolution of the A/C pipe issue. Until the pipe controversy is resolved, Staff recommended that Eternit-Manila not take further steps in encouraging the government to establish occupational standards for asbestos exposure or independent studies of other A/C building products. The current situation simply is too volatile to interject those potentially inflammatory subjects now. At this point it is not known whether any public hearing will be held. Ideally, it should not since these issues are best resolved by scientists, such as those on the Presidential Advisory Committee, rather than legislators. Any decisions will have a substantial political component, regardless. It is particularly fortunate that the ground -5- 1 CAPCO JEN 0033101 work done by Cartuyvels and Borromeo in advance of Staff's arrival allowed the timely dissemination of the same information to all parties studying the issue. Hopefully a harmonious and consistent conclusion will be drawn. Finally, it is disconcerting to note that there appears to be a pattern developing in the Middle East and Far East with regards to concerns about the safety of A/C pipe. In addition to the Phillipines, the nations of Kuwait, Saudi Arabia and the Sultanate of Oman have organized study committees to evaluate the product. The causation for these events could be pure circumstance or the continued effort by competitive interests to discredit the product. Action Plan and Recommendations 1. Eternit will closely monitor deliberations of the Presidential Advisory Committee and Subcommittee on Environmental Health, and respond to any questions or concerns that emerge. Both Borromeo and Cartuyvels are articulate and now knowledgeable about the health issue. Barring the emergence of difficult technical questions on the corrosion of A/C pipe or on less important studies, future liaison probably can be handled by Eternit. 2. Eternit will should monitor development of MWSS and LWUA position papers on A/C pipe and obtain copies of respective briefs in advance of any public hearing. 3. AACPP contacted CDM, Inc. on November 30 and requested chemical data on raw and treated waters in Metropolitan Manila. Deputy Resident Manger Richardson mentioned the possibility of taking asbestos counts in Manila. Eternit also should keep in touch with Kevin Reilly (CDM-Manila) in the event that such data is gathered. 5. Eternit should attempt to obtain a sample of the 25 year old A/C pipe removed from the San Juan section of the city, observe its physical appearance and conduct independent structual testing if possible. 6. Consideration should be given to conducting "backgrounders" with the print media. Staff recommends that this be done only after discussing industry intentions with the Presidential Advisory Committee and Subcommittee on Environmental Health. However, if adverse articles persist, Eternit should aggressively attempt to have the industry's position aired. Staff left some press kits to facilitate this effort, if required. 7. Eternit should scan major newspapers for home water filter advertisements that may perpetuate public or government concerns about asbestos in drinking water. If necessary, public relations or legal action should be taken to correct fallacious or inflammatory claims. 8. Since there will be a continuing need for Eternit-Manila and Italit to provide information to the government, Staff will solicit their membership in AACPP. JFW/ajb Enclosures 6- I 1 CAPCO JEN 0033102 cc: A. Kahn, Esq. Jacques Cartuyvels (Eternit-Manila) Asbestos International Association AIA/NA Canadian Asbestos Information Center South Pacific Asbestos Association eoDies to: Executive Committee International Affairs Committee L. Ambler J. Cran L. Taylor E. van der Rest L. Giannitrapani A. Saoulis R. Jalan C. Barton M. Delcourt B. Giboin J. Schmaus Dubuc R. Dorner P. Hart S. Al-Tarkait V. Pattabhi H. Hudson J. Cuvelier G. Zaviezo J. Rodrigues Dimatit 0172121301 Chrono -7i i. :i CAPCO JEN 0033103 AMlANT'J'J ASBESTOS SERVICES ATTACHMENT 1 Philippines ' TIMES JOURNAL, SEPTEMBER 5,1982". ! T11E World Safety Organiza tion is pressing for a more thorough evaluation of as bestos which has been de scribed as "a dangerous min eral.". During a meeting of the organization in Manila last week, safety professionals agreed that a systematic eva luation of asbestos is ex tremely necessary to deter mine if it should be partially or totally banned. Barbara J. Peters of Santa Monica, California, said that certain diseases have been associated with asbestos: asbestosis, lung cancer, mesothelioma, pieural plaques and adhe sions, and colpulmonale. These diseases do not occur immediately but are incura ble once contracted. Asbes tosis, for instance, takes place after 10 to 20 years of exposure to asbestos, Peters said. She added that a large segment of the society is open to asbestos "pollu tion." Exposure reportedly begins from the time the mineral is mined to the time ' it is used as an end product. "What's worse, exposure to the dangers asbetos creates is- not limited to the people who directly handle it," she added. Asbestos fibers are found to' be airborne particularly in areas where it is.sprayed on buildings or as a result .of asbestos insulation. Peters also discussed as bestos cement pipe as a pre sent day controversy. She cited a recent study which tested 39 pairs of a* water samples. The first 391 samples were taken- from? water before it had travelled' through asbestos cement pipe, the second set of sam-: pies were taken after the water had flowed throughthe asbestos cement pipe. - The study found that the asbestos content of the sec ond set of samples had in creased by 115 times. In addition, asbestos concen tration in the second set of samples were as high as 1,000,000 fibers per liter. TIMES JOURNAL, SEPTEMBER 7, 1982 '"'r"'1 ">" <"*--nm --rn wnawi i mv --'.Tmrers^r 111U C.OVhRNMHNT will cuiitiuuc to allow thc use of asbestos ce ment pipes by the Me tropolitan Waterworks and Sewerage System in the absence of a conclusive study on ilio levels of asbestos that may be consi dered dangerous. Health Minister Je sus A/.urin said yester day his ministry has already made inquiries trom the World Health (hganizalion on I he mallei hut was told that WHO has yet .to enine up with its stand on it. r Concern about the use of asbestos ce ment was triggered by a statement by I he World Safety Organi zation that asbestos was a dangerous mine- . ral. The organization, meeting in Manila, said several incurable and long-term diseases have been associated with asbestos, such as lung cancer and other forms of pulmonary ailment. The meeting, at tended by safety pro fessionals the world o\er. wjs also present ed with a study that To Page 10 water which had tra velled through asbes tos cement pipes con tains as many as one million fibers per liter. In response to a ministry query, Hiro shi Nakajima, WHO regional director for. the Western Pacific,said the organization does not have an of ficial stand on the safety, or lack of it, of asbestos cement pipes in water supply sys tems. He >ld the interna tional standards for drinking water issued by WHO in 1971 alsodonot specify any limitation, on the presence of asbestos: fibers in the water. There are no sufficient data to warrant a specific recommended fiber level at present, he said. Azurin said the Philip pines would have to de pend mainly on the con clusion of studies made by the World Health Orgmization in connection with the use of asbestos cement. Meanwhile, the UN Commission on Trans national Corporations urged that consumerprotection provisions be clearly outlined in the code of conduct for transnational corpora tions to safeguard the in terest of consumers in developing countries. On the fifth day of the commission's meeting at the Philippine Interna tional Convention Cen ter, a position paper was issued saying that "con sumer-oriented informa tion should not be limit ed to marketing infor mation for the benefit of the producer or seller but should include informa tion necessary for the protection of the health and safety of the consumer." | CAPCO JEN 0033104 ATTACHMENT 2 Tw, /i tw* PRESIDENT - Marcos yesterday, directed- the Metropolitan Waterworks and Sewerage System to stop contractors from_using asbestos pipes because, asbestos is believed to cause cancer. - The MWSS is studying the harmful effects of asbestos water pipes. The study was prompted by widespread public concern' over the conti nued use of asbestos pipes in MWSS installa tions all over Metro Manila.'-' In another move, the President rought to stop the dumping of wastes into Manila Bay, which be said causes' marine pollution and undermines the national development efforts.- The" President directed MWSS Manager Oscar Ilustre to set up immediately a sewage treat ment plant on a five-hectare lot in the Tondo reclamation area.; He issued the order in the wake of com- ' plaints from fishermen in the bay that indiscrk;' r miriate dumping of. waste has not only des-, - - troyed fish and other marine life but also en-' dangered the health of communities along the bay. "... '. : . The President told Ilustre to make a study of ' other sites in the Metro Manila area where sew age treatment plants may be set up to,sanitize waste before it is pumped into the bay. The President directed Ilustre to,speed up ; the cleaning of all public and. private septic:" . tanks in the Metro Manila area. ' >.' ; ,, The MWSS has_; scheduled,, to clean up some 300,000 septic tanks in Metro Manila for - free. . v. Those who want priority in having their septic tanks cleaned will have to pay a minimal fee, Ilustre said.- - EB&9 -Tnc.... :t CAPCO JEN 0033105 .* .'-'upon themselvgn :.tri vlha's':asked iprbvineial j. '.-Bwp MWSS contractors .'j-xbhtractpfs to stop the": -// from'/further.iaytng`;iise'of asbestos pipes' as" asbestos pipes because /ordered 'by /.President \ .. they "Were not /com-/-' Marcos.'J; plying with the p_re^ A'XThe"Presi'dent,'": ---'idential directive.--i^>v".'.'actiiig to'protect the'.' /V.Monfort cited axe/T./people's .`health/ i'i.'/ port that . Dr.'.Irving /ordered'the'Metropoli- i;*.' :Ffelikoff, a professor at /'.tan -.Waterworks and -It'-'Mt "Sinai School'.of'-. Sewerage System last .1; _ Medicine in New York,.'`/Sunday to stop the use had established' a defi- / ofasbestos pipes as wa^': '-'nite :'link' Between-ter -mains in Metro' ..,,.__.r_il-dress;;inquiry->j. _. ... .. . .. , into fcHes *continu4<i""uso -v^Assoniblyinsn-^'NarcisO' /;be:ieyed;;that asbestos '/persistent reports that: /^fibers `are/the; likely >. asbestos'.''water pipe's i "t //cause of cancer of.the `'/endanger public health./ UnitGQ.^^ States tnst r-. ru gastro-intestinal tract, "and may cause cancer ' 'The LWUA/a gov^' /-.--a^lonfort also ..refer- . ernment * red to reports of Dr. * -* /- -William Blot:of;the,-'s?ons^ f American:National **' ^r=.cancer Institute that' ^ g &- fio" appear j^ygs had earlier - to be the neatest sing-v-; ^ .the -- of le cause of occupation- ^ pip^ * at. ' = 'V- /-'-least 15 water projects -V; -Qut'of-.the 59 water- ^V^.is expected to be med : svstemvcoastTMctioa .-fe-'.r". The.use of asbestos /from using-'asbestos fi/v/pipes as water conduits ./ pipes - was' issued by //-" .outside 'Metro Manila ;/L W U"A"/e y e n / d s; ':'**--*-* a a nTriortvi '/ a ffartprl "contractors run/t/ -'Jdf'-'th'e; presidential ' ^vordeiv/J^i/f/ri//: d;: ' Opposite/'views ab-' `/` outtiie supposed harm-' /i nil .'effects d.f.iasbestqs'' rHwa'ter/pip.es'Voif/the . /health ` of.'-the-:people; Ylhave Been' expressed. ~; /si f.Alava/himself ,`said"-.-that asbestos materials. -/axe presentin.raw wa- ` vjtor_and even with'the; `'riise of filtration'equip-;Z./meht, a small quantity.' './bf'the Allegedly-harm-' ' ,'-ful substance is-ieft.m ' f_ l- CAPCO JEN 0033106 mi muii'icm i* November 17, 19B2 KIS EXCELLENCY PRESIDES!' FERDIiiAHD E. KARCOS SERUDLIC OF TEE I-HILII-PIicES . MALACAiiAhG, METRO MANILA Sin ASBESTOS-CEMENT PIPES AND HEALTH He are, Eternit Corporation mid Xfcaiit Construction u Development Corporation, tne two manufacturers of ashes tos-cenent pipes in the w-.n .ippinas established for xuore than 30 years. He are requesting His Excellency, President Ferdinand E. Marcos, to: 1. Lift tiie ban for the use of asbestos-cement pipes until such time tiiat an independent scientific and medical study shall have been conducted to look into the relationship between the use of asbestos-cement pipes and health hazard for the consumers. 2. Enjoin the media from further generating undue alarm arid concern with a populace, which has for tore than three decades already beer, drinking water from asbestos-cement pipes unless valid findings prove a definite relationship to health as submitted by competent medical and scientific authorities. Your Excellency, wo ask you to consider: " 1. The use of asbestos-cement pipes means substantial savings in foreign exchange for the country, since only <10% of the raw materials used for asbestos-cement pipes are imported, whereas tnis percentage for other types of pipes is at least 90%. 2. The S-100 Million invested in our facilities. 3. The annual capacity of 50,000 tons to serve the needs of the country and thus stabilizing prices. 4. The employment of 350 heads of families, affecting about 2,000 dependents.. "' 5. The Dollar earnings realised by export of. our products. He maintain. Your Excellency, that: 1. There has been no established fact that asbestos-cement pipes is a health hazard. Reference Appendix A. ... 2/ 1' CAPCO JEN 0033107 -2- 2* Both developed as well as developing countries have been using and ' continue to use asbestos-cement pipes.'- A list of countries using asbestos-cement pipes would be too long in the present context but we IDcelirily -to mention the following countries: the United Kingdom, Germany, Italy, Prance, Switzerland, Belgium, Canada, Japan, and the United states. your Excellency, we are inclined to believe that the unfavorable publicity given asbestos products, is motivated more by competitive and commercial reasons than by reasons of public health.. ` Wa maintain that third and second hand information have been quoted out of context in an effort to misrepresent as a consumer hazard what would be, at worst an industrial hazard related to the mining and handling of the raw fibers without due industrial safeguards. We maintain that an objective, scientific and medical investigation will reveal the facts about asbestos-cement pipes and that the findings will uphold our contention and the contention of asbestos-cement pipe lasers the world over regarding the safety of those pipes. Your Excellency, we reiterate our request for a scientific investigation into this matter. Our faith in both your concern fcr public good as well as justice leads us to anticipate your favorable consideration of our request for the peace of mind of -the public and the continued life of our industry. ITALIC COh'SYEUCTIOa & DSVELOPHErlY COEPOEAYIOZi RAM01! R. . PASTOR President Ends. - Appendix A '' * i CAPCO JEN 0033108 APPENDIX A' 1. Memorandum Circular dated December 10, 1980 signed by Col. C. beano of LNUA. Re - Asbestos-Cement Pipes. 2. Asbestos in Drinking Water: A Review dated January 1979 issued by Water Research Centre 3. Asbestos in VJater .. The Risks 4. A/C Pipe Producers Association Advisory dated October 1, 1981, Volume No. 1 Issue No. 2 - Minnesota Study Finds No Link Between Ingested Asbestos and Cancer. b. Advisory dated January, 1982, Volume No. 1 Issue No. 3 - Evidence Pointing Strongly Away from Asbestos Ingestion and Csncer Link, Experts Report. 6. Advisory dated Kay, 1982, Volume No. 1 Issue No. 5 - Authority Reports "No Experimental Evidence of Harmful Effects from Mineral Fiber Ingestion. 7. Advisory dated May, 1982, Volume No. 1 Issue Ho. 6 - Animal Study Reports Ho Penetration of Gastrointestinal Tract By Asbestos Fibers. 5. Advisory dated June, 1982, Volume No. 1 Issue No. 8 - Asbestos Feeding Study Finds Ho Gastrointestinal Cancer in Test Animals. ^iGC/est 11.17.82 CAPCO JEN 0033109 I ) INDUSTRY STATEMENT: AS3EST0S-CEMENT PIPES AND PUBLIC HEALTH'" The asbestos-cement manufacturing industry in the Philippines is happy to hear of the decision of the President to have a committee conduct an inquiry into the relationship between the use of asbestos-cement pipes arid public health. We have always maintained that an objective, scientific and medical investigation should be conducted in order to bring out the facts about asbestos-cement pipes. We are extremely- confident that the findings will uphold our contention and that of asbestos-cement pipe users all over the world, that the use of these pipes pose no danger to public health. Wa have always remained silent in the past whenever unfavorable commen taries and articles are printed about asbestos-cement pipes. We had elected to remain silent, knowing that any statements coming from the manufacturers would always be viewed as self-serving. It is, therefore, with relief that we receive the news that an objective inquiry has been ordered by the President. We confidently anticipate that the inquiry will produce similar findings to those of other inquiries conducted by medical and scientific autho rities of other asbestos-cement pipe-using countries: that there exists no established hazard to public health from the use of asbestos-cement pipes. We reiterate that we welcome this inquiry, so that this issue which has so one-sidedly plagued our industry can be objectively investigated, for the peace of mind of the public and the- continued life of our industry. ETERNIT CORPORATION . ITALIT CONSTRUCTION 6 DEVELOPMENT' CORP. CARLOS M. BORROMEO Acting Secretary Fibro-Cement Pipe Manufacturers (Eternit Corporation/Italit Construction s Development Corporation) *i CAPCO JEN 0033110 ATTACHMENT 5 ' CAPCO JEN 0033111 ATTACHMENT 6 "^3S3B 1U >n,t~JU /Vot , ?kv. /$. /<?.? President Marcos today created a *The President has* authorized rcial presidential advisory commit* : in the wake of mounting public .special committee .'to. call upon ' office or government official for' ncern on the danger of the use of The orderprovided that pending the/p2 biliiorUcy u its task.-t*'--* n'f-rr-^T - jestos cement pipes for distribution promulgation of a national policy'onJ-.Abouf'one-third of the pipes'to be ' Health Minister Jesus C Azurin potable water. ` : **V* *. named chairman of the commit: 'n Administrative Order No; 4SS * He Will be assisted by Dr. C ued in Malacadang, the* President Roque,. 'executive director. of '.powered the special committee to Administration (LWUA) can still use ., ... . f . National Environmental * Protec tr.er data and materials and study . and buy asbestos cement pipes...-,-i **. The MWSS claimed'that- asbestos Council (NEPC); Dr. Emil Q. Ja* J assess ell the issues relevant to The MWSS and the LWUA have been 'cement pipes have been'certified-as director-general of the National Sc : asbestos pipes controversy.. - using asbestos cement pipes in potable safe by a Swiss medical office, ce and Technology Authority (NS` i`ne President ordered the commit*. water distribution."- . V; .- However, several health sources re- Dr. Ignacio Salcedo/director of i to submit the resutts of its study At present, the MWSS is undertak* vealed that asbestos pipes could cause Product Standard Agency, and i d recommendations v/itbia three mg a foreign-assisted Metro Manila cancer. /; "V* * ' Elizalde, president of the Philip Chamber of Commerce and Indu. ) (T*1TM *> P3; "'M V.vL".FM Forms..V.; -! ... \f ' ' ' `v- (Conlinurd from paj;e 1) :-y~\ 'f" ' ' as members of the committee. . .. ; Earlier,' the Batasang Pambansa (BP) scheduled for Nov. 23 a special, public hearing on the asbestos pipes j. controversy.' ' j Invited to the hearing were local and' | foreign health experts. ` . J //_ HEARING V \VrI. The hearing will determine if asbesi ' tos pipes are really dangerous to the. " people's health. It was reported that US 'scientists. . claimed that ."asbestos fibers cause, .`cancer.*".':. .s'. 'Z.:-.'*/ C-". , These initial findings on the danger . of asbestos have forced the President to'' order the MWSS to stop using : asbestos'in the manufacture'of water pipes. < ' : ' The `asbestos 'pipe .controversy worsened-because of the'uncertainty-; of replacement; `*" vr. ' * Oscar Ilustre, MWSS general mana ger, said that polyvinyl chloride or - plastic pipes, which were earlier cons* . idered as replacement for' asbestos t` pipes,'might also cause cancer. CAPCO JEN 0033112 ....______________ l ^ :.v ra `HIM- -* a*; ATTACHMENT 7 " *. ! "'**"*. ' V*>,T*r? ` .*t|/J , ,.*v ``,'iyj;-/\'\ PRESIDENT Marcos yesterday .lifted the1 j*ban on `the use of asbestosrreinforced. *, water pipes until after a thorough study' ; proves tiwt'they are'dangerous to public. . health. ' .- :' V ^ *. ;- : V5;.v The'Presidenfs move was prompted by *..a report of the Metropolitan Waterworks, ' and Sewerage -/System that these water * pipes are actually'made of cement .with* !` asbestos merely^used as an outer material to strengthen them*!*"*'-4'' *** ............ .The asbestos cover j makes up only 5 per] cent of the entire pipe 7 and the asbestos itself! - does- -not actually touch the water' said * Manager Oscar Iiustre of the.water agency, in his talks with the President. /.`Trie asbestos'scare ' was prompted.by*`io** ports - that it, causes '..cancer.- The `reports `said asbestos fibers in water pipes that con* tain the mineral, *..are,, .carried, in the .water .and pose grave danger' *'to those who drink it The World jKealth j'*0 rgariization^how*` ,* ever, ''has'/nohymade .`any stand'on.whether 'ct not thefoienai is, ' `indeed,. a'^carcinogen ;*cr cancer agent* This' prompted Health Mi*, i nister Jesus Azurih to . say** -a few months ^baek that the *..water i agency `can .continue ' using the ssbestos, reinforced * .v"W a t e r . `pipes. ` I'.Jr Weeks later,* how- .ever, the / President ^issued ` the*'ban.*Re-' : acting, llustre said it would cost the govern* intent billions of pesos to dig up allthe^asbes* V'tos-remforce'd `water : pipes in the country. . llustre. brought '.with him -to'Malaci* hang'- for. the Presi dent's personal inspec* \ tiojf several excavated **V" ,*: .ToPageS ..V. .-.y.l.- iMiasfe|tSr - !. The .President';. . ......... vvexamined the pipes'"'v;*^5S*,P,PM we*e fJP**' casing.VThe 'rest will ;:v and agreed with ll'us* '* potted _ by cast iron . *be made of cast iron. *tie . that they-were*"`f3. femjorced steel * Kiniorceii . steel and )-''-large!y_made._o..ce-~^-t*?nty Id yean `othermaterials. meat., with .'asbestos l ;VOt~however, when-/,.:"w ; 4 . sewing only'es outer *:,the enUre length of ; - .The. water expan* `.`.matSbi : :-;`-the then Highway 54,' 5 aon ' J* ' - -- -i--i-cr/s.siiT-'. now Epxfanio de los fje^eed by the World '.`vvisory committee'to *'Husi** *a:d ^.* '.lionaboutP 1.2 billion 1 '.^conduct :a study *'on\~Metro .-Manuaj there has been set aside for the"dahgers of usingv-v*re only ;1,700 jkdo*-:-*;:**' ^jahovordered a'shnilar.^thlrd ."'of Jthese. are"f..Veight milHon clients of > v.studyvdn Ithe `uie-'onff^<l_'m_a1 dc*of cement'with **tVheI.*-IMI.W.SlSi..'i.in Metro 'llustre asthive the v*. earner toomeu > for * the .ban,."wMuw-Scc5 con* ;hhold '| his request for the lift-. \.'.'r-rIn' his presentation`--waterworks expansion .^V-tled ^by-r competent *;rvThe*furqrcYer`^c-'^comp!eUaii < of.--thc-'V-**.-;:*^e .people s : LW. ^projtw u Wly n, : : pipe, .started In -.the . year. ,JvL. J__ \ 1 CAPCO JEN 0033113 3W*" ^ . ?Uy.&,/***- ' pfesent^ ^dangers; : FroirapjjaV '* 'AN' INTERNATfO.V-' years ago in;! the bestos .in. air' con* Drinking Water of the *al health expert yes-':, United States. r'..! .-.ditioners to keep in.* WHO has not sped* 'terday. called attcn- /; : -The practice'is also, the cold in the duct. \ . fled any levels of tier, to, .the "more dlscounged here, but ../W.hilc some, : tcxicicy for asbestos .present" danger of the .* building owners `dis- scientists'.claim as-*;* in drinking water. * .use of asbestos as in-".'" "regard the warnings ''.bestos could . ceruse*, Lee said that in the sulator ar.d acoustics . and merely cover-the .icancex of the gastio-\ absence of any con* agent in theaters, and / asbestos*'lining "of ^intestinal '.tract *and - elusive study, asbestos} supermarkets. walls with - extra /other organs outside ' was not included in! ''' Studies have loivg coatings ofpaint. .`the respiratory sys-. the WHO guidelines.] .established the a2- Others-leave the as- ` tem, no conclusive "However, .updated* 'ments caused by in* bestos lining open to ,, study has shown the rules s "to -be `issuedI ``halation of asbestos wear and tear. v -* * 21 effects of the Chets'" late this year may in `fibers, he said. .: . .`Filipinos , should '..when ingested with clude asbestos if ' But it will take a therefore guard :'drinking water. enough conclusive! .`couple or more years against large amounts Dr. Edwin Lee, re* data can be obtained,. `'of study to determine of fiber po--s--s-i-b- l,y still . gional consultant on he said. * . . if drinking `asbestos- Coating around ?inn ,, environmental health ;..The WHO official r-ingested water poses . . tuhieaiteexrs andu suppecri- '/oofi tlht.ec Wnuourlud Health explained that even in health problems. `markets,' the .expert 1,Organization,said yes- the US and Canada, .The expert said the *; said. '**.*' *I*.terday even the Inter- 'officials are careful ' use of asbestos as in- v'.; `He ' also .warned . national Standards for " about attributing high .,sulator.,was ..banned .against the use of as-. . . -ToPis*6 ' asbestos content in water to the asbestos cement pipes. They realized that in some cases, the fibers camo from `natural rock j formations near the .reservoir, :or some* -.where along the water routes. . *. *,, . / `Two main methods :of .reducing asbestos ^content--are' being [-tried:!-by >filtering ;water:at their main .sources, "or >.treating them with zinc,`which sticks to the walls of . Tthe pices, and acts as a coat to prevent the ! fibers .from leaching, LLccsaid. *, .) I I CAPCO JEN 0033114 ^|ch'hen r -'ij* ' v^.The'.cbmmittee', tV'behcailed by ' iQs-strengthened cement pipes " Health ' Minister Jesus ' *Azurin,' .was.' `watteerr'dQiisstirrimbuutiion system penndaiinngg-{a President that the asbestos itself.does [told jo"'submit within three*months' . thorough " -'study-'and ^Cliying `te.^VV>\rV,V1 _Its>ecommendations fora policy on', down of o policy ort iteute^M - 2*5 >the!rpatter.;/`;:'V.N'-:vVlr' . -m. - n a 1 expressed concern.over the use of the 'v/>''aiTftehr-.ehe Pwaress.-iindffeonrmti-medadbeyj-tthheer-Mmeotvroe-! c..ac.s-l.obVse'us**troes-opfiprrce.cs-evbn-et-cf.ai.nudstengosfrt.-hcthLa'e-t-.'a; s-"dbUjte:ss;--/'' pohton ftatenorb and Sewerage ~t0; .fibcV Windginic br .While the`study .[is'going on,* the"' `President.said, thc. asbcstos pipescan . bemused:and. boWht'.by' both.the ^System thatrte prpes arc actually |-j*lWSS'and'the "Local Water "and.Uti . made of cement with asbestos.used Sv . /\w. lities Administration (LW'UA).. `} .'merely ,as an, outer strengthening .-v:THE 'PRESIDENT'--formed yes-'. :;.MWSS-manager Oscar Ilustre took { material, consisting of .only five per-,.-terday.a.five-man advisory* commit- , ......-,.v -- , cent`of the pipe. - / -.'.tee to .conduct scientific-study, .on y..;} "(Please turn to Page 6) V-'- (FroniPage I) -',to -g/Malaeanang several excavated iron, reinforced 'steet . and . other `'pipes being used in Metro Manila for 'mjtcrijR . the President's inspection. ' ' , LEARNING of :he<e. the. Provident ,<' Tltc.pipcs included tltove nude of .siid total prohibition on uve of cement J 'cast iron reinforced by steel and pipe* u>in; avtv'tuv would mean tlteeittp *v cement reinforced by asbestos laid ; out 29 years ago. the presence of some of his up all of tho>c already laid underground at a lime when the MUSS ha* secured Iojuv for itv wjt.TAurkc expansion. Under thi< proprjin onjninc mihv -'callers, numbers of the president's 1979. an addilionjJ .1.500 kilometers of , 'Staff and other officials." the Presi pipe* arc io .lx* -Liid'out to increase .the dent examined the pipes at the front \dopr of/Malacafiaitg and found ^'according "to a Malacanang press' water 'supply in'the motropolitju.arca from 350 million to 660 million pilous a day - a turret hoped for by nc\t vejr. Of the total length of pipeline. 300 kilo- .; release ,-j* that in the case of those meters are to tv made,of the asbestos- j-made of 'cement, the asbestos was 'merely used as a strengthening outer /.matc.rijl and consisted of only 5 per- covered pipes. ; , -* - .7, -. With the ` President'* directive, the contractors can proceed with the layinc out of the pipes wltielt had already tven jycdndiicting a'scpjfatC inquiry ontlic director.- product Standard A'jxney, jnd use,, ui^rncse pip-s... -.Chamber uf Commeur end Jndu.uy. ..nssessment and hi ii.ror.u it of the . . NmRa.0RTS to tl* Pa-iMem il . r.crcatipp j-.`of the special advisory MWSS ci,c<j.opinion of then Mimvtcr of ~ ycomhliitcc' Studying'-the '`.matter. /'Health Enrique Garcia and the Philippine iv.TIfe-MWSS submitted Stathlics Cancer Society on;the use of.jueh pipes. . sluiwir.g ihi'l cenicui-pipes slrcnilh.' ' "''.'f or Uie PUiUppino - .cncd.by.ai sb, cstos are rusred, .in m- "any -.Cancer Sormcie(ltiyn!.thautllaicthprelivnetnt tthheere is n,,or , countries, .and that -.worldwidcl' ail ,,abestoi pipes to lastro-intotatal cancert** csiiinatcd"T.5 million" miles In length titcPCSsaid In 1981. r"-- * ; of suell "pipes Iiavebticii euiislruel'cd r'-'Minhln Carcia.inhis opinion buiedln r.e.s,' .. 1980, on the other hand, *ad -die opi-. ` - - >M.. ' nion,- of tltc Minuter -of Health that, "if\m `'i >'v *''1 - * ' . ' . r - asbestos fiber, ir inersted into tlioysienv' * - IN METRO Manila, out of about' will not constitute a health hazard as it is 3.700 kflometen ut',' cM'vtin/ pipeline, * normally diwitarped with excreta.** #-;r i'ohly' alxiut .297 kms.-or about 17 ; Garcia said that piboto>'fiber* anr J ..^percent .are nude' of -such matetiaU haiardous to human health when Inhaled. " Ywhite ilte rest* are made " 'of cavt ^ b*q "N^r btpejted. " `i CAPCO JEN 0033115  ATTACHMENT TO ....... ; ; ;Vy.<(Coni i from jiagt - j) safety- ;'6f /aslBes^oljl^ 'the'body;'iV.-.`iv;,.P/ pofed, '.those'who* re-'. Emilianol.Camaril- ;move the pipe.and ...... . ...................'!c;''pre5:dest:director.' ithose'who are exposed i. .Health, professionals firmed'that persons'w'hof'-S:'j general -of the /World -to the asbestos, from; were' divided on ;tbeir , inhale** asbestos'fiberv'-'''*.''.] .Organization, the `pipe after it has. . views on the safety of the particularly those work- /.- > -j-presented to the; :been placed at a waste. use .of asbestos cement ing in asbestos-related in% I a .finding. that -"site face grave .danger.' pipes for water supply..:,; dustries, develop lung dis-*/ "' *! PlPf? .7-Peters* 'pointed out . Dr."Edwin Lee, World eases.' Even families';bf*.-. have_ been-linked ,to: -{hat exposure'to asbes-- Health Organization ` these employes-can de%`"` ?. ] c?nc.r.*. sto.m3j '-'"'tos'ean cause asbesto-"' (WHO)' regional adviser" velop'lung ailments from*-*,-*;' intestine, abdo- -rsjs'avprogressive, -on environmental health, the asbestos thai'remain* * .Iaen .lu,a2 a.na [Pan*` ;.`untreatable thickening . said yesterday there is no* conclusive evidence 'that asbestos cement pipes are hazardous to health. ., He noted that a study .on. the clothing of the., *. !j ire,as,, lnxrareas. /and hardening of the workers, she added. -.Minnesota, jung'tissue brought on .The late Health MinisI'-m I;| aa" Quebec where asbestos in the ter Enrique Garcia, in-fr ; \ ta*se pipes are. used. ;lungs; lung cancer; and In a study entitled a rare Corn of; cancer on the safety of the pipes known 'as mesothe is' being undertaken in lioma which spreads the . United States. . He - (MWSS) and the Local! stressed, -however, .that ' Water Utilities Adminis-" | vention,*. lawyer Bar-" rapidly, ` affecting ` the lining of the heart and sufficient -evidence -has shown that asbestos,may be-harmful if inhaled, prompting some countries . to ban .its use as insula- ` tors and roofing mate- rials.f .. In view of this danger, Lee recommended that tration (LWUA) two years* /,'bara Peters of. Sta. ago, said that asbestos fib -^Monica," California ber if ingested ;into the! . said that the danger in system will not constitu_te_ 1 the use of asbestos ce- a*heaTth hozard since it is- / /.'.ment pipes will not be- normally discharged from, *'..lva" onty Penons wp- <?* -^ lungs." *, .''Meanwhile, the sub; * 'comfcjittee on environ mental health and re lB,,aatetadsamn actotemrsm.i.to.tefethoen _it. w'.vthe manufacture of the' reriew the possible in- government authorities check o'n theaters, super-. pipe, those living near -"volveraent of mulcina! the factory*, those who tionals in the procure- markets,"and other build cut thepipe'and there-. -of these pipes. ings .which he suspects ;by generate dust to-. "Assemblyman,., still use-.asbestos as in-. jwhich *they and per- 'Ho'naldo' Zamora . sulators or materials for,* .sons neax them'are ex- ` '(KBL, ".Metro Manila),* /sound. proofing. . He said that asbestos 1 fibers which fall apart af ter -`several, years are simply sprayed with paint in some buildings to keep them in place or, coyer, them .up but still pose .a ... danger: " ..'i v- Dr.!.`Priscilla' Tablari, i :. director of the Lung Cen-* "'ter of the Philippines, con** minister of .*state for. .V Assemblyman Roge- ' decision of President youth affairs who pres-'._*lio .Quiambao .(KBL, ` \Marcosto set up a com- ided[ oyer yesterday's ';'.Metro'.":Manila),''co-'^ mittee tq look into the mating ofMetro legist ` author of the Monfort >,ffect;'>of, asbestoslabors, said .the .Preri-. resoiutiop and member* -7;ceraent pipes oh public, dent's decision had cast of the two "subcommit-^J; health. v* s': `doubt -on [whether.-or ,, tees!investigating Ithe*^ 7>A spokesman' of * not the dangers posed : Metro Manila diggings .\AEternit yCqrpbration by asbestos.to"human', "and '-asbestos' pipes^v-and Italitponstniction 3 health was considered 'urgeV;lSpeake.r\**iand Development `in the procurement of Querube'C. Makalintal^-fCorp., -local ^mariufac- Ithese,pipes. : *!/"' "V.': ta issue.'a subpoena to;-"! turers of the material, {; Meanwhile Assemb\.* Iluste for his failure to;' [called for `mi objective lvman Alfonso Garda , appeir.T;'! v, * ;;`.':; and scientific .inves- *(K B L,:<W estern V-'Makalintal, :howe`v-k *' tigation "to bring 'out JVisayas),, subcoramit-. ".er, said llustrc should" "the .facts about /ashes'tee chairman, reported [;be given, a chance%to'.*jtqs-cement pipes.",-:-, . .that-MWSS .General .* attend the ` hearings * 7:vCarios M.;Bofromeo, .Manager Oscar liustre' 'voluntarily ^without " 'acting secretary'of the failed to appear last .any.summon from the group, said the 'inanuweek in another hear-', assembly. .7."';*;" ;v-'facturers are`confident ing on diggings .dm-' ` "'."* ' that the findings will ducted by the subcom - - .Representatives of uphold thelr^ conten mittee on public works: fibro-cement :.pipe tion .the use';of*these which Garcia also" manufacturers * wel- pipes'."pose no' danger heads. , corned yesterday -the "to fhe'public.**-A-..J *1 CAPCO JEN 0033116 ATTACHMENT 11 President 'Marcos /`meal studies,'its"fmd-'.V-Presiderit'' created ,a' '* and to submit . 'within submit to the Batasai directed the.Metropoli- : ings on asbestos-fiber- ^.five-man\presidential ` three'months its "re-.'.V-which is conducting;! tan Waterworks and ..reinforced'cement.wa^'.Jadvisory/committee 'commendations for a separate -inquiry ini Sewerage**Systern .`.ter. mains.*- 'A'\.'r\V^Sbeadedj-'by :Hea]th 'policy that would best':`the .effects on publi yesterday to :submit to 'y -To safeguard'.public ".Minister `Jesus Azurin serve the interest of all - health of-these pipethe BatasangParaban-health ;and.''eaeMto conduct an exhais- .the citirpnry." ; -V > -* the MWSS assessmer. a; after further tech- apprehension, ."the/, tive* scientific stidy ,\' .The President..in', and to -.inform;th< -veffect-lifted the ban on - legislature'of the cfea the use of cement pipes-*, tion '.of'the^ specia reinforced by asbestos- -advisory 'committee fibers.' conducting a thorough " 'In the presence bfhis'Y./study of the matter.-; staff and some `callers ' Pending completion at* the .front .doorvof. of the ' two-pronged Malacanang, the Presi - study and the formula^' dent .examined the -tion.of a policy ori.the "'pipes. He found that in 'use of asbestos- \ the case of those made ireinforced cement ;.oi cement, asoesios u-^- pjpes, tne .-.rresiaent ..ber was merely used as V!-said, the/cement pipes strengthening materialcan bemused and purch- and constituted a mere 'ased by both the MWSS five per cent ofthe total and' the ''Local* Water', .pipe material, v ".*;?/_ Utilities* Administra- ; * He' reportedly jpiired whether.the.w`a*'S'rr^ Pa$* $ fflyQ vter>actually 'touched*; Jthej- asbestos. -MWSS i Is1'*# 8V.| .-.officials replied in'the ^negative.' '?;?% :&r * pr-'-Asbestos 'dust or fi- ; J.bers'.}inhaled into.'the!. ij.lungs have been known \ to cause cancer^ accord-^, '"ing td:recent findings, >;and that asbestos fiber j freight be* carcinogenic ? -'-.or; cancer-causing/^?*l ' V-V';`vpipcs being usedin'the'watcr distribu-. system in Metro ^lahila.Mnclud-. 'V-\`rV ing pipes, of cement -strengthened by ->*Th e..'Presiderit /directed.-.the _;MWSS .'jgeneral./manager..to V-.';' asbestos/ .The . pipes ;were taken.'-to **-. Malacafiatig by MWSS .General Mana- * v ger 'Oaca'r Iluslre.' ' i?;---J}/^ . ..0. . 1. -A- 1`U.->. \ CAPCO JEN 0033117 .#8 'BULLETIN TODAY,. SAT.~, :NOV. 20.1982- ' meters more of.such ;-ASBESTOS; pipes'.strengthened by /countries .-pipes. with `an* Earlier, in response *(Cont*d'from asbestos fiber, laid out -`aggregate,"length 'of t;to`complaints and pub- i; tion or their 'oontrac-. 29 years `ago by .'.the ., 1,500,000 miles. In the 7 lie,.apprehension over . V >vr , Metropolitan Water:" /United States, many 7the use of what are 1 , T'MWSS General i works* and Sewerage `'cities .have laid . out -considered 'carci /.^Manager Oscar Hustre Authority^ and mains ' 300,000 miles of such nogenic materials for .' pbrought..to'`;Malaca- made of cast iron .and, pipes. - ; public health purposes, ^*nang 'for. the Presi* .* reinforced steel../. , According to llustre; .the President had sus- " -jdehfs personal irtspec- ` -The' MWSS.submit the Philippines has ' .'pended the use of such .Vtion "several excavated . ted statistics*to-the only 297 Jdlometers of pipes because''of ra 'rpip^s being used in the ...President showing that /cement 'pipes .'.rein-', pports .that "asbestos J iMetro' Manila "water cera'entVpipes -streng-' .forced with asbestos fi-' pipes" were being used ' /distribution -system*, -? thened byv asbestos fi ,`ber: Plans call f9r the . for-water .mains.". *' ;2These included cement -> ber were .used .in'" 40" flaying out of.300 kilo-;,, The government has -.an ongoing program to - improve the MWSS water distribution sya-~ tern in" the metropoli sten area, assisted*by the 'World Bank, and /the `Asian .Develop- /me'nt Bank," involving ',**a total outlay of P3.4 '-billion, P1.2-billion of ] - which is* allocated for . CAPCO JEN 0033118 Vi?/I00/>2 Kovoubcr 25, 1S22 /iE-asa'i:?. c-rsus azasixs iliiiiu'sry of health SiUi Lamm CecpOUUd M AUIX. A bear Jilivioter Anuria: I;" >'" . '.A " * Devsiopstunt Corporstcicjs arcs nariutecturom of" ashes fcoa--cfc'neti'c pipe and building xiszo^ucicb. in the Kulipsinss. Tne corporations, established over twenty yc-iirG neo, presently er.ploy CSO persons ;<nO hve Sox the r&zanz hied r-tillioa invested. in facilities. iiiO brerait ai.,i i;h Zcoiit Carp prafci oft& endorse the o?v:-oin'iKenfc of a Presidential Advisory Co-nrittee on the safety os K/C pipe for the coGveynnao of critir.iiv: sxcr, v."e rtsinfain that such objective, scientific innuirrer, best: serve tho i-iterest* of all partins*. the public, coverrwai {or. initu-try. lr; ths spirit of cooi^-rfAior,, enclosed axa (1) a succory of ten ji'{.-dical j:o scientific studies conducted on .injected asbestos, ami (2) references cited in tee susuter.*/. Xhis Rut-aary was prepared by the A/C Vice yrccmcors Associntion., an international associatim ;:cadq;:art;..r<.; in W-iiiiiiii-jter, ii.C. the Association is n worldwide ir.foraatioc bcvxco on file ;..-.c.itortcrj, cosier:', insra1.tesion <\-'ai perfortssricf: of i/C V'ipo yroC^cte, .3- weii e.= toe industry's; ypocosiiart on occupational health sail cr.virmneotoi c-artor:;- ;cr. At zirl Zteiit Cvnshri-ocic-ii a bavelccrscnr. Cc-rporatiar. r.aintciir, roc- y.ciiiiiOA tec-.!; there is no link between asbestos in driotiny water cei any firanascv A/C siye is as cafe ns any ptrier water p-i.p-in-p natsrini. . Shis-- . judeei-ent is based on /line yearw of jicifeut-vsic studies of hurxn populations ec-g.orcd to asbestos in drinking water, end. fifteen years of research on innovatory ani-aals sbiin;.storc-d lax-ee eicsunts of ancestor, ir. drinking water or fcoc. 7.11 of these studies vain-, cone by ineiepeiiCoai: or govor/rssr.t- . scisr.tUits, viiO have no financial it-tor esc in and motive no firsunci al 'support free rr.e >/C pipe industry, licsc- show that teare is & c-au-'e and effect1^:!/;/, rolationoaip bc-tw&en asbestos in drinking water, A/C pipe ar-o any' adverse."'J': health effect. : CAPCO JEN 0033119 rV?/100/02 2- - - - Htarr.it Corporation and Italit Construction 3 D&volopni-tit Corporation*5^ pledge their continuing supxxsrt and cooperation during the Advisory-V; Consulttea deliberations. Vfe would be pleased^ to respond to any <iudstlons~ V !''>>? and concerns raises* therefrer.. ' . A-';-:'tj .. ' ' x-rai.iT cotiSTicuc-riOH a dsv. cdoS-onATiKt'^ ' V '' ce: Sail Q. Onvier, Kini-ster, National Science * Technology Authority Dr. Cairo 'Aequo, l-recutive Director, National ihiviroisssofeal frotnotioa Council Dr. Ignacio Salcedo, Director,Product Standard Agency ...' i'-red Eliseide, Ar-isidsut, rhilippir.e Chamber of cosawirco 5 Industry Duds, j Curssary of itedioal and Scientific Studies on Ingested Asbectcn hclerece.= Cited on the Sur-saary v AecLiea! end Scientific Studies on Ingested idabentoa ..." CAPCO JEN 0033120 zvp/iQi/az Keyether 25, IS62 Ahi-ftliibfhnh AU'OliSO C&P.CIA H&t&sang pariboiisa ;.csao:i cist - Dear ftastsablyaan Garcias AShHSXOv-Cihihl? PIPK Aim hhAI/Th jjy a-cana cf introduction, sterait- Corporation and Xtalit construction & bcveloi-cient Corporation are naturaetorero or sjib.saccu~c<MonC pipe and building products in' the Philippines. Tne corporations, established cv*r twoany ys-ftra ago, j.-reaeuciy cnpicy 550 parsons and have for the torrent *10v rdiilon ir-.vostvd In i'acilitisc. Tr.& and tnv italic Corpora cior.n endorse the study:i>y:UketSubcocivifetae or SnviroKacatol health on tno safety of the :i/C piya dor the conveyance of cricking Viter. lie maintain that ouch objective, scientific inquiries best serve th:.- inkc-rc-nts of all forties: the- public, goverr.ivtxit and industry. In taw spirit of cooperatior., enclosed sre <i) a aur-eary of the radical and cci-.::ifiic.` studies; conducted on ingested asbeotos, <i:di {2) reierd.'scuii cited in th.y sutssary. "his scn.tj-.ry was prepared by chu A/C Pipe Predators Atscc.iation, an international association headyaartarad in. Vte.uhzr.5t0n, O.C. ths Association in a worldwide- infoxnation source on the nanuiactcrisg, design, installation a:.d pcrforsiarce at i'./C Pico products, no veil sa the industry's syohasir-sn 0:1 cccu'-atioriil health and cr.viroi .rental mutor-t. iterniu Cory-orafcios ar.d itaiit Construction n Oevoloptient Corr-oxaticn znintuia ch<= position mat there is r.o lint between aabustoe in drinking water and any di^sacej A/C pipe is us aufc any othar v>c<ter i-iping- batczial. This 3ur.lac-Rer.fc is based on nine years of scientific studies of inzean populations ftstosed to asbestos in drinking water, and fifteen years of research on laboratory' nnir.uls adrlnisfcvrea large ottoiuifcs of aooeutoa in diir3d.ivj uatr or food. Jill of these studies were cone by independent or government' ' ' 1 coin'r.bi, who have no financial interest in end receive no tir.tr,c'iai support, fren ci'.a h/C pipe Industry, li-nut.* sViow that there is.a attic nad offset - relAtic-nship between esbesics in drinking water, i'./C pipe -and any adverse > health effect. . .. -., ' . '....'# 1 CAPCO JEN 0033121 EVP/101/32 ' \r-hi'- itemit Corporation and Italit Cons truetier, fi Seva Xoprumt Corporation pltidya their continuing support and cooperation daring the deliberations. h'o voald be pleased to resound to any questions and ' ; concerns raised tberefroa. lours{faithfully/ ETibWir co:<'-OiWioii - ~ V ,lw c-T*'i,I iIfI-.' !/ 'i CfJfcYCiXVKLS i,r^d-'-at dC'CI/Sj-i^T/CSt Asaoah-iyuan. xarciso Xonicrc AKsesbiysan Coaii-erto taaauiy Xcgeiic puiarbeo Assctsblyiyys Casus Xtonro tncic.; its-mry c.I Kudical tea Scientific Ktudic-s on Insisted I'-sb-sst'SS Uofuroncas Cited on the surc-ary o Jiedical and ociur.iu.iic Studies on in-yisccd .'isi'sstos i CAPCO JEN 0033122 A/C Pipe Producers Association' Public Affairs Committee TO International Affairs Committee PROP J. F. Welch, Director, Public Affairs Interna! Correspondence date October 22, 1981 News Article - Plastic Pipe Hazards REF: JFW correspondence, Article on Potential Health Effects of Piping Materials, March 26, 1981. ACTION REQUIRED: Review for information Enclosed is a news article forwarded by Winner/Wagner & Associates, Inc., AACPP's special counsel in California. It reports on an ongoing controversy about the safety of plastic pipe for use in home and commercial buildings. It is understood that the end uses primarily involve drain waste and vent applications. If you have any questions, please do not hesitate to call. JFW/ajb Enclosure cc: A. Kahn, Esq. N. Rahn, Esq. B. Garcia (Winner/Wagner) w/o enclosure copies to: Public Affairs Committee International Affairs Committee H. Olson I. Adams W. Perrell J. Woods J. Baker T. Dougherty D. Stinson W. McCallie B. Collier R. Dorner B. Giboin C. Walters R. Hobbs A. Saoulis R. Jalan V. Pattabhi H. Hudson C. Barton S. Al-Tarkait E. van der Rest HEGA/Library Chrono ii CAPCO JEN 0033123 < l 22 Part I/Saturday, October 10,1981 -- " ------------------- *_ * CosAngeles Sfones fGroiip Fears Plastic Pipe Hazards : Coalition Opposes Expanded Use Until Safety Is Proven . By RON HARRIS, Times Staff Writer CSting potential health and fire hazards, two legislar . tors heading a coalition of environmentalists said EYiday they will fight any efforts to expand use of plastic pipes in homes and commercial buildings in California until the plastic pipe has been proven safe. Speaking for Californians for Safe Building Materials, ; Senate Minority Leader William Campbell (R-Hacien- : da- Heights) and Assemblyman Louis Papan (D-Mili- brae) said at a press conference preliminary tests indi-. ; catethat using certain plastic pipe for drinking water i3 ; a fire hazard and that such pipes may'cause cancer. They compared use of the pipes with use of asbestos. 1 I don't want to have another system evolve like we ; have with the use of asbestos," said Papan', chairman of , the Assembly Rules Committee. "We have schools in many areas where it is used and we can't find the neces- : sary funds to remove that asbestos. '' . Californians for Safe Building Material wants IAPMO to delay approval until toe state's Department of Hous-' tag and Community Development completes a study on the safety of plastic pipe. . , "We're not condemning the pipe, or saying that there is something wrong with it, but we think there is "enough evidence that indicates further testing is neces sary before it is approved," Campbell said. The state agency undertook the study after prelimin ary tests found that water stored in plastic pipes for two weeks contained three carcinogens at levels far exceed ing the acceptable risk standard approved by toe En vironmental Protection Agency, Campbell said. The new study has been delayed because pipe manu- i facturers, who paid for the preliminary report, will not i pay for the project, Papan said. ! . Members of the International Association of Plumb ing' and Mechanical officials, made up of hundreds of plumbing code enforcement officials from citiesjj 11 ; Western states, France and South America, are meeting The Cutting Edge Sunday in Reno to decide whether codes should be - amended to allow builders to use certain types of plastic "AWOODCRAFTER'S pipe for plumbing in homes and multi-;story buildings. ,,The association establishes the uniform plumbing cqde, which is usually adopted by most cities mid coun ties, according to Les Chatfield, Los Angeles chief plumbing inspector. Chatfield. a member of toe assoda. tion's code committee, said his panel has recommended . approval of expanded use of the pipe, which is cheajier 'than metal pipe and easier to instalL In California, the amendments would be adopted by toe state Housing Commission,' which ''traditionally. : sticks pretty close to the uniform code," Chatfield said.' ' The coalition vowed to fightstate approval. DREAM STORE" Sunset Magazine The Cutting Edge is the complete woodworking supply store. Featuring over 3,000 of the finest hand and power tools, hundreds of exotic hard woods. plus an extensive selection ot woodcraft books and classes. Come to The . Cutting Edge and see why Sunset Magazine ' called us "A woodcrafter's dream store." ;'' - INCA & LUREM POWER TOOLS SUPERB CARVING TOOLS EXOTIC HARDWOODS '' - ; ' WOODCRAFT BOOKS & CLASSES ' r. .. I" I CAPCO JEN 0033124