Comment Opposing Proposed Rule 10CFR76 Re Regulation of U
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. _ _ - _ _ _ _ . * | ' , United States bternal Aff a rs (A 100AE) ' '. EnWonmental Protect on Wash,rgton DC 20460 /f Agency Federal Actyt es - ?. ' '88 JL 25 All :30 JUL 2 21988 , l . I fL ' s g , 5; v0CXn,iP.'.Ni u | t ! | O | Mr. Samuel Chilk Secretary of the Commission PROPOSED RutE d' ii _ 2A._ U.S. Nuclear Regulatory Commission 63FA /12Rs Washington, D.C. 20555 ATTN: Docketing and Service Branch . I Dear Mr. Chilk: In accordance with Section 309 of the Clean Air Act the U.S. Environment 'l Protection Agency (EPA) has reviewed the U.S. Nuclear Regulatory Commission (NRC) Advance Notice of Pruposed Rulemaking ( ANPR) for the Regulation of Uraniun Enrichment Facilities (53 FR 13276). While we have not identified any significant radiation protection issues in the notice, the proposal may not adequately protect the public from exposure to hydrogen fluoride (HF). Presently, EPA is evaluating HF as a candidate for regulation under the Clean Air Act, including possible regulation under Section 112 Although no decision regarding regulation has been made, EPA's efforts may be helpf ul to the Commission. Specifically, NRC stated that short-term public exposure to less than 26 sg/md of HF "will not have a significant adverse ef fect on the health and safety of the public." The ANPR does not specify the length of exposure. If "short tem" implies periods longer than minutes, then this statement is inconsistent with some existing health studies and reported evaluations by other organizations. First, there are several scientific reports which suggest that short- tenn exposure to 26 mg/m3 of HF is not protective of puolic health. Halton, et al. (1984) estimated that the lowest lethal concentration for a 5 minute period (LDLo 5 minutes) for human exposure to HF to be as low as 41 mg/m3 Just and Emiler (1984) noted that irritation is experienced by humans when exposed to 13 mg/m3 for more than 10 minutes. Also, E. J. Largent indicated that repeated human exposure to concentrations above 2.b mg/m3 produced some burning and irritation of the nose and eyes. Second, both the American Conference of Govermental and Industrial Hygienists ( ACGIH) and the National institute of Occupational Safety and Health have reviewed the available health data and have made reca,mendations for the protection of workers that are pertinent to HRC's preliminary detennination of acceptable HF exposure levels. The National Institute for Occupational Safety and Health found that exposures to concentrations greater than 20 ppm (16 mg/m3) for thirty minutes are "immediately dangerous 8808010243 880722 PDR PR 76 53FR13276 PDR DSk _ _ _ _ _ _ _ _ _ _ _ _ . * : | 's . 2 to life and health." In addition, they recommended using a 15 minute ceiling of 5 mg/m3 to protect workers from undue exposure. Also, the ACGIH has recommended that a ceiling limit (not to be exceeded) of 3 ppm (2.5 mg/d) be used as a guide in regulating HF worker exposure. When considering the above infomation, we have identified two additional concerns. The available data are based on a limited number of exposed people and probably do not reflect the potential effect on sensitive subgroups. Also, it presently is not clear how severe the reported irritation.was in the exposed individuals. Because the levels which cause "irritation" are not that far removed from levels that cause very serious health effects, we suspect that the "irritation" may be quite sig ti ficant. Unfortunately, the available data do not paint a clear picture for the EPA or the NRC to make a quick detemination nf acceptable HF levels. In concl1sion, we believe that, although limited, thp available health effects data suggest that some level below 26 mg/mJ be considered to protect against "significant adverse effect on the health and safety of the public." The length of possible exposure is a key factor in determining what this level should be. We are attaching 'or your use a preliminary draft of a health assessment document prepared by EPA's Of fice of Health and Environmental Assessment. The references in my letter are listed in the draft report, and other infomation in the report, though of a preliminary and draft nature, may be useful to the Commission and its staff. I believe it would be helpful if our staffs met to discuss this further. I have asked Dr. W. Alexander Williams (382-5909) of my staff to call the Commission staf f to arrange a meeting or a teleconference. Sincerely, j ptg tr v ---- Richard E. Sai r rson Director Of fice of Federal Activities Enclosure | | __ - _ - - -____ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ - _ _ - _ _ _ . _ _ - _ - _ _ - - - - _ _ _ _ - _ _ - - _ _ - - - - _ _ _ _ _ _ - _ _ - - _ . _ _ - _ - - _ _ _ _ - - - _ _ _ _ _ _ - - _ . _ _ | '' .. \ . " OAOPSREvitO United States scAo.n.istA *, Environmental Protection July 1947 s Agency internet Drott Report .J 4 f#~ . GEPA Research and PRE LIMINARY DR AFT 1 gyg Q %Q DO NOT QUOTE OR CITE l ' SUMMARY REVIEW OF HEALTH EFFECTS ASSOCIATED WITH HYDROGEN FLUORIDE AND RELATED COMPOUNDS: HEALTH ISSUE ASSESSMENT Prepared for OFFICE OF AIR QUALITY PLANNING AND STANDARDS OFFICE OF AIR AND RADIATION Prepared by OFFICE OF HEALTH AND | ENVIRONMENTAL ASSESSMENT WASHINGTON, DC 20460 | This docunw et is e pre'im:nery draft and is intended for internal Aeoney one only, it has wt been formeity releoned by the U.S. Environmental Protection Agency ses s'.eund not et this stege be construed to reprocent Atency pohey. It is beie *, circulated for comments on ?ts technical merit and policy implications. - . _ - - - . _ _ _ _ . ~ - . _ - - - - _ - , , - _ _ - - _ _ , . _ . _ . , _ _ . _ _ . - _ . - - _ - . - - . _ _ _ _ , , . _ _ . - - _ _ _ _ _ _______ _ _ - ' , , ' , . DISCLAIMER This r.fociment has been reviewed in accordance with United States Environmental Protection Agency policy and approved for publication. Mention | of trade names or comercial products does not constitute endorsement or recomendation for use. i | | , 11 - _ _____ _ __ _ _____________ ._. ' .| . PREFACE The Office of Health and Environmental Assessment has prepared this health assessment to serve as a source document for use by the Office of Air Quality Planning and Standards to support decision making regarding possible regulation of hydrogen fluoride as a hazardous air pollutant. ' In the development of this assessment document, the scientific literature through January 1987 has been inventoried, key studies have been evaluated, and summary / conclusions have been prepared so that the chemical's toxicity and related characteristics are qualitatively identified. Observed effect levels and other measures of dose-response relationships are discussed, where appro- priate, so that the nature of the adverse health responses is placed in perspective with observed environmental levels, g Any *information regarding sources, emissions, ambient air concentrations, f and public exposure has been included only to give the reader a preliminary [ indication of the potential presence of this substance in the ambient air. f While the available information is presented as accurately as possible, it is acknowledged to be limited and dependent in some instances on assumption rather than specific data. ,.This information is not intended, nor should it be used, to support any conclusions regarding risk to public health. If a review o/f the health information indicates that the Agency should consider regulat[ry action for this substance, a considerable effort.will be undertaken to obtain appropriate information regarding sources, emissions, and ambient air concentrations. Such data will provide additional information for drawing regul'atory conclusions regarding the extent and significance of public exposure to this substance. : . iii . _ _ _ _ . ____ _ __ __ _ _ _ . _ _ _ _ . _____. - . _ _ . i . ! : .- .- 1 l . l I i CONTENTS | , 1 Ph92 | , TABLES ............................................................ v | 1. SUMMARY AND CONCLUSIONS ....................................... 1-1 2. INTRODUCTION .................................................. 2-1 3. AIR QUALITY AND ENVIRONMENTAL FATE ............................ 3-1 3.1 SOURCES .................................................. 3-1 3.2 DISTRIBUTION AND FATE .................................... 3-4 3.3 AMBIENT LEVELS ........................................... 3-5 3.4 EXPOSURE ................................................. 3-7 4. PHARMAC 0 KINETICS .............................................. 41 4.1 ABSORPTION ............................................... 4-1 4.2 RETENTION AND DISTRIBUTION ............................... 4-2 4.3 EXCRETION ................................................ 4-3 5. MUTAGENICITY AND CARCINOGENICITY .............................. 5-1 5.1 MUTAGENICITY ............................................. 5-1 5.2 CARCINOGENICITY .......................................... 5-2 6. DEVELOPMENTAL AND REPRODUCTIVE T0XICITY ....................... 6-1 7. OTHE R T0X I C E F F ECT S . 7-1 7.1 ACUTE T0XICITY ........................................... 7-1 7.2 CHRONIC T0XICITY ......................................... 7-2 7.3 BIOCHEMICAL EFFECTS ...................................... 7-4 8, BENEFICIAL EFFECTS ............................................ 8-1 9. REFERENCES .................................................... 9-1 , iv . _ - _ - - .. _. , . .. s . p i TABLES Number Pa2' 1-1 Summary of human fluoride intake from various sources ...... 1-6 1-2 Summary of effects on humans of various levels of fluoride , intake ....................................................