Document LJOBV5kdOap2jK0gVwj3dRoz7

,25 1980 NOTICE TO ALL RESP1RATQR MANUFACTURERS The purpose of this letter is to express the concerns of the National Institute (or Occupational Safety and Health (NIOSH) regarding the use of air-purifying respirators against asbestos and other eareinogenic substances and to announce a course of action to address these concerns. First, the present requirements of 30 CFR. Part 11 preclude MSHA/NtOSH from voiding approval of dust fume, end mist respirators for use against asbestos and other carcinogenic substances without following appropriate administrative procedures. Section 11.130(f) of Subpart 1C mentions ' respirators with replaceable filters, designed as respiratory protection against asbestos-containing dusts and mists. Section 11.130(h) mentions single-use duet respirators designed as respiratory protection against pneumoconiosis and fibrosis-producing duns, or dusts and mists, including but net limited to aluminum, asbestos, coal, flour, iron ore. and free silica. e However, we ere deeply concerned about the use of dust, fume, and mist respirators, and other air-purifying respirators, against earcir.sger.ic substances. Our concerns are based on two major issues: 1) the ability of the filter media to effectively remove the carcinogenic substance during the entire period of use, and 2) the qotfetionsble face fit of at lean same dust; fume, end mist respirators, particularly the single-use type. Excessive leakage of a substance such es asbestos into the respirator due to either ineffective filtration or leakage around a poor seal is unacceptable and presents a potentially serious hazard to the wearer. The possibility of the development of lung cancer or mesothelioma, in the cate of asbestos exposure, cannot be ignored when both filtration efficiency and adequate face seal are questionable. On the issue of asbestos, the institute wishes to state thatafthough esbestos can produce fibrosis, this effect pales in significance in comparison to the known human and animal carcinogenicity of this fibrous material. It is not bur position that single-use dust respirators wilt provide adequate protection against the cancer causing potential ofasbestos. In tight of the present knowledge concerning the carcinogenicity of asbestos, the listing of asbestos as sn example of a "fibrosis-producing dust" in Section 11.130(h) can only be viewed as misleading. In the document entitled "Workplace Exposure to Asbestos: Review and Recommendations.*' the Institute concluded that "there is no asbestos exposure level below which elinical effects do not oecur; significant disease can occur following very short (1 day to three men*, exposure periods; worker exposures to esbestos must controlled to the maximum extent possible; end hum occupational exposures to eH oommercial esbesios fiber rr, have been associated with high rates of lung cancer i mesothelioma." The above concerns,focused largely on asbestos, also appi other eareinogenic substances referenced in 30 CFR. Far. Sections 11.130UX1) and 11.130(b) refer to dun. fume, mist respirators, either whh replaceable or reusable fin designed es respiratory protaction against dusts such arsenic, cadmium, and chromium. aO of which are suspee human carcinogens. Section 11.130(d) refers to respirat with replaceable filters, designed es respiratory prottcagainst dust, fumes, and mists of beryfllumandradionuriic which can produce* cancer. Eased on the fans that th purifying components of these devices ere tested not aga the carcinogens themselves but rather against ot materials (/'*..' do the filters effectively remove carcinogenic agent during the entire period of reeommen use?) and that the face teals of many of thesa devices marginal or inadequate, we ere concerned about their against carcinogenic substance* Respirators whh protection factors may net provide adequate prottc against carcinogens. . Accordingly. NIOSH intends to undertake a study of the us air-purifying respirators against asbestos and e: carcinogenic substances in an effort to resolve our cense in order to effectively accomplish this goal, it is essential the respirator manufacturers and ethers engsged in respir research provide NIOSH with aN relevant data in t possession. We herewith request: 1) aQ data relating to efficiency of yeur devices in rtmeving coma mins.particularly any data involving aetual testing agsi carcinogenic agents; and 2) any data pertaining to caieuia of protection factors for your devices. In essence, becaus the potential health consequences the Institute befievts the approval, of air-purifying respirators for use sgi esbestos and other carcinogens should be based on t demonstrated effectiveness trtd not on a policy adopted *. the carcinogenicity of certain chemicals and other substar wes unrecognised. Your assistance in this vary important assessment is vit you have any questions please write or telephone (301 } 3680. Slnecrely yours. Jon R. May. Rh.D. * DU 030433 Special Assistant to (he Director NIOSH. /or Testing and Ctrtifkaticn DUP 0913768