641—40.50 (136C) Use of individual respiratory protection equipment.
	 40.50(1) If the licensee assigns or permits the use of respiratory protection equipment to limit intakes pursuant to 40.49(136C):
	  a.   	 The licensee shall use only respiratory protection equipment that is tested and certified by the National Institute for Occupational Safety and Health (NIOSH), except as otherwise noted in this subrule.
	  b.   	 If the licensee wishes to use equipment that has not been tested or certified by the National Institute for Occupational Safety and Health or for which there is no schedule for testing or certification, the licensee shall submit an application for authorized use of that equipment, including a demonstration by testing, or a demonstration on the basis of reliable test information, that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use.
	  c.   	 The licensee or registrant shall implement and maintain a respiratory protection program that includes:
	 (1) 	 Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate doses;
	 (2) 	 Surveys and bioassays, as appropriate, to evaluate actual intakes;
	 (3) 	 Testing of respirators for operability (user seal check for face sealing devices and functional check for others) immediately prior to each use;
	 (4) 	 Written procedures regarding monitoring, including air sampling and bioassays; supervision and training of respirator user; fit testing; respirator selection; breathing air quality; inventory and control; storage, issuance, maintenance, repair, testing, and quality assurance of respiratory protection equipment; record keeping; and limitations on periods of respirator use and relief from respirator use;
	 (5) 	 Determination by a physician that the individual user is medically fit to use respiratory protection equipment: before the initial fitting of a face-sealing respirator; before the first field use of non-face-sealing respirators; and either every 12 months thereafter, or periodically at a frequency determined by a physician; and
	 (6) 	 Fit testing, with a fit factor equal to or greater than 10 times the APF for negative pressure devices, and a fit factor equal to or greater than 500 for any positive pressure, continuous flow, and pressure-demand devices, before the first field use of tight-fitting, face-sealing respirators and periodically thereafter at a frequency not to exceed one year. Fit testing must be performed with the facepiece operating in the negative pressure mode.
	  d.   	 The licensee shall advise each respirator user that the user may leave the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication failure, significant deterioration of operating conditions, or any other conditions that might require such relief.
	  e.   	 The licensee shall also consider limitations appropriate to the type and mode of use. When selecting respiratory devices, the licensee shall provide for vision correction, adequate communication, low temperature work environments, and the concurrent use of other safety or radiological protection equipment. The licensee shall use equipment in such a way as not to interfere with the proper operation of the respirator.
	  f.   	 Standby rescue persons are required whenever one-piece atmosphere-supplying suits or any combination of supplied air respiratory protection devices and personnel protection equipment is used from which an unaided individual would have difficulty extricating himself or herself. The standby rescue persons must be equipped with respiratory protection devices or other apparatus appropriate for the potential hazards. The standby rescue persons shall observe or otherwise maintain continuous communication (visual, voice, signal line, telephone, radio, or other suitable means) with the workers, and be immediately available to assist the workers in case of a failure of the air supply or for any other reason that requires relief from distress. A sufficient number of standby rescue persons must be immediately available to assist all users of this type of equipment and to provide effective emergency rescue if needed.
	  g.   	 Atmosphere-supplying respirators must be supplied with respirable air of grade D quality or better as defined by the Compressed Gas Association in publication G-7.1, “Commodity Specification for Air,” 1997, and included in the regulations of the Occupational Safety and Health Administration (29 CFR 1910.134(i)(1)(ii)(A) through (E)). Grade D quality air criteria include:
	 (1) 	 Oxygen content (v/v) of 19.5 to 23.5 percent;
	 (2) 	 Hydrocarbon (condensed) content of 5 milligrams per cubic meter of air or less;
	 (3) 	 Carbon monoxide (CO) content of 10 ppm or less;
	 (4) 	 Carbon dioxide content of 1000 ppm or less; and
	 (5) 	 Lack of noticeable odor.
	  h.   	 The licensee shall ensure that no objects, materials or substances, such as facial hair, or any conditions that interfere with the face, facepiece seal or valve function, and that are under the control of the respirator wearer, are present between the skin of the wearer’s face and the sealing surface of a tight-fitting respirator facepiece.
	  i.   	 In the estimation of the dose to individuals from intake of airborne radioactive materials, the concentration of radioactive material in the air that is inhaled when respirators are worn is initially assumed to be the ambient concentration in air without respiratory protection, divided by the assigned protection factor. If the dose is later found to be greater than the estimated dose, the corrected value must be used. If the dose is later found to be less than the estimated dose, the corrected value may be used.
	 40.50(2) When estimating exposure of individuals to airborne radioactive materials, the licensee may make allowance for respiratory protection equipment used to limit intakes pursuant to 40.49(136C), provided that the following conditions, in addition to those in 40.50(1), are satisfied:
	  a.   	 The licensee selects respiratory protection equipment that provides a protection factor, specified in Appendix A, greater than the multiple by which peak concentrations of airborne radioactive materials in the working area are expected to exceed the values specified in Appendix B, Table I, Column 3. However, if the selection of respiratory protection equipment with a protection factor greater than the multiple defined in the preceding sentence is inconsistent with the goal specified in 40.49(136C) of keeping the total effective dose equivalent ALARA, the licensee or registrant may select respiratory protection equipment with a lower protection factor provided that such a selection would result in a total effective dose equivalent that is ALARA. The concentration of radioactive material in the air that is inhaled when respirators are worn may be initially estimated by dividing the average concentration in air, during each period of uninterrupted use, by the protection factor. If the exposure is later found to be greater than initially estimated, the corrected value shall be used; if the exposure is later found to be less than initially estimated, the corrected value may be used.
	  b.   	 The licensee shall obtain authorization from the agency before assigning respiratory protection factors in excess of those specified in Appendix A. The agency may authorize a licensee to use higher protection factors on receipt of an application that:
	 (1) 	 Describes the situation for which a need exists for higher protection factors, and
	 (2) 	 Demonstrates that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use.
	 40.50(3) In an emergency, the licensee shall use as emergency equipment only respiratory protection equipment that has been specifically certified or had certification extended for emergency use by the National Institute for Occupational Safety and Health and the Mine Safety and Health Administration.
	 40.50(4) Further restrictions.
	  a.   	 The licensee shall notify the agency in writing at least 30 days before the date that respiratory protection equipment is first used pursuant to either 40.50(1) or 40.50(2).
	  b.   	 The agency may impose restrictions in addition to those listed in these rules in order to:
	 (1) 	 Ensure that the respiratory protection program of the licensee is adequate to limit doses to individuals from intakes of airborne radioactive materials consistent with maintaining total effective dose equivalent ALARA; and
	 (2) 	 Limit the extent to which a licensee may use respiratory protection equipment instead of process or other engineering controls.