On June 25, 2012, the Department of Health and Human Services (HHS) published a notice of proposed rulemaking proposing to update respirator approval standards in response to a petition to amend our regulations, current requirements for self-contained breathing apparatus (SCBA) remaining service-life indicators or warning devices. These indicators are built into a respirator to alert the user that the breathing air provided by the respirator is close to depletion. In this final rule, HHS responds to public comment on the proposed rule and revises the current standard, employed by the National Institute for Occupational Safety and Health (NIOSH) located within the Centers for Disease Control and Prevention (CDC), to allow greater flexibility in the setting of the indicator alarm to ensure that the alarm more effectively meets the different worker protection needs of different work operations. This final rule sets a minimum alarm point at 25 percent of the rated service time and allows the manufacturer to offer remaining service life set point at a higher value or values appropriate to the purchaser’s use scenario.
In 2003, NIOSH received a petition from David Bernzweig of the Columbus (OH) Professional Firefighters International Association of Fire Fighters (IAFF) Local 67 requesting that the agency initiate rulemaking to amend 42 CFR 84.83(f). [1] The current rule requires that the self-contained breathing apparatus (SCBA) service-life indicator (also known in the firefighter community as an end-of-service-time indicator (EOSTI), or a low-air alarm) give an alarm within the 20 to 25 percent range. Stakeholders in agreement with Mr. Bernzweig requested that HHS eliminate the lower value (20 percent) and require the indicator to alarm no later than at 25 percent of rated service time. NIOSH considered the request and facilitated discussion among stakeholders by holding a public meeting to discuss underlying issues and technical matters on December 2, 2008, in Pittsburgh, Pennsylvania (73 FR 65860, November 5, 2008). [2]
The National Fire Protection Association (NFPA), which sets standards for personal protective equipment used in the fire service, initiated an effort in 2008 to develop consensus on the matter and recently decided to amend NFPA 1981: Standard on Open-Circuit Self-Contained Breathing Apparatus (SCBA) for Emergency Services [3] to require that the indicator alarm at 33 percent.
For reasons discussed in the notice of proposed rulemaking published in the Federal Register on June 25, 2012 (77 FR 37862), HHS finds that amending § 84.83(f) to allow greater latitude with regard to setting the indicator alarm would not reduce the amount of protection afforded to firefighters and other SCBA users. In fact, HHS has determined that specifying a minimum setting of 25 percent and allowing manufacturers to offer different alarm settings more suited to purchasers’ use scenarios will result in a more meaningful alarm that may offer greater protection for users.
The amendment to 42 CFR 84.83(f) establishes that the low-air indicator must activate at a minimum setting of 25 percent of the SCBA’s rated service time. If a purchaser has determined that an earlier alarm will benefit the specific occupational purpose for which the respirator is to be used, the purchaser may request that the manufacturer offer a remaining service-life indicator alarm set-point at a higher value (or values) appropriate to the purchaser’s use scenario. If the manufacturer chooses to offer a respirator with a different set-point (at no less than 25 percent of the SCBA’s rated service time), the modified respirator must be approved by NIOSH. Purchasers may also have the indicator setting modified for already fielded SCBA units by an authorized representative of the manufacturer, provided that the respirator model has received a new NIOSH approval specifying the new alarm set-point. The final rule also codifies a long-standing NIOSH policy requiring the indicator for demand and pressure-demand open-circuit (OC)SCBA to alarm continuously until the respirator’s breathing air supply is depleted.
Changes to the proposed rule text are made in response to public comment, to clarify our overall intent; to specify that the requirement for continuous alarming is intended for open-circuit, demand and pressure demand units only; and to require that manufacturers identify the indicator setting on each unit. Specific comments and responses are discussed below. The rule text is also amended slightly to better comply with Federal plain language requirements.
Comment: Two commenters were fully supportive of the rulemaking. One commenter stated that requiring fire service respirators to alarm when breathing air reaches 25 percent “does not serve the needs or interests of today’s fire service.” According to the commenter, “[t]here is no safety purpose served by not allowing an earlier set point for the EOSTI. An earlier set point would allow for a greater margin of safety for the end user. Not having an earlier set point would continue to place firefighters at risk by not having an adequate air reserve when the EOSTI activates.” The commenter further agreed that the alarm should not be field-adjustable and that purchasers should be able to specify the setting at the time of purchase or service.
HHS response: We received two comments that appeared to confuse the standard proposed by HHS (a default of 25 percent unless the purchaser requests a different, higher, value) with the standard being developed by NFPA (alarm activation at 33 percent). One commenter expressed approval for giving purchasers the ability to set the remaining service-life indicator alarm between 33 percent and 50 percent. The other commenter expressed disapproval for changing the indicator to activate at 33 percent rather than 25 percent.
HHS response: The amended standard is responsive to the various concerns. Manufacturers are not required to modify existing approvals to comply with this rule; they may continue to market and sell respirators approved under the current standard, indefinitely. If, in response to purchaser needs, the manufacturer chooses to market and sell respirators that activate at the 25 percent minimum requirement or earlier, the manufacturer must obtain a new or revised NIOSH approval.
Comment: One commenter supported the inclusion of a 50 percent upper limit for the alarm set-point; other commenters neither supported nor opposed the upper limit.
HHS response: We did not receive justification for applying a 50 percent upper limit. It is conceivable that some use scenarios might warrant an earlier alarm point. Accordingly, we have not revised the proposal in response to the comment.
Comment: One commenter suggested that allowing individual fire departments to determine their own remaining service-life indicator setting may cause “incident related” problems. The commenter further stated that there was no discussion in the notice of proposed rulemaking about the use of the heads-up-display for monitoring breathing air depletion or the reliance on teamwork to maintain situational awareness.
HHS response: This comment raises training issues regarding the users’ response to an alarm being activated. We understand that a change in the mechanical alarm setting may necessitate a change in training protocols. However, training for the proper use of these respirators is outside the scope of this rulemaking.
Comment: One commenter agreed with the intent of the proposed rule text but suggested a number of edits. The commenter stated that the proposed rule text did not account for the distinction between respirator models whose alarms are designed either to activate electronically or activate using the device’s compressed air. According to the commenter, “[i]f the EOSTI is activated electrically then the alarm can sound continuously until the depletion of the breathing air supply. If the EOSTI is activated using the compressed air in the system then at some point the alarm sound will decrease in decibels and even cease to sound before the breathing air is depleted.” The commenter suggested adding the text “if electrically controlled or to a pressure of 10 bar (145 psi) if operated by the compressed air in the system” to the text in § 84.83(f).
HHS response: The purpose of the alarm is to advise the user that the system is depleting its air supply. While the rule text does not specifically identify models that alarm either electronically or using compressed air, we intend for the indicator to alarm until the air supply runs out in order to warn the user of the situation so they can take appropriate action for their setting. That the indicator may not continue to alarm until the air supply is absolutely depleted is understood and is evaluated in NIOSH testing (see NIOSH standard testing procedure RCT-ASR-STP-0124, Determination of Remaining Service-Life Indicator—Open-Circuit, Demand and Pressure-Demand, Self-Contained Breathing Apparatus, at http://www.cdc.gov/niosh/npptl/stps/pdfs/RCT-ASR-0124.pdf, which will be updated to comport with this rulemaking).
Comment: Another comment referred to long duration closed-circuit breathing apparatus (CCBA), which are also regulated under Subpart H in Part 84. The commenter stated that “it can be interpreted that even long duration CCBA would also need to meet the proposed new requirements. For example, this would require that a CCBA with a rated service time of 4 hours would need to have the EOSTI alarm continuously for 1 hour and this would be annoying to the users and may affect their activities in a negative manner.” The commenter accordingly suggested that the text in § 84.83(f) should address only open-circuit devices, and offers a new § 84.83(g) which suggests that, for closed-circuit devices, the indicator should alarm for a limited time period when the reserve capacity of the apparatus is reached, and a continuous alarm when a prescribed pressure is reached.
HHS response: HHS did not intend for the continuous alarm requirement to pertain to long-duration closed-circuit devices. However, the open-circuit demand and pressure-demand devices are expected to alarm continuously once activated. Accordingly, we have amended the final rule text to require that only open-circuit demand and pressure-demand (as described in 42 CFR 84.70(a)(2)(i) and 42 CFR 84.70(a)(2)(ii)) respirators need to alarm continuously.
Comment: One commenter suggested that only purchasers who are required by a third-party standard to request an alarm set-point other than the default 25 percent be allowed to request a different alarm setting.
HHS response: We do not agree that the 25 percent default value should only be raised when prescribed by a third party standard. While § 84.83(f) is amended in response to a petition on behalf of the U.S. fire service, we note that OC-SCBAs are used by industries and in occupational settings other than firefighting. We intend to maintain flexibility with regard to the alarm setting requirement to avoid further limitations on the ability of purchasers to request an alarm set-point appropriate to their use scenarios and the ability of manufacturers to offer such respirators.
Comment: One commenter stated that the terms `default’ and `adjusted’ used in the rule summary are vague and “cause policy or test requirement issues.” The commenter recommended that the word `default’ be removed because it “implies the product must meet the minimum setting and shall be capable of fulfilling a higher setting. We believe this is not the intent of the proposed changes and can lead to unnecessarily design-restrictive interpretations.” The commenter requested that, in addition to adjustable designs, the rule should “allow flexibility to permit others such as dedicated set point designs.” The commenter suggested that the rule text should be modified to state: “Each remaining service-life indicator or warning device shall give an alarm when the remaining service life of the apparatus is reduced to the manufacturers’ specified range and shall alarm continuously until the breathing air supply approaches depletion. The manufacturer can specify either a set point of 25 or 33 percent of its rated service time in response to the user’s specific request.”
HHS response: The terms `default’ and `adjusted’ do not occur in the rule text; however, HHS does intend for the product to be able to meet the 25 percent value as the minimum setting and/or any higher setting requested by the purchaser. During performance testing for approval, NIOSH will test the alarm setting identified by the manufacturer in its request for approval of the respirator system. If the manufacturer does not identify an alarm setting, the indicator will be tested to show that it activates at the value of 25 percent of its rated service life. The rule does not specify or restrict how manufacturers must comply with its provisions; manufacturers who find it in their best interest may offer specific set-points. Manufacturers are not required to produce a device that is adjustable to different users’ needs, and can continue to market and sell SCBA models approved by NIOSH prior to the effective date of this rule. However, should the manufacturer wish to modify such a model for any reason, including a change to their service-life indicator set point, the manufacturer is required to apply to NIOSH for a new approval. Additionally, in evaluating this comment, HHS determined that the user should be able to readily identify a respirator’s alarm setting to distinguish models from one another. Models that meet the revised performance requirements of this rule should have labels and/or markings that identify the alarm setting for that particular model. At the discretion of the manufacturer, these markings could be addressed as part of the cautions and limitations associated with these devices, or as an additional label. In accordance with this determination, the final rule text is amended to address labels and/or markings.
Comment: One commenter recommended that 42 CFR 84.82 “include an additional section for a 33 percent” remaining service-life indicator. According to the commenter, “[a]llowing manufacturers the ability to utilize the same gauge for both alarm set points will reduce cost and complexity within the market.”
HHS response: HHS has determined that the provisions in 42 CFR 84.82 are sufficiently flexible to allow manufacturers to produce gauges that accurately indicate the amount of breathing air contained in a unit.
Comment: HHS received one comment on the E.O. 12866 and E.O. 13563 analysis in Section IV.A., below. According to the commenter, “[i]t is important to realize that additional costs for multiple or adjustable set points are inevitable. In addition to added design and documentation costs, options introduced into production will increase assembly and inspection times. Inventory costs increase with optional material warehousing.* * *. While they may be independent, other pressure gauges and electronic systems must be designed to correlate with the RSLI and the system(s) must be thoroughly verified. Differing RSLI settings may require differing gauge faces and electronics/programming designs tomaintain correlation. For all these reasons, costs will increase.”
HHS response: The commenter misunderstands the requirement. HHS does not require manufacturers to produce products with new features allowing for adjustment of the service life indicator alarm set point, or for various product models with different set points. Any manufacturer can choose to meet product demand by either manufacturing products with fixed set points or by manufacturing products with manufacturer-adjustable set points. Alternatively, the manufacturer can choose to take no action, and continue to sell respirators under existing NIOSH approvals. HHS is reducing the longstanding constraint on these product designs for a single alarm set point. Accordingly, we continue to conclude that there are no costs associated with this rulemaking, and solely benefits in terms of greater flexibility for manufacturers to meet the diverse needs of their customers.
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