Additional Quantitative Fit-Testing Protocols for the Respiratory Protection Standard, 3526-3534 [E9-922]

Download as PDF 3526 Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Proposed Rules paragraph and § 1.861–12T(c)(2)) in the stock of the redeeming corporation). These adjustments are to be made annually and are noncumulative. (vii) Examples. Certain of the rules of this paragraph (c)(2) may be illustrated by the following examples: Examples 1 and 2. [Reserved]. For further guidance, see § 1.861– 12T(c)(2)(vii), Examples 1 and 2. Example 3. X, an unaffiliated domestic corporation that was organized on January 1, 2000, owns all of the stock of Y, a foreign corporation with a functional currency other than the U.S. dollar since January 1, 2000. The Y stock held by X includes Class A and Class B common stock. X’s adjusted basis in the Class A and Class B common stock is $25,000 and $50,000, respectively. Y has earnings and profits for the 2008 taxable year of $40,000. During the 2008 taxable year, Y redeems all of the Class A common stock held by X for $40,000. Because X still owns all of the outstanding stock of Y, the redemption is treated as a distribution with respect to the stock of Y under section 301. Under § 1.302–5(a)(3), X’s $ 25,000 adjusted basis in the redeemed shares of Class A common stock is treated as a loss recognized on the date of the redemption, none of which is taken into account in 2008. Under paragraph (c)(2)(vi) of this section, solely for purposes of apportioning expenses on the basis of the tax book value of assets, X’s adjusted basis in its remaining Class B common stock of Y is considered to be $75,000 ($50,000 adjusted basis in the Class B common stock plus $ 25,000 unrecovered basis in the redeemed Class A common stock). (c)(2)(viii) Effective/applicability date. Paragraph (c)(2)(vi) and Example 3 apply to transactions that occur after the date these regulations are published as final regulations in the Federal Register. (c)(3) through (j) [Reserved]. For further guidance, see § 1.861–12T(c)(3) through (j). § 1.1002–1 [Redesignated as § 1.1001–6] Par. 18. Section 1.1002–1 is redesignated as 1.1001–6 and amended by revising paragraph (c) and adding a new paragraph (e) to read as follows: § 1.1001–6 Sales or exchanges. mstockstill on PROD1PC66 with PROPOSALS * * * * * (c) Certain exceptions to general rule. Exceptions to the general rule are made, for example, by sections 351(a), 354, 361(a), 721, 1031, 1035, and 1036. These sections describe certain specific exchanges of property in which at the time of the exchange particular differences exist between the property parted with and the property acquired, but such differences are more formal than substantial. As to these, the Internal Revenue Code provides that such differences shall not be deemed controlling, and that gain or loss shall VerDate Nov<24>2008 16:26 Jan 16, 2009 Jkt 217001 not be recognized at the time of the exchange. The underlying assumption of these exceptions is that the new property is substantially a continuation of the old investment still unliquidated; and, in the case of reorganizations, that the new enterprise, the new corporate structure and the new property are substantially continuations of the old still unliquidated. Solely for purposes of determining whether the exceptions to the general rule under sections 354 and 361 apply to an exchange, to the extent the terms of the exchange specify that a particular property is received in exchange for a particular property, such terms shall control provided such terms are economically reasonable. * * * * * (e) Effective/applicability date. This section applies to exchanges that occur after the date these regulations are published as final regulations in the Federal Register. For exchanges that occur on or before the date these regulations are published as final regulations in the Federal Register, see this section as contained in 26 CFR part 1 revised April 1, for the year before these regulations are published as final regulations in the Federal Register. Par. 19. Section 1.1016–2 is amended by adding paragraphs (e) and (f) to read as follows: § 1.1016–2 Items properly chargeable to capital account. * * * * * (e) Solely for purposes of determining basis in stock, in the case of a shareholder capital contribution to which section 118 applies, the principles of § 1.358–2(g)(3) (allocation of basis in a section 351 transaction in which stock is deemed received) shall apply. (f) This section applies to transactions that occur after the date these regulations are published as final regulations in the Federal Register. For exchanges that occur on or before the date these regulations are published as final regulations in the Federal Register, see this section as contained in 26 CFR part 1 revised April 1, for the year before these regulations are published as final regulations in the Federal Register. Par. 20. Section 1.1374–10, the first sentence of paragraph (a) is revised to read as follows: § 1.1374–10 rules. Effective date and additional (a) In general. For transactions to which § 1.302–5 applies [Reserved]. Sections 1.1374–1 through 1.1374–9, other than § 1.1374–3(b) and (c) Examples 2 through 4, apply for taxable years ending on or after December 27, PO 00000 Frm 00077 Fmt 4702 Sfmt 4702 1994, but only in cases where the S corporation’s return for the taxable year is filed pursuant to an S election or a section 1374(d)(8) transaction occurring on or after December 27, 1994. * * * * * * * * Linda M. Kroening, (Acting) Deputy Commissioner for Services and Enforcement. [FR Doc. E9–1100 Filed 1–16–09; 8:45 am] BILLING CODE 4830–01–P DEPARTMENT OF LABOR Occupational Safety and Health Administration 29 CFR Part 1910 [Docket No. OSHA–2007–0007] RIN 1218–AC39 Additional Quantitative Fit-Testing Protocols for the Respiratory Protection Standard AGENCY: Occupational Safety and Health Administration (OSHA); Labor. ACTION: Notice of proposed rulemaking; request for comments. SUMMARY: OSHA is proposing to add two PortaCount® quantitative fit-testing protocols to its Respiratory Protection Standard (29 CFR 1910.134); the proposed protocols would apply to employers in general industry, shipyard employment, and the construction industry. The first of the two proposed protocols consists of the eight fit-testing exercises described in Part I.A.14 of Appendix A of the Respiratory Protection Standard, except each exercise would last 30 seconds instead of the currently required 60 seconds.1 The second proposed protocol would eliminate two of the eight fit-testing exercises, and each of the remaining six exercises would last 40 seconds; in addition, this proposed protocol would increase the current minimum pass-fail fit-testing criterion from a fit factor of 100 to 200 for half masks, and from 500 to 1,000 for full facepieces. DATES: Submit comments to this proposal, including comments to the information collection (paperwork) determination described under the section this preamble titled SUPPLEMENTARY INFORMATION, as well as 1 Except for the grimace exercise, which currently lasts 15 seconds and would remain at 15 seconds in both of the proposed protocols. However, neither the current nor proposed protocols include the fit factor obtained from this exercise in determining the overall fit factor for a respirator tested using a quantitative fit test. E:\FR\FM\21JAP1.SGM 21JAP1 Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Proposed Rules other information, by March 23, 2009. All submissions must bear a postmark or provide other evidence of the submission date. (See the following section titled ADDRESSES for methods used in submitting comments to the docket.) Submit comments, identified by docket number OSHA– 2007–0007 or regulatory information number (RIN) 1218–AC39, by any of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • Fax: (202) 693–1648 for comments that are 10 pages or fewer in length (including attachments). Instead of transmitting facsimile copies of attachments that supplement these comments (e.g., studies, journal articles), commenters may submit these attachments, in triplicate hard copy, to the OSHA Docket Office, Technical Data Center, Room N–2625, OSHA, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210. These attachments must clearly identify the sender’s name, date, subject, and docket number or RIN number (i.e., OSHA–2007–0007 or 1218–AC39, respectively) so that the Agency can attach them to the appropriate comments. • Mail, Hand Delivery, or Courier (for Paper, Disk, or CD–ROM Submissions): OSHA Docket Office, Docket No. OSHA–2007–0007 or RIN No. 1218– AC39, Technical Data Center, Room N– 2625, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210; telephone: (202) 693–2350. (OSHA’s TTY number is (877) 889– 5627.) Contact the OSHA Docket Office for information about security procedures concerning delivery of materials by express delivery, hand delivery, and messenger service. The hours of operation for the OSHA Docket Office are 8:15 a.m. to 4:45 p.m., e.t. • Instructions: All submissions must include the agency name and the docket number or RIN number (i.e., OSHA– 2007–0007 or 1218–AC39, respectively) for this rulemaking. All comments received will be posted without change to https://www.regulations.gov, including any personal information provided. For detailed instruction on submitting comments and additional information on the rulemaking process, see the ‘‘Public Participation’’ heading of the SUPPLEMENTARY INFORMATION section of this document. • Docket: For access to the docket to read background documents or comments received, go to https:// www.regulations.gov and/or to the mstockstill on PROD1PC66 with PROPOSALS ADDRESSES: VerDate Nov<24>2008 16:26 Jan 16, 2009 Jkt 217001 OSHA Docket Office in Room N–2625, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC. The https://www.regulations.gov index lists the documents in the docket; however, some information (e.g., copyrighted material) is not publicly available to read or download through this Web site. All submissions, including copyrighted material, are available for inspection and copying at the OSHA Docket Office. Contact the OSHA Docket Office for assistance in locating docket submissions. FOR FURTHER INFORMATION CONTACT: • General information and press inquiries: Contact Ms. Jennifer Ashley, Director, Office of Communications, OSHA, U.S. Department of Labor, Room N–3637, 200 Constitution Avenue, NW., Washington, DC 20210; telephone: (202) 693–1999; facsimile: (202) 693–1634. • Technical inquiries: Contact Mr. John Steelnack, Directorate of Standards and Guidance, Room N–3718, OSHA, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210; telephone: (202) 693–2289; facsimile: (202) 693–1678. • Copies of this Federal Register notice: Electronic copies of this Federal Register notice, news releases, and other similar documents are available on OSHA’s Web page at https:// www.osha.gov (select ‘‘Federal Register,’’ ‘‘Date of Publication,’’ and then ‘‘2008’’). SUPPLEMENTARY INFORMATION: Table of Contents I. Background II. Summary and Explanation of the Proposal A. Introduction B. Summary of the Peer-Reviewed Article C. Conclusions D. Issues for Public Comment III. Procedural Determinations A. Legal Authority B. Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis C. Paperwork Reduction Act D. Federalism E. State-Plan States F. Unfunded Mandates Reform Act G. Applicability of Existing Consensus Standards H. Review of the Proposed Standard by the Advisory Committee for Construction Safety and Health I. Public Participation List of Subjects Authority and Signature IV. Proposed Amendment to the Standard I. Background Appendix A of OSHA’s Respiratory Protection Standard at 29 CFR 1910.134 currently includes three quantitative fittesting protocols using the following challenge agents: A non-hazardous generated aerosol such as corn oil, PO 00000 Frm 00078 Fmt 4702 Sfmt 4702 3527 polyethylene glycol 400, di-2-ethyl hexyl sebacate, or sodium chloride; ambient aerosol; and controlled negative pressure. Appendix A of the Respiratory Protection Standard also specifies the procedure for adding new fit-testing protocols to this standard. The criteria for determining whether OSHA must publish a fit-testing protocol for noticeand-comment rulemaking under Section 6(b)(7) of the Occupational Safety and Health Act of 1970 (the ‘‘Act’’) (29 U.S.C. 655) include: (1) A test report prepared by an independent government research laboratory (e.g., Lawrence Livermore National Laboratory, Los Alamos National Laboratory, the National Institute for Standards and Technology) stating that the laboratory tested the protocol and found it to be accurate and reliable; or (2) an article published in a peerreviewed industrial-hygiene journal describing the protocol and explaining how the test data support the protocol’s accuracy and reliability. Using this procedure, OSHA has added one fittesting protocol (i.e., the controlled negative pressure REDON quantitative fit-testing protocol) to Appendix A of its Respiratory Protection Standard (see 69 FR 46986). II. Summary and Explanation of the Proposal A. Introduction In the letter submitting two new quantitative fit-testing protocols for review under the provisions of Appendix A of OSHA’s Respiratory Protection Standard (Ex. OSHA–2007– 0007–0002), Mr. Jeff Weed of TSI Inc. included a copy of a peer-reviewed article from an industrial-hygiene journal describing the accuracy and reliability of these proposed protocols (Ex. OSHA–2007–0007–0003).2 The submission letter also included instructions that described in detail the equipment and procedures required to administer the proposed protocols. According to this description, the proposed protocols are variations of the existing ambient-aerosol condensationnuclei-counter quantitative fit-testing protocol developed by TSI Inc., in the 1980’s, commonly referred to as the standard PortaCount® quantitative fittesting protocol (hereafter, ‘‘the standard PortaCount® QNFT protocol’’). OSHA included the standard PortaCount® QNFT protocol in Appendix A of its final Respiratory Protection Standard. 2 This letter and the accompanying article describe three fit-testing protocols, but Mr. Weed of TSI Inc., in a subsequent telephone call to OSHA staff, requested that the Agency include only two of them in this proposed rulemaking. E:\FR\FM\21JAP1.SGM 21JAP1 3528 Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Proposed Rules (For consistency, OSHA will refer to the two proposed protocols as ‘‘revised PortaCount® quantitative fit-testing protocols 1 and 2’’ (i.e., ‘‘revised PortaCount® QNFT protocols 1 and 2’’). The proposed protocols use the same fit-testing requirements and instrumentation specified for the standard PortaCount® QNFT protocol in paragraphs (a) and (b) of Part I.C.3 of Appendix A of the Respiratory Protection Standard, with the following exceptions: • Revised PortaCount® QNFT protocol 1 reduces the duration of the eight fit-testing exercises from 60 seconds to 30 seconds; and • Revised PortaCount® QNFT protocol 2 eliminates two of the eight fit-testing exercises, with each of the remaining six exercises having a duration of 40 seconds; in addition, this proposed protocol increases the current minimum pass-fail fit-testing criterion from a fit factor of 100 to 200 for half masks, and from 500 to 1,000 for full facepieces. B. Summary of the Peer-Reviewed Article Peer-reviewed industrial-hygiene journal article. The peer-reviewed article submitted by Mr. Jeff Weed of TSI Inc., entitled ‘‘Evaluation of Three New Fit Test Protocols for Use with the TSI PortaCount,’’ appeared in the Fall/ Winter 2005 issue of the Journal of the International Society for Respiratory Protection (Ex. OSHA–2007–0007– 0003). This article describes a study that determined whether performing the proposed protocols yields fit-testing results similar to results obtained with the standard PortaCount® QNFT protocol (i.e., the standard PortaCount® QNFT protocol was the criterion measure or ‘‘gold standard’’). Test subjects and respirator selection. The study involved 30 test subjects who performed 140 fit tests while wearing elastomeric half-mask and full-facepiece respirators equipped with P100 filters. The test subjects selected respirators from among 24 models, with some test subjects using more than one model during fit testing. Respirator fit varied across the test subjects, with 60 of 140 fit factors below 100, and 91 of 140 fit factors less than 500, as determined by the standard PortaCount® QNFT protocol.3 Poor respirator fit resulted from improper respirator selection by the test subjects themselves, or from assigning respirators to test subjects that were either too small or too large. Test subjects could adjust the respirator for comfort, but they did not perform user seal checks. Procedures. In conducting the study, the authors followed the recommendations for evaluating new fit- testing protocols specified by Annex A2 (‘‘Criteria for Evaluating Fit Tests Methods’’) of ANSI Z88.10–2001 (‘‘Respirator Fit Testing Methods’’). Specially designed testing software allowed for calculation of fit factors every 10 seconds during the in-mask sampling periods without disturbing the facepiece (i.e., at 10-, 20-, and 30-second intervals for comparison with the 40second in-mask sampling intervals determined using the standard PortaCount® QNFT protocol). The authors used TSI-supplied sampling adaptors, or respirators with fixed probes provided by the respirator manufacturer, to collect samples inside the respirators. The sampling point inside the respirator was between the nose and the mouth. During sampling, the test subjects performed the exercises listed in Part I.A.14 of Appendix A of OSHA’s Respiratory Protection Standard, which include: initial normal breathing, deep breathing, turning the head side to side, moving the head up and down, reading a passage, grimace, bending over, and final normal breathing. The TSI PortaCount® Plus fit-testing instrument performed particle counts on samples collected during the study. The table below provides the exercise and sampling parameters for each of the protocols used in the study. Number of exercises Protocol Standard PortaCount® QNFT Protocol ....................................................................................... Revised PortaCount® QNFT Protocol 1 ...................................................................................... Revised PortaCount® QNFT Protocol 2 ...................................................................................... 8 8 26 Duration of each exercise (secs.) In-mask sampling duration for each exercise (secs.) 1 60 30 40 40 10 20 1 Does mstockstill on PROD1PC66 with PROPOSALS 2 This not include 20 seconds for each exercise to collect ambient-air samples and to purge the in-mask and ambient-air sampling tubes. protocol eliminated the initial normal-breathing exercise and the deep-breathing exercise. Results. To pass a fit test using revised PortaCount® QNFT protocol 1, test subjects had to attain a fit factor of 100 for half masks and 500 for full-facepiece respirators; the pass-fail criteria for fullfacepiece respirators using revised PortaCount® QNFT protocol 2 were 200 for half masks and 1,000 for fullfacepiece respirators. Based on these criteria, the authors determined the following statistics for the two proposed protocols: test sensitivity; predictive value of a pass; test specificity; predictive value of a fail; and the kappa statistic. In calculating these statistics, the authors adopted the variables defined by ANSI Z88.10–2001, in which: A = false positives (passed the fit test with a fit factor < 100); B = true positives (passed the fit test with a fit factor ≥ 100); C = true negatives (failed the fit test with a fit factor < 100); D = false negatives (failed the fit test with a fit factor ≥ 100); Po = observed proportion of the two fit tests that are concordant; and Pe = expected proportion of the two fit tests expected to be concordant when the two tests are statistically independent. Using these variables, ANSI Z88.10–2001 specifies the formula and recommended value (‘‘RV’’) for each statistic as follows: Test sensitivity = C/(A + C), RV ≥ 0.95; predictive value of a pass = B/(A + B), RV ≥ 0.95; test specificity = B/(B + D), RV > 0.50; predictive value of a fail = C/(C + D), RV > 0.50; and the kappa statistic = (Po¥Pe)/(1¥Pe). Using the standard PortaCount® QNFT protocol as the criterion measure, the variables for the two proposed protocols had values for half masks and full-facepiece respirators listed in the following two tables. 3 After excluding from the analysis fit factors within one standard deviation of the reference fit- factor pass-fail criterion, these figures are 57 of 135 fit factors below 100, and 91 of 135 fit factors less than 500. VerDate Nov<24>2008 16:26 Jan 16, 2009 Jkt 217001 PO 00000 Frm 00079 Fmt 4702 Sfmt 4702 E:\FR\FM\21JAP1.SGM 21JAP1 3529 Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Proposed Rules Values for half-mask respirators Variables Sensitivity ............................................................................................................. Predictive Value of a Pass .................................................................................. Specificity ............................................................................................................. Predictive Value of a Fail .................................................................................... Kappa Statistic ..................................................................................................... 1= 2= Revised PortaCount® QNFT Protocol 1 ANSI requirement ≥0.95 ≥0.95 >0.50 >0.50 >0.70 Revised PortaCount® QNFT Protocol 2 1 0.91 1.00 1.00 0.81 0.79 0.78 2 0.94 0.99 0.98 0.91 Fail. Borderline fail. Values for full-facepiece respirators Variables Sensitivity ............................................................................................................. Predictive Value of a Pass .................................................................................. Specificity ............................................................................................................. Predictive Value of a Fail .................................................................................... Kappa Statistic ..................................................................................................... mstockstill on PROD1PC66 with PROPOSALS 1= Revised PortaCount® QNFT Protocol 1 ANSI requirement ≥0.95 ≥0.95 >0.50 >0.50 >0.70 0.97 1 0.94 0.98 0.99 0.94 Revised PortaCount® QNFT Protocol 2 1.00 1.00 0.84 0.92 0.87 Borderline fail. For half masks, revised PortaCount® QNFT protocol 1 failed to meet the sensitivity value specified by ANSI Z88.10–2001, and, consistent with this failure, the value for the predictivevalue-of-a-pass variable was marginal. However, for full-facepiece respirators, the sensitivity value for this proposed protocol exceeded the ANSI requirement, although the predictivevalue-of-a-pass variable was again slightly below the ANSI specification. The failure of this proposed protocol to attain an adequate sensitivity value when applied to half masks indicates that, for half masks, the proposed protocol is susceptible to alpha, or false positive, error—i.e., it would pass some half masks that would function below a fit factor of 100 when tested with the protocol used as the criterion measure (i.e., the standard PortaCount® QNFT protocol). The authors did not provide an explanation for this deficiency. However, the deficiency is unlikely to be the result of statistical error because the number of test subjects appeared to be adequate, and a procedural or measurement error should have decreased the sensitivity value for revised PortaCount® QNFT protocol 2, which was not the case. Despite these problems, revised PortaCount® QNFT protocol 1 performed well above the values established by the ANSI standard for the three remaining variables, including specificity, predictive value of a fail, and the kappa statistic. These values indicate that the vast majority of the test subjects who passed (or failed) the criterion measure also passed (or failed) the proposed protocol, and the VerDate Nov<24>2008 16:26 Jan 16, 2009 Jkt 217001 proposed protocol correlated highly with the criterion measure. Nonetheless, the fact that revised PortaCount® QNFT protocol 1 failed to meet the sensitivity value specified by ANSI Z88.10–2001 for half masks raises the question of whether it is as protective as the standard PortaCount® QNFT protocol, and OSHA has raised this as an issue for public comment (see below). The variables for revised PortaCount® QNFT protocol 2 had sensitivity values for both half masks and full-facepiece respirators well in excess of the sensitivity value specified by the ANSI standard. The sensitivity values for this proposed protocol demonstrate that it identified 100% of the poorly fitting half masks and full-facepiece respirators. In addition, this proposed protocol performed well above the values listed in the ANSI standard for the four remaining variables, including predictive value of a pass, specificity, predictive value of a fail, and the kappa statistic. Consistent with the sensitivity values derived for this proposed protocol, these four values indicate that the proposed protocol resulted in fit factors that accurately identified half masks and full-facepiece respirators with acceptable and poor fits, and that these fit factors agreed closely with the fit factors attained from the criterion measure. In discussing the results for revised PortaCount® QNFT protocol 2, the authors noted that excluding the two least strenuous fit-testing exercises (i.e., the initial normal-breathing exercise and the deep-breathing exercise) from this proposed protocol was a conservative approach in that the PO 00000 Frm 00080 Fmt 4702 Sfmt 4702 proposed protocol was more likely than protocols consisting of eight fit-testing exercises to detect respirator leakage (i.e., using data from less strenuous fittesting exercises inappropriately inflates the overall fit factor for respirators, thereby increasing alpha error). Another conservative approach used by this proposed protocol was raising the passfail criterion for half masks from a fit factor of 100 to 200, and, for fullfacepiece respirators, from 500 to 1,000. This approach likely enhanced the sensitivity of the proposed protocol. However, enhancing sensitivity may increase beta (false-negative) error, which would increase the number of repeated tests and, consequently, the total testing time required by some employees to identify a respirator having an acceptable fit. C. Conclusions OSHA believes that the information submitted by Mr. Weed in support of the proposed protocols meets the criteria for determining whether OSHA must publish fit-testing protocols for notice-and-comment rulemaking established by the Agency in Part II of Appendix A of its Respiratory Protection Standard. Therefore, the Agency concludes that the proposed protocols warrant notice-and-comment rulemaking under Section 6(b)(7) of the Act (29 U.S.C. 655), and is initiating this rulemaking to determine whether to approve these proposed protocols for inclusion in Part I of Appendix A of its Respiratory Protection Standard. The only differences between the two proposed protocols and the standard PortaCount® QNFT protocol specified E:\FR\FM\21JAP1.SGM 21JAP1 3530 Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Proposed Rules currently in Part I.C.3 of Appendix A of the Respiratory Protection Standard are the duration of the exercises used during fit testing, and for revised PortaCount® QNFT protocol 2, the exclusion of the two least strenuous fittesting exercises and the raising of the minimum passing criteria. Therefore, the Agency is proposing to add the proposed protocols to Part I.C.3 of Appendix A (see section IV of this preamble titled ‘‘Proposed Amendment to the Standard’’). In addition to decreasing exercise durations from 60 seconds to 30 or 40 seconds, the proposed revisions to the regulatory text would limit use of revised PortaCount® QNFT protocol 2 to respirator users who demonstrate a minimum passing criteria of 200 for half masks or 1,000 for fullfacepiece respirators. If approved, the proposed protocols would be alternatives to the existing quantitative fit-testing protocols already listed in the Part I of Appendix A of the Respiratory Protection Standard; employers would be free to select these alternatives or to continue using any of the other protocols currently listed in the appendix. mstockstill on PROD1PC66 with PROPOSALS D. Issues for Public Comment OSHA invites comments and data from the public regarding the accuracy and reliability of the two proposed protocols, their effectiveness in detecting respirator leakage, and their usefulness in selecting respirators that will protect employees from airborne contaminants in the workplace. Specifically, the Agency invites public comment on the following issues: • Was the study described in the peer-reviewed journal article well controlled, and conducted according to accepted experimental design practices and principles? • Were the results of the study described in this article properly, fully, and fairly presented and interpreted? • Will the proposed protocols generate reproducible fit-testing results? • Will the proposed protocols reliably identify respirators with unacceptable fit as effectively as the quantitative fittesting protocols, including the standard PortaCount® QNFT protocol, already listed in Part I.C.3 of Appendix A of the Respiratory Protection Standard? • Is the test-sensitivity value of 0.91 obtained for half masks by revised PortaCount® QNFT protocol 1 acceptable in view of the test-sensitivity value of 0.95 required by ANSI Z88.10– 2001. If not, would it be appropriate for OSHA to limit application of revised PortaCount® QNFT protocol 1 to fullfacepiece respirators? VerDate Nov<24>2008 16:26 Jan 16, 2009 Jkt 217001 • The study evaluating the proposed protocols involved only elastomeric half-mask and full-facepiece respirators. Accordingly, is it appropriate to apply the results of the study to other types of respirators (e.g., filtering-facepiece respirators)? III. Procedural Determinations A. Legal Authority The purpose of the Occupational Safety and Health Act of 1970 (‘‘the Act’’; 29 U.S.C. 651 et seq.) is ‘‘to assure so far as possible every working man and woman in the nation safe and healthful working conditions and to preserve our human resources’’ (29 U.S.C. 651(b)). To achieve this goal, Congress authorized the Secretary of Labor to promulgate and enforce occupational safety and health standards (29 U.S.C. 655(b) and 654(b)). Under the Act, a safety or health standard is a standard that ‘‘requires conditions, or the adoption or use of one or more practices, means, methods, operations, or processes, reasonably necessary or appropriate to provide safe or healthful employment or places of employment’’ (29 U.S.C. 652(8)). A standard is reasonably necessary or appropriate within the meaning of Section 652(8) of the Act when it substantially reduces or eliminates a significant workplace risk, and is technologically and economically feasible, cost effective, consistent with prior Agency action or supported by a reasoned justification for departing from prior Agency action, and supported by substantial evidence; it also must effectuate the Act’s purposes better than any national consensus standard it supersedes (see International Union, UAW v. OSHA (LOTO II), 37 F.3d 665 (D.C. Cir. 1994); and 58 FR 16612–16616 (March 30, 1993)). Rules promulgated by the Agency must be highly protective (see 58 FR 16612, 16614–15 (March 30, 1993); LOTO II, 37 F.3d 665, 669 (D.C. Cir. 1994)). Moreover, Section 8(g)(2) of the Act authorizes OSHA ‘‘to prescribe such rules and regulations as [it] may deem necessary to carry out its responsibilities under the Act’’ (see 29 U.S.C. 657(g)(2)). Based on the available evidence, OSHA has preliminarily determined that the protocols described in the proposed rule meet the legal requirements to provide substantial protection to employees who use respirators when exposed to hazardous atmospheres (see Industrial Union Dept. v. American Petroleum Institute, 448 U.S. 607, 655 (1980); International Union v. Pendergrass, 878 F.2d 389, 392–93 (DC Cir. 1989); Building and PO 00000 Frm 00081 Fmt 4702 Sfmt 4702 Construction Trades Dept., AFL-CIO v. Brock, 838 F.2d 1258, 1264–65 (DC Cir. 1988)). OSHA also made a preliminary finding that the proposed rule is technologically feasible because the protective measures it requires already exist (see American Textile Mfrs. Institute v. OSHA (Cotton Dust), 452 U.S. 490, 513 (1981); American Iron and Steel Institute v. OSHA (Lead II), 939 F.2d 975, 980 (DC Cir. 1991)). Specifically, employers covered by this proposal already must comply with the fit-testing requirements specified in paragraph (f) of OSHA’s Respiratory Protection Standard at 29 CFR 1910.134. Accordingly, these provisions currently are protecting their employees from the significant risk that results from poorly fitting respirators. In this regard, for OSHA to adopt the proposed protocols in the final rule, OSHA would have to determine that the proposed protocols provide employees with protection that is comparable to the protection afforded to them by the provisions of the standard PortaCount® QNFT protocol. If adopted, the protocols would not replace existing fit-testing protocols, but instead would be alternatives to them. Therefore, OSHA preliminarily finds that the proposal would not directly increase or decrease the protection afforded to employees, nor would it increase employers’ compliance burdens. As demonstrated in the following section, the proposal may reduce employers’ compliance burdens by decreasing the time required to fit test respirators for employee use. Accordingly, OSHA concludes that it is unnecessary to determine significant risk or the extent to which this proposal would reduce that risk, as typically would be required by Industrial Union Department, AFL-CIO v. American Petroleum Institute, 448 U.S. 607 (1980). The Agency believes that the proposed rule is economically feasible because the employers can absorb or pass on the costs of compliance without threatening their long-term profitability or competitive structure (see Cotton Dust, 452 U.S. at 530 n. 55 (1981); Lead II, 939 F.2d 975, 980 (DC Cir. 1991)). Moreover, the preliminary economic analysis of the proposed rule describes the benefits and costs of the proposed rule (see section III.B. of this preamble, ‘‘Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis’’). Based on this information, OSHA made a preliminary determination that the proposed rule is an economically feasible means of meeting its statutory objective of reducing the risk associated with employee exposure to hazardous atmospheres while using respirators (see E:\FR\FM\21JAP1.SGM 21JAP1 Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Proposed Rules mstockstill on PROD1PC66 with PROPOSALS Cotton Dust, 453 U.S. at 514 n. 32 (1981); LOTO II, 37 F.3d 665, 668 (DC Cir. 1994)). B. Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis The proposal is not economically significant within the context of Executive Order (‘‘E.O.’’) 12866 (58 FR 51735), or a ‘‘major rule’’ under Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (‘‘SBREFA’’; 5 U.S.C. 804). The proposal would impose no additional costs on any private-or public-sector entity, and does not meet any of the criteria for a significant or major rule specified by E.O. 12866 or other relevant statutes. The proposal offers employers additional options to fit test their employees for respirator use. In this regard, OSHA would supplement the standard PortaCount® QNFT protocol currently in Appendix A of the Respiratory Protection Standard with the proposed protocols if it approves them as a result of this proposed rulemaking. According to a recent survey of respirator use conducted by the National Institute for Occupational Safety and Health and the Bureau of Labor Statistics, approximately 7,500 establishments currently use an ambient-aerosol protocol out of nearly 282,000 establishments found by the survey to require respirator use (Ex. 6– 3, Docket No. H049C (‘‘Respiratory Protection—Assigned Protection Factors’’).4 Under this proposal, employers would have a choice between the standard PortaCount® QNFT protocol consisting of exercises lasting one minute each, or the proposed protocols with exercises (six or eight) lasting 30 or 40 seconds each. By providing regulatory flexibility to these employers, the proposal may reduce their costs by decreasing fit-testing time. In this regard, OSHA assumes that the proposed protocols would be adopted by some employers who currently use the standard PortaCount® QNFT protocol for their employees. These employers would adopt the proposed protocols because these protocols would take less time to administer than the standard PortaCount® QNFT protocol, thereby decreasing the cost required for fit testing their employees. However, the Agency believes that the proposed protocols are unlikely to be adopted by employers who currently perform fit testing using other quantitative or qualitative fit tests because of the 4 The standard PortaCount® QNFT protocol is the only ambient-aerosol protocol currently listed in Appendix A of the Respiratory Protection Standard. VerDate Nov<24>2008 16:26 Jan 16, 2009 Jkt 217001 significant equipment and training investment they already have made to administer these fit tests. Based on the above discussion, the Agency preliminarily concludes that this proposed rulemaking would impose no additional costs on employers, thereby eliminating the need for a preliminary economic analysis. Moreover, OSHA certifies that the proposal would not have a significant impact on a substantial number of small entities, and that the Agency does not have to prepare an initial regulatory flexibility analysis for this rulemaking under the SBREFA (5 U.S.C. 601 et seq.). C. Paperwork Reduction Act After thoroughly analyzing the proposed fit-testing provisions in terms of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. and 5 CFR part 1320), OSHA believes that these provisions would not add to the existing collection of information (i.e., paperwork) requirements regarding fit testing employees for respirator use. The paperwork requirement specified in paragraph (m)(2) of OSHA’s Respiratory Protection Standard at 29 CFR 1910.134 specifies that employers must document and maintain the following information on quantitative fit tests administered to employees: the name or identification of the employee tested; the type of fit test performed; the specific make, model, style, and size of respirator tested; the date of the test; and the test results. The employer must maintain this record until the next fit test is administered. However, this paperwork requirement would remain the same whether employers currently use the other fittesting protocols already listed in Part I of Appendix A of the Respiratory Protection Standard, or implement the proposed fit-testing protocols instead. Therefore, using one of the proposed fittesting protocols in the context of the existing fit-testing protocols would not involve an additional paperwork-burden determination by OSHA because it already accounts for this burden under the paperwork analysis for the Respiratory Protection Standard (OMB Control Number 1218–0099). Members of the public may send comments on this paperwork analysis to: Office of Information and Regulatory Affairs (Attention: Desk Officer for OSHA), Office of Management and Budget, Room 10235, 725 17th Street, NW., Washington, DC 20503. The Agency also encourages commenters to submit a copy of their comments on this paperwork analysis to OSHA, along with their other comments on the proposed rule. PO 00000 Frm 00082 Fmt 4702 Sfmt 4702 3531 D. Federalism The Agency reviewed the proposal according to the most recent Executive Order (‘‘E.O.’’) on Federalism (E.O. 13132; 64 FR 43225). This E.O. requires that Federal agencies, to the extent possible, refrain from limiting State policy options, consult with States before taking actions that restrict their policy options, and take such actions only when clear constitutional authority exists and the problem is national in scope. The E.O. allows Federal agencies to preempt State law only with the expressed consent of Congress. In such cases, Federal agencies must limit preemption of State law to the extent possible. Section 18 of the Act; 29 U.S.C. 651 et seq.), expressly provides OSHA with authority to preempt State occupational safety and health standards to the extent that the Agency promulgates a Federal standard under Section 6 of the Act. Accordingly, Section 18 of the Act authorizes the Agency to preempt State promulgation and enforcement of requirements dealing with occupational safety and health issues covered by OSHA standards unless the State has an OSHA-approved occupational safety and health plan (namely, is a ‘‘Stateplan State’’). (See Gade v. National Solid Waste Management Association, 112 S. Ct. 2374 (1992).) With respect to States that do not have OSHA-approved plans, the Agency concludes that this proposed rule conforms to the preemption provisions of the Act. Additionally, Section 18 of the Act prohibits States without approved plans from issuing citations for violations of OSHA standards; the Agency finds that the proposed rulemaking does not expand this limitation. Therefore, for States that do not have approved occupational safety and health plans, this proposed rule would not affect the preemption provisions of Section 18 of the Act. OSHA has authority under E.O. 13132 to propose the use of additional fittesting protocols under its Respiratory Protection Standard at 29 CFR 1910.134 because the problems addressed by these fit-testing requirements are national in scope. The Agency preliminarily concludes that the fittesting protocols proposed by this rulemaking would provide employers in every State with procedures that would assist them in protecting their employees from the risks of exposure to atmospheric hazards. In this regard, the proposal offers thousands of employers across the nation an opportunity to use additional protocols to assess respirator fit among their employees. Therefore, E:\FR\FM\21JAP1.SGM 21JAP1 3532 Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Proposed Rules mstockstill on PROD1PC66 with PROPOSALS the proposal would provide employers in every State with an alternative means of complying with the fit-testing requirements specified by paragraph (f) of OSHA’s Respiratory Protection Standard. Should the Agency adopt a proposed standard in a final rulemaking, Section 18(c)(2) of the Act (29 U.S.C. 667(c)(2)) requires State-plan States to adopt the same standard, or to develop and enforce an alternative standard that is at least as effective as the OSHA standard. However, the new fit-testing protocols proposed in this rulemaking would only provide employers with an alternative to the existing requirements for fittesting protocols specified in the Respiratory Protection Standard; therefore, the alternative is not, itself, a mandatory standard. Accordingly, States with OSHA-approved State Plans would not be obligated to adopt the final provisions that may result from this proposed rulemaking. Nevertheless, OSHA strongly encourages them to adopt the final provisions to provide additional compliance options to employers in their States. In summary, this proposed rule complies with E.O. 13132. In States without OSHA-approved State Plans, Congress expressly provides for OSHA standards to preempt State job safety and health rules in areas addressed by the Federal standards; in these States, this proposed rule would limit State policy options in the same manner as every standard promulgated by the Agency. In States with OSHA-approved State Plans, this rulemaking does not significantly limit State policy options. E. State-Plan States Section 18(c)(2) of the Act (29 U.S.C. 667(c)(2)) requires State-Plan States to adopt mandatory standards promulgated by OSHA. However, as noted in the previous section of this preamble, States with OSHA-approved State Plans would not be obligated to adopt the final provisions that may result from this proposed rulemaking. Nevertheless, OSHA strongly encourages them to adopt the final provisions to provide compliance options to employers in their States. In this regard, OSHA preliminarily concludes that the fittesting protocols proposed by this rulemaking would provide employers in the State-Plan States with procedures that would protect the safety and health of employees who use respirators against hazardous airborne substances in their workplace at least as well as the standard PortaCount® QNFT protocol. The 24 States and two Territories with State Plans are: Alaska, Arizona, California, Hawaii, Indiana, Iowa, VerDate Nov<24>2008 16:26 Jan 16, 2009 Jkt 217001 Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, and Wyoming. Connecticut, New Jersey, New York, and the Virgin Islands have OSHA-approved State Plans that apply to State and local government employees only. F. Unfunded Mandates Reform Act OSHA reviewed the proposal according to the Unfunded Mandates Reform Act of 1995 (‘‘UMRA’’; 2 U.S.C. 1501 et seq.) and Executive Order 12875 (58 FR 58093). As discussed above in section III.B of this preamble (‘‘Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis’’), the Agency made a preliminary determination that the proposal imposes no additional costs on any private-or public-sector entity. The substantive content of the proposal applies only to employers whose employees use respirators for protection against airborne workplace contaminants, and compliance with the proposal would be strictly optional for these employers. Accordingly, the proposal would require no additional expenditures by either public-or private-sector employers; therefore, this proposal is not a significant regulatory action within the meaning of Section 202 of the UMRA (2 U.S.C. 1532). Under voluntary agreement with OSHA, some States enforce compliance with their State standards on publicsector entities, and these agreements specify that these State standards must be equivalent to OSHA standards. Thus, although OSHA preliminarily concludes that the proposed protocols would impose no additional costs on publicsector employers, the proposal would not involve any unfunded mandates imposed on any other State or local government entity. Consequently, this proposal does not meet the definition of a ‘‘Federal intergovernmental mandate’’ (see Section 421(5) of the UMRA (2 U.S.C. 658(5))). Therefore, for the purposes of the UMRA, the Agency preliminarily certifies that this proposal does not mandate that State, local, or tribal governments adopt new, unfunded regulatory obligations, nor does the proposed rule increase expenditures by the private sector of more than $100 million a year. G. Applicability of Existing Consensus Standards Section 6(b)(8) of the Act (29 U.S.C. 655(b(8)) requires OSHA to explain ‘‘why a rule promulgated by the Secretary differs substantially from an existing national consensus standard,’’ PO 00000 Frm 00083 Fmt 4702 Sfmt 4702 by publishing ‘‘a statement of the reasons why the rule as adopted will better effectuate the purposes of the Act than the national consensus standard.’’ In this regard, when OSHA promulgated its original respirator fit-testing protocols under Appendix A of its final Respiratory Protection Standard (29 CFR 1910.134), no national consensus standards addressed these protocols. Later, the American National Standards Institute (ANSI) developed a national consensus standard on fit-testing protocols (‘‘Respirator Fit Testing Methods,’’ ANSI Z88.10–2001) as an adjunct to its national consensus standard on respiratory-protection programs. Paragraph 7.2 of ANSI Z88.10–2001 specifies the requirements for conducting a PortaCount® quantitative fit test, which differ substantially from the standard PortaCount® QNFT protocol provided in Part I.C.3 of OSHA’s Respiratory Protection Standard. These protocols differ in terms of the fit-testing exercises required, and the duration of these exercises. In addition, the ANSI standard provides no data or information on the accuracy and reliability of its protocol. The Agency believes that limiting fit-testing options to the protocol currently specified by the ANSI standard would seriously impede the development of fit-testing protocols that are more accurate and reliable, and less costly to administer, than the ANSI protocol. H. Advisory Committee for Construction Safety and Health Review of the Proposed Standard The proposal to add two quantitative fit-testing protocols to Part I.C of Appendix A of OSHA’s Respiratory Protection Standard would affect the construction industry because it revises the fit-testing requirements specified by the standard, which is applicable to the construction industry.5 Whenever the Agency proposes a rule involving construction activities, the Contract Work Hours and Safety Standards Act (Construction Safety Act) (40 U.S.C. 3704), OSHA regulations governing the Advisory Committee for Construction Safety and Health (ACCSH) (i.e., 29 CFR 1912.3), and provisions governing OSHA rulemaking (i.e., 29 CFR 1911.10) require OSHA to consult with the ACCSH. Specifically, 29 CFR 1911.10 requires that the Assistant Secretary provide the ACCSH with ‘‘any proposal 5 The Respiratory Protection Standard for the construction industry at 29 CFR 1926.103 crossreferences the Respiratory Protection Standard for general industry at 29 CFR 1910.134. E:\FR\FM\21JAP1.SGM 21JAP1 Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Proposed Rules mstockstill on PROD1PC66 with PROPOSALS of his own,’’ together with ‘‘all pertinent factual information available to him, including the results of research, demonstrations, and experiments.’’ Accordingly, OSHA provided the ACCSH members with copies of the proposal and other relevant information several weeks before the January 24, 2008, ACCSH meeting. OSHA staff met with the ACCSH at that meeting to discuss the proposal, and to answer members’ questions about it. At the end of this session, the ACCSH voted to defer making any recommendations to OSHA regarding the proposal until their next meeting so they could thoroughly review the proposal and the other relevant information, including the peer-reviewed article described above under section II.B of this notice (‘‘Summary of the Peer-Reviewed Article’’). At the May 16, 2008, ACCSH meeting, OSHA staff again met with the ACCSH to discuss the proposal. Following this discussion, the ACCSH recommended unanimously that OSHA: (1) Remove the PortaCount® QNFT protocol 1 from the proposal because it failed to meet the ANSI Z88.10–2001 criteria for test sensitivity and predicted value of a pass; and (2) include the PortaCount® QNFT protocol 2 in the proposal because it met all of the ANSI Z88.10– 2001 criteria. I. Public Participation OSHA encourages members of the public to participate in this rulemaking by submitting comments on the proposal, as well as documentary evidence in support of these comments. Accordingly, the Agency invites interested parties having knowledge of, or experience with, respirator fit-testing protocols to participate in this process, and welcomes any pertinent information that will provide it with the best available evidence on which to develop the final regulatory provisions. The Agency invites interested parties to submit written views, arguments, and data concerning this proposed rule, including: responses to the issues specified under section II.B of this preamble (‘‘Issues for Public Comment’’), and comments on OSHA’s determination of the economic or other regulatory impacts of the proposed rule on the regulated community. Comments may be submitted in response to this Federal Register notice: (1) Electronically at https:// www.regulations.gov, which is the Federal eRulemaking portal; (2) by facsimile (fax); or (3) by hard copy. When submitting comments, follow the procedures specified above in the sections of this preamble titled DATES VerDate Nov<24>2008 16:26 Jan 16, 2009 Jkt 217001 and ADDRESSES. All comments, attachments, and other material must identify the Agency name and the OSHA docket number for this rulemaking (Docket No. OSHA–2007– 0007). In addition, comments must clearly identify the provision of the proposal being addressed, the position taken with respect to an issue, and the basis for that position. Comments, along with supporting data and references, received by the end of the specified comment period will become part of the proceedings record. This material, including comments, is available for public inspection without change at https://www.regulations.gov 6 and at OSHA’s docket Web site at https:// www.dockets.osha.gov (under Docket No. OSHA–2007–0007). Therefore, OSHA cautions commenters about submitting personal information such as social security numbers and birth dates with their comments. Exhibits referenced in this Federal Register notice also will be available at https:// www.regulations.gov and https:// www.dockets.osha.gov under the same docket number. Material that supplements electronic comments may be uploaded electronically (including by fax). Supplemental material also may be mailed to the OSHA Docket Office (see the section of this preamble titled ADDRESSES) provided it identifies the electronic comments using the commenter’s name, comment submission date, and docket number so OSHA can attach the materials to the appropriate comments. Reading or downloading some of this material (e.g., copyrighted material) from the https:// www.regulations.gov and https:// www.dockets.osha.gov Web sites is not possible; however, this material is available for inspection and copying (along with comments and exhibits) at the OSHA Docket Office (see the section of this preamble titled ADDRESSES). Security-related procedures may delay significantly the delivery of comments and other material submitted through the regular mail. For information about security procedures involving the regular mail, as well as express delivery and messenger or courier service, contact the OSHA Docket Office at (202) 693–2350 (TTY (877) 889–5627). Electronic copies of this Federal Register notice are available at https:// www.regulations.gov. This notice, as well as news releases and other relevant 6 Information on using this Web site to submit comments and to access dockets is available at the Web site’s ‘‘User Tips’’ link. Contact the OSHA Docket Office for information and assistance about using the Internet to locate docket submissions. PO 00000 Frm 00084 Fmt 4702 Sfmt 4702 3533 information, also are available at OSHA’s Web site at https:// www.osha.gov. List of Subjects in 29 CFR Part 1910 Fit testing, Hazardous substances, Health, Occupational safety and health, Respirators, Toxic substances. Authority and Signature Thomas M. Stohler, Acting Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210, directed the preparation of this notice. Accordingly, the Agency issues the proposed amendment under the following authorities: Sections 4, 6(b), 8(c), and 8(g) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Section 3704 of the Contract Work Hours and Safety Standards Act (40 U.S.C. 3701 et seq.); Section 41 of the Longshore and Harbor Worker’s Compensation Act (33 U.S.C. 941); Secretary of Labor’s Order No. 5–2007 (72 FR 31159); and 29 CFR part 1911. Signed at Washington, DC, on January 13, 2009. Thomas M. Stohler, Acting Assistant Secretary of Labor for Occupational Safety and Health. IV. Proposed Amendment to the Standard For the reasons stated above in the preamble, the Agency proposes to amend 29 CFR part 1910 as follows: PART 1910—[AMENDED] Subpart I—[Amended] 1. Revise the authority citation for subpart I of part 1910 to read as follows: Authority: Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, and 657); Section 3704 of the Contract Work Hours and Safety Standards Act (40 U.S.C. 3701 et seq.); Section 41, Longshore and Harbor Worker’s Compensation Act (33 U.S.C. 941); and Secretary of Labor’s Order Nos. 8–76 (41 FR 25059), 9–83 (48 FR 35736), 1–90 (55 FR 9033), 6–96 (62 FR 111), 3–2000 (65 FR 50017), 5–2002 (67 FR 65008), or 5–2007 (72 FR 31159), as applicable. Sections 29 CFR 1910.132, 1910.134, and 1910.138 also issued under 29 CFR part 1911. Sections 29 CFR 1910.133, 1910.135, and 1910.136 also issued under 29 CFR part 1911 and 5 U.S.C. 553. 2. Add paragraphs (c) and (d) to section C.3 of Appendix A to § 1910.134 to read as follows: § 1910.134 Respiratory protection. * * E:\FR\FM\21JAP1.SGM * 21JAP1 * * 3534 Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Proposed Rules (c) Revised PortaCount® Quantitative FitTesting Protocol 1. (1) When administrating this protocol to test subjects (i.e., employees), employers must comply with the requirements specified in paragraphs (a) and (b) of Part 1.C.3 of this appendix. In addition, employers must use the eight fit-testing exercises specified in * * * * * * * * * * C. * * * * * 3. * * * * * Overall Fit Factor = Note to Paragraph (c)(2): Only seven of the eight fit-testing exercises are used in this calculation because the results for the grimace exercise (ff6) are not included in the calculation. (d) Revised PortaCount® Quantitative FitTesting Protocol 2. (1) When administrating this protocol to test subjects (i.e., employees), employers must comply with the requirements specified in paragraphs (a) and (b) of Part 1.C.3 of this 7 1/ff1 + 1/ff 2 + 1/ff3 + 1/ff 4 + 1/ff5 + 1/ff 7 + 1/ff8 appendix. In addition, employers must use the fit-testing exercises specified in section I.A.14 of this appendix when administering this protocol, except that test subjects must not perform the fit-testing exercises specified by paragraphs (a)(1) and (a)(2) of section I.A.14 (i.e., the initial normal-breathing exercise and the deep-breathing exercise, respectively). Test subjects must perform these fit-testing exercises for at least 40 seconds, except for the grimace exercise, Overall Fit Factor = Note to Paragraph (d)(3): Only five of the eight fit-testing exercises are used in this calculation because test subjects do not perform the initial normal-breathing exercise (ff1) and the deep-breathing exercise (ff2), and the results for the grimace exercise (ff6) are not included in the calculation. * * * * * [FR Doc. E9–922 Filed 1–16–09; 8:45 am] BILLING CODE 4510–26–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Parts 160, 161, 164, and 165 [USCG–2005–21869] RIN 1625–AA99 Vessel Requirements for Notices of Arrival and Departure, and Automatic Identification System Coast Guard, DHS. Notice of public meeting; request for comments. AGENCY: mstockstill on PROD1PC66 with PROPOSALS ACTION: SUMMARY: The Coast Guard announces a public meeting to receive comments on a notice of proposed rulemaking to amend Coast Guard regulations governing Notice of Arrival and Departure (NOAD) and Automatic Identification System (AIS) requirements. VerDate Nov<24>2008 18:22 Jan 16, 2009 Jkt 217001 5 1/ff3 + 1/ff 4 + 1/ff5 + 1/ff 7 + 1/ff8 DATES: A public meeting will be held on March 5, 2009, from 12:30 p.m. to 3 p.m. to provide an opportunity for oral comments. Written comments and related material may also be submitted to Coast Guard personnel specified at that meeting. The comment period for the proposed rule closes April 15, 2009. All comments and related material submitted after the meeting must either be submitted to our online docket via https://www.regulations.gov on or before April 15, 2009, or reach the Docket Management Facility by that date. ADDRESSES: The public meeting will be held at the United States Coast Guard Headquarters Building, Room 2415, 2100 2nd Street, SW., Washington, DC 20593; a government-issued photo identification (for example, a driver’s license) will be required for entrance to the building. You may submit written comments identified by docket number USCG– 2005–21869 before or after the meeting using any one of the following methods: (1) Federal eRulemaking Portal: https://www.regulations.gov. (2) Fax: 202–493–2251. (3) Mail: Docket Management Facility (M–30), U.S. Department of Transportation, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE, Washington, DC 20590– 0001. (4) Hand delivery: Same as mail address above, between 9 a.m. and 5 p.m., Monday through Friday, except PO 00000 Frm 00085 which test subjects must perform for 15 seconds. (2) This protocol requires the following minimum pass-fail fit-testing criteria: for half masks, an overall fit factor of 200 (instead of the usual 100); and, for full-facepiece respirators, an overall fit factor of 1,000 (instead of the usual 500). (3) Calculate the overall fit factor for this protocol as follows: Fmt 4702 Sfmt 4702 Federal holidays. The telephone number is 202–366–9329. To avoid duplication, please use only one of these four methods. Our online docket for this rulemaking is available on the Internet at https:// www.regulations.gov under docket number USCG–2005–21869. FOR FURTHER INFORMATION CONTACT: If you have questions concerning the NOAD portion of this proposed rulemaking or concerning the public meeting, please contact Lieutenant Sharmine Jones, Office of Vessel Activities (CG–543), Coast Guard, Sharmine.N.Jones@uscg.mil, telephone 202–372–1234. If you have questions on the AIS portion of this proposed rulemaking, contact Mr. Jorge Arroyo, Office of Navigation Systems (CG–5413), Coast Guard, Jorge.Arroyo@uscg.mil, telephone 202–372–1563. If you have questions on viewing or submitting material to the docket, call Ms. Renee V. Wright, Program Manager, Docket Operations, telephone 202–366–9826. SUPPLEMENTARY INFORMATION: Background and Purpose We published a notice of proposed rulemaking (NPRM) in the Federal Register on December 16, 2008 (73 FR 76295), entitled ‘‘Vessel Requirements for Notices of Arrival and Departure, and Automatic Identification System.’’ In it we stated our intention to hold a public meeting, and to publish a notice E:\FR\FM\21JAP1.SGM 21JAP1 EP21JA09.122</GPH> * section I.A.14 of this appendix when administering this protocol. Test subjects must perform these fit-testing exercises for at least 30 seconds, except for the grimace exercise, which test subjects must perform for 15 seconds. (2) Calculate the overall fit factor for this protocol as follows: EP21JA09.126</GPH> Appendix A to § 1910.134: Fit Testing Procedures (Mandatory)

Agencies

[Federal Register Volume 74, Number 12 (Wednesday, January 21, 2009)]
[Proposed Rules]
[Pages 3526-3534]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-922]


=======================================================================
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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910

[Docket No. OSHA-2007-0007]
RIN 1218-AC39


Additional Quantitative Fit-Testing Protocols for the Respiratory 
Protection Standard

AGENCY: Occupational Safety and Health Administration (OSHA); Labor.

ACTION: Notice of proposed rulemaking; request for comments.

-----------------------------------------------------------------------

SUMMARY: OSHA is proposing to add two PortaCount[supreg] quantitative 
fit-testing protocols to its Respiratory Protection Standard (29 CFR 
1910.134); the proposed protocols would apply to employers in general 
industry, shipyard employment, and the construction industry. The first 
of the two proposed protocols consists of the eight fit-testing 
exercises described in Part I.A.14 of Appendix A of the Respiratory 
Protection Standard, except each exercise would last 30 seconds instead 
of the currently required 60 seconds.\1\ The second proposed protocol 
would eliminate two of the eight fit-testing exercises, and each of the 
remaining six exercises would last 40 seconds; in addition, this 
proposed protocol would increase the current minimum pass-fail fit-
testing criterion from a fit factor of 100 to 200 for half masks, and 
from 500 to 1,000 for full facepieces.
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    \1\ Except for the grimace exercise, which currently lasts 15 
seconds and would remain at 15 seconds in both of the proposed 
protocols. However, neither the current nor proposed protocols 
include the fit factor obtained from this exercise in determining 
the overall fit factor for a respirator tested using a quantitative 
fit test.

DATES: Submit comments to this proposal, including comments to the 
information collection (paperwork) determination described under the 
section this preamble titled SUPPLEMENTARY INFORMATION, as well as

[[Page 3527]]

other information, by March 23, 2009. All submissions must bear a 
postmark or provide other evidence of the submission date. (See the 
following section titled ADDRESSES for methods used in submitting 
---------------------------------------------------------------------------
comments to the docket.)

ADDRESSES: Submit comments, identified by docket number OSHA-2007-0007 
or regulatory information number (RIN) 1218-AC39, by any of the 
following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Fax: (202) 693-1648 for comments that are 10 pages or 
fewer in length (including attachments). Instead of transmitting 
facsimile copies of attachments that supplement these comments (e.g., 
studies, journal articles), commenters may submit these attachments, in 
triplicate hard copy, to the OSHA Docket Office, Technical Data Center, 
Room N-2625, OSHA, U.S. Department of Labor, 200 Constitution Avenue, 
NW., Washington, DC 20210. These attachments must clearly identify the 
sender's name, date, subject, and docket number or RIN number (i.e., 
OSHA-2007-0007 or 1218-AC39, respectively) so that the Agency can 
attach them to the appropriate comments.
     Mail, Hand Delivery, or Courier (for Paper, Disk, or CD-
ROM Submissions): OSHA Docket Office, Docket No. OSHA-2007-0007 or RIN 
No. 1218-AC39, Technical Data Center, Room N-2625, U.S. Department of 
Labor, 200 Constitution Avenue, NW., Washington, DC 20210; telephone: 
(202) 693-2350. (OSHA's TTY number is (877) 889-5627.) Contact the OSHA 
Docket Office for information about security procedures concerning 
delivery of materials by express delivery, hand delivery, and messenger 
service. The hours of operation for the OSHA Docket Office are 8:15 
a.m. to 4:45 p.m., e.t.
     Instructions: All submissions must include the agency name 
and the docket number or RIN number (i.e., OSHA-2007-0007 or 1218-AC39, 
respectively) for this rulemaking. All comments received will be posted 
without change to https://www.regulations.gov, including any personal 
information provided. For detailed instruction on submitting comments 
and additional information on the rulemaking process, see the ``Public 
Participation'' heading of the SUPPLEMENTARY INFORMATION section of 
this document.
     Docket: For access to the docket to read background 
documents or comments received, go to https://www.regulations.gov and/or 
to the OSHA Docket Office in Room N-2625, U.S. Department of Labor, 200 
Constitution Avenue, NW., Washington, DC. The https://
www.regulations.gov index lists the documents in the docket; however, 
some information (e.g., copyrighted material) is not publicly available 
to read or download through this Web site. All submissions, including 
copyrighted material, are available for inspection and copying at the 
OSHA Docket Office. Contact the OSHA Docket Office for assistance in 
locating docket submissions.

FOR FURTHER INFORMATION CONTACT:
     General information and press inquiries: Contact Ms. 
Jennifer Ashley, Director, Office of Communications, OSHA, U.S. 
Department of Labor, Room N-3637, 200 Constitution Avenue, NW., 
Washington, DC 20210; telephone: (202) 693-1999; facsimile: (202) 693-
1634.
     Technical inquiries: Contact Mr. John Steelnack, 
Directorate of Standards and Guidance, Room N-3718, OSHA, U.S. 
Department of Labor, 200 Constitution Avenue, NW., Washington, DC 
20210; telephone: (202) 693-2289; facsimile: (202) 693-1678.
     Copies of this Federal Register notice: Electronic copies 
of this Federal Register notice, news releases, and other similar 
documents are available on OSHA's Web page at https://www.osha.gov 
(select ``Federal Register,'' ``Date of Publication,'' and then 
``2008'').

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Background
II. Summary and Explanation of the Proposal
    A. Introduction
    B. Summary of the Peer-Reviewed Article
    C. Conclusions
    D. Issues for Public Comment
III. Procedural Determinations
    A. Legal Authority
    B. Preliminary Economic Analysis and Initial Regulatory 
Flexibility Analysis
    C. Paperwork Reduction Act
    D. Federalism
    E. State-Plan States
    F. Unfunded Mandates Reform Act
    G. Applicability of Existing Consensus Standards
    H. Review of the Proposed Standard by the Advisory Committee for 
Construction Safety and Health
    I. Public Participation
List of Subjects
Authority and Signature
IV. Proposed Amendment to the Standard

I. Background

    Appendix A of OSHA's Respiratory Protection Standard at 29 CFR 
1910.134 currently includes three quantitative fit-testing protocols 
using the following challenge agents: A non-hazardous generated aerosol 
such as corn oil, polyethylene glycol 400, di-2-ethyl hexyl sebacate, 
or sodium chloride; ambient aerosol; and controlled negative pressure. 
Appendix A of the Respiratory Protection Standard also specifies the 
procedure for adding new fit-testing protocols to this standard. The 
criteria for determining whether OSHA must publish a fit-testing 
protocol for notice-and-comment rulemaking under Section 6(b)(7) of the 
Occupational Safety and Health Act of 1970 (the ``Act'') (29 U.S.C. 
655) include: (1) A test report prepared by an independent government 
research laboratory (e.g., Lawrence Livermore National Laboratory, Los 
Alamos National Laboratory, the National Institute for Standards and 
Technology) stating that the laboratory tested the protocol and found 
it to be accurate and reliable; or (2) an article published in a peer-
reviewed industrial-hygiene journal describing the protocol and 
explaining how the test data support the protocol's accuracy and 
reliability. Using this procedure, OSHA has added one fit-testing 
protocol (i.e., the controlled negative pressure REDON quantitative 
fit-testing protocol) to Appendix A of its Respiratory Protection 
Standard (see 69 FR 46986).

II. Summary and Explanation of the Proposal

A. Introduction

    In the letter submitting two new quantitative fit-testing protocols 
for review under the provisions of Appendix A of OSHA's Respiratory 
Protection Standard (Ex. OSHA-2007-0007-0002), Mr. Jeff Weed of TSI 
Inc. included a copy of a peer-reviewed article from an industrial-
hygiene journal describing the accuracy and reliability of these 
proposed protocols (Ex. OSHA-2007-0007-0003).\2\ The submission letter 
also included instructions that described in detail the equipment and 
procedures required to administer the proposed protocols. According to 
this description, the proposed protocols are variations of the existing 
ambient-aerosol condensation-nuclei-counter quantitative fit-testing 
protocol developed by TSI Inc., in the 1980's, commonly referred to as 
the standard PortaCount[supreg] quantitative fit-testing protocol 
(hereafter, ``the standard PortaCount[supreg] QNFT protocol''). OSHA 
included the standard PortaCount[supreg] QNFT protocol in Appendix A of 
its final Respiratory Protection Standard.

[[Page 3528]]

(For consistency, OSHA will refer to the two proposed protocols as 
``revised PortaCount[supreg] quantitative fit-testing protocols 1 and 
2'' (i.e., ``revised PortaCount[supreg] QNFT protocols 1 and 2'').
---------------------------------------------------------------------------

    \2\ This letter and the accompanying article describe three fit-
testing protocols, but Mr. Weed of TSI Inc., in a subsequent 
telephone call to OSHA staff, requested that the Agency include only 
two of them in this proposed rulemaking.
---------------------------------------------------------------------------

    The proposed protocols use the same fit-testing requirements and 
instrumentation specified for the standard PortaCount[supreg] QNFT 
protocol in paragraphs (a) and (b) of Part I.C.3 of Appendix A of the 
Respiratory Protection Standard, with the following exceptions:
     Revised PortaCount[supreg] QNFT protocol 1 reduces the 
duration of the eight fit-testing exercises from 60 seconds to 30 
seconds; and
     Revised PortaCount[supreg] QNFT protocol 2 eliminates two 
of the eight fit-testing exercises, with each of the remaining six 
exercises having a duration of 40 seconds; in addition, this proposed 
protocol increases the current minimum pass-fail fit-testing criterion 
from a fit factor of 100 to 200 for half masks, and from 500 to 1,000 
for full facepieces.

B. Summary of the Peer-Reviewed Article

    Peer-reviewed industrial-hygiene journal article. The peer-reviewed 
article submitted by Mr. Jeff Weed of TSI Inc., entitled ``Evaluation 
of Three New Fit Test Protocols for Use with the TSI PortaCount,'' 
appeared in the Fall/Winter 2005 issue of the Journal of the 
International Society for Respiratory Protection (Ex. OSHA-2007-0007-
0003). This article describes a study that determined whether 
performing the proposed protocols yields fit-testing results similar to 
results obtained with the standard PortaCount[supreg] QNFT protocol 
(i.e., the standard PortaCount[supreg] QNFT protocol was the criterion 
measure or ``gold standard'').
    Test subjects and respirator selection. The study involved 30 test 
subjects who performed 140 fit tests while wearing elastomeric half-
mask and full-facepiece respirators equipped with P100 filters. The 
test subjects selected respirators from among 24 models, with some test 
subjects using more than one model during fit testing. Respirator fit 
varied across the test subjects, with 60 of 140 fit factors below 100, 
and 91 of 140 fit factors less than 500, as determined by the standard 
PortaCount[supreg] QNFT protocol.\3\ Poor respirator fit resulted from 
improper respirator selection by the test subjects themselves, or from 
assigning respirators to test subjects that were either too small or 
too large. Test subjects could adjust the respirator for comfort, but 
they did not perform user seal checks.
---------------------------------------------------------------------------

    \3\ After excluding from the analysis fit factors within one 
standard deviation of the reference fit-factor pass-fail criterion, 
these figures are 57 of 135 fit factors below 100, and 91 of 135 fit 
factors less than 500.
---------------------------------------------------------------------------

    Procedures. In conducting the study, the authors followed the 
recommendations for evaluating new fit-testing protocols specified by 
Annex A2 (``Criteria for Evaluating Fit Tests Methods'') of ANSI 
Z88.10-2001 (``Respirator Fit Testing Methods''). Specially designed 
testing software allowed for calculation of fit factors every 10 
seconds during the in-mask sampling periods without disturbing the 
facepiece (i.e., at 10-, 20-, and 30-second intervals for comparison 
with the 40-second in-mask sampling intervals determined using the 
standard PortaCount[supreg] QNFT protocol). The authors used TSI-
supplied sampling adaptors, or respirators with fixed probes provided 
by the respirator manufacturer, to collect samples inside the 
respirators. The sampling point inside the respirator was between the 
nose and the mouth. During sampling, the test subjects performed the 
exercises listed in Part I.A.14 of Appendix A of OSHA's Respiratory 
Protection Standard, which include: initial normal breathing, deep 
breathing, turning the head side to side, moving the head up and down, 
reading a passage, grimace, bending over, and final normal breathing.
    The TSI PortaCount[supreg] Plus fit-testing instrument performed 
particle counts on samples collected during the study. The table below 
provides the exercise and sampling parameters for each of the protocols 
used in the study.

----------------------------------------------------------------------------------------------------------------
                                                                                                      In-mask
                                                                                    Duration of      sampling
                            Protocol                                 Number of     each exercise   duration for
                                                                     exercises        (secs.)      each exercise
                                                                                                    (secs.) \1\
----------------------------------------------------------------------------------------------------------------
Standard PortaCount[supreg] QNFT Protocol.......................               8              60              40
Revised PortaCount[supreg] QNFT Protocol 1......................               8              30              10
Revised PortaCount[supreg] QNFT Protocol 2......................           \2\ 6              40              20
----------------------------------------------------------------------------------------------------------------
\1\ Does not include 20 seconds for each exercise to collect ambient-air samples and to purge the in-mask and
  ambient-air sampling tubes.
\2\ This protocol eliminated the initial normal-breathing exercise and the deep-breathing exercise.

    Results. To pass a fit test using revised PortaCount[supreg] QNFT 
protocol 1, test subjects had to attain a fit factor of 100 for half 
masks and 500 for full-facepiece respirators; the pass-fail criteria 
for full-facepiece respirators using revised PortaCount[supreg] QNFT 
protocol 2 were 200 for half masks and 1,000 for full-facepiece 
respirators. Based on these criteria, the authors determined the 
following statistics for the two proposed protocols: test sensitivity; 
predictive value of a pass; test specificity; predictive value of a 
fail; and the kappa statistic. In calculating these statistics, the 
authors adopted the variables defined by ANSI Z88.10-2001, in which: A 
= false positives (passed the fit test with a fit factor < 100); B = 
true positives (passed the fit test with a fit factor >= 100); C = true 
negatives (failed the fit test with a fit factor < 100); D = false 
negatives (failed the fit test with a fit factor >= 100); Po 
= observed proportion of the two fit tests that are concordant; and 
Pe = expected proportion of the two fit tests expected to be 
concordant when the two tests are statistically independent. Using 
these variables, ANSI Z88.10-2001 specifies the formula and recommended 
value (``RV'') for each statistic as follows: Test sensitivity = C/(A + 
C), RV >= 0.95; predictive value of a pass = B/(A + B), RV >= 0.95; 
test specificity = B/(B + D), RV > 0.50; predictive value of a fail = 
C/(C + D), RV > 0.50; and the kappa statistic = (Po-
Pe)/(1-Pe).
    Using the standard PortaCount[supreg] QNFT protocol as the 
criterion measure, the variables for the two proposed protocols had 
values for half masks and full-facepiece respirators listed in the 
following two tables.

[[Page 3529]]



----------------------------------------------------------------------------------------------------------------
                                                 Values for half-mask respirators
                                   -----------------------------------------------------------
             Variables                                        Revised             Revised
                                     ANSI requirement   PortaCount[supreg]  PortaCount[supreg]
                                                          QNFT Protocol 1     QNFT Protocol 2
----------------------------------------------------------------------------------------------
Sensitivity.......................              >=0.95            \1\ 0.91                1.00
Predictive Value of a Pass........              >=0.95            \2\ 0.94                1.00
Specificity.......................               >0.50                0.99                0.81
Predictive Value of a Fail........               >0.50                0.98                0.79
Kappa Statistic...................               >0.70                0.91                0.78
----------------------------------------------------------------------------------------------------------------
\1\ = Fail.
\2\ = Borderline fail.


----------------------------------------------------------------------------------------------------------------
                                               Values for full-facepiece respirators
                                   -----------------------------------------------------------
             Variables                                        Revised             Revised
                                     ANSI requirement   PortaCount[supreg]  PortaCount[supreg]
                                                          QNFT Protocol 1     QNFT Protocol 2
----------------------------------------------------------------------------------------------
Sensitivity.......................              >=0.95                0.97                1.00
Predictive Value of a Pass........              >=0.95            \1\ 0.94                1.00
Specificity.......................               >0.50                0.98                0.84
Predictive Value of a Fail........               >0.50                0.99                0.92
Kappa Statistic...................               >0.70                0.94                0.87
----------------------------------------------------------------------------------------------------------------
\1\ = Borderline fail.

    For half masks, revised PortaCount[supreg] QNFT protocol 1 failed 
to meet the sensitivity value specified by ANSI Z88.10-2001, and, 
consistent with this failure, the value for the predictive-value-of-a-
pass variable was marginal. However, for full-facepiece respirators, 
the sensitivity value for this proposed protocol exceeded the ANSI 
requirement, although the predictive-value-of-a-pass variable was again 
slightly below the ANSI specification. The failure of this proposed 
protocol to attain an adequate sensitivity value when applied to half 
masks indicates that, for half masks, the proposed protocol is 
susceptible to alpha, or false positive, error--i.e., it would pass 
some half masks that would function below a fit factor of 100 when 
tested with the protocol used as the criterion measure (i.e., the 
standard PortaCount[supreg] QNFT protocol). The authors did not provide 
an explanation for this deficiency. However, the deficiency is unlikely 
to be the result of statistical error because the number of test 
subjects appeared to be adequate, and a procedural or measurement error 
should have decreased the sensitivity value for revised 
PortaCount[supreg] QNFT protocol 2, which was not the case. Despite 
these problems, revised PortaCount[supreg] QNFT protocol 1 performed 
well above the values established by the ANSI standard for the three 
remaining variables, including specificity, predictive value of a fail, 
and the kappa statistic. These values indicate that the vast majority 
of the test subjects who passed (or failed) the criterion measure also 
passed (or failed) the proposed protocol, and the proposed protocol 
correlated highly with the criterion measure. Nonetheless, the fact 
that revised PortaCount[supreg] QNFT protocol 1 failed to meet the 
sensitivity value specified by ANSI Z88.10-2001 for half masks raises 
the question of whether it is as protective as the standard 
PortaCount[supreg] QNFT protocol, and OSHA has raised this as an issue 
for public comment (see below).
    The variables for revised PortaCount[supreg] QNFT protocol 2 had 
sensitivity values for both half masks and full-facepiece respirators 
well in excess of the sensitivity value specified by the ANSI standard. 
The sensitivity values for this proposed protocol demonstrate that it 
identified 100% of the poorly fitting half masks and full-facepiece 
respirators. In addition, this proposed protocol performed well above 
the values listed in the ANSI standard for the four remaining 
variables, including predictive value of a pass, specificity, 
predictive value of a fail, and the kappa statistic. Consistent with 
the sensitivity values derived for this proposed protocol, these four 
values indicate that the proposed protocol resulted in fit factors that 
accurately identified half masks and full-facepiece respirators with 
acceptable and poor fits, and that these fit factors agreed closely 
with the fit factors attained from the criterion measure.
    In discussing the results for revised PortaCount[supreg] QNFT 
protocol 2, the authors noted that excluding the two least strenuous 
fit-testing exercises (i.e., the initial normal-breathing exercise and 
the deep-breathing exercise) from this proposed protocol was a 
conservative approach in that the proposed protocol was more likely 
than protocols consisting of eight fit-testing exercises to detect 
respirator leakage (i.e., using data from less strenuous fit-testing 
exercises inappropriately inflates the overall fit factor for 
respirators, thereby increasing alpha error). Another conservative 
approach used by this proposed protocol was raising the pass-fail 
criterion for half masks from a fit factor of 100 to 200, and, for 
full-facepiece respirators, from 500 to 1,000. This approach likely 
enhanced the sensitivity of the proposed protocol. However, enhancing 
sensitivity may increase beta (false-negative) error, which would 
increase the number of repeated tests and, consequently, the total 
testing time required by some employees to identify a respirator having 
an acceptable fit.

C. Conclusions

    OSHA believes that the information submitted by Mr. Weed in support 
of the proposed protocols meets the criteria for determining whether 
OSHA must publish fit-testing protocols for notice-and-comment 
rulemaking established by the Agency in Part II of Appendix A of its 
Respiratory Protection Standard. Therefore, the Agency concludes that 
the proposed protocols warrant notice-and-comment rulemaking under 
Section 6(b)(7) of the Act (29 U.S.C. 655), and is initiating this 
rulemaking to determine whether to approve these proposed protocols for 
inclusion in Part I of Appendix A of its Respiratory Protection 
Standard.
    The only differences between the two proposed protocols and the 
standard PortaCount[supreg] QNFT protocol specified

[[Page 3530]]

currently in Part I.C.3 of Appendix A of the Respiratory Protection 
Standard are the duration of the exercises used during fit testing, and 
for revised PortaCount[supreg] QNFT protocol 2, the exclusion of the 
two least strenuous fit-testing exercises and the raising of the 
minimum passing criteria. Therefore, the Agency is proposing to add the 
proposed protocols to Part I.C.3 of Appendix A (see section IV of this 
preamble titled ``Proposed Amendment to the Standard''). In addition to 
decreasing exercise durations from 60 seconds to 30 or 40 seconds, the 
proposed revisions to the regulatory text would limit use of revised 
PortaCount[supreg] QNFT protocol 2 to respirator users who demonstrate 
a minimum passing criteria of 200 for half masks or 1,000 for full-
facepiece respirators. If approved, the proposed protocols would be 
alternatives to the existing quantitative fit-testing protocols already 
listed in the Part I of Appendix A of the Respiratory Protection 
Standard; employers would be free to select these alternatives or to 
continue using any of the other protocols currently listed in the 
appendix.

D. Issues for Public Comment

    OSHA invites comments and data from the public regarding the 
accuracy and reliability of the two proposed protocols, their 
effectiveness in detecting respirator leakage, and their usefulness in 
selecting respirators that will protect employees from airborne 
contaminants in the workplace. Specifically, the Agency invites public 
comment on the following issues:
     Was the study described in the peer-reviewed journal 
article well controlled, and conducted according to accepted 
experimental design practices and principles?
     Were the results of the study described in this article 
properly, fully, and fairly presented and interpreted?
     Will the proposed protocols generate reproducible fit-
testing results?
     Will the proposed protocols reliably identify respirators 
with unacceptable fit as effectively as the quantitative fit-testing 
protocols, including the standard PortaCount[supreg] QNFT protocol, 
already listed in Part I.C.3 of Appendix A of the Respiratory 
Protection Standard?
     Is the test-sensitivity value of 0.91 obtained for half 
masks by revised PortaCount[supreg] QNFT protocol 1 acceptable in view 
of the test-sensitivity value of 0.95 required by ANSI Z88.10-2001. If 
not, would it be appropriate for OSHA to limit application of revised 
PortaCount[supreg] QNFT protocol 1 to full-facepiece respirators?
     The study evaluating the proposed protocols involved only 
elastomeric half-mask and full-facepiece respirators. Accordingly, is 
it appropriate to apply the results of the study to other types of 
respirators (e.g., filtering-facepiece respirators)?

III. Procedural Determinations

A. Legal Authority

    The purpose of the Occupational Safety and Health Act of 1970 
(``the Act''; 29 U.S.C. 651 et seq.) is ``to assure so far as possible 
every working man and woman in the nation safe and healthful working 
conditions and to preserve our human resources'' (29 U.S.C. 651(b)). To 
achieve this goal, Congress authorized the Secretary of Labor to 
promulgate and enforce occupational safety and health standards (29 
U.S.C. 655(b) and 654(b)).
    Under the Act, a safety or health standard is a standard that 
``requires conditions, or the adoption or use of one or more practices, 
means, methods, operations, or processes, reasonably necessary or 
appropriate to provide safe or healthful employment or places of 
employment'' (29 U.S.C. 652(8)). A standard is reasonably necessary or 
appropriate within the meaning of Section 652(8) of the Act when it 
substantially reduces or eliminates a significant workplace risk, and 
is technologically and economically feasible, cost effective, 
consistent with prior Agency action or supported by a reasoned 
justification for departing from prior Agency action, and supported by 
substantial evidence; it also must effectuate the Act's purposes better 
than any national consensus standard it supersedes (see International 
Union, UAW v. OSHA (LOTO II), 37 F.3d 665 (D.C. Cir. 1994); and 58 FR 
16612-16616 (March 30, 1993)). Rules promulgated by the Agency must be 
highly protective (see 58 FR 16612, 16614-15 (March 30, 1993); LOTO II, 
37 F.3d 665, 669 (D.C. Cir. 1994)). Moreover, Section 8(g)(2) of the 
Act authorizes OSHA ``to prescribe such rules and regulations as [it] 
may deem necessary to carry out its responsibilities under the Act'' 
(see 29 U.S.C. 657(g)(2)).
    Based on the available evidence, OSHA has preliminarily determined 
that the protocols described in the proposed rule meet the legal 
requirements to provide substantial protection to employees who use 
respirators when exposed to hazardous atmospheres (see Industrial Union 
Dept. v. American Petroleum Institute, 448 U.S. 607, 655 (1980); 
International Union v. Pendergrass, 878 F.2d 389, 392-93 (DC Cir. 
1989); Building and Construction Trades Dept., AFL-CIO v. Brock, 838 
F.2d 1258, 1264-65 (DC Cir. 1988)). OSHA also made a preliminary 
finding that the proposed rule is technologically feasible because the 
protective measures it requires already exist (see American Textile 
Mfrs. Institute v. OSHA (Cotton Dust), 452 U.S. 490, 513 (1981); 
American Iron and Steel Institute v. OSHA (Lead II), 939 F.2d 975, 980 
(DC Cir. 1991)). Specifically, employers covered by this proposal 
already must comply with the fit-testing requirements specified in 
paragraph (f) of OSHA's Respiratory Protection Standard at 29 CFR 
1910.134. Accordingly, these provisions currently are protecting their 
employees from the significant risk that results from poorly fitting 
respirators. In this regard, for OSHA to adopt the proposed protocols 
in the final rule, OSHA would have to determine that the proposed 
protocols provide employees with protection that is comparable to the 
protection afforded to them by the provisions of the standard 
PortaCount[supreg] QNFT protocol. If adopted, the protocols would not 
replace existing fit-testing protocols, but instead would be 
alternatives to them. Therefore, OSHA preliminarily finds that the 
proposal would not directly increase or decrease the protection 
afforded to employees, nor would it increase employers' compliance 
burdens. As demonstrated in the following section, the proposal may 
reduce employers' compliance burdens by decreasing the time required to 
fit test respirators for employee use. Accordingly, OSHA concludes that 
it is unnecessary to determine significant risk or the extent to which 
this proposal would reduce that risk, as typically would be required by 
Industrial Union Department, AFL-CIO v. American Petroleum Institute, 
448 U.S. 607 (1980).
    The Agency believes that the proposed rule is economically feasible 
because the employers can absorb or pass on the costs of compliance 
without threatening their long-term profitability or competitive 
structure (see Cotton Dust, 452 U.S. at 530 n. 55 (1981); Lead II, 939 
F.2d 975, 980 (DC Cir. 1991)). Moreover, the preliminary economic 
analysis of the proposed rule describes the benefits and costs of the 
proposed rule (see section III.B. of this preamble, ``Preliminary 
Economic Analysis and Initial Regulatory Flexibility Analysis''). Based 
on this information, OSHA made a preliminary determination that the 
proposed rule is an economically feasible means of meeting its 
statutory objective of reducing the risk associated with employee 
exposure to hazardous atmospheres while using respirators (see

[[Page 3531]]

Cotton Dust, 453 U.S. at 514 n. 32 (1981); LOTO II, 37 F.3d 665, 668 
(DC Cir. 1994)).

B. Preliminary Economic Analysis and Initial Regulatory Flexibility 
Analysis

    The proposal is not economically significant within the context of 
Executive Order (``E.O.'') 12866 (58 FR 51735), or a ``major rule'' 
under Section 804 of the Small Business Regulatory Enforcement Fairness 
Act of 1996 (``SBREFA''; 5 U.S.C. 804). The proposal would impose no 
additional costs on any private-or public-sector entity, and does not 
meet any of the criteria for a significant or major rule specified by 
E.O. 12866 or other relevant statutes.
    The proposal offers employers additional options to fit test their 
employees for respirator use. In this regard, OSHA would supplement the 
standard PortaCount[supreg] QNFT protocol currently in Appendix A of 
the Respiratory Protection Standard with the proposed protocols if it 
approves them as a result of this proposed rulemaking. According to a 
recent survey of respirator use conducted by the National Institute for 
Occupational Safety and Health and the Bureau of Labor Statistics, 
approximately 7,500 establishments currently use an ambient-aerosol 
protocol out of nearly 282,000 establishments found by the survey to 
require respirator use (Ex. 6-3, Docket No. H049C (``Respiratory 
Protection--Assigned Protection Factors'').\4\
---------------------------------------------------------------------------

    \4\ The standard PortaCount[supreg] QNFT protocol is the only 
ambient-aerosol protocol currently listed in Appendix A of the 
Respiratory Protection Standard.
---------------------------------------------------------------------------

    Under this proposal, employers would have a choice between the 
standard PortaCount[supreg] QNFT protocol consisting of exercises 
lasting one minute each, or the proposed protocols with exercises (six 
or eight) lasting 30 or 40 seconds each. By providing regulatory 
flexibility to these employers, the proposal may reduce their costs by 
decreasing fit-testing time. In this regard, OSHA assumes that the 
proposed protocols would be adopted by some employers who currently use 
the standard PortaCount[supreg] QNFT protocol for their employees. 
These employers would adopt the proposed protocols because these 
protocols would take less time to administer than the standard 
PortaCount[supreg] QNFT protocol, thereby decreasing the cost required 
for fit testing their employees. However, the Agency believes that the 
proposed protocols are unlikely to be adopted by employers who 
currently perform fit testing using other quantitative or qualitative 
fit tests because of the significant equipment and training investment 
they already have made to administer these fit tests.
    Based on the above discussion, the Agency preliminarily concludes 
that this proposed rulemaking would impose no additional costs on 
employers, thereby eliminating the need for a preliminary economic 
analysis. Moreover, OSHA certifies that the proposal would not have a 
significant impact on a substantial number of small entities, and that 
the Agency does not have to prepare an initial regulatory flexibility 
analysis for this rulemaking under the SBREFA (5 U.S.C. 601 et seq.).

C. Paperwork Reduction Act

    After thoroughly analyzing the proposed fit-testing provisions in 
terms of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. 
and 5 CFR part 1320), OSHA believes that these provisions would not add 
to the existing collection of information (i.e., paperwork) 
requirements regarding fit testing employees for respirator use. The 
paperwork requirement specified in paragraph (m)(2) of OSHA's 
Respiratory Protection Standard at 29 CFR 1910.134 specifies that 
employers must document and maintain the following information on 
quantitative fit tests administered to employees: the name or 
identification of the employee tested; the type of fit test performed; 
the specific make, model, style, and size of respirator tested; the 
date of the test; and the test results. The employer must maintain this 
record until the next fit test is administered. However, this paperwork 
requirement would remain the same whether employers currently use the 
other fit-testing protocols already listed in Part I of Appendix A of 
the Respiratory Protection Standard, or implement the proposed fit-
testing protocols instead. Therefore, using one of the proposed fit-
testing protocols in the context of the existing fit-testing protocols 
would not involve an additional paperwork-burden determination by OSHA 
because it already accounts for this burden under the paperwork 
analysis for the Respiratory Protection Standard (OMB Control Number 
1218-0099).
    Members of the public may send comments on this paperwork analysis 
to: Office of Information and Regulatory Affairs (Attention: Desk 
Officer for OSHA), Office of Management and Budget, Room 10235, 725 
17th Street, NW., Washington, DC 20503. The Agency also encourages 
commenters to submit a copy of their comments on this paperwork 
analysis to OSHA, along with their other comments on the proposed rule.

D. Federalism

    The Agency reviewed the proposal according to the most recent 
Executive Order (``E.O.'') on Federalism (E.O. 13132; 64 FR 43225). 
This E.O. requires that Federal agencies, to the extent possible, 
refrain from limiting State policy options, consult with States before 
taking actions that restrict their policy options, and take such 
actions only when clear constitutional authority exists and the problem 
is national in scope. The E.O. allows Federal agencies to preempt State 
law only with the expressed consent of Congress. In such cases, Federal 
agencies must limit preemption of State law to the extent possible.
    Section 18 of the Act; 29 U.S.C. 651 et seq.), expressly provides 
OSHA with authority to preempt State occupational safety and health 
standards to the extent that the Agency promulgates a Federal standard 
under Section 6 of the Act. Accordingly, Section 18 of the Act 
authorizes the Agency to preempt State promulgation and enforcement of 
requirements dealing with occupational safety and health issues covered 
by OSHA standards unless the State has an OSHA-approved occupational 
safety and health plan (namely, is a ``State-plan State''). (See Gade 
v. National Solid Waste Management Association, 112 S. Ct. 2374 
(1992).)
    With respect to States that do not have OSHA-approved plans, the 
Agency concludes that this proposed rule conforms to the preemption 
provisions of the Act. Additionally, Section 18 of the Act prohibits 
States without approved plans from issuing citations for violations of 
OSHA standards; the Agency finds that the proposed rulemaking does not 
expand this limitation. Therefore, for States that do not have approved 
occupational safety and health plans, this proposed rule would not 
affect the preemption provisions of Section 18 of the Act.
    OSHA has authority under E.O. 13132 to propose the use of 
additional fit-testing protocols under its Respiratory Protection 
Standard at 29 CFR 1910.134 because the problems addressed by these 
fit-testing requirements are national in scope. The Agency 
preliminarily concludes that the fit-testing protocols proposed by this 
rulemaking would provide employers in every State with procedures that 
would assist them in protecting their employees from the risks of 
exposure to atmospheric hazards. In this regard, the proposal offers 
thousands of employers across the nation an opportunity to use 
additional protocols to assess respirator fit among their employees. 
Therefore,

[[Page 3532]]

the proposal would provide employers in every State with an alternative 
means of complying with the fit-testing requirements specified by 
paragraph (f) of OSHA's Respiratory Protection Standard.
    Should the Agency adopt a proposed standard in a final rulemaking, 
Section 18(c)(2) of the Act (29 U.S.C. 667(c)(2)) requires State-plan 
States to adopt the same standard, or to develop and enforce an 
alternative standard that is at least as effective as the OSHA 
standard. However, the new fit-testing protocols proposed in this 
rulemaking would only provide employers with an alternative to the 
existing requirements for fit-testing protocols specified in the 
Respiratory Protection Standard; therefore, the alternative is not, 
itself, a mandatory standard. Accordingly, States with OSHA-approved 
State Plans would not be obligated to adopt the final provisions that 
may result from this proposed rulemaking. Nevertheless, OSHA strongly 
encourages them to adopt the final provisions to provide additional 
compliance options to employers in their States.
    In summary, this proposed rule complies with E.O. 13132. In States 
without OSHA-approved State Plans, Congress expressly provides for OSHA 
standards to preempt State job safety and health rules in areas 
addressed by the Federal standards; in these States, this proposed rule 
would limit State policy options in the same manner as every standard 
promulgated by the Agency. In States with OSHA-approved State Plans, 
this rulemaking does not significantly limit State policy options.

E. State-Plan States

    Section 18(c)(2) of the Act (29 U.S.C. 667(c)(2)) requires State-
Plan States to adopt mandatory standards promulgated by OSHA. However, 
as noted in the previous section of this preamble, States with OSHA-
approved State Plans would not be obligated to adopt the final 
provisions that may result from this proposed rulemaking. Nevertheless, 
OSHA strongly encourages them to adopt the final provisions to provide 
compliance options to employers in their States. In this regard, OSHA 
preliminarily concludes that the fit-testing protocols proposed by this 
rulemaking would provide employers in the State-Plan States with 
procedures that would protect the safety and health of employees who 
use respirators against hazardous airborne substances in their 
workplace at least as well as the standard PortaCount[supreg] QNFT 
protocol. The 24 States and two Territories with State Plans are: 
Alaska, Arizona, California, Hawaii, Indiana, Iowa, Kentucky, Maryland, 
Michigan, Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto 
Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, 
and Wyoming. Connecticut, New Jersey, New York, and the Virgin Islands 
have OSHA-approved State Plans that apply to State and local government 
employees only.

F. Unfunded Mandates Reform Act

    OSHA reviewed the proposal according to the Unfunded Mandates 
Reform Act of 1995 (``UMRA''; 2 U.S.C. 1501 et seq.) and Executive 
Order 12875 (58 FR 58093). As discussed above in section III.B of this 
preamble (``Preliminary Economic Analysis and Initial Regulatory 
Flexibility Analysis''), the Agency made a preliminary determination 
that the proposal imposes no additional costs on any private-or public-
sector entity. The substantive content of the proposal applies only to 
employers whose employees use respirators for protection against 
airborne workplace contaminants, and compliance with the proposal would 
be strictly optional for these employers. Accordingly, the proposal 
would require no additional expenditures by either public-or private-
sector employers; therefore, this proposal is not a significant 
regulatory action within the meaning of Section 202 of the UMRA (2 
U.S.C. 1532).
    Under voluntary agreement with OSHA, some States enforce compliance 
with their State standards on public-sector entities, and these 
agreements specify that these State standards must be equivalent to 
OSHA standards. Thus, although OSHA preliminarily concludes that the 
proposed protocols would impose no additional costs on public-sector 
employers, the proposal would not involve any unfunded mandates imposed 
on any other State or local government entity. Consequently, this 
proposal does not meet the definition of a ``Federal intergovernmental 
mandate'' (see Section 421(5) of the UMRA (2 U.S.C. 658(5))). 
Therefore, for the purposes of the UMRA, the Agency preliminarily 
certifies that this proposal does not mandate that State, local, or 
tribal governments adopt new, unfunded regulatory obligations, nor does 
the proposed rule increase expenditures by the private sector of more 
than $100 million a year.

G. Applicability of Existing Consensus Standards

    Section 6(b)(8) of the Act (29 U.S.C. 655(b(8)) requires OSHA to 
explain ``why a rule promulgated by the Secretary differs substantially 
from an existing national consensus standard,'' by publishing ``a 
statement of the reasons why the rule as adopted will better effectuate 
the purposes of the Act than the national consensus standard.'' In this 
regard, when OSHA promulgated its original respirator fit-testing 
protocols under Appendix A of its final Respiratory Protection Standard 
(29 CFR 1910.134), no national consensus standards addressed these 
protocols. Later, the American National Standards Institute (ANSI) 
developed a national consensus standard on fit-testing protocols 
(``Respirator Fit Testing Methods,'' ANSI Z88.10-2001) as an adjunct to 
its national consensus standard on respiratory-protection programs.
    Paragraph 7.2 of ANSI Z88.10-2001 specifies the requirements for 
conducting a PortaCount[supreg] quantitative fit test, which differ 
substantially from the standard PortaCount[supreg] QNFT protocol 
provided in Part I.C.3 of OSHA's Respiratory Protection Standard. These 
protocols differ in terms of the fit-testing exercises required, and 
the duration of these exercises. In addition, the ANSI standard 
provides no data or information on the accuracy and reliability of its 
protocol. The Agency believes that limiting fit-testing options to the 
protocol currently specified by the ANSI standard would seriously 
impede the development of fit-testing protocols that are more accurate 
and reliable, and less costly to administer, than the ANSI protocol.

H. Advisory Committee for Construction Safety and Health Review of the 
Proposed Standard

    The proposal to add two quantitative fit-testing protocols to Part 
I.C of Appendix A of OSHA's Respiratory Protection Standard would 
affect the construction industry because it revises the fit-testing 
requirements specified by the standard, which is applicable to the 
construction industry.\5\ Whenever the Agency proposes a rule involving 
construction activities, the Contract Work Hours and Safety Standards 
Act (Construction Safety Act) (40 U.S.C. 3704), OSHA regulations 
governing the Advisory Committee for Construction Safety and Health 
(ACCSH) (i.e., 29 CFR 1912.3), and provisions governing OSHA rulemaking 
(i.e., 29 CFR 1911.10) require OSHA to consult with the ACCSH. 
Specifically, 29 CFR 1911.10 requires that the Assistant Secretary 
provide the ACCSH with ``any proposal

[[Page 3533]]

of his own,'' together with ``all pertinent factual information 
available to him, including the results of research, demonstrations, 
and experiments.'' Accordingly, OSHA provided the ACCSH members with 
copies of the proposal and other relevant information several weeks 
before the January 24, 2008, ACCSH meeting. OSHA staff met with the 
ACCSH at that meeting to discuss the proposal, and to answer members' 
questions about it. At the end of this session, the ACCSH voted to 
defer making any recommendations to OSHA regarding the proposal until 
their next meeting so they could thoroughly review the proposal and the 
other relevant information, including the peer-reviewed article 
described above under section II.B of this notice (``Summary of the 
Peer-Reviewed Article'').
---------------------------------------------------------------------------

    \5\ The Respiratory Protection Standard for the construction 
industry at 29 CFR 1926.103 cross-references the Respiratory 
Protection Standard for general industry at 29 CFR 1910.134.
---------------------------------------------------------------------------

    At the May 16, 2008, ACCSH meeting, OSHA staff again met with the 
ACCSH to discuss the proposal. Following this discussion, the ACCSH 
recommended unanimously that OSHA: (1) Remove the PortaCount[supreg] 
QNFT protocol 1 from the proposal because it failed to meet the ANSI 
Z88.10-2001 criteria for test sensitivity and predicted value of a 
pass; and (2) include the PortaCount[supreg] QNFT protocol 2 in the 
proposal because it met all of the ANSI Z88.10-2001 criteria.

I. Public Participation

    OSHA encourages members of the public to participate in this 
rulemaking by submitting comments on the proposal, as well as 
documentary evidence in support of these comments. Accordingly, the 
Agency invites interested parties having knowledge of, or experience 
with, respirator fit-testing protocols to participate in this process, 
and welcomes any pertinent information that will provide it with the 
best available evidence on which to develop the final regulatory 
provisions. The Agency invites interested parties to submit written 
views, arguments, and data concerning this proposed rule, including: 
responses to the issues specified under section II.B of this preamble 
(``Issues for Public Comment''), and comments on OSHA's determination 
of the economic or other regulatory impacts of the proposed rule on the 
regulated community. Comments may be submitted in response to this 
Federal Register notice: (1) Electronically at https://
www.regulations.gov, which is the Federal eRulemaking portal; (2) by 
facsimile (fax); or (3) by hard copy. When submitting comments, follow 
the procedures specified above in the sections of this preamble titled 
DATES and ADDRESSES. All comments, attachments, and other material must 
identify the Agency name and the OSHA docket number for this rulemaking 
(Docket No. OSHA-2007-0007). In addition, comments must clearly 
identify the provision of the proposal being addressed, the position 
taken with respect to an issue, and the basis for that position. 
Comments, along with supporting data and references, received by the 
end of the specified comment period will become part of the proceedings 
record. This material, including comments, is available for public 
inspection without change at https://www.regulations.gov \6\ and at 
OSHA's docket Web site at https://www.dockets.osha.gov (under Docket No. 
OSHA-2007-0007). Therefore, OSHA cautions commenters about submitting 
personal information such as social security numbers and birth dates 
with their comments. Exhibits referenced in this Federal Register 
notice also will be available at https://www.regulations.gov and https://
www.dockets.osha.gov under the same docket number.
---------------------------------------------------------------------------

    \6\ Information on using this Web site to submit comments and to 
access dockets is available at the Web site's ``User Tips'' link. 
Contact the OSHA Docket Office for information and assistance about 
using the Internet to locate docket submissions.
---------------------------------------------------------------------------

    Material that supplements electronic comments may be uploaded 
electronically (including by fax). Supplemental material also may be 
mailed to the OSHA Docket Office (see the section of this preamble 
titled ADDRESSES) provided it identifies the electronic comments using 
the commenter's name, comment submission date, and docket number so 
OSHA can attach the materials to the appropriate comments. Reading or 
downloading some of this material (e.g., copyrighted material) from the 
https://www.regulations.gov and https://www.dockets.osha.gov Web sites is 
not possible; however, this material is available for inspection and 
copying (along with comments and exhibits) at the OSHA Docket Office 
(see the section of this preamble titled ADDRESSES).
    Security-related procedures may delay significantly the delivery of 
comments and other material submitted through the regular mail. For 
information about security procedures involving the regular mail, as 
well as express delivery and messenger or courier service, contact the 
OSHA Docket Office at (202) 693-2350 (TTY (877) 889-5627).
    Electronic copies of this Federal Register notice are available at 
https://www.regulations.gov. This notice, as well as news releases and 
other relevant information, also are available at OSHA's Web site at 
https://www.osha.gov.

List of Subjects in 29 CFR Part 1910

    Fit testing, Hazardous substances, Health, Occupational safety and 
health, Respirators, Toxic substances.

Authority and Signature

    Thomas M. Stohler, Acting Assistant Secretary of Labor for 
Occupational Safety and Health, U.S. Department of Labor, 200 
Constitution Avenue, NW., Washington, DC 20210, directed the 
preparation of this notice. Accordingly, the Agency issues the proposed 
amendment under the following authorities: Sections 4, 6(b), 8(c), and 
8(g) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 
655, 657); Section 3704 of the Contract Work Hours and Safety Standards 
Act (40 U.S.C. 3701 et seq.); Section 41 of the Longshore and Harbor 
Worker's Compensation Act (33 U.S.C. 941); Secretary of Labor's Order 
No. 5-2007 (72 FR 31159); and 29 CFR part 1911.

    Signed at Washington, DC, on January 13, 2009.
Thomas M. Stohler,
Acting Assistant Secretary of Labor for Occupational Safety and Health.

IV. Proposed Amendment to the Standard

    For the reasons stated above in the preamble, the Agency proposes 
to amend 29 CFR part 1910 as follows:

PART 1910--[AMENDED]

Subpart I--[Amended]

    1. Revise the authority citation for subpart I of part 1910 to read 
as follows:

    Authority: Sections 4, 6, and 8 of the Occupational Safety and 
Health Act of 1970 (29 U.S.C. 653, 655, and 657); Section 3704 of 
the Contract Work Hours and Safety Standards Act (40 U.S.C. 3701 et 
seq.); Section 41, Longshore and Harbor Worker's Compensation Act 
(33 U.S.C. 941); and Secretary of Labor's Order Nos. 8-76 (41 FR 
25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-
2000 (65 FR 50017), 5-2002 (67 FR 65008), or 5-2007 (72 FR 31159), 
as applicable. Sections 29 CFR 1910.132, 1910.134, and 1910.138 also 
issued under 29 CFR part 1911. Sections 29 CFR 1910.133, 1910.135, 
and 1910.136 also issued under 29 CFR part 1911 and 5 U.S.C. 553.

    2. Add paragraphs (c) and (d) to section C.3 of Appendix A to Sec.  
1910.134 to read as follows:


Sec.  1910.134  Respiratory protection.

* * * * *

[[Page 3534]]

Appendix A to Sec.  1910.134: Fit Testing Procedures (Mandatory)

* * * * *
    C. * * *
* * * * *
    3. * * *
* * * * *
    (c) Revised PortaCount[supreg] Quantitative Fit-Testing Protocol 
1.
    (1) When administrating this protocol to test subjects (i.e., 
employees), employers must comply with the requirements specified in 
paragraphs (a) and (b) of Part 1.C.3 of this appendix. In addition, 
employers must use the eight fit-testing exercises specified in 
section I.A.14 of this appendix when administering this protocol. 
Test subjects must perform these fit-testing exercises for at least 
30 seconds, except for the grimace exercise, which test subjects 
must perform for 15 seconds.
    (2) Calculate the overall fit factor for this protocol as 
follows:
[GRAPHIC] [TIFF OMITTED] TP21JA09.126


    Note to Paragraph (c)(2): Only seven of the eight fit-testing 
exercises are used in this calculation because the results for the 
grimace exercise (ff6) are not included in the 
calculation.

    (d) Revised PortaCount[supreg] Quantitative Fit-Testing Protocol 
2.
    (1) When administrating this protocol to test subjects (i.e., 
employees), employers must comply with the requirements specified in 
paragraphs (a) and (b) of Part 1.C.3 of this appendix. In addition, 
employers must use the fit-testing exercises specified in section 
I.A.14 of this appendix when administering this protocol, except 
that test subjects must not perform the fit-testing exercises 
specified by paragraphs (a)(1) and (a)(2) of section I.A.14 (i.e., 
the initial normal-breathing exercise and the deep-breathing 
exercise, respectively). Test subjects must perform these fit-
testing exercises for at least 40 seconds, except for the grimace 
exercise, which test subjects must perform for 15 seconds.
    (2) This protocol requires the following minimum pass-fail fit-
testing criteria: for half masks, an overall fit factor of 200 
(instead of the usual 100); and, for full-facepiece respirators, an 
overall fit factor of 1,000 (instead of the usual 500).
    (3) Calculate the overall fit factor for this protocol as 
follows:
[GRAPHIC] [TIFF OMITTED] TP21JA09.122


    Note to Paragraph (d)(3): Only five of the eight fit-testing 
exercises are used in this calculation because test subjects do not 
perform the initial normal-breathing exercise (ff1) and 
the deep-breathing exercise (ff2), and the results for 
the grimace exercise (ff6) are not included in the 
calculation.

* * * * *
 [FR Doc. E9-922 Filed 1-16-09; 8:45 am]
BILLING CODE 4510-26-P
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