Federal Registers - Table of Contents Federal Registers - Table of Contents
• Publication Date: 01/21/2009
• Publication Type: Proposed Rules
• Fed Register #: 74:3526-3534
• Standard Number: 1910; 1910.134; 1911.10; 1912.3; 1926.103
• Title: Additional Quantitative Fit-Testing Protocols for the Respiratory Protection Standard

[Federal Register: January 21, 2009 (Volume 74, Number 12)]
[Proposed Rules]               
[Page 3526-3534]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21ja09-36]                         

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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.

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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.
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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
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: http://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 http://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 http://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 http://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 http://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® quantitative fit-testing protocol 
(hereafter, "the standard PortaCount® QNFT protocol"). OSHA 
included the standard PortaCount® QNFT protocol in Appendix A of 
its final Respiratory Protection Standard.
(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").
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    \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® 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.
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    \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® 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.

-------------------------------------------------------------------------------------------------
                                                                                       In-mask
                                                                     Duration of      sampling
                            Protocol                  Number of     each exercise   duration for
                                                      exercises        (secs.)      each exercise
                                                                                     (secs.) \1\
-------------------------------------------------------------------------------------------------
Standard PortaCount® QNFT Protocol........               8              60              40
Revised PortaCount® QNFT Protocol 1.......               8              30              10
Revised PortaCount® 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® 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® 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® 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.

-------------------------------------------------------------------------------------------------
                                                 Values for half-mask respirators
                                   -----------------------------------------------------------
             Variables                                        Revised             Revised
                                     ANSI requirement   PortaCount®  PortaCount®
                                                          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®  PortaCount®
                                                          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® 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® 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 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 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® QNFT protocol specified
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 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® 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® 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 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® 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
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\
---------------------------------------------------------------------------

    \4\ The standard PortaCount® 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® 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 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, 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® 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® 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 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® 
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 http://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 http://www.regulations.gov \6\ and at 
OSHA's docket Web site at http://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 http://www.regulations.gov and http://
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 
http://www.regulations.gov and 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 
http://www.regulations.gov. This notice, as well as news releases and 
other relevant information, also are available at OSHA's Web site at 
http://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.

* * * * *

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

* * * * *
    C. * * *
* * * * *
    3. * * *
* * * * *
    (c) Revised PortaCount® 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:
Calculate the 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 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:
Calculate the 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

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