30250 Federal Register / Vol. 74, No. 121 / Thursday, June 25, 2009 / Proposed Rules 

by a controlled party to the value of an 

intangible owned by another controlled 

party, and modifying the regulations 

under section 861 concerning 

stewardship expenses to be consistent 

with the changes made to the guidance 

under section 482. 

FOR FURTHER INFORMATION CONTACT: 

Concerning REG–146893–02 and REG– 

115037–03, Carol B. Tan or Gregory A. 

Spring, (202) 435–5265; Concerning 

REG–138603–03, Richard L. Chewning, 

(202) 622–3850 (not toll-free numbers). 

SUPPLEMENTARY INFORMATION: 

Background 

The notice of proposed rulemaking 

(REG–146893–02, REG–115037–00 and 

REG–138603–03) that is the subject of 

this document is under sections 482, 

861, 6038, 6662, and 3121 of the 

Internal Revenue Code. 

Need for Correction 

As published, the notice of proposed 

rulemaking (REG–146893–02, REG– 

115037–00, and REG–138603–03) 

contains regulation identification 

numbers (RINs) that must be corrected. 

Correction of Publication 

Accordingly, the publication of a 

notice of proposed rulemaking (REG– 

146893–02, REG–115037–00, and REG– 

138603–03), which was the subject of 

FR Doc. 06–6674, is corrected as 

follows: 

On page 44247, in the document 

heading, the language ‘‘RIN 1545–BB31, 

1545–AY38, 1545–BC52’’ is corrected to 

read ‘‘RIN 1545–BI78, 1545–BI80, 1545– 

BI79’’. 

LaNita Van Dyke, 

Chief, Publications and Regulations Branch, 

Legal Processing Division, Associate Chief 

Counsel (Procedure and Administration). 

[FR Doc. E9–14927 Filed 6–24–09; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF LABOR 

Occupational Safety and Health 

Administration 

29 CFR Part 1910 

[Docket No. OSHA–2007–0006] 

RIN 1218–AC29 

Abbreviated Bitrex® Qualitative FitTesting Protocol 

AGENCY: Occupational Safety and Health 

Administration (OSHA); Labor. 

ACTION: Proposed rule; withdrawal. 

SUMMARY: After thoroughly reviewing 

the comments and other information 

available in the record for the proposed 

rulemaking, OSHA decided that the 

abbreviated Bitrex® qualitative fit test is 

not sufficiently accurate to include 

among the qualitative fits tests listed in 

Part II of Appendix A of its Respiratory 

Protection Standard. Therefore, OSHA 

is withdrawing the proposed rule 

without prejudice, and is inviting 

resubmission of the proposed fit test 

after conducting further research to 

improve the accuracy of the protocol. 

DATES: Effective June 25, 2009, the 

proposed rule published December 26, 

2007 (72 FR 72971) is withdrawn. 

FOR FURTHER INFORMATION CONTACT: 

General information and press inquiries: 

Contact Ms. Jennifer Ashley, Office of 

Communications, Room N–3647, OSHA, 

U.S. Department of Labor, 200 

Constitution Avenue, NW., Washington, 

DC 20210; telephone (202) 693–1999. 

Technical inquiries: Contact Mr. John 

E. 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. Electronic 

copies of this Federal Register notice, as 

well as news releases and other relevant 

documents, are available at OSHA’s 

Web page at http://www.osha.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Part I to Appendix A of OSHA’s 

Respiratory Protection Standard at 29 

CFR 1910.134 currently includes four 

qualitative fit-testing protocols using the 

following challenge agents: Isoamyl 

acetate; saccharin-solution aerosol; 

Bitrex® (denatonium benzoate) aerosol 

in solution; and irritant smoke (stannic 

chloride). Part II to Appendix A 

specifies the procedure by which OSHA 

determines whether to propose adding a 

new fit-testing protocol to the 

Respiratory Protection Standard. The 

criteria used in making this 

determination 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. If a fit-testing 

protocol meets one of these criteria, 

OSHA must initiate notice-andcomment rulemaking on the proposed 

fit-testing protocol under Section 6(b)(7) 

of the Occupational Safety and Health 

Act of 1970 (29 U.S.C. 655). 

II. Summary and Explanation of the 

Withdrawal Notice 

A. Introduction 

In the letter submitting the 

abbreviated Bitrex® qualitative fittesting (ABQLFT) protocol for review 

under the provisions of Appendix A of 

OSHA’s Respiratory Protection Standard 

(Ex. OSHA–2007–0006–0002), Dr. 

Michael L. Runge of the 3M Company 

included a copy of a peer-reviewed 

article from an industrial-hygiene 

journal describing the accuracy and 

reliability of the ABQLFT protocol (Ex. 

OSHA–2007–0006–0003). This article 

also described in detail the equipment 

and procedures required to administer 

the ABQLFT protocol. According to this 

description, the protocol is a variation 

of the existing Bitrex® qualitative fittesting protocol developed by the 3M 

Company in the early 1990s, which 

OSHA approved for inclusion in the 

final Respiratory Protection Standard. 

The ABQLFT protocol uses the same fittesting requirements and 

instrumentation specified for the 

existing Bitrex® qualitative fit-testing 

protocol in paragraphs (a) and (b) of Part 

I.B.4 of Appendix A of the Respiratory 

Protection Standard, with the following 

two exceptions: 

• Exercise times are reduced from 60 

seconds to 15 seconds; and 

• The ABQLFT protocol is used only 

with test subjects who can taste the 

Bitrex® screening solution within the 

first 10 squeezes of the nebulizer bulb 

(referred to as ‘‘Level 1 sensitivity’’). 

The peer-reviewed article submitted 

by the 3M Company describing the 

study conducted on the ABQLFT, 

entitled ‘‘Development of an 

Abbreviated Qualitative Fit Test Using 

Bitter Aerosol,’’ appeared in the Fall/ 

Winter 2003 issue of the Journal of the 

International Society for Respiratory 

Protection (hereafter, ‘‘the ABQLFT 

study’’ or ‘‘the study’’; Ex. OSHA–2007– 

0006–0003). The authors of the study 

were T.J. Nelson of NIHS, Inc., and L.L. 

Janssen, M.D. Luinenburg, and H.E. 

Mullins of the 3M Company; the 3M 

Company supported the study. The 

study described by the article 

determined whether performing a fit test 

involving seven exercises lasting 15 

seconds each while exposed to Bitrex®

solution aerosol yielded fit-testing 

results similar to results obtained with 

a generated-aerosol (i.e., corn oil) 

quantitative fit test (GAQNFT) using 

one-minute exercises (i.e., the GAQNFT 

was the criterion measure or ‘‘gold 

standard’’). 


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1The test subjects did not perform the grimace 

exercise. 

The study involved 43 experienced 

respirator users, 20 females and 23 

males. The test subjects followed the 

existing Bitrex® qualitative fit-testing 

protocol in Appendix A of OSHA’s 

Respiratory Protection Standard except 

that they performed each of the fittesting exercises for 15 seconds (instead 

of 60 seconds) while wearing a NIOSHcertified elastomeric half-mask 

respirator equipped with P100 filters. 

The authors selected the best fitting 

respirator for each test subject from 

among four models, each available in 

three sizes; some test subjects used more 

than one model during fit testing. In 

addition, the authors induced poor 

respirator fits by assigning a respirator 

to test subjects that was one or two sizes 

too small or too large as determined by 

the Los Alamos National Laboratory 

panel-grid size and observation of the 

test subjects’ facial characteristics. Test 

subjects could adjust the respirator 

facepiece for comfort, but they did not 

perform user seal checks. 

In conducting the study, the authors 

used the recommendations for 

evaluating new fit-test methods 

specified by Annex A2 of ANSI Z88.10– 

2001, including sequencing the 

ABQLFT and GAQNFT in random order 

without disturbing facepiece fit. The 

authors used fit-test sample adaptors or 

respirators with fixed probes to collect 

samples inside the respirator. The 

sample point inside the respirator was 

located between the nose and the 

mouth. For both fit tests, the authors 

had the test subjects perform seven of 

the eight exercises listed in Part I.A.14 

of Appendix A of OSHA’s Respiratory 

Protection Standard, which included: 

Normal breathing, deep breathing, 

turning the head side to side, moving 

the head up and down, reading a 

passage, bending over, and normal 

breathing.1 For the GAQNFT, the 

authors performed particle counts at 

one-second intervals inside a test 

chamber for 15–30 seconds before and 

after fit testing, and inside the respirator 

for the 60-second duration of each 

exercise. 

The 43 test subjects used in the study 

had Level 1 sensitivity to Bitrex®

because they were able to taste the 

Bitrex® aerosol within 10 squeezes of 

the nebulizer bulb. Subjects having 

Level 2 or 3 sensitivity to Bitrex® were 

excluded from further participation in 

the study because the nebulizer could 

not be replenished for additional taste 

testing within the 15 seconds allotted to 

perform each fit-testing exercise. After 

the test subjects passed a Bitrex®

sensitivity-screening test, the authors 

administered the ABQLFT using the 

procedures and techniques specified for 

the existing Bitrex® qualitative fittesting protocol in Part I.B.14 of 

Appendix A of OSHA’s Respiratory 

Protection Standard, and determined 

the fit factor using the particle count for 

the 15-second duration of each exercise. 

The authors required a fit factor of 

100 to pass a fit test, which served as 

the basis for determining the following 

statistics for the ABQLFT: Test 

sensitivity; predictive value of a pass; 

test specificity; and predictive value of 

a fail. 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); and D = false 

negatives (failed the fit test with a fit 

factor ≥ 100). 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; and 

predictive value of a fail = C/(C + D), RV 

> 0.50. 

Using the GAQNFT as the criterion 

measure, the variables for the ABQLFT 

had the following values: A = 4; B = 95; 

C = 48; and D = 20. The statistics 

calculated for the ABQLFT from these 

values were: Test sensitivity = 0.92; 

predictive value of a pass = 0.96; test 

specificity = 0.83; and predictive value 

of a fail = 0.71. Therefore, every statistic 

for the ABQLFT, except test sensitivity, 

attained a value in excess of the ANSI 

Z88.10–2001 recommended value. 

The test-sensitivity value of 0.92 for 

the ABQLFT fell below the ANSI 

recommended value of 0.95. The 

authors state that this slight difference 

represents a single false positive value 

for the ABQLFT (i.e., failed the 

GAQNFT but passed the ABQLFT). 

However, an additional peer-reviewed 

article submitted by Dr. Runge of the 3M 

Company suggests an alternative 

approach to examining these testsensitivity values (see Ex. OSHA–2007– 

0006–0004). This article, entitled 

‘‘Recommendations for the Acceptance 

Criteria for New Fit Test Methods’’ and 

published in the Spring/Summer 2004 

issue of the Journal of the International 

Society for Respiratory Protection, 

describes an analytical study conducted 

by T. J. Nelson of NIHS, Inc. and H. 

Mullins of the 3M Company, and 

supported by the 3M Company. In this 

study, the authors performed a binary 

logistic-regression analysis on pass-fail 

fit-testing data from published studies 

involving two quantitative, and two 

qualitative, fit tests. The authors justify 

using the binary logistic-regression 

analysis for this purpose as follows: 

When a simple sensitivity test is used to 

describe a new test, the result can be affected 

by the distribution of the data. In several 

cases using the theoretical distributions 

described in this paper, the outcome of a 

sensitivity test for the Bitrex and Ambient 

Particle Counter fit tests could have failed to 

meet the ANSI Z88.10 sensitivity 

requirement. The method used to determine 

acceptability should be independent of 

specific data collected. (See Ex. OSHA–2007– 

0006–0004, p. 8.) 

The results of the binary logisticregression analysis performed on the 

ABQLFT data showed that the ABQLFT 

had a 0.20 probability of passing a 

respirator user with a fit factor of 50 and 

a 0.33 probability of passing a respirator 

user with a fit factor of 100. Figure 3 of 

the article compares the binary logisticregression analysis results of testsensitivity values obtained for a popular 

quantitative fit test and the existing 60- 

second Bitrex® qualitative fit test. The 

authors conclude that the analysis 

demonstrates that the distribution of fittesting data affected the test-sensitivity 

values derived using the ANSI Z88.10– 

2001 test-sensitivity calculations. Based 

on this analysis, the authors assert that 

‘‘a sensitivity calculation may not be the 

best indicator of fit test method 

performance. The binary logistic 

regression analysis shows that the result 

of the 15 second exercise time test is 

very similar to the ambient aerosol and 

60 second bitter aerosol tests’’ (Ex. 

OSHA–2007–0006–0003, p. 108). In 

summarizing the results, the authors 

state that ‘‘[t]he 15 second bitter aerosol 

protocol sufficiently screens for 

adequate respirator fit in subjects with 

Level 1 Bitrex taste sensitivity.’’ 

After carefully reviewing the peerreviewed articles submitted in support 

of the ABQLFT, OSHA determined that 

the protocol met the second criterion 

specified in Appendix A of the 

Respiratory Protection Standard, and 

then developed a proposal to add a new 

fit-testing protocol to the standard. 

OSHA published the proposal in the 

Federal Register on December 26, 2007 

(see 72 FR 72971). 

B. Issues Raised for Public Comment 

In the Federal Register notice 

announcing the proposal, OSHA invited 

comments and data from the public 

regarding the accuracy and reliability of 

the proposed ABQLFT protocol, its 

effectiveness in detecting respirator 

leakage, and its usefulness in selecting 

respirators that will protect employees 


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from airborne contaminants in the 

workplace. Specifically, the Agency 

invited public comment on the 

following issues: 

• Were the studies described in the 

submitted articles well controlled, and 

conducted according to accepted 

experimental design practices and 

principles? 

• Were the results of the studies 

described in the submitted articles 

properly, fully, and fairly presented and 

interpreted? 

• Will the proposed ABQLFT 

protocol generate reproducible fittesting results, and what additional 

experiments or analyses of existing data 

are necessary to answer this question? 

• Will the proposed ABQLFT 

protocol reliably identify respirators 

with unacceptable fit as effectively as 

the qualitative fit-testing protocols, 

including the existing Bitrex®

qualitative fit-testing protocol, already 

listed in Part I.B of Appendix A of the 

Respiratory Protection Standard? 

• What is the significance of the testsensitivity value of 0.92 obtained for the 

ABQLFT relative to the test-sensitivity 

value of 0.95 recommended by ANSI 

Z88.10–2001, and does the authors’ 

assertion that ‘‘a sensitivity calculation 

may not be the best indicator of fit test 

method performance’’ adequately 

account for the lower test-sensitivity 

value? 

• What is the significance of limiting 

the ABQLT to respirator users who 

demonstrate Level 1 sensitivity to 

Bitrex®? 

C. Summary of the Public Comments 

Received 

Twenty-two commenters submitted 

responses to the proposal. The following 

paragraphs in this section address the 

responses made to each of the six issues 

described previously, as well as 

additional issues addressed by the 

commenters themselves. 

1. Were the studies described in the 

submitted articles well controlled, and 

conducted according to accepted 

experimental design practices and 

principles? In addressing this issue, 

NIOSH stated: 

The primary journal article cited, 

Development of an Abbreviated Qualitative 

Fit Test Using Bitter Aerosol by Nelson et al. 

[2003], does not provide sufficient detail 

about the study design and protocol to enable 

a complete assessment of how well it was 

controlled and conducted. The description in 

the article does indicate that design and 

principles met acceptable practices. (See Ex. 

OSHA–2007–0006–0026.) 

Jeff Weed asserted that the study did not 

exclude from the statistical analysis the 

fit factors used to determine the 

reference-method fit factors within one 

standard deviation of the required fit 

factor, a determination required under 

ANSI Z88.10–2001 (Ex. OSHA–2007– 

0006–0020.1). 

Generally, the NIOSH comment 

appears to support the design practices 

and principles used in the study, and 

did not elaborate on what additional 

detail would ‘‘enable a complete 

assessment of how well [the study] was 

controlled and conducted.’’ Jeff Weed’s 

comment appears to be mistaken 

because page 104 of the article 

describing the study (see Ex. OSHA– 

2007–0006–0003) states that the ‘‘[f]ive 

fit factors within one standard deviation 

of the required fit factor of 100 (86 to 

114) were excluded from the data 

analysis as recommended by Z88.10.’’ 

Therefore, OSHA concludes that the 

study was well controlled, and 

conducted according to accepted 

experimental design practices and 

principles. 

2. Were the results of the studies 

described in the submitted articles 

properly, fully, and fairly presented and 

interpreted? NIOSH made the following 

comments regarding this issue: 

NIOSH is concerned that the interpretation 

of the study results does not appropriately 

represent the performance of the fit testing 

protocol. The authors correctly stated that a 

shortened bitter aerosol fit test method relies 

on two assumptions: (1) Fit does not 

significantly change during an exercise and 

(2) people being tested will respond to the 

bitter taste of Bitrex® in the shorter time 

period. The results of the study support the 

second assumption, i.e., the test subjects 

classified with Level 1 sensitivity responded 

to the bitter taste of Bitrex® in the shorter 

time period. However, the study results do 

not provide convincing evidence to support 

the first assumption. * * * 

The consistency of the respirator’s fit 

throughout each of seven exercises is 

important in the assessment of the 

performance of the ABQLFT fit test protocol. 

The fit factor assigned for each ABQLFT 

exercise in the study is based on a 15-second 

increment, in contrast to a 60-second 

increment for each of the same exercises 

performed in quantitative fit test (GAQNFT) 

protocol. Change in fit during an exercise 

suggests that the fit at the start of the next 

60-second exercise in the GAQNFT is more 

likely to differ from the fit at the start of the 

corresponding 15-second exercise period of 

the ABQLFT. There is no indication that the 

authors considered the significance of the 

noted changes in fit on the accuracy of the 

assigned fit factors. (See Ex. OSHA–2007– 

0006–0026.) 

Pages 104, 105, and 107 of the article 

describing the study (see Ex. OSHA– 

2007–0006–0003) addressed NIOSH’s 

concerns about the variability of 

respirator fit for the 15-second and 60- 

second exercise periods, at least for the 

GAQNFT. Page 104 of the article states 

that the correlation between fit factors 

assessed for the two exercise periods 

was highly significant, with r = 0.97, 

while the text and figure on page 108 of 

the article note that variability was low 

for fit factors less than 100 and over 

6,000. These results demonstrate 

convincingly that respirator fit factors, 

especially for fit factors in the range of 

interest (i.e., having values at and below 

100), were reasonably consistent and 

stable across the 15-second and 60- 

second exercise periods. 

Jeff Weed commented (see Ex. OSHA– 

2007–0006–0020.1) that the study did 

not report a Kappa value, which ANSI 

Z88.10–2001 defines as the ‘‘statistic (K) 

used to calculate some degree of 

agreement between two fit tests’’; the 

ANSI standard recommends a minimum 

Kappa value greater than 0.70. Based on 

the equation for the Kappa statistic 

provided in Annex A2 of the ANSI 

standard, Mr. Weed calculated the 

Kappa value for the study data as 0.69, 

which corresponds closely to our 

calculation of 0.70, rounded from a 

figure of 0.69565. OSHA concludes, that 

the Kappa value calculated from the 

study data indicates an acceptable 

degree of agreement between the two fit 

tests used in the study, and conforms 

satisfactorily with the value 

recommended by the ANSI standard. 

3. Will the proposed ABQLFT protocol 

generate reproducible fit-testing results, 

and what additional experiments or 

analyses of existing data are necessary 

to answer this question? NIOSH 

questioned the reproducibility of the fittesting results, stating: 

Based on review of Nelson et al. [2003] and 

Nelson and Mullins [2004], NIOSH 

concludes that the evidence is inadequate to 

demonstrate reproducible fit testing results. 

Further investigation is required to compare 

potential changes in fit across the proposed 

15-second exercise intervals in the ABQLFT 

protocol and the standard 60 second exercise 

intervals in the GAQNFT protocol. At a 

minimum, the frequency and consistency of 

leaks during each exercise, as well as the 

magnitude and type of those leaks (e.g. start 

of exercise, end of exercise, throughout 

exercise period) need to be identified and 

analyzed. (See Ex. OSHA–2007–0006–0026.) 

OSHA addressed NIOSH’s concern 

regarding the variability of respirator fit 

for the 15-second and 60-second 

exercise periods above (see item C.2 of 

this section). 

Jeff Weed questioned whether 

employers could reproduce the results 

of the ABQLFT study in the workplace, 

stating: 

When qualitative fit test (QLFT) methods 

such as the ABQLFT are performed in a 

laboratory by researchers, the results are 


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reasonably reproducible. Researchers are 

keenly aware of the potential mistakes that 

cause variability, such as the manner in 

which the nebulizer bulb is squeezed (e.g. 

fully vs. partly, with the palm vs. the fingers, 

slowly vs. quickly). The way the nebulizer is 

used has a significant affect on the mass of 

agent that is injected into the fit test hood. 

Unfortunately, studies such as the one by 

Nelson do not take the practicality of the fit 

test method into account, when implemented 

by lay-persons. (See Ex. OSHA–2007–0006– 

0020.1.) 

The authors of the ABQLFT study 

mention on page 103 of the article 

describing the study (see Ex. OSHA– 

2007–0006–0003) that ‘‘[t]he bitter 

aerosol fit test followed the procedure 

outlined in the OSHA respirator 

standard, except that a 15 second 

exercise period was used.’’ Section B.4 

of Part I in Appendix A of that standard 

describes in elaborate detail how to 

administer properly the Bitrex® solution 

aerosol using the nebulizer bulb. OSHA 

holds that this description of the 

procedure is adequate, and that 

employers are responsible for 

complying fully with the procedure as 

described in OSHA’s Respiratory 

Protection Standard. In addition, Mr. 

Weed’s comment appears to be 

speculative in that he provided no 

evidence to support it. 

Ching-tsen Bien mentioned that 

‘‘[t]here is only one repeated test on the 

same test subject with a standard 

deviation of 14’’ (Ex. OSHA–2007– 

0006–0017.1). In a response to Mr. Bien, 

Robert A. Weber of 3M stated (see Ex. 

OSHA–2007–0006–0021.1) that Mr. 

Bien’s comment describes the 

requirement specified in Annex A2 of 

ANSI Z88.10–2001. Mr. Weber quotes 

this requirement from Annex A2 as 

follows: ‘‘One standard deviation for the 

reference method can be approximated 

by identifying a subject having a fit 

factor near the required fit factor and 

making measurements on this subject 

during a single mask donning to 

determine system reproducibility.’’ 

OSHA believes that Mr. Weber’s 

response appropriately addresses Mr. 

Bien’s concern. 

4. Will the proposed ABQLFT protocol 

reliably identify respirators with 

unacceptable fit as effectively as the 

qualitative fit-testing protocols, 

including the existing Bitrex®

qualitative fit-testing protocol, already 

listed in Part I.B of Appendix A of the 

Respiratory Protection Standard? Pete 

Stafford of the Building and 

Construction Trades Department, AFL– 

CIO, questioned whether the 15-second 

exercise periods prescribed by the 

proposed ABQLFT protocol were 

sufficient to challenge the face-tofacepiece seal, stating: 

In the abbreviated protocol, normal and 

deep breathing exercises would only allow 

four to five breaths in 15 seconds. Side to 

side and up and down exercises might only 

allow one cycle of each in 15 seconds. The 

talking exercise would be difficult to 

accomplish, as the rainbow passage presents 

a variety of facial expressions, and could not 

be completed in the 15 second time frame.’’ 

(See Ex. OSHA–2007–0006–0024.) 

NIOSH argued that with the aerosol 

concentration replenished only once 

every 30 seconds, the exercise occurring 

during the first 15 seconds of this 30- 

second period would be near the 

maximum aerosol concentration, while 

the exercise occurring during the last 

15-second period would be near the 

minimum concentration that occurs 

after filtration removes much of the 

aerosol from the hood. NIOSH further 

noted: 

* * * [T]he 60-second exercise duration in 

the OSHA-accepted Bitrex® protocol would 

be conducted through two complete 30- 

second concentration-cycles, whereas the 15- 

second exercises of the ABQLFT were 

conducted through only half of one. While 

the variation in the aerosol concentration 

during this procedure has not been 

documented, the fact that the replenishing 

amount is half the quantity to establish the 

appropriate test challenge (for a fit factor of 

at least 100) suggests that variability could 

significantly affect the results. In addition, 

the variability in subjects’ ability to taste 

Bitrex® at reduced concentrations, and the 

impact on the pass/fail results, needs to be 

determined and analyzed. (See Ex. OSHA– 

2007–0006–0024.) 

OSHA finds that the comments 

submitted by both Pete Stafford and 

NIOSH did not adequately consider the 

effects the alleged deficiencies should 

have on the results of the ABQLFT 

study. Failure to adequately challenge 

the facepiece-to-face seal, and low levels 

of aerosol present during an exercise, 

should increase the number of false 

positives, but the study data show no 

such effect. Therefore, absent any 

supporting data or analyses, OSHA 

considers these comments to be 

speculative. 

A number of commenters stated that 

the proposed protocol would not 

reliably assess proper fit for filteringfacepiece respirators because the 

authors did not include these respirators 

in the study design. In this regard, 

NIOSH noted that ‘‘the submitted study 

did not include any filtering facepiece 

respirators. This type of respirator is 

commonly used and likely to be 

evaluated by the ABQLFT protocol. 

NIOSH encourages evaluation of 

filtering facepiece respirators before 

acceptance of the ABQLFT protocol’’ 

(Ex. OSHA–2007–0006–0026). Chingtsen Bien asserted that ‘‘the validation 

testing should be performed on a variety 

of shapes of N–95 filtering facepieces to 

ensure that this method would reject 

inadequate fits for respirators of this 

type’’ (Ex. OSHA–2007–0006–0017.2). 

OSHA received additional comments 

on this issue from Timothy Roberts, 

who stated, ‘‘Another major concern is 

that the primary article [Nelson, 2003] 

did not include filtering facepiece 

respirators as part of the tests. Filtering 

facepiece respirators are often tested 

with the Bitrex qualitative protocol and 

therefore, the data may not be 

representative of the adequacy of the 

ABQLFT proposal for this class of 

respirators’’ (Ex. OSHA–2007–0006– 

0022). James S. Johnson recommended 

further testing of filtering facepieces 

using the proposed ABQLFT protocol, 

noting, ‘‘A similar study (Article 1) 

needs to be done with filtering facepiece 

respirators to demonstrate acceptable 

performance is achieved with this type 

of half mask respirator’’ (Ex. OSHA– 

2007–0006–0028). 

Robert Weber of 3M addressed the 

issue of testing filtering-facepiece 

respirators in his comments (see Ex. 

OSHA–2007–0006–0021.1), stating, ‘‘It 

is not possible to use N95 filtering 

facepieces to validate a fit test with 

submicrometer particle QNFT,’’ adding 

that ‘‘[i]t is an evaluation of facepiece[- 

]to-face seal only; filter penetration is 

not included. While filter penetration of 

submicrometer particles through N95 

filters is small, it is not zero.’’ Mr. 

Weber concludes, ‘‘The use of N95 

[filtering-facepiece respirators] would 

therefore skew the data by increasing 

[false-negative] error, i.e. rejecting 

adequate fits.’’ 

Contrary to Mr. Weber’s comments, 

OSHA finds that testing N95 filteringfacepiece respirators as recommended 

by the other commenters is not 

validation testing, but instead is testing 

that would demonstrate that the 

proposed ABQLFT protocol performs 

adequately with N95 filtering-facepiece 

respirators, even when filter penetration 

increases false-negative error. Therefore, 

OSHA could not approve using the 

proposed ABQLFT protocol for fit 

testing filtering-facepiece respirators 

absent appropriate results 

demonstrating that the proposed 

protocol adequately determines fit for 

these respirators. 

5. What is the significance of the testsensitivity value of 0.92 obtained for the 

ABQLFT relative to the test-sensitivity 

value of 0.95 recommended by ANSI 

Z88.10–2001, and does the authors’ 

assertion that ‘‘a sensitivity calculation 

may not be the best indicator of fit test 

method performance’’ adequately 

account for the lower test-sensitivity 


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30254 Federal Register / Vol. 74, No. 121 / Thursday, June 25, 2009 / Proposed Rules 

2The proposal cited a figure of ‘‘approximately 

25,000 establishments,’’ but this figure is for the 

original Controlled Negative Pressure quantitative 

fit-testing protocol specified by OSHA when it first 

published the Respiratory Protection Standard in 

1998, not for the existing Bitrex® qualitative fittesting protocol. 

3The term ‘‘size classes’’ refers to the number of 

employees in the establishments; the NIOSH–BLS 

survey designates these classes as follows: 1–10 

employees; 11–19 employees; 11–49 employees; 

50–249 employees; 250–999 employees; and 1,000 

and more employees. A cursory review of the sizeclass distribution in the NIOSH–BLS survey shows 

that 0.088% of the total number of establishments 

have 1,000 or more employees, while 0.094% of 

establishments administering the existing Bitrex®

qualitative fit-testing protocol have 1,000 or more 

employees; this comparison indicates that the 

distribution of size classes for the latter 

establishments is similar to the distribution of size 

classes for the establishments as a whole. 

value? In addressing the first part of this 

issue (i.e., the significance of the testsensitivity value of 0.92), Jeff Weed 

stated, ‘‘[I]t should be noted that of the 

5 ANSI criteria, test sensitivity is the 

only one that ANSI states ‘shall’ be met. 

The others carry the ‘should’ qualifier. 

In ANSI parlance (paragraph 1.3), the 

word ‘shall’ implies a mandatory 

provision, and ‘should’ is used for 

advisory provisions’’ (Ex. OSHA–2007– 

0006–0020.1). Similarly, Bill Kajola of 

the AFL–CIO stated recommended that 

OSHA withdraw the proposed rule 

because ‘‘the most important ANSI 

criterion for approving a new test 

method has not been achieved,’’ and 

that ‘‘[t]he research paper used by 3M in 

support of its application for approval 

(Ex. OSHA–2007–0006–0003) 

acknowledges the failure of the 15 

second Bitrex fit test protocol to achieve 

the ANSI test sensitivity of 0.95 or 

greater, a consensus criteria established 

by the respiratory protection 

community’’ (Ex. OSHA–2007–0006– 

0019.1). Timothy Roberts, Mark 

Haskew, and Ching-tsen Bien stated that 

failure to achieve the ANSI testsensitivity criterion was sufficient 

justification for OSHA not to adopt the 

ABQLFT (see Exs. OSHA–2007–0006– 

0022, –0023, and 0017.2, respectively). 

NIOSH believed that the reduced 

sensitivity-test value demonstrated that 

the proposed ABQLFT protocol was 

defective, stating, ‘‘A sufficient number 

of subjects met fit testing requirements 

using the ABQLFT protocol and failed 

using the GAQNFT protocol,’’ and that 

‘‘[t]he sensitivity test is a critical 

criterion to ensure the rejection of 

inadequately fitting respirators’’ (Ex. 

OSHA–2007–0006–0026). NIOSH 

concluded that ‘‘[b]ecause the observed 

value of 0.92 is below the ANSI 

criterion of 0.95, NIOSH considers the 

value unacceptable.’’ 

In the article describing the ABQLFT 

study (see Ex. OSHA–2007–0006–0003), 

the authors state that ‘‘[a]dvisory criteria 

for evaluating new fit test methods 

outlined in Annex A2 to ANSI Standard 

Z88.10–2001 were used. * * *’’ 

Therefore, the authors adopted the ANSI 

standard as the method by which to 

evaluate the results of the study, 

including the test-sensitivity criterion 

which, as stated above by Mr. Weed, is 

the only criterion in the ANSI standard 

that is mandatory. OSHA believes 

adopting the ANSI standard is 

appropriate because that standard 

represents the consensus of the 

industrial-hygiene community regarding 

the criteria to use in assessing fit-testing 

protocols. The comments described in 

the previous paragraph clearly 

demonstrate that the industrial-hygiene 

community generally supports using the 

ANSI standard for this purpose. 

In comments submitted to the record, 

Robert Weber of 3M noted that ‘‘there is 

little significance to the test sensitivity 

of 0.92 versus a criterion of 0.95’’ (Ex. 

OSHA–2007–0006–0021.1). On page 

108 of the article describing the 

ABQLFT study (see Ex. OSHA–2007– 

0006–0003), the authors observe that 

‘‘[t]he difference between a sensitivity of 

0.92 and a value greater than 0.95 in this 

comparison is one fit test where a 

person with a generated fit factor less 

than 100 passed the bitter aerosol fit 

test.’’ Based on Table 1 in this article, 

the 0.95 criterion would permit three 

false-positive test subjects out of 167 

subjects tested (i.e., 0.018% of the total 

subjects tested), while the obtained 

value of 0.92 resulted in four falsepositive test subjects (i.e., 0.024% of the 

subjects tested). 

In the NIOSH–Bureau of Labor 

Statistics survey of respirator use cited 

in the proposal (NIOSH–BLS survey; Ex. 

6–3, Docket H–049C), 282,000 

establishments in the United States 

required respirator use, and these 

establishments fit tested about 3.3 

million employees each year. According 

to the NIOSH–BLS survey, 18,938 

(0.067%) of these establishments used 

the existing Bitrex® qualitative fittesting protocol.2 Assuming that these 

establishments would substitute the 

proposed ABQLFT protocol for the 

existing Bitrex® qualitative fit-testing 

protocol, and that the distribution of 

employees across size classes for these 

establishments is representative of the 

establishments as a whole,3 then 

221,100 employees would receive the 

proposed ABQLFT protocol annually 

(i.e., 0.067% × 3.3 million employees). 

Under the 0.95 sensitivity-test 

criterion value for the ANSI Z88.10– 

2001 standard, about 3,980 employees 

with improperly fitting respirators 

would pass the proposed ABQLFT 

protocol each year (i.e., a 0.018% falsepositive rate × 221,100 total employees 

tested), while the 0.92 sensitivity-test 

value obtained for the proposed 

protocol would result in about 5,306 

employees passing the test with 

improperly fitting respirators (i.e., a 

0.024% false-positive rate × 221,100 

total employees tested). OSHA believes 

that the 3,980 employees with falsepositive values that would result from 

using the sensitivity-test criterion from 

the ANSI standard are too high; 

therefore, adding 1,326 employees each 

year to this already excessive figure is 

unacceptable. Contrary to the previously 

cited statement made by Mr. Weber 

from 3M, OSHA finds that the 

significance between test sensitivity 

values of 0.92 and 0.95, when viewed in 

practical terms, is highly significant 

because an additional 1,326 employees 

would not have adequate respiratory 

protection in the workplace. OSHA 

believes that the contribution of ANSI 

Z88.10–2001 to the process of 

evaluating proposed respirator fittesting protocols is to provide 

procedures that OSHA can use in 

determining the practical effects of 

errors that result from the 

administration of these proposed 

protocols. Therefore, based on this 

analysis involving the sensitivity-test 

criterion from the ANSI standard, OSHA 

concludes that it cannot include the 

proposed ABQLFT protocol among the 

qualitative fit tests currently listed in 

Part I.B of Appendix A of its Respiratory 

Protection Standard. 

Regarding the second part of this 

issue (i.e., that the sensitivity 

calculations may not be the best 

indicator of fit-test performance), the 

authors of the study recommended 

using binary logistic-regression analysis 

to determine sensitivity of the proposed 

protocol instead of the test-sensitivity 

criterion specified by ANSI Z88.10– 

2001. Every comment submitted to the 

record opposed this recommendation. 

For example, NIOSH stated: 

A second cited journal article [Nelson and 

Mullins 2004] examined the treatment of data 

from previously reported studies, including 

the 2003 Nelson study, by use of a new 

method of data analysis. A more thorough 

evaluation of the method of data analysis 

should be undertaken to ensure the studies 

used to validate the new method include an 

appropriate range of fit factors and respirator 

designs. 

* * * * * 

The argument by the study authors that 

‘‘the method used to determine acceptability 

should be independent of specific data 

collected’’ is not convincing. A sufficient 

number of subjects met fit testing 

requirements using the ABQLFT protocol 


sroberts on PROD1PC70 with PROPOSALS
Federal Register / Vol. 74, No. 121 / Thursday, June 25, 2009 / Proposed Rules 30255 

and failed using the GAQNFT protocol. 

These results were determined to be below 

the ANSI Z88.10–2001 recommended criteria 

of 0.95 for the test-sensitivity value. 

Recalculating test sensitivity (proportion of 

failed reference method fit tests that also 

failed the new fit-test method) via alternative 

statistical techniques, or questioning the 

validity of the sensitivity calculation as an 

appropriate indicator of fit-test method 

performance to rationalize a positive 

conclusion, is a questionable response to the 

study outcome. The sensitivity test is a 

critical criterion to ensure the rejection of 

inadequately fitting respirators. Because the 

observed value of 0.92 is below the ANSI 

criterion of 0.95, NIOSH considers the value 

unacceptable. If the method of data analysis 

is changed, the new method needs to be 

thoroughly evaluated before challenging the 

standard criterion. (See Ex. OSHA–2007– 

0006–0026.) 

Bill Kajola of the AFL–CIO 

recommended that OSHA not sanction 

the binary logistic-regression analysis as 

an alternate method for analyzing the 

study results, stating, ‘‘There is no data 

or confirmation to suggest that a ‘binary 

logistic regression analysis’ is an 

appropriate and adequate means to 

evaluate a new fit test method’’ (OSHA– 

2007–0006–0019.1). James S. Johnson 

believed it was premature to use binary 

logistic-regression analysis to analyze 

the study data, asserting that ‘‘[t]he 

proposed change is too significant to be 

based on one study that has to have 

additional mathematical analysis and 

assumptions proposed to pass the ANSI 

Z88.10 requirements’’ (Ex. OSHA–2007– 

0006–0028). Daniel K. Shipp of the 

International Safety Equipment 

Association commented that binary 

logistic-regression analysis ‘‘be 

validated by an additional source’’ (Ex. 

OSHA–2007–0006–0027). 

As noted earlier, none of the 

comments submitted to the record 

supported using binary logisticregression analysis to interpret the study 

results. These comments clearly 

indicate that this analytic technique is 

currently inappropriate for use in 

determining the sensitivity of fit-testing 

protocols. OSHA agrees with these 

comments, and believes that the 

technique requires additional validation 

before it will be acceptable for this 

purpose. 

6. What is the significance of limiting 

the ABQLT to respirator users who 

demonstrate Level 1 sensitivity to 

Bitrex®? Few commenters responded to 

this issue. NIOSH observed that 

information about ‘‘the number or 

percentage of subjects in [the] study 

who did not meet Level 1 sensitivity to 

Bitrex®’’ was not available in the article 

describing the study (see Ex. OSHA– 

2007–0006–0003), and, therefore, 

‘‘NIOSH is unable to estimate the 

proportion of workers in the population 

who demonstrate Level 1 sensitivity to 

Bitrex®’’ (Ex. OSHA–2007–0006–0026). 

As a result, NIOSH found that ‘‘the 

utility of the proposed ABQLFT 

protocol can not be determined at this 

time.’’ James S. Johnson commented 

that determining Level 1 sensitivity is a 

restriction that ‘‘adds another level of 

complexity to the test protocol’’ (Ex. 

OSHA–2007–0006–0028). Ching-tsen 

Bien believed that using Level 1 

sensitivity for screening purposes ‘‘does 

not prevent some test conductors who 

ignore this limitation and use the 

ABQLFT method to fit test any worker, 

and it may result in the selection of [the] 

wrong respirator for workers with 

Levels 2 or 3 sensitivity * * *’’ (Ex. 

OSHA–2007–0006–0017.1). None of 

these comments challenged the validity 

or accuracy of the Level 1 sensitivity 

procedure; accordingly, OSHA 

concludes that the ABQLFT study used 

the procedure appropriately, and that it 

accurately screened the test subjects for 

sensitivity to Bitrex®. 

7. Miscellaneous issues addressed by 

the comments. Several commenters 

objected that the test subjects in the 

ABQLFT study did not perform seal 

checks while using the respirators. For 

example, James S. Johnson stated that 

‘‘[t]he exclusion of the users seal check 

may bias the data and this isn’t 

representative of how this procedure is 

normally done’’ (Ex. OSHA–2007–0006– 

0028). In response to the commenters, 

OSHA notes that the test subjects in the 

study used respirators that were one or 

two sizes too small or too large to ensure 

that a number of poor respirator fits 

occurred. This procedure induced poor 

facepiece-to-face seals, which caused 

the respirators to leak. These leaks, in 

turn, provided data for use in 

determining how effectively the 

proposed ABQLFT protocol detected 

such leaks. The authors of the ABQLFT 

study explained the absence of seal 

checks as follows: ‘‘Experience in this 

laboratory has shown that people who 

participate in fit tests on a frequent basis 

and who are allowed to perform user 

seal checks can adjust most respirators 

to fit well enough to pass a fit test 

(Janssen, 2002). For this reason, the 

subjects were instructed to adjust the 

facepiece until comfortable but were not 

permitted to perform a user seal check’’ 

(Ex. OSHA–2007–0006–0003). 

Therefore, OSHA concludes that 

removing seal checks from the study 

was necessary to obtain leakage data for 

use in determining the effectiveness of 

the proposed ABQLFT protocol. 

D. Conclusions 

Based on a complete and thorough 

review of the rulemaking record, OSHA 

concludes that: 

1. The study was well controlled, and 

conducted according to accepted 

experimental design practices and 

principles. 

2. The authors of the studies 

described in the submitted articles 

presented the the results properly, fully, 

and fairly in the context of the ANSI 

Z88.10–2001 consensus standard. 

3. The results generated by the 

proposed protocol provided 

reproducible fit-testing results, and the 

experiments and analyses were 

adequate for this purpose. 

4. The results for the proposed 

protocol were reliable, but OSHA can 

reach no conclusion regarding how the 

proposed protocol compares to other 

qualitative fit-testing protocols because 

the study did not make these 

comparisons. Additionally, the study 

did not demonstrate that the proposed 

protocol accurately determined fit for 

N95 filtering-facepiece respirators; 

therefore, OSHA could not approve the 

proposed protocol for fit testing this 

class of respirators. 

5. The test-sensitivity value of 0.92 

would increase substantially the 

number of employees who would pass 

the proposed protocol with improperly 

fitting respirators, thereby making the 

proposed protocol unacceptable for 

listing in Part I.B. of Appendix A of 

OSHA’s Respiratory Protection 

Standard. In addition, using binary 

logistic-regression analysis as a 

substitute for the sensitivity-test 

criterion in ANSI Z88.10–2001 is 

premature because the analysis requires 

additional validation. 

6. The results indicate that limiting 

the proposed protocol to test subjects 

who demonstrated Level 1 sensitivity to 

Bitrex® was appropriate. 

7. To ensure adequate respirator 

leakage, the study justifiably omitted 

seal checks from the experimental 

procedures. 

Additional validation testing of, or 

revisions to, the proposed ABQLFT 

protocol may provide new results for 

the protocol that meet or exceed the 

sensitivity-test criterion established by 

the ANSI Z88.10 consensus standard. 

After submitting these new results and 

supporting documentation to OSHA, 

OSHA would evaluate this information 

and, if appropriate, would submit it to 

the public for notice and comment. If 

the revised protocol is to apply to 

filtering-facepiece respirators, then the 

resubmission should include testing on 

these respirators demonstrating that the 


sroberts on PROD1PC70 with PROPOSALS
30256 Federal Register / Vol. 74, No. 121 / Thursday, June 25, 2009 / Proposed Rules 

revised protocol accurately identifies 

poor fit among test subjects who use 

them. 

List of Subjects in 29 CFR Part 1910 

Hazardous substances, Health, 

Occupational safety and health, Toxic 

substances. 

Authority and Signature 

Jordan Barab, 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 this notice 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 31160); and 29 CFR part 1911. 

Signed at Washington, DC, on June 22, 

2009. 

Jordan Barab, 

Acting Assistant Secretary of Labor for 

Occupational Safety and Health. 

[FR Doc. E9–14979 Filed 6–24–09; 8:45 am] 

BILLING CODE 4510–26–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket No. USCG–2009–0460] 

RIN 1625–AA08 

Special Local Regulation for Marine 

Events; Mattaponi River, Wakema, VA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard proposes to 

establish special local regulations 

during the ‘‘Mattaponi Madness Drag 

Boat Race Series,’’ a series of power boat 

races to be held on the waters of the 

Mattaponi River, near Wakema, 

Virginia. These special local regulations 

are necessary to provide for the safety of 

life on navigable waters during the 

events. This action is intended to 

restrict vessel traffic during the power 

boat races in a segment of the Mattaponi 

River that flows along the border of King 

William County and King and Queen 

County near Wakema, Virginia. 

DATES: Comments and related material 

must be received by the Coast Guard on 

or before July 27, 2009. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2009–0460 using any one of the 

following methods: 

(1) Federal eRulemaking Portal: 

http://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 

Federal holidays. The telephone number 

is 202–366–9329. 

To avoid duplication, please use only 

one of these four methods. See the 

‘‘Public Participation and Request for 

Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section 

below for instructions on submitting 

comments. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this proposed 

rule, call or e-mail Dennis Sens, Project 

Manager, Fifth Coast Guard District 

Prevention Division, Portsmouth, VA, 

telephone (757) 398–6204, e-mail 

Dennis.M.Sens@uscg.mil. If you have 

questions on viewing or submitting 

material to the docket, call Renee V. 

Wright, Program Manager, Docket 

Operations, telephone 202–366–9826. 

SUPPLEMENTARY INFORMATION: 

Public Participation and Request for 

Comments 

We encourage you to participate in 

this rulemaking by submitting 

comments and related materials. All 

comments received will be posted 

without change to http:// 

www.regulations.gov and will include 

any personal information you have 

provided. 

Submitting Comments 

If you submit a comment, please 

include the docket number for this 

rulemaking (USCG–2009–0460), 

indicate the specific section of this 

document to which each comment 

applies, and provide a reason for each 

suggestion or recommendation. You 

may submit your comments and 

material online (via http:// 

www.regulations.gov) or by fax, mail, or 

hand delivery, but please use only one 

of these means. If you submit a 

comment online via http:// 

www.regulations.gov, it will be 

considered received by the Coast Guard 

when you successfully transmit the 

comment. If you fax, hand delivery, or 

mail your comment, it will be 

considered as having been received by 

the Coast Guard when it is received at 

the Docket Management Facility. We 

recommend that you include your name 

and a mailing address, an e-mail 

address, or a telephone number in the 

body of your document so that we can 

contact you if we have questions 

regarding your submission. 

To submit your comment online, go to 

http://www.regulations.gov, select the 

Advanced Docket Search option on the 

right side of the screen, insert ‘‘USCG– 

2009–0460’’ in the Docket ID box, press 

Enter, and then click on the balloon 

shape in the Actions column. If you 

submit your comments by mail or hand 

delivery, submit them in an unbound 

format, no larger than 81⁄2 by 11 inches, 

suitable for copying and electronic 

filing. If you submit comments by mail 

and would like to know that they 

reached the Facility, please enclose a 

stamped, self-addressed postcard or 

envelope. We will consider all 

comments and material received during 

the comment period and may change 

the rule based on your comments. 

Viewing Comments and Documents 

To view comments, as well as 

documents mentioned in this preamble 

as being available in the docket, go to 

http://www.regulations.gov, select the 

Advanced Docket Search option on the 

right side of the screen, insert USCG– 

2009–0460 in the Docket ID box, press 

Enter, and then click on the item in the 

Docket ID column. You may also visit 

the Docket Management Facility in 

Room W12–140 on the ground floor of 

the Department of Transportation West 

Building, 1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. We have an 

agreement with the Department of 

Transportation to use the Docket 

Management Facility. 

Privacy Act 

Anyone can search the electronic 

form of comments received into any of 

our dockets by the name of the 

individual submitting the comment (or 

signing the comment, if submitted on 

behalf of an association, business, labor 

union, etc.). You may review a Privacy 

Act notice regarding our public dockets 

in the January 17, 2008 issue of the 

Federal Register (73 FR 3316). 

Public Meeting 

We do not now plan to hold a public 

meeting. But you may submit a request 

for one using one of the four methods 


sroberts on PROD1PC70 with PROPOSALS