\[Federal Register: June 6, 2003 (Volume 68, Number 109)\]

\[Proposed Rules\]

\[Page 33887-33894\]

From the Federal Register Online via GPO Access \[wais.access.gpo.gov\]

\[DOCID:fr06jn03-24\]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910

\[Docket No. H-049D\]

RIN 1218-AC05

Controlled Negative Pressure REDON **Fit** Testing Protocol

AGENCY: Occupational Safety and Health Administration (**OSHA**),

Department of Labor.

ACTION: Notice of proposed rulemaking and request for comments.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

SUMMARY: **OSHA** is proposing to approve an additional controlled
negative

pressure (CNP) **fit** testing protocol for its Respiratory Protection

Standard. The proposed protocol would affect **OSHA** respiratory

protection standards for shipyard employment and construction. The

proposed protocol is referred to as the CNP REDON **fit** testing
protocol.

Provisions contained in **OSHA**\'s current Respiratory Protection
Standard

allow individuals to propose additional **fit** testing protocols. This

proposed revision is based on a new quantitative **fit** testing
protocol

submitted to **OSHA** for addition to the standard.

The proposed protocol requires three different **test** exercises

followed by two

\[\[Page 33888\]\]

redonnings of the respirator, while the currently approved CNP protocol

specifies eight **test** exercises, including one redonning of the

respirator. In addition to amending the Respiratory Protection Standard

to include the proposed protocol, this rulemaking is proposing to make

several editorial and non-substantive technical revisions to this

standard associated with the proposed protocol and the approved CNP

protocol.

DATES: Submit written comments regarding this proposal, including

comments on the information-collection determination described in

section IV.C (Paperwork Reduction Act) of this notice, by the following

dates:

Hard copy. Submitted (postmarked or sent) by September 4, 2003.

Facsimile and electronic transmission. Sent by September 4, 2003.

Please see the section below entitled SUPPLEMENTARY INFORMATION for

additional information on submitting written comments.

ADDRESSES: Submit comments and attachments to comments using one of the

procedures described below:

Regular mail, express delivery, hand-delivery, and messenger

service. Submit three copies of written comments and attachments to the

**OSHA** Docket Office, Docket No. H-049D, Technical Data Center, Room
N-

2625, U.S. Department of Labor, 200 Constitution Ave., NW., Washington,

DC 20210; telephone (202) 693-2350. **OSHA** Docket Office and
Department

of Labor hours of operation are 8:15 a.m. to 4:45 p.m., EST.

Please note that security-related problems may result in

significant delays in receiving comments and other written materials by

regular mail. Telephone the **OSHA** Docket Office at (202) 693-2350 for

information regarding security procedures associated with delivery of

materials by express delivery, hand delivery, and messenger service.

Facsimile. Transmit written comments (including attachments)

consisting of 10 or fewer pages by facsimile to the **OSHA** Docket
Office

at (202) 693-1648. You must include the docket number of this notice,

Docket No. H-049D, in your comments.

Electronic. You may submit comments electronically through the

Internet on **OSHA**\'s Homepage at
[http://ecomments.**[osha]{.underline}**.gov](http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://ecomments.osha.gov).
If you would

like to submit additional studies or journal articles, you must submit

three copies of them to the **OSHA** Docket Office at the address above.

These materials must clearly identify your electronic comments by name,

date, subject, and docket number so we can attach them to your

comments.

All comments and submissions will be available for inspection and

copying in the **OSHA** Docket Office at the address above. Comments and

submissions posted on **OSHA**\'s web page will be available at
[http://www.**[osha]{.underline}**.gov](http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.osha.gov).

Contact the **OSHA** Docket Office at (202) 693-2350 for

information about materials not available on the **OSHA** web page and
for

assistance in using this web page to locate docket submissions. Because

comments sent to the docket or to **OSHA**\'s web page are available for

public inspection, the Agency cautions against including in these

comments personal information such as social security numbers and birth

dates.

FOR FURTHER INFORMATION CONTACT: For 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 or facsimile (202) 693-

1678\. Copies of this Federal Register notice are available from the

**OSHA** Office of Publications, Room N-3101, U.S. Department of Labor,
200

Constitution Avenue, NW., Washington DC 20210; telephone (202) 693-

1888\. For an electronic copy of this notice, go to **OSHA**\'s website

([http://www.**[osha]{.underline}**.gov](http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.osha.gov)),
and select \`\`Federal Register,\'\' \`\`Date of

Publication,\'\' and then \`\`2003.\'\'

SUPPLEMENTARY INFORMATION:

I. Background

The Respiratory Protection Standard currently includes three (3)

quantitative **fit** testing protocols: Generated aerosol **fit**
testing

protocol; ambient aerosol condensation nuclei counter (CNC) **fit**
testing

protocol; and controlled negative pressure (CNP) **fit** testing
protocol.

The standard specifies the procedure to be followed to add new **test**

protocols as they are developed and validated. The criteria for

determining that a **fit** testing protocol is valid 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. When a protocol

meets such criteria, **OSHA** conducts a notice-and-comment rulemaking

under Section 6(b)(7) of the Occupational Safety and Health Act of

1970\. **OSHA** believes the CNP REDON meets these criteria as described

below.

II\. Summary and Explanation of the Proposal

Introduction. In his letter submitting the protocol for review, Dr.

Crutchfield included copies of two peer-reviewed articles from

industrial hygiene journals describing the accuracy and reliability of

the CNP REDON **fit** testing protocol. (See Exs. 2 and 3; Section III

below provides complete reference information on these articles.) In

this submission, Dr. Crutchfield also described in detail the equipment

and procedures required to administer the proposed protocol. According

to this description, the proposed protocol is a variation of the

controlled negative pressure (CNP) **fit** testing protocol developed by

Dr. Crutchfield in the early 1990s, which **OSHA** approved for
inclusion

in Part I.C of Appendix A when the Agency developed the final

Respiratory Protection Standard. The proposed protocol uses the same

**fit** **test** requirements and **test** instrumentation specified for
the CNP

**fit** testing protocol in paragraphs (a) and (c) of Part I.C.4 of

Appendix A of this standard. However, the proposed protocol includes

only three **test** exercises followed by two redonnings of the
respirator,

instead of the eight **test** exercises and one respirator redonning

required in paragraph (b) of the CNP **fit** testing protocol. The three

tests, listed in order of administration, are normal breathing, bending

over, and head shaking. The procedures for administering these three

**test** exercises and the two respirator donnings to an employee, and
for

measuring respirator leakage during each **test**, are described below:

\[sbull\] Facing forward. In a normal standing position, without

talking, the **test** participant shall breathe normally; then, while

facing forward, he/she shall hold his/her breath for 10 seconds for

**test** measurement.

\[sbull\] Bending over. The **test** participant shall bend at the waist

as if he/she is going to touch his/her toes; then, while facing

parallel to the floor, he/she shall hold his/her breath for 10 seconds

for **test** measurement.

\[sbull\] Head shaking. The **test** participant shall shake his/her
head

back and forth vigorously several times while shouting for

approximately three seconds; then, while facing forward, he/she shall

hold his/her breath for 10 seconds for **test** measurement.

\[sbull\] First redonning (REDON-1). The **test** participant shall

remove and redon the respirator mask; after redonning the

\[\[Page 33889\]\]

mask, he/she shall face forward and hold his/her breath for 10 seconds

for **test** measurement.

\[sbull\] Second redonning (REDON-2). The **test** participant shall

remove and redon the respirator mask again; after redonning the mask,

he/she shall face forward and hold his/her breath for 10 seconds for

**test** measurement.

As noted earlier, Dr. Crutchfield submitted two peer-reviewed

journal articles that provided information on the accuracy and

reliability of the proposed CNP REDON **fit** testing protocol. In the

first of these articles, the most important conclusion made by the

authors is that the proposed CNP REDON **fit** testing protocol results
in

substantially lower respirator **fit** factors overall than the most

commonly used ambient aerosol (AA) **fit** testing protocol.
Accordingly,

lower **fit** factors indicate that the proposed protocol would detect
more

respirator leaks than the AA protocol, thereby providing employees with

an increased margin of safety when they select respirators. The main

conclusion reached by the authors in the second article is that the

overall **fit** factors obtained from the three exercises and two

redonnings required by the proposed protocol are the same as the

overall **fit** factors found when using the eight-exercise CNP protocol

described in the Respiratory Protection Standard. Therefore, compared

to the eight-exercise CNP protocol, the same overall **fit** factors can
be

obtained in less time using the proposed protocol.

Peer-reviewed articles. In the first peer-reviewed article,

entitled \`\`Effect of exercise and mask donning on measured respirator

**fit**\'\' and published in Applied Occupational and Environmental
Hygiene,

Dr. Crutchfield and his colleagues tested 14 Air Force personnel who

wore elastomeric full facepiece or half mask air purifying respirators

while being **fit** tested using either AA **fit** testing equipment
(the

Portacount Plus\[reg\], manufactured by TSI, Inc., St. Paul, MN) or CNP

**fit** testing equipment (FitTester 3000\[reg\], manufactured by

Occupational Health Dyanmics, Birmingham, AL) (Ex. 2). The study

participants wore their usual respirator mask for half of the tests

(mask 1), and a respirator mask that was either a size larger or

smaller than their usual mask for the other half of the tests (mask 2).

The purpose of using the second mask was to obtain poor respirator
**fit**

(i.e., to ensure respirator leakage on some of the tests). Each study

participant received three **fit** tests per day for five consecutive
days;

they removed and redonned the respirator between **fit** tests. During a

**fit** **test**, they engaged in one of two **test**-exercise
procedures. The

first procedure (procedure 1) consisted of the three **test** exercises

described in the proposed protocol (i.e., facing forward, bending over,

and head shaking), with no repeated donnings. The second procedure

(procedure 2) consisted of the following nine exercises (listed in

order of administration): Normal breathing; deep breathing; side-to-

side head turning (pausing to inhale at each extreme position); up-and-

down head nodding (pausing to inhale at each extreme position); talking

loudly (reading a standard passage, counting backward from 100, or

reciting a memorized poem or song ); grimacing (contracting the facial

muscles); bending over (as if touching the toes); jogging in place; and

normal breathing. Only the first AA **fit** **test** administered each
day with

each mask (1 and 2) used the second **test**-exercise procedure; the

remaining AA **fit** tests, and all of the CNP **fit** tests, used the
first

**test**-exercise procedure.

The authors used the AA **fit** **test** equipment to compare **fit**
factors

for both procedures 1 and 2 under the two mask conditions. This

comparison showed that, for mask 1, the log-transformed median overall

**fit** factor obtained under procedure 1 was significantly lower than
it

was for procedure 2, while no significant difference was found between

the procedures for mask 2. Additionally, the authors compared **fit**

factors obtained from the two types of **fit** **test** equipment (i.e.,
CNP

and AA) under procedure 1. Accordingly, they found that the log-

transformed median **fit** factors obtained using either type of
equipment

did not differ significantly among the three **test** exercises (i.e.,

facing forward, bending over, and head shaking) for mask 1. However,

for mask 2, the data obtained using both types of equipment showed that

the bending over **test** exercise resulted in a significantly lower
log-

transformed mean **fit** factor than was obtained using the normal

breathing **test** exercise.

Assessing the **fit** factors for procedure 2 using the AA **fit**
**test**

equipment, the authors found that the talking exercise resulted in a

significantly lower log-transformed mean **fit** factor than the **fit**
factor

determined using the normal breathing exercise for mask 1; for mask 2,

the log-transformed mean **fit** factors for both the talking and
bending

over exercises were significantly lower than the **fit** factor obtained

for the normal breathing exercise. A subsequent analysis showed that

the initial normal breathing exercise, as well as the bending over and

the head shaking exercises, accounted for most of the **fit** testing

failures. Finally, after collapsing the data across mask conditions and

exercise procedures, the authors found that the log-transformed median

**fit** factor for the CNP equipment was significantly lower than the
log-

transformed median **fit** factor for the AA equipment.

The authors concluded that the results obtained using the AA

equipment showed that the three exercises in procedure 1 were as

effective in determining poor mask **fit** as the nine exercises that

composed procedure 2. In reaching this conclusion, they specifically

discounted the talking exercise, which was assessed in this study using

only the AA equipment. In doing so, they asserted that the prolonged

exhalation associated with the talking exercise may increase particle

migration from the lungs to the sampling probe, which would cause the

probe to detect an increase in particle concentration; consequently,

the talking exercise likely results in artificially low **fit** factors.

They also concluded that CNP equipment used with the three exercises in

procedure 1 detected more poorly fitting masks than AA equipment used

with either exercise procedure. The authors noted as well that the

study participants took substantially less time to perform the three

exercises in procedure 1 than the nine exercises in procedure 2,

regardless of the type of equipment used.

The second peer-reviewed article, entitled \`\`A faster, more

rigorous protocol for **fit** testing emergency response respirators\'\'
and

published in Semiconductor Safety Association Journal, describes a

study in which 511 firefighters were **fit** tested for the Scott Model
AV-

2000 self-contained breathing apparatus using CNP **fit** testing
equipment

(Ex. 3). To detect respirator leakage, the authors converted the

respirator, which normally operates at positive pressure, to operate in

the negative pressure mode. During **fit** testing, the firefighters

performed one of two exercise procedures. The first exercise procedure

(procedure 1), administered to 407 firefighters, consisted of the full

complement of exercises described in the proposed protocol (i.e.,

facing forward, bending over, head shaking, and two mask redonnings).

The second procedure (procedure 2), administered to 104 of the

firefighters, replicated the CNP **test** exercises listed in Part
I.4(b)

of Appendix A in the Respiratory Protection Standard, including (listed

in order of administration): Normal breathing; deep breathing; side-to-

side head turning (pausing to inhale at each extreme position); up-and-

down head nodding (pausing to inhale at each

\[\[Page 33890\]\]

extreme position); talking (reading a standard passage, counting

backward from 100, or reciting a memorized poem or song); grimacing

(contracting the facial muscles); bending over (as if touching the

toes); and breathing normally (remove and redon the respirator mask,

then breathe normally). In addition, the authors used a short screening

procedure to identify firefighters who could not pass the a complete

**fit** testing protocol. Eighty-five (85) of the firefighters in
procedure

1 (20.9%) and 30 of the firefighters in procedure 2 (28.8%) did not

pass this screening **test**.

Comparisons among the firefighters who completed a **fit** testing

protocol showed that the log-transformed median overall **fit** factor
did

not vary significantly between the two exercise procedures. However,

after plotting the overall **fit** factors of the individual
firefighters

for the two exercises (i.e., one plot for each exercise), the authors

noted that the overall **fit** factors for procedure 1 were
substantially

less than the **fit** factors for procedure 2 at the low end of the two

distributions. They interpreted this difference as indicating that the

**fit** factors obtained using procedure 1 were more conservative (i.e.,

lower) than the **fit** factors obtained for procedure 2 at lower levels
of

respirator **fit**. Based on these results, the authors concluded that
the

two exercise procedures resulted in similar **fit** factors, and that

procedure 1, with three exercises and two respirator redonnings, took

substantially less time to administer than procedure 2, with eight

exercises (including one redonning).

Editorial and technical revisions to the Respiratory Protection

Standard. In addition to proposing the CNP REDON **fit** testing
protocol,

this rulemaking is proposing to make several editorial and technical

revisions to the Respiratory Protection Standard. The first editorial

revision would add the proposed CNP REDON protocol to the exception

already specified for the approved CNP protocol under paragraph 14(a)

of Part I.A in Appendix A of the Standard. Accordingly, paragraph 14(a)

would except both the approved CNP protocol and the CNP REDON protocol

from the **test** exercises specified for the other approved **fit**
testing

protocols listed in the appendix. **OSHA** believes that this revision
is

necessary because the proposed protocol consists of a **test** exercise

procedure that differs substantially from the procedure required for

the other approved **fit** testing protocols.

The second editorial revision involves the introductory paragraph

describing the CNP protocol under Part I.C.4 of Appendix A. The eighth

sentence in this paragraph refers to the CNP instrument manufacturer as

\`\`Dynatech Nevada.\'\' However, the instrument manufacturer now is

Occupational Health Dynamics of Birmingham, Alabama. **OSHA** is
proposing

to revise this sentence to identify the current manufacturer of this

instrument.

In an earlier comment to **OSHA** (Ex. 14), Dr. Crutchfield noted that

**test** administrators use either an auditory warning device or the
screen

tracing currently provided on the CNP **test** instrument to detect

participants\' failure to hold their breath for the required 10-second

period when measuring respirator **fit**. While using the screen tracing

for this purpose was not part of the CNP protocol approved earlier by

**OSHA**, the Agency believes that such a visual warning device would be

useful in measuring respirator **fit** under both the approved CNP
protocol

and the proposed CNP REDON protocol. Therefore, **OSHA** is proposing to

revise paragraph (c) of the approved CNP protocol (under Part I.A.4 of

the standard) to include the screen tracing currently provided on the

CNP **test** instrument as a visual warning device to detect
non-compliance

with the breath hold procedure.

In a 1998 journal article entitled \`\`CNP **fit** testing under
**OSHA**\'s

updated respiratory protection standard\'\' published in Respiratory

Protection Update, Dr. Crutchfield indicated that **OSHA**\'s
description of

the CNP **fit** **test** requirements in paragraphs (a)(2) and (a)(5) of
the

approved CNP protocol contained several errors (Ex. 8). In this regard,

the default **test** pressure in paragraph (a)(2) should read -15 (not -

1.5) mm of water, while the breath hold requirement in paragraph (a)(5)

should be 10 (not 20) seconds. Accordingly, the Agency is proposing to

revise these parameters because implementing correct **fit** **test**

procedures will improve the assessment of respirator **fit** factors
using

the approved CNP protocol, as well as the proposed CNP REDON protocol

should the Agency approve it in a final rulemaking.

Conclusions. **OSHA** believes that the information submitted by Dr.

Crutchfield in support of the proposed protocol meets the criteria for

proposed **fit** testing protocols established by the Agency in Part II
of

Appendix A of the Respiratory Protection Standard. Therefore, the

Agency concludes that the proposed protocol warrants notice-and-comment

rulemaking under Section 6(b)(7) of the OSH Act, and is initiating this

rulemaking to determine whether to approve the proposed protocol for

inclusion in Part I of Appendix A of the standard. However, because the

only difference between the proposed protocol and the existing CNP

protocol in Part I.C.4 of Appendix A is the exercise procedure used

during **fit** testing, the Agency is limiting the proposed regulatory
text

(see section V below) to a description of the exercise procedure, and

is referring to paragraphs (a) and (c) of Part I.C.4 for information on

the CNP **fit** **test** requirements and the CNP **test** instrument.
In addition,

if approved, the protocol would be an alternative to the existing

quantitative **fit** testing protocols already listed in the Part I of

Appendix A; employers would be free to select this alternative or to

continue using any of the other protocols currently listed in the

appendix. The Agency also believes that the proposed editorial and

technical revisions to Part I of Appendix A are necessary for proper

implementation of both the approved CNP protocol and the proposed CNP

REDON protocol.

Issues for public comment. **OSHA** invites comments and data from the

public regarding the accuracy and reliability of the CNP REDON

protocol, as well as its effectiveness in detecting respirator leakage

and its usefulness in selecting respirators that will protect employees

from airborne contaminants in the workplace. Specifically, the Agency

invites public comment on the following issues:

\[sbull\] Were the studies described in the peer-reviewed articles

well controlled, and conducted according to accepted experimental

design practices and principles?

\[sbull\] Were the results of the studies described in the peer-

reviewed articles properly, fully, and fairly presented and

interpreted?

\[sbull\] Will the proposed protocol reliably identify respirators

with unacceptable **fit** as effectively as the quantitative **fit**
testing

protocols already listed in Part I.C of Appendix A of the Respiratory

Protection Standard?

\[sbull\] Will the proposed protocol generate reproducible **fit**

testing results?

\[sbull\] Should **OSHA** expand application of the proposed protocol
**fit**

**test** exercises to other quantitative **fit** tests (e.g., ambient
aerosol

tests)?

\[sbull\] Will the proposed editorial and technical revisions to Part

I of Appendix A improve proper implementation of the approved CNP

protocol and the proposed CNP REDON protocol?

III\. References

The preamble to this proposal cites the following references:

\(1\) Crutchfield C.D., E.O. Fairbank, and S.L. Greenstein. \`\`Effect

of exercise

\[\[Page 33891\]\]

and mask donning on measured respirator **fit**.\'\' Applied
Occupational and

Environmental Hygiene, vol. 14 (no. 12), pages 827-837, 1999. (See Ex.

2.)

\(2\) Crutchfield, C.D., W.F. Peate, and D.W. Kautz. \`\`A faster, more

rigorous protocol for **fit** testing emergency response
respirators.\'\'

Semiconductor Safety Association Journal,\\1\\ vol. 13 (no. 4), pages
23-

29, 1999. (See Ex. 3.)

Copies of these references are available from the **OSHA**\'s Docket

Office, Room N-2625, U.S. Department of Labor, 200 Constitution Avenue,

N.W., Washington, DC 20210; telephone (202) 693-2350 or facsimile (202)

693-1648.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\\1\\ Now the Semiconductor Environmental Safety and Health

Association Journal.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

IV\. Procedural Determinations

A. Legal Considerations

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. For this proposal, the Agency

preliminarily determined that the new CNP **fit** testing protocol
provides

employees with protection that is comparable to the protection afforded

to them by the existing **fit** testing provisions. In this regard, the

proposal is not expected to replace existing **fit** testing protocols,
but

instead would be an alternative 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 for **fit** testing respirators for employee use.

B. Preliminary Economic Analysis and Regulatory Flexibility

Certification

The proposal is not a significant rulemaking under Executive Order

12866, or a \`\`major rule\'\' under the Unfunded Mandates Reform Act of

1995 (2 U.S.C. 1501) or Section 801 of the Small Business Regulatory

Enforcement Fairness Act of 1996 (5 U.S.C. 601). 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 the Executive Order or relevant statutes.

The proposal offers employers an additional option to **fit** **test**

their employees for respirator use. In addition to the existing CNP

protocol, which would continue to be an option, the Agency would add

the CNP REDON protocol as a supplemental option. According to a recent

NIOSH-BLS survey of respirator use, approximately 25,000 establishments

currently use the existing CNP **fit** testing protocol out of some
282,000

establishments requiring respirator use (Ex. 6-3, Docket H-049C).

Employers would have a choice between the existing protocol consisting

of eight exercises, including one redonning of the respirator, or the

new protocol, which involves three exercises and two redonnings of the

respirator. By providing regulatory flexibility to these employers, the

proposal may reduce their costs in terms of decreasing **fit** testing

time. In this regard, **OSHA** assumes that the proposed CNP REDON
protocol

would be adopted by some employers who use the existing CNP protocol,

as well as some employers who are purchasing new or replacement

equipment for administering **fit** tests; these employers would adopt
the

proposed protocol because it consists of fewer exercises than the

existing CNP and ambient aerosol protocols, thereby decreasing the time

and cost required for **fit** testing. However, the Agency believes that

the proposed protocol is unlikely to be adopted by employers who

currently use the ambient aerosol protocols because of the equipment

and training investment they have already made to administer these

protocols. Finally, the Agency proposes to include the screen tracing

in the existing and proposed CNP **fit** testing protocols as a visual

warning device to detect non-compliance with the breath hold procedure.

**OSHA** concludes that this proposal would add no additional cost
burden

to employers because, as noted earlier, the manufacturer already

provides this capability on the CNP **test** equipment. Therefore, the

Agency preliminarily concludes that this proposed rulemaking would

impose no additional costs on these employers. Consequently, the

proposal requires no Preliminary Economic Analysis. Furthermore,

because the proposal imposes no costs on employers, **OSHA** certifies
that

it would not have a significant impact on a substantial number of small

businesses. Accordingly, the Agency need not prepare an Initial

Regulatory Flexibility Analysis.

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 the existing

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 strip chart recording or other recording
of

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 protocol

instead. Therefore, use of the proposed **fit** testing protocol in the

context of the existing **fit** testing protocols does not require an

additional paperwork burden determination because **OSHA** already

accounted for this burden during the final rulemaking for the

Respiratory Protection Standard (see 63 FR 1152-1154; OMB Control

Number 1218-0099).

Interested parties who wish to comment on **OSHA**\'s determination that

the proposed **fit** testing protocol contains no additional paperwork

requirements compared to the existing paperwork requirements must send

their written comments to the Office of Information and Regulatory

Affairs, Attn: OMB 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 their comments on this

paperwork determination 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 on Federalism (Executive Order 13132, 64 FR 43225,

August 10, 1999). This Executive Order 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 Executive Order allows

Federal agencies to preempt state law

\[\[Page 33892\]\]

only with the expressed consent of Congress. In such cases, Federal

agencies must limit preemption of state law to the extent possible.

Under section 18 of the Occupational Safety and Health Act of 1970

(OSH Act), Congress 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 OSH Act.

Accordingly, section 18 of the OSH 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

(i.e., is a State-plan State). (See Gade v. National Solid Wastes

Management Association, 112 S. Ct. 2374 (1992).) Therefore, with

respect to states that do not have **OSHA**-approved plans, the Agency

concludes that this proposal conforms to the preemption provisions of

the OSH Act. Additionally, section 18 of the OSH 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.

**OSHA** has authority under Executive Order 13132 to propose adding

the CNP REDON **fit** testing protocol to its Respiratory Protection

Standard at 29 CFR 1910.134 because the problems addressed by these

requirements are national in scope. In this regard, the proposal offers

hundreds of thousands of employers across the nation an opportunity to

adopt an additional protocol to use in assessing 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 in paragraph (f) of **OSHA**\'s Respiratory

Protection Standard.

Should **OSHA** adopt the proposed **fit** testing protocol in a final

rulemaking, section 18(c)(2) of the OSH Act (29 U.S.C. 667(c)(2))

requires State-plan States to adopt the same protocol, or develop an

alternative that is at least as effective as that protocol. However,

compliance with the new **fit** testing protocol would only provide

employers with an alternative to the existing requirements for **fit**

testing protocols specified in its Respiratory Protection Standard;

therefore, the alternative is not, itself, a mandatory standard.

Accordingly, State-plan States are not obligated to adopt the final

provisions that result from this rulemaking. Nevertheless, **OSHA**

strongly encourages them to adopt the final provisions to provide

compliance options to employers in their states.

E. State Plans

The Agency strongly encourages the 24 states and two territories

with their own **OSHA**-approved occupational safety and health plans to

revise their current Respiratory Protection Standard should the Agency

adopt the proposed **fit** testing protocol based on this rulemaking.
**OSHA**

believes that such a revision would provide employers in the State-plan

States with any economic benefits that may accrue from its enactment,

while protecting the safety and health of employees who use respirators

against airborne hazardous substances in the workplace. These states

and territories 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, Virgin Islands, Washington, and Wyoming.

Connecticut, New Jersey, and New York have **OSHA**-approved State Plans

that apply to state and local government employees only.

F. Unfunded Mandates

**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\. As discussed above in section IV.B (Preliminary Economic

Analysis and Regulatory Flexibility Certification) of this preamble,

the Agency has 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 employers.

**OSHA** standards do not apply to state and local governments, except

in states that have voluntarily elected to adopt a State Plan approved

by the Agency. Consequently, the proposal does not meet the definition

of a \`\`Federal intergovernmental mandate\'\' (see section 421(5) of
the

UMRA (2 U.S.C. 658(5)). In conclusion, the proposal does not mandate

that state, local, and tribal governments adopt new, unfunded

regulatory obligations.

G. Applicability of Existing Consensus Standards

When **OSHA** promulgated its original respirator **fit** testing
protocols

on January 8, 1998 under Appendix A of its final Respiratory Protection

Standard (29 CFR 1910.134), no national consensus standards addressed

these protocols. However, the American National Standards Institute

(ANSI) subsequently developed a national consensus standard on **fit**

testing protocols as an adjunct to its respiratory protection program,

ANSI Z88.2-1992. ANSI approved this national consensus standard,

entitled \`\`Respirator **Fit** Testing Methods,\'\' on June 8, 2001 as
ANSI

Z88.10-2001.

Paragraph 7.3 of ANSI Z88.10-2001 provides the requirements for

conducting the CNP **fit** **test**, including requirements for **test**

instrumentation and administering the **fit** **test**; these
requirements are

consistent with the CNP **fit** **test** requirements specified in 1998
by **OSHA**

in Part I.C.4 of its Respiratory Protection Standard. In addition,

section 9 and Table 1 of ANSI Z88.10-2001 describe the exercises

required during CNP **fit** testing; these required exercises duplicate
the

exercises described in this CNP REDON proposal, except that the second

respirator redonning is optional under the ANSI standard.\\2\\ However,

paragraph 9.2 of the ANSI standard specifies that one optional exercise

must be included with the required exercises.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\\2\\ Other optional exercises include deep breathing, side-to-

side head movement, up-and-down head movement, stepping up and down,

a second normal breathing exercise, grimacing followed by normal

breathing, painter or sand-blaster movements, and other job-specific

movements.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

**OSHA** concludes that the CNP REDON **fit** testing protocol proposed
in

this rulemaking closely matches the requirements of the recent ANSI

Z88.10-2001 standard. The proposed CNP REDON protocol relies on the CNP

**test** procedures and instrumentation described in paragraphs (a) and
(c)

of Part I.C.4 in Appendix A of the Respiratory Protection Standard,

which are similar to requirements specified in paragraph 7.3 of the

ANSI standard. Any differences between these **OSHA** requirements and
the

provisions of the ANSI standard appear to be minor. In addition, the

**fit** testing exercises in the proposed CNP REDON protocol are the
same

exercises in the ANSI standard when a second respirator redonning is

selected as the optional exercise.

\[\[Page 33893\]\]

H. Review of the Proposed Standard by the Advisory Committee for

Construction Safety and Health (ACCSH)

This proposal would revise Part I.C of Appendix A of **OSHA**\'s current

Respiratory Protection Standard (29 CFR 1910.134) by including the CNP

REDON protocol with the three **fit** testing protocols already approved
by

the Agency, and would also make several technical revisions to the

approved CNP protocol. Accordingly, this proposal would revise the
**fit**

testing requirements specified by the Respiratory Protection Standard

for the construction industry (see 29 CFR 1926.103).

**OSHA**\'s regulation governing the Advisory Committee on Construction

Safety and Health (ACCSH) at 29 CFR 1912.3 requires the Agency to

consult with the ACCSH whenever the Agency proposes a rulemaking that

involves the occupational safety and health of construction employees.

**OSHA** met with the ACCSH and described the CNP proposed rule at the

ACCSH meeting on December 5, 2002. The ACCSH members had no questions

or comments on this proposal at this meeting. Subsequently, **OSHA**

distributed the proposed CNP rule to the ACCSH membership for their

review prior to their next regular meeting on May 22, 2003. **OSHA**
staff

discussed the CNP proposal and answered questions from the ACCSH

members during their meeting on May 22, 2003. The ACCSH then

recommended that **OSHA** proceed with publishing the proposal.

I. Public Participation

The Agency requests members of the public to submit written

comments and other information concerning this proposal. These comments

may include objections to the proposal, as well as comments that

endorse or support the proposed amendment set forth in this notice.

**OSHA** welcomes such comments and information so that the record of
this

rulemaking will represent a balanced public response on the issues

involved. (See the sections above titled DATES and ADDRESSES for

information on submitting these comments and information to the

Agency.) Submissions received within the specified comment period will

become part of the record, and will be available for public inspection

and copying in the **OSHA** Docket Office.

J. List of Subjects in 29 CFR Part 1910

Hazardous substances; Health; Occupational safety and health;

Quantitative **fit** testing; Respirators; Respirator selection.

K. Authority and Signature

John L. Henshaw, 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 107, Contract Work Hours and Safety Standards Act.

(Construction Safety Act; 40 U.S.C. 333); Section 41, Longshore and

Harbor Worker\'s Compensation Act (33 U.S.C. 941); Secretary of

Labor\'s Order No. 5-2002 (67 FR 65008); and 29 CFR part 1911.

Signed at Washington, DC on May 28, 2003.

John L. Henshaw,

Assistant Secretary of Labor.

V. Proposed Amendment to Standard

For the reasons stated 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 107,

Contract Work Hours and Safety Standards Act (the Construction

Safety Act; 40 U.S.C. 333); 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), or 5-2002 (67 FR

65008), 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\. Appendix A to Sec. 1910.134 is amended as follows in Part I:

A. In Section A, revise the introductory text of paragraph 14(a);

B. In Section C, paragraph 4, 8th sentence, remove the name

\`\`Dynatech Nevada\'\' and add, in its place, \`\`Occupational Health

Dynamics of Birmingham, Alabama.\'\'

C. In Section C, paragraphs 4(a)(2) and (5) are revised.

D. In Section C, paragraph 4(c)(1) is revised.

E. In Section C, paragraph 5 is added at the end of Part I.

The revised and added text reads as follows:

Sec. 1910.134 Respiratory protection.

\* \* \* \* \*

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

\* \* \* \* \*

Part I. **OSHA**\--Accepted **Fit** Testing Protocols

A. **Fit** Testing Procedures\--General Requirements

\* \* \* \* \*

14\. **Test** Exercises. (a) Employers shall perform the following

**test** exercises for all **fit** testing methods prescribed in this

appendix, except for the CNP quantitative **fit** testing protocol and

the CNP REDON quantitative **fit** testing protocol. For these two

protocols, employers shall ensure that the **test** subjects (i.e.,

employees) perform the exercise procedure specified in Part I.C.4(b)

of this appendix for the CNP quantitative **fit** testing protocol, or

the exercise procedure described in Part I.C.5(b) of this appendix

for the CNP REDON quantitative **fit** testing protocol. For the

remaining **fit** testing methods, employers shall ensure that the
**test**

exercises are performed in the appropriate **test** environment in the

following manner:

\* \* \* \* \*

C. \* \* \*

\* \* \* \* \*

\(a\) \* \* \*

\* \* \* \* \*

\(2\) The CNP system default selected for **test** pressure shall be

set at -15.0 mm (-0.58 inches) of water, and the modeled inspiratory

flow rate shall be 53.8 liters per minute for performing **fit** tests.

\* \* \* \* \*

\(5\) The **test** subject shall be trained to hold his/her breath for

at least 10 seconds.

\* \* \* \* \*

\(c\) \* \* \*

\(1\) The **test** instrument shall have an effective audio warning

device, or a visual warning device in the form of a screen tracing,

that indicates when the **test** subject fails to hold his/her breath

during the **test**. The **test** shall be terminated if the **test**
subject

fails to hold his/her breath during the **test**. The **test** subject
then

may be refitted and retested.

\* \* \* \* \*

5\. Controlled negative pressure (CNP) REDON quantitative **fit**

testing protocol.

\(a\) When administering this protocol to **test** subjects, employers

shall comply with the requirements specified in paragraphs (a) and

\(c\) of Part I.C.4 of this appendix (Controlled negative pressure

(CNP) quantitative **fit** testing protocol), except they may use the

**test** exercises described below in paragraph (b) of this protocol

instead of the **test** exercises specified in paragraph (b) of Part

I.C.4 of this appendix.

\(b\) Employers shall ensure that each **test** subject being **fit**

tested using this protocol follows the exercise and measurement

procedures, including the order of administration, described below

in Table A-1 of this appendix.

\[\[Page 33894\]\]

Table A-1.\--CNP REDON Quantitative **Fit** Testing Protocol

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

Measurement

Name of exercise \\1\\ Exercise procedure procedure

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

Facing Forward\...\...\...\..... Stand and breathe Face forward while

normally, without holding breath for

talking. 10 seconds.

Bending Over\...\...\...\...\.... Bend at the waist as Face parallel to
the

if going to touch floor while holding

his/her toes. breath for 10

seconds.

Head Shaking\...\...\...\...\.... For about three Face forward while

seconds, shake head holding breath for

back and forth 10 seconds.

vigorously several

times while

shouting.

REDON-1\...\...\...\...\...\...\... Remove and redon the Face forward
while

respirator mask. holding breath for

10 seconds.

REDON-2\...\...\...\...\...\...\... Remove and redon the Face forward
while

respirator mask holding breath for

again. 10 seconds.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\\1\\ Exercises are listed in the order in which they are to be

administered.

\(c\) After completing the **test** exercises, the **test**
administrator

shall question each **test** subject regarding the comfort of the

respirator. If the **test** subject states that the respirator is

unacceptable, the employer shall ensure that the **test** administrator

repeats the protocol using another respirator model.

\(d\) When calculating the overall **fit** factor for each **test**

subject, employers shall determine the harmonic mean of the **fit**

factors measured for each **test** exercise.

\[FR Doc. 03-13748 Filed 6-5-03; 8:45 am\]

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